Rationale and design of PRIMA II: A multicenter, randomized clinical trial to study the impact of in-hospital guidance for acute decompensated heart failure treatment by a predefined NT-PRoBNP target on the reduction of readmIssion and Mortality rAtes.

PubMed

Stienen, Susan; Salah, Khibar; Moons, Andreas H M; Bakx, Adrianus L M; van Pol, Petra E; Schroeder-Tanka, Jutta M; Voogel, Albertus J; Keijer, Jan T; Kortz, R A Mikael; Dickhoff, Cathelijne; Meregalli, Paola G; Tijssen, Jan G; Pinto, Yigal M; Kok, Wouter E

2014-07-01

Hospital admissions for acute decompensated heart failure (ADHF) are frequent and are accompanied by high percentages of mortality and readmissions. Brain natriuretic peptide (BNP) and the inactive N-terminal fragment of its precursor proBNP (NT-proBNP) are currently the best predictors of prognosis in heart failure (HF) patients. In the setting of chronic HF, studies that performed guidance of therapy by NT-proBNP have had only limited success. For patients with ADHF, retrospective studies have shown that a reduction in NT-proBNP of ≤30% during admission is a significant predictor of HF readmissions and mortality. These data suggest a role for NT-proBNP guidance in the setting of ADHF admissions. The PRIMA II is an investigator-initiated, multicenter, randomized, controlled, prospective 2-arm trial that investigates the impact of inhospital guidance for ADHF treatment by a predefined NT-proBNP target (>30% reduction during admission) on the reduction of readmission and mortality rates within 180 days. Consenting ADHF patients with NT-proBNP levels of >1,700 ng/L are eligible. After achieving clinical stability, a total of 340 patients are randomized to either NT-proBNP-guided or conventional treatment (1:1). The primary end point is dual, that is, a composite of all-cause mortality and readmission for HF in 180 days and the number of days alive out of hospital in 180 days. Secondary end points are readmissions and/or mortality in 180 days, cost effectiveness of hospitalization days in 180 days, readmissions and mortality in 90 days, and quality of life. The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF. Copyright © 2014 Mosby, Inc. All rights reserved.

Rationale and Design of the "Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) Trial:" A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Combined Diuretic Therapy (Loop Diuretics With Thiazide-Type Diuretics) Among Patients With Decompensated Heart Failure.

PubMed

Trullàs, Joan Carles; Morales-Rull, José Luís; Casado, Jesús; Freitas Ramírez, Adriana; Manzano, Luís; Formiga, Francesc

2016-07-01

Fluid overload refractory to loop diuretic therapy can complicate acute or chronic heart failure (HF) management. The Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) trial (Clinicaltrials.gov identifier NCT01647932) will test the hypothesis that blocking distal tubule sodium reabsorption with hydrochlorothiazide can antagonize the renal adaptation to chronic loop diuretic therapy and improve diuretic resistance. CLOROTIC is a randomized, placebo-controlled, double-blind, multicenter study. Three hundred and four patients with decompensated HF will be randomly assigned to receive hydrochlorothiazide or placebo in addition to a furosemide regimen. The main inclusion criteria are: age ≥18 years, history of chronic HF (irrespective of etiology and/or ejection fraction), admission for acute decompensation, and previous treatment with an oral loop diuretic for at least 1 month before randomization. The 2 coprimary endpoints are changes in body weight and changes in patient-reported dyspnea during hospital admission. Morbidity, mortality, and safety aspects will also be addressed. CLOROTIC is the first large-scale trial to evaluate whether the addition of a thiazide diuretic (hydrochlorothiazide) to a loop diuretic (furosemide) is a safe and effective strategy for improving congestive symptoms resulting from HF. This trial will provide important information and will therefore have a major impact on treatment strategies and future trials in these patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

PubMed

Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

2008-01-07

Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

Repeated Melatonin Supplementation Improves Sleep in Hypertensive Patients Treated with Beta-Blockers: A Randomized Controlled Trial

PubMed Central

Scheer, Frank A.J.L.; Morris, Christopher J.; Garcia, Joanna I.; Smales, Carolina; Kelly, Erin E.; Marks, Jenny; Malhotra, Atul; Shea, Steven A.

2012-01-01

Study Objectives: In the United States alone, approximately 22 million people take beta-blockers chronically. These medications suppress endogenous nighttime melatonin secretion, which may explain a reported side effect of insomnia. Therefore, we tested whether nightly melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers. Design: Randomized, double-blind, placebo-controlled, parallel-group design. Setting: Clinical and Translational Research Center at Brigham and Women’s Hospital, Boston. Patients: Sixteen hypertensive patients (age 45-64 yr; 9 women) treated with the beta-blockers atenolol or metoprolol. Interventions: Two 4-day in-laboratory admissions including polysomnographically recorded sleep. After the baseline assessment during the first admission, patients were randomized to 2.5 mg melatonin or placebo (nightly for 3 weeks), after which sleep was assessed again during the second 4-day admission. Baseline-adjusted values are reported. One patient was removed from analysis because of an unstable dose of prescription medication. Measurements and Results: In comparison with placebo, 3 weeks of melatonin supplementation significantly increased total sleep time (+36 min; P = 0.046), increased sleep efficiency (+7.6%; P = 0.046), and decreased sleep onset latency to Stage 2 (-14 min; P = 0.001) as assessed by polysomnography. Compared with placebo, melatonin significantly increased Stage 2 sleep (+41 min; P = 0.037) but did not significantly change the durations of other sleep stages. The sleep onset latency remained significantly shortened on the night after discontinuation of melatonin administration (-25 min; P = 0.001), suggesting a carryover effect. Conclusion: n hypertensive patients treated with beta-blockers, 3 weeks of nightly melatonin supplementation significantly improved sleep quality, without apparent tolerance and without rebound sleep disturbance during withdrawal of melatonin supplementation (in fact, a positive carryover effect was demonstrated). These findings may assist in developing countermeasures against sleep disturbances associated with beta-blocker therapy. Clinical Trial Information: his study is registered with ClinicalTrials.gov, identifier: NCT00238108; trial name: Melatonin Supplements for Improving Sleep in Individuals with Hypertension; URL: http://www.clinicaltrials.gov/ct2/show/NCT00238108. Citation: Scheer FAJL; Morris CJ; Garcia JI; Smales C; Kelly EE; Marks J; Malhotra A; Shea SA. Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers: a randomized controlled trial. SLEEP 2012;35(10):1395-1402. PMID:23024438

Effect of Systematic Intensive Care Unit Triage on Long-term Mortality Among Critically Ill Elderly Patients in France: A Randomized Clinical Trial.

PubMed

Guidet, Bertrand; Leblanc, Guillaume; Simon, Tabassome; Woimant, Maguy; Quenot, Jean-Pierre; Ganansia, Olivier; Maignan, Maxime; Yordanov, Youri; Delerme, Samuel; Doumenc, Benoit; Fartoukh, Muriel; Charestan, Pierre; Trognon, Pauline; Galichon, Bertrand; Javaud, Nicolas; Patzak, Anabela; Garrouste-Orgeas, Maïté; Thomas, Caroline; Azerad, Sylvie; Pateron, Dominique; Boumendil, Ariane

2017-10-17

The high mortality rate in critically ill elderly patients has led to questioning of the beneficial effect of intensive care unit (ICU) admission and to a variable ICU use among this population. To determine whether a recommendation for systematic ICU admission in critically ill elderly patients reduces 6-month mortality compared with usual practice. Multicenter, cluster-randomized clinical trial of 3037 critically ill patients aged 75 years or older, free of cancer, with preserved functional status (Index of Independence in Activities of Daily Living ≥4) and nutritional status (absence of cachexia) who arrived at the emergency department of one of 24 hospitals in France between January 2012 and April 2015 and were followed up until November 2015. Centers were randomly assigned either to use a program to promote systematic ICU admission of patients (n=1519 participants) or to follow standard practice (n=1518 participants). The primary outcome was death at 6 months. Secondary outcomes included ICU admission rate, in-hospital death, functional status, and quality of life (12-Item Short Form Health Survey, ranging from 0 to 100, with higher score representing better self-reported health) at 6 months. One patient withdrew consent, leaving 3036 patients included in the trial (median age, 85 [interquartile range, 81-89] years; 1361 [45%] men). Patients in the systematic strategy group had an increased risk of death at 6 months (45% vs 39%; relative risk [RR], 1.16; 95% CI, 1.07-1.26) despite an increased ICU admission rate (61% vs 34%; RR, 1.80; 95% CI, 1.66-1.95). After adjustments for baseline characteristics, patients in the systematic strategy group were more likely to be admitted to an ICU (RR, 1.68; 95% CI, 1.54-1.82) and had a higher risk of in-hospital death (RR, 1.18; 95% CI, 1.03-1.33) but had no significant increase in risk of death at 6 months (RR, 1.05; 95% CI, 0.96-1.14). Functional status and physical quality of life at 6 months were not significantly different between groups. Among critically ill elderly patients in France, a program to promote systematic ICU admission increased ICU use but did not reduce 6-month mortality. Additional research is needed to understand the decision to admit elderly patients to the ICU. clinicaltrials.gov Identifier: NCT01508819.

Comorbidity, hospitalization, and medication use and their influence on mental and motor development of young infants with Down syndrome.

PubMed

van Trotsenburg, A S Paul; Heymans, Hugo S A; Tijssen, Jan G P; de Vijlder, Jan J M; Vulsma, Thomas

2006-10-01

Young infants with Down syndrome have an increased occurrence of several well-known medical conditions such as congenital heart and gastrointestinal disease. The aim of this study was to establish consequences like hospitalization and medication use rates and to determine their possible influence on early neurodevelopment. This study compared 2 years of thyroxine treatment with placebo in 196 neonates with Down syndrome who were included in a previously reported randomized clinical trial. Parents were interviewed about comorbidity, hospitalization, and medication use at random assignment and regularly thereafter. Data were cross-checked with discharge letters when available. The influence of comorbidity on neurodevelopment at 2 years old (Bayley Scales of Infant Development II) was determined by stepwise multiple linear-regression analysis. Before trial entry, 163 infants with Down syndrome had been admitted to hospital for an average of 14.01 days, whereas during the trial, 95 of 181 infants who completed the trial were hospitalized for an average 19.75 days. Main hospitalization reasons during the trial were lung/airway and congenital heart and gastrointestinal disease. The 48 infants operated on for heart or gastrointestinal disease accounted for 1401 of the total number of 1876 hospital admission days during the trial and for 33 of 62 admissions for lung/airway infection. During their second year of life, approximately 60% of the infants were prescribed drugs, mostly antibiotics and pulmonary. Regression analysis showed infantile spasms, "other" central nervous system disease, and gastrointestinal disease necessitating surgery to be associated with greater developmental age delays at 24 months old (mental: 6.87, 3.52, and 1.69 months; and motor: 3.59, 2.54, and 1.68 months, respectively). Hospital admission and medication use rates in young infants with Down syndrome are still very high, mainly because of congenital heart and gastrointestinal disease and acquired respiratory disease. Central nervous system disease and gastrointestinal disease necessitating surgery were independently associated with a worse developmental outcome.

Hospital costs for treatment of acute heart failure: economic analysis of the REVIVE II study.

PubMed

de Lissovoy, Greg; Fraeman, Kathy; Teerlink, John R; Mullahy, John; Salon, Jeff; Sterz, Raimund; Durtschi, Amy; Padley, Robert J

2010-04-01

Acute heart failure (AHF) is the leading cause of hospital admission among older Americans. The Randomized EValuation of Intravenous Levosimendan Efficacy (REVIVE II) trial compared patients randomly assigned to a single infusion of levosimendan (levo) or placebo (SOC), each in addition to local standard treatments for AHF. We report an economic analysis of REVIVE II from the hospital perspective. REVIVE II enrolled patients (N = 600) hospitalized for treatment of acute decompensated heart failure (ADHF) who remained dyspneic at rest despite treatment with intravenous diuretics. Case report forms documented index hospital treatment (drug administration, procedures, days of treatment by care unit), as well as subsequent hospital and emergency department admissions during follow-up ending 90 days from date of randomization. These data were used to impute cost of admission based on an econometric cost function derived from >100,000 ADHF hospital billing records selected per REVIVE II inclusion criteria. Index admission mean length of stay (LOS) was shorter for the levo group compared with standard of care (SOC) (7.03 vs 8.96 days, P = 0.008) although intensive care unit (ICU)/cardiac care unit (CCU) days were similar (levo 2.88, SOC 3.22, P = 0.63). Excluding cost for levo, predicted mean (median) cost for the index admission was levo US $13,590 (9,458), SOC $19,021 (10,692) with a difference of $5,431 (1,234) favoring levo (P = 0.04). During follow-up through end of study day 90, no significant differences were observed in numbers of hospital admissions (P = 0.67), inpatient days (P = 0.81) or emergency department visits (P = 0.41). Cost-effectiveness was performed with a REVIVE-II sub-set conforming to current labeling, which excluded patients with low baseline blood pressure. Assuming an average price for levo in countries where currently approved, there was better than 50% likelihood that levo was both cost-saving and improved survival. Likelihood that levo would be cost-effective for willingness-to-pay below $50,000 per year of life gained was about 65%. In the REVIVE II trial, patients treated with levo had shorter LOS and lower cost for the initial hospital admission relative to patients treated with SOC. Based on sub-group analysis of patients administered per the current label, levo appears cost-effective relative to SOC.

Cost Analysis of the STONE Randomized Trial: Can Health Care Costs be Reduced One Test at a Time?

PubMed

Melnikow, Joy; Xing, Guibo; Cox, Ginger; Leigh, Paul; Mills, Lisa; Miglioretti, Diana L; Moghadassi, Michelle; Smith-Bindman, Rebecca

2016-04-01

Decreasing the use of high-cost tests may reduce health care costs. To compare costs of care for patients presenting to the emergency department (ED) with suspected kidney stones randomized to 1 of 3 initial imaging tests. Patients were randomized to point-of-care ultrasound (POC US, least costly), radiology ultrasound (RAD US), or computed tomography (CT, most costly). Subsequent testing and treatment were the choice of the treating physician. A total of 2759 patients at 15 EDs were randomized to POC US (n=908), RAD US, (n=893), or CT (n=958). Mean age was 40.4 years; 51.8% were male. All medical care documented in the trial database in the 7 days following enrollment was abstracted and coded to estimate costs using national average 2012 Medicare reimbursements. Costs for initial ED care and total 7-day costs were compared using nonparametric bootstrap to account for clustering of patients within medical centers. Initial ED visit costs were modestly lower for patients assigned to RAD US: $423 ($411, $434) compared with patients assigned to CT: $448 ($438, $459) (P<0.0001). Total costs were not significantly different between groups: $1014 ($912, $1129) for POC US, $970 ($878, $1078) for RAD US, and $959 ($870, $1044) for CT. Hospital admissions contributed over 50% of total costs, though only 11% of patients were admitted. Mean total costs (and admission rates) varied substantially by site from $749 to $1239. Assignment to a less costly test had no impact on overall health care costs for ED patients. System-level interventions addressing variation in admission rates from the ED might have greater impact on costs.

Methodological challenges in evaluating the effectiveness of women's crisis houses compared with psychiatric wards: findings from a pilot patient preference RCT.

PubMed

Howard, Louise M; Leese, Morven; Byford, Sarah; Killaspy, Helen; Cole, Laura; Lawlor, Caroline; Johnson, Sonia

2009-10-01

There are several methodological difficulties to address when evaluating acute psychiatric services. This study explored potential methods in evaluating the effectiveness of women's crisis houses compared with psychiatric wards in a pilot patient preference randomized controlled trial. Women requiring voluntary admission to a psychiatric hospital or women's crisis house were asked to enter this pilot and different options for recruitment were explored, including different recruitment sites in the pathway to admission and methods for including women without capacity. Forty-one percent (n = 42) of women entering the study agreed to be randomized and 59% (n = 61) entered patient preference arms. Only 7% of women were recruited before admission and 1 woman without capacity entered the study, despite procedures to facilitate this. Recruitment of patients with acute psychiatric crises is therefore challenging; researchers evaluating acute services should establish a consensus on how ethically and practically to recruit patients in this setting.

Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

PubMed

Susukida, Ryoko; Crum, Rosa M; Stuart, Elizabeth A; Ebnesajjad, Cyrus; Mojtabai, Ramin

2016-07-01

To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001. In the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. © 2016 Society for the Study of Addiction.

Budesonide nebulization added to systemic prednisolone in the treatment of acute asthma in children: a double-blind, randomized, controlled trial.

PubMed

Alangari, Abdullah A; Malhis, Nidal; Mubasher, Mohamed; Al-Ghamedi, Najwa; Al-Tannir, Mohamad; Riaz, Muhammad; Umetsu, Dale T; Al-Tamimi, Saleh

2014-04-01

Inhaled corticosteroids, known to be effective as a maintenance medication in chronic asthma, have also been suggested as a therapy for acute asthma when given at high doses. A double-blind, randomized, placebo-controlled trial was conducted in children aged 2 to 12 years with moderate or severe acute asthma, as determined based on a clinical score of 5 to 15 points, where 15 is the most severe. We compared the addition of budesonide 1,500 μg vs placebo to standard acute asthma treatment, which included salbutamol, ipratropium bromide, and a single dose of prednisolone 2 mg/kg given at the beginning of therapy. The primary outcome was hospital admission rate within 4 h. A total of 906 ED visits by children with moderate or severe acute asthma were evaluated. Seventy-five cases out of 458 (16.4%) in the budesonide group vs 82 of 448 (18.3%) in the placebo group were admitted (OR, 0.84; 95% CI, 0.58-1.23; P=.38). However, among cases with high baseline clinical score (≥13), significantly fewer children were admitted in the budesonide group (27 of 76 [35.5%]) than in the placebo group (39 of 73 [53.4%]; OR, 0.42; 95% CI, 0.19-0.94; P=.03). The addition of budesonide nebulization did not decrease the admission rate of children with acute asthma overall. However, it may decrease the admission rate of children with severe acute asthma. ClinicalTrials.gov; No.: NCT01524198; URL: www.clinicaltrials.gov

Distance management of inflammatory bowel disease: Systematic review and meta-analysis

PubMed Central

Huang, Vivian W; Reich, Krista M; Fedorak, Richard N

2014-01-01

AIM: To review the effectiveness of distance management methods in the management of adult inflammatory bowel disease (IBD) patients. METHODS: A systematic review and meta-analysis of randomized controlled trials comparing distance management and standard clinic follow-up in the management of adult IBD patients. Distance management intervention was defined as any remote management method in which there is a patient self-management component whereby the patient interacts remotely via a self-guided management program, electronic interface, or self-directs open access to clinic follow up. The search strategy included electronic databases (Medline, PubMed, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE, KTPlus, Web of Science, and SCOPUS), conference proceedings, and internet search for web publications. The primary outcome was the mean difference in quality of life, and the secondary outcomes included mean difference in relapse rate, clinic visit rate, and hospital admission rate. Study selection, data extraction, and risk of bias assessment were completed by two independent reviewers. RESULTS: The search strategy identified a total of 4061 articles, but only 6 randomized controlled trials met the inclusion and exclusion criteria for the systematic review and meta-analysis. Three trials involved telemanagement, and three trials involved directed patient self-management and open access clinics. The total sample size was 1463 patients. There was a trend towards improved quality of life in distance management patients with an end IBDQ quality of life score being 7.28 (95%CI: -3.25-17.81) points higher than standard clinic follow-up. There was a significant decrease in the clinic visit rate among distance management patients mean difference -1.08 (95%CI: -1.60--0.55), but no significant change in relapse rate or hospital admission rate. CONCLUSION: Distance management of IBD significantly decreases clinic visit utilization, but does not significantly affect relapse rates or hospital admission rates. PMID:24574756

Hospital-acquired complications in a randomized controlled clinical trial of a geriatric consultation team.

PubMed

Becker, P M; McVey, L J; Saltz, C C; Feussner, J R; Cohen, H J

1987-05-01

As part of a controlled clinical trial of a geriatric consultation team (GCT), we investigated whether a GCT could affect the incidence of hospital-acquired complications in elderly patients. One hundred eighty-five patients, aged 75 years and older, were randomized into an intervention (N = 92) and a control (N = 93) group. Members of the intervention group received a GCT consultation and were routinely followed up throughout their hospitalization. The incidence of hospital-acquired complications for the entire study population was 38%. The type and rate of hospital-acquired complications in the intervention and control groups were not significantly different. Functional status on admission and admission to the psychiatry service were predictive for the occurrence of a hospital-acquired complication. In a broadly selected population such as this, the intensity of care available through a GCT was unable to reduce the occurrence of hospital-acquired complications. However, since this is only one aspect of a GCT function, and others may be of great importance, such aspects, and more targeted populations, must be evaluated before final conclusions can be reached about GCT efficiency.

A randomized placebo controlled trial of ibuprofen for respiratory syncytial infection in a bovine model study

USDA-ARS?s Scientific Manuscript database

Background: Respiratory syncytial virus (RSV) is the most common cause of bronchiolitis and hospital admission in infants. An analogous disease occurs in cattle and costs US agriculture a billion dollars a year. RSV causes much of its morbidity indirectly via adverse effects of the host response to ...

Rationale and design of a randomized trial comparing initial stress echocardiography versus coronary CT angiography in low-to-intermediate risk emergency department patients with chest pain.

PubMed

Levsky, Jeffrey M; Haramati, Linda B; Taub, Cynthia C; Spevack, Daniel M; Menegus, Mark A; Travin, Mark I; Vega, Shayna; Lerer, Rikah; Brown-Manhertz, Durline; Hirschhorn, Esther; Tobin, Jonathan N; Garcia, Mario J

2014-07-01

Comparative effectiveness research (CER) has become a major focus of cardiovascular disease investigation to optimize diagnosis and treatment paradigms and decrease healthcare expenditures. Acute chest pain is a highly prevalent reason for evaluation in the Emergency Department (ED) that results in hospital admission for many patients and excess expense. Improvement in noninvasive diagnostic algorithms can potentially reduce unnecessary admissions. To compare the performance of treadmill stress echocardiography (SE) and coronary computed tomography angiography (CTA) in ED chest pain patients with low-to-intermediate risk of significant coronary artery disease. This is a single-center, randomized controlled trial (RCT) comparing SE and CTA head-to-head as the initial noninvasive imaging modality. The primary outcome measured is the incidence of hospitalization. The study is powered to detect a reduction in admissions from 28% to 15% with a sample size of 400. Secondary outcomes include length of stay in the ED/hospital and estimated cost of care. Safety outcomes include subsequent visits to the ED and hospitalizations, as well as major adverse cardiovascular events at 30 days and 1 year. Patients who do not meet study criteria or do not consent for randomization are offered entry into an observational registry. This RCT will add to our understanding of the roles of different imaging modalities in triaging patients with suspected angina. It will increase the CER evidence base comparing SE and CTA and provide insight into potential benefits and limitations of appropriate use of treadmill SE in the ED. © 2013, Wiley Periodicals, Inc.

Effect of Fat-based versus Carbohydrate-based Enteral Feeding on Glycemic Control in Critically Ill Patients: A Randomized Clinical Trial.

PubMed

Nourmohammadi, Mahdieh; Moghadam, Omid Moradi; Lahiji, Mohammad Niakan; Hatamian, Sevak; Shariatpanahi, Zahra Vahdat

2017-08-01

The aim of this study was to evaluate the preventive effects of high-fat enteral feeding on glycemic control and clinical outcomes in critically ill patients: a randomized clinical trial. This study was done on 42 normoglycemic patients admitted to Intensive Care Unit (ICU). Patients were randomly classified into three groups of 14 each. Control group (A) received carbohydrate-based diet (protein: 20%, fat: 30%, and carbohydrate: 50%), study groups received two types of high-fat diet; Group B (protein: 20%, fat: 45% including half of olive oil and half sunflower oil, and carbohydrate: 35%); and Group C (protein: 20%, fat: 45% including sunflower oil, and carbohydrate: 35%) in the first 48 h of admission. Basal characteristics of participants were the same. After the feeding trial, there was no difference between the groups in mean plasma and capillary glucose levels and insulin requirements. Serum high density lipoprotein (HDL)-cholesterol level was increased significantly in Group B on day 10 compared to admission level (40.75 ± 5.58 vs. 43.56 ± 2.25, P = 0.05). We did not find any difference in organ failure involvement and mortality rate between groups. The number of ICU free days was significantly more in Group B compared to the control group ( P = 0.04). High-fat diets have no preventive effect on stress hyperglycemia. High monounsaturated fat diet may increase serum HDL-cholesterol level and decrease the length of stay in ICU.

Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic.

PubMed

Annane, Djillali; Antona, Marion; Lehmann, Blandine; Kedzia, Cecile; Chevret, Sylvie

2012-01-01

To analyze the hurdles in implementing a randomized trial of corticosteroids for severe 2009 H1N1 influenza infections. This was an investigator-led, multicenter, randomized, placebo-controlled, double-blind trial of corticosteroids in ICU patients with 2009 H1N1 influenza pneumonia requiring mechanical ventilation. The feasibility of and hurdles in designing and initiating a phase III trial in a short-lived pandemic crisis were analyzed. The regulatory agency and ethics committee approved the study's scientific, financial, and ethical aspects within 4 weeks. Hydrocortisone and placebo were prepared centrally and shipped to participating hospitals within 6 weeks. The inclusion period started on November 9, 2009. From August 1, 2009 to March 8, 2010, only 205/224 ICU patients with H1N1 infections required mechanical ventilation. The peak of the wave was missed by 2-3 weeks and only 26 patients were randomized. The two main reasons for non-inclusion were patients' admission before the beginning of the trial and ICU personnel overwhelmed by clinical duties. Parallel rather than sequential regulatory and ethics approval, and preparation and masking of study drugs by local pharmacists would have allowed the study to start 1 month earlier and before the peak of the "flu" wave. A dedicated research team in each participating center would have increased the ratio of screened to randomized patients. This report highlights the main hurdles in implementing a randomized trial for a pandemic critical illness and proposes solutions for future trials.

Admission Glucose and Effect of Intra-Arterial Treatment in Patients With Acute Ischemic Stroke.

PubMed

Osei, Elizabeth; den Hertog, Heleen M; Berkhemer, Olvert A; Fransen, Puck S S; Roos, Yvo B W E M; Beumer, Debbie; van Oostenbrugge, Robert J; Schonewille, Wouter J; Boiten, Jelis; Zandbergen, Adrienne A M; Koudstaal, Peter J; Dippel, Diederik W J

2017-05-01

Hyperglycemia on admission is common after ischemic stroke. It is associated with unfavorable outcome after treatment with intravenous thrombolysis and after intra-arterial treatment. Whether hyperglycemia influences the effect of reperfusion treatment is unknown. We assessed whether increased admission serum glucose modifies the effect of intra-arterial treatment in patients with acute ischemic stroke. We used data from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). Hyperglycemia was defined as admission serum glucose >7.8 mmol/L. The primary outcome measure was the adjusted common odds ratio for a shift in the direction of a better outcome on the modified Rankin Scale at 90 days, estimated with ordinal logistic regression. Secondary outcome variable was symptomatic intracranial hemorrhage. We assessed treatment effect modification of hyperglycemia and admission serum glucose levels with multiplicative interaction factors and adjusted for prognostic variables. Four hundred eighty-seven patients were included. Mean admission serum glucose was 7.2 mmol/L (SD, 2.2). Fifty-seven of 226 patients (25%) randomized to intra-arterial treatment were hyperglycemic compared with 61 of 261 patients (23%) in the control group. The interaction of either hyperglycemia or admission serum glucose levels and treatment effect on modified Rankin Scale scores was not significant ( P =0.67 and P =0.87, respectively). The same applied for occurrence of symptomatic hemorrhage ( P =0.39 for hyperglycemia, P =0.39 for admission serum glucose). We found no evidence for effect modification of intra-arterial treatment by admission serum glucose in patients with acute ischemic stroke. URL: www.isrctn.com. Unique identifier: ISRCTN10888758. © 2017 American Heart Association, Inc.

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial.

PubMed

Musekamp, Gunda; Gerlich, Christian; Ehlebracht-König, Inge; Faller, Hermann; Reusch, Andrea

2016-02-03

Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.

What Works Clearinghouse Quick Review: "Evaluation of the College Possible Program: Results from a Randomized Controlled Trial"

ERIC Educational Resources Information Center

What Works Clearinghouse, 2013

2013-01-01

This study investigated the effect of the "College Possible" program, which is designed to serve low-income high school students. "College Possible" provides a 2-year afterschool curriculum to high school juniors and seniors that includes SAT and ACT test preparation services, college admissions and financial aid consulting,…

Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR): NTR2666 PMID:22236534

Early High-dosage Atorvastatin Treatment Improved Serum Immune-inflammatory Markers and Functional Outcome in Acute Ischemic Strokes Classified as Large Artery Atherosclerotic Stroke

PubMed Central

Tuttolomondo, Antonino; Di Raimondo, Domenico; Pecoraro, Rosaria; Maida, Carlo; Arnao, Valentina; Corte, Vittoriano Della; Simonetta, Irene; Corpora, Francesca; Di Bona, Danilo; Maugeri, Rosario; Iacopino, Domenico Gerardo; Pinto, Antonio

2016-01-01

Abstract Statins have beneficial effects on cerebral circulation and brain parenchyma during ischemic stroke and reperfusion. The primary hypothesis of this randomized parallel trial was that treatment with 80 mg/day of atorvastatin administered early at admission after acute atherosclerotic ischemic stroke could reduce serum levels of markers of immune-inflammatory activation of the acute phase and that this immune-inflammatory modulation could have a possible effect on prognosis of ischemic stroke evaluated by some outcome indicators. We enrolled 42 patients with acute ischemic stroke classified as large arteries atherosclerosis stroke (LAAS) randomly assigned in a randomized parallel trial to the following groups: Group A, 22 patients treated with atorvastatin 80 mg (once-daily) from admission day until discharge; Group B, 20 patients not treated with atorvastatin 80 mg until discharge, and after discharge, treatment with atorvastatin has been started. At 72 hours and at 7 days after acute ischemic stroke, subjects of group A showed significantly lower plasma levels of tumor necrosis factor-α, interleukin (IL)-6, vascular cell adhesion molecule-1, whereas no significant difference with regard to plasma levels of IL-10, E-Selectin, and P-Selectin was observed between the 2 groups. At 72 hours and 7 days after admission, stroke patients treated with atorvastatin 80 mg in comparison with stroke subjects not treated with atorvastatin showed a significantly lower mean National Institutes of Health Stroke Scale and modified Rankin scores. Our findings provide the first evidence that atorvastatin acutely administered immediately after an atherosclerotic ischemic stroke exerts a lowering effect on immune-inflammatory activation of the acute phase of stroke and that its early use is associated to a better functional and prognostic profile. PMID:27043681

Adrenaline for out-of-hospital cardiac arrest resuscitation: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Lin, Steve; Callaway, Clifton W; Shah, Prakesh S; Wagner, Justin D; Beyene, Joseph; Ziegler, Carolyn P; Morrison, Laurie J

2014-06-01

The evidence for adrenaline in out-of-hospital cardiac arrest (OHCA) resuscitation is inconclusive. We systematically reviewed the efficacy of adrenaline for adult OHCA. We searched in MEDLINE, EMBASE, and Cochrane Library from inception to July 2013 for randomized controlled trials (RCTs) evaluating standard dose adrenaline (SDA) to placebo, high dose adrenaline (HDA), or vasopressin (alone or combination) in adult OHCA patients. Meta-analyses were performed using random effects modeling. Subgroup analyses were performed stratified by cardiac rhythm and by number of drug doses. The primary outcome was survival to discharge and the secondary outcomes were return of spontaneous circulation (ROSC), survival to admission, and neurological outcome. Fourteen RCTs (n=12,246) met inclusion criteria: one compared SDA to placebo (n=534), six compared SDA to HDA (n=6174), six compared SDA to an adrenaline/vasopressin combination (n=5202), and one compared SDA to vasopressin alone (n=336). There was no survival to discharge or neurological outcome differences in any comparison group, including subgroup analyses. SDA showed improved ROSC (RR 2.80, 95%CI 1.78-4.41, p<0.001) and survival to admission (RR 1.95, 95%CI 1.34-2.84, p<0.001) compared to placebo. SDA showed decreased ROSC (RR 0.85, 95%CI 0.75-0.97, p=0.02; I(2)=48%) and survival to admission (RR 0.87, 95%CI 0.76-1.00, p=0.049; I(2)=34%) compared to HDA. There were no differences in outcomes between SDA and vasopressin alone or in combination with adrenaline. There was no benefit of adrenaline in survival to discharge or neurological outcomes. There were improved rates of survival to admission and ROSC with SDA over placebo and HDA over SDA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Effect of Fat-based versus Carbohydrate-based Enteral Feeding on Glycemic Control in Critically Ill Patients: A Randomized Clinical Trial

PubMed Central

Nourmohammadi, Mahdieh; Moghadam, Omid Moradi; Lahiji, Mohammad Niakan; Hatamian, Sevak; Shariatpanahi, Zahra Vahdat

2017-01-01

Background and Aims: The aim of this study was to evaluate the preventive effects of high-fat enteral feeding on glycemic control and clinical outcomes in critically ill patients: a randomized clinical trial. Materials and Methods: This study was done on 42 normoglycemic patients admitted to Intensive Care Unit (ICU). Patients were randomly classified into three groups of 14 each. Control group (A) received carbohydrate-based diet (protein: 20%, fat: 30%, and carbohydrate: 50%), study groups received two types of high-fat diet; Group B (protein: 20%, fat: 45% including half of olive oil and half sunflower oil, and carbohydrate: 35%); and Group C (protein: 20%, fat: 45% including sunflower oil, and carbohydrate: 35%) in the first 48 h of admission. Results: Basal characteristics of participants were the same. After the feeding trial, there was no difference between the groups in mean plasma and capillary glucose levels and insulin requirements. Serum high density lipoprotein (HDL)-cholesterol level was increased significantly in Group B on day 10 compared to admission level (40.75 ± 5.58 vs. 43.56 ± 2.25, P = 0.05). We did not find any difference in organ failure involvement and mortality rate between groups. The number of ICU free days was significantly more in Group B compared to the control group (P = 0.04). Conclusion: High-fat diets have no preventive effect on stress hyperglycemia. High monounsaturated fat diet may increase serum HDL-cholesterol level and decrease the length of stay in ICU. PMID:28904479

Effect of extended physiotherapy and high-dose vitamin D on rate of falls and hospital re-admission after acute hip fracture: a randomized controlled trial

USDA-ARS?s Scientific Manuscript database

Guidelines for post-fracture care of elderly hip fracture patients are not established despite the significant socio-economic burden of post hip fracture morbidity and mortality. Using a factorial design, we studied the effects of extended physiotherapy (supervised 1 hour per day during acute care p...

Effects of acarbose on cardiovascular and diabetes outcomes in patients with coronary heart disease and impaired glucose tolerance (ACE): a randomised, double-blind, placebo-controlled trial.

PubMed

Holman, Rury R; Coleman, Ruth L; Chan, Juliana C N; Chiasson, Jean-Louis; Feng, Huimei; Ge, Junbo; Gerstein, Hertzel C; Gray, Richard; Huo, Yong; Lang, Zhihui; McMurray, John J; Rydén, Lars; Schröder, Stefan; Sun, Yihong; Theodorakis, Michael J; Tendera, Michal; Tucker, Lynne; Tuomilehto, Jaakko; Wei, Yidong; Yang, Wenying; Wang, Duolao; Hu, Dayi; Pan, Changyu

2017-11-01

The effect of the α-glucosidase inhibitor acarbose on cardiovascular outcomes in patients with coronary heart disease and impaired glucose tolerance is unknown. We aimed to assess whether acarbose could reduce the frequency of cardiovascular events in Chinese patients with established coronary heart disease and impaired glucose tolerance, and whether the incidence of type 2 diabetes could be reduced. The Acarbose Cardiovascular Evaluation (ACE) trial was a randomised, double-blind, placebo-controlled, phase 4 trial, with patients recruited from 176 hospital outpatient clinics in China. Chinese patients with coronary heart disease and impaired glucose tolerance were randomly assigned (1:1), in blocks by site, by a centralised computer system to receive oral acarbose (50 mg three times a day) or matched placebo, which was added to standardised cardiovascular secondary prevention therapy. All study staff and patients were masked to treatment group allocation. The primary outcome was a five-point composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospital admission for unstable angina, and hospital admission for heart failure, analysed in the intention-to-treat population (all participants randomly assigned to treatment who provided written informed consent). The secondary outcomes were a three-point composite outcome (cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke), death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, development of diabetes, and development of impaired renal function. The safety population comprised all patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, number NCT00829660, and the International Standard Randomised Controlled Trial Number registry, number ISRCTN91899513. Between March 20, 2009, and Oct 23, 2015, 6522 patients were randomly assigned and included in the intention-to-treat population, 3272 assigned to acarbose and 3250 to placebo. Patients were followed up for a median of 5·0 years (IQR 3·4-6·0) in both groups. The primary five-point composite outcome occurred in 470 (14%; 3·33 per 100 person-years) of 3272 acarbose group participants and in 479 (15%; 3·41 per 100 person-years) of 3250 placebo group participants (hazard ratio 0·98; 95% CI 0·86-1·11, p=0·73). No significant differences were seen between treatment groups for the secondary three-point composite outcome, death from any cause, cardiovascular death, fatal or non-fatal myocardial infarction, fatal or non-fatal stroke, hospital admission for unstable angina, hospital admission for heart failure, or impaired renal function. Diabetes developed less frequently in the acarbose group (436 [13%] of 3272; 3·17 per 100 person-years) compared with the placebo group (513 [16%] of 3250; 3·84 per 100 person-years; rate ratio 0·82, 95% CI 0·71-0·94, p=0·005). Gastrointestinal disorders were the most common adverse event associated with drug discontinuation or dose changes (215 [7%] of 3263 patients in the acarbose group vs 150 [5%] of 3241 in the placebo group [p=0·0007]; safety population). Numbers of non-cardiovascular deaths (71 [2%] of 3272 vs 56 [2%] of 3250, p=0·19) and cancer deaths (ten [<1%] of 3272 vs 12 [<1%] of 3250, p=0·08) did not differ between groups. In Chinese patients with coronary heart disease and impaired glucose tolerance, acarbose did not reduce the risk of major adverse cardiovascular events, but did reduce the incidence of diabetes. Bayer AG. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nasogastric hydration versus intravenous hydration for infants with bronchiolitis: a randomised trial.

PubMed

Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Acworth, Jason; Krieser, David; Dalziel, Stuart; Davidson, Andrew; Donath, Susan; Jachno, Kim; South, Mike; Theophilos, Theane; Babl, Franz E

2013-04-01

Bronchiolitis is the most common lower respiratory tract infection in infants and the leading cause of hospital admission. Hydration is a mainstay of treatment, but insufficient evidence exists to guide clinical practice. We aimed to assess whether intravenous hydration or nasogastric hydration is better for treatment of infants. In this multicentre, open, randomised trial, we enrolled infants aged 2-12 months admitted to hospitals in Australia and New Zealand with a clinical diagnosis of bronchiolitis during three bronchiolitis seasons (April 1-Oct 31, in 2009, 2010, and 2011). We randomly allocated infants to nasogastric hydration or intravenous hydration by use of a computer-generated sequence and opaque sealed envelopes, with three randomly assigned block sizes and stratified by hospital site and age group (2-<6 months vs 6-12 months). The primary outcome was length of hospital stay, assessed in all randomly assigned infants. Secondary outcomes included rates of intensive-care unit admission, adverse events, and success of insertion. This trial is registered with the Australian and New Zealand clinical trials registry, ACTRN12605000033640. Mean length of stay for 381 infants assigned nasogastric hydration was 86·6 h (SD 58·9) compared with 82·2 h (58·8) for 378 infants assigned intravenous hydration (absolute difference 4·5 h [95% CI -3·9 to 12·9]; p=0·30). Rates of admission to intensive-care units, need for ventilatory support, and adverse events did not differ between groups. At randomisation, seven infants assigned nasogastric hydration were switched to intravenous hydration and 56 infants assigned intravenous hydration were switched to nasogastric hydration because the study-assigned method was unable to be inserted. For those infants who had data available for successful insertion, 275 (85%) of 323 infants in the nasogastric hydration group and 165 (56%) of 294 infants in the intravenous hydration group required only one attempt for successful insertion. Intravenous hydration and nasogastric hydration are appropriate means to hydrate infants with bronchiolitis. Nasogastric insertion might require fewer attempts and have a higher success rate of insertion than intravenous hydration. Australian National Health and Medical Research Council, Samuel Nissen Charitable Foundation (Perpetual), Murdoch Children's Research Institute, Victorian Government. Copyright © 2013 Elsevier Ltd. All rights reserved.

The Effect of Dexamethasone on Symptoms of Posttraumatic Stress Disorder and Depression After Cardiac Surgery and Intensive Care Admission: Longitudinal Follow-Up of a Randomized Controlled Trial.

PubMed

Kok, Lotte; Hillegers, Manon H; Veldhuijzen, Dieuwke S; Cornelisse, Sandra; Nierich, Arno P; van der Maaten, Joost M; Rosseel, Peter M; Hofland, Jan; Sep, Milou S; Dieleman, Jan M; Vinkers, Christiaan H; Peelen, Linda M; Joëls, Marian; van Dijk, Diederik

2016-03-01

Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission. Follow-up study of a randomized clinical trial. Five Dutch heart centers. Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial. A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way. Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p < 0.01) and depression (odds ratio, 0.29; 95% CI, 0.11-0.77; p < 0.01) in female patients after dexamethasone administration. Health-related quality of life did not differ between groups and was not associated with psychopathology. Overall, our findings suggest that exogenous administration of the glucocorticoid receptor agonist dexamethasone-compared with placebo-during cardiac surgery does not positively or negatively affect the prevalence of posttraumatic stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

Poor efficacy of preemptive amoxicillin clavulanate for preventing secondary infection from Bothrops snakebites in the Brazilian Amazon: A randomized controlled clinical trial

PubMed Central

Sachett, Jacqueline A. G.; da Silva, Iran Mendonça; Alves, Eliane Campos; Oliveira, Sâmella S.; do Vale, Fábio Francesconi; dos Santos, Marcelo Cordeiro; Marques, Hedylamar Oliveira; Colombini, Mônica; da Silva, Ana Maria Moura; Wen, Fan Hui; Lacerda, Marcus V. G.; Monteiro, Wuelton M.

2017-01-01

Background Secondary bacterial infections from snakebites contribute to the high complication rates that can lead to permanent function loss and disabilities. Although common in endemic areas, routine empirical prophylactic use of antibiotics aiming to prevent secondary infection lacks a clearly defined policy. The aim of this work was to estimate the efficacy of amoxicillin clavulanate for reducing the secondary infection incidence in patients bitten by Bothrops snakes, and, secondarily, identify risk factors for secondary infections from snakebites in the Western Brazilian Amazon. Methods and findings This was an open-label, two-arm individually randomized superiority trial to prevent secondary infection from Bothrops snakebites. The antibiotic chosen for this clinical trial was oral amoxicillin clavulanate per seven days compared to no intervention. A total of 345 patients were assessed for eligibility in the study period. From this total, 187 accomplished the inclusion criteria and were randomized, 93 in the interventional group and 94 in the untreated control group. All randomized participants completed the 7 days follow-up period. Enzyme immunoassay confirmed Bothrops envenoming diagnosis in all participants. Primary outcome was defined as secondary infection (abscess and/or cellulitis) until day 7 after admission. Secondary infection incidence until 7 days after admission was 35.5% in the intervention group and 44.1% in the control group [RR = 0.80 (95%CI = 0.56 to 1.15; p = 0.235)]. Survival analysis demonstrated that the time from patient admission to the onset of secondary infection was not different between amoxicillin clavulanate treated and control group (Log-rank = 2.23; p = 0.789).Secondary infections incidence in 7 days of follow-up was independently associated to fibrinogen >400 mg/dL [AOR = 4.78 (95%CI = 2.17 to 10.55; p<0.001)], alanine transaminase >44 IU/L [AOR = 2.52 (95%CI = 1.06 to 5.98; p = 0.037)], C-reactive protein >6.5 mg/L [AOR = 2.98 (95%CI = 1.40 to 6.35; p = 0.005)], moderate pain [AOR = 24.30 (95%CI = 4.69 to 125.84; p<0.001)] and moderate snakebites [AOR = 2.43 (95%CI = 1.07 to 5.50; p = 0.034)]. Conclusions/Significance Preemptive amoxicillin clavulanate was not effective for preventing secondary infections from Bothrops snakebites. Laboratorial markers, such as high fibrinogen, alanine transaminase and C-reactive protein levels, and severity clinical grading of snakebites, may help to accurately diagnose secondary infections. Trial registration Brazilian Clinical Trials Registry (ReBec): RBR-3h33wy; UTN Number: U1111-1169-1005. PMID:28692641

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

An educational intervention to improve cost-effective care among medicine housestaff: a randomized controlled trial.

PubMed

Sommers, Benjamin D; Desai, Nihar; Fiskio, Julie; Licurse, Adam; Thorndike, Mary; Katz, Joel T; Bates, David W

2012-06-01

High medical costs create significant burdens. Research indicates that doctors have little awareness of costs. This study tested whether a brief educational intervention could increase residents' awareness of cost-effectiveness and reduce costs without negatively affecting patient outcomes. The authors conducted a clustered randomized controlled trial of 33 teams (96 residents) at an internal medicine residency program (2009-2010). The intervention was a 45-minute teaching session; residents reviewed the hospital bill of a patient for whom they had cared and discussed reducing unnecessary costs. Primary outcomes were laboratory, pharmacy, radiology, and total hospital costs per admission. Secondary measures were length of stay (LOS), intensive care unit (ICU) admission, 30-day readmission, and 30-day mortality. Multivariate adjustment controlled for patient demographics and health. A follow-up survey assessed resident attitudes three months later. Among 1,194 patients, there were no significant cost differences between intervention and control groups. In the intervention group, 30-day readmission was higher (adjusted odds ratio 1.51, P = .010). There was no effect on LOS or the composite outcome of readmission, mortality, and ICU transfer. In a subgroup analysis of 835 patients newly admitted during the study, the intervention group incurred $163 lower adjusted lab costs per admission (P = .046). The follow-up survey indicated persistent differences in residents' exposure to concepts of cost-effectiveness (P = .041). A brief intervention featuring a discussion of hospital bills can fill a gap in resident education and reduce laboratory costs for a subset of patients, but may increase readmission risk.

The effectiveness of alternative planned durations of residential drug abuse treatment.

PubMed Central

McCusker, J; Vickers-Lahti, M; Stoddard, A; Hindin, R; Bigelow, C; Zorn, M; Garfield, F; Frost, R; Love, C; Lewis, B

1995-01-01

Randomized controlled trials were conducted at two residential drug abuse treatment facilities to compare programs that differed in planned duration. One trial compared a 6-month and a 12-month therapeutic community program (n = 184), and the second compared a 3-month and a 6-month relapse prevention program (n = 444). Retention rates over comparable time periods differed minimally by planned treatment duration, and the longer programs had lower completion rates. There was no effect in either trial of planned treatment duration on changes in psychosocial variables between admission and exit or on rates or patterns of drug use at follow-up between 2 and 6 months after exit. PMID:7573630

Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial.

PubMed

Nedergaard, Helene Korvenius; Jensen, Hanne Irene; Lauridsen, Jørgen T; Sjøgaard, Gisela; Toft, Palle

2015-07-23

Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative impact on the degree of independence and quality of life. In the NONSEDA trial we randomize critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit. It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit. Investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 700 patients in total, with a substudy concerning 200 of these patients. Inclusion criteria will be intubated, mechanically ventilated patients with expected duration of mechanical ventilation >24 h. Exclusion criteria will be patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or placing the patient in a prone position. The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up trial. The co-primary outcome will be quality of life regarding physical function (SF-36, physical component) and degree of independence in activities of daily living (Barthel Index), and this will be assessed for all 700 patients participating in the NONSEDA trial. The secondary outcomes, which will be assessed for the subpopulation of 200 NONSEDA patients in the trial site, Kolding, will be 6-min walking distance, handgrip strength, muscle size (ultrasonographic measurement of the rectus femoris muscle cross-sectional area) and biomechanical data on lower extremity function (maximal voluntary contraction, rate of force development and endurance). This study is the first to investigate the effect of no sedation during critical illness on physical function. If an effect is found, it will add important information on how to prevent muscle weakness following critical illness. The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02034942, 9 January 2014).

Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

PubMed

Andersson, M; Kolodziej, B; Andersson, R E

2017-10-01

The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P < 0·001), fewer admissions (29·5 versus 42·8 per cent; P < 0·001), and fewer negative explorations (1·6 versus 3·2 per cent; P = 0·030) and operations for non-perforated appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

2018-01-30

It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial.

PubMed

Fowler, Robert A; Mittmann, Nicole; Geerts, William H; Heels-Ansdell, Diane; Gould, Michael K; Guyatt, Gordon; Krahn, Murray; Finfer, Simon; Pinto, Ruxandra; Chan, Brian; Ormanidhi, Orges; Arabi, Yaseen; Qushmaq, Ismael; Rocha, Marcelo G; Dodek, Peter; McIntyre, Lauralyn; Hall, Richard; Ferguson, Niall D; Mehta, Sangeeta; Marshall, John C; Doig, Christopher James; Muscedere, John; Jacka, Michael J; Klinger, James R; Vlahakis, Nicholas; Orford, Neil; Seppelt, Ian; Skrobik, Yoanna K; Sud, Sachin; Cade, John F; Cooper, Jamie; Cook, Deborah

2014-12-20

Venous thromboembolism (VTE) is a common complication of critical illness with important clinical consequences. The Prophylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) is a multicenter, blinded, randomized controlled trial comparing the effectiveness of the two most common pharmocoprevention strategies, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) dalteparin, in medical-surgical patients in the intensive care unit (ICU). E-PROTECT is a prospective and concurrent economic evaluation of the PROTECT trial. The primary objective of E-PROTECT is to identify and quantify the total (direct and indirect, variable and fixed) costs associated with the management of critically ill patients participating in the PROTECT trial, and, to combine costs and outcome results to determine the incremental cost-effectiveness of LMWH versus UFH, from the acute healthcare system perspective, over a data-rich time horizon of ICU admission and hospital admission. We derive baseline characteristics and probabilities of in-ICU and in-hospital events from all enrolled patients. Total costs are derived from centers, proportional to the numbers of patients enrolled in each country. Direct costs include medication, physician and other personnel costs, diagnostic radiology and laboratory testing, operative and non-operative procedures, costs associated with bleeding, transfusions and treatment-related complications. Indirect costs include ICU and hospital ward overhead costs. Outcomes are the ratio of incremental costs per incremental effects of LMWH versus UFH during hospitalization; incremental cost to prevent a thrombosis at any site (primary outcome); incremental cost to prevent a pulmonary embolism, deep vein thrombosis, major bleeding event or episode of heparin-induced thrombocytopenia (secondary outcomes) and incremental cost per life-year gained (tertiary outcome). Pre-specified subgroups and sensitivity analyses will be performed and confidence intervals for the estimates of incremental cost-effectiveness will be obtained using bootstrapping. This economic evaluation employs a prospective costing methodology concurrent with a randomized controlled blinded clinical trial, with a pre-specified analytic plan, outcome measures, subgroup and sensitivity analyses. This economic evaluation has received only peer-reviewed funding and funders will not play a role in the generation, analysis or decision to submit the manuscripts for publication. Clinicaltrials.gov Identifier: NCT00182143 . Date of registration: 10 September 2005.

Cardiotocography versus intermittent auscultation of fetal heart on admission to labour ward for assessment of fetal wellbeing.

PubMed

Devane, Declan; Lalor, Joan G; Daly, Sean; McGuire, William; Smith, Valerie

2012-02-15

The admission cardiotocograph (CTG) is a commonly used screening test consisting of a short (usually 20 minutes) recording of the fetal heart rate (FHR) and uterine activity performed on the mother's admission to the labour ward. To compare the effects of admission CTG with intermittent auscultation of the FHR on maternal and infant outcomes for pregnant women without risk factors on their admission to the labour ward. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (17 May 2011) (CENTRAL) (The Cochrane Library 2011 Issue 2 of 4), MEDLINE (1966 to 17 May 2011), CINAHL (1982 to 17 May 2011), Dissertation Abstracts (1980 to 17 May 2011) and the reference list of retrieved papers. All randomised and quasi-randomised trials comparing admission CTG with intermittent auscultation of the FHR for pregnant women between 37 and 42 completed weeks of pregnancy and considered to be at low risk of intrapartum fetal hypoxia and of developing complications during labour. Two authors independently assessed trial eligibility and quality, and extracted data. Data were checked for accuracy. We included four trials involving more than 13,000 women. All four studies included women in labour. Overall, the studies were at low risk of bias. Although not statistically significant using a strict P < 0.05 criterion, data are consistent with women allocated to admission CTG having, on average, a higher probability of an increase in incidence of caesarean section than women allocated to intermittent auscultation (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.00 to 1.44, four trials, 11,338 women, T² = 0.00, I² = 0%). There was no significant difference in the average treatment effect across included trials between women allocated to admission CTG and women allocated to intermittent auscultation in instrumental vaginal birth (RR 1.10, 95% CI 0.95 to 1.27, four trials, 11,338 women, T² = 0.01, I² = 38%) and fetal and neonatal deaths (RR 1.01, 95% CI 0.30 to 3.47, four trials, 11339 infants, T² = 0.00, I² = 0%).Women allocated to admission CTG had, on average, significantly higher rates of continuous electronic fetal monitoring during labour (RR 1.30, 95% CI 1.14 to 1.48, three trials, 10,753 women, T² = 0.01, I² = 79%) and fetal blood sampling (RR 1.28, 95% CI 1.13 to 1.45, three trials, 10,757 women, T² = 0.00, I² = 0%) than women allocated to intermittent auscultation. There were no differences between groups in other secondary outcome measures. Contrary to continued use in some clinical areas, we found no evidence of benefit for the use of the admission cardiotocograph (CTG) for low-risk women on admission in labour.We found no evidence of benefit for the use of the admission CTG for low-risk women on admission in labour. Furthermore, the probability is that admission CTG increases the caesarean section rate by approximately 20%. The data lacked power to detect possible important differences in perinatal mortality. However, it is unlikely that any trial, or meta-analysis, will be adequately powered to detect such differences. The findings of this review support recommendations that the admission CTG not be used for women who are low risk on admission in labour. Women should be informed that admission CTG is likely associated with an increase in the incidence of caesarean section without evidence of benefit.

Cardiotocography versus intermittent auscultation of fetal heart on admission to labour ward for assessment of fetal wellbeing.

PubMed

Devane, Declan; Lalor, Joan G; Daly, Sean; McGuire, William; Cuthbert, Anna; Smith, Valerie

2017-01-26

The admission cardiotocograph (CTG) is a commonly used screening test consisting of a short (usually 20 minutes) recording of the fetal heart rate (FHR) and uterine activity performed on the mother's admission to the labour ward. This is an update of a review published in 2012. To compare the effects of admission cardiotocography with intermittent auscultation of the FHR on maternal and infant outcomes for pregnant women without risk factors on their admission to the labour ward. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register to 30 November 2016 and we planned to review the reference list of retrieved papers All randomised and quasi-randomised trials comparing admission CTG with intermittent auscultation of the FHR for pregnant women between 37 and 42 completed weeks of pregnancy and considered to be at low risk of intrapartum fetal hypoxia and of developing complications during labour. Two authors independently assessed trial eligibility and quality, and extracted data. Data were checked for accuracy. We included no new trials in this update. We included four trials involving more than 13,000 women which were conducted in the UK and Ireland and included women in labour. Three trials were funded by the hospitals where the trials took place and one trial was funded by the Scottish government. No declarations of interest were made in two trials; the remaining two trials did not mention declarations of interest. Overall, the studies were assessed as low risk of bias. Results reported in the 2012 review remain unchanged.Although not statistically significant using a strict P < 0.05 criterion, data were consistent with women allocated to admission CTG having, on average, a higher probability of an increase in incidence of caesarean section than women allocated to intermittent auscultation (risk ratio (RR) 1.20, 95% confidence interval (CI) 1.00 to 1.44, 4 trials, 11,338 women, I² = 0%, moderate quality evidence). There was no clear difference in the average treatment effect across included trials between women allocated to admission CTG and women allocated to intermittent auscultation in instrumental vaginal birth (RR 1.10, 95% CI 0.95 to 1.27, 4 trials, 11,338 women, I² = 38%, low quality evidence) and perinatal mortality rate (RR 1.01, 95% CI 0.30 to 3.47, 4 trials, 11,339 infants, I² = 0%, moderate quality evidence).Women allocated to admission CTG had, on average, higher rates of continuous electronic fetal monitoring during labour (RR 1.30, 95% CI 1.14 to 1.48, 3 trials, 10,753 women, I² = 79%, low quality evidence) and fetal blood sampling (RR 1.28, 95% CI 1.13 to 1.45, 3 trials, 10,757 women, I² = 0%) than women allocated to intermittent auscultation. There were no differences between groups in other secondary outcome measures including incidence and severity of hypoxic ischaemic encephalopathy (incidence only reported) (RR 1.19, 95% CI 0.37 to 3.90; 2367 infants; 1 trial; very low quality evidence) and incidence of seizures in the neonatal period (RR 0.72, 95% CI 0.32 to 1.61; 8056 infants; 1 trial; low quality evidence). There were no data reported for severe neurodevelopmental disability assessed at greater than, or equal to, 12 months of age. Contrary to continued use in some clinical areas, we found no evidence of benefit for the use of the admission CTG for low-risk women on admission in labour.Furthermore, the probability is that admission CTG increases the caesarean section rate by approximately 20%. The data lacked power to detect possible important differences in perinatal mortality. However, it is unlikely that any trial, or meta-analysis, will be adequately powered to detect such differences. The findings of this review support recommendations that the admission CTG not be used for women who are low risk on admission in labour. Women should be informed that admission CTG is likely associated with an increase in the incidence of caesarean section without evidence of benefit.Evidence quality ranged from moderate to very low, with downgrading decisions based on imprecision, inconsistency and a lack of blinding for participants and personnel. All four included trials were conducted in developed Western European countries. One additional study is ongoing.The usefulness of the findings of this review for developing countries will depend on FHR monitoring practices. However, an absence of benefit and likely harm associated with admission CTG will have relevance for countries where questions are being asked about the role of the admission CTG.Future studies evaluating the effects of the admission CTG should consider including women admitted with signs of labour and before a formal diagnosis of labour. This would include a cohort of women currently having admission CTGs and not included in current trials.

Rationale and design of a randomized trial of automated hovering for post-myocardial infarction patients: The HeartStrong program.

PubMed

Troxel, Andrea B; Asch, David A; Mehta, Shivan J; Norton, Laurie; Taylor, Devon; Calderon, Tirza A; Lim, Raymond; Zhu, Jingsan; Kolansky, Daniel M; Drachman, Brian M; Volpp, Kevin G

2016-09-01

Coronary artery disease is the single leading cause of death in the United States, and medications can significantly reduce the rate of repeat cardiovascular events and treatment procedures. Adherence to these medications, however, is very low. HeartStrong is a national randomized trial offering 3 innovations. First, the intervention is built on concepts from behavioral economics that we expect to enhance its effectiveness. Second, the implementation of the trial takes advantage of new technology, including wireless pill bottles and remote feedback, to substantially automate procedures. Third, the trial's design includes an enhancement of the standard randomized clinical trial that allows rapid-cycle innovation and ongoing program enhancement. Using a system involving direct data feeds from 6 insurance partners followed by mail, telephone, and email contact, we enrolled 1,509 patients discharged from the hospital with acute myocardial infarction in a 2:1 ratio of intervention:usual care. The intervention period lasts 1 year; the primary outcome is time to first fatal or nonfatal acute vascular event or revascularization, including acute myocardial infarction, unstable angina, stroke, acute coronary syndrome admission, or death. Our randomized controlled trial of the HeartStrong program will provide an evaluation of a state-of-the-art behavioral economic intervention with a number of important pragmatic features. These include a tailored intervention responding to patient activity, streamlining of consent and implementation processes using new technologies, outcomes centrally important to patients, and the ability to implement rapid-cycle innovation. Copyright © 2016 Elsevier Inc. All rights reserved.

Systematic Review of Economic Evaluations of Units Dedicated to Acute Coronary Syndromes.

PubMed

Azeredo-Da-Silva, André Luis Ferreira; Perini, Silvana; Rigotti Soares, Pedro Henrique; Polaczyk, Carisi Anne

2016-01-01

Dedicated units for the care of acute coronary syndrome (ACS) have been submitted to economic evaluations; however, the results have not been systematically presented. To identify and summarize economic outcomes of studies on hospital units dedicated to the initial care of patients with suspected or confirmed ACS. A systematic review of literature to identify economic evaluations of chest pain unit (CPU), coronary care unit (CCU), or equivalent units was done. Two search strategies were used: the first one to identify economic evaluations irrespective of study design, and the second one to identify randomized clinical trials that reported economic outcomes. The following databases were searched: MEDLINE, EMBASE, CENTRAL, and National Health Service (NHS)Economic Evaluation Database. Data extraction was performed by two independent reviewers. Costs were inflated to 2012 values. Search strategies retrieved five partial economic evaluations based on observational studies, six randomized clinical trials that reported economic outcomes, and five model-based economic evaluations. Overall, cost estimates based on observational studies and randomized clinical trials reported statistically significant cost savings of more than 50% with the adoption of CPU care instead of routine hospitalization or CCU care for suspected low-to-intermediate risk patients with ACS (median per-patient cost US $1,969.89; range US $1,002.12-13,799.15). Model-based economic evaluations reported incremental cost-effectiveness ratios below US $ 50,000/quality-adjusted life-year for all comparisons between intermediate care unit, CPU, or CCU with routine hospital admissions. This finding was sensible to myocardial infarction probability. Published economic evaluations indicate that more intensive care is likely to be cost-effective in comparison to routine hospital admission for patients with suspected ACS. Copyright © 2016. Published by Elsevier Inc.

Use of predefined biochemical admission profiles does not reduce the number of tests or total cost: a randomized-controlled pilot study.

PubMed

Pareek, Manan; Haidl, Felix; Folkestad, Lars; Brabrand, Mikkel

2014-02-01

The objective of this pilot study was to evaluate whether the use of predefined biochemical profiles as an alternative to individually ordered blood tests by the treating physicians resulted in fewer tests or a lower total cost. This was a randomized-controlled trial of 191 adult patients admitted to a medical admission unit. Upon admission, the patients were randomized to have their blood tests determined by either using a predefined profile (used routinely and designed by the department head) or ordered individually by the treating physician. All patients were initially assessed by junior physicians. We compared the number of tests, estimated total cost, and length of stay. Data are presented as median (interquartile range). Differences were compared using the Wilcoxon rank-sum test and Fishers' exact test. Ninety-two patients were men, median age 65 years. Patients randomized to the use of the predefined profile had median 17 (14-22) blood tests drawn and patients randomized to physician discretion had median 17 (12-21) tests drawn (P=0.3). The median total cost of tests in the profile group was 618 DKK (493-803) and the cost in the physician group was 564 DKK (434-812) (P=0.19). Length of stay in the profile group was a median of 4 days (2-6 days) and 2 days (2-6 days) in the physician group (P=0.08). The use of a predefined blood test panel did not significantly affect the number of tests, total cost, or length of stay for acutely admitted medical patients compared with tests ordered at the discretion of the treating physician.

Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial.

PubMed

Schache, Margaret B; McClelland, Jodie A; Webster, Kate E

2016-06-13

Total knee arthroplasty (TKA) is effective in reducing pain and improving function for end-stage knee osteoarthritis. However, muscle weakness and functional limitations persist despite assistance from post-operative rehabilitation programs that traditionally focus on quadriceps strengthening and range of movement exercises. Hip abductor muscle weakness is evident in knee osteoarthritis and hip muscle strengthening reduces knee pain in this group. Following TKA, people with weak hip abductor strength perform more poorly on measures of physical function. However, very little is known of the effectiveness of including hip abductor strengthening exercises in post-operative rehabilitation. The aim of this trial is to compare the effects of targeted hip abductor strengthening to those of traditional care in a TKA rehabilitation program on muscle strength, patient reported outcomes and functional performance measures. This protocol describes a single-blinded randomized controlled trial, where 104 participants referred for inpatient rehabilitation following TKA will be recruited. Participants will be randomized using computer-generated numbers to one of two groups: usual care or usual care with additional hip strengthening exercises. Participants will attend physiotherapy daily during their inpatient length of stay, and will then attend between six and eight physiotherapy sessions as an outpatient. Primary outcomes are isometric hip abductor strength and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes are stair climb test, 6 min walk test, timed up and go, 40 m fast-paced walk test, 30 second chair stand test, isometric quadriceps strength, Lower Extremity Functional Scale (LEFS) and SF-12. Outcome measures will be recorded at baseline (admission to inpatient rehabilitation), and then 3 weeks, 6 weeks and 6 months post admission to rehabilitation. The findings of this study will determine whether the addition of targeted hip strengthening to usual care rehabilitation improves physical performance and patient reported outcomes following TKA when compared to usual care rehabilitation. This will then determine whether targeted hip strengthening exercises should be included in traditional rehabilitation programs to improve the outcomes following total knee arthroplasty. The trial protocol was registered with the Australian Clinical Trial Registry ( ACTRN12615000863538 ) on 18 August 2015.

Does aspirin use prevent acute coronary syndrome in patients with pneumonia: multicenter prospective randomized trial.

PubMed

Oz, Fahrettin; Gul, Sule; Kaya, Mehmet G; Yazici, Mehmet; Bulut, Ismet; Elitok, Ali; Ersin, Gunay; Abakay, Ozlem; Akkoyun, Cayan D; Oncul, Aytac; Cetinkaya, Erdogan; Gibson, Michael C; Oflaz, Huseyin

2013-05-01

The aim of this study was to test the hypothesis that aspirin would reduce the risk for acute coronary syndromes (ACSs) in patients with pneumonia. Pooled data suggest that pneumonia may trigger an ACS as a result of inflammatory reactions and the prothrombotic changes in patients with pneumonia. Hypothetically considering its antiaggregating and anti-inflammatory effects, aspirin might also be beneficial for the primary prevention of ACS in patients with pneumonia. One hundred and eighty-five patients with pneumonia who had more than one risk factor for cardiovascular disease were randomized to an aspirin group (n=91) or a control group (n=94). The patients in the aspirin group received 300 mg of aspirin daily for 1 month. ECGs were recorded on admission and 48 h and 30 days after admission to assess silent ischemia. The level of high-sensitivity cardiac troponin T was measured on admission and 48 h after admission. The primary endpoint was the development of ACS within 1 month. The secondary endpoints included cardiovascular death and death from any cause within 1 month. The χ-test showed that the rates of ACS at 1 month were 1.1% (n=1) in the aspirin group and 10.6% (n=10) in the control group (relative risk, 0.103; 95% confidence interval 0.005-0.746; P=0.015). Aspirin therapy was associated with a 9% absolute reduction in the risk for ACS. There was no significant decrease in the risk of death from any cause (P=0.151), but the aspirin group had a decreased risk of cardiovascular death (risk reduction: 0.04, P=0.044). This randomized open-label study shows that acetyl salicylic acid is beneficial in the reduction of ACS and cardiovascular mortality among patients with pneumonia.

Effects of rosuvastatin and atorvastatin on the apolipoprotein B/apolipoprotein A-1 ratio in patients with an acute coronary syndrome: The CENTAURUS trial design.

PubMed

Lablanche, Jean-Marc; Danchin, Nicolas; Farnier, Michel; Tedgui, Alain; Vicaut, Eric; Alonso, Joaquim; Crean, Peter; Leone, Attilio; Morais, Joa; Santini, Massimo; Licour, Muriel; Farah, Mohamed; Tardif, Jean-Claude

2008-06-01

The mechanism underlying rapid, statin-induced event reduction in patients with an acute coronary syndrome (ACS) remains to be clarified. The primary objective is to compare the efficacy of rosuvastatin 20 mg/day and atorvastatin 80 mg/day in reducing the apolipoprotein B/apolipoprotein A-1 (apoB/apoA-1) ratio at three months, in ACS patients. Secondary objectives include a comparison of the effects of early-started rosuvastatin and placebo on inflammatory markers. This is a randomized, double-blind, parallel-group study. Patients with non-ST-segment elevation ACS, symptom onset less than 48 h before admission, and for whom a percutaneous coronary intervention is planned, are eligible for inclusion and are randomized into three groups (G1, G2 and G3). The study comprises two double-blind periods. Period 1 starts at hospital admission and lasts until Day 0 (discharge or less or equal to 6 days after admission); patients in G1 receive one tablet of rosuvastatin 20 mg/day and patients in G2 and G3 receive one matching placebo tablet per day. Period 2 starts at Day 0 and lasts for three months; patients in G1 continue to receive rosuvastatin 20 mg/day, patients in G2 receive rosuvastatin 20 mg/day and patients in G3 receive atorvastatin 80 mg/day. Recruitment of 1075 patients will ensure an 80 power to detect a 3% difference in percentage change in the apoB/apoA-1 ratio and a 20% difference in percentage change in high-sensitivity C-reactive protein. Inclusion phase is complete; results will be reported at a later date. This is the first trial investigating the effect of statins on apolipoproteins in ACS patients.

Impact of a computer-assisted Screening, Brief Intervention and Referral to Treatment on reducing alcohol consumption among patients with hazardous drinking disorder in hospital emergency departments. The randomized BREVALCO trial.

PubMed

Duroy, David; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe; Estellat, Candice; Lejoyeux, Michel

2016-08-01

To assess the impact of a computer-assisted Screening, Brief Intervention, and Referral to Treatment (SBIRT) on daily consumption of alcohol by patients with hazardous drinking disorder detected after systematic screening during their admission to an emergency department (ED). Two-arm, parallel group, multicentre, randomized controlled trial with a centralised computer-generated randomization procedure. Four EDs in university hospitals located in the Paris area in France. Patients admitted in the ED for any reason, with hazardous drinking disorder detected after systematic screening (i.e., Alcohol Use Disorder Identification Test score ≥5 for women and 8 for men OR self-reported alcohol consumption by week ≥7 drinks for women and 14 for men). The experimental intervention was computer-assisted SBIRT and the comparator was a placebo-controlled intervention (i.e., a computer-assisted education program on nutrition). Interventions were administered in the ED and followed by phone reinforcements at 1 and 3 months. The primary outcome was the mean number of alcohol drinks per day in the previous week, at 12 months. Results From May 2005 to February 2011, 286 patients were randomized to the computer-assisted SBIRT and 286 to the comparator intervention. The two groups did not differ in the primary outcome, with an adjusted mean difference of 0.12 (95% confidence interval, -0.88 to 1.11). There was no additional benefit of the computer-assisted alcohol SBIRT as compared with the computer-assisted education program on nutrition among patients with hazardous drinking disorder detected by systematic screening during their admission to an ED. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

PubMed

Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

2017-04-01

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

Nasal Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

PubMed

Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Goyal, Kanika; Bahl, Pinky; Puliyel, Jacob M

2018-01-15

To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. Participants: 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. The outcome was assessed after 60 minutes. If nCPAP was not tolerated or the distress increased, the infant was switched to standard care. Analysis was done on intention-to-treat basis. Change in respiratory rate, Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score. 14 out of 32 in nCPAP group and 5 out of 35 in standard care group had change in respiratory rate ≥10 (P=0.008). The mean (SD) change in respiratory rate [8.0 (5.8) vs 5.1 (4.0), P=0.02] in Silverman-Anderson score [0.78 (0.87) vs 0.39 (0.73), P=0.029] and in Modified Pediatric Society of New Zealand Severity Score [2.5 (3.01) vs. 1.08 (1.3), P=0.012] were significantly different in the nCPAP and standard care groups, respectively. nCPAP helped reduce respiratory distress significantly compared to standard care.

Randomized placebo controlled trial of furosemide on subjective perception of dyspnoea in patients with pulmonary oedema because of hypertensive crisis.

PubMed

Holzer-Richling, Nina; Holzer, Michael; Herkner, Harald; Riedmüller, Eva; Havel, Christof; Kaff, Alfred; Malzer, Reinhard; Schreiber, Wolfgang

2011-06-01

To compare the administration of furosemide with placebo on the subjective perception of dyspnoea in patients with acute pulmonary oedema because of hypertensive crisis. Design  Randomized, controlled and double-blinded clinical trial. Municipal emergency medical service system and university-based emergency department. Fifty-nine patients with pulmonary oedema because of hypertensive crisis. Additional to administration of oxygen, morphine-hydrochloride and urapidil until the systolic blood pressure was below 160mmHg, the patients were randomized to receive furosemide 80mg IV bolus (furosemide group) or saline placebo (placebo group). The primary outcome was the subjective perception of dyspnoea as measured with a modified BORG scale at one hour after randomization. Secondary outcome parameters were the subjective perception of dyspnoea of patients as measured with a modified BORG scale and a visual analogue scale at 2, 3 and 6h after randomization of the patient; course of the systolic arterial pressure and peripheral oxygen saturation and lactate at admission and at 6h after admission. In 25 patients in the furosemide group and in 28 patients in the placebo group, a BORG score could be obtained. There was no statistically significant difference in the severity of dyspnoea at one hour after randomization (P=0·40). The median BORG score at 1h after randomization in the furosemide group was 3 (IQR 2 to 4) compared to 3 (IQR 2 to 7) in the placebo group (P=0·40). Those patients who were randomized to the placebo group needed higher doses of urapidil at 20min after randomization. There were no significant differences in the rate of adverse events, nonfatal cardiac arrests or death between the two groups. The subjective perception of dyspnoea in patients with hypertensive pulmonary oedema was not influenced by the application of a loop-diuretic. Therefore, additional furosemide therapy needs to be scrutinized in the therapy of these patients. © 2010 The Authors. European Journal of Clinical Investigation © 2010 Stichting European Society for Clinical Investigation Journal Foundation.

Effect of the Pulmonary Embolism Rule-Out Criteria on Subsequent Thromboembolic Events Among Low-Risk Emergency Department Patients: The PROPER Randomized Clinical Trial.

PubMed

Freund, Yonathan; Cachanado, Marine; Aubry, Adeline; Orsini, Charlotte; Raynal, Pierre-Alexis; Féral-Pierssens, Anne-Laure; Charpentier, Sandrine; Dumas, Florence; Baarir, Nacera; Truchot, Jennifer; Desmettre, Thibaut; Tazarourte, Karim; Beaune, Sebastien; Leleu, Agathe; Khellaf, Mehdi; Wargon, Mathias; Bloom, Ben; Rousseau, Alexandra; Simon, Tabassome; Riou, Bruno

2018-02-13

The safety of the pulmonary embolism rule-out criteria (PERC), an 8-item block of clinical criteria aimed at ruling out pulmonary embolism (PE), has not been assessed in a randomized clinical trial. To prospectively validate the safety of a PERC-based strategy to rule out PE. A crossover cluster-randomized clinical noninferiority trial in 14 emergency departments in France. Patients with a low gestalt clinical probability of PE were included from August 2015 to September 2016, and followed up until December 2016. Each center was randomized for the sequence of intervention periods. In the PERC period, the diagnosis of PE was excluded with no further testing if all 8 items of the PERC rule were negative. The primary end point was the occurrence of a thromboembolic event during the 3-month follow-up period that was not initially diagnosed. The noninferiority margin was set at 1.5%. Secondary end points included the rate of computed tomographic pulmonary angiography (CTPA), median length of stay in the emergency department, and rate of hospital admission. Among 1916 patients who were cluster-randomized (mean age 44 years, 980 [51%] women), 962 were assigned to the PERC group and 954 were assigned to the control group. A total of 1749 patients completed the trial. A PE was diagnosed at initial presentation in 26 patients in the control group (2.7%) vs 14 (1.5%) in the PERC group (difference, 1.3% [95% CI, -0.1% to 2.7%]; P = .052). One PE (0.1%) was diagnosed during follow-up in the PERC group vs none in the control group (difference, 0.1% [95% CI, -∞ to 0.8%]). The proportion of patients undergoing CTPA in the PERC group vs control group was 13% vs 23% (difference, -10% [95% CI, -13% to -6%]; P < .001). In the PERC group, rates were significantly reduced for the median length of emergency department stay (mean reduction, 36 minutes [95% CI, 4 to 68]) and hospital admission (difference, 3.3% [95% CI, 0.1% to 6.6%]). Among very low-risk patients with suspected PE, randomization to a PERC strategy vs conventional strategy did not result in an inferior rate of thromboembolic events over 3 months. These findings support the safety of PERC for very low-risk patients presenting to the emergency department. clinicaltrials.gov Identifier: NCT02375919.

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2015-02-01

25.0) 9 (47.4) Marital Status Single 12 (30.8) 6 (30.0) 6 (31.6) Married 20 (51.3) 11 (55.0) 9 (47.4) Cohabitating/ Unmarried Partner 1 (2.6) 0 1...inpatient stay, we have not met our recruitment goal. Please see Figure 1 below, which displays the rate of recruitment, projected vs . actual. Page

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial.

PubMed

Muscedere, John; Maslove, David; Boyd, John Gordon; O'Callaghan, Nicole; Lamontagne, Francois; Reynolds, Steven; Albert, Martin; Hall, Rick; McGolrick, Danielle; Jiang, Xuran; Day, Andrew G

2016-09-29

Nosocomial infections remain an important source of morbidity, mortality, and increased health care costs in hospitalized patients. This is particularly problematic in intensive care units (ICUs) because of increased patient vulnerability due to the underlying severity of illness and increased susceptibility from utilization of invasive therapeutic and monitoring devices. Lactoferrin (LF) and the products of its breakdown have multiple biological effects, which make its utilization of interest for the prevention of nosocomial infections in the critically ill. This is a phase II randomized, multicenter, double-blinded trial to determine the effect of LF on antibiotic-free days in mechanically ventilated, critically ill, adult patients in the ICU. Eligible, consenting patients will be randomized to receive either LF or placebo. The treating clinician will remain blinded to allocation during the study; blinding will be maintained by using opaque syringes and containers. The primary outcome will be antibiotic-free days, defined as the number of days alive and free of antibiotics 28 days after randomization. Secondary outcomes will include: antibiotic utilization, adjudicated diagnosis of nosocomial infection (longer than 72 h of admission to ICU), hospital and ICU length of stay, change in organ function after randomization, hospital and 90-day mortality, incidence of tracheal colonization, changes in gastrointestinal permeability, and immune function. Outcomes to inform the conduct of a larger definitive trial will also be evaluated, including feasibility as determined by recruitment rates and protocol adherence. The results from this study are expected to provide insight into a potential novel therapeutic use for LF in critically ill adult patients. Further, analysis of study outcomes will inform a future, large-scale phase III randomized controlled trial powered on clinically important outcomes related to the use of LF. The trial was registered at www.ClinicalTrials.gov on 18 November 2013. NCT01996579 .

Disease management program for chronic obstructive pulmonary disease: a randomized controlled trial.

PubMed

Rice, Kathryn L; Dewan, Naresh; Bloomfield, Hanna E; Grill, Joseph; Schult, Tamara M; Nelson, David B; Kumari, Sarita; Thomas, Mel; Geist, Lois J; Beaner, Caroline; Caldwell, Michael; Niewoehner, Dennis E

2010-10-01

The effect of disease management for chronic obstructive pulmonary disease (COPD) is not well established. To determine whether a simplified disease management program reduces hospital admissions and emergency department (ED) visits due to COPD. We performed a randomized, adjudicator-blinded, controlled, 1-year trial at five Veterans Affairs medical centers of 743 patients with severe COPD and one or more of the following during the previous year: hospital admission or ED visit for COPD, chronic home oxygen use, or course of systemic corticosteroids for COPD. Control group patients received usual care. Intervention group patients received a single 1- to 1.5-hour education session, an action plan for self-treatment of exacerbations, and monthly follow-up calls from a case manager. We determined the combined number of COPD-related hospitalizations and ED visits per patient. Secondary outcomes included hospitalizations and ED visits for all causes, respiratory medication use, mortality, and change in Saint George's Respiratory Questionnaire. After 1 year, the mean cumulative frequency of COPD-related hospitalizations and ED visits was 0.82 per patient in usual care and 0.48 per patient in disease management (difference, 0.34; 95% confidence interval, 0.15-0.52; P < 0.001). Disease management reduced hospitalizations for cardiac or pulmonary conditions other than COPD by 49%, hospitalizations for all causes by 28%, and ED visits for all causes by 27% (P < 0.05 for all). A relatively simple disease management program reduced hospitalizations and ED visits for COPD. Clinical trial registered with www.clinicaltrials.gov (NCT00126776).

Nutritional support for critically ill children.

PubMed

Joffe, Ari; Anton, Natalie; Lequier, Laurance; Vandermeer, Ben; Tjosvold, Lisa; Larsen, Bodil; Hartling, Lisa

2016-05-27

Nutritional support in the critically ill child has not been well investigated and is a controversial topic within paediatric intensive care. There are no clear guidelines as to the best form or timing of nutrition in critically ill infants and children. This is an update of a review that was originally published in 2009. . The objective of this review was to assess the impact of enteral and parenteral nutrition given in the first week of illness on clinically important outcomes in critically ill children. There were two primary hypotheses:1. the mortality rate of critically ill children fed enterally or parenterally is different to that of children who are given no nutrition;2. the mortality rate of critically ill children fed enterally is different to that of children fed parenterally.We planned to conduct subgroup analyses, pending available data, to examine whether the treatment effect was altered by:a. age (infants less than one year versus children greater than or equal to one year old);b. type of patient (medical, where purpose of admission to intensive care unit (ICU) is for medical illness (without surgical intervention immediately prior to admission), versus surgical, where purpose of admission to ICU is for postoperative care or care after trauma).We also proposed the following secondary hypotheses (a priori), pending other clinical trials becoming available, to examine nutrition more distinctly:3. the mortality rate is different in children who are given enteral nutrition alone versus enteral and parenteral combined;4. the mortality rate is different in children who are given both enteral feeds and parenteral nutrition versus no nutrition. In this updated review we searched: the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 2); Ovid MEDLINE (1966 to February 2016); Ovid EMBASE (1988 to February 2016); OVID Evidence-Based Medicine Reviews; ISI Web of Science - Science Citation Index Expanded (1965 to February 2016); WebSPIRS Biological Abstracts (1969 to February 2016); and WebSPIRS CAB Abstracts (1972 to February 2016). We also searched trial registries, reviewed reference lists of all potentially relevant studies, handsearched relevant conference proceedings, and contacted experts in the area and manufacturers of enteral and parenteral nutrition products. We did not limit the search by language or publication status. We included studies if they were randomized controlled trials; involved paediatric patients, aged one day to 18 years of age, who were cared for in a paediatric intensive care unit setting (PICU) and had received nutrition within the first seven days of admission; and reported data for at least one of the pre-specified outcomes (30-day or PICU mortality; length of stay in PICU or hospital; number of ventilator days; and morbid complications, such as nosocomial infections). We excluded studies if they only reported nutritional outcomes, quality of life assessments, or economic implications. Furthermore, we did not address other areas of paediatric nutrition, such as immunonutrition and different routes of delivering enteral nutrition, in this review. Two authors independently screened the searches, applied the inclusion criteria, and performed 'Risk of bias' assessments. We resolved discrepancies through discussion and consensus. One author extracted data and a second checked data for accuracy and completeness. We graded the evidence based on the following domains: study limitations, consistency of effect, imprecision, indirectness, and publication bias. We identified only one trial as relevant. Seventy-seven children in intensive care with burns involving more than 25% of the total body surface area were randomized to either enteral nutrition within 24 hours or after at least 48 hours. No statistically significant differences were observed for mortality, sepsis, ventilator days, length of stay, unexpected adverse events, resting energy expenditure, nitrogen balance, or albumin levels. We assessed the trial as having unclear risk of bias. We consider the quality of the evidence to be very low due to there being only one small trial. In the most recent search update we identified a protocol for a relevant randomized controlled trial examining the impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients; no results have been published. There was only one randomized trial relevant to the review question. Research is urgently needed to identify best practices regarding the timing and forms of nutrition for critically ill infants and children.

Adaptive adjustment of the randomization ratio using historical control data.

PubMed

Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

2013-01-01

Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

N-Acetylcysteine as adjunctive treatment in severe malaria: A randomized double blinded placebo controlled clinical trial

PubMed Central

Charunwatthana, Prakaykaew; Faiz, M. Abul; Ruangveerayut, Ronnatrai; Maude, Richard; Rahman, M. Ridwanur; Roberts, L. Jackson; Moore, Kevin; Yunus, Emran Bin; Hoque, M. Gofranul; Hasan, Mahatab Uddin; Lee, Sue J.; Pukrittayakamee, Sasithon; Newton, Paul N.; White, Nicholas J.; Day, Nicholas P.J.; Dondorp, Arjen M.

2009-01-01

Objective Markers of oxidative stress are reported to be increased in severe malaria. It has been suggested that the antioxidant N-acetylcysteine (NAC) may be beneficial in treatment. We studied the efficacy and safety of parenteral N-acetylcysteine as an adjunct to artesunate treatment of severe falciparum malaria. Design A randomized double-blind placebo controlled trial on the use of high dose intravenous NAC as adjunctive treatment to artesunate. Setting A provincial hospital in Western Thailand and a tertiary referral hospital in Chittagong, Bangladesh. Patients One hundred and eight adult patients with severe falciparum malaria. Interventions Patients were randomized to receive N-acetylcysteine or placebo as adjunctive treatment to intravenous artesunate. Measurements and main results A total of 56 patients were treated with NAC and 52 received placebo. NAC had no significant effect on mortality, lactate clearance times (p=0.74) or coma recovery times (p=0.46). Parasite clearance time was increased from 30h (range 6h to 144h) to 36h (range 6h to 120h) (p=0.03), but this could be explained by differences in admission parasitemia. Urinary F2-isoprostane metabolites, measured as a marker of oxidative stress, were increased in severe malaria compared to patients with uncomplicated malaria and healthy volunteers. Admission red cell rigidity correlated with mortality, but did not improve with NAC. Conclusion Systemic oxidative stress is increased in severe malaria. Treatment with N-acetylcysteine had no effect on outcome in patients with severe falciparum malaria in this setting. PMID:19114891

The Effects of Oxygen Therapy on Myocardial Salvage in ST Elevation Myocardial Infarction Treated with Acute Percutaneous Coronary Intervention: The Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion (SOCCER) Study.

PubMed

Khoshnood, Ardavan; Carlsson, Marcus; Akbarzadeh, Mahin; Bhiladvala, Pallonji; Roijer, Anders; Bodetoft, Stefan; Höglund, Peter; Zughaft, David; Todorova, Lizbet; Erlinge, David; Ekelund, Ulf

2015-01-01

Despite a lack of scientific evidence, oxygen has long been a part of standard treatment for patients with acute myocardial infarction (AMI). However, several studies suggest that oxygen therapy may have negative cardiovascular effects. We here describe a randomized controlled trial, i.e. Supplemental Oxygen in Catheterized Coronary Emergency Reperfusion (SOCCER), aiming to evaluate the effect of oxygen therapy on myocardial salvage and infarct size in patients with ST elevation myocardial infarction (STEMI) treated with a primary percutaneous coronary intervention (PCI). One hundred normoxic STEMI patients accepted for a primary PCI are randomized in the ambulance to either standard oxygen therapy or no supplemental oxygen. All patients undergo cardiovascular magnetic resonance imaging (CMR) 2-6 days after the primary PCI, and a subgroup of 50 patients undergo an extended echocardiography during admission and at 6 months. All patients are followed for 6 months for hospital admission for heart failure and subjective perception of health. The primary endpoint is the myocardial salvage index on CMR. Even though oxygen therapy is a part of standard care, oxygen may not be beneficial for patients with AMI and is possibly even harmful. The results of the present and concurrent oxygen trials may change international treatment guidelines for patients with AMI or ischemia.

An international randomized study of a home-based self-management program for severe COPD: the COMET.

PubMed

Bourbeau, Jean; Casan, Pere; Tognella, Silvia; Haidl, Peter; Texereau, Joëlle B; Kessler, Romain

2016-01-01

Most hospitalizations and costs related to COPD are due to exacerbations and insufficient disease management. The COPD patient Management European Trial (COMET) is investigating a home-based multicomponent COPD self-management program designed to reduce exacerbations and hospital admissions. Multicenter parallel randomized controlled, open-label superiority trial. Thirty-three hospitals in four European countries. A total of 345 patients with Global initiative for chronic Obstructive Lung Disease III/IV COPD. The program includes extensive patient coaching by health care professionals to improve self-management (eg, develop skills to better manage their disease), an e-health platform for reporting frequent health status updates, rapid intervention when necessary, and oxygen therapy monitoring. Comparator is the usual management as per the center's routine practice. Yearly number of hospital days for acute care, exacerbation number, quality of life, deaths, and costs.

Effect of a Pediatric Early Warning System on All-Cause Mortality in Hospitalized Pediatric Patients: The EPOCH Randomized Clinical Trial.

PubMed

Parshuram, Christopher S; Dryden-Palmer, Karen; Farrell, Catherine; Gottesman, Ronald; Gray, Martin; Hutchison, James S; Helfaer, Mark; Hunt, Elizabeth A; Joffe, Ari R; Lacroix, Jacques; Moga, Michael Alice; Nadkarni, Vinay; Ninis, Nelly; Parkin, Patricia C; Wensley, David; Willan, Andrew R; Tomlinson, George A

2018-03-13

There is limited evidence that the use of severity of illness scores in pediatric patients can facilitate timely admission to the intensive care unit or improve patient outcomes. To determine the effect of the Bedside Paediatric Early Warning System (BedsidePEWS) on all-cause hospital mortality and late admission to the intensive care unit (ICU), cardiac arrest, and ICU resource use. A multicenter cluster randomized trial of 21 hospitals located in 7 countries (Belgium, Canada, England, Ireland, Italy, New Zealand, and the Netherlands) that provided inpatient pediatric care for infants (gestational age ≥37 weeks) to teenagers (aged ≤18 years). Participating hospitals had continuous physician staffing and subspecialized pediatric services. Patient enrollment began on February 28, 2011, and ended on June 21, 2015. Follow-up ended on July 19, 2015. The BedsidePEWS intervention (10 hospitals) was compared with usual care (no severity of illness score; 11 hospitals). The primary outcome was all-cause hospital mortality. The secondary outcome was a significant clinical deterioration event, which was defined as a composite outcome reflecting late ICU admission. Regression analyses accounted for hospital-level clustering and baseline rates. Among 144 539 patient discharges at 21 randomized hospitals, there were 559 443 patient-days and 144 539 patients (100%) completed the trial. All-cause hospital mortality was 1.93 per 1000 patient discharges at hospitals with BedsidePEWS and 1.56 per 1000 patient discharges at hospitals with usual care (adjusted between-group rate difference, 0.01 [95% CI, -0.80 to 0.81 per 1000 patient discharges]; adjusted odds ratio, 1.01 [95% CI, 0.61 to 1.69]; P = .96). Significant clinical deterioration events occurred during 0.50 per 1000 patient-days at hospitals with BedsidePEWS vs 0.84 per 1000 patient-days at hospitals with usual care (adjusted between-group rate difference, -0.34 [95% CI, -0.73 to 0.05 per 1000 patient-days]; adjusted rate ratio, 0.77 [95% CI, 0.61 to 0.97]; P = .03). Implementation of the Bedside Paediatric Early Warning System compared with usual care did not significantly decrease all-cause mortality among hospitalized pediatric patients. These findings do not support the use of this system to reduce mortality. clinicaltrials.gov Identifier: NCT01260831.

Adaptive adjustment of the randomization ratio using historical control data

PubMed Central

Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

2013-01-01

Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

The Seamless Transfer-of-Care Protocol: a randomized controlled trial assessing the efficacy of an electronic transfer-of-care communication tool.

PubMed

Okoniewska, Barbara M; Santana, Maria J; Holroyd-Leduc, Jayna; Flemons, Ward; O'Beirne, Maeve; White, Deborah; Clement, Fiona; Forster, Alan; Ghali, William A

2012-11-21

The transition between acute care and community care represents a vulnerable period in health care delivery. The vulnerability of this period has been attributed to changes to patients' medication regimens during hospitalization, failure to reconcile discrepancies between admission and discharge and the burdening of patients/families to take over care responsibilities at discharge and to relay important information to the primary care physician. Electronic communication platforms can provide an immediate link between acute care and community care physicians (and other community providers), designed to ensure consistent information transfer. This study examines whether a transfer-of-care (TOC) communication tool is efficacious and cost-effective for reducing hospital readmission, adverse events and adverse drug events as well as reducing death. A randomized controlled trial conducted on the Medical Teaching Unit of a Canadian tertiary care centre will evaluate the efficacy and cost-effectiveness of a TOC communication tool. Medical in-patients admitted to the unit will be considered for this study. Data will be collected upon admission, and a total of 1400 patients will be randomized. The control group's acute care stay will be summarized using a traditional dictated summary, while the intervention group will have a summary generated using the TOC communication tool. The primary outcome will be a composite, at 3 months, of death or readmission to any Alberta acute-care hospital. Secondary outcomes will be the occurrence of post-discharge adverse events and adverse drug events at 1 month post discharge. Patients with adverse outcomes will have their cases reviewed by two Royal College certified internists or College-certified family physicians, blinded to patients' group assignments, to determine the type, severity, preventability and ameliorability of all detected adverse outcomes. An accompanying economic evaluation will assess the cost per life saved, cost per readmission avoided and cost per QALY gained with the TOC communication tool compared to traditional dictation summaries. This paper outlines the study protocol for a randomized controlled trial evaluating an electronic transfer-of-care communication tool, with sufficient statistical power to assess the impact of the tool on the significant outcomes of post-discharge death or readmission. The study findings will inform health systems around the world on the potential benefits of such tools, and the value for money associated with their widespread implementation. ClinicalTrials.gov NCT01402609.

Orthogeriatric care: improving patient outcomes

PubMed Central

Tarazona-Santabalbina, Francisco José; Belenguer-Varea, Ángel; Rovira, Eduardo; Cuesta-Peredó, David

2016-01-01

Hip fractures are a very serious socio-economic problem in western countries. Since the 1950s, orthogeriatric units have introduced improvements in the care of geriatric patients admitted to hospital because of hip fractures. During this period, these units have reduced mean hospital stays, number of complications, and both in-hospital mortality and mortality over the middle term after hospital discharge, along with improvements in the quality of care and a reduction in costs. Likewise, a recent clinical trial has reported greater functional gains among the affected patients. Studies in this field have identified the prognostic factors present upon admission or manifesting themselves during admission and that increase the risk of patient mortality or disability. In addition, improved care afforded by orthogeriatric units has proved to reduce costs. Nevertheless, a number of management issues remain to be clarified, such as the optimum anesthetic, analgesic, and thromboprophylactic protocols; the type of diagnostic and therapeutic approach best suited to patients with cognitive problems; or the efficiency of the programs used in convalescence units or in home rehabilitation care. Randomized clinical trials are needed to consolidate the evidence in this regard. PMID:27445466

Randomized Trial of Complete Versus Lesion-Only Revascularization in Patients Undergoing Primary Percutaneous Coronary Intervention for STEMI and Multivessel Disease

PubMed Central

Gershlick, Anthony H.; Khan, Jamal Nasir; Kelly, Damian J.; Greenwood, John P.; Sasikaran, Thiagarajah; Curzen, Nick; Blackman, Daniel J.; Dalby, Miles; Fairbrother, Kathryn L.; Banya, Winston; Wang, Duolao; Flather, Marcus; Hetherington, Simon L.; Kelion, Andrew D.; Talwar, Suneel; Gunning, Mark; Hall, Roger; Swanton, Howard; McCann, Gerry P.

2015-01-01

Background The optimal management of patients found to have multivessel disease while undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction is uncertain. Objectives CvLPRIT (Complete versus Lesion-only Primary PCI trial) is a U.K. open-label randomized study comparing complete revascularization at index admission with treatment of the infarct-related artery (IRA) only. Methods After they provided verbal assent and underwent coronary angiography, 296 patients in 7 U.K. centers were randomized through an interactive voice-response program to either in-hospital complete revascularization (n = 150) or IRA-only revascularization (n = 146). Complete revascularization was performed either at the time of P-PCI or before hospital discharge. Randomization was stratified by infarct location (anterior/nonanterior) and symptom onset (≤3 h or >3 h). The primary endpoint was a composite of all-cause death, recurrent myocardial infarction (MI), heart failure, and ischemia-driven revascularization within 12 months. Results Patient groups were well matched for baseline clinical characteristics. The primary endpoint occurred in 10.0% of the complete revascularization group versus 21.2% in the IRA-only revascularization group (hazard ratio: 0.45; 95% confidence interval: 0.24 to 0.84; p = 0.009). A trend toward benefit was seen early after complete revascularization (p = 0.055 at 30 days). Although there was no significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. There was no reduction in ischemic burden on myocardial perfusion scintigraphy or in the safety endpoints of major bleeding, contrast-induced nephropathy, or stroke between the groups. Conclusions In patients presenting for P-PCI with multivessel disease, index admission complete revascularization significantly lowered the rate of the composite primary endpoint at 12 months compared with treating only the IRA. In such patients, inpatient total revascularization may be considered, but larger clinical trials are required to confirm this result and specifically address whether this strategy is associated with improved survival. (Complete Versus Lesion-only Primary PCI Pilot Study [CvLPRIT]; ISRCTN70913605) PMID:25766941

Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial.

PubMed

Marchetti, Federico; Maestro, Alessandra; Rovere, Francesca; Zanon, Davide; Arrighini, Alberto; Bertolani, Paolo; Biban, Paolo; Da Dalt, Liviana; Di Pietro, Pasquale; Renna, Salvatore; Guala, Andrea; Mannelli, Francesco; Pazzaglia, Anna; Messi, Gianni; Perri, Francesco; Reale, Antonino; Urbino, Antonio Francesco; Valletta, Enrico; Vitale, Antonio; Zangardi, Tiziana; Tondelli, Maria Teresa; Clavenna, Antonio; Bonati, Maurizio; Ronfani, Luca

2011-02-10

Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled. The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results. ClinicalTrials.gov: NCT01257672.

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2014-02-01

updates on any changes to the IRB or submission process and to answer any questions. Attendance is prioritized to maintain a relationship with the...inclusion, which would assess areas related to social support and integration, use of prescription, drugs , readiness to engage in treatment, and...inclusion/exclusion criteria  (4) TBI, psychosis , cognitive impairment  (90) Ideation without attempt  (6) Not active duty, retired, or veteran  30

Post Admission Cognitive Therapy (PACT) for the Inpatient Treatment of Military Personnel with Suicidal Behaviors: A Multi-Site Randomized Controlled Trial

DTIC Science & Technology

2013-02-01

author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. 1...Operations and Reports (0704-0188), 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302. Respondents should be aware that...required, WRNMMC credentialing office will NOT renew privileges unless a peer review can be conducted. However, as it currently stands, peer review

Cardiac Valve Noise Reduction by Non-Drug Interventions Improves the Sleep Quality of Patients after Mechanical Cardiac Valve Implantation.

PubMed

Lin, Yanjuan; Xu, Le; Huang, Xizhen; Jiang, Fei; Lin, Fen; Ye, Qingyang; Lin, Jianling

2016-01-01

To investigate the effects of non-drug interventions on the sleep quality of patients after mechanical cardiac valve implantation. In this prospective, randomized, controlled trial, 64 patients scheduled for mechanical mitral valve replacement were recruited. Patients underwent cognitive behavioral therapy and wore noise cancelling earplugs and eye mask. Sleep quality was evaluated on the 4th after admission and the 5th days after operation. The primary outcome was the total sleep quality score differences between the 4th day after admission and the 5th day after operation. All patients had been suffering from poor sleep quality for a month before admission. There was no difference between both groups on the 4th day after admission. Overall sleep quality in the intervention group was better than in the control group on the 5th day after operation. The subjective sleep quality of the patients in each group was significantly lower on the 5th day after the operation than on the 4th day after admission (P <0.05). Non-drug intervention could improve the sleep quality of patients after mechanical cardiac valve implantation and help the postoperative recovery of the patients. ( ChiCTR-TRC-14004405, 21 March 2014.).

Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial.

PubMed

Bergamin, Fabricio S; Almeida, Juliano P; Landoni, Giovanni; Galas, Filomena R B G; Fukushima, Julia T; Fominskiy, Evgeny; Park, Clarice H L; Osawa, Eduardo A; Diz, Maria P E; Oliveira, Gisele Q; Franco, Rafael A; Nakamura, Rosana E; Almeida, Elisangela M; Abdala, Edson; Freire, Maristela P; Filho, Roberto K; Auler, Jose Otavio C; Hajjar, Ludhmila A

2017-05-01

To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Single center, randomized, double-blind controlled trial. Teaching hospital. Adult cancer patients with septic shock in the first 6 hours of ICU admission. Patients were randomized to the liberal (hemoglobin threshold, < 9 g/dL) or to the restrictive strategy (hemoglobin threshold, < 7 g/dL) of RBC transfusion during ICU stay. Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.

Five Year Follow-Up of a Randomized Controlled Trial on Warming and Humidification of Insufflation Gas in Laparoscopic Colonic Surgery—Impact on Small Bowel Obstruction and Oncologic Outcomes

PubMed Central

Sammour, Tarik; Hill, Andrew G.

2015-01-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA. PMID:25875541

Five year follow-up of a randomized controlled trial on warming and humidification of insufflation gas in laparoscopic colonic surgery--impact on small bowel obstruction and oncologic outcomes.

PubMed

Sammour, Tarik; Hill, Andrew G

2015-04-01

Warming and humidification of insufflation gas has been shown to reduce adhesion formation and tumor implantation in the laboratory setting, but clinical evidence is lacking. We aimed to test the hypothesis that warming and humidification of insufflation CO2 would lead to reduced adhesion formation, and improve oncologic outcomes in laparoscopic colonic surgery. This was a 5-year follow-up of a multicenter, double-blinded, randomized, controlled trial investigating warming and humidification of insufflation gas. The study group received warmed (37°C), humidified (98%) insufflation carbon dioxide, and the control group received standard gas (19°C, 0%). All other aspects of patient care were standardized. Admissions for small bowel obstruction were recorded, as well as whether management was operative or nonoperative. Local and systemic cancer recurrence, 5-year overall survival, and cancer specific survival rates were also recorded. Eighty two patients were randomized, with 41 in each arm. Groups were well matched at baseline. There was no difference between the study and control groups in the rate of clinical small bowel obstruction (5.7% versus 0%, P 0.226); local recurrence (6.5% versus 6.1%, P 1.000); overall survival (85.7% versus 82.1%, P 0.759); or cancer-specific survival (90.3% versus 87.9%, P 1.000). Warming and humidification of insufflation CO2 in laparoscopic colonic surgery does not appear to confer a clinically significant long term benefit in terms of adhesion reduction or oncological outcomes, although a much larger randomized controlled trial (RCT) would be required to confirm this. ClinicalTrials.gov Trial identifier: NCT00642005; US National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894, USA.

Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

PubMed

Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

2014-12-01

To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%). Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs. clinicaltrials.gov Identifier: NCT01602159.

Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study).

PubMed

Gill, Thomas M; Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

2016-02-03

To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Eight centers across the United States, February 2010 to December 2011. 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m. A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Influence of Prior Heart Failure Hospitalization on Cardiovascular Events in Patients with Reduced and Preserved Ejection Fraction

PubMed Central

Bello, Natalie A.; Claggett, Brian; Desai, Akshay S.; McMurray, John J.V.; Granger, Christopher B.; Yusuf, Salim; Swedberg, Karl; Pfeffer, Marc A.; Solomon, Scott D.

2014-01-01

Background Hospitalization for acute heart failure (HF) is associated with high rates of subsequent mortality and readmission. We assessed the influence of the time interval between prior HF hospitalization and randomization in the CHARM trials on clinical outcomes in patients with both reduced and preserved ejection fraction. Methods and Results CHARM enrolled 7,599 patients with NYHA class II-IV heart failure, of whom 5,426 had a history of prior HF hospitalization. Cox proportional hazards regression models were utilized to assess the association between time from prior HF hospitalization and randomization and the primary outcome of cardiovascular death or unplanned admission to hospital for the management of worsening HF over a median of 36.6 months. For patients with HF and reduced (HFrEF) or preserved (HFpEF) ejection fraction, rates of CV mortality and HF hospitalization were higher among patients with prior HF hospitalization than those without. The risk for mortality and hospitalization varied inversely with the time interval between hospitalization and randomization. Rates were higher for HFrEF patients within each category. Event rates for those with HFpEF and a HF hospitalization in the 6 months prior to randomization were comparable to the rate in HFrEF patients with no prior HF hospitalization. Conclusions Rates of CV death or HF hospitalization are greatest in those who have been previously hospitalized for HF. Independent of EF, rates of death and readmission decline as time from HF hospitalization to trial enrollment increased. Recent HF hospitalization identifies a high risk population for future clinical trials in HFrEF and HFpEF. Clinical Trial Registration URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00634400. PMID:24874200

Effect of structured physical activity on prevention of serious fall injuries in adults aged 70-89: randomized clinical trial (LIFE Study)

PubMed Central

Pahor, Marco; Guralnik, Jack M; McDermott, Mary M; King, Abby C; Buford, Thomas W; Strotmeyer, Elsa S; Nelson, Miriam E; Sink, Kaycee M; Demons, Jamehl L; Kashaf, Susan S; Walkup, Michael P; Miller, Michael E

2016-01-01

Objective To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations. Design Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study). Setting Eight centers across the United States, February 2010 to December 2011. Participants 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤9, but who were able to walk 400 m. Interventions A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises. Main outcome measures Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis. Results Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction). Conclusions In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men. Trial registration ClinicalsTrials.gov NCT01072500. PMID:26842425

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial.

PubMed

Kalfon, Pierre; Baumstarck, Karine; Estagnasie, Philippe; Geantot, Marie-Agnès; Berric, Audrey; Simon, Georges; Floccard, Bernard; Signouret, Thomas; Boucekine, Mohamed; Fromentin, Mélanie; Nyunga, Martine; Sossou, Achille; Venot, Marion; Robert, René; Follin, Arnaud; Audibert, Juliette; Renault, Anne; Garrouste-Orgeas, Maïté; Collange, Olivier; Levrat, Quentin; Villard, Isabelle; Thevenin, Didier; Pottecher, Julien; Patrigeon, René-Gilles; Revel, Nathalie; Vigne, Coralie; Azoulay, Elie; Mimoz, Olivier; Auquier, Pascal

2017-12-01

Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients. Clinicaltrials.gov Identifier NCT02442934.

Design of the effect of adaptive servo-ventilation on survival and cardiovascular hospital admissions in patients with heart failure and sleep apnoea: the ADVENT-HF trial.

PubMed

Lyons, Owen D; Floras, John S; Logan, Alexander G; Beanlands, Robert; Cantolla, Joaquin Durán; Fitzpatrick, Michael; Fleetham, John; John Kimoff, R; Leung, Richard S T; Lorenzi Filho, Geraldo; Mayer, Pierre; Mielniczuk, Lisa; Morrison, Debra L; Ryan, Clodagh M; Series, Frederic; Tomlinson, George A; Woo, Anna; Arzt, Michael; Parthasarathy, Sairam; Redolfi, Stefania; Kasai, Takatoshi; Parati, Gianfranco; Delgado, Diego H; Bradley, T Douglas

2017-04-01

Both types of sleep-disordered breathing (SDB), obstructive and central sleep apnoea (OSA and CSA, respectively), are common in patients with heart failure and reduced ejection fraction (HFrEF). In such patients, SDB is associated with increased cardiovascular morbidity and mortality but it remains uncertain whether treating SDB by adaptive servo-ventilation (ASV) in such patients reduces morbidity and mortality. ADVENT-HF is designed to assess the effects of treating SDB with ASV on morbidity and mortality in patients with HFrEF. ADVENT-HF is a multicentre, multinational, randomized, parallel-group, open-label trial with blinded assessment of endpoints of standard medical therapy for HFrEF alone vs. with the addition of ASV in patients with HFrEF and SDB. Patients with a history of HFrEF undergo echocardiography and polysomnography. Those with a left ventricular ejection fraction ≤45% and SDB (apnoea-hypopnoea index ≥15) are eligible. SDB is stratified into OSA with ≥50% of events obstructive or CSA with >50% of events central. Those with OSA must not have excessive daytime sleepiness (Epworth score of ≤10). Patients are then randomized to receive or not receive ASV. The primary outcome is the composite of all-cause mortality, cardiovascular hospital admissions, new-onset atrial fibrillation requiring anti-coagulation but not hospitalization, and delivery of an appropriate discharge from an implantable cardioverter-defibrillator not resulting in hospitalization during a maximum follow-up time of 5 years. The ADVENT-HF trial will help to determine whether treating SDB by ASV in patients with HFrEF improves morbidity and mortality. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

A randomized controlled trial of movement strategies compared with exercise for people with Parkinson's disease.

PubMed

Morris, Meg E; Iansek, Robert; Kirkwood, Beth

2009-01-15

This randomized controlled clinical trial was conducted to compare the effects of movement rehabilitation strategies and exercise therapy in hospitalized patients with idiopathic Parkinson's disease. Participants were randomly assigned to a group that received movement strategy training or musculoskeletal exercises during 2 consecutive weeks of hospitalization. The primary outcome was disability as measured by the Unified Parkinson's Disease Rating Scale, UPDRS (motor and ADL components). Secondary outcomes were balance, walking speed, endurance, and quality of life. Assessments were carried out by blinded testers at baseline, after the 2 weeks of treatment and 3 months after discharge. The movement strategy group showed improvements on several outcome measures from admission to discharge, including the UPDRS, 10 m walk, 2 minute walk, balance, and PDQ39. However, from discharge to follow up there was significant regression in performance on the 2 minute walk and PDQ39. For the exercise group, quality of life improved significantly during inpatient hospitalization and this was retained at follow-up. Inpatient rehabilitation produces short term reductions in disability and improvements in quality of life in people with Parkinson's disease.

The metabolic and renal effects of adrenaline and milrinone in patients with myocardial dysfunction after coronary artery bypass grafting

PubMed Central

Heringlake, Matthias; Wernerus, Marit; Grünefeld, Julia; Klaus, Stephan; Heinze, Hermann; Bechtel, Matthias; Bahlmann, Ludger; Poeling, Jochen; Schön, Julika

2007-01-01

Introduction Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot study analyzes the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary artery bypass grafting (CABG). Methods During an 18-month period, 251 patients were screened for low cardiac output upon intensive care unit (ICU) admission after elective, isolated CABG surgery. Patients presenting with a cardiac index (CI) of less than 2.2 liters/minute per square meter upon ICU admission – despite adequate mean arterial (titrated with noradrenaline or sodium nitroprusside) and filling pressures – were randomly assigned to 14-hour treatment with adrenaline (n = 7) or milrinone (n = 11) to achieve a CI of greater than 3.0 liters/minute per square meter. Twenty patients not needing inotropes served as controls. Hemodynamics, plasma lactate, pyruvate, glucose, acid-base status, insulin requirements, the urinary excretion of alpha-1-microglobuline, and creatinine clearance were determined during the treatment period, and cystatin-C levels were determined up to 48 hours after surgery (follow-up period). Results After two to four hours after ICU admission, the target CI was achieved in both intervention groups and maintained during the observation period. Plasma lactate, pyruvate, the lactate/pyruvate ratio, plasma glucose, and insulin doses were higher (p < 0.05) in the adrenaline-treated patients than during milrinone or control conditions. The urinary excretion of alpha-1-microglobuline was higher in the adrenaline than in the control group 6 to 14 hours after admission (p < 0.05). No between-group differences were observed in creatinine clearance, whereas plasma cystatin-C levels were significantly higher in the adrenaline than in the milrinone or the control group after 48 hours (p < 0.05). Conclusion This suggests that the use of adrenaline for the treatment of postoperative myocardial dysfunction – in contrast to treatment with the PDE-III inhibitor milrinone – is associated with unwarranted metabolic and renal effects. Clinical trials registration: ClinicalTrials.gov NCT00446017. PMID:17470271

Promoting Activity in Geriatric Rehabilitation: A Randomized Controlled Trial of Accelerometry.

PubMed

Peel, Nancye M; Paul, Sanjoy K; Cameron, Ian D; Crotty, Maria; Kurrle, Susan E; Gray, Leonard C

2016-01-01

Low activity levels in inpatient rehabilitation are associated with adverse outcomes. The study aimed to test whether activity levels can be increased by the provision of monitored activity data to patients and clinicians in the context of explicit goal setting. A randomized controlled trial in three sites in Australia included 255 inpatients aged 60 and older who had a rehabilitation goal to become ambulant. The primary outcome was patients' walking time measured by accelerometers during the rehabilitation admission. Walking times from accelerometry were made available daily to treating therapists and intervention participants to motivate patients to improve incidental activity levels and reach set goals. For the control group, 'usual care' was followed, including the setting of mobility goals; however, for this group, neither staff nor patients received data on walking times to aid the setting of daily walking time targets. The median daily walking time in the intervention group increased from 10.3 minutes at baseline to 32.1 minutes at day 28, compared with an increase from 9.5 to 26.5 minutes per day in the control group. Subjects in the intervention group had significantly higher non-therapy walking time by about 7 minutes [mean (95% CI): 24.6 (21.7, 27.4)] compared to those in the control group [mean(95% CI): 17.3 (14.4, 20.3)] (p = 0.001). Daily feedback to patients and therapists using an accelerometer increased walking times during rehabilitation admissions. The results of this study suggest objective monitoring of activity levels could provide clinicians with information on clinically important, mobility-related activities to assist goal setting. Australian New Zealand Clinical Trials Registry ACTRN12611000034932 http://www.ANZCTR.org.au/.

Randomised crossover trial of telemonitoring in chronic respiratory patients (TeleCRAFT trial)

PubMed Central

Chatwin, M; Hawkins, G; Panicchia, L; Woods, A; Hanak, A; Lucas, R; Baker, E; Ramhamdany, E; Mann, B; Riley, J; Cowie, M R; Simonds, A K

2016-01-01

Objective To assess the impact of home telemonitoring on health service use and quality of life in patients with severe chronic lung disease. Design Randomised crossover trial with 6 months of standard best practice clinical care (control group) and 6 months with the addition of telemonitoring. Participants 68 patients with chronic lung disease (38 with COPD; 30 with chronic respiratory failure due to other causes), who had a hospital admission for an exacerbation within 6 months of randomisation and either used long-term oxygen therapy or had an arterial oxygen saturation (SpO2) of <90% on air during the previous admission. Individuals received telemonitoring (second-generation system) via broadband link to a hospital-based care team. Outcome measures Primary outcome measure was time to first hospital admission for an acute exacerbation. Secondary outcome measures were hospital admissions, general practitioner (GP) consultations and home visits by nurses, quality of life measured by EuroQol-5D and hospital anxiety and depression (HAD) scale, and self-efficacy score (Stanford). Results Median (IQR) number of days to first admission showed no difference between the two groups—77 (114) telemonitoring, 77.5 (61) control (p=0.189). Hospital admission rate at 6 months increased (0.63 telemonitoring vs 0.32 control p=0.026). Home visits increased during telemonitoring; GP consultations were unchanged. Self-efficacy fell, while HAD depression score improved marginally during telemonitoring. Conclusions Telemonitoring added to standard care did not alter time to next acute hospital admission, increased hospital admissions and home visits overall, and did not improve quality of life in chronic respiratory patients. Trial registration number NCT02180919 (ClinicalTrials.gov). PMID:26962013

Healthcare utilization in adults with opioid dependence receiving extended release naltrexone compared to treatment as usual.

PubMed

Soares, William E; Wilson, Donna; Rathlev, Niels; Lee, Joshua D; Gordon, Michael; Nunes, Edward V; O'Brien, Charles P; Friedmann, Peter D

2018-02-01

Opioid use disorders have reached epidemic proportions, with overdose now the leading cause of accidental death in the United States. Extended release naltrexone (XR-NTX) has emerged as a medication treatment that reduces opioid use and craving. However, the effect of XR-NTX therapy on acute healthcare utilization, including emergency department visits and inpatient hospitalizations, remains uncertain. The objective of the current study is to evaluate hospital-based healthcare resource utilization in adults involved in the criminal justice system with a history of opioid use disorder randomized to XR-NTX therapy compared with treatment as usual (TAU) during a 6-month treatment phase and 12months post-treatment follow up. This retrospective exploratory analysis uses data collected in a published randomized trial. Comparisons of the number of emergency department visits and hospital admissions (for drug detox, psychiatric care and other medical reasons) were performed using chi square tests for any admission and negative binomial models for number of admissions. Of the 308 participants randomized, 96% had utilization data (76% complete 6months, 67% complete follow up). No significant differences were seen in overall healthcare utilization (IRR=0.88, 95%CI 0.63-1.23, p=0.45), or substance use-related drug detox hospitalizations (IRR=0.83, 95%CI 0.32-2.16, p=0.71). Despite having more participants report chronic medical problems at baseline (43% vs. 32%, p=0.05), those receiving XR-NTX generally experienced equivalent or lower rates of healthcare utilization compared to TAU. The XR-NTX group had significantly lower medical/surgical related hospital admissions (IRR=0.55, 95%CI 0.30-1.00, p=0.05) during the course of the entire study. XR-NTX did not significantly increase rates of healthcare utilization compared to TAU. Provider concerns regarding healthcare utilization should not preclude the consideration of XR-NTX as therapy for opioid use disorders. Copyright © 2018 Elsevier Inc. All rights reserved.

Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

PubMed Central

2011-01-01

Background Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. Objectives To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. Methods/Design Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled. Discussion The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results. Trial Registration ClinicalTrials.gov: NCT01257672 PMID:21310051

The role of adding metformin in insulin-resistant diabetic pregnant women: a randomized controlled trial.

PubMed

Ibrahim, Moustafa Ibrahim; Hamdy, Ahmed; Shafik, Adel; Taha, Salah; Anwar, Mohammed; Faris, Mohammed

2014-05-01

The aim of the present study is to assess the impact of adding oral metformin to insulin therapy in pregnant women with insulin-resistant diabetes mellitus. The current non-inferiority randomized controlled trial was conducted at Ain Shams University Maternity Hospital. The study included pregnant women with gestational or pre-existing diabetes mellitus at gestations between 20 and 34 weeks, who showed insulin resistance (defined as poor glycemic control at a daily dose of ≥1.12 units/kg). Recruited women were randomized into one of two groups: group I, including women who received oral metformin without increasing the insulin dose; and group II, including women who had their insulin dose increased. The primary outcome was maternal glycemic control. Secondary outcomes included maternal bouts of hypoglycemia, need for another hospital admission for uncontrolled diabetes during pregnancy, gestational age at delivery, mode of delivery, birth weight, birth trauma, congenital anomalies, 1- and 5-min Apgar score, neonatal hypoglycemia, need for neonatal intensive care unit (NICU) admission and adverse neonatal outcomes. A total number of 154 women with diabetes mellitus with pregnancy were approached; of them 90 women were eligible and were randomly allocated and included in the final analysis. The recruited 90 women were randomized into one of two groups: group I (metformin group) (n = 46), including women who received oral metformin in addition to the same initial insulin dose; and group II (control group) (n = 44), including women who had their insulin dose increased according to the standard protocol. The mean age of included women was 29.84 ± 5.37 years (range 20-42 years). The mean gestational age at recruitment was 28.7 ± 3.71 weeks (range 21-34 weeks). Among the 46 women of group I, 17 (36.9 %) women reached proper glycemic control at a daily metformin dose of 1,500 mg, 18 (39.2 %) at a daily dose of 2,000 mg, while 11 (23.9 %) received metformin at a daily dose of 2,000 mg without reaching proper glycemic control and needed raising the dose of insulin dose. Adding metformin to insulin therapy in women with insulin-resistant diabetes mellitus with pregnancy seems to be effective in proper glycemic control in a considerable proportion of women, along with benefits of reduced hospital stay, reduced frequency of maternal hypoglycemia as well as reduced frequency of neonatal hypoglycemia, NICU admission and neonatal respiratory distress syndrome.

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

PubMed

Becker, Jan; Beutel, Manfred E; Gerzymisch, Katharina; Schulz, Dirk; Siepmann, Martin; Knickenberg, Rudolf J; Schmädeke, Stefan; Ferdinand, Peter; Zwerenz, Rüdiger

2016-06-13

Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation. All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform. We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation. ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

PubMed

Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim

2017-05-01

The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up. This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint, but it improved health-related quality of life and depression. A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care. Clinicaltrials.gov identifier: NCT00533013 . Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.

Malaria and nutritional status among children with severe acute malnutrition in Niger: a prospective cohort study.

PubMed

Oldenburg, Catherine E; Guerin, Philippe J; Berthé, Fatou; Grais, Rebecca F; Isanaka, Sheila

2018-03-07

The relationship between malaria infection and nutritional status is complex and previous studies suggest malaria may increase the incidence and severity of malnutrition while malnutrition may increase the risk of malaria infection. Here, we report bi-directional associations between malaria and nutritional status among children with uncomplicated severe acute malnutrition (SAM). The present study is a secondary analysis of a randomized controlled trial for the treatment of uncomplicated SAM in Niger. Children between 6-59 months were enrolled and followed for 12 weeks. Malaria infection was assessed using an HRP2 rapid diagnostic test at admission and at any follow-up visit with fever. We assessed the association of 1) nutritional status at admission on malaria incidence using Cox proportional hazards regression, and 2) malaria infection at admission on nutritional recovery, weight and height gain using linear regression. Of 2,399 children included in the analysis, 1,327 (55.3%) were infected with malaria at admission. Malaria incidence was 12.1 cases per 100 person-months among those without malaria infection at admission. Nutritional status at admission was not associated with malaria incidence. Children with malaria infection at admission, subsequently treated with an artemisinin based combination therapy, had increased weight gain (0.38 g/kg/day, 95% confidence interval [CI] 0.07 to 0.69) and reduced height gain (-0.002 mm/day, 95% CI -0.004 to -0.0008). Malaria infection was common among children treated for uncomplicated SAM. Malaria infection may impair height gain. Proper medical and nutritional management should be assured to prevent adverse effects of malaria infection.

Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial.

PubMed

Mistraletti, Giovanni; Mantovani, Elena S; Cadringher, Paolo; Cerri, Barbara; Corbella, Davide; Umbrello, Michele; Anania, Stefania; Andrighi, Elisa; Barello, Serena; Di Carlo, Alessandra; Martinetti, Federica; Formenti, Paolo; Spanu, Paolo; Iapichino, Gaetano

2013-04-03

A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake. Clinicaltrials.gov #NCT01360346.

Costs and effects of screening and treating low risk women with a singleton pregnancy for asymptomatic bacteriuria, the ASB study

PubMed Central

2012-01-01

Background The prevalence of asymptomatic bacteriuria (ASB) in pregnancy is 2-10% and is associated with both maternal and neonatal adverse outcomes as pyelonephritis and preterm delivery. Antibiotic treatment is reported to decrease these adverse outcomes although the existing evidence is of poor quality. Methods/Design We plan a combined screen and treat study in women with a singleton pregnancy. We will screen women between 16 and 22 weeks of gestation for ASB using the urine dipslide technique. The dipslide is considered positive when colony concentration ≥105 colony forming units (CFU)/mL of a single microorganism or two different colonies but one ≥105 CFU/mL is found, or when Group B Streptococcus bacteriuria is found in any colony concentration. Women with a positive dipslide will be randomly allocated to receive nitrofurantoin or placebo 100 mg twice a day for 5 consecutive days (double blind). Primary outcomes of this trial are maternal pyelonephritis and/or preterm delivery before 34 weeks. Secondary outcomes are neonatal and maternal morbidity, neonatal weight, time to delivery, preterm delivery rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal admission days and costs. Discussion This trial will provide evidence for the benefit and cost-effectiveness of dipslide screening for ASB among low risk women at 16–22 weeks of pregnancy and subsequent nitrofurantoin treatment. Trial registration Dutch trial registry: NTR-3068 PMID:22892110

Assessment and prevalence of pulmonary oedema in contemporary acute heart failure trials: a systematic review.

PubMed

Platz, Elke; Jhund, Pardeep S; Campbell, Ross T; McMurray, John J

2015-09-01

Pulmonary oedema is a common and important finding in acute heart failure (AHF). We conducted a systematic review to describe the methods used to assess pulmonary oedema in recent randomized AHF trials and report its prevalence in these trials. Of 23 AHF trials published between 2002 and 2013, six were excluded because they were very small or not randomized, or missing full-length publications. Of the remaining 17 (n = 200-7141) trials, six enrolled patients with HF and reduced ejection fraction (HF-REF) and 11, patients with both HF-REF and HF with preserved ejection fraction (HF-PEF). Pulmonary oedema was an essential inclusion criterion, in most trials, based upon findings on physical examination ('rales'), radiographic criteria ('signs of congestion'), or both. The prevalence of pulmonary oedema in HF-REF trials ranged from 75% to 83% and in combined HF-REF and HF-PEF trials from 51% to 100%. Five trials did not report the prevalence or extent of pulmonary oedema assessed by either clinical examination or chest x-ray. Improvement of pulmonary congestion with treatment was inconsistently reported and commonly grouped with other signs of congestion into a score. One trial suggested that patients with rales over >2/3 of the lung fields on admission were at higher risk of adverse outcomes than those without. Although pulmonary oedema is a common finding in AHF, represents a therapeutic target, and may be of prognostic importance, recent trials used inconsistent criteria to define it, and did not consistently report its severity at baseline or its response to treatment. Consistent and ideally quantitative, methods for the assessment of pulmonary oedema in AHF trials are needed. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

PubMed

Borstlap, W A A; Buskens, C J; Tytgat, K M A J; Tuynman, J B; Consten, E C J; Tolboom, R C; Heuff, G; van Geloven, N; van Wagensveld, B A; C A Wientjes, C A; Gerhards, M F; de Castro, S M M; Jansen, J; van der Ven, A W H; van der Zaag, E; Omloo, J M; van Westreenen, H L; Winter, D C; Kennelly, R P; Dijkgraaf, M G W; Tanis, P J; Bemelman, W A

2015-06-28

At least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. In this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity. ClincalTrials.gov: NCT02243735 .

Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge: a randomized controlled trial.

PubMed

Beck, Anne Marie; Kjær, Stine; Hansen, Birthe Stenbæk; Storm, Rikke Lunau; Thal-Jantzen, Kirsten; Bitz, Christian

2013-06-01

To assess the additional benefits of individualized nutritional counselling by a registered dietitian in geriatric patients' home after discharge from hospital, in relation to risk of re-admissions, functional status, nutritional status, use of social services and mortality. Twelve-week single-blind randomized controlled study. Geriatric medical patients (65+ years) at nutritional risk. Participants were randomly allocated to receive a visit in their homes, either three individualized nutritional counselling by a registered dietitian complemented with three follow-up visits by general practitioners or three follow-up visits by general practitioners alone. Primary outcome was risk of re-admissions. Secondary outcomes were functional status (hand grip strength, chair stand, mobility, disability and tiredness in daily activities, rehabilitation capacity), nutritional status (weight, BMI, energy and protein intake), need of social services (home care, home nursing, meals-on-wheels) and mortality. One hundred and fifty-two patients were included; 132 (87%) completed the first and 124 (82%) the second data collection after 12 weeks. Ten per cent of the participants had three contacts with their general practitioner, while compliance with the dietetic intervention was almost 100%. Odds ratio for re-admission and mortality after 26 weeks was 1.62 (95% confidence interval (CI) 0.85 to 3.10) and 0.60 (95% CI 0.17 to 2.13). The intervention had a positive effect on functional status (i.e. mobility, P = 0.029), and nutritional status (i.e. weight, P = 0.035; energy intake, P < 0.001; protein intake, P = 0.001) and the use of meals-on wheels was reduced (P = 0.084). Follow-up home visits with registered dietitians have a positive effect on the functional and nutritional status of geriatric medical patients after discharge.

Treatment of abnormal vaginal flora in early pregnancy with clindamycin for the prevention of spontaneous preterm birth: a systematic review and metaanalysis

PubMed Central

Lamont, Ronald F.; Nhan-Chang, Chia-Ling; Sobel, Jack D.; Workowski, Kimberly; Conde-Agudelo, Agustin; Romero, Roberto

2011-01-01

The purpose of this study was to determine whether the administration of clindamycin to women with abnormal vaginal flora at <22 weeks of gestation reduces the risk of preterm birth and late miscarriage. We conducted a systematic review and metaanalysis of randomized controlled trials of the early administration of clindamycin to women with abnormal vaginal flora at <22 weeks of gestation. Five trials that comprised 2346 women were included. Clindamycin that was administered at <22 weeks of gestation was associated with a significantly reduced risk of preterm birth at <37 weeks of gestation and late miscarriage. There were no overall differences in the risk of preterm birth at <33 weeks of gestation, low birthweight, very low birthweight, admission to neonatal intensive care unit, stillbirth, peripartum infection, and adverse effects. Clindamycin in early pregnancy in women with abnormal vaginal flora reduces the risk of spontaneous preterm birth at <37 weeks of gestation and late miscarriage. There is evidence to justify further randomized controlled trials of clindamycin for the prevention of preterm birth. However, a deeper understanding of the vaginal microbiome, mucosal immunity, and the biology of bacterial vaginosis will be needed to inform the design of such trials. PMID:22071048

Is ursodeoxycholic acid effective for intrahepatic cholestasis of pregnancy?

PubMed

Sepúlveda Marín, Sebastián; Contreras Maragaño, Valeria; Vera, Claudio

2016-01-08

Intrahepatic cholestasis of pregnancy is a condition associated with fetal morbidity and mortality. Ursodeoxycholic acid has been proposed as a treatment alternative, but its use remains controversial. Searching in Epistemonikos database, which is maintained by screening 30 databases, we identified three systematic reviews including eight randomized trials. We combined the evidence using meta-analysis and generated a summary of findings table following the GRADE approach. We concluded ursodeoxycholic acid reduces prematurity risk and need for admission in neonatal intensive care units. It might also reduce maternal pruritus.

Biomarkers from distinct biological pathways improve early risk stratification in medical emergency patients: the multinational, prospective, observational TRIAGE study.

PubMed

Schuetz, Philipp; Hausfater, Pierre; Amin, Devendra; Amin, Adina; Haubitz, Sebastian; Faessler, Lukas; Kutz, Alexander; Conca, Antoinette; Reutlinger, Barbara; Canavaggio, Pauline; Sauvin, Gabrielle; Bernard, Maguy; Huber, Andreas; Mueller, Beat

2015-10-29

Early risk stratification in the emergency department (ED) is vital to reduce time to effective treatment in high-risk patients and to improve patient flow. Yet, there is a lack of investigations evaluating the incremental usefulness of multiple biomarkers measured upon admission from distinct biological pathways for predicting fatal outcome and high initial treatment urgency in unselected ED patients in a multicenter and multinational setting. We included consecutive, adult, medical patients seeking ED care into this observational, cohort study in Switzerland, France and the USA. We recorded initial clinical parameters and batch-measured prognostic biomarkers of inflammation (pro-adrenomedullin [ProADM]), stress (copeptin) and infection (procalcitonin). During a 30-day follow-up, 331 of 7132 (4.6 %) participants reached the primary endpoint of death within 30 days. In logistic regression models adjusted for conventional risk factors available at ED admission, all three biomarkers strongly predicted the risk of death (AUC 0.83, 0.78 and 0.75), ICU admission (AUC 0.67, 0.69 and 0.62) and high initial triage priority (0.67, 0.66 and 0.58). For the prediction of death, ProADM significantly improved regression models including (a) clinical information available at ED admission (AUC increase from 0.79 to 0.84), (b) full clinical information at ED discharge (AUC increase from 0.85 to 0.88), and (c) triage information (AUC increase from 0.67 to 0.83) (p <0.01 for each comparison). Similarly, ProADM also improved clinical models for prediction of ICU admission and high initial treatment urgency. Results were robust in regard to predefined patient subgroups by center, main diagnosis, presenting symptoms, age and gender. Combination of clinical information with results of blood biomarkers measured upon ED admission allows early and more adequate risk stratification in individual unselected medical ED patients. A randomized trial is needed to answer the question whether biomarker-guided initial patient triage reduces time to initial treatment of high-risk patients in the ED and thereby improves patient flow and clinical outcomes. ClinicalTrials.gov NCT01768494 . Registered January 9, 2013.

Reducing medical service utilization by encouraging vaccines: randomized controlled trial.

PubMed

Berg, Gregory D; Thomas, Eileen; Silverstein, Steven; Neel, Cheryl L; Mireles, Matthew

2004-11-01

Vaccination against influenza is associated with reductions in hospitalizations for heart disease, cerebrovascular disease, pneumonia, or influenza, and the risk of death from all causes during the influenza season. Randomized controlled trial. All members enrolled in the Blue Cross Blue Shield Association's Government Wide Service Benefit Program in the states of Oklahoma, Rhode Island, Kentucky, California, Arizona, Utah, and Colorado in October 2002. The sample size was 339,220 members. Two identical influenza/pneumonia direct mail marketing pieces that encouraged members to receive influenza and pneumococcal vaccinations. The study period was October 15, 2002 through March 15, 2003 when most influenza cases occur. Data were collected in July 2003 and analyzed during August 2003. Administrative claims based on influenza/pneumonia inpatient admissions and emergency department (ED) visits. The intervention group experienced a 2.62% (p=0.010) higher rate of influenza vaccinations; 4.61% (p=0.080) higher rate of pneumonia vaccinations; 9.67% (p=0.136) lower rate of influenza/pneumonia inpatient admissions; and 22.64% (p=0.002) lower rate of influenza/pneumonia ED visits compared to the control group. The benefit-cost ratio (return on investment) from this intervention was estimated to be US dollar 2.21 per dollar spent. Administrative claims data suggest that members respond to health plan mailings with an increase in influenza vaccination rates. Health plans can cost-effectively impact medical service utilization and vaccination rates by mailing information to their members.

Black Clouds vs Random Variation in Hospital Admissions.

PubMed

Ong, Luei Wern; Dawson, Jeffrey D; Ely, John W

2018-06-01

Physicians often accuse their peers of being "black clouds" if they repeatedly have more than the average number of hospital admissions while on call. Our purpose was to determine whether the black-cloud phenomenon is real or explainable by random variation. We analyzed hospital admissions to the University of Iowa family medicine service from July 1, 2010 to June 30, 2015. Analyses were stratified by peer group (eg, night shift attending physicians, day shift senior residents). We analyzed admission numbers to find evidence of black-cloud physicians (those with significantly more admissions than their peers) and white-cloud physicians (those with significantly fewer admissions). The statistical significance of whether there were actual differences across physicians was tested with mixed-effects negative binomial regression. The 5-year study included 96 physicians and 6,194 admissions. The number of daytime admissions ranged from 0 to 10 (mean 2.17, SD 1.63). Night admissions ranged from 0 to 11 (mean 1.23, SD 1.22). Admissions increased from 1,016 in the first year to 1,523 in the fifth year. We found 18 white-cloud and 16 black-cloud physicians in simple regression models that did not control for this upward trend. After including study year and other potential confounding variables in the regression models, there were no significant associations between physicians and admission numbers and therefore no true black or white clouds. In this study, apparent black-cloud and white-cloud physicians could be explained by random variation in hospital admissions. However, this randomness incorporated a wide range in workload among physicians, with potential impact on resident education at the low end and patient safety at the high end.

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

Efficacy and safety of withholding antimicrobial treatment in children with cancer, fever and neutropenia, with a demonstrated viral respiratory infection: a randomized clinical trial.

PubMed

Santolaya, M E; Alvarez, A M; Acuña, M; Avilés, C L; Salgado, C; Tordecilla, J; Varas, M; Venegas, M; Villarroel, M; Zubieta, M; Toso, A; Bataszew, A; Farfán, M J; de la Maza, V; Vergara, A; Valenzuela, R; Torres, J P

2017-03-01

To determine efficacy and safety of withholding antimicrobials in children with cancer, fever and neutropenia (FN) with a demonstrated respiratory viral infection. Prospective, multicentre, randomized study in children presenting with FN at five hospitals in Santiago, Chile, evaluated at admission for diagnosis of bacterial and viral pathogens including PCR-microarray for 17 respiratory viruses. Children positive for a respiratory virus, negative for a bacterial pathogen and with a favourable evolution after 48 h of antimicrobial therapy were randomized to either maintain or withhold antimicrobials. Primary endpoint was percentage of episodes with uneventful resolution. Secondary endpoints were days of fever/hospitalization, bacterial infection, sepsis, admission to paediatric intensive care unit (PICU) and death. A total of 319 of 951 children with FN episodes recruited between July 2012 and December 2015 had a respiratory virus as a unique identified microorganism, of which 176 were randomized, 92 to maintain antimicrobials and 84 to withdraw. Median duration of antimicrobial use was 7 days (range 7-9 days) versus 3 days (range 3-4 days), with similar frequency of uneventful resolution (89/92 (97%) and 80/84 (95%), respectively, not significant; OR 1.48; 95% CI 0.32-6.83, p 0.61), and similar number of days of fever (2 versus 1), days of hospitalization (6 versus 6) and bacterial infections throughout the episode (2%-1%), with one case of sepsis requiring admission to PICU in the group that maintained antimicrobials, without any deaths. The reduction of antimicrobials in children with FN and respiratory viral infections, based on clinical and microbiological/molecular diagnostic criteria, should favour the adoption of evidence-based management strategies in this population. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial.

PubMed

van Zijl, Maud D; Koullali, Bouchra; Naaktgeboren, Christiana A; Schuit, Ewoud; Bekedam, Dick J; Moll, Etelka; Oudijk, Martijn A; van Baal, Wilhelmina M; de Boer, Marjon A; Visser, Henricus; van Drongelen, Joris; van de Made, Flip W; Vollebregt, Karlijn C; Muller, Moira A; Bekker, Mireille N; Brons, Jozien T J; Sueters, Marieke; Langenveld, Josje; Franssen, Maureen T; Schuitemaker, Nico W; van Beek, Erik; Scheepers, Hubertina C J; de Boer, Karin; Tepe, Eveline M; Huisjes, Anjoke J M; Hooker, Angelo B; Verheijen, Evelyn C J; Papatsonis, Dimitri N; Mol, Ben Willem J; Kazemier, Brenda M; Pajkrt, Eva

2017-09-04

Preterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments. The Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16-22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study. Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first. Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs. This trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples. Trial registration number: NTR 4414 . Date of registration January 29th 2014.

Is cost effectiveness sustained after weekend inpatient rehabilitation? 12 month follow up from a randomized controlled trial.

PubMed

Brusco, Natasha Kareem; Watts, Jennifer J; Shields, Nora; Taylor, Nicholas F

2015-04-18

Our previous work showed that providing additional rehabilitation on a Saturday was cost effective in the short term from the perspective of the health service provider. This study aimed to evaluate if providing additional rehabilitation on a Saturday was cost effective at 12 months, from a health system perspective inclusive of private costs. Cost effectiveness analyses alongside a single-blinded randomized controlled trial with 12 months follow up inclusive of informal care. Participants were adults admitted to two publicly funded inpatient rehabilitation facilities. The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus additional Saturday rehabilitation. Incremental cost effectiveness ratios were reported as cost per quality adjusted life year (QALY) gained and for a minimal clinical important difference (MCID) in functional independence. A total of 996 patients [mean age 74 years (SD 13)] were randomly assigned to the intervention (n = 496) or control group (n = 500). The intervention was associated with improvements in QALY and MCID in function, as well as a non-significant reduction in cost from admission to 12 months (mean difference (MD) AUD$6,325; 95% CI -4,081 to 16,730; t test p = 0.23 and MWU p = 0.06), and a significant reduction in cost from admission to 6 months (MD AUD$6,445; 95% CI 3,368 to 9,522; t test p = 0.04 and MWU p = 0.01). There is a high degree of certainty that providing additional rehabilitation services on Saturday is cost effective. Sensitivity analyses varying the cost of informal carers and self-reported health service utilization, favored the intervention. From a health system perspective inclusive of private costs the provision of additional Saturday rehabilitation for inpatients is likely to have sustained cost savings per QALY gained and for a MCID in functional independence, for the inpatient stay and 12 months following discharge, without a cost shift into the community. Australian and New Zealand Clinical Trials Registry November 2009 ACTRN12609000973213.

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications. Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation. This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. Methods/design The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo. Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. Trial registration ISRCTN69423238; EudraCT number: 2010-019469-26 PMID:24947817

A Blinded Randomized Controlled Trial of Motivational Interviewing to Improve Adherence with Osteoporosis Medications: Design of the OPTIMA Trial

PubMed Central

Solomon, Daniel H.; Gleeson, Timothy; Iversen, Maura; Avorn, Jerome; Brookhart, M. Alan; Lii, Joyce; Losina, Elena; May, Frank; Patrick, Amanda; Shrank, William H.; Katz, Jeffrey N.

2010-01-01

Purpose While many effective treatments exist for osteoporosis, most people do not adhere to such treatments long-term. No proven interventions exist to improve osteoporosis medication adherence. We report here on the design and initial enrollment in an innovative randomized controlled trial aimed at improving adherence to osteoporosis treatments. Methods The trial represents a collaboration between academic researchers and a state-run pharmacy benefits program for low-income older adults. Beneficiaries beginning treatment with a medication for osteoporosis are targeted for recruitment. We randomize consenting individuals to receive 12-months of mailed education (control arm) or an intervention consisting of one-on-one telephone-based counseling and the mailed education. Motivational Interviewing forms the basis for the counseling program which is delivered by seven trained and supervised health counselors over ten telephone calls. The counseling sessions include scripted dialogue, open-ended questions about medication adherence and its barriers, as well as structured questions. The primary endpoint of the trial is medication adherence measured over the 12-month intervention period. Secondary endpoints include fractures, nursing home admissions, health care resource utilization, and mortality. Results During the first 7 months of recruitment, we have screened 3,638 potentially eligible subjects. After an initial mailing, 1,115 (30.6%) opted out of telephone recruitment and 1,019 (28.0%) could not be successfully contacted. Of the remaining, 879 (24.2%) consented to participate and were randomized. Women comprise over 90% of all groups, mean ages range from 77–80 years old, and the majority in all groups was white. The distribution of osteoporosis medications was comparable across groups and the median number of different prescription drugs used in the prior year was 8–10. Conclusions We have developed a novel intervention for improving osteoporosis medication adherence. The intervention is currently being tested in a large scale randomized controlled trial. If successful, the intervention may represent a useful model for improving adherence to other chronic treatments. PMID:19436935

Role of massage therapy on reduction of neonatal hyperbilirubinemia in term and preterm neonates: a review of clinical trials.

PubMed

Garg, Bhawan Deep; Kabra, Nandkishor S; Balasubramanian, Haribalakrishna

2017-09-13

Neonatal hyperbilirubinemia (NNH) is one of the leading causes of admissions in nursery throughout the world. It affects approximately 2.4-15% of neonates during the first 2 weeks of life. To evaluate the role of massage therapy for reduction of NNH in both term and preterm neonates. The literature search was done for various randomized control trials (RCTs) by searching the Cochrane Library, PubMed, and EMBASE. This review included total of 10 RCTs (two in preterm neonates and eight in term neonates) that fulfilled inclusion criteria. In most of the trials, Field massage was given. Six out of eight trials reported reduction in bilirubin levels in term neonates. However, only one trial (out of two) reported significant reduction in bilirubin levels in preterm neonates. Both trials in preterm neonates and most of the trials in term neonates (five trials) reported increased stool frequencies. Role of massage therapy in the management of NNH is supported by the current evidence. However, due to limitations of the trials, current evidences are not sufficient to use massage therapy for the management of NNH in routine practice.

Continuing or Temporarily Stopping Prestroke Antihypertensive Medication in Acute Stroke: An Individual Patient Data Meta-Analysis.

PubMed

Woodhouse, Lisa J; Manning, Lisa; Potter, John F; Berge, Eivind; Sprigg, Nikola; Wardlaw, Joanna; Lees, Kennedy R; Bath, Philip M; Robinson, Thompson G

2017-05-01

Over 50% of patients are already taking blood pressure-lowering therapy on hospital admission for acute stroke. An individual patient data meta-analysis from randomized controlled trials was undertaken to determine the effect of continuation versus temporarily stopping preexisting antihypertensive medication in acute stroke. Key databases were searched for trials against the following inclusion criteria: randomized design; stroke onset ≤48 hours; investigating the effect of continuation versus stopping prestroke antihypertensive medication; and follow-up of ≥2 weeks. Two randomized controlled trials were identified and included in this meta-analysis of individual patient data from 2860 patients with ≤48 hours of acute stroke. Risk of bias in each study was low. In adjusted logistic regression and multiple regression analyses (using random effects), we found no significant association between continuation of prestroke antihypertensive therapy (versus stopping) and risk of death or dependency at final follow-up: odds ratio 0.96 (95% confidence interval, 0.80-1.14). No significant associations were found between continuation (versus stopping) of therapy and secondary outcomes at final follow-up. Analyses for death and dependency in prespecified subgroups revealed no significant associations with continuation versus temporarily stopping therapy, with the exception of patients randomized ≤12 hours, in whom a difference favoring stopping treatment met statistical significance. We found no significant benefit with continuation of antihypertensive treatment in the acute stroke period. Therefore, there is no urgency to administer preexisting antihypertensive therapy in the first few hours or days after stroke, unless indicated for other comorbid conditions. © 2017 American Heart Association, Inc.

A multicenter randomized clinical trial investigating the cost-effectiveness of treatment strategies with or without antibiotics for uncomplicated acute diverticulitis (DIABOLO trial).

PubMed

Unlü, Cağdaş; de Korte, Niels; Daniels, Lidewine; Consten, Esther C J; Cuesta, Miguel A; Gerhards, Michael F; van Geloven, Anna A W; van der Zaag, Edwin S; van der Hoeven, Joost A B; Klicks, Rutger; Cense, Huib A; Roumen, Rudi M H; Eijsbouts, Quirijn A J; Lange, Johan F; Fockens, Paul; de Borgie, Corianne A J M; Bemelman, Wilem A; Reitsma, Johannes B; Stockmann, Hein B A C; Vrouenraets, Bart C; Boermeester, Marja A

2010-07-20

Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects. A randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included. A clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach. NCT01111253.

Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study)

PubMed Central

Hegarty, Joanne Elizabeth; Harding, Jane Elizabeth; Gamble, Gregory David; Crowther, Caroline Anne; Edlin, Richard; Alsweiler, Jane Marie

2016-01-01

Background Neonatal hypoglycaemia is common, affecting up to 15% of newborns, and can cause brain damage. Currently, there are no strategies, beyond early feeding, to prevent neonatal hypoglycaemia. Our aim was to determine a dose of 40% oral dextrose gel that will prevent neonatal hypoglycaemia in newborn babies at risk. Methods and Findings We conducted a randomised, double-blind, placebo-controlled dose-finding trial of buccal dextrose gel to prevent neonatal hypoglycaemia at two hospitals in New Zealand. Babies at risk of hypoglycaemia (infant of a mother with diabetes, late preterm delivery, small or large birthweight, or other risk factors) but without indication for admission to a neonatal intensive care unit (NICU) were randomly allocated either to one of four treatment groups: 40% dextrose at one of two doses (0.5 ml/kg = 200 mg/kg, or 1 ml/kg = 400 mg/kg), either once at 1 h of age or followed by three additional doses of dextrose (0.5 ml/kg before feeds in the first 12 h); or to one of four corresponding placebo groups. Treatments were administered by massaging gel into the buccal mucosa. The primary outcome was hypoglycaemia (<2.6 mM) in the first 48 h. Secondary outcomes included admission to a NICU, admission for hypoglycaemia, and breastfeeding at discharge and at 6 wk. Prespecified potential dose limitations were tolerance of gel, time taken to administer, messiness, and acceptability to parents. From August 2013 to November 2014, 416 babies were randomised. Compared to babies randomised to placebo, the risk of hypoglycaemia was lowest in babies randomised to a single dose of 200 mg/kg dextrose gel (relative risk [RR] 0.68; 95% confidence interval [CI] 0.47–0.99, p = 0.04) but was not significantly different between dose groups (p = 0.21). Compared to multiple doses, single doses of gel were better tolerated, quicker to administer, and less messy, but these limitations were not different between dextrose and placebo gel groups. Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo (RR 0.79; 95% CI 0.64–0.98, p = 0.03; number needed to treat = 10, 95% CI 5–115). Rates of NICU admission were similar (RR 0.64; 95% CI 0.33–1.25, p = 0.19), but admission for hypoglycaemia was less common in babies randomised to dextrose gel (RR 0.46; 95% CI 0.21–1.01, p = 0.05). Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. A limitation of this study was that most of the babies in the trial were infants of mothers with diabetes (73%), which may reduce the applicability of the results to babies from other risk groups. Conclusions The incidence of neonatal hypoglycaemia can be reduced with a single dose of buccal 40% dextrose gel 200 mg/kg. A large randomised trial (Hypoglycaemia Prevention with Oral Dextrose [hPOD]) is under way to determine the effects on NICU admission and later outcomes. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12613000322730 PMID:27780197

Prophylactic Oral Dextrose Gel for Newborn Babies at Risk of Neonatal Hypoglycaemia: A Randomised Controlled Dose-Finding Trial (the Pre-hPOD Study).

PubMed

Hegarty, Joanne Elizabeth; Harding, Jane Elizabeth; Gamble, Gregory David; Crowther, Caroline Anne; Edlin, Richard; Alsweiler, Jane Marie

2016-10-01

Neonatal hypoglycaemia is common, affecting up to 15% of newborns, and can cause brain damage. Currently, there are no strategies, beyond early feeding, to prevent neonatal hypoglycaemia. Our aim was to determine a dose of 40% oral dextrose gel that will prevent neonatal hypoglycaemia in newborn babies at risk. We conducted a randomised, double-blind, placebo-controlled dose-finding trial of buccal dextrose gel to prevent neonatal hypoglycaemia at two hospitals in New Zealand. Babies at risk of hypoglycaemia (infant of a mother with diabetes, late preterm delivery, small or large birthweight, or other risk factors) but without indication for admission to a neonatal intensive care unit (NICU) were randomly allocated either to one of four treatment groups: 40% dextrose at one of two doses (0.5 ml/kg = 200 mg/kg, or 1 ml/kg = 400 mg/kg), either once at 1 h of age or followed by three additional doses of dextrose (0.5 ml/kg before feeds in the first 12 h); or to one of four corresponding placebo groups. Treatments were administered by massaging gel into the buccal mucosa. The primary outcome was hypoglycaemia (<2.6 mM) in the first 48 h. Secondary outcomes included admission to a NICU, admission for hypoglycaemia, and breastfeeding at discharge and at 6 wk. Prespecified potential dose limitations were tolerance of gel, time taken to administer, messiness, and acceptability to parents. From August 2013 to November 2014, 416 babies were randomised. Compared to babies randomised to placebo, the risk of hypoglycaemia was lowest in babies randomised to a single dose of 200 mg/kg dextrose gel (relative risk [RR] 0.68; 95% confidence interval [CI] 0.47-0.99, p = 0.04) but was not significantly different between dose groups (p = 0.21). Compared to multiple doses, single doses of gel were better tolerated, quicker to administer, and less messy, but these limitations were not different between dextrose and placebo gel groups. Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo (RR 0.79; 95% CI 0.64-0.98, p = 0.03; number needed to treat = 10, 95% CI 5-115). Rates of NICU admission were similar (RR 0.64; 95% CI 0.33-1.25, p = 0.19), but admission for hypoglycaemia was less common in babies randomised to dextrose gel (RR 0.46; 95% CI 0.21-1.01, p = 0.05). Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. A limitation of this study was that most of the babies in the trial were infants of mothers with diabetes (73%), which may reduce the applicability of the results to babies from other risk groups. The incidence of neonatal hypoglycaemia can be reduced with a single dose of buccal 40% dextrose gel 200 mg/kg. A large randomised trial (Hypoglycaemia Prevention with Oral Dextrose [hPOD]) is under way to determine the effects on NICU admission and later outcomes. Australian New Zealand Clinical Trials Registry ACTRN12613000322730.

A Randomized Trial of Heart Failure Disease Management in Skilled Nursing Facilities: Design and Rationale

PubMed Central

Boxer, Rebecca S.; Dolansky, Mary A.; Bodnar, Christine A.; Singer, Mendel E.; Albert, Jeffery M.; Gravenstein, Stefan

2013-01-01

Background Heart failure disease management can improve health outcomes for older community dwelling patients with heart failure. Heart failure disease management has not been studied in skilled nursing facilities, a major site of transitional care for older adults. Methods and Anticipated Results The objective of this trial is to investigate if a heart failure disease management program (HF-DMP) in skilled nursing facilities (SNF) will decrease all-cause rehospitalizations for the first 60 days post SNF admission. The trial is a randomized cluster trial to be conducted in 12 for-profit SNF in the greater Cleveland area. The study population is inclusive of patients with heart failure regardless of ejection fraction but excludes those patients on dialysis and with a life expectancy of 6 months or less. The HF-DMP includes 7 elements considered standard of care for patients with heart failure: documentation of left ventricular function, tracking of weight and symptoms, medication titration, discharge instructions, 7 day follow up appointment post SNF discharge, patient education. The HF-DMP is conducted by a research nurse tasked with adhering to each element of the program and regularly audited to maintain fidelity of the program. Additional outcomes include health status, self-care management, and discharge destination. Conclusion The SNF-Connect Trial is the first trial of its kind to assess if a HF-DMP will improve outcomes for patients in SNFs. This trial will provide evidence on the effectiveness of HF-DMP to improve outcomes for older frail heart failure patients undergoing post-acute rehabilitation. PMID:23871475

A randomized trial of heart failure disease management in skilled nursing facilities: design and rationale.

PubMed

Boxer, Rebecca S; Dolansky, Mary A; Bodnar, Christine A; Singer, Mendel E; Albert, Jeffery M; Gravenstein, Stefan

2013-09-01

Heart failure (HF) disease management can improve health outcomes for older community dwelling patients with heart failure. HF disease management has not been studied in skilled nursing facilities, a major site of transitional care for older adults. The objective of this trial is to investigate if a HF- disease management program (HF-DMP) in skilled nursing facilities (SNF)s will decrease all-cause rehospitalizations for the first 60 days post-SNF admission. The trial is a randomized cluster trial to be conducted in 12 for-profit SNF in the greater Cleveland area. The study population is inclusive of patients with HF regardless of ejection fraction but excludes those patients on dialysis and with a life expectancy of 6 months or less. The HF-DMP includes 7 elements considered standard of care for patients with HF documentation of left ventricular function, tracking of weight and symptoms, medication titration, discharge instructions, 7-day follow-up appointment post-SNF discharge, and patient education. The HF-DMP is conducted by a research nurse tasked with adhering to each element of the program and regularly audited to maintain fidelity of the program. Additional outcomes include health status, self-care management, and discharge destination. The SNF-Connect Trial is the first trial of its kind to assess if a HF-DMP will improve outcomes for patients in SNFs. This trial will provide evidence on the effectiveness of HF-DMP to improve outcomes for older frail HF patients undergoing postacute rehabilitation. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

PubMed

Blanc-Bisson, C; Dechamps, A; Gouspillou, G; Dehail, P; Bourdel-Marchasson, I

2008-01-01

To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual care. acute care geriatric medicine ward. A total of 76 acutely ill patients, acutely bedridden or with reduced mobility but who were autonomous for mobility within the previous 3 months. Patients in palliative care or with limiting mobility pathology were excluded. Mean age was 85.4 (SD 6.6) years. At admission, at clinical stability and one month later: anthropometry, energy and protein intakes, hand grip strength, ADL scores, and baseline inflammatory parameters. An exploratory principal axis analysis was performed on the baseline characteristics and general linear models were used to explore the course of ADL and nutritional variables. A 4-factor solution was found explaining 71.7% of variance with a factor "nutrition", a factor "function" (18.8% of variance) for ADL, handgrip strength, bedridden state, energy and protein intakes, serum albumin and C-reactive protein concentrations; a factor "strength" and a fourth factor . During follow-up, dietary intakes, handgrip strength, and ADL scores improved but no changes occurred for anthropometric variables. Intervention was associated only with an increase in protein intake. Better improvement in ADL was found in intervention group when model was adjusted on "function" factor items. Physical intervention programs should be proposed according to nutritional intakes with the aim of preventing illness induced disability.

The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial.

PubMed

Ford, Andrew H; Flicker, Leon; Passage, Jurgen; Wibrow, Bradley; Anstey, Matthew; Edwards, Mark; Almeida, Osvaldo P

2016-01-28

Delirium is a common occurrence in patients undergoing major cardiac surgery and is associated with a number of adverse consequences for the individual, their family and the health system. Current approaches to the prevention of delirium include identifying those at risk together with various non-pharmacological and pharmacological strategies, although the efficacy of these is often modest. Emerging evidence suggests that melatonin may be biologically implicated in the development of delirium and that melatonin supplementation may be beneficial in reducing the incidence of delirium in medical and surgical patients. We designed this trial to determine whether melatonin reduces the incidence of delirium following cardiac surgery compared with placebo. The Healthy Heart-Mind trial is a randomized, double-blind, placebo-controlled clinical trial of 3 mg melatonin or matching placebo administered on seven consecutive days for the prevention of delirium following cardiac surgery. We will recruit 210 adult participants, aged 50 and older, undergoing elective or semi-elective cardiac surgery with the primary outcome of interest for this study being the difference in the incidence of delirium between the groups within 7 days of surgery. Secondary outcomes of interest include the difference between groups in the severity and duration of delirious episodes, hospital length of stay and referrals to mental health services during admission. In addition, we will assess differences in depressive and anxiety symptoms, as well as cognitive performance, at discharge and 3 months after surgery. The results of this trial will clarify whether melatonin reduces the incidence of delirium following cardiac surgery. The trial is registered with the Australian Clinical Trials Registry, trial number ACTRN12615000819527 (10 August 2015).

Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition: A Randomized Controlled Trial.

PubMed

Bartels, Rosalie H; Bourdon, Céline; Potani, Isabel; Mhango, Brian; van den Brink, Deborah A; Mponda, John S; Muller Kobold, Anneke C; Bandsma, Robert H; Boele van Hensbroek, Michael; Voskuijl, Wieger P

2017-11-01

To assess the benefits of pancreatic enzyme replacement therapy (PERT) in children with complicated severe acute malnutrition. We conducted a randomized, controlled trial in 90 children aged 6-60 months with complicated severe acute malnutrition at the Queen Elizabeth Central Hospital in Malawi. All children received standard care; the intervention group also received PERT for 28 days. Children treated with PERT for 28 days did not gain more weight than controls (13.7 ± 9.0% in controls vs 15.3 ± 11.3% in PERT; P = .56). Exocrine pancreatic insufficiency was present in 83.1% of patients on admission and fecal elastase-1 levels increased during hospitalization mostly seen in children with nonedematous severe acute malnutrition (P <.01). Although the study was not powered to detect differences in mortality, mortality was significantly lower in the intervention group treated with pancreatic enzymes (18.6% vs 37.8%; P < .05). Children who died had low fecal fatty acid split ratios at admission. Exocrine pancreatic insufficiency was not improved by PERT, but children receiving PERT were more likely to be discharged with every passing day (P = .02) compared with controls. PERT does not improve weight gain in severely malnourished children but does increase the rate of hospital discharge. Mortality was lower in patients on PERT, a finding that needs to be investigated in a larger cohort with stratification for edematous and nonedematous malnutrition. Mortality in severe acute malnutrition is associated with markers of poor digestive function. ISRCTN.com: 57423639. Copyright © 2017 Elsevier Inc. All rights reserved.

Telemedicine Provides Non-Inferior Research Informed Consent for Remote Study Enrollment: A Randomized Controlled Trial

PubMed Central

Bobb, Morgan R.; Van Heukelom, Paul G.; Faine, Brett A.; Ahmed, Azeemuddin; Messerly, Jeffrey T.; Bell, Gregory; Harland, Karisa K.; Simon, Christian; Mohr, Nicholas M.

2016-01-01

Objective Telemedicine networks are beginning to provide an avenue for conducting emergency medicine research, but using telemedicine to recruit participants for clinical trials has not been validated. The goal of this consent study is to determine whether patient comprehension of telemedicine-enabled research informed consent is non-inferior to standard face-to-face research informed consent. Methods A prospective, open-label randomized controlled trial was performed in a 60,000-visit Midwestern academic Emergency Department (ED) to test whether telemedicine-enabled research informed consent provided non-inferior comprehension compared with standard consent. This study was conducted as part of a parent clinical trial evaluating the effectiveness of oral chlorhexidine gluconate 0.12% in preventing hospital-acquired pneumonia among adult ED patients with expected hospital admission. Prior to being recruited into the study, potential participants were randomized in a 1:1 allocation ratio to consent by telemedicine versus standard face-to-face consent. Telemedicine connectivity was provided using a commercially available interface (REACH platform, Vidyo Inc., Hackensack, NJ) to an emergency physician located in another part of the ED. Comprehension of research consent (primary outcome) was measured using the modified Quality of Informed Consent (QuIC) instrument, a validated tool for measuring research informed consent comprehension. Parent trial accrual rate and qualitative survey data were secondary outcomes. Results One-hundred thirty-one patients were randomized (n = 64, telemedicine), and 101 QuIC surveys were completed. Comprehension of research informed consent using telemedicine was not inferior to face-to-face consent (QuIC scores 74.4 ± 8.1 vs. 74.4 ± 6.9 on a 100-point scale, p = 0.999). Subjective understanding of consent (p=0.194) and parent trial study accrual rates (56% vs. 69%, p = 0.142) were similar. Conclusion Telemedicine is non-inferior to face-to-face consent for delivering research informed consent, with no detected differences in comprehension and patient-reported understanding. This consent study will inform design of future telemedicine-enabled clinical trials. PMID:26990899

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

PubMed

Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

2017-10-11

There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle-income countries. ClinicalTrials.gov, ID: NCT02763345 . Registered on 3 May 2016.

A Cognitive Behavioral Smoking Abstinence Intervention for Adults with Chronic Pain: A Randomized Controlled Pilot Trial

PubMed Central

Hooten, W. Michael; Townsend, Cynthia O.; Hays, J. Taylor; Ebnet, Kaye L.; Gauvin, Thomas R.; Gehin, Jessica M.; Laures, Heidi J.; Patten, Christi A.; Warner, David O.

2015-01-01

Current evidence suggests it may be difficult for patients with chronic pain to quit smoking and, based on previous formative work, a 7-session individual and group-based cognitive behavioral (CB) intervention was developed. The primary aim of this randomized controlled pilot trial was to test the hypothesis that abstinence at month 6 would be greater among patients with chronic pain who received the CB intervention compared to a control condition. Upon admission to a 3-week interdisciplinary pain treatment (IPT) program, patients were randomized to receive the CB intervention (n = 30) or the control condition (n = 30). The 7-day point prevalence of self-reported smoking status was assessed at week 3 (upon completion of the 3-week IPT program) and at month 6 in an intent-to-treat analysis. At week 3, 30% (n=9) of patients in the CB condition were abstinent from smoking compared to 10% (n=3) in the control group (P=.104). At month 6, 20% (n=6) of patients who received the CB intervention were abstinent compared to none in the control group (P=.024). At week 3, a significant group by time interaction effect was found where the CB patients experienced greater improvements in self-efficacy from baseline compared to the control group (P=.002). A greater proportion of patients randomized to the CB group completed the IPT program (P=.052). The findings of this pilot trial suggest that integration of a CB-based smoking abstinence intervention into ongoing pain therapy may be an effective treatment for smokers with chronic pain. PMID:24333035

Modified Reporting of Positive Urine Cultures to Reduce Inappropriate Treatment of Asymptomatic Bacteriuria Among Nonpregnant, Noncatheterized Inpatients: A Randomized Controlled Trial.

PubMed

Daley, Peter; Garcia, David; Inayatullah, Raheel; Penney, Carla; Boyd, Sarah

2018-05-28

DESIGNWe conducted a randomized, parallel, unblinded, superiority trial of a laboratory reporting intervention designed to reduce antibiotic treatment of asymptomatic bacteriuria (ASB).METHODSResults of positive urine cultures from 110 consecutive inpatients at 2 urban acute-care hospitals were randomized to standard report (control) or modified report (intervention). The standard report included bacterial count, bacterial identification, and antibiotic susceptibility information including drug dosage and cost. The modified report stated: "This POSITIVE urine culture may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory … for identification and susceptibility results." We used the following exclusion criteria: age <18 years, pregnancy, presence of an indwelling urinary catheter, samples from patients already on antibiotics, neutropenia, or admission to an intensive care unit. The primary efficacy outcome was the proportion of appropriate antibiotic therapy prescribed.RESULTSAccording to our intention-to-treat (ITT) analysis, the proportion of appropriate treatment (urinary tract infection treated plus ASB not treated) was higher in the modified arm than in the standard arm: 44 of 55 (80.0%) versus 29 of 55 (52.7%), respectively (absolute difference, -27.3%; RR, 0.42; P = .002; number needed to report for benefit, 3.7).CONCLUSIONSModified reporting resulted in a significant reduction in inappropriate antibiotic treatment without an increase in adverse events. Safety should be further assessed in a large effectiveness trial before implementationTRIAL REGISTRATION. clinicaltrials.gov#NCT02797613Infect Control Hosp Epidemiol 2018;1-6.

High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial): protocol of a multicentre randomised double-blind clinical trial

PubMed Central

Márta, Katalin; Szabó, Anikó N; Pécsi, Dániel; Varjú, Péter; Bajor, Judit; Gódi, Szilárd; Sarlós, Patrícia; Mikó, Alexandra; Szemes, Kata; Papp, Mária; Tornai, Tamás; Vincze, Áron; Márton, Zsolt; Vincze, Patrícia A; Lankó, Erzsébet; Szentesi, Andrea; Molnár, Tímea; Hágendorn, Roland; Faluhelyi, Nándor; Battyáni, István; Kelemen, Dezső; Papp, Róbert; Miseta, Attila; Verzár, Zsófia; Lerch, Markus M; Neoptolemos, John P; Sahin-Tóth, Miklós; Petersen, Ole H; Hegyi, Péter

2017-01-01

Introduction Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury, suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several high quality experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP. Methods/design This is a randomised controlled two-arm double-blind multicentre trial. Patients with AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24 hours of hospital admission) or B (low energy administration during the first 72 hours of hospital admission). Energy will be delivered by nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multiorgan failure for more than 48 hours and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalisation or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to. Ethics and dissemination The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961-2/2016/EKU). This study will provide evidence as to whether early high energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors. Trial registration The trial has been registered at the ISRCTN (ISRTCN 63827758). PMID:28912191

Monthly plasmapheresis for systemic lupus erythematosus with diffuse proliferative glomerulonephritis: a pilot study

PubMed Central

Clark, William F.; Lindsay, Robert M.; Cattran, Daniel C.; Chodirker, William B.; Barnes, Colin C.; Linton, Adam L.

1981-01-01

Twelve patients with systemic lupus erythematosus and biopsy-proved diffuse proliferative glomerulonephritis were randomly allocated to a control group (to continue receiving conventional therapy only) or to a plasmapheresis group (to receive conventional therapy along with one 4-I plasma exchange a month). The six patients treated with plasmapheresis had better preservation of renal function, reduced disease activity, fewer admissions to hospital and less need for steroid and immunosuppressive therapy than the six control patients. The patients treated with plasmapheresis also showed evidence of reduced immunologic activity and had no side effects attributable to the plasma exchange. These results suggest that monthly plasma exchange should be assessed in a controlled randomized trial as a possible therapeutic adjunct in patients with systemic lupus erythematosus and diffuse proliferative glomerulonephritis. PMID:7272867

Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial.

PubMed

McClinton, Sam; Starr, Kathryn; Thomas, Ruth; McLennan, Graeme; McPherson, Gladys; McDonald, Alison; Lam, Thomas; N'Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Burr, Jennifer

2014-06-20

Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications.Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation.This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo.Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The primary economic outcome is a reduction in the incremental cost per quality-adjusted life years, determined at 12 weeks. The analysis will be based on all participants as randomized (intention to treat). The trial has 90% power with a type I error rate of 5% to detect a 10% increase in primary outcome between the tamsulosin and nifedipine treatment groups. ISRCTN69423238; EudraCT number: 2010-019469-26.

Onyalai--therapeutic effects of vincristine sulphate. A prospective randomized trial.

PubMed

Hesseling, P B; Girdle-Brown, B; Smit, J

1986-08-16

Twenty out of 40 patients with onyalai admitted to Rundu State Hospital, Kavango, SWA/Namibia, were randomized to receive a vincristine sulphate bolus of 1.5 mg/m2 or an equivalent volume of normal saline intravenously on days 8 and 15 when haemorrhage or a platelet count of less than 50 X 10(9)/l persisted for more than 1 week after admission. All patients were observed in hospital for at least 21 days. Five out of 10 patients who received vincristine achieved a platelet count in excess of 100 X 10(9)/l on day 21 and only 2 out of 10 patients who received placebo achieved a similar rise in the platelet count. Two patients, neither of whom was treated with vincristine, died of cerebral haemorrhage.

Efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II trial): study protocol for a randomized controlled trial.

PubMed

Tamura, Tomoyoshi; Hayashida, Kei; Sano, Motoaki; Onuki, Shuko; Suzuki, Masaru

2017-10-23

Hydrogen gas inhalation (HI) improved survival and neurological outcomes in an animal model of post-cardiac arrest syndrome (PCAS). The feasibility and safety of HI for patients with PCAS was confirmed in a pilot study. The objective of this study is to evaluate the efficacy of HI for patients with PCAS. The efficacy of inhaled HYdrogen on neurological outcome following BRain Ischemia During post-cardiac arrest care (HYBRID II) trial is an investigator-initiated, randomized, double-blind, placebo-controlled trial designed to enroll 360 adult comatose (Glasgow Coma Scale score < 8) patients who will be resuscitated following an out-of-hospital cardiac arrest of a presumed cardiac cause. The patients will be randomized (1:1) to either the HI or control group. Patients in the HI group will inhale 2% hydrogen with 24% to 50% oxygen, and those in the control group will inhale 24% to 50% oxygen for 18 h after admission via mechanical ventilation. Multidisciplinary post-arrest care, including targeted temperature management (TTM) between 33 °C and 36 °C, will be provided in accordance with the latest guidelines. The primary outcome of interest is the 90-day neurological outcome, as evaluated using the Cerebral Performance Categories scale (CPC). The secondary outcomes of interest are the 90-day survival rate and other neurological outcomes. This study will provide 80% power to detect a 15% change in the proportion of patients with good neurological outcomes (CPCs of 1 and 2), from 50% to 65%, with an overall significance level of 0.05. The first multicenter randomized trial is underway to confirm the efficacy of HI on neurological outcomes in comatose out-of-hospital cardiac arrest survivors. Our study has the potential to address HI as an appealing and innovative therapeutic strategy for PCAS in combination with TTM. University Hospital Medical Information Network (UMIN), 000019820 . Registered on 17 November 2015.

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

PubMed

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

Metformin in women with type 2 diabetes in pregnancy (MiTy): a multi-center randomized controlled trial.

PubMed

Feig, Denice S; Murphy, Kellie; Asztalos, Elizabeth; Tomlinson, George; Sanchez, Johanna; Zinman, Bernard; Ohlsson, Arne; Ryan, Edmond A; Fantus, I George; Armson, Anthony B; Lipscombe, Lorraine L; Barrett, Jon F R

2016-07-19

The incidence of type 2 diabetes in pregnancy is rising and rates of serious adverse maternal and fetal outcomes remain high. Metformin is a biguanide that is used as first-line treatment for non-pregnant patients with type 2 diabetes. We hypothesize that metformin use in pregnancy, as an adjunct to insulin, will decrease adverse outcomes by reducing maternal hyperglycemia, maternal insulin doses, maternal weight gain and gestational hypertension/pre-eclampsia. In addition, since metformin crosses the placenta, metformin treatment of the fetus may have a direct beneficial effect on neonatal outcomes. Our aim is to compare the effectiveness of the addition of metformin to insulin, to standard care (insulin plus placebo) in women with type 2 diabetes in pregnancy. The MiTy trial is a multi-centre randomized trial currently enrolling pregnant women with type 2 diabetes, who are on insulin, between the ages of 18-45, with a gestational age of 6 weeks 0 days to 22 weeks 6 days. In this randomized, double-masked, parallel placebo-controlled trial, after giving informed consent, women are randomized to receive either metformin 1,000 mg twice daily or placebo twice daily. A web-based block randomization system is used to assign women to metformin or placebo in a 1:1 ratio, stratified for site and body mass index. The primary outcome is a composite neonatal outcome of pregnancy loss, preterm birth, birth injury, moderate/severe respiratory distress, neonatal hypoglycemia, or neonatal intensive care unit admission longer than 24 h. Secondary outcomes are large for gestational age, cord blood gas pH < 7.0, congenital anomalies, hyperbilirubinemia, sepsis, hyperinsulinemia, shoulder dystocia, fetal fat mass, as well as maternal outcomes: maternal weight gain, maternal insulin doses, maternal glycemic control, maternal hypoglycemia, gestational hypertension, preeclampsia, cesarean section, number of hospitalizations during pregnancy, and duration of hospital stays. The trial aims to enroll 500 participants. The results of this trial will inform endocrinologists, obstetricians, family doctors, and other healthcare professionals caring for women with type 2 diabetes in pregnancy, as to the benefits of adding metformin to insulin in this high risk population. ClinicalTrials.gov Identifier: no. NCT01353391 . Registered February 6, 2009.

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial.

PubMed

Cornelis, Jurgen; Barakat, Ansam; Dekker, Jack; Schut, Tessy; Berk, Sandra; Nusselder, Hans; Ruhl, Nikander; Zoeteman, Jeroen; Van, Rien; Beekman, Aartjan; Blankers, Matthijs

2018-02-27

Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU. A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU. RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations internationally. The trial is registered in the Netherlands Trial Register as # NTR-6151 . Registered 23 November 2016.

Continuous versus bolus intermittent loop diuretic infusion in acutely decompensated heart failure: a prospective randomized trial

PubMed Central

2014-01-01

Introduction Intravenous loop diuretics are a cornerstone of therapy in acutely decompensated heart failure (ADHF). We sought to determine if there are any differences in clinical outcomes between intravenous bolus and continuous infusion of loop diuretics. Methods Subjects with ADHF within 12 hours of hospital admission were randomly assigned to continuous infusion or twice daily bolus therapy with furosemide. There were three co-primary endpoints assessed from admission to discharge: the mean paired changes in serum creatinine, estimated glomerular filtration rate (eGFR), and reduction in B-type natriuretic peptide (BNP). Secondary endpoints included the rate of acute kidney injury (AKI), change in body weight and six months follow-up evaluation after discharge. Results A total of 43 received a continuous infusion and 39 were assigned to bolus treatment. At discharge, the mean change in serum creatinine was higher (+0.8 ± 0.4 versus -0.8 ± 0.3 mg/dl P <0.01), and eGFR was lower (-9 ± 7 versus +5 ± 6 ml/min/1.73 m2P <0.05) in the continuous arm. There was no significant difference in the degree of weight loss (-4.1 ± 1.9 versus -3.5 ± 2.4 kg P = 0.23). The continuous infusion arm had a greater reduction in BNP over the hospital course, (-576 ± 655 versus -181 ± 527 pg/ml P = 0.02). The rates of AKI were comparable (22% and 15% P = 0.3) between the two groups. There was more frequent use of hypertonic saline solutions for hyponatremia (33% versus 18% P <0.01), intravenous dopamine infusions (35% versus 23% P = 0.02), and the hospital length of stay was longer in the continuous infusion group (14. 3 ± 5 versus 11.5 ± 4 days, P <0.03). At 6 months there were higher rates of re-admission or death in the continuous infusion group, 58% versus 23%, (P = 0.001) and this mode of treatment independently associated with this outcome after adjusting for baseline and intermediate variables (adjusted hazard ratio = 2.57, 95% confidence interval, 1.01 to 6.58 P = 0.04). Conclusions In the setting of ADHF, continuous infusion of loop diuretics resulted in greater reductions in BNP from admission to discharge. However, this appeared to occur at the consequence of worsened renal filtration function, use of additional treatment, and higher rates of rehospitalization or death at six months. Trial registration ClinicalTrials.gov NCT01441245. Registered 23 September 2011. PMID:24974232

EMPOWER: An Intervention to Address Barriers to Pain Management in Hospice

PubMed Central

Cagle, John G.; Zimmerman, Sheryl; Cohen, Lauren W.; Porter, Laura S.; Hanson, Laura C.; Reed, David

2017-01-01

Context Concerns about pain medications are major barriers to pain management in hospice, but few studies have focused on systematic methods to address these concerns. Objective We conducted a pilot cluster randomized controlled trial with four hospices to test preliminary efficacy of the EMPOWER intervention which included: hospice staff education; staff screening of barriers to pain management at admission; and discussion about misunderstandings regarding pain management with family caregivers and patients. Methods 126 family caregivers (55 intervention; 71 control) were interviewed at two weeks post-admission. If patients survived three months post-admission, caregivers were re-interviewed. Results At two weeks, caregivers in the intervention group reported better knowledge about pain management (p=.001), fewer concerns about pain and pain medications (p=.008), and lower patient pain over the past week (p=.014); and trended toward improvement in most other areas under study. Exploratory analyses suggest EMPOWER had a greater effect for Black subjects (vs. Whites) on reducing concern about stigma. At three months, the intervention group trended better on most study outcomes. Conclusion EMPOWER is a promising model to reduce barriers to pain management in hospice. PMID:24880000

Costs and effects of screening and treating low risk women with a singleton pregnancy for asymptomatic bacteriuria, the ASB study.

PubMed

Kazemier, Brenda M; Schneeberger, Caroline; De Miranda, Esteriek; Van Wassenaer, Aleid; Bossuyt, Patrick M; Vogelvang, Tatjana E; Reijnders, Frans J L; Delemarre, Friso M C; Verhoeven, Corine J M; Oudijk, Martijn A; Van Der Ven, Jeanine A; Kuiper, Petra N; Feiertag, Nicolette; Ott, Alewijn; De Groot, Christianne J M; Mol, Ben Willem J; Geerlings, Suzanne E

2012-06-21

The prevalence of asymptomatic bacteriuria (ASB) in pregnancy is 2-10% and is associated with both maternal and neonatal adverse outcomes as pyelonephritis and preterm delivery. Antibiotic treatment is reported to decrease these adverse outcomes although the existing evidence is of poor quality. We plan a combined screen and treat study in women with a singleton pregnancy. We will screen women between 16 and 22 weeks of gestation for ASB using the urine dipslide technique. The dipslide is considered positive when colony concentration ≥105 colony forming units (CFU)/mL of a single microorganism or two different colonies but one ≥105 CFU/mL is found, or when Group B Streptococcus bacteriuria is found in any colony concentration. Women with a positive dipslide will be randomly allocated to receive nitrofurantoin or placebo 100 mg twice a day for 5 consecutive days (double blind). Primary outcomes of this trial are maternal pyelonephritis and/or preterm delivery before 34 weeks. Secondary outcomes are neonatal and maternal morbidity, neonatal weight, time to delivery, preterm delivery rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal admission days and costs. This trial will provide evidence for the benefit and cost-effectiveness of dipslide screening for ASB among low risk women at 16-22 weeks of pregnancy and subsequent nitrofurantoin treatment. Dutch trial registry: NTR-3068.

Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis.

PubMed

Anderson, Lindsey; Oldridge, Neil; Thompson, David R; Zwisler, Ann-Dorthe; Rees, Karen; Martin, Nicole; Taylor, Rod S

2016-01-05

Although recommended in guidelines for the management of coronary heart disease (CHD), concerns have been raised about the applicability of evidence from existing meta-analyses of exercise-based cardiac rehabilitation (CR). The goal of this study is to update the Cochrane systematic review and meta-analysis of exercise-based CR for CHD. The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and Science Citation Index Expanded were searched to July 2014. Retrieved papers, systematic reviews, and trial registries were hand-searched. We included randomized controlled trials with at least 6 months of follow-up, comparing CR to no-exercise controls following myocardial infarction or revascularization, or with a diagnosis of angina pectoris or CHD defined by angiography. Two authors screened titles for inclusion, extracted data, and assessed risk of bias. Studies were pooled using random effects meta-analysis, and stratified analyses were undertaken to examine potential treatment effect modifiers. A total of 63 studies with 14,486 participants with median follow-up of 12 months were included. Overall, CR led to a reduction in cardiovascular mortality (relative risk: 0.74; 95% confidence interval: 0.64 to 0.86) and the risk of hospital admissions (relative risk: 0.82; 95% confidence interval: 0.70 to 0.96). There was no significant effect on total mortality, myocardial infarction, or revascularization. The majority of studies (14 of 20) showed higher levels of health-related quality of life in 1 or more domains following exercise-based CR compared with control subjects. This study confirms that exercise-based CR reduces cardiovascular mortality and provides important data showing reductions in hospital admissions and improvements in quality of life. These benefits appear to be consistent across patients and intervention types and were independent of study quality, setting, and publication date. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned.

PubMed

Daddato, Andrea; Wald, Heidi L; Horney, Carolyn; Fairclough, Diane L; Leister, Erin C; Coors, Marilyn; Capell, Warren H; Boxer, Rebecca S

2017-06-01

Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities. Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed. Description of the trial design and barriers to facility and patient recruitment along with regulatory issues are presented. The recruitment of Denver-metro skilled nursing facilities was facilitated by key stakeholders of the skilled nursing facilities community. However, there were still a number of barriers to facility recruitment including leadership turnover, varying policies regarding research, fear of litigation and of an increased workload. Engagement of facilities was facilitated by their strong interest in reducing hospital readmissions, marketing potential to hospitals, and heart failure management education for their staff. Recruitment of patients proved difficult and there were few facilitators. Identified patient recruitment challenges included patients being unaware of their heart failure diagnosis, patients overwhelmed with their illness and care, and frequently there was no available proxy for cognitively impaired patients. Flexibility in changing the recruitment approach and targeting skilled nursing facilities with higher rates of admissions helped to overcome some barriers. Recruitment of skilled nursing facilities and patients in skilled nursing facilities for clinical trials is challenging. Strategies to attract both facilities and patients are warranted. These include aligning study goals with facility incentives and flexible recruitment protocols to work with patients in "transition crisis."

Critical periods after stroke study: translating animal stroke recovery experiments into a clinical trial

PubMed Central

Dromerick, Alexander W.; Edwardson, Matthew A.; Edwards, Dorothy F.; Giannetti, Margot L.; Barth, Jessica; Brady, Kathaleen P.; Chan, Evan; Tan, Ming T.; Tamboli, Irfan; Chia, Ruth; Orquiza, Michael; Padilla, Robert M.; Cheema, Amrita K.; Mapstone, Mark E.; Fiandaca, Massimo S.; Federoff, Howard J.; Newport, Elissa L.

2015-01-01

Introduction: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. Methods: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2–3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. Conclusion: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial. PMID:25972803

Predictive risk stratification model: a progressive cluster-randomised trial in chronic conditions management (PRISMATIC) research protocol

PubMed Central

2013-01-01

Background An ageing population increases demand on health and social care. New approaches are needed to shift care from hospital to community and general practice. A predictive risk stratification tool (Prism) has been developed for general practice that estimates risk of an emergency hospital admission in the following year. We present a protocol for the evaluation of Prism. Methods/Design We will undertake a mixed methods progressive cluster-randomised trial. Practices begin as controls, delivering usual care without Prism. Practices will receive Prism and training randomly, and thereafter be able to use Prism with clinical and technical support. We will compare costs, processes of care, satisfaction and patient outcomes at baseline, 6 and 18 months, using routine data and postal questionnaires. We will assess technical performance by comparing predicted against actual emergency admissions. Focus groups and interviews will be undertaken to understand how Prism is perceived and adopted by practitioners and policy makers. We will model data using generalised linear models and survival analysis techniques to determine whether any differences exist between intervention and control groups. We will take account of covariates and explanatory factors. In the economic evaluation we will carry out a cost-effectiveness analysis to examine incremental cost per emergency admission to hospital avoided and will examine costs versus changes in primary and secondary outcomes in a cost-consequence analysis. We will also examine changes in quality of life of patients across the risk spectrum. We will record and transcribe focus groups and interviews and analyse them thematically. We have received full ethical and R&D approvals for the study and Information Governance Review Panel (IGRP) permission for the use of routine data. We will comply with the CONSORT guidelines and will disseminate the findings at national and international conferences and in peer-reviewed journals. Discussion The proposed study will provide information on costs and effects of Prism; how it is used in practice, barriers and facilitators to its implementation; and its perceived value in supporting the management of patients with and at risk of developing chronic conditions. Trial registration Controlled Clinical Trials ISRCTN no. ISRCTN55538212. PMID:24330749

Tranexamic Acid for Lower GI Hemorrhage: A Randomized Placebo-Controlled Clinical Trial.

PubMed

Smith, Stephen R; Murray, David; Pockney, Peter G; Bendinelli, Cino; Draganic, Brian D; Carroll, Rosemary

2018-01-01

Lower GI hemorrhage is a common source of morbidity and mortality. Tranexamic acid is an antifibrinolytic that has been shown to reduce blood loss in a variety of clinical conditions. Information regarding the use of tranexamic acid in treating lower GI hemorrhage is lacking. The aim of this trial was to determine the clinical efficacy of tranexamic acid when used for lower GI hemorrhage. This was a prospective, double-blind, placebo-controlled, randomized clinical trial. The study was conducted at a tertiary referral university hospital in Australia. Consecutive patients aged >18 years with lower GI hemorrhage requiring hospital admission from November 2011 to January 2014 were screened for trial eligibility (N = 265). A total of 100 patients were recruited after exclusions and were randomly assigned 1:1 to either tranexamic acid or placebo. The primary outcome was blood loss as determined by reduction in hemoglobin levels. The secondary outcomes were transfusion rates, transfusion volume, intervention rates for bleeding, length of hospital stay, readmission, and complication rates. There was no difference between groups with respect to hemoglobin drop (11 g/L of tranexamic acid vs 13 g/L of placebo; p = 0.9445). There was no difference with respect to transfusion rates (14/49 tranexamic acid vs 16/47 placebo; p = 0.661), mean transfusion volume (1.27 vs 1.93 units; p = 0.355), intervention rates (7/49 vs 13/47; p = 0.134), length of hospital stay (4.67 vs 4.74 d; p = 0.934), readmission, or complication rates. No complications occurred as a direct result of tranexamic acid use. A larger multicenter trial may be required to determine whether there are more subtle advantages with tranexamic acid use in some of the secondary outcomes. Tranexamic acid does not appear to decrease blood loss or improve clinical outcomes in patients presenting with lower GI hemorrhage in the context of this trial. see Video Abstract at http://links.lww.com/DCR/A453.

Supreme Laryngeal Mask Airway versus Face Mask during Neonatal Resuscitation: A Randomized Controlled Trial.

PubMed

Trevisanuto, Daniele; Cavallin, Francesco; Nguyen, Loi Ngoc; Nguyen, Tien Viet; Tran, Linh Dieu; Tran, Chien Dinh; Doglioni, Nicoletta; Micaglio, Massimo; Moccia, Luciano

2015-08-01

To assess the effectiveness of supreme laryngeal mask airway (SLMA) over face mask ventilation for preventing need for endotracheal intubation at birth. We report a prospective, randomized, parallel 1:1, unblinded, controlled trial. After a short-term educational intervention on SLMA use, infants ≥34-week gestation and/or expected birth weight ≥1500 g requiring positive pressure ventilation (PPV) at birth were randomized to resuscitation by SLMA or face mask. The primary outcome was the success rate of the resuscitation devices (SLMA or face mask) defined as the achievement of an effective PPV preventing the need for endotracheal intubation. We enrolled 142 patients (71 in SLMA and 71 in face mask group, respectively). Successful resuscitation rate was significantly higher with the SLMA compared with face mask ventilation (91.5% vs 78.9%; P = .03). Apgar score at 5 minutes was significantly higher in SLMA than in face mask group (P = .02). Neonatal intensive care unit admission rate was significantly lower in SLMA than in face mask group (P = .02). No complications related to the procedure occurred. In newborns with gestational age ≥34 weeks and/or expected birth weight ≥1500 g needing PPV at birth, the SLMA is more effective than face mask to prevent endotracheal intubation. The SLMA is effective in clinical practice after a short-term educational intervention. Registered with ClinicalTrials.gov: NCT01963936. Copyright © 2015 Elsevier Inc. All rights reserved.

A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

PubMed Central

2010-01-01

Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

Effect of a facility-based multifaceted intervention on the quality of obstetrical care: a cluster randomized controlled trial in Mali and Senegal

PubMed Central

2013-01-01

Background Maternal mortality in referral hospitals in Mali and Senegal surpasses 1% of obstetrical admissions. Poor quality obstetrical care contributes to high maternal mortality; however, poor care is often linked to insufficient hospital resources. One promising method to improve obstetrical care is maternal death review. With a cluster randomized trial, we assessed whether an intervention, based on maternal death review, could improve obstetrical quality of care. Methods The trial began with a pre-intervention year (2007), followed by two years of intervention activities and a post-intervention year. We measured obstetrical quality of care in the post-intervention year using a criterion-based clinical audit (CBCA). We collected data from 32 of the 46 trial hospitals (16 in each trial arm) and included 658 patients admitted to the maternity unit with a trial of labour. The CBCA questionnaire measured 5 dimensions of care- patient history, clinical examination, laboratory examination, delivery care and postpartum monitoring. We used adjusted mixed models to evaluate differences in CBCA scores by trial arms and examined how levels of hospital human and material resources affect quality of care differences associated with the intervention. Results For all women, the mean percentage of care criteria met was 66.3 (SD 13.5). There were significantly greater mean CBCA scores in women treated at intervention hospitals (68.2) compared to control hospitals (64.5). After adjustment, women treated at intervention sites had 5 points’ greater scores than those at control sites. This difference was mostly attributable to greater clinical examination and post-partum monitoring scores. The association between the intervention and quality of care was the same, irrespective of the level of resources available to a hospital; however, as resources increased, so did quality of care scores in both arms of the trial. Trial registration The QUARITE trial is registered on the Current Controlled Trials website under ISRCTN46950658 PMID:23351269

Ketosis After Cardiopulmonary Bypass in Children Is Associated With an Inadequate Balance Between Oxygen Transport and Consumption.

PubMed

Klee, Philippe; Arni, Delphine; Saudan, Sonja; Schwitzgebel, Valérie M; Sharma, Ruchika; Karam, Oliver; Rimensberger, Peter C

2016-09-01

Hyperglycemia after cardiac surgery and cardiopulmonary bypass in children has been associated with worse outcome; however, causality has never been proven. Furthermore, the benefit of tight glycemic control is inconsistent. The purpose of this study was to describe the metabolic constellation of children before, during, and after cardiopulmonary bypass, in order to identify a subset of patients that might benefit from insulin treatment. Prospective observational study, in which insulin treatment was initiated when postoperative blood glucose levels were more than 12 mmol/L (216 mg/dL). Tertiary PICU. Ninety-six patients 6 months to 16 years old undergoing cardiac surgery with cardiopulmonary bypass. None. Metabolic tests were performed before anesthesia, at the end of cardiopulmonary bypass, at PICU admission, and 4 and 12 hours after PICU admission, as well as 4 hours after initiation of insulin treatment. Ketosis was present in 17.9% patients at the end of cardiopulmonary bypass and in 31.2% at PICU admission. Young age was an independent risk factor for this condition. Ketosis at PICU admission was an independent risk factor for an increased difference between arterial and venous oxygen saturation. Four hours after admission (p = 0.05). Insulin corrected ketosis within 4 hours. In this study, we found a high prevalence of ketosis at PICU admission, especially in young children. This was independently associated with an imbalance between oxygen transport and consumption and was corrected by insulin. These results set the basis for future randomized controlled trials, to test whether this subgroup of patients might benefit from increased glucose intake and insulin during surgery to avoid ketosis, as improving oxygen transport and consumption might improve patient outcome.

Correlation of Admission Heart Rate With Angiographic and Clinical Outcomes in Patients With Right Coronary Artery ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: HORIZONS-AMI (The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) Trial.

PubMed

Kosmidou, Ioanna; McAndrew, Thomas; Redfors, Björn; Embacher, Monica; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-07-19

Bradycardia on presentation is frequently observed in patients with right coronary artery ST-segment elevation myocardial infarction, but it is largely unknown whether it predicts poor angiographic or clinical outcomes in that patient population. We sought to determine the prognostic implications of admission heart rate (AHR) in patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion. We analyzed 1460 patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion enrolled in the randomized HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) trial who underwent primary percutaneous coronary intervention. Patients presenting with high-grade atrioventricular block were excluded. Outcomes were examined according to AHR range (AHR <60, 61-79, 80-99, and ≥100 beats per minute). Baseline and procedural characteristics did not vary significantly with AHR except for a more frequent history of diabetes mellitus, longer symptom-to-balloon time, more frequent cardiogenic shock, and less frequent restoration of thrombolysis in myocardial infarction 3 flow in patients with admission tachycardia (AHR >100 beats per minute). Angiographic analysis showed no significant association between AHR and lesion location or complexity. On multivariate analysis, admission bradycardia (AHR <60 beats per minute) was not associated with increased 1-year mortality (hazard ratio 1.33; 95% CI 0.41-4.34, P =0.64) or major adverse cardiac events (hazard ratio 1.08; 95% CI 0.62-1.88, P =0.78), whereas admission tachycardia was a strong independent predictor of mortality (hazard ratio 5.02; 95% CI 1.95-12.88, P =0.0008) and major adverse cardiac events (hazard ratio 2.20; 95% CI 1.29-3.75, P =0.0004). In patients with ST-segment elevation myocardial infarction and a right coronary artery culprit lesion undergoing primary percutaneous coronary intervention, admission bradycardia was not associated with increased mortality or major adverse cardiac events at 1 year. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00433966. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Case conferences between general practitioners and specialist teams to plan end of life care of people with end stage heart failure and lung disease: an exploratory pilot study

PubMed Central

2014-01-01

Background Most people die of non-malignant disease, but most patients of specialist palliative care services have cancer. Adequate end of life care for people with non-malignant disease requires acknowledgement of their limited prognosis and appropriate care planning. Case conferences between specialist palliative care services and GPs improve outcomes in cancer-based populations. We report a pilot study of case conferences between the patient’s GP and specialist staff to facilitate care planning for people with end stage heart failure or non-malignant lung disease in a regional health service in Queensland Australia. Methods Single face to face case conferences about patients with a primary diagnosis of advanced heart failure or respiratory failure from non-malignant disease were conducted between a palliative care consultant, a case management nurse and the patient’s GP. Annualised rates of service utilisation (emergency department [ED] presentations, ED discharges back to home, hospital admissions, and admission length of stay) before and after case conference were calculated. Content and counts of case conference recommendations, and the rate of adherence to recommendations were also assessed. A process evaluation of case conferences was undertaken. Results Twenty-three case conferences involving 21 GPs were conducted between November 2011 and November 2012. One GP refused to participate. Ten patients died, three at home. Of 82 management recommendations made, 55 (67%) were enacted. ED admissions fell from 13.9 per annum (pa) to 2.1 (difference 11.8, 95% CI 2.2-21.3, p = 0.001); ED admissions leading to discharge home from 3.9 to 0.4 pa (difference 3.5, 95% CI -0.4-7.5, p = 0.05); hospital admissions from 11.4 to 3.5 pa (difference 7.9, 95% CI 2.2-13.7, p = 0.002); and length of stay from 7.0 to 3.7 days (difference 3.4, 95% CI 0.9-5.8, p = 0.007). Participating health professionals were enthusiastic about the process. Conclusions This pilot is the initial step in the development and testing of a complex intervention based on a model of integrated care. A single case conference involving the patient’s heart or lung failure team is associated with significant reductions in service utilization, apparently by improving case coordination, enhancing symptom management and assessing and managing carer needs. A randomized controlled trial is being developed. Trial registration Australian and New Zealand Controlled Trials Register ACTRN12613001377729: Registered 16/12/2013. PMID:24829539

Telehealth by an Interprofessional Team in Patients With CKD: A Randomized Controlled Trial.

PubMed

Ishani, Areef; Christopher, Juleen; Palmer, Deirdre; Otterness, Sara; Clothier, Barbara; Nugent, Sean; Nelson, David; Rosenberg, Mark E

2016-07-01

Telehealth and interprofessional case management are newer strategies of care within chronic disease management. We investigated whether an interprofessional team using telehealth was a feasible care delivery strategy and whether this strategy could affect health outcomes in patients with chronic kidney disease (CKD). Randomized clinical trial. Minneapolis Veterans Affairs Health Care System (VAHCS), St. Cloud VAHCS, and affiliated clinics March 2012 to November 2013 in patients with CKD (estimated glomerular filtration rate < 60mL/min/1.73m(2)). Patients were randomly assigned to receive an intervention (n=451) consisting of care by an interprofessional team (nephrologist, nurse practitioner, nurses, clinical pharmacy specialist, psychologist, social worker, and dietician) using a telehealth device (touch screen computer with peripherals) or to usual care (n=150). The primary end point was a composite of death, hospitalization, emergency department visits, or admission to skilled nursing facilities, compared to usual care. Baseline characteristics of the overall study group: mean age, 75.1±8.1 (SD) years; men, 98.5%; white, 97.3%; and mean estimated glomerular filtration rate, 37±9mL/min/1.73m(2). Telehealth and interprofessional care were successfully implemented with meaningful engagement with the care system. One year after randomization, 208 (46.2%) patients in the intervention group versus 70 (46.7%) in the usual-care group had the primary composite outcome (HR, 0.98; 95% CI, 0.75-1.29; P=0.9). There was no difference between groups for any component of the primary outcome: all-cause mortality (HR, 1.46; 95% CI, 0.42-5.11), hospitalization (HR, 1.15; 95% CI, 0.80-1.63), emergency department visits (HR, 0.92; 95% CI, 0.68-1.24), or nursing home admission (HR, 3.07; 95% CI, 0.71-13.24). Older population, mostly men, potentially underpowered/wide CIs. Telehealth by an interprofessional team is a feasible care delivery strategy in patients with CKD. There was no statistically significant evidence of superiority of this intervention on health outcomes compared to usual care. Published by Elsevier Inc.

The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned.

PubMed

Yusen, Roger D; Criner, Gerard J; Sternberg, Alice L; Au, David H; Fuhlbrigge, Anne L; Albert, Richard K; Casaburi, Richard; Stoller, James K; Harrington, Kathleen F; Cooper, J Allen D; Diaz, Philip; Gay, Steven; Kanner, Richard; MacIntyre, Neil; Martinez, Fernando J; Piantadosi, Steven; Sciurba, Frank; Shade, David; Stibolt, Thomas; Tonascia, James; Wise, Robert; Bailey, William C

2018-01-01

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial.

PubMed

Subirana Magdaleno, Helena; Caro Tarragó, Aleidis; Olona Casas, Carles; Díaz Padillo, Alba; Franco Chacón, Mario; Vadillo Bargalló, Jordi; Saludes Serra, Judit; Jorba Martín, Rosa

2018-02-01

Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation. Registered in ISRCTN number ISRCTN83787412. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD.

PubMed

Schmickl, Christopher N; Li, Man; Li, Guangxi; Wetzstein, Marnie M; Herasevich, Vitaly; Gajic, Ognjen; Benzo, Roberto P

2011-10-01

Participant recruitment is an important process in successful conduct of randomized controlled trials. To facilitate enrollment into a National Institutes of Health-sponsored clinical trial involving patients with chronic obstructive pulmonary disease (COPD), we developed and prospectively validated an automated electronic screening tool based on boolean free-text search of admission notes in electronic medical records. During a 2-week validation period, all patients admitted to prespecified general medical services were screened for eligibility by both the electronic screening tool and a COPD nurse. Group discussion was the gold standard for confirmation of true-positive results. Compared with the gold standard, electronic screening yielded 100% sensitivity, 92% specificity, 100% negative predictive value, and 72% positive predictive value. Compared with traditional manual screening, electronic screening demonstrated time-saving potential of 76%. Thus, the electronic screening tool accurately identifies potential study subjects and improves efficiency of patient accrual for a clinical trial on COPD. This method may be expanded into other institutional and clinical settings. Copyright © 2011 Elsevier Ltd. All rights reserved.

Does structured patient education improve the recovery and clinical outcomes of patients with neck pain? A systematic review from the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration.

PubMed

Yu, Hainan; Côté, Pierre; Southerst, Danielle; Wong, Jessica J; Varatharajan, Sharanya; Shearer, Heather M; Gross, Douglas P; van der Velde, Gabrielle M; Carroll, Linda J; Mior, Silvano A; Ameis, Arthur; Jacobs, Craig L; Taylor-Vaisey, Anne L

2016-12-01

In 2008, the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders recommended patient education for the management of neck pain. However, the effectiveness of education interventions has recently been challenged. To update the findings of the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders and evaluate the effectiveness of structured patient education for the management of patients with whiplash-associated disorders (WAD) or neck pain and associated disorders (NAD). Systematic review of the literature and best-evidence synthesis. Randomized controlled trials that compared structured patient education with other conservative interventions. Self-rated recovery, functional recovery (eg, disability, return to activities, work, or school), pain intensity, health-related quality of life, psychological outcomes such as depression or fear, or adverse effects. We systematically searched eight electronic databases (MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Central Register of Controlled Trials, DARE, PubMed, and ICL) from 2000 to 2012. Randomized controlled trials, cohort studies, and case-control studies meeting our selection criteria were eligible for critical appraisal. Random pairs of independent reviewers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria. Scientifically admissible studies were summarized in evidence tables and synthesized following best-evidence synthesis principles. We retrieved 4,477 articles. Of those, nine were eligible for critical appraisal and six were scientifically admissible. Four admissible articles investigated patients with WAD and two targeted patients with NAD. All structured patient education interventions included advice on activation or exercises delivered orally combined with written information or as written information alone. Overall, as a therapeutic intervention, structured patient education was equal or less effective than other conservative treatments including massage, supervised exercise, and physiotherapy. However, structured patient education may provide small benefits when combined with physiotherapy. Either mode of delivery (ie, oral or written education) provides similar results in patients with recent WAD. This review adds to the Bone and Joint Decade 2000 to 2010 Task Force on Neck Pain and Its Associated Disorders by defining more specifically the role of structured patient education in the management of WAD and NAD. Results suggest that structured patient education alone cannot be expected to yield large benefits in clinical effectiveness compared with other conservative interventions for patients with WAD or NAD. Moreover, structured patient education may be of benefit during the recovery of patients with WAD when used as an adjunct therapy to physiotherapy or emergency room care. These benefits are small and short lived. Copyright © 2014 Elsevier Inc. All rights reserved.

Effect of a geriatric consultation team on functional status of elderly hospitalized patients. A randomized, controlled clinical trial.

PubMed

McVey, L J; Becker, P M; Saltz, C C; Feussner, J R; Cohen, H J

1989-01-01

To evaluate the impact of a geriatric consultation team on the functional status of hospitalized elderly patients. Randomized controlled clinical trial. University-affiliated referral Veterans Administration Medical Center. One hundred and seventy-eight hospitalized elderly men 75 years or older admitted to medical, surgical, and psychiatry services, but excluding patients admitted to intensive care units. Eighty-eight intervention group patients received multidimensional evaluation by an interdisciplinary geriatric consultation team composed of a faculty geriatrician, geriatrics fellow, geriatric clinical nurse specialist, and a social worker trained in geriatrics. Results of the evaluation, including problem identification and recommendations, were given to the patients' physicians. Ninety control group patients received only usual care. Intervention and control groups were comparable initially. The major outcome variable was the Index of Independence in the Activities of Daily Living (ADL) (Katz). Thirty-nine percent of the total study population was functionally independent on admission, 27% required assistance with one to three ADL, 22% required assistance with four to six ADL, and 12% were completely dependent. Many patients remained unchanged from admission to discharge: intervention group, 38%; control group, 39%. In the intervention group, 34% improved and 28% declined; in the control group, 26% improved and 36% declined. Although these changes reflected a trend toward greater improvement in the intervention group, the results were not statistically significant. Among elderly patients entering an acute-care hospital, approximately 60% had some degree of, and one third had serious functional disability. Such patients are at risk for further decline during hospitalization. A geriatric consultation team was unable to alter the degree of functional decline. Geriatric units or consultation teams may have to offer direct preventive or restorative services in addition to advice if improvements are to be made.

A two-arm cluster randomized control trial to determine the effectiveness of a pressure ulcer prevention bundle for critically ill patients.

PubMed

Tayyib, Nahla; Coyer, Fiona; Lewis, Peter A

2015-05-01

This study tested the effectiveness of a pressure ulcer (PU) prevention bundle in reducing the incidence of PUs in critically ill patients in two Saudi intensive care units (ICUs). A two-arm cluster randomized experimental control trial. Participants in the intervention group received the PU prevention bundle, while the control group received standard skin care as per the local ICU policies. Data collected included demographic variables (age, diagnosis, comorbidities, admission trajectory, length of stay) and clinical variables (Braden Scale score, severity of organ function score, mechanical ventilation, PU presence, and staging). All patients were followed every two days from admission through to discharge, death, or up to a maximum of 28 days. Data were analyzed with descriptive correlation statistics, Kaplan-Meier survival analysis, and Poisson regression. The total number of participants recruited was 140: 70 control participants (with a total of 728 days of observation) and 70 intervention participants (784 days of observation). PU cumulative incidence was significantly lower in the intervention group (7.14%) compared to the control group (32.86%). Poisson regression revealed the likelihood of PU development was 70% lower in the intervention group. The intervention group had significantly less Stage I (p = .002) and Stage II PU development (p = .026). Significant improvements were observed in PU-related outcomes with the implementation of the PU prevention bundle in the ICU; PU incidence, severity, and total number of PUs per patient were reduced. Utilizing a bundle approach and standardized nursing language through skin assessment and translation of the knowledge to practice has the potential to impact positively on the quality of care and patient outcome. © 2015 Sigma Theta Tau International.

Similar Outcomes for Contact Aspiration and Stent Retriever Use According to the Admission Clot Burden Score in ASTER.

PubMed

Zhu, François; Lapergue, Bertrand; Kyheng, Maéva; Blanc, Raphael; Labreuche, Julien; Ben Machaa, Malek; Duhamel, Alain; Marnat, Gautier; Saleme, Suzana; Costalat, Vincent; Bracard, Serge; Richard, Sébastien; Desal, Hubert; Mazighi, Mikael; Consoli, Arturo; Piotin, Michel; Gory, Benjamin

2018-07-01

The clot burden score (CBS) at admission reliably evaluates the thrombus burden in acute ischemic stroke patients with anterior circulation large vessel occlusion. Mechanical thrombectomy has been diversified, especially with contact aspiration technique, and its efficiency with respect to the thrombus burden is not known. We compared reperfusion, adverse events, neurological recovery, and 90-day functional outcome of stent retriever use versus contact aspiration according to the admission CBS. This is a post hoc analysis of the ASTER (Contact Aspiration Versus Stent Retriever for Successful Revascularization) randomized trial. The primary outcome was successful reperfusion after all procedures, defined as modified Thrombolysis in Cerebral Infarction scores 2b/3. Secondary outcomes were 90-day functional outcome, assessed with the modified Rankin Scale. Safety outcomes included 90-day mortality and any intracerebral hemorrhage. A total of 231 randomized patients were included in this study: 114 patients had a CBS of 0 to 6 and 117 a CBS ≥7 at admission. Successful reperfusion at procedure end was achieved more frequently in patients with CBS ≥7 (88.9%) than patients with a CBS 0 to 6 (81.6%; fully adjusted risk ratio, 1.09; 95% confidence interval, 1.01-1.28). Favorable outcome (modified Rankin Scale score, 0-2) at 90 days was achieved in significantly more patients with CBS ≥7 (61.9%) than in patients with CBS 0 to 6 (41.8%; fully adjusted risk ratio, 1.19; 95% confidence interval, 1.02-1.40). No outcome differences of first-line mechanical thrombectomy strategy (aspiration versus stent) on any angiographic or clinical outcomes were observed between the 2 groups. We also found no evidence of interaction between first-line mechanical thrombectomy strategy and CBS groups regarding safety. First-line mechanical thrombectomy with contact aspiration compared with stent retriever did not result in an increased successful reperfusion rate in acute ischemic stroke patients with large vessel occlusion of the anterior circulation according to the admission CBS. The latter, however, seems to be a reliable prognostic indicator of angiographic and clinical outcome. © 2018 American Heart Association, Inc.

The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial.

PubMed

Lloyd-Evans, Brynmor; Fullarton, Kate; Lamb, Danielle; Johnston, Elaine; Onyett, Steve; Osborn, David; Ambler, Gareth; Marston, Louise; Hunter, Rachael; Mason, Oliver; Henderson, Claire; Goater, Nicky; Sullivan, Sarah A; Kelly, Kathleen; Gray, Richard; Nolan, Fiona; Pilling, Stephen; Bond, Gary; Johnson, Sonia

2016-03-22

As an alternative to hospital admission, crisis resolution teams (CRTs) provide intensive home treatment to people experiencing mental health crises. Trial evidence supports the effectiveness of the CRT model, but research suggests that the anticipated reductions in inpatient admissions and increased user satisfaction with acute care have been less than hoped for following the scaling up of CRTs nationally in England, as mandated by the National Health Service (NHS) Plan in 2000. The organisation and service delivery of the CRTs vary substantially. This may reflect the lack of a fully specified CRT model and the resources to enhance team model fidelity and to improve service quality. We will evaluate the impact of a CRT service improvement programme over a 1-year period on the service users' experiences of care, service use, staff well-being, and team model fidelity. Twenty-five CRTs from eight NHS Trusts across England will be recruited to this cluster-randomised trial: 15 CRTs will be randomised to receive the service improvement programme over a 1-year period, and ten CRTs will not receive the programme. Data will be collected from 15 service users and all clinical staff from each participating CRT at baseline and at the end of the intervention. Service use data will be collected from the services' electronic records systems for two 6-month periods: the period preceding and the period during months 7-12 of the intervention. The study's primary outcome is service user satisfaction with CRT care, measured using a client satisfaction questionnaire. Secondary outcomes include the following: perceived continuity of care, hospital admission rates and bed use, rates of readmission to acute care following CRT support, staff morale, job satisfaction, and general health. The adherence of the services to a model of best practice will be assessed at baseline and follow-up. Outcomes will be compared between the intervention and control teams, adjusting for baseline differences and participant characteristics using linear random effects modelling. Qualitative investigations with participating CRT managers and staff and programme facilitators will explore the experiences of the service improvement programme. Our trial will show whether a theoretically underpinned and clearly defined package of resources are effective in supporting service improvement and improving outcomes for mental health crisis resolution teams. Current Controlled Trials ISRCTN47185233.

The "physician on call patient engagement trial" (POPET): measuring the impact of a mobile patient engagement application on health outcomes and quality of life in allergic rhinitis and asthma patients.

PubMed

Cingi, Cemal; Yorgancioglu, Arzu; Cingi, Can Cemal; Oguzulgen, Kıvılcım; Muluk, Nuray Bayar; Ulusoy, Seçkin; Orhon, Nezih; Yumru, Cengiz; Gokdag, Dursun; Karakaya, Gul; Çelebi, Şaban; Çobanoglu, H Bengü; Unlu, Halis; Aksoy, Mehmet Akif

2015-06-01

In this prospective, multicenter, randomized, controlled, double-blind study, we investigated the impact of a mobile patient engagement application on health outcomes and quality of life in allergic rhinitis (AR) and asthma patients. In total, 327 patients with diagnoses of persistent AR or mild-to-severe persistent asthma were randomized into 2 intervention groups and 2 control groups upon their admission at outpatient clinics. The intervention groups (POPET-AR and POPET-Asthma) received a mobile phone application ("physician on call patient engagement trial" [POPET]), enabling them to communicate with their physician, and record their health status and medication compliance. The AR groups completed the Rhinitis Quality of Life Questionnaire (RQLQ) at initiation and at the first month of the study. The asthma groups completed the Asthma Control Test (ACT) at initiation and at the third month of the study. The POPET-AR group showed better clinical improvement than the control group in terms of the overall RQLQ score as well in measures of general problems, activity, symptoms other than nose/eye, and emotion domains (p < 0.05). In the POPET-Asthma group, more patients (49%) achieved a well-controlled asthma score (ACT > 19) compared with the control group (27%); this was statistically significant (p < 0.05). Use of a mobile engagement platform, such as POPET, can have a significant impact on health outcomes and quality of life in both AR and asthma, potentially decreasing the number of hospital admissions, repeat doctor visits, and losses in productivity. Improvements were seen in domains related to activity, productivity, perception of disease, and emotion. © 2015 ARS-AAOA, LLC.

Home visits during pregnancy: consequences on pregnancy outcome, use of health services, and women's situations.

PubMed

Blondel, B; Bréart, G

1995-08-01

This review of eight randomized controlled trials assessed two different types of home visits during pregnancy: (1) those offering social support to high-risk women; and (2) those providing medical care to women with complications. In both categories, pregnancy outcome was not improved when women received home visits. The summary odds ratio for preterm delivery (< 37 weeks) was 1.0 (95% CI: 0.8 to 1.1). Nor did the home visits decrease the rate of hospital admission for women with complications (mainly threatened preterm labor or toxemia); the corresponding summary odds ratio was 0.9 (95% CI: 0.7 to 1.2). Nevertheless in some trials home visits had positive effects on women (medical knowledge, support levels, health habits, and satisfaction). The randomized controlled trials provide little evidence that programs offering home visits are effective in improving either pregnancy outcome or the use of health services. A better integration of hospital and home services might allow a more rational use of health services for women with complications. In addition, we need to define more precisely the content of home visits providing social support. For this, further research is required on how emotional support, health education, and advice influence the health of women and infants and mother-child interactions.

Motor/Prefrontal Transcranial Direct Current Stimulation (tDCS) Following Lumbar Surgery Reduces Postoperative Analgesia Use.

PubMed

Glaser, John; Reeves, Scott T; Stoll, William David; Epperson, Thomas I; Hilbert, Megan; Madan, Alok; George, Mark S; Borckardt, Jeffrey J

2016-05-01

Randomized, controlled pilot trial. The present study is the first randomized, double-blind, sham-controlled pilot clinical trial of transcranial direct current stimulation (tDCS) for pain and patient-controlled analgesia (PCA) opioid usage among patients receiving spine surgery. Lumbar spinal surgeries are common, and while pain is often a complaint that precedes surgical intervention, the procedures themselves are associated with considerable postoperative pain lasting days to weeks. Adequate postoperative pain control is an important factor in determining recovery and new analgesic strategies are needed that can be used adjunctively to existing strategies potentially to reduce reliance on opioid analgesia. Several novel brain stimulation technologies including tDCS are beginning to demonstrate promise as treatments for a variety of pain conditions. Twenty-seven patients undergoing lumbar spine procedures at Medical University of South Carolina were randomly assigned to receive four 20-minute sessions of real or sham tDCS during their postsurgical hospital stay. Patient-administered hydromorphone usage was tracked along with numeric rating scale pain ratings. The effect of tDCS on the slope of the cumulative PCA curve was significant (P < 0.001) and tDCS was associated with a 23% reduction in PCA usage. In the real tDCS group a 31% reduction was observed in pain-at-its-least ratings from admission to discharge (P = 0.027), but no other changes in numeric rating scale pain ratings were significant in either group. The present pilot trial is the first study to demonstrate an opioid sparing effect of tDCS after spine surgical procedures. Although this was a small pilot trial in a heterogeneous sample of spinal surgery patients, a moderate effect-size was observed for tDCS, suggesting that future work in this area is warranted. 2.

Induction of labour for improving birth outcomes for women at or beyond term

PubMed Central

Gülmezoglu, A Metin; Crowther, Caroline A; Middleton, Philippa; Heatley, Emer

2014-01-01

Background As a pregnancy continues beyond term the risks of babies dying inside the womb or in the immediate newborn period increase. Whether a policy of labour induction at a predetermined gestational age can reduce this increased risk is the subject of this review. Objectives To evaluate the benefits and harms of a policy of labour induction at term or post-term compared with awaiting spontaneous labour or later induction of labour. Search methods We searched the Cochrane Pregnancy and Childbirth Group’s Trials Register (31 March 2012). Selection criteria Randomised controlled trials conducted in women at or beyond term. The eligible trials were those comparing a policy of labour induction with a policy of awaiting spontaneous onset of labour. Cluster-randomised trials and cross-over trials are not included. Quasi-random allocation schemes such as alternation, case record numbers or open random-number lists were not eligible. Data collection and analysis Two review authors independently assessed trials for inclusion. Two review authors independently assessed trial quality and extracted data. Data were checked for accuracy. Outcomes are analysed in two main categories: gestational age and cervix status. Main results We included 22 trials reporting on 9383 women. The trials were generally at moderate risk of bias. Compared with a policy of expectant management, a policy of labour induction was associated with fewer (all-cause) perinatal deaths: risk ratio (RR) 0.31, 95% confidence interval (CI) 0.12 to 0.88; 17 trials, 7407 women. There was one perinatal death in the labour induction policy group compared with 13 perinatal deaths in the expectant management group. The number needed to treat to benefit (NNTB) with induction of labour in order to prevent one perinatal death was 410 (95% CI 322 to 1492). For the primary outcome of perinatal death and most other outcomes, no differences between timing of induction subgroups were seen; the majority of trials adopted a policy of induction at 41 completed weeks (287 days) or more. Fewer babies in the labour induction group had meconium aspiration syndrome (RR 0.50, 95% CI 0.34 to 0.73; eight trials, 2371 infants) compared with a policy of expectant management. There was no statistically significant difference between the rates of neonatal intensive care unit (NICU) admission for induction compared with expectant management (RR 0.90, 95% CI 0.78 to 1.04; 10 trials, 6161 infants). For women in the policy of induction arms of trials, there were significantly fewer caesarean sections compared with expectant management in 21 trials of 8749 women (RR 0.89, 95% CI 0.81 to 0.97). Authors’ conclusions A policy of labour induction compared with expectant management is associated with fewer perinatal deaths and fewer caesarean sections. Some infant morbidities such as meconium aspiration syndrome were also reduced with a policy of post-term labour induction although no significant differences in the rate of NICU admission were seen. However, the absolute risk of perinatal death is small. Women should be appropriately counselled in order to make an informed choice between scheduled induction for a post-term pregnancy or monitoring without induction (or delayed induction). PMID:22696345

The effect of uterine fundal pressure on the duration of the second stage of labor: a randomized controlled trial.

PubMed

Api, Olus; Balcin, Muge Emeksiz; Ugurel, Vedat; Api, Murat; Turan, Cem; Unal, Orhan

2009-01-01

To determine the effect of uterine fundal pressure on shortening the second stage of labor and on the fetal outcome. Randomized controlled trial. Teaching and research hospital. One hundred ninety-seven women between 37 and 42 gestational weeks with singleton cephalic presentation admitted to the delivery unit. Random allocation into groups with or without manual fundal pressure during the second stage of labor. The primary outcome measure was the duration of the second stage of labor. Secondary outcome measures were umbilical artery pH, HCO3-, base excess, pO2, pCO2 values and the rate of instrumental delivery, severe maternal morbidity/mortality, neonatal trauma, admission to neonatal intensive care unit, and neonatal death. There were no significant differences in the mean duration of the second stage of labor and secondary outcome measures except for mean pO2 which was lower and mean pCO2 which was higher in the fundal pressure group. Nevertheless, the values still remained within normal ranges and there were no neonates with an Apgar score <7 in either of the groups. Application of fundal pressure on a delivering woman was ineffective in shortening the second stage of labor.

Evaluation of the effectiveness of low-dose aspirin and omega 3 in treatment of asymmetrically intrauterine growth restriction: A randomized clinical trial.

PubMed

Ali, Mohammed K; Amin, Maggy E; Amin, Ahmed F; Abd El Aal, Diaa Eldeen M

2017-03-01

To test the effect of aspirin and omega 3 on fetal weight as well as feto-maternal blood flow in asymmetrical intrauterine growth restriction (IUGR). This study is a clinically registered (NCT02696577), open, parallel, randomized controlled trial, conducted at Assiut Woman's Health Hospital, Egypt including 80 pregnant women (28-30 weeks) with IUGR. They were randomized either to group I: aspirin or group II: aspirin plus omega 3. The primary outcome was the fetal weight after 6 weeks of treatment. Secondary outcomes included Doppler blood flow changes in both uterine and umbilical arteries, birth weight, time and method of delivery and admission to NICU. The outcome variables were analyzed using paired and unpaired t-test. The estimated fetal weight increased significant in group II more than group I (p=0.00). The uterine and umbilical arteries blood flow increased significantly in group II (p<0.05). The birth weight in group II was higher than that observed in group I (p<0.05). The using of aspirin with omega 3 is more effective than using aspirin only in increasing fetal weight and improving utero-placental blood flow in IUGR. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Learning spinal manipulation: A best-evidence synthesis of teaching methods.

PubMed

Stainsby, Brynne E; Clarke, Michelle C S; Egonia, Jade R

2016-10-01

The purpose of this study was to evaluate the effectiveness of different reported methods used to teach spinal manipulative therapy to chiropractic students. For this best-evidence literature synthesis, 5 electronic databases were searched from 1900 to 2015. Eligible studies were critically appraised using the criteria of the Scottish Intercollegiate Guidelines Network. Scientifically admissible studies were synthesized following best-evidence synthesis principles. Twenty articles were critically appraised, including 9 randomized clinical trials, 9 cohort studies, and 2 systematic reviews/meta-analyses. Eleven articles were accepted as scientifically admissible. The type of teaching method aids included a Thrust in Motion cervical manikin, instrumented cardiopulmonary reanimation manikin, padded contact with a load cell, instrumented treatment table with force sensor/transducer, and Dynadjust instrument. Several different methods exist in the literature for teaching spinal manipulative therapy techniques; however, future research in this developing area of chiropractic education is proposed. It is suggested that various teaching methods be included in the regular curricula of chiropractic colleges to aid in developing manipulation skills, efficiency, and knowledge of performance.

Randomized Trial of Dexamethasone Versus Prednisone for Children with Acute Asthma Exacerbations.

PubMed

Paniagua, Natalia; Lopez, Rebeca; Muñoz, Natalia; Tames, Miriam; Mojica, Elisa; Arana-Arri, Eunate; Mintegi, Santiago; Benito, Javier

2017-12-01

To determine whether 2 doses of dexamethasone is as effective as 5 days of prednisolone/prednisone therapy in improving symptoms and quality of life of children with asthma exacerbations admitted to the emergency department (ED). We conducted a randomized, noninferiority trial including patients aged 1-14 years who presented to the ED with acute asthma to compare the efficacy of 2 doses of dexamethasone (0.6 mg/kg/dose, experimental treatment) vs a 5-day course of prednisolone/prednisone (1.5 mg/kg/d, followed by 1 mg/kg/d on days 2-5, conventional treatment). Two follow-up telephone interviews were completed at 7 and 15 days. The primary outcome measures were the percentage of patients with asthma symptoms and quality of life at day 7. Secondary outcomes were unscheduled returns, admissions, adherence, and vomiting. During the study period, 710 children who met the inclusion criteria were invited to participate and 590 agreed. Primary outcome data were available in 557 patients. At day 7, experimental and conventional groups did not show differences related to persistence of symptoms (56.6%, 95% CI 50.6-62.6 vs 58.3%, 95% CI 52.3-64.2, respectively), quality of life score (80.0 vs 77.7, not significant [ns]), admission rate (23.9% vs 21.7%, ns), unscheduled ED return visits (4.6% vs 3.3%, ns), and vomiting (2.1% vs 4.4%, ns). Adherence was greater in the dexamethasone group (99.3% vs 96.0%, P < .05). Two doses of dexamethasone may be an effective alternative to a 5-day course of prednisone/prednisolone for asthma exacerbations, as measured by persistence of symptoms and quality of life at day 7. clinicaltrialsregister.eu: 2013-003145-42. Copyright © 2017 Elsevier Inc. All rights reserved.

Could the survival and outcome benefit of adrenaline also be dependent upon the presence of gasping upon arrival of emergency rescuers?

PubMed

Rottenberg, Eric M

2014-09-01

A recent systematic review and meta-analysis of randomized controlled trials of adrenaline use during resuscitation of out-of-hospital cardiac arrest found no benefit of adrenaline in survival to discharge or neurological outcomes. It did, however, find an advantage of standard dose adrenaline (SDA) over placebo and high dose adrenaline over SDA in overall survival to admission and return of spontaneous circulation (ROSC), which was also consistent with previous reviews. As a result, the question that remains is "Why is there no difference in the rate of survival to discharge when there are increased rates of ROSC and survival to admission in patients who receive adrenaline?" It was suggested that the lack of efficacy and effectiveness of adrenaline may be confounded by the quality of cardiopulmonary resuscitation (CPR) during cardiac arrest, which has been demonstrated in animal models. CPR quality was not measured or reported in the included randomized controlled trials. However, the survival and outcome benefit of adrenaline may also depend upon the presence of witnessed gasping and/or gasping upon arrival of emergency rescuers, which is a critical factor not accounted for in the analyses of the cited animal studies that allowed gasping but showed the survival and neurological outcome benefits of adrenaline use. Moreover, without the aid of gasping, very few rescuers can provide high-quality CPR. Also, age and the absence of gasping observed by bystanders and/or upon arrival of emergency- rescuers may be important factors in the determination of whether vasopressin instead of adrenaline should be used first. Copyright © 2014 Elsevier Inc. All rights reserved.

Randomised trial of neonatal hypoglycaemia prevention with oral dextrose gel (hPOD): study protocol.

PubMed

Harding, Jane E; Hegarty, Joanne E; Crowther, Caroline A; Edlin, Richard; Gamble, Greg; Alsweiler, Jane M

2015-09-16

Neonatal hypoglycaemia is common, affecting up to 15% of newborn babies and 50% of those with risk factors (preterm, infant of a diabetic, high or low birthweight). Hypoglycaemia can cause brain damage and death, and babies born at risk have an increased risk of developmental delay in later life. Treatment of hypoglycaemia usually involves additional feeding, often with infant formula, and admission to Neonatal Intensive Care for intravenous dextrose. This can be costly and inhibit the establishment of breast feeding. Prevention of neonatal hypoglycaemia would be desirable, but there are currently no strategies, beyond early feeding, for prevention of neonatal hypoglycaemia. Buccal dextrose gel is safe and effective in treatment of hypoglycaemia. The aim of this trial is to determine whether 40% dextrose gel given to babies at risk prevents neonatal hypoglycaemia and hence reduces admission to Neonatal Intensive Care. Randomised, multicentre, placebo controlled trial. Babies at risk of hypoglycaemia (preterm, infant of a diabetic, small or large), less than 1 h old, with no apparent indication for Neonatal Intensive Care Unit admission and mother intends to breastfeed. Trial entry & randomisation: Eligible babies of consenting parents will be allocated by online randomisation to the dextrose gel group or placebo group, using a study number and corresponding trial intervention pack. Babies will receive a single dose of 0.5 ml/kg study gel at 1 h after birth; either 40% dextrose gel (200 mg/kg) or 2% hydroxymethylcellulose placebo. Gel will be massaged into the buccal mucosal and followed by a breast feed. Primary study outcome: Admission to Neonatal Intensive Care. 2,129 babies are required to detect a decrease in admission to Neonatal Intensive Care from 10-6% (two-sided alpha 0.05, 90% power, 5% drop-out rate). This study will investigate whether admission to Neonatal Intensive Care can be prevented by prophylactic oral dextrose gel; a simple, cheap and painless intervention that requires no special expertise or equipment and hence is applicable in almost any birth setting. Australian New Zealand Clinical Trials Registry--ACTRN 12614001263684.

Determinants of health-related quality of life in the postpartum period after obstetric complications.

PubMed

Prick, Babette W; Bijlenga, Denise; Jansen, A J Gerard; Boers, Kim E; Scherjon, Sicco A; Koopmans, Corine M; van Pampus, Marielle G; Essink-Bot, Marie-Louise; van Rhenen, Dick J; Mol, Ben W; Duvekot, Johannes J

2015-02-01

To determine the influence of socio-demographic, clinical parameters and obstetric complications on postpartum health-related quality of life (HRQoL). We used data of three randomized controlled trials to investigate HRQoL determinants in women after an obstetric complication. The DIGITAT and HYPITAT trials compared induction of labor and expectant management in women with intra-uterine growth restriction (IUGR) and hypertensive disorders. The WOMB trial randomized anemic women after postpartum hemorrhage to red blood cell transfusion or expectant management. The HRQoL-measure Short-Form36 was completed at six weeks postpartum. Multivariable analyses were used to identify which parameters affected the Short-Form36 physical component score (PCS) and mental component score (MCS). HRQoL analyses included 1391 women (60%) of the 2310 trial participants. HYPITAT and DIGITAT participants had significantly lower MCS than WOMB participants. In multivariable analysis, PCS after elective and emergency cesarean section was 5-6 points lower than after vaginal delivery. Gestational hypertension, neonatal admission and delivery in an academic hospital had a small negative effect on PCS. No effect was found for randomization status, maternal age, BMI, country of birth, education, parity, induction of labor, analgesics, birth weight, perineal laceration, delivery of placenta, postpartum hemorrhage, congenital anomaly, urinary tract infection, thromboembolic event or endometritis. MCS was influenced only mildly by these parameters. IUGR and hypertensive disorders lead to lower HRQoL scores postpartum than PPH. In a heterogeneous obstetric population, only mode of delivery by cesarean section has a profound, negative impact, on physical HRQoL (PCS). No profound impacts on MCS were detected. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Predicting Performance in Higher Education Using Proximal Predictors.

PubMed

Niessen, A Susan M; Meijer, Rob R; Tendeiro, Jorge N

2016-01-01

We studied the validity of two methods for predicting academic performance and student-program fit that were proximal to important study criteria. Applicants to an undergraduate psychology program participated in a selection procedure containing a trial-studying test based on a work sample approach, and specific skills tests in English and math. Test scores were used to predict academic achievement and progress after the first year, achievement in specific course types, enrollment, and dropout after the first year. All tests showed positive significant correlations with the criteria. The trial-studying test was consistently the best predictor in the admission procedure. We found no significant differences between the predictive validity of the trial-studying test and prior educational performance, and substantial shared explained variance between the two predictors. Only applicants with lower trial-studying scores were significantly less likely to enroll in the program. In conclusion, the trial-studying test yielded predictive validities similar to that of prior educational performance and possibly enabled self-selection. In admissions aimed at student-program fit, or in admissions in which past educational performance is difficult to use, a trial-studying test is a good instrument to predict academic performance.

Statin Treatment and Clinical Outcomes of Heart Failure Among Africans: An Inverse Probability Treatment Weighted Analysis.

PubMed

Bonsu, Kwadwo Osei; Owusu, Isaac Kofi; Buabeng, Kwame Ohene; Reidpath, Daniel D; Kadirvelu, Amudha

2017-04-01

Randomized control trials of statins have not demonstrated significant benefits in outcomes of heart failure (HF). However, randomized control trials may not always be generalizable. The aim was to determine whether statin and statin type-lipophilic or -hydrophilic improve long-term outcomes in Africans with HF. This was a retrospective longitudinal study of HF patients aged ≥18 years hospitalized at a tertiary healthcare center between January 1, 2009 and December 31, 2013 in Ghana. Patients were eligible if they were discharged from first admission for HF (index admission) and followed up to time of all-cause, cardiovascular, and HF mortality or end of study. Multivariable time-dependent Cox model and inverse-probability-of-treatment weighting of marginal structural model were used to estimate associations between statin treatment and outcomes. Adjusted hazard ratios were also estimated for lipophilic and hydrophilic statin compared with no statin use. The study included 1488 patients (mean age 60.3±14.2 years) with 9306 person-years of observation. Using the time-dependent Cox model, the 5-year adjusted hazard ratios with 95% CI for statin treatment on all-cause, cardiovascular, and HF mortality were 0.68 (0.55-0.83), 0.67 (0.54-0.82), and 0.63 (0.51-0.79), respectively. Use of inverse-probability-of-treatment weighting resulted in estimates of 0.79 (0.65-0.96), 0.77 (0.63-0.96), and 0.77 (0.61-0.95) for statin treatment on all-cause, cardiovascular, and HF mortality, respectively, compared with no statin use. Among Africans with HF, statin treatment was associated with significant reduction in mortality. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Intensive Hemodialysis, Left Ventricular Hypertrophy, and Cardiovascular Disease.

PubMed

McCullough, Peter A; Chan, Christopher T; Weinhandl, Eric D; Burkart, John M; Bakris, George L

2016-11-01

The prevalence of cardiovascular disease, including cardiac arrhythmia, coronary artery disease, cardiomyopathy, and valvular heart disease, is higher in hemodialysis (HD) patients than in the US resident population. Cardiovascular disease is the leading cause of death in HD patients and the principal discharge diagnosis accompanying 1 in 4 hospital admissions. Furthermore, the rate of hospital admissions for either heart failure or fluid overload is persistently high despite widespread use of β-blockers and renin-angiotensin system inhibitors and attempts to manage fluid overload with ultrafiltration. An important predictor of cardiovascular mortality and morbidity in dialysis patients is left ventricular hypertrophy (LVH). LVH is an adaptive response to increased cardiac work, typically caused by combined pressure and volume overload, resulting in cardiomyocyte hypertrophy and increased intercellular matrix. In new dialysis patients, the prevalence of LVH is 75%. Regression of LVH may reduce cardiovascular risk, including the incidence of heart failure, complications after myocardial infarction, and sudden arrhythmic death. Multiple randomized clinical trials show that intensive HD reduces left ventricular mass, a measure of LVH. Short daily and nocturnal schedules in the Frequent Hemodialysis Network trial reduced left ventricular mass by 14 (10%) and 11 (8%) g, respectively, relative to 3 sessions per week. Comparable efficacy was observed in an earlier trial of nocturnal HD. Intensive HD also improves cardiac rhythm. Clinical benefits have been reported only in observational studies. Daily home HD is associated with 17% and 16% lower risks for cardiovascular death and hospitalization, respectively; admissions for cerebrovascular disease, heart failure, and hypertensive disease, which collectively constitute around half of cardiovascular hospitalizations, were less likely with daily home HD. Relative to peritoneal dialysis, daily home HD is likewise associated with lower risk for cardiovascular hospitalization. In conclusion, intensive HD likely reduces left ventricular mass and may lead to lower risks for adverse cardiac events. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Primary versus secondary closure of cutaneous abscesses in the emergency department: a randomized controlled trial.

PubMed

Singer, Adam J; Taira, Breena R; Chale, Stuart; Bhat, Rahul; Kennedy, David; Schmitz, Gillian

2013-01-01

Cutaneous abscesses have traditionally been treated with incision and drainage (I&D) and left to heal by secondary closure. The objective was to compare the healing rates of cutaneous abscesses following I&D after primary or secondary closure. This was a randomized, controlled, trial, balanced by center, with blocked randomization created by a random-number generator. One urban and one suburban academic emergency department (ED) participated. Subjects were randomized to primary or secondary wound closure following I&D of the abscess. Main outcome measures were the percentage of healed wounds (wound was completely closed by visual inspection; a 40% difference in wound healing was sought) and overall failure rate (need for additional intervention including suture removal, additional drainage, antibiotics, or admission within 7 days after drainage). Fifty-six adult patients with simple localized cutaneous abscesses were included; 29 were randomized to primary closure, and 27 were randomized to secondary closure. Healing rates at 7 days were similar between the primary and secondary closure groups (69.6%, 95% confidence interval [CI] = 49.1% to 84.4% vs. 59.3%, 95% CI = 40.7% to 75.5%; difference 10.3%, 95% CI = -15.8% to 34.1%). Overall failure rates at 7 days were also similar between the primary and secondary closure groups (30.4%, 95% CI = 15.6% to 50.9% vs. 28.6%, 95% CI = 15.2% to 47.1%; difference 1.8%, 95% CI = -24.2% to 28.8%). The rates of wound healing and treatment failure following I&D of simple abscesses in the ED are similar after primary or secondary closure. The authors did not detect a difference of at least 40% in healing rates between primary and secondary closure. © 2013 by the Society for Academic Emergency Medicine.

Effects of dexmedetomidine on heart arrhythmia prevention in off-pump coronary artery bypass surgery: A randomized clinical trial

PubMed Central

Soltani, Ghasem; Jahanbakhsh, Saeed; Tashnizi, Mohammad Abbasi; Fathi, Mehdi; Amini, Shahram; Zirak, Nahid; Sheybani, Shima

2017-01-01

Background Arrhythmia occurring during and after surgery is one of the major complications in open-heart surgery. Dexmedetomidine is an intravenous alpha-2 agonist and very specific short-acting drug to protect the various organs against ischemic injuries and blood reflow. However, the effect of dexmedetomidine for preventing intraoperative heart arrhythmias has not been recognized. Objective This study aimed to determine the effect of dexmedetomidine on the incidence rate of heart arrhythmias and anesthetic required in off-pump coronary artery bypass surgery. Methods This randomized clinical trial was conducted on patients who were candidates for off-pump coronary artery bypass referring to Imam Reza Hospital of Mashhad, Iran, from July 2016 through January 2017. The patients were randomly assigned to two groups of intervention (infusion of 0.5 mcg/kg/h dexmedetomidine together with induction followed by infusion of 0.5 mcg/kg/h by the end of the surgery) or control (saline infusion). Mean arterial pressure (MAP) and heart rate (HR) were measured before induction, during surgery operation and ICU admission. Data were analyzed by SPSS version 18 using Chi Square and independent-samples t-test. Results A total of 76 patients with a mean age of 59.8 ± 8.2 years (in two groups of 38) were studied. The two groups had no statistically significant difference in terms of background variables. The MAP and HR values before induction, during surgery and ICU admission were significantly higher in the control group than in the intervention group (p=0.001). Out of the studied arrhythmias, the values of PAC (55.2% vs. 15.7%), PVC (81.5% vs. 21.0%), AF (26.3% vs. 7.8%), VTAC (21.0% vs. 2.6%) were significantly lower in dexmedetomidine group (p=0.001). Conclusion It seems that dexmedetomidine administration during induction and surgery can cause significant reduction in most of the common arrhythmias in off-pump coronary bypass surgery. The use of dexmedetomidine maintains MAP and HR at significantly lower values, and changes compared to the control group as well as reduces the need for anesthetic compounds. Trial Registration The present study has been registered at the Iranian Registry of Clinical Trials (www.IRCT.IR) with a code of IRCT2016072413159N9 before starting the study. Founding This study was fully sponsored by the Research Deputy at Mashhad University of Medical Sciences, Iran (grant number 941413). PMID:29238500

The effect of early in-hospital medication review on health outcomes: a systematic review.

PubMed

Hohl, Corinne M; Wickham, Maeve E; Sobolev, Boris; Perry, Jeff J; Sivilotti, Marco L A; Garrison, Scott; Lang, Eddy; Brasher, Penny; Doyle-Waters, Mary M; Brar, Baljeet; Rowe, Brian H; Lexchin, Joel; Holland, Richard

2015-07-01

Adverse drug events are an important cause of emergency department visits, unplanned admissions and prolonged hospital stays. Our objective was to synthesize the evidence on the effect of early in-hospital pharmacist-led medication review on patient-oriented outcomes based on observed data. We systematically searched eight bibliographic reference databases, electronic grey literature, medical journals, conference proceedings, trial registries and bibliographies of relevant papers. We included studies that employed random or quasi-random methods to allocate subjects to pharmacist-led medication review or control. Medication review had to include, at a minimum, obtaining a best possible medication history and reviewing medications for appropriateness and adverse drug events. The intervention had to be initiated within 24 h of emergency department presentation or 72 h of admission. We extracted data in duplicate and pooled outcomes from clinically homogeneous studies of the same design using random effects meta-analysis. We retrieved 4549 titles of which seven were included, reporting the outcomes of 3292 patients. We pooled data from studies of the same design, and found no significant differences in length of hospital admission (weighted mean difference [WMD] -0.04 days, 95% confidence interval [CI] -1.63, 1.55), mortality (odds ratio [OR] 1.09, 95% CI 0.69, 1.72), readmissions (OR 1.15, 95% CI 0.81, 1.63) or emergency department revisits at 3 months (OR 0.60, 95% CI 0.27, 1.32). Two large studies reporting reductions in readmissions could not be included in our pooled estimates due to differences in study design. Wide confidence intervals suggest that additional research is likely to influence the effect size estimates and clarify the effect of medication review on patient-oriented outcomes. This systematic review failed to identify an effect of pharmacist-led medication review on health outcomes. © 2015 The British Pharmacological Society.

Factors affecting return to oral intake in inpatient rehabilitation after acquired brain injury.

PubMed

Kjaersgaard, Annette; Nielsen, Lars Hedemann; Sjölund, Bengt H

2015-01-01

To extend previous observations by investigating if differences exist in time to initiation or to recovery of total oral intake in patients with acquired brain injury assessed by either Facial-Oral Tract Therapy (F.O.T.T.) or Fibreoptic Endoscopic Evaluation of Swallowing (FEES) and to investigate whether other factors influence these outcomes. Randomized controlled trial. One hundred and nineteen patients with dysphagia in inpatient neurorehabilitation were randomized. The main outcome was time to maximum on the Functional Oral Intake Scale. There was no difference in time to initiation or recovery of total oral intake using F.O.T.T. or FEES. Oral intake was initiated for 42% on admission and 92% at discharge; 2.5% of the patients were on total oral intake within 24 hours of admission and 37% at discharge. The likelihood of recovery to total oral intake before discharge was found to depend on age, Functional Independence Measure score, length of stay and number of dysphagia interventions. There was no significant difference in time to initiation and recovery of total oral intake before discharge, whether assessed by F.O.T.T. or FEES, indicating that an instrumental assessment is unnecessary for standard evaluation. Age, functional independence and length of stay had a significant influence.

Very early diagnosis of chest pain by point-of-care testing: comparison of the diagnostic efficiency of a panel of cardiac biomarkers compared with troponin measurement alone in the RATPAC trial.

PubMed

Collinson, Paul; Goodacre, Steve; Gaze, David; Gray, Alasdair

2012-02-01

To assess the impact of triple marker testing on patient management and the diagnostic efficiencies of different biomarker strategies examined. A prospective randomised trial of triple marker testing by point-of-care testing (POCT); the Randomised Assessment of Panel Assay of Cardiac markers (RATPAC) study. Six emergency departments. Low-risk patients presenting with chest pain to diagnostic assessment with a cardiac panel measured by POCT or to diagnosis when biomarker measurement was based on central laboratory testing. Interventions 1125 patients were randomly assigned to POCT measurement of the triple marker panel of cardiac troponin I (cTnI), myoglobin and the MB isoenzyme of creatine kinase (CK-MB) on admission and 90 min from admission. Myocardial infarction (MI) was defined by the universal definition of MI. The following diagnostic strategies were compared by receiver operator characteristic (ROC) curve analysis and comparison of area under the curve (AUC): individual marker values, change (Δ) in CK-MB and myoglobin and the combination of presentation or 90 min value plus Δ value. Admission sample measurement of cTnI was the most diagnostically efficient AUC 0.96 (0.93-0.98) with areas under the ROC curve statistically significantly greater than CK-MB 0.85 (0.80-0.90) and myoglobin 0.75 (0.68-0.81). At 90 min cTnI measurement had the highest AUC 0.95 (0.87-1.00) but was statistically significantly different only from Δmyoglobin and ΔCK-MB. Measurement of cTnI alone is sufficient for diagnosis. Measurement of a marker panel does not facilitate diagnosis.

False confessions, expert testimony, and admissibility.

PubMed

Watson, Clarence; Weiss, Kenneth J; Pouncey, Claire

2010-01-01

The confession of a criminal defendant serves as a prosecutor's most compelling piece of evidence during trial. Courts must preserve a defendant's constitutional right to a fair trial while upholding the judicial interests of presenting competent and reliable evidence to the jury. When a defendant seeks to challenge the validity of that confession through expert testimony, the prosecution often contests the admissibility of the expert's opinion. Depending on the content and methodology of the expert's opinion, testimony addressing the phenomenon of false confessions may or may not be admissible. This article outlines the scientific and epistemological bases of expert testimony on false confession, notes the obstacles facing its admissibility, and provides guidance to the expert in formulating opinions that will reach the judge or jury. We review the 2006 New Jersey Superior Court decision in State of New Jersey v. George King to illustrate what is involved in the admissibility of false-confession testimony and use the case as a starting point in developing a best-practice approach to working in this area.

Does Treatment Adherence Therapy reduce expense of healthcare use in patients with psychotic disorders? Cost-minimization analysis in a randomized controlled trial.

PubMed

Gilden, J; Staring, A B P; der Gaag, M van; Mulder, C L

2011-12-01

Adherence interventions in psychotic disorders have produced mixed results. Even when an intervention improved adherence, benefits to patients were unclear. Treatment Adherence Therapy (TAT) also improved adherence relative to Treatment As Usual (TAU), but it had no effects on symptoms or quality of life. TAT may or may not reduce healthcare costs. To determine whether TAT reduces the use of healthcare resources, and thus healthcare costs. Randomized controlled trial of TAT versus TAU with 98 patients. Interviews were conducted at baseline (T0), six months later, when TAT had been completed (T1) and at six-month follow-up (T2). We have used admission data and part of the Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TiC-P). We compared total costs in the TAT group with those in the control group with the help of multivariate analysis of covariance. TAT did not significantly minimize total costs. In the TAT group, the mean one-year health-treatment cost per patient (including TAT sessions) was € 23 003.64 (SD=19 317.95), whereas in the TAU group it was € 22 489.88 (SD=25 224.57) (F(1)=.652, p=.42). However, there were two significant differences at item-level, both with higher costs for the TAU group: psychiatric nurse contacts and legal proceedings for court-ordered admissions. Because TAT did not reduce total healthcare costs, it did not contribute to cost-minimization. Its benefits are therefore questionable. No other adherence intervention has included analysis of cost-effectiveness or cost-minimization. Copyright © 2011 Elsevier B.V. All rights reserved.

Effects of dexmedetomidine on heart arrhythmia prevention in off-pump coronary artery bypass surgery: A randomized clinical trial.

PubMed

Soltani, Ghasem; Jahanbakhsh, Saeed; Tashnizi, Mohammad Abbasi; Fathi, Mehdi; Amini, Shahram; Zirak, Nahid; Sheybani, Shima

2017-10-01

Arrhythmia occurring during and after surgery is one of the major complications in open-heart surgery. Dexmedetomidine is an intravenous alpha-2 agonist and very specific short-acting drug to protect the various organs against ischemic injuries and blood reflow. However, the effect of dexmedetomidine for preventing intraoperative heart arrhythmias has not been recognized. This study aimed to determine the effect of dexmedetomidine on the incidence rate of heart arrhythmias and anesthetic required in off-pump coronary artery bypass surgery. This randomized clinical trial was conducted on patients who were candidates for off-pump coronary artery bypass referring to Imam Reza Hospital of Mashhad, Iran, from July 2016 through January 2017. The patients were randomly assigned to two groups of intervention (infusion of 0.5 mcg/kg/h dexmedetomidine together with induction followed by infusion of 0.5 mcg/kg/h by the end of the surgery) or control (saline infusion). Mean arterial pressure (MAP) and heart rate (HR) were measured before induction, during surgery operation and ICU admission. Data were analyzed by SPSS version 18 using Chi Square and independent-samples t-test. A total of 76 patients with a mean age of 59.8 ± 8.2 years (in two groups of 38) were studied. The two groups had no statistically significant difference in terms of background variables. The MAP and HR values before induction, during surgery and ICU admission were significantly higher in the control group than in the intervention group (p=0.001). Out of the studied arrhythmias, the values of PAC (55.2% vs. 15.7%), PVC (81.5% vs. 21.0%), AF (26.3% vs. 7.8%), VTAC (21.0% vs. 2.6%) were significantly lower in dexmedetomidine group (p=0.001). It seems that dexmedetomidine administration during induction and surgery can cause significant reduction in most of the common arrhythmias in off-pump coronary bypass surgery. The use of dexmedetomidine maintains MAP and HR at significantly lower values, and changes compared to the control group as well as reduces the need for anesthetic compounds. The present study has been registered at the Iranian Registry of Clinical Trials (www.IRCT.IR) with a code of IRCT2016072413159N9 before starting the study. This study was fully sponsored by the Research Deputy at Mashhad University of Medical Sciences, Iran (grant number 941413).

Underutilization of IV nitrates in the treatment of acute heart failure.

PubMed

Mohan, Mohapradeep; Hawkey, Sean; Baig, Fatima; Choy, Anna Maria; Lang, Chim C

2015-08-01

Acute heart failure (AHF) is a growing public health concern with high inhospital mortality and costs. Clinical practice guidelines, underpinned by positive randomized controlled trials, recommend the early use of intravenous (IV) nitrates in the treatment of AHF. However, the "real-world" usage of IV nitrates has not been clearly defined. The objective of this study was to examine the use of IV nitrates in the treatment of AHF as recommended by clinical practice guidelines. A case-record analysis was conducted of all admissions with AHF at a large teaching hospital. Of the 81 AHF patients (mean age 77 ± 11, mean SBP 130 ± 27 mmHg) enrolled for this analysis, only 5 (6%) received IV nitrates at the time of AHF admission. Forty (49%, mean age 77 ± 11, mean SBP 131 ± 27 mmHg) of these 81 patients met the guideline criteria for suitability for IV nitrates and only 5 (12%) of these received them during this admission. Patients who received IV nitrates were more likely to have higher blood pressure and all had myocardial ischemia as a precipitant. Seventy-five (93%) of the total population received loop diuretics on admission. Overall, this study shows that loop diuretics remain the first-line therapy in AHF with little use of IV nitrates, despite recommendations from clinical practice guidelines. © 2015 John Wiley & Sons Ltd.

Prevention of posttraumatic hypoxaemia in isolated lower limb long bone fractures with a minimal prophylactic dose of corticosteroids.

PubMed

Babalis, George A; Yiannakopoulos, Christos K; Karliaftis, Konstantinos; Antonogiannakis, Emmanuel

2004-03-01

The efficacy of a minimum dose of methylprednisolone for the prevention of posttraumatic hypoxaemia and fat embolism syndrome (FES) was prospectively studied in 87 patients with isolated, closed or grade I open, femoral and tibial fractures. On admission, the patients were randomly allocated either to a control group given placebo (40 patients) or to a methylprednisolone-treated group (47 patients). A total dose of 6 mg/kg BW methylprednisolone (SoluMedrol, Upjohn) was administered intravenously, divided in six equal doses at 8 h intervals. Six patients (12.8%) in the control group and one patient (2.5%) in the trial group developed FES (P = 0.079) but the difference is not statistically significant. Twenty-four hours after admission, the steroid-treated patients displayed statistically significant higher p(O2) values compared to the control group (P = 0.035) and this difference persisted on the second and the third post-admission day as well (P = 0.008). No corticosteroid-related side-effects were noticed in any of the patients during hospitalisation. Our results support the prophylactic administration of methylprednisolone in small dosage to prevent posttraumatic hypoxaemia and probably FES in patients with isolated lower limb long bone fractures, especially when early fracture stabilisation is not possible.

Reducing depressive or anxiety symptoms in post-stroke patients: Pilot trial of a constructive integrative psychosocial intervention

PubMed Central

Fang, Yihong; Mpofu, Elias; Athanasou, James

2017-01-01

Background: About 30% of stroke survivors clinically have depressive symptoms at some point following stroke and anxiety prevalence is around 20-25%. Objective: The purpose of this brief report is to evaluate a pilot trial of a constructive integrative psychosocial intervention (CIPI) over standard care in post-stroke depression or anxiety. Methods: Patients were randomly assigned to either CIPI (n = 23) or standard care (n = 19). Patients were assessed using the Hospital Anxiety and Depression Scale at the 1st, 3rd, and 6th months to monitor changes of mood. Results: A Wilcoxon signed-rank test indicated that compared to admission baseline, patients with the intervention had significantly normal post-stroke depression symptom levels at the 1st, 3rd, and 6th months (P < 0.005). Conclusion: CIPI appears to be of incremental value in treating depression as well as anxiety in subacute care. PMID:29085269

Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

PubMed Central

Khot, Sandeep P.; Davis, Arielle P.; Crane, Deborah A.; Tanzi, Patricia M.; Li Lue, Denise; Claflin, Edward S.; Becker, Kyra J.; Longstreth, W.T.; Watson, Nathaniel F.; Billings, Martha E.

2016-01-01

Study Objectives: Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. Methods: In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. Results: Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). Conclusions: A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding—though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials. Citation: Khot SP, Davis AP, Crane DA, Tanzi PM, Li Lue D, Claflin ES, Becker KJ, Longstreth WT, Watson NF, Billings ME. Effect of continuous positive airway pressure on stroke rehabilitation: a pilot randomized sham-controlled trial. J Clin Sleep Med 2016;12(7):1019–1026. PMID:27092703

COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

PubMed

Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

2015-09-15

Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff's knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular. ClinicalTrials.gov NCT02238652.

Can generic paediatric mortality scores calculated 4 hours after admission be used as inclusion criteria for clinical trials?

PubMed Central

Leteurtre, Stéphane; Leclerc, Francis; Wirth, Jessica; Noizet, Odile; Magnenant, Eric; Sadik, Ahmed; Fourier, Catherine; Cremer, Robin

2004-01-01

Introduction Two generic paediatric mortality scoring systems have been validated in the paediatric intensive care unit (PICU). Paediatric RISk of Mortality (PRISM) requires an observation period of 24 hours, and PRISM III measures severity at two time points (at 12 hours and 24 hours) after admission, which represents a limitation for clinical trials that require earlier inclusion. The Paediatric Index of Mortality (PIM) is calculated 1 hour after admission but does not take into account the stabilization period following admission. To avoid these limitations, we chose to conduct assessments 4 hours after PICU admission. The aim of the present study was to validate PRISM, PRISM III and PIM at the time points for which they were developed, and to compare their accuracy in predicting mortality at those times with their accuracy at 4 hours. Methods All children admitted from June 1998 to May 2000 in one tertiary PICU were prospectively included. Data were collected to generate scores and predictions using PRISM, PRISM III and PIM. Results There were 802 consecutive admissions with 80 deaths. For the time points for which the scores were developed, observed and predicted mortality rates were significantly different for the three scores (P < 0.01) whereas all exhibited good discrimination (area under the receiver operating characteristic curve ≥0.83). At 4 hours after admission only the PIM had good calibration (P = 0.44), but all three scores exhibited good discrimination (area under the receiver operating characteristic curve ≥0.82). Conclusions Among the three scores calculated at 4 hours after admission, all had good discriminatory capacity but only the PIM score was well calibrated. Further studies are required before the PIM score at 4 hours can be used as an inclusion criterion in clinical trials. PMID:15312217

Mechanical versus manual chest compressions for out-of-hospital cardiac arrest: a meta-analysis of randomized controlled trials

PubMed Central

Tang, Lu; Gu, Wan-Jie; Wang, Fei

2015-01-01

Recent evidence regarding mechanical chest compressions in out-of-hospital cardiac arrest (OHCA) is conflicting. The objective of this study was to perform a meta-analysis of randomized controlled trials (RCTs) to compare the effect of mechanical versus manual chest compressions on resuscitation outcomes in OHCA. PubMed, Embase, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched. In total, five RCTs with 12,510 participants were included. Compared with manual chest compressions, mechanical chest compressions did not significantly improve survival with good neurological outcome to hospital discharge (relative risks (RR) 0.80, 95% CI 0.61–1.04, P = 0.10; I2 = 65%), return of spontaneous circulation (RR 1.02, 95% CI 0.95–1.09, P = 0.59; I2 = 0%), or long-term (≥6 months) survival (RR 0.96, 95% CI 0.79–1.16, P = 0.65; I2 = 16%). In addition, mechanical chest compressions were associated with worse survival to hospital admission (RR 0.94, 95% CI 0.89–1.00, P = 0.04; I2 = 0%) and to hospital discharge (RR 0.88, 95% CI 0.78–0.99, P = 0.03; I2 = 0%). Based on the current evidence, widespread use of mechanical devices for chest compressions in OHCA cannot be recommended. PMID:26503429

An equivalence study of interview platform: Does videoconference technology impact medical school acceptance rates of different groups?

PubMed

Ballejos, Marlene P; Oglesbee, Scott; Hettema, Jennifer; Sapien, Robert

2018-02-14

Web-based interviewing may be an effective element of a medical school's larger approach to promotion of holistic review, as recommended by the Association of American Medical Colleges, by facilitating the feasibility of including rural and community physicians in the interview process. Only 10% of medical schools offer videoconference interviews to applicants and little is known about the impact of this interview modality on the admissions process. This study investigated the impact of overall acceptance rates using videoconference interviews and face-to-face interviews in the medical school selection process using an equivalence trial design. The University of New Mexico School of Medicine integrated a videoconferencing interview option for community and rural physician interviewers in a pseudo-random fashion during the 2014-2016 admissions cycles. Logistic regression was conducted to examine whether videoconference interviews impacted acceptance rates or the characteristics of accepted students. Demographic, admissions and diversity factors were analyzed that included applicant age, MCAT score, cumulative GPA, gender, underrepresented in medicine, socioeconomic status and geographic residency. Data from 752 interviews were analyzed. Adjusted rates of acceptance for face-to-face (37.0%; 95% CI 28.2, 46.7%) and videoconference (36.1%; 95% CI 17.8, 59.5%) interviews were within an a priori ± 5% margin of equivalence. Both interview conditions yielded highly diverse groups of admitted students. Having a higher medical college admission test score, grade point average, and self-identifying as disadvantaged increased odds of admission in both interview modalities. Integration of the videoconference interview did not impact the overall acceptance of a highly diverse and qualified group of applicants, and allowed rural and community physicians to participate in the medical school interview process as well as allowed campus faculty and medical student committee members to interview remotely.

"Hospital at home" for neuromuscular disease patients with respiratory tract infection: a pilot study.

PubMed

Vianello, Andrea; Savoia, Francesca; Pipitone, Emanuela; Nordio, Beatrice; Gallina, Giulia; Paladini, Luciana; Concas, Alessandra; Arcaro, Giovanna; Gallan, Federico; Pegoraro, Elena

2013-12-01

The "hospital-at-home" model may provide adequate care without an adverse effect on clinical outcome, and is generally well received by users. Our objective was to compare hospital-at-home and in-patient hospital care for neuromuscular disease (NMD) patients with respiratory tract infections. We conducted a prospective randomized controlled trial in a university teaching hospital offering secondary care service to a population of approximately 500,000. We recruited selected NMD patients with respiratory tract infection for whom hospital admission had been recommended after medical assessment. Hospital-at-home was provided as an alternative to in-patient admission. The main outcome measures were need for hospitalization, treatment failure, time to recovery, death during the first 3 months following exacerbation, and cost of patient care. Among 59 consecutive NMD patients eligible for the study, 53 met the criteria for hospital-at-home. Twenty-six subjects were randomized to home care and 27 to hospital care. No significant differences were found in treatment failure (8/26 vs 13/27, P = .19), time to recovery (8.9 ± 4.6 vs 9 ± 8.9 d, P = .21), or mortality at 3 months (3/26 vs 4/27 deaths, P = .42) between the groups. Hospital-at-home failure was independently correlated with type of NMD (P = .004) with an odds ratio of failure of 17.3 (95% CI 2.1 to infinity) for subjects with amyotrophic lateral sclerosis. The total and daily direct cost of patient healthcare was significantly lower for the subjects who were successfully treated at home, compared to the hospitalized individuals. Hospital-at-home is an effective alternative to hospital admission for selected NMD patients with respiratory tract infections.

Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial.

PubMed

Mosquera, Ricardo A; Avritscher, Elenir B C; Samuels, Cheryl L; Harris, Tomika S; Pedroza, Claudia; Evans, Patricia; Navarro, Fernando; Wootton, Susan H; Pacheco, Susan; Clifton, Guy; Moody, Shade; Franzini, Luisa; Zupancic, John; Tyson, Jon E

Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness. To assess whether an enhanced medical home providing comprehensive care prevents serious illness (death, intensive care unit [ICU] admission, or hospital stay >7 days) and/or reduces costs among children with chronic illness. Randomized clinical trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) treated at a high-risk clinic at the University of Texas, Houston, and randomized to comprehensive care (n = 105) or usual care (n = 96). Enrollment was between March 2011 and February 2013 (when predefined stopping rules for benefit were met) and outcome evaluations continued through August 31, 2013. Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care. Usual care was provided locally in private offices or faculty-supervised clinics without modification. Primary outcome: children with a serious illness (death, ICU admission, or hospital stay >7 days), costs (health system perspective). Secondary outcomes: individual serious illnesses, medical services, Medicaid payments, and medical school revenues and costs. In an intent-to-treat analysis, comprehensive care decreased both the rate of children with a serious illness (10 per 100 child-years vs 22 for usual care; rate ratio [RR], 0.45 [95% CI, 0.28-0.73]), and total hospital and clinic costs ($16,523 vs $26,781 per child-year, respectively; cost ratio, 0.58 [95% CI, 0.38-0.88]). In analyses of net monetary benefit, the probability that comprehensive care was cost neutral or cost saving was 97%. Comprehensive care reduced (per 100 child-years) serious illnesses (16 vs 44 for usual care; RR, 0.33 [95% CI, 0.17-0.66]), emergency department visits (90 vs 190; RR, 0.48 [95% CI, 0.34-0.67]), hospitalizations (69 vs 131; RR, 0.51 [95% CI, 0.33-0.77]), pediatric ICU admissions (9 vs 26; RR, 0.35 [95% CI, 0.18-0.70]), and number of days in a hospital (276 vs 635; RR, 0.36 [95% CI, 0.19-0.67]). Medicaid payments were reduced by $6243 (95% CI, $1302-$11,678) per child-year. Medical school losses (costs minus revenues) increased by $6018 (95% CI, $5506-$6629) per child-year. Among high-risk children with chronic illness, an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs. These findings from a single site of selected patients with a limited number of clinicians require study in larger, broader populations before conclusions about generalizability to other settings can be reached. clinicaltrials.gov Identifier: NCT02128776.

The ICU trial: a new admission policy for cancer patients requiring mechanical ventilation.

PubMed

Lecuyer, Lucien; Chevret, Sylvie; Thiery, Guillaume; Darmon, Michael; Schlemmer, Benoît; Azoulay, Elie

2007-03-01

Cancer patients requiring mechanical ventilation are widely viewed as poor candidates for intensive care unit (ICU) admission. We designed a prospective study evaluating a new admission policy titled The ICU Trial. Prospective study. Intensive care unit. One hundred eighty-eight patients requiring mechanical ventilation and having at least one other organ failure. Over a 3-yr period, all patients with hematologic malignancies or solid tumors proposed for ICU admission underwent a triage procedure. Bedridden patients and patients in whom palliative care was the only cancer treatment option were not admitted to the ICU. Patients at earliest phase of the malignancy (diagnosis < 30 days) were admitted without any restriction. All other patients were prospectively included in The ICU Trial, consisting of a full-code ICU admission followed by reappraisal of the level of care on day 5. Among the 188 patients, 103 survived the first 4 ICU days and 85 died from the acute illness. Hospital survival was 21.8% overall. Among the 103 survivors on day 5, none of the characteristics of the malignancy were significantly different between the 62 patients who died and the 41 who survived. Time course of organ dysfunction over the first 6 ICU days differed significantly between survivors and nonsurvivors. Organ failure scores were more accurate on day 6 than at admission or on day 3 for predicting survival. All patients who required initiation of mechanical ventilation, vasopressors, or dialysis after 3 days in the ICU died. Survival was 40% in mechanically ventilated cancer patients who survived to day 5 and 21.8% overall. If these results are confirmed in future interventional studies, we recommend ICU admission with full-code management followed by reappraisal on day 6 in all nonbedridden cancer patients for whom lifespan-extending cancer treatment is available.

A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

PubMed

Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

2012-03-01

Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

Reduction of Methicillin-Resistant Staphylococcus aureus (MRSA) Infection in Long Term Care is Possible While Maintaining Patient Socialization: A Prospective Randomized Clinical Trial

PubMed Central

Peterson, Lance R.; Boehm, Susan; Beaumont, Jennifer L.; Patel, Parul A.; Schora, Donna M.; Peterson, Kari E.; Burdsall, Deborah; Hines, Carolyn; Fausone, Maureen; Robicsek, Ari; Smith, Becky A.

2016-01-01

Background Antibiotic resistance is a challenge in Long Term Care Facilities (LTCFs). The objective was to demonstrate that a novel, minimally invasive program not interfering with activities of daily living (ADL) or socialization could lower methicillin-resistant Staphylococcus aureus (MRSA) disease. Methods This was a prospective, cluster-randomized, non-blinded trial initiated at three LTCFs. During Year 1 units were stratified by type of care and randomized to intervention or control. In Year 2 all units were converted to intervention consisting of universal decolonization using intranasal mupirocin and a chlorhexidine bath performed twice (two decolonization/bathing cycles one month apart) at the start of the intervention period. Subsequently, after initial decolonization, all admissions were screened on site using real-time PCR and those MRSA positive were decolonized, but not isolated. Units received annual instruction on hand hygiene. Enhanced bleach wipe cleaning of flat surfaces was done every four months. Results 16,773 tests were performed. The MRSA infection rate decreased 65% between the baseline (44 infections during 365,809 patient-days) and Year 2 (12 during 287,847 patient-days; p<0.001); significant reduction was observed at each of the LTCFs (p<0.03). Discussion and Conclusion On-site MRSA surveillance with targeted decolonization resulted in a significant decrease in clinical MRSA infection among LTCF residents. PMID:27492790

Frequency, predictors, and consequences of crossing over to revascularization within 12 months of randomization to optimal medical therapy in the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

PubMed

Spertus, John A; Maron, David J; Cohen, David J; Kolm, Paul; Hartigan, Pam; Weintraub, William S; Berman, Daniel S; Teo, Koon K; Shaw, Leslee J; Sedlis, Steven P; Knudtson, Merril; Aslan, Mihaela; Dada, Marcin; Boden, William E; Mancini, G B John

2013-07-01

In the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial, some patients with stable ischemic heart disease randomized to optimal medical therapy (OMT) crossed over to early revascularization. The predictors and outcomes of patients who crossed over from OMT to revascularization are unknown. We compared characteristics of OMT patients who did and did not undergo revascularization within 12 months and created a Cox regression model to identify predictors of early revascularization. Patients' health status was measured with the Seattle Angina Questionnaire. To quantify the potential consequences of initiating OMT without percutaneous coronary intervention, we compared the outcomes of crossover patients with a matched cohort randomized to immediate percutaneous coronary intervention. Among 1148 patients randomized to OMT, 185 (16.1%) underwent early revascularization. Patient characteristics independently associated with early revascularization were worse baseline Seattle Angina Questionnaire scores and healthcare system. Among 156 OMT patients undergoing early revascularization matched to 156 patients randomized to percutaneous coronary intervention, rates of mortality (hazard ratio=0.51 [0.13-2.1]) and nonfatal myocardial infarction (hazard ratio=1.9 [0.75-4.6]) were similar, as were 1-year Seattle Angina Questionnaire scores. OMT patients, however, experienced worse health status over the initial year of treatment and more unstable angina admissions (hazard ratio=2.8 [1.1-7.5]). Among COURAGE patients assigned to OMT alone, patients' angina, dissatisfaction with their current treatment, and, to a lesser extent, their health system were associated with early revascularization. Because early crossover was not associated with an increase in irreversible ischemic events or impaired 12-month health status, these findings support an initial trial of OMT in stable ischemic heart disease with close follow-up of the most symptomatic patients. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00007657.

Early Intervention for Preterm Infants and Their Mothers: A Systematic Review.

PubMed

Zhang, Xin; Kurtz, Melissa; Lee, Shih-Yu; Liu, Huaping

2014-11-18

This systematic review evaluates the efficacy of various early interventions on maternal emotional outcomes, mother-infant interaction, and subsequent infant outcomes during neonatal intensive care unit admission and postdischarge. Key interventions associated with outcomes in both the neonatal intensive care unit and postdischarge (ie, home) settings are summarized. A comprehensive search of peer-reviewed randomized controlled trials involving early interventions for infants and their mother published between 1993 and 2013 in the electronic databases PubMed, CINAHL, EMBASE, PsychINFO, and Cochrane was undertaken. Methodological quality was assessed using the PEDro scale to evaluate internal and external validity of the study. Twelve randomized controlled trials were included in the review, and all used some form of parenting education. The interventions had limited effects on maternal stress and mother-infant interaction and positive effects on maternal anxiety, depressive symptoms, and maternal coping. There were positive effects on infants' short-term outcomes for length of stay and breast-feeding rate. Positive and clinically meaningful effects of early interventions were seen in some physiological/psychological outcomes of mothers and preterm infants. It is important for nurses to foster close mother-infant contact and increase maternal competence during and after the infant's hospitalization period.

A randomized controlled trial of intensive care management for disabled Medicaid beneficiaries with high health care costs.

PubMed

Bell, Janice F; Krupski, Antoinette; Joesch, Jutta M; West, Imara I; Atkins, David C; Court, Beverly; Mancuso, David; Roy-Byrne, Peter

2015-06-01

To evaluate outcomes of a registered nurse-led care management intervention for disabled Medicaid beneficiaries with high health care costs. Washington State Department of Social and Health Services Client Outcomes Database, 2008-2011. In a randomized controlled trial with intent-to-treat analysis, outcomes were compared for the intervention (n = 557) and control groups (n = 563). A quasi-experimental subanalysis compared outcomes for program participants (n = 251) and propensity score-matched controls (n = 251). Administrative data were linked to describe costs and use of health services, criminal activity, homelessness, and death. In the intent-to-treat analysis, the intervention group had higher odds of outpatient mental health service use and higher prescription drug costs than controls in the postperiod. In the subanalysis, participants had fewer unplanned hospital admissions and lower associated costs; higher prescription drug costs; higher odds of long-term care service use; higher drug/alcohol treatment costs; and lower odds of homelessness. We found no health care cost savings for disabled Medicaid beneficiaries randomized to intensive care management. Among participants, care management may have the potential to increase access to needed care, slow growth in the number and therefore cost of unplanned hospitalizations, and prevent homelessness. These findings apply to start-up care management programs targeted at high-cost, high-risk Medicaid populations. © Health Research and Educational Trust.

A practical Bayesian stepped wedge design for community-based cluster-randomized clinical trials: The British Columbia Telehealth Trial.

PubMed

Cunanan, Kristen M; Carlin, Bradley P; Peterson, Kevin A

2016-12-01

Many clinical trial designs are impractical for community-based clinical intervention trials. Stepped wedge trial designs provide practical advantages, but few descriptions exist of their clinical implementational features, statistical design efficiencies, and limitations. Enhance efficiency of stepped wedge trial designs by evaluating the impact of design characteristics on statistical power for the British Columbia Telehealth Trial. The British Columbia Telehealth Trial is a community-based, cluster-randomized, controlled clinical trial in rural and urban British Columbia. To determine the effect of an Internet-based telehealth intervention on healthcare utilization, 1000 subjects with an existing diagnosis of congestive heart failure or type 2 diabetes will be enrolled from 50 clinical practices. Hospital utilization is measured using a composite of disease-specific hospital admissions and emergency visits. The intervention comprises online telehealth data collection and counseling provided to support a disease-specific action plan developed by the primary care provider. The planned intervention is sequentially introduced across all participating practices. We adopt a fully Bayesian, Markov chain Monte Carlo-driven statistical approach, wherein we use simulation to determine the effect of cluster size, sample size, and crossover interval choice on type I error and power to evaluate differences in hospital utilization. For our Bayesian stepped wedge trial design, simulations suggest moderate decreases in power when crossover intervals from control to intervention are reduced from every 3 to 2 weeks, and dramatic decreases in power as the numbers of clusters decrease. Power and type I error performance were not notably affected by the addition of nonzero cluster effects or a temporal trend in hospitalization intensity. Stepped wedge trial designs that intervene in small clusters across longer periods can provide enhanced power to evaluate comparative effectiveness, while offering practical implementation advantages in geographic stratification, temporal change, use of existing data, and resource distribution. Current population estimates were used; however, models may not reflect actual event rates during the trial. In addition, temporal or spatial heterogeneity can bias treatment effect estimates. © The Author(s) 2016.

Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial

PubMed Central

Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

2018-01-01

Background Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. Objective This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. Methods At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Results Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference −4.53, 95% CI −7.16 to −1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. Conclusions This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be especially useful for patients struggling with adherence. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12615000259549; http://www.anzctr.org.au (Archived by WebCite at  http://www.webcitation.org/6whIjptLS) PMID:29439942

[Impact of admission heart rate on short-term outcome of ST-elevation myocardial infarction patients].

PubMed

Zhang, Han; Yang, Yan-min; Zhu, Jun; Tan, Hui-qiong; Liu, Li-sheng

2012-01-01

To evaluate the impact of admission heart rate (HR) on 30-day all-cause death and cardiovascular events in Chinese patients with ST-elevation acute myocardial infarction (STEMI). A total of 7485 Chinese STEMI patients from a global randomized controlled trial (CREATE) database were divided into six groups by admission HR: < 60, 60 - 69, 70 - 79, 80 - 89, 90 - 99 and ≥ 100 bpm. The primary outcome was 30-day all-cause death; the secondary outcomes were the composite of 30-day all-cause death, reinfarction, cardiogenic shock or deadly arrhythmia. Admission glucose level, proportion of female gender, incidence of anterior myocardial infarction, previous diabetes mellitus, hypertension and Killip level II-IV were significantly higher in patients with admission HR ≥ 90 bpm compared to 60 - 69 bpm group (P < 0.05). The 30-day mortality was lowest (6.3%) in the 60 - 69 bpm group and was 9.6% in HR < 60 bpm group (P < 0.05 vs. 60 - 69 bpm group). In patients with admission HR > 60 bpm, the 30-day mortality increased in proportion to higher admission HR: 8.1% in 70 - 79 bpm, 9.2% in 80 - 89 bpm, 12.6% in 90 - 99 bpm and 24.6% in ≥ 100 bpm groups (all P < 0.05 vs. 60 - 69 bpm group). The incidence of MACE was similar as that of 30-day mortality: 27.0% in < 60 bpm, 12.5% in 60 - 69 bpm, 13.7% in 70 - 79 bpm, 14.3% in 80 - 89 bpm, 17.5% in 90 - 99 bpm and 31.1% in ≥ 100 bpm groups. Multivariate analysis showed that the incidence of 30-day mortality positively correlated with the admission HR (P < 0.05) except in the patients with admission HR < 60 bpm (OR = 0.832, P = 0.299), the risk of joint endpoint events was higher in the patients with HR < 60 bpm (OR = 1.532, 95%CI: 1.201 - 1.954, P < 0.05), 90 - 99 bpm (OR = 1.436, 95%CI: 1.091 - 1.889, P < 0.05) or ≥ 100 bpm (OR = 1.893, 95%CI: 1.471 - 2.436, P < 0.001). Admission HR is an independent risk factor for short-term outcome in Chinese STEMI patients.

Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial.

PubMed

Giannelli, Marco; Formigli, Lucia; Bani, Daniele

2014-04-01

The use of lasers in periodontology is a matter of debate, mainly because of the lack of consensual therapeutic protocols. In this randomized, split-mouth trial, the clinical efficacy of two different photoablative dental lasers, erbium:yttrium-aluminum-garnet (Er:YAG) and diode, for the treatment of gingival hyperpigmentation is compared. Twenty-one patients requiring treatment for mild-to-severe gingival hyperpigmentation were enrolled. Maxillary or mandibular left or right quadrants were randomly subjected to photoablative deepithelialization with either Er:YAG or diode laser. Masked clinical assessments of each laser quadrant were made at admission and days 7, 30, and 180 postoperatively by an independent observer. Histologic examination was performed before and soon after treatment and 6 months after irradiation. Patients also compiled a subjective evaluation questionnaire. Both diode and Er:YAG lasers gave excellent results in gingival hyperpigmentation. However, Er:YAG laser induced deeper gingival tissue injury than diode laser, as judged by bleeding at surgery, delayed healing, and histopathologic analysis. The use of diode laser showed additional advantages compared to Er:YAG in terms of less postoperative discomfort and pain. This study highlights the efficacy of diode laser for photoablative deepithelialization of hyperpigmented gingiva. It is suggested that this laser can represent an effective and safe therapeutic option for gingival photoablation.

Neuromuscular electrical stimulation in mechanically ventilated patients: a randomized, sham-controlled pilot trial with blinded outcome assessment.

PubMed

Kho, Michelle E; Truong, Alexander D; Zanni, Jennifer M; Ciesla, Nancy D; Brower, Roy G; Palmer, Jeffrey B; Needham, Dale M

2015-02-01

The purpose of the study is to compare neuromuscular electrical stimulation (NMES) vs sham on leg strength at hospital discharge in mechanically ventilated patients. We conducted a randomized pilot study of NMES vs sham applied to 3 bilateral lower extremity muscle groups for 60 minutes daily in the intensive care unit (ICU). Between June 2008 and March 2013, we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission. The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score (maximum, 30). Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening. Clinicaltrials.gov: NCT00709124. We stopped enrollment early after 36 patients due to slow patient accrual and the end of research funding. For NMES vs sham, mean (SD) lower extremity strength was 28 (2) vs 27 (3), P = .072. Among secondary outcomes, NMES vs sham patients had a greater mean (SD) walking distance (514 [389] vs 251 [210] ft, P = .050) and increase in muscle strength (5.7 [5.1] vs 1.8 [2.7], P = .019). In this pilot randomized trial, NMES did not significantly improve leg strength at hospital discharge. Significant improvements in secondary outcomes require investigation in future research. Copyright © 2014 Elsevier Inc. All rights reserved.

Creative music therapy to promote brain structure, function, and neurobehavioral outcomes in preterm infants: a randomized controlled pilot trial protocol.

PubMed

Haslbeck, Friederike Barbara; Bucher, Hans-Ulrich; Bassler, Dirk; Hagmann, Cornelia

2017-01-01

Preterm birth is associated with increased risk of neurological impairment and deficits in cognition, motor function, and behavioral problems. Limited studies indicate that multi-sensory experiences support brain development in preterm infants. Music appears to promote neurobiological processes and neuronal learning in the human brain. Creative music therapy (CMT) is an individualized, interactive therapeutic approach based on the theory and methods of Nordoff and Robbins. CMT may promote brain development in preterm infants via concurrent interaction and meaningful auditory stimulation. We hypothesize that preterm infants who receive creative music therapy during neonatal intensive care admission will have developmental benefits short- and long-term brain function. A prospective, randomized controlled single-center pilot trial involving 60 clinically stable preterm infants under 32 weeks of gestational age is conducted in preparation for a multi-center trial. Thirty infants each are randomized to either standard neonatal intensive care or standard care with CMT. Music therapy intervention is approximately 20 min in duration three times per week. A trained music therapist sings for the infants in lullaby style, individually entrained and adjusted to the infant's rhythm and affect. Primary objectives of this study are feasibility of protocol implementation and investigating the potential mechanism of efficacy for this new intervention. To examine the effect of this new intervention, non-invasive, quantitative magnetic resonance imaging (MRI) methods at corrected age and standardized neurodevelopmental assessments using the Bayley Scales of Infant and Toddler Development third edition at a corrected age of 24 months and Kaufman Assessment Battery for Children at 5 years will be performed. All assessments will be performed and analyzed by blinded experts. To our knowledge, this is the first randomized controlled clinical trial to systematically examine possible effects of creative music therapy on short- and long-term brain development in preterm infants. This project lies at the interface of music therapy, neuroscience, and medical imaging. New insights into the potential role and impact of music on brain function and development may be elucidated. If such a low-cost, low-risk intervention is demonstrated in a future multi-center trial to be effective in supporting brain development in preterm neonates, findings could have broad clinical implications for this vulnerable patient population. ClinicalTrials.gov, NCT02434224.

Omega-3 supplementation to prevent recurrent preterm birth: a systematic review and metaanalysis of randomized controlled trials.

PubMed

Saccone, Gabriele; Berghella, Vincenzo

2015-08-01

The purpose of this study was to evaluate the efficacy of omega-3 supplementation for the prevention of recurrent preterm birth (PTB) in asymptomatic singleton gestations with previous PTB. We searched fish oil, long chain polyunsaturated fatty acids, pregnancy, and omega-3 in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, and the Cochrane Central Register of Controlled Trials from inception of each database to December 2014 with no limit for language. In addition the reference lists of all identified articles were examined to identify studies that were not captured by electronic searches. We performed a metaanalysis of randomized controlled trials of asymptomatic singleton gestations with previous PTB who were assigned randomly to prophylactic omega-3 supplementation vs control (either placebo or no treatment). The primary outcome was predefined as PTB at <37 weeks of gestation. The pooled results were reported as relative risk (RR) with 95% confidence interval (95% CI). The protocol of this review was registered with PROSPERO (registration number: CRD42015016371). Two randomized controlled trials that included 1080 women were analyzed. The mean gestational age at randomization was approximately 134 days in both groups (mean difference, 0.01 days; 95% CI, -0.13 to 0.14). Women who received omega-3 had similar rates of PTB at <37 weeks of gestation (34.5% vs 39.8%; RR, 0.81; 95% CI, 0.59-1.12) and PTB at <34 weeks of gestation (12.0% vs 15.4%; RR, 0.62; 95% CI, 0.26-1.46) compared with control subjects. The omega-3 groups had a statistically significantly longer latency (mean difference, 2.10 days; 95% CI, 1.98-2.22) and higher birthweight (mean difference, 102.52 g; 95% CI, 20.09-184.95) compared with control subjects; the other secondary outcomes (which included gestational age at delivery, spontaneous PTB at <37 and 34 weeks of gestation, admission to the intensive care unit, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and perinatal death) were similar. Omega-3 supplementation during pregnancy does not prevent recurrent PTB in asymptomatic singleton gestations with previous PTB. The benefits in longer latency and higher birth weight may deserve further study. Copyright © 2015 Elsevier Inc. All rights reserved.

[Evaluation of hospital admissions: admission guidelines implementation in a pediatric emergency department].

PubMed

Katz, Manuel; Warshawsky, Sheila S; Rosen, Shirley; Barak, Nurit; Press, Joseph

2004-10-01

To develop and implement locally tailored pediatric admission guidelines for use in a pediatric emergency department and evaluate the appropriateness of admissions based on these guidelines. Our Study was based on the development of admission guidelines by senior physicians, using the Delphi Consensus Process, for use in the Pediatric Emergency Department (PED) at Soroka University Medical Center (Soroka). We evaluated the appropriateness of admissions to the pediatric departments of Soroka on 33 randomly selected days in 1999 and 2000 prior to guideline implementation and 30 randomly selected days in 2001, after guideline implementation. A total of 1037 files were evaluated. A rate of 12.4% inappropriate admissions to the pediatric departments was found based on locally tailored admission guidelines. There was no change in the rate of inappropriate admissions after implementation of admission guidelines in PED. Inappropriate admissions were associated with age above 3 years, hospital stay of two days or less and the season. The main reasons for evaluating an admission as inappropriate were that the admission did not comply with the guidelines and that the case could be managed in an ambulatory setting. There were distinctive differences in the characteristics of the Bedouin and Jewish populations admitted to the pediatric departments, although no difference was found in the rate of inappropriate admissions between these populations. Patient management in Soroka PED is tailored to the conditions of this medical center and to the characteristics of the population it serves. The admission guidelines developed reflect these special conditions. Lack of change in the rate of inappropriate admissions following implementation of the guidelines indicates that the guidelines reflect the physicians' approach to patient management that existed in Soroka PED prior to guideline implementation. Hospital admission guidelines have a role in the health management system; however, these guidelines must be tailored to reflect local characteristics and needs.

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial

PubMed Central

2012-01-01

Background Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. Methods/design A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance. Discussion Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment. Trial registration ClinicalTrials.gov Identifier: NCT01566617 PMID:23270509

Higher versus lower blood pressure targets for vasopressor therapy in shock: a multicentre pilot randomized controlled trial.

PubMed

Lamontagne, François; Meade, Maureen O; Hébert, Paul C; Asfar, Pierre; Lauzier, François; Seely, Andrew J E; Day, Andrew G; Mehta, Sangeeta; Muscedere, John; Bagshaw, Sean M; Ferguson, Niall D; Cook, Deborah J; Kanji, Salmaan; Turgeon, Alexis F; Herridge, Margaret S; Subramanian, Sanjay; Lacroix, Jacques; Adhikari, Neill K J; Scales, Damon C; Fox-Robichaud, Alison; Skrobik, Yoanna; Whitlock, Richard P; Green, Robert S; Koo, Karen K Y; Tanguay, Teddie; Magder, Sheldon; Heyland, Daren K

2016-04-01

In shock, hypotension may contribute to inadequate oxygen delivery, organ failure and death. We conducted the Optimal Vasopressor Titration (OVATION) pilot trial to inform the design of a larger trial examining the effect of lower versus higher mean arterial pressure (MAP) targets for vasopressor therapy in shock. We randomly assigned critically ill patients who were presumed to suffer from vasodilatory shock regardless of admission diagnosis to a lower (60-65 mmHg) versus a higher (75-80 mmHg) MAP target. The primary objective was to measure the separation in MAP between groups. We also recorded days with protocol deviations, enrolment rate, cardiac arrhythmias and mortality for prespecified subgroups. A total of 118 patients were enrolled from 11 centres (2.3 patients/site/month of screening). The between-group separation in MAP was 9 mmHg (95% CI 7-11). In the lower and higher MAP groups, we observed deviations on 12 versus 8% of all days on vasopressors (p = 0.059). Risks of cardiac arrhythmias (20 versus 36%, p = 0.07) and hospital mortality (30 versus 33%, p = 0.84) were not different between lower and higher MAP arms. Among patients aged 75 years or older, a lower MAP target was associated with reduced hospital mortality (13 versus 60%, p = 0.03) but not in younger patients. This pilot study supports the feasibility of a large trial comparing lower versus higher MAP targets for shock. Further research may help delineate the reasons for vasopressor dosing in excess of prescribed targets and how individual patient characteristics modify the response to vasopressor therapy.

Randomized trial of computerized quantitative pretest probability in low-risk chest pain patients: effect on safety and resource use.

PubMed

Kline, Jeffrey A; Zeitouni, Raghid A; Hernandez-Nino, Jackeline; Jones, Alan E

2009-06-01

We hypothesize that the presentation of a quantitative pretest probability of acute coronary syndrome would safely reduce unnecessary resource use in low-risk emergency department (ED) chest pain patients. Randomized controlled trial of adult patients with chest pain paired with their clinicians. Patients had neither obvious evidence of acute coronary syndrome nor obvious other reason for admission. Clinicans provided their unstructured point estimate for pretest probability before randomization. Clinicans and patients in the intervention group received a printout of pretest probability of acute coronary syndrome result displayed numerically and graphically. Controls received no printout. Patients were followed for 45 days for predefined criteria of acute coronary syndrome and efficacy endpoints. Endpoints were compared between groups, with 95% confidence intervals (CIs) for differences. Four hundred were enrolled, and 31 were excluded for cocaine use or elopement from care. The mean pretest probability estimates of acute coronary syndrome were 4 (SD 5%) from clinicians and 4 (SD 6%) from the computer. Safety and efficacy endpoints for controls (n=185) versus intervention patients (n=184) were as follows: (1) delayed or missed diagnosis of acute coronary syndrome: 1 of 185 versus 0 of 184 (95% CI for difference -2.8% to 15.0%); (2) hospital admission with no significant cardiovascular diagnosis, 11% versus 5% (-0.2% to 11%); (3) thoracic imaging imparting greater than 5 mSv radiation with a negative result, 20% versus 9% (95% CI for difference = 3.8% to 18.0%); (4) median length of stay, 11.4 hours versus 9.2 hours (95% CI for difference = -2.9 to 7.6 hours); (5) reported feeling "very satisfied" with clinician explanation of problem on follow-up survey, 38% versus 49% (95% CI for difference = 0.9% to 21.0%); (6) readmitted within 7 days, 11% versus 4% (95% CI for difference = 2.5% to 13.2%). Presentation of a quantitative estimate of the pretest probability of acute coronary syndrome to clinicians and low-risk ED chest pain patients was associated with reduced resource use, without evidence of increased rate of premature discharge of patients with acute coronary syndrome.

Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial.

PubMed

da Silva, José Roberto; Borges, Paulo Sérgio; Agra, Karine F; Pontes, Isabelle Albuquerque; Alves, João Guilherme Bezerra

2013-11-19

Gestational diabetes mellitus (GDM) is increasing worldwide and has been associated with adverse perinatal outcomes and high risk for chronic disease both for the mother and for the child. Physical exercise is feasible for diabetic pregnant women and contributes to better glycemic control and to a decrease in adverse perinatal outcomes. However, there are no randomized controlled trials (RCT) assessing the effects of aquatic physical exercise on GDM control and adverse maternal and fetal outcomes. An RCT will be conducted at Instituto de Medicina Integral Prof Fernando Figueira (IMIP), Brazil. A total of 72 pregnant women will be studied; 36 gestational diabetics will undergo an aquatic physical exercise program in a thermal pool, 3 times per week over 2 months. The primary endpoint will be glucose level control and use of insulin; secondary endpoints will be the following maternal and fetal outcomes: weight gain during pregnancy, blood pressure, pre-eclampsia diagnosis, intrauterus growth restriction, preterm birth, Cesarean section, macrosomia and maternal or neonatal intensive care admission. Endpoints between intervention and control group will analyzed by t test for unpaired data and χ² test, and the level of significance will set at <0.05. The physical proprieties of water make aquatic exercises ideal for pregnant women. An aquatic physical exercise program developed for GDM women will be trialed in a thermal pool and under the supervision of physiotherapist to ensure compliance. It is expected that this study will provide evidence as to the effect of aquatic physical exercise on GDM control. ClinicalTrial.gov, NCT01940003.

High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial): protocol of a multicentre randomised double-blind clinical trial.

PubMed

Márta, Katalin; Szabó, Anikó N; Pécsi, Dániel; Varjú, Péter; Bajor, Judit; Gódi, Szilárd; Sarlós, Patrícia; Mikó, Alexandra; Szemes, Kata; Papp, Mária; Tornai, Tamás; Vincze, Áron; Márton, Zsolt; Vincze, Patrícia A; Lankó, Erzsébet; Szentesi, Andrea; Molnár, Tímea; Hágendorn, Roland; Faluhelyi, Nándor; Battyáni, István; Kelemen, Dezső; Papp, Róbert; Miseta, Attila; Verzár, Zsófia; Lerch, Markus M; Neoptolemos, John P; Sahin-Tóth, Miklós; Petersen, Ole H; Hegyi, Péter

2017-09-14

Acute pancreatitis (AP) is an inflammatory disease with no specific treatment. Mitochondrial injury followed by ATP depletion in both acinar and ductal cells is a recently discovered early event in its pathogenesis. Importantly, preclinical research has shown that intracellular ATP delivery restores the physiological function of the cells and protects from cell injury, suggesting that restoration of energy levels in the pancreas is therapeutically beneficial. Despite several high quality experimental observations in this area, no randomised trials have been conducted to date to address the requirements for energy intake in the early phase of AP. This is a randomised controlled two-arm double-blind multicentre trial. Patients with AP will be randomly assigned to groups A (30 kcal/kg/day energy administration starting within 24 hours of hospital admission) or B (low energy administration during the first 72 hours of hospital admission). Energy will be delivered by nasoenteric tube feeding with additional intravenous glucose supplementation or total parenteral nutrition if necessary. A combination of multiorgan failure for more than 48 hours and mortality is defined as the primary endpoint, whereas several secondary endpoints such as length of hospitalisation or pain will be determined to elucidate more detailed differences between the groups. The general feasibility, safety and quality checks required for high quality evidence will be adhered to. The study has been approved by the relevant organisation, the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (55961-2/2016/EKU). This study will provide evidence as to whether early high energy nutritional support is beneficial in the clinical management of AP. The results of this trial will be published in an open access way and disseminated among medical doctors. The trial has been registered at the ISRCTN (ISRTCN 63827758). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Trends in U.S. Hospitalizations Rates and Rhythm Control Therapies Following Publication of the AFFIRM and RACE Trials

PubMed Central

Martin-Doyle, William; Essebag, Vidal; Zimetbaum, Peter; Reynolds, Matthew R.

2010-01-01

Introduction The impact of trials comparing rate vs. rhythm control for AF on subsequent use of rhythm control therapies and hospitalizations at a national level has not been described. Methods and Results We queried the Healthcare Cost & Utilization Project on the frequency of hospital admissions and performance of specific rhythm control procedures from 1998–2006. We analyzed trends in hospitalization for AF as principal diagnosis before and after the publication of key rate vs. rhythm trials in 2002. We also reviewed the use of electrical cardioversion and catheter ablation as principal procedures during hospital admissions for any cause and for AF as principal diagnosis. We additionally appraised the overall outpatient utilization of antiarrhythmic drugs during this same time frame using IMS Health’s National Prescription Audit.™ Admissions for AF as a principal diagnosis increased at 5%/year from 1998–2002. Following publication of the AFFIRM and RACE trials in 2002, admissions declined by 2%/year from 2002–2004, before rising again from 2004–06. In-hospital electrical cardioversion followed a similar pattern. National prescription volumes for antiarrhythmic drugs grew at <1%/yr from 2002–06, with a marked decline in the use of Class I-A agents, while catheter ablations during admissions for AF as the principal diagnosis increased at 30%/year. Conclusion The use of rhythm control therapies in the U.S. declined significantly in the first few years after publication of AFFIRM and RACE. This trend reversed by 2005, at which time rapid growth in the use of catheter ablation for AF was observed. PMID:21087329

Millennials Invading: Building Training for Today's Admissions Counselors

ERIC Educational Resources Information Center

Barnds, W. Kent

2009-01-01

As chief admissions officer at two small colleges, the author has been responsible, in part, for ensuring that entry-level admissions counselors are trained properly. He learned through trial and error, and has adapted his methods to be increasingly sensitive to the learning curve of new employees. His thoughts about training new admissions…

Supported self-management for patients with COPD who have recently been discharged from hospital: a systematic review and meta-analysis

PubMed Central

Majothi, Saimma; Jolly, Kate; Heneghan, Nicola R; Price, Malcolm J; Riley, Richard D; Turner, Alice M; Bayliss, Susan E; Moore, David J; Singh, Sally J; Adab, Peymané; Fitzmaurice, David A; Jordan, Rachel E

2015-01-01

Purpose Although many hospitals promote self-management to chronic obstructive pulmonary disease (COPD) patients post discharge from hospital, the clinical effectiveness of this is unknown. We undertook a systematic review of the evidence as part of a Health Technology Assessment review. Methods A comprehensive search strategy with no language restrictions was conducted across relevant databases from inception to May 2012. Randomized controlled trials of patients with COPD, recently discharged from hospital after an acute exacerbation and comparing a self-management intervention with control, usual care or other intervention were included. Study selection, data extraction, and risk of bias assessment were undertaken by two reviewers independently. Results Of 13,559 citations, 836 full texts were reviewed with nine randomized controlled trials finally included in quantitative syntheses. Interventions were heterogeneous. Five trials assessed highly supported multi-component interventions and four trials were less supported with fewer contacts with health care professionals and mainly home-based interventions. Total sample size was 1,466 (range 33–464 per trial) with length of follow-up 2–12 months. Trials varied in quality; poor patient follow-up and poor reporting was common. No evidence of effect in favor of self-management support was observed for all-cause mortality (pooled hazard ratio =1.07; 95% confidence interval [0.74 to 1.55]; I2=0.0%, [n=5 trials]). No clear evidence of effect on all-cause hospital admissions was observed (hazard ratio 0.88 [0.61, 1.27] I2=66.0%). Improvements in St George’s Respiratory Questionnaire score were seen in favor of self-management interventions (mean difference =3.84 [1.29 to 6.40]; I2=14.6%), although patient follow-up rates were low. Conclusion There is insufficient evidence to support self-management interventions post-discharge. There is a need for good quality primary research to identify effective approaches. PMID:25995625

Study design for the "effect of METOprolol in CARDioproteCtioN during an acute myocardial InfarCtion" (METOCARD-CNIC): a randomized, controlled parallel-group, observer-blinded clinical trial of early pre-reperfusion metoprolol administration in ST-segment elevation myocardial infarction.

PubMed

Ibanez, Borja; Fuster, Valentin; Macaya, Carlos; Sánchez-Brunete, Vicente; Pizarro, Gonzalo; López-Romero, Pedro; Mateos, Alonso; Jiménez-Borreguero, Jesús; Fernández-Ortiz, Antonio; Sanz, Ginés; Fernández-Friera, Leticia; Corral, Ervigio; Barreiro, Maria-Victoria; Ruiz-Mateos, Borja; Goicolea, Javier; Hernández-Antolín, Rosana; Acebal, Carlos; García-Rubira, Juan Carlos; Albarrán, Agustín; Zamorano, José Luis; Casado, Isabel; Valenciano, Juan; Fernández-Vázquez, Felipe; de la Torre, José María; Pérez de Prado, Armando; Iglesias-Vázquez, José Antonio; Martínez-Tenorio, Pedro; Iñiguez, Andrés

2012-10-01

Infarct size predicts post-infarction mortality. Oral β-blockade within 24 hours of a ST-segment elevation acute myocardial infarction (STEMI) is a class-IA indication, however early intravenous (IV) β-blockers initiation is not encouraged. In recent magnetic resonance imaging (MRI)-based experimental studies, the β(1)-blocker metoprolol has been shown to reduce infarct size only when administered before coronary reperfusion. To date, there is not a single trial comparing the pre- vs. post-reperfusion β-blocker initiation in STEMI. The METOCARD-CNIC trial is testing whether the early initiation of IV metoprolol before primary percutaneous coronary intervention (pPCI) could reduce infarct size and improve outcomes when compared to oral post-pPCI metoprolol initiation. The METOCARD-CNIC trial is a randomized parallel-group single-blind (to outcome evaluators) clinical effectiveness trial conducted in 5 Counties across Spain that will enroll 220 participants. Eligible are 18- to 80-year-old patients with anterior STEMI revascularized by pPCI ≤6 hours from symptom onset. Exclusion criteria are Killip-class ≥III, atrioventricular block or active treatment with β-blockers/bronchodilators. Primary end point is infarct size evaluated by MRI 5 to 7 days post-STEMI. Prespecified major secondary end points are salvage-index, left ventricular ejection fraction recovery (day 5-7 to 6 months), the composite of (death/malignant ventricular arrhythmias/reinfarction/admission due to heart failure), and myocardial perfusion. The METOCARD-CNIC trial is testing the hypothesis that the early initiation of IV metoprolol pre-reperfusion reduces infarct size in comparison to initiation of oral metoprolol post-reperfusion. Given the implications of infarct size reduction in STEMI, if positive, this trial might evidence that a refined use of an approved inexpensive drug can improve outcomes of patients with STEMI. Copyright © 2012 Mosby, Inc. All rights reserved.

A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service

PubMed Central

Grude, Nils; Lindbaek, Morten

2015-01-01

Objective. To compare the clinical outcome of patients presenting with symptoms of uncomplicated cystitis who were seen by a doctor, with patients who were given treatment following a diagnostic algorithm. Design. Randomized controlled trial. Setting. Out-of-hours service, Oslo, Norway. Intervention. Women with typical symptoms of uncomplicated cystitis were included in the trial in the time period September 2010–November 2011. They were randomized into two groups. One group received standard treatment according to the diagnostic algorithm, the other group received treatment after a regular consultation by a doctor. Subjects. Women (n = 441) aged 16–55 years. Mean age in both groups 27 years. Main outcome measures. Number of days until symptomatic resolution. Results. No significant differences were found between the groups in the basic patient demographics, severity of symptoms, or percentage of urine samples with single culture growth. A median of three days until symptomatic resolution was found in both groups. By day four 79% in the algorithm group and 72% in the regular consultation group were free of symptoms (p = 0.09). The number of patients who contacted a doctor again in the follow-up period and received alternative antibiotic treatment was insignificantly higher (p = 0.08) after regular consultation than after treatment according to the diagnostic algorithm. There were no cases of severe pyelonephritis or hospital admissions during the follow-up period. Conclusion. Using a diagnostic algorithm is a safe and efficient method for treating women with symptoms of uncomplicated cystitis at an out-of-hours service. This simplification of treatment strategy can lead to a more rational use of consultation time and a stricter adherence to National Antibiotic Guidelines for a common disorder. PMID:25961367

A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service.

PubMed

Bollestad, Marianne; Grude, Nils; Lindbaek, Morten

2015-06-01

To compare the clinical outcome of patients presenting with symptoms of uncomplicated cystitis who were seen by a doctor, with patients who were given treatment following a diagnostic algorithm. Randomized controlled trial. Out-of-hours service, Oslo, Norway. Women with typical symptoms of uncomplicated cystitis were included in the trial in the time period September 2010-November 2011. They were randomized into two groups. One group received standard treatment according to the diagnostic algorithm, the other group received treatment after a regular consultation by a doctor. Women (n = 441) aged 16-55 years. Mean age in both groups 27 years. Number of days until symptomatic resolution. No significant differences were found between the groups in the basic patient demographics, severity of symptoms, or percentage of urine samples with single culture growth. A median of three days until symptomatic resolution was found in both groups. By day four 79% in the algorithm group and 72% in the regular consultation group were free of symptoms (p = 0.09). The number of patients who contacted a doctor again in the follow-up period and received alternative antibiotic treatment was insignificantly higher (p = 0.08) after regular consultation than after treatment according to the diagnostic algorithm. There were no cases of severe pyelonephritis or hospital admissions during the follow-up period. Using a diagnostic algorithm is a safe and efficient method for treating women with symptoms of uncomplicated cystitis at an out-of-hours service. This simplification of treatment strategy can lead to a more rational use of consultation time and a stricter adherence to National Antibiotic Guidelines for a common disorder.

Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods.

PubMed

Krupski, Antoinette; Joesch, Jutta M; Dunn, Chris; Donovan, Dennis; Bumgardner, Kristin; Lord, Sarah Peregrine; Ries, Richard; Roy-Byrne, Peter

2012-12-14

A substantial body of research has established the effectiveness of brief interventions for problem alcohol use. Following these studies, national dissemination projects of screening, brief intervention (BI), and referral to treatment (SBIRT) for alcohol and drugs have been implemented on a widespread scale in multiple states despite little existing evidence for the impact of BI on drug use for non-treatment seekers. This article describes the design of a study testing the impact of SBIRT on individuals with drug problems, its contributions to the existing literature, and its potential to inform drug policy. The study is a randomized controlled trial of an SBIRT intervention carried out in a primary care setting within a safety net system of care. Approximately 1,000 individuals presenting for scheduled medical care at one of seven designated primary care clinics who endorse problematic drug use when screened are randomized in a 1:1 ratio to BI versus enhanced care as usual (ECAU). Individuals in both groups are reassessed at 3, 6, 9, and 12 months after baseline. Self-reported drug use and other psychosocial measures collected at each data point are supplemented by urine analysis and public health-related data from administrative databases. This study will contribute to the existing literature by providing evidence for the impact of BI on problem drug use based on a broad range of measures including self-reported drug use, urine analysis, admission to drug abuse treatment, and changes in utilization and costs of health care services, arrests, and death with the intent of informing policy and program planning for problem drug use at the local, state, and national levels. ClinicalTrials.gov NCT00877331.

Learning spinal manipulation: A best-evidence synthesis of teaching methods*

PubMed Central

Stainsby, Brynne E.; Clarke, Michelle C.S.; Egonia, Jade R.

2016-01-01

Objective: The purpose of this study was to evaluate the effectiveness of different reported methods used to teach spinal manipulative therapy to chiropractic students. Methods: For this best-evidence literature synthesis, 5 electronic databases were searched from 1900 to 2015. Eligible studies were critically appraised using the criteria of the Scottish Intercollegiate Guidelines Network. Scientifically admissible studies were synthesized following best-evidence synthesis principles. Results: Twenty articles were critically appraised, including 9 randomized clinical trials, 9 cohort studies, and 2 systematic reviews/meta-analyses. Eleven articles were accepted as scientifically admissible. The type of teaching method aids included a Thrust in Motion cervical manikin, instrumented cardiopulmonary reanimation manikin, padded contact with a load cell, instrumented treatment table with force sensor/transducer, and Dynadjust instrument. Conclusions: Several different methods exist in the literature for teaching spinal manipulative therapy techniques; however, future research in this developing area of chiropractic education is proposed. It is suggested that various teaching methods be included in the regular curricula of chiropractic colleges to aid in developing manipulation skills, efficiency, and knowledge of performance. PMID:26998630

Exercise rehabilitation following intensive care unit discharge for recovery from critical illness: executive summary of a Cochrane Collaboration systematic review.

PubMed

Connolly, Bronwen; Salisbury, Lisa; O'Neill, Brenda; Geneen, Louise; Douiri, Abdel; Grocott, Michael P W; Hart, Nicholas; Walsh, Timothy S; Blackwood, Bronagh

2016-12-01

Skeletal muscle wasting and weakness are major complications of critical illness and underlie the profound physical and functional impairments experienced by survivors after discharge from the intensive care unit (ICU). Exercise-based rehabilitation has been shown to be beneficial when delivered during ICU admission. This review aimed to determine the effectiveness of exercise rehabilitation initiated after ICU discharge on primary outcomes of functional exercise capacity and health-related quality of life. We sought randomized controlled trials, quasi-randomized controlled trials, and controlled clinical trials comparing an exercise intervention commenced after ICU discharge vs. any other intervention or a control or 'usual care' programme in adult survivors of critical illness. Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database, and Cumulative Index to Nursing and Allied Health Literature databases were searched up to February 2015. Dual, independent screening of results, data extraction, and quality appraisal were performed. We included six trials involving 483 patients. Overall quality of evidence for both outcomes was very low. All studies evaluated functional exercise capacity, with three reporting positive effects in favour of the intervention. Only two studies evaluated health-related quality of life and neither reported differences between intervention and control groups. Meta-analyses of data were precluded due to variation in study design, types of interventions, and selection and reporting of outcome measurements. We were unable to determine an overall effect on functional exercise capacity or health-related quality of life of interventions initiated after ICU discharge for survivors of critical illness. Findings from ongoing studies are awaited. Future studies need to address methodological aspects of study design and conduct to enhance rigour, quality, and synthesis.

Cost-effectiveness of antibiotic treatment strategies for community-acquired pneumonia: results from a cluster randomized cross-over trial.

PubMed

van Werkhoven, Cornelis H; Postma, Douwe F; Mangen, Marie-Josee J; Oosterheert, Jan Jelrik; Bonten, Marc J M

2017-01-10

To determine the cost-effectiveness of strategies of preferred antibiotic treatment with beta-lactam/macrolide combination or fluoroquinolone monotherapy compared to beta-lactam monotherapy. Costs and effects were estimated using data from a cluster-randomized cross-over trial of antibiotic treatment strategies, primarily from the reduced third payer perspective (i.e. hospital admission costs). Cost-minimization analysis (CMA) and cost-effectiveness analysis (CEA) were performed using linear mixed models. CMA results were expressed as difference in costs per patient. CEA results were expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per prevented death. A total of 2,283 patients were included. Crude average costs within 90 days from the reduced third payer perspective were €4,294, €4,392, and €4,002 per patient for the beta-lactam monotherapy, beta-lactam/macrolide combination, and fluoroquinolone monotherapy strategy, respectively. CMA results were €106 (95% CI €-697 to €754) for the beta-lactam/macrolide combination strategy and €-278 (95%CI €-991 to €396) for the fluoroquinolone monotherapy strategy, both compared to the beta-lactam monotherapy strategy. The ICER was not statistically significantly different between the strategies. Other perspectives yielded similar results. There were no significant differences in cost-effectiveness of strategies of preferred antibiotic treatment of CAP on non-ICU wards with either beta-lactam monotherapy, beta-lactam/macrolide combination therapy, or fluoroquinolone monotherapy. The trial was registered with ClinicalTrials.gov, number NCT01660204 , on May 2nd, 2012.

Long-term benefit of early pre-reperfusion metoprolol administration in patients with acute myocardial infarction: results from the METOCARD-CNIC trial (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction).

PubMed

Pizarro, Gonzalo; Fernández-Friera, Leticia; Fuster, Valentin; Fernández-Jiménez, Rodrigo; García-Ruiz, José M; García-Álvarez, Ana; Mateos, Alonso; Barreiro, María V; Escalera, Noemí; Rodriguez, Maite D; de Miguel, Antonio; García-Lunar, Inés; Parra-Fuertes, Juan J; Sánchez-González, Javier; Pardillos, Luis; Nieto, Beatriz; Jiménez, Adriana; Abejón, Raquel; Bastante, Teresa; Martínez de Vega, Vicente; Cabrera, José A; López-Melgar, Beatriz; Guzman, Gabriela; García-Prieto, Jaime; Mirelis, Jesús G; Zamorano, José Luis; Albarrán, Agustín; Goicolea, Javier; Escaned, Javier; Pocock, Stuart; Iñiguez, Andrés; Fernández-Ortiz, Antonio; Sánchez-Brunete, Vicente; Macaya, Carlos; Ibanez, Borja

2014-06-10

The goal of this trial was to study the long-term effects of intravenous (IV) metoprolol administration before reperfusion on left ventricular (LV) function and clinical events. Early IV metoprolol during ST-segment elevation myocardial infarction (STEMI) has been shown to reduce infarct size when used in conjunction with primary percutaneous coronary intervention (pPCI). The METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) trial recruited 270 patients with Killip class ≤II anterior STEMI presenting early after symptom onset (<6 h) and randomized them to pre-reperfusion IV metoprolol or control group. Long-term magnetic resonance imaging (MRI) was performed on 202 patients (101 per group) 6 months after STEMI. Patients had a minimal 12-month clinical follow-up. Left ventricular ejection fraction (LVEF) at the 6 months MRI was higher after IV metoprolol (48.7 ± 9.9% vs. 45.0 ± 11.7% in control subjects; adjusted treatment effect 3.49%; 95% confidence interval [CI]: 0.44% to 6.55%; p = 0.025). The occurrence of severely depressed LVEF (≤35%) at 6 months was significantly lower in patients treated with IV metoprolol (11% vs. 27%, p = 0.006). The proportion of patients fulfilling Class I indications for an implantable cardioverter-defibrillator (ICD) was significantly lower in the IV metoprolol group (7% vs. 20%, p = 0.012). At a median follow-up of 2 years, occurrence of the pre-specified composite of death, heart failure admission, reinfarction, and malignant arrhythmias was 10.8% in the IV metoprolol group versus 18.3% in the control group, adjusted hazard ratio (HR): 0.55; 95% CI: 0.26 to 1.04; p = 0.065. Heart failure admission was significantly lower in the IV metoprolol group (HR: 0.32; 95% CI: 0.015 to 0.95; p = 0.046). In patients with anterior Killip class ≤II STEMI undergoing pPCI, early IV metoprolol before reperfusion resulted in higher long-term LVEF, reduced incidence of severe LV systolic dysfunction and ICD indications, and fewer heart failure admissions. (Effect of METOprolol in CARDioproteCtioN During an Acute Myocardial InfarCtion. The METOCARD-CNIC Trial; NCT01311700). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

PubMed

Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

2017-07-01

A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Principal findings of systematic reviews of acute asthma treatment in childhood.

PubMed

Castro-Rodriguez, Jose A; J Rodrigo, Gustavo; E Rodríguez-Martínez, Carlos

2015-01-01

The objective of this study is to summarize the principal findings in the literature about acute asthma management in children. Systematic reviews of randomized clinical trials (SRCTs) with or without meta-analysis in children (1-18 years) admitted to the emergency department (ED) were retrieved using five data bases. Methodological quality was determined using the AMSTAR tool. One hundred and three studies were retrieved. Among those, 28 SRCTs were included: seven SRCTs related to short-acting beta2-agonists (SABA), three to ipratropium bromide (IB), eight to corticosteroids, one to racemic adrenaline, one to leukotriene receptor antagonists (LTRA), four to magnesium sulfate, one to intravenous (IV) SABA, one to IV aminophylline, one to IV ketamine, and one to antibiotics. It was determined that administering SABA by MDI-VHC is superior to using a nebulizer, because it decreases the hospital admission rate, improves the clinical score, results in a shorter time in the ED, and causes fewer adverse effects. Levalbuterol and albuterol were similar. In patients with moderate to severe exacerbations, IB+SABA was superior to SABA, decreasing hospital admission and improving the clinical score. SABA heliox administered by nebulizer decreased exacerbation severity compared to oxygen. Inhaled corticosteroids (ICS), especially administered by nebulizer, showed results similar to oral corticosteroids (OCS) with respect to reducing hospital admission, unscheduled visits, and the requirement of additional systemic corticosteroids. ICS or OCS following ED discharge was similar with regard to relapse. Compared with a placebo, IV magnesium reduced hospital admission and improved lung function. SRCTs are useful for guiding decisions in acute asthma treatment.

Mobile Technologies for Managing Heart Failure: A Systematic Review and Meta-analysis.

PubMed

Carbo, Anisleidy; Gupta, Manish; Tamariz, Leonardo; Palacio, Ana; Levis, Silvina; Nemeth, Zsuzsanna; Dang, Stuti

2018-04-02

Randomized clinical trials (RCTs) conducted among heart failure (HF) patients have reported that mobile technologies can improve HF-related outcomes. Our aim was to conduct a meta-analysis to evaluate m-Health's impact on healthcare services utilization, mortality, and cost. We searched MEDLINE, Cochrane, CINAHL, and EMBASE for studies published between 1966 and May-2017. We included studies that compared the use of m-Health in HF patients to usual care. m-Health is defined as the use of mobile computing and communication technologies to record and transmit data. The outcomes were HF-related and all-cause hospital days, cost, admissions, and mortality. Our search strategy resulted in 1,494 articles. We included 10 RCTs and 1 quasi-experimental study, which represented 3,109 patients in North America and Europe. Patient average age range was 53-80 years, New York Heart Association (NYHA) class III, and Left Ventricular Ejection Fraction <50%. Patients were mostly monitored daily and followed for an average of 6 months. A reduction was seen in HF-related hospital days. Nonsignificant reductions were seen in HF-related cost, admissions, and mortality and total mortality. We found no significant differences for all-cause hospital days and admissions, and an increase in total cost. m-Health reduced HF-related hospital days, showed reduction trends in total mortality and HF-related admissions, mortality and cost, and increased total costs related to more clinic visits and implementation of new technologies. More studies reporting consistent quality outcomes are warranted to give conclusive information about the effectiveness and cost-effectiveness of m-Health interventions for HF.

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

PubMed

Stephens, John R; Liles, E Allen; Dancel, Ria; Gilchrist, Michael; Kirsch, Jonathan; DeWalt, Darren A

2014-04-01

Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. Patients presenting for alcohol detoxification. Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

A randomized trial of the effectiveness of the neutropenic diet versus food safety guidelines on infection rate in pediatric oncology patients.

PubMed

Moody, Karen M; Baker, Rebecca A; Santizo, Ruth O; Olmez, Inan; Spies, Jeanie M; Buthmann, Amanda; Granowetter, Linda; Dulman, Robin Y; Ayyanar, Kanyalakshmi; Gill, Jonathan B; Carroll, Aaron E

2018-01-01

The neutropenic diet (ND) is prescribed to avoid introduction of bacteria into a host's gastrointestinal tract and reduce infection. Due to a lack of evidence to support the ND, there continues to be debate among pediatric oncologists regarding its usefulness. This prospective randomized controlled trial evaluated the difference in neutropenic infection rates in pediatric oncology patients randomized to Food and Drug Administration approved food safety guidelines (FSGs) versus the ND plus FSGs during one cycle of chemotherapy. Pediatric patients receiving cancer treatment with myelosuppressive chemotherapy were eligible. Neutropenic infection was the primary outcome and defined as (i) fever with neutropenia or (ii) hospital admission and treatment for clinical infection and neutropenia. The rate of neutropenic infection was compared with Student's t-test for independent samples. Documented infections were identified by comprehensive chart review and compared between groups using a χ 2 test. One hundred fifty patients were randomly assigned to FSGs (n = 73) or ND + FSGs (n = 77). The most common diagnoses were acute lymphoblastic leukemia (32%) and sarcoma (32%). There was no significant difference between the groups in the percentage of patients who developed neutropenic infection: FSGs 33% versus ND + FSGs 35% (P = 0.78). Patients randomized to ND + FSGs reported that following the diet required more effort than those on FSGs alone. The ND offers no benefit over FSGs in the prevention of infection in pediatric oncology patients undergoing myelosuppressive chemotherapy and adherence requires more effort for patients and families. Institutions caring for children with cancer should consider replacing ND guidelines with FSGs. © 2017 Wiley Periodicals, Inc.

A comparison of two treatment protocols in the management of exercise-associated postural hypotension: a randomised clinical trial.

PubMed

Anley, Cameron; Noakes, Timothy; Collins, Malcolm; Schwellnus, Martin P

2011-11-01

To investigate which of two commonly used treatment protocols for exercise-associated postural hypotension (EAPH) resulted in earlier discharge from the medical facility. This randomised clinical field trial was undertaken at two Ironman Triathlon competitions and one ultra-distance footrace. All collapsed athletes admitted to the medical facilities were considered for the trial. Following clinical assessment and special investigations to confirm the diagnosis of EAPH, 28 athletes were randomly assigned to an oral fluid and Trendelenburg position (OT=14) or an intravenous fluid (IV=14) treatment group. Following admission fluid intake was recorded, and all athletes were assessed clinically (blood pressure, heart rate, level of consciousness) every 15 min until discharge criteria were met. The main measure of outcome was the time to discharge (min). On admission, subjects in the OT and IV groups were similar with respect to age, systolic blood pressure, heart rate and serum sodium concentration. There were no significant differences in heart rate, systolic and diastolic blood pressure between groups and over time until discharge. The fluid intake during the treatment period was significantly greater in the IV group (IV 1045 ± 185 ml, OT 204 ± 149 ml; p<0.001). The average time to discharge for the OT group (58 ± 23 min) was similar to that of the IV group (52.5 ± 18 min; p=0.47). Endurance athletes with EAPH can be treated effectively using the Trendelenburg position and oral fluids and the administration of intravenous fluids does not reduce the time to discharge. The findings of this study support the hypothesis that EAPH is a result of venous pooling due to peripheral vasodilatation, rather than dehydration.

Recruiting older people at nutritional risk for clinical trials: what have we learned?

PubMed

Piantadosi, Cynthia; Chapman, Ian M; Naganathan, Vasi; Hunter, Peter; Cameron, Ian D; Visvanathan, Renuka

2015-04-15

The difficulty of recruiting older people to clinical trials is well described, but there is limited information about effective ways to screen and recruit older people into trials, and the reasons for their reluctance to enrol. This paper examines recruitment efforts for a community-based health intervention study that targeted older adults. One year randomized control trial. Undernourished men and women, aged ≥ 65 years and living independently in the community were recruited in three Australian states. Participants were allocated to either oral testosterone undecanoate and high calorie oral nutritional supplement or placebo medication and low calorie oral nutritional supplementation. Hospital admissions, functional status, nutritional health, muscle strength, and other variables were assessed. 4023 potential participants were identified and 767 were screened by a variety of methods: hospital note screening, referrals from geriatric health services, advertising and media segments/appearances. 53 participants (7% of total screened) were recruited. The majority of potentially eligible participants declined participation in the trial after reading the information sheet. Media was the more successful method of recruiting, whereas contacting people identified by screening a large number of hospital records was not successful in recruiting any participants. Recruitment of frail and older participants is difficult and multiple strategies are required to facilitate participation. Australian Clinical Trial Registry: ACTRN 12610000356066 date registered 4/5/2010.

EMPOWER: an intervention to address barriers to pain management in hospice.

PubMed

Cagle, John G; Zimmerman, Sheryl; Cohen, Lauren W; Porter, Laura S; Hanson, Laura C; Reed, David

2015-01-01

Concerns about pain medications are major barriers to pain management in hospice, but few studies have focused on systematic methods to address these concerns. The objective of this study was to test the preliminary efficacy of the Effective Management of Pain: Overcoming Worries to Enable Relief (EMPOWER) intervention, which included hospice staff education, staff screening of barriers to pain management at admission, and discussion about misunderstandings regarding pain management with family caregivers and patients. We conducted a pilot, cluster randomized, controlled trial with four hospices. One hundred twenty-six family caregivers (55 interventions and 71 controls) were interviewed at two weeks after admission. If patients survived three months after admission, caregivers were reinterviewed. At two weeks, caregivers in the intervention group reported better knowledge about pain management (P = 0.001), fewer concerns about pain and pain medications (P = 0.008), and lower patient pain over the past week (P = 0.014) and trended toward improvement in most other areas under study. Exploratory analyses suggest that EMPOWER had a greater effect for black subjects (vs. whites) on reducing concern about stigma. At three months, the intervention group trended better on most study outcomes. EMPOWER is a promising model to reduce barriers to pain management in hospice. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J; Dam, Hester Ten; Zuithoff, Nicolaas P A; Numans, Mattijs E; de Wit, Niek J

2016-09-01

To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Primary care setting, 39 general practices in the Netherlands. Community-dwelling people aged 60 and older (N = 3,092). A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Boosting enrollment in neurology trials with Local Identification and Outreach Networks (LIONs)

PubMed Central

Kernan, W N.; Viscoli, C M.; DeMarco, D; Mendes, B; Shrauger, K; Schindler, J L.; McVeety, J C.; Sicklick, A; Moalli, D; Greco, P; Bravata, D M.; Eisen, S; Resor, L; Sena, K; Story, D; Brass, L M.; Furie, K L.; Gutmann, L; Hinnau, E; Gorman, M; Lovejoy, A M.; Inzucchi, S E.; Young, L H.; Horwitz, R I.

2009-01-01

Objective: Our purpose was to develop a geographically localized, multi-institution strategy for improving enrolment in a trial of secondary stroke prevention. Methods: We invited 11 Connecticut hospitals to participate in a project named the Local Identification and Outreach Network (LION). Each hospital provided the names of patients with stroke or TIA, identified from electronic admission or discharge logs, to researchers at a central coordinating center. After obtaining permission from personal physicians, researchers contacted each patient to describe the study, screen for eligibility, and set up a home visit for consent. Researchers traveled throughout the state to enroll and follow participants. Outside the LION, investigators identified trial participants using conventional recruitment strategies. We compared recruitment success for the LION and other sites using data from January 1, 2005, through June 30, 2007. Results: The average monthly randomization rate from the LION was 4.0 participants, compared with 0.46 at 104 other Insulin Resistance Intervention after Stroke (IRIS) sites. The LION randomized on average 1.52/1,000 beds/month, compared with 0.76/1,000 beds/month at other IRIS sites (p = 0.03). The average cost to randomize and follow one participant was $8,697 for the LION, compared with $7,198 for other sites. Conclusion: A geographically based network of institutions, served by a central coordinating center, randomized substantially more patients per month compared with sites outside of the network. The high enrollment rate was a result of surveillance at multiple institutions and greater productivity at each institution. Although the cost per patient was higher for the network, compared with nonnetwork sites, cost savings could result from more rapid completion of research. GLOSSARY BMI = body mass index; HIPAA = Health Insurance Portability and Accountability Act; HOMA = homeostastis model assessment of insulin resistance; ICD-9 = International Classification of Diseases, 9th Revision; IRB = institutional review board; IRIS = Insulin Resistance Intervention after Stroke; LION = Local Identification and Outreach Network. PMID:19365056

Impact of a Clinical Decision Model for Febrile Children at Risk for Serious Bacterial Infections at the Emergency Department: A Randomized Controlled Trial

PubMed Central

de Vos-Kerkhof, Evelien; Nijman, Ruud G.; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W.; van der Lei, Johan; Moll, Henriëtte A.; Oostenbrink, Rianne

2015-01-01

Objectives To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Methods Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n=219) or the control group (usual care; n=220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for “pneumonia” and “other SBI”. Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses’ compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. Results The decision model had good discriminative ability for both pneumonia (n=33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n=22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value<0.05) and more urine-dipstick testing (71% vs. 61%, p-value<0.05). Conclusions In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Trial Registration Nederlands Trial Register NTR2381 PMID:26024532

Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT).

PubMed

van den Brink, Rob H S; van Melle, Joost P; Honig, Adriaan; Schene, Aart H; Crijns, Harry J G M; Lambert, Frank P G; Ormel, Johan

2002-08-01

Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these patients. The rationale and outline of the study are described. In this multicenter randomized clinical trial, 2140 patients admitted for MI are screened for depressive symptoms with a questionnaire 0, 3, 6, 9, and 12 months after MI. Patients with symptoms undergo a standardized psychiatric interview. Those with a post-MI depressive episode are randomized to intervention (ie, antidepressive treatment; n = 190) or care-as-usual (CAU; n = 130). In the intervention arm, the research diagnosis is to be confirmed by a psychiatrist. First-choice treatment consists of placebo-controlled treatment with mirtazapine. In case of refusal or nonresponse, alternative open treatment with citalopram is offered. In the CAU arm, the patient is not informed about the research diagnosis. Psychiatric treatment outside the study is recorded, but no treatment is offered. Both arms are followed for end points (cardiac death or hospital admission for MI, unstable angina, heart failure, or ventricular tachyarrhythmia) during an average period of 27 months. Analysis is on an intention-to-treat basis. The MIND-IT study will show whether treatment of post-MI depression can improve cardiac prognosis.

The effects of counseling spouse caregivers of people with Alzheimer disease taking donepezil and of country of residence on rates of admission to nursing homes and mortality.

PubMed

Brodaty, Henry; Mittelman, Mary; Gibson, Louisa; Seeher, Katrin; Burns, Alistair

2009-09-01

Does psychosocial intervention for caregivers whose spouses with Alzheimer disease (AD) are taking donepezil delay nursing home (NH) placement or death of patients? Randomized controlled trial with 2 years of active treatment and up to 8.5 years of follow-up (mean: 5.4 years, SD: 2.4). Outpatients of research clinics in Australia, the United Kingdom, and the United States. One hundred and fifty-five persons with AD and their spouses. Five sessions of individual and family counseling (+ prn ad hoc counseling) or usual care. Time to institutionalization and death using Cox proportional hazards methods. Over a mean of 5.4 years (SD: 2.4), there were no differences in NH placement or mortality by intervention group, but there were by country, with Australian patients admitted to NHs earlier than U.S. than U.K. patients. Earlier NH admission of Australian compared to U.K. and U.S. subjects may be due to differences in health care, NH systems, availability, and affordability.

Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial

PubMed Central

2013-01-01

Background To strengthen suicide prevention skills in mental health care in The Netherlands, multidisciplinary teams throughout the country are trained in the application of the new Dutch guideline on the assessment and treatment of suicidal behavior. Previous studies have shown beneficial effects of additional efforts for guideline implementation on professionals’ attitude, knowledge, and skills. However, the effects on patients are equally important, but are rarely measured. The main objective of this study is to examine whether patients of multidisciplinary teams who are trained in guideline application show greater recovery from suicide ideation than patients of untrained teams. Methods/Design This is a multicentre cluster randomized controlled trial (RCT), in which multidisciplinary teams from mental health care institutions are matched in pairs, and randomly allocated to either the experimental or control condition. In the experimental condition, next to the usual dissemination of the guideline (internet, newsletter, books, publications, and congresses), teams will be trained in the application of the guideline via a 1-day small interactive group training program supported by e-learning modules. In the control condition, no additional actions next to usual dissemination of the guideline will be undertaken. Assessments at patient level will start when the experimental teams are trained. Assessments will take place upon admission and after 3 months, or earlier if the patient is discharged. The primary outcome is suicide ideation. Secondary outcomes are non-fatal suicide attempts, level of treatment satisfaction, and societal costs. Both a cost-effectiveness and cost-utility analysis will be performed. The effects of the intervention will be examined in multilevel models. Discussion The strengths of this study are the size of the study, RCT design, training of complete multidisciplinary teams, and the willingness of both management and staff to participate. Trial registration Netherlands trial register: NTR3092 PMID:24195781

A Patient Navigator Intervention to Reduce Hospital Readmissions among High-Risk Safety-Net Patients: A Randomized Controlled Trial.

PubMed

Balaban, Richard B; Galbraith, Alison A; Burns, Marguerite E; Vialle-Valentin, Catherine E; Larochelle, Marc R; Ross-Degnan, Dennis

2015-07-01

Evidence-based interventions to reduce hospital readmissions may not generalize to resource-constrained safety-net hospitals. To determine if an intervention by patient navigators (PNs), hospital-based Community Health Workers, reduces readmissions among high risk, low socioeconomic status patients. Randomized controlled trial. General medicine inpatients having at least one of the following readmission risk factors: (1) age ≥60 years, (2) any in-network inpatient admission within the past 6 months, (3) length of stay ≥3 days, (4) admission diagnosis of heart failure, or (5) chronic obstructive pulmonary disease. The analytic sample included 585 intervention patients and 925 controls. PNs provided coaching and assistance in navigating the transition from hospital to home through hospital visits and weekly telephone outreach, supporting patients for 30 days post-discharge with discharge preparation, medication management, scheduling of follow-up appointments, communication with primary care, and symptom management. The primary outcome was in-network 30-day hospital readmissions. Secondary outcomes included rates of outpatient follow-up. We evaluated outcomes for the entire cohort and stratified by patient age >60 years (425 intervention/584 controls) and ≤60 years (160 intervention/341 controls). Overall, 30-day readmission rates did not differ between intervention and control patients. However, the two age groups demonstrated marked differences. Intervention patients >60 years showed a statistically significant adjusted absolute 4.1% decrease [95% CI: -8.0%, -0.2%] in readmission with an increase in 30-day outpatient follow-up. Intervention patients ≤60 years showed a statistically significant adjusted absolute 11.8% increase [95% CI: 4.4%, 19.0%] in readmission with no change in 30-day outpatient follow-up. A patient navigator intervention among high risk, safety-net patients decreased readmission among older patients while increasing readmissions among younger patients. Care transition strategies should be evaluated among diverse populations, and younger high risk patients may require novel strategies.

Multicenter Trial of Rivaroxaban for Early Discharge of Pulmonary Embolism From the Emergency Department (MERCURY PE): Rationale and Design.

PubMed

Singer, Adam J; Xiang, Jim; Kabrhel, Christopher; Merli, Gino J; Pollack, Charles; Tapson, Victor F; Wildgoose, Peter; Peacock, W Frank

2016-11-01

Traditionally, patients with pulmonary embolism (PE) are admitted from the emergency department and treated with low-molecular-weight heparin followed by warfarin. Several studies now demonstrate that it is possible to identify low-risk PE patients that can safely be treated as outpatients. The advent of the direct-acting oral anticoagulants such as rivaroxaban has made it easier than ever to manage patients outside of the hospital. This article describes the design of a randomized controlled trial aimed at testing the hypothesis that low-risk PE patients can be safely and effectively managed at home using rivaroxaban, resulting in fewer days of hospitalization than standard-of-care treatment. We have initiated a multicenter, open-label, randomized clinical trial in which low-risk adult PE patients (identified by the Hestia criteria) are randomized to outpatient management with oral rivaroxaban 15 mg twice daily for 21 days followed by 20 mg once daily for 90 days versus standard care, determined by the treating physician and based on local practices. The primary clinical endpoint will be the total number of inpatient hospital days (including the index admission) for venous thromboembolic or bleeding-related events during the first 30 days after randomization. A total of 150 subjects per group will provide 82% power to detect a difference of 1 day or greater in the primary outcome. Patient enrollment is ongoing at present in 45 of 60 planned sites. No interim analysis is planned and the study is being monitored by a data safety management board. The MERCURY PE study is designed to test the hypothesis that outpatient management of low-risk PE patients with rivaroxaban reduces the number of hospitalization days from venous thromboembolism and bleeding compared with standard care. This article describes the rationale and methodology for this study. © 2016 by the Society for Academic Emergency Medicine.

The Use of Criminal History Information in College Admissions Decisions

ERIC Educational Resources Information Center

Pierce, Matthew W.; Runyan, Carol W.; Bangdiwala, Shrikant I.

2014-01-01

To understand the potential public health and social justice implications of criminal background screening on college admissions, we examined postsecondary institutions' reasons for collecting or not collecting applicants' criminal justice information. We invited heads of admissions from 300 randomly sampled postsecondary institutions to complete…

Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan.

PubMed

Westendorp, Willeke F; Vermeij, Jan-Dirk; Dippel, Diederik W J; Dijkgraaf, Marcel G W; van der Poll, Tom; Prins, Jan M; Vermeij, Frederique H; Roos, Yvo B W E M; Brouwer, Matthijs C; Zwinderman, Aeilko H; van de Beek, Diederik; Nederkoorn, Paul J

2014-10-01

Infections occur in 30% of stroke patients and are associated with unfavorable outcomes. Preventive antibiotic therapy lowers the infection rate after stroke, but the effect of preventive antibiotic treatment on functional outcome in patients with stroke is unknown. The PASS is a multicenter, prospective, phase three, randomized, open-label, blinded end-point (PROBE) trial of preventive antibiotic therapy in acute stroke. Patients are randomly assigned to either ceftriaxone at a dose of 2 g, given every 24 h intravenously for 4 days, in addition to standard stroke-unit care, or standard stroke-unit care without preventive antibiotic therapy. The aim of this study is to assess whether preventive antibiotic treatment improves functional outcome at 3 months by preventing infections. This paper presents in detail the statistical analysis plan (SAP) of the Preventive Antibiotics in Stroke Study (PASS) and was submitted while the investigators were still blinded for all outcomes. The primary outcome is the score on the modified Rankin Scale (mRS), assessed by ordinal logistic regression analysis according to a proportional odds model. Secondary analysis of the primary outcome is the score on the mRS dichotomized as a favorable outcome (mRS 0 to 2) versus unfavorable outcome (mRS 3 to 6). Secondary outcome measures are death rate at discharge and 3 months, infection rate during hospital admission, length of hospital admission, volume of post-stroke care, use of antibiotics during hospital stay, quality-adjusted life years and costs. Complications of treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are reported as safety outcomes. The data from PASS will establish whether preventive antibiotic therapy in acute stroke improves functional outcome by preventing infection and will be analyzed according to this pre-specified SAP. Current controlled trials; ISRCTN66140176. Date of registration: 6 April 2010.

Pre-admission antibiotics for suspected cases of meningococcal disease.

PubMed

Sudarsanam, Thambu D; Rupali, Priscilla; Tharyan, Prathap; Abraham, Ooriapadickal Cherian; Thomas, Kurien

2013-08-02

Meningococcal disease can lead to death or disability within hours after onset. Pre-admission antibiotics aim to reduce the risk of serious disease and death by preventing delays in starting therapy before confirmation of the diagnosis. To study the effectiveness and safety of pre-admission antibiotics versus no pre-admission antibiotics or placebo, and different pre-admission antibiotic regimens in decreasing mortality, clinical failure and morbidity in people suspected of meningococcal disease. We updated searches of CENTRAL (2013, Issue 4), MEDLINE (1966 to April week 4, 2013), EMBASE (1980 to May 2013), Web of Science (1985 to May 2013), CAB Abstracts (1985 to May 2013), LILACS (1982 to May 2013) and prospective trials registries to May 2013. Randomised controlled trials (RCTs) or quasi-RCTs comparing antibiotics versus placebo or no intervention, in people with suspected meningococcal infection, or different antibiotics administered before admission to hospital or confirmation of the diagnosis. Two review authors independently assessed trial quality and extracted data from the search results. We calculated the risk ratio (RR) and 95% confidence interval (CI) for dichotomous data. We included only one trial so data synthesis was not performed. We assessed the overall quality of the evidence using the GRADE approach. We found no RCTs that compared pre-admission antibiotics versus no pre-admission antibiotics or placebo. One open-label, non-inferiority RCT, conducted during an epidemic in Niger, evaluated a single dose of intramuscular ceftriaxone versus a single dose of intramuscular long-acting (oily) chloramphenicol. Ceftriaxone was not inferior to chloramphenicol in reducing mortality (RR 1.2, 95% CI 0.6 to 2.6; N = 503; 308 confirmed meningococcal meningitis; 26 deaths; moderate-quality evidence), clinical failures (RR 0.8, 95% CI 0.3 to 2.2; N = 477, 18 clinical failures; moderate-quality evidence) or neurological sequelae (RR 1.3, 95% CI 0.6 to 2.6; N = 477; 29 with sequelae; low-quality evidence). No adverse effects of treatment were reported. Estimated treatment costs were similar. No data were available on disease burden due to sequelae. We found no reliable evidence to support or refute the use of pre-admission antibiotics for suspected cases of non-severe meningococcal disease. Evidence of moderate quality from one RCT indicated that single intramuscular injections of ceftriaxone and long-acting chloramphenicol were equally effective, safe and economical in reducing serious outcomes. The choice between these antibiotics would be based on affordability, availability and patterns of antibiotic resistance.Further RCTs comparing different pre-admission antibiotics, accompanied by intensive supportive measures, are ethically justifiable in participants with severe illness, and are needed to provide reliable evidence in different clinical settings.

Pre-admission antibiotics for suspected cases of meningococcal disease.

PubMed

Sudarsanam, Thambu D; Rupali, Priscilla; Tharyan, Prathap; Abraham, Ooriapadickal Cherian; Thomas, Kurien

2017-06-14

Meningococcal disease can lead to death or disability within hours after onset. Pre-admission antibiotics aim to reduce the risk of serious disease and death by preventing delays in starting therapy before confirmation of the diagnosis. To study the effectiveness and safety of pre-admission antibiotics versus no pre-admission antibiotics or placebo, and different pre-admission antibiotic regimens in decreasing mortality, clinical failure, and morbidity in people suspected of meningococcal disease. We searched CENTRAL (6 January 2017), MEDLINE (1966 to 6 January 2017), Embase (1980 to 6 January 2017), Web of Science (1985 to 6 January 2017), LILACS (1982 to 6 January 2017), and prospective trial registries to January 2017. We previously searched CAB Abstracts from 1985 to June 2015, but did not update this search in January 2017. Randomised controlled trials (RCTs) or quasi-RCTs comparing antibiotics versus placebo or no intervention, in people with suspected meningococcal infection, or different antibiotics administered before admission to hospital or confirmation of the diagnosis. Two review authors independently assessed trial quality and extracted data from the search results. We calculated the risk ratio (RR) and 95% confidence interval (CI) for dichotomous data. We included only one trial and so did not perform data synthesis. We assessed the overall quality of the evidence using the GRADE approach. We found no RCTs comparing pre-admission antibiotics versus no pre-admission antibiotics or placebo. We included one open-label, non-inferiority RCT with 510 participants, conducted during an epidemic in Niger, evaluating a single dose of intramuscular ceftriaxone versus a single dose of intramuscular long-acting (oily) chloramphenicol. Ceftriaxone was not inferior to chloramphenicol in reducing mortality (RR 1.21, 95% CI 0.57 to 2.56; N = 503; 308 confirmed meningococcal meningitis; 26 deaths; moderate-quality evidence), clinical failures (RR 0.83, 95% CI 0.32 to 2.15; N = 477; 18 clinical failures; moderate-quality evidence), or neurological sequelae (RR 1.29, 95% CI 0.63 to 2.62; N = 477; 29 with sequelae; low-quality evidence). No adverse effects of treatment were reported. Estimated treatment costs were similar. No data were available on disease burden due to sequelae. We found no reliable evidence to support the use pre-admission antibiotics for suspected cases of non-severe meningococcal disease. Moderate-quality evidence from one RCT indicated that single intramuscular injections of ceftriaxone and long-acting chloramphenicol were equally effective, safe, and economical in reducing serious outcomes. The choice between these antibiotics should be based on affordability, availability, and patterns of antibiotic resistance.Further RCTs comparing different pre-admission antibiotics, accompanied by intensive supportive measures, are ethically justified in people with less severe illness, and are needed to provide reliable evidence in different clinical settings.

Multicentre randomized controlled trial of structured transition on diabetes care management compared to standard diabetes care in adolescents and young adults with type 1 diabetes (Transition Trial).

PubMed

Spaic, Tamara; Mahon, Jeff L; Hramiak, Irene; Byers, Nicole; Evans, Keira; Robinson, Tracy; Lawson, Margaret L; Malcolm, Janine; Goldbloom, Ellen B; Clarson, Cheril L

2013-10-09

Transition from pediatric to adult diabetes care is a high risk period during which there is an increased rate of disengagement from care. Suboptimal transition has been associated with higher risks for acute and chronic diabetes-related complications. The period of emerging adulthood challenges current systems of healthcare delivery as many young adults with type 1 diabetes (T1D) default from diabetes care and are at risk for diabetes complications which are undetected and therefore untreated. Despite the importance of minimizing loss to follow-up there are no randomized control trials evaluating models of transition from pediatric to adult diabetes care. This is a multicentre randomized controlled trial. A minimum of 188 subjects with T1D aged between 17 and 20 years will be evaluated. Eligible subjects will be recruited from three pediatric care centres and randomly assigned in a 1:1 ratio to a structured transition program that will span 18 months or to receive standard diabetes care. The structured transition program is a multidisciplinary, complex intervention aiming to provide additional support in the transition period. A Transition Coordinator will provide transition support and will provide the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention to facilitate ongoing contact with the medical system as well as education and clinical support where appropriate. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment. The primary outcome is the proportion of subjects who fail to attend at least one outpatient adult diabetes specialist visit during the second year after transition to adult diabetes care. Secondary outcome measures include A1C frequency measurement and levels, diabetes related emergency room visits and hospital admissions, frequency of complication screening, and subject perception and satisfaction with care. This trial will determine if the support of a Transition Coordinator improves health outcomes for this at-risk population of young adults. NCT01351857.

Effectiveness of telemonitoring integrated into existing clinical services on hospital admission for exacerbation of chronic obstructive pulmonary disease: researcher blind, multicentre, randomised controlled trial

PubMed Central

Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; Lewis, Stephanie; Stoddart, Andrew; van der Pol, Marjon; MacNee, William; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

2013-01-01

Objective To test the effectiveness of telemonitoring integrated into existing clinical services such that intervention and control groups have access to the same clinical care. Design Researcher blind, multicentre, randomised controlled trial. Setting UK primary care (Lothian, Scotland). Participants Adults with at least one admission for chronic obstructive pulmonary disease (COPD) in the year before randomisation. We excluded people who had other significant lung disease, who were unable to provide informed consent or complete the study, or who had other significant social or clinical problems. Interventions Participants were recruited between 21 May 2009 and 28 March 2011, and centrally randomised to receive telemonitoring or conventional self monitoring. Using a touch screen, telemonitoring participants recorded a daily questionnaire about symptoms and treatment use, and monitored oxygen saturation using linked instruments. Algorithms, based on the symptom score, generated alerts if readings were omitted or breached thresholds. Both groups received similar care from existing clinical services. Main outcome measures The primary outcome was time to hospital admission due to COPD exacerbation up to one year after randomisation. Other outcomes included number and duration of admissions, and validated questionnaire assessments of health related quality of life (using St George’s respiratory questionnaire (SGRQ)), anxiety or depression (or both), self efficacy, knowledge, and adherence to treatment. Analysis was intention to treat. Results Of 256 patients completing the study, 128 patients were randomised to telemonitoring and 128 to usual care; baseline characteristics of each group were similar. The number of days to admission did not differ significantly between groups (adjusted hazard ratio 0.98, 95% confidence interval 0.66 to 1.44). Over one year, the mean number of COPD admissions was similar in both groups (telemonitoring 1.2 admissions per person (standard deviation 1.9) v control 1.1 (1.6); P=0.59). Mean duration of COPD admissions over one year was also similar between groups (9.5 days per person (standard deviation 19.1) v 8.8 days (15.9); P=0.88). The intervention had no significant effect on SGRQ scores between groups (68.2 (standard deviation 16.3) v 67.3 (17.3); adjusted mean difference 1.39 (95% confidence interval −1.57 to 4.35)), or on other questionnaire outcomes. Conclusions In participants with a history of admission for exacerbations of COPD, telemonitoring was not effective in postponing admissions and did not improve quality of life. The positive effect of telemonitoring seen in previous trials could be due to enhancement of the underpinning clinical service rather than the telemonitoring communication. Trial registration ISRCTN96634935. Funding: The trial was funded by an NHS applied research programme grant from the Chief Scientist Office of the Scottish government (ARPG/07/03). The funder had no role in study design and the collection, analysis, and interpretation of data and the writing of the article and the decision to submit it for publication. NHS Lothian supported the telemonitoring service and the clinical services. PMID:24136634

Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial.

PubMed

Wong, Holly; Kaufman, Jaime; Baylis, Barry; Conly, John M; Hogan, David B; Stelfox, Henry T; Southern, Danielle A; Ghali, William A; Ho, Chester H

2015-09-29

Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge). This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers. ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).

Rationale and design of the IMPACT EU-trial: improve management of heart failure with procalcitonin biomarkers in cardiology (BIC)-18.

PubMed

Möckel, Martin; Slagman, Anna; Vollert, Jörn Ole; Ebmeyer, Stefan; Wiemer, Jan C; Searle, Julia; Giannitsis, Evangelos; Kellum, John A; Maisel, Alan

2018-02-01

To evaluate the effectiveness of procalcitonin (PCT)-guided antibiotic treatment compared to current treatment practice to reduce 90-day all-cause mortality in emergency patients with shortness of breath (SOB) and suspected acute heart failure (AHF). Concomitant AHF and lower respiratory tract (or other bacterial) infection in emergency patients with dyspnea are common and can be difficult to diagnose. Early and adequate initiation of antibiotic therapy (ABX) significantly improves patient outcome, but superfluous prescription of ABX maybe harmful. In a multicentre, prospective, randomized, controlled process trial with an open intervention, adult emergency patients with SOB and increased levels of natriuretic peptides will be randomized to either a standard care group or a PCT-guided group with respect to the initiation of antibiotic treatment. In the PCT-guided group, the initiation of antibiotic therapy is based on the results of acute PCT measurements at admission, using a cut-off of 0.2 ng/ml. A two-stage sample-size adaptive design is used; an interim analysis was done after completion of 50% of patients and the final sample size remained unchanged. Primary endpoint is 90-day all-cause mortality. The current study will provide evidence, whether the routine use of PCT in patients with suspected AHF improves outcome.

Commensurate Priors for Incorporating Historical Information in Clinical Trials Using General and Generalized Linear Models

PubMed Central

Hobbs, Brian P.; Sargent, Daniel J.; Carlin, Bradley P.

2014-01-01

Assessing between-study variability in the context of conventional random-effects meta-analysis is notoriously difficult when incorporating data from only a small number of historical studies. In order to borrow strength, historical and current data are often assumed to be fully homogeneous, but this can have drastic consequences for power and Type I error if the historical information is biased. In this paper, we propose empirical and fully Bayesian modifications of the commensurate prior model (Hobbs et al., 2011) extending Pocock (1976), and evaluate their frequentist and Bayesian properties for incorporating patient-level historical data using general and generalized linear mixed regression models. Our proposed commensurate prior models lead to preposterior admissible estimators that facilitate alternative bias-variance trade-offs than those offered by pre-existing methodologies for incorporating historical data from a small number of historical studies. We also provide a sample analysis of a colon cancer trial comparing time-to-disease progression using a Weibull regression model. PMID:24795786

Comparative effectiveness of post-discharge interventions for hospitalized smokers: study protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background A hospital admission offers smokers an opportunity to quit. Smoking cessation counseling provided in the hospital is effective, but only if it continues for more than one month after discharge. Providing smoking cessation medication at discharge may add benefit to counseling. A major barrier to translating this research into clinical practice is sustaining treatment during the transition to outpatient care. An evidence-based, practical, cost-effective model that facilitates the continuation of tobacco treatment after discharge is needed. This paper describes the design of a comparative effectiveness trial testing a hospital-initiated intervention against standard care. Methods/design A two-arm randomized controlled trial compares the effectiveness of standard post-discharge care with a multi-component smoking cessation intervention provided for three months after discharge. Current smokers admitted to Massachusetts General Hospital who receive bedside smoking cessation counseling, intend to quit after discharge and are willing to consider smoking cessation medication are eligible. Study participants are recruited following the hospital counseling visit and randomly assigned to receive Standard Care or Extended Care after hospital discharge. Standard Care includes a recommendation for a smoking cessation medication and information about community resources. Extended Care includes up to three months of free FDA-approved smoking cessation medication and five proactive computerized telephone calls that use interactive voice response technology to provide tailored motivational messages, offer additional live telephone counseling calls from a smoking cessation counselor, and facilitate medication refills. Outcomes are assessed at one, three, and six months after hospital discharge. The primary outcomes are self-reported and validated seven-day point prevalence tobacco abstinence at six months. Other outcomes include short-term and sustained smoking cessation, post-discharge utilization of smoking cessation treatment, hospital readmissions and emergency room visits, and program cost per quit. Discussion This study tests a disseminable smoking intervention model for hospitalized smokers. If effective and widely adopted, it could help to reduce population smoking rates and thereby reduce tobacco-related mortality, morbidity, and health care costs. Trial registration United States Clinical Trials Registry NCT01177176. PMID:22852832

Subgroup analysis of telehealthcare for patients with chronic obstructive pulmonary disease: the cluster-randomized Danish Telecare North Trial

PubMed Central

Witt Udsen, Flemming; Lilholt, Pernille H; Hejlesen, Ole K; Ehlers, Lars H

2017-01-01

Purpose Results from the Danish cluster-randomized trial of telehealthcare to 1,225 patients with chronic obstructive pulmonary disease (COPD), the Danish Telecare North Trial, concluded that the telehealthcare solution was unlikely to be cost-effective, by applying international willingness-to-pay threshold values. The purpose of this article was to assess potential sources of variation across subgroups, which could explain overall cost-effectiveness results or be utilized in future economic studies in telehealthcare research. Methods First, the cost-structures and cost-effectiveness across COPD severities were analyzed. Second, five additional subgroup analyses were conducted, focusing on differences in cost-effectiveness across a set of comorbidities, age-groups, genders, resource patterns (resource use in the social care sector prior to randomization), and delivery sites. All subgroups were investigated post hoc. In analyzing cost-effectiveness, two separate linear mixed-effects models with treatment-by-covariate interactions were applied: one for quality-adjusted life-year (QALY) gain and one for total healthcare and social sector costs. Probabilistic sensitivity analysis was used for each subgroup result in order to quantify the uncertainty around the cost-effectiveness results. Results The study concludes that, across the COPD severities, patients with severe COPD (GOLD 3 classification) are likely to be the most cost-effective group. This is primarily due to lower hospital-admission and primary-care costs. Telehealthcare for patients younger than 60 years is also more likely to be cost-effective than for older COPD patients. Overall, results indicate that existing resource patterns of patients and variations in delivery-site practices might have a strong influence on cost-effectiveness, possibly stronger than the included health or sociodemographic sources of heterogeneity. Conclusion Future research should focus more on sources of heterogeneity found in the implementation context and the way telehealthcare is adopted (eg, by integrating formative evaluation into cost-effectiveness analyses). Trial registration Clinicaltrials.gov, NCT01984840. PMID:28740411

Randomized, Placebo-controlled Trial of Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis: The ACROSS Trial

PubMed Central

Janz, David R; Bastarache, Julie A; Rice, Todd W; Bernard, Gordon R; Warren, Melissa A; Wickersham, Nancy; Sills, Gillian; Oates, John A; Roberts, L Jackson; Ware, Lorraine B

2014-01-01

Objective This trial evaluated the efficacy of acetaminophen in reducing oxidative injury, as measured by plasma F2-Isoprostanes, in adult patients with severe sepsis and detectable plasma cell-free hemoglobin. Design Single center, randomized, double-blind, placebo controlled phase II trial. Setting Medical ICU in a tertiary, academic medical center. Patients Critically ill patients ≥18 years old with severe sepsis and detectable plasma cell-free hemoglobin. Interventions Patients were randomized 1:1 to enteral acetaminophen 1 gram every 6 hours for three days (n = 18) or placebo (n = 22) with the same dosing schedule and duration. Measurements and Main Results F2-Isoprostanes on study day 3, the primary outcome, did not differ between acetaminophen (30 pg/mL, IQR 24–41) and placebo (36 pg/mL, IQR 25–80, p = 0.35). However, F2-Isoprostanes were significantly reduced on study day 2 in the acetaminophen group (24 pg/mL, IQR 19 – 36) compared with placebo (36 pg/mL, IQR 23–55, p = 0.047). Creatinine on study day 3, a secondary outcome, was significantly lower in the acetaminophen group (1.0 mg/dL, IQR 0.6–1.4) compared with placebo (1.3 mg/dL, IQR 0.83 – 2.0, p = 0.039). There was no statistically significant difference in hospital mortality (acetaminophen 5.6% vs. placebo 18.2%, p = 0.355) or adverse events (AST or ALT >400)(acetaminophen 9.5% vs. placebo 4.3%, p = 0.599). Conclusions In adults with severe sepsis and detectable plasma cell-free hemoglobin, treatment with acetaminophen within 24 hours of ICU admission may reduce oxidative injury and improve renal function. Further study is needed to confirm these findings and determine the effect of acetaminophen on patient-centered outcomes. PMID:25474535

Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

PubMed Central

2011-01-01

Background In predicted severe acute pancreatitis, infections have a negative effect on clinical outcome. A start of enteral nutrition (EN) within 24 hours of onset may reduce the number of infections as compared to the current practice of starting an oral diet and EN if necessary at 3-4 days after admission. Methods/Design The PYTHON trial is a randomised controlled, parallel-group, superiority multicenter trial. Patients with predicted severe acute pancreatitis (Imrie-score ≥ 3 or APACHE-II score ≥ 8 or CRP > 150 mg/L) will be randomised to EN within 24 hours or an oral diet and EN if necessary, after 72 hours after hospital admission. During a 3-year period, 208 patients will be enrolled from 20 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite of mortality or infections (bacteraemia, infected pancreatic or peripancreatic necrosis, pneumonia) during hospital stay or within 6 months following randomisation. Secondary endpoints include other major morbidity (e.g. new onset organ failure, need for intervention), intolerance of enteral feeding and total costs from a societal perspective. Discussion The PYTHON trial is designed to show that a very early (< 24 h) start of EN reduces the combined endpoint of mortality or infections as compared to the current practice of an oral diet and EN if necessary at around 72 hours after admission for predicted severe acute pancreatitis. Trial Registration ISRCTN: ISRCTN18170985 PMID:21392395

Heart rate informed artificial pancreas system enhances glycemic control during exercise in adolescents with T1D.

PubMed

DeBoer, Mark D; Cherñavvsky, Daniel R; Topchyan, Katarina; Kovatchev, Boris P; Francis, Gary L; Breton, Marc D

2017-11-01

To evaluate the safety and performance of using a heart rate (HR) monitor to inform an artificial pancreas (AP) system during exercise among adolescents with type 1 diabetes (T1D). In a randomized, cross-over trial, adolescents with T1D age 13 - 18 years were enrolled to receive on separate days either the unmodified UVa AP (stdAP) or an AP system connected to a portable HR monitor (AP-HR) that triggered an exercise algorithm for blood glucose (BG) control. During admissions participants underwent a structured exercise regimen. Hypoglycemic events and CGM tracings were compared between the two admissions, during exercise and for the full 24-hour period. Eighteen participants completed the trial. While number of hypoglycemic events during exercise and rest was not different between visits (0.39 AP-HR vs 0.50 stdAP), time below 70 mg dL -1 was lower on AP-HR compared to stdAP, 0.5±2.1% vs 7.4±12.5% (P = 0.028). Time with BG within 70-180 mg dL -1 was higher for the AP-HR admission vs stdAP during the exercise portion and overall (96% vs 87%, and 77% vs 74%), but these did not reach statistical significance (P = 0.075 and P = 0.366). Heart rate signals can safely and efficaciously be integrated in a wireless AP system to inform of physical activity. While exercise contributes to hypoglycemia among adolescents, even when using an AP system, informing the system of exercise via a HR monitor improved time <70 mg dL -1 . Nonetheless, it did not significantly reduce the total number of hypoglycemic events, which were low in both groups. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

PubMed

Sperandio da Silva, Gilberto M; Chambela, Mayara C; Sousa, Andrea S; Sangenis, Luiz Henrique C; Xavier, Sergio S; Costa, Andréa R; Brasil, Pedro Emmanuel A A; Hasslocher-Moreno, Alejandro M; Saraiva, Roberto M

2012-12-27

Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance. Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment. ClinicalTrials.gov Identifier: NCT01566617.

Exercise rehabilitation on home-dwelling patients with Alzheimer's disease--a randomized, controlled trial. Study protocol.

PubMed

Pitkala, Kaisu H; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo S; Kautiainen, Hannu; Strandberg, Timo E

2010-10-06

Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD. During years 2008-2010, patients with AD (n = 210) living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1) tailored home-based exercise twice weekly 2) group-based exercise twice weekly in rehabilitation center 3) control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36). Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up. To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention. ACTRN12608000037303.

Prehospital therapeutic hypothermia after cardiac arrest: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Diao, Mengyuan; Huang, Fenglou; Guan, Jun; Zhang, Zhe; Xiao, Yan; Shan, Yi; Lin, Zhaofen; Ding, Liangcai

2013-08-01

Therapeutic hypothermia has been recommended for the treatment of cardiac arrest patients who remain comatose after the return of spontaneous circulation. However, the optimal time to initiate therapeutic hypothermia remains unclear. The objective of the present study is to assess the effectiveness and safety of prehospital therapeutic hypothermia after cardiac arrest. Databases such as MEDLINE, Embase, and Cochrane Library were searched from their establishment date to May of 2012 to retrieve randomized control trials on prehospital therapeutic hypothermia after cardiac arrest. Thereafter, the studies retrieved were screened based on predefined inclusion and exclusion criteria. Data were extracted and the quality of the included studies was evaluated. A meta-analysis was performed by using the Cochrane Collaboration Review Manager 5.1.6 software. Five studies involving 633 cases were included, among which 314 cases were assigned to the treatment group and the other 319 cases to the control group. The meta-analysis indicated that prehospital therapeutic hypothermia after cardiac arrest produced significant differences in temperature on hospital admission compared with in-hospital therapeutic hypothermia or normothermia (patient data; mean difference=-0.95; 95% confidence interval -1.15 to -0.75; I(2)=0%). However, no significant differences were observed in the survival to the hospital discharge, favorable neurological outcome at hospital discharge, and rearrest. The risk of bias was low; however, the quality of the evidence was very low. This review demonstrates that prehospital therapeutic hypothermia after cardiac arrest can decrease temperature on hospital admission. On the other hand, regarding the survival to hospital discharge, favorable neurological outcome at hospital discharge, and rearrest, our meta-analysis and review produces non-significant results. Using the Grading of Recommendations, Assessment, Development and Evaluation methodology, we conclude that the quality of evidence is very low. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The effect of protein intake and resistance training on muscle mass in acutely ill old medical patients - A randomized controlled trial.

PubMed

Buhl, Sussi F; Andersen, Aino L; Andersen, Jens R; Andersen, Ove; Jensen, Jens-Erik B; Rasmussen, Anne Mette L; Pedersen, Mette M; Damkjær, Lars; Gilkes, Hanne; Petersen, Janne

2016-02-01

Stress metabolism is associated with accelerated loss of muscle that has large consequences for the old medical patient. The aim of this study was to investigate if an intervention combining protein and resistance training was more effective in counteracting loss of muscle than standard care. Secondary outcomes were changes in muscle strength, functional ability and body weight. 29 acutely admitted old (>65 years) patients were randomly assigned to the intervention (n = 14) or to standard care (n = 15). The Intervention Group received 1.7 g protein/kg/day during admission and a daily protein supplement (18.8 g protein) and resistance training 3 times per week the 12 weeks following discharge. Muscle mass was assessed by Dual-energy X-ray Absorptiometry. Muscle strength was assessed by Hand Grip Strength and Chair Stand Test. Functional ability was assessed by the de Morton Mobility Index, the Functional Recovery Score and the New Mobility Score. Changes in outcomes from time of admission to three-months after discharge were analysed by linear regression analysis. The intention-to-treat analysis showed no significant effect of the intervention on lean mass (unadjusted: β-coefficient = -1.28 P = 0.32, adjusted for gender: β-coefficient = -0.02 P = 0.99, adjusted for baseline lean mass: β-coefficient = -0.31 P = 0.80). The de Morton Mobility Index significantly increased in the Control Group (β-coefficient = -11.43 CI: 0.72-22.13, P = 0.04). No other differences were found. No significant effect on muscle mass was observed in this group of acutely ill old medical patients. High compliance was achieved with the dietary intervention, but resistance training was challenging. Clinical trials identifier NCT02077491. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

The Effect of Skin Traction on Preoperative Pain and Need for Analgesics in Patients With Intertrochanteric Fractures: A Randomized Clinical Trial

PubMed Central

Manafi Rasi, Alireza; Amoozadeh, Farzad; Khani, Salim; Kamrani Rad, Amin; Sazegar, Ali

2015-01-01

Background: Preoperative skin traction is applied for many patients with hip fracture. However, the efficacy of this modality in pain relief is controversial. Objectives: The aim of the current study was to investigate the effects of skin traction on pain in patients with intertrochanteric fractures. Patients and Methods: A total of 40 patients contributed in this randomized clinical trial. Patients were randomly allocated into two equal groups: the skin traction (3 kg) and control groups. The severity of pain was recorded at admission and 30 minutes, one, six, 12, and 24 hours after skin traction application utilizing a Visual Analogue Scale (VAS). In addition, the number of requests for analgesics was recorded. Finally, the mean severity of pain in each measurement and the mean number of analgesic requests were compared between the two groups. Results: The severity of pain was significantly decreased in skin traction group only at the end of the first day after traction application (2.7 ± 0.8 vs. 3.3 ± 0.9; P = 0.042), while there was no significant difference between the two groups in other pain measurements. The number of requests for analgesics was the same between the two groups. Conclusions: Although skin traction had no effect on analgesic consumption, it significantly decreased the pain at the end of the first day. The application of skin traction in patients with intertrochanteric fractures is recommended. PMID:26401491

A comparison of total intravenous anaesthesia using propofol with sevoflurane or desflurane in ambulatory surgery: systematic review and meta-analysis.

PubMed

Kumar, G; Stendall, C; Mistry, R; Gurusamy, K; Walker, D

2014-10-01

With the popularity of ambulatory surgery ever increasing, we carried out a systematic review and meta-analysis to determine whether the type of anaesthesia used had any bearing on patient outcomes. Total intravenous propofol anaesthesia was compared with two of the newer inhalational agents, sevoflurane and desflurane. In total, 18 trials were identified; only trials where nitrous oxide was administered to, or omitted from, both groups were included. A total of 1621 patients were randomly assigned to either propofol (685 patients) or inhalational anaesthesia (936 patients). If surgical causes of unplanned admissions were excluded, there was no difference in unplanned admission to hospital between propofol and inhalational anaesthesia (1.0% vs 2.9%, respectively; p = 0.13). The incidence of postoperative nausea and vomiting was lower with propofol than with inhalational agents (13.8% vs 29.2%, respectively; p < 0.001). However, no difference was noted in post-discharge nausea and vomiting (23.9% vs 20.8%, respectively; p = 0.26). Length of hospital stay was shorter with propofol, but the difference was only 14 min on average. The use of propofol was also more expensive, with a mean (95% CI) difference of £6.72 (£5.13-£8.31 (€8.16 (€6.23-€10.09); $11.29 ($8.62-$13.96))) per patient-anaesthetic episode (p < 0.001). Therefore, based on the published evidence to date, maintenance of anaesthesia using propofol appeared to have no bearing on the incidence of unplanned admission to hospital and was more expensive, but was associated with a decreased incidence of early postoperative nausea and vomiting compared with sevoflurane or desflurane in patients undergoing ambulatory surgery. © 2014 The Association of Anaesthetists of Great Britain and Ireland.

Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.

PubMed

Löffler, Christin; Drewelow, Eva; Paschka, Susanne D; Frankenstein, Martina; Eger, Julia; Jatsch, Lisa; Reisinger, Emil C; Hallauer, Johannes F; Drewelow, Bernd; Heidorn, Karen; Schröder, Helmut; Wollny, Anja; Kundt, Günther; Schmidt, Christian; Altiner, Attila

2014-10-06

Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. Current Controlled Trials ISRCTN42003273.

Effect of timing of umbilical cord clamping on anaemia at 8 and 12 months and later neurodevelopment in late pre-term and term infants; a facility-based, randomized-controlled trial in Nepal.

PubMed

Kc, Ashish; Målqvist, Mats; Rana, Nisha; Ranneberg, Linda Jarawka; Andersson, Ola

2016-03-10

Delayed cord clamping at birth has shown to benefit neonates with increased placental transfusion leading to higher haemoglobin concentrations, additional iron stores and less anaemia later in infancy, higher red blood cell flow to vital organs and better cardiopulmonary adaptation. As iron deficiency in infants even without anaemia has been associated with impaired development, delayed cord clamping seems to benefit full term infants also in regions with a relatively low prevalence of iron deficiency anaemia. In Nepal, there is a high anaemia prevalence among children between 6 and 17 months (72-78 %). The objective of the proposed study is to evaluate the effects of delayed and early cord clamping on anaemia (and haemoglobin level) at 8 and 12 months, ferritin at 8 and 12 months, bilirubin at 2-3 days, admission to Neonatal Intensive Care Unit (NICU) or special care nursery, and development at 12 and 18-24 months of age. A randomized, controlled trial comparing delayed and early cord clamping will be implemented at Paropakar Maternity and Women's Hospital in Kathmandu, Nepal. Pregnant woman of gestational age 34-41 weeks who deliver vaginally will be included in the study. The interventions will consist of delayed clamping of the umbilical cord (≥180 s after delivery) or early clamping of the umbilical cord (≤60 s). At 8 and 12 months of age, infant's iron status and developmental milestones will be measured. This trial is important to perform because, although strong indications for the beneficial effect of delayed cord clamping on anaemia at 8 to 12 months of age exist, it has not yet been evaluated by a randomized trial in this setting. The proposed study will analyse both outcome as well as safety effects. Additionally, the results may not only contribute to practice in Nepal, but also to the global community, in particular to other low-income countries with a high prevalence of iron deficiency anaemia. Clinical trial.gov NCT02222805 . Registered August 19 2014.

The effects of crisis plans for patients with psychotic and bipolar disorders: a randomised controlled trial.

PubMed

Ruchlewska, A; Mulder, C L; Smulders, R; Roosenschoon, B J; Koopmans, G; Wierdsma, A

2009-07-09

Crises and (involuntary) admissions have a strong impact on patients and their caregivers. In some countries, including the Netherlands, the number of crises and (involuntary) admissions have increased in the last years. There is also a lack of effective interventions to prevent their occurrence. Previous research has shown that a form of psychiatric advance statement - joint crisis plan - may prevent involuntary admissions, but another study showed no significant results for another form. The question remains which form of psychiatric advance statement may help to prevent crisis situations. This study examines the effects of two other psychiatric advance statements. The first is created by the patient with help from a patient's advocate (Patient Advocate Crisis Plan: PACP) and the second with the help of a clinician only (Clinician facilitated Crisis Plan: CCP). We investigate whether patients with a PACP or CCP show fewer emergency visits and (involuntary) admissions as compared to patients without a psychiatric advance statement. Furthermore, this study seeks to identify possible mechanisms responsible for the effects of a PACP or a CCP. This study is a randomised controlled trial with two intervention groups and one control condition. Both interventions consist of a crisis plan, facilitated through the patient's advocate or the clinician respectively.Outpatients with psychotic or bipolar disorders, who experienced at least one psychiatric crisis during the previous two years, are randomly allocated to one of the three groups. Primary outcomes are the number of emergency (after hour) visits, (involuntary) admissions and the length of stay in hospital. Secondary outcomes include psychosocial functioning and treatment satisfaction. The possible mediator variables of the effects of the crisis plans are investigated by assessing the patient's involvement in the creation of the crisis plan, working alliance, insight into illness, recovery style, social support, locus of control, service engagement and coping with crises situations. The interviews take place before randomisation, nine month later and finally eighteen months after randomisation. This study examines the effects of two types of crisis plans. In addition, the results offer an understanding of the way these advance statements work and whether it is more effective to include a patients' advocate in the process of creating a psychiatric advance statement. These statements may be an intervention to prevent crises and the use of compulsion in mental health care. The strength and limitations of this study are discussed. Current Controlled Trails NTR1166.

Infrared coagulation: a new treatment for hemorrhoids

DOE Office of Scientific and Technical Information (OSTI.GOV)

Leicester, R.J.; Nicholls, R.J.; Mann, C.V.

Many methods, which have effectively reduced the number of patients requiring hospital admission, have been described for the outpatient treatment of hemorrhoids. However, complications have been reported, and the methods are often associated with unpleasant side effects. In 1977 Neiger et al. described a new method that used infrared coagulation, which produced minimal side effects. The authors have conducted a prospective, randomized trial to evaluate infrared coagulation compared with more traditional methods of treatment. The authors' results show that it may be more effective than injection sclerotherapy in treating non-prolapsing hemorrhoids and that it compares favorably with rubber band ligationmore » in most prolapsing hemorrhoids. No complications occurred, and significantly fewer patients experienced pain after infrared coagulation (P . less than 0.001).« less

Costs and expected gain in lifetime health from intensive care versus general ward care of 30,712 individual patients: a distribution-weighted cost-effectiveness analysis.

PubMed

Lindemark, Frode; Haaland, Øystein A; Kvåle, Reidar; Flaatten, Hans; Norheim, Ole F; Johansson, Kjell A

2017-08-21

Clinicians, hospital managers, policy makers, and researchers are concerned about high costs, increased demand, and variation in priorities in the intensive care unit (ICU). The objectives of this modelling study are to describe the extra costs and expected health gains associated with admission to the ICU versus the general ward for 30,712 patients and the variation in cost-effectiveness estimates among subgroups and individuals, and to perform a distribution-weighted economic evaluation incorporating extra weighting to patients with high severity of disease. We used a decision-analytic model that estimates the incremental cost per quality-adjusted life year (QALY) gained (ICER) from ICU admission compared with general ward care using Norwegian registry data from 2008 to 2010. We assigned increasing weights to health gains for those with higher severity of disease, defined as less expected lifetime health if not admitted. The study has inherent uncertainty of findings because a randomized clinical trial comparing patients admitted or rejected to the ICU has never been performed. Uncertainty is explored in probabilistic sensitivity analysis. The mean cost-effectiveness of ICU admission versus ward care was €11,600/QALY, with 1.6 QALYs gained and an incremental cost of €18,700 per patient. The probability (p) of cost-effectiveness was 95% at a threshold of €22,000/QALY. The mean ICER for medical admissions was €10,700/QALY (p = 97%), €12,300/QALY (p = 93%) for admissions after acute surgery, and €14,700/QALY (p = 84%) after planned surgery. For individualized ICERs, there was a 50% probability that ICU admission was cost-effective for 85% of the patients at a threshold of €64,000/QALY, leaving 15% of the admissions not cost-effective. In the distributional evaluation, 8% of all patients had distribution-weighted ICERs (higher weights to gains for more severe conditions) above €64,000/QALY. High-severity admissions gained the most, and were more cost-effective. On average, ICU admission versus general ward care was cost-effective at a threshold of €22,000/QALY (p = 95%). According to the individualized cost-effectiveness information, one in six ICU admissions was not cost-effective at a threshold of €64,000/QALY. Almost half of these admissions that were not cost-effective can be regarded as acceptable when weighted by severity of disease in terms of expected lifetime health. Overall, existing ICU services represent reasonable resource use, but considerable uncertainty becomes evident when disaggregating into individualized results.

Factors associated with family caregiver dissatisfaction with acute hospital care of older cognitively impaired relatives.

PubMed

Whittamore, Kathy H; Goldberg, Sarah E; Bradshaw, Lucy E; Harwood, Rowan H

2014-12-01

To identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults. Secondary analysis of data from a randomized controlled trial. An 1,800-bed general hospital in England providing the only emergency medical services in its area. Cognitively impaired individuals aged 65 and older randomly assigned to a specialist unit or standard geriatric or internal medical wards (N = 600) and related caregivers (N = 488). Patient and caregiver health status was measured at baseline, including delirium, cognitive impairment, behavioral and psychological symptoms, activities of daily living, and caregiver strain. Caregiver satisfaction with quality of care was ascertained after hospital discharge or death. Four hundred sixty-two caregivers completed satisfaction questionnaires. Regardless of assignment, 54% of caregivers were dissatisfied with some aspects of care, but overall 87% were satisfied with care. The main areas of dissatisfaction were communication, discharge planning, and medical management. Dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission, caregiver strain and poor psychological well-being at admission, a diagnosis of delirium, and the relationship between the caregiver and the patient. There was less dissatisfaction from caregivers of patients managed on the specialist Medical and Mental Health Unit than those on standard wards, after controlling for multiple factors. Dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care. © 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society.

Intermittent preventive antimalarial treatment for children with anaemia.

PubMed

Athuman, Mwaka; Kabanywanyi, Abdunoor M; Rohwer, Anke C

2015-01-13

Anaemia is a global public health problem. Children under five years of age living in developing countries (mostly Africa and South-East Asia) are highly affected. Although the causes for anaemia are multifactorial, malaria has been linked to anaemia in children living in malaria-endemic areas. Administering intermittent preventive antimalarial treatment (IPT) to children might reduce anaemia, since it could protect children from new Plasmodium parasite infection (the parasites that cause malaria) and allow their haemoglobin levels to recover. To assess the effect of IPT for children with anaemia living in malaria-endemic areas. We searched the Cochrane Infectious Diseases Group Specialized Register, Cochrane Central of Controlled Trials (CENTRAL), published in The Cochrane Library; MEDLINE; EMBASE; and LILACS. We also searched the World Health Organization (WHO) International Clinical Trial Registry Platform and metaRegister of Controlled Trials (mRCT) for ongoing trials up to 4 December 2014. Randomized controlled trials (RCTs) evaluating the effect of IPT on children with anaemia. Two review authors independently extracted data and assessed risk of bias. We analysed data by conducting meta-analyses, stratifying data according to whether participants received iron supplements or not. We used GRADE to assess the quality of evidence. Six trials with 3847 participants met our inclusion criteria. Trials were conducted in areas of low malaria endemicity (three trials), and moderate to high endemicity (three trials). Four trials were in areas of seasonal malaria transmission. Iron was given to all children in two trials, and evaluated in a factorial design in a further two trials.IPT for children with anaemia probably has little or no effect on the proportion anaemic at 12 weeks follow-up (four trials, 2237 participants, (moderate quality evidence).IPT in anaemic children probably increases the mean change in haemoglobin levels from baseline to follow-up at 12 weeks on average by 0.32 g/dL (MD 0.32, 95% CI 0.19 to 0.45; four trials, 1672 participants, moderate quality evidence); and may improve haemoglobin levels at 12 weeks (MD 0.35, 95% CI 0.06 to 0.64; four trials, 1672 participants, low quality evidence). For both of these outcomes, subgroup analysis did not demonstrate a difference between children receiving iron and those that did not.IPT for children with anaemia probably has little or no effect on mortality or hospital admissions at six months (three trials, 3160 participants moderate quality evidence). Subgroup analysis did not show a difference between those children receiving iron supplements and those that did not. Trials did show a small effect on average haemoglobin levels but this did not appear to translate into an effect on mortality and hospital admissions. Three of the six trials were conducted in low endemicity areas where transmission is low and thus any protective effect is likely to be modest.

Additional Saturday rehabilitation improves functional independence and quality of life and reduces length of stay: a randomized controlled trial

PubMed Central

2013-01-01

Background Many inpatients receive little or no rehabilitation on weekends. Our aim was to determine what effect providing additional Saturday rehabilitation during inpatient rehabilitation had on functional independence, quality of life and length of stay compared to 5 days per week of rehabilitation. Methods This was a multicenter, single-blind (assessors) randomized controlled trial with concealed allocation and 12-month follow-up conducted in two publically funded metropolitan inpatient rehabilitation facilities in Melbourne, Australia. Patients were eligible if they were adults (aged ≥18 years) admitted for rehabilitation for any orthopedic, neurological or other disabling conditions excluding those admitted for slow stream rehabilitation/geriatric evaluation and management. Participants were randomly allocated to usual care Monday to Friday rehabilitation (control) or to Monday to Saturday rehabilitation (intervention). The additional Saturday rehabilitation comprised physiotherapy and occupational therapy. The primary outcomes were functional independence (functional independence measure (FIM); measured on an 18 to 126 point scale), health-related quality of life (EQ-5D utility index; measured on a 0 to 1 scale, and EQ-5D visual analog scale; measured on a 0 to 100 scale), and patient length of stay. Outcome measures were assessed on admission, discharge (primary endpoint), and at 6 and 12 months post discharge. Results We randomly assigned 996 adults (mean (SD) age 74 (13) years) to Monday to Saturday rehabilitation (n = 496) or usual care Monday to Friday rehabilitation (n = 500). Relative to admission scores, intervention group participants had higher functional independence (mean difference (MD) 2.3, 95% confidence interval (CI) 0.5 to 4.1, P = 0.01) and health-related quality of life (MD 0.04, 95% CI 0.01 to 0.07, P = 0.009) on discharge and may have had a shorter length of stay by 2 days (95% CI 0 to 4, P = 0.1) when compared to control group participants. Intervention group participants were 17% more likely to have achieved a clinically significant change in functional independence of 22 FIM points or more (risk ratio (RR) 1.17, 95% CI 1.03 to 1.34) and 18% more likely to have achieved a clinically significant change in health-related quality of life (RR 1.18, 95% CI 1.04 to 1.34) on discharge compared to the control group. There was some maintenance of effect for functional independence and health-related quality of life at 6-month follow-up but not at 12-month follow-up. There was no difference in the number of adverse events between the groups (incidence rate ratio = 0.81, 95% CI 0.61 to 1.08). Conclusions Providing an additional day of rehabilitation improved functional independence and health-related quality of life at discharge and may have reduced length of stay for patients receiving inpatient rehabilitation. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000973213 Please see related commentary: http://www.biomedcentral.com/10.1186/1741-7015-11-199. PMID:24228854

Association Between Peritoneal Glucose Exposure and Peritonitis in Peritoneal Dialysis Patients: The balANZ Trial.

PubMed

Nataatmadja, Melissa; Cho, Yeoungjee; Pascoe, Elaine M; Darssan, Darsy; Hawley, Carmel M; Johnson, David W

2017-01-01

Glucose is the primary osmotic medium used in most peritoneal dialysis (PD) solutions, and exposure to glucose has been shown to exert detrimental effects both locally, at the peritoneal membrane, and systemically. Moreover, high dialysate glucose exposure may predispose patients to an increased risk of peritonitis, perhaps as a result of impaired host defences, vascular disease, and damage to the peritoneal membrane. In this post-hoc analysis of a multicenter, multinational, open-label randomized controlled trial of neutral pH, low-glucose degradation product (GDP) versus conventional PD solutions ( bal ANZ trial), the relationship between peritonitis rates of low (< 123.1 g/day) versus high (≥ 123.1 g/day) dialysate glucose exposure was evaluated in 177 incident PD patients over a 2-year study period. Peritonitis rates were 0.44 episodes per patient-year in the low-glucose exposure group and 0.31 episodes per patient-year in the high-glucose exposure group, (incidence rate ratio [IRR] 0.69, p = 0.09). There was no significant association between dialysate glucose exposure and peritonitis-free survival on univariable analysis (high glucose exposure hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.40 - 1.08) or on multivariable analysis (adjusted HR 0.64, 95% CI 0.39 - 1.05). Moreover, there was no relationship between peritoneal glucose exposure and type of organism causing peritonitis. Physician-rated severity of first peritonitis episodes was similar between groups, as was rate and duration of hospital admission. Overall, this study did not identify an association between peritoneal dialysate glucose exposure and peritonitis occurrence, severity, hospitalization, or outcomes. A further large-scale, prospective, randomized controlled trial evaluating patient-level outcomes is merited. Copyright © 2017 International Society for Peritoneal Dialysis.

Rationale and design of the dal-OUTCOMES trial: efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome.

PubMed

Schwartz, Gregory G; Olsson, Anders G; Ballantyne, Christie M; Barter, Phillip J; Holme, Ingar M; Kallend, David; Leiter, Lawrence A; Leitersdorf, Eran; McMurray, John J V; Shah, Prediman K; Tardif, Jean-Claude; Chaitman, Bernard R; Duttlinger-Maddux, Regina; Mathieson, John

2009-12-01

Despite contemporary therapies for acute coronary syndrome (ACS), morbidity and mortality remain high. Low levels of high-density lipoprotein (HDL) cholesterol are common among patients with ACS and may contribute to ongoing risk. Strategies that raise levels of HDL cholesterol, such as inhibition of cholesterol ester transfer protein (CETP), might reduce risk after ACS. Dal-OUTCOMES is a multicenter, randomized, double-blind, placebo-controlled trial designed to test the hypothesis that CETP inhibition with dalcetrapib reduces cardiovascular morbidity and mortality in patients with recent ACS. The study will randomize approximately 15,600 patients to receive daily doses of dalcetrapib 600 mg or matching placebo, beginning 4 to 12 weeks after an index ACS event. There are no prespecified boundaries for HDL cholesterol levels at entry. Other elements of care, including management of low-density lipoprotein cholesterol, are to follow best evidence-based practice. The primary efficacy measure is time to first occurrence of coronary heart disease death, nonfatal acute myocardial infarction, unstable angina requiring hospital admission, resuscitated cardiac arrest, or atherothrombotic stroke. The trial will continue until 1,600 primary end point events have occurred, all evaluable subjects have been followed for at least 2 years, and 80% of evaluable subjects have been followed for at least 2.5 years. Dal-OUTCOMES will determine whether CETP inhibition with dalcetrapib, added to current evidence-based care, reduces cardiovascular morbidity and mortality after ACS.

Comparison of the antiplatelet effect of two clopidogrel bisulfate formulations: Plavix and generic-Egitromb.

PubMed

Komosa, A; Siller-Matula, J M; Kowal, J; Lesiak, M; Siniawski, A; Mączyński, M; Michalak, M; Mularek-Kubzdela, T; Grajek, S

2015-01-01

Due to expansion of the pharmaceutical market it seems necessary to prove the efficacy of the generic drugs. The aim of this study is to compare the effects of two clopidogrel formulations: brand-name-Plavix and generic drug - Egitromb. This is a prospective, randomized study comparing two groups of patients treated with two clopidogrel: brand-name Plavix and generic drug- Egitromb. The 53 consecutive patients with stable coronary artery disease qualifying for coronary angiography and PCI were enrolled in this trial. They were randomized into two groups. In the group A (n = 28) patients received Egitromb 300 mg at admission followed by 8 days of 75 mg Egitromb daily. In the group B (n = 25) patients received Plavix 300 mg on the admission followed by 8 days of 75 mg Plavix maintenance therapy. Blood samples for multiple electrode aggregometry testing were drawn at baseline, 5 hours and 8 days after taking the loading dose. Median values of platelet aggregation inhibition did not differ between the Plavix and Egitromb groups when assessed at baseline: 239AU/min (IQR:329) vs. 209 (IQR:406; p = 0.894), 5 hours after loading: 183 AU/min (IQR:107) vs. 165 (IQR:171; p = 0.831) or at day 8: 174 AU/min (IQR:133) vs. 211 (IQR:133; p = 0.332. The study showed no difference in the therapeutic effect of two clopidogrel formulations (Egitromb and Plavix).

The way in which a physiotherapy service is structured can improve patient outcome from a surgical intensive care: a controlled clinical trial

PubMed Central

2012-01-01

Introduction The physiological basis of physiotherapeutic interventions used in intensive care has been established. We must determine the optimal service approach that will result in improved patient outcome. The aim of this article is to report on the estimated effect of providing a physiotherapy service consisting of an exclusively allocated physiotherapist providing evidence-based/protocol care, compared with usual care on patient outcomes. Methods An exploratory, controlled, pragmatic, sequential-time-block clinical trial was conducted in the surgical unit of a tertiary hospital in South Africa. Protocol care (3 weeks) and usual care (3 weeks) was provided consecutively for two 6-week intervention periods. Each intervention period was followed by a washout period. The physiotherapy care provided was based on the unit admission date. Data were analyzed with Statistica in consultation with a statistician. Where indicated, relative risks with 95% confidence intervals (CIs) are reported. Significant differences between groups or across time are reported at the alpha level of 0.05. All reported P values are two-sided. Results Data of 193 admissions were analyzed. No difference was noted between the two patient groups at baseline. Patients admitted to the unit during protocol care were less likely to be intubated after unit admission (RR, 0.16; 95% CI, 0.07 to 0.71; RRR, 0.84; NNT, 5.02; P = 0.005) or to fail an extubation (RR, 0.23; 95% CI, 0.05 to 0.98; RRR, 0.77; NNT, 6.95; P = 0.04). The mean difference in the cumulative daily unit TISS-28 score during the two intervention periods was 1.99 (95% CI, 0.65 to 3.35) TISS-28 units (P = 0.04). Protocol-care patients were discharged from the hospital 4 days earlier than usual-care patients (P = 0.05). A tendency noted for more patients to reach independence in the transfers (P = 0.07) and mobility (P = 0.09) categories of the Barthel Index. Conclusions A physiotherapy service approach that includes an exclusively allocated physiotherapist providing evidence-based/protocol care that addresses pulmonary dysfunction and promotes early mobility improves patient outcome. This could be a more cost-effective service approach to care than is usual care. This information can now be considered by administrators in the management of scarce physiotherapy resources and by researchers in the planning of a multicenter randomized controlled trial. Trial registration PACTR201206000389290 PMID:23232109

Self management for patients with chronic obstructive pulmonary disease.

PubMed

Zwerink, Marlies; Brusse-Keizer, Marjolein; van der Valk, Paul D L P M; Zielhuis, Gerhard A; Monninkhof, Evelyn M; van der Palen, Job; Frith, Peter A; Effing, Tanja

2014-03-19

Self management interventions help patients with chronic obstructive pulmonary disease (COPD) acquire and practise the skills they need to carry out disease-specific medical regimens, guide changes in health behaviour and provide emotional support to enable patients to control their disease. Since the first update of this review in 2007, several studies have been published. The results of the second update are reported here. 1. To evaluate whether self management interventions in COPD lead to improved health outcomes.2. To evaluate whether self management interventions in COPD lead to reduced healthcare utilisation. We searched the Cochrane Airways Group Specialised Register of trials (current to August 2011). Controlled trials (randomised and non-randomised) published after 1994, assessing the efficacy of self management interventions for individuals with COPD, were included. Interventions with fewer than two contact moments between study participants and healthcare providers were excluded. Two review authors independently assessed trial quality and extracted data. Investigators were contacted to ask for additional information. When appropriate, study results were pooled using a random-effects model. The primary outcomes of the review were health-related quality of life (HRQoL) and number of hospital admissions. Twenty-nine studies were included. Twenty-three studies on 3189 participants compared self management versus usual care; six studies on 499 participants compared different components of self management on a head-to-head basis. Although we included non-randomised controlled clinical trials as well as RCTs in this review, we restricted the primary analysis to RCTs only and reported these trials in the abstract.In the 23 studies with a usual care control group, follow-up time ranged from two to 24 months. The content of the interventions was diverse. A statistically relevant effect of self management on HRQoL was found (St George's Respiratory Questionnaire (SGRQ) total score, mean difference (MD) -3.51, 95% confidence interval (CI) -5.37 to -1.65, 10 studies, 1413 participants, moderate-quality evidence). Self management also led to a lower probability of respiratory-related hospitalisation (odds ratio (OR) 0.57, 95% CI 0.43 to 0.75, nine studies, 1749 participants, moderate-quality evidence). Over one year of follow-up, eight (95% CI 5 to 14) participants with a high baseline risk of respiratory-related hospital admission needed to be treated to prevent one participant with at least one hospital admission, and 20 (95% CI 15 to 35) participants with a low baseline risk of hospitalisation needed to be treated to prevent one participant with at least one respiratory-related hospital admission.No statistically significant effect of self management on all-cause hospitalisation (OR 0.77, 95% CI 0.45 to 1.30, 6 studies, 1365 participants, low-quality evidence) or mortality (OR 0.79, 95% CI 0.58 to 1.07, 8 studies, 2134 participants, very low-quality evidence) was detected. Also, dyspnoea measured by the (modified) Medical Research Council Scale ((m)MRC) was reduced in individuals who participated in self management (MD -0.83, 95% CI -1.36 to -0.30, 3 studies, 119 participants, low-quality evidence). The difference in exercise capacity as measured by the six-minute walking test was not statistically significant (MD 33.69 m, 95% CI -9.12 to 76.50, 6 studies, 570 participants, very low-quality evidence). Subgroup analyses depending on the use of an exercise programme as part of the intervention revealed no statistically significant differences between studies with and without exercise programmes in our primary outcomes of HRQoL and respiratory-related hospital admissions.We were unable to pool head-to-head trials because of heterogeneity among interventions and controls; thus results are presented narratively within the review. Self management interventions in patients with COPD are associated with improved health-related quality of life as measured by the SGRQ, a reduction in respiratory-related hospital admissions, and improvement in dyspnoea as measured by the (m)MRC. No statistically significant differences were found in other outcome parameters. However, heterogeneity among interventions, study populations, follow-up time and outcome measures makes it difficult to formulate clear recommendations regarding the most effective form and content of self management in COPD.

Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis.

PubMed

Gerent, Aline Rejane Muller; Almeida, Juliano Pinheiro; Fominskiy, Evgeny; Landoni, Giovanni; de Oliveira, Gisele Queiroz; Rizk, Stephanie Itala; Fukushima, Julia Tizue; Simoes, Claudia Marques; Ribeiro, Ulysses; Park, Clarice Lee; Nakamura, Rosana Ely; Franco, Rafael Alves; Cândido, Patricia Inês; Tavares, Cintia Rosa; Camara, Ligia; Dos Santos Rocha Ferreira, Graziela; de Almeida, Elisangela Pinto Marinho; Filho, Roberto Kalil; Galas, Filomena Regina Barbosa Gomes; Hajjar, Ludhmila Abrahão

2018-05-23

Perioperative goal-directed hemodynamic therapy (GDHT) has been advocated in high-risk patients undergoing noncardiac surgery to reduce postoperative morbidity and mortality. We hypothesized that using cardiac index (CI)-guided GDHT in the postoperative period for patients undergoing high-risk surgery for cancer treatment would reduce 30-day mortality and postoperative complications. A randomized, parallel-group, superiority trial was performed in a tertiary oncology hospital. All adult patients undergoing high-risk cancer surgery who required intensive care unit admission were randomly allocated to a CI-guided GDHT group or to a usual care group. In the GDHT group, postoperative therapy aimed at CI ≥ 2.5 L/min/m 2 using fluids, inotropes and red blood cells during the first 8 postoperative hours. The primary outcome was a composite endpoint of 30-day all-cause mortality and severe postoperative complications during the hospital stay. A meta-analysis was also conducted including all randomized trials of postoperative GDHT published from 1966 to May 2017. A total of 128 patients (64 in each group) were randomized. The primary outcome occurred in 34 patients of the GDHT group and in 28 patients of the usual care group (53.1% vs 43.8%, absolute difference 9.4 (95% CI, - 7.8 to 25.8); p = 0.3). During the 8-h intervention period more patients in the GDHT group received dobutamine when compared to the usual care group (55% vs 16%, p < 0.001). A meta-analysis of nine randomized trials showed no differences in postoperative mortality (risk ratio 0.85, 95% CI 0.59-1.23; p = 0.4; p for heterogeneity = 0.7; I 2  = 0%) and in the overall complications rate (risk ratio 0.88, 95% CI 0.71-1.08; p = 0.2; p for heterogeneity = 0.07; I 2  = 48%), but a reduced hospital length of stay in the GDHT group (mean difference (MD) - 1.6; 95% CI - 2.75 to - 0.46; p = 0.006; p for heterogeneity = 0.002; I 2  = 74%). CI-guided hemodynamic therapy in the first 8 postoperative hours does not reduce 30-day mortality and severe complications during hospital stay when compared to usual care in cancer patients undergoing high-risk surgery. www.clinicaltrials.gov , NCT01946269 . Registered on 16 September 2013.

Tight control of mild-moderate pre-existing or non-proteinuric gestational hypertension.

PubMed

Nabhan, Ashraf F; Elsedawy, Maged M

2011-07-06

The question of the target blood pressure in pregnant women with mild-moderate hypertension continues to be an area of debate. To compare tight versus very tight control of mild-moderate pre-existing or non-proteinuric gestational hypertension for improving outcomes We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2011), CENTRAL (The Cochrane Library 2011, Issue 3), MEDLINE (January 1966 to March 2011), and the metaRegister of Controlled Trials (31 March 2011). We handsearched citation lists of relevant publications, review articles, and included studies. Randomized controlled trials of tight versus very tight control in pregnant women with mild or moderate pre-existing or non-proteinuric gestational hypertension. Two authors independently assessed trial quality and extracted data. We expressed results as risk ratio (RR) or mean differences, together with their 95% confidence intervals (CI). We included two studies (256 participants) with mild-moderate pre-existing or non-proteinuric gestational hypertension. There was no evidence of a difference between tight and very tight control groups regarding severe pre-eclampsia (risk ratio (RR) 1.28, 95% CI 0.97 to 1.70; two trials, 256 participants). More women in the tight group were hospitalized during their pregnancy (RR 2.53, 95% CI 1.14 to 5.63; one trial, 125 participants). There was no evidence of a difference in other outcome measures including fetal distress, IUGR, neonatal admission to a NICU, perinatal deaths, induction of labor and cesarean delivery between the tight and the very tight control groups. Gestational age at delivery had a non-significant mean difference (MD) of -0.15 weeks between the tight and very tight control groups (MD -0.15, 95% CI -1.52 to 1.21, random-effects, T² = 0.75, I² = 77%; two trials, 256 participants). The MD in birthweight between the tight and the very tight control group was not significant (MD -100.00 grams, 95% CI -363.69 to 163.69; one trial, 125 participants). For pregnant women with non-severe pre-existing or non-proteinuric gestational hypertension, there is insufficient evidence to determine how tight control of hypertension should be achieved to improve maternal and fetal-neonatal outcomes.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hehenkamp, Wouter J.K.; Volkers, Nicole A.; Birnie, Erwin

Purpose. To evaluate the safety and efficacy of uterine artery embolization (UAE) and hysterectomy for symptomatic uterine fibroids by means of a randomized controlled trial. The present paper analyses short-term outcomes, i.e., pain and return to daily activities. Methods. Patients were randomized (1:1) to UAE or hysterectomy. Pain was assessed during admission and after discharge, both quantitatively and qualitatively, using a numerical rating scale and questionnaires. Time to return to daily activities was assessed by questionnaire. Results. Seventy-five patients underwent hysterectomy and 81 patients underwent UAE. UAE patients experienced significantly less pain during the first 24 hr after treatment (pmore » = 0.012). Non-white patients had significantly higher pain scores. UAE patients returned significantly sooner to daily activities than hysterectomy patients (for paid work: 28.1 versus 63.4 days; p < 0.001). In conclusion, pain appears to be less after UAE during hospital stay. Return to several daily activities was in favor of UAE in comparison with hysterectomy.« less

Intermittent Preventive Treatment of Malaria in Pregnancy with Mefloquine in HIV-Infected Women Receiving Cotrimoxazole Prophylaxis: A Multicenter Randomized Placebo-Controlled Trial

PubMed Central

Abdulla, Salim; Aponte, John J.; Bulo, Helder; Kabanywanyi, Abdunoor M.; Katana, Abraham; Maculuve, Sonia; Mayor, Alfredo; Nhacolo, Arsenio; Otieno, Kephas; Pahlavan, Golbahar; Rupérez, María; Sevene, Esperança; Slutsker, Laurence; Vala, Anifa; Williamsom, John; Menéndez, Clara

2014-01-01

Background Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ) in women receiving CTXp and long-lasting insecticide treated nets (LLITNs). Methods and Findings A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg) or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27–0.82]; p = 0.008), placental malaria (RR, 0.52 [95% CI 0.29–0.90]; p = 0.021), and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37–0.95]; p = 0.031) in the intention to treat (ITT) analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration). HIV viral load at delivery was higher in the MQ group compared to the control group (p = 0.048) in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14–3.33]; p = 0.015). The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. Conclusions An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with better tolerability to reduce malaria in this particularly vulnerable group. MQ was associated with an increased risk of mother to child transmission of HIV, which warrants a better understanding of the pharmacological interactions between antimalarials and antiretroviral drugs. Trial registration ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001813440 Please see later in the article for the Editors' Summary PMID:25247995

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

PubMed Central

2012-01-01

Background Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in ‘real-world’ services. Methods/Design The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers’ patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrolment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms’ severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in ‘real-world’ clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction. Trial registration ClinicalTrials.gov Identifier NCT01436331 PMID:22647399

Effectiveness and cost-effectiveness of admissions to women's crisis houses compared with traditional psychiatric wards: pilot patient-preference randomised controlled trial.

PubMed

Howard, L; Flach, C; Leese, M; Byford, S; Killaspy, H; Cole, L; Lawlor, C; Betts, J; Sharac, J; Cutting, P; McNicholas, S; Johnson, S

2010-08-01

Women's crisis houses have been developed in the UK as a less stigmatising and less institutional alternative to traditional psychiatric wards. To examine the effectiveness and cost-effectiveness of women's crisis houses by first examining the feasibility of a pilot patient-preference randomised controlled trial (PP-RCT) design (ISRCTN20804014). We used a PP-RCT study design to investigate women presenting in crisis needing informal admission. The four study arms were the patient preference arms of women's crisis house or hospital admission, and randomised arms of women's crisis house or hospital admission. Forty-one women entered the randomised arms of the trial (crisis house n = 19, wards n = 22) and 61 entered the patient-preference arms (crisis house n = 37, ward n = 24). There was no significant difference in outcomes (symptoms, functioning, perceived coercion, stigma, unmet needs or quality of life) or costs for any of the groups (randomised or preference arms), but women who obtained their preferred intervention were more satisfied with treatment. Although the sample sizes were too small to allow definite conclusions, the results suggest that when services are able to provide interventions preferred by patients, those patients are more likely to be satisfied with treatment. This pilot study provides some evidence that women's crisis houses are as effective as traditional psychiatric wards, and may be more cost-effective.

Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth?

PubMed

Shaw-Battista, Jenna

Health sciences research was systematically reviewed to assess randomized controlled trials of standard care versus immersion hydrotherapy in labor before conventional childbirth. Seven studies of 2615 women were included. Six trials examined hydrotherapy in midwifery care and found an effect of pain relief; of these, 2 examined analgesia and found reduced use among women who bathed in labor. One study each found that hydrotherapy reduced maternal anxiety and fetal malpresentation, increased maternal satisfaction with movement and privacy, and resulted in cervical dilation progress equivalent to standard labor augmentation practices. Studies examined more than 30 fetal and neonatal outcomes, and no benefit or harm of hydrotherapy was identified. Two trials had anomalous findings of increased newborn resuscitation or nursery admission after hydrotherapy, which were not supported by additional results in the same or other studies. Review findings demonstrate that intrapartum immersion hydrotherapy is a helpful and benign practice. Hydrotherapy facilitates physiologic childbirth and may increase satisfaction with care. Maternity care providers are recommended to include hydrotherapy among routine labor pain management options and consider immersion to promote progress of normal or protracted labor, particularly among women with preferences to avoid obstetric medications and procedures.

Influence of timing of admission in labour and management of labour on method of birth: results from a randomised controlled trial of caseload midwifery (COSMOS trial).

PubMed

Davey, Mary-Ann; McLachlan, Helen L; Forster, Della; Flood, Margaret

2013-12-01

to explore the relationship between the degree to which labour is established on admission to hospital and method of birth. a recent randomised controlled trial found fewer caesarean sections (CS) in women allocated to caseload midwifery (19.4%) compared with standard care (24.9%). There is interest in exploring what specific aspects of the care might have resulted in this reduction. a large tertiary-level maternity service in Melbourne, Australia. English-speaking women with no previous caesarean section at low risk of complications in pregnancy were recruited to a randomised controlled trial. Trial participants whose management did not include a planned caesarean and who were admitted to hospital in spontaneous labour were included in this secondary analysis of trial data (n=1532). this secondary analysis included women admitted to hospital in spontaneous labour who were randomised to caseload midwifery compared with those randomised to standard care with regard to timing of admission in labour, augmentation of labour and use of epidural analgesia. In a further analysis randomised groups were pooled to examine predictors of caesarean section for first births only using multiple logistic regression. nulliparous women randomised to standard care were more likely to have labour augmented than those having caseload care (54.2% and 45.5% respectively, p=0.008), but were no more likely to use epidural analgesia. They were admitted earlier in labour, spending 1.1 hours longer than those in the caseload arm in hospital before the birth (p=0.003). Parous women allocated to standard care were more likely than those in the caseload arm to use epidural analgesia (10.0% and 5.3% respectively, p=0.047), but were no more likely to have labour augmented. They were also admitted earlier in labour, with a median cervical dilatation of 4 cm compared with 5 cm in the caseload arm (p=0.012). Pooling the two randomised groups of nulliparous women, and after adjusting for randomised group, maternal age and maternal body mass index, early admission to hospital was strongly associated with caesarean section. Admission before the cervix was 5 cm dilated increased the odds 2.4-fold (95%CI 1.4, 4.0; p=0.001). Augmentation of labour and use of epidural analgesia were each strongly associated with caesarean section (adjusted odds ratios 3.10 (95%CI 2.1, 4.5) and 5.77 (95%CI 4.0, 8.4) respectively. these findings that women allocated to caseload care were admitted to hospital later in labour, and that earlier admission was strongly associated with birth by caesarean section, suggest that remaining at home somewhat longer in labour may be one of the mechanisms by which caseload care was effective in reducing caesarean section in the COSMOS trial. Copyright © 2013 Elsevier Ltd. All rights reserved.

Deep massage to posterior calf muscles in combination with neural mobilization exercises as a treatment for heel pain: a pilot randomized clinical trial.

PubMed

Saban, Bernice; Deutscher, Daniel; Ziv, Tomer

2014-04-01

Plantar heel pain syndrome (PHPS) is a common foot disorder; however, there is limited clinical evidence on which to base treatment. Repeated clinical observations indicating heel pain during heel rise and minisquat on the affected leg, involving activation of posterior calf muscles, formed the basis of this study. To compare deep massage therapy to posterior calf muscles and neural mobilization with a self-stretch exercise program (DMS) to a common treatment protocol of ultrasound therapy to the painful heel area with the same self-stretch exercises (USS). Patients with PHPS were assigned to a program of 8 treatments over a period of 4-6 weeks in a single-blind randomized clinical trial. Functional status (FS) at admission and discharge from therapy as measured by the Foot & Ankle Computerized Adaptive Test was the main outcome measure. Sixty-nine patients were included in the trial (mean age 53, standard deviation (SD) 13, range 25-86, 57% women), 36 received DMS treatment and 33 with USS. The overall group-by-time interaction for the mixed-model analysis of variance (ANOVA) was found statistically significant (p=0.034), with a change of (mean (confidence interval, CI)) 15 (9-21) and 6 (1-11) FS points for the DMS and USS groups, respectively. Data indicated that both treatment protocols resulted in an overall short-term improvement, however, DMS treatment was significantly more effective in treating PHPS than USS treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effectiveness of Fluticasone Furoate-Vilanterol for COPD in Clinical Practice.

PubMed

Vestbo, Jørgen; Leather, David; Diar Bakerly, Nawar; New, John; Gibson, J Martin; McCorkindale, Sheila; Collier, Susan; Crawford, Jodie; Frith, Lucy; Harvey, Catherine; Svedsater, Henrik; Woodcock, Ashley

2016-09-29

Evidence for the management of chronic obstructive pulmonary disease (COPD) comes from closely monitored efficacy trials involving groups of patients who were selected on the basis of restricted entry criteria. There is a need for randomized trials to be conducted in conditions that are closer to usual clinical practice. In a controlled effectiveness trial conducted in 75 general practices, we randomly assigned 2799 patients with COPD to a once-daily inhaled combination of fluticasone furoate at a dose of 100 μg and vilanterol at a dose of 25 μg (the fluticasone furoate-vilanterol group) or to usual care (the usual-care group). The primary outcome was the rate of moderate or severe exacerbations among patients who had had an exacerbation within 1 year before the trial. Secondary outcomes were the rates of primary care contact (contact with a general practitioner, nurse, or other health care professional) and secondary care contact (inpatient admission, outpatient visit with a specialist, or visit to the emergency department), modification of the initial trial treatment for COPD, and the rate of exacerbations among patients who had had an exacerbation within 3 years before the trial, as assessed in a time-to-event analysis. The rate of moderate or severe exacerbations was significantly lower, by 8.4% (95% confidence interval, 1.1 to 15.2), with fluticasone furoate-vilanterol therapy than with usual care (P=0.02). There was no significant difference in the annual rate of COPD-related contacts to primary or secondary care. There were no significant between-group differences in the rates of the first moderate or severe exacerbation and the first severe exacerbation in the time-to-event analyses. There were no excess serious adverse events of pneumonia in the fluticasone furoate-vilanterol group. The numbers of other serious adverse events were similar in the two groups. In patients with COPD and a history of exacerbations, a once-daily treatment regimen of combined fluticasone furoate and vilanterol was associated with a lower rate of exacerbations than usual care, without a greater risk of serious adverse events. (Funded by GlaxoSmithKline; Salford Lung Study ClinicalTrials.gov number, NCT01551758 .).

Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial).

PubMed

Anstey, Matthew H; Wibrow, Bradley; Thevathasan, Tharusan; Roberts, Brigit; Chhangani, Khushi; Ng, Pauline Yeung; Levine, Alexander; DiBiasio, Alan; Sarge, Todd; Eikermann, Matthias

2017-03-21

Patients admitted to intensive care units (ICU) are often treated with intravenous (IV) vasopressors. Persistent hypotension and dependence on IV vasopressors in otherwise resuscitated patients lead to delay in discharge from ICU. Midodrine is an oral alpha-1 adrenergic agonist approved for treatment of symptomatic orthostatic hypotension. This trial aims to evaluate whether oral administration of midodrine is an effective adjunct to standard therapy to reduce the duration of IV vasopressor treatment, and allow earlier discharge from ICU and hospital. The MIDAS trial is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial being conducted in the USA and Australia. We are targeting 120 patients. Adult patients admitted to the ICU who are resuscitated and otherwise stable on low dose IV vasopressors for at least 24 h will be considered for recruitment. Participants will be randomized to receive midodrine (20 mg) or placebo three times a day, in addition to standard care. The primary outcome is time (hours) from initiation of midodrine or placebo to discontinuation of IV vasopressors. Secondary outcomes include time (hours) from ICU admission to discharge readiness, ICU length of stay (LOS) (days), hospital LOS (days), rates of ICU readmission, and rates of adverse events related to midodrine administration. Midodrine is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic orthostatic hypotension. In August 2010, FDA proposed to withdraw approval of midodrine because of lack of studies that verify the clinical benefit of the drug. We obtained Investigational New Drug (IND 113,330) approval to study its effects in critically ill patients who require IV vasopressors but are otherwise ready for discharge from the ICU. A pilot observational study in a cohort of surgical ICU patients showed that the rate of decline in vasopressor requirements increased after initiation of midodrine treatment. We hypothesize that midodrine administration is effective to wean IV vasopressors and shorten ICU and hospital LOS. This trial may have significant implications on lowering costs of hospital care and obtaining FDA approval for new indications for midodrine. This study has been registered at clinicaltrials.gov on 02/09/2012 (NCT01531959).

Peg-interferon plus nucleotide analogue treatment versus no treatment in patients with chronic hepatitis B with a low viral load: a randomised controlled, open-label trial.

PubMed

de Niet, Annikki; Jansen, Louis; Stelma, Femke; Willemse, Sophie B; Kuiken, Sjoerd D; Weijer, Sebastiaan; van Nieuwkerk, Carin M J; Zaaijer, Hans L; Molenkamp, Richard; Takkenberg, R Bart; Koot, Maarten; Verheij, Joanne; Beuers, Ulrich; Reesink, Hendrik W

2017-08-01

Antiviral treatment is currently not recommended for patients with chronic hepatitis B with a low viral load. However, they might benefit from acquiring a functional cure (hepatitis B surface antigen [HBsAg] loss with or without formation of antibodies against hepatitis B surface antigen [anti-HBs]). We assessed HBsAg loss during peg-interferon-alfa-2a (peg-IFN) and nucleotide analogue combination therapy in patients with chronic hepatitis B with a low viral load. In this randomised controlled, open-label trial, patients were enrolled from the Academic Medical Center (AMC), Amsterdam, Netherlands. Eligible patients were HBsAg positive and hepatitis B e antigen (HBeAg) negative for more than 6 months, could be treatment naive or treatment experienced, and had alanine aminotransferase (ALT) concentrations less than 5 × upper limit of normal (ULN). Participants were randomly assigned (1:1:1) by a computerised randomisation programme (ALEA Randomisation Service) to receive peg-IFN 180 μg/week plus adefovir 10 mg/day, peg-IFN 180 μg/week plus tenofovir disoproxil fumarate 245 mg/day, or no treatment for 48 weeks. The primary endpoint was the proportion of patients with serum HBsAg loss among those who received at least one dose of study drug or had at least one study visit (modified intention-to-treat population [mITT]). All patients have finished the initial study of 72 weeks and will be observed for up to 5 years of follow-up. This study is registered with ClinicalTrials.gov, number NCT00973219. Between Aug 4, 2009, and Oct 17, 2013, 167 patients were screened for enrolment, of whom 151 were randomly assigned (52 to peg-IFN plus adefovir, 51 to peg-IFN plus tenofovir, and 48 to no treatment). 46 participants in the peg-IFN plus adefovir group, 45 in the peg-IFN plus tenofovir group, and 43 in the no treatment group began treatment or observation and were included in the mITT population. At week 72, two (4%) patients in the peg-IFN plus adefovir group and two (4%) patients in the peg-IFN plus tenofovir group had achieved HBsAg loss, compared with none of the patients in the no treatment group (p=0·377). The most frequent adverse events (>30%) were fatigue, headache, fever, and myalgia, which were attributed to peg-IFN dosing. Two (4%) serious adverse events were reported in the peg-IFN plus adefovir group (admission to hospital for alcohol-related pancreatitis [week 6; n=1] and pregnancy, which was electively aborted [week 9; n=1]), three (7%) in the peg-IFN plus tenofovir group (admission to hospital after a suicide attempt during a severe depression [week 23; n=1], admission to hospital for abdominal pain [week 2; n=1], and an elective laminectomy [week 40; n=1]), and three (7%) in the no treatment group (admission to hospital for septic arthritis [week 72; n=1], endocarditis [week 5; n=1], and hyperthyroidism [week 20; n=1]). In patients with chronic hepatitis B with a low viral load, combination treatment (peg-IFN plus adefovir and peg-IFN plus tenofovir) did not result in significant HBsAg loss compared with no treatment, which does not support the use of combination treatment in this population of patients. Roche, Fonds NutsOhra. Copyright © 2017 Elsevier Ltd. All rights reserved.

One step versus two step approach for gestational diabetes screening: systematic review and meta-analysis of the randomized trials.

PubMed

Saccone, Gabriele; Caissutti, Claudia; Khalifeh, Adeeb; Meltzer, Sara; Scifres, Christina; Simhan, Hyagriv N; Kelekci, Sefa; Sevket, Osman; Berghella, Vincenzo

2017-12-03

To compare both the prevalence of gestational diabetes mellitus (GDM) as well as maternal and neonatal outcomes by either the one-step or the two-step approaches. Electronic databases were searched from their inception until June 2017. We included all randomized controlled trials (RCTs) comparing the one-step with the two-step approaches for the screening and diagnosis of GDM. The primary outcome was the incidence of GDM. Three RCTs (n = 2333 participants) were included in the meta-analysis. 910 were randomized to the one step approach (75 g, 2 hrs), and 1423 to the two step approach. No significant difference in the incidence of GDM was found comparing the one step versus the two step approaches (8.4 versus 4.3%; relative risk (RR) 1.64, 95%CI 0.77-3.48). Women screened with the one step approach had a significantly lower risk of preterm birth (PTB) (3.7 versus 7.6%; RR 0.49, 95%CI 0.27-0.88), cesarean delivery (16.3 versus 22.0%; RR 0.74, 95%CI 0.56-0.99), macrosomia (2.9 versus 6.9%; RR 0.43, 95%CI 0.22-0.82), neonatal hypoglycemia (1.7 versus 4.5%; RR 0.38, 95%CI 0.16-0.90), and admission to neonatal intensive care unit (NICU) (4.4 versus 9.0%; RR 0.49, 95%CI 0.29-0.84), compared to those randomized to screening with the two step approach. The one and the two step approaches were not associated with a significant difference in the incidence of GDM. However, the one step approach was associated with better maternal and perinatal outcomes.

Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies.

PubMed

Li, Ling; Li, Sheyu; Deng, Ke; Liu, Jiali; Vandvik, Per Olav; Zhao, Pujing; Zhang, Longhao; Shen, Jiantong; Bala, Malgorzata M; Sohani, Zahra N; Wong, Evelyn; Busse, Jason W; Ebrahim, Shanil; Malaga, German; Rios, Lorena P; Wang, Yingqiang; Chen, Qunfei; Guyatt, Gordon H; Sun, Xin

2016-02-17

To examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and the risk of heart failure or hospital admission for heart failure in patients with type 2 diabetes. Systematic review and meta-analysis of randomised and observational studies. Medline, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov searched up to 25 June 2015, and communication with experts. Randomised controlled trials, non-randomised controlled trials, cohort studies, and case-control studies that compared DPP-4 inhibitors against placebo, lifestyle modification, or active antidiabetic drugs in adults with type 2 diabetes, and explicitly reported the outcome of heart failure or hospital admission for heart failure. Teams of paired reviewers independently screened for eligible studies, assessed risk of bias, and extracted data using standardised, pilot tested forms. Data from trials and observational studies were pooled separately; quality of evidence was assessed by the GRADE approach. Eligible studies included 43 trials (n=68,775) and 12 observational studies (nine cohort studies, three nested case-control studies; n=1,777,358). Pooling of 38 trials reporting heart failure provided low quality evidence for a possible similar risk of heart failure between DPP-4 inhibitor use versus control (42/15,701 v 33/12,591; odds ratio 0.97 (95% confidence interval 0.61 to 1.56); risk difference 2 fewer (19 fewer to 28 more) events per 1000 patients with type 2 diabetes over five years). The observational studies provided effect estimates generally consistent with trial findings, but with very low quality evidence. Pooling of the five trials reporting admission for heart failure provided moderate quality evidence for an increased risk in patients treated with DPP-4 inhibitors versus control (622/18,554 v 552/18,474; 1.13 (1.00 to 1.26); 8 more (0 more to 16 more)). The pooling of adjusted estimates from observational studies similarly suggested (with very low quality evidence) a possible increased risk of admission for heart failure (adjusted odds ratio 1.41, 95% confidence interval 0.95 to 2.09) in patients treated with DPP-4 inhibitors (exclusively sitagliptin) versus no use. The relative effect of DPP-4 inhibitors on the risk of heart failure in patients with type 2 diabetes is uncertain, given the relatively short follow-up and low quality of evidence. Both randomised controlled trials and observational studies, however, suggest that these drugs may increase the risk of hospital admission for heart failure in those patients with existing cardiovascular diseases or multiple risk factors for vascular diseases, compared with no use. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Randomised controlled trial of joint crisis plans to reduce compulsory treatment for people with psychosis: economic outcomes.

PubMed

Barrett, Barbara; Waheed, Waquas; Farrelly, Simone; Birchwood, Max; Dunn, Graham; Flach, Clare; Henderson, Claire; Leese, Morven; Lester, Helen; Marshall, Max; Rose, Diana; Sutherby, Kim; Szmukler, George; Thornicroft, Graham; Byford, Sarah

2013-01-01

Compulsory admission to psychiatric hospitals may be distressing, disruptive to patients and families, and associated with considerable cost to the health service. Improved patient experience and cost reductions could be realised by providing cost-effective crisis planning services. Economic evaluation within a multi-centre randomised controlled trial comparing Joint Crisis Plans (JCP) plus treatment as usual (TAU) to TAU alone for patients aged over 16, with at least one psychiatric hospital admission in the previous two years and on the Enhanced Care Programme Approach register. JCPs, containing the patient's treatment preferences for any future psychiatric emergency, are a form of crisis intervention that aim to mitigate the negative consequences of relapse, including hospital admission and use of coercion. Data were collected at baseline and 18-months after randomisation. The primary outcome was admission to hospital under the Mental Health Act. The economic evaluation took a service perspective (health, social care and criminal justice services) and a societal perspective (additionally including criminal activity and productivity losses). The addition of JCPs to TAU had no significant effect on compulsory admissions or total societal cost per participant over 18-months follow-up. From the service cost perspective, however, evidence suggests a higher probability (80%) of JCPs being the more cost-effective option. Exploration by ethnic group highlights distinct patterns of costs and effects. Whilst the evidence does not support the cost-effectiveness of JCPs for White or Asian ethnic groups, there is at least a 90% probability of the JCP intervention being the more cost-effective option in the Black ethnic group. The results by ethnic group are sufficiently striking to warrant further investigation into the potential for patient gain from JCPs among black patient groups. Current Controlled Trials ISRCTN11501328.

Economic evaluation of an extended nutritional intervention in older Australian hospitalized patients: a randomized controlled trial.

PubMed

Sharma, Yogesh; Thompson, Campbell; Miller, Michelle; Shahi, Rashmi; Hakendorf, Paul; Horwood, Chris; Kaambwa, Billingsley

2018-02-05

Prevalence of malnutrition in older hospitalized patients is 30%. Malnutrition is associated with poor clinical outcomes in terms of high morbidity and mortality and is costly for hospitals. Extended nutrition interventions improve clinical outcomes but limited studies have investigated whether these interventions are cost-effective. In this randomized controlled trial, 148 malnourished general medical patients ≥60 years were recruited and randomized to receive either an extended nutritional intervention or usual care. Nutrition intervention was individualized and started with 24 h of admission and was continued for 3 months post-discharge with a monthly telephone call whereas control patients received usual care. Nutrition status was confirmed by Patient generated subjective global assessment (PG-SGA) and health-related quality of life (HRQoL) was measured using EuroQoL 5D (EQ-5D-5 L) questionnaire at admission and at 3-months follow-up. A cost-effectiveness analysis was conducted for the primary outcome (incremental costs per unit improvement in PG-SGA) while a cost-utility analysis (CUA) was undertaken for the secondary outcome (incremental costs per quality adjusted life year (QALY) gained). Nutrition status and HRQoL improved in intervention patients. Mean per included patient Australian Medicare costs were lower in intervention group compared to control arm (by $907) but these differences were not statistically significant (95% CI: -$2956 to $4854). The main drivers of higher costs in the control group were higher inpatient ($13,882 versus $13,134) and drug ($838 versus $601) costs. After adjusting outcomes for baseline differences and repeated measures, the intervention was more effective than the control with patients in this arm reporting QALYs gained that were higher by 0.0050 QALYs gained per patient (95% CI: -0.0079 to 0.0199). The probability of the intervention being cost-effective at willingness to pay values as low as $1000 per unit improvement in PG-SGA was > 98% while it was 78% at a willingness to pay $50,000 per QALY gained. This health economic analysis suggests that the use of extended nutritional intervention in older general medical patients is likely to be cost-effective in the Australian health care setting in terms of both primary and secondary outcomes. ACTRN No. 12614000833662 . Registered 6 August 2014.

Cost-effectiveness of point-of-care testing for dehydration in the pediatric ED.

PubMed

Whitney, Rachel E; Santucci, Karen; Hsiao, Allen; Chen, Lei

2016-08-01

Acute gastroenteritis (AGE) and subsequent dehydration account for a large proportion of pediatric emergency department (PED) visits. Point-of-care (POC) testing has been used in conjunction with clinical assessment to determine the degree of dehydration. Despite the wide acceptance of POC testing, little formal cost-effective analysis of POC testing in the PED exists. We aim to examine the cost-effectiveness of using POC electrolyte testing vs traditional serum chemistry testing in the PED for children with AGE. This was a cost-effective analysis using data from a randomized control trial of children with AGE. A decision analysis model was constructed to calculate cost-savings from the point of view of the payer and the provider. We used parameters obtained from the trial, including cost of testing, admission rates, cost of admission, and length of stay. Sensitivity analyses were performed to evaluate the stability of our model. Using the data set of 225 subjects, POC testing results in a cost savings of $303.30 per patient compared with traditional serum testing from the point of the view of the payer. From the point-of-view of the provider, POC testing results in consistent mean savings of $36.32 ($8.29-$64.35) per patient. Sensitivity analyses demonstrated the stability of the model and consistent savings. This decision analysis provides evidence that POC testing in children with gastroenteritis-related moderate dehydration results in significant cost savings from the points of view of payers and providers compared to traditional serum chemistry testing. Copyright © 2016 Elsevier Inc. All rights reserved.

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Clinical evaluation of an inspiratory impedance threshold device during standard cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest.

PubMed

Aufderheide, Tom P; Pirrallo, Ronald G; Provo, Terry A; Lurie, Keith G

2005-04-01

To determine whether an impedance threshold device, designed to enhance circulation, would increase acute resuscitation rates for patients in cardiac arrest receiving conventional manual cardiopulmonary resuscitation. Prospective, randomized, double-blind, intention-to-treat. Out-of-hospital trial conducted in the Milwaukee, WI, emergency medical services system. Adults in cardiac arrest of presumed cardiac etiology. On arrival of advanced life support, patients were treated with standard cardiopulmonary resuscitation combined with either an active or a sham impedance threshold device. We measured safety and efficacy of the impedance threshold device; the primary end point was intensive care unit admission. Statistical analyses performed included the chi-square test and multivariate regression analysis. One hundred sixteen patients were treated with a sham impedance threshold device, and 114 patients were treated with an active impedance threshold device. Overall intensive care unit admission rates were 17% with the sham device vs. 25% in the active impedance threshold device (p = .13; odds ratio, 1.64; 95% confidence interval, 0.87, 3.10). Patients in the subgroup presenting with pulseless electrical activity had intensive care unit admission and 24-hr survival rates of 20% and 12% in sham (n = 25) vs. 52% and 30% in active impedance threshold device groups (n = 27) (p = .018, odds ratio, 4.31; 95% confidence interval, 1.28, 14.5, and p = .12, odds ratio, 3.09; 95% confidence interval, 0.74, 13.0, respectively). A post hoc analysis of patients with pulseless electrical activity at any time during the cardiac arrest revealed that intensive care unit and 24-hr survival rates were 20% and 11% in the sham (n = 56) vs. 41% and 27% in the active impedance threshold device groups (n = 49) (p = .018, odds ratio, 2.82; 95% confidence interval, 1.19, 6.67, and p = .037, odds ratio, 3.01; 95% confidence interval, 1.07, 8.96, respectively). There were no statistically significant differences in outcomes for patients presenting in ventricular fibrillation and asystole. Adverse event and complication rates were also similar. During this first clinical trial of the impedance threshold device during standard cardiopulmonary resuscitation, use of the new device more than doubled short-term survival rates in patients presenting with pulseless electrical activity. A larger clinical trial is underway to determine the potential longer term benefits of the impedance threshold device in cardiac arrest.

Clinical outcomes of Joint Crisis Plans to reduce compulsory treatment for people with psychosis: a randomised controlled trial.

PubMed

Thornicroft, Graham; Farrelly, Simone; Szmukler, George; Birchwood, Max; Waheed, Waquas; Flach, Clare; Barrett, Barbara; Byford, Sarah; Henderson, Claire; Sutherby, Kim; Lester, Helen; Rose, Diana; Dunn, Graham; Leese, Morven; Marshall, Max

2013-05-11

The CRIMSON (CRisis plan IMpact: Subjective and Objective coercion and eNgagement) study is an individual level, randomised controlled trial that compared the effectiveness of Joint Crisis Plans (JCPs) with treatment as usual for people with severe mental illness. The JCP is a negotiated statement by a patient of treatment preferences for any future psychiatric emergency, when he or she might be unable to express clear views. We assessed whether the additional use of JCPs improved patient outcomes compared with treatment as usual. Patients were eligible if they had at least one psychiatric admission in the previous 2 years and were on the Enhanced Care Programme Approach register. The study was done with 64 generic and specialist community mental health teams in four English mental health care provider organisations (trusts). Hypotheses tested were that, compared with the control group, the intervention group would experience: fewer compulsory admissions (primary outcome); fewer psychiatric admissions; shorter psychiatric stays; lower perceived coercion; improved therapeutic relationships; and improved engagement. We stratified participants by centre. The research team but not participants nor clinical staff were masked to allocation. This study is registered with ClinicalTrials.gov, number ISRCTN11501328. 569 participants were randomly assigned (285 to the intervention group and 284 to the control group). No significant treatment effect was seen for the primary outcome (56 [20%] sectioned in the control group and 49 [18%] in the JCP group; odds ratio 0·90 [95% CI 0·58-1·39, p=0·63]) or any secondary outcomes, with the exception of an improved secondary outcome of therapeutic relationships (17·3 [7·6] vs 16·0 [7·1]; adjusted difference -1·28 [95% CI -2·56 to -0·01, p=0·049]). Qualitative data supported this finding. Our findings are inconsistent with two earlier JCP studies, and show that the JCP is not significantly more effective than treatment as usual. There is evidence to suggest the JCPs were not fully implemented in all study sites, and were combined with routine clinical review meetings which did not actively incorporate patients' preferences. The study therefore raises important questions about implementing new interventions in routine clinical practice. Medical Research Council UK and the National Institute for Health Research. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of Bag-Mask Ventilation vs Endotracheal Intubation During Cardiopulmonary Resuscitation on Neurological Outcome After Out-of-Hospital Cardiorespiratory Arrest: A Randomized Clinical Trial.

PubMed

Jabre, Patricia; Penaloza, Andrea; Pinero, David; Duchateau, Francois-Xavier; Borron, Stephen W; Javaudin, Francois; Richard, Olivier; de Longueville, Diane; Bouilleau, Guillem; Devaud, Marie-Laure; Heidet, Matthieu; Lejeune, Caroline; Fauroux, Sophie; Greingor, Jean-Luc; Manara, Alessandro; Hubert, Jean-Christophe; Guihard, Bertrand; Vermylen, Olivier; Lievens, Pascale; Auffret, Yannick; Maisondieu, Celine; Huet, Stephanie; Claessens, Benoît; Lapostolle, Frederic; Javaud, Nicolas; Reuter, Paul-Georges; Baker, Elinor; Vicaut, Eric; Adnet, Frédéric

2018-02-27

Bag-mask ventilation (BMV) is a less complex technique than endotracheal intubation (ETI) for airway management during the advanced cardiac life support phase of cardiopulmonary resuscitation of patients with out-of-hospital cardiorespiratory arrest. It has been reported as superior in terms of survival. To assess noninferiority of BMV vs ETI for advanced airway management with regard to survival with favorable neurological function at day 28. Multicenter randomized clinical trial comparing BMV with ETI in 2043 patients with out-of-hospital cardiorespiratory arrest in France and Belgium. Enrollment occurred from March 9, 2015, to January 2, 2017, and follow-up ended January 26, 2017. Participants were randomized to initial airway management with BMV (n = 1020) or ETI (n = 1023). The primary outcome was favorable neurological outcome at 28 days defined as cerebral performance category 1 or 2. A noninferiority margin of 1% was chosen. Secondary end points included rate of survival to hospital admission, rate of survival at day 28, rate of return of spontaneous circulation, and ETI and BMV difficulty or failure. Among 2043 patients who were randomized (mean age, 64.7 years; 665 women [32%]), 2040 (99.8%) completed the trial. In the intention-to-treat population, favorable functional survival at day 28 was 44 of 1018 patients (4.3%) in the BMV group and 43 of 1022 patients (4.2%) in the ETI group (difference, 0.11% [1-sided 97.5% CI, -1.64% to infinity]; P for noninferiority = .11). Survival to hospital admission (294/1018 [28.9%] in the BMV group vs 333/1022 [32.6%] in the ETI group; difference, -3.7% [95% CI, -7.7% to 0.3%]) and global survival at day 28 (55/1018 [5.4%] in the BMV group vs 54/1022 [5.3%] in the ETI group; difference, 0.1% [95% CI, -1.8% to 2.1%]) were not significantly different. Complications included difficult airway management (186/1027 [18.1%] in the BMV group vs 134/996 [13.4%] in the ETI group; difference, 4.7% [95% CI, 1.5% to 7.9%]; P = .004), failure (69/1028 [6.7%] in the BMV group vs 21/996 [2.1%] in the ETI group; difference, 4.6% [95% CI, 2.8% to 6.4%]; P < .001), and regurgitation of gastric content (156/1027 [15.2%] in the BMV group vs 75/999 [7.5%] in the ETI group; difference, 7.7% [95% CI, 4.9% to 10.4%]; P < .001). Among patients with out-of-hospital cardiorespiratory arrest, the use of BMV compared with ETI failed to demonstrate noninferiority or inferiority for survival with favorable 28-day neurological function, an inconclusive result. A determination of equivalence or superiority between these techniques requires further research. clinicaltrials.gov Identifier: NCT02327026.

Randomized controlled trial of toothbrushing to reduce ventilator-associated pneumonia pathogens and dental plaque in a critical care unit.

PubMed

Needleman, Ian G; Hirsch, Nicholas P; Leemans, Michele; Moles, David R; Wilson, Michael; Ready, Derren R; Ismail, Salim; Ciric, Lena; Shaw, Michael J; Smith, Martin; Garner, Anne; Wilson, Sally

2011-03-01

To investigate the effect of a powered toothbrush on colonization of dental plaque by ventilator-associated pneumonia (VAP)-associated organisms and dental plaque removal. Parallel-arm, single-centre, examiner- and analyst-masked randomized controlled trial. Forty-six adults were recruited within 48 h of admission. Test intervention: powered toothbrush, control intervention: sponge toothette, both used four times per day for 2 min. Groups received 20 ml, 0.2% chlorhexidine mouthwash at each time point. The results showed a low prevalence of respiratory pathogens throughout with no statistically significant differences between groups. A highly statistically significantly greater reduction in dental plaque was produced by the powered toothbrush compared with the control treatment; mean plaque index at day 5, powered toothbrush 0.75 [95% confidence interval (CI) 0.53, 1.00], sponge toothette 1.35 (95% CI 0.95, 1.74), p=0.006. Total bacterial viable count was also highly statistically significantly lower in the test group at day 5; Log(10) mean total bacterial counts: powered toothbrush 5.12 (95% CI 4.60, 5.63), sponge toothette 6.61 (95% CI 5.93, 7.28), p=0.002. Powered toothbrushes are highly effective for plaque removal in intubated patients in a critical unit and should be tested for their potential to reduce VAP incidence and health complications. © 2011 John Wiley & Sons A/S.

Efficacy of an adjunctive brief psychodynamic psychotherapy to usual inpatient treatment of depression: rationale and design of a randomized controlled trial

PubMed Central

2012-01-01

Background A few recent studies have found indications of the effectiveness of inpatient psychotherapy for depression, usually of an extended duration. However, there is a lack of controlled studies in this area and to date no study of adequate quality on brief psychodynamic psychotherapy for depression during short inpatient stay exists. The present article describes the protocol of a study that will examine the relative efficacy, the cost-effectiveness and the cost-utility of adding an Inpatient Brief Psychodynamic Psychotherapy to pharmacotherapy and treatment-as-usual for inpatients with unipolar depression. Methods/Design The study is a one-month randomized controlled trial with a two parallel group design and a 12-month naturalistic follow-up. A sample of 130 consecutive adult inpatients with unipolar depression and Montgomery-Asberg Depression Rating Scale score over 18 will be recruited. The study is carried out in the university hospital section for mood disorders in Lausanne, Switzerland. Patients are assessed upon admission, and at 1-, 3- and 12- month follow-ups. Inpatient therapy is a manualized brief intervention, combining the virtues of inpatient setting and of time-limited dynamic therapies (focal orientation, fixed duration, resource-oriented interventions). Treatment-as-usual represents the best level of practice for a minimal treatment condition usually proposed to inpatients. Final analyses will follow an intention–to-treat strategy. Depressive symptomatology is the primary outcome and secondary outcome includes measures of psychiatric symptomatology, psychosocial role functioning, and psychodynamic-emotional functioning. The mediating role of the therapeutic alliance is also examined. Allocation to treatment groups uses a stratified block randomization method with permuted block. To guarantee allocation concealment, randomization is done by an independent researcher. Discussion Despite the large number of studies on treatment of depression, there is a clear lack of controlled research in inpatient psychotherapy during the acute phase of a major depressive episode. Research on brief therapy is important to take into account current short lengths of stay in psychiatry. The current study has the potential to scientifically inform appropriate inpatient treatment. This study is the first to address the issue of the economic evaluation of inpatient psychotherapy. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12612000909820) PMID:23110608

N-acetylcysteine in Acute Organophosphorus Pesticide Poisoning: A Randomized, Clinical Trial.

PubMed

El-Ebiary, Ahmad A; Elsharkawy, Rasha E; Soliman, Nema A; Soliman, Mohammed A; Hashem, Ahmed A

2016-08-01

Organophosphorus poisoning is a major global health problem with hundreds of thousands of deaths each year. Research interest in N-acetylcysteine has grown among increasing evidence of the role of oxidative stress in organophosphorus poisoning. We aimed to assess the safety and efficacy of N-acetylcysteine as an adjuvant treatment in patients with acute organophosphorus poisoning. This was a randomized, controlled, parallel-group trial on 30 patients suffering from acute organophosphorus poisoning, who were admitted to the Poison Control Center of Tanta University Emergency Hospital, Tanta, Egypt, between April and September 2014. Interventions included oral N-acetylcysteine (600 mg three times daily for 3 days) as an added treatment to the conventional measures versus only the conventional treatment. Outcome measures included mortality, total dose of atropine administered, duration of hospitalization and the need for ICU admission and/or mechanical ventilation. A total of 46 patients were screened and 30 were randomized. No significant difference was found between both groups regarding demographic characteristics and the nature or severity of baseline clinical manifestations. No major adverse effects to N-acetylcysteine therapy were reported. Malondialdehyde significantly decreased and reduced glutathione significantly increased only in the NAC-treated patients. The patients on NAC therapy required less atropine doses than those who received only the conventional treatment; however, the length of hospital stay showed no significant difference between both groups. The study concluded that the use of N-acetylcysteine as an added treatment was apparently safe, and it reduced atropine requirements in patients with acute organophosphorus pesticide poisoning. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

Implementing Group Medical Visits for Older Adults at Group Health Cooperative

PubMed Central

Levine, Martin D.; Ross, Tyler R.; Balderson, Benjamin H.K.; Phelan, Elizabeth A.

2010-01-01

In a pair of randomized controlled trials in Kaiser Colorado in the 1990s, Group Visits for older adults (monthly non disease-specific group medical appointments for a cohort of patients led by primary care teams) were proven to reduce costs, decrease hospitalizations, and improve patient and provider satisfaction. As part of a translational effort, this Group Visit intervention was replicated in a delivery system in Seattle, WA, and the log of total health care costs measured in the first year of the intervention. Utilization and patient and physician satisfaction were secondary outcomes. For the cost and utilization analysis, a retrospective case-control design compared 221 case patients 65 years of age and older with high outpatient utilization in the previous 18 months with 1,015 control patient selected randomly from clinics not participating in the intervention. Controls were matched to cases on the number of primary care visits in the prior 18 months. Total costs were not statistically different for intervention patients compared to controls ($8,845 vs. $10,288, p=0.11), nor were there statistically significant differences in utilization, including hospital admissions and outpatient visits. However, patient and provider satisfaction was high. This translational effort did not demonstrate the cost savings of the original efficacy trials. Possible explanations for these divergent results may have to do with differences in those who participated and differences between the two delivery systems. PMID:20002506

A Randomized Trial to Assess the Contribution of a Novel Thorax Support Vest (Corset) in Preventing Mechanical Complications of Median Sternotomy.

PubMed

Caimmi, Philippe P; Sabbatini, Maurizio; Kapetanakis, Emmanouil I; Cantone, Silvia; Ferraz, Marcus V; Cannas, Mario; Tesler, Ugo F

2017-06-01

Mechanical complications of median sternotomy may cause significant morbidity and mortality in cardiac surgical patients. This study was aimed at assessing the role of Posthorax support vest (Epple, Inc., Vienna, Austria) in the prevention of sternal complications and the improvement of anatomical healing in patients at high risk for mechanical sternal dehiscence after cardiac surgery by mean of median sternotomy. A prospective, randomized, study was performed and 310 patients with predisposing factors for sternal dehiscence after sternotomy for cardiac surgery were included. The patients were divided into two groups: patients who received the Posthorax support vest after surgery, and patients who did not. Primary variables assessed included the incidence of mechanical sternal complications, the quality of sternal healing, the rate of re-operation, the duration of hospitalization, rate and duration of hospital, re-admission for sternal complications. Secondary variables assessed were the post-operative pain, the number of requests for supplemental analgesia and the quality of life measured by means of the EQ-5D format. Patients using vest demonstrated a lower incidence of mechanical sternal complications, a better anatomical sternum healing, lower hospital stay, no re-operations for sternal dehiscence before discharge and lower re-admissions for mechanical sternal complication. In addition, patients using a vest reported a better quality of life with better freedom from limitations in mobility, self-care, and pain. Our findings demonstrate that the use of the Posthorax vest reduces post-sternotomy mechanical complications and improves the healing of the sternotomy, the clinical course, and the post-operative quality of life.

Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial

PubMed Central

Foot, Holly; Freeman, Christopher; Hemming, Karla; Scott, Ian; Coombes, Ian D; Williams, Ian D; Connelly, Luke; Whitty, Jennifer A; Sturman, Nancy; Kirsa, Sue; Nicholson, Caroline; Russell, Grant; Kirkpatrick, Carl; Cottrell, Neil

2017-01-01

Introduction A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. Methods and analysis This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease. The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant’s care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge. The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. Ethics and dissemination The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. Trial registration number ACTRN12616001627448 PMID:28408545

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study)

PubMed Central

van Hooft, Jeanin E; Bemelman, Willem A; Breumelhof, Ronald; Siersema, Peter D; Kruyt, Philip M; van der Linde, Klaas; Veenendaal, Roeland A; Verhulst, Marie-Louise; Marinelli, Andreas W; Gerritsen, Josephus JGM; van Berkel, Anne-Marie; Timmer, Robin; Grubben, Marina JAL; Scholten, Pieter; Geraedts, Alfons AM; Oldenburg, Bas; Sprangers, Mirjam AG; Bossuyt, Patrick MM; Fockens, Paul

2007-01-01

Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment) or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS). Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267. PMID:17608947

Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Recent studies in North American contexts have suggested that the Housing First model is a promising strategy for providing effective services to homeless people with mental illness. In the context of the highly generous French national health and social care system, which is easily accessible and does not require out-of-pocket payment, the French Health Ministry insists on rigorous techniques, including randomized protocols, to evaluate the impact of Housing First approaches in France. Method and design A prospective randomized trial was designed to assess the impact of a Housing First intervention on health outcomes and costs over a period of 24 months on homeless people with severe mental illness, compared to Treatment-As-Usual. The study is being conducted in four cities in France: Lille, Marseille, Paris and Toulouse. The inclusion criteria are as follows: over 18 years of age, absolutely homeless or in precarious housing, and possessing a ‘high’ level of need: diagnosis of schizophrenia or bipolar disorder and moderate to severe disability according to the Multnomah Community Ability Scale (score ≤ 62) and at least one of the following three criteria: 1) having been hospitalized for mental illness two or more times in any one year during the preceding five years; 2) co-morbid alcohol or substance use; and 3) having been recently arrested or incarcerated. Participants will be randomized to receiving the Housing First intervention or Treatment-As-Usual. The Housing First intervention provides immediate access to independent housing and community care. The primary outcome criterion is the use of high-cost health services (that is,, number of hospital admissions and number of emergency department visits) during the 24-month follow-up period. Secondary outcome measures include health outcomes, social functioning, housing stability and contact with police services. An evaluation of the cost-effectiveness and cost-utility of Housing First will also be conducted. A total of 300 individuals per group will be included. Discussion This is the first study to examine the impact of a Housing First intervention compared to Treatment-As-Usual in France. It should provide key information to policymakers concerning the cost-effectiveness and health outcomes of the Housing First model in the French context. Trial registration The current clinical trial number is NCT01570712 PMID:24063556

Serum biomarkers as predictors of long-term outcome in severe traumatic brain injury: analysis from a randomized placebo-controlled Phase II clinical trial.

PubMed

Raheja, Amol; Sinha, Sumit; Samson, Neha; Bhoi, Sanjeev; Subramanian, Arulselvi; Sharma, Pushpa; Sharma, Bhawani Shankar

2016-09-01

OBJECTIVE There has been increased interest in the potential importance of biochemical parameters as predictors of outcome in severe traumatic brain injury (sTBI). METHODS Of 107 patients with sTBI (age 18-65 years with a Glasgow Coma Scale score of 4-8 presenting within 8 hours after injury) who were randomized for a placebo-controlled Phase II trial of progesterone with or without hypothermia, the authors serially analyzed serum biomarkers (S100-B, glial fibrillary acidic protein [GFAP], neuron-specific enolase [NSE], tumor necrosis factor-α, interleukin-6 [IL-6], estrogen [Eg], and progesterone [Pg]). This analysis was performed using the sandwich enzyme-linked immunosorbent assay technique at admission and 7 days later for 86 patients, irrespective of assigned group. The long-term predictive values of serum biomarkers for dichotomized Glasgow Outcome Scale (GOS) score, functional independence measure, and survival status at 6 and 12 months were analyzed using an adjusted binary logistic regression model and receiver operating characteristic curve. RESULTS A favorable GOS score (4-5) at 1 year was predicted by higher admission IL-6 (above 108.36 pg/ml; area under the curve [AUC] 0.69, sensitivity 52%, and specificity 78.6%) and Day 7 Pg levels (above 3.15 ng/ml; AUC 0.79, sensitivity 70%, and specificity 92.9%). An unfavorable GOS score (1-3) at 1 year was predicted by higher Day 7 GFAP levels (above 9.50 ng/ml; AUC 0.82, sensitivity 78.6%, and specificity 82.4%). Survivors at 1 year had significantly higher Day 7 Pg levels (above 3.15 ng/ml; AUC 0.78, sensitivity 66.7%, and specificity 90.9%). Nonsurvivors at 1 year had significantly higher Day 7 GFAP serum levels (above 11.14 ng/ml; AUC 0.81, sensitivity 81.8%, and specificity 88.9%) and Day 7 IL-6 serum levels (above 71.26 pg/ml; AUC 0.87, sensitivity 81.8%, and specificity 87%). In multivariate logistic regression analysis, independent predictors of outcome at 1 year were serum levels of Day 7 Pg (favorable GOS-OR 3.24, CI 1.5-7, p = 0.003; and favorable survival-OR 2, CI 1.2-3.5, p = 0.01); admission IL-6 (favorable GOS-OR 1.04, CI 1.00-1.08, p = 0.04); and Day 7 GFAP (unfavorable GOS-OR 0.79, CI 0.65-0.95, p = 0.01; and unfavorable survival-OR 0.80, CI 0.66-0.96, p = 0.01). CONCLUSIONS Serial Pg, GFAP, and IL-6 monitoring could aid in prognosticating outcomes in patients with acute sTBI. A cause and effect relationship or a mere association of these biomarkers to outcome needs to be further studied for better understanding of the pathophysiology of sTBI and for choosing potential therapeutic targets. Clinical trial registration no.: CTRI/2009/091/000893 ( http://www.ctri.nic.in ).

A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department.

PubMed

Miller, Melissa K; Dowd, Mary Denise; Friesen, Craig A; Walsh-Kelly, Christine M

2012-02-01

This study aimed to compare efficacy of enema versus polyethylene glycol (PEG) 3350 for pediatric fecal impaction treatment. We conducted a prospective, randomized comparison of treatments of fecal impaction in children in a pediatric emergency department (ED). Treatment arms were a single milk and molasses enema in the ED or PEG 3350 for 3 days outpatient. Telephone follow-up was done on days 1, 3, and 5. The primary outcome was main symptom improvement. Additional outcomes were stool frequency, consistency, and ease of stool passage. Treatment failures (home enema, ED return, or hospital admission) were tracked. Seventy-nine subjects participated (39 PEG; 40 enema). At day 1, PEG subjects were less likely to have improved main symptom (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.1-0.8) but no difference in other outcomes. Half (54%) in enema arm were reported as upset by ED therapy, whereas no children in PEG arm were upset (P < 0.05). At day 3, more patients in enema arm reported ideal stool consistency (74% vs 38%; P < 0.05). At day 5, no difference between groups was noted. Most treatment failures were in PEG arm (83%; P = 0.08). This pilot study suggests that disimpaction by enema may be superior to PEG for immediate relief of symptoms. Larger trials are needed to assess any advantage.

SARP: a value-based approach to hospice admissions triage.

PubMed

MacDonald, D

1995-01-01

As hospices become established and case referrals increase, many programs are faced with the necessity of instituting waiting lists. Prioritizing cases for order of admission requires a triage method that is rational, fair, and consistent. This article describes the SARP method of hospice admissions triage, which evaluates prospective cases according to seniority, acuity, risk, and political significance. SARP's essential features, operative assumptions, advantages, and limitations are discussed, as well as the core hospice values which underlie its use. The article concludes with a call for trial and evaluation of SARP in other hospice settings.

Effects of remote monitoring on clinical outcomes and use of healthcare resources in heart failure patients with biventricular defibrillators: results of the MORE-CARE multicentre randomized controlled trial.

PubMed

Boriani, Giuseppe; Da Costa, Antoine; Quesada, Aurelio; Ricci, Renato Pietro; Favale, Stefano; Boscolo, Gabriele; Clementy, Nicolas; Amori, Valentina; Mangoni di S Stefano, Lorenza; Burri, Haran

2017-03-01

The aim of this study was to evaluate the clinical efficacy and safety of remote monitoring in patients with heart failure implanted with a biventricular defibrillator (CRT-D) with advanced diagnostics. The MORE-CARE trial is an international, prospective, multicentre, randomized controlled trial. Within 8 weeks of de novo implant of a CRT-D, patients were randomized to undergo remote checks alternating with in-office follow-ups (Remote arm) or in-office follow-ups alone (Standard arm). The primary endpoint was a composite of death and cardiovascular (CV) and device-related hospitalization. Use of healthcare resources was also evaluated. A total of 865 eligible patients (mean age 66 ± 10 years) were included in the final analysis (437 in the Remote arm and 428 in the Standard arm) and followed for a median of 24 (interquartile range = 15-26) months. No significant difference was found in the primary endpoint between the Remote and Standard arms [hazard ratio 1.02, 95% confidence interval (CI) 0.80-1.30, P = 0.89] or in the individual components of the primary endpoint (P > 0.05). For the composite endpoint of healthcare resource utilization (i.e. 2-year rates of CV hospitalizations, CV emergency department admissions, and CV in-office follow-ups), a significant 38% reduction was found in the Remote vs. Standard arm (incidence rate ratio 0.62, 95% CI 0.58-0.66, P < 0.001) mainly driven by a reduction of in-office visits. In heart failure patients implanted with a CRT-D, remote monitoring did not reduce mortality or risk of CV or device-related hospitalization. Use of healthcare resources was significantly reduced as a result of a marked reduction of in-office visits without compromising patient safety. NCT00885677. © 2016 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Cost effectiveness of interpersonal community psychiatric treatment for people with long-term severe non-psychotic mental disorders: protocol of a multi-centre randomized controlled trial.

PubMed

van Veen, Mark; Koekkoek, Bauke; Mulder, Niels; Postulart, Debby; Adang, Eddy; Teerenstra, Steven; Schoonhoven, Lisette; van Achterberg, Theo

2015-05-02

This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders. Present care for this population has a limited evidence base, is often open ended, little effective, and expensive. Recent epidemiological data shows that 43.5% of the Dutch are affected by mental illness during their life. About 80% of all patients receiving mental health services (MHS) have one or more non-psychotic disorders. Particularly for this group, long-term treatment and care is poorly developed. Care As Usual (CAU) currently is a form of low-structured treatment/care. Interpersonal Community Psychiatric Treatment (ICPT) is a structured treatment for people with long-term, non-psychotic disorders, developed together with patients, professionals, and experts. ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study. Multi-centre cluster-randomized clinical trial: 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12 months, and a follow-up of 6 months. 180 Patients between 18-65 years of age will be included, who have been diagnosed with a non-psychotic psychiatric disorder (depressive, anxiety, personality or substance abuse disorder), have long-term (>2 years) or high care use (>1 outpatient contact per week or >2 crisis contacts per year or >1 inpatient admission per year), and who receive treatment in a specialized mental health care setting. The primary outcome variable is quality of life; secondary outcomes are costs, recovery, general mental health, therapeutic alliance, professional-perceived difficulty of patient, care needs and social contacts. No RCT, nor cost-effectiveness study, has been conducted on ICPT so far. The empirical base for current CAU is weak, if not absent. This study will fill this void, and generate data needed to improve daily mental health care. Netherlands Trial Register (NTR): 3988 . Registered 13th of May 2013.

Short-term forecasting of emergency inpatient flow.

PubMed

Abraham, Gad; Byrnes, Graham B; Bain, Christopher A

2009-05-01

Hospital managers have to manage resources effectively, while maintaining a high quality of care. For hospitals where admissions from the emergency department to the wards represent a large proportion of admissions, the ability to forecast these admissions and the resultant ward occupancy is especially useful for resource planning purposes. Since emergency admissions often compete with planned elective admissions, modeling emergency demand may result in improved elective planning as well. We compare several models for forecasting daily emergency inpatient admissions and occupancy. The models are applied to three years of daily data. By measuring their mean square error in a cross-validation framework, we find that emergency admissions are largely random, and hence, unpredictable, whereas emergency occupancy can be forecasted using a model combining regression and autoregressive integrated moving average (ARIMA) model, or a seasonal ARIMA model, for up to one week ahead. Faced with variable admissions and occupancy, hospitals must prepare a reserve capacity of beds and staff. Our approach allows estimation of the required reserve capacity.

Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study.

PubMed

Muramatsu, Takashi; Matsushita, Kunihiro; Yamashita, Kentaro; Kondo, Takahisa; Maeda, Kengo; Shintani, Satoshi; Ichimiya, Satoshi; Ohno, Miyoshi; Sone, Takahito; Ikeda, Nobuo; Watarai, Masato; Murohara, Toyoaki

2012-03-01

It has not been fully examined whether angiotensin II receptor blocker is superior to calcium channel blocker to reduce cardiovascular events in hypertensive patients with glucose intolerance. A prospective, open-labeled, randomized, controlled trial was conducted for Japanese hypertensive patients with type 2 diabetes mellitus or impaired glucose tolerance. A total of 1150 patients (women: 34%; mean age: 63 years; diabetes mellitus: 82%) were randomly assigned to receive either valsartan- or amlodipine-based antihypertensive treatment. Primary outcome was a composite of acute myocardial infarction, stroke, coronary revascularization, admission attributed to heart failure, or sudden cardiac death. Blood pressure was 145/82 and 144/81 mm Hg, and glycosylated hemoglobin was 7.0% and 6.9% at baseline in the valsartan group and the amlodipine group, respectively. Both of them were equally controlled between the 2 groups during the study. The median follow-up period was 3.2 years, and primary outcome had occurred in 54 patients in the valsartan group and 56 in the amlodipine group (hazard ratio: 0.97 [95% CI: 0.66-1.40]; P=0.85). Patients in the valsartan group had a significantly lower incidence of heart failure than in the amlodipine group (hazard ratio: 0.20 [95% CI: 0.06-0.69]; P=0.01). Other components and all-cause mortality were not significantly different between the 2 groups. Composite cardiovascular outcomes were comparable between the valsartan- and amlodipine-based treatments in Japanese hypertensive patients with glucose intolerance. Admission because of heart failure was significantly less in the valsartan group.

Centre-related variability in hospital admissions of patients with spondyloarthritis.

PubMed

Andrés, Mariano; Sivera, Francisca; Pérez-Vicente, Sabina; Carmona, Loreto; Vela, Paloma

2016-09-01

The aim of this study was to explore the variability in hospital admissions of patients with spondyloarthritis (SpA) in Spain, and the centre factors that may influence that variability. Descriptive cross-sectional study, part of the emAR II study, performed in Spain (2009-2010). Health records of patients with a diagnosis of SpA and at least one visit to the rheumatology units within the previous 2 years were reviewed. Variables related to hospital admissions, to the SpA, and to the patient and centre were collected. A multilevel logistic regression analysis of random intercept with non-random slopes was performed to assess variability between centres. From 45 centres, 1168 patients' health records were reviewed. Main SpA forms were ankylosing spondylitis (55.2 %) and psoriatic arthritis (22.2 %). A total of 248 admissions were registered for 196 patients (19.2 %, n = 1020). An adjusted variability of 17.6 % in hospitalizations between centres was noted. The following hospital-related factors showed a significant association with admissions: the total number of admissions of the centre, the existence of electronic admission, and the availability of ultrasound in rheumatology. However, these factors only explained 42.9 % of the inter-centre variability. The risk of a patient with SpA of being admitted could double (median OR 2.09), depending on the hospital where the patient was being managed. Hospital admissions of patients with SpA varied between hospitals due to centre characteristics. Further studies are needed to ascertain which specific factors may be causing the variation, as studied variables explained less than half of the variability.

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial.

PubMed

Li, Xiao-Mei; Zhou, Kai-Na; Yan, Hong; Wang, Duo-Lao; Zhang, Yin-Ping

2012-05-01

  This paper is a report of a clinical trial of the effects of music therapy on anxiety of female breast cancer patients following radical mastectomy.   There is insufficient evidence on the effects of music therapy on state anxiety of breast cancer patients following radical mastectomy.   A Hall's Core, Care, and Cure Model-based clinical trial was conducted in 120 female breast cancer patients from March to November 2009. A randomized controlled design was utilized. The patients were randomly allocated to the experimental group (n = 60) received music therapy in addition to routine nursing care, and the control group (n = 60) only received routine nursing care. A standardized questionnaire and the State Anxiety Inventory were applied. The primary endpoint was the state anxiety score measured at pretest (on the day before radical mastectomy) and at three post-tests (on the day before patients were discharged from hospital, the second and third time of admission to hospital for chemotherapy respectively).   The pretest score revealed that the majority of the patients had a moderate level (77·5%) and 15% had severe level of state anxiety. The repeated-measure ancova model analysis indicated that the mean state anxiety score was significantly lower in the experimental group than those in the control group at each of the three post-test measurements. The mean difference between the experimental and control group together with 95% confidence intervals were -4·57 (-6·33, -2·82), -8·91 (-10·75, -7·08) and -9·69 (-11·52, -7·85) at the 1st post-test, 2nd post-test and 3rd post-test respectively.   Music therapy is found to have positive effects on decreasing state anxiety score. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

High-dose levofloxacin in community-acquired pneumonia: a randomized, open-label study.

PubMed

Lee, Jin Hwa; Kim, Seo Woo; Kim, Ji Hye; Ryu, Yon Ju; Chang, Jung Hyun

2012-09-01

The conventional treatment for community-acquired pneumonia (CAP) involves combination therapy consisting of a β-lactam penicillin or a cephalosporin with a macrolide. Alternatively, high-dose levofloxacin treatment has been used as single-agent therapy for treating CAP, covering atypical pathogens. This study compared the clinical efficacy and safety of high-dose levofloxacin with combined ceftriaxone and azithromycin for the treatment of CAP. This phase IV, prospective, randomized, open-label trial enrolled patients admitted to a tertiary referral hospital for CAP treatment from 2010 to 2011. Hospital admission was decided based on clinical judgement and the pneumonia severity index. Forty subjects were enrolled and assigned to two treatment arms using a random numbers table. The 20 subjects in the experimental group were given levofloxacin 750 mg intravenously once daily, followed by the same dose of oral levofloxacin at discharge when clinically improved and the 20 subjects in the control group were given ceftriaxone 2.0 g intravenously once daily plus oral azithromycin 500 mg for 3 consecutive days, followed by oral cefpodoxime 200 mg per day at discharge after clinical improvement. The primary outcome was the clinical success rate. Secondary outcomes were the microbiological success rate and adverse events during the study. Of the 40 subjects enrolled, 36 completed the study: 17 in the experimental group and 19 in the control group. The groups did not differ in terms of demographic factors or clinical findings at baseline. The clinical success rate (cured + improved) was 94% in the experimental (levofloxacin) group and 84% in the control group (p > 0.05). The microbiological success rate and overall adverse events were also similar in both groups. Single-agent, high-dose levofloxacin treatment exhibited excellent clinical and microbiological efficacy with a safety profile comparable to that of ceftriaxone plus azithromycin therapy. Large-scale clinical trials are required to verify these results. WHO International Clinical Trials Registry: KCT0000374; Daiichi-Sankyo Korea study code: T11-13-V1.

Excluding infection through procalcitonin testing improves outcomes of congestive heart failure patients presenting with acute respiratory symptoms: results from the randomized ProHOSP trial.

PubMed

Schuetz, Philipp; Kutz, Alexander; Grolimund, Eva; Haubitz, Sebastian; Demann, Désirée; Vögeli, Alaadin; Hitz, Fabienne; Christ-Crain, Mirjam; Thomann, Robert; Falconnier, Claudine; Hoess, Claus; Henzen, Christoph; Marlowe, Robert J; Zimmerli, Werner; Mueller, Beat

2014-08-20

We sought to determine whether exclusion of infection and antibiotic stewardship with the infection biomarker procalcitonin improves outcomes in congestive heart failure (CHF) patients presenting to emergency departments with respiratory symptoms and suspicion of respiratory infection. We performed a secondary analysis of patients with a past medical history of CHF formerly included in a Swiss multicenter randomized-controlled trial. The trial compared antibiotic stewardship according to a procalcitonin algorithm or state-of-the-art guidelines (controls). The primary endpoint was a 30-day adverse outcome (death, intensive care unit admission); the secondary endpoints included a 30-day antibiotic exposure. In the 110/233 analyzed patients (47.2%) with low initial procalcitonin (<0.25 μg/L), suggesting the absence of systemic bacterial infection, those randomized to procalcitonin guidance (n=50) had a significantly lower adverse outcome rate compared to controls (n=60): 4% vs. 20% (absolute difference -16.0%, 95% confidence interval (CI) -28.4% to -3.6%, P=0.01), and significantly reduced antibiotic exposure [days] (mean 3.7 ± 4.0 vs. 6.5 ± 4.4, difference -2.8 [95% CI, -4.4 to -1.2], P<0.01). When initial procalcitonin was ≥0.25 μg/L, procalcitonin-guided patients had significantly reduced antibiotic exposure due to early stop of therapy without any difference in adverse outcomes (25.8% vs. 24.6%, difference [95% CI] 1.2% [-14.5% to 16.9%, P=0.88]). CHF patients presenting to the emergency department with respiratory symptoms and suspicion for respiratory infection had decreased antibiotic exposure and improved outcomes when procalcitonin measurement was used to exclude bacterial infection and guide antibiotic treatment. These data provide further evidence for the potential harmful effects of antibiotic / fluid treatment when used instead of diuretics and heart failure medication in clinically symptomatic CHF patients without underlying infection. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

PubMed

Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah

2016-01-27

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. NCT02202330 (28 January 2015).

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

PubMed

Pai, Menaka; Lloyd, Nancy S; Cheng, Ji; Thabane, Lehana; Spencer, Frederick A; Cook, Deborah J; Haynes, R Brian; Schünemann, Holger J; Douketis, James D

2013-01-02

Venous thromboembolism (VTE) is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. We conducted a 16-week pilot cluster randomized controlled trial (RCT) to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines) within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians' orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters) in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place). Blinding was not used. A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group) were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022), and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE prophylaxis strategy, including local champions, support from clinical and administrative leaders, mandatory use, and a simple, clinically relevant risk assessment tool. Hospitals allocated to our multicomponent intervention did not have a higher rate of medical inpatients appropriately managed for thromboprophylaxis than did hospitals that were not allocated to this strategy.

A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

PubMed Central

2012-01-01

Background Clinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke. Methods This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates. Results Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm. Conclusions CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided evidence on how CPs can work. Trial registration ClinicalTrials.gov ID: [NCT00673491]. PMID:22781160

Prognostic effects of rosuvastatin in patients with co-existing chronic obstructive pulmonary disease and chronic heart failure: A sub-analysis of GISSI-HF trial.

PubMed

Rossi, Andrea; Inciardi, Riccardo M; Rossi, Andrea; Temporelli, Pier Luigi; Lucci, Donata; Gonzini, Lucio; Marchioli, Roberto; Nicolosi, Gian Luigi; Tavazzi, Luigi

2017-06-01

Rising evidences showed a possible protective role of statins in chronic obstructive pulmonary disease (COPD). We aimed to evaluate in a post-hoc analysis of the GISSI-HF trial the prognostic effect of the use of rosuvastatin in patients with co-existing COPD and HF, assuming that the anti-inflammatory properties of these drugs may imply a potential beneficial effect in these associated chronic inflammatory conditions. We analyzed patients with chronic HF and history of COPD deriving from the GISSI-HF study. Of all 4574 patients eligible to statin, 1060 ambulatory patients with HF and concomitant COPD were enrolled and randomly assigned to rosuvastatin 10 mg daily (538 patients) or placebo (522 patients). The primary end-point was to compare all cause death rate in patients randomized to rosuvastatin or placebo. Further, we assessed the effects of rosuvastatin (10 mg daily) on cardiovascular (CV) death, non-CV death and hospital admissions. Median follow-up was 3.9 years with an interquartile range (IQR) of 3.0-4.4. During the follow-up 438 (41.3%) patients died, 304 (28.6%) for CV death and 687 (64.8%) had at least one hospitalization. The two patient groups had similar outcome, irrespective of randomization, in terms of all-cause mortality (log-rank test p = 0.30) CV, non CV-death (p = 0.88 and 0.09 respectively) and all-cause hospitalization (p = 0.82). Cox regression analysis did not show a favorable association between the use of statin and the examined end-points both on unadjusted and adjusted models. Statin use is not associated with a beneficial effects on all cause, CV, non CV mortality and hospitalization in patients with coexistent chronic HF and history of COPD. ClinicalTrials.gov Identifier: NCT00336336. Copyright © 2017. Published by Elsevier Ltd.

Stroke With Unknown Time of Symptom Onset: Baseline Clinical and Magnetic Resonance Imaging Data of the First Thousand Patients in WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke: A Randomized, Doubleblind, Placebo-Controlled Trial).

PubMed

Thomalla, Götz; Boutitie, Florent; Fiebach, Jochen B; Simonsen, Claus Z; Nighoghossian, Norbert; Pedraza, Salvador; Lemmens, Robin; Roy, Pascal; Muir, Keith W; Ebinger, Martin; Ford, Ian; Cheng, Bastian; Galinovic, Ivana; Cho, Tae-Hee; Puig, Josep; Thijs, Vincent; Endres, Matthias; Fiehler, Jens; Gerloff, Christian

2017-03-01

We describe clinical and magnetic resonance imaging (MRI) characteristics of stroke patients with unknown time of symptom onset potentially eligible for thrombolysis from a large prospective cohort. We analyzed baseline data from WAKE-UP (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke: A Randomized, Doubleblind, Placebo-Controlled Trial), an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset. MRI judgment included assessment of the mismatch between visibility of the acute ischemic lesion on diffusion-weighted imaging and fluid-attenuated inversion recovery. Of 1005 patients included, diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch was present in 479 patients (48.0%). Patients with daytime-unwitnessed stroke (n=138, 13.7%) had a shorter delay between symptom recognition and hospital arrival (1.5 versus 1.8 hours; P =0.002), a higher National Institutes of Stroke Scale score on admission (8 versus 6; P <0.001), and more often aphasia (72.5% versus 34.0%; P <0.001) when compared with stroke patients waking up from nighttime sleep. Frequency of diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch was comparable between both groups (43.7% versus 48.7%; P =0.30). Almost half of the patients with unknown time of symptom onset stroke otherwise eligible for thrombolysis had MRI findings making them likely to be within a time window for safe and effective thrombolysis. Patients with daytime onset unwitnessed stroke differ from wake-up stroke patients with regards to clinical characteristics but are comparable in terms of MRI characteristics of lesion age. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01525290. URL: https://www.clinicaltrialsregister.eu. Unique identifier: 2011-005906-32. © 2017 American Heart Association, Inc.

Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

PubMed Central

Spijker, Anouk; Verhey, Frans; Graff, Maud; Grol, Richard; Adang, Eddy; Wollersheim, Hub; Vernooij-Dassen, Myrra

2009-01-01

Background Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD). The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. Methods and design In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. Discussion A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient. Trial Registration NCT00147693 PMID:19500421

High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial.

PubMed

Azoulay, Elie; Lemiale, Virginie; Mokart, Djamel; Nseir, Saad; Argaud, Laurent; Pène, Frédéric; Kontar, Loay; Bruneel, Fabrice; Klouche, Kada; Barbier, François; Reignier, Jean; Stoclin, Anabelle; Louis, Guillaume; Constantin, Jean-Michel; Mayaux, Julien; Wallet, Florent; Kouatchet, Achille; Peigne, Vincent; Perez, Pierre; Girault, Christophe; Jaber, Samir; Oziel, Johanna; Nyunga, Martine; Terzi, Nicolas; Bouadma, Lila; Lebert, Christine; Lautrette, Alexandre; Bigé, Naike; Raphalen, Jean-Herlé; Papazian, Laurent; Rabbat, Antoine; Darmon, Michael; Chevret, Sylvie; Demoule, Alexandre

2018-03-05

Acute respiratory failure (ARF) is the leading reason for intensive care unit (ICU) admission in immunocompromised patients. High-flow nasal oxygen (HFNO) therapy is an alternative to standard oxygen. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates via nasal cannula devices, with FiO 2 values of nearly 100%. Benefits include alleviation of dyspnea and discomfort, decreased respiratory distress and decreased mortality in unselected patients with acute hypoxemic respiratory failure. However, in preliminary reports, HFNO benefits are controversial in immunocompromised patients in whom it has never been properly evaluated. This is a multicenter, open-label, randomized controlled superiority trial in 30 intensive care units, part of the Groupe de Recherche Respiratoire en Réanimation Onco-Hématologique (GRRR-OH). Inclusion criteria will be: (1) adults, (2) known immunosuppression, (3) ARF, (4) oxygen therapy ≥ 6 L/min, (5) written informed consent from patient or proxy. Exclusion criteria will be: (1) imminent death (moribund patient), (2) no informed consent, (3) hypercapnia (PaCO 2 ≥ 50 mmHg), (4) isolated cardiogenic pulmonary edema, (5) pregnancy or breastfeeding, (6) anatomical factors precluding insertion of a nasal cannula, (7) no coverage by the French statutory healthcare insurance system, and (8) post-surgical setting from day 1 to day 6 (patients with ARF occurring after day 6 of surgery can be included). The primary outcome measure is day-28 mortality. Secondary outcomes are intubation rate, comfort, dyspnea, respiratory rate, oxygenation, ICU length of stay, and ICU-acquired infections. Based on an expected 30% mortality rate in the standard oxygen group, and 20% in the HFNO group, error rate set at 5%, and a statistical power at 90%, 389 patients are required in each treatment group (778 patients overall). Recruitment period is estimated at 30 months, with 28 days of additional follow-up for the last included patient. The HIGH study will be the largest multicenter, randomized controlled trial seeking to demonstrate that survival benefits from HFNO reported in unselected patients also apply to a large immunocompromised population. ClinicalTrials.gov, ID: NCT02739451 . Registered on 15 April 2016.

Impact of a clinical decision model for febrile children at risk for serious bacterial infections at the emergency department: a randomized controlled trial.

PubMed

de Vos-Kerkhof, Evelien; Nijman, Ruud G; Vergouwe, Yvonne; Polinder, Suzanne; Steyerberg, Ewout W; van der Lei, Johan; Moll, Henriëtte A; Oostenbrink, Rianne

2015-01-01

To assess the impact of a clinical decision model for febrile children at risk for serious bacterial infections (SBI) attending the emergency department (ED). Randomized controlled trial with 439 febrile children, aged 1 month-16 years, attending the pediatric ED of a Dutch university hospital during 2010-2012. Febrile children were randomly assigned to the intervention (clinical decision model; n = 219) or the control group (usual care; n = 220). The clinical decision model included clinical symptoms, vital signs, and C-reactive protein and provided high/low-risks for "pneumonia" and "other SBI". Nurses were guided by the intervention to initiate additional tests for high-risk children. The clinical decision model was evaluated by 1) area-under-the-receiver-operating-characteristic-curve (AUC) to indicate discriminative ability and 2) feasibility, to measure nurses' compliance to model recommendations. Primary patient outcome was defined as correct SBI diagnoses. Secondary process outcomes were defined as length of stay; diagnostic tests; antibiotic treatment; hospital admission; revisits and medical costs. The decision model had good discriminative ability for both pneumonia (n = 33; AUC 0.83 (95% CI 0.75-0.90)) and other SBI (n = 22; AUC 0.81 (95% CI 0.72-0.90)). Compliance to model recommendations was high (86%). No differences in correct SBI determination were observed. Application of the clinical decision model resulted in less full-blood-counts (14% vs. 22%, p-value < 0.05) and more urine-dipstick testing (71% vs. 61%, p-value < 0.05). In contrast to our expectations no substantial impact on patient outcome was perceived. The clinical decision model preserved, however, good discriminatory ability to detect SBI, achieved good compliance among nurses and resulted in a more standardized diagnostic approach towards febrile children, with less full blood-counts and more rightfully urine-dipstick testing. Nederlands Trial Register NTR2381.

Central Fetal Monitoring With and Without Computer Analysis: A Randomized Controlled Trial.

PubMed

Nunes, Inês; Ayres-de-Campos, Diogo; Ugwumadu, Austin; Amin, Pina; Banfield, Philip; Nicoll, Antony; Cunningham, Simon; Sousa, Paulo; Costa-Santos, Cristina; Bernardes, João

2017-01-01

To evaluate whether intrapartum fetal monitoring with computer analysis and real-time alerts decreases the rate of newborn metabolic acidosis or obstetric intervention when compared with visual analysis. A randomized clinical trial carried out in five hospitals in the United Kingdom evaluated women with singleton, vertex fetuses of 36 weeks of gestation or greater during labor. Continuous central fetal monitoring by computer analysis and online alerts (experimental arm) was compared with visual analysis (control arm). Fetal blood sampling and electrocardiographic ST waveform analysis were available in both arms. The primary outcome was incidence of newborn metabolic acidosis (pH less than 7.05 and base deficit greater than 12 mmol/L). Prespecified secondary outcomes included operative delivery, use of fetal blood sampling, low 5-minute Apgar score, neonatal intensive care unit admission, hypoxic-ischemic encephalopathy, and perinatal death. A sample size of 3,660 per group (N=7,320) was planned to be able to detect a reduction in the rate of metabolic acidosis from 2.8% to 1.8% (two-tailed α of 0.05 with 80% power). From August 2011 through July 2014, 32,306 women were assessed for eligibility and 7,730 were randomized: 3,961 to computer analysis and online alerts, and 3,769 to visual analysis. Baseline characteristics were similar in both groups. Metabolic acidosis occurred in 16 participants (0.40%) in the experimental arm and 22 participants (0.58%) in the control arm (relative risk 0.69 [0.36-1.31]). No statistically significant differences were found in the incidence of secondary outcomes. Compared with visual analysis, computer analysis of fetal monitoring signals with real-time alerts did not significantly reduce the rate of metabolic acidosis or obstetric intervention. A lower-than-expected rate of newborn metabolic acidosis was observed in both arms of the trial. ISRCTN Registry, http://www.isrctn.com, ISRCTN42314164.

Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF).

PubMed

McMurray, John J V; Anand, Inder S; Diaz, Rafael; Maggioni, Aldo P; O'Connor, Christopher; Pfeffer, Marc A; Solomon, Scott D; Tendera, Michal; van Veldhuisen, Dirk J; Albizem, Moetaz; Cheng, Sunfa; Scarlata, Debra; Swedberg, Karl; Young, James B

2013-03-01

This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes. Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate < 60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106-117) g/L. The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.

A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients.

PubMed

Rajasekhar, Anita; Lottenberg, Lawrence; Lottenberg, Richard; Feezor, Robert J; Armen, Scott B; Liu, Huazhi; Efron, Philip A; Crowther, Mark; Ang, Darwin

2011-08-01

Placement of prophylactic inferior vena cava filters (pIVCFs) for the prevention of pulmonary embolism (PE) in high-risk trauma patients (HRTPs) are widely practiced despite the lack of Level I data supporting this use. We report the 2-year interim analysis of the Filters in Trauma pilot study. This is a single institution, prospective randomized controlled pilot feasibility study in a Level I trauma center. HRTPs were identified for pIVCF placement by the Eastern Association for the Surgery of Trauma guidelines. From November 2008 to November 2010, HRTPs were enrolled and randomized to either pIVCF or no pIVCF. All patients received pharmacologic prophylaxis when safe. Primary outcomes included feasibility objectives and secondary outcomes were incidence of PE, deep vein thrombosis (DVT), and death. Thirty-four of 38 enrolled patients were eligible for analysis. The baseline sociodemographic characteristics were balanced between the both groups. Results of the feasibility objectives included: time from admission to enrollment (mean, 47.4 hours ± 22.0 hours), time from enrollment to randomization (mean, 4.8 hours ± 9.1 hours), time from randomization to IVCF placement (mean, 16.9 hours ± 9.2 hours), adherence to weekly compression ultrasound within first month (IVCF group = 44.4%; non-IVCF group = 62.5%), and 1-month clinical follow-up (IVCF group = 83.3%; non-IVCF group = 100%). At 6-month follow-up, one PE in the nonfilter group and one DVT in the filter group had occurred. One non-PE-related death occurred in the filter group. Barriers to enrollment included inability to obtain informed consent due to patient refusal or no next of kin identified and delayed notification of eligibility status. Our pilot study demonstrates for the first time that a randomized controlled trial evaluating the efficacy of pIVCFs in trauma patients is feasible. This pilot data will be used to inform the design of a multicenter randomized controlled trial to determine the incidence of PE and DVT in HRTPs receiving pIVCFs versus no pIVCF.

Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial.

PubMed

Poldervaart, Judith M; Reitsma, Johannes B; Backus, Barbra E; Koffijberg, Hendrik; Veldkamp, Rolf F; Ten Haaf, Monique E; Appelman, Yolande; Mannaerts, Herman F J; van Dantzig, Jan-Melle; van den Heuvel, Madelon; El Farissi, Mohamed; Rensing, Bernard J W M; Ernst, Nicolette M S K J; Dekker, Ineke M C; den Hartog, Frank R; Oosterhof, Thomas; Lagerweij, Ghizelda R; Buijs, Eugene M; van Hessen, Maarten W J; Landman, Marcel A J; van Kimmenade, Roland R J; Cozijnsen, Luc; Bucx, Jeroen J J; van Ofwegen-Hanekamp, Clara E E; Cramer, Maarten-Jan; Six, A Jacob; Doevendans, Pieter A; Hoes, Arno W

2017-05-16

The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score is an easy-to-apply instrument to stratify patients with chest pain according to their short-term risk for major adverse cardiac events (MACEs), but its effect on daily practice is unknown. To measure the effect of use of the HEART score on patient outcomes and use of health care resources. Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT01756846). Emergency departments in 9 Dutch hospitals. Unselected patients with chest pain presenting at emergency departments in 2013 and 2014. All hospitals started with usual care. Every 6 weeks, 1 hospital was randomly assigned to switch to "HEART care," during which physicians calculated the HEART score to guide patient management. For safety, a noninferiority margin of a 3.0% absolute increase in MACEs within 6 weeks was set. Other outcomes included use of health care resources, quality of life, and cost-effectiveness. A total of 3648 patients were included (1827 receiving usual care and 1821 receiving HEART care). Six-week incidence of MACEs during HEART care was 1.3% lower than during usual care (upper limit of the 1-sided 95% CI, 2.1% [within the noninferiority margin of 3.0%]). In low-risk patients, incidence of MACEs was 2.0% (95% CI, 1.2% to 3.3%). No statistically significant differences in early discharge, readmissions, recurrent emergency department visits, outpatient visits, or visits to general practitioners were observed. Physicians were hesitant to refrain from admission and diagnostic tests in patients classified as low risk by the HEART score. Using the HEART score during initial assessment of patients with chest pain is safe, but the effect on health care resources is limited, possibly due to nonadherence to management recommendations. Netherlands Organisation for Health Research and Development.

Procalcitonin-guided antibiotic therapy in patients with fever in a general emergency department population: a multicenter noninferiority randomized clinical trial (HiTEMP study).

PubMed

van der Does, Yuri; Limper, Maarten; Jie, Kim E; Schuit, Stephanie C E; Jansen, Henry; Pernot, Niki; van Rosmalen, Joost; Poley, Marten J; Ramakers, Christian; Patka, Peter; van Gorp, Eric C M; Rood, Pleunie P M

2018-06-02

Overuse of broad-spectrum antibiotics in emergency departments(EDs) results in antibiotic resistance. We determined if procalcitonin(PCT)-guided therapy can be used to reduce antibiotic regimens in EDs by investigating efficacy, safety and accuracy. This was a noninferiority multicenter randomized clinical trial, performed in two Dutch hospitals. Adult patients with fever ≥38.2°C(100.8°F) in triage were randomized between standard diagnostic workup(control group) and PCT-guided therapy, defined as standard workup with addition of one single PCT measurement. Treatment algorithm encouraged withholding antibiotic regimens with PCT<0.5μg/L, and starting antibiotic regimens PCT≥0.5μg/L. Exclusion criteria were immunocompromised conditions, pregnancy, moribund patients, patients <72h after surgery or requiring primary surgical intervention. Primary outcomes were efficacy, defined as number of prescribed antibiotic regimens; safety, defined as combined-safety-endpoint(CSE) consisting of 30-days mortality, intensive-care unit admission, ED-return-visit within 2 weeks; accuracy, defined as sensitivity, apecificity and area-under-the-curve(AUC) of PCT for bacterial infections. Noninferiority margin for safety outcome was 7.5%. Between August 2014 and January 2017, 551 patients were included. In the PCT-guided group(n=275) 200(73%)patients were prescribed antibiotic regimens, in the control group(n=276) 212(77%)(p=0.28). There was no significant difference in CSE between the PCT-guided group, 29(11%), and control group, 46(16%)(p=0.16), with a noninferiority margin of 0.46%(n=526). AUC for confirmed bacterial infections for PCT was 0.681(95%CI0.633-0.730), for CRP 0.619(95%CI 0.569-0.669).: CONCLUSIONS.: PCT-guided therapy was noninferior in terms of safety, but did not reduce prescription of antibiotic regimens in an ED population with fever. In this heterogeneous population, the accuracy of PCT in diagnosing bacterial infections was poor. TRIAL REGISTRATION IN NETHERLANDS TRIAL REGISTER: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4949. Copyright © 2018. Published by Elsevier Ltd.

Using novel Canadian resources to improve medication reconciliation at discharge: study protocol for a randomized controlled trial.

PubMed

Tamblyn, Robyn; Huang, Allen R; Meguerditchian, Ari N; Winslade, Nancy E; Rochefort, Christian; Forster, Alan; Eguale, Tewodros; Buckeridge, David; Jacques, André; Naicker, Kiyuri; Reidel, Kristen E

2012-08-27

Adverse drug events are responsible for up to 7% of all admissions to acute care hospitals. At least 58% of these are preventable, resulting from incomplete drug information, prescribing or dispensing errors, and overuse or underuse of medications. Effective implementation of medication reconciliation is considered essential to reduce preventable adverse drug events occurring at transitions between community and hospital care. An electronically enabled discharge reconciliation process represents an innovative approach to this problem. Participants will be recruited in Quebec and are eligible for inclusion if they are using prescription medication at admission, covered by the Quebec drug insurance plan, admitted from the community, 18 years or older, admitted to a general or intensive care medical or surgical unit, and discharged alive. A sample size of 3,714 will be required to detect a 5% reduction in adverse drug events. The intervention will comprise electronic retrieval of the community drug list, combined with an electronic discharge reconciliation module and an electronic discharge communication module. The primary outcomes will be adverse drug events occurring 30 days post-discharge, identified by a combination of patient self-report and chart abstraction. All emergency room visits and hospital readmission during this period will be measured as secondary outcomes. A cluster randomization approach will be used to allocate 16 medical and 10 surgical units to electronic discharge reconciliation and communication versus usual care. An intention-to-treat approach will be used to analyse data. Logistic regression will be undertaken within a generalized estimating equation framework to account for clustering within units. The goal of this prospective trial is to determine if electronically enabled discharge reconciliation will reduce the risk of adverse drug events, emergency room visits and readmissions 30 days post-discharge compared with usual care. We expect that this intervention will improve adherence to medication reconciliation at discharge, the accuracy of the community-based drug history and effective communication of hospital-based treatment changes to community care providers. The results may support policy-directed investments in computerizing and training of hospital staff, generate key requirements for future hospital accreditation standards, and highlight functional requirements for software vendors. NCT01179867.

Neuraxial and Combined Neuraxial/General Anesthesia Compared to General Anesthesia for Major Truncal and Lower Limb Surgery: A Systematic Review and Meta-analysis.

PubMed

Smith, Lauren M; Cozowicz, Crispiana; Uda, Yoshiaki; Memtsoudis, Stavros G; Barrington, Michael J

2017-12-01

Neuraxial anesthesia may improve perioperative outcomes when compared to general anesthesia; however, this is controversial. We performed a systematic review and meta-analysis using randomized controlled trials and population-based observational studies identified in MEDLINE, PubMed, and EMBASE from 2010 to May 31, 2016. Studies were included for adult patients undergoing major surgery of the trunk and lower extremity that reported: 30-day mortality (primary outcome), cardiopulmonary morbidity, surgical site infection, thromboembolic events, blood transfusion, and resource use. Perioperative outcomes were compared with general anesthesia for the following subgroups: combined neuraxial-general anesthesia and neuraxial anesthesia alone. Odds ratios (ORs) and 99% confidence intervals (CIs) were calculated to identify the impact of anesthetic technique on outcomes. Twenty-seven observational studies and 11 randomized control trials were identified. This analysis comprises 1,082,965 records from observational studies or databases and 1134 patients from randomized controlled trials. There was no difference in 30-day mortality identified when combined neuraxial-general anesthesia was compared with general anesthesia (OR 0.88; 99% CI, 0.77-1.01), or when neuraxial anesthesia was compared with general anesthesia (OR 0.98; 99% CI, 0.92-1.04). When combined neuraxial-general anesthesia was compared with general anesthesia, combined neuraxial-general anesthesia was associated with a reduced odds of pulmonary complication (OR 0.84; 99% CI, 0.79-0.88), surgical site infection (OR 0.93; 99% CI, 0.88-0.98), blood transfusion (OR 0.90; 99% CI, 0.87-0.93), thromboembolic events (OR 0.84; 99% CI, 0.73-0.98), length of stay (mean difference -0.16 days; 99% CI, -0.17 to -0.15), and intensive care unit admission (OR 0.77; 99% CI, 0.73-0.81). For the combined neuraxial-general anesthesia subgroup, there were increased odds of myocardial infarction (OR 1.18; 99% CI, 1.01-1.37). There was no difference identified in the odds of pneumonia (OR 0.94; 99% CI, 0.87-1.02) or cardiac complications (OR 1.04; 99% CI, 1.00-1.09) for the combined neuraxial-general anesthesia subgroup. When neuraxial anesthesia was compared to general anesthesia, there was a decreased odds of any pulmonary complication (OR 0.38; 99% CI, 0.36-0.40), surgical site infection (OR 0.76; 99% CI, 0.71-0.82), blood transfusion (OR 0.85; 99% CI, 0.82-0.88), thromboembolic events (OR 0.79; 99% CI, 0.68-0.91), length of stay (mean difference -0.29 days; 99% CI, -0.29 to -0.28), and intensive care unit admission (OR 0.50; 99% CI, 0.48-0.53). There was no difference in the odds of cardiac complications (OR 0.99; 99% CI, 0.94-1.03), myocardial infarction (OR 0.91; 99% CI, 0.81-1.02), or pneumonia (OR 0.92; 99% CI, 0.84-1.01). Randomized control trials revealed no difference in requirement for blood transfusion (RR 1.05; 99% CI, 0.65-1.71) and a decreased length of stay (mean difference -0.15 days; 99% CI, -0.27 to -0.04). Neuraxial anesthesia when combined with general anesthesia or when used alone was not associated with decreased 30-day mortality. Neuraxial anesthesia may improve pulmonary outcomes and reduce resource use when compared with general anesthesia. However, because observational studies were included in this analysis, there is a risk of residual confounding and therefore these results should be interpreted with caution.

What's in a title? An assessment of whether randomized controlled trial in a title means that it is one.

PubMed

Koletsi, Despina; Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2012-06-01

In this study, we aimed to investigate whether studies published in orthodontic journals and titled as randomized clinical trials are truly randomized clinical trials. A second objective was to explore the association of journal type and other publication characteristics on correct classification. American Journal of Orthodontics and Dentofacial Orthopedics, European Journal of Orthodontics, Angle Orthodontist, Journal of Orthodontics, Orthodontics and Craniofacial Research, World Journal of Orthodontics, Australian Orthodontic Journal, and Journal of Orofacial Orthopedics were hand searched for clinical trials labeled in the title as randomized from 1979 to July 2011. The data were analyzed by using descriptive statistics, and univariable and multivariable examinations of statistical associations via ordinal logistic regression modeling (proportional odds model). One hundred twelve trials were identified. Of the included trials, 33 (29.5%) were randomized clinical trials, 52 (46.4%) had an unclear status, and 27 (24.1%) were not randomized clinical trials. In the multivariable analysis among the included journal types, year of publication, number of authors, multicenter trial, and involvement of statistician were significant predictors of correctly classifying a study as a randomized clinical trial vs unclear and not a randomized clinical trial. From 112 clinical trials in the orthodontic literature labeled as randomized clinical trials, only 29.5% were identified as randomized clinical trials based on clear descriptions of appropriate random number generation and allocation concealment. The type of journal, involvement of a statistician, multicenter trials, greater numbers of authors, and publication year were associated with correct clinical trial classification. This study indicates the need of clear and accurate reporting of clinical trials and the need for educating investigators on randomized clinical trial methodology. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

The Role of Access to Head Start and Quality Ratings for Spanish-Speaking Dual Language Learners’ (DLLs) Participation in Early Childhood Education

PubMed Central

2014-01-01

Data from the Head Start Impact Study (N = 4,442) were used to test for differences between Spanish-speaking Dual Language Learners (DLLs) and monolingual English-speaking children in: (1) Head Start attendance rates when randomly assigned admission; and (2) quality ratings of other early childhood education (ECE) programs attended when not randomly assigned admission to Head Start. Logistic regressions showed that Spanish-speaking DLL children randomly assigned a spot in Head Start were more likely than monolingual-English learners to attend. Further, Spanish-speaking DLLs not randomly assigned a spot in Head Start were more likely to attend higher-quality ECE centers than non-DLL children. Policy implications are discussed, suggesting that, if given access, Spanish-speaking DLL families will take advantage of quality ECE programs. PMID:25018585

Thrombolysis during resuscitation for out-of-hospital cardiac arrest.

PubMed

Böttiger, Bernd W; Arntz, Hans-Richard; Chamberlain, Douglas A; Bluhmki, Erich; Belmans, Ann; Danays, Thierry; Carli, Pierre A; Adgey, Jennifer A; Bode, Christoph; Wenzel, Volker

2008-12-18

Approximately 70% of persons who have an out-of-hospital cardiac arrest have underlying acute myocardial infarction or pulmonary embolism. Therefore, thrombolysis during cardiopulmonary resuscitation may improve survival. In a double-blind, multicenter trial, we randomly assigned adult patients with witnessed out-of-hospital cardiac arrest to receive tenecteplase or placebo during cardiopulmonary resuscitation. Adjunctive heparin or aspirin was not used. The primary end point was 30-day survival; the secondary end points were hospital admission, return of spontaneous circulation, 24-hour survival, survival to hospital discharge, and neurologic outcome. After blinded review of data from the first 443 patients, the data and safety monitoring board recommended discontinuation of enrollment of asystolic patients because of low survival, and the protocol was amended. Subsequently, the trial was terminated prematurely for futility after enrolling a total of 1050 patients. Tenecteplase was administered to 525 patients and placebo to 525 patients; the two treatment groups had similar clinical profiles. We did not detect any significant differences between tenecteplase and placebo in the primary end point of 30-day survival (14.7% vs. 17.0%; P=0.36; relative risk, 0.87; 95% confidence interval, 0.65 to 1.15) or in the secondary end points of hospital admission (53.5% vs. 55.0%, P=0.67), return of spontaneous circulation (55.0% vs. 54.6%, P=0.96), 24-hour survival (30.6% vs. 33.3%, P=0.39), survival to hospital discharge (15.1% vs. 17.5%, P=0.33), or neurologic outcome (P=0.69). There were more intracranial hemorrhages in the tenecteplase group. When tenecteplase was used without adjunctive antithrombotic therapy during advanced life support for out-of-hospital cardiac arrest, we did not detect an improvement in outcome, in comparison with placebo. (ClinicalTrials.gov number, NCT00157261.) 2008 Massachusetts Medical Society

A Double-Blinded, Randomized, Placebo-Controlled Clinical Trial of Aminophylline to Prevent Acute Kidney Injury in Children Following Congenital Heart Surgery With Cardiopulmonary Bypass.

PubMed

Axelrod, David M; Sutherland, Scott M; Anglemyer, Andrew; Grimm, Paul C; Roth, Stephen J

2016-02-01

Acute kidney injury occurs commonly in children following congenital cardiac surgery with cardiopulmonary bypass and has been associated with increased morbidity and mortality. Aminophylline, a methylxanthine nonselective adenosine receptor antagonist, has been effective in the management of acute kidney injury in certain populations. This study sought to determine whether postoperative administration of aminophylline attenuates acute kidney injury in children undergoing congenital cardiac surgery with cardiopulmonary bypass. Single-center, double-blinded, placebo-controlled, randomized clinical trial. Tertiary center, pediatric cardiovascular ICU. A total of 144 children after congenital heart surgery with cardiopulmonary bypass. Seventy-two patients were randomized to receive aminophylline and 72 patients received placebo. Study drug was administered every 6 hours for 72 hours. The primary outcome variable was the development of any acute kidney injury, defined by the serum creatinine criteria of the Kidney Diseases: Improving Global Outcomes. Secondary outcomes included the development of severe acute kidney injury, time between cardiovascular ICU admission and first successful extubation, percent fluid overload, total fluid balance, urine output, bioelectrical impedance, and serum neutrophil gelatinase-associated lipocalin. The unadjusted rate and severity of acute kidney injury were not different between groups; 43 of 72 (60%) of the treatment group and 36 of 72 (50%) of the placebo group developed acute kidney injury (p = 0.32). Stage 2/3 acute kidney injury occurred in 23 of 72 (32%) of the treatment group and 15 of 72 (21%) of the placebo group (p = 0.18). Secondary outcome measures also demonstrated no significant difference between treatment and placebo groups. Aminophylline administration was safe; no deaths occurred in either group, and rates of adverse events were similar (14% in the treatment group vs 18% in the placebo group; p = 0.30). In this placebo-controlled randomized clinical trial, we found no effect of aminophylline to prevent acute kidney injury in children recovering from cardiac surgery performed with cardiopulmonary bypass. Future study of preoperative aminophylline administration to prevent acute kidney injury may be warranted.

On the Road, Measuring the Miles per Applicant

ERIC Educational Resources Information Center

Hoover, Eric

2008-01-01

Most people in admissions have a road story. There are tales of wrong turns, lost suitcases, and days when they were just well-dressed ghosts, walking in and out of high schools where no students came to see them. These are the trials of admissions representatives who leave their campuses for several weeks each fall. They trek near and far to meet…

A Comprehensive Analysis of the Impact of Pseudomonas aeruginosa Colonization on Prognosis in Adult Bronchiectasis.

PubMed

Finch, Simon; McDonnell, Melissa J; Abo-Leyah, Hani; Aliberti, Stefano; Chalmers, James D

2015-11-01

Eradication and suppression of Pseudomonas aeruginosa is a key priority in national guidelines for bronchiectasis and is a major focus of drug development and clinical trials. An accurate estimation of the clinical impact of P. aeruginosa in bronchiectasis is therefore essential. Data derived from 21 observational cohort studies comparing patients with P. aeruginosa colonization with those without it were pooled by random effects meta-analysis. Data were collected for key longitudinal clinical outcomes of mortality, hospital admissions, exacerbations, and lung function decline, along with cross-sectional outcomes such as quality of life. In the aggregate, the included studies comprised 3,683 patients. P. aeruginosa was associated with a highly significant and consistent increase in all markers of disease severity, including mortality (odds ratio [OR], 2.95; 95% confidence interval [CI], 1.98-4.40; P < 0.0001), hospital admissions (OR, 6.57; 95% CI, 3.19-13.51; P < 0.0001), and exacerbations (mean difference, 0.97/yr; 95% CI, 0.64-1.30; P < 0.0001). The patients with P. aeruginosa also had worse quality of life on the basis of their St. George's Respiratory Questionnaire results (mean difference, 18.2 points; 95% CI, 14.7-21.8; P < 0.0001). Large differences in lung function and radiological severity were also observed. The definitions of colonization were inconsistent among the studies, but the findings were robust regardless of the definition used. P. aeruginosa is associated with an approximately threefold increased risk of death and an increase in hospital admissions and exacerbations in adult bronchiectasis.

Support during pregnancy for women at increased risk of low birthweight babies.

PubMed

Hodnett, Ellen D; Fredericks, Suzanne; Weston, Julie

2010-06-16

Studies consistently show a relationship between social disadvantage and low birthweight. Many countries have programs offering special assistance to women thought to be at risk for giving birth to a low birthweight infant. These programs may include advice and counseling (about nutrition, rest, stress management, alcohol, and recreational drug use), tangible assistance (e.g., transportation to clinic appointments, household help), and emotional support. The programs may be delivered by multidisciplinary teams of health professionals, specially trained lay workers, or combination of lay and professional workers. The primary objective was to assess effects of programs offering additional social support compared with routine care, for pregnant women believed at high risk for giving birth to babies that are either preterm or weigh less than 2500 gm, or both, at birth. Secondary objectives were to determine whether effectiveness of support was mediated by timing of onset (early versus later in pregnancy) or type of provider (healthcare professional or lay woman). We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2010). Randomized trials of additional support during at-risk pregnancy by either a professional (social worker, midwife, or nurse) or specially trained lay person, compared to routine care. We defined additional support as some form of emotional support (e.g., counseling, reassurance, sympathetic listening) and information or advice or both, either in home visits or during clinic appointments, and could include tangible assistance (e.g., transportation to clinic appointments, assistance with care of other children at home). Two review authors evaluated methodological quality. We performed double data entry. We included 17 trials (12,264 women). Programs offering additional social support for at-risk pregnant women were not associated with improvements in any perinatal outcomes, but there was a reduction in the likelihood of antenatal hospital admission (three trials; n = 737; RR 0.79, 95% CI 0.68 to 0.92) and caesarean birth (nine trials; n = 4522; RR 0.87, 95% CI 0.78 to 0.97). Pregnant women need the support of caring family members, friends, and health professionals. While programs which offer additional support during pregnancy are unlikely to prevent the pregnancy from resulting in a low birthweight or preterm baby, they may be helpful in reducing the likelihood of antenatal hospital admission and caesarean birth.

Standard versus atrial fibrillation-specific management strategy (SAFETY) to reduce recurrent admission and prolong survival: pragmatic, multicentre, randomised controlled trial.

PubMed

Stewart, Simon; Ball, Jocasta; Horowitz, John D; Marwick, Thomas H; Mahadevan, Gnanadevan; Wong, Chiew; Abhayaratna, Walter P; Chan, Yih K; Esterman, Adrian; Thompson, David R; Scuffham, Paul A; Carrington, Melinda J

2015-02-28

Patients are increasingly being admitted with chronic atrial fibrillation, and disease-specific management might reduce recurrent admissions and prolong survival. However, evidence is scant to support the application of this therapeutic approach. We aimed to assess SAFETY--a management strategy that is specific to atrial fibrillation. We did a pragmatic, multicentre, randomised controlled trial in patients admitted with chronic, non-valvular atrial fibrillation (but not heart failure). Patients were recruited from three tertiary referral hospitals in Australia. 335 participants were randomly assigned by computer-generated schedule (stratified for rhythm or rate control) to either standard management (n=167) or the SAFETY intervention (n=168). Standard management consisted of routine primary care and hospital outpatient follow-up. The SAFETY intervention comprised a home visit and Holter monitoring 7-14 days after discharge by a cardiac nurse with prolonged follow-up and multidisciplinary support as needed. Clinical reviews were undertaken at 12 and 24 months (minimum follow-up). Coprimary outcomes were death or unplanned readmission (both all-cause), measured as event-free survival and the proportion of actual versus maximum days alive and out of hospital. Analyses were done on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry (ANZCTRN 12610000221055). During median follow-up of 905 days (IQR 773-1050), 49 people died and 987 unplanned admissions were recorded (totalling 5530 days in hospital). 127 (76%) patients assigned to the SAFETY intervention died or had an unplanned readmission (median event-free survival 183 days [IQR 116-409]) and 137 (82%) people allocated standard management achieved a coprimary outcome (199 days [116-249]; hazard ratio 0·97, 95% CI 0·76-1·23; p=0·851). Patients assigned to the SAFETY intervention had 99·5% maximum event-free days (95% CI 99·3-99·7), equating to a median of 900 (IQR 767-1025) of 937 maximum days alive and out of hospital. By comparison, those allocated to standard management had 99·2% (95% CI 98·8-99·4) maximum event-free days, equating to a median of 860 (IQR 752-1047) of 937 maximum days alive and out of hospital (effect size 0·22, 95% CI 0·21-0·23; p=0·039). A post-discharge management programme specific to atrial fibrillation was associated with proportionately more days alive and out of hospital (but not prolonged event-free survival) relative to standard management. Disease-specific management is a possible strategy to improve poor health outcomes in patients admitted with chronic atrial fibrillation. National Health and Medical Research Council of Australia. Copyright © 2015 Elsevier Ltd. All rights reserved.

Music does not alter anxiety in patients with suspected lung cancer undergoing bronchoscopy: a randomised controlled trial.

PubMed

Jeppesen, Elisabeth; Pedersen, Carsten M; Larsen, Klaus R; Rehl, Anne; Bartholdy, Karen; Walsted, Emil S; Backer, Vibeke

2016-01-01

The use of music to relieve anxiety has been examined in various studies, but the results are inconclusive. From April to October 2015, 160 patients undergoing examination of pulmonary nodules were randomly assigned to MusiCure or no music. MusiCure was administered through earplugs to ensure blinding of the staff and was played from admission to the operating theatre to the end of the bronchoscopy. Spielberger's State-Trait Anxiety Inventory (STAI) was administered on admission, immediately before bronchoscopy, and on discharge. Secondary outcomes were p -cortisol, physiological variables, dosage of sedatives, movements measured by Actigraph, bronchoscopy duration, number of re-examinations, and overall perception of the sounds in the operating theatre measured by Visual analogue scale. The STAI scores were similar on admission, but after a 10-min wait in the operating theatre, scores varied significantly between patients with and without music, with lower scores in the music group [median (interquartile range, IQR) 35 (18) vs. 43 (25); p= 0.03]. Post hoc multiple regression revealed treatment group as insignificant when adjusting for sex and baseline anxiety. However, there was a significantly more positive perception of the sounds in the operating theatre in the music group (median (IQR) 8.2 (1.8) vs. 5.4 (6.8); p <0.0001) and fewer re-examinations in the music group (19.2% vs. 7.7%, p< 0.032). Ten minutes with MusiCure does not alter anxiety when adjusting for baseline anxiety and sex. The current study indicates that this field of research has many confounders.

Prognostic significance of blood lactate and lactate clearance in trauma patients.

PubMed

Régnier, Marie-Alix; Raux, Mathieu; Le Manach, Yannick; Asencio, Yves; Gaillard, Johann; Devilliers, Catherine; Langeron, Olivier; Riou, Bruno

2012-12-01

Lactate has been shown to be a prognostic biomarker in trauma. Although lactate clearance has already been proposed as an intermediate endpoint in randomized trials, its precise role in trauma patients remains to be determined. Blood lactate levels and lactate clearance (LC) were calculated at admission and 2 and 4 h later in trauma patients. The association of initial blood lactate level and lactate clearance with mortality was tested using receiver-operating characteristics curve, logistic regression using triage scores, Trauma Related Injury Severity Score as a reference standard, and reclassification method. The authors evaluated 586 trauma patients (mean age 38±16 yr, 84% blunt and 16% penetrating, mortality 13%). Blood lactate levels at admission were elevated in 327 (56%) patients. The lactate clearance should be calculated within the first 2 h after admission as LC0-2 h was correlated with LC0-4 h (R=0.55, P<0.001) but not with LC2-4 h (R=0.04, not significant). The lactate clearance provides additional predictive information to initial blood lactate levels and triage scores and the reference score. This additional information may be summarized using a categorical approach (i.e., less than or equal to -20 %/h) in contrast to initial blood lactate. The results were comparable in patients with high (5 mM/l or more) initial blood lactate. Early (0-2 h) lactate clearance is an important and independent prognostic variable that should probably be incorporated in future decision schemes for the resuscitation of trauma patients.

Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children.

PubMed

Grandy, Giuseppe; Medina, Marcos; Soria, Richard; Terán, Carlos G; Araya, Magdalena

2010-08-25

Evidence suggests that probiotics reduce rotavirus diarrhoea duration. Although there are several probiotic strains potentially useful, daily practice is often limited by the type and number of products locally available. In general, information about combined products is scarce. In this study we compare the effect of two probiotic products in the treatment of diarrhoea in children less than 2 years of age. A Randomized double-blind controlled clinical trial in children hospitalized for acute rotavirus diarrhoea, in the Paediatric Centre Albina Patino, Cochabamba, Bolivia.Participants were children aged 1 - 23 months, who were randomly assigned to receive one of three treatments: Oral rehydration therapy plus placebo; Oral rehydration solution plus Saccharomyces boulardii; or Oral rehydration solution plus a compound containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii. Sample size was 20 per group and the outcomes were duration of diarrhoea, of fever, of vomiting and of hospitalization. 64 cases finished the protocol. On admission, patients' characteristics were similar. Median duration of diarrhoea (p = 0.04) in children who received the single species product (58 hours) was shorter than in controls (84.5 hrs). Comparing children that received the single probiotic product and controls showed shorter duration of fever (18 vs 67 hrs) (p = 0.0042) and the mixed probiotic of vomiting (0 vs 42.5 hrs) (p = 0.041). There was no effect on duration of hospitalization (p = 0.31). When experimental groups were merged, statistical significance of changes increased (total duration of diarrhoea, fever and vomiting P = 0.025, P = 0.025 and P = 0.014, respectively). Both products decreased the duration of diarrhoea compared to oral rehydration solution alone. This decrease was significant only for the single species product which also decreased the duration of fever. With the multiple species product there was no vomiting subsequent to the initiation of treatment. The quantity of probiotic bacteria needed for optimum treatment of gastroenteritis remains to be determined, particularly when multiple species are included in the product.Trial registration: ClinicalTrials.gov ID: NCT00981877Link: https://register.clinicaltrials.gov/prs/app/action/SelectProtocol/sid/S0002653/selectaction/View/ts/2/uid/U0000N04 Clinical trials NCT ID: NCT00981877.

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0.007). Furthermore, a significant decline in death rate was noted in case group as compared to control group ( P = 0.03). Goal-directed optimized patients with perforation peritonitis were discharged early as compared to control group with significantly lesser mortality as compared with randomly optimized patients in the perioperative period.

Edinburgh Emergency Asthma Admission Service: report on 10 years' experience.

PubMed Central

Crompton, G K; Grant, I W; Bloomfield, P

1979-01-01

In December 1968 an emergency service was begun in Edinburgh to expedite admission to hospital of patients with severe acute asthma. During the first 10 years requests were made to admit 112 patients to a respiratory unit with provision for intensive care on 360 occasions. Four of the patients died of their disease, one in hospital and three before admission. It was thought that the death rate would have been much higher had conventional admission procedures been observed. Owing to ethical objections to a controlled trial it was not possible to obtain substantive proof that the service reduced deaths from asthma. Nevertheless, there was strong circumstantial evidence that organised facilities for the immediate admission to hospital of patients with a history of life-threatening attacks would result in fewer deaths at home. Earlier admission also apparently reduced hospital mortality and the number of patients requiring tracheal intubation and mechanical ventilation. It is concluded that there is a prima facie case for an emergency asthma admission serivce similar to that operating in Edinburgh to be established in all cities and large towns. PMID:519358

Active compression-decompression cardiopulmonary resuscitation (CPR) versus standard CPR for cardiac arrest patients: a meta-analysis

PubMed Central

Luo, Xu-rui; Zhang, Hui-li; Chen, Geng-jin; Ding, Wen-shu; Huang, Liang

2013-01-01

BACKGROUND: Active compression-decompression cardiopulmonary resuscitation (ACDCPR) has been popular in the treatment of patients with cardiac arrest (CA). However, the effect of ACD-CPR versus conventional standard CPR (S-CRP) is contriversial. This study was to analyze the efficacy and safety of ACD-CPR versus S-CRP in treating CA patients. METHODS: Randomized or quasi-randomized controlled trials published from January 1990 to March 2011 were searched with the phrase “active compression-decompression cardiopulmonary resuscitation and cardiac arrest” in PubMed, EmBASE, and China Biomedical Document Databases. The Cochrane Library was searched for papers of meta-analysis. Restoration of spontaneous circulation (ROSC) rate, survival rate to hospital admission, survival rate at 24 hours, and survival rate to hospital discharge were considered primary outcomes, and complications after CPR were viewed as secondary outcomes. Included studies were critically appraised and estimates of effects were calculated according to the model of fixed or random effects. Inconsistency across the studies was evaluated using the I2 statistic method. Sensitivity analysis was made to determine statistical heterogeneity. RESULTS: Thirteen studies met the criteria for this meta-analysis. The studies included 396 adult CA patients treated by ACD-CPR and 391 patients by S-CRP. Totally 234 CA patients were found out hospitals, while the other 333 CA patients were in hospitals. Two studies were evaluated with high-quality methodology and the rest 11 studies were of poor quality. ROSC rate, survival rate at 24 hours and survival rate to hospital discharge with favorable neurological function indicated that ACD-CPR is superior to S-CRP, with relative risk (RR) values of 1.39 (95% CI 0.99–1.97), 1.94 (95% CI 1.45–2.59) and 2.80 (95% CI 1.60–5.24). No significant differences were found in survival rate to hospital admission and survival rate to hospital discharge for ACD-CPR versus S-CRP with RR values of 1.06 (95% CI 0.76–1.60) and 1.00 (95% CI 0.73–1.38). CONCLUSION: Quality controlled studies confirmed the superiority of ACD-CPR to S-CRP in terms of ROSC rate and survival rate at 24 hours. Compared with S-CRP, ACD-CPR could not improve survival rate to hospital admission or survival rate to hospital discharge. PMID:25215130

Passive leg raise (PLR) during cardiopulmonary (CPR) – a method article on a randomised study of survival in out-of-hospital cardiac arrest (OHCA)

PubMed Central

2014-01-01

Background It is estimated that about 275,000 inhabitants experience an out-of-hospital cardiac arrest (OHCA) every year in Europe. Survival in out-of-hospital cardiac arrest is relatively low, generally between five per cent and 10%. Being able to explore new methods to improve the relatively low survival rate is vital for people with these conditions. Passive leg raise (PLR) during cardiopulmonary resuscitation (CPR) has been found to improve cardiac preload and blood flow during chest compressions. The aim of our study is to evaluate whether early PLR during CPR also has an impact on one-month survival in sudden and unexpected out-of-hospital cardiac arrest (OHCA). Method/Design A prospective, randomized, controlled trial in which all patients (≥18 years) receiving out-of hospital CPR are randomized by envelope to be treated with either PLR or in the flat position. The ambulance crew use a special folding stool which allows the legs to be elevated about 20 degrees. Primary end-point: survival to one month. Secondary end-point: survival to hospital admission to one month and to one year with acceptable cerebral performance classification (CPC) 1–2. Discussion PLR is a simple and fast maneuver. We believe that the greatest benefit with PLR is when performed early in the process, during the first minutes of CPR and before the first defibrillation. To reach power this study need 3000 patients, we hope that this method article will encourage other sites to contact us and take part in our study. Trial registration ClinicalTrials.gov NCT01952197. PMID:24993861

Hypocaloric vs Normocaloric Nutrition in Critically Ill Patients: A Prospective Randomized Pilot Trial.

PubMed

Petros, Sirak; Horbach, Monika; Seidel, Frank; Weidhase, Lorenz

2016-02-01

Optimal nutrition of critically ill patients is still a matter of debate. This pilot trial aimed to compare the impact of normocaloric vs hypocaloric feeding in critically ill patients in the first 7 days in the intensive care unit (ICU). The primary end point was the rate of nosocomial infections during the ICU stay. Critically ill patients requiring artificial nutrition for at least 72 hours were included within 24 hours of ICU admission and randomized into a normocaloric group (receiving 100% of their daily energy expenditure) and a hypocaloric group (receiving 50% of their daily energy expenditure). One hundred patients were included (54 in the normocaloric group and 46 in the hypocaloric group). There were 66 male and 34 female patients with a mean age of 65.8 ± 11.6 years. The mean daily caloric supply was 19.7 ± 5.7 kcal/kg for the normocaloric group and 11.3 ± 3.1 kcal/kg for the hypocaloric group (P = .0001). Insulin demand was significantly higher and gastrointestinal intolerance more frequent in the normocaloric group than in the hypocaloric group. Nosocomial infections were detected more frequently in the hypocaloric group than in the normocaloric group (26.1% vs 11.1%, respectively). The ICU mortality rate was 22.2% in the normocaloric group and 21.7% in the hypocaloric group (not significant). The hospital mortality rate was 31.5% in the normocaloric group and 37.0% in the hypocaloric group (P = .67). Hypocaloric feeding in the first 7 days in critically ill patients was associated with more nosocomial infections but less insulin demand and less gastrointestinal intolerance compared with normocaloric feeding. DRKS00000104 (German Clinical Trials Register). © 2014 American Society for Parenteral and Enteral Nutrition.

Fever, thrombocytopenia, and AKI-A profile of malaria, dengue, and leptospirosis with renal failure in a South Indian tertiary-care hospital.

PubMed

Prabhu, Mayoor V; S, Arun; Ramesh, Venkat

In the tropics, the triad of fever, thrombocytopenia, and AKI portends a grim prognosis with high mortality and a severe strain on already-stretched resources. Malaria, dengue, and leptospirosis account for most cases. We undertook a review of cases to determine factors accounting for adverse prognosis. All patients presenting to the emergency room (ER) with a history of fever, thrombocytopenia, and renal failure were included in the study. Patients were followed until discharge or death, and end points looked at were 1-week and 30-day mortality, and renal function upon discharge. Parameters like liver function test (LFT), renal function, and platelet count upon discharge were also documented. A total of 43 patients was included in the study. Mean age was 42.5 years with 86% males. Mean APACHE and SOFA scores on admission were 23.89 and 15.42, respectively. Mean admission platelet counts were 41,000. Mean serum creatinine was 4.1, and bilirubin was 9.94. A platelet count of < 34,000, serum creatinine of > 4, albumin of > 2.3, SOFA score of > 20, and APACHE score of > 32.2 were significantly predictive of 1 week mortality. Need for mechanical ventilation, oliguria on admission, and need for dialysis all were highly predictive of 30-day mortality. In addition, a serum bicarbonate of < 12, INR of > 1.5, hemoglobin of < 9.5 were highly predictive of higher 30 day mortality. Overall, 1-week mortality was 16.3%, of which 48% was accounted for by patients with leptospirosis. Factors like low platelet count, oliguria, need for dialysis, high APACHE and SOFA scores on admission, need for mechanical ventilation, and low serum albumin portend a grave prognosis. There is need for randomized control trials (RCT) to further determine adverse prognostic factors in this subsect of patients.

OpT2mise: a randomized controlled trial to compare insulin pump therapy with multiple daily injections in the treatment of type 2 diabetes-research design and methods.

PubMed

Aronson, Ronnie; Cohen, Ohad; Conget, Ignacio; Runzis, Sarah; Castaneda, Javier; de Portu, Simona; Lee, Scott; Reznik, Yves

2014-07-01

In insulin-requiring type 2 diabetes patients, current insulin therapy approaches such as basal-alone or basal-bolus multiple daily injections (MDI) have not consistently provided achievement of optimal glycemic control. Previous studies have suggested a potential benefit of continuous subcutaneous insulin infusion (CSII) in these patients. The OpT2mise study is a multicenter, randomized, trial comparing CSII with MDI in a large cohort of subjects with evidence of persistent hyperglycemia despite previous MDI therapy. Subjects were enrolled into a run-in period for optimization of their MDI insulin regimen. Subjects showing persistent hyperglycemia (glycated hemoglobin [HbA1c] ≥8% and ≤12%) were then randomly assigned to CSII or continuing an MDI regimen for a 6-month phase followed by a single crossover of the MDI arm, switching to CSII. The primary end point is the between-group difference in mean change in HbA1c from baseline to 6 months. Secondary end points include change in mean 24-h glucose values, area under the curve and time spent in hypoglycemia and hyperglycemia, measures of glycemic excursions, change in postprandial hyperglycemia, and evaluation of treatment satisfaction. Safety end points include hypoglycemia, hospital admissions, and emergency room visits. When subject enrollment was completed in May 2013, 495 subjects had been enrolled in the study. The study completion for the primary end point is expected in January 2014. OpT2mise will represent the largest studied homogeneous cohort of type 2 diabetes patients with persistent hyperglycemia despite optimized MDI therapy. OpT2mise will help define the role of CSII in insulin intensification and define its safety, rate of hypoglycemia, patient adherence, and patient satisfaction.

Tramadol/paracetamol combination tablet for postoperative pain following ambulatory hand surgery: a double-blind, double-dummy, randomized, parallel-group trial

PubMed Central

Rawal, Narinder; Macquaire, Valery; Catalá, Elena; Berti, Marco; Costa, Rui; Wietlisbach, Markus

2011-01-01

This randomized, double-blind, double-dummy, multicenter trial compared efficacy and safety of tramadol HCL 37.5 mg/paracetamol 325 mg combination tablet with tramadol HCL 50 mg capsule in the treatment of postoperative pain following ambulatory hand surgery with iv regional anesthesia. Patients received trial medication at admission, immediately after surgery, and every 6 hours after discharge until midnight of the first postoperative day. Analgesic efficacy was assessed by patients (n = 128 in each group, full analysis set) and recorded in a diary on the evening of surgery day and of the first postoperative day. They also documented the occurrence of adverse events. By the end of the first postoperative day, the proportion of treatment responders based on treatment satisfaction (primary efficacy variable) was comparable between the groups (78.1% combination, 71.9% tramadol; P = 0.24) and mean pain intensity (rated on a numerical scale from 0 = no pain to 10 = worst imaginable pain) had been reduced to 1.7 ± 2.0 for both groups. Under both treatments, twice as many patients experienced no pain (score = 0) on the first postoperative day compared to the day of surgery (35.9% vs 16.4% for tramadol/paracetamol and 36.7% vs 18% for tramadol treatment). Rescue medication leading to withdrawal (diclofenac 50 mg) was required by 17.2% patients with tramadol/paracetamol and 13.3% with tramadol. Adverse events (mainly nausea, dizziness, somnolence, vomiting, and increased sweating) occurred less frequently in patients under combination treatment (P = 0.004). Tramadol/paracetamol combination tablets provided comparable analgesic efficacy with a better safety profile to tramadol capsules in patients experiencing postoperative pain following ambulatory hand surgery. PMID:21559356

Inhaled versus systemic corticosteroids for acute asthma in children. A systematic review.

PubMed

Beckhaus, Andrea A; Riutort, Maria C; Castro-Rodriguez, Jose A

2014-04-01

To compare the effects of inhaled corticosteroids (ICS) against systemic corticosteroids (SC) in children consulting in emergency department (ED) or equivalent for asthma exacerbation. Electronic search in MEDLINE, CENTRAL, CINAHL, and LILACS databases and other sources. Study selection criteria: children 2-18 years of age, consulting in ED or equivalent for asthma exacerbation, comparison between ICS and SC, randomized controlled trials. hospital admission rate, unscheduled visits for asthma symptoms, need of additional course of SC. improvement of lung function, length of stay in ED, clinical scores, and adverse effects. Eight studies met inclusion criteria (N = 797), published between 1995 and 2006. All used prednisolone as SC and budesonide, fluticasone, dexamethasone, and flunisolide were administered as ICS. No significant difference between ICS versus SC was found in terms of hospital admission (RR: 1.02; 95% CI: 0.41-2.57), unscheduled visits for asthma symptoms (RR: 9.55; 95% CI: 0.53-170.52) nor for need of additional course of SC (RR: 1.45; 95% CI: 0.28-7.62). The change in % of predicted FEV1 at fourth hour was significantly higher for SC group, but there was no significant difference between both groups after this time. There was insufficient data to perform meta-analysis of length of stay during first consult in ED and of symptom scores. Vomiting was similar among both groups. There is no evidence of a difference between ICS and SC in terms of hospital admission rates, unscheduled visits for asthma symptoms and need of additional course of SC in children consulting for asthma exacerbations. © 2013 Wiley Periodicals, Inc.

Early administration of tolvaptan preserves renal function in elderly patients with acute decompensated heart failure.

PubMed

Kimura, Kazuhiro; Momose, Tomoyasu; Hasegawa, Tomoya; Morita, Takehiro; Misawa, Takuo; Motoki, Hirohiko; Izawa, Atsushi; Ikeda, Uichi

2016-05-01

Loop diuretics used in the treatment of heart failure often induce renal impairment. This study was conducted in order to evaluate the renal protective effect of adding tolvaptan (TLV), compared to increasing the furosemide (FRM) dose, for the treatment of acute decompensated heart failure (ADHF) in a real-world elderly patient population. This randomized controlled trial enrolled 52 consecutive hospitalized patients (age 83.4±9.6 years) with ADHF. The patients were assigned alternately to either the TLV group (TLV plus conventional treatment, n=26) or the FRM group (increasing the dose of FRM, n=26). TLV was administered within 24h from admission. The incidence of worsening renal function (WRF) within 7 days from admission was significantly lower in the TLV group (26.9% vs. 57.7%, p=0.025). Furthermore, the rates of occurrence of persistent and late-onset (≥5 days from admission) WRF were significantly lower in the TLV group. Persistent and late-onset WRF were significantly associated with a higher incidence of cardiac death or readmission for worsening heart failure in the 90 days following discharge, compared to transient and early-onset WRF, respectively. Early administration of TLV, compared to increased FRM dosage, reduces the incidence of WRF in real-world elderly ADHF patients. In addition, it reduces the occurrence of 'worse' WRF-persistent and late-onset WRF-which are associated with increased rates of cardiac death or readmission for worsening heart failure in the 90 days after discharge. Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study.

PubMed

Charleer, Sara; Mathieu, Chantal; Nobels, Frank; De Block, Christophe; Radermecker, Regis P; Hermans, Michel P; Taes, Youri; Vercammen, Chris; T'Sjoen, Guy; Crenier, Laurent; Fieuws, Steffen; Keymeulen, Bart; Gillard, Pieter

2018-03-01

Randomized controlled trials evaluating real-time continuous glucose monitoring (RT-CGM) patients with type 1 diabetes (T1D) show improved glycemic control, but limited data are available on real-world use. To assess impact of RT-CGM in real-world settings on glycemic control, hospital admissions, work absenteeism, and quality of life (QOL). Prospective, observational, multicenter, cohort study. A total of 515 adults with T1D on continuous subcutaneous insulin infusion (CSII) therapy starting in the Belgian RT-CGM reimbursement program. Initiation of RT-CGM reimbursement. Hemoglobin A1c (HbA1c) evolution from baseline to 12 months. Between September 1, 2014, and December 31, 2016, 515 adults entered the reimbursement system. Over this period, 417 (81%) patients used RT-CGM for at least 12 months. Baseline HbA1c was 7.7 ± 0.9% (61 ± 9.8 mmol/mol) and decreased to 7.4 ± 0.8% (57 ± 8.7 mmol/mol) at 12 months (P < 0.0001). Subjects who started RT-CGM because of insufficient glycemic control showed stronger decrease in HbA1c at 4, 8, and 12 months compared with patients who started because of hypoglycemia or pregnancy. In the year preceding reimbursement, 16% of patients were hospitalized for severe hypoglycemia or ketoacidosis in contrast to 4% (P < 0.0005) the following year, with decrease in admission days from 54 to 18 per 100 patient years (P < 0.0005). In the same period, work absenteeism decreased and QOL improved significantly, with strong decline in fear of hypoglycemia. Sensor-augmented pump therapy in patients with T1D followed in specialized centers improves HbA1c, fear of hypoglycemia, and QOL, whereas work absenteeism and admissions for acute diabetes complications decreased.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly. Results and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05) production of E2, suppressed (P<0.05) blood FSH, Thyroid (T3) and Adrenocorticotropic hormones, Cortisol, and BMI, increased (P<0.05) low density lipoproteins, blood Iron and alleviated (P<0.001) menopausal symptoms. Maca-GO noticeably increased bone density markers. In conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes along the Hypothalamus-Pituitary-Ovarian axis, (ii) balanced hormone levels and (iii) relieved symptoms of menopausal discomfort, (hot flushes and night sweating in particular), thus, (iv) exhibited a distinctive function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence on hormone therapy programs (HRT). PMID:23675006

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (III) Clinical responses of early-postmenopausal women to Maca in double blind, randomized, Placebo-controlled, crossover configuration, outpatient study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This is the second, conclusive part of the clinical study on clinical responses of early-postmenopausal women to standardized doses of pre-Gelatinized Organic Maca (Maca-GO). Total of 34 Caucasian women volunteers participated in a double-blind, randomized, four months outpatient crossover configuration Trial. After fulfilling the criteria of being early-postmenopausal: blood Estrogen (E2<40 pg/ml) and Follicle Stimulating Hormone (FSH>30 IU/ml) at admission, they were randomly allocated to Placebo (P) and Maca-GO (M) treatments (2 groups of 11 participants each). Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day). At admission and follow-up monthly intervals, body mass index (BMI), blood pressure, levels of gonadal, pituitary, thyroid and adrenal hormones, lipids and key minerals were measured. Bone markers were determined after four months M and P use in 12 participants. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly. Results and canonical variate technique was applied to GMS and KMI matrices. Two months application of Maca-GO stimulated (P<0.05) production of E2, suppressed (P<0.05) blood FSH, Thyroid (T3) and Adrenocorticotropic hormones, Cortisol, and BMI, increased (P<0.05) low density lipoproteins, blood Iron and alleviated (P<0.001) menopausal symptoms. Maca-GO noticeably increased bone density markers. In conclusion, Maca-GO applied to early-postmenopausal women (i) acted as a toner of hormonal processes along the Hypothalamus-Pituitary-Ovarian axis, (ii) balanced hormone levels and (iii) relieved symptoms of menopausal discomfort, (hot flushes and night sweating in particular), thus, (iv) exhibited a distinctive function peculiar to adaptogens, providing an alternative non-hormonal plant option to reduce dependence on hormone therapy programs (HRT).

Multidisciplinary approach to management of maternal asthma (MAMMA [copyright]): the PROTOCOL for a randomized controlled trial.

PubMed

Lim, Angelina; Stewart, Kay; Abramson, Michael J; Walker, Susan P; George, Johnson

2012-12-19

Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy. A pilot single-blinded parallel-group randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA©) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV(1)/FEV(6) will be also investigated during this trial as a marker for asthma control. If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy. Australian New Zealand Clinical Trials Registry (ACTRN12612000681853).

Effectiveness of multifaceted hand hygiene interventions in long-term care facilities in Hong Kong: a cluster-randomized controlled trial.

PubMed

Ho, Mei-lin; Seto, Wing-hong; Wong, Lai-chin; Wong, Tin-yau

2012-08-01

To determine the effectiveness of World Health Organization (WHO) multimodal strategy in promoting hand hygiene (HH) among healthcare workers (HCWs) in long-term care facilities (LTCFs). Cluster-randomized controlled trial. Eighteen homes for the elderly in Hong Kong were randomly allocated to 2 intervention arms and a control arm. Direct observation of HH practice was conducted by trained nurses. Either handrubbing with alcohol-based handrub (ABHR) or handwashing with liquid soap and water was counted as a compliant action. Disease notification data during 2007-2010 were used to calculate incidence rate ratio (IRR). Managers and HCWs of the participating homes. The WHO multimodal strategy was employed. All intervention homes were supplied with ABHR (WHO formulation I), ABHR racks, pull reels, HH posters and reminders, a health talk, video clips, training materials, and performance feedback. The only difference was that intervention arms 1 and 2 were provided with slightly powdered and powderless gloves, respectively. A total of 11,669 HH opportunities were observed. HH compliance increased from 27.0% to 60.6% and from 22.2% to 48.6% in intervention arms 1 and 2, respectively. Both intervention arms showed increased HH compliance after intervention compared to controls, at 21.6% compliance (both [Formula: see text]). Provision of slightly powdered versus powderless gloves did not have any significant impact on ABHR usage. Respiratory outbreaks (IRR, 0.12; 95% confidence interval [CI], 0.01-0.93; [Formula: see text]) and methicillin-resistant Staphylococcus aureus infections requiring hospital admission (IRR, 0.61; 95% CI, 0.38-0.97; [Formula: see text]) were reduced after intervention. A promotion program applying the WHO multimodal strategy was effective in improving HH among HCWs in LTCFs.

Assessment and support during early labour for improving birth outcomes.

PubMed

Kobayashi, Shinobu; Hanada, Nobutsugu; Matsuzaki, Masayo; Takehara, Kenji; Ota, Erika; Sasaki, Hatoko; Nagata, Chie; Mori, Rintaro

2017-04-20

The progress of labour in the early or latent phase is usually slow and may include painful uterine contractions. Women may feel distressed and lose their confidence during this phase. Support and assessment interventions have been assessed in two previous Cochrane Reviews. This review updates and replaces these two reviews, which have become out of date. To investigate the effectiveness of assessment and support interventions for women during early labour.In order to measure the effectiveness of the interventions, we compared the duration of labour, the rate of obstetrical interventions, and the rate of other maternal or neonatal outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 October 2016) and reference lists of retrieved studies. Randomised controlled trials of any assessment or support intervention in the latent phase of labour. We planned to include cluster-randomised trials if they were eligible. We did not include quasi-randomised trials. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We resolved any disagreement by discussion or by involving a third assessor. The quality of the evidence was assessed using the GRADE approach. We included five trials with a total of 10,421 pregnant women in this review update. The trials were conducted in the UK, Canada and America. The trials compared interventions in early labour versus usual care. We examined three comparisons: early labour assessment versus immediate admission to hospital; home visits by midwives versus usual care (telephone triage); and one-to-one structured midwifery care versus usual care. These trials were at moderate- risk of bias mainly because blinding women and staff to these interventions is not generally feasible. For important outcomes we assessed evidence using GRADE; we downgraded evidence for study design limitations, imprecision, and where we carried out meta-analysis, for inconsistency.One trial with 209 women compared early labour assessment with direct admission to hospital. Duration of labour from the point of hospital admission was reduced for women in the assessment group (mean difference (MD) -5.20 hours, 95% confidence interval (CI) -7.06 to -3.34; 209 women, low-quality evidence). There were no clear differences between groups for the number of women undergoing caesarean section or instrumental vaginal birth (risk ratio (RR) 0.72, 95% CI 0.30 to 1.72, very low quality evidence; and, RR 0.86, 95% CI 0.58 to 1.26, very low quality evidence, respectively). Serious maternal morbidity was not reported. Women in the early assessment group were slightly less likely to have epidural anaesthesia (RR 0.87, 95% CI 0.78 to 0.98, low-quality evidence), and considerably less likely to have oxytocin for labour augmentation (RR 0.57, 95% CI 0.37 to 0.86) and this group also had increased satisfaction with their care compared with women in the immediate admission group (MD 16.00, 95% CI 7.53 to 24.47). No babies were born before admission to hospital and only one infant had a low Apgar score at five minutes after the birth (very low quality evidence). Admission to neonatal special care was not reported.Three studies examined home assessment and midwifery support versus telephone triage. One trial reported the duration of labour; home visits did not appear to have any clear impact compared with usual care (MD 0.29 hours, 95% CI -0.14 to 0.72; 1 trial, 3474 women, low-quality evidence). There was no clear difference for the rate of caesarean section (RR 1.05, 95% CI 0.95 to 1.17; 3 trials, 5170 women; I² = 0%; moderate-quality evidence) or the rate of instrumental vaginal birth (average RR 0.95, 95% CI 0.79 to 1.15; 2 trials, 4933 women; I² = 69%; low-quality evidence). One trial reported birth before arrival at hospital or unplanned home birth; there was no clear difference between the groups (RR 1.33, 95% CI 0.30 to 5.95; 1 trial, 3474 women). No clear differences were identified for serious maternal morbidity (RR 0.93, 95% CI 0.61 to 1.42; 1 trial, 3474 women; low-quality evidence), or use of epidural (average RR 0.95, 95% CI 0.87 to 1.05; 3 trials, 5168 women; I² = 60%; low-quality evidence). There were no clear differences for neonatal admission to special care (average RR 0.84, 95% CI 0.50 to 1.42; 3 trials, 5170 infants; I² = 71%; very low quality evidence), or for Apgar score less than seven at five minutes after birth (RR 1.19, 95% CI 0.71 to 1.99; 3 trials, 5170 infants; I² = 0%; low-quality evidence).One study, with 5002 women, examined one-to-one structured care in early labour versus usual care. Length of labour was not reported. There were no clear differences between groups for the rate of caesarean section (RR 0.93, 95% CI 0.84 to 1.02; 4996 women, high-quality evidence), or for instrumental vaginal birth (RR 0.94, 95% CI 0.82 to 1.08; 4996 women, high-quality evidence). No clear differences between groups were reported for serious maternal morbidity (RR 1.13, 95% CI 0.84 to 1.52; 4996 women, moderate-quality evidence). Use of epidural was similar in the two groups (RR 1.00, 95% CI 0.99 to 1.01; 4996 women, high-quality evidence). For infant outcomes, there were no clear differences between groups (admission to neonatal intensive care unit: RR 0.98, 95% CI 0.80 to 1.21; 4989 infants, high-quality evidence; Apgar score less than seven at five minutes: RR 1.07, 95% CI 0.64 to 1.79; 4989 infants, moderate-quality evidence). Assessment and support in early labour does not have a clear impact on rate of caesarean section or instrumental vaginal birth, or whether the baby was born before arrival at hospital or in an unplanned home birth. However, evidence suggested that interventions may have an impact on reducing the use of epidural anaesthesia, labour augmentation and on increasing maternal satisfaction with giving birth. Evidence about the effectiveness of early labour assessment versus immediate admission was very limited and more research is needed in this area.

Impact of statins in outcomes of septic patients: a systematic review.

PubMed

Tralhão, António Filipe; Cés de Souza-Dantas, Vicente; Salluh, Jorge Ibrain; Póvoa, Pedro Manuel

2014-11-01

The pleiotropic effects of statins have prompted considerable research in fields other than cardiovascular disease. We reviewed the literature aiming to summarize and critically evaluate the current evidence about the potential use of statins in sepsis. We searched the Pubmed, SciELO, and Cochrane electronic databases from inception through November 1, 2013, for randomized controlled trials (RCTs) and cohort studies that examined the association between statin use (upon hospital admission or previous users) and the risk or outcome of sepsis. Data on study characteristics, measurement of statin use, and outcomes (adjusted for potential confounders) were extracted. We structured our review according to the Principles of Reporting in Systematic Reviews and Meta-Analysis criteria. Quality assessment of cohort studies was performed using the Ottawa-Newcastle Scale. Twenty-three cohort studies and 5 RCTs were eligible, comprising 42 549 statin users and 54 201 non-statin users, from 1995 to 2013. The populations included varied from patients admitted to general wards or intensive care units with bacterial infections, community-acquired pneumonia, ventilator-associated pneumonia, bacteremia, or sepsis, to outpatients with chronic kidney disease or established cardiovascular disease. Overall, 16 studies reported a benefit from statin use in morbidity or mortality outcomes (range of adjusted odds ratio, 0.06-0.62; α = 0.05). The remaining 12 studies found no protective effect associated with statin use upon hospital admission or previous users. Among the 5 RCTs, none demonstrated a reduction in mortality. There is insufficient evidence to support the use of statins in patients with sepsis, as the existing studies failed to prove a consistent mortality benefit. More clinical trials are warranted to provide more conclusive knowledge and ultimately change clinical practice.

Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial.

PubMed

Jahn, Patrick; Kuss, Oliver; Schmidt, Heike; Bauer, Alexander; Kitzmantel, Maria; Jordan, Karin; Krasemann, Susann; Landenberger, Margarete

2014-04-01

Patients' self-management skills are affected by their knowledge, activities, and attitudes toward pain management. This trial aimed to test the Self Care Improvement through Oncology Nursing (SCION)-PAIN program, a multimodular structured intervention to reduce patients' barriers to self-management of cancer pain. Two hundred sixty-three patients with diagnosed malignancy, pain>3 days, and average pain > or = 3/10 participated in a cluster-randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, in addition to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic, nonpharmacologic pain management, and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training, and counseling. Starting with admission, patients received booster sessions every third day and one follow-up telephone counseling session within 2 to 3 days after discharge. Patients in the control group received standard care. Primary end point was the group difference in patient-related barriers to self-management of cancer pain (Barriers Questionnaire-BQ II) 7 days after discharge. The SCION-PAIN program resulted in a significant reduction of patient-related barriers to pain management 1 week after discharge from the hospital: mean difference on BQ II was -0.49 points (95% confidence interval -0.87 points to -0.12 points; P=0.02). Furthermore, patients showed improved adherence to pain medication; odds ratio 8.58 (95% confidence interval 1.66-44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Estimated GFR and the Effect of Intensive Blood Pressure Lowering After Acute Intracerebral Hemorrhage.

PubMed

Zheng, Danni; Sato, Shoichiro; Arima, Hisatomi; Heeley, Emma; Delcourt, Candice; Cao, Yongjun; Chalmers, John; Anderson, Craig S

2016-07-01

The kidney-brain interaction has been a topic of growing interest. Past studies of the effect of kidney function on intracerebral hemorrhage (ICH) outcomes have yielded inconsistent findings. Although the second, main phase of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2) suggests the effectiveness of early intensive blood pressure (BP) lowering in improving functional recovery after ICH, the balance of potential benefits and harms of this treatment in those with decreased kidney function remains uncertain. Secondary analysis of INTERACT2, which randomly assigned patients with ICH with elevated systolic BP (SBP) to intensive (target SBP<140mmHg) or contemporaneous guideline-based (target SBP<180mmHg) BP management. 2,823 patients from 144 clinical hospitals in 21 countries. Admission estimated glomerular filtration rates (eGFRs) of patients were categorized into 3 groups based on the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation: normal or high, mildly decreased, and moderately to severely decreased (>90, 60-90, and <60mL/min/1.73m(2), respectively). The effect of admission eGFR on the primary outcome of death or major disability at 90 days (defined as modified Rankin Scale scores of 3-6) was analyzed using a multivariable logistic regression model. Potential effect modification of intensive BP lowering treatment by admission eGFR was assessed by interaction terms. Of 2,623 included participants, 912 (35%) and 280 (11%) had mildly and moderately/severely decreased eGFRs, respectively. Patients with moderately/severely decreased eGFRs had the greatest risk for death or major disability at 90 days (adjusted OR, 1.82; 95% CI, 1.28-2.61). Effects of early intensive BP lowering were consistent across different eGFRs (P=0.5 for homogeneity). Generalizability issues arising from a clinical trial population. Decreased eGFR predicts poor outcome in acute ICH. Early intensive BP lowering provides similar treatment effects in patients with ICH with decreased eGFRs. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Effectiveness of EMDR in patients with substance use disorder and comorbid PTSD: study protocol for a randomized controlled trial.

PubMed

Schäfer, Ingo; Chuey-Ferrer, Laycen; Hofmann, Arne; Lieberman, Peter; Mainusch, Günter; Lotzin, Annett

2017-03-16

Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based treatment for PTSD. However, it is unclear whether EMDR shows the same effectiveness in patients with substance use disorders (SUD) and comorbid PTSD. In this trial, we examine the effectiveness of EMDR in reducing PTSD symptoms in patients with SUD and PTSD. We conduct a single-blinded RCT among 158 patients with SUD and comorbid PTSD admitted to a German addiction rehabilitation center specialized for the treatment of patients with SUD and comorbid PTSD. Patients are randomized to receive either EMDR, added to SUD rehabilitation and non-trauma-focused PTSD treatment (TAU), or TAU alone. The primary outcome is change from baseline in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale at 6-month follow-up. Secondary outcomes are change from baseline in substance use, addiction-related problems, depressive symptoms, dissociative symptoms, emotion dysregulation and quality of life. Assessments are carried out by blinded raters at admission, at end of treatment, and at 3- and 6-month follow-up. We expect that EMDR plus TAU will be more effective in reducing PTSD symptoms than TAU alone. Mixed models will be conducted using an intention-to-treat and per-protocol approach. This study aims to expand the knowledge about the effectiveness of EMDR in patients with SUD and comorbid PTSD. The expected finding of the superiority of EMDR in reducing PTSD symptoms compared to non-trauma-focused PTSD treatment may enhance the use of trauma-focused treatment approaches for patients with SUD and co-morbid PTSD. German Clinical Trials Register: DRKS00009007 ; U1111-1172-9213. Retrospectively registered 01 Juni 2016.

Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol

PubMed Central

García‐Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin‐Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García‐Gutiérrez, Susana

2017-01-01

Abstract Aims Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta‐blockers (BBs), angiotensin‐converting‐enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse‐managed) and control (cardiologist‐managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. Methods We have designed a multicentre (20 hospitals) non‐inferiority randomized controlled trial, including patients with new‐onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II–III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N‐terminal pro B‐type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. Conclusions The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. PMID:29154427

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa J; Knight, Laura D; Presneill, Jeffrey; Rechnitzer, Thomas; Forsyth, Adrienne; Gill, Benjamin M T; Mourtzakis, Marina; MacIsaac, Christopher

2018-04-27

International guidelines recommend greater protein delivery to critically ill patients than they currently receive. This pilot randomized clinical trial aimed to determine whether a volume-target enteral protocol with supplemental protein delivered greater amounts of protein and energy to critically ill patients compared with standard care. Sixty participants received either the intervention (volume-based protocol, with protein supplementation) or standard nutrition care (hourly-rate-based protocol, without protein supplementation) in the intensive care unit (ICU). Coprimary outcomes were average daily protein and energy delivery. Secondary outcomes included change in quadriceps muscle layer thickness (QMLT, ultrasound) and malnutrition (subjective global assessment) at ICU discharge. Mean (SD) protein and energy delivery per day from nutrition therapy for the intervention were 1.2 (0.30) g/kg and 21 (5.2) kcal/kg compared with 0.75 (0.11) g/kg and 18 (2.7) kcal/kg for standard care. The mean difference between groups in protein and energy delivery per day was 0.45 g/kg (95% CI, 0.33-0.56; P < .001) and 2.8 kcal/kg (95% CI, 0.67-4.9, P = .01). Muscle loss (QMLT) at discharge was attenuated by 0.22 cm (95% CI, 0.06-0.38, P = .01) in patients receiving the intervention compared with standard care. The number of malnourished patients was fewer in the intervention [2 (7%) vs 8 (28%); P = .04]. Mortality and duration of admission were similar between groups. A high-protein volume-based protocol with protein supplementation delivered greater amounts of protein and energy. This intervention was associated with attenuation of QMLT loss and reduced prevalence of malnutrition at ICU discharge. © 2018 American Society for Parenteral and Enteral Nutrition.

Pregabalin for decreasing pancreatic pain in chronic pancreatitis.

PubMed

Gurusamy, Kurinchi Selvan; Lusuku, Charnelle; Davidson, Brian R

2016-02-02

Chronic abdominal pain is one of the major symptoms in people with chronic pancreatitis. The role of pregabalin in people with chronic pancreatic pain due to chronic pancreatitis is uncertain. To assess the benefits and harms of pregabalin in people with chronic abdominal pain due to chronic pancreatitis. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library 2015, issue 6, and MEDLINE, EMBASE, Science Citation Index Expanded, trials registers until June 2015. We also searched the references of included trials to identify further trials. We considered only randomised controlled trials (RCT) performed in people with chronic pancreatic pain due to chronic pancreatitis, irrespective of language, blinding, or publication status for inclusion in the review. Two review authors independently identified trials and independently extracted data. We calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI) with RevMan 5, based on intention-to-treat analysis. Only one study, funded by Pfizer, met the inclusion criteria for the review. A total of 64 participants (with chronic pain due to chronic pancreatitis) were randomly assigned to receive escalating doses of pregabalin (150 mg per day to 600 mg per day; 34 participants) or matching placebo (30 participants). Participants received pregabalin or placebo for three weeks on an outpatient basis; the outcomes were measured at the end of the treatment (i.e. three weeks from commencement of treatment). Potential participants taking concomitant analgesic medication and expected to stay on a stable regime during the trial were allowed to enter the study. This trial was at low risk of bias. The overall quality of evidence was low or moderate.Only the short-term outcomes were available in this trial. The medium and long-term outcomes, number of work days lost, and length of hospital stay due to admissions for pain control were not available. This trial found that the changes in opiate use (MD -26.00 mg; 95% CI -47.36 to -4.64; participants = 64; moderate-quality evidence), and pain score percentage changes from baseline (MD -12.00; 95% CI -21.82 to -2.18; participants = 64; moderate-quality evidence) were better in participants taking pregabalin compared to those taking placebo. This trial also found that there were more adverse events in participants taking pregabalin compared to those taking placebo (RR 1.71; 95% CI 1.20 to 2.43; participants = 64). The differences between pregabalin and placebo were imprecise for short-term health-related quality of life measured with the EORTC CLQ-30 questionnaire (MD 11.40; 95% CI -3.28 to 26.08; participants = 64; moderate-quality evidence), proportion of people with serious adverse events (RR 1.76; 95% CI 0.35 to 8.96; participants = 64; low-quality evidence), and proportion of people requiring hospital admissions (RR 0.44; 95% CI 0.04 to 4.62; participants = 64; low quality evidence). Based on low- to moderate-quality evidence, short-term use of pregabalin decreases short-term opiate use, and short-term pain scores, but increases the adverse events compared to placebo, in people with chronic pain due to chronic pancreatitis. The clinical implication of the decreases in short-term opiate use and short-term pain scores is not known.Future trials assessing the role of pregabalin in decreasing chronic pain in chronic pancreatitis should assess the medium- or long-term effects of pregabalin and should include outcomes such as, quality of life, treatment-related adverse events, number of work days lost, number of hospital admissions, and the length of hospital stay, in addition to pain scores, to assess the clinical and socioeconomic impact.

Economic Evaluation of Complete Revascularization for Patients with Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention.

PubMed

Barton, Garry R; Irvine, Lisa; Flather, Marcus; McCann, Gerry P; Curzen, Nick; Gershlick, Anthony H

2017-06-01

To determine the cost-effectiveness of complete revascularization at index admission compared with infarct-related artery (IRA) treatment only, in patients with multivessel disease undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction. An economic evaluation of a multicenter randomized trial was conducted, comparing complete revascularization at index admission to IRA-only P-PCI in patients with multivessel disease (12-month follow-up). Overall hospital costs (costs for P-PCI procedure(s), hospital length of stay, and any subsequent re-admissions) were estimated. Outcomes were major adverse cardiac events (MACEs, a composite of all-cause death, recurrent myocardial infarction, heart failure, and ischemia-driven revascularization) and quality-adjusted life-years (QALYs) derived from the three-level EuroQol five-dimensional questionnaire. Multiple imputation was undertaken. The mean incremental cost and effect, with associated 95% confidence intervals, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve were estimated. On the basis of 296 patients, the mean incremental overall hospital cost for complete revascularization was estimated to be -£215.96 (-£1390.20 to £958.29), compared with IRA-only, with a per-patient mean reduction in MACEs of 0.170 (0.044 to 0.296) and a QALY gain of 0.011 (-0.019 to 0.041). According to the cost-effectiveness acceptability curve, the probability of complete revascularization being cost-effective was estimated to be 72.0% at a willingness-to-pay threshold value of £20,000 per QALY. Complete revascularization at index admission was estimated to be more effective (in terms of MACEs and QALYs) and cost-effective (overall costs were estimated to be lower and complete revascularization thereby dominated IRA-only). There was, however, some uncertainty associated with this decision. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial.

PubMed

Wiberg, Sebastian; Hassager, Christian; Thomsen, Jakob Hartvig; Frydland, Martin; Høfsten, Dan Eik; Engstrøm, Thomas; Køber, Lars; Schmidt, Henrik; Møller, Jacob Eifer; Kjaergaard, Jesper

2016-06-30

Attenuating the neurological damage occurring after out-of-hospital cardiac arrest is an ongoing research effort. This dual-centre study investigates the neuroprotective effects of the glucagon-like-peptide-1 analogue Exenatide administered within 4 hours from the return of spontaneous circulation to comatose patients resuscitated from out-of-hospital cardiac arrest. This pilot study will randomize a total of 120 unconscious patients with sustained return of spontaneous circulation after out-of-hospital cardiac arrest undergoing targeted temperature management in a blinded one-to-one fashion to a 6-hour and 15-minute infusion of either Exenatide or placebo. Patients are eligible for inclusion if resuscitated from cardiac arrest with randomization from 20 minutes to 240 minutes after return of spontaneous circulation. The co-primary endpoint is feasibility, defined as the initiation of treatment within the inclusion window in more than 90 % of participants, and efficacy, defined as the area under the neuron-specific enolase curve from 0 to 72 hours after admission. Secondary endpoints include all-cause mortality at 30 days and Cerebral Performance Category as well as a modified Rankin Score at 180 days. The study has been approved by the Danish National Board of Health and the local Ethics Committee and is monitored by Good Clinical Practice units. The study is currently enrolling. This paper presents the methods and planned statistical analyses used in the GLP-1 trial and aims to minimize bias and data-driven reporting of results. 1) Danish National Board of Health, EudraCT 2013-004311-45. Registered on 25 March 2014. 2) Videnskabsetisk komité C, Region Hovedstaden, No. 45728. Registered on 29 January 2014. 3) Clinicaltrial.gov, NCT02442791 . Registered on 25 of January 2015.

Treatments for symptomatic urinary tract infections during pregnancy.

PubMed

Vazquez, Juan C; Abalos, Edgardo

2011-01-19

Urinary tract infections, including pyelonephritis, are serious complications that may lead to significant maternal and neonatal morbidity and mortality. There is a large number of drugs, and combination of them, available to treat urinary tract infections, most of them tested in non-pregnant women. Attempts to define the optimal antibiotic regimen for pregnancy have, therefore, been problematic. The objective of this review was to determine, from the best available evidence from randomised controlled trials, which agent is the most effective for the treatment of symptomatic urinary tract infections during pregnancy in terms of cure rates, recurrent infection, incidence of preterm delivery and premature rupture of membranes, admission to neonatal intensive care unit, need for change of antibiotic, and incidence of prolonged pyrexia. We searched the Cochrane Pregnancy and Childbirth Group Trials Register (November 2009) and reference lists of articles. We considered all trials where the intention was to allocate participants randomly to one of at least two alternative treatments for any symptomatic urinary tract infection. Both review authors assessed trial quality and extracted data. We included 10 studies, recruiting a total of 1125 pregnant women. In most of the comparisons there were no significant differences between the treatments under study with regard to cure rates, recurrent infection, incidence of preterm delivery, admission to neonatal intensive care unit, need for change of antibiotic and incidence of prolonged pyrexia. When cefuroxime and cephradine were compared, there were better cure rates (29/49 versus 41/52) and fewer recurrences (20/49 versus 11/52) in the cefuroxime group. There was only one other statistically significant difference when comparing outpatient versus inpatient treatment. Gestational age at birth was greater in women from the outpatient group (38.86 versus 37.21), while birthweight was on average greater in the inpatient group (3120 versus 2659). Although antibiotic treatment is effective for the cure of urinary tract infections, there are insufficient data to recommend any specific drug regimen for treatment of symptomatic urinary tract infections during pregnancy. All the antibiotics studied were shown to be very effective in decreasing the incidence of the different outcomes. Complications were very rare. All included trials had very small sample sizes to reliably detect important differences between treatments. Future studies should evaluate the most promising antibiotics, in terms of class, timing, dose, acceptability, maternal and neonatal outcomes and costs.

Mobile access to virtual randomization for investigator-initiated trials.

PubMed

Deserno, Thomas M; Keszei, András P

2017-08-01

Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization becomes available for investigator-initiated trials and potentially for large multi-center trials.

Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial.

PubMed

Gupta, Shuchita; Agarwal, Ramesh; Aggarwal, Kailash Chandra; Chellani, Harish; Duggal, Anil; Arya, Sugandha; Bhatia, Sunita; Sankar, Mari Jeeva; Sreenivas, Vishnubhatla; Jain, Vandana; Gupta, Arun Kumar; Deorari, Ashok K; Paul, Vinod K

2017-05-01

Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation. In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31-33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ 12 ) based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149. Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ 12 between two groups: -1·6 (SD 1·2) in the 4 month group versus -1·6 (SD 1·3) in the 6 month group (mean difference 0·005, 95% CI -0·24 to 0·25; p=0·965). There were more hospital admissions in the 4 month group compared with the 6 month group: 2·5 episodes per 100 infant-months in the 4 month group versus 1·4 episodes per 100 infant-months in the 6 month group (incidence rate ratio 1·8, 95% CI 1·0-3·1, p=0·03). 34 (18%) of 188 infants in the 4 month group required hospital admission, compared with 18 (9%) of 192 infants in the 6 month group. Although there was no evidence of effect for the primary endpoint of WAZ 12 , the higher rate of hospital admission in the 4 month group suggests a recommendation to initiate complementary feeding at 6 months over 4 months of corrected age in infants less than 34 weeks of gestation. Indian Council of Medical Research supported the study until Nov 14, 2015. Subsequently, Shuchita Gupta's salary was supported for 2 months by an institute fellowship from All India Institute Of Medical Sciences, and a grant by Wellcome Trust thereafter. Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Comparative effectiveness of coronary CT angiography vs stress cardiac imaging in patients following hospital admission for chest pain work-up: The Prospective First Evaluation in Chest Pain (PERFECT) Trial.

PubMed

Uretsky, Seth; Argulian, Edgar; Supariwala, Azhar; Agarwal, Shiv K; El-Hayek, Georges; Chavez, Patricia; Awan, Hira; Jagarlamudi, Ashadevi; Puppala, Siva P; Cohen, Randy; Rozanski, Alan

2017-08-01

Because the frequency of cardiac event rates is low among chest pain patients following either performance of coronary CT angiography (CCTA) or stress testing, there is a need to better assess how these tests influence the central management decisions that follow from cardiac testing. The present study was performed to assess the relative impact of CCTA vs stress testing on medical therapies and downstream resource utilization among patients admitted for the work-up of chest pain. The admitted patients were randomized in a 1:1 ratio to either cardiac imaging stress test or CCTA. Primary outcomes were time to discharge, change in medication usage, and frequency of downstream testing, cardiac interventions, and cardiovascular re-hospitalizations. We randomized 411 patients, 205 to stress testing, and 206 to CCTA. There were no differences in time to discharge or initiation of new cardiac medications at discharge. At 1 year follow-up, there was no difference in the number of patients who underwent cardiovascular downstream tests in the CCTA vs stress test patients (21% vs 15%, P = .1) or cardiovascular hospitalizations (14% vs 16%, P = .5). However, there was a higher frequency of invasive angiography in the CCTA group (11% vs 2%, P = .001) and percutaneous coronary interventions (6% vs 0%, P < .001). Randomization of hospitalized patients admitted for chest pain work-up to either CCTA or to stress testing resulted in similar discharge times, change in medical therapies at discharge, frequency of downstream noninvasive testing, and repeat hospitalizations. However, a higher frequency of invasive coronary angiography and revascularization procedures were performed in the CCTA arm. (ClinicalTrials.gov number, NCT01604655.).

Impact of empiric nesiritide or milrinone infusion on early postoperative recovery after Fontan surgery: a randomized, double-blind, placebo-controlled trial.

PubMed

Costello, John M; Dunbar-Masterson, Carolyn; Allan, Catherine K; Gauvreau, Kimberlee; Newburger, Jane W; McGowan, Francis X; Wessel, David L; Mayer, John E; Salvin, Joshua W; Dionne, Roger E; Laussen, Peter C

2014-07-01

We sought to determine whether empirical nesiritide or milrinone would improve the early postoperative course after Fontan surgery. We hypothesized that compared with milrinone or placebo, patients assigned to receive nesiritide would have improved early postoperative outcomes. In a single-center, randomized, double-blinded, placebo-controlled, multi-arm parallel-group clinical trial, patients undergoing primary Fontan surgery were assigned to receive nesiritide, milrinone, or placebo. A loading dose of study drug was administered on cardiopulmonary bypass followed by a continuous infusion for ≥12 hours and ≤5 days after cardiac intensive care unit admission. The primary outcome was days alive and out of the hospital within 30 days of surgery. Secondary outcomes included measures of cardiovascular function, renal function, resource use, and adverse events. Among 106 enrolled subjects, 35, 36, and 35 were randomized to the nesiritide, milrinone, and placebo groups, respectively, and all were analyzed based on intention to treat. Demographics, patient characteristics, and operative factors were similar among treatment groups. No significant treatment group differences were found for median days alive and out of the hospital within 30 days of surgery (nesiritide, 20 [minimum to maximum, 0-24]; milrinone, 18 [0-23]; placebo, 20 [0-23]; P=0.38). Treatment groups did not significantly differ in cardiac index, arrhythmias, peak lactate, inotropic scores, urine output, duration of mechanical ventilation, intensive care or chest tube drainage, or adverse events. Compared with placebo, empirical perioperative nesiritide or milrinone infusions are not associated with improved early clinical outcomes after Fontan surgery. http://www.clinicaltrials.gov. Unique identifier: NCT00543309. © 2014 American Heart Association, Inc.

Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction: A meta-analysis of randomized clinical trials.

PubMed

Campo, Gianluca; Pavasini, Rita; Morciano, Giampaolo; Lincoff, A Michael; Gibson, C Michael; Kitakaze, Masafumi; Lonborg, Jacob; Ahluwalia, Amrita; Ishii, Hideki; Frenneaux, Michael; Ovize, Michel; Galvani, Marcello; Atar, Dan; Ibanez, Borja; Cerisano, Giampaolo; Biscaglia, Simone; Neil, Brandon J; Asakura, Masanori; Engstrom, Thomas; Jones, Daniel A; Dawson, Dana; Ferrari, Roberto; Pinton, Paolo; Ottani, Filippo

2017-10-01

To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. Inclusion criteria: RCTs enrolling STEMI patients treated with primary percutaneous coronary intervention (PCI) and comparing drugs targeting mitochondrial function vs. placebo. Odds ratios (OR) were computed from individual studies and pooled with random-effect meta-analysis. Fifteen studies were identified involving 5680 patients. When compared with placebo, drugs targeting mitochondrial component/pathway were not associated with significant reduction of cardiovascular and all-cause mortality (OR 0.9, 95% CI 0.7-1.17 and OR 0.92, 95% CI 0.69-1.23, respectively). However, these agents significantly reduced hospital admission for heart failure (HF) (OR 0.64; 95% CI 0.45-0.92) and increased left ventricular ejection fraction (LVEF) (OR 1.44; 95% CI 1.15-1.82). After analysis for subgroups according to the mechanism of action, drugs with direct/selective action did not reduce any outcome. Conversely, those with indirect/unspecific action showed a significant effect on cardiovascular mortality (0.65, 95% CI 0.46-0.92), all-cause mortality (OR 0.69, 95% CI 0.52-0.92), hospital readmission for HF (OR 0.41, 95% CI 0.28-0.6) and LVEF (OR 1.49, 95% CI 1.09-2.05). Administration of drugs targeting mitochondrial function in STEMI patients undergoing primary PCI appear to have no effect on mortality, but may reduce hospital readmission for HF. The drugs with a broad-spectrum mechanism of action seem to be more effective in reducing adverse events. Copyright © 2017 Elsevier B.V. All rights reserved.

Waveform analysis-guided treatment versus a standard shock-first protocol for the treatment of out-of-hospital cardiac arrest presenting in ventricular fibrillation: results of an international randomized, controlled trial.

PubMed

Freese, John P; Jorgenson, Dawn B; Liu, Ping-Yu; Innes, Jennifer; Matallana, Luis; Nammi, Krishnakant; Donohoe, Rachael T; Whitbread, Mark; Silverman, Robert A; Prezant, David J

2013-08-27

Ventricular fibrillation (VF) waveform properties have been shown to predict defibrillation success and outcomes among patients treated with immediate defibrillation. We postulated that a waveform analysis algorithm could be used to identify VF unlikely to respond to immediate defibrillation, allowing selective initial treatment with cardiopulmonary resuscitation in an effort to improve overall survival. In a multicenter, double-blind, randomized study, out-of-hospital cardiac arrest patients in 2 urban emergency medical services systems were treated with automated external defibrillators using either a VF waveform analysis algorithm or the standard shock-first protocol. The VF waveform analysis used a predefined threshold value below which return of spontaneous circulation (ROSC) was unlikely with immediate defibrillation, allowing selective treatment with a 2-minute interval of cardiopulmonary resuscitation before initial defibrillation. The primary end point was survival to hospital discharge. Secondary end points included ROSC, sustained ROSC, and survival to hospital admission. Of 6738 patients enrolled, 987 patients with VF of primary cardiac origin were included in the primary analysis. No immediate or long-term survival benefit was noted for either treatment algorithm (ROSC, 42.5% versus 41.2%, P=0.70; sustained ROSC, 32.4% versus 33.4%, P=0.79; survival to admission, 34.1% versus 36.4%, P=0.46; survival to hospital discharge, 15.6% versus 17.2%, P=0.55, respectively). Use of a waveform analysis algorithm to guide the initial treatment of out-of-hospital cardiac arrest patients presenting in VF did not improve overall survival compared with a standard shock-first protocol. Further study is recommended to examine the role of waveform analysis for the guided management of VF.

A randomized clinical trial comparing an extended-use hygroscopic condenser humidifier with heated-water humidification in mechanically ventilated patients.

PubMed

Kollef, M H; Shapiro, S D; Boyd, V; Silver, P; Von Harz, B; Trovillion, E; Prentice, D

1998-03-01

To determine the safety and cost-effectiveness of mechanical ventilation with an extended-use hygroscopic condenser humidifier (Duration; Nellcor Puritan-Bennett; Eden Prairie, Minn) compared with mechanical ventilation with heated-water humidification. Prospective randomized clinical trial. Medical and surgical ICUs of Barnes-Jewish Hospital, St. Louis, a university-affiliated teaching hospital. Three hundred ten consecutive qualified patients undergoing mechanical ventilation. Patients requiring mechanical ventilation were randomly assigned to receive humidification with either an extended-use hygroscopic condenser humidifier (for up to the first 7 days of mechanical ventilation) or heated-water humidification. Occurrence of ventilator-associated pneumonia, endotracheal tube occlusion, duration of mechanical ventilation, lengths of intensive care and hospitalization, acquired multiorgan dysfunction, and hospital mortality. One hundred sixty-three patients were randomly assigned to receive humidification with an extended-use hygroscopic condenser humidifier, and 147 patients were randomly assigned to receive heated-water humidification. The two groups were similar at the time of randomization with regard to demographic characteristics, ICU admission diagnoses, and severity of illness. Risk factors for the development of ventilator-associated pneumonia were also similar during the study period for both treatment groups. Ventilator-associated pneumonia was seen in 15 (9.2%) patients receiving humidification with an extended-use hygroscopic condenser humidifier and in 15 (10.2%) patients receiving heated-water humidification (relative risk, 0.90; 95% confidence interval=0.46 to 1.78; p=0.766). No statistically significant differences for hospital mortality, duration of mechanical ventilation, lengths of stay in the hospital ICU, or acquired organ system derangements were found between the two treatment groups. No episode of endotracheal tube occlusion occurred during the study period in either treatment group. The total cost of providing humidification was $2,605 for patients receiving a hygroscopic condenser humidifier compared with $5,625 for patients receiving heated-water humidification. Our findings suggest that the initial application of an extended-use hygroscopic condenser humidifier is a safe and more cost-effective method of providing humidification to patients requiring mechanical ventilation compared with heated-water humidification.

A randomized placebo-controlled trial of an omega-3 fatty acid and vitamins E+C in schizophrenia.

PubMed

Bentsen, H; Osnes, K; Refsum, H; Solberg, D K; Bøhmer, T

2013-12-17

Membrane lipid metabolism and redox regulation may be disturbed in schizophrenia. We examined the clinical effect of adding an omega-3 fatty acid and/or vitamins E+C to antipsychotics. It was hypothesized that lower baseline levels of polyunsaturated fatty acids (PUFAs) would predict more benefit from the add-on treatment. The trial had a multicenter, randomized, double-blind, placebo-controlled 2 × 2 factorial design. Patients aged 18-39 years with schizophrenia or related psychoses were consecutively included at admission to psychiatric departments in Norway. They received active or placebo ethyl-eicosapentaenoate (EPA) 2 g day⁻¹ and active or placebo vitamin E 364 mg day⁻¹+vitamin C 1000 mg day⁻¹ (vitamins) for 16 weeks. The main outcome measures were Positive and Negative Syndrome Scale (PANSS) total and subscales scores, analyzed by linear mixed models. Ninety-nine patients were included. At baseline, erythrocyte PUFA were measured in 97 subjects. Given separately, EPA and vitamins increased drop-out rates, whereas when combined they did not differ from placebo. In low PUFA patients, EPA alone impaired the course of total PANSS (Cohen's d=0.29; P=0.03) and psychotic symptoms (d=0.40; P=0.003), especially persecutory delusions (d=0.48; P=0.0004). Vitamins alone impaired the course of psychotic symptoms (d= 0.37; P=0.005), especially persecutory delusions (d=0.47; P=0.0005). Adding vitamins to EPA neutralized the detrimental effect on psychosis (interaction d=0.31; P=0.02). In high PUFA patients, there were no significant effects of trial drugs on PANSS scales. In conclusion, given separately during an acute episode, EPA and vitamins E+C induce psychotic symptoms in patients with low levels of PUFA. Combined, these agents seem safe.

An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions.

PubMed

Steventon, Adam; Grieve, Richard; Bardsley, Martin

2015-11-01

Policy makers require estimates of comparative effectiveness that apply to the population of interest, but there has been little research on quantitative approaches to assess and extend the generalizability of randomized controlled trial (RCT)-based evaluations. We illustrate an approach using observational data. Our example is the Whole Systems Demonstrator (WSD) trial, in which 3230 adults with chronic conditions were assigned to receive telehealth or usual care. First, we used novel placebo tests to assess whether outcomes were similar between the RCT control group and a matched subset of nonparticipants who received usual care. We matched on 65 baseline variables obtained from the electronic medical record. Second, we conducted sensitivity analysis to consider whether the estimates of treatment effectiveness were robust to alternative assumptions about whether "usual care" is defined by the RCT control group or nonparticipants. Thus, we provided alternative estimates of comparative effectiveness by contrasting the outcomes of the RCT telehealth group and matched nonparticipants. For some endpoints, such as the number of outpatient attendances, the placebo tests passed, and the effectiveness estimates were robust to the choice of comparison group. However, for other endpoints, such as emergency admissions, the placebo tests failed and the estimates of treatment effect differed markedly according to whether telehealth patients were compared with RCT controls or matched nonparticipants. The proposed placebo tests indicate those cases when estimates from RCTs do not generalize to routine clinical practice and motivate complementary estimates of comparative effectiveness that use observational data. Future RCTs are recommended to incorporate these placebo tests and the accompanying sensitivity analyses to enhance their relevance to policy making. © The Author(s) 2015.

Effectiveness of chronic obstructive pulmonary disease-management programs: systematic review and meta-analysis.

PubMed

Peytremann-Bridevaux, Isabelle; Staeger, Philippe; Bridevaux, Pierre-Olivier; Ghali, William A; Burnand, Bernard

2008-05-01

Disease-management programs may enhance the quality of care provided to patients with chronic diseases, such as chronic obstructive pulmonary disease (COPD). The aim of this systematic review was to assess the effectiveness of COPD disease-management programs. We conducted a computerized search of MEDLINE, EMBASE, CINAHL, PsychINFO, and the Cochrane Library (CENTRAL) for studies evaluating interventions meeting our operational definition of disease management: patient education, 2 or more different intervention components, 2 or more health care professionals actively involved in patients' care, and intervention lasting 12 months or more. Programs conducted in hospital only and those targeting patients receiving palliative care were excluded. Two reviewers evaluated 12,749 titles and fully reviewed 139 articles; among these, data from 13 studies were included and extracted. Clinical outcomes considered were all-cause mortality, lung function, exercise capacity (walking distance), health-related quality of life, symptoms, COPD exacerbations, and health care use. A meta-analysis of exercise capacity and all-cause mortality was performed using random-effects models. The studies included were 9 randomized controlled trials, 1 controlled trial, and 3 uncontrolled before-after trials. Results indicate that the disease-management programs studied significantly improved exercise capacity (32.2 m, 95% confidence interval [CI], 4.1-60.3), decreased risk of hospitalization, and moderately improved health-related quality of life. All-cause mortality did not differ between groups (pooled odds ratio 0.84, 95% CI, 0.54-1.40). COPD disease-management programs modestly improved exercise capacity, health-related quality of life, and hospital admissions, but not all-cause mortality. Future studies should explore the specific elements or characteristics of these programs that bring the greatest benefit.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-07-02

The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9-7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18-2.13, and relative risk 14.42, 95% confidence interval 9.40-22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83-14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0-81.0). Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing to a lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed.

SMOKING CESSATION INTERVENTIONS FOR HOSPITALIZED SMOKERS: A SYSTEMATIC REVIEW

PubMed Central

Rigotti, Nancy A.; Munafo, Marcus R.; Stead, Lindsay F.

2009-01-01

Background A hospital admission provides an opportunity to help people stop smoking. Providing smoking cessation advice, counselling, or medication is now a quality-of-care measure for U.S. hospitals. We assessed the effectiveness of smoking cessation interventions initiated during a hospital stay. Methods We searched the Cochrane Tobacco Addiction Review Group's register for randomized and quasi-randomized controlled trials of smoking cessation interventions (behavioral counselling and/or pharmacotherapy) that began during hospitalization and had a minimum of 6 months follow-up. Two authors independently extracted data from each paper, with disagreements resolved by consensus. Results 33 trials met inclusion criteria. Smoking counselling that began during hospitalization and included supportive contacts for >1 month after discharge increased smoking cessation rates at 6-12 months (pooled OR 1.65, 95% CI 1.44-1.90). No benefit was found for interventions with less post-discharge contact. Counselling was effective when offered to all hospitalized smokers and to the subset admitted for cardiovascular disease. Adding nicotine replacement therapy to counselling produced a trend toward efficacy over counseling alone (OR 1.47, 95% CI 0.92-2.35). One study added bupropion to counselling. It had a nonsignificant result (OR 1.56, 95% CI 0.79-3.06). Conclusions Offering smoking cessation counselling to all hospitalized smokers is effective as long as supportive contacts continue for >1 month after discharge. Adding NRT to counselling may further increase smoking cessation rates and should be offered when clinically indicated, especially to hospitalized smokers with nicotine withdrawal symptoms. PMID:18852395

Automatic control of tracheal tube cuff pressure in ventilated patients in semirecumbent position: a randomized trial.

PubMed

Valencia, Mauricio; Ferrer, Miquel; Farre, Ramon; Navajas, Daniel; Badia, Joan Ramon; Nicolas, Josep Maria; Torres, Antoni

2007-06-01

The aspiration of subglottic secretions colonized by bacteria pooled around the tracheal tube cuff due to inadvertent deflation (<20 cm H2O) of the cuff plays a relevant role in the pathogenesis of ventilator-associated pneumonia. We assessed the efficacy of an automatic, validated device for the continuous regulation of tracheal tube cuff pressure in preventing ventilator-associated pneumonia. Prospective randomized controlled trial. Respiratory intensive care unit and general medical intensive care unit. One hundred and forty-two mechanically ventilated patients (age, 64 +/- 17 yrs; Acute Physiology and Chronic Health Evaluation II score, 18 +/- 6) without pneumonia or aspiration at admission. Within 24 hrs of intubation, patients were randomly allocated to undergo continuous regulation of the cuff pressure with the automatic device (n = 73) or routine care of the cuff pressure (control group, n = 69). Patients remained in a semirecumbent position in bed. The primary end point variable was the incidence of ventilator-associated pneumonia. Main causes for intubation were decreased consciousness (43, 30%) and exacerbation of chronic respiratory diseases (38, 27%). Cuff pressure <20 cm H2O was more frequently observed in the control than the automatic group (45.3 vs. 0.7% determinations, p < .001). However, the rate of ventilator-associated pneumonia with clinical criteria (16, 22% vs. 20, 29%) and microbiological confirmation (11, 15% vs. 10, 15%), the distribution of early and late onset, the causative microorganisms, and intensive care unit (20, 27% vs. 16, 23%) and hospital mortality (30, 41% vs. 23, 33%) were similar for the automatic and control groups, respectively. Cuff pressure is better controlled with the automatic device. However, it did not result in additional benefits to the semirecumbent position in preventing ventilator-associated pneumonia.

The effect of aortic morphology on peri-operative mortality of ruptured abdominal aortic aneurysm.

PubMed

2015-06-01

To investigate whether aneurysm shape and extent, which indicate whether a patient with ruptured abdominal aortic aneurysm (rAAA) is eligible for endovascular repair (EVAR), influence the outcome of both EVAR and open surgical repair. The influence of six morphological parameters (maximum aortic diameter, aneurysm neck diameter, length and conicality, proximal neck angle, and maximum common iliac diameter) on mortality and reinterventions within 30 days was investigated in rAAA patients randomized before morphological assessment in the Immediate Management of the Patient with Rupture: Open Versus Endovascular strategies (IMPROVE) trial. Patients with a proven diagnosis of rAAA, who underwent repair and had their admission computerized tomography scan submitted to the core laboratory, were included. Among 458 patients (364 men, mean age 76 years), who had either EVAR (n = 177) or open repair (n = 281) started, there were 155 deaths and 88 re-interventions within 30 days of randomization analysed according to a pre-specified plan. The mean maximum aortic diameter was 8.6 cm. There were no substantial correlations between the six morphological variables. Aneurysm neck length was shorter in those undergoing open repair (vs. EVAR). Aneurysm neck length (mean 23.3, SD 16.1 mm) was inversely associated with mortality for open repair and overall: adjusted OR 0.72 (95% CI 0.57, 0.92) for each 16 mm (SD) increase in length. There were no convincing associations of morphological parameters with reinterventions. Short aneurysm necks adversely influence mortality after open repair of rAAA and preclude conventional EVAR. This may help explain why observational studies, but not randomized trials, have shown an early survival benefit for EVAR. ISRCTN 48334791. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

Early initiation of aspirin after prostate and transurethral bladder surgeries is not associated with increased incidence of postoperative bleeding: a prospective, randomized trial.

PubMed

Ehrlich, Y; Yossepowitch, O; Margel, D; Lask, D; Livne, P M; Baniel, J

2007-08-01

Lower urinary tract operations are being increasingly performed in elderly patients, in whom aspirin intake is common for preventing cardiovascular disease. We determined the safety of early aspirin re-initiation after lower urinary tract surgeries. A randomized, open label clinical trial was done. The study cohort included patients referred for transurethral prostatectomy, open prostatectomy and transurethral resection of bladder tumor while receiving aspirin prophylaxis. After controlling for surgical modality patients were randomized into 2 arms, including aspirin treatment initiation 24 hours after discontinuing of bladder irrigation (early treatment group) and aspirin treatment initiation 3 weeks after surgery (late treatment group). Primary end points were pre-discharge hematuria necessitating the restoration of bladder irrigation or the cessation of aspirin treatment and late hematuria treated in an urgent care setting, requiring hospital admission or compelling the cessation of aspirin treatment. A total of 120 patients were enrolled, including 60 per treatment group. There were no significant differences between the groups in surgery related factors that could have affected postoperative bleeding. Primary end points were attained by 16 of the 120 patients (13.6%), including 10 of the 60 (16.7%) in the early treatment group and 6 (10%) in the late treatment group (p = 0.28). Time to catheter removal and persistent hematuria duration were similar in the 2 groups. Cardiovascular morbidity was noted in 3 of 120 patients, of whom all were assigned to the early treatment group. Early aspirin initiation after lower urinary tract surgeries does not appear to carry an increased risk of postoperative bleeding. Thus, it may be considered in patients at high risk for cardiovascular morbidity.

Randomized trial of pragmatic education for low-risk COPD patients: impact on hospitalizations and emergency department visits.

PubMed

Siddique, Haamid H; Olson, Raymond H; Parenti, Connie M; Rector, Thomas S; Caldwell, Michael; Dewan, Naresh A; Rice, Kathryn L

2012-01-01

Most interventions aimed at reducing hospitalizations and emergency department (ED) visits in patients with chronic obstructive pulmonary disease (COPD) have employed resource-intense programs in high-risk individuals. Although COPD is a progressive disease, little is known about the effectiveness of proactive interventions aimed at preventing hospitalizations and ED visits in the much larger population of low-risk (no known COPD-related hospitalizations or ED visits in the prior year) patients, some of whom will eventually become high-risk. We tested the effect of a simple educational and self-efficacy intervention (n = 2243) versus usual care (n = 2182) on COPD/breathing-related ED visits and hospitalizations in a randomized study of low-risk patients at three Veterans Affairs (VA) medical centers in the upper Midwest. Administrative data was used to track VA admissions and ED visits. A patient survey was used to determine health-related events outside the VA. Rates of COPD-related VA hospitalizations in the education and usual care group were not significantly different (3.4 versus 3.6 admissions per 100 person-years, respectively; 95% CI of difference -1.3 to 1.0, P = 0.77). The much higher patient-reported rates of non-VA hospitalizations for breathing-related problems were lower in the education group (14.0 versus 19.0 per 100 person-years; 95% CI -8.6 to -1.4, P = 0.006). Rates of COPD-related VA ED visits were not significantly different (6.8 versus 5.3; 95% CI -0.1 to 3.0, P = 0.07), nor were non-VA ED visits (32.4 versus 36.5; 95% CI -9.3 to 1.1, P = 0.12). All-cause VA admission and ED rates did not differ. Mortality rates (6.9 versus 8.3 per 100 person-years, respectively; 95% CI -3.0 to 0.4, P = 0.13) did not differ. An educational intervention that is practical for large numbers of low-risk patients with COPD may reduce the rate of breathing-related hospitalizations. Further research that more closely tracks hospitalizations to non-VA facilities is needed to confirm this finding.

Dysglycemia, Glycemic Variability, and Outcome After Cardiac Arrest and Temperature Management at 33°C and 36°C.

PubMed

Borgquist, Ola; Wise, Matt P; Nielsen, Niklas; Al-Subaie, Nawaf; Cranshaw, Julius; Cronberg, Tobias; Glover, Guy; Hassager, Christian; Kjaergaard, Jesper; Kuiper, Michael; Smid, Ondrej; Walden, Andrew; Friberg, Hans

2017-08-01

Dysglycemia and glycemic variability are associated with poor outcomes in critically ill patients. Targeted temperature management alters blood glucose homeostasis. We investigated the association between blood glucose concentrations and glycemic variability and the neurologic outcomes of patients randomized to targeted temperature management at 33°C or 36°C after cardiac arrest. Post hoc analysis of the multicenter TTM-trial. Primary outcome of this analysis was neurologic outcome after 6 months, referred to as "Cerebral Performance Category." Thirty-six sites in Europe and Australia. All 939 patients with out-of-hospital cardiac arrest of presumed cardiac cause that had been included in the TTM-trial. Targeted temperature management at 33°C or 36°C. Nonparametric tests as well as multiple logistic regression and mixed effects logistic regression models were used. Median glucose concentrations on hospital admission differed significantly between Cerebral Performance Category outcomes (p < 0.0001). Hyper- and hypoglycemia were associated with poor neurologic outcome (p = 0.001 and p = 0.054). In the multiple logistic regression models, the median glycemic level was an independent predictor of poor Cerebral Performance Category (Cerebral Performance Category, 3-5) with an odds ratio (OR) of 1.13 in the adjusted model (p = 0.008; 95% CI, 1.03-1.24). It was also a predictor in the mixed model, which served as a sensitivity analysis to adjust for the multiple time points. The proportion of hyperglycemia was higher in the 33°C group compared with the 36°C group. Higher blood glucose levels at admission and during the first 36 hours, and higher glycemic variability, were associated with poor neurologic outcome and death. More patients in the 33°C treatment arm had hyperglycemia.

A randomised, double-blind, multi-centre trial comparing vasopressin and adrenaline in patients with cardiac arrest presenting to or in the Emergency Department.

PubMed

Ong, Marcus Eng Hock; Tiah, Ling; Leong, Benjamin Sieu-Hon; Tan, Elaine Ching Ching; Ong, Victor Yeok Kein; Tan, Elizabeth Ai Theng; Poh, Bee Yen; Pek, Pin Pin; Chen, Yuming

2012-08-01

To compare vasopressin and adrenaline in the treatment of patients with cardiac arrest presenting to or in the Emergency Department (ED). A randomised, double-blind, multi-centre, parallel-design clinical trial in four adult hospitals. Eligible cardiac arrest patients (confirmed by the absence of pulse, unresponsiveness and apnea) aged >16 (aged>21 for one hospital) were randomly assigned to intravenous adrenaline (1mg) or vasopressin (40 IU) at ED. Patients with traumatic cardiac arrest or contraindication for cardiopulmonary resuscitation (CPR) were excluded. Patients received additional open label doses of adrenaline as per current guidelines. Primary outcome was survival to hospital discharge (defined as participant discharged alive or survival to 30 days post-arrest). The study recruited 727 participants (adrenaline = 353; vasopressin = 374). Baseline characteristics of the two groups were comparable. Eight participants (2.3%) from adrenaline and 11 (2.9%) from vasopressin group survived to hospital discharge with no significant difference between groups (p = 0.27, RR = 1.72, 95% CI = 0.65-4.51). After adjustment for race, medical history, bystander CPR and prior adrenaline given, more participants survived to hospital admission with vasopressin (22.2%) than with adrenaline (16.7%) (p = 0.05, RR = 1.43, 95% CI = 1.02-2.04). Sub-group analysis suggested improved outcomes for vasopressin in participants with prolonged arrest times. Combination of vasopressin and adrenaline did not improve long term survival but seemed to improve survival to admission in patients with prolonged cardiac arrest. Further studies on the effect of vasopressin combined with therapeutic hypothermia on patients with prolonged cardiac arrest are needed. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Disease Management Plus Recommended Care versus Recommended Care Alone for Ambulatory COPD Patients.

PubMed

Kalter-Leibovici, Ofra; Benderly, Michal; Freedman, Laurence S; Kaufman, Galit; Molcho Falkenberg Luft, Tchiya; Murad, Havi; Olmer, Liraz; Gluch, Meri; Segev, David; Gilad, Avi; Elkrinawi, Said; Cukierman-Yaffe, Tali; Chen, Baruch; Jacobson, Orit; Key, Calanit; Shani, Mordechai; Fink, Gershon

2018-03-01

The efficacy of disease management programs in the treatment of patients with chronic obstructive pulmonary disease (COPD) remains uncertain. To study the effect of disease management (DM) added to recommended care (RC) in ambulatory COPD patients. In this trial, 1,202 COPD patients (age >40 years), with moderate to very severe airflow limitation were randomly assigned either to DM plus RC (study intervention) or to RC alone (control intervention). RC included follow-up by pulmonologists; inhaled long-acting bronchodilators and corticosteroids; smoking cessation intervention; nutritional advice and psychosocial support when indicated, and supervised physical activity sessions. DM, delivered by trained nurses during patients' visits to the designated COPD centers and remote contacts with the patients between these visits, included patient self-care education; monitoring patients' symptoms and adherence to treatment; provision of advice in case of acute disease exacerbation, and coordination of care vis-à-vis other healthcare providers. The primary composite endpoint was first hospital admission for respiratory symptoms or death from any cause. During 3,537 patient-years, 284 (47.2%) patients in the control group and 264 (44.0%) in the study intervention group had a primary endpoint event. The median (range) time elapsed until a primary endpoint event was 1.0 (0-4.0) years among patients assigned to the study intervention and 1.1 (0-4.1) years among patients assigned to the control intervention; adjusted hazard ratio, 0.92 (95%CI: 0.77 to 1.08). DM added to RC was not superior to RC alone in delaying first hospital admission or death among ambulatory COPD patients. Clinical trial registration available at www.clinicaltrials.gov, ID NCT00982384.

Randomized trials published in some Chinese journals: how many are randomized?

PubMed Central

Wu, Taixiang; Li, Youping; Bian, Zhaoxiang; Liu, Guanjian; Moher, David

2009-01-01

Background The approximately 1100 medical journals now active in China are publishing a rapidly increasing number of research reports, including many studies identified by their authors as randomized controlled trials. It has been noticed that these reports mostly present positive results, and their quality and authenticity have consequently been called into question. We investigated the adequacy of randomization of clinical trials published in recent years in China to determine how many of them met acceptable standards for allocating participants to treatment groups. Methods The China National Knowledge Infrastructure electronic database was searched for reports of randomized controlled trials on 20 common diseases published from January 1994 to June 2005. From this sample, a subset of trials that appeared to have used randomization methods was selected. Twenty-one investigators trained in the relevant knowledge, communication skills and quality control issues interviewed the original authors of these trials about the participant randomization methods and related quality-control features of their trials. Results From an initial sample of 37,313 articles identified in the China National Knowledge Infrastructure database, we found 3137 apparent randomized controlled trials. Of these, 1452 were studies of conventional medicine (published in 411 journals) and 1685 were studies of traditional Chinese medicine (published in 352 journals). Interviews with the authors of 2235 of these reports revealed that only 207 studies adhered to accepted methodology for randomization and could on those grounds be deemed authentic randomized controlled trials (6.8%, 95% confidence interval 5.9–7.7). There was no statistically significant difference in the rate of authenticity between randomized controlled trials of traditional interventions and those of conventional interventions. Randomized controlled trials conducted at hospitals affiliated to medical universities were more likely to be authentic than trials conducted at level 3 and level 2 hospitals (relative risk 1.58, 95% confidence interval 1.18–2.13, and relative risk 14.42, 95% confidence interval 9.40–22.10, respectively). The likelihood of authenticity was higher in level 3 hospitals than in level 2 hospitals (relative risk 9.32, 95% confidence interval 5.83–14.89). All randomized controlled trials of pre-market drug clinical trial were authentic by our criteria. Of the trials conducted at university-affiliated hospitals, 56.3% were authentic (95% confidence interval 32.0–81.0). Conclusion Most reports of randomized controlled trials published in some Chinese journals lacked an adequate description of randomization. Similarly, most so called 'randomized controlled trials' were not real randomized controlled trials owing toa lack of adequate understanding on the part of the authors of rigorous clinical trial design. All randomized controlled trials of pre-market drug clinical trial included in this research were authentic. Randomized controlled trials conducted by authors in high level hospitals, especially in hospitals affiliated to medical universities had a higher rate of authenticity. That so many non-randomized controlled trials were published as randomized controlled trials reflected the fact that peer review needs to be improved and a good practice guide for peer review including how to identify the authenticity of the study urgently needs to be developed. PMID:19573242

Altering Public University Admission Standards to Preserve White Group Position in the United States: Results from a Laboratory Experiment

ERIC Educational Resources Information Center

Samson, Frank L.

2013-01-01

This study identifies a theoretical mechanism that could potentially affect public university admissions standards in a context of demographic change. I explore how demographic changes at a prestigious public university in the United States affect individuals' evaluations of college applications. Responding to a line graph that randomly displays a…

Intramuscular midazolam versus intravenous diazepam for treatment of seizures in the pediatric emergency department: a randomized clinical trial.

PubMed

Portela, J L; Garcia, P C R; Piva, J P; Barcelos, A; Bruno, F; Branco, R; Tasker, R C

2015-04-01

To compare the therapeutic efficacy of intramuscular midazolam (MDZ-IM) with that of intravenous diazepam (DZP-IV) for seizures in children. Randomized clinical trial. Pediatric emergency department. Children aged 2 months to 14 years admitted to the study facility with seizures. Patients were randomized to receive DZP-IV or MDZ-IM. Groups were compared with respect to time to treatment start (min), time from drug administration to seizure cessation (min), time to seizure cessation (min), and rate of treatment failure. Treatment was considered successful when seizure cessation was achieved within 5min of drug administration. Overall, 32 children (16 per group) completed the study. Intravenous access could not be obtained within 5min in four patients (25%) in the DZP-IV group. Time from admission to active treatment and time to seizure cessation was shorter in the MDZ-IM group (2.8 versus 7.4min; p<0.001 and 7.3 versus 10.6min; p=0.006, respectively). In two children per group (12.5%), seizures continued after 10min of treatment, and additional medications were required. There were no between-group differences in physiological parameters or adverse events (p=0.171); one child (6.3%) developed hypotension in the MDZ-IM group and five (31%) developed hyperactivity or vomiting in the DZP-IV group. Given its efficacy and ease and speed of administration, intramuscular midazolam is an excellent option for treatment of childhood seizures, enabling earlier treatment and shortening overall seizure duration. There were no differences in complications when applying MDZ-IM or DZP-IV. Copyright © 2013 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Lithium carbonate in the management of cannabis withdrawal: a randomized placebo-controlled trial in an inpatient setting.

PubMed

Johnston, Jennifer; Lintzeris, Nicholas; Allsop, David J; Suraev, Anastasia; Booth, Jessica; Carson, Dean S; Helliwell, David; Winstock, Adam; McGregor, Iain S

2014-12-01

Preclinical studies suggest that lithium carbonate (lithium) can reduce precipitated cannabinoid withdrawal in rats by stimulating release of the neuropeptide oxytocin, while two open-label studies indicate lithium may ameliorate cannabis withdrawal symptoms in humans. This study was conducted to examine the efficacy and safety of lithium in the inpatient management of cannabis withdrawal and to determine whether lithium affects plasma oxytocin and the rate of elimination of plasma cannabinoids during abstinence. Treatment-seeking cannabis-dependent adults (n = 38) were admitted for 8 days to an inpatient withdrawal unit and randomized to either oral lithium (500 mg) or placebo given twice a day under double-blind randomized controlled trial (RCT) conditions. Primary outcomes included withdrawal severity [cannabis withdrawal scale (CWS)], rates of detoxification completion, and adverse events. Plasma cannabinoids, plasma oxytocin and serum lithium levels were measured repeatedly over admission. Follow-up research interviews were conducted at 14, 30, and 90 days postdischarge. Lithium did not significantly affect total CWS scores relative to placebo, although it significantly reduced individual symptoms of "loss of appetite," "stomach aches," and "nightmares/strange dreams." No significant group differences were found in treatment retention or adverse events. Lithium did not increase plasma oxytocin levels nor influence the rate of elimination of cannabinoids. Both placebo- and lithium-treated participants showed reduced levels of cannabis use (verified by urinalysis) and improved health and psychosocial outcomes at 30- and 90-day follow-up relative to pretreatment baselines. Despite the strong rationale for the present study, the efficacy of lithium over placebo in the management of cannabis withdrawal was not demonstrated.

Antibiotics for preventing suppurative complications from undifferentiated acute respiratory infections in children under five years of age.

PubMed

Alves Galvão, Márcia G; Rocha Crispino Santos, Marilene Augusta; Alves da Cunha, Antonio J L

2016-02-29

Undifferentiated acute respiratory infections (ARIs) are a large and heterogeneous group of infections not clearly restricted to one specific part of the upper respiratory tract, which last for up to seven days. They are more common in pre-school children in low-income countries and are responsible for 75% of the total amount of prescribed antibiotics in high-income countries. One possible rationale for prescribing antibiotics is the wish to prevent bacterial complications. To assess the effectiveness and safety of antibiotics in preventing bacterial complications in children aged two months to 59 months with undifferentiated ARIs. We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (1950 to August week 1, 2015) and EMBASE (1974 to August 2015). Randomised controlled trials (RCTs) or quasi-RCTs comparing antibiotic prescriptions with placebo or no treatment in children aged two months to 59 months with an undifferentiated ARI for up to seven days. Two review authors independently assessed trial quality and extracted and analysed data using the standard Cochrane methodological procedures. We identified four trials involving 1314 children. Three trials investigated the use of amoxicillin/clavulanic acid to prevent otitis and one investigated ampicillin to prevent pneumonia.The use of amoxicillin/clavulanic acid compared to placebo to prevent otitis showed a risk ratio (RR) of 0.70 (95% confidence interval (CI) 0.45 to 1.11, three trials, 414 selected children, moderate-quality evidence). Methods of random sequence generation and allocation concealment were not clearly stated in two trials. Performance, detection and reporting bias could not be ruled out in three trials.Ampicillin compared to supportive care (continuation of breastfeeding, clearing of the nose and paracetamol for fever control) to prevent pneumonia showed a RR of 1.05 (95% CI 0.74 to 1.49, one trial, 889 selected children, moderate-quality evidence). The trial was non-blinded. Random sequence generation and allocation concealment methods were not clearly stated, so the possibility of reporting bias could not be ruled out.Harm outcomes could not be analysed as they were expressed only in percentages.We found no studies assessing mastoiditis, quinsy, abscess, meningitis, hospital admission or death. There is insufficient evidence for antibiotic use as a means of reducing the risk of otitis or pneumonia in children up to five years of age with undifferentiated ARIs. Further high-quality research is needed to provide more definitive evidence of the effectiveness of antibiotics in this population.

Prophylactic versus clinically-driven antibiotics in comatose survivors of out-of-hospital cardiac arrest-A randomized pilot study.

PubMed

Ribaric, Suada Filekovic; Turel, Matjaz; Knafelj, Rihard; Gorjup, Vojka; Stanic, Rade; Gradisek, Primoz; Cerovic, Ognjen; Mirkovic, Tomislav; Noc, Marko

2017-02-01

To investigate benefits of prophylactic antibiotics in comatose survivors of out-of-hospital cardiac arrest (OHCA). Patients without evidence of tracheobronchial aspiration on admission bronchoscopy were randomized to prophylactic Amoxicillin-Clavulanic acid 1.2g every 8h (P) or clinically-driven antibiotics (C) administered if signs of infection developed during initial 7days of intensive care unit (ICU) stay. Among 83 patients enrolled between September 2013 and February 2015, tracheobronchial aspiration was documented in 23 (28%). Accordingly, 60 patients were randomized. Percentage of patients on antibiotics between days 1-5 was significantly greater in P group. White blood count, C-reactive protein, procalcitonin (PCT) and CD 64 significantly increased during the postresuscitation phase. Except for lower CRP and PCT in group P on day 6 (p<0.05), there was no significant differences. Mini BAL on day 3 was less often positive in group P (7% vs. 42%; p<0.01). There was no significant difference in other microbiological samples and X-ray signs of pneumonia cumulatively documented in 50% in both groups. Use of vasopressors/inotropes (93% in both groups), duration of mechanical ventilation (5.4±3.7 vs. 5.2±3.1 days), tracheal intubation (6.5±4.6 vs. 5.9±4.3 days), ICU stay (7.7±5.2 vs. 6.9±4.5 days), survival (73% vs. 73%) and survival with good neurological outcome (50% vs. 40%) were also comparable between P and C groups. Bronchoscopy on admission documented tracheobronchial aspiration in 28% of comatose survivors of OHCA. In the absence of aspiration, prophylactic antibiotics did not significantly alter systemic inflammatory response, postresuscitation pneumonia, ICU treatment and outcome (ClinicalTrials.gov Identifier: NCT02899507). Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-infected women receiving cotrimoxazole prophylaxis: a multicenter randomized placebo-controlled trial.

PubMed

González, Raquel; Desai, Meghna; Macete, Eusebio; Ouma, Peter; Kakolwa, Mwaka A; Abdulla, Salim; Aponte, John J; Bulo, Helder; Kabanywanyi, Abdunoor M; Katana, Abraham; Maculuve, Sonia; Mayor, Alfredo; Nhacolo, Arsenio; Otieno, Kephas; Pahlavan, Golbahar; Rupérez, María; Sevene, Esperança; Slutsker, Laurence; Vala, Anifa; Williamsom, John; Menéndez, Clara

2014-09-01

Intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-negative pregnant women, but it is contraindicated in HIV-infected women taking daily cotrimoxazole prophylaxis (CTXp) because of potential added risk of adverse effects associated with taking two antifolate drugs simultaneously. We studied the safety and efficacy of mefloquine (MQ) in women receiving CTXp and long-lasting insecticide treated nets (LLITNs). A total of 1,071 HIV-infected women from Kenya, Mozambique, and Tanzania were randomized to receive either three doses of IPTp-MQ (15 mg/kg) or placebo given at least one month apart; all received CTXp and a LLITN. IPTp-MQ was associated with reduced rates of maternal parasitemia (risk ratio [RR], 0.47 [95% CI 0.27-0.82]; p=0.008), placental malaria (RR, 0.52 [95% CI 0.29-0.90]; p=0.021), and reduced incidence of non-obstetric hospital admissions (RR, 0.59 [95% CI 0.37-0.95]; p=0.031) in the intention to treat (ITT) analysis. There were no differences in the prevalence of adverse pregnancy outcomes between groups. Drug tolerability was poorer in the MQ group compared to the control group (29.6% referred dizziness and 23.9% vomiting after the first IPTp-MQ administration). HIV viral load at delivery was higher in the MQ group compared to the control group (p=0.048) in the ATP analysis. The frequency of perinatal mother to child transmission of HIV was increased in women who received MQ (RR, 1.95 [95% CI 1.14-3.33]; p=0.015). The main limitation of the latter finding relates to the exploratory nature of this part of the analysis. An effective antimalarial added to CTXp and LLITNs in HIV-infected pregnant women can improve malaria prevention, as well as maternal health through reduction in hospital admissions. However, MQ was not well tolerated, limiting its potential for IPTp and indicating the need to find alternatives with better tolerability to reduce malaria in this particularly vulnerable group. MQ was associated with an increased risk of mother to child transmission of HIV, which warrants a better understanding of the pharmacological interactions between antimalarials and antiretroviral drugs. ClinicalTrials.gov NCT 00811421; Pan African Clinical Trials Registry PACTR 2010020001813440 Please see later in the article for the Editors' Summary.

Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT).

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Ten Dam, Valerie H; Numans, Mattijs E; Schuurmans, Marieke J; de Wit, Niek J

2012-04-25

Currently, primary care for frail older people is reactive, time consuming and does not meet patients' needs. A transition is needed towards proactive and integrated care, so that daily functioning and a good quality of life can be preserved. To work towards these goals, two interventions were developed to enhance the care of frail older patients in general practice: a screening and monitoring intervention using routine healthcare data (U-PRIM) and a nurse-led multidisciplinary intervention program (U-CARE). The U-PROFIT trial was designed to evaluate the effectiveness of these interventions. The aim of this paper is to describe the U-PROFIT trial design and to discuss methodological issues and challenges. The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate. The primary outcome is the effect on activities of daily living as measured with the Katz ADL index. Secondary outcomes are quality of life, mortality, nursing home admission, emergency department and out-of-hours General Practice (GP), surgery visits, and caregiver burden. In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur. Recruitment and retention of patients and feasibility of the interventions are important issues. To enable broad generalizability of results, careful choices of the design and outcome measures are required. Taking this into account, the U-PROFIT trial aims to provide robust evidence for a structured and integrated approach to provide care for frail older people in primary care. NTR2288.

Evaluation of effect of letrozole prior to misoprostol in comparison with misoprostol alone in success rate of induced abortion.

PubMed

Behroozi-Lak, T; Derakhshan-Aydenloo, S; Broomand, F

2018-03-01

Abortion, spontaneous or induced, is a common complication of pregnancy and exploration of available and safe regimens for medical abortion in developing countries seems crucial. The present study was aimed to assess the effect of letrozole in combination with misoprostol in women eligible for legal therapeutic abortion with gestational age ≤14weeks. This clinical randomized trial was conducted on 78 women who were candidate of medical abortion and eligible for legal abortion with gestational age ≤14 weeks that were randomly divided into two groups of case and controls. Case group received daily oral dose of 10mg letrozole for three days followed by vaginal misoprostol. In control group the patients received only vaginal misoprostol. The rate of complete abortion, induction-of-abortion time, and side-effects were assessed. Complete abortion was observed in 30 patients (76.9%) in case group and 9 (23.1%) cases were failed. In control group there was 16 (41.03%) complete abortions and 23 (58.97%) cases were failed to abort. Patients with gestational age of between 6 and 10 weeks did not show significant difference in both groups (P=0.134). Regarding pregnancy remnants there were significant differences between two groups (P=0.034). The time form admission to discharge in case groups were significantly shorter than those in control group (P=0.001). The indication for curettage in case group was significantly less than control group (P=0.001). A 3-day course of letrozole (10mg/daily) followed by misoprostol was associated with a higher complete abortion and lower curettage rates and reduction in time from admission to discharge in women with gestational age ≤14 weeks compared to misoprostol alone. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Usefulness of the admission electrocardiogram to predict long-term outcomes after non-ST-elevation acute coronary syndrome (from the FRISC II, ICTUS, and RITA-3 [FIR] Trials).

PubMed

Damman, Peter; Holmvang, Lene; Tijssen, Jan G P; Lagerqvist, Bo; Clayton, Tim C; Pocock, Stuart J; Windhausen, Fons; Hirsch, Alexander; Fox, Keith A A; Wallentin, Lars; de Winter, Robbert J

2012-01-01

The aim of this study was to evaluate the independent prognostic value of qualitative and quantitative admission electrocardiographic (ECG) analysis regarding long-term outcomes after non-ST-segment elevation acute coronary syndromes (NSTE-ACS). From the Fragmin and Fast Revascularization During Instability in Coronary Artery Disease (FRISC II), Invasive Versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS), and Randomized Intervention Trial of Unstable Angina 3 (RITA-3) patient-pooled database, 5,420 patients with NSTE-ACS with qualitative ECG data, of whom 2,901 had quantitative data, were included in this analysis. The main outcome was 5-year cardiovascular death or myocardial infarction. Hazard ratios (HRs) were calculated with Cox regression models, and adjustments were made for established outcome predictors. The additional discriminative value was assessed with the category-less net reclassification improvement and integrated discrimination improvement indexes. In the 5,420 patients, the presence of ST-segment depression (≥1 mm; adjusted HR 1.43, 95% confidence interval [CI] 1.25 to 1.63) and left bundle branch block (adjusted HR 1.64, 95% CI 1.18 to 2.28) were independently associated with long-term cardiovascular death or myocardial infarction. Risk increases were short and long term. On quantitative ECG analysis, cumulative ST-segment depression (≥5 mm; adjusted HR 1.34, 95% CI 1.05 to 1.70), the presence of left bundle branch block (adjusted HR 2.15, 95% CI 1.36 to 3.40) or ≥6 leads with inverse T waves (adjusted HR 1.22, 95% CI 0.97 to 1.55) was independently associated with long-term outcomes. No interaction was observed with treatment strategy. No improvements in net reclassification improvement and integrated discrimination improvement were observed after the addition of quantitative characteristics to a model including qualitative characteristics. In conclusion, in the FRISC II, ICTUS, and RITA-3 NSTE-ACS patient-pooled data set, admission ECG characteristics provided long-term prognostic value for cardiovascular death or myocardial infarction. Quantitative ECG characteristics provided no incremental discrimination compared to qualitative data. Copyright © 2012 Elsevier Inc. All rights reserved.

Efficacy of Synbiotics for Treatment of Bacillary Dysentery in Children: A Double-Blind, Randomized, Placebo-Controlled Study.

PubMed

Kahbazi, Manijeh; Ebrahimi, Marzieh; Zarinfar, Nader; Arjomandzadegan, Mohammad; Fereydouni, Taha; Karimi, Fatemeh; Najmi, Amir Reza

2016-01-01

Bacillary dysentery is a major cause of children's admission to hospitals. To assess the probiotic and prebiotic (synbiotics) effects in children with dysentery in a randomized clinical trial, 200 children with dysentery were studied in 2 groups: the synbiotic group received 1 tablet/day of synbiotic for 3-5 days and the placebo group received placebo tablets (identical tablet form like probiotics). The standard treatment was administered for all patients. Duration of hospitalization, dysentery, fever, and the weight loss were assessed in each group. It was concluded that there was no significant difference in both groups in the baseline characteristics. The mean duration of dysentery reduced ( P < 0.05). The mean duration of fever has been significantly reduced in the synbiotic group (1.64 ± 0.87 days) in comparison to the placebo group (2.13 ± 0.94 days) ( P < 0.001). Average amount of weight loss was significantly lower in the synbiotic group in comparison to that in the placebo group (129.5 ± 23.388 grams and 278 ± 28.385 grams, resp.; P < 0.001). There was no significant difference in the mean duration of hospitalization in both groups ( P > 0.05). The use of synbiotics as an adjuvant therapy to the standard treatment of dysentery significantly reduces the duration of dysentery, fever, and rate of weight losses. The trial is registered with IRCT201109267647N1.

Insufficient evidence of benefit regarding mortality due to albumin substitution in HCC-free cirrhotic patients undergoing large volume paracentesis.

PubMed

Kütting, Fabian; Schubert, Jens; Franklin, Jeremy; Bowe, Andrea; Hoffmann, Vera; Demir, Muenevver; Pelc, Agnes; Nierhoff, Dirk; Töx, Ulrich; Steffen, Hans-Michael

2017-02-01

Current guidelines for clinical practice recommend the infusion of human albumin after large volume paracentesis. After inspecting the current evidence behind this recommendation, we decided to conduct a systematic review and meta-analysis in order to address the effect of albumin on mortality and morbidity in the context of large volume paracentesis. We performed a comprehensive search of large databases and abstract books of conference proceedings up to March 15th 2016 for randomized controlled trials, testing the infusion of human albumin against alternatives (vs no treatment, vs plasma expanders; vs vasoconstrictors) in HCC-free patients suffering from cirrhosis. We analyzed these trials with regard to mortality, changes in plasma renin activity (PRA), hyponatremia, renal impairment, recurrence of ascites with consequential re-admission into hospital and additional complications. We employed trial sequential analysis in order to calculate the number of patients required in controlled trials to be able to determine a statistically significant advantage of the administration of one agent over another with regard to mortality. We were able to include 21 trials totaling 1277 patients. While the administration of albumin prevents a rise in PRA as well as hyponatremia, no improvement in strong clinical endpoints such as mortality could be demonstrated. Trial sequential analysis showed that at least 1550 additional patients need to be recruited into RCTs and analyzed with regard to this question in order to detect or disprove a 25% mortality effect. There is insufficient evidence that the infusion of albumin after LVP significantly lowers mortality in HCC-free patients with advanced liver disease. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

Does Telehealth Monitoring Identify Exacerbations of Chronic Obstructive Pulmonary Disease and Reduce Hospitalisations? An Analysis of System Data

PubMed Central

Bentley, Claire L; Mountain, Gail A

2017-01-01

Background The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable. Health care organizations are focusing on ways to support self-management and prevent hospital admissions, including telehealth-monitoring services capturing physiological and health status data. This paper reports on data captured during a pilot randomized controlled trial of telehealth-supported care within a community-based service for patients discharged from hospital following an exacerbation of their COPD. Objective The aim was to undertake the first analysis of system data to determine whether telehealth monitoring can identify an exacerbation of COPD, providing clinicians with an opportunity to intervene with timely treatment and prevent hospital readmission. Methods A total of 23 participants received a telehealth-supported intervention. This paper reports on the analysis of data from a telehealth monitoring system that captured data from two sources: (1) data uploaded both manually and using Bluetooth peripheral devices by the 23 participants and (2) clinical records entered as nursing notes by the clinicians. Rules embedded in the telehealth monitoring system triggered system alerts to be reviewed by remote clinicians who determined whether clinical intervention was required. We also analyzed data on the frequency and length (bed days) of hospital admissions, frequency of hospital Accident and Emergency visits that did not lead to hospital admission, and frequency and type of community health care service contacts—other than the COPD discharge service—for all participants for the duration of the intervention and 6 months postintervention. Results Patients generated 512 alerts, 451 of which occurred during the first 42 days that all participants used the equipment. Patients generated fewer alerts over time with typically seven alerts per day within the first 10 days and four alerts per day thereafter. They also had three times more days without alerts than with alerts. Alerts were most commonly triggered by reports of being more tired, having difficulty with self-care, and blood pressure being out of range. During the 8-week intervention, and for 6-month follow-up, eight of the 23 patients were hospitalized. Hospital readmission rates (2/23, 9%) in the first 28 days of service were lower than the 20% UK norm. Conclusions It seems that the clinical team can identify exacerbations based on both an increase in alerts and the types of system-generated alerts as evidenced by their efforts to provided treatment interventions. There was some indication that telehealth monitoring potentially delayed hospitalizations until after patients had been discharged from the service. We suggest that telehealth-supported care can fulfill an important role in enabling patients with COPD to better manage their condition and remain out of hospital, but adequate resourcing and timely response to alerts is a critical factor in supporting patients to remain at home. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 68856013; http://www.isrctn.com/ISRCTN68856013 (Archived by WebCite at http://www.webcitation.org/6ofApNB2e) PMID:28330829

The effect on physical performance of a functional assessment and immediate rehabilitation of acutely admitted elderly patients with reduced functional performance: the design of a randomised clinical trial

PubMed Central

Bruun, Inge Hansen; Nørgaard, Birgitte; Maribo, Thomas; Schiøttz-Christensen, Berit; Mogensen, Christian Backer

2014-01-01

Introduction Illness and hospitalisation, even of short duration, pose separate risks for permanently reduced functional performance in elderly medical patients. Functional assessment in the acute pathway will ensure early detection of declining performance and form the basis for mobilisation during hospitalisation and subsequent rehabilitation. For optimal results rehabilitation should begin immediately after discharge.The aim of this study is to investigate the effect of a systematic functional assessment in the emergency department (ED) of elderly medical patients with reduced functional performance when combined with immediate postdischarge rehabilitation. Method and analysis The study is a two-way factorial randomised clinical trial. Participants will be recruited among patients admitted to the ED who are above 65 years of age with reduced functional performance. Patients will be randomly assigned to one of four groups: (1) functional assessment and immediate rehabilitation; (2) functional assessment and rehabilitation as usual; (3) assessment as usual and immediate rehabilitation; (4) assessment and rehabilitation as usual. Primary outcome 30 s chair-stand test administered at admission and 3 weeks after discharge. Ethics and dissemination The study has been approved by the Regional Scientific Ethical Committees of Southern Denmark in February 2014. The study findings will be published in peer-reviewed journals and presented at national and international conferences. Trial registration number: ClinicalTrials.gov Identifier: NCT02062541. PMID:24939812

Preoperative hydration with 0.9% normal saline to prevent acute kidney injury after major elective open abdominal surgery: A randomised controlled trial.

PubMed

Serrano, Ana B; Candela-Toha, Angel M; Zamora, Javier; Vera, Jorge; Muriel, Alfonso; Del Rey, Jose M; Liaño, Fernando

2016-06-01

Postoperative acute kidney injury (AKI) is the second leading cause of hospital-acquired AKI. Although many preventive strategies have been tested, none of them has been totally effective. We investigated whether preoperative intravenous hydration with 0.9% normal saline could prevent postoperative AKI. Randomised controlled trial. University Ramón y Cajal Hospital, Spain, from June 2006 to February 2011. Total 328 inpatients scheduled for major elective open abdominal surgery. 0.9% normal saline at a dose of 1.5 ml kg h for 12 h before surgery. The primary outcome was the overall postoperative AKI incidence during the first week after surgery defined by risk, injury, failure, loss, end-stage kidney disease (RIFLE) and AKI network (AKIN) creatinine criteria. Secondary endpoints were the need for ICU admission, renal replacement therapy during the study period and adverse events and hospital mortality during hospital admission. There was no difference in the incidence of AKI between groups: 4.7% in the normal saline group versus 5.0% in the control group and 11.4% in the 0.9% normal saline group versus 7.9% in the control group as assessed by the RIFLE and AKIN creatinine criteria, respectively. Absolute risk reductions (95% confidence interval) were -0.3% (-5.3 to 4.7%) for RIFLE and 3.5% (-10.2 to 3.6%) for AKIN. ICU admission after surgery was required in 44.5% of all participants. Only 2 (0.7%) patients required renal replacement therapy during the first week after surgery. The analysis of adverse events did not show statistically significant differences between the groups except for pain. In our population, 8 (2.4%) patients died during their hospital admission. Intravenous hydration with 0.9% normal saline before major open abdominal surgery was not effective in preventing postoperative AKI. No safety concerns were identified during the trial. Clinical trials.gov: NCT00953940 and EUDRA CT: 2005-004755-35.

Pilot trial of diabetes self-management education in the hospital setting.

PubMed

Korytkowski, Mary T; Koerbel, Glory L; Kotagal, Lindsey; Donihi, Amy; DiNardo, Monica M

2014-10-01

Diabetes self-management education (DSME) is recommended for all patients with diabetes. Current estimates indicate that <50% of patients receive DSME, increasing risk for hospitalization which occurs more frequently with diabetes. Hospitalization presents opportunities to provide DSME, potentially decreasing readmissions. To address this, we investigated the feasibility of providing DSME to inpatients with diabetes. Patients hospitalized on four medicine units were randomized to receive DSME (Education Group) (n=9) prescribed by a certified diabetes educator and delivered by a registered nurse, or Usual Care (n=12). Participants completed Diabetes Knowledge Tests (DKT), Medical Outcomes Short Form (SF-36), Diabetes Treatment Satisfaction Questionnaire (DTSQ), and the DTSQ-inpatient (DTSQ-IP). Bedside capillary blood glucoses (CBG) on day of admission, randomization and discharge were compared. There were no group differences in demographics, diabetes treatment, admission CBG (186±93 mg/dL vs. 219±84 mg/dL, p=0.40), DKT scores (Education vs. Usual Care 48±25 vs. 68±19, p=0.09), SF-36, and DTSQ scores (28±6 vs. 25±7, p=0.41). Patients receiving education reported more satisfaction with inpatient treatment (83±13 vs. 65±19, p=0.03), less hyperglycemia prior to (2.7±4.5 vs. 4.5±1.4, p=0.03) and during hospitalization (3.9±1.9 vs. 5.5±1.2, p=0.04); and had lower mean discharge CBG (159±38 mg/dL vs. 211±67 mg/dL, p=0.02). Inpatient diabetes education has potential to improve treatment satisfaction, and reduce CBG. Copyright © 2013. Published by Elsevier Ltd.

Optimal timing of coronary angiography and potential intervention in non-ST-elevation acute coronary syndromes.

PubMed

Katritsis, Demosthenes G; Siontis, George C M; Kastrati, Adnan; van't Hof, Arnoud W J; Neumann, Franz-Josef; Siontis, Konstantinos C M; Ioannidis, John P A

2011-01-01

An invasive approach is superior to medical management for the treatment of patients with acute coronary syndromes without ST-segment elevation (NSTE-ACS), but the optimal timing of coronary angiography and subsequent intervention, if indicated, has not been settled. We conducted a meta-analysis of randomized trials addressing the optimal timing (early vs. delayed) of coronary angiography in NSTE-ACS. Four trials with 4013 patients were eligible (ABOARD, ELISA, ISAR-COOL, TIMACS), and data for longer follow-up periods than those published became available for this meta-analysis by the ELISA and ISAR-COOL investigators. The median time from admission or randomization to coronary angiography ranged from 1.16 to 14 h in the early and 20.8-86 h in the delayed strategy group. No statistically significant difference of risk of death [random effects risk ratio (RR) 0.85, 95% confidence interval (CI) 0.64-1.11] or myocardial infarction (MI) (RR 0.94, 95% CI 0.61-1.45) was detected between the two strategies. Early intervention significantly reduced the risk for recurrent ischaemia (RR 0.59, 95% CI 0.38-0.92, P = 0.02) and the duration of hospital stay (by 28%, 95% CI 22-35%, P < 0.001). Furthermore, decreased major bleeding events (RR 0.78, 95% CI 0.57-1.07, P = 0.13), and less major events (death, MI, or stroke) (RR 0.91, 95% CI 0.82-1.01, P = 0.09) were observed with the early strategy but these differences were not nominally significant. Early coronary angiography and potential intervention reduces the risk of recurrent ischaemia, and shortens hospital stay in patients with NSTE-ACS.

Warming preterm infants in the delivery room: polyethylene bags, exothermic mattresses or both?

PubMed

McCarthy, Lisa K; O'Donnell, Colm P F

2011-12-01

To compare the admission temperature of infants treated with polyethylene bags alone to infants treated with exothermic mattresses in addition to bags in the delivery room. We prospectively studied infants born at <31 weeks' gestation who were placed in bags at birth. Some infants were also placed on mattresses. Admission axillary temperatures were measured in all infants on admission to the neonatal intensive care. We compared the temperatures of infants treated with bags alone to those treated with mattresses and bags. We studied 43 infants: 15 were treated with bags while 28 were treated with a bag and mattress. Mean admission temperature was similar between the groups. Hypothermia and hyperthermia occurred more frequently in infants treated with a bag and mattress, and more infants treated with a bag had admission temperatures 36.5-37.5°C. The use of exothermic mattresses in addition to polyethylene bags, particularly in younger, smaller newborns, may result in more hypothermia and hyperthermia on admission. A randomised controlled trial is necessary to determine which strategy results in more infants having admission temperatures in the normal range. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial.

PubMed

Dennis, M S; Lewis, S C; Warlow, C

Undernutrition is common in patients admitted with stroke. We aimed to establish whether the timing and route of enteral tube feeding after stroke affected patients' outcomes at 6 months. The FOOD trials consist of three pragmatic multicentre randomised controlled trials, two of which included dysphagic stroke patients. In one trial, patients enrolled within 7 days of admission were randomly allocated to early enteral tube feeding or no tube feeding for more than 7 days (early versus avoid). In the other, patients were allocated percutaneous endoscopic gastrostomy (PEG) or nasogastric feeding. The primary outcome was death or poor outcome at 6 months. Analysis was by intention to treat. Between Nov 1, 1996, and July 31, 2003, 859 patients were enrolled by 83 hospitals in 15 countries into the early versus avoid trial. Early tube feeding was associated with an absolute reduction in risk of death of 5.8% (95% CI -0.8 to 12.5, p=0.09) and a reduction in death or poor outcome of 1.2% (-4.2 to 6.6, p=0.7). In the PEG versus nasogastric tube trial, 321 patients were enrolled by 47 hospitals in 11 countries. PEG feeding was associated with an absolute increase in risk of death of 1.0% (-10.0 to 11.9, p=0.9) and an increased risk of death or poor outcome of 7.8% (0.0 to 15.5, p=0.05). Early tube feeding might reduce case fatality, but at the expense of increasing the proportion surviving with poor outcome. Our data do not support a policy of early initiation of PEG feeding in dysphagic stroke patients.

Can we predict 4-year graduation in podiatric medical school using admission data?

PubMed

Sesodia, Sanjay; Molnar, David; Shaw, Graham P

2012-01-01

This study examined the predictive ability of educational background and demographic variables, available at the admission stage, to identify applicants who will graduate in 4 years from podiatric medical school. A logistic regression model was used to identify two predictors of 4-year graduation: age at matriculation and total Medical College Admission Test score. The model was cross-validated using a second independent sample from the same population. Cross-validation gives greater confidence that the results could be more generally applied. Total Medical College Admission Test score was the strongest predictor of 4-year graduation, with age at matriculation being a statistically significant but weaker predictor. Despite the model's capacity to predict 4-year graduation better than random assignment, a sufficient amount of error in prediction remained, suggesting that important predictors are missing from the model. Furthermore, the high rate of false-positives makes it inappropriate to use age and Medical College Admission Test score as admission screens in an attempt to eliminate attrition by not accepting at-risk students.

A small-scale randomised controlled trial of home telemonitoring in patients with severe chronic obstructive pulmonary disease.

PubMed

Shany, Tal; Hession, Michael; Pryce, David; Roberts, Mary; Basilakis, Jim; Redmond, Stephen; Lovell, Nigel; Schreier, Guenter

2017-08-01

Introduction This was a pilot study to examine the effects of home telemonitoring (TM) of patients with severe chronic obstructive pulmonary disease (COPD). Methods A randomised controlled 12-month trial of 42 patients with severe COPD was conducted. Home TM of oximetry, temperature, pulse, electrocardiogram, blood pressure, spirometry, and weight with telephone support and home visits was tested against a control group receiving only identical telephone support and home visits. Results The results suggest that TM had a reduction in COPD-related admissions, emergency department presentations, and hospital bed days. TM also seemed to increase the interval between COPD-related exacerbations requiring a hospital visit and prolonged the time to the first admission. The interval between hospital visits was significantly different between the study arms, while the other findings did not reach significance and only suggest a trend. There was a reduction in hospital admission costs. TM was adopted well by most patients and eventually, also by the nursing staff, though it did not seem to change patients' psychological well-being. Discussion Ability to draw firm conclusions is limited due to the small sample size. However the trends of reducing hospital visits warrant a larger study of a similar design. When designing such a trial, one should consider the potential impact of the high quality of care already made available to this patient cohort.

AiRCare: A naturalistic evaluation of the effectiveness of a protracted telephone-based recovery assistance program on continuing care outcomes.

PubMed

Proctor, Steven L; Wainwright, Jaclyn L; Herschman, Philip L; Kopak, Albert M

2017-02-01

Substance use disorder treatments are increasingly being contextualized within a disease management framework. Within this context, there is an identified need to maintain patients in treatment for longer periods of time in order to help them learn how to manage their disease. One way to meet this need is through telephone-based interventions that engage patients, and include more active outreach attempts and involvement of the patient's family. This study sought to evaluate the effectiveness of three formats of an intensive 12-month post-discharge telephone-based case management approach (AiRCare) on adherence to continuing care plans and substance use outcomes. Data were abstracted from electronic medical records for 379 patients (59.9% male) discharged from a residential treatment program located in the southwestern U.S. from 2013 to 2015. Patients were categorized into one of three groups and received telephone contacts based on their self-selection upon admission to residential treatment (i.e., patient only, family only, and both patient and family). Outcome variables included re-engagement and re-admission rates, quality of life, abstinence rates at 6 and 12 months, and compliance with continuing care plans. Favorable short- and long-term outcomes were found for the majority of patients, irrespective of case management group. There appeared to be some value in the addition of family contacts to patient contacts with respect to reducing risk for 12-month re-admission to residential care. These positive but preliminary indications of the effectiveness of AiRCare require replication in a well-powered, randomized controlled trial. Copyright © 2016 Elsevier Inc. All rights reserved.

Revisiting sample size: are big trials the answer?

PubMed

Lurati Buse, Giovanna A L; Botto, Fernando; Devereaux, P J

2012-07-18

The superiority of the evidence generated in randomized controlled trials over observational data is not only conditional to randomization. Randomized controlled trials require proper design and implementation to provide a reliable effect estimate. Adequate random sequence generation, allocation implementation, analyses based on the intention-to-treat principle, and sufficient power are crucial to the quality of a randomized controlled trial. Power, or the probability of the trial to detect a difference when a real difference between treatments exists, strongly depends on sample size. The quality of orthopaedic randomized controlled trials is frequently threatened by a limited sample size. This paper reviews basic concepts and pitfalls in sample-size estimation and focuses on the importance of large trials in the generation of valid evidence.

Stapled haemorrhoidopexy for the treatment of haemorrhoids: a systematic review.

PubMed

Burch, J; Epstein, D; Sari, A Baba-Akbari; Weatherly, H; Jayne, D; Fox, D; Woolacott, N

2009-03-01

This systematic review aimed to evaluate the short- and long-term safety, efficacy and costs of stapled haemorrhoidopexy (SH) compared with conventional haemorrhoidectomy. We searched 26 electronic databases and websites for studies in any language up to July 2006. Inclusion criteria were predefined, and each stage of the review process was conducted in duplicate. Twenty-seven randomized controlled trials were included (n = 2279). All had some methodological flaws. Postoperatively, 19 trials (95%) reported less pain, 17 (89%) reported a shorter operating time, 14 (88%) a shorter hospital stay, and 14 (93%) a shorter convalescence time following SH. However, prolapse was significantly more common after SH (OR 3.38; 95% CI: 1.00, 11.47). In the longer term, prolapse was significantly more common after SH (OR 4.34; 95% CI: 1.67, 11.28) as was reintervention for prolapse (OR 6.78; 95% CI: 2.00, 23.00). There were no differences in the rate or type of complications. Conventional haemorrhoidectomy and SH had similar costs during the initial admission. Compared with conventional haemorrhoidectomy, SH resulted in less postoperative pain, shorter operating time, a shorter hospital stay, and a shorter convalescence, but a higher rate of prolapse and reintervention for prolapse.

Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial.

PubMed

De Vera, Mary A; Sadatsafavi, Mohsen; Tsao, Nicole W; Lynd, Larry D; Lester, Richard; Gastonguay, Louise; Galo, Jessica; FitzGerald, J Mark; Brasher, Penelope; Marra, Carlo A

2014-12-13

Medication regimens for asthma are particularly vulnerable to adherence problems because of the requirement for long-term use and periods of symptom remission experienced by patients. Pharmacists are suited to impact medication adherence given their training, skills, and frequent contact with patients. The Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS) trial involves an intervention leveraging mobile health (mHealth) technology to support community pharmacy practice with the hypothesis of improved medication adherence in asthma. This study is a pragmatic pharmacy-based, cluster, randomized controlled trial with 12 months of intervention delivery and follow-up. Pharmacies (the clusters) will be randomized at a 1:1 ratio to provide intervention or usual care. The EmPhAsIS intervention consists of patient asthma education, short message service (SMS)-based monthly assessment of adherence, and follow-up of non-adherent individuals by community pharmacists. There are no inclusion or exclusion criteria for pharmacies. Patients are eligible if they: are 14 years of age or older, fill a prescription for inhaled corticosteroid (either monotherapy or in a combination inhaler with long-acting beta-agonists), have been diagnosed with asthma, possess a mobile phone with SMS capabilities, and have no communication difficulties such as inability to communicate in English, or significant impairment in vision, hearing, or speech. The primary outcome is adherence to inhaled corticosteroids ascertained by the medication possession ratio, the ratio of the days of medication supplied to days in a given time interval. This study will also evaluate secondary outcomes including: asthma control, asthma-related quality of life, asthma-related hospital admissions, and use of reliever medications during the follow-up period. A nested economic evaluation using a probabilistic decision-analytic model will be used to perform a cost-effectiveness analysis from the societal perspective of the intervention compared with usual care over a 10-year time horizon. Considering the prevalence of asthma, the extent of the non-adherence problem in this disease, and the availability of effective treatments, there is a tremendous potential to reduce the burden of asthma through improving adherence. This is the first study of an intervention based on mobile communication technology involving community pharmacists in asthma management. ClinicalTrials.gov identifier: NCT02170883; date of registration: 19 June 2014.

Clinical Importance of Temporal Bone Features for the Efficacy of Contrast-Enhanced Sonothrombolysis: a Retrospective Analysis of the NOR-SASS Trial.

PubMed

Novotny, Vojtech; Nacu, Aliona; Kvistad, Christopher E; Fromm, Annette; Neckelmann, Gesche F; Khanevski, Andrej N; Tobro, Haakon; Waje-Andreassen, Ulrike; Naess, Halvor; Thomassen, Lars; Logallo, Nicola

2017-11-08

Contrast-enhanced sonothrombolysis (CEST) seems to be a safe and promising treatment in acute ischemic stroke. It remains unknown if temporal bone features may influence the efficacy of CEST. We investigated the association between different temporal bone features on admission computed tomography (CT) scan and the outcome in acute ischemic stroke patients included in the randomized Norwegian Sonothrombolysis in Acute Stroke Study (NOR-SASS). Patients diagnosed as stroke mimics and those with infratentorial stroke or with incorrect insonation were excluded. We retrospectively assessed temporal bone heterogeneity (presence of diploë), diploë ratio, thickness, and density on admission CT scans. National institute of Health Stroke Scale (NIHSS) at 24 h and modified Rankin Scale (mRS) at 3 months were correlated with CT findings both in CEST and sham CEST patients. A total of 99 patients were included of which 52 were assigned to CEST and 47 to sham CEST. Approximately 20% patients had a heterogeneous temporal bone in both the CEST and sham CEST group. All temporal bone CT features studied were associated with female sex. In the CEST group, temporal bone heterogeneity (p = 0.006) and higher temporal bone diploë ratio (p = 0.002) were associated with higher NIHSS at 24 h. There was no association between temporal bone features and mRS at 3 months. Approximately 20% of acute ischemic stroke patients have heterogeneous temporal bone and may be resistant to standard 2-MHz transcranial Doppler ultrasound treatment. Sonothrombolysis resistance may easily be predicted by admission CT for better selection.

The Paradox of Pelvic Exenteration: The Interaction of Clinical and Psychological Variables.

PubMed

Arnaboldi, Paola; Santoro, Luigi; Mazzocco, Ketti; Oliveri, Serena; Maggioni, Angelo; Pravettoni, Gabriella

2015-10-01

To text the feasibility of a psychological intervention package administered to 49 pelvic exenteration candidates, aimed at evaluating the preoperative prevalence of psychological distress and assessing the presence of any correlation between preoperative psychological distress and clinical variables such as pain and hospitalization length. Patients were referred to the psychology unit from the very beginning of their clinical pathway and were administered the Psychological Distress Inventory (PDI) and the Mini-Mental Adjustment to Cancer (Mini-MAC) questionnaire at prehospital admission. Patients presenting with a significant level of distress received nonstandardized psychological support. Statistical analyses were performed to detect the presence of any correlation between psychological variables at prehospital admission and clinical outcomes. The 40% of patients had significant levels of distress at prehospital admission (PDI ≥ 30). As regards Mini-MAC, the mean value of fighting spirit attitude and fatalism was higher in our sample than in the normative sample of the Mini-MAC validation study in the Italian cancer population. Their anxious preoccupation attitude was lower. There were no correlations between clinical and psychological variables: level of postsurgery pain was higher (3.7) in the subgroup of patients with presurgery PDI < 30 compared with those with PDI ≥ 30 (3.5). However, this difference was not statistically significant (P = 1.00). Considering hospitalization length, the above described trend was similar. Although highly distressed, pelvic exenteration candidates show an adaptive range of coping mechanisms. This calls for a greater effort in studying the complexity of their psychoemotional status to provide them with the best multidisciplinary care. Extensive study of the real effectiveness of psychological intervention is warranted: randomized clinical trials could help in detecting the presence of any correlation between clinical and psychological variables in a multidisciplinary approach.

Methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association, 1999-2013.

PubMed

Landorf, Karl B; Menz, Hylton B; Armstrong, David G; Herbert, Robert D

2015-07-01

Randomized trials must be of high methodological quality to yield credible, actionable findings. The main aim of this project was to evaluate whether there has been an improvement in the methodological quality of randomized trials published in the Journal of the American Podiatric Medical Association (JAPMA). Randomized trials published in JAPMA during a 15-year period (January 1999 to December 2013) were evaluated. The methodological quality of randomized trials was evaluated using the PEDro scale (scores range from 0 to 10, with 0 being lowest quality). Linear regression was used to assess changes in methodological quality over time. A total of 1,143 articles were published in JAPMA between January 1999 and December 2013. Of these, 44 articles were reports of randomized trials. Although the number of randomized trials published each year increased, there was only minimal improvement in their methodological quality (mean rate of improvement = 0.01 points per year). The methodological quality of the trials studied was typically moderate, with a mean ± SD PEDro score of 5.1 ± 1.5. Although there were a few high-quality randomized trials published in the journal, most (84.1%) scored between 3 and 6. Although there has been an increase in the number of randomized trials published in JAPMA, there is substantial opportunity for improvement in the methodological quality of trials published in the journal. Researchers seeking to publish reports of randomized trials should seek to meet current best-practice standards in the conduct and reporting of their trials.

Effectiveness of assistive technology in improving the safety of people with dementia: a systematic review and meta-analysis.

PubMed

Brims, Lucy; Oliver, Kathryn

2018-04-10

Assistive technology (AT) may enable people with dementia to live safely at home for longer, preventing care home admission. This systematic review assesses the effectiveness of AT in improving the safety of people with dementia living in the domestic setting, by searching for randomised controlled trials, non-randomised controlled trials and controlled before-after studies which compared safety AT with treatment as usual. Measures of safety include care home admission; risky behaviours, accidents and falls at home; and numbers of deaths. The review updates the safety aspect of Fleming and Sum's 2014 systematic review. Seven bibliographic databases, the Social Care Institute for Excellence website and the Alzheimer's Society website were searched for published and unpublished literature between 2011-2016. Search terms related to AT, dementia and older people. Common outcomes were meta-analysed. Three randomised controlled trials were identified, including 245 people with dementia. No significant differences were found between intervention and control groups in care home admission (risk ratio 0.85 95% CI [0.37, 1.97]; Z = 0.37; p = 0.71). The probability of a fall occurring was 50% lower in the intervention group (risk ratio 0.50 95% CI [0.32, 0.78]; Z = 3.03; p = 0.002). One included study found that a home safety package containing AT significantly reduced risky behaviour and accidents (F(45) = 4.504, p < 0.001). Limitations include the few studies found and the inclusion of studies in English only. AT's effectiveness in decreasing care home admission is inconclusive. However, the AT items and packages tested improved safety through reducing falls risk, accidents and other risky behaviour.

Safety and efficacy of alternative antibiotic regimens compared with 7 day injectable procaine benzylpenicillin and gentamicin for outpatient treatment of neonates and young infants with clinical signs of severe infection when referral is not possible: a randomised, open-label, equivalence trial.

PubMed

Baqui, Abdullah H; Saha, Samir K; Ahmed, A S M Nawshad Uddin; Shahidullah, Mohammad; Quasem, Iftekhar; Roth, Daniel E; Samsuzzaman, A K M; Ahmed, Wazir; Tabib, S M Shahnawaz Bin; Mitra, Dipak K; Begum, Nazma; Islam, Maksuda; Mahmud, Arif; Rahman, Mohammad Hefzur; Moin, Mamun Ibne; Mullany, Luke C; Cousens, Simon; El Arifeen, Shams; Wall, Stephen; Brandes, Neal; Santosham, Mathuram; Black, Robert E

2015-05-01

Severe infections remain one of the main causes of neonatal deaths worldwide. Possible severe infection is diagnosed in young infants (aged 0-59 days) according to the presence of one or more clinical signs. The recommended treatment is hospital admission with 7-10 days of injectable antibiotic therapy. In low-income and middle-income countries, barriers to hospital care lead to delayed, inadequate, or no treatment for many young infants. We aimed to identify effective alternative antibiotic regimens to expand treatment options for situations where hospital admission is not possible. We did this randomised, open-label, equivalence trial in four urban hospitals and one rural field site in Bangladesh to determine whether two alternative antibiotic regimens with reduced numbers of injectable antibiotics combined with oral antibiotics had similar efficacy and safety to the standard regimen, which was also used as outpatient treatment. We randomly assigned infants who showed at least one clinical sign of severe, but not critical, infection (except fast breathing alone), whose parents refused hospital admission, to one of the three treatment regimens. We stratified randomisation by study site and age (<7 days or 7-59 days) using computer-generated randomisation sequences. The standard treatment was intramuscular procaine benzylpenicillin and gentamicin once per day for 7 days (group A). The alternative regimens were intramuscular gentamicin once per day and oral amoxicillin twice per day for 7 days (group B) or intramuscular procaine benzylpenicillin and gentamicin once per day for 2 days, then oral amoxicillin twice per day for 5 days (group C). The primary outcome was treatment failure within 7 days after enrolment. Assessors of treatment failure were masked to treatment allocation. Primary analysis was per protocol. We used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with ClinicalTrials.gov, number NCT00844337. Between July 1, 2009, and June 30, 2013, we recruited 2490 young infants into the trial. We assigned 830 infants to group A, 831 infants to group B, and 829 infants to group C. 2367 (95%) infants fulfilled per-protocol criteria. 78 (10%) of 795 per-protocol infants had treatment failure in group A compared with 65 (8%) of 782 infants in group B (risk difference -1.5%, 95% CI -4.3 to 1.3) and 64 (8%) of 790 infants in group C (-1.7%, -4.5 to 1.1). In group A, 14 (2%) infants died before day 15, compared with 12 (2%) infants in group B and 12 (2%) infants in group C. Non-fatal relapse rates were similar in all three groups (12 [2%] infants in group A vs 13 [2%] infants in group B and 10 [1%] infants in group C). Our results suggest that the two alternative antibiotic regimens for outpatient treatment of clinical signs of severe infection in young infants whose parents refused hospital admission are as efficacious as the standard regimen. This finding could increase treatment options in resource-poor settings when referral care is not available or acceptable. Copyright © 2015 Baqui et al. Open Access article distributed under the terms of CC BY. Published by .. All rights reserved.

A Randomized Controlled Trial for the Effectiveness of Aromatherapy in Decreasing Salivary Gland Damage following Radioactive Iodine Therapy for Differentiated Thyroid Cancer.

PubMed

Nakayama, Michihiro; Okizaki, Atsutaka; Takahashi, Koji

2016-01-01

Objective. The aim of this study was to investigate effects of aromatherapy in decreasing salivary gland damage for patients undergoing radioactive iodine (RAI) therapy with differentiated thyroid cancer (DTC). Materials and Methods. The subjects were 71 patients with DTC. They were divided into aromatherapy group (group A, n = 35) and a control group (group B, n = 36). We blended 1.0 mL of lemon and 0.5 mL of ginger essential oils. The patients in the inhalation aromatherapy group inhaled this blend oil and those in the control group inhaled distilled water as placebo for 10 min during admission. We statistically compared salivary gland function before and after treatment between groups A and B. Results. In comparison with group B, the rate of change of the accumulation rate was significantly higher in the parotid glands and submandibular glands of group A ( P < 0.05). In comparison with group B, a significant increase in rate of secretion change before and after treatment was noted in the bilateral parotid glands in group A ( P < 0.05). Conclusion. Because an amelioration of salivary gland function was observed in the present study, our results suggest the efficacy of aromatherapy in the prevention of treatment-related salivary gland disorder. This trial is registered with UMIN Clinical Trial Registry: UMIN000013968.

A Randomized Controlled Trial for the Effectiveness of Aromatherapy in Decreasing Salivary Gland Damage following Radioactive Iodine Therapy for Differentiated Thyroid Cancer

PubMed Central

Okizaki, Atsutaka; Takahashi, Koji

2016-01-01

Objective. The aim of this study was to investigate effects of aromatherapy in decreasing salivary gland damage for patients undergoing radioactive iodine (RAI) therapy with differentiated thyroid cancer (DTC). Materials and Methods. The subjects were 71 patients with DTC. They were divided into aromatherapy group (group A, n = 35) and a control group (group B, n = 36). We blended 1.0 mL of lemon and 0.5 mL of ginger essential oils. The patients in the inhalation aromatherapy group inhaled this blend oil and those in the control group inhaled distilled water as placebo for 10 min during admission. We statistically compared salivary gland function before and after treatment between groups A and B. Results. In comparison with group B, the rate of change of the accumulation rate was significantly higher in the parotid glands and submandibular glands of group A (P < 0.05). In comparison with group B, a significant increase in rate of secretion change before and after treatment was noted in the bilateral parotid glands in group A (P < 0.05). Conclusion. Because an amelioration of salivary gland function was observed in the present study, our results suggest the efficacy of aromatherapy in the prevention of treatment-related salivary gland disorder. This trial is registered with UMIN Clinical Trial Registry: UMIN000013968. PMID:28042578

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

PubMed

Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

2011-12-01

Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial.

PubMed

Ovesen, Christian; Jakobsen, Janus Christian; Gluud, Christian; Steiner, Thorsten; Law, Zhe; Flaherty, Katie; Dineen, Rob A; Bath, Philip M; Sprigg, Nikola; Christensen, Hanne

2018-06-13

We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status. Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( http://www.isrctn.com ).

YKL-40, CCL18 and SP-D predict mortality in patients hospitalized with community-acquired pneumonia.

PubMed

Spoorenberg, Simone M C; Vestjens, Stefan M T; Rijkers, Ger T; Meek, Bob; van Moorsel, Coline H M; Grutters, Jan C; Bos, Willem Jan W

2017-04-01

The aim of this study was to investigate the prognostic value of four biomarkers, YKL-40, chemokine (C-C motif) ligand 18 (CCL18), surfactant protein-D (SP-D) and CA 15-3, in patients admitted with community-acquired pneumonia (CAP). These markers have been studied extensively in chronic pulmonary disease, but in acute pulmonary disease their prognostic value is unknown. A total of 289 adult patients who were hospitalized with CAP and participated in a randomized controlled trial were enrolled. Biomarker levels were measured on the day of admission. Intensive care unit admission, 30-day, 1-year and long-term mortality (median follow-up of 5.4 years, interquartile range (IQR): 4.7-6.1) were recorded as outcomes. Median YKL-40 and CCL18 levels were significantly higher and levels of SP-D were significantly lower in CAP patients compared to healthy controls. Significantly higher YKL-40, CCL18 and SP-D levels were found in patients classified in pneumonia severity index classes 4-5 and with a CURB-65 score ≥2 compared to patients with less severe pneumonia. Furthermore, these three markers were significant predictors for long-term mortality in multivariate analysis and compared with C-reactive protein and procalcitonin level on admission, area under the curves were higher for 30-day, 1-year and long-term mortality. CA 15-3 levels were less predictive. YKL-40, CCL18 and SP-D levels were higher in patients with more severe pneumonia, possibly reflecting the extent of pulmonary inflammation. Of these, YKL-40 most significantly predicts mortality for CAP. © 2016 Asian Pacific Society of Respirology.

Dementia care initiative in primary practice – study protocol of a cluster randomized trial on dementia management in a general practice setting

PubMed Central

Holle, Rolf; Gräßel, Elmar; Ruckdäschel, Stefan; Wunder, Sonja; Mehlig, Hilmar; Marx, Peter; Pirk, Olaf; Butzlaff, Martin; Kunz, Simone; Lauterberg, Jörg

2009-01-01

Background Current guidelines for dementia care recommend the combination of drug therapy with non-pharmaceutical measures like counselling and social support. However, the scientific evidence concerning non-pharmaceutical interventions for dementia patients and their informal caregivers remains inconclusive. Targets of modern comprehensive dementia care are to enable patients to live at home as long and as independent as possible and to reduce the burden of caregivers. The objective of the study is to compare a complex intervention including caregiver support groups and counselling against usual care in terms of time to nursing home placement. In this paper the study protocol is described. Methods/Design The IDA (Initiative Demenzversorgung in der Allgemeinmedizin) project is designed as a three armed cluster-randomized trial where dementia patients and their informal caregivers are recruited by general practitioners. Patients in the study region of Middle Franconia, Germany, are included if they have mild or moderate dementia, are at least 65 years old, and are members of the German AOK (Allgemeine Ortskrankenkasse) sickness fund. In the control group patients receive regular treatment, whereas in the two intervention groups general practitioners participate in a training course in evidence based dementia treatment, recommend support groups and offer counseling to the family caregivers either beginning at baseline or after the 1-year follow-up. The study recruitment and follow-up took place from July 2005 to January 2009. 303 general practitioners were randomized of which 129 recruited a total of 390 patients. Time to nursing home admission within the two year intervention and follow-up period is the primary endpoint. Secondary endpoints are cognitive status, activities of daily living, burden of care giving as well as healthcare costs. For an economic analysis from the societal perspective, data are collected from caregivers as well as by the use of routine data from statutory health insurance and long-term care insurance. Discussion From a public health perspective, the IDA trial is expected to lead to evidence based results on the community effectiveness of non-pharmaceutical support measures for dementia patients and their caregivers in the primary care sector. For health policy makers it is necessary to make their decisions about financing new services based on strong knowledge about the acceptance of measures in the population and their cost-effectiveness. Trial registration ISRCTN68329593 PMID:19500383

Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

PubMed

Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe; Damsbo-Svendsen, Signe; Kreinfeldt Skovgaard Møller, Tina; Boll Hansen, Eigil; Keiding, Hans

2014-08-28

Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition. Hence a structured and multidisciplinary approach, focusing on the nutritional risk factors and involving e.g. dieticians, occupational therapists, and physiotherapist, may be necessary to achieve benefits. Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care, identified by screening with the Eating validation Scheme. Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator, the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support. Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening, by involving physiotherapist, registered dietician, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (for participants from home-care), use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary support.Furthermore, interviews with nursing home and home-care management, nursing staff and nutrition coordinators in both the control and intervention groups, participants in the intervention group and the involved multidisciplinary team will be performed. In this study we will evaluate in a randomized controlled trial whether multidisciplinary nutritional support is cost-effective, in undernourished older adults in home-care and nursing home and contribute to important research. ClinicalTrials.gov 2013 NCT01873456.

Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study)

PubMed Central

van den Broek, Frank JC; de Graaf, Eelco JR; Dijkgraaf, Marcel GW; Reitsma, Johannes B; Haringsma, Jelle; Timmer, Robin; Weusten, Bas LAM; Gerhards, Michael F; Consten, Esther CJ; Schwartz, Matthijs P; Boom, Maarten J; Derksen, Erik J; Bijnen, A Bart; Davids, Paul HP; Hoff, Christiaan; van Dullemen, Hendrik M; Heine, G Dimitri N; van der Linde, Klaas; Jansen, Jeroen M; Mallant-Hent, Rosalie CH; Breumelhof, Ronald; Geldof, Han; Hardwick, James CH; Doornebosch, Pascal G; Depla, Annekatrien CTM; Ernst, Miranda F; van Munster, Ivo P; de Hingh, Ignace HJT; Schoon, Erik J; Bemelman, Willem A; Fockens, Paul; Dekker, Evelien

2009-01-01

Background Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications. The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. Methods/design Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma ≥ 3 cm, located between 1–15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment. Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures. Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group. Discussion The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas. Trial registration number (trialregister.nl) NTR1422 PMID:19284647

Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

PubMed

NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

2017-08-01

Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

Sustainability of Evidence-Based Acute Pain Management Practices for Hospitalized Older Adults.

PubMed

Shuman, Clayton J; Xie, Xian-Jin; Herr, Keela A; Titler, Marita G

2017-11-01

Little is known regarding sustainability of evidence-based practices (EBPs) following implementation. This article reports sustainability of evidence-based acute pain management practices in hospitalized older adults following testing of a multifaceted Translating Research Into Practice (TRIP) implementation intervention. A cluster randomized trial with follow-up period was conducted in 12 Midwest U.S. hospitals (six experimental, six comparison). Use of evidence-based acute pain management practices and mean pain intensity were analyzed using generalized estimating equations across two time points (following implementation and 18 months later) to determine sustainability of TRIP intervention effects. Summative Index scores and six of seven practices were sustained. Experimental and comparison group differences for mean pain intensity over 72 hours following admission were sustained. Results revealed most evidence-based acute pain management practices were sustained for 18 months following implementation. Further work is needed to identify factors affecting sustainability of EBPs to guide development and testing of sustainability strategies.

Diabetes disease management in Medicare Advantage reduces hospitalizations and costs.

PubMed

Rosenzweig, James L; Taitel, Michael S; Norman, Gordon K; Moore, Tim J; Turenne, Wendy; Tang, Pei

2010-07-01

To evaluate the effectiveness of a telephonic diabetes disease management intervention in a Medicare Advantage population with comorbid diabetes and coronary artery disease (CAD). Prospective unequal randomization design of 526 members from a Medicare Advantage segment of one region of a large national health plan from May 2005 through April 2007. High-risk and high-cost patients with diabetes and CAD who were enrolled in telephonic diabetes disease management were compared with a randomly selected comparison group receiving usual care. Wilcoxon signed-rank tests were used to compare the groups on all-cause hospital admissions, diabetes-related hospital admissions, all-cause and diabetes-related emergency department (ED) visits, and all-cause medical costs. Changes in self-reported clinical outcomes also were measured in the intervention group. Patients receiving telephonic diabetes disease management had significantly decreased all-cause hospital admissions and diabetes-related hospital admissions (P <.05). The intervention group had decreased all-cause and diabetes-related ED visits, although the difference was not statistically significant. The comparison group had increased ED utilization. The intervention group decreased their all-cause total medical costs by $984.87 per member per year (PMPY) compared with a $4547.06 PMPY increase in the comparison group (P <.05). All clinical measures significantly improved (P <.05) in the intervention group. A disease management program for high-risk patients with diabetes and CAD was effective in reducing hospital inpatient admission and total costs in a Medicare Advantage population.

Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial.

PubMed

Bøtker, Hans Erik; Kharbanda, Rajesh; Schmidt, Michael R; Bøttcher, Morten; Kaltoft, Anne K; Terkelsen, Christian J; Munk, Kim; Andersen, Niels H; Hansen, Troels M; Trautner, Sven; Lassen, Jens Flensted; Christiansen, Evald Høj; Krusell, Lars R; Kristensen, Steen D; Thuesen, Leif; Nielsen, Søren S; Rehling, Michael; Sørensen, Henrik Toft; Redington, Andrew N; Nielsen, Torsten T

2010-02-27

Remote ischaemic preconditioning attenuates cardiac injury at elective surgery and angioplasty. We tested the hypothesis that remote ischaemic conditioning during evolving ST-elevation myocardial infarction, and done before primary percutaneous coronary intervention, increases myocardial salvage. 333 consecutive adult patients with a suspected first acute myocardial infarction were randomly assigned in a 1:1 ratio by computerised block randomisation to receive primary percutaneous coronary intervention with (n=166 patients) versus without (n=167) remote conditioning (intermittent arm ischaemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff). Allocation was concealed with opaque sealed envelopes. Patients received remote conditioning during transport to hospital, and primary percutaneous coronary intervention in hospital. The primary endpoint was myocardial salvage index at 30 days after primary percutaneous coronary intervention, measured by myocardial perfusion imaging as the proportion of the area at risk salvaged by treatment; analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00435266. 82 patients were excluded on arrival at hospital because they did not meet inclusion criteria, 32 were lost to follow-up, and 77 did not complete the follow-up with data for salvage index. Median salvage index was 0.75 (IQR 0.50-0.93, n=73) in the remote conditioning group versus 0.55 (0.35-0.88, n=69) in the control group, with median difference of 0.10 (95% CI 0.01-0.22; p=0.0333); mean salvage index was 0.69 (SD 0.27) versus 0.57 (0.26), with mean difference of 0.12 (95% CI 0.01-0.21; p=0.0333). Major adverse coronary events were death (n=3 per group), reinfarction (n=1 per group), and heart failure (n=3 per group). Remote ischaemic conditioning before hospital admission increases myocardial salvage, and has a favourable safety profile. Our findings merit a larger trial to establish the effect of remote conditioning on clinical outcomes. Fondation Leducq. Copyright 2010 Elsevier Ltd. All rights reserved.

Heat and moisture exchangers (HMEs) and heated humidifiers (HHs) in adult critically ill patients: a systematic review, meta-analysis and meta-regression of randomized controlled trials.

PubMed

Vargas, Maria; Chiumello, Davide; Sutherasan, Yuda; Ball, Lorenzo; Esquinas, Antonio M; Pelosi, Paolo; Servillo, Giuseppe

2017-05-29

The aims of this systematic review and meta-analysis of randomized controlled trials are to evaluate the effects of active heated humidifiers (HHs) and moisture exchangers (HMEs) in preventing artificial airway occlusion and pneumonia, and on mortality in adult critically ill patients. In addition, we planned to perform a meta-regression analysis to evaluate the relationship between the incidence of artificial airway occlusion, pneumonia and mortality and clinical features of adult critically ill patients. Computerized databases were searched for randomized controlled trials (RCTs) comparing HHs and HMEs and reporting artificial airway occlusion, pneumonia and mortality as predefined outcomes. Relative risk (RR), 95% confidence interval for each outcome and I 2 were estimated for each outcome. Furthermore, weighted random-effect meta-regression analysis was performed to test the relationship between the effect size on each considered outcome and covariates. Eighteen RCTs and 2442 adult critically ill patients were included in the analysis. The incidence of artificial airway occlusion (RR = 1.853; 95% CI 0.792-4.338), pneumonia (RR = 932; 95% CI 0.730-1.190) and mortality (RR = 1.023; 95% CI 0.878-1.192) were not different in patients treated with HMEs and HHs. However, in the subgroup analyses the incidence of airway occlusion was higher in HMEs compared with HHs with non-heated wire (RR = 3.776; 95% CI 1.560-9.143). According to the meta-regression, the effect size in the treatment group on artificial airway occlusion was influenced by the percentage of patients with pneumonia (β = -0.058; p = 0.027; favors HMEs in studies with high prevalence of pneumonia), and a trend was observed for an effect of the duration of mechanical ventilation (MV) (β = -0.108; p = 0.054; favors HMEs in studies with longer MV time). In this meta-analysis we found no superiority of HMEs and HHs, in terms of artificial airway occlusion, pneumonia and mortality. A trend favoring HMEs was observed in studies including a high percentage of patients with pneumonia diagnosis at admission and those with prolonged MV. However, the choice of humidifiers should be made according to the clinical context, trying to avoid possible complications and reaching the appropriate performance at lower costs.

AIDE-Acute Illness and Depression in Elderly Patients. Cognitive Behavioral Group Psychotherapy in Geriatric Patients With Comorbid Depression: A Randomized, Controlled Trial.

PubMed

Hummel, Jana; Weisbrod, Cecilia; Boesch, Leila; Himpler, Katharina; Hauer, Klaus; Hautzinger, Martin; Gaebel, Andrea; Zieschang, Tania; Fickelscherer, Andrea; Diener, Slawomira; Dutzi, Ilona; Krumm, Bertram; Oster, Peter; Kopf, Daniel

2017-04-01

Comorbid depression is highly prevalent in geriatric patients and associated with functional loss, frequent hospital re-admissions, and a higher mortality rate. Cognitive behavioral psychotherapy (CBT) has shown to be effective in older depressive patients living in the community. To date, CBT has not been applied to older patients with acute physical illness and comorbid depression. To evaluate the effectiveness of CBT in depressed geriatric patients, hospitalized for acute somatic illness. Randomized controlled trial with waiting list control group. Postdischarge intervention in a geriatric day clinic; follow-up evaluations at the patients' homes. A total of 155 randomized patients, hospitalized for acute somatic illness, aged 82 ± 6 years and suffering from depression [Hospital Anxiety and Depression Scale (HADS) scores >7]. Exclusion criteria were dementia, delirium, and terminal state of medical illness. Fifteen, weekly group sessions based on a CBT manual. Commencement of psychotherapy immediately after discharge in the intervention group and a 4-month waiting list interval with usual care in the control group. HADS depression total score after 4 months. Secondary endpoints were functional, cognitive, psychosocial and physical status, resource utilization, caregiver burden, and amount of contact with physician. The intervention group improved significantly in depression scores (HADS baseline 18.8; after 4 months 11.4), whereas the control group deteriorated (HADS baseline 18.1; after 4 months 21.6). Significant improvement in the intervention group, but not in the control group, was observed for most secondary outcome parameters such as the Barthel and Karnofsky indexes. Intervention effects were less pronounced in patients with cognitive impairment or acute fractures. CBT is feasible and highly effective in geriatric patients. The benefits extend beyond effective recovery and include improvement in physical and functional parameters. Early diagnosis, good access to psychotherapy, and early intervention could improve care for depressive older patients. www.germanctr.de German Trial Register DRKS 00004728. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Effects of labor support from close female relative on labor and maternal satisfaction in a Thai setting.

PubMed

Yuenyong, Siriwan; O'Brien, Beverley; Jirapeet, Veena

2012-01-01

To evaluate the efficacy of a close female relative providing emotional and physical support during active labor and birth. Randomized, two-group controlled clinical trial. Regional teaching hospital in the eastern part of Thailand with 782 beds. Primiparous women (N = 120) whose gestational ages were ≥ 36 weeks and who had uncomplicated pregnancies. Participants were randomly assigned to receive usual care and support from a chosen close female relative from admission until 2 hours after birth or usual care only. Within 24 hours of birth, labor outcomes (length of labor & type of birth) and levels of maternal satisfaction were assessed. Those in the experimental group had a significantly shorter duration of active labor and were more satisfied with their childbirth experiences than those in the control group. Differences between groups with respect to incidence of spontaneous delivery were not found. A close female relative was effective in providing supportive care during labor and delivery. The integration of this nursing intervention for women and their families at public hospitals in Thailand is supported. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Supported self-management for patients with moderate to severe chronic obstructive pulmonary disease (COPD): an evidence synthesis and economic analysis.

PubMed

Jordan, Rachel E; Majothi, Saimma; Heneghan, Nicola R; Blissett, Deirdre B; Riley, Richard D; Sitch, Alice J; Price, Malcolm J; Bates, Elizabeth J; Turner, Alice M; Bayliss, Susan; Moore, David; Singh, Sally; Adab, Peymane; Fitzmaurice, David A; Jowett, Susan; Jolly, Kate

2015-05-01

Self-management (SM) support for patients with chronic obstructive pulmonary disease (COPD) is variable in its coverage, content, method and timing of delivery. There is insufficient evidence for which SM interventions are the most effective and cost-effective. To undertake (1) a systematic review of the evidence for the effectiveness of SM interventions commencing within 6 weeks of hospital discharge for an exacerbation for COPD (review 1); (2) a systematic review of the qualitative evidence about patient satisfaction, acceptance and barriers to SM interventions (review 2); (3) a systematic review of the cost-effectiveness of SM support interventions within 6 weeks of hospital discharge for an exacerbation of COPD (review 3); (4) a cost-effectiveness analysis and economic model of post-exacerbation SM support compared with usual care (UC) (economic model); and (5) a wider systematic review of the evidence of the effectiveness of SM support, including interventions (such as pulmonary rehabilitation) in which there are significant components of SM, to identify which components are the most important in reducing exacerbations, hospital admissions/readmissions and improving quality of life (review 4). The following electronic databases were searched from inception to May 2012: MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Science Citation Index [Institute of Scientific Information (ISI)]. Subject-specific databases were also searched: PEDro physiotherapy evidence database, PsycINFO and the Cochrane Airways Group Register of Trials. Ongoing studies were sourced through the metaRegister of Current Controlled Trials, International Standard Randomised Controlled Trial Number database, World Health Organization International Clinical Trials Registry Platform Portal and ClinicalTrials.gov. Specialist abstract and conference proceedings were sourced through ISI's Conference Proceedings Citation Index and British Library's Electronic Table of Contents (Zetoc). Hand-searching through European Respiratory Society, the American Thoracic Society and British Thoracic Society conference proceedings from 2010 to 2012 was also undertaken, and selected websites were also examined. Title, abstracts and full texts of potentially relevant studies were scanned by two independent reviewers. Primary studies were included if ≈90% of the population had COPD, the majority were of at least moderate severity and reported on any intervention that included a SM component or package. Accepted study designs and outcomes differed between the reviews. Risk of bias for randomised controlled trials (RCTs) was assessed using the Cochrane tool. Random-effects meta-analysis was used to combine studies where appropriate. A Markov model, taking a 30-year time horizon, compared a SM intervention immediately following a hospital admission for an acute exacerbation with UC. Incremental costs and quality-adjusted life-years were calculated, with sensitivity analyses. From 13,355 abstracts, 10 RCTs were included for review 1, one study each for reviews 2 and 3, and 174 RCTs for review 4. Available studies were heterogeneous and many were of poor quality. Meta-analysis identified no evidence of benefit of post-discharge SM support on admissions [hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.52 to 1.17], mortality (HR 1.07, 95% CI 0.74 to 1.54) and most other health outcomes. A modest improvement in health-related quality of life (HRQoL) was identified but this was possibly biased due to high loss to follow-up. The economic model was speculative due to uncertainty in impact on readmissions. Compared with UC, post-discharge SM support (delivered within 6 weeks of discharge) was more costly and resulted in better outcomes (£683 cost difference and 0.0831 QALY gain). Studies assessing the effect of individual components were few but only exercise significantly improved HRQoL (3-month St George's Respiratory Questionnaire 4.87, 95% CI 3.96 to 5.79). Multicomponent interventions produced an improved HRQoL compared with UC (mean difference 6.50, 95% CI 3.62 to 9.39, at 3 months). Results were consistent with a potential reduction in admissions. Interventions with more enhanced care from health-care professionals improved HRQoL and reduced admissions at 1-year follow-up. Interventions that included supervised or unsupervised structured exercise resulted in significant and clinically important improvements in HRQoL up to 6 months. This review was based on a comprehensive search strategy that should have identified most of the relevant studies. The main limitations result from the heterogeneity of studies available and widespread problems with their design and reporting. There was little evidence of benefit of providing SM support to patients shortly after discharge from hospital, although effects observed were consistent with possible improvement in HRQoL and reduction in hospital admissions. It was not easy to tease out the most effective components of SM support packages, although interventions containing exercise seemed the most effective. Future work should include qualitative studies to explore barriers and facilitators to SM post exacerbation and novel approaches to affect behaviour change, tailored to the individual and their circumstances. Any new trials should be properly designed and conducted, with special attention to reducing loss to follow-up. Individual participant data meta-analysis may help to identify the most effective components of SM interventions. This study is registered as PROSPERO CRD42011001588. The National Institute for Health Research Health Technology Assessment programme.

Perforated peptic ulcer: how to improve outcome?

PubMed

Møller, Morten Hylander; Adamsen, Sven; Wøjdemann, Morten; Møller, Ann Merete

2009-01-01

Despite the introduction of histamine H2-receptor antagonists, proton-pump inhibitors and the discovery of Helicobacter pylori, both the incidence of emergency surgery for perforated peptic ulcer and the mortality rate for patients undergoing surgery for peptic ulcer perforation have increased. This increase has occurred despite improvements in perioperative treatment and monitoring. To improve the outcome of these patients, it is necessary to investigate the reasons behind this high mortality rate. In this review we evaluate the existing evidence in order to identify significant risk factors with an emphasis on risks that are preventable. A systematic review including randomized studies was carried out. There are a limited number of studies of patients with peptic ulcer perforation. Most of these studies are of low evident status. Only a few randomized, controlled trials have been published. The mortality rate and the extent of postoperative complications are fairly high but the reasons for this have not been thoroughly explained, even though a number of risk factors have been identified. Some of these risk factors can be explained by the septic state of the patient on admission. In order to improve the outcome of patients with peptic ulcer perforation, sepsis needs to be factored into the existing knowledge and treatment.

Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients.

PubMed

Koh, Gerald Choon-Huat; Yen, Shih Cheng; Tay, Arthur; Cheong, Angela; Ng, Yee Sien; De Silva, Deidre Anne; Png, Carolina; Caves, Kevin; Koh, Karen; Kumar, Yogaprakash; Phan, Shi Wen; Tai, Bee Choo; Chen, Cynthia; Chew, Effie; Chao, Zhaojin; Chua, Chun En; Koh, Yen Sin; Hoenig, Helen

2015-09-05

Most acute stroke patients with disabilities do not receive recommended rehabilitation following discharge to the community. Functional and social barriers are common reasons for non-adherence to post-discharge rehabilitation. Home rehabilitation is an alternative to centre-based rehabilitation but is costlier. Tele-rehabilitation is a possible solution, allowing for remote supervision of rehabilitation and eliminating access barriers. The objective of the Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial is to determine if a novel tele-rehabilitation intervention for the first three months after stroke admission improves functional recovery compared to usual care. This is a single blind (evaluator blinded), parallel, two-arm randomised controlled trial study design involving 100 recent stroke patients. The inclusion criteria are age ≥40 years, having caregiver support and recent stroke defined as stroke diagnosis within 4 weeks. Consenting participants will be randomized with varying block size of 4 or 6 assuming a 1:1 treatment allocation with the participating centre as the stratification factor. The baseline assessment will be done within 4 weeks of stroke onset, followed by follow-up assessments at 3 and 6 months. The tele-rehabilitation intervention lasts for 3 months and includes exercise 5-days-a-week using an iPad-based system that allows recording of daily exercise with video and sensor data and weekly video-conferencing with tele-therapists after data review. Those allocated to the control group will receive usual care. The primary outcome measure is improvement in life task's social activity participation at three months as measured by the disability component of the Jette Late Life Functional and Disability Instrument (LLFDI). Secondary outcome variables consist of gait speed (Timed 5-Meter Walk Test) and endurance (Two-Minute Walk test), performance of basic activities of daily living (Shah-modified Barthel Index), balance confidence (Activities-Specific Balance Confidence Scale), patient self-reported health-related quality-of-life [Euro-QOL (EQ-5D)], health service utilization (Singapore Stroke Study Health Service Utilization Form) and caregiver reported stress (Zarit Caregiver Burden Inventory). The goal of this trial is to provide evidence on the potential benefit and cost-effectiveness of this novel tele-rehabilitation programme which will guide health care decision-making and potentially improve performance of post-stroke community-based rehabilitation. This trial protocol was registered under ClinicalTrials.gov on 18 July 2013 as study title "The Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) Study" (ID: The STARS Study, ClinicalTrials.gov Identifier: NCT01905917 ).

Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

PubMed Central

2012-01-01

Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775 PMID:22625878

Effect of an education program on knowledge, self-care behavior and handwashing competence on prevention of febrile neutropenia among breast cancer patients receiving Doxorubicin and Cyclophosphamide in Chemotherapy Day Centre

PubMed Central

Mak, Wai Chi; Yin Ching, Shirley Siu

2015-01-01

Objective: To evaluate the efficacy of an education program on the prevention of febrile neutropenia (FN) among breast cancer patients receiving AC regimen. Methods: Randomized controlled trial with the repeated-measures design was conducted in a Chemotherapy Day Centre of an acute hospital in Hong Kong. Twenty-five subjects in the intervention group received an individual education session followed by three follow-up sessions and routine care. Twenty-four subjects in the control group received routine care. Primary outcomes included the incidence of admission due to FN, the self-care behavior adherence, the knowledge level on prevention of FN and the self-efficacy in self-management, handwashing competence were assessed by self-designed questionnaires, Chinese version of patient activation measure, and handwashing competence checklist. Results: No statistically significant difference between the intervention group and the control group on the incidence of admission due to FN, the self-efficacy in self-management, and the knowledge on prevention of FN. The self-care behavior adherence was significant at cycle 4 of AC regimen in favor of the intervention group (P = 0.036). Handwashing competence improved more significantly among subjects in the intervention group than the control group (P = 0.009). Conclusions: The education program on the prevention of FN had significantly favorable effects on self-care behavior adherence and handwashing competence across time. However, the intervention did not lead to statistically significant improvement on the incidence of admission due to FN, the self-efficacy in self-management and the knowledge level on prevention of FN. PMID:27981125

Beneficial role of green plantain [Musa paradisiaca] in the management of persistent diarrhea: a prospective randomized trial.

PubMed

Alvarez-Acosta, Thais; León, Cira; Acosta-González, Salvador; Parra-Soto, Haydeé; Cluet-Rodriguez, Isabel; Rossell, Maria Rosario; Colina-Chourio, José A

2009-04-01

To evaluate the beneficial effects of green plantain-based diet on stool volume, frequency and weight gain as compared with a traditional yogurt-based diet in children with persistent diarrhea. In a prospective, in-hospital controlled trial, two different treatments were administered to a sample of 80 children of both sexes, with ages ranging from 1 to 28 months, who had experienced >or= 14 days of persistent diarrhea. The sample was divided into two groups of isocaloric (100 kcal/kg/d) diets: experimental and control, of 40 patients each. The experimental group was randomly given a-week treatment consisting of a 50 g/L of cooked green plantain-based diet. The control group was fed on a yogurt-based diet. Both groups were not statistically different at admission. Pathogens were isolated from stools in 21.2% and 25% of patients in the experimental and control groups respectively; Aeromonas hydrophilia and Shigela flexneri were the most frequently found bacteria. The experimental group fed on a green plantain diet had a significantly better response in: diminishing stool output and consistency (p < 0.002), stool weight, diarrhea duration (p < 0.001), and increasing daily body weight gain (p < 0.001) than the yogurt-based diet group. The average duration of diarrhea in the plantain-based diet group was 18 hours shorter (p < 0.005) and it also had lower cost (p < 0.005). Our results support the benefits of green plantain in the dietary management of persistent diarrhea in hospitalized children, in relation to diarrheal duration, weight gain and costs.

Using Robots at Home to Support Patients With Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.

PubMed

Broadbent, Elizabeth; Garrett, Jeff; Jepsen, Nicola; Li Ogilvie, Vickie; Ahn, Ho Seok; Robinson, Hayley; Peri, Kathryn; Kerse, Ngaire; Rouse, Paul; Pillai, Avinesh; MacDonald, Bruce

2018-02-13

Socially assistive robots are being developed for patients to help manage chronic health conditions such as chronic obstructive pulmonary disease (COPD). Adherence to medication and availability of rehabilitation are suboptimal in this patient group, which increases the risk of hospitalization. This pilot study aimed to investigate the effectiveness of a robot delivering telehealth care to increase adherence to medication and home rehabilitation, improve quality of life, and reduce hospital readmission compared with a standard care control group. At discharge from hospital for a COPD admission, 60 patients were randomized to receive a robot at home for 4 months or to a control group. Number of hospitalization days for respiratory admissions over the 4-month study period was the primary outcome. Medication adherence, frequency of rehabilitation exercise, and quality of life were also assessed. Implementation interviews as well as benefit-cost analysis were conducted. Intention-to-treat and per protocol analyses showed no significant differences in the number of respiratory-related hospitalizations between groups. The intervention group was more adherent to their long-acting inhalers (mean number of prescribed puffs taken per day=48.5%) than the control group (mean 29.5%, P=.03, d=0.68) assessed via electronic recording. Self-reported adherence was also higher in the intervention group after controlling for covariates (P=.04). The intervention group increased their rehabilitation exercise frequency compared with the control group (mean difference -4.53, 95% CI -7.16 to -1.92). There were no significant differences in quality of life. Of the 25 patients who had the robot, 19 had favorable attitudes. This pilot study suggests that a homecare robot can improve adherence to medication and increase exercise. Further research is needed with a larger sample size to further investigate effects on hospitalizations after improvements are made to the robots. The robots could be especially useful for patients struggling with adherence. Australian New Zealand Clinical Trials Registry ACTRN12615000259549; http://www.anzctr.org.au (Archived by WebCite at  http://www.webcitation.org/6whIjptLS). ©Elizabeth Broadbent, Jeff Garrett, Nicola Jepsen, Vickie Li Ogilvie, Ho Seok Ahn, Hayley Robinson, Kathryn Peri, Ngaire Kerse, Paul Rouse, Avinesh Pillai, Bruce MacDonald. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 13.02.2018.

Double-Blind Prospective Randomized Controlled Trial of Dopamine Versus Epinephrine as First-Line Vasoactive Drugs in Pediatric Septic Shock.

PubMed

Ventura, Andréa M C; Shieh, Huei Hsin; Bousso, Albert; Góes, Patrícia F; de Cássia F O Fernandes, Iracema; de Souza, Daniela C; Paulo, Rodrigo Locatelli Pedro; Chagas, Fabiana; Gilio, Alfredo E

2015-11-01

The primary outcome was to compare the effects of dopamine or epinephrine in severe sepsis on 28-day mortality; secondary outcomes were the rate of healthcare-associated infection, the need for other vasoactive drugs, and the multiple organ dysfunction score. Double-blind, prospective, randomized controlled trial from February 1, 2009, to July 31, 2013. PICU, Hospital Universitário da Universidade de São Paulo, Brazil. Consecutive children who are 1 month to 15 years old and met the clinical criteria for fluid-refractory septic shock. Exclusions were receiving vasoactive drug(s) prior to hospital admission, having known cardiac disease, having already participated in the trial during the same hospital stay, refusing to participate, or having do-not-resuscitate orders. Patients were randomly assigned to receive either dopamine (5-10 μg/kg/min) or epinephrine (0.1-0.3 μg/kg/min) through a peripheral or intraosseous line. Patients not reaching predefined stabilization criteria after the maximum dose were classified as treatment failure, at which point the attending physician gradually stopped the study drug and started another catecholamine. Physiologic and laboratory data were recorded. Baseline characteristics were described as proportions and mean (± SD) and compared using appropriate statistical tests. Multiple regression analysis was performed, and statistical significance was defined as a p value of less than 0.05. Baseline characteristics and therapeutic interventions for the 120 children enrolled (63, dopamine; 57, epinephrine) were similar. There were 17 deaths (14.2%): 13 (20.6%) in the dopamine group and four (7%) in the epinephrine group (p=0.033). Dopamine was associated with death (odds ratio, 6.5; 95% CI, 1.1-37.8; p=0.037) and healthcare-associated infection (odds ratio, 67.7; 95% CI, 5.0-910.8; p=0.001). The use of epinephrine was associated with a survival odds ratio of 6.49. Dopamine was associated with an increased risk of death and healthcare-associated infection. Early administration of peripheral or intraosseous epinephrine was associated with increased survival in this population. Limitations should be observed while interpreting these results.

The Prince Henry Hospital dementia caregivers' training programme.

PubMed

Brodaty, H; Gresham, M; Luscombe, G

1997-02-01

To describe the theory, elements and practice of a successful caregiver training programme; and report the 8-year outcome. Prospective, randomized control trial and longitudinal follow-up over approximately 8 years. Psychiatry unit, general teaching hospital, Sydney, Australia. 96 persons less than 80 years old with mild to moderate dementia and their cohabiting caregivers. All patients received a 10-day structured memory retraining and activity programme. Caregivers in the immediate and wait-list caregiver training groups received a structured, residential, intensive 10-day training programme, boosted by follow-ups and telephone conferences over 12 months. Those in the wait-list group entered the programme after waiting 6 months. The third group of caregivers received 10 days' respite (while patients underwent their memory retraining programme) and 12 months booster sessions as for the other groups. Nursing home admission; time until patient death. 64% of patients whose caregivers were in the immediate training group, 53% of wait-list group patients and 70% of memory retraining patients had died. Nursing home admission had occurred in 79% of the immediate training, 83% of the delayed and 90% of the memory retraining group. Eight-year survival analysis indicated that patients whose caregivers received training stayed at home significantly longer (p = 0.037) and tended to live longer (p = 0.08). Caregiver training programmes demonstrably can delay institutionalization of people with dementia.

Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial

PubMed Central

Gajdos, Vincent; Katsahian, Sandrine; Beydon, Nicole; Abadie, Véronique; de Pontual, Loïc; Larrar, Sophie; Epaud, Ralph; Chevallier, Bertrand; Bailleux, Sylvain; Mollet-Boudjemline, Alix; Bouyer, Jean; Chevret, Sylvie; Labrune, Philippe

2010-01-01

Background Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis. Methods and Findings We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n = 246) or nasal suction (NS, control group, n = 250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97–2.73) for the control group and 2.02 days (95% CI 1.96–2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]  = 1.09, 95% CI 0.91–1.31, p = 0.33). No treatment by age interaction was found (p = 0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]  = 10.2, 95% CI 1.3–78.8, p = 0.005 and RR  = 5.4, 95% CI 1.6–18.4, p = 0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR  = 1.0, 95% CI 0.2–5.0, p = 1.00 and RR  = 3.6, 95% CI 0.7–16.9, p = 0.10, respectively) was found during the procedure. Parents reported that the procedure was more arduous in the group treated with IET (mean difference  = 0.88, 95% CI 0.33–1.44, p = 0.002), whereas there was no difference regarding the assessment of the child's comfort between both groups (mean difference  = −0.07, 95% CI −0.53 to 0.38, p = 0.40). No evidence of differences between groups in intensive care admission (RR  = 0.7, 95% CI 0.3–1.8, p = 0.62), ventilatory support (RR  = 2.5, 95% CI 0.5–13.0, p = 0.29), and antibiotic treatment (RR  = 1.0, 95% CI 0.7–1.3, p = 1.00) was observed. Conclusions IET + AC had no significant effect on time to recovery in this group of hospitalized infants with bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations and for infants without a history of atopy. Trial registration ClinicalTrials.gov NCT00125450 Please see later in the article for the Editors' Summary PMID:20927359

Acute pain in children and adults with sickle cell disease: management in the absence of evidence-based guidelines.

PubMed

Field, Joshua J; Knight-Perry, Jessica E; Debaun, Michael R

2009-05-01

Acute, vaso-occlusive pain is the most characteristic complication of sickle cell disease (SCD). Although there has been rigorous work examining the pathogenesis of vaso-occlusion, fewer studies have focused on approaches to the clinical management of acute pain. In this review, we will examine the epidemiology and management strategies of acute pain events and we will identify limitations in the best available studies. Most acute pain events in adults with SCD are managed at home without physician contact. Prior descriptions of the natural history of pain episodes from the Cooperative Study of Sickle Cell Disease relied on physician contact, limiting the generalizability of these findings to current practice. Patient-controlled analgesia has replaced on-demand therapy to become the standard for management of severe pain events in children and adults with SCD requiring hospital admission. Unfortunately, most clinical practice guidelines for the management of acute pain are not based on randomized clinical trials. As a result, our practice of pain management is primarily limited to expert opinion and inferences from observational studies. Additional clinical trials in management of acute pain in children and adults with SCD are critical for the development of evidence-based guidelines.

The effectiveness of non-surgical interventions in the treatment of Charcot foot.

PubMed

Smith, Caroline; Kumar, Saravana; Causby, Ryan

2007-12-01

Background  Charcot neuropathic osteoarthropathy is commonly known as 'Charcot foot'. It is a serious foot complication of diabetes mellitus that can frequently lead to foot ulceration, gangrene, hospital admission and foot amputation. A multidisciplinary approach to the management of Charcot foot is taken involving medical and allied health professionals. The management approach may also differ between different countries. To date, there is no systematic review of the literature undertaken to identify the clinical effectiveness of non-operative interventions in the treatment of acute Charcot foot. Objective  The objective of this review was to identify the effectiveness of non-surgical interventions with reducing lesions, ulceration, the rate of surgical intervention, reducing hospital admissions and improve the quality of life of subjects with Charcot foot. Search strategy  A comprehensive search strategy was undertaken on databases available from University of South Australia from their inception to November 2006. Selection criteria  Randomised controlled trials or clinical controlled trials were primarily sought. Critical appraisal of study quality and data extraction was undertaken using Joanna Briggs Institute instruments. Review Manager software was used to calculate comparative statistics. Results  This review identified 11 trials and five trials were included in the review. Three trials involved the use of bisphosphonate, a pharmacological agent. Two experimental treatments were also included, evaluating palliative radiology and magnetic fields. No trials were found using immobilisation and off-loading interventions for acute Charcot foot. The overall methodological quality score of the five studies was moderate. Owing to heterogeneous data, meta-analysis could not be performed. The trials did not report on reducing lesions, ulceration, rate of surgical intervention, hospital admissions and the quality of life of subjects with Charcot foot. The trials evaluating bisphosphonates reported greater reduction in foot temperature and disease activity for intervention subjects compared with controls. Another outcome of this review indicated additional beneficial effects of bisphosphonates in reducing pain and discomfort. The trial evaluating palliative radiotherapy found no difference between groups on any outcome. A significant reduction in the amount of deformity and reduced healing time to consolidation was found after treatment in the group receiving magnetic therapy treatment. Discussion  There is a lack of clinical trials evaluating the effectiveness of non-operative interventions for the management of Charcot foot (immobilisation, removable cast walkers, advice/dispensing of footwear and prescribing of orthotics). Bisphosphonates may be useful adjuncts to standard management of Charcot foot by improved healing demonstrated by a reduction in disease activity indicated by skin temperature and bone destruction. Magnetic therapy may reduce deformity, joint destruction and improve mobility. Conclusion  There is a lack of evidence supporting the use of pharmacological or non-surgical interventions with reducing lesions, ulceration, rate of surgical intervention, hospital admissions and improving the quality of life of subjects with Charcot foot. Bisphosphonates may improve the healing of Charcot foot by reducing skin temperature and disease activity of Charcot foot, when applied in addition to standard interventions to control the position and shape of the foot.

Clinical and cost-effectiveness analysis of early detection of patients at nutrition risk during their hospital stay through the new screening method CIPA: a study protocol.

PubMed

Suárez-Llanos, José Pablo; Benítez-Brito, Néstor; Vallejo-Torres, Laura; Delgado-Brito, Irina; Rosat-Rodrigo, Adriá; Hernández-Carballo, Carolina; Ramallo-Fariña, Yolanda; Pereyra-García-Castro, Francisca; Carlos-Romero, Juan; Felipe-Pérez, Nieves; García-Niebla, Jennifer; Calderón-Ledezma, Eduardo Mauricio; González-Melián, Teresa de Jesús; Llorente-Gómez de Segura, Ignacio; Barrera-Gómez, Manuel Ángel

2017-04-20

Malnutrition is highly prevalent in hospitalized patients and results in a worsened clinical course as well as an increased length of stay, mortality, and costs. Therefore, simple nutrition screening systems, such as CIPA (control of food intake, protein, anthropometry), may be implemented to facilitate the patient's recovery process. The aim of this study is to evaluate the effectiveness and cost-effectiveness of implementing such screening tool in a tertiary hospital, consistent with the lack of similar, published studies on any hospital nutrition screening system. The present study is carried out as an open, controlled, randomized study on patients that were admitted to the Internal Medicine and the General and Digestive Surgery ward; the patients were randomized to either a control or an intervention group (n = 824, thereof 412 patients in each of the two study arms). The control group underwent usual inpatient clinical care, while the intervention group was evaluated with the CIPA screening tool for early detection of malnutrition and treated accordingly. CIPA nutrition screening was performed upon hospital admission and classified positive when at least one of the following parameters was met: 72 h food intake control < 50%, serum albumin < 3 g/dL, body mass index < 18.5 kg/m 2 (or mid-upper arm circumference ≤ 22.5 cm). In this case, the doctor decided on whether or not providing nutrition support. The following variables will be evaluated: hospital length of stay (primary endpoint), mortality, 3-month readmission, and in-hospital complications. Likewise, the quality of life questionnaires EQ-5D-5 L are being collected for all patients at hospital admission, discharge, and 3 months post-discharge. Analysis of cost-effectiveness will be performed by measuring effectiveness in terms of quality-adjusted life years (QALYs). The cost per patient will be established by identifying health care resource utilization; cost-effectiveness will be determined through the incremental cost-effectiveness ratio (ICER). We will calculate the incremental cost per QALY gained with respect to the intervention. This ongoing trial aims to evaluate the cost-effectiveness of implementing the malnutrition screening tool CIPA in a tertiary hospital. Clinical Trial.gov ( NCT02721706 ). First receivevd: March 1, 2016 Last updated: April 8, 2017 Last verified: April 2017.

Experimental Treatment of Ebola Virus Disease with TKM-130803: A Single-Arm Phase 2 Clinical Trial.

PubMed

Dunning, Jake; Sahr, Foday; Rojek, Amanda; Gannon, Fiona; Carson, Gail; Idriss, Baimba; Massaquoi, Thomas; Gandi, Regina; Joseph, Sebatu; Osman, Hassan K; Brooks, Timothy J G; Simpson, Andrew J H; Goodfellow, Ian; Thorne, Lucy; Arias, Armando; Merson, Laura; Castle, Lyndsey; Howell-Jones, Rebecca; Pardinaz-Solis, Raul; Hope-Gill, Benjamin; Ferri, Mauricio; Grove, Jennifer; Kowalski, Mark; Stepniewska, Kasia; Lang, Trudie; Whitehead, John; Olliaro, Piero; Samai, Mohammed; Horby, Peter W

2016-04-01

TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. Pan African Clinical Trials Registry PACTR201501000997429.

The National Early Warning Score (NEWS) for outcome prediction in emergency department patients with community-acquired pneumonia: results from a 6-year prospective cohort study

PubMed Central

Sbiti-Rohr, Diana; Kutz, Alexander; Christ-Crain, Mirjam; Thomann, Robert; Zimmerli, Werner; Hoess, Claus; Henzen, Christoph; Mueller, Beat; Schuetz, Philipp

2016-01-01

Objective To investigate the accuracy of the National Early Warning Score (NEWS) to predict mortality and adverse clinical outcomes for patients with community-acquired pneumonia (CAP) compared to standard risk scores such as the pneumonia severity index (PSI) and CURB-65. Design Secondary analysis of patients included in a previous randomised-controlled trial with a median follow-up of 6.1 years. Settings Patients with CAP included on admission to the emergency departments (ED) of 6 tertiary care hospitals in Switzerland. Participants A total of 925 patients with confirmed CAP were included. NEWS, PSI and CURB-65 scores were calculated on admission to the ED based on admission data. Main outcome measure Our primary outcome was all-cause mortality within 6 years of follow-up. Secondary outcomes were adverse clinical outcome defined as intensive care unit (ICU) admission, empyema and unplanned hospital readmission all occurring within 30 days after admission. We used regression models to study associations of baseline risk scores and outcomes with the area under the receiver operating curve (AUC) as a measure of discrimination. Results 6-year overall mortality was 45.1% (n=417) with a stepwise increase with higher NEWS categories. For 30 day and 6-year mortality prediction, NEWS showed only low discrimination (AUC 0.65 and 0.60) inferior compared to PSI and CURB-65. For prediction of ICU admission, NEWS showed moderate discrimination (AUC 0.73) and improved the prognostic accuracy of a regression model, including PSI (AUC from 0.66 to 0.74, p=0.001) and CURB-65 (AUC from 0.64 to 0.73, p=0.015). NEWS was also superior to PSI and CURB-65 for prediction of empyema, but did not well predict rehospitalisation. Conclusions NEWS provides additional prognostic information with regard to risk of ICU admission and complications and thereby improves traditional clinical-risk scores in the management of patients with CAP in the ED setting. Trial registration number ISRCTN95122877; Post-results. PMID:27683509

Cost analysis of nurse telephone consultation in out of hours primary care: evidence from a randomised controlled trial

PubMed Central

Lattimer, Val; Sassi, Franco; George, Steve; Moore, Michael; Turnbull, Joanne; Mullee, Mark; Smith, Helen

2000-01-01

Objective To undertake an economic evaluation of nurse telephone consultation using decision support software in comparison with usual general practice care provided by a general practice cooperative. Design Cost analysis from an NHS perspective using stochastic data from a randomised controlled trial. Setting General practice cooperative with 55 general practitioners serving 97 000 registered patients in Wiltshire, England. Subjects All patients contacting the service, or about whom the service was contacted during the trial year (January 1997 to January 1998). Main outcome measures Costs and savings to the NHS during the trial year. Results The cost of providing nurse telephone consultation was £81 237 per annum. This, however, determined a £94 422 reduction of other costs for the NHS arising from reduced emergency admissions to hospital. Using point estimates for savings, the cost analysis, combined with the analysis of outcomes, showed a dominance situation for the intervention over general practice cooperative care alone. If a larger improvement in outcomes is assumed (upper 95% confidence limit) NHS savings increase to £123 824 per annum. Savings of only £3728 would, however, arise in a scenario where lower 95% confidence limits for outcome differences were observed. To break even, the intervention would have needed to save 138 emergency hospital admissions per year, around 90% of the effect achieved in the trial. Additional savings of £16 928 for general practice arose from reduced travel to visit patients at home and fewer surgery appointments within three days of a call. Conclusions Nurse telephone consultation in out of hours primary care may reduce NHS costs in the long term by reducing demand for emergency admission to hospital. General practitioners currently bear most of the cost of nurse telephone consultation and benefit least from the savings associated with it. This indicates that the service produces benefits in terms of service quality, which are beyond the reach of this cost analysis. PMID:10764368

Effectiveness of disease-specific self-management education on health outcomes in patients with chronic obstructive pulmonary disease: An updated systematic review and meta-analysis.

PubMed

Wang, Tao; Tan, Jing-Yu; Xiao, Lily Dongxia; Deng, Renli

2017-08-01

To update a previously published systematic review on the effectiveness of self-management education (SME) for patients with chronic obstructive pulmonary disease (COPD). Electronic databases were accessed (from inception to July 2016) to find relevant randomized controlled trials. Studies that compared SME with routine methods of care in COPD patients were retrieved. Both data synthesis and descriptive analysis were used for outcome assessment (e.g. quality of life and healthcare utilization). Twenty-four studies were included. Data synthesis showed better quality of life among COPD patients receiving SME. Significant reductions in COPD-related hospital admissions and emergency department visits were identified in the SME group. SME may positively affect the reduction of COPD patients' emotional distress. No significant reduction in smoking rate and mortality rate was observed between groups. No clear evidence supports the improvement of pulmonary functions, dyspnea, and nutritional status in COPD patients with the use of SME. SME can be a useful strategy to improve quality of life and disease-specific knowledge in patients with COPD. It also reduces respiratory-related hospital admissions and emergency department visits in COPD patients. Inclusion of SME as one of the key components for the comprehensive management of COPD is encouraged. Copyright © 2017 Elsevier B.V. All rights reserved.

Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

ERIC Educational Resources Information Center

Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

2016-01-01

Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

Effectiveness of aquatic versus land physiotherapy in the treatment of peripheral neuropathies: a randomized controlled trial.

PubMed

Zivi, Ilaria; Maffia, Sara; Ferrari, Vanessa; Zarucchi, Alessio; Molatore, Katia; Maestri, Roberto; Frazzitta, Giuseppe

2018-05-01

To compare the effects on gait and balance of aquatic physiotherapy versus on-land training, in the context of an inpatient rehabilitation treatment tailored for peripheral neuropathies. Parallel-group, single-center, single-blind randomized controlled trial. Consecutive patients affected by peripheral neuropathy admitted in our Neuro-Rehabilitation Unit. Patients received a four-week rehabilitation program composed by daily sessions of conventional physiotherapy and three sessions/week of specific treatment (aquatic vs. on-land). Primary outcome measures were Berg Balance Scale and Dynamic Gait Index. Secondary outcome measures were Neuropathic Pain Scale, Overall Neuropathy Limitations Scale, Functional Independence Measure, Functional Ambulation Classification, Conley Scale and Medical Research Council Scale score for the strength of hip and ankle flexor and extensor muscles. For each scale, we calculated the difference between the scores at discharge and admission and compared it between the two groups. Forty patients were enrolled: 21 in the water-based rehabilitation group and 19 in the land-based one. Patients were similar between groups. When comparing the groups, we found that "in-water" patients had a significant better improvement in the Dynamic Gait Index score (6.00 (4.00, 7.25) vs. 4.00 (1.25, 6.00), P = 0.0433). On the opposite, the "on-land" group showed a better improvement of the Functional Ambulation Classification score (1.0 (0.75, 1.0) vs. 1.0 (1.0, 2.0), P = 0.0386). Aquatic physiotherapy showed an effect comparable to the land-based rehabilitation on gait and balance dysfunctions of neuropathic patients.

International multicentre trial protocol to assess the efficacy and safety of tenecteplase during cardiopulmonary resuscitation in patients with out-of-hospital cardiac arrest: the Thrombolysis in Cardiac Arrest (TROICA) Study.

PubMed

Spöhr, F; Arntz, H R; Bluhmki, E; Bode, C; Carli, P; Chamberlain, D; Danays, T; Poth, J; Skamira, C; Wenzel, V; Böttiger, B W

2005-05-01

Prehospital cardiac arrest has been associated with a very poor prognosis. Acute myocardial infarction and massive pulmonary embolism are the underlying causes of out-of-hospital cardiac arrest in 50-70% of patients. Although fibrinolysis is an effective treatment strategy for both myocardial infarction and pulmonary embolism, clinical experience for this therapy performed during resuscitation has been limited owing to the anticipated risk of severe bleeding complications. The TROICA study is planned as one of the largest randomized, double-blind, placebo-controlled trials to assess the efficacy and safety of prehospital thrombolytic therapy in cardiac arrest of presumed cardiac origin. Approximately 1000 patients with cardiac arrest will be randomized at approximately 60 international study centres to receive either a weight-adjusted dose of tenecteplase or placebo after the first dose of a vasopressor. Patients can be included if they are at least 18 years, presenting with a witnessed cardiac arrest of presumed cardiac origin, and if either basic life support had started within 10 min of onset and had been performed up to 10 min or advanced life support is started within 10 min of onset of cardiac arrest. Primary endpoint of the study is the 30-day survival rate, and the coprimary endpoint is hospital admission. Secondary endpoints are the return of spontaneous circulation (ROSC), survival after 24 h, survival to hospital discharge, and neurological performance. Safety endpoints include major bleeding complications and symptomatic intracranial haemorrhage.

The effects of the empowerment education program in older adults with total hip replacement surgery.

PubMed

Huang, Tzu-Ting; Sung, Chia-Chun; Wang, Woan-Shyuan; Wang, Bi-Hwa

2017-08-01

To measure the effectiveness of an education empowerment program on primary (self-efficacy and self-care competence) and secondary outcomes (Activities of Daily Life, mobility, depressive mood and quality of life) for older adults with total hip replacement surgery. Degenerative arthritis is a common and serious chronic illness that impacts the quality of life of older adults. As joints continue to degenerate and the hip damaged by arthritis, activities of daily life will be difficult to perform due to severe hip pain and joint stiffness. Therefore, hip replacement surgery should be considered and effective nursing care should be provided to improve the recovery of older adults. A prospective randomized control trial. A trial was conducted from September 2013 - May 2014 in two hospitals in northern Taiwan. 108 participants were random assigned to either the education empowerment group or in the comparison group. The researchers collected baseline data at admission and outcomes on the day of discharge, one month after and three months after the discharge. After the interventions, the education empowerment group participants demonstrated significantly higher self-care competence and self-efficacy and lower depressive inclinations compared with those in the comparison group. Participants in both groups significantly improved on activities of daily life, mobility and quality of life over the course of the interventions. This education empowerment intervention was very effective in enhancing participants' outcomes. Moreover, involving both older adults and their caregivers for the participation this program is recommended for a greater impact. © 2017 John Wiley & Sons Ltd.

Mortality, Morbidity, and Developmental Outcomes in Infants Born to Women Who Received Either Mefloquine or Sulfadoxine-Pyrimethamine as Intermittent Preventive Treatment of Malaria in Pregnancy: A Cohort Study

PubMed Central

Rupérez, María; González, Raquel; Mombo-Ngoma, Ghyslain; Kabanywanyi, Abdunoor M.; Sevene, Esperança; Ouédraogo, Smaïla; Kakolwa, Mwaka A.; Vala, Anifa; Accrombessi, Manfred; Briand, Valérie; Aponte, John J.; Manego Zoleko, Rella; Adegnika, Ayôla A.; Cot, Michel; Kremsner, Peter G.; Massougbodji, Achille; Abdulla, Salim; Ramharter, Michael; Macete, Eusébio; Menéndez, Clara

2016-01-01

Background Little is known about the effects of intermittent preventive treatment of malaria in pregnancy (IPTp) on the health of sub-Saharan African infants. We have evaluated the safety of IPTp with mefloquine (MQ) compared to sulfadoxine-pyrimethamine (SP) for important infant health and developmental outcomes. Methods and Findings In the context of a multicenter randomized controlled trial evaluating the safety and efficacy of IPTp with MQ compared to SP in pregnancy carried out in four sub-Saharan countries (Mozambique, Benin, Gabon, and Tanzania), 4,247 newborns, 2,815 born to women who received MQ and 1,432 born to women who received SP for IPTp, were followed up until 12 mo of age. Anthropometric parameters and psychomotor development were assessed at 1, 9, and 12 mo of age, and the incidence of malaria, anemia, hospital admissions, outpatient visits, and mortality were determined until 12 mo of age. No significant differences were found in the proportion of infants with stunting, underweight, wasting, and severe acute malnutrition at 1, 9, and 12 mo of age between infants born to women who were on IPTp with MQ versus SP. Except for three items evaluated at 9 mo of age, no significant differences were observed in the psychomotor development milestones assessed. Incidence of malaria, anemia, hospital admissions, outpatient visits, and mortality were similar between the two groups. Information on the outcomes at 12 mo of age was unavailable in 26% of the infants, 761 (27%) from the MQ group and 377 (26%) from the SP group. Reasons for not completing the study were death (4% of total study population), study withdrawal (6%), migration (8%), and loss to follow-up (9%). Conclusions No significant differences were found between IPTp with MQ and SP administered in pregnancy on infant mortality, morbidity, and nutritional outcomes. The poorer performance on certain psychomotor development milestones at 9 mo of age in children born to women in the MQ group compared to those in the SP group may deserve further studies. Trial registration ClinicalTrials.gov NCT00811421 PMID:26905278

Antibiotics for treating bacterial vaginosis in pregnancy.

PubMed

Brocklehurst, Peter; Gordon, Adrienne; Heatley, Emer; Milan, Stephen J

2013-01-31

Bacterial vaginosis is an imbalance of the normal vaginal flora with an overgrowth of anaerobic bacteria and a lack of the normal lactobacillary flora. Women may have symptoms of a characteristic vaginal discharge but are often asymptomatic. Bacterial vaginosis during pregnancy has been associated with poor perinatal outcomes and, in particular, preterm birth (PTB). Identification and treatment may reduce the risk of PTB and its consequences. To assess the effects of antibiotic treatment of bacterial vaginosis in pregnancy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2012), searched cited references from retrieved articles and reviewed abstracts, letters to the editor and editorials. Randomised trials comparing antibiotic treatment with placebo or no treatment, or comparing two or more antibiotic regimens in pregnant women with bacterial vaginosis or intermediate vaginal flora whether symptomatic or asymptomatic and detected through screening. Two review authors independently assessed trials for inclusion, trial quality and extracted data. We contacted study authors for additional information. We included 21 trials of good quality, involving 7847 women diagnosed with bacterial vaginosis or intermediate vaginal flora.Antibiotic therapy was shown to be effective at eradicating bacterial vaginosis during pregnancy (average risk ratio (RR) 0.42; 95% confidence interval (CI) 0.31 to 0.56; 10 trials, 4403 women; random-effects, T² = 0.19, I² = 91%). Antibiotic treatment also reduced the risk of late miscarriage (RR 0.20; 95% CI 0.05 to 0.76; two trials, 1270 women, fixed-effect, I² = 0%).Treatment did not reduce the risk of PTB before 37 weeks (average RR 0.88; 95% CI 0.71 to 1.09; 13 trials, 6491 women; random-effects, T² = 0.06, I² = 48%), or the risk of preterm prelabour rupture of membranes (RR 0.74; 95% CI 0.30 to 1.84; two trials, 493 women). It did increase the risk of side-effects sufficient to stop or change treatment (RR 1.66; 95% CI 1.02 to 2.68; four trials, 2323 women, fixed-effect, I² = 0%).In this updated review, treatment before 20 weeks' gestation did not reduce the risk of PTB less than 37 weeks (average RR 0.85; 95% CI 0.62 to 1.17; five trials, 4088 women; random-effects, T² = 0.06, I² = 49%).In women with a previous PTB, treatment did not affect the risk of subsequent PTB (average RR 0.78; 95% CI 0.42 to 1.48; three trials, 421 women; random-effects, T² = 0.19, I² = 72%).In women with abnormal vaginal flora (intermediate flora or bacterial vaginosis), treatment may reduce the risk of PTB before 37 weeks (RR 0.53; 95% CI 0.34 to 0.84; two trials, 894 women).One small trial of 156 women compared metronidazole and clindamycin, both oral and vaginal, with no significant differences seen for any of the pre-specified primary outcomes. Statistically significant differences were seen for the outcomes of prolongation of gestational age (days) (mean difference (MD) 1.00; 95% CI 0.26 to 1.74) and birthweight (grams) (MD 75.18; 95% CI 25.37 to 124.99) however these represent relatively small differences in the clinical setting.Oral antibiotics versus vaginal antibiotics did not reduce the risk of PTB (RR 1.09; 95% CI 0.78 to 1.52; two trials, 264 women). Oral antibiotics had some advantage over vaginal antibiotics (whether metronidazole or clindamycin) with respect to admission to neonatal unit (RR 0.63; 95% CI 0.42 to 0.92, one trial, 156 women), prolongation of gestational age (days) (MD 9.00; 95% CI 8.20 to 9.80; one trial, 156 women) and birthweight (grams) (MD 342.13; 95% CI 293.04 to 391.22; one trial, 156 women).Different frequency of dosing of antibiotics was assessed in one small trial and showed no significant difference for any outcome assessed. Antibiotic treatment can eradicate bacterial vaginosis in pregnancy. The overall risk of PTB was not significantly reduced. This review provides little evidence that screening and treating all pregnant women with bacterial vaginosis will prevent PTB and its consequences. When screening criteria were broadened to include women with abnormal flora there was a 47% reduction in preterm birth, however this is limited to two included studies.

A Systematic Review of Surgical Randomized Controlled Trials: Part 2. Funding Source, Conflict of Interest, and Sample Size in Plastic Surgery.

PubMed

Voineskos, Sophocles H; Coroneos, Christopher J; Ziolkowski, Natalia I; Kaur, Manraj N; Banfield, Laura; Meade, Maureen O; Chung, Kevin C; Thoma, Achilleas; Bhandari, Mohit

2016-02-01

The authors examined industry support, conflict of interest, and sample size in plastic surgery randomized controlled trials that compared surgical interventions. They hypothesized that industry-funded trials demonstrate statistically significant outcomes more often, and randomized controlled trials with small sample sizes report statistically significant results more frequently. An electronic search identified randomized controlled trials published between 2000 and 2013. Independent reviewers assessed manuscripts and performed data extraction. Funding source, conflict of interest, primary outcome direction, and sample size were examined. Chi-squared and independent-samples t tests were used in the analysis. The search identified 173 randomized controlled trials, of which 100 (58 percent) did not acknowledge funding status. A relationship between funding source and trial outcome direction was not observed. Both funding status and conflict of interest reporting improved over time. Only 24 percent (six of 25) of industry-funded randomized controlled trials reported authors to have independent control of data and manuscript contents. The mean number of patients randomized was 73 per trial (median, 43, minimum, 3, maximum, 936). Small trials were not found to be positive more often than large trials (p = 0.87). Randomized controlled trials with small sample size were common; however, this provides great opportunity for the field to engage in further collaboration and produce larger, more definitive trials. Reporting of trial funding and conflict of interest is historically poor, but it greatly improved over the study period. Underreporting at author and journal levels remains a limitation when assessing the relationship between funding source and trial outcomes. Improved reporting and manuscript control should be goals that both authors and journals can actively achieve.

Experimental Treatment of Ebola Virus Disease with TKM-130803: A Single-Arm Phase 2 Clinical Trial

PubMed Central

Rojek, Amanda; Gannon, Fiona; Carson, Gail; Idriss, Baimba; Massaquoi, Thomas; Gandi, Regina; Joseph, Sebatu; Osman, Hassan K.; Brooks, Timothy J. G.; Simpson, Andrew J. H.; Goodfellow, Ian; Thorne, Lucy; Arias, Armando; Merson, Laura; Castle, Lyndsey; Howell-Jones, Rebecca; Pardinaz-Solis, Raul; Hope-Gill, Benjamin; Ferri, Mauricio; Grove, Jennifer; Kowalski, Mark; Stepniewska, Kasia; Lang, Trudie; Whitehead, John; Olliaro, Piero; Samai, Mohammed; Horby, Peter W.

2016-01-01

Background TKM-130803, a small interfering RNA lipid nanoparticle product, has been developed for the treatment of Ebola virus disease (EVD), but its efficacy and safety in humans has not been evaluated. Methods and Findings In this single-arm phase 2 trial, adults with laboratory-confirmed EVD received 0.3 mg/kg of TKM-130803 by intravenous infusion once daily for up to 7 d. On days when trial enrolment capacity was reached, patients were enrolled into a concurrent observational cohort. The primary outcome was survival to day 14 after admission, excluding patients who died within 48 h of admission. After 14 adults with EVD had received TKM-130803, the pre-specified futility boundary was reached, indicating a probability of survival to day 14 of ≤0.55, and enrolment was stopped. Pre-treatment geometric mean Ebola virus load in the 14 TKM-130803 recipients was 2.24 × 109 RNA copies/ml plasma (95% CI 7.52 × 108, 6.66 × 109). Two of the TKM-130803 recipients died within 48 h of admission and were therefore excluded from the primary outcome analysis. Of the remaining 12 TKM-130803 recipients, nine died and three survived. The probability that a TKM-130803 recipient who survived for 48 h will subsequently survive to day 14 was estimated to be 0.27 (95% CI 0.06, 0.58). TKM-130803 infusions were well tolerated, with 56 doses administered and only one possible infusion-related reaction observed. Three patients were enrolled in the observational cohort, of whom two died. Conclusions Administration of TKM-130803 at a dose of 0.3 mg/kg/d by intravenous infusion to adult patients with severe EVD was not shown to improve survival when compared to historic controls. Trial registration Pan African Clinical Trials Registry PACTR201501000997429 PMID:27093560

Effect of the 2011 vs 2003 duty hour regulation-compliant models on sleep duration, trainee education, and continuity of patient care among internal medicine house staff: a randomized trial.

PubMed

Desai, Sanjay V; Feldman, Leonard; Brown, Lorrel; Dezube, Rebecca; Yeh, Hsin-Chieh; Punjabi, Naresh; Afshar, Kia; Grunwald, Michael R; Harrington, Colleen; Naik, Rakhi; Cofrancesco, Joseph

2013-04-22

On July 1, 2011, the Accreditation Council for Graduate Medical Education implemented further restrictions of its 2003 regulations on duty hours and supervision. It remains unclear if the 2003 regulations improved trainee well-being or patient safety. To determine the effects of the 2011 Accreditation Council for Graduate Medical Education duty hour regulations compared with the 2003 regulations concerning sleep duration, trainee education, continuity of patient care, and perceived quality of care among internal medicine trainees. Crossover study design in an academic research setting. Medical house staff. General medical teams were randomly assigned using a sealed-envelope draw to an experimental model or a control model. We randomly assigned 4 medical house staff teams (43 interns) using a 3-month crossover design to a 2003-compliant model of every fourth night overnight call (control) with 30-hour duty limits or to one of two 2011-compliant models of every fifth night overnight call (Q5) or a night float schedule (NF), both with 16-hour duty limits. We measured sleep duration using actigraphy and used admission volumes, educational opportunities, the number of handoffs, and satisfaction surveys to assess trainee education, continuity of patient care, and perceived quality of care. RESULTS The study included 560 control, 420 Q5, and 140 NF days that interns worked and 834 hospital admissions. Compared with controls, interns on NF slept longer during the on call period (mean, 5.1 vs 8.3 hours; P = .003), and interns on Q5 slept longer during the postcall period (mean, 7.5 vs 10.2 hours; P = .05). However, both the Q5 and NF models increased handoffs, decreased availability for teaching conferences, and reduced intern presence during daytime work hours. Residents and nurses in both experimental models perceived reduced quality of care, so much so with NF that it was terminated early. Compared with a 2003-compliant model, two 2011 duty hour regulation-compliant models were associated with increased sleep duration during the on-call period and with deteriorations in educational opportunities, continuity of patient care, and perceived quality of care.

Exercise and health-related quality of life during the first year following acute stroke. A randomized controlled trial.

PubMed

Langhammer, Birgitta; Stanghelle, Johan K; Lindmark, Birgitta

2008-02-01

To evaluate the impact of two different physiotherapy exercise regimes in patients after acute stroke on health-related quality of life (HRQoL) and to investigate how the degree of motor and balance function, gait capacity, activities of daily living and instrumental activities of daily living influenced HRQoL. A longitudinal randomized controlled stratified trial of two interventions: the intensive exercise groups with scheduled intensive training during four periods of the first year after stroke and the regular exercise group with self-initiated training. There was a tendency of better HRQoL in the regular exercise group on NHP total score (p = 0.05). Patients with low scores in activities of daily living, balance and motor function and inability to perform 6-minute walk test on admission, scored lower on self-perceived health than patients with high scores and ability to perform the walking test. At 1 year post-stroke, total scores on NHP were moderately associated with motor function (r = -0.63), balance (r = -0.56), gait (r = -0.57), activities of daily living (r = -0.57) and instrumental activities of daily living (r = -0.49-0.58). The physical mobility sub-scale of NHP had the strongest association ranging from r = -0.47-0.82. The regular exercise group with self-initiated training seemed to enhance HRQoL more than the intensive exercise group with scheduled intensive training. The degree of motor function, balance, walking capacity and independence in activities of daily living is of importance for perceived HRQoL.

The 'Big Five'. Hypothesis generation: a multidisciplinary intervention package reduces disease-specific hospitalisations from long-term care: a post hoc analysis of the ARCHUS cluster-randomised controlled trial.

PubMed

Connolly, Martin J; Broad, Joanna B; Boyd, Michal; Zhang, Tony Xian; Kerse, Ngaire; Foster, Susan; Lumley, Thomas; Whitehead, Noeline

2016-05-01

long-term care (LTC) residents have higher hospitalisation rates than non-LTC residents. Rapid decline may follow hospitalisations, hence the importance of preventing unnecessary hospitalisations. Literature describes diagnosis-specific interventions (for cardiac failure, ischaemic heart disease, chronic obstructive pulmonary disease, stroke, pneumonia-termed 'big five' diagnoses), impacting on hospitalisations of older community-dwellers, but few RCTs show reductions in acute admissions from LTC. LTC facilities with higher than expected hospitalisations were recruited for a cluster-randomised controlled trial (RCT) of facility-based complex, non-disease-specific, 9-month intervention comprising gerontology nurse specialist (GNS)-led staff education, facility benchmarking, GNS resident review and multidisciplinary discussion of residents selected using standard criteria. In this post hoc exploratory analysis, the outcome was acute hospitalisations for 'big five' diagnoses. Re-randomisation analyses were used for end points during months 1-14. For end points during months 4-14, proportional hazards models are adjusted for within-facility clustering. we recruited 36 facilities with 1,998 residents (1,408 female; mean age 82.9 years); 1,924 were alive at 3 months. The intervention did not impact overall rates of acute hospitalisations or mortality (previously published), but resulted in fewer 'big five' admissions (RR = 0.73, 95% CI = 0.54-0.99; P = 0.043) with no significant difference in the rate of other acute admissions. When considering events occurring after 3 months (only), the intervention group were 34.7% (HR = 0.65; 95% CI = 0.49-0.88; P = 0.005) less likely to have a 'big five' acute admission than controls, with no differences in likelihood of acute admissions for other diagnoses (P = 0.96). this generic intervention may reduce admissions for common conditions which the literature shows are impacted by disease-specific admission reduction strategies. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Intermittent preventive antimalarial treatment for children with anaemia

PubMed Central

Athuman, Mwaka; Kabanywanyi, Abdunoor M; Rohwer, Anke C

2015-01-01

Background Anaemia is a global public health problem. Children under five years of age living in developing countries (mostly Africa and South-East Asia) are highly affected. Although the causes for anaemia are multifactorial, malaria has been linked to anaemia in children living in malaria-endemic areas. Administering intermittent preventive antimalarial treatment (IPT) to children might reduce anaemia, since it could protect children from new Plasmodium parasite infection (the parasites that cause malaria) and allow their haemoglobin levels to recover. Objectives To assess the effect of IPT for children with anaemia living in malaria-endemic areas. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, Cochrane Central of Controlled Trials (CENTRAL), published in The Cochrane Library; MEDLINE; EMBASE; and LILACS. We also searched the World Health Organization (WHO) International Clinical Trial Registry Platform and metaRegister of Controlled Trials (mRCT) for ongoing trials up to 4 December 2014. Selection criteria Randomized controlled trials (RCTs) evaluating the effect of IPT on children with anaemia. Data collection and analysis Two review authors independently extracted data and assessed risk of bias. We analysed data by conducting meta-analyses, stratifying data according to whether participants received iron supplements or not. We used GRADE to assess the quality of evidence. Main results Six trials with 3847 participants met our inclusion criteria. Trials were conducted in areas of low malaria endemicity (three trials), and moderate to high endemicity (three trials). Four trials were in areas of seasonal malaria transmission. Iron was given to all children in two trials, and evaluated in a factorial design in a further two trials. IPT for children with anaemia probably has little or no effect on the proportion anaemic at 12 weeks follow-up (four trials, 2237 participants, (moderate quality evidence). IPT in anaemic children probably increases the mean change in haemoglobin levels from baseline to follow-up at 12 weeks on average by 0.32 g/dL (MD 0.32, 95% CI 0.19 to 0.45; four trials, 1672 participants, moderate quality evidence); and may improve haemoglobin levels at 12 weeks (MD 0.35, 95% CI 0.06 to 0.64; four trials, 1672 participants, low quality evidence). For both of these outcomes, subgroup analysis did not demonstrate a difference between children receiving iron and those that did not. IPT for children with anaemia probably has little or no effect on mortality or hospital admissions at six months (three trials, 3160 participants moderate quality evidence). Subgroup analysis did not show a difference between those children receiving iron supplements and those that did not. Authors' conclusions Trials did show a small effect on average haemoglobin levels but this did not appear to translate into an effect on mortality and hospital admissions. Three of the six trials were conducted in low endemicity areas where transmission is low and thus any protective effect is likely to be modest. Plain Language Summary Antimalarial drugs as a treatment of anaemia in children living in malaria-endemic areas Children living in malaria areas may develop severe anaemia, often caused by malaria infection, and this can cause death if not treated properly. Intermittent preventive treatment (IPT) is a course of malaria treatment given regularly to these children in order to prevent infection and malaria illness. It has been suggested that IPT could be used to treat children with anaemia in these areas. We aimed to find all the studies looking at treating anaemic children with IPT in order to see what the overall effect is. We examined the evidence available up to 4 December 2014. We included six trials in this review, with a total number of 3847 participants. In all the trials, one group received IPT and the control group received placebo. Three trials were done in low malaria endemicity areas and the other three in high endemicity areas. In some trials, iron supplements were also given to children, which is also a treatment for anaemia, and we took this into consideration when analysing the data. Our results did not find that the number of children who died or were admitted to hospital was lower in the group receiving IPT, irrespective of whether they received iron (moderate quality evidence); and there was no difference in the number of children with anaemia at the end of follow-up (moderate quality evidence). Average haemoglobin levels were higher in the IPT group compared to the placebo group, but the effect was modest (low quality evidence). Although our results show that there are small benefits in haemoglobin levels when treating anaemic children with IPT, we did not detect an effect on death or hospital admissions. However, three of the six included trials were conducted in low endemicity areas where malaria transmission is low and thus any protective effect is likely to be modest. PMID:25582096

Impact of a Patient Navigator Program on Hospital-Based and Outpatient Utilization Over 180 Days in a Safety-Net Health System.

PubMed

Balaban, Richard B; Zhang, Fang; Vialle-Valentin, Catherine E; Galbraith, Alison A; Burns, Marguerite E; Larochelle, Marc R; Ross-Degnan, Dennis

2017-09-01

With emerging global payment structures, medical systems need to understand longer-term impacts of care transition strategies. To determine the effect of a care transition program using patient navigators (PNs) on health service utilization among high-risk safety-net patients over a 180-day period. Randomized controlled trial conducted October 2011 through April 2013. Patients admitted to the general medicine service with ≥1 readmission risk factor: (1) age ≥ 60; (2) in-network inpatient admission within prior 6 months; (3) index length of stay ≥ 3 days; or (4) admission diagnosis of heart failure or (5) chronic obstructive pulmonary disease. The analytic sample included 739 intervention patients, 1182 controls. Through hospital visits and 30 days of post-discharge telephone outreach, PNs provided coaching and assistance with medications, appointments, transportation, communication with primary care, and self-care. Primary outcomes: (1) hospital-based utilization, a composite of ED visits and hospital admissions; (2) hospital admissions; (3) ED visits; and (4) outpatient visits. We evaluated outcomes following an index discharge, stratified by patient age (≥ 60 and < 60 years), using a 180-day time frame divided into six 30-day periods. The PN program produced starkly different outcomes by patient age. Among older PN patients, hospital-based utilization was consistently lower than controls, producing an 18.7% cumulative decrease at 180 days (p = 0.038); outpatient visits increased in the critical first 30-day period (p = 0.006). Among younger PN patients, hospital-based utilization was 31.7% (p = 0.038) higher at 180 days, largely reflecting sharply higher utilization in the initial 30 days (p = 0.002), with non-significant changes thereafter; outpatient visits experienced no significant changes. A PN program serving high-risk safety-net patients differentially impacted patients based on age, and among younger patients, outcomes varied over time. Our findings highlight the importance for future research to evaluate care transition programs among different subpopulations and over longer time periods.

Intracoronary Gene Transfer of Adenylyl Cyclase 6 in Patients With Heart Failure

PubMed Central

Hammond, H. Kirk; Penny, William F.; Traverse, Jay H.; Henry, Timothy D.; Watkins, Matthew W.; Yancy, Clyde W.; Sweis, Ranya N.; Adler, Eric D.; Patel, Amit N.; Murray, David R.; Ross, Robert S.; Bhargava, Valmik; Maisel, Alan; Barnard, Denise D.; Lai, N. Chin; Dalton, Nancy D.; Lee, Martin L.; Narayan, Sanjiv M.; Blanchard, Daniel G.; Gao, Mei Hua

2017-01-01

Importance Gene transfer has rarely been tested in randomized clinical trials. Objective To evaluate the safety and efficacy of intracoronary delivery of adenovirus 5 encoding adenylyl cyclase 6 (Ad5.hAC6) in heart failure. Design, Setting, and Participants A randomized, double-blind, placebo-controlled, phase 2 clinical trial was conducted in US medical centers (randomization occurred from July 19, 2010, to October 30, 2014). Participants 18 to 80 years with symptomatic heart failure (ischemic and nonischemic) and an ejection fraction (EF) of 40% or less were screened; 86 individuals were enrolled, and 56 were randomized. Data analysis was of the intention-to-treat population. Participants underwent exercise testing and measurement of left ventricular EF (echocardiography) and then cardiac catheterization, where left ventricular pressure development (+dP/dt)and decline (−dP/dt) were recorded. Participants were randomized (3:1 ratio) to receive 1 of 5 doses of intracoronary Ad5.hAC6 or placebo. Participants underwent a second catheterization 4 weeks later for measurement of dP/dt. Exercise testing and EF were assessed 4 and 12 weeks after randomization. Interventions Intracoronary administration of Ad5.hAC6 (3.2 × 109 to 1012 virus particles) or placebo. Main Outcomes and Measures Primary end points included exercise duration and EF before and 4 and 12 weeks after randomization and peak rates of +dP/dt and −dP/dt before and 4 weeks after randomization. Fourteen placebo participants were compared (intention to treat) with 24 Ad5.hAC6 participants receiving the highest 2 doses (D4 + 5). Results Fifty-six individuals were randomized and monitored for up to 1 year. Forty-two participants (75%) received Ad5.hAC6 (mean [SE] age, 63 [1] years; EF, 30% [1%]), and 14 individuals (25%) received placebo (age, 62 [1] years; EF, 30% [2%]). Exercise duration showed no significant group differences (4 weeks, P = .27; 12 weeks, P = .47, respectively). The D4 + 5 participants had increased EF at 4 weeks (+6.0 [1.7] EF units; n = 21; P < .004), but not 12 weeks (+3.0 [2.4] EF units; n = 21; P= .16). Placebo participants showed no increase in EF at 4 weeks or 12 weeks. Exercise duration showed no between-group differences (4-week change from baseline: placebo, 27 [36] seconds; D4 + 5, 44 [25] seconds; P = .27; 12-week change from baseline: placebo, 44 [28] seconds; D4 + 5, 58 [29 seconds, P = .47). AC6 gene transfer increased basal left ventricular peak −dP/dt (4-week change from baseline: placebo, +93 [51] mm Hg/s; D4 + 5, -39 [33] mm Hg/s; placebo [n = 21]; P < .03); AC6 did not increase arrhythmias. The admission rate for patients with heart failure was 9.5% (4 of 42) in the AC6 group and 28.6% (4 of 14) in the placebo group (relative risk, 0.33 [95% CI, 0.08-1.36]; P = .10). Conclusions and Relevance AC6 gene transfer safely increased LV function beyond standard heart failure therapy, attainable with one-time administration. Larger trials are warranted. Trial Registration clinicaltrials.gov Identifier: NCT00787059 PMID:27437887

Bayesian adaptive trials offer advantages in comparative effectiveness trials: an example in status epilepticus.

PubMed

Connor, Jason T; Elm, Jordan J; Broglio, Kristine R

2013-08-01

We present a novel Bayesian adaptive comparative effectiveness trial comparing three treatments for status epilepticus that uses adaptive randomization with potential early stopping. The trial will enroll 720 unique patients in emergency departments and uses a Bayesian adaptive design. The trial design is compared to a trial without adaptive randomization and produces an efficient trial in which a higher proportion of patients are likely to be randomized to the most effective treatment arm while generally using fewer total patients and offers higher power than an analogous trial with fixed randomization when identifying a superior treatment. When one treatment is superior to the other two, the trial design provides better patient care, higher power, and a lower expected sample size. Copyright © 2013 Elsevier Inc. All rights reserved.

The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing.

PubMed

Wayne, Peter M; Gagnon, Margaret M; Macklin, Eric A; Travison, Thomas G; Manor, Bradley; Lachman, Margie; Thomas, Cindy P; Lipsitz, Lewis A

2017-09-01

Supporting the health of growing numbers of frail older adults living in subsidized housing requires interventions that can combat frailty, improve residents' functional abilities, and reduce their health care costs. Tai Chi is an increasingly popular multimodal mind-body exercise that incorporates physical, cognitive, social, and meditative components in the same activity and offers a promising intervention for ameliorating many of the conditions that lead to poor health and excessive health care utilization. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study is an ongoing two-arm cluster randomized, attention-controlled trial designed to examine the impact of Tai Chi on functional indicators of health and health care utilization. We are enrolling participants from 16 urban subsidized housing facilities (n=320 participants), conducting the Tai Chi intervention or education classes and social calls (attention control) in consenting subjects within the facilities for one year, and assessing these subjects at baseline, 6months, and 1year. Physical function (quantified by the Short Physical Performance Battery), and health care utilization (emergency visits, hospitalizations, skilled nursing and nursing home admissions), assessed at 12months are co-primary outcomes. Our discussion highlights our strategy to balance pragmatic and explanatory features into the study design, describes efforts to enhance site recruitment and participant adherence, and summarizes our broader goal of post study dissemination if effectiveness and cost-effectiveness are demonstrated, by preparing training and protocol manuals for use in housing facilities across the U.S. Copyright © 2017 Elsevier Inc. All rights reserved.

Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home)

PubMed Central

2016-01-01

Background Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. Objective The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. Methods This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner. Results It is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system. Conclusions While there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases. ClinicalTrial ClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax) PMID:27977002

Computer-Assisted Decision Support for Student Admissions Based on Their Predicted Academic Performance.

PubMed

Muratov, Eugene; Lewis, Margaret; Fourches, Denis; Tropsha, Alexander; Cox, Wendy C

2017-04-01

Objective. To develop predictive computational models forecasting the academic performance of students in the didactic-rich portion of a doctor of pharmacy (PharmD) curriculum as admission-assisting tools. Methods. All PharmD candidates over three admission cycles were divided into two groups: those who completed the PharmD program with a GPA ≥ 3; and the remaining candidates. Random Forest machine learning technique was used to develop a binary classification model based on 11 pre-admission parameters. Results. Robust and externally predictive models were developed that had particularly high overall accuracy of 77% for candidates with high or low academic performance. These multivariate models were highly accurate in predicting these groups to those obtained using undergraduate GPA and composite PCAT scores only. Conclusion. The models developed in this study can be used to improve the admission process as preliminary filters and thus quickly identify candidates who are likely to be successful in the PharmD curriculum.

Assertive community treatment for elderly people with severe mental illness

PubMed Central

2010-01-01

Background Adults aged 65 and older with severe mental illnesses are a growing segment of the Dutch population. Some of them have a range of serious problems and are also difficult to engage. While assertive community treatment is a common model for treating difficult to engage severe mental illnesses patients, no special form of it is available for the elderly. A special assertive community treatment team for the elderly is developed in Rotterdam, the Netherlands and tested for its effectiveness. Methods We will use a randomized controlled trial design to compare the effects of assertive community treatment for the elderly with those of care as usual. Primary outcome measures will be the number of dropouts, the number of patients engaged in care and patient's psychiatric symptoms, somatic symptoms, and social functioning. Secondary outcome measures are the number of unmet needs, the subjective quality of life and patients' satisfaction. Other secondary outcomes include the number of crisis contacts, rates of voluntary and involuntary admission, and length of stay. Inclusion criteria are aged 65 plus, the presence of a mental disorder, a lack of motivation for treatment and at least four suspected problems with functioning (addiction, somatic problems, daily living activities, housing etc.). If patients meet the inclusion criteria, they will be randomly allocated to either assertive community treatment for the elderly or care as usual. Trained assessors will use mainly observational instruments at the following time points: at baseline, after 9 and 18 months. Discussion This study will help establish whether assertive community treatment for the elderly produces better results than care as usual in elderly people with severe mental illnesses who are difficult to engage. When assertive community treatment for the elderly proves valuable in these respects, it can be tested and implemented more widely, and mechanisms for its effects investigated. Trial Registration The Netherlands National Trial Register NTR1620 PMID:20958958

Comparison of healing rate in diabetes-related foot ulcers with low frequency ultrasonic debridement versus non-surgical sharps debridement: a randomised trial protocol

PubMed Central

2014-01-01

Background Foot ulceration has been reported as the leading cause of hospital admission and amputation in individuals with diabetes. Diabetes-related foot ulcers require multidisciplinary management and best practice care, including debridement, offloading, dressings, management of infection, modified footwear and management of extrinsic factors. Ulcer debridement is a commonly applied management approach involving removal of non-viable tissue from the ulcer bed. Different methods of debridement have been reported in the literature including autolytic debridement via moist wound healing, mechanical debridement utilising wet to dry dressings, theatre based sharps debridement, biological debridement, non-surgical sharps debridement and newer technology such as low frequency ultrasonic debridement. Methods People with diabetes and a foot ulcer, referred to and treated by the Podiatry Department at Monash Health and who meet the inclusion criteria will be invited to participate in this randomised controlled trial. Participants will be randomly and equally allocated to either the non-surgical sharps debridement (control) or low frequency ultrasonic debridement (intervention) group (n = 322 ulcers/n = 108 participants). Where participants have more than one ulcer, only the participant will be randomised, not the ulcer. An investigator not involved in participant recruitment or assessment will be responsible for preparing the random allocation sequence and envelopes. Each participant will receive weekly treatment for six months including best practice podiatric management. Each ulcer will be measured on a weekly basis by calculating total area in centimetres squared. Measurement will be undertaken by a trained research assistant to ensure outcomes are blinded from the treating podiatrist. Another member of the research team will assess the final primary outcome. Discussion The primary aim of this study is to compare healing rates for diabetes-related foot ulcers using non-surgical sharps debridement versus low frequency ultrasonic debridement over a six month period. The primary outcome measure for this study is the proportion of ulcers healed by the six month follow-up period. Secondary outcomes will include a quality of life measure, assessment of pain and health care resource use between the two treatment modalities. Trial registration Australian New Zealand Clinical Trial Registry: ACTRN12612000490875. PMID:24423411

Admission EEG findings in diverse paediatric cerebral malaria populations predict outcomes.

PubMed

Postels, Douglas G; Wu, Xiaoting; Li, Chenxi; Kaplan, Peter W; Seydel, Karl B; Taylor, Terrie E; Kousa, Youssef A; Idro, Richard; Opoka, Robert; John, Chandy C; Birbeck, Gretchen L

2018-05-22

Electroencephalography at hospital presentation may offer important insights regarding prognosis that can inform understanding of cerebral malaria (CM) pathophysiology and potentially guide patient selection and risk stratification for future clinical trials. Electroencephalogram (EEG) findings in children with CM in Uganda and Malawi were compared and associations between admission EEG findings and outcome across this diverse population were assessed. Demographic, clinical and admission EEG data from Ugandan and Malawian children admitted from 2009 to 2012 with CM were gathered, and survivors assessed for neurological abnormalities at discharge. 281 children were enrolled (Uganda n = 122, Malawi n = 159). The Malawian population was comprised only of retinopathy positive children (versus 72.5% retinopathy positive in Uganda) and were older (4.2 versus 3.7 years; p = 0.046), had a higher HIV prevalence (9.0 versus 2.8%; p = 0.042), and worse hyperlactataemia (7.4 versus 5.2 mmol/L; p < 0.001) on admission compared to the Ugandan children. EEG findings differed between the two groups in terms of average voltage and frequencies, reactivity, asymmetry, and the presence/absence of sleep architecture. In univariate analyses pooling EEG and outcomes data for both sites, higher average and maximum voltages, faster dominant frequencies, and retained reactivity were associated with survival (all p < 0.05). Focal slowing was associated with death (OR 2.93; 95% CI 1.77-7.30) and a lower average voltage was associated with neurological morbidity in survivors (p = 0.0032). Despite substantial demographic and clinical heterogeneity between subjects in Malawi and Uganda as well as different EEG readers at each site, EEG findings on admission predicted mortality and morbidity. For CM clinical trials aimed at decreasing mortality or morbidity, EEG may be valuable for risk stratification and/or subject selection.

Cost-effectiveness of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic, multicentre randomized trial cohort - The WHICH? study (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care).

PubMed

Maru, Shoko; Byrnes, Joshua; Carrington, Melinda J; Chan, Yih-Kai; Thompson, David R; Stewart, Simon; Scuffham, Paul A

2015-12-15

To assess the long-term cost-effectiveness of two multidisciplinary management programs for elderly patients hospitalized with chronic heart failure (CHF) and how it is influenced by patient characteristics. A trial-based analysis was conducted alongside a randomized controlled trial of 280 elderly patients with CHF discharged to home from three Australian tertiary hospitals. Two interventions were compared: home-based intervention (HBI) that involved home visiting with community-based care versus specialized clinic-based intervention (CBI). Bootstrapped incremental cost-utility ratios were computed based on quality-adjusted life-years (QALYs) and total healthcare costs. Cost-effectiveness acceptability curves were constructed based on incremental net monetary benefit (NMB). We performed multiple linear regression to explore which patient characteristics may impact patient-level NMB. During median follow-up of 3.2 years, HBI was associated with slightly higher QALYs (+0.26 years per person; p=0.078) and lower total healthcare costs (AU$ -13,100 per person; p=0.025) mainly driven by significantly reduced duration of all-cause hospital stay (-10 days; p=0.006). At a willingness-to-pay threshold of AU$ 50,000 per additional QALY, the probability of HBI being better-valued was 96% and the incremental NMB of HBI was AU$ 24,342 (discounted, 5%). The variables associated with increased NMB were HBI (vs. CBI), lower Charlson Comorbidity Index, no hyponatremia, fewer months of HF, fewer prior HF admissions <1 year and a higher patient's self-care confidence. HBI's net benefit further increased in those with fewer comorbidities, a lower self-care confidence or no hyponatremia. Compared with CBI, HBI is likely to be cost-effective in elderly CHF patients with significant comorbidity. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Warming of intravenous and irrigation fluids for preventing inadvertent perioperative hypothermia.

PubMed

Campbell, Gillian; Alderson, Phil; Smith, Andrew F; Warttig, Sheryl

2015-04-13

Inadvertent perioperative hypothermia (a drop in core temperature to below 36°C) occurs because of interference with normal temperature regulation by anaesthetic drugs, exposure of skin for prolonged periods and receipt of large volumes of intravenous and irrigation fluids. If the temperature of these fluids is below core body temperature, they can cause significant heat loss. Warming intravenous and irrigation fluids to core body temperature or above might prevent some of this heat loss and subsequent hypothermia. To estimate the effectiveness of preoperative or intraoperative warming, or both, of intravenous and irrigation fluids in preventing perioperative hypothermia and its complications during surgery in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 2), MEDLINE Ovid SP (1956 to 4 February 2014), EMBASE Ovid SP (1982 to 4 February 2014), the Institute for Scientific Information (ISI) Web of Science (1950 to 4 February 2014), Cumulative Index to Nursing and Allied Health Literature (CINAHL) EBSCOhost (1980 to 4 February 2014) and reference lists of identified articles. We also searched the Current Controlled Trials website and ClinicalTrials.gov. We included randomized controlled trials or quasi-randomized controlled trials comparing fluid warming methods versus standard care or versus other warming methods used to maintain normothermia. Two review authors independently extracted data from eligible trials and settled disputes with a third review author. We contacted study authors to ask for additional details when needed. We collected data on adverse events only if they were reported in the trials. We included in this review 24 studies with a total of 1250 participants. The trials included various numbers and types of participants. Investigators used a range of methods to warm fluids to temperatures between 37°C and 41°C. We found that evidence was of moderate quality because descriptions of trial design were often unclear, resulting in high or unclear risk of bias due to inappropriate or unclear randomization and blinding procedures. These factors may have influenced results in some way. Our protocol specified the risk of hypothermia as the primary outcome; as no trials reported this, we decided to include data related to mean core temperature. The only secondary outcome reported in the trials that provided useable data was shivering. Evidence was unclear regarding the effects of fluid warming on bleeding. No data were reported on our other specified outcomes of cardiovascular complications, infection, pressure ulcers, bleeding, mortality, length of stay, unplanned intensive care admission and adverse events.Researchers found that warmed intravenous fluids kept the core temperature of study participants about half a degree warmer than that of participants given room temperature intravenous fluids at 30, 60, 90 and 120 minutes, and at the end of surgery. Warmed intravenous fluids also further reduced the risk of shivering compared with room temperature intravenous fluidsInvestigators reported no statistically significant differences in core body temperature or shivering between individuals given warmed and room temperature irrigation fluids. Warm intravenous fluids appear to keep patients warmer during surgery than room temperature fluids. It is unclear whether the actual differences in temperature are clinically meaningful, or if other benefits or harms are associated with the use of warmed fluids. It is also unclear if using fluid warming in addition to other warming methods confers any benefit, as a ceiling effect is likely when multiple methods of warming are used.

Efficacy of a chronic disease management model for patients with chronic liver failure.

PubMed

Wigg, Alan J; McCormick, Rosemary; Wundke, Rachel; Woodman, Richard J

2013-07-01

Despite the economic impacts of chronic liver failure (CLF) and the success of chronic disease management (CDM) programs in routine clinical practice, there have been no randomized controlled trials of CDM for CLF. We investigated the efficacy of CDM programs for CLF patients in a prospective, controlled trial. Sixty consecutive patients with cirrhosis and complications from CLF were assigned randomly to groups given intervention (n = 40) or usual care (n = 20), from 2009 to 2010. The 12-month intervention comprised 4 CDM components: delivery system redesign, self-management support, decision support, and clinical information systems. The primary outcome was the number of days spent in a hospital bed for liver-related reasons. Secondary outcomes were rates of other hospital use measures, rate of attendance at planned outpatient care, disease severity, quality of life, and quality of care. The intervention did not reduce the number of days patients spent in hospital beds for liver-related reasons, compared with usual care (17.8 vs 11.0 bed days/person/y, respectively; incidence rate ratio, 1.6; 95% confidence interval, 0.5-4.8; P = .39), or affect other measures of hospitalization. Patients given the intervention had a 30% higher rate of attendance at outpatient care (incidence rate ratio, 1.3; 95% confidence interval, 1.1-1.5; P = .004) and significant increases in quality of care, based on adherence to hepatoma screening, osteoporosis and vaccination guidelines, and referral to transplant centers (P < .05 for all). In a pilot study to determine the efficacy of CDM for patients with CLF, patients receiving CDM had significant increases in attendance at outpatient centers and quality of care, compared with patients who did not receive CDM. However, CDM did not appear to reduce hospital admission rates or disease severity or improve patient quality of life. Larger trials with longer follow-up periods are required to confirm these findings and assess cost effectiveness. Copyright © 2013 AGA Institute. Published by Elsevier Inc. All rights reserved.

Pentobarbital versus thiopental in the treatment of refractory intracranial hypertension in patients with traumatic brain injury: a randomized controlled trial

PubMed Central

Pérez-Bárcena, Jon; Llompart-Pou, Juan A; Homar, Javier; Abadal, Josep M; Raurich, Joan M; Frontera, Guillem; Brell, Marta; Ibáñez, Javier; Ibáñez, Jordi

2008-01-01

Introduction Experimental research has demonstrated that the level of neuroprotection conferred by the various barbiturates is not equal. Until now no controlled studies have been conducted to compare their effectiveness, even though the Brain Trauma Foundation Guidelines recommend that such studies be undertaken. The objectives of the present study were to assess the effectiveness of pentobarbital and thiopental in terms of controlling refractory intracranial hypertension in patients with severe traumatic brain injury, and to evaluate the adverse effects of treatment. Methods This was a prospective, randomized, cohort study comparing two treatments: pentobarbital and thiopental. Patients who had suffered a severe traumatic brain injury (Glasgow Coma Scale score after resuscitation ≤ 8 points or neurological deterioration during the first week after trauma) and with refractory intracranial hypertension (intracranial pressure > 20 mmHg) first-tier measures, in accordance with the Brain Trauma Foundation Guidelines. Results A total of 44 patients (22 in each group) were included over a 5-year period. There were no statistically significant differences in ' baseline characteristics, except for admission computed cranial tomography characteristics, using the Traumatic Coma Data Bank classification. Uncontrollable intracranial pressure occurred in 11 patients (50%) in the thiopental treatment group and in 18 patients (82%) in the pentobarbital group (P = 0.03). Under logistic regression analysis – undertaken in an effort to adjust for the cranial tomography characteristics, which were unfavourable for pentobarbital – thiopental was more effective than pentobarbital in terms of controlling intracranial pressure (odds ratio = 5.1, 95% confidence interval 1.2 to 21.9; P = 0.027). There were no significant differences between the two groups with respect to the incidence of arterial hypotension or infection. Conclusions Thiopental appeared to be more effective than pentobarbital in controlling intracranial hypertension refractory to first-tier measures. These findings should be interpreted with caution because of the imbalance in cranial tomography characteristics and the different dosages employed in the two arms of the study. The incidence of adverse effects was similar in both groups. Trial Registration (Trial registration: US Clinical Trials registry NCT00622570.) PMID:18759980

Assessments of the quality of randomized controlled trials published in International Journal of Urology from 1994 to 2011.

PubMed

Cho, Hee Ju; Chung, Jae Hoon; Jo, Jung Ki; Kang, Dong Hyuk; Cho, Jeong Man; Yoo, Tag Keun; Lee, Seung Wook

2013-12-01

Randomized controlled trials are one of the most reliable resources for assessing the effectiveness and safety of medical treatments. Low quality randomized controlled trials carry a large bias that can ultimately impair the reliability of their conclusions. The present study aimed to evaluate the quality of randomized controlled trials published in International Journal of Urology by using multiple quality assessment tools. Randomized controlled trials articles published in International Journal of Urology were found using the PubMed MEDLINE database, and qualitative analysis was carried out with three distinct assessment tools: the Jadad scale, the van Tulder scale and the Cochrane Collaboration Risk of Bias Tool. The quality of randomized controlled trials was analyzed by publication year, type of subjects, intervention, presence of funding and whether an institutional review board reviewed the study. A total of 68 randomized controlled trial articles were published among a total of 1399 original articles in International Journal of Urology. Among these randomized controlled trials, 10 (2.70%) were from 1994 to 1999, 23 (4.10%) were from 2000 to 2005 and 35 (4.00%) were from 2006 to 2011 (P = 0.494). On the assessment with the Jadad and van Tulder scale, the numbers and percentage of high quality randomized controlled trials increased over time. The studies that had institutional review board reviews, funding resources or that were carried out in multiple institutions had an increased percentage of high quality articles. The numbers and percentage of high-quality randomized controlled trials published in International Journal of Urology have increased over time. Furthermore, randomized controlled trials with funding resources, institutional review board reviews or carried out in multiple institutions have been found to be of higher quality compared with others not presenting these features. © 2013 The Japanese Urological Association.

Randomized trial of pragmatic education for low-risk COPD patients: impact on hospitalizations and emergency department visits

PubMed Central

Siddique, Haamid H; Olson, Raymond H; Parenti, Connie M; Rector, Thomas S; Caldwell, Michael; Dewan, Naresh A; Rice, Kathryn L

2012-01-01

Background: Most interventions aimed at reducing hospitalizations and emergency department (ED) visits in patients with chronic obstructive pulmonary disease (COPD) have employed resource-intense programs in high-risk individuals. Although COPD is a progressive disease, little is known about the effectiveness of proactive interventions aimed at preventing hospitalizations and ED visits in the much larger population of low-risk (no known COPD-related hospitalizations or ED visits in the prior year) patients, some of whom will eventually become high-risk. Methods: We tested the effect of a simple educational and self-efficacy intervention (n = 2243) versus usual care (n = 2182) on COPD/breathing-related ED visits and hospitalizations in a randomized study of low-risk patients at three Veterans Affairs (VA) medical centers in the upper Midwest. Administrative data was used to track VA admissions and ED visits. A patient survey was used to determine health-related events outside the VA. Results: Rates of COPD-related VA hospitalizations in the education and usual care group were not significantly different (3.4 versus 3.6 admissions per 100 person-years, respectively; 95% CI of difference −1.3 to 1.0, P = 0.77). The much higher patient-reported rates of non-VA hospitalizations for breathing-related problems were lower in the education group (14.0 versus 19.0 per 100 person-years; 95% CI −8.6 to −1.4, P = 0.006). Rates of COPD-related VA ED visits were not significantly different (6.8 versus 5.3; 95% CI −0.1 to 3.0, P = 0.07), nor were non-VA ED visits (32.4 versus 36.5; 95% CI −9.3 to 1.1, P = 0.12). All-cause VA admission and ED rates did not differ. Mortality rates (6.9 versus 8.3 per 100 person-years, respectively; 95% CI −3.0 to 0.4, P = 0.13) did not differ. Conclusion: An educational intervention that is practical for large numbers of low-risk patients with COPD may reduce the rate of breathing-related hospitalizations. Further research that more closely tracks hospitalizations to non-VA facilities is needed to confirm this finding. PMID:23118535

[Pharmacoeconomic analysis of community-acquired pneumonia treatment with telithromycin or clarithromycin].

PubMed

Rubio-Terrés, C; Cots, J M; Domínguez-Gil, A; Herreras, A; Sánchez Gascón, F; Chang, J; Trilla, A

2003-09-01

A pharmacoeconomic analysis was carried out comparing the efficacy of two treatment options for community-acquired pneumonia (CAP): telithromycin and clarithromycin. It was a retrospective analysis using a decision tree model. The efficacy of the two treatment options was estimated from a randomized, double-blind clinical trial, in which 800 mg/day oral telithromycin for 10 days was compared to 1000 mg/day oral clarithromycin for 10 days in patients with CAP (162 and 156 respectively). The use of resources was estimated based on the clinical trial and Spanish sources, and the unit costs from a Spanish health costs database. Costs were evaluated for the acquisition of antibiotic treatments, change of antibiotic due to therapeutic failure, hospital admissions, adverse reactions to treatment, primary care visits, tests and indirect costs (working days lost). The model was validated by a panel of Spanish clinical experts. As the clinical trial was designed to show equivalence, there were no significant differences in efficacy between the treatment options (clinical cure rate 88.3% and 88.5%, respectively), and a cost minimization analysis was performed. In the base case, the average cost of the disease per patient was 308.29 euros with telithromycin and 331.5 euros with clarithromycin (a difference of 23.21 euros). The results were stable in the susceptibility analysis, with differences favorable to telithromycin ranging between 5.50 and 45.45 euros. Telithromycin results in a cost savings of up to 45.45 euros per CAP patient compared to clarithromycin.

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Telegerontology as a Novel Approach to Address Health and Safety by Supporting Community-Based Rural Dementia Care Triads: Randomized Controlled Trial Protocol

PubMed Central

2018-01-01

Background Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly practical for addressing current limitations in rural community-based dementia care. Objective Using the remotely-delivered expertise of the Telegerontology dementia care team, we aim to enhance the caregiver/patient/physician triad and thereby provide the necessary support for the person with dementia to “age in place.” Methods This is a cluster randomized feasibility trial with four rural regions in the province of Newfoundland and Labrador, Canada (2 regions randomly assigned to “intervention” and 2 to “control”). The study population includes 22 “dementia triads” that consist of a community-dwelling older Canadian with moderate to late dementia, their family caregivers, and their Primary Care Physician (PCP). Over the 6-month active study period, all participants will be provided an iPad. The intervention is intended as an adjunct to existing PCP care, consisting of weekly Skype-based videoconferencing calls with the Telegerontology physician, and other team members as needed (occupational therapist, physical therapist etc). Control participants receive usual community-based dementia care with their PCP. A baseline (pre-) assessment will be performed during a home visit with the study team. Post intervention, 6- and 12-month follow-up assessments will be collected remotely using specialized dementia monitoring applications and Skype calls. Primary outcomes include admission to long-term care, falls, emergency room visits, hospital stays, and caregiver burden. Results Results will be available in March of 2018. Conclusions Results from this study will demonstrate a novel approach to dementia care that has the potential to impact both rural PCPs, family caregivers, and people with dementia, as well as provide evidence for the utility of Telegerontology in models of eHealth-based care. PMID:29472178

Telegerontology as a Novel Approach to Address Health and Safety by Supporting Community-Based Rural Dementia Care Triads: Randomized Controlled Trial Protocol.

PubMed

Wallack, Elizabeth M; Harris, Chelsea; Ploughman, Michelle; Butler, Roger

2018-02-22

Telegerontology is an approach using videoconferencing to connect an interdisciplinary team in a regional specialty center to patients in rural communities, which is becoming increasingly practical for addressing current limitations in rural community-based dementia care. Using the remotely-delivered expertise of the Telegerontology dementia care team, we aim to enhance the caregiver/patient/physician triad and thereby provide the necessary support for the person with dementia to "age in place." This is a cluster randomized feasibility trial with four rural regions in the province of Newfoundland and Labrador, Canada (2 regions randomly assigned to "intervention" and 2 to "control"). The study population includes 22 "dementia triads" that consist of a community-dwelling older Canadian with moderate to late dementia, their family caregivers, and their Primary Care Physician (PCP). Over the 6-month active study period, all participants will be provided an iPad. The intervention is intended as an adjunct to existing PCP care, consisting of weekly Skype-based videoconferencing calls with the Telegerontology physician, and other team members as needed (occupational therapist, physical therapist etc). Control participants receive usual community-based dementia care with their PCP. A baseline (pre-) assessment will be performed during a home visit with the study team. Post intervention, 6- and 12-month follow-up assessments will be collected remotely using specialized dementia monitoring applications and Skype calls. Primary outcomes include admission to long-term care, falls, emergency room visits, hospital stays, and caregiver burden. Results will be available in March of 2018. Results from this study will demonstrate a novel approach to dementia care that has the potential to impact both rural PCPs, family caregivers, and people with dementia, as well as provide evidence for the utility of Telegerontology in models of eHealth-based care. ©Elizabeth M. Wallack, Chelsea Harris, Michelle Ploughman, Roger Butler. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

The effects of labor and delivery on maternal and neonatal outcomes in term twins: a retrospective cohort study.

PubMed

Wenckus, D J; Gao, W; Kominiarek, M A; Wilkins, I

2014-08-01

To compare maternal and neonatal outcomes in twins undergoing a trial of labor versus pre-labor caesarean. Retrospective cohort study. 19 US hospitals from the Consortium on Safe Labor. Of 2225 twin sets ≥36 weeks' gestation. Maternal (abruption, estimated blood loss, postpartum haemorrhage, transfusion, chorioamnionitis, hysterectomy, ICU admission, death) and neonatal outcomes (birth injury, 5-minute Apgar <7, NICU admission, RDS, TTN, sepsis, asphyxia, NICU length of stay, death) were compared between the trial of labour and pre-labour caesarean groups with univariate and multivariate logistic and linear regression analyses. Similar analyses were performed for actual delivery modes. Maternal and neonatal outcomes. Among the 2225 twin sets, 1078 had a trial of labour, and 65.9% of those delivered vaginally. There was an increased risk for postpartum haemorrhage [OR 2.5, 95% confidence interval (CI) 1.4-4.5] and blood transfusion (OR 1.9, 95%CI 1.2-3.2) for the trial of labour compared with pre-labour caesarean groups. Birth injury only occurred in the trial of labour group, 1% Twin A, 0.4% Twin B. Both twins had a higher risk of 5-minute Apgar <7 with trial of labour compared to pre-labour caesarean (A: OR 3.9, 95%CI 1.05-14.5; B: OR 3.9, 95%CI 1.3-12.3). Term twins undergoing a trial of labour have increased maternal haemorrhage and transfusions along with neonatal birth trauma and lower Apgar scores, but these absolute neonatal occurrences were rare. Trial of labour in twins remains a safe and reasonable option in appropriately selected cases. © 2014 Royal College of Obstetricians and Gynaecologists.

Implementation and evaluation of an integrated computerized asthma management system in a pediatric emergency department: a randomized clinical trial.

PubMed

Dexheimer, Judith W; Abramo, Thomas J; Arnold, Donald H; Johnson, Kevin; Shyr, Yu; Ye, Fei; Fan, Kang-Hsien; Patel, Neal; Aronsky, Dominik

2014-11-01

The use of evidence-based guidelines can improve the care for asthma patients. We implemented a computerized asthma management system in a pediatric emergency department (ED) to integrate national guidelines. Our objective was to determine whether patient eligibility identification by a probabilistic disease detection system (Bayesian network) combined with an asthma management system embedded in the workflow decreases time to disposition decision. We performed a prospective, randomized controlled trial in an urban, tertiary care pediatric ED. All patients 2-18 years of age presenting to the ED between October 2010 and February 2011 were screened for inclusion by the disease detection system. Patients identified to have an asthma exacerbation were randomized to intervention or control. For intervention patients, asthma management was computer-driven and workflow-integrated including computer-based asthma scoring in triage, and time-driven display of asthma-related reminders for re-scoring on the electronic patient status board combined with guideline-compliant order sets. Control patients received standard asthma management. The primary outcome measure was the time from triage to disposition decision. The Bayesian network identified 1339 patients with asthma exacerbations, of which 788 had an asthma diagnosis determined by an ED physician-established reference standard (positive predictive value 69.9%). The median time to disposition decision did not differ among the intervention (228 min; IQR=(141, 326)) and control group (223 min; IQR=(129, 316)); (p=0.362). The hospital admission rate was unchanged between intervention (25%) and control groups (26%); (p=0.867). ED length of stay did not differ among intervention (262 min; IQR=(165, 410)) and control group (247 min; IQR=(163, 379)); (p=0.818). The control and intervention groups were similar in regards to time to disposition; the computerized management system did not add additional wait time. The time to disposition decision did not change; however the management system integrated several different information systems to support clinicians' communication. Copyright © 2014. Published by Elsevier Ireland Ltd.

Does universal active MRSA surveillance influence anti-MRSA antibiotic use? A retrospective analysis of the treatment of patients admitted with suspicion of infection at Veterans Affairs Medical Centers between 2005 and 2010

PubMed Central

Jones, Makoto; Huttner, Benedikt; Leecaster, Molly; Huttner, Angela; Damal, Kavitha; Tanner, Windy; Nielson, Christopher; Rubin, Michael A.; Goetz, Matthew Bidwell; Madaras-Kelly, Karl; Samore, Matthew H.

2014-01-01

Objectives After the implementation of an active surveillance programme for MRSA in US Veterans Affairs (VA) Medical Centers, there was an increase in vancomycin use. We investigated whether positive MRSA admission surveillance tests were associated with MRSA-positive clinical admission cultures and whether the availability of surveillance tests influenced prescribers' ability to match initial anti-MRSA antibiotic use with anticipated MRSA results from clinical admission cultures. Methods Analyses were based on barcode medication administration data, microbiology data and laboratory data from 129 hospitals between January 2005 and September 2010. Hospitalized patient admissions were included if clinical cultures were obtained and antibiotics started within 2 days of admission. Mixed-effects logistic regression was used to examine associations between positive MRSA admission cultures and (i) admission MRSA surveillance test results and (ii) initial anti-MRSA therapy. Results Among 569 815 included admissions, positive MRSA surveillance tests were strong predictors of MRSA-positive admission cultures (OR 8.5; 95% CI 8.2–8.8). The negative predictive value of MRSA surveillance tests was 97.6% (95% CI 97.5%–97.6%). The diagnostic OR between initial anti-MRSA antibiotics and MRSA-positive admission cultures was 3.2 (95% CI 3.1–3.4) for patients without surveillance tests and was not significantly different for admissions with surveillance tests. Conclusions The availability of nasal MRSA surveillance tests in VA hospitals did not seem to improve the ability of prescribers to predict the necessity of initial anti-MRSA treatment despite the high negative predictive value of MRSA surveillance tests. Prospective trials are needed to establish the safety and effectiveness of using MRSA surveillance tests to guide antibiotic therapy. PMID:25103488

A Randomized Controlled Trial of the Group-Based Modified Story Memory Technique in TBI

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-16-1-0726 TITLE: A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI PRINCIPAL...2017 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER A Randomized Controlled Trial of the Group -Based Modified Story Memory Technique in TBI 5b. GRANT...forthcoming, The current study addresses this need through a double blind, placebo- controlled , randomized clinical trial (RCT) of a group

Effect of Home Visit Training Program on Growth and Development of Preterm Infants: A Double Blind Randomized Controlled Trial

PubMed Central

Edraki, Mitra; Moravej, Hossian; Rambod, Masoume

2015-01-01

Background: Home visit program can be effective in infants’ growth and development. The present study aimed to investigate the effect of home visit program on preterm infants’ growth and development within 6 months. Methods: It was a double-blind clinical trial study. The study was conducted in Hafez, Hazrat-e-Zeinab, and Namazee Hospitals affiliated to Shiraz University of Medical Sciences, Shiraz, Iran from 2010 to 2011. Preterm infants were divided into intervention (n=30) and control groups (n=30) through blocked randomization. The intervention group received home visit training program for 6 months, while the control group only received the hospital’s routine care. Then, the infants’ growth indexes, including weight, height, and head circumference, and development criteria were compared on the first day of admission in Neonatal Intensive Care Unit, and then first, second, third, and sixth months. The data were analyzed using Chi-square, independent t-test, and repeated measures ANCOVA. Results: The mean weight of the intervention and control group infants was 7207.3±1129.74 and 6366.7±922.26 gr in the sixth month. Besides, the intervention group infants’ mean weight was higher compared to the control group after six months (t=-3.05, P=0.03). Also, a significant difference was found between the two groups regarding development indexes, such as following moving objects with the head, keeping the head stable when changing the position from lying to sitting,  producing “Agha” sound, and taking objects by hand (P<0.05) during six months of age. Conclusion: The results showed that the home visit program was effective in preterm infants’ weight gain and some development indexes at the sixth month. Considering the importance of infants’ growth and development, healthcare staff is recommended to incorporate home visit training into their programs, so that steps can be taken towards improvement of preterm infants’ health. Trial Registration Number: IRCT2014082013690N3  PMID:25553330

Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

PubMed

Oyanguren, Juana; García-Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin-Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García-Gutiérrez, Susana

2017-11-01

Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Access to Higher Education by the Luck of the Draw

ERIC Educational Resources Information Center

Stone, Peter

2013-01-01

Random selection is a fair way to break ties between applicants of equal merit seeking admission to institutions of higher education (with "merit" defined here in terms of the intrinsic contribution higher education would make to the applicant's life). Opponents of random selection commonly argue that differences in strength between…

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study.

PubMed

Meissner, H O; Mscisz, A; Reich-Bilinska, H; Kapczynski, W; Mrozikiewicz, P; Bobkiewicz-Kozlowska, T; Kedzia, B; Lowicka, A; Barchia, I

2006-12-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene's Score (GMS) and Kupperman's Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) - hence, reducing dependence on hormone therapy programs.

Hormone-Balancing Effect of Pre-Gelatinized Organic Maca (Lepidium peruvianum Chacon): (II) Physiological and Symptomatic Responses of Early-Postmenopausal Women to Standardized doses of Maca in Double Blind, Randomized, Placebo-Controlled, Multi-Centre Clinical Study

PubMed Central

Meissner, H. O.; Mscisz, A.; Reich-Bilinska, H.; Kapczynski, W.; Mrozikiewicz, P.; Bobkiewicz-Kozlowska, T.; Kedzia, B.; Lowicka, A.; Barchia, I.

2006-01-01

This was a double-blind, randomized, placebo-corrected, outpatient, multi-centre (five sites) clinical study, in which a total of 168 Caucasian early-postmenopausal women volunteers (age>49 years) participated after fulfilling the criteria: follicle stimulating hormone (FSH) >30 IU/ml and estrogen (E2) <40 pg/ml levels at admission. They were randomly allocated to Placebo and Pre-Gelatinized Organic Maca (Maca-GO) treatment, according to different monthly treatment sequences scheduled for each site. Two 500 mg vegetable hard gel capsules with Maca-GO or Placebo powder were self-administered twice daily with meals (total 2 g/day) during three (Trial I; n=102) or four (Trial II; n=66) months study periods. At the baseline and follow- up monthly intervals, blood levels of FSH, E2, progesterone (PRG) and lutinizing hormone (LH), as well as serum cholesterol (CHOL), triglycerides (TRG), high- and low density lipoproteins (HDL and LDL) were measured. Menopausal symptoms were assessed according to Greene’s Score (GMS) and Kupperman’s Index (KMI). Data were analyzed using multivariate technique on blocs of monthly results in one model and Maca versus Placebo contrast in another model. A total of 124 women concluded the study. Maca-GO significantly stimulated production of E2 (P<0.001) with a simultaneous suppression (P<0.05) of blood FSH, increase (P<0.05) in HDL. Maca-GO significantly reduced both frequency and severity of individual menopausal symptoms (hot flushes and night sweating in particular) resulting in significant (P<0.001) alleviation of KMI (from 22 to 10), thus, offering an attractive non-hormonal addition to the choices available to early-postmenopausal women in the form of a natural plant alternative to Hormone Replacement Therapy (HRT) – hence, reducing dependence on hormone therapy programs. PMID:23675005

Cement augmentation of the Proximal Femoral Nail Antirotation (PFNA) - A multicentre randomized controlled trial.

PubMed

Kammerlander, Christian; Hem, Einar S; Klopfer, Tim; Gebhard, Florian; Sermon, An; Dietrich, Michael; Bach, Olaf; Weil, Yoram; Babst, Reto; Blauth, Michael

2018-04-22

New implant designs like the Proximal Femoral Nail Antirotation (PFNA) were developed to reduce failure rates in unstable pertrochanteric fractures in the elderly. Standardized implant augmentation with up to 6 mL of polymethylmethacrylate (PMMA) cement has been introduced to enhance implant anchorage by increasing the implant-bone interface in osteoporotic bone conditions. Biomechanically, loads to failure were significantly higher with augmentation. The primary objective of this study was to compare the mobility of patients with closed unstable trochanteric fractures treated by PFNA either with or without cement augmentation. A prospective multicentre, randomized, patient-blinded trial was conducted with ambulatory patients aged 75 or older who sustained a closed, unstable trochanteric fracture. Surgical fixation had to be performed within 72 h after admission. Outcomes were evaluated at baseline, during surgery, 3 to 14 days after surgery, 3 months, 6 months, and 12 months after surgery. To evaluate the primary objective, patients' walking speed was assessed by the Timed Up and Go (TUG) test. Secondary objectives included the analysis of implant migration assessed on radiographs, quality of life measured by the Barthel Index, mobility measured by the Parker Mobility Score, and complications. Of 253 randomized patients, 223 patients were eligible: 105 patients were allocated to the PFNA Augmentation group and 118 to PFNA group. At 3 to 14 days after surgery, there was no statistical significant difference in mean walking speed between the treatment groups. For the secondary objectives, also no statistical significant differences were found. However, no patient in the PFNA Augmentation group had a reoperation due to mechanical failure or symptomatic implant migration compared to 6 patients in the PFNA group. Augmentation of the PFNA blade did not improve patients' walking ability compared to the use of a non-augmented PFNA but might have the potential to prevent reoperations by strengthening the osteosynthesis construct. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Pressure ulcer prevention: a randomized controlled trial of 2 risk-directed strategies for patient surface assignment.

PubMed

Inman, K J; Dymock, K; Fysh, N; Robbins, B; Rutledge, F S; Sibbald, W J

1999-03-01

To compare the clinical utility, in terms of incidence of pressure ulcer (PU) development, and economic impact of 2 programs of patient surface assignment for PU prevention. Randomized controlled clinical trial with economic evaluation. 30-bed multidisciplinary intensive care unit (ICU), serving as the regional trauma center. 144 consecutive eligible patients at risk for the development of PUs. PU risk was assessed on admission using the Skin Ulcer Risk Evaluation (SURE) Score, and patients were randomized to either the experimental (purchase) or control group (purchase/rent). Based on their SURE Score, patients were assigned a specialty surface if needed. Patients received head-to-toe skin assessments twice weekly, new PUs were documented, a new SURE Score was calculated, and specialty surfaces were upgraded or downgraded as necessary. The incidence of PUs by site and severity, and cost. Multivariate logistic regression and decision modeling. No significant differences were detected between groups with respect to baseline population characteristics, nor in the development of PUs. Predictors of PU development were ICU length of stay and SURE Score. The experimental (purchase) group was the less costly strategy. Under baseline assumptions, surface costs per at-risk patient were $76 CDN and $171 CDN in the experimental and control groups, respectively. The savings of $95 CDN per at-risk patient translates into conservative annual savings of $47,500 CDN. Using an objective, risk-based method of patient surface assignment, the authors compared the clinical and economic outcomes of 2 programs of PU prevention. In a direct comparison of alternatives, the strategy that emphasized purchased rather than rented products proved to be the more economical. Finally, this approach illustrates how by prospectively capturing data on both the costs and consequences of competing alternatives, a more objective and informed decision-making process can result.

TAILOR - tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder in remission of psychotic symptoms: study protocol for a randomized clinical trial.

PubMed

Stürup, Anne Emilie; Jensen, Heidi Dorthe; Dolmer, Signe; Birk, Merete; Albert, Nikolai; Nielsen, Mai; Hjorthøj, Carsten; Eplov, Lene; Ebdrup, Bjørn H; Mors, Ole; Nordentoft, Merete

2017-09-29

The aim of the TAILOR trial is to investigate the effect of closely monitored tapering/discontinuation versus maintenance therapy with antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder and with minimum 3 months' remission of psychotic symptoms. Two hundred and fifty patients will be included from the psychiatric early intervention program, OPUS, in two regions in Denmark. Inclusion criteria are: ICD-10 diagnoses schizophrenia (F20, except F20.6) or persistent delusional disorder (F22), minimum 3 months' remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine). The patients will be randomized to maintenance therapy or tapering/discontinuation with antipsychotic medication in a 1-year intervention. The tapering/discontinuation group will be using a smartphone application to monitor early warning signs of psychotic relapse. Patients will be assessed at baseline, 1-, 2- and 5-year follow-up regarding psychotic and negative symptoms, side-effects of antipsychotic medication, social functioning, cognitive functioning, perceived health status, patient satisfaction, substance and alcohol use, sexual functioning and quality of life. The primary outcome will be remission of psychotic symptoms and no antipsychotic medication after 1 year. Secondary outcome measures will include: co-occurrence of remission of psychotic symptoms and 0-1-mg haloperidol equivalents of antipsychotic medication after 1-year intervention; antipsychotic dose; antipsychotic side effects; negative symptoms; social functioning; cognitive functioning; and patient satisfaction. Exploratory outcomes will include remission, clinical recovery, substance and alcohol use, sexual functioning, quality of life, self-beliefs of coping and user experience of support from health workers. Safety measures will include death, admissions to psychiatric hospital, severe self-harm and psychotic relapses. The TAILOR trial will contribute knowledge about the effect of tapering/discontinuation of antipsychotic medication in the early phases of schizophrenia and related disorders and the results may guide future clinical treatment regimens of antipsychotic treatment. EU Clinical Trials Register - EudraCT number: 2016-000565-23 . Registered on 5 February 2016.

Efficacy of Clarithromycin-Naproxen-Oseltamivir Combination in the Treatment of Patients Hospitalized for Influenza A(H3N2) Infection: An Open-label Randomized, Controlled, Phase IIb/III Trial.

PubMed

Hung, Ivan F N; To, Kelvin K W; Chan, Jasper F W; Cheng, Vincent C C; Liu, Kevin S H; Tam, Anthony; Chan, Tuen-Ching; Zhang, Anna Jinxia; Li, Patrick; Wong, Tin-Lun; Zhang, Ricky; Cheung, Michael K S; Leung, William; Lau, Johnson Y N; Fok, Manson; Chen, Honglin; Chan, Kwok-Hung; Yuen, Kwok-Yung

2017-05-01

Influenza causes excessive hospitalizations and deaths. The study assessed the efficacy and safety of a clarithromycin-naproxen-oseltamivir combination for treatment of serious influenza. From February to April 2015, we conducted a prospective open-label, randomized, controlled trial. Adult patients hospitalized for A(H3N2) influenza were randomly assigned to a 2-day combination of clarithromycin 500 mg, naproxen 200 mg, and oseltamivir 75 mg twice daily, followed by 3 days of oseltamivir or to oseltamivir 75 mg twice daily without placebo for 5 days as a control method (1:1). The primary end point was 30-day mortality. The secondary end points were 90-day mortality, serial nasopharyngeal aspirate (NPA) virus titer, percentage of neuraminidase-inhibitor-resistant A(H3N2) virus (NIRV) quasispecies, pneumonia severity index (PSI), and duration of hospital stay. Among the 217 patients with influenza A(H3N2) enrolled, 107 were randomly assigned to the combination treatment. The median age was 80 years, and 53.5% were men. Adverse events were uncommon. Ten patients died during the 30-day follow-up. The combination treatment was associated with lower 30-day mortality (P = .01), less frequent high dependency unit admission (P = .009), and shorter hospital stay (P < .0001). The virus titer and PSI (days 1-3; P < .01) and the NPA specimens with NIRV quasispecies ≥ 5% (days 1-2; P < .01) were significantly lower in the combination treatment group. Multivariate analysis showed that combination treatment was the only independent factor associated with lower 30-day mortality (OR, 0.06; 95% CI, 0.004-0.94; P = .04). Combination treatment reduced both 30- and 90-day mortality and length of hospital stay. Further study of the antiviral and immunomodulatory effects of this combination treatment of severe influenza is warranted. BioMed Central; No.: ISRCTN11273879 DOI 10.1186/ISRCTN11273879; URL: www.isrctn.com/ISRCTN11273879. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Sensitive Troponin I and Stress Testing in the Emergency Department for the Early Management of Chest Pain Using 2-Hour Protocol.

PubMed

Dadkhah, Shahriar; Almuwaqqat, Zakaria; Sulaiman, Samian; Husein, Husein; Nguyen, Quang; Ali, Saad; Taskesen, Tuncay

2017-09-01

Despite improvements in identifying high-risk patients with non-ST segment ACS (acute coronary syndrome), low risk patients presenting with atypical chest pain and non-diagnostic Electrocardiogram (ECG) continued to undergo unnecessary admissions and testing. Since 1992, our chest pain protocol included using 4-hour serial biomarkers from ED admission in combination with stress testing to evaluate these patients. Our study aimed at determining whether a new accelerated diagnostic protocol using sensitive cardiac troponin I (cTnI) 2 hours after admission to the ED followed by stress testing is safe and effective in emergency settings, allowing for appropriate triage, earlier discharge and reducing costs. We conducted a single center randomized trial at Presence St. Francis Hospital Chest pain center in Evanston, Illinois enrolling sixty-four consecutive patients with atypical chest pain and non-diagnostic ECG, participants were randomized to accelerated 2 hrs protocol or our pre-existing 4-hrs protocol. Sixty patients completed the protocol and were randomized to either a 2-hour (29 patients) or 4-hour protocol using both I-STAT and PATHFAST cTnI (31 Patients). Troponin I was evaluated at 0 and at 2 hours from ED presentation with and additional draw for patients in the 4-hour rule out-group. Patients with normal serial biomarkers were then evaluated with stress testing and qualified for earlier discharge if the stress test was negative, while those with a positive biomarker at any time were admitted. Thirty-six patients had exercise treadmill stress test and 24 patients had either nuclear or Echo stress test. Fifty-three patients had a normal stress test and were discharged home. One patient in the 4-hour group with normal serial troponins developed ventricular tachycardia/fibrillation during the recovery period of a regular stress test. Six patients had a positive PATHFAST cTnI and a normal I-STAT cTnI at 2-hours. Two out of these six patients evaluated by coronary angiography. One patient had severe tortuous coronaries but no significant obstructive lesion and one had a severe CAD who needed Coronary artery bypass grafting (CABG). Three of the six patients had a normal stress test and one patient decided to leave without further testing. None of the patients with a normal stress test had a major cardiac event or adverse cardiac outcome at six-month follow up. This study demonstrates that the 2 hours accelerated protocol using high sensitivity Troponin assay at 0 and 2 hours with comprehensive clinical evaluation and ECG followed by stress testing might be successful in identifying low-risk patient population who may benefit from early discharge from ED reducing associated costs and length of stay.

Effects of music therapy on pain among female breast cancer patients after radical mastectomy: results from a randomized controlled trial.

PubMed

Li, Xiao-Mei; Yan, Hong; Zhou, Kai-Na; Dang, Shao-Nong; Wang, Duo-Lao; Zhang, Yin-Ping

2011-07-01

Music therapy has been used in multiple health care settings to reduce patient pain, anxiety, and stress. However, few available studies have investigated its effect on pain among breast cancer patients after radical mastectomy. The aim of this study was to explore the effects of music therapy on pain reduction in patients with breast cancer after radical mastectomy. This randomized controlled trial was conducted at the Surgical Department of Oncology Center, First Affiliated Hospital of Xi'an Jiaotong University from March to November 2009. A total of 120 breast cancer patients who received Personal Controlled Analgesia (PCA) following surgery (mastectomy) were randomly allocated to two groups, an intervention group and a control group (60 patients in each group). The intervention group accepted music therapy from the first day after radical mastectomy to the third admission to hospital for chemotherapy in addition to the routine nursing care, while the control group received only routine nursing care. Pain scores were measured at baseline and three post-tests using the General Questionnaire and Chinese version of Short-Form of McGill Pain Questionnaire. The primary endpoint was the change in the Pain Rating Index (PRI-total) score from baseline. Music therapy was found to reduce the PRI-total score in the intervention group significantly compared with the control group with a mean difference (95% CI) of -2.38 (-2.80, -1.95), -2.41 (-2.85, -1.96), and -1.87 (-2.33, -1.42) for the 1st, 2nd, and 3rd post-tests, respectively. Similar results were found for Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) scores. The findings of the study provide some evidence that music therapy has both short- and long-term positive effects on alleviating pain in breast cancer patients following radical mastectomy.

Prognostic value of major extracranial injury in traumatic brain injury: an individual patient data meta-analysis in 39,274 patients.

PubMed

van Leeuwen, Nikki; Lingsma, Hester F; Perel, Pablo; Lecky, Fiona; Roozenbeek, Bob; Lu, Juan; Shakur, Haleema; Weir, James; Steyerberg, Ewout W; Maas, Andrew I R

2012-04-01

Major extracranial injury (MEI) is common in traumatic brain injury (TBI) patients, but the effect on outcome is controversial. To assess the prognostic value of MEI on mortality after TBI in an individual patient data meta-analysis of 3 observational TBI studies (International Mission on Prognosis and Clinical Trial Design in TBI [IMPACT]), a randomized controlled trial (Corticosteroid Randomization After Significant Head Injury [CRASH]), and a trauma registry (Trauma Audit and Research Network [TARN]). MEI (extracranial injury with an Abbreviated Injury Scale ≥ 3 or requiring hospital admission) was related to mortality with logistic regression analysis, adjusted for age, Glasgow Coma Scale motor score, and pupil reactivity and stratified by TBI severity. We pooled odds ratios (ORs) with random-effects meta-analysis. We included 39,274 patients. Mortality was 25%, and 32% had MEI. MEI was a strong predictor for mortality in TARN, with adjusted odds ratios of 2.81 (95% confidence interval [CI], 2.44-3.23) in mild, 2.18 (95% CI, 1.80-2.65) in moderate, and 2.14 (95% CI, 1.95-2.35) in severe TBI patients. The prognostic effect was smaller in IMPACT and CRASH, with pooled adjusted odds ratios of 2.14 (95% CI, 0.93-4.91) in mild, 1.46 (95% CI, 1.14-1.85) in moderate, and 1.18 (95% CI, 1.03-1.55) in severe TBI. When patients who died within 6 hours after injury were excluded from TARN, the effect of MEI was comparable with IMPACT and CRASH. MEI is an important prognostic factor for mortality in TBI patients. However, the effect varies by population, which explains the controversy in the literature. The strength of the effect is smaller in patients with more severe brain injury and depends on time of inclusion in a study.

Meeting a Forensic Podiatry Admissibility Challenge: A Daubert Case Study.

PubMed

Nirenberg, Michael

2016-05-01

This article is an introduction to the United States Supreme Court's standard of admissibility of forensic evidence and testimony at trial, known as the Daubert standard, with emphasis on how this standard applies to the field of forensic podiatry. The author, a forensic podiatrist, provided law enforcement with evidence tying a bloody sock-clad footprint found at the scene of a homicide to the suspect. In 2014, the author testified at a pretrial hearing, known as "a Daubert hearing," to address the admissibility of this evidence in court. This was the first instance of forensic podiatry being the primary subject of a Daubert hearing. The hearing resulted in the court ordering this evidence admissible. The expert's testimony contributed to the suspect's conviction. This article serves as a reference for forensic podiatrists and experts in similar fields that involve impression evidence, providing evidentiary standards and their impact on expert evidence and testimony. © 2016 American Academy of Forensic Sciences.

Assessing the Generalizability of Randomized Trial Results to Target Populations

PubMed Central

Stuart, Elizabeth A.; Bradshaw, Catherine P.; Leaf, Philip J.

2014-01-01

Recent years have seen increasing interest in and attention to evidence-based practices, where the “evidence” generally comes from well-conducted randomized trials. However, while those trials yield accurate estimates of the effect of the intervention for the participants in the trial (known as “internal validity”), they do not always yield relevant information about the effects in a particular target population (known as “external validity”). This may be due to a lack of specification of a target population when designing the trial, difficulties recruiting a sample that is representative of a pre-specified target population, or to interest in considering a target population somewhat different from the population directly targeted by the trial. This paper first provides an overview of existing design and analysis methods for assessing and enhancing the ability of a randomized trial to estimate treatment effects in a target population. It then provides a case study using one particular method, which weights the subjects in a randomized trial to match the population on a set of observed characteristics. The case study uses data from a randomized trial of School-wide Positive Behavioral Interventions and Supports (PBIS); our interest is in generalizing the results to the state of Maryland. In the case of PBIS, after weighting, estimated effects in the target population were similar to those observed in the randomized trial. The paper illustrates that statistical methods can be used to assess and enhance the external validity of randomized trials, making the results more applicable to policy and clinical questions. However, there are also many open research questions; future research should focus on questions of treatment effect heterogeneity and further developing these methods for enhancing external validity. Researchers should think carefully about the external validity of randomized trials and be cautious about extrapolating results to specific populations unless they are confident of the similarity between the trial sample and that target population. PMID:25307417