Haptoglobin phenotype predicts cerebral vasospasm and clinical deterioration after aneurysmal subarachnoid hemorrhage.

PubMed

Ohnishi, Hiroyuki; Iihara, Koji; Kaku, Yasuyuki; Yamauchi, Keita; Fukuda, Kenji; Nishimura, Kunihiro; Nakai, Michikazu; Satow, Tetsu; Nakajima, Norio; Ikegawa, Masaya

2013-05-01

Vasospasm (VS) and delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) are thought to greatly affect prognosis. Haptoglobin (Hp) is a hemoglobin-binding protein expressed by a genetic polymorphism (1-1, 2-1, and 2-2). Our objects were to investigate whether the Hp phenotype could predict the incidence of cerebral infarction, favorable outcome, clinical deterioration by DCI, and angiographical VS after aneurysmal SAH. Ninety-five consecutive patients who underwent clipping or coil embolization were studied. Favorable functional outcome was defined as a modified Rankin Scale score of 0-2 at 3 months. Angiographical VS was diagnosed based on cerebral angiography findings performed between days 7 and 10 after SAH. The Hp 2-2 group had a significantly greater risk of angiographical VS than that of Hp 2-1 and 1-1 groups combined on univariate (odds ratio [OR]: 3.60, confidence interval [CI]: 1.49-8.67, P = .003) and multivariate logistic regression analyses after being adjusted for age, sex, Fisher groups, and other risk factors (OR: 3.75, CI: 1.54-9.16, P = .004). The Hp 2-2 group also showed the tendency of a greater risk of clinical deterioration by DCI with marginal significance on univariate and age- and sex-adjusted analyses (univariate OR: 2.46, CI: .90-6.74, P = .080; age- and sex-adjusted OR: 2.46, CI: .89-6.82, P = .080) but not after being adjusted for other multiple risk factors. The Hp 2-2 group was not associated with the favorable 3-month outcome and cerebral infarction (univariate: P = .867, P = .209; multivariate: P = .905, P = .292). The Hp phenotype seems to be associated with a higher rate of angiographical VS and clinical deterioration by DCI but does not affect the incidence of cerebral infarction and favorable outcome. Copyright © 2013 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Exposure to violence and psychosocial adjustment among urban school-aged children.

PubMed

Purugganan, Oscar H; Stein, Ruth E K; Silver, Ellen Johnson; Benenson, Blanch S

2003-12-01

This study determines the relationship between psychosocial adjustment in school-aged children and one aspect of exposure to violence, the proximity of exposure, in terms of (1) "physical" proximity and (2) "emotional" proximity to the victims of violence. A convenience sample of 175 children aged 9 to 12 years from a primary care clinic of a large urban hospital were interviewed about their exposure to violence using the Children's Report of Exposure to Violence. Psychosocial adjustment was measured through maternal reports using the Child Behavior Checklist (CBCL) and the Personal Adjustment and Role Skills Scale (PARS III). Children were categorized into three groups according to their closest proximity to exposure to violence ("victim" > "witness" > exposure through other people's "report") and two groups according to emotional proximity (victim was a "familiar person" or "stranger"). All children (23/175) who scored above the CBCL clinical cutoff (T score > 63) were witnesses or victims of violence. The CBCL total T scores (higher score = more maladjustment) showed that the "victims" group (mean 52.4) scored significantly higher than the "witness" group (mean 50.0) and "report" group (mean 47.4). The PARS III total scores (lower scores = more maladjustment) showed that the "victims" group (mean 87.5) scored significantly lower than the "witness" group (mean 93.1) and "report" group (mean 98.2). The relationship of the child to the victim was not associated with significantly different CBCL and PARS III scores. Children exposed to more proximal forms of violence as victims or witnesses exhibited more psychosocial maladjustment.

Ethnic Variations in Prognosis of Patients with Dementia: A Prospective Nationwide Registry Linkage Study in The Netherlands.

PubMed

Agyemang, Charles; van de Vorst, Irene E; Koek, Huiberdina L; Bots, Michiel L; Seixas, Azizi; Norredam, Marie; Ikram, Umar; Stronks, Karien; Vaartjes, Ilonca

2017-01-01

Data on dementia prognosis among ethnic minority groups are limited in Europe. We assessed differences in short-term (1-year) and long-term (3-year) mortality and readmission risk after a first hospitalization or first ever referral to a day clinic for dementia between ethnic minority groups and the ethnic Dutch population in the NetherlandsMethods: Nationwide prospective cohorts of first hospitalized dementia patients (N = 55,827) from January 1, 2000 to December 31, 2010 were constructed. Differences in short-term and long-term mortality and readmission risk following hospitalization or referral to the day clinic between ethnic minority groups (Surinamese, Turkish, Antilleans, Indonesians) and the ethnic Dutch population were investigated using Cox proportional hazard regression models with adjustment for age, sex, and comorbidities. Age-sex-adjusted short-term and long-term risks of death following a first hospitalization with dementia were comparable between the ethnic minority groups and the ethnic Dutch. Age- and sex-adjusted risk of admission was higher only in Turkish compared with ethnic Dutch (HR 1.57, 95% CI,1.08-2.29). The difference between Turkish and the Dutch attenuated and was no longer statistically significant after further adjustment for comorbidities. There were no ethnic differences in short-term and long-term risk of death, and risk of readmission among day clinic patients. Compared with Dutch patients with a comparable comorbidity rate, ethnic minority patients with dementia did not have a worse prognosis. Given the poor prognosis of dementia, timely and targeted advance care planning is essential, particularly in ethnic minority groups who are mired by cultural barriers and where uptake of advance care planning is known to be low.

Effect of Fixed Versus Adjusted Transcutaneous Electrical Nerve Stimulation Amplitude on Chronic Mechanical Low Back Pain.

PubMed

Elserty, Noha; Kattabei, Omaima; Elhafez, Hytham

2016-07-01

This study aimed to investigate the effect of adjusting pulse amplitude of transcutaneous electrical nerve stimulation versus fixed pulse amplitude in treatment of chronic mechanical low back pain. Randomized clinical trial. El-sahel Teaching Hospital, Egypt. Forty-five patients with chronic low back pain assigned to three equal groups. Their ages ranged from 20 to 50 years. The three groups received the same exercise program. Group A received transcutaneous electrical nerve stimulation with fixed pulse amplitude for 40 minutes. Group B received transcutaneous electrical nerve stimulation with adjusted pulse amplitude for 40 minutes, with the pulse amplitude adjusted every 5 minutes. Group C received exercises only. Treatment sessions were applied three times per week for 4 weeks for the three groups. A visual analogue scale was used to assess pain severity, the Oswestry Disability Index was used to assess functional level, and a dual inclinometer was used to measure lumbar range of motion. Evaluations were performed before and after treatment. Visual analogue scale, Oswestry Disability Index, and back range of motion significantly differed between the two groups that received transcutaneous electrical nerve stimulation and the control group and did not significantly differ between fixed and adjusted pulse amplitude of transcutaneous electrical nerve stimulation. Adjusting pulse amplitude of transcutaneous electrical nerve stimulation does not produce a difference in the effect of transcutaneous electrical nerve stimulation used to treat chronic low back pain.

LACK OF CORRELATION BETWEEN OPIOID DOSE ADJUSTMENT AND PAIN SCORE CHANGE IN A GROUP OF CHRONIC PAIN PATIENTS

PubMed Central

Chen, Lucy; Vo, Trang; Seefeld, Lindsey; Malarick, Charlene; Houghton, Mary; Ahmed, Shihab; Zhang, Yi; Cohen, Abigail; Retamozo, Cynthia; Hilaire, Kristen St.; Zhang, Vivian; Mao, Jianren

2013-01-01

Despite the increasing use of opioid analgesics for chronic pain management, it is unclear whether opioid dose escalation leads to better pain relief during chronic opioid therapy. In this study, we retrospectively analyzed clinical data collected from the Massachusetts General Hospital (MGH) Center for Pain Medicine over a 7-year period. We examined 1) the impact of opioid dose adjustment (increase or decrease) on clinical pain score, 2) gender and age differences in response to opioid therapy, and 3) the influence of clinical pain conditions on the opioid analgesic efficacy. A total of 109 subjects met the criteria for data collection. We found that neither opioid dose increase, nor decrease, correlated with point changes in clinical pain score in a subset of chronic pain patients over a prolonged course of opioid therapy (an average of 704 days). This lack of correlation was consistent regardless of the type of chronic pain including neuropathic, nociceptive, or mixed pain conditions. Neither gender nor age differences showed a significant influence on the clinical response to opioid therapy in these subjects. These results suggest that dose adjustment during opioid therapy may not necessarily alter long-term clinical pain score in a group of chronic pain patients and that individualized opioid therapy based on the clinical effectiveness should be considered to optimize the treatment outcome. Perspectives The study reports a relationship, or lack thereof, between opioid dose change and clinical pain score in a group of chronic pain patients. The study also calls for further investigation into the effectiveness of opioid therapy in the management of chronic non-malignant pain conditions. PMID:23452826

A randomised trial of high and low pressure level settings on an adjustable ventriculoperitoneal shunt valve for idiopathic normal pressure hydrocephalus: results of the Dutch evaluation programme Strata shunt (DEPSS) trial.

PubMed

Delwel, Ernst J; de Jong, Dirk A; Dammers, Ruben; Kurt, Erkan; van den Brink, Wimar; Dirven, Clemens M F

2013-07-01

In treating idiopathic normal pressure hydrocephalus (INPH) with a shunt there is always a risk of underdrainage or overdrainage. The hypothesis is tested whether patients treated using an adjustable valve preset at the highest opening pressure leads to comparable good clinical results with less subdural effusions than in a control group with an opening pressure preset at a low pressure level. A multicentre prospective randomised trial was performed on a total of 58 patients suspected of INPH. Thirty patients were assigned to (control) group 1 and received a Strata shunt (Medtronic, Goleta, USA) with the valve preset at a performance level (PL) of 1.0, while 28 patients were assigned to group 2 and received a Strata shunt with the valve preset at PL 2.5. In this group the PL was allowed to be lowered until improvement or radiological signs of overdrainage were met. Significantly more subdural effusions were observed in the improved patients of group 1. There was no statistically significant difference in improvement between both groups overall. On the basis of this multicentre prospective randomised trial it is to be recommended to treat patients with INPH with a shunt with an adjustable valve, preset at the highest opening pressure and lowered until clinical improvement or radiological signs of overdrainage occur although slower improvement and more shunt adjustments might be the consequence.

Performance Evaluation of Different d-Dimer Cutoffs in Bedridden Hospitalized Elderly Patients.

PubMed

Kassim, Nevine A; Farid, Tamer M; Pessar, Shaimaa Abdelmalik; Shawkat, Salma A

2017-11-01

A rapid and accurate diagnosis of venous thromboembolism (VTE) in the elderly individuals represents a dilemma due to nonspecific clinical presentation, confusing laboratory results, and the hazards of radiological examination in this age-group. d-Dimer test is used mainly in combination with non-high clinical pretest probability (PTP) to exclude VTE. d-Dimer testing retains its sensitivity, however, its specificity decreases in the elderly individuals. Raising the cutoff level improves the specificity of the d-dimer test without compromising its sensitivity. The current study aimed to explore the reliability of higher d-dimer cutoff values for the diagnosis of asymptomatic VTE in a population of bedridden hospitalized elderly patients with non-high clinical PTP. This retrospective study included 252 bedridden hospitalized elderly patients (>65 years) who were admitted to the Ain shams University Specialized Hospital with non-high clinical probability and developed later reduced mobility; all underwent quantitation of d-dimer and Doppler examination. Considering the whole population (>65 years), the age-adjusted cutoff achieved the best performance in comparison with the conventional and receiver operating characteristic (ROC)-derived cutoffs. When stratified according to age, the age-adjusted cutoff showed the best performance in the age-group 65-70 and comparable performance with the ROC-derived cutoff in the age-group 71-80, however, its sensitivity compromised in those older than 80 years. In conclusion, it is recommended to use age-adjusted cutoff value of d-dimer together with the clinical probability score in elderly individuals (65-80 years).

Coping with persistent pain: a comparison of persistent pain sufferers in a specialty pain clinic and in a family practice clinic.

PubMed

Crook, J; Tunks, E; Kalaher, S; Roberts, J

1988-08-01

Coping has been defined as an effort to manage external and internal demands and conflicts that tax or exceed a person's resources. This paper examines the types of coping strategies used by two groups of persistent pain sufferers: one from a family practice clinic and the other from a specialty pain clinic. The relationship between the use of different types of coping strategies and adjustment was determined. The two study groups of persistent pain sufferers differed significantly from each other on many of the indices developed to tap adjustment but did not differ on any of the Billings and Moos original categories of coping strategies. When a factor analysis of coping items was performed, 5 valid clusters relevant to the chronic pain patient samples were determined. The factor the authors entitled 'adversarialness' with the qualities of dysphoric withdrawal, avoidant behavior and catastrophizing was found to explain adjustment defined by several indices. The authors conclude that it may be important to help persistent pain sufferers to alter their attitudes and behavior that tend toward catastrophizing, avoidance and withdrawal, rather than simply concentrate on trying to teach them techniques for 'coping with stress.'

Factors associated with the course of symptoms in bipolar disorder during a 1-year follow-up: depression vs. sub-threshold mixed state.

PubMed

Mazza, Marianna; Mandelli, Laura; Zaninotto, Leonardo; Nicola, Marco Di; Martinotti, Giovanni; Harnic, Desiree; Bruschi, Angelo; Catalano, Valeria; Tedeschi, Daniela; Colombo, Roberto; Bria, Pietro; Serretti, Alessandro; Janiri, Luigi

2011-12-01

Mixed mood states, even in their sub-threshold forms, may significantly affect the course and outcome of bipolar disorder (BD). To compare two samples of BD patients presenting a major depressive episode and a sub-threshold mixed state in terms of global functioning, clinical outcome, social adjustment and quality of life during a 1-year follow-up. The sample was composed by 90 subjects (Group 1, D) clinically diagnosed with a major depressive episode and 41 patients (Group 2, Mx) for a sub-threshold mixed state. All patients were administered with a pharmacological treatment and evaluated for depressive, anxious and manic symptoms by common rating scales. Further evaluations included a global assessment of severity and functioning, social adjustment and quality of life. All evaluations were performed at baseline and after 1, 3, 6 and 12 months of treatment. The two groups were no different for baseline as well as improvement in global severity and functioning. Though clearly different for symptoms severity, the amount of change of depressive and anxiety symptoms was also no different. Manic symptoms showed instead a trend to persist over time in group 2, whereas a slight increase of manic symptoms was observed in group 1, especially after 6 months of treatment. Moreover, in group 1, some manic symptoms were also detected at the Young Mania Rating Scale (n = 24, 26.6%). Finally, improvement in quality of life and social adjustment was similar in the two groups, though a small trend toward a faster improvement in social adjustment in group 1. Sub-threshold mixed states have a substantial impact on global functioning, social adjustment and subjective well-being, similarly to that of acute phases, or at least major depression. In particular, mixed features, even in their sub-threshold forms, tend to be persistent over time. Finally, manic symptoms may be still often underestimated in depressive episodes, even in patients for BD.

Comparison of economic and clinical outcomes between patients undergoing laparoscopic bariatric surgery with powered versus manual endoscopic surgical staplers.

PubMed

Roy, Sanjoy; Yoo, Andrew; Yadalam, Sashi; Fegelman, Elliott J; Kalsekar, Iftekhar; Johnston, Stephen S

2017-04-01

To compare economic and clinical outcomes between patients undergoing laparoscopic Roux-en-Y gastric bypass (LRY) or laparoscopic sleeve gastrectomy (LSG) with use of powered vs manual endoscopic surgical staplers. Patients (aged ≥21 years) who underwent LRY or LSG during a hospital admission (January 1, 2012-September 30, 2015) were identified from the Premier Perspective Hospital Database. Use of powered vs manual staplers was identified from hospital administrative billing records. Multivariable analyses were used to compare the following outcomes between the powered and manual stapler groups, adjusting for patient and hospital characteristics and hospital-level clustering: hospital length of stay (LOS), total hospital costs, medical/surgical supply costs, room and board costs, operating room costs, operating room time, discharge status, bleeding/transfusion during the hospital admission, and 30, 60, and 90-day all-cause readmissions. The powered and manual stapler groups comprised 9,851 patients (mean age = 44.6 years; 79.3% female) and 21,558 patients (mean age = 45.0 years; 78.0% female), respectively. In the multivariable analyses, adjusted mean hospital LOS was 2.1 days for both the powered and manual stapler groups (p = .981). Adjusted mean total hospital costs ($12,415 vs $13,547, p = .003), adjusted mean supply costs ($4,629 vs $5,217, p = .011), and adjusted mean operating room costs ($4,126 vs $4,413, p = .009) were significantly lower in the powered vs manual stapler group. The adjusted rate of bleeding and/or transfusion during the hospital admission (2.46% vs 3.22%, p = .025) was significantly lower in the powered vs manual stapler group. The adjusted rates of 30, 60, and 90-day all-cause readmissions were similar between the groups (all p > .05). Sub-analysis by manufacturer showed similar results. This observational study cannot establish causal linkages. In this analysis of patients who underwent LRY or LSG, the use of powered staplers was associated with better economic outcomes, and a lower rate of bleeding/transfusion vs manual staplers in the real-world setting.

Broad- versus Narrow-Spectrum Oral Antibiotic Transition and Outcomes in Health Care-associated Pneumonia.

PubMed

Buckel, Whitney R; Stenehjem, Edward; Sorensen, Jeff; Dean, Nathan; Webb, Brandon

2017-02-01

Guidelines recommend a switch from intravenous to oral antibiotics once patients who are hospitalized with pneumonia achieve clinical stability. However, little evidence guides the selection of an oral antibiotic for patients with health care-associated pneumonia, especially where no microbiological diagnosis is made. To compare outcomes between patients who were transitioned to broad- versus narrow-spectrum oral antibiotics after initially receiving broad-spectrum intravenous antibiotic coverage. We performed a secondary analysis of an existing database of adults with community-onset pneumonia admitted to seven Utah hospitals. We identified 220 inpatients with microbiology-negative health care-associated pneumonia from 2010 to 2012. After excluding inpatient deaths and treatment failures, 173 patients remained in which broad-spectrum intravenous antibiotics were transitioned to an oral regimen. We classified oral regimens as broad-spectrum (fluoroquinolone) versus narrow-spectrum (usually a β-lactam). We compared demographic and clinical characteristics between groups. Using a multivariable regression model, we adjusted outcomes by severity (electronically calculated CURB-65), comorbidity (Charlson Index), time to clinical stability, and length of intravenous therapy. Age, severity, comorbidity, length of intravenous therapy, and clinical response were similar between the two groups. Observed 30-day readmission (11.9 vs. 21.4%; P = 0.26) and 30-day all-cause mortality (2.3 vs. 5.3%; P = 0.68) were also similar between the narrow and broad oral antibiotic groups. In multivariable analysis, we found no statistically significant differences for adjusted odds of 30-day readmission (adjusted odds ratio, 0.56; 95% confidence interval, 0.06-5.2; P = 0.61) or 30-day all-cause mortality (adjusted odds ratio, 0.55; 95% confidence interval, 0.19-1.6; P = 0.26) between narrow and broad oral antibiotic groups. On the basis of analysis of a limited number of patients observed retrospectively, our findings suggest that it may be safe to switch from broad-spectrum intravenous antibiotic coverage to a narrow-spectrum oral antibiotic once clinical stability is achieved for hospitalized patients with health care-associated pneumonia when no microbiological diagnosis is made. A larger retrospective study with propensity matching or regression-adjusted test of equivalence or ideally a prospective comparative effectiveness study will be necessary to confirm our observations.

An information and communication technology-based centralized clinical trial to determine the efficacy and safety of insulin dose adjustment education based on a smartphone personal health record application: a randomized controlled trial.

PubMed

Kim, Gyuri; Bae, Ji Cheol; Yi, Byoung Kee; Hur, Kyu Yeon; Chang, Dong Kyung; Lee, Moon-Kyu; Kim, Jae Hyeon; Jin, Sang-Man

2017-07-18

A Personal Health Record (PHR) is an online application that allows patients to access, manage, and share their health data. PHRs not only enhance shared decision making with healthcare providers, but also enable remote monitoring and at-home-collection of detailed data. The benefits of PHRs can be maximized in insulin dose adjustment for patients starting or intensifying insulin regimens, as frequent self-monitoring of glucose, self-adjustment of insulin dose, and precise at-home data collection during the visit-to-visit period are important for glycemic control. The aim of this study is to examine the efficacy and safety of insulin dose adjustment based on a smartphone PHR application in patients with diabetes mellitus (DM) and to confirm the validity and stability of an information and communication technology (ICT)-based centralized clinical trial monitoring system. This is a 24-week, open-label, randomized, multi-center trial. There are three follow-up measures: baseline, post-intervention at week 12, and at week 24. Subjects diagnosed with type 1 DM, type 2 DM, and/or post-transplant DM who initiate basal insulin or intensify their insulin regimen to a basal-bolus regimen are included. After education on insulin dose titration and prevention for hypoglycemia and a 1-week acclimation period, subjects are randomized in a 1:1 ratio to either an ICT-based intervention group or a conventional intervention group. Subjects in the conventional intervention group will save and send their health information to the server via a PHR application, whereas those in ICT-based intervention group will receive additional algorithm-based feedback messages. The health information includes level of blood glucose, insulin dose, details on hypoglycemia, food diary, and step count. The primary outcome will be the proportion of patients who reach an optimal insulin dose within 12 weeks of study enrollment, without severe hypoglycemia or unscheduled clinic visits. This clinical trial will reveal whether insulin dose adjustment based on a smartphone PHR application can facilitate the optimization of insulin doses in patients with DM. In addition, the process evaluation will provide information about the validity and stability of the ICT-based centralized clinical trial monitoring system in this research field. Clinicaltrials.gov NCT 03112343 . Registered on 12 April 2017.

[Validity of adjusted morbidity groups with respect to clinical risk groups in the field of primary care].

PubMed

Monterde, David; Vela, Emili; Clèries, Montse; García Eroles, Luis; Pérez Sust, Pol

2018-02-09

To compare the performance in terms of goodness of fit and explanatory power of 2morbidity groupers in primary care (PC): adjusted morbidity groups (AMG) and clinical risk groups (CRG). Cross-sectional study. PC in the Catalan Institute for the Health (CIH), Catalonia, Spain. Population allocated in primary care centers of the CIH for the year 2014. Three indicators of interest are analyzed such as urgent hospitalization, number of visits and spending in pharmacy. A stratified analysis by centers is applied adjusting generalized lineal models from the variables age, sex and morbidity grouping to explain each one of the 3variables of interest. The statistical measures to analyze the performance of the different models applied are the Akaike index, the Bayes index and the pseudo-variability explained by deviance change. The results show that in the area of the primary care the explanatory power of the AMGs is higher to that offered by the CRGs, especially for the case of the visits and the pharmacy. The performance of GMAs in the area of the CIH PC is higher than that shown by the CRGs. Copyright © 2018 The Authors. Publicado por Elsevier España, S.L.U. All rights reserved.

Anxiety in medical students: is preparation for full-time clinical attachments more dependent upon differences in maturity or on educational programmes for undergraduate and graduate entry students?

PubMed

Hayes, K; Feather, A; Hall, A; Sedgwick, P; Wannan, G; Wessier-Smith, A; Green, T; McCrorie, P

2004-11-01

The transition to full-time clinical studies holds anxieties for most medical students. While graduate entry medical education has only recently begun in the UK, the parallel undergraduate and graduate entry MBBS courses taught at our school allowed us to study how 2 differently prepared groups perceived this vital time at a comparable stage in their training. An anonymous questionnaire collected demographic data and graded anxiety in 13 statements relating to starting full-time clinical attachments. Two open questions allowed free text comment on the most positive and negative influences perceived during this time. Both a statistical analysis and a qualitative assessment were performed to compare the 2 groups of students. The 2 groups were similar with respect to gender but the graduate entry students were significantly older. The graduate entry students were significantly less anxious about most aspects of the transition period compared to the undergraduates. These course differences remained after adjusting for age and sex. When adjusted for course and age, male students expressed less anxiety. The main positive qualitative statements related to continual clinical and communication skills training in the graduate entry group. The main qualitative concerns in both groups related to 'fitting in' and perceived lack of factual knowledge. These data support the early introduction of clinical skills teaching, backed up by a fully integrated clinically relevant curriculum with continued assessment, in preparing students and reducing levels of anxiety before they start full-time clinical attachments. These course design differences appear to be more important than any differences in maturity between the 2 groups.

Diabetes Screening Reminder for Women With Prior Gestational Diabetes: A Randomized Controlled Trial.

PubMed

Zera, Chloe A; Bates, David W; Stuebe, Alison M; Ecker, Jeffrey L; Seely, Ellen W

2015-07-01

To evaluate whether an electronic health record (EHR) reminder improves rates of screening for type 2 diabetes in women with prior gestational diabetes. We randomly allocated primary care providers (by clinic site) to a reminder for type 2 diabetes screening within the EHR or to usual care. Women with previous gestational diabetes mellitus were identified through an automated search of laboratory results and the problem list. We compared rates of screening during the study period (2010-2012) in women at intervention sites with those at control sites. With a sample size of 850 participants, we had 80% power to detect a 15% difference in screening rates. We included 847 individuals seen at a participating clinic during the study period, of whom 471 were at a reminder clinic and 376 were at a control clinic. A similar proportion of women were screened for type 2 diabetes in both groups (n=265, 56.3% of the reminder group compared with n=206, 54.8% of the control group, P=.67; adjusted odds ratio [OR] 1.04, 95% confidence interval [CI] 0.79-1.38). Patient characteristics associated with risk for diabetes including body mass index (adjusted OR per kg/m 1.05, 95% CI 1.01-1.08) and race (adjusted OR for nonwhite race 2.14, 95% CI 1.57-2.92) were significantly associated with screening. A simple EHR reminder did not increase the rate of diabetes screening in women with prior gestational diabetes mellitus. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01288144. I.

Adjustable valves in normal-pressure hydrocephalus: a retrospective study of 218 patients.

PubMed

Zemack, Göran; Romner, Bertil

2002-12-01

We sought to assess the value of adjusting shunt valve opening pressure, complications, and outcomes with the use of an adjustable shunt valve in the treatment of patients with normal-pressure hydrocephalus (NPH). In a single-center retrospective study, 231 adjustable valves (range, 30-200 mm H(2)O) were the first shunt implantations in 147 patients with idiopathic NPH (INPH) and 71 patients with secondary NPH (SNPH). The effect of adjustment on gait disturbance, cognitive impairment, urinary incontinence and other symptoms were evaluated, and an improvement index was created. In the INPH group, 138 adjustments were performed in 49.0% of the patients (average, 0.94 adjustments/patient). For the SNPH group, 49 adjustments were performed in 32.4% of the patients (average, 0.69 adjustments/patient). The reasons for adjustment were overdrainage in 48 patients (25.7%), underdrainage in 98 patients (52.4%), subdural hematoma in 37 patients (19.8%), and other reasons in 2 patients (2.1%). Clinical status improved after 56 (49.1%) of all 114 adjustments, whereas 23 (42.6%) of 54 minor (< or =20 mm H2O) and 33 (66.0%) of 50 larger adjustments improved the patient's clinical status. The correlation of the improvement index with the size of the individual adjustments was not significant. Complications occurred in 43 (19.7%) of 218 patients, valve malfunction occurred in 3 patients (1.3%), infection occurred in 14 patients (6.4%), and nontraumatic subdural effusion occurred in 15 patients (6.9%; 8 were treated by adjustment alone). The 5-year shunt survival rate was 80.2%. Outcomes were excellent or good in 71 (78.9%) of 90 patients with INPH and in 30 (69.8%) of 43 patients with SNPH. Noninvasive, particularly consecutive, minor or single larger adjustments to the valve opening pressure can further improve outcome in patients with NPH who undergo shunting.

Patterns Exploration on Patterns of Empirical Herbal Formula of Chinese Medicine by Association Rules

PubMed Central

Huang, Li; Yuan, Jiamin; Yang, Zhimin; Xu, Fuping; Huang, Chunhua

2015-01-01

Background. In this study, we use association rules to explore the latent rules and patterns of prescribing and adjusting the ingredients of herbal decoctions based on empirical herbal formula of Chinese Medicine (CM). Materials and Methods. The consideration and development of CM prescriptions based on the knowledge of CM doctors are analyzed. The study contained three stages. The first stage is to identify the chief symptoms to a specific empirical herbal formula, which can serve as the key indication for herb addition and cancellation. The second stage is to conduct a case study on the empirical CM herbal formula for insomnia. Doctors will add extra ingredients or cancel some of them by CM syndrome diagnosis. The last stage of the study is to divide the observed cases into the effective group and ineffective group based on the assessed clinical effect by doctors. The patterns during the diagnosis and treatment are selected by the applied algorithm and the relations between clinical symptoms or indications and herb choosing principles will be selected by the association rules algorithm. Results. Totally 40 patients were observed in this study: 28 patients were considered effective after treatment and the remaining 12 were ineffective. 206 patterns related to clinical indications of Chinese Medicine were checked and screened with each observed case. In the analysis of the effective group, we used the algorithm of association rules to select combinations between 28 herbal adjustment strategies of the empirical herbal formula and the 190 patterns of individual clinical manifestations. During this stage, 11 common patterns were eliminated and 5 major symptoms for insomnia remained. 12 association rules were identified which included 5 herbal adjustment strategies. Conclusion. The association rules method is an effective algorithm to explore the latent relations between clinical indications and herbal adjustment strategies for the study on empirical herbal formulas. PMID:26495415

Economic evaluation of an implementation strategy for the management of low back pain in general practice.

PubMed

Jensen, Cathrine Elgaard; Riis, Allan; Petersen, Karin Dam; Jensen, Martin Bach; Pedersen, Kjeld Møller

2017-05-01

In connection with the publication of a clinical practice guideline on the management of low back pain (LBP) in general practice in Denmark, a cluster randomised controlled trial was conducted. In this trial, a multifaceted guideline implementation strategy to improve general practitioners' treatment of patients with LBP was compared with a usual implementation strategy. The aim was to determine whether the multifaceted strategy was cost effective, as compared with the usual implementation strategy. The economic evaluation was conducted as a cost-utility analysis where cost collected from a societal perspective and quality-adjusted life years were used as outcome measures. The analysis was conducted as a within-trial analysis with a 12-month time horizon consistent with the follow-up period of the clinical trial. To adjust for a priori selected covariates, generalised linear models with a gamma family were used to estimate incremental costs and quality-adjusted life years. Furthermore, both deterministic and probabilistic sensitivity analyses were conducted. Results showed that costs associated with primary health care were higher, whereas secondary health care costs were lower for the intervention group when compared with the control group. When adjusting for covariates, the intervention was less costly, and there was no significant difference in effect between the 2 groups. Sensitivity analyses showed that results were sensitive to uncertainty. In conclusion, the multifaceted implementation strategy was cost saving when compared with the usual strategy for implementing LBP clinical practice guidelines in general practice. Furthermore, there was no significant difference in effect, and the estimate was sensitive to uncertainty.

Comparisons of Prognosis between Surgically and Clinically Diagnosed Idiopathic Pulmonary Fibrosis Using Gap Model

PubMed Central

Lee, Sang Hoon; Kim, Song Yee; Kim, Dong Soon; Kim, Young Whan; Chung, Man Pyo; Uh, Soo Taek; Park, Choon Sik; Jeong, Sung Hwan; Park, Yong Bum; Lee, Hong Lyeol; Shin, Jong Wook; Lee, Eun Joo; Lee, Jin Hwa; Jegal, Yangin; Lee, Hyun Kyung; Kim, Yong Hyun; Song, Jin Woo; Park, Moo Suk

2016-01-01

Abstract Although a multidisciplinary approach has become an important criterion for an idiopathic pulmonary fibrosis (IPF) diagnosis, lung biopsies remain crucial. However, the prognosis of patients with surgically diagnosed IPF (sIPF) is uncertain. We aimed to investigate the prognosis of patients with clinically diagnosed IPF (cIPF) and sIPF. In this retrospective observational study, the Korean Interstitial Lung Disease Study Group conducted a national survey to evaluate the clinical, physiological, radiological, and survival characteristics of patients with IPF from January 1, 2003 to December 31, 2007. Patients were recruited from 54 universities and teaching hospitals across the Republic of Korea. IPF diagnoses were established according to the 2002 American Thoracic Society (ATS)/European Respiratory Society criteria (ERS) guideline. A total of 1685 patients with IPF (1027 cIPF and 658 sIPF) were enrolled. Patients with sIPF were significantly younger, predominantly female, and nonsmokers (all P < 0.001). sIPF group had significantly better initial pulmonary function. The proportion of computed tomography-based honeycomb findings of patients with cIPF was higher than in those with sIPF (P < 0.001). A Kaplan-Meier analysis showed that the sIPF group had a better prognosis (P = 0.001). A survival analysis showed that age, pulmonary function parameters, pulmonary oxygen tension, honeycombing change, and combined lung cancer had a significant influence on patient prognosis. However, there was no significant difference in prognosis between the cIPF and sIPF groups after adjusting for GAP (gender, age, physiology) stage. The patients with sIPF had better clinical features than those with cIPF. However, after adjusting for GAP stage, the sIPF group showed similar prognoses as the cIPF group. This study showed that after adjusting for GAP stage, the prognosis of patients with IPF is the same regardless of the diagnostic method used. PMID:26986154

Comparisons of Prognosis between Surgically and Clinically Diagnosed Idiopathic Pulmonary Fibrosis Using Gap Model: A Korean National Cohort Study.

PubMed

Lee, Sang Hoon; Kim, Song Yee; Kim, Dong Soon; Kim, Young Whan; Chung, Man Pyo; Uh, Soo Taek; Park, Choon Sik; Jeong, Sung Hwan; Park, Yong Bum; Lee, Hong Lyeol; Shin, Jong Wook; Lee, Eun Joo; Lee, Jin Hwa; Jegal, Yangin; Lee, Hyun Kyung; Kim, Yong Hyun; Song, Jin Woo; Park, Moo Suk

2016-03-01

Although a multidisciplinary approach has become an important criterion for an idiopathic pulmonary fibrosis (IPF) diagnosis, lung biopsies remain crucial. However, the prognosis of patients with surgically diagnosed IPF (sIPF) is uncertain. We aimed to investigate the prognosis of patients with clinically diagnosed IPF (cIPF) and sIPF. In this retrospective observational study, the Korean Interstitial Lung Disease Study Group conducted a national survey to evaluate the clinical, physiological, radiological, and survival characteristics of patients with IPF from January 1, 2003 to December 31, 2007. Patients were recruited from 54 universities and teaching hospitals across the Republic of Korea. IPF diagnoses were established according to the 2002 American Thoracic Society (ATS)/European Respiratory Society criteria (ERS) guideline. A total of 1685 patients with IPF (1027 cIPF and 658 sIPF) were enrolled. Patients with sIPF were significantly younger, predominantly female, and nonsmokers (all P < 0.001). sIPF group had significantly better initial pulmonary function. The proportion of computed tomography-based honeycomb findings of patients with cIPF was higher than in those with sIPF (P < 0.001). A Kaplan-Meier analysis showed that the sIPF group had a better prognosis (P = 0.001). A survival analysis showed that age, pulmonary function parameters, pulmonary oxygen tension, honeycombing change, and combined lung cancer had a significant influence on patient prognosis. However, there was no significant difference in prognosis between the cIPF and sIPF groups after adjusting for GAP (gender, age, physiology) stage. The patients with sIPF had better clinical features than those with cIPF. However, after adjusting for GAP stage, the sIPF group showed similar prognoses as the cIPF group. This study showed that after adjusting for GAP stage, the prognosis of patients with IPF is the same regardless of the diagnostic method used.

A randomized clinical trial of theory-based activities for the behavioral symptoms of dementia in nursing home residents.

PubMed

Kolanowski, Ann; Litaker, Mark; Buettner, Lin; Moeller, Joyel; Costa, Paul T

2011-06-01

To test the main and interactive effects of activities derived from the Need-Driven Dementia-Compromised Behavior model for responding to behavioral symptoms in nursing home residents. Randomized double-blind clinical trial. Nine community-based nursing homes. One hundred twenty-eight cognitively impaired residents randomly assigned to activities adjusted to functional level (FL) (n=32), personality style of interest (PSI) (n=33), functional level and personality style of interest (FL+PSI) (n=31), or active control (AC) (n=32). Three weeks of activities provided twice daily. Agitation, passivity, engagement, affect, and mood assessed from video recordings and real-time observations during baseline, intervention, random times outside of intervention, and 1 week after intervention. All treatments improved outcomes during intervention except mood, which worsened under AC. During intervention the PSI group demonstrated greater engagement, alertness, and attention than the other groups; the FL+PSI group demonstrated greater pleasure. During random times, engagement returned to baseline levels except in the FL group in which it decreased. There was also less agitation and passivity in groups with a component adjusted to PSI. One week after the intervention, mood, anxiety, and passivity improved over baseline; significantly less pleasure was displayed after withdrawal of treatment. The hypothesis that activities adjusted to FL+PSI would improve behavioral outcomes to a greater extent than partially adjusted or nonadjusted activities was partially supported. PSI is a critical component of individualized activity prescription. © 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.

An interpersonal perspective on depression: the role of marital adjustment, conflict communication, attributions, and attachment within a clinical sample.

PubMed

Heene, Els; Buysse, Ann; Van Oost, Paulette

2007-12-01

Previous studies have focused on the difficulties in psychosocial functioning in depressed persons, underscoring the distress experienced by both spouses. We selected conflict communication, attribution, and attachment as important domains of depression in the context of marital adjustment, and we analyzed two hypotheses in one single study. First, we analyzed whether a clinical sample of couples with a depressed patient would differ significantly from a control group on these variables. Second, we explored to what degree these variables mediate/moderate the relationship between depressive symptoms and marital adjustment. The perspectives of both spouses were taken into account, as well as gender differences. In total, 69 clinical and 69 control couples were recruited, and a series of multivariate analyses of variance and regression analyses were conducted to test both hypotheses. Results indicated that both patients and their partners reported less marital adjustment associated with more negative perceptions on conflict communication, causal attributions, and insecure attachment. In addition, conflict communication and causal attributions were significant mediators of the association between depressive symptoms and marital adjustment for both depressed men and women, and causal attributions also moderated this link. Ambivalent attachment was a significant mediator only for the female identified patients. Several sex differences and clinical implications are discussed.

A DBT Skills Training Group for Family Caregivers of Persons with Dementia

ERIC Educational Resources Information Center

Drossel, Claudia; Fisher, Jane E.; Mercer, Victoria

2011-01-01

A Dialectical Behavior Therapy Skills training manual (DBT Skills) was adapted for use with caregivers of individuals with dementia. Implementation occurred in a community clinic with a heterogeneous caregiver group at risk for elder abuse. Sixteen caregivers completed the 9-week group. The results point to improved psychosocial adjustment,…

[Adjusted Clinical Groups Method (ACG) to allocate resources according to the disease burden of each health center].

PubMed

Santelices C, Emilio; Muñoz P, Fernando; Muñiz, Patricio; Rojas, José

2016-03-01

Health care must be provided with strong primary health care models, emphasizing prevention and a continued, integrated and interdisciplinary care. Tools should be used to allow a better planning and more efficient use of resources. To assess risk adjustment methodologies, such as the Adjusted Clinical Groups (ACG) developed by The Johns Hopkins University, to allow the identification of chronic condition patterns and allocate resources accordingly. We report the results obtained applying the ACG methodology in primary care systems of 22 counties for three chronic diseases, namely Diabetes Mellitus, Hypertension and Heart Failure. The outcomes show a great variability in the prevalence of these conditions in the different health centers. There is also a great diversity in the use of resources for a given condition in the different health care centers. This methodology should contribute to a better distribution of health care resources, which should be based on the disease burden of each health care center.

Continuous Covariate Imbalance and Conditional Power for Clinical Trial Interim Analyses

PubMed Central

Ciolino, Jody D.; Martin, Renee' H.; Zhao, Wenle; Jauch, Edward C.; Hill, Michael D.; Palesch, Yuko Y.

2014-01-01

Oftentimes valid statistical analyses for clinical trials involve adjustment for known influential covariates, regardless of imbalance observed in these covariates at baseline across treatment groups. Thus, it must be the case that valid interim analyses also properly adjust for these covariates. There are situations, however, in which covariate adjustment is not possible, not planned, or simply carries less merit as it makes inferences less generalizable and less intuitive. In this case, covariate imbalance between treatment groups can have a substantial effect on both interim and final primary outcome analyses. This paper illustrates the effect of influential continuous baseline covariate imbalance on unadjusted conditional power (CP), and thus, on trial decisions based on futility stopping bounds. The robustness of the relationship is illustrated for normal, skewed, and bimodal continuous baseline covariates that are related to a normally distributed primary outcome. Results suggest that unadjusted CP calculations in the presence of influential covariate imbalance require careful interpretation and evaluation. PMID:24607294

Improved clinical documentation leads to superior reportable outcomes: An accurate representation of patient's clinical status.

PubMed

Elkbuli, Adel; Godelman, Steven; Miller, Ashley; Boneva, Dessy; Bernal, Eileen; Hai, Shaikh; McKenney, Mark

2018-05-01

Clinical documentation can be an underappreciated. Trauma Centers (TCs) are now routinely evaluated for quality performance. TCs with poor documentation may not accurately reflect actual injury burden or comorbidities and can impact accuracy of mortality measures. Markers exist to adjust crude death rates for injury severity: observed over expected deaths (O/E) adjust for injury; Case Mix Index (CMI) reflects disease burden, and Severity of Illness (SOI) measures organ dysfunction. We aim to evaluate the impact of implementing a Clinical Documentation Improvement Program (CDIP) on reported outcomes. Review of 2-years of prospectively collected data for trauma patients, during the implementation of CDIP. A two-group prospective observational study design was used to evaluate the pre-implementation and the post-implementation phase of improved clinical documentation. T-test and Chi-Squared were used with significance defined as p < 0.05. In the pre-implementation period, there were 49 deaths out of 1419 (3.45%), while post-implementation period, had 38 deaths out of 1454 (2.61%), (non-significant). There was however, a significant difference between O/E ratios. In the pre-phase, the O/E was 1.36 and 0.70 in the post-phase (p < 0.001). The two groups also differed on CMI with a pre-group mean of 2.48 and a post-group of 2.87 (p < 0.001), indicating higher injury burden in the post-group. SOI started at 2.12 and significantly increased to 2.91, signifying more organ system dysfunction (p < 0.018). Improved clinical documentation results in improved accuracy of measures of mortality, injury severity, and comorbidities and a more accurate reflection in O/E mortality ratios, CMI, and SOI. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents.

PubMed

Win, Htut K; Caldera, Angel E; Maresh, Kelly; Lopez, John; Rihal, Charanjit S; Parikh, Manish A; Granada, Juan F; Marulkar, Sachin; Nassif, Deborah; Cohen, David J; Kleiman, Neal S

2007-05-09

Clinical trials that have excluded patients at high risk for cardiac events have led to commercial labeling approval of drug-eluting stents; nevertheless, such high-risk patients commonly undergo stent placement in clinical practice. The degree to which they experience cardiac events at a higher rate than non-high-risk patients is unclear. To assess the rates of major adverse cardiac events during the index admission and 1 year after the implantation of drug-eluting stents in patients with high-risk angiographic and clinical features. From July 2004 to September 2005, consecutive patients who underwent attempted stent placement at 42 different hospitals throughout the United States were enrolled in a prospective multicenter registry. We analyzed outcomes of 3323 patients who received at least 1 drug-eluting stent for a reason other than acute ST-segment elevation myocardial infarction. The study population was divided into 2 groups based on presence of at least 1 of 9 off-label characteristics based on the current US Food and Drug Administration-approved indications for sirolimus- and paclitaxel-eluting stents. The composite clinical outcomes of death, myocardial infarction, or target vessel revascularization during the index admission and death, myocardial infarction, or target lesion revascularization at 1 year were evaluated. Of the 3323 patients, 1817 (54.7%) had at least 1 off-label characteristic. During the index hospitalization, the composite clinical outcome occurred in 198 (10.9%) of patients in the off-label group and 76 (5.0%) of patients in the on-label group (adjusted odds ratio, 2.32; 95% confidence interval [CI], 1.75-3.07; P<.001). At 1 year, the composite clinical outcome occurred more often in the off-label group compared with the on-label group; 309 (17.5%) vs 131 (8.9%) (adjusted hazard ratio [HR], 2.16; 95% CI, 1.74-2.67; P<.001). Stent thrombosis also occurred more frequently among patients in the off-label group during the initial hospitalization (8 [0.4%] vs 0) and at 1 year: 29 (1.6%) vs 13 (0.9%), adjusted HR, 2.29 (95% CI, 1.02-5.16; P = .05). Compared with on-label use, off-label use of drug-eluting stents is associated with a higher rate of adverse outcomes during the index admission and at 1 year. Stent thrombosis occurred predominantly in patients who underwent off-label drug-eluting stent implantation. Clinicians should be cautious about extrapolating the benefits of drug-eluting stents over bare-metal stents observed in randomized clinical trials to higher-risk clinical settings that have not been assessed.

Intra-dialytic hypertension is associated with high mortality in hemodialysis patients

PubMed Central

Yoon, Kyu Tae; Gil, Hyo Wook; Hong, Sae Yong

2017-01-01

Background Intra-dialytic hypertension (IDH) is emerging as an important issue in hemodialysis patients. Its risk factors and clinical outcomes are unclear. Methods A total of 73 prevalent hemodialysis patients were enrolled. They included 14 (19.2%) patients with baseline IDH and 59 patients without IDH. Their clinical parameters, laboratory parameters, and mortality were investigated over 78 months. Results The risks factor of IDH included low serum potassium levels, low ultrafiltration, and low arm muscle area. Lower median survival was evident in the IDH group compared to the non-IDH group, but was not significantly different. After adjusting for relevant confounders for age, the IDH group displayed 2.846 times higher mortality rate than the non-IDH Group (adjusted hazard ratio: 2.846; 95% confidence interval: 1.081–7.490; P = 0.034). Conclusion IDH is associated with high mortality in hemodialysis patients. Clinicians should be aware of the risk factors. Future research studies are needed to explore the mechanisms involved in the association between IDH and mortality. PMID:28742805

Comparison of haemodialysis patients and non-haemodialysis patients with respect to clinical characteristics and 3-year clinical outcomes after sirolimus-eluting stent implantation: insights from the Japan multi-centre post-marketing surveillance registry.

PubMed

Otsuka, Yoritaka; Ishiwata, Sugao; Inada, Tsukasa; Kanno, Hiroyuki; Kyo, Eisho; Hayashi, Yasuhiko; Fujita, Hiroshi; Michishita, Ichiro

2011-04-01

Long-term outcomes after sirolimus-eluting stent (SES) implantation in haemodialysis (HD) patients have remained controversial. We investigated the impact of HD on outcomes after SES implantation. We analysed the data on 2050 patients who underwent SES implantation in a multi-centre prospective registry in Japan. Three-year clinical outcomes were compared between the HD group (n = 106) and the non-haemodialysis (NH) group (n = 1944). At the 3-year clinical follow-up, the rates of unadjusted cardiac mortality (HD: 16.3 vs. NH: 2.3%) and target-lesion revascularization (TLR) (HD: 19.4 vs. NH: 6.6%) were significantly higher in the HD group than the NH group (P < 0.001). Although HD group had a numerically higher stent thrombosis rate, the difference in stent thrombosis between the two groups (HD: 2.0 vs. NH: 0.7%) did not reach statistical significance. Using Cox's proportional-hazard models with propensity score adjustment for baseline differences, the HD group had higher risks of TLR [HD: 16.3 vs. NH: 6.1%; hazard ratio, 2.83; 95% confidence interval (CI): 1.62-4.93, P = 0.0003] and cardiac death (HD: 12.3 vs. NH: 2.3%; hazard ratio, 5.51; 95% CI: 2.58-11.78, P < 0.0001). The consistent results of analyses, whether unadjusted or adjusted for other baseline clinical and procedural differences, identify HD as an independent risk factor for cardiac death and TLR. Percutaneous coronary intervention with SES in HD patients has a higher incidence of repeat revascularization and mortality compared with those in NH patients. Haemodialysis appears to be strongly associated with mortality and repeat revascularization even after SES implantation.

Serum levels of leptin and adiponectin and clinical parameters in women with fibromyalgia and overweight/obesity.

PubMed

Paiva, Eduardo S; Andretta, Aline; Batista, Emmanuelle Dias; Lobo, Márcia Maria Marques Teles; Miranda, Renata Costa de; Nisihara, Renato; Schieferdecker, Maria Eliana Madalozzo; Boguszewski, César L

2017-01-01

The objectives of this study were to evaluate the serum levels of adipokines in women with fibromyalgia with and without overweight/obesity, and to correlate the adipokines levels with clinical parameters associated with fibromyalgia and adipose tissue mass (body fat). The study included 100 women divided into four groups: (a) fibromyalgia and overweight/obesity; (b) fibromyalgia and normal weight; (c) controls and overweight/obesity; and (d) controls and normal weight. Patients and controls were evaluated for clinical, anthropometric, and fibromyalgia-related parameters. Assessments included serum levels of leptin, adiponectin, monocyte chemoattractant protein-1 (MCP-1), and C-reactive protein (CRP). Levels of adipokines were further adjusted for fat mass. Fibromyalgia patients with overweight/obesity or normal weight had no differences in clinical parameters. Unadjusted leptin levels were lower in fibromyalgia patients than controls, a finding that was more remarkable in fibromyalgia patients with overweight/obesity. Leptin levels had no correlation with clinical parameters of fibromyalgia or inflammation markers (MCP-1 and CRP), and adiponectin levels showed no difference between groups. No correlation was observed between adjusted leptin levels and clinical parameters of fibromyalgia. Patients with fibromyalgia and overweight/obesity presented lower levels of leptin than controls with overweight/obesity.

Emotional indicators in children's human figure drawings.

PubMed

Catte, M; Cox, M V

1999-06-01

The human figure drawings of a group of emotionally-disturbed boys were compared with those of a group of well-adjusted boys closely matched for chronological age and another for mental age. A comparison based on Koppitz's (1968) original emotional indicators and another, based on new UK norms, showed that the emotionally-disturbed children included significantly more indicators in their drawings than their well-adjusted peers. Although this difference was statistically significant it is actually quite small. In addition, there were no differences among the groups in the kinds of indicators they exhibited. The usefulness of the Koppitz test as a tool for clinical use is questioned.

Prognostic value of the new Grade Groups in Prostate Cancer: a multi-institutional European validation study.

PubMed

Mathieu, R; Moschini, M; Beyer, B; Gust, K M; Seisen, T; Briganti, A; Karakiewicz, P; Seitz, C; Salomon, L; de la Taille, A; Rouprêt, M; Graefen, M; Shariat, S F

2017-06-01

We aimed to assess the prognostic relevance of the new Grade Groups in Prostate Cancer (PCa) within a large cohort of European men treated with radical prostatectomy (RP). Data from 27 122 patients treated with RP at seven European centers were analyzed. We investigated the prognostic performance of the new Grade Groups (based on Gleason score 3+3, 3+4, 4+3, 8 and 9-10) on biopsy and RP specimen, adjusted for established clinical and pathological characteristics. Multivariable Cox proportional hazards regression models assessed the association of new Grade Groups with biochemical recurrence (BCR). Prognostic accuracies of the models were assessed using Harrell's C-index. Median follow-up was 29 months (interquartile range, 13-54). The 4-year estimated BCR-free survival (bRFS) for biopsy Grade Groups 1-5 were 91.3, 81.6, 69.8, 60.3 and 44.4%, respectively. The 4-year estimated bRFS for RP Grade Groups 1-5 were 96.1%, 86.7%, 67.0%, 63.1% and 41.0%, respectively. Compared with Grade Group 1, all other Grade Groups based both on biopsy and RP specimen were independently associated with a lower bRFS (all P<0.01). Adjusted pairwise comparisons revealed statistically differences between all Grade Groups, except for group 3 and 4 on RP specimen (P=0.10). The discriminations of the multivariable base prognostic models based on the current three-tier and the new five-tier systems were not clinically different (0.3 and 0.9% increase in discrimination for clinical and pathological model). We validated the independent prognostic value of the new Grade Groups on biopsy and RP specimen from European PCa men. However, it does not improve the accuracies of prognostic models by a clinically significant margin. Nevertheless, this new classification may help physicians and patients estimate disease aggressiveness with a user-friendly, clinically relevant and reproducible method.

Clinical Risk Factors Associated With Peripartum Maternal Bacteremia.

PubMed

Easter, Sarah Rae; Molina, Rose L; Venkatesh, Kartik K; Kaimal, Anjali; Tuomala, Ruth; Riley, Laura E

2017-10-01

To evaluate risk factors associated with maternal bacteremia in febrile peripartum women. We performed a case-control study of women with fevers occurring between 7 days before and up to 42 days after delivery of viable neonates at two academic hospitals. Women with positive blood cultures were matched with the next two febrile women meeting inclusion criteria with negative blood cultures in the microbiology data without other matching parameters. We compared maternal and neonatal characteristics and outcomes between women in the case group and those in the control group with univariate analysis. We then used logistic regression to examine the association between clinical characteristics and maternal bacteremia. After excluding blood cultures positive only for contaminants, we compared 115 women in the case group with 285 in the control group. Bacteremic women were more likely to experience their initial fever during labor (40.9% compared with 22.8%, P<.01) and more likely to have fever at or above 102°F (62.6% compared with 31.6%, P<.01). These associations persisted in the adjusted analysis: multiparity (adjusted odds ratio [OR] 1.75, 95% CI 1.07-2.87), initial fever during labor (adjusted OR 2.82, 95% CI 1.70-4.70), and fever at or above 102°F (adjusted OR 3.83, 95% CI 2.37-6.19). In an analysis restricted to neonates whose mothers had initial fevers before or in the immediate 24 hours after delivery, neonates born to women in the case group had higher rates of bacteremia compared with those born to women in the control group (9.0% compared with 1.3%, P<.01). Eight of the nine bacteremic neonates born to bacteremic mothers (89%) grew the same organism as his or her mother in blood culture. Maternal bacteremia is associated with multiparity, initial fever during labor, and fever at or above 102°F; however, 37.5% of cases of bacteremia occurred in women with maximum fevers below this threshold. Obstetricians should maintain a heightened suspicion for an infectious source of fever in women with these clinical characteristics.

International students in speech-language pathology clinical education placements: Perceptions of experience and competency development.

PubMed

Attrill, Stacie; Lincoln, Michelle; McAllister, Sue

2015-06-01

This study aimed to describe perceptions of clinical placement experiences and competency development for international speech-language pathology students and to determine if these perceptions were different for domestic students. Domestic and international students at two Australian universities participated in nine focus group interviews. Thematic analysis led to the identification of two themes shared by international and domestic students and several separate themes. Shared themes identified the important influence of students' relationships with clinical educators, unique opportunities and learning that occurs on placement. International student themes included concerns about their communication skills and the impact of these skills on client progress. They also explored their adjustment to unfamiliar placement settings and relationships, preferring structured placements to assist this adjustment. Domestic student themes explored the critical nature of competency attainment and assessment on placement, valuing placements that enabled them to achieve their goals. The findings of this study suggest that international students experience additional communication, cultural and contextual demands on clinical placement, which may increase their learning requirements. Clinical education practices must be responsive to the learning needs of diverse student populations. Strategies are suggested to assist all students to adjust to the professional and learning expectations of clinical education placements.

Marginal discrepancy of noble metal-ceramic fixed dental prosthesis frameworks fabricated by conventional and digital technologies.

PubMed

Afify, Ahmed; Haney, Stephan; Verrett, Ronald; Mansueto, Michael; Cray, James; Johnson, Russell

2018-02-01

Studies evaluating the marginal adaptation of available computer-aided design and computer-aided manufacturing (CAD-CAM) noble alloys for metal-ceramic prostheses are lacking. The purpose of this in vitro study was to evaluate the vertical marginal adaptation of cast, milled, and direct metal laser sintered (DMLS) noble metal-ceramic 3-unit fixed partial denture (FDP) frameworks before and after fit adjustments. Two typodont teeth were prepared for metal-ceramic FDP abutments. An acrylic resin pattern of the prepared teeth was fabricated and cast in nickel-chromium (Ni-Cr) alloy. Each specimen group (cast, milled, DMLS) was composed of 12 casts made from 12 impressions (n=12). A single design for the FDP substructure was created on a laboratory scanner and used for designing the specimens in the 3 groups. Each specimen was fitted to its corresponding cast by using up to 5 adjustment cycles, and marginal discrepancies were measured on the master Ni-Cr model before and after laboratory fit adjustments. The milled and DMLS groups had smaller marginal discrepancy measurements than those of the cast group (P<.001). Significant differences were found in the number of adjustments among the groups, with the milled group requiring the minimum number of adjustments, followed by the DMLS and cast groups (F=30.643, P<.001). Metal-ceramic noble alloy frameworks fabricated by using a CAD-CAM workflow had significantly smaller marginal discrepancies compared with those with a traditional cast workflow, with the milled group demonstrating the best marginal fit among the 3 test groups. Manual refining significantly enhanced the marginal fit of all groups. All 3 groups demonstrated marginal discrepancies within the range of clinical acceptability. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

[Clinical characteristics of patients with workplace-associated mood disorder --comparison with non-workplace-associated group].

PubMed

Okazaki, Tsubasa; Kato, Satoshi

2011-01-01

The purpose of this study was to describe the clinical characteristics of patients with workplace-associated mood disorder. We conducted a clinical survey involving 84 clinical cases (regular employees suffering from mood disorder) who were hospitalized in the Psychiatry Department of Jichi Medical University Hospital, for a period over 8 years and 4 months between April 1st, 2000 and July 31st, 2008. The size of the workplace-associated group as a percentage of those patients in whom the onset of the symptom was occasioned by an evident issue at their workplace was 65%. This rate accounted for 74% of the total patients if clinical cases in which an evident issue at the workplace served as a significant trigger for the symptom were added to these patients in the case of an initial episode in the "non-workplace associated group". In the workplace-associated group, cases in which the premorbid character was a "depression-related personality" comprised only 42%, and was noticeably characterized by a perfection-oriented habit, enthusiastic character, conformity with other people, etc. Furthermore, the percentage of patients who were diagnosed with a "depression-related personality" comprised only 59% of the "overworked group", in which a heavy workload was evident in the workplace-associated group. In the workplace-associated group, the percentage of cases involving managerial workers was significantly high; their rate as initial cases was significantly high, as well the proportion of favorable outcomes. In the workplace-associated group, the percentage of patients who showed unambiguous depression at the initial stage was significantly low. Likewise, a similar result was obtained in the overworked group. Workplace-associated mood disorder today tends to have a stress-related aspect, or aspect of adjustment disorder. There was a period in many cases during which the main symptoms were insomnia, headache, panic attack, etc., prior to the onset of unambiguous depression in the workplace-associated mood disorder group. In depression associated with workplace-associated mood disorder, there are two pathological stages. The stage of adjustment disorder is the period in which such conditions are the main symptoms, and a serious or moderate stage of major depressive disorder is the period after full-scale depression develops in the wake of the former stage. What contributes to protection against depression are a proper diagnosis of depression whose pathological condition is at an early adjustment disorder stage and appropriate therapeutic measures.

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

PubMed

Gudavalli, M Ram; Salsbury, Stacie A; Vining, Robert D; Long, Cynthia R; Corber, Lance; Patwardhan, Avinash G; Goertz, Christine M

2015-06-05

Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented. This pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain. ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012).

Effectiveness of an e-learning course in evidence-based medicine for foundation (internship) training.

PubMed

Hadley, Julie; Kulier, Regina; Zamora, Javier; Coppus, Sjors F P J; Weinbrenner, Susanne; Meyerrose, Berrit; Decsi, Tamas; Horvath, Andrea R; Nagy, Eva; Emparanza, Jose I; Arvanitis, Theodoros N; Burls, Amanda; Cabello, Juan B; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karen; Kunz, Regina; Wilkie, Veronica; Wall, David; Mol, Ben Wj; Khan, Khalid S

2010-07-01

To evaluate the educational effectiveness of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content. We conducted a cluster randomized controlled trial to compare a clinically integrated e-learning EBM course (intervention) to a lecture-based course (control) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midlands region. Knowledge gain among participants was measured with a validated instrument using multiple choice questions. Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations (GEE) model. There were seven clusters involving teaching of 237 trainees (122 in the intervention and 115 in the control group). The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group. After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups. The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points (95% CI -1.2-1.4). An e-learning course in EBM was as effective in improving knowledge as a standard lecture-based course. The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows standardization of teaching materials and is a potential cost-effective alternative to standard lecture-based teaching.

Worldwide Esophageal Cancer Collaboration: clinical staging data.

PubMed

Rice, T W; Apperson-Hansen, C; DiPaola, L M; Semple, M E; Lerut, T E M R; Orringer, M B; Chen, L-Q; Hofstetter, W L; Smithers, B M; Rusch, V W; Wijnhoven, B P L; Chen, K N; Davies, A R; D'Journo, X B; Kesler, K A; Luketich, J D; Ferguson, M K; Räsänen, J V; van Hillegersberg, R; Fang, W; Durand, L; Allum, W H; Cecconello, I; Cerfolio, R J; Pera, M; Griffin, S M; Burger, R; Liu, J-F; Allen, M S; Law, S; Watson, T J; Darling, G E; Scott, W J; Duranceau, A; Denlinger, C E; Schipper, P H; Ishwaran, H; Blackstone, E H

2016-10-01

To address uncertainty of whether clinical stage groupings (cTNM) for esophageal cancer share prognostic implications with pathologic groupings after esophagectomy alone (pTNM), we report data-simple descriptions of patient characteristics, cancer categories, and non-risk-adjusted survival-for clinically staged patients from the Worldwide Esophageal Cancer Collaboration (WECC). Thirty-three institutions from six continents submitted data using variables with standard definitions: demographics, comorbidities, clinical cancer categories, and all-cause mortality from first management decision. Of 22,123 clinically staged patients, 8,156 had squamous cell carcinoma, 13,814 adenocarcinoma, 116 adenosquamous carcinoma, and 37 undifferentiated carcinoma. Patients were older (62 years) men (80%) with normal body mass index (18.5-25 mg/kg 2 , 47%), little weight loss (2.4 ± 7.8 kg), 0-1 ECOG performance status (67%), and history of smoking (67%). Cancers were cT1 (12%), cT2 (22%), cT3 (56%), cN0 (44%), cM0 (95%), and cG2-G3 (89%); most involved the distal esophagus (73%). Non-risk-adjusted survival for squamous cell carcinoma was not distinctive for early cT or cN; for adenocarcinoma, it was distinctive for early versus advanced cT and for cN0 versus cN+. Patients with early cancers had worse survival and those with advanced cancers better survival than expected from equivalent pathologic categories based on prior WECC pathologic data. Thus, clinical and pathologic categories do not share prognostic implications. This makes clinically based treatment decisions difficult and pre-treatment prognostication inaccurate. These data will be the basis for the 8th edition cancer staging manuals following risk adjustment for patient characteristics, cancer categories, and treatment characteristics and should direct 9th edition data collection. © 2016 International Society for Diseases of the Esophagus.

Worldwide Esophageal Cancer Collaboration: clinical staging data

PubMed Central

Rice, T. W.; Apperson-Hansen, C.; DiPaola, L. M.; Semple, M. E.; Lerut, T. E. M. R.; Orringer, M. B.; Chen, L.-Q.; Hofstetter, W. L.; Smithers, B. M.; Rusch, V. W.; Wijnhoven, B. P. L.; Chen, K. N.; Davies, A. R.; D’Journo, X. B.; Kesler, K. A.; Luketich, J. D.; Ferguson, M. K.; Räsänen, J. V.; van Hillegersberg, R.; Fang, W.; Durand, L.; Allum, W. H.; Cecconello, I.; Cerfolio, R. J.; Pera, M.; Griffin, S. M.; Burger, R.; Liu, J.-F; Allen, M. S.; Law, S.; Watson, T. J.; Darling, G. E.; Scott, W. J.; Duranceau, A.; Denlinger, C. E.; Schipper, P. H.; Ishwaran, H.; Blackstone, E. H.

2017-01-01

SUMMARY To address uncertainty of whether clinical stage groupings (cTNM) for esophageal cancer share prognostic implications with pathologic groupings after esophagectomy alone (pTNM), we report data—simple descriptions of patient characteristics, cancer categories, and non-risk-adjusted survival—for clinically staged patients from the Worldwide Esophageal Cancer Collaboration (WECC). Thirty-three institutions from six continents submitted data using variables with standard definitions: demographics, comorbidities, clinical cancer categories, and all-cause mortality from first management decision. Of 22,123 clinically staged patients, 8,156 had squamous cell carcinoma, 13,814 adenocarcinoma, 116 adenosquamous carcinoma, and 37 undifferentiated carcinoma. Patients were older (62 years) men (80%) with normal body mass index (18.5–25 mg/kg2, 47%), little weight loss (2.4 ± 7.8 kg), 0–1 ECOG performance status (67%), and history of smoking (67%). Cancers were cT1 (12%), cT2 (22%), cT3 (56%), cNO (44%), cMO (95%), and cG2–G3 (89%); most involved the distal esophagus (73%). Non-risk-adjusted survival for squamous cell carcinoma was not distinctive for early cT or cN; for adenocarcinoma, it was distinctive for early versus advanced cT and for cNO versus cN+. Patients with early cancers had worse survival and those with advanced cancers better survival than expected from equivalent pathologic categories based on prior WECC pathologic data. Thus, clinical and pathologic categories do not share prognostic implications. This makes clinically based treatment decisions difficult and pre-treatment prognostication inaccurate. These data will be the basis for the 8th edition cancer staging manuals following risk adjustment for patient characteristics, cancer categories, and treatment characteristics and should direct 9th edition data collection. PMID:27731549

Response Adjusted for Days of Antibiotic Risk (RADAR): evaluation of a novel method to compare strategies to optimize antibiotic use.

PubMed

Schweitzer, V A; van Smeden, M; Postma, D F; Oosterheert, J J; Bonten, M J M; van Werkhoven, C H

2017-12-01

The Response Adjusted for Days of Antibiotic Risk (RADAR) statistic was proposed to improve the efficiency of trials comparing antibiotic stewardship strategies to optimize antibiotic use. We studied the behaviour of RADAR in a non-inferiority trial in which a β-lactam monotherapy strategy (n = 656) was non-inferior to fluoroquinolone monotherapy (n = 888) for patients with moderately severe community-acquired pneumonia. Patients were ranked according to clinical outcome, using five or eight categories, and antibiotic use. RADAR was calculated as the probability that the β-lactam group had a more favourable ranking than the fluoroquinolone group. To investigate the sensitivity of RADAR to detrimental clinical outcome we simulated increasing rates of 90-day mortality in the β-lactam group and performed the RADAR and non-inferiority analysis. The RADAR of the β-lactam group compared with the fluoroquinolone group was 60.3% (95% CI 57.9%-62.7%) using five and 58.4% (95% CI 56.0%-60.9%) using eight clinical outcome categories, all in favour of β-lactam. Sample sizes for RADAR were 38% (250/653) and 89% (580/653) of the non-inferiority sample size calculation, using five or eight clinical outcome categories, respectively. With simulated mortality rates, loss of non-inferiority of the β-lactam group occurred at a relative risk of 1.125 in the conventional analysis, whereas using RADAR the β-lactam group lost superiority at a relative risk of mortality of 1.25 and 1.5, with eight and five clinical outcome categories, respectively. RADAR favoured β-lactam over fluoroquinolone therapy for community-acquired pneumonia. Although RADAR required fewer patients than conventional non-inferiority analysis, the statistic was less sensitive to detrimental outcomes. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Regular wine consumption in chronic heart failure: impact on outcomes, quality of life, and circulating biomarkers.

PubMed

Cosmi, Franco; Di Giulio, Paola; Masson, Serge; Finzi, Andrea; Marfisi, Rosa Maria; Cosmi, Deborah; Scarano, Marco; Tognoni, Gianni; Maggioni, Aldo P; Porcu, Maurizio; Boni, Silvana; Cutrupi, Giovanni; Tavazzi, Luigi; Latini, Roberto

2015-05-01

Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P<0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P=0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P<0.0001, and pentraxin-3, P=0.01) after adjusting for possible confounders. We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT0033633. © 2015 American Heart Association, Inc.

Clinical Fit of Partial Removable Dental Prostheses Based on Alginate or Polyvinyl Siloxane Impressions.

PubMed

Fokkinga, Wietske A; Witter, Dick J; Bronkhorst, Ewald M; Creugers, Nico H

The aim of this study was to analyze the clinical fit of metal-frame partial removable dental prostheses (PRDPs) based on custom trays used with alginate or polyvinyl siloxane impression material. Fifth-year students of the Nijmegen Dental School made 25 correct impressions for 23 PRDPs for 21 patients using alginate, and 31 correct impressions for 30 PRDPs for 28 patients using polyvinyl siloxane. Clinical fit of the framework as a whole and of each retainer separately were evaluated by calibrated supervisors during framework try-in before (first evaluation) and after (second evaluation) possible adjustments (score 0 = poor fit, up to score 3 = good fit). Framework fit and fit of the denture base were evaluated at delivery (third evaluation). Finally, postinsertion sessions were evaluated and total number of sessions needed, sore spots, adjustments to the denture base, and reported food-impaction were recorded. No significant differences in clinical fit (of the framework as a whole, for the retainers, or for the denture base) were found between the groups in the three evaluation sessions. Differences were not found for postinsertion sessions with one exception: in the alginate group, four subjects reported food impaction, versus none in the polyvinyl siloxane group. Clinical fit of metal-frame PRDPs based on impressions with custom trays combined with alginate or polyvinyl siloxane was similar.

The effects of medical group practice and physician payment methods on costs of care.

PubMed Central

Kralewski, J E; Rich, E C; Feldman, R; Dowd, B E; Bernhardt, T; Johnson, C; Gold, W

2000-01-01

OBJECTIVE: To assess the effects of payment methods on the costs of care in medical group practices. DATA SOURCES: Eighty-six clinics providing services for a Blue Cross managed care program during 1995. The clinics were analyzed to determine the relationship between payment methods and cost of care. Cost and patient data were obtained from Blue Cross records, and medical group practice clinic data were obtained by a survey of those organizations. STUDY DESIGN: The effects of clinic and physician payment methods on per member per year (PMPY) adjusted patient costs are evaluated using a two-stage regression model. Patient costs are adjusted for differences in payment schedules; patient age, gender, and ACG; clinic organizational variables are included as explanatory variables. DATA COLLECTION: Patient cost data were extracted from Blue Cross claims files, and patient and physician data from their enrollee and provider data banks. Medical group practice data were obtained by a mailed survey with telephone follow-up. PRINCIPAL FINDINGS: Capitation payment is correlated with lower patient care costs. When combined with fee-for-service with withhold provisions, this effect is smaller indicating that these two clinic payment methods are not interchangeable. Clinics with more physician compensation based on measures of resource use or based on some share of the net revenue of the clinic have lower patient care costs than those with more compensation related to productivity or based on salary. Salary compensation is strongly associated with higher costs. The use of physician profiles and clinical guidelines is associated with lower costs, but referral management systems have no such effect. The lower cost clinics are the smaller, multispecialty clinics. CONCLUSIONS: This study indicates that payment methods at both the medical group practice and physician levels influence the cost of care. However, the methods by which that influence is manifest is not clear. Although the organizational structure of clinics and their use of managed care programs appear to play a role, this influence is less than expected. PMID:10966087

Factor Analysis of the Modified Sexual Adjustment Questionnaire-Male

PubMed Central

Wilmoth, Margaret C.; Hanlon, Alexandra L.; Ng, Lit Soo; Bruner, Debra W.

2015-01-01

Background and Purpose The Sexual Adjustment Questionnaire (SAQ) is used in National Cancer Institute–sponsored clinical trials as an outcome measure for sexual functioning. The tool was revised to meet the needs for a clinically useful, theory-based outcome measure for use in both research and clinical settings. This report describes the modifications and validity testing of the modified Sexual Adjustment Questionnaire-Male (mSAQ-Male). Methods This secondary analysis of data from a large Radiation Therapy Oncology Group trial employed principal axis factor analytic techniques in estimating validity of the revised tool. The sample size was 686; most subjects were White, older than the age 60 years, and with a high school education and a Karnofsky performance scale (KPS) score of greater than 90. Results A 16-item, 3-factor solution resulted from the factor analysis. The mSAQ-Male was also found to be sensitive to changes in physical sexual functioning as measured by the KPS. Conclusion The mSAQ-Male is a valid self-report measure of sexuality that can be used clinically to detect changes in male sexual functioning. PMID:25255676

Suicidal tendency in a sample of adolescent outpatients with adjustment disorder: gender differences.

PubMed

Ferrer, Laia; Kirchner, Teresa

2014-08-01

Although Adjustment Disorder (AD) is a prevalent diagnosis in adolescent mental health services and linked to suicidal tendency in adolescence, little research exists examining prevalence and gender differences of suicidal symptoms among AD patients using standardized instruments. The present study aims to assess the presence of suicidal tendency in a clinical sample of Spanish adolescents with AD analyzing gender differences. Ninety-seven adolescents with AD were recruited at a public mental health center and included in the AD sample; they were administered the Inventario de Riesgo Suicida para Adolescentes (Suicide Risk Inventory for Adolescents-IRIS) and the Millon Adolescent Clinical Inventory (MACI). Ninety-nine community adolescents were recruited and administered the IRIS inventory. The community sample works as a contrast group. Girls with AD show higher levels of suicidal symptoms than boys on both the IRIS Suicidal Ideation and Intention scale (t=8.15, p<.001) and the MACI Suicidal Tendency scale (t=6.6, p<.001). Girls with AD scored significantly higher than girls from the community contrast group sample in the IRIS Suicidal Ideation and Intention scale, but boys with AD presented no differences with regard to boys form the community contrast group sample. Compared with normative clinical samples of the MACI, no differences in the Suicidal Tendency scale scores were found between AD and normative girls, but AD boys showed significantly lower mean scores than normative boys. Suicidal symptoms were presented by 27% of girls and 18% of boys, although only 6% of the girls and none of the boys presented clear suicidal tendencies. Considering suicidal tendencies in adolescents with Adjustment Disorder is important-especially in girls, who present high suicidal tendencies in relation both to boys and to community peers and the normative clinical population. Copyright © 2014 Elsevier Inc. All rights reserved.

Hepatitis C infection among injecting drug users in general practice: a cluster randomised controlled trial of clinical guidelines' implementation.

PubMed

Cullen, Walter; Stanley, June; Langton, Deirdre; Kelly, Yvonne; Staines, Anthony; Bury, Gerard

2006-11-01

Hepatitis C is a common infection among injecting drug users and has important implications for general practice. Although several clinical guidelines concerning the infection have been published, their effectiveness has yet to be tested. To assess the effectiveness of a general practice-based complex intervention to support the implementation of clinical guidelines for hepatitis C management among current or former drug users attending general practice. Cluster randomised controlled trial. General practices in the Eastern Regional Health Authority area of Ireland. Twenty-six practices were randomly allocated within strata to receive the intervention under study or to provide care as usual for a period of 6 months. There was screening for patients attending general practice for methadone maintenance treatment for hepatitis C and referral of anti-HCV antibody positive patients to a specialist hepatology department for assessment. At study completion, patients in the intervention group were significantly more likely to have been screened for hepatitis C than those in the control group, odds ratio adjusted for clustering 3.76 (95% confidence interval [CI] = 1.3 to 11.3) and this association remained significant after adjusting for other potentially confounding variables, using multiple logistic regression, with the odds ratio adjusted for clustering 4.53 (95% CI = 1.39 to 14.78). Although anti-HCV antibody positive patients in the intervention group were more likely to have been referred to a hepatology clinic, this was not statistically significant (P = 0.06). General practice has an important role in the care of people at risk of hepatitis C and when appropriately supported can effectively implement current best practice.

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

PubMed

van der Meer, Victor; Bakker, Moira J; van den Hout, Wilbert B; Rabe, Klaus F; Sterk, Peter J; Kievit, Job; Assendelft, Willem J J; Sont, Jacob K

2009-07-21

The Internet may support patient self-management of chronic conditions, such as asthma. To evaluate the effectiveness of Internet-based asthma self-management. Randomized, controlled trial. 37 general practices and 1 academic outpatient department in the Netherlands. 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. The study was unblinded and lasted only 12 months. Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

The efficacy of intravenous ketorolac for pain relief in single-stage adjustable strabismus surgery: a prospective, randomized, placebo-controlled trial

PubMed Central

Rhiu, S; Chung, S A; Kim, W K; Chang, J H; Bae, S J; Lee, J B

2011-01-01

Purpose To determine the efficacy of preoperative intravenous ketorolac in reducing intraoperative and postoperative pain and improving patient satisfaction in patients undergoing single-stage adjustable strabismus surgery. Methods A prospective, randomized, placebo-controlled clinical trial was performed with 67 patients who underwent horizontal recti muscle surgery with adjustable sutures. The test group received intravenous ketorolac (60 mg) before surgery, and the control group received intravenous normal saline. Topical 0.5% proparacaine was administered to both groups during surgery. Vital signs including heart rate and blood pressure were recorded every 10 min throughout the surgery. The patients were asked to rate their maximum intraoperative and postoperative pain scores using a numerical pain rating scale. Patient satisfaction was also assessed using a five-point analogue scale. Results The ketorolac-premedicated patients had less pain both during and after surgery (P=0.033 and P=0.024, respectively). There were no differences in vital signs during surgery and patient satisfaction between the two groups. Conclusions Intravenous ketorolac, when administered preoperatively for single-stage adjustable strabismus surgery under topical anaesthesia, was effective in reducing pain during and after surgery. PMID:21102493

Estimation of group means when adjusting for covariates in generalized linear models.

PubMed

Qu, Yongming; Luo, Junxiang

2015-01-01

Generalized linear models are commonly used to analyze categorical data such as binary, count, and ordinal outcomes. Adjusting for important prognostic factors or baseline covariates in generalized linear models may improve the estimation efficiency. The model-based mean for a treatment group produced by most software packages estimates the response at the mean covariate, not the mean response for this treatment group for the studied population. Although this is not an issue for linear models, the model-based group mean estimates in generalized linear models could be seriously biased for the true group means. We propose a new method to estimate the group mean consistently with the corresponding variance estimation. Simulation showed the proposed method produces an unbiased estimator for the group means and provided the correct coverage probability. The proposed method was applied to analyze hypoglycemia data from clinical trials in diabetes. Copyright © 2014 John Wiley & Sons, Ltd.

Randomized clinical trial to assess the effectiveness of remote patient monitoring and physician care in reducing office blood pressure.

PubMed

Kim, Yoon-Nyun; Shin, Dong Gu; Park, Sungha; Lee, Chang Hee

2015-07-01

The effectiveness of remote patient monitoring and physician care for the treatment of hypertension has not been demonstrated in a randomized clinical trial. The objective of this study was to evaluate the effectiveness of remote patient monitoring with or without remote physician care in reducing office blood pressure in patients with hypertension. A total of 374 hypertensive patients over 20 years of age were randomized into the following three groups: group (1) control, the patients received usual clinical care with home BP monitoring; group (2) the patients were remotely monitored and received office follow-up; and group (3) the patients received remote monitoring without physician office care using the remote monitoring device. For each group, in-office follow-up care was scheduled every 8 weeks for 24 weeks. The primary end point was the difference in sitting SBP at the 24-week follow-up. No difference between the three groups was observed in the primary end point (adjusted mean sitting SBP was as follows: group 1: -8.9±15.5 mm Hg, group 2: -11.3±15.9 mm Hg, group 3: -11.6±19.8 mm Hg, (NS). Significant differences in achieving the target BP at the 24th week of follow-up were observed between groups 1 and 2. The subjects over 55-years old had a significant decrease in the adjusted mean sitting SBP in groups 2 and 3 compared with that of the control group. Remote monitoring alone or remote monitoring coupled with remote physician care was as efficacious as the usual office care for reducing blood pressure with comparable safety and efficacy in hypertensive patients.

The effect of educational package on functional status and maternal self-confidence of primiparous women in postpartum period: a randomized controlled clinical trial.

PubMed

Bagherinia, Marzieh; Mirghafourvand, Mojgan; Shafaie, Fahimeh Sehhatie

2017-10-01

The aim of this study was to determine the effect of a training package on functional status and self-confidence of primiparous women in the postpartum period. This randomized controlled clinical trial was conducted on 136 primiparous women who were referred to health centers in Tabriz, Iran, for their second postpartum care (10-15 days after delivery). These women were randomly assigned to education (n= 68) and control (n = 68) groups. The education group was provided with a face-to-face training session, three phone sessions, and a booklet. The control group received the routine postpartum care on days 1-3, 10-15 and 42-60. Participants completed the functional status and maternal self-confidence questionnaires before the interventio n and eight weeks postpartum. Independent t, chi-square and Fisher's exact tests were used for data analysis. No statistically significant difference was observed between the two groups in terms of sociodemographic characteristics, except for infant's gender (p > .05). At six weeks after the intervention and by adjusting for baseline scores and infant's sex, mean scores of functional status (adjusted mean difference: 0.9; 95% CI: 0.8-1.03, p < .001) and maternal self-confidence (adjusted mean difference: 16.6; 95% CI: 13.8-19.3, p < .001) were significantly higher in the education group than in the control group. This study showed that training women has a positive effect in increasing their self-confidence and improving their functional status.

Long-acting injectables and risk for rehospitalization among patients with schizophrenia in the home care program in Taiwan.

PubMed

Ju, Po-Chung; Chou, Frank Huang-Chih; Lai, Te-Jen; Chuang, Po-Ya; Lin, Yung-Jung; Yang, Ching-Wen Wendy; Tang, Chao-Hsiun

2014-02-01

We aimed at evaluating the relationship between medication and treatment effectiveness in a home care setting among patients with schizophrenia. Patients with schizophrenia hospitalized between 2004 and 2009 with a primary International Classification of Diseases, Ninth Revision, Clinical Modification code of 295 were identified from Psychiatric Inpatient Medical Claims Data released by the National Health Research Institute in Taiwan. Patients who joined the home care program after discharge and were prescribed long-acting injection (LAI) (the LAI group) or oral antipsychotic medications (the oral group) were included as study subjects. The final sample for the study included 810 participants in the LAI group and 945 in the oral group. Logistic regression was performed to examine the independent effect of LAI medication on the risk for rehospitalization within the 12-month observation window after controlling for patient and hospital characteristics and propensity score quintile adjustment. The unadjusted odds ratio for rehospitalization risk was 0.80 (confidence interval, 0.65-0.98) for the LAI group compared to the oral group. The adjusted odds ratio was further reduced to 0.78 (confidence interval, 0.63-0.97). Results remained unchanged when the propensity score quintiles were entered into the regression for further adjustment. In a home care setting, patients treated with long-acting antipsychotic agents are at a significantly lower risk for psychiatric rehospitalization than those treated with oral medication. Consequently, LAI home-based treatment for the prevention of schizophrenia relapse may lead to substantial clinical and economic benefits.

Self-esteem, ethnic identity, and behavioral adjustment among Anglo and Chicano adolescents in West Texas.

PubMed

Grossman, B; Wirt, R; Davids, A

1985-03-01

This study provides a comparison of similarities and differences with respect to ethnic identity between Anglo and Chicano adolescents from Texas. A path analysis model was used to test a theoretical assumption concerning proposed antecedents and consequences of self-esteem. Research instruments included the Rosenberg Self Esteem Scale, the Semantic Differential (scales for Myself and My Ethnic Group) and the McGuire White Measure of Social Status. Results were consistent with the interpretation that there is a relationship between being Chicano and having lower self-esteem, lower behavioral adjustment, and higher ethnic esteem. The prediction that ethnic esteem would mediate between ethnic group and self-esteem was upheld. Variables such as ethnic group membership per se and sex appear as or more important to the prediction of behavioral level. Clinical implications include recognizing that Chicanos low in self-esteem or behavioral adjustment should not automatically be considered unusual. The problems faced by this group are considered as having something in common with other groups of people who have more problems, lesser status, fewer resources, and fewer sources of available help.

Dietary intake in adults at risk for Huntington disease: analysis of PHAROS research participants.

PubMed

Marder, K; Zhao, H; Eberly, S; Tanner, C M; Oakes, D; Shoulson, I

2009-08-04

To examine caloric intake, dietary composition, and body mass index (BMI) in participants in the Prospective Huntington At Risk Observational Study (PHAROS). Caloric intake and macronutrient composition were measured using the National Cancer Institute Food Frequency Questionnaire (FFQ) in 652 participants at risk for Huntington disease (HD) who did not meet clinical criteria for HD. Logistic regression was used to examine the relationship between macronutrients, BMI, caloric intake, and genetic status (CAG <37 vs CAG > or =37), adjusting for age, gender, and education. Linear regression was used to determine the relationship between caloric intake, BMI, and CAG repeat length. A total of 435 participants with CAG <37 and 217 with CAG > or =37 completed the FFQ. Individuals in the CAG > or =37 group had a twofold odds of being represented in the second, third, or fourth quartile of caloric intake compared to the lowest quartile adjusted for age, gender, education, and BMI. This relationship was attenuated in the highest quartile when additionally adjusted for total motor score. In subjects with CAG > or =37, higher caloric intake, but not BMI, was associated with both higher CAG repeat length (adjusted regression coefficient = 0.26, p = 0.032) and 5-year probability of onset of HD (adjusted regression coefficient = 0.024; p = 0.013). Adjusted analyses showed no differences in macronutrient composition between groups. Increased caloric intake may be necessary to maintain body mass index in clinically unaffected individuals with CAG repeat length > or =37. This may be related to increased energy expenditure due to subtle motor impairment or a hypermetabolic state.

Success of a Faculty Development Program for Teachers at the Mayo Clinic

PubMed Central

Lee, Staci M.; Lee, Mark C.; Reed, Darcy A.; Halvorsen, Andrew J.; Berbari, Elie F.; McDonald, Furman S.; Beckman, Thomas J.

2014-01-01

Background There has been limited research on the improvement of underperforming clinical teachers. Objective To determine whether a faculty development program could improve the evaluations of clinical teachers in an internal medicine residency program. Methods A total of 123 teachers completed faculty development at the Mayo Clinic from 2009 to 2012. The faculty enhancement and education development program (FEED) consists of 6 interactive, small group, 2-hour sessions taught by experienced Mayo Clinic faculty over 1 year. These sessions address the following competencies: asking questions, diagnosing learners, giving feedback, using teaching frameworks, recognizing learning styles, and providing clinical supervision. Resident-of-faculty Mayo teaching effectiveness (MTE) scores have previously demonstrated content, internal structure, and criterion validity. Teachers were grouped into the top 80% or the bottom 20%, according to baseline MTE scores. Mixed linear models were used to compare these groups regarding changes in MTE scores after completion of FEED. Results were adjusted for teacher age, sex, medical specialty, academic rank, and teaching awards. Results For all participants combined, the adjusted MTE scores (mean; standard error) improved from baseline (3.80; 0.04) to completion of FEED (3.93; 0.04; P < .001). However, the bottom 20% had a significantly greater improvement in scores than the top 80% (score-change difference  =  0.166, P < .001). Conclusions We describe a low-intensity faculty development intervention that benefited all clinical teachers, but was particularly effective for underperforming teachers in internal medicine. The approach may be suitable for adoption or adaptation in other graduate medical education programs. PMID:26140122

Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost.

PubMed

Zelen, Charles M; Serena, Thomas E; Gould, Lisa; Le, Lam; Carter, Marissa J; Keller, Jennifer; Li, William W

2016-04-01

Advanced therapies such as bioengineered skin substitutes (BSS) and dehydrated human amnion/chorion membrane (dHACM) have been shown to promote healing of chronic diabetic ulcers. An interim analysis of data from 60 patients enrolled in a prospective, randomised, controlled, parallel group, multi-centre clinical trial showed that dHACM (EpiFix, MiMedx Group Inc., Marietta, GA) is superior to standard wound care (SWC) and BSS (Apligraf, Organogenesis, Inc., Canton, MA) in achieving complete wound closure within 4-6 weeks. Rates and time to closure at a longer time interval and factors influencing outcomes remained unassessed; therefore, the study was continued in order to achieve at least 100 patients. With the larger cohort, we compare clinical outcomes at 12 weeks in 100 patients with chronic lower extremity diabetic ulcers treated with weekly applications of Apligraf (n = 33), EpiFix (n = 32) or SWC (n = 35) with collagen-alginate dressing as controls. A Cox regression was performed to analyse the time to heal within 12 weeks, adjusting for all significant covariates. A Kaplan-Meier analysis was conducted to compare time-to-heal within 12 weeks for the three treatment groups. Clinical characteristics were well matched across study groups. The proportion of wounds achieving complete closure within the 12-week study period were 73% (24/33), 97% (31/32), and 51% (18/35) for Apligraf, EpiFix and SWC, respectively (adjusted P = 0·00019). Subjects treated with EpiFix had a very significant higher probability of their wounds healing [hazard ratio (HR: 5·66; adjusted P: 1·3 x 10(-7) ] compared to SWC alone. No difference in probability of healing was observed for the Apligraf and SWC groups. Patients treated with Apligraf were less likely to heal than those treated with EpiFix [HR: 0·30; 95% confidence interval (CI): 0·17-0·54; unadjusted P: 5·8 x 10(-5) ]. Increased wound size and presence of hypertension were significant factors that influenced healing. Mean time-to-heal within 12 weeks was 47·9 days (95% CI: 38·2-57·7) with Apligraf, 23·6 days (95% CI: 17·0-30·2) with EpiFix group and 57·4 days (95%CI: 48·2-66·6) with the SWC alone group (adjusted P = 3·2 x 10(-7) ). Median number of grafts used per healed wound were six (range 1-13) and 2·5 (range 1-12) for the Apligraf and EpiFix groups, respectively. Median graft cost was $8918 (range $1,486-19,323) per healed wound for the Apligraf group and $1,517 (range $434-25,710) per healed wound in the EpiFix group (P < 0·0001). These results provide further evidence of the clinical and resource utilisation superiority of EpiFix compared to Apligraf for the treatment of lower extremity diabetic wounds. © 2015 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Comparison of Aspirin and Naoxintong Capsule () with Adjusted-Dose Warfarin in Elderly Patients with High-Risk of Non-Valvular Atrial Fibrillation and Genetic Variants of Vitamin K Epoxide Reductase.

PubMed

Wang, Huan; Zhou, Xiao-Kai; Zheng, Li-Fan; Wu, Xiao-Ying; Chen, Hui

2018-04-01

To compared the therapeutic effect of a Chinese patent medicine Naoxintong Capsule (, NXT) and aspirin with adjusted-dose warfarin in Chinese elderly patients (over 65 years) with nonvalvular atrial fibrillation (NVAF) and genetic variants of vitamin K epoxide reductase (VKORC1), who are at high-risk of thromboembolism. A total of 151 patients, with NVAF and AA genotype of VKORC1-1639 (a sensitive genotype to warfarin) and a CHA 2 DS 2 -VASc clinical risk score of 2 or above, were chosen for this study. Patients were randomized into two groups and orally treated with a combination of aspirin (100 mg/day) and NXT (1.6 g thrice a day) or adjusted-dose warfarin [international normalized ratio 2.0-3.0). The primary end points including ischemic stroke and death as well as the secondary end points including hemorrhage events were followed up for at least 1 year. Baseline clinical data and the rates of primary end points were similar between groups. However, the rate of serious bleeding (secondary event) in the combination therapy group was lower than that in the adjusted-dose warfarin group (0% vs. 7.9%, odds ratio: 0.921, 95% confidence interval: 0.862-0.984, P=0.028). Aspirin combined with NXT and warfarin displayed comparable rates of primary end point including ischemic stroke and all-cause death during the 1-year follow-up. However, as compared with warfarin, the combination therapy reduced the rate of serious bleeding. Therefore, aspirin combined with NXT might provide an alternative pharmacotherapy in preventing ischemic stroke for elderly patients with NAVF who cannot tolerate warfarin. (No. ChiCTR-TRC-13003596).

Hospital costs estimation and prediction as a function of patient and admission characteristics.

PubMed

Ramiarina, Robert; Almeida, Renan Mvr; Pereira, Wagner Ca

2008-01-01

The present work analyzed the association between hospital costs and patient admission characteristics in a general public hospital in the city of Rio de Janeiro, Brazil. The unit costs method was used to estimate inpatient day costs associated to specific hospital clinics. With this aim, three "cost centers" were defined in order to group direct and indirect expenses pertaining to the clinics. After the costs were estimated, a standard linear regression model was developed for correlating cost units and their putative predictors (the patients gender and age, the admission type (urgency/elective), ICU admission (yes/no), blood transfusion (yes/no), the admission outcome (death/no death), the complexity of the medical procedures performed, and a risk-adjustment index). Data were collected for 3100 patients, January 2001-January 2003. Average inpatient costs across clinics ranged from (US$) 1135 [Orthopedics] to 3101 [Cardiology]. Costs increased according to increases in the risk-adjustment index in all clinics, and the index was statistically significant in all clinics except Urology, General surgery, and Clinical medicine. The occupation rate was inversely correlated to costs, and age had no association with costs. The (adjusted) per cent of explained variance varied between 36.3% [Clinical medicine] and 55.1% [Thoracic surgery clinic]. The estimates are an important step towards the standardization of hospital costs calculation, especially for countries that lack formal hospital accounting systems.

Complementary nonparametric analysis of covariance for logistic regression in a randomized clinical trial setting.

PubMed

Tangen, C M; Koch, G G

1999-03-01

In the randomized clinical trial setting, controlling for covariates is expected to produce variance reduction for the treatment parameter estimate and to adjust for random imbalances of covariates between the treatment groups. However, for the logistic regression model, variance reduction is not obviously obtained. This can lead to concerns about the assumptions of the logistic model. We introduce a complementary nonparametric method for covariate adjustment. It provides results that are usually compatible with expectations for analysis of covariance. The only assumptions required are based on randomization and sampling arguments. The resulting treatment parameter is a (unconditional) population average log-odds ratio that has been adjusted for random imbalance of covariates. Data from a randomized clinical trial are used to compare results from the traditional maximum likelihood logistic method with those from the nonparametric logistic method. We examine treatment parameter estimates, corresponding standard errors, and significance levels in models with and without covariate adjustment. In addition, we discuss differences between unconditional population average treatment parameters and conditional subpopulation average treatment parameters. Additional features of the nonparametric method, including stratified (multicenter) and multivariate (multivisit) analyses, are illustrated. Extensions of this methodology to the proportional odds model are also made.

Patterns of coordination and clinical outcomes: a study of surgical services.

PubMed Central

Young, G J; Charns, M P; Desai, K; Khuri, S F; Forbes, M G; Henderson, W; Daley, J

1998-01-01

OBJECTIVE: To test the hypothesis that surgical services combining relatively high levels of feedback and programming approaches to the coordination of surgical staff would have better quality of care than surgical services using low levels of both coordination approaches as well as those surgical service using low levels of either coordination approach. STUDY SETTING: A study sample of 44 academically affiliated surgical services that are part of the Department of Veterans Affairs. STUDY DESIGN: In a cross-sectional analysis, surgical services were assigned to one of three groups based on their scores on feedback and programming coordination measures: high on both measures; high on one measure, low on the other; and low on both. Univariate and multivariate analyses were used to assess differences among these groups with respect to three quality indicators: risk-adjusted mortality, risk-adjusted morbidity, and staff perceptions of quality. DATA COLLECTION/EXTRACTION METHODS: Risk-adjusted mortality and morbidity came from an outcomes reporting program within the Department of Veterans Affairs that entails the prospective collection of clinical data from patient charts. Data on coordination practices and perceived quality came from a survey of surgical staff at each of the 44 participating surgical services. PRINCIPAL FINDINGS: The group of surgical services using high feedback and high programming had the best perceived quality. This group also had the lowest morbidity, but the difference was statistically significant with respect to only one of the two other groups: the group with low feedback and low programming. No significant group differences were found for mortality. CONCLUSIONS: Study results provide partial support for the hypothesis that high levels of feedback and programming should be combined for optimal quality of care. Study results also suggest that staff coordination is more important for improving morbidity than mortality in surgical services. PMID:9865218

Topography-modified refraction (TMR): adjustment of treated cylinder amount and axis to the topography versus standard clinical refraction in myopic topography-guided LASIK.

PubMed

Kanellopoulos, Anastasios John

2016-01-01

To evaluate the safety, efficacy, and contralateral eye comparison of topography-guided myopic LASIK with two different refraction treatment strategies. Private clinical ophthalmology practice. A total of 100 eyes (50 patients) in consecutive cases of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond and EX500 excimer lasers) were randomized for treatment as follows: one eye with the standard clinical refraction (group A) and the contralateral eye with the topographic astigmatic power and axis (topography-modified treatment refraction; group B). All cases were evaluated pre- and post-operatively for the following parameters: refractive error, best corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), topography (Placido-disk based) and tomography (Scheimpflug-image based), wavefront analysis, pupillometry, and contrast sensitivity. Follow-up visits were conducted for at least 12 months. Mean refractive error was -5.5 D of myopia and -1.75 D of astigmatism. In group A versus group B, respectively, the average UDVA improved from 20/200 to 20/20 versus 20/16; post-operative CDVA was 20/20 and 20/13.5; 1 line of vision gained was 27.8% and 55.6%; and 2 lines of vision gained was 5.6% and 11.1%. In group A, 27.8% of eyes had over -0.50 diopters of residual refractive astigmatism, in comparison to 11.7% in group B ( P <0.01). The residual percentages in both groups were measured with refractive astigmatism of more than -0.5 diopters. Topography-modified refraction (TMR): topographic adjustment of the amount and axis of astigmatism treated, when different from the clinical refraction, may offer superior outcomes in topography-guided myopic LASIK. These findings may change the current clinical paradigm of the optimal subjective refraction utilized in laser vision correction.

Topography-modified refraction (TMR): adjustment of treated cylinder amount and axis to the topography versus standard clinical refraction in myopic topography-guided LASIK

PubMed Central

Kanellopoulos, Anastasios John

2016-01-01

Purpose To evaluate the safety, efficacy, and contralateral eye comparison of topography-guided myopic LASIK with two different refraction treatment strategies. Setting Private clinical ophthalmology practice. Patients and methods A total of 100 eyes (50 patients) in consecutive cases of myopic topography-guided LASIK procedures with the same refractive platform (FS200 femtosecond and EX500 excimer lasers) were randomized for treatment as follows: one eye with the standard clinical refraction (group A) and the contralateral eye with the topographic astigmatic power and axis (topography-modified treatment refraction; group B). All cases were evaluated pre- and post-operatively for the following parameters: refractive error, best corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), topography (Placido-disk based) and tomography (Scheimpflug-image based), wavefront analysis, pupillometry, and contrast sensitivity. Follow-up visits were conducted for at least 12 months. Results Mean refractive error was −5.5 D of myopia and −1.75 D of astigmatism. In group A versus group B, respectively, the average UDVA improved from 20/200 to 20/20 versus 20/16; post-operative CDVA was 20/20 and 20/13.5; 1 line of vision gained was 27.8% and 55.6%; and 2 lines of vision gained was 5.6% and 11.1%. In group A, 27.8% of eyes had over −0.50 diopters of residual refractive astigmatism, in comparison to 11.7% in group B (P<0.01). The residual percentages in both groups were measured with refractive astigmatism of more than −0.5 diopters. Conclusion Topography-modified refraction (TMR): topographic adjustment of the amount and axis of astigmatism treated, when different from the clinical refraction, may offer superior outcomes in topography-guided myopic LASIK. These findings may change the current clinical paradigm of the optimal subjective refraction utilized in laser vision correction. PMID:27843292

Factors influencing adjustment to a colostomy in Chinese patients: a cross-sectional study.

PubMed

Hu, Ailing; Pan, Yunfeng; Zhang, Meifen; Zhang, June; Zheng, Meichun; Huang, Manrong; Ye, Xinmei; Wu, Xianrong

2014-01-01

We evaluated persons living with a colostomy in order to characterize and describe relationships among adjustment, self-care ability, and social support. One hundred twenty-nine colostomy patients from 5 hospitals in Guangzhou, capital city of the Guangdong province, were recruited by convenience sampling. Cross-sectional data were collected from a survey that included demographic and pertinent clinical data related to their ostomy. The survey also incorporated Chinese language versions of the Ostomy Adjustment Scale, Exercise of Self-Care Agency Scale, and Perceived Social Support Scale. These scales were used to measure the levels and degrees of adjustment, self-care ability, and social support of colostomy patients. Respondents completed the survey during outpatient clinics visit after creation of a colostomy. Scores from the Ostomy Adjustment Scale revealed that 96.9% of colostomy patients reported low to moderate adjustment (128.6 ± 19.38) to their stoma. Self-care ability and social support of patients were positively correlated with the adjustment level (R = 0.33, R = 0.21). Several factors, including being a housewife, paying medical expense by oneself, inability to manage the ostomy without assistance, and not participating in an ostomy support group, were associated with a lower level of adjustment (P < .05). Worries about odor and antipathy toward the ostomy significantly contributed to lower levels of adjustment to the stoma (P < .01). Overall adjustment to a colostomy was moderate. Self-care ability and social support associated with having a colostomy positively influenced adjustment. Adjustment was also influenced by occupation, health insurance provider, and ability to care for the stoma without requiring assistance.

Associations of maternal iodine status and thyroid function with adverse pregnancy outcomes in Henan Province of China.

PubMed

Yang, Jin; Liu, Yang; Liu, Hongjie; Zheng, Heming; Li, Xiaofeng; Zhu, Lin; Wang, Zhe

2018-05-01

The study aimed to explore the effects of maternal iodine status and thyroid diseases on adverse pregnancy outcomes. A prospective study was conducted on 2347 pregnant women, who provided 2347 urinary samples tested for iodine, 1082 serum samples tested for thyroid function, and 2347 questionnaires about demographic information. Their pregnancy outcomes were recorded and compared between different urinary iodine concentration (UIC) and thyroid function groups. Pregnant women with UIC between 150 and 249 μg/L had lower incidences of preeclampsia (adjusted odds ratio (OR) 0.12, 95% CI: 0.01-0.87), placenta previa (adjusted OR 0.06, 95% CI: 0.01-0.69) and fetal distress (adjusted OR 0.10, 95% CI: 0.02-0.64) than the reference group (UIC < 50 μg/L). Women with UIC between 100 and 149 μg/L had lower risks of abnormal amniotic fluid (adjusted OR 0.32, 95% CI: 0.12-0.87) and fetal distress (adjusted OR 0.08, 95% CI: 0.01-0.82). Women with UIC above 249 μg/L had a significant higher rate of abnormal amniotic fluid (adjusted OR 0.38, 95% CI: 0.16-0.89). Clinical and subclinical hypothyroidism during pregnancy increased the risk of preterm delivery by 4.4 times (P = 0.009) and 3.0 times (P =  0.014), respectively. Isolated hypothyroxinemia had increased odds of having macrosomia (adjusted OR 2.22, 95% CI: 1.13-4.85). Clinical hyperthyroidism was significantly associated with miscarriage (adjusted OR 2.12, 95% CI: 1.92-96.67) and fetal distress (adjusted OR 9.53, 95% CI: 1.05--81.81). Subclinical hyperthyroidism had a significant association with umbilical cord entanglement (adjusted OR 3.82, 95% CI: 1.38-10.58). Isolated hyperthyroxinemia was associated with preterm delivery (adjusted OR 4.73, 95% CI: 1.49-15.05). Maternal iodine status and thyroid diseases during pregnancy were associated with adverse pregnancy outcomes. Copyright © 2018 Elsevier GmbH. All rights reserved.

Change in Quality of Life with Velopharyngeal Insufficiency Surgery

PubMed Central

Skirko, Jonathan R.; Weaver, Edward M.; Perkins, Jonathan A.; Kinter, Sara; Eblen, Linda; Martina, Julie; Sie, Kathleen C.Y.

2018-01-01

Objective 1) Define the minimal clinically important difference (MCID) of the Velopharyngeal Insufficiency (VPI) Effects on Life Outcomes (VELO) instrument, and 2) test for change in quality of life after VPI surgery. Study Design Prospective observational cohort. Setting VPI clinic at a tertiary pediatric medical center. Subjects and Methods Children with VPI and their parents completed the VELO instrument (higher score is better quality of life) at enrollment and then underwent VPI surgery (Furlow palatoplasty or sphincter pharyngoplasty, n=32), other treatments (obturator or oronasal fistula repair, n=7), or no treatment (n=18). They completed the VELO instrument again and an instrument of global rating of change in quality of life at one year. MCID was anchored to the global change instrument scores corresponding to “a little” or “somewhat” better. Within-group (paired t-test) and between-group (Student’s t-test) changes in VELO were tested for the VPI surgery and no treatment groups. The association between treatment group and VELO change was tested with multivariate linear regression, adjusting for confounders. Results Follow up was obtained on 37/57 (65%) of patients. The mean (SD) VELO change scores corresponding to the MCID anchor was 15 (13). The VELO score improved significantly more in the VPI surgery group (change 22 [15]), p<0.001) than in the no-treatment group (change 9 [12], p=0.04), after adjusting for confounders (p=0.007 between groups). Conclusion VPI surgery using the Furlow palatoplasty or sphincter pharyngoplasty improves VPI specific quality-of-life, and the improvement is clinically important. PMID:26124262

Risk factors and clinical features of ovarian pregnancy: a case–control study

PubMed Central

Zhu, Qian; Li, Cheng; Zhao, Wei-Hong; Yuan, Jiang-Jing; Yan, Ming-Xing; Qin, Guo-Juan; Zhang, Jian

2014-01-01

Objective To identify risk factors for ovarian pregnancy (OP) and compare clinical features between OP and tubal pregnancy (TP) patients. Design Case–control study. Setting University hospital. Participants A case–control study was conducted from January 2005 to May 2014. Women diagnosed with OP were recruited as the case group (n=71), 145 women with TP and 146 with intrauterine pregnancy (IUP) were matched as controls at a ratio of 1:2:2. Women who refused interviews or provided incomplete information were excluded. Results OP risk was lower than TP risk in women with serological evidence of Chlamydia trachomatis infection (adjusted OR1 0.17, 95% CI 0.06 to 0.52), previous adnexal surgery (adjusted OR1 0.25, 95% CI 0.07 to 0.95), and current levonorgestrel emergency contraceptive use (adjusted OR1 0.24, 95% CI 0.07 to 0.78). In vitro fertilisation-embryo transfer (IVF-ET) carried a higher risk of OP (adjusted OR1 12.18, 95% CI 2.23 to 66.58) than natural conception. When Controlled by IUP women, current users of intrauterine devices (IUDs) carried a higher risk of OP than non-users of any contraceptives (adjusted OR2 9.60, 95% CI 1.76 to 42.20). β-Human chorionic gonadotropin (hCG) levels on the day of surgery were higher in OP patients than in TP patients (p<0.01). Women with OP were less likely to initially present with vaginal bleeding than those with TP (p=0.02). Moreover, shock (p=0.02), rupture (p<0.01), haemoperitoneum (p<0.01) and emergency laparotomy (p<0.01) were more common in the OP group than in the TP group. Conclusions IVF-ET and IUD use may be risk factors for OP, and OP patients tend to have high β-hCG levels and a poor clinical outcome (shock, rupture, haemoperitoneum and need for emergency laparotomy). Our findings may contribute to the prevention and early diagnosis of OP. PMID:25472658

The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial.

PubMed

Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Newell, John; O'Shea, Eamon; Scarrott, Carl; Gillespie, Paddy; Kirwan, Collette; Murphy, Andrew W

2013-10-01

To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD). Two-arm, cluster randomised controlled trial. 32 general practices in the Republic of Ireland. 350 participants with a diagnosis of moderate or severe COPD. Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care. Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12-14 weeks postcompletion of the programme. Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen. A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD. ISRCTN52403063.

Socioeconomic disparities in outcomes after acute myocardial infarction.

PubMed

Bernheim, Susannah M; Spertus, John A; Reid, Kimberly J; Bradley, Elizabeth H; Desai, Rani A; Peterson, Eric D; Rathore, Saif S; Normand, Sharon-Lise T; Jones, Philip G; Rahimi, Ali; Krumholz, Harlan M

2007-02-01

Patients of low socioeconomic status (SES) have higher mortality after acute myocardial infarction (AMI). Little is known about the underlying mechanisms or the relationship between SES and rehospitalization after AMI. We analyzed data from the PREMIER observational study, which included 2142 patients hospitalized with AMI from 18 US hospitals. Socioeconomic status was measured by self-reported household income and education level. Sequential multivariable modeling assessed the relationship of socioeconomic factors with 1-year all-cause mortality and all-cause rehospitalization after adjustment for demographics, clinical factors, and quality-of-care measures. Both household income and education level were associated with higher risk of mortality (hazard ratio 2.80, 95% CI 1.37-5.72, lowest to highest income group) and rehospitalization after AMI (hazard ratio 1.55, 95% CI 1.17-2.05). Patients with low SES had worse clinical status at admission and received poorer quality of care. In multivariable modeling, the relationship between household income and mortality was attenuated by adjustment for demographic and clinical factors (hazard ratio 1.19, 95% CI 0.54-2.62), with a further small decrement in the hazard ratio after adjustment for quality of care. The relationship between income and rehospitalization was only partly attenuated by demographic and clinical factors (hazard ratio 1.38, 95% CI 1.01-1.89) and was not influenced by adjustment for quality of care. Patients' baseline clinical status largely explained the relationship between SES and mortality, but not rehospitalization, among patients with AMI.

Comparison of clinical probability-adjusted D-dimer and age-adjusted D-dimer interpretation to exclude venous thromboembolism.

PubMed

Takach Lapner, Sarah; Julian, Jim A; Linkins, Lori-Ann; Bates, Shannon; Kearon, Clive

2017-10-05

Two new strategies for interpreting D-dimer results have been proposed: i) using a progressively higher D-dimer threshold with increasing age (age-adjusted strategy) and ii) using a D-dimer threshold in patients with low clinical probability that is twice the threshold used in patients with moderate clinical probability (clinical probability-adjusted strategy). Our objective was to compare the diagnostic accuracy of age-adjusted and clinical probability-adjusted D-dimer interpretation in patients with a low or moderate clinical probability of venous thromboembolism (VTE). We performed a retrospective analysis of clinical data and blood samples from two prospective studies. We compared the negative predictive value (NPV) for VTE, and the proportion of patients with a negative D-dimer result, using two D-dimer interpretation strategies: the age-adjusted strategy, which uses a progressively higher D-dimer threshold with increasing age over 50 years (age in years × 10 µg/L FEU); and the clinical probability-adjusted strategy which uses a D-dimer threshold of 1000 µg/L FEU in patients with low clinical probability and 500 µg/L FEU in patients with moderate clinical probability. A total of 1649 outpatients with low or moderate clinical probability for a first suspected deep vein thrombosis or pulmonary embolism were included. The NPV of both the clinical probability-adjusted strategy (99.7 %) and the age-adjusted strategy (99.6 %) were similar. However, the proportion of patients with a negative result was greater with the clinical probability-adjusted strategy (56.1 % vs, 50.9 %; difference 5.2 %; 95 % CI 3.5 % to 6.8 %). These findings suggest that clinical probability-adjusted D-dimer interpretation is a better way of interpreting D-dimer results compared to age-adjusted interpretation.

Medication Use in Early-HD Participants in Track-HD: an Investigation of its Effects on Clinical Performance.

PubMed

Keogh, Ruth; Frost, Chris; Owen, Gail; Daniel, Rhian M; Langbehn, Doug R; Leavitt, Blair; Durr, Alexandra; Roos, Raymund A C; Landwehrmeyer, G Bernhard; Reilmann, Ralf; Borowsky, Beth; Stout, Julie; Craufurd, David; Tabrizi, Sarah J

2016-01-11

 Insufficient evidence exists to guide the long-term pharmacological management of Huntington's disease (HD) although most current interventions rely on symptomatic management. The effect of many frontline treatments on potential endpoints for HD clinical trials remains unknown. Our objective was to investigate how therapies widely used to manage HD affect the symptom for which they are prescribed and other endpoints using data from TRACK-HD. We used longitudinal models to estimate effects of medication use on performance on tests of motor, cognitive and neuropsychiatric function using data from 123 TRACK-HD stage 1/2 participants across four study visits. Adjustment for confounding by prior medication use, prior clinical performance, concomitant use of other medications, and baseline variables (sex, disease group, age, CAG, study site, education) enabled a closer-to-causal interpretation of the associations. Adjusting for baseline variables only, medication use was typically associated with worse clinical performance, reflecting greater medication use in more advanced patients. After additional adjustment for longitudinal confounders such "inverse" associations were generally eliminated and in the expected directions: participants taking neuroleptics tended to have better motor performance, improved affect and poorer cognitive performance, and those taking SSRI/SNRIs had less apathy, less affect and better total behaviour scores. However, we uncovered few statistically significant associations. Limitations include sample size and unmeasured confounding. In conclusion, adjustment for confounding by prior measurements largely eliminated associations between medication use and poorer clinical performance from simple analyses. However, there was little convincing evidence of causal effects of medication on clinical performance and larger cohorts or trials are needed.

Long-term efficacy and safety of ustekinumab for Crohn's disease through the second year of therapy.

PubMed

Sandborn, W J; Rutgeerts, P; Gasink, C; Jacobstein, D; Zou, B; Johanns, J; Sands, B E; Hanauer, S B; Targan, S; Ghosh, S; de Villiers, W J S; Colombel, J-F; Feagan, B G

2018-05-24

In Phase 3 studies of ustekinumab, a fully human monoclonal IL-12/23p40 antibody approved for moderate-to-severe Crohn's disease, patients entered a long-term extension after completing 8 weeks of induction and 44 weeks of maintenance treatment. Efficacy through 92 weeks and safety through 96 weeks of IM-UNITI maintenance are reported. UNITI-1 (TNF-antagonist failures) and UNITI-2 (conventional therapy failures) patients (N = 1281) entered IM-UNITI, including 397 ustekinumab intravenous induction responders randomised to subcutaneous ustekinumab 90 mg every 12 weeks, every 8 weeks, or placebo and 884 nonrandomised patients. Dose-adjustment to 90 mg every 8 weeks occurred in patients randomised to 90 mg every 12 weeks and placebo patients with loss of response (Weeks 8-32). All Week 44 completers could enter the long-term extension without further dose adjustment. Placebo patients discontinued following study unblinding. A total of 718 patients (all treated) entered the long-term extension (298 randomised and 420 not randomised). Overall, 86.5% (621/718) completed Week 96. The proportions of randomised patients in clinical remission were generally maintained from Week 44 through 92 in ustekinumab 90 mg every 12 weeks (77.4% to 72.6%), every 8 weeks (84.1% to 74.4%), and prior dose adjustment groups (63.4% to 53.5%). At Week 92, the proportions of patients in clinical remission were similar in the ustekinumab 90 mg every 12 weeks and every 8 weeks groups and lower in patients with prior dose adjustment. Proportions of patients in clinical remission at Week 92 for all treated every 8 weeks (64.4%) and every 12 weeks (64.3%) groups were lower than randomised every 8 weeks (74.4%) and every 12 weeks (72.6%) groups, but similarly maintained. Safety events (per hundred patient-years) were similar among all placebo and ustekinumab patients (Week 0-96), including adverse events (484.39 vs 447.76), serious adverse events (19.24 vs 18.82), and serious infections (4.09 vs 4.02). No dose effect was observed. Subcutaneous ustekinumab maintained clinical response and remission through Week 92. No new safety signals were observed. ClinicalTrials.gov number NCT01369355. © 2018 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma receiving definitive radiotherapy or concurrent chemoradiotherapy through intensity-modulated radiation therapy techniques.

PubMed

Yen, Yu-Chun; Chang, Jer-Hwa; Lin, Wei-Cheng; Chiou, Jeng-Fong; Chang, Yin-Chun; Chang, Chia-Lun; Hsu, Han-Lin; Chow, Jyh-Ming; Yuan, Kevin Sheng-Po; Wu, Alexander T H; Wu, Szu-Yuan

2017-06-01

Few large, prospective, randomized studies have investigated the effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma (TESCC) who receive definitive radiotherapy (RT) or concurrent chemoradiotherapy (CCRT) through modern, intensity modulated-RT (IMRT) techniques. The therapeutic effects of esophagectomy in patients with TESCC were evaluated using modern clinical staging and RT techniques and suitable RT doses. The authors analyzed data from patients with TESCC from the Taiwan Cancer Registry database. Patients were categorized into the following groups on the basis of treatment modality to compare their outcomes: group 1 received definitive CCRT, group 2 received neoadjuvant RT followed by esophagectomy (total IMRT dose, ≥50 grays [Gy]), and group 3 receiving neoadjuvant CCRT followed by esophagectomy (total IMRT dose, ≥ 50 Gy). The median total RT dose and fraction size were 50.4 Gy and 1.8 Gy per fraction, respectively. Group 1 was used as the control arm for investigating the risk of mortality after treatment. In total, 3123 patients who had TESCC without distant metastasis were enrolled. Patient ages 65 years and older, Charlson comorbidity index scores ≥3, advanced clinical stages (IIA-IIIC), alcohol consumption, and cigarette smoking were identified as significant, independent poor prognostic risk factors for overall survival in multivariate Cox regression analyses. In group 3, after adjustment for confounders, the adjusted hazard ratios (95% confidence intervals [CIs]) for overall mortality were 0.62 (95% CI, 0.41-0.93) for patients with clinical stage IIA disease, 0.61 (95% CI, 0.41-0.91) for those with clinical stage IIB disease, 0.47 (95% CI, 0.38-0.55) for those with clinical stage IIIA disease, 0.47 (95% CI, 0.39-0.56) for those with clinical stage IIIB disease, and 0.46 (95% CI, 0.37-0.57) for those with clinical stage IIIC disease. Esophagectomy can be beneficial in patients with TESCC after definitive CCRT, especially in those who have advanced-stage disease. Cancer 2017;123:2043-2053. © 2017 American Cancer Society. © 2017 American Cancer Society.

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.

PubMed

Kasivisvanathan, Veeru; Rannikko, Antti S; Borghi, Marcelo; Panebianco, Valeria; Mynderse, Lance A; Vaarala, Markku H; Briganti, Alberto; Budäus, Lars; Hellawell, Giles; Hindley, Richard G; Roobol, Monique J; Eggener, Scott; Ghei, Maneesh; Villers, Arnauld; Bladou, Franck; Villeirs, Geert M; Virdi, Jaspal; Boxler, Silvan; Robert, Grégoire; Singh, Paras B; Venderink, Wulphert; Hadaschik, Boris A; Ruffion, Alain; Hu, Jim C; Margolis, Daniel; Crouzet, Sébastien; Klotz, Laurence; Taneja, Samir S; Pinto, Peter; Gill, Inderbir; Allen, Clare; Giganti, Francesco; Freeman, Alex; Morris, Stephen; Punwani, Shonit; Williams, Norman R; Brew-Graves, Chris; Deeks, Jonathan; Takwoingi, Yemisi; Emberton, Mark; Moore, Caroline M

2018-05-10

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited. In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer. A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001). The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).

The Costs of Decedents in the Medicare Program: Implications for Payments to Medicare+Choice Plans

PubMed Central

Buntin, Melinda Beeuwkes; Garber, Alan M; McClellan, Mark; Newhouse, Joseph P

2004-01-01

Objective To discuss and quantify the incentives that Medicare managed care plans have to avoid (through selective enrollment or disenrollment) people who are at risk for very high costs, focusing on Medicare beneficiaries in the last year of life—a group that accounts for more than one-quarter of Medicare's annual expenditures. Data Source Medicare administrative claims for 1994 and 1995. Study Design We calculated the payment a plan would have received under three risk-adjustment systems for each beneficiary in our 1995 sample based on his or her age, gender, county of residence, original reason for Medicare entitlement, and principal inpatient diagnoses received during any hospital stays in 1994. We compared these amounts to the actual costs incurred by those beneficiaries. We then looked for clinical categories that were predictive of costs, including costs in a beneficiary's last year of life, not accounted for by the risk adjusters. Data Extraction Methods The analyses were conducted using claims for a 5 percent random sample of Medicare beneficiaries who died in 1995 and a matched group of survivors. Principal Findings Medicare is currently implementing the Principal Inpatient Diagnostic Cost Groups (PIP-DCG) risk adjustment payment system to address the problem of risk selection in the Medicare+Choice program. We quantify the strong financial disincentives to enroll terminally ill beneficiaries that plans still have under this risk adjustment system. We also show that up to one-third of the selection observed between Medicare HMOs and the traditional fee-for-service system could be due to differential enrollment of decedents. A risk adjustment system that incorporated more of the available diagnostic information would attenuate this disincentive; however, plans could still use clinical information (not included in the risk adjustment scheme) to identify beneficiaries whose expected costs exceed expected payments. Conclusions More disaggregated prospective risk adjustment methods and alternative payment systems that compensate plans for delivering care to certain classes of patients should be considered to ensure access to high-quality managed care for all beneficiaries. PMID:14965080

Exploring methods for comparing the real-world effectiveness of treatments for osteoporosis: adjusted direct comparisons versus using patients as their own control.

PubMed

Karlsson, Linda; Mesterton, Johan; Tepie, Maurille Feudjo; Intorcia, Michele; Overbeek, Jetty; Ström, Oskar

2017-09-21

Using Swedish and Dutch registry data for women initiating bisphosphonates, we evaluated two methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for differences in patient baseline characteristics. Each method has advantages and disadvantages; both are potential complements to clinical trial analyses. We evaluated methods of comparing the real-world effectiveness of osteoporosis treatments that attempt to adjust for both observed and unobserved confounding. Swedish and Dutch registry data for women initiating zoledronate or oral bisphosphonates (OBPs; alendronate/risedronate) were used; the primary outcome was fracture. In adjusted direct comparisons (ADCs), regression and matching techniques were used to account for baseline differences in known risk factors for fracture (e.g., age, previous fracture, comorbidities). In an own-control analysis (OCA), for each treatment, fracture incidence in the first 90 days following treatment initiation (the baseline risk period) was compared with fracture incidence in the 1-year period starting 91 days after treatment initiation (the treatment exposure period). In total, 1196 and 149 women initiating zoledronate and 14,764 and 25,058 initiating OBPs were eligible in the Swedish and Dutch registries, respectively. Owing to the small Dutch zoledronate sample, only the Swedish data were used to compare fracture incidences between treatment groups. ADCs showed a numerically higher fracture incidence in the zoledronate than in the OBPs group (hazard ratio 1.09-1.21; not statistically significant, p > 0.05). For both treatment groups, OCA showed a higher fracture incidence in the baseline risk period than in the treatment exposure period, indicating a treatment effect. OCA showed a similar or greater effect in the zoledronate group compared with the OBPs group. ADC and OCA each possesses advantages and disadvantages. Combining both methods may provide an estimate of real-world treatment efficacy that could potentially complement clinical trial findings.

Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial.

PubMed

Philipsen, Alexandra; Jans, Thomas; Graf, Erika; Matthies, Swantje; Borel, Patricia; Colla, Michael; Gentschow, Laura; Langner, Daina; Jacob, Christian; Groß-Lesch, Silke; Sobanski, Esther; Alm, Barbara; Schumacher-Stien, Martina; Roesler, Michael; Retz, Wolfgang; Retz-Junginger, Petra; Kis, Bernhard; Abdel-Hamid, Mona; Heinrich, Viola; Huss, Michael; Kornmann, Catherine; Bürger, Arne; Perlov, Evgeniy; Ihorst, Gabriele; Schlander, Michael; Berger, Mathias; Tebartz van Elst, Ludger

2015-12-01

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder with high prevalence in adulthood. There is a recognized need to assess the efficacy of psychotherapy in adult ADHD. To evaluate the efficacy of cognitive behavioral group psychotherapy (GPT) compared with individual clinical management (CM) and that of methylphenidate hydrochloride compared with placebo. Prospective, multicenter, randomized clinical trial of 18- to 58-year-old outpatients with ADHD from 7 German study centers. Patients were recruited between January 2007 and August 2010, treatment was finalized in August 2011, and final follow-up assessments occurred in March 2013. Sessions of GPT and CM were held weekly for the first 12 weeks and monthly thereafter (9 months). Patients received either methylphenidate or placebo for 1 year. The primary outcome was the change in the ADHD Index of the Conners Adult ADHD Rating Scale from baseline to the end of the 3-month intensive treatment (blinded observer ratings). Secondary outcomes included ADHD ratings after 1 year, blinded observer ratings using the Clinical Global Impression Scale, and self-ratings of depression. Among 1480 prescreened patients, 518 were assessed for eligibility, 433 were centrally randomized, and 419 were analyzed as randomized. After 3 months, the ADHD Index all-group baseline mean of 20.6 improved to adjusted means of 17.6 for GPT and 16.5 for CM, with no significant difference between groups. Methylphenidate (adjusted mean, 16.2) was superior to placebo (adjusted mean, 17.9) (difference, -1.7; 97.5% CI, -3.0 to -0.4; P = .003). After 1 year, treatment effects remained essentially stable. Descriptive analyses showed that methylphenidate was superior to placebo in patients assigned to GPT (difference, -1.7; 95% CI, -3.2 to -0.1; P = .04) or CM (difference, -1.7; 95% CI, -3.3 to -0.2; P = .03). Regarding depression, no significant differences were found. In contrast, GPT was superior to CM for all visits in the Clinical Global Impression global assessment of effectiveness. Highly structured group intervention did not outperform individual CM with regard to the primary outcome. Psychological interventions resulted in better outcomes during a 1-year period when combined with methylphenidate as compared with placebo. isrctn.org Identifier: ISRCTN54096201.

Evaluating diagnosis-based risk-adjustment methods in a population with spinal cord dysfunction.

PubMed

Warner, Grace; Hoenig, Helen; Montez, Maria; Wang, Fei; Rosen, Amy

2004-02-01

To examine performance of models in predicting health care utilization for individuals with spinal cord dysfunction. Regression models compared 2 diagnosis-based risk-adjustment methods, the adjusted clinical groups (ACGs) and diagnostic cost groups (DCGs). To improve prediction, we added to our model: (1) spinal cord dysfunction-specific diagnostic information, (2) limitations in self-care function, and (3) both 1 and 2. Models were replicated in 3 populations. Samples from 3 populations: (1) 40% of veterans using Veterans Health Administration services in fiscal year 1997 (FY97) (N=1,046,803), (2) veteran sample with spinal cord dysfunction identified by codes from the International Statistical Classification of Diseases, 9th Revision, Clinical Modifications (N=7666), and (3) veteran sample identified in Veterans Affairs Spinal Cord Dysfunction Registry (N=5888). Not applicable. Inpatient, outpatient, and total days of care in FY97. The DCG models (R(2) range,.22-.38) performed better than ACG models (R(2) range,.04-.34) for all outcomes. Spinal cord dysfunction-specific diagnostic information improved prediction more in the ACG model than in the DCG model (R(2) range for ACG,.14-.34; R(2) range for DCG,.24-.38). Information on self-care function slightly improved performance (R(2) range increased from 0 to.04). The DCG risk-adjustment models predicted health care utilization better than ACG models. ACG model prediction was improved by adding information.

[Family characteristics, organic risk factors, psychopathological picture and premorbid adjustment of hospitalized adolescent patients].

PubMed

Małkiewicz-Borkowska, M; Namysłowska, I; Siewierska, A; Puzyńska, E; Sredniawa, H; Zechowski, C; Iwanek, A; Ruszkowska, E

1996-01-01

The relation of some family characteristics such as cohesion and adaptability with organic risk factors, developmental psychopathology, clinical picture and premorbid adjustment was assessed in the group of 100 hospitalized adolescent patients and families. We found correlation between: some of organic risk factors (pathology of neonatal period, pathology of early childhood), some of indicators of developmental psychopathology (eating disorders, conduct disorders), some of clinical signs (mannerism, grandiosity, hostility, suspciousness, disturbances of content of thinking), premorbid adjustment, and variables related to families, described before. We think that biological variables characterizing child (pathology of neonatal period, pathology of early childhood) have an influence on some family characteristics as independent variable. General system theory and circular thinking support these conclusions. In order to verify them, it is necessary to undertake further investigations, based on other methodology, using this results as preliminary findings.

Dose Adjustment for Normal Eating: A Role for the Expert Patient?

PubMed Central

2014-01-01

The Dose Adjustment for Normal Eating (DAFNE) programme of intensive insulin therapy for type 1 diabetes provides a structured educational intervention to improve glycemic control, reduce hypoglycemia and improve quality of life. Enhancement of self-management skills is a key element of DAFNE and patients acquire detailed skills in insulin dose adjustment. Following DAFNE training, patients report improved confidence in their ability to manage their own insulin dosing, but generally still seek and require the assistance of health professionals when making substantial changes to their insulin regimens. Some DAFNE trained patients may be able to assist their peers in aspects of diabetes management within a group environment, but widespread introduction of the expert patient/peer educator role in the self-management of type 1 diabetes, in particular related to insulin dose management, would require formal and detailed evaluation, preferably in randomized controlled clinical trials, before being introduced into routine clinical practice. PMID:24851201

Food groups and weight gain in Japanese men.

PubMed

Ibe, Y; Takahashi, Y; Sone, H

2014-06-01

Identifying subjects at high risk of weight gain according to consumption of food groups is important for individualizing nutritional education, but prospective studies of this issue have been few. We determined whether intake of specific food groups could predict future weight gain. We evaluated data from health checkups on 1236 Japanese men aged 28 to 87 years in 2005 and 2006. Dietary intake was assessed by a 24-h dietary recall at baseline. Weight change was measured after 1 year. Weight increased in 44.7% (n = 553) of participants. Multivariate regression analysis involving many food groups showed a significant association between sugar intake and weight gain after adjustment for age, body mass index (BMI), total energy intake, alcohol, smoking and regular physical exercise (β = 0.22, P = 0.04). The effect of intake of 'fats and oils' was significant when adjusted for age and BMI, however, it became insignificant after adjustment for age, BMI and total energy intake. Intake of sugar, which was evaluated as a food group, was predictive of subsequent weight gain among Japanese men, even after adjustment for many confounders. This corroborates the evidence so far concerning the links between sugar intake and weight gain. Further long-term research is required to give robust recommendation to the public. © 2014 The Authors. Clinical Obesity © 2014 International Association for the Study of Obesity.

Comparison of BMSs with SES for Symptomatic Intracranial Disease of the Middle Cerebral Artery Stenosis

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

Yue Xuanye; Yin Qin; Xi Gangming

2011-02-15

This study was designed to compare the clinical and angiographic outcomes of patients with symptomatic atherosclerotic middle cerebral artery stenosis treated with balloon-mounted stents (BMS) and self-expandable Wingspan system (SES). We reviewed the 69 consecutive stent placement procedures for symptomatic atherosclerotic stenosis ({>=}70) in M1 segment of middle cerebral artery in 67 patients in 3 years. According to the stent types, the patients were classed as BMS and SES groups. The demographic characteristics, conventional risk factors of ischemic stroke, degree of stenosis, periprocedural complications, stent types, and clinical and angiographic outcomes were analyzed. There were 39 patients in the BMSmore » group and 28 patients in the SES group. The demographic characteristics, conventional risk factors, and periprocedural complications were similar but different in residual stenosis after stenting in both groups (5.9% {+-} 9.9% vs. 14.4% {+-} 14.6%; P = 0.01). For the overall cohort, the rate of stroke or death and restenosis was 10.9% (7/66) and 24.5% (14/57), respectively. The frequency of restenosis was higher in the SES group than in the BMS group (log-rank, P = 0.04; crude hazard ratio = 3.03; 95% confidence interval (CI), 1.01-9.15; P = 0.049; and adjusted hazard ratio = 3.61; 95% CI, 1.06-12.27; P = 0.04); however, there was no difference in clinical outcomes (log-rank, P = 0.51; crude hazard ratio = 1.66; 95% CI, 0.36-7.61; P = 0.51; and adjusted hazard ratio = 0.59; 95% CI, 0.04-7.89; P = 0.69). The corrected degree of restenosis was higher in the SES than the BMS group. The prevalence of restenosis was higher in the SES than the BMS group, but the perioperative complications and follow-up clinical outcomes had no significant difference.« less

Influence of class IV laser therapy on the outcomes of tibial plateau leveling osteotomy in dogs.

PubMed

Renwick, S Michelle; Renwick, Alasdair I; Brodbelt, David C; Ferguson, John; Abreu, Humberto

2018-04-26

To determine the effects of low-level laser therapy (LLLT) on clinical outcomes in dogs with cranial cruciate ligament disease treated with tibial plateau leveling osteotomy (TPLO). Randomized, placebo-controlled clinical trial. Owners and surgeons (care providers and assessors) were masked. Ninety-five dogs were admitted for TPLO and assigned to 1 of 2 groups, laser group (LG; n = 51) or placebo group (PG; n = 44). Three treatments (laser or placebo) were administered within a 4-day perioperative period. A fourth treatment was recommended and was accepted in 28.4% of cases (LG, n = 14; PG, n = 13). Dogs in the LG group received laser at wavelengths 660 nm red (100 mW) and at 800, 905 and 970 nm infrared (maximum 15 W continuous wave, 20 W peak pulsed wave), administered simultaneously. Dogs in the PG group received placebo laser (660 nm, 4 mW). Other treatments were identical. Outcomes were measured by difference in clinical metrology instruments (Liverpool Osteoarthritis in Dogs and adjusted Canine Orthopedic Index [COI]), osteotomy healing on a radiographic scale, time to cessation of nonsteroidal anti-inflammatory drug administration, and wound healing by owner questionnaire. The only difference detected between groups consisted of a greater improvement in the gait section of the adjusted COI (ACOI) in the LG group (median [interquartile range; IQR] = 6 [4-7.5]) compared with the PG group (median [IQR] = 4 [2-6]; P < .05). The laser protocol used in this study was associated with a greater improvement in ACOI gait in dogs treated with TPLO but did not improve any other clinical metrology instrument scores or bone healing. This study provides some evidence that LLLT may improve the gait of dogs recovering from a TPLO, as assessed by owners. © 2018 The American College of Veterinary Surgeons.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Clinical outcome of statin plus ezetimibe versus high-intensity statin therapy in patients with acute myocardial infarction propensity-score matching analysis.

PubMed

Ji, Mi Seon; Jeong, Myung Ho; Ahn, Young Keun; Kim, Sang Hyung; Kim, Young Jo; Chae, Shung Chull; Hong, Taek Jong; Seong, In Whan; Chae, Jei Keon; Kim, Chong Jin; Cho, Myeong Chan; Rha, Seung-Woon; Bae, Jang Ho; Seung, Ki Bae; Park, Seung Jung

2016-12-15

It is unclear whether simvastatin-ezetimibe could be an alternative therapy to high-intensity statin therapy in high-risk patients. The aim of this study was to compare the clinical outcomes of simvastatin-ezetimibe and high-intensity statin therapy in patients with acute myocardial infarction (AMI), and especially in those with high-risk factor. A total of 3520 AMI patients in the KAMIR (Korea Acute Myocardial Infarction Registry) were classified into simvastatin-ezetimibe group (n=1249) and high-intensity statin group (n=2271). Multivariate analysis and propensity-score matching analysis were performed. The primary endpoint was major adverse cardiac events (MACE) at 12-months follow-up. In overall AMI patients, MACE occurred in 116 patients (9.3%) in simvastatin-ezetimibe group and 116 patients (5.1%) in high-intensity statin group. The difference in MACE between groups was driven by repeat revascularization (5.9% vs. 2.2%). After propensity matching analysis, simvastatin-ezetimibe was associated with a higher incidence of MACE than high-intensity statin therapy (adjusted hazard ratio: 3.090, 95% confidence interval: 1.715 to 5.566, p<0.001). However, in patients with high-risk factors, such as diabetes, old age, or heart failure, simvastatin-ezetimibe had similar incidence of MACE compared with high-intensity statin therapy in further adjusted analysis. In overall AMI patients, high-intensity statin therapy had better clinical outcomes than simvastatin-ezetimibe. However, in patients with high-risk factor, simvastatin-ezetimibe had comparable clinical outcomes to high-intensity statin therapy. Therefore, simvastatin-ezetimibe could be used as an alternative to high-intensity statin therapy in such patients. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Participation in clinical trials among women living with HIV in Canada

PubMed Central

Hankins, C; Lapointe, N; Walmsley, S

1998-01-01

BACKGROUND: To describe participation in clinical trials among HIV-positive women enrolled since 1993 in the Canadian Women's HIV Study, a prospective open cohort study. METHODS: All HIV-positive women being followed at hospital-based or community-based clinics at 28 sites in 11 Canadian cities were eligible to participate in the Canadian Women's HIV Study. Baseline and follow-up information was collected for 413 women every 6 months by study nurses using standardized questionnaires. Data included sociodemographic variables, HIV exposure group, CD4 count, disease classification, use of antiretroviral therapies and participation in clinical trials. RESULTS: At study intake 15.0% (62/413) of the women had participated in a clinical trial; an additional 8.5% (35/413) participated during a median follow-up of 18 months. Multivariate analysis revealed that the following factors were independently associated with participation in a clinical trial: white race (adjusted odds ratio [OR] 3.38, p = 0.001), current use of antiretroviral therapy (adjusted OR 2.01, p = 0.008), completion of secondary school (adjusted OR 1.97, p = 0.024) and residence in the Prairies or Atlantic provinces (adjusted OR 1.98, p = 0.043). INTERPRETATION: Although the overall clinical trial participation rate of 23.5% was relatively high among HIV-positive women, injection drug users were underrepresented in this study population, and non-white women, women who did not complete high school and women not receiving antiretroviral therapy were less likely than white women, women of higher education and women receiving antiretroviral therapy to participate in clinical trials in Canada. Because of the importance of trial participants being representative of the population for which therapeutic agents are intended, HIV clinical trials must recruit women with lower literacy levels, non-white women, women not receiving antiretroviral therapy and women who are injection drug users to ensure generalizability of research findings. Further study is needed to assess factors that act as barriers and motivators to women's participation in HIV clinical trials. PMID:9861204

Parental control, parental warmth, and psychosocial adjustment in a sample of substance-abusing mothers and their school-aged and adolescent children

PubMed Central

Suchman, Nancy E.; Rounsaville, Bruce; DeCoste, Cindy; Luthar, Suniya

2007-01-01

Parenting interventions for substance-abusing adults have been broadly based on two approaches, one emphasizing parental control as a means to managing children’s behavior and the second emphasizing parental warmth and sensitivity as means to fostering children’s psychological development. In this investigation, we examined associations of parental control and parental warmth, respectively, with children’s behavioral and psychological adjustment in a sample of 98 women enrolled in methadone maintenance and their school-aged and adolescent children. Using collateral data collected during the baseline phase of a randomized clinical trial (Luthar, S. S., Suchman, N. E., & Altomare, M. [in press]. Relational Psychotherapy Mothers Group: A randomized clinical trial for substance abusing mothers [in preparation]), we tested predictions that (a) parental control would be more strongly associated with children’s behavioral adjustment and (b) parental warmth would be more strongly associated with children’s psychological adjustment. Both predictions were generally confirmed, although some crossover among parenting and child dimensions was also evident. Results support the theoretical stance that parental limit setting and autonomy support, as well as nurturance and involvement, are important factors, respectively, in children’s behavioral and psychological adjustment. PMID:17175393

High-Flow Nasal Cannula versus Conventional Oxygen Therapy in Children with Respiratory Distress.

PubMed

Sitthikarnkha, Punthila; Samransamruajkit, Rujipat; Prapphal, Nuanchan; Deerojanawong, Jitladda; Sritippayawan, Suchada

2018-05-01

The aim of this study is to determine the clinical efficacy of high-flow nasal cannula (HFNC) therapy compared with conventional oxygen therapy in children presented with respiratory distress. This was a randomized controlled study. Infants and children aged between 1 month to 5 years who were admitted to our tertiary referral center for respiratory distress (July 1, 2014 to March 31, 2015) and met the inclusion criteria were recruited. Infants and children hospitalized with respiratory distress were randomized into two groups of interventions. All clinical data, for example, respiratory score, pulse rate, and respiratory rate were recorded. The results were subsequently analyzed. A total of 98 respiratory distress children were enrolled during the study period. Only 4 children (8.2%) failed in HFNC therapy, compared with 10 children (20.4%) in conventional oxygen therapy group ( P = 0.09). After adjusted for body weight, underlying diseases, and respiratory distress score, there was an 85% reduction in the odds of treatment failure in HFNC therapy group (adjusted odds ratio 0.15, 95% confidence interval 0.03-0.66, P = 0.01). Most children in HFNC therapy group had significant improvement in clinical respiratory score, heart rate, and respiratory rate at 240, 360, and 120 min compared with conventional oxygen therapy ( P = 0.03, 0.04, and 0.03). HFNC therapy revealed a potential clinical advantage in management children hospitalized with respiratory distress compared with conventional respiratory therapy. The early use of HFNC in children with moderate-to-severe respiratory distress may prevent endotracheal tube intubation. TCTR 20170222007.

A multicenter, randomized, double-blind, retrospective comparison of 5- and 10-day regimens of levofloxacin in a subgroup of patients aged > or =65 years with community-acquired pneumonia.

PubMed

Shorr, Andrew F; Zadeikis, Neringa; Xiang, Jim X; Tennenberg, Alan M; Wes Ely, E

2005-08-01

This subgroup analysis sought to determine the efficacy and tolerability of a 5-day regimen of levofloxacin 750 mg/d compared with a 10-day regimen of levofloxacin 500 mg/d in the treatment of community-acquired pneumonia (CAP) in elderly patients (aged > or =65 years). This subgroup analysis was based on the outcomes in patients aged > or =65 years from a randomized, double-blind, controlled trial conducted at 70 US centers. Patients in Pneumonia Severity Index (PSI) class I/II and III/IV were randomized to receive levofloxacin 750 mg/d for 5 days or levofloxacin 500 mg/d for 10 days. Study investigators assessed clinical and microbiologic outcomes 7 to 14 days after administration of the last dose of medication and collected adverse events for 30 days after the last dose. This analysis included 177 elderly patients, 80 receiving levofloxacin 750 mg/d for 5 days and 97 receiving levofloxacin 500 mg/d for 10 days. Although most demographic and baseline clinical characteristics were comparable between the 2 groups, the group that received levofloxacin 500 mg/d was older than the group that received levofloxacin 750 mg/d (median age, 76.0 vs 72.5 years, respectively; P = 0.029) and had a higher mean PSI score (90.7 vs 83.1; P = 0.017). Despite the halved duration of therapy, unadjusted clinical success rates were comparable between the 2 groups (89.0% and 91.9% in the 750- and 500-mg arms, respectively; 95% CI, -7.1 to 12.7). Microbiologic eradication rates were 90.3% (28/31) in the 750-mg arm and 87.5% (14/16) in the 500-mg arm (P = NS). Multivariate analysis adjusting for baseline PSI score indicated that treatment assignment was not statistically associated with clinical success (adjusted odds ratio for clinical success with 500-mg dose, 1.92; 95% CI, 0.62 to 5.99). The incidence of treatment-emergent adverse events did not differ between the 2 study treatments. The most common adverse events in both groups were insomnia, constipation, and headache. This subgroup analysis found that levofloxacin 750 mg/d for 5 days was well tolerated in the treatment of CAP in elderly patients. Undajusted and adjusted rates of clinical success were statistically similar between levofloxacin 750 mg/d for 5 days and levofloxacin 500 mg/d for 10 days.

The relationship between effectiveness and costs measured by a risk-adjusted case-mix system: multicentre study of Catalonian population data bases.

PubMed

Sicras-Mainar, Antoni; Navarro-Artieda, Ruth; Blanca-Tamayo, Milagrosa; Velasco-Velasco, Soledad; Escribano-Herranz, Esperanza; Llopart-López, Josep Ramon; Violan-Fors, Concepción; Vilaseca-Llobet, Josep Maria; Sánchez-Fontcuberta, Encarna; Benavent-Areu, Jaume; Flor-Serra, Ferran; Aguado-Jodar, Alba; Rodríguez-López, Daniel; Prados-Torres, Alejandra; Estelrich-Bennasar, Jose

2009-06-25

The main objective of this study is to measure the relationship between morbidity, direct health care costs and the degree of clinical effectiveness (resolution) of health centres and health professionals by the retrospective application of Adjusted Clinical Groups in a Spanish population setting. The secondary objectives are to determine the factors determining inadequate correlations and the opinion of health professionals on these instruments. We will carry out a multi-centre, retrospective study using patient records from 15 primary health care centres and population data bases. The main measurements will be: general variables (age and sex, centre, service [family medicine, paediatrics], and medical unit), dependent variables (mean number of visits, episodes and direct costs), co-morbidity (Johns Hopkins University Adjusted Clinical Groups Case-Mix System) and effectiveness.The totality of centres/patients will be considered as the standard for comparison. The efficiency index for visits, tests (laboratory, radiology, others), referrals, pharmaceutical prescriptions and total will be calculated as the ratio: observed variables/variables expected by indirect standardization.The model of cost/patient/year will differentiate fixed/semi-fixed (visits) costs of the variables for each patient attended/year (N = 350,000 inhabitants). The mean relative weights of the cost of care will be obtained. The effectiveness will be measured using a set of 50 indicators of process, efficiency and/or health results, and an adjusted synthetic index will be constructed (method: percentile 50).The correlation between the efficiency (relative-weights) and synthetic (by centre and physician) indices will be established using the coefficient of determination. The opinion/degree of acceptance of physicians (N = 1,000) will be measured using a structured questionnaire including various dimensions. multiple regression analysis (procedure: enter), ANCOVA (method: Bonferroni's adjustment) and multilevel analysis will be carried out to correct models. The level of statistical significance will be p < 0.05.

Pregnancy and neonatal outcomes following letrozole use in frozen-thawed single embryo transfer cycles.

PubMed

Tatsumi, T; Jwa, S C; Kuwahara, A; Irahara, M; Kubota, T; Saito, H

2017-06-01

Are pregnancy and neonatal outcomes following letrozole use comparable with natural and HRT cycles in patients undergoing single frozen-thawed embryo transfer (FET)? Letrozole use was significantly associated with higher rates of clinical pregnancy, clinical pregnancy with fetal heart beat and live birth, and with a lower rate of miscarriage, compared with natural and HRT cycles. Letrozole is the most commonly used aromatase inhibitor for mild ovarian stimulation in ART. However, the effect of letrozole on pregnancy and neonatal outcomes in FET are not well known. A retrospective cohort study was conducted using data from the Japanese national ART registry between 2012 and 2013. A total of 110 722 single FET cycles with letrozole (n = 2409), natural (n = 41 470) or HRT cycles (n = 66 843) were included. The main outcomes were the rates of clinical pregnancy, clinical pregnancy with fetal heart beat, miscarriage and live birth. Adjusted odds ratios and relative risks (RRs) were calculated using a generalized estimating equation adjusting for correlations within clinics. The rates of clinical pregnancy, clinical pregnancy with fetal heart beat, and live birth were significantly higher, while the rate of miscarriage was significantly lower in the letrozole group compared with the natural and HRT groups. In blastocyst stage transfers, the adjusted RRs for clinical pregnancy with fetal heart beat of letrozole compared with natural and HRT cycles were 1.48 (95% CI: 1.41-1.55) and 1.62 (95% CI: 1.54-1.70), respectively. Similarly, the adjusted RRs of letrozole for miscarriage compared with natural and HRT cycles were 0.91 (95% CI: 0.88-0.93) and 0.84 (95% CI: 0.82-0.87), respectively. Neonatal outcomes were mostly similar in letrozole, natural and HRT cycles. Important limitations of this study included the lack of information concerning the reasons for selecting the specific FET method, parity, the number of previous ART failures, embryo quality and the dose and duration of letrozole intake. These results suggest that letrozole use may improve clinical pregnancy, clinical pregnancy with fetal heart beat, and live births and reduce the risk of miscarriage in patients undergoing single FET cycles. No external funding was used for this study. There are no conflicts of interest. Not applicable. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Combined dietary and exercise intervention for control of serum cholesterol in the workplace

NASA Technical Reports Server (NTRS)

Angotti, C. M.; Chan, W. T.; Sample, C. J.; Levine, M. S.

2000-01-01

PURPOSE: To elucidate a potential combined dietary and exercise intervention affect on cardiovascular risk reduction of the National Aeronautics and Space Administration Headquarters employees. DESIGN: A nonexperimental, longitudinal, clinical-chart review study (1987 to 1996) of an identified intervention group and a reference (not a control) group. SETTING: The study group worked in an office environment and participated in the annual medical examinations. SUBJECTS: An intervention group of 858 people with initially elevated serum cholesterol, and a reference group of 963 people randomly sampled from 10% of the study group. MEASURES: Serum cholesterol data were obtained for both groups, respectively, from pre- and postintervention and annual examinations. The reference group was adjusted by statistical exclusion of potential intervention participants. Regression equations (cholesterol vs. study years) for the unadjusted/adjusted reference groups were tested for statistical significance. INTERVENTION: An 8-week individualized, combined dietary and exercise program was instituted with annual follow-ups and was repeated where warranted. RESULTS: Only the unadjusted (but not the adjusted) reference group with initial mean total serum cholesterol levels above 200 mg/dL shows a significant 9-year decline trend and significant beta coefficient tests. An intervention effect is suggested. Mean high density lipoprotein cholesterol rose slightly in the intervention group but was maintained in the reference group. CONCLUSION: With potential design limitations, the NASA intervention program focusing on a high risk group may be associated to some degree, if not fully, with an overall cardiovascular risk profile improvement.

Comparison of the predictive validity of diagnosis-based risk adjusters for clinical outcomes.

PubMed

Petersen, Laura A; Pietz, Kenneth; Woodard, LeChauncy D; Byrne, Margaret

2005-01-01

Many possible methods of risk adjustment exist, but there is a dearth of comparative data on their performance. We compared the predictive validity of 2 widely used methods (Diagnostic Cost Groups [DCGs] and Adjusted Clinical Groups [ACGs]) for 2 clinical outcomes using a large national sample of patients. We studied all patients who used Veterans Health Administration (VA) medical services in fiscal year (FY) 2001 (n = 3,069,168) and assigned both a DCG and an ACG to each. We used logistic regression analyses to compare predictive ability for death or long-term care (LTC) hospitalization for age/gender models, DCG models, and ACG models. We also assessed the effect of adding age to the DCG and ACG models. Patients in the highest DCG categories, indicating higher severity of illness, were more likely to die or to require LTC hospitalization. Surprisingly, the age/gender model predicted death slightly more accurately than the ACG model (c-statistic of 0.710 versus 0.700, respectively). The addition of age to the ACG model improved the c-statistic to 0.768. The highest c-statistic for prediction of death was obtained with a DCG/age model (0.830). The lowest c-statistics were obtained for age/gender models for LTC hospitalization (c-statistic 0.593). The c-statistic for use of ACGs to predict LTC hospitalization was 0.783, and improved to 0.792 with the addition of age. The c-statistics for use of DCGs and DCG/age to predict LTC hospitalization were 0.885 and 0.890, respectively, indicating the best prediction. We found that risk adjusters based upon diagnoses predicted an increased likelihood of death or LTC hospitalization, exhibiting good predictive validity. In this comparative analysis using VA data, DCG models were generally superior to ACG models in predicting clinical outcomes, although ACG model performance was enhanced by the addition of age.

The Assessment of Family Functions, Dyadic Adjustment, and Parental Attitude in Adolescents with Substance Use Disorder.

PubMed

Öngel Atar, Ayça; Yalçin, Özhan; Uygun, Ersin; Çiftçi Demirci, Arzu; Erdoğan, Ayten

2016-03-01

Family structure and family attitudes have been reported to be important factors in the development of substance use disorders. In this study, we aimed to assess the relationship between substance use and family functions, parental attitude, and parental dyadic adjustment of adolescents with substance use disorder. The study was conducted on 50 patients, comprising 9 female and 41 male adolescents between the ages of 14 and 18 years, treated at Bakırköy Mental Health Hospital, Substance Abuse Research, Treatment and Education Center for Children Adolescents (ÇEMATEM), Turkey, with the diagnosis of substance use disorder according to DSM-5 and their parents and a control group comprising 50 healthy adolescents without any psychopathology or substance use disorder and their parents. The study was designed as a matched case-control study for age and gender. Sociodemographic Data Form (SDF), Parental Attitude Scale (PAS), Dyadic Adjustment Scale (DAS), and Family Assessment Device (FAD) were applied to both groups. When the study and control groups were compared with regard to the PAS, the study group scores determined for "involvement-acceptance," "psychological autonomy," and "control-supervision" dimensions were significantly lower than the control group scores. Compared with the control group, dyadic adjustment was lower in terms of "dyadic cohesion," "dyadic consensus," and "affectional expression." Living with biological parents and the togetherness of parents were lower in the study group. "Problem solving," "communication," "roles," "affective responsiveness," "affective involvement," "behavior control," and "general functioning" dimension scores according to FAD were also significantly higher in the study group. Compared with togetherness of the controls, the dyadic adjustment of their parents was lower and family functions as perceived by the parents and adolescents were unhealthier in the adolescents using substances. These findings indicate that the family functions, dyadic adjustment, and parental attitude styles need to be assessed in the risk groups to determine familial risk factors and to structure protective measures. These assessments may guide clinicians and policy-makers toward good clinical practice and help build protective measures.

Return to Work in Employees on Sick Leave due to Neck or Shoulder Pain: A Randomized Clinical Trial Comparing Multidisciplinary and Brief Intervention with One-Year Register-Based Follow-Up.

PubMed

Moll, Line Thorndal; Jensen, Ole Kudsk; Schiøttz-Christensen, Berit; Stapelfeldt, Christina Malmose; Christiansen, David Høyrup; Nielsen, Claus Vinther; Labriola, Merete

2018-06-01

Purpose The aim of this study was to evaluate the effect of a multidisciplinary intervention (MDI) compared to a brief intervention (BI) with respect to return to work (RTW), pain and disability in workers on sick leave because of neck or shoulder pain. Methods 168 study participants with sickness absence for 4-16 weeks due to neck or shoulder pain were enrolled in a hospital-based clinical study and randomized to either MDI or BI. The primary outcome was RTW obtained by a national registry on public transfer payments. Secondary outcomes were self-reported pain and disability levels. One-year follow-up RTW rates were estimated by Cox proportional hazard regression adjusted for gender, age, sick leave prior to inclusion, part-time sick leave and clinical diagnosis. Secondary outcomes were analysed using logistic and linear regression analysis for pain and disability, respectively. Results In the MDI group, 50 participants (59%) experienced four or more continuous weeks of RTW while 48 (58%) returned to work in the BI group during the 1 year of follow-up. Results showed a statistically non significant tendency towards a lower rate of RTW in the MDI group than in the BI group (adjusted HR = 0.84, 95% CI 0.54, 1.31). There were no statistically significant differences in secondary outcomes between the MDI and BI groups. Conclusion The brief and the multidisciplinary interventions performed equally with respect to both primary and secondary outcomes. The added focus on RTW in the multidisciplinary group did not improve RTW rates in this group.

Return to work after work-related stress: a randomized controlled trial of a work-focused cognitive behavioral intervention.

PubMed

Dalgaard, Vita Ligaya; Aschbacher, Kirstin; Andersen, Johan Hviid; Glasscock, David John; Willert, Morten Vejs; Carstensen, Ole; Biering, Karin

2017-09-01

Objectives This study aimed to evaluate the effect of a stress management intervention (SMI) on lasting return to work (RTW) among patients with work-related stress complaints. Methods Sickness benefit departments from three local municipalities referred patients on sick leave with work-related adjustment disorders or mild depression to the Department of Occupational Medicine, Regional Hospital West Jutland. A 2× randomization procedure allocated patients into one of three groups: intervention (N=58), control A (which received a clinical assessment; N=56), or control B (no assessment; N=49). Treatment comprised individual work-focused cognitive behavioral therapy (CBT) with an optional workplace intervention. The outcome was time until lasting RTW (16 and 44 weeks follow-up) using register data. Results Median number of weeks until lasting RTW was 15, 19, and 32 for the intervention group, control A, and control B respectively. However, for group B, clinical assessment was not part of the inclusion process, which may have introduced selection bias. In the fully-adjusted Cox regression model, the intervention group exhibited significantly faster lasting RTW at 44 weeks; hazard ratio (HR) 1.57 [95% confidence interval (95% CI) 1.01-2.44] relative to control group A, with a non-significant trend evident at 16 weeks; HR 1.70 (95% CI 0.94-3.10), when controlling for age, gender, occupation, sick leave during previous year, full or partial sick leave, and diagnosis. Unadjusted analyses remained directionally consistent but were reduced to marginal significance. Conclusions There was a tendency towards faster lasting RTW in the intervention group compared to control A, which received clinical assessment, in all analyses. The intervention group returned to work about 4 weeks earlier than control A, which could translate into substantial financial gains.

Early versus Late Parenteral Nutrition in Critically Ill Children.

PubMed

Fivez, Tom; Kerklaan, Dorian; Mesotten, Dieter; Verbruggen, Sascha; Wouters, Pieter J; Vanhorebeek, Ilse; Debaveye, Yves; Vlasselaers, Dirk; Desmet, Lars; Casaer, Michael P; Garcia Guerra, Gonzalo; Hanot, Jan; Joffe, Ari; Tibboel, Dick; Joosten, Koen; Van den Berghe, Greet

2016-03-24

Recent trials have questioned the benefit of early parenteral nutrition in adults. The effect of early parenteral nutrition on clinical outcomes in critically ill children is unclear. We conducted a multicenter, randomized, controlled trial involving 1440 critically ill children to investigate whether withholding parenteral nutrition for 1 week (i.e., providing late parenteral nutrition) in the pediatric intensive care unit (ICU) is clinically superior to providing early parenteral nutrition. Fluid loading was similar in the two groups. The two primary end points were new infection acquired during the ICU stay and the adjusted duration of ICU dependency, as assessed by the number of days in the ICU and as time to discharge alive from ICU. For the 723 patients receiving early parenteral nutrition, parenteral nutrition was initiated within 24 hours after ICU admission, whereas for the 717 patients receiving late parenteral nutrition, parenteral nutrition was not provided until the morning of the 8th day in the ICU. In both groups, enteral nutrition was attempted early and intravenous micronutrients were provided. Although mortality was similar in the two groups, the percentage of patients with a new infection was 10.7% in the group receiving late parenteral nutrition, as compared with 18.5% in the group receiving early parenteral nutrition (adjusted odds ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66). The mean (±SE) duration of ICU stay was 6.5±0.4 days in the group receiving late parenteral nutrition, as compared with 9.2±0.8 days in the group receiving early parenteral nutrition; there was also a higher likelihood of an earlier live discharge from the ICU at any time in the late-parenteral-nutrition group (adjusted hazard ratio, 1.23; 95% CI, 1.11 to 1.37). Late parenteral nutrition was associated with a shorter duration of mechanical ventilatory support than was early parenteral nutrition (P=0.001), as well as a smaller proportion of patients receiving renal-replacement therapy (P=0.04) and a shorter duration of hospital stay (P=0.001). Late parenteral nutrition was also associated with lower plasma levels of γ-glutamyltransferase and alkaline phosphatase than was early parenteral nutrition (P=0.001 and P=0.04, respectively), as well as higher levels of bilirubin (P=0.004) and C-reactive protein (P=0.006). In critically ill children, withholding parenteral nutrition for 1 week in the ICU was clinically superior to providing early parenteral nutrition. (Funded by the Flemish Agency for Innovation through Science and Technology and others; ClinicalTrials.gov number, NCT01536275.).

Trunk postural adjustments: Medium-term reliability and correlation with changes of clinical outcomes following an 8-week lumbar stabilization exercise program.

PubMed

Boucher, Jean-Alexandre; Preuss, Richard; Henry, Sharon M; Nugent, Marilee; Larivière, Christian

2018-04-22

Low back pain (LBP) has been previously associated with delayed anticipatory postural adjustments (APAs) determined by trunk muscle activation. Lumbar stabilization exercise programs (LSEP) for patients with LBP may restore the trunk neuromuscular control of the lumbar spine, and normalize APAs. This exploratory study aimed at testing the reliability of EMG and kinematics-based postural adjustment measures over an 8-week interval, assessing their sensitivity to LBP status and treatment and examining their relationship with clinical outcomes. Muscle activation of 10 trunk muscles, using surface electromyography (EMG), and lumbar angular kinematics were recorded during a rapid arm-raising/lowering task. Patients with LBP were tested before and after an 8-week LSEP. Healthy controls receiving no treatment were assessed over the same interval to determine the reliability of the measures and act as a control group at baseline. Muscle activation onsets and reactive range of motion, range of velocities and accelerations were assessed for between group differences at baseline and pre- to post-treatment effects within patients with LBP using t-tests. Correlations between these dependent variables and the change of clinical outcomes (pain, disability) over treatment were also explored. Kinematic-based measures showed comparable reliability to EMG-based measures. Between-group differences were found in lumbar lateral flexion ROM at baseline (patients < controls). In the patients with LBP, lateral flexion velocity and acceleration significantly increased following the LSEP. Correlational analyses revealed that lumbar angular kinematics were more sensitive to changes in pain intensity following the LSEP compared to EMG measures. These findings are interpreted in from the perspective of guarding behaviors and lumbar stability hypotheses. Future clinical trials are needed to target patients with and without delayed APAs at baseline and to explore the sensitivity of different outcome measures related to APAs. Different tasks more challenging to postural stability may need to be explored to more effectively reveal APA dysfunction. Copyright © 2018. Published by Elsevier Ltd.

Differences in case-mix can influence the comparison of standardised mortality ratios even with optimal risk adjustment: an analysis of data from paediatric intensive care.

PubMed

Manktelow, Bradley N; Evans, T Alun; Draper, Elizabeth S

2014-09-01

The publication of clinical outcomes for consultant surgeons in 10 specialties within the NHS has, along with national clinical audits, highlighted the importance of measuring and reporting outcomes with the aim of monitoring quality of care. Such information is vital to be able to identify good and poor practice and to inform patient choice. The need to adequately adjust outcomes for differences in case-mix has long been recognised as being necessary to provide 'like-for-like' comparisons between providers. However, directly comparing values of the standardised mortality ratio (SMR) between different healthcare providers can be misleading even when the risk-adjustment perfectly quantifies the risk of a poor outcome in the reference population. An example is shown from paediatric intensive care. Using observed case-mix differences for 33 paediatric intensive care units (PICUs) in the UK and Ireland for 2009-2011, SMRs were calculated under four different scenarios where, in each scenario, all of the PICUs were performing identically for each patient type. Each scenario represented a clinically plausible difference in outcome from the reference population. Despite the fact that the outcome for any patient was the same no matter which PICU they were to be admitted to, differences between the units were seen when compared using the SMR: scenario 1, 1.07-1.21; scenario 2, 1.00-1.14; scenario 3, 1.04-1.13; scenario 4, 1.00-1.09. Even if two healthcare providers are performing equally for each type of patient, if their patient populations differ in case-mix their SMRs will not necessarily take the same value. Clinical teams and commissioners must always keep in mind this weakness of the SMR when making decisions. 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.

The Medication Recommendation Tracking Form: a novel tool for tracking changes in prescribed medication, clinical decision making, and use in comparative effectiveness research.

PubMed

Reilly-Harrington, Noreen A; Sylvia, Louisa G; Leon, Andrew C; Shesler, Leah W; Ketter, Terence A; Bowden, Charles L; Calabrese, Joseph R; Friedman, Edward S; Ostacher, Michael J; Iosifescu, Dan V; Rabideau, Dustin J; Thase, Michael E; Nierenberg, Andrew A

2013-11-01

This paper describes the development and use of the Medication Recommendation Tracking Form (MRTF), a novel method for capturing physician prescribing behavior and clinical decision making. The Bipolar Trials Network developed and implemented the MRTF in a comparative effectiveness study for bipolar disorder (LiTMUS). The MRTF was used to assess the frequency, types, and reasons for medication adjustments. Changes in treatment were operationalized by the metric Necessary Clinical Adjustments (NCA), defined as medication adjustments to reduce symptoms, optimize treatment response and functioning, or to address intolerable side effects. Randomized treatment groups did not differ in rates of NCAs, however, responders had significantly fewer NCAs than non-responders. Patients who had more NCAs during their previous visit had significantly lower odds of responding at the current visit. For each one-unit increase in previous CGI-BP depression score and CGI-BP overall severity score, patients had an increased NCA rate of 13% and 15%, respectively at the present visit. Ten-unit increases in previous Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) scores resulted in an 18% and 14% increase in rates of NCAs, respectively. Patients with fewer NCAs had increased quality of life and decreased functional impairment. The MRTF standardizes the reporting and rationale for medication adjustments and provides an innovative metric for clinical effectiveness. As the first tool in psychiatry to track the types and reasons for medication changes, it has important implications for training new clinicians and examining clinical decision making. (ClinicalTrials.gov number NCT00667745). Copyright © 2013. Published by Elsevier Ltd.

Prediction of loss to follow-up in long-term supportive periodontal therapy in patients with chronic periodontitis

PubMed Central

Yang, Hai Jing

2018-01-01

Aim This study examined the predictors of loss to follow-up in long-term supportive periodontal therapy in patients with chronic periodontitis. Methods A total of 280 patients with moderate to severe chronic periodontitis in a tertiary care hospital in China were investigated and followed over the course of study. Questionnaires on clinical and demographic characteristics, self-efficacy for oral self-care and dental fear at baseline were completed. Participants were followed to determine whether they could adhere to long-term supportive periodontal therapy. Binary logistic regression analysis was used to examine the association between clinical and demographic characteristics, self-efficacy for oral self-care, dental fear and loss to follow-up in long-term supportive periodontal therapy. Results The loss to follow-up in long-term supportive periodontal therapy was significantly associated with age [adjusted OR = 1.042, 95% confidence interval (CI): 1.012–1.074, p = 0.006], severe periodontitis [adjusted OR = 4.892, 95%CI: 2.280–10.499, p<0.001], periodontal surgery [adjusted OR = 11.334, 95% CI: 2.235–57.472, p = 0.003], and middle and low-scoring of self-efficacy scale for self-care groups. The adjusted ORs of loss to follow-up for the middle- (54–59) and low-scoring groups (15–53) were 71.899 (95%CI: 23.926–216.062, p<0.001) and 4.800 (95% CI: 2.263–10.182, p<0.001), respectively, compared with the high-scoring SESS group (60–75). Conclusion Age, severity of periodontitis, periodontal surgery and the level of self-efficacy for self-care may be effective predictors of loss to follow-up in long-term supportive periodontal therapy in patients with chronic periodontitis. PMID:29420586

Explaining prescription drug use and expenditures using the adjusted clinical groups case-mix system in the population of British Columbia, Canada.

PubMed

Hanley, Gillian E; Morgan, Steve; Reid, Robert J

2010-05-01

Given that prescription drugs have become a major financial component of health care, there is an increased need to explain variations in the use of and expenditure on medicines. Case-mix systems built from existing administrative datasets may prove very useful for such prediction. We estimated the concurrent and prospective predictive validity of the adjusted clinical groups (ACG) system in pharmaceutical research and compared the ACG system with the Charlson index of comorbidity. We ran a generalized linear models to examine the predictive validity of the ACG system and the Charlson index and report the correlation between the predicted and observed expenditures. We reported mean predictive ratios across medical condition and cost-defined groups. When predicting use of medicines, we used C-statistics to summarize the area under the receiver operating characteristic curve. The 3,908,533 British Columbia residents who were registered for the universal health care plan for 275+ days in the calendar years 2004 and 2005. Outcomes were total pharmaceutical expenditures, use of any medicines, and use of medicines from 4+ different therapeutic categories. The ACG case mix system predicted drug expenditures better than the Charlson index. The mean predictive ratios for the ACG system models were all within 4% of the actual costs when examining medical condition group and the C-stats for the 2 dichotomous outcomes were between 0.82 and 0.89. ACG case-mix adjusters are a valuable predictor of pharmaceutical use and expenditures with much higher predictive power than age, sex, and the Charlson index of comorbidity.

Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial.

PubMed

Pépin, J L; Tamisier, R; Baguet, J P; Lepaulle, B; Arbib, F; Arnol, N; Timsit, J F; Lévy, P

2016-08-01

Millions of individuals with obstructive sleep apnoea (OSA) are treated by CPAP aimed at reducing blood pressure (BP) and thus cardiovascular risk. However, evidence is scarce concerning the impact of different CPAP modalities on BP evolution. This double-blind, randomised clinical trial of parallel groups of patients with OSA indicated for CPAP treatment compared the efficacy of fixed-pressure CPAP (FP-CPAP) with auto-adjusting CPAP (AutoCPAP) in reducing BP. The primary endpoint was the change in office systolic BP after 4 months. Secondary endpoints included 24 h BP measurements. Patients (322) were randomised to FP-CPAP (n=161) or AutoCPAP (n=161). The mean apnoea+hypopnoea index (AHI) was 43/h (SD, 21); mean age was 57 (SD, 11), with 70% of males; mean body mass index was 31.3 kg/m(2) (SD, 6.6) and median device use was 5.1 h/night. In the intention-to-treat analysis, office systolic blood pressure decreased by 2.2 mm Hg (95% CI -5.8 to 1.4) and 0.4 mm Hg (-4.3 to 3.4) in the FP-CPAP and AutoCPAP group, respectively (group difference: -1.3 mm Hg (95% CI -4.1 to 1.5); p=0.37, adjusted for baseline BP values). 24 h diastolic BP (DBP) decreased by 1.7 mm Hg (95% CI -3.9 to 0.5) and 0.5 mm Hg (95% CI -2.3 to 1.3) in the FP-CPAP and AutoCPAP group, respectively (group difference: -1.4 mm Hg (95% CI -2.7 to -0.01); p=0.048, adjusted for baseline BP values). The result was negative regarding the primary outcome of office BP, while FP-CPAP was more effective in reducing 24 h DBP (a secondary outcome). NCT01090297. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Strategy aimed at reduction of sputum eosinophils decreases exacerbation rate in patients with asthma.

PubMed

Chlumský, J; Striz, I; Terl, M; Vondracek, J

2006-01-01

Under Global Initiative for Asthma guidelines, the clinical control of disease activity and the adjustment of treatment in patients with asthma are based on symptoms, use of rescue medication, lung function and peak expiratory flow measurement (standard strategy). We investigated whether a strategy to reduce the number of sputum eosinophils (EOS strategy) gives better clinical control and a lower exacerbation rate compared with the standard strategy. Fifty-five patients with moderate to severe asthma entered this open, randomized, parallel-group study and visited the out-patient department every 3 months for 18 months. The dose of corticosteroids was adjusted according to the standard strategy or the percentage of sputum eosinophils (EOS strategy). During the study period, the EOS strategy led to a significantly lower incidence of asthma exacerbations compared with the standard strategy group (0.22 and 0.78 exacerbations per year per patient, respectively). There were significant differences between the strategies in time to first exacerbation.

An investigation of the relationship between ethnicity and success in a BSc (Hons) Physiotherapy degree programme in the UK.

PubMed

Williams, Annabel; Norris, Meriel; Cassidy, Elizabeth; Naylor, Sandra; Marston, Louise; Shiers, Pam

2015-06-01

To explore the potential relationship between ethnicity and achievement within undergraduate physiotherapy education. A retrospective analysis of assessment marks awarded for academic and clinical modules. A London University offering undergraduate physiotherapy education. Four hundred forty-eight undergraduate students enrolled onto the Physiotherapy honours degree programme between 2005 and 2009. Marks awarded following academic or clinical assessment. These were modelled through multivariable regression analysis to evaluate the relationship between marks awarded and ethnicity. Differences were noted between ethnic categories in final programme success and across academic and clinical modules. Our multivariable analysis demonstrated students from Asian backgrounds had decreased odds of succeeding compared with white British students (adjusted OR 0.43 95%CI 0.24, 0.79 P=0.006), as had Black students (adjusted OR 0.42 95%CI 0.19, 0.95 P=0.036) and students from Other ethnic backgrounds (adjusted OR 0.41 95%CI 0.20, 0.87 P=0.020). This analysis of undergraduate physiotherapy students illustrated a persistent difference in attainment between students from white British and those from BME backgrounds. Heterogeneity in academic outcomes both within and between minority ethnic groups was illustrated. This study not only reinforces the need to consider ethnicity within physiotherapy education but also raises further questions about why physiotherapy students from BME groups perform less well than their white British peers. Copyright © 2014. Published by Elsevier Ltd.

Clinical and psychosocial predictors of exceeding target length of stay during inpatient stroke rehabilitation.

PubMed

Lai, Wesley; Buttineau, Mackenzie; Harvey, Jennifer K; Pucci, Rebecca A; Wong, Anna P M; Dell'Erario, Linda; Bosnyak, Stephanie; Reid, Shannon; Salbach, Nancy M

2017-10-01

In Ontario, Canada, patients admitted to inpatient rehabilitation hospitals post-stroke are classified into rehabilitation patient groups based on age and functional level. Clinical practice guidelines, called quality-based procedures, recommend a target length of stay (LOS) for each group. The study objective was to evaluate the extent to which patients post-stroke at an inpatient rehabilitation hospital are meeting LOS targets and to identify patient characteristics that predict exceeding target LOS. A quantitative, longitudinal study from an inpatient rehabilitation hospital was conducted. Participants included adult patients (≥18 years) with stroke, admitted to an inpatient rehabilitation hospital between 2014 and 2015. The percentage of patients exceeding the recommended target LOS was determined. Logistic regression was performed to identify clinical and psychosocial patient characteristics associated with exceeding target LOS after adjusting for stroke severity. Of 165 patients, 38.8% exceeded their target LOS. Presence of ataxia, recurrent stroke, living alone, absence of a caregiver at admission, and acquiring a caregiver during hospital LOS was each associated with significantly higher odds of exceeding target LOS in comparison to patients without these characteristics after adjusting for stroke severity (p < 0.05). Findings suggest that social and stroke-specific factors may be helpful to adjust LOS expectations and promote efficient resource allocation. This exploratory study was limited to findings from one inpatient rehabilitation hospital. Cross-validation of results using data-sets from multiple rehabilitation hospitals across Ontario is recommended.

Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG).

PubMed

Eriksson, Carl; Marsal, Jan; Bergemalm, Daniel; Vigren, Lina; Björk, Jan; Eberhardson, Michael; Karling, Pontus; Söderman, Charlotte; Myrelid, Pär; Cao, Yang; Sjöberg, Daniel; Thörn, Mari; Karlén, Per; Hertervig, Erik; Strid, Hans; Ludvigsson, Jonas F; Almer, Sven; Halfvarson, Jonas

Clinical trials have demonstrated the efficacy of vedolizumab in inflammatory bowel disease (IBD). However, these findings may not reflect the clinical practice. Therefore, we aimed to describe a vedolizumab-treated patient population and assess long-term effectiveness. Patients initiating vedolizumab between 1 June 2014 and 30 May 2015 were identified through the Swedish National Quality Registry for IBD. Prospectively collected data on treatment and disease activity were extracted. Clinical remission was defined as Patient Harvey Bradshaw index <5 in Crohn's disease (CD) and Patient Simple Clinical Colitis Activity index <3 in ulcerative colitis (UC). Two-hundred forty-six patients (147 CD, 92 UC and 7 IBD-Unclassified) were included. On study entry, 86% had failed TNF-antagonist and 48% of the CD patients had undergone ≥1 surgical resection. After a median follow-up of 17 (IQR: 14-20) months, 142 (58%) patients remained on vedolizumab. In total, 54% of the CD- and 64% of the UC patients were in clinical remission at the end of follow-up, with the clinical activity decreasing (p < .0001 in both groups). Faecal-calprotectin decreased in CD (p < .0001) and in UC (p = .001), whereas CRP decreased in CD (p = .002) but not in UC (p = .11). Previous anti-TNF exposure (adjusted HR: 4.03; 95% CI: 0.96-16.75) and elevated CRP at baseline (adjusted HR: 2.22; 95% CI: 1.10-4.35) seemed to be associated with discontinuation because of lack of response. Female sex was associated with termination because of intolerance (adjusted HR: 2.75; 95% CI: 1.16-6.48). Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

Is the distinction between adjustment disorder with depressed mood and adjustment disorder with mixed anxious and depressed mood valid?

PubMed

Zimmerman, Mark; Martinez, Jennifer H; Dalrymple, Kristy; Martinez, Jennifer H; Chelminski, Iwona; Young, Diane

2013-11-01

In the DSM-IV, adjustment disorder is subtyped according to the predominant presenting feature. The different diagnostic code numbers assigned to each subtype suggest their significance in DSM-IV. However, little research has examined the validity of these subtypes. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared the demographic and clinical profiles of patients diagnosed with adjustment disorder subtypes to determine whether there was enough empirical evidence supporting the retention of multiple adjustment disorder subtypes in future versions of the DSM. A total of 3,400 psychiatric patients presenting to the Rhode Island Hospital outpatient practice were evaluated with semistructured diagnostic interviews for DSM-IV Axis I and Axis II disorders and measures of psychosocial morbidity. Approximately 7% (224 of 3,400) of patients were diagnosed with current adjustment disorder. Adjustment disorder with depressed mood and with mixed anxious and depressed mood were the most common subtypes, accounting for 80% of the patients diagnosed with adjustment disorder. There was no significant difference between these 2 groups with regard to demographic variables, current comorbid Axis I or Axis II disorders, lifetime history of major depressive disorder or anxiety disorders, psychosocial morbidity, or family history of psychiatric disorders. The only difference between the groups was lifetime history of drug use, which was significantly higher in the patients diagnosed with adjustment disorder with depressed mood. There is no evidence supporting the retention of both of these adjustment disorder subtypes, and DSM-IV previously set a precedent for eliminating adjustment disorder subtypes in the absence of any data. Therefore, in the spirit of nosologic parsimony, consideration should be given to collapsing the 2 disorders into 1: adjustment disorder with depressed mood.

Compensatory but not anticipatory adjustments are altered in older adults during lateral postural perturbations.

PubMed

Claudino, Renato; dos Santos, Eloá C C; Santos, Marcio J

2013-08-01

This study investigated anticipatory postural adjustments (APAs) and compensatory postural adjustments (CPAs) and their relationship in older adults during lateral postural perturbations. Unpredictable and predictable postural disturbances were induced by a swinging pendulum that impacted at the shoulder level of two groups of older adults, non-fallers (20) and fallers (20), and in a group of young control subjects (20). The electromyographic (EMG) activity of the postural muscles and the center of pressure (COP) displacement were recorded and quantified within the time intervals typical for APAs and CPAs. Both groups of older adults (non-fallers and fallers) showed higher magnitude of EMG activity in the lateral muscles and increased COP displacement, particularly, during the CPAs time interval when compared to the young group. Older adults, however, were able to change the electrical activity of the muscles during the predictable task by generating APAs with similar magnitudes of those found in young subjects. Compensatory but not anticipatory adjustments are altered in older adults during predictable lateral postural perturbations. These findings provide new data on the role of APAs and CPAs in their relationship in older adults during external lateral perturbations and may advance current rehabilitative management strategies to improve balance control in older individuals. Copyright © 2013 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Adjustable Polyurethane Foam as Filling Material for a Novel Spondyloplasty: Biomechanics and Biocompatibility.

PubMed

Jiang, Hongzhen; Sitoci-Ficici, Kerim Hakan; Reinshagen, Clemens; Molcanyi, Marek; Zivcak, Jozef; Hudak, Radovan; Laube, Thorsten; Schnabelrauch, Matthias; Weisser, Jürgen; Schäfer, Ute; Pinzer, Thomas; Schackert, Gabriele; Zhang, Xifeng; Wähler, Mario; Brautferger, Uta; Rieger, Bernhard

2018-04-01

To investigate the biomechanics and biocompatibility of polyurethane (PU) foam with adjustable stiffness as a filling material for a novel spondyloplasty that is designed to reduce the risk of postoperative adjacent level fractures. Sixty individual porcine lumbar vertebrae were randomly split into 4 groups: A, B, C, and D. Group A served as unmodified vertebral body controls. Groups B, C, and D consisted of hollowed vertebral bodies. Vertebrae of groups C and D were filled with adjustable PU foams of different stiffness. The compressive strength and stiffness of vertebrae from groups A-D were recorded and analyzed. 3T3 mouse fibroblasts were cultured with preformed PU foams for 4 days to test biocompatibility. The strength and stiffness of the hollowed groups were lower than in group A. However, the differences were not statistically significant between group A and group C (P > 0.05), and were obviously different between group A and group B or group D (P < 0.01 and <0.05, respectively). Moreover, the strength and stiffness after filling foams in group C or group D were significantly greater than in group B (P < 0.01 and <0.05, respectively). Live/dead staining of 3T3 cells confirmed the biocompatibility of the PU foam. The new PU foam shows adaptability regarding its stiffness and excellent cytocompatibility in vitro. The results support the clinical translation of the new PU foams as augmentation material in the development of a novel spondyloplasty. Copyright © 2018 Elsevier Inc. All rights reserved.

Clinical Significance of the Number of Depressive Symptoms in Major Depressive Disorder: Results from the CRESCEND Study.

PubMed

Park, Seon-Cheol; Sakong, Jeongkyu; Koo, Bon Hoon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

2016-04-01

Our study aimed to establish the relationship between the number of depressive symptoms and the clinical characteristics of major depressive disorder (MDD). This would enable us to predict the clinical significance of the number of depressive symptoms in MDD patients. Using data from the Clinical Research Center for Depression (CRESCEND) study in Korea, 853 patients with DSM-IV MDD were recruited. The baseline and clinical characteristics of groups with different numbers of depressive symptoms were compared using the χ(2) test for discrete variables and covariance (ANCOVA) for continuous variables. In addition, the scores of these groups on the measurement tools were compared by ANCOVA after adjusting the potential effects of confounding variables. After adjusting the effects of monthly income and history of depression, a larger number of depressive symptoms indicated higher overall severity of depression (F [4, 756] = 21.458, P < 0.001) and higher levels of depressive symptoms (F [4, 767] = 19.145, P < 0.001), anxiety symptoms (F [4, 765] = 12.890, P < 0.001) and suicidal ideation (F [4, 653] = 6.970, P < 0.001). It also indicated lower levels of social function (F [4, 760] = 13.343, P < 0.001), and quality of life (F [4, 656] = 11.975, P < 0.001). However, there were no significant differences in alcohol consumption (F [4, 656] = 11.975, P < 0.001). The number of depressive symptoms can be used as an index of greater illness burden in clinical psychiatry.

Post-instrumentation pain after the use of either Mtwo or the SAF system: a randomized controlled clinical trial.

PubMed

Saumya-Rajesh, P; Krithikadatta, J; Velmurugan, N; Sooriaprakas, C

2017-08-01

This randomized controlled trial compared the incidence of post-instrumentation pain associated with Mtwo rotary NiTi files and the self-adjusting file system following canal shaping and cleaning. Following sample size estimation, a total of 130 patients were randomized into two groups based on selection criteria [group Mtwo and group SAF (self-adjusting file)]. Root canal treatment was carried out in two appointments. The teeth were endodontically treated with the appropriate allotted systems following the similar clinical parameters. Patients were asked to rate the intensity of pre-instrumentation and post-instrumentation pain (at 2, 4, 6, 8, 24, 48 h) using the VAS score. The Kruskal-Wallis test was carried out for the overall comparisons of the two systems. The Friedman test was used to compare between time-points with each system. Subgroup analyses for independent variables (gender, pulp status and diagnosis) used the Mann-Whitney test and Wilcoxon signed ranks test (P < 0.05). No significant difference was found between the two groups with respect to post-instrumentation pain. Teeth with pulpal necrosis had significant pain at 8 h compared with teeth with vital pulps (P = 0.04). Teeth with vital pulps in the SAF group had significantly less post-instrumentation pain compared with those in the Mtwo group at 6 h (P = 0.042). Patients who had teeth with nonvital pulps in the SAF group experienced more post-instrumentation pain at 8 h (P = 0.017) and 24 h (P = 0.005). The incidence of post-instrumentation pain at different time intervals in patients undergoing root canal treatment was similar for both the self-adjusting file and Mtwo file systems. © 2016 International Endodontic Journal. Published by John Wiley & Sons Ltd.

Psychobehavioral Profiles to Assist Tailoring of Interventions for Patients With Hypertension: Latent Profile Analysis.

PubMed

Tanaka, Rika; Nolan, Robert P

2018-05-11

Practice guidelines advocate combining pharmacotherapy with lifestyle counseling for patients with hypertension. To allow for appropriate tailoring of interventions to meet individual patient needs, a comprehensive understanding of baseline patient characteristics is essential. However, few studies have empirically assessed behavioral profiles of hypertensive patients in Web-based lifestyle counseling programs. The objectives of this study were to (1) specify baseline psychobehavioral profiles of patients with hypertension who were enrolled in a Web-based lifestyle counseling trial, and (2) examine mean differences among the identified profile groups in demographics, psychological distress, self-reported self-care behaviors, physiological outcomes, and program engagement to determine prognostic implications. Participants (N=264; mean age 57.5 years; 154/264, 58.3% female; 193/264, 73.1% white) were recruited into a longitudinal, double-blind, randomized controlled trial, designed to evaluate an online lifestyle intervention for hypertensive patients. A series of latent profile analyses identified psychobehavioral profiles, indicated by baseline measures of mood, motivation, and health behaviors. Mean differences between profile groups were then explored. A 2-class solution provided the best model fit (the Bayesian information criterion (BIC) is 10,133.11; sample-size adjusted BIC is 10,006.54; Lo-Mendell-Rubin likelihood ratio test is 65.56, P=.001). The 2 profile groups were (1) adaptive adjustment, marked by low distress, high motivation, and somewhat satisfactory engagement in health behaviors and (2) affectively distressed, marked by clinically significant distress. At baseline, on average, affectively distressed patients had lower income, higher body mass index, and endorsed higher stress compared with their adaptive adjustment counterparts. At 12-months post intervention, treatment effects were sustained for systolic blood pressure and Framingham risk index in the adaptive adjustment group, and those in the adaptive adjustment group were 2.4 times more likely to complete the 12-month intervention study, compared with their affectively distressed counterparts. Interventions for patients who are adaptively adjusted may differ in focus from those designed for the affectively distressed patients. As such, this study underscores the importance of identifying psychobehavioral profiles, as they allow for evidence-based tailoring of lifestyle counseling programs for patients with hypertension. ClinicalTrials.gov NCT01541540; https://clinicaltrials.gov/ct2/show/NCT01541540 (Archived by WebCite at http://www.webcitation.org/6yzZYZcWF). ©Rika Tanaka, Robert P Nolan. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 11.05.2018.

Comparing the effect of e-learning and educational booklet on the childbirth self-efficacy: a randomized controlled clinical trial.

PubMed

Abbasi, Parastoo; Mohammad-Alizadeh Charandabi, Sakineh; Mirghafourvand, Mojgan

2018-03-01

This study aimed to compare the effect of e-learning and educational booklet on the childbirth self-efficacy (CBSE). This randomized controlled clinical trial was conducted on 153 pregnant women referred to health centers in the city of Miandoab, Iran in 2015-2016. Participants were assigned into two intervention groups (e-learning and educational booklet) and the control group. A single face-to-face session was held for intervention groups about the management of labor pain in 30-34 weeks of pregnancy and the booklet and software were provided. The CBSE questionnaire was filled out by the participants before intervention and active phase of labor at 4-5 cm dilatation of cervix. One-way ANOVA and ANCOVA test with adjusting the baseline scores were used to compare the mean score of self-efficacy among study groups respectively before and after the intervention. There was no significant difference between the three groups in terms of socio-demographic characteristics (p > 0.05). After the intervention, the mean score of the CBSE in the educational booklet group (adjusted mean difference: 113.4; confidence interval 95%: 100.7-126.1) and e-learning group (159.3; 146.5-172.0) was significantly higher than the control group. Also, the mean score of the CBSE in the e-learning group had a significant increase compared to the educational booklet group (45.9; 33.0-58.7). The results indicate that e-learning and educational booklet are effective in enhancing mothers' CBSE. Thus, the mothers are recommended to use these teaching methods.

Efficacy of an evidence-based clinical decision support in primary care practices: a randomized clinical trial.

PubMed

McGinn, Thomas G; McCullagh, Lauren; Kannry, Joseph; Knaus, Megan; Sofianou, Anastasia; Wisnivesky, Juan P; Mann, Devin M

2013-09-23

There is consensus that incorporating clinical decision support into electronic health records will improve quality of care, contain costs, and reduce overtreatment, but this potential has yet to be demonstrated in clinical trials. To assess the influence of a customized evidence-based clinical decision support tool on the management of respiratory tract infections and on the effectiveness of integrating evidence at the point of care. In a randomized clinical trial, we implemented 2 well-validated integrated clinical prediction rules, namely, the Walsh rule for streptococcal pharyngitis and the Heckerling rule for pneumonia. INTERVENTIONS AND MAIN OUTCOMES AND MEASURES: The intervention group had access to the integrated clinical prediction rule tool and chose whether to complete risk score calculators, order medications, and generate progress notes to assist with complex decision making at the point of care. The intervention group completed the integrated clinical prediction rule tool in 57.5% of visits. Providers in the intervention group were significantly less likely to order antibiotics than the control group (age-adjusted relative risk, 0.74; 95% CI, 0.60-0.92). The absolute risk of the intervention was 9.2%, and the number needed to treat was 10.8. The intervention group was significantly less likely to order rapid streptococcal tests compared with the control group (relative risk, 0.75; 95% CI, 0.58-0.97; P= .03). The integrated clinical prediction rule process for integrating complex evidence-based clinical decision report tools is of relevant importance for national initiatives, such as Meaningful Use. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01386047.

Subclinical and clinical correlates of left ventricular wall motion abnormalities in the community.

PubMed

Tsao, Connie W; Gona, Philimon; Salton, Carol; Danias, Peter G; Blease, Susan; Hoffmann, Udo; Fox, Caroline S; Albert, Mark; Levy, Daniel; O'Donnell, Christopher J; Manning, Warren J; Yeon, Susan B

2011-03-15

The prevalence and clinical correlates of left ventricular (LV) wall motion abnormalities (WMAs), associated with morbidity and mortality, have not been well-characterized in the population. Framingham Heart Study Offspring Cohort participants (n = 1,794, 844 men, age 65 ± 9 years) underwent cine cardiovascular magnetic resonance for evaluation of LV function. A subset (n = 1,009, 460 men) underwent cardiac multidetector computed tomography for analysis of coronary artery calcium. The presence of coronary heart disease and heart failure (CHD-HF) were assessed in relation to the presence of WMAs. WMAs were present in 117 participants (6.5%) and were associated with male gender, elevated hemoglobin A1c, LV mass, LV end-diastolic volume, and lower LV ejection fraction. Of the 1,637 participants without CHD-HF, 68 (4.2%) had WMAs. In this group, WMAs were associated with obesity, hypertension, and Framingham coronary heart disease risk score in the age- and gender-adjusted analyses and were associated with male gender and hypertension on multivariate analysis. Most subjects with WMAs were in the greatest coronary artery calcium groups. The presence of coronary artery calcium greater than the seventy-fifth percentile and Agatston score >100 were associated with a greater than twofold risk of WMAs in the age- and gender-adjusted analysis but were no longer significant when additionally adjusted for CHD-HF. Previous Q-wave myocardial infarction was present in 29% of the 117 participants with WMAs. In conclusion, in the present longitudinally followed free-living population, 4.2% of the participants without CHD-HF had WMAs. WMAs were associated with the clinical parameters associated with cardiovascular disease risk. Aggressive risk factor modification may be prudent for subjects with WMAs, particularly those free of clinical CHD-HF. Copyright © 2011 Elsevier Inc. All rights reserved.

The Relationship Between Psychosocial Adjustment and Coping Strategies Among Patients With Multiple Sclerosis in Turkey.

PubMed

Okanli, Ayse; Tanriverdi, Derya; Ipek Coban, Gülay; Asi Karakaş, Sibel

Multiple sclerosis (MS) is a disease with significant psychosocial adjustment challenges. The objective of the study was to assess the psychosocial adjustment and coping strategies in patients with MS and to put forth the relationships between them. The sample group comprised 85 outpatients with MS who were admitted to the Neurology Clinic of a university hospital for treatment between October 2007 and July 2008. Data were acquired via an information form and the Psychosocial Adjustment to Illness Scale and Coping Strategy Indicator. It was determined that 55% of the patients had poor psychosocial adjustment levels. Statistically significant relationship was found between Psychosocial Adjustment to Illness Scale-Self-Report and problem solving as well as seeking social support coping strategies ( p < .01). Psychosocial adjustment got worse with decreasing problem-solving and seeking-social support coping strategies of patients. The psychosocial adjustment to MS of patients is closely related with effective coping strategies. The results have emphasized the significant role of mental health and social services and coping strategies regarding the comprehensive care needs of these patients.

Lower Urinary Tract and Functional Bowel Symptoms in Women With Vulvar Diseases and Controls.

PubMed

Swenson, Carolyn W; Menees, Stacy B; Haefner, Hope K; Berger, Mitchell B

2015-01-01

This study aims to compare the prevalences of lower urinary tract symptoms (LUTS), irritable bowel syndrome (IBS) and constipation in women with vulvar diseases to those from the general population. Three groups of women were recruited from the University of Michigan Gynecology Clinics, women with: (1) biopsy proven lichen sclerosus (LS), (2) non-LS vulvar diseases (vulvar controls, VC), and (3) presenting for annual examinations (AE). All patients completed self-administered surveys and validated pelvic floor symptom questionnaires. 317 subjects were enrolled: 101 with LS, 86 VCs, and 130 AEs. Compared to women in the VC and AE groups, LS subjects were older and of higher parity, and also had a higher prevalence of overactive bladder and urinary incontinence. The IBS was more common in the LS and VC groups compared to the AE group but no difference in constipation was seen. Similar results were found when all women with vulvar disease (LS and VC) were compared to the AEs. Age (adjusted odds ratio [OR], 1.28; P = 0.003) and IBS (adjusted OR, 3.05; P < 0.001) were the 2 variables predictive of overactive bladder. Urinary incontinence was predicted by age (adjusted OR, 1.35; P = 0.002), vulvar disease categorization (adjusted OR, 2.31; P = 0.004) and IBS (adjusted OR, 4.51; P < 0.001). We find a significantly greater prevalence of LUTS and IBS in women with vulvar disease compared to women presenting for annual gynecologic exams, but no difference in constipation. Similar rates of LUTS, IBS, and constipation were seen in women with LS and non-LS vulvar disease.

Impact of coronary artery calcification in percutaneous coronary intervention with paclitaxel-eluting stents: Two-year clinical outcomes of paclitaxel-eluting stents in patients from the ARRIVE program.

PubMed

Lee, Michael S; Yang, Tae; Lasala, John; Cox, David

2016-11-15

The purpose of this study was to evaluate clinical outcomes after percutaneous coronary intervention (PCI) in patients with coronary artery calcification (CAC). Smaller studies have reported worse clinical outcomes in patients with CAC who undergo PCI. The impact of CAC in the drug-eluting stent era is unclear. Data from 7,492 patients treated by PCI with ≥1 TAXUS Express stent in the ARRIVE registry with no inclusion/exclusion criteria were stratified by the severity of CAC, as determined by the operator. Endpoints were independently adjudicated. All major adverse cardiac events were assessed at 2 years. Moderate/severe CAC was present in 19.6%. The nil/mild CAC group had higher rate of current smokers. The moderate/severe CAC group was older and had a higher prevalence of hypertension, kidney disease, prior coronary artery bypass grafting, congestive heart failure, and left main disease. After adjustment for imbalanced baseline variables, patients with moderate/severe CAC had higher 2 year rates of major adverse cardiac events (18.3% vs 13.5%, p = 0.01) and death (10.3% vs 5.6%, p = 0.02). Moderate/severe CAC was associated with increased clinical events in patients who underwent PCI with TAXUS stents. This may be explained in part due to differences important baseline characteristics including more patients with more comorbidities and more complex lesions. After adjustment for imbalanced baseline variables, the moderate/severe CAC group had a higher risk of major adverse cardiac events and death. Improvements in treatment strategies are needed for this high-risk group of patients who undergo PCI. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Nutrition education intervention for women with breast cancer: effect on nutritional factors and oxidative stress.

PubMed

Schiavon, Cecilia C; Vieira, Francilene G K; Ceccatto, Vanessa; de Liz, Sheyla; Cardoso, Alyne L; Sabel, Cristiane; Gonzalez-Chica, David A; da Silva, Edson L; Galvan, Daisy; Crippa, Carlos G; Di Pietro, Patricia F

2015-01-01

To assess the effect of a nutrition education intervention on nutritional factors and oxidative stress during treatment of breast cancer. Nonrandomized clinical trial conducted in 2010-2011, including an evaluation at baseline and after 12 months. Women from Brazil who had breast cancer, divided into an intervention group (IG) (n = 18) and comparison group (n = 75). To increase intake of fruits and vegetables and reduce red and processed meats, via telephone and printed materials. Food intake, anthropometry, and levels of lipid hydroperoxide, carbonyl proteins, reduced glutathione, and ferric reducing antioxidant power. Chi-square, Mann-Whitney or t tests for baseline data; Wilcoxon or paired t tests for intra-group outcomes, linear regression models, and Bonferroni multiplicity adjustment. The researchers observed an increase in fruit and vegetable intake, reduction in red and processed meat intake, no change in body weight, and an increase in glutathione in the IG over the comparison group. However, after Bonferroni adjustment, only the consumption of fruits and vegetables and fruit was significantly higher in IG. This study presents improved dietary changes after a theory-driven nutrition education intervention. Although the sample size is small, it has proven to be clinically relevant. Copyright © 2015 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes.

PubMed

Orlandini, Andrés; Díaz, Rafael; Wojdyla, Daniel; Pieper, Karen; Van de Werf, Frans; Granger, Christopher B; Harrington, Robert A; Boersma, Eric; Califf, Robert M; Armstrong, Paul; White, Harvey; Simes, John; Paolasso, Ernesto

2006-03-01

To evaluate whether there is an association between 30-day mortality in patients with ST-segment elevation myocardial infarction (STEMI) included in clinical trials and country gross national income (GNI). A retrospective analysis of the databases of five randomized trials including 50 310 patients with STEMI (COBALT 7169, GIK-2 2931, HERO-2 17,089, ASSENT-2 17,005, and ASSENT-3 6116 patients) from 53 countries was performed. Countries were divided into three groups according to their GNI based on the World Bank data: low (less than 2900 US dollars), medium (between 2900 US dollars and 9000 US dollars), and high GNI (more than 9000 US dollars per capita). Baseline characteristics, in-hospital management variables, and 30-day outcomes were evaluated. A previously defined logistic regression model was used to adjust for differences in baseline characteristics and to predict mortality. The observed mortality was higher than the predicted mortality in the low (12.1 vs. 11.8%) and in the medium income groups (9.4 vs. 7.9%), whereas it was lower in the high income group (4.9 vs. 5.6%). An inverse relationship between mortality and GNI was observed in STEMI clinical trials. Most of the variability in mortality can be explained by differences in baseline characteristics; however, after adjustment, lower income countries have higher mortality than the expected.

Analysis of variation in charges and prices paid for vaginal and caesarean section births: a cross-sectional study.

PubMed

Hsia, Renee Y; Akosa Antwi, Yaa; Weber, Ellerie

2014-01-15

To examine the between-hospital variation of charges and discounted prices for uncomplicated vaginal and caesarean section deliveries, and to determine the institutional and market-level characteristics that influence adjusted charges. Using data from the California Office of Statewide Health Planning and Development (OSHPD), we conducted a cross-sectional study of all privately insured patients admitted to California hospitals in 2011 for uncomplicated vaginal delivery (diagnosis-related group (DRG) 775) or uncomplicated caesarean section (DRG 766). Hospital charges and discounted prices adjusted for each patient's clinical and demographic characteristics. We analysed 76 766 vaginal deliveries and 32 660 caesarean sections in California in 2011. After adjusting for patient demographic and clinical characteristics, we found that the average California woman could be charged as little as US$3296 or as much as US$37 227 for a vaginal delivery, and US$8312-US$70 908 for a caesarean section depending on which hospital she was admitted to. The discounted prices were, on an average, 37% of the charges. We found that hospitals in markets with middling competition had significantly lower adjusted charges for vaginal deliveries, while hospitals with higher wage indices and casemixes, as well as for-profit hospitals, had higher adjusted charges. Hospitals in markets with higher uninsurance rates charged significantly less for caesarean sections, while for-profit hospitals and hospitals with higher wage indices charged more. However, the institutional and market-level factors included in our models explained only 35-36% of the between-hospital variation in charges. These results indicate that charges and discounted prices for two common, relatively homogeneous diagnosis groups-uncomplicated vaginal delivery and caesarean section-vary widely between hospitals and are not well explained by observable patient or hospital characteristics.

Pilot clinical application of an adaptive robotic system for young children with autism

PubMed Central

Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

2013-01-01

It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

Attention-Deficit/Hyperactivity Disorder Medication Treatment Impact on Response to Growth Hormone Therapy: Results from the ANSWER Program, a Non-Interventional Study.

PubMed

Rose, Susan R; Reeves, Grafton; Gut, Robert; Germak, John

2015-12-01

To examine whether attention-deficit/hyperactivity disorder (ADHD) stimulant medication modified the linear growth response to growth hormone (GH) treatment in children enrolled in the American Norditropin Studies: Web-Enabled Research Program. Short, GH treatment-naive children with or without GH deficiency (GHD) received GH therapy. A subset also received ADHD stimulant medication (n = 1190), and others did not (n = 7230). Linear mixed models (adjusted means) examined height SDS (HSDS) and body mass index (BMI) SDS from baseline through year 4. Analyses were repeated with ADHD groups matched for baseline age, height, weight, BMI, and sex. Groups with and without GHD were compared between ADHD groups. Adjusted change in HSDS for the group receiving ADHD stimulant medication was slightly lower than that for patients not receiving stimulant medication at years 1 to 4 (P < .05). However, adjusted change in HSDS was similar between children receiving and not receiving ADHD stimulant medication when matched for baseline measurements. At year 4, 86.7% of patients receiving ADHD stimulant medication, 86.8% of total patients not receiving ADHD stimulant medication, and 84.6% of matched group patients not receiving ADHD stimulant medication achieved HSDS >-2. Year 4 adjusted change in BMI SDS was greater in the patients receiving ADHD stimulant medication compared with both groups not receiving ADHD stimulant medication (P < .05). Patients with GHD showed comparable differences in adjusted change in BMI SDS among the ADHD groups at year 4, whereas patients without GHD showed no significant differences. ADHD medication did not affect the linear growth response of children treated with GH when those receiving or not receiving ADHD stimulant medication were matched for baseline measurements. Underlying reasons for the observed greater increase in BMI in patients with GHD concomitantly treated with ADHD medication remain to be elucidated. ClinicalTrials.gov: NCT01009905. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Endoscopic Evacuation of Basal Ganglia Hemorrhage via Keyhole Approach Using an Adjustable Cannula in Comparison with Craniotomy

PubMed Central

Zhang, Heng-Zhu; Li, Yu-Ping; Yan, Zheng-cun; Wang, Xing-dong; She, Lei; Wang, Xiao-dong; Dong, Lun

2014-01-01

Neuroendoscopic (NE) surgery as a minimal invasive treatment for basal ganglia hemorrhage is a promising approach. The present study aims to evaluate the efficacy and safety of NE approach using an adjustable cannula to treat basal ganglia hemorrhage. In this study, we analysed the clinical and radiographic outcomes between NE group (21 cases) and craniotomy group (30 cases). The results indicated that NE surgery might be an effective and safe approach for basal ganglia haemorrhage, and it is also suggested that NE approach may improve good functional recovery. However, NE approach only suits the selected patient, and the usefulness of NE approach needs further randomized controlled trials (RCTs) to evaluate. PMID:24949476

Do different case-mix measures affect assessments of provider efficiency? Lessons from the Department of Veterans Affairs.

PubMed

Rosen, Amy K; Loveland, Susan A; Rakovski, Carter C; Christiansen, Cindy L; Berlowitz, Dan R

2003-01-01

Although case-mix adjustment is critical for provider profiling, little is known regarding whether different case-mix measures affect assessments of provider efficiency. We examine whether two case-mix measures, Adjusted Clinical Groups (ACGs) and Diagnostic Cost Groups (DCGs), result in different assessments of efficiency across service networks within the Department of Veterans Affairs (VA). Three profiling indicators examine variation in resource use. Although results from the ACGs and DCGs generally agree on which networks have greater or lesser efficiency than average, assessments of individual network efficiency vary depending upon the case-mix measure used. This suggests that caution should be used so that providers are not misclassified based on reported efficiency.

Is There a Sex-Related Difference in the Obesity Paradox in Systolic Heart Failure? Sex-Related Difference in the Obesity Paradox.

PubMed

Hong, Soonchang; Lee, Ji Hyun; Kim, Kyung Min; Lee, Jun Won; Youn, Young Jin; Ahn, Min Soo; Ahn, Sung Gyun; Lee, Seung Hwan; Yoon, Junghan; Choe, Kyung Hoon; Yoo, Byung Su

2018-01-01

Obesity is often associated with better clinical outcomes in heart failure (HF). This so-called obesity paradox remains controversial. The aim of present study was to investigate the prognostic value of obesity in patients hospitalized for systolic HF. We performed a pooled analysis of data from two multicenter, observational HF studies. Patients hospitalized for systolic HF were eligible for the present study. We divided the subjects into two groups, a normal body mass index (BMI) group and a high BMI group. Study endpoints included all-cause mortality and any re-hospitalization within 1 year. We enrolled 3145 patients (male, 1824; female, 1321). The high BMI group was significantly associated with lower 1-year mortality rate [odds ratio (OR), 0.543; 95% confidence interval (CI), 0.355-0.832] after adjusting for age, hypertension, diabetes, ischemic HF, previous myocardial infarction, serum creatinine level, anemia, and ejection fraction in men. After adjustment for clinical characteristics, high BMI was not significantly associated with 1-year mortality (OR, 0.739; 95% CI, 0.450-1.216) or 1-year re-hospitalization (OR, 0.958; 95% CI, 0.696-1.319) in women. In pooled analysis of data from two Korean HF registries, the high BMI group was independently associated with lower 1-year mortality rate from systolic HF, especially in men. © Copyright: Yonsei University College of Medicine 2018

Influence of marital and educational status on clients' psychosocial adjustment to HIV/AIDS in Calabar, Nigeria.

PubMed

Akpabio, Idongesit I; Uyanah, David A; Osuchukwu, Nelson C; Samson-Akpan, Patience E

2010-06-01

A comparative descriptive design and a stratified random sampling technique were adopted to study the influence of marital and educational status on the psychological, social, and spiritual adjustment of 280 respondents living with HIV/AIDS in two randomly selected clinics within Calabar, Nigeria. A 30 item questionnaire, with a content validity index of 0.92 and a Cronbach's alpha reliability coefficient of 0.94, was used for data collection, with due attention to ethical considerations. The findings showed that marital status had a significant influence on the respondents' psychological and social adjustment but not on their spiritual adjustment. Those that were married and those with higher educational qualifications had better psychological adjustment than those who had never married. The marital and educational status of clients should be considered when conducting education or counseling, making recommendations, or organizing support groups for living with HIV/AIDS. Furthermore, advocacy aimed at meeting the psychosocial needs of single and less-educated clients could enhance their psychosocial adjustment.

Individual dose adjustment of riociguat in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

PubMed

Hill, Nicholas S; Rahaghi, Franck F; Sood, Namita; Frey, Reiner; Ghofrani, Hossein-Ardeschir

2017-08-01

Riociguat is a soluble guanylate cyclase stimulator that has been approved for the treatment of pulmonary arterial hypertension and inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension following pulmonary endarterectomy. Riociguat is administered using an 8-week individual dose-adjustment scheme whereby a patient initially receives riociguat 1.0 mg three times daily (tid), and the dose is then increased every 2 weeks in the absence of hypotension, indicated by systolic blood pressure measurements and symptoms, up to a maximum dose of 2.5 mg tid. The established riociguat dose-adjustment scheme allows the dose of riociguat to be individually optimized in terms of tolerability and efficacy. The majority of patients in the phase III clinical trials and their long-term extension phases achieved the maximum riociguat dose, whereas some patients remained on lower doses. There is evidence that these patients may experience benefits at riociguat doses lower than 2.5 mg tid, with improvement in exercise capacity being observed after only 2-4 weeks of treatment in the phase III studies and in the exploratory 1.5 mg-maximum patient group of PATENT-1. This review aims to provide an overview of the rationale behind the riociguat dose-adjustment scheme and examine its application to both clinical trials and real-life clinical practice. Copyright © 2017 Elsevier Ltd. All rights reserved.

a Comparison Between Chemically Dependent Mothers and Drug-Free Mothers: Lifestyle during the Perinatal Period

NASA Astrophysics Data System (ADS)

Uskokovic, Lila Milica

This study compared maternal lifestyle variables pertinent to the perinatal period in groups of chemically dependent mothers and drug-free mothers. Twenty-nine cocaine -abusing mothers were compared to 29 drug-free mothers carefully matched on age, race, education, and primipara versus multipara status. The drug history of each chemically dependent woman was explicitly documented. The chemically dependent group was subdivided into two groups, mothers who abused cocaine and those who abused cocaine with concomitant opiate use. Each of these two subgroups was compared to its respective matched drug-free control group. Finally, a comparison was made between the two drug subgroups. All subjects were interviewed within 48 hours after delivery using the following measures: State-Trait Anxiety Inventory (A-State), Center for Epidemiologic Studies - Depression Scale, The Self-Esteem Scale, Maternal Adjustment and Maternal Attitude Questionnaire, The Neonatal Perception Inventory, The Psychiatric Epidemiology Research Interview Life Events Scale, Maternal Social Support Index, and Short Marital Adjustment Test. A t-test analysis revealed significant differences (p <.05) between the total experimental group and its matched control group on state anxiety, depression, self-esteem, maternal adjustment and attitudes, and life events. An analysis of covariance indicated that life events was the only significant variable when the influence of all other variables was removed. Comparisons made between each drug subgroup and its respective matched control group showed similar results, except that those who abused opiates with cocaine did not differ from their controls on depression and maternal adjustment and attitudes. No significant differences were obtained in the drug subgroup comparisons. These results identify increased life events and specific negative affect states that clinical intervention programs should address to assure the best possible outcome for chemically dependent mothers and their infants.

Comparison of associated features and drug treatment between co-occurring unipolar and bipolar disorders in depressed eating disorder patients.

PubMed

Tseng, Mei-Chih Meg; Chang, Chin-Hao; Liao, Shih-Cheng; Chen, Hsi-Chung

2017-02-27

To examine the differences of associated characteristics and prescription drug use between co-occurring unipolar and bipolar disorders in patients with eating disorders (EDs). Patients with EDs and major depressive episode (MDE) were recruited from psychiatric outpatient clinics. They were interviewed and completed self-administered measures assessing eating and general psychopathology. The prescribed drugs at the index outpatient visit were recorded. Clinical characteristics and prescription drugs of groups with major depressive disorder (ED-MDD), MDE with lifetime mania (ED-BP I), and MDE with lifetime hypomania (ED-BP II) were compared. Continuous variables between groups were compared using generalized linear regression with adjustments of age, gender, and ED subtype for pair-wise comparisons. Multivariate logistic regression with adjustments of age, gender, and ED subtype was employed to estimate adjusted odds ratios with 95% confidence intervals between groups. Two hundred and twenty-seven patients with EDs had a current MDE. Among them, 17.2% and 24.2% experienced associated manic and hypomanic episodes, respectively. Bipolar I and II patients displayed significantly poorer weight regulation, more severe impulsivity and emotional lability, and higher rates of co-occurring alcohol use disorders than ED-MDD patients. ED-BP I patients were found to have the lowest IQ, poorest working memory, and the most severe depression, suicidality and functional impairment among all patients. Patients with ED-BP II shared affect and behavioral dysregulations with ED-BP I, but had less severe degrees of cognitive and functional impairments than ED-BP I. Patients with ED-BP I were significantly less likely than those in the ED-MDD and ED-BP II groups to be on antidepressant monotherapy, but a great rate (27%) of ED-BP I individuals taking antidepressant monotherapy had potential risk of mood switch during the course of treatment. Our study identified discriminative features of bipolar I and II disorders from MDD among a group of depressed ED patients. We suggest that the associated mania, hypomania, and mood lability are predictors of clinical severity and should be identified from ED patients presented with depressive features. Accurate diagnosis of bipolar disorders may have implications for pharmacotherapy in patients with EDs.

Evaluation of a comprehensive intervention with a behavioural modification strategy for childhood obesity prevention: a nonrandomized cluster controlled trial.

PubMed

Wang, Jing-jing; Lau, Wing-chung Patrick; Wang, Hai-jun; Ma, Jun

2015-12-03

With regard to the global childhood obesity epidemic, it is imperative that effective lifestyle interventions are devised to combat childhood obesity. This paper describes the development and implementation of a comprehensive (a combination of diet and physical activity (PA)), social cognitive behaviour modification intervention using accelerometry and a dietary diary to tackle child overweight and obesity. The comprehensive intervention effect was evaluated in a comparison with diet only, PA only and a no-treatment control group. A pilot study was conducted with a non-randomized cluster design. Four hundred thirty-eight overweight and obese children aged 7-12 years from ten primary schools in Beijing were recruited to receive a one-year intervention. Participants were allocated into one of four groups: the comprehensive intervention group; the PA only group (Happy 10 program); the diet only group (nutrition education program); and a control group. The effects of intervention on adiposity, blood pressure, and biochemical indicators were assessed by examining 2-way interactions (time × intervention) in linear mixed models. Means and 95 % confidence intervals (CI) for the adjusted changes between post-intervention and baseline relative to changes in the control group were calculated and reported as effect sizes. The percentage of body fat in the comprehensive intervention group showed a significant relative decrease (adjusted change: -1.01 %, 95 % CI: (-1.81, -0.20) %) compared with the PA only, diet only or control groups (P < 0.001). Systolic blood pressure significantly decreased in the comprehensive intervention group (adjusted change: -4.37 mmHg, 95 % CI: (-8.42, -0.33) mmHg), as did diastolic blood pressure (adjusted change: -5.50 mmHg, 95 % CI (-8.81, -2.19) mmHg) (P < 0.05). Compared with the other two intervention groups and the control group, positive adjusted changes in fasting glucose in the comprehensive group were found, although not for the biochemical lipid metabolism indicators. Positive but non-significant adjusted changes in body mass index and waist circumference were observed. Compared with the diet or PA only intervention groups, the current comprehensive program had superior positive effects on body fat percentage and blood pressure but not on the biochemical lipid metabolism indicators in Chinese overweight and obese children. Future randomized controlled trials and long-term follow-up studies are required to elaborate the findings of the current intervention. ClinicalTrials.gov identifier: NCT02228434.

Characterizing Facial Skin Ageing in Humans: Disentangling Extrinsic from Intrinsic Biological Phenomena

PubMed Central

Trojahn, Carina; Dobos, Gabor; Lichterfeld, Andrea; Blume-Peytavi, Ulrike; Kottner, Jan

2015-01-01

Facial skin ageing is caused by intrinsic and extrinsic mechanisms. Intrinsic ageing is highly related to chronological age. Age related skin changes can be measured using clinical and biophysical methods. The aim of this study was to evaluate whether and how clinical characteristics and biophysical parameters are associated with each other with and without adjustment for chronological age. Twenty-four female subjects of three age groups were enrolled. Clinical assessments (global facial skin ageing, wrinkling, and sagging), and biophysical measurements (roughness, colour, skin elasticity, and barrier function) were conducted at both upper cheeks. Pearson's correlations and linear regression models adjusted for age were calculated. Most of the measured parameters were correlated with chronological age (e.g., association with wrinkle score, r = 0.901) and with each other (e.g., residual skin deformation and wrinkle score, r = 0.606). After statistical adjustment for age, only few associations remained (e.g., mean roughness (R z) and luminance (L *),  β = −0.507, R 2 = 0.377). Chronological age as surrogate marker for intrinsic ageing has the most important influence on most facial skin ageing signs. Changes in skin elasticity, wrinkling, sagging, and yellowness seem to be caused by additional extrinsic ageing. PMID:25767806

Provisional versus elective two-stent strategy for unprotected true left main bifurcation lesions: Insights from a FAILS-2 sub-study.

PubMed

Kawamoto, Hiroyoshi; Chieffo, Alaide; D'Ascenzo, Fabrizio; Jabbour, Richard J; Naganuma, Toru; Cerrato, Enrico; Ugo, Fabrizio; Pavani, Marco; Varbella, Ferdinando; Boccuzzi, Giacomo; Pennone, Mauro; Garbo, Roberto; Conrotto, Federico; Biondi-Zoccai, Giuseppe; D'Amico, Maurizio; Moretti, Claudio; Escaned, Javier; Gaita, Fiorenzo; Nakamura, Sunao; Colombo, Antonio

2018-01-01

This study sought to investigate the optimal percutaneous coronary intervention (PCI) strategy for true unprotected left main coronary artery (ULMCA) bifurcations. The FAILS-2 was a retrospective multi-center study including patients with ULMCA disease treated with second-generation drug-eluting stents. Of these, we compared clinical outcomes of a provisional strategy (PS; n=216) versus an elective two-stent strategy (E2S; n=161) for true ULMCA bifurcations. The primary endpoint was the incidence of major adverse cardiac events (MACEs) at 3-years. We further performed propensity-score adjustment for clinical outcomes. There were no significant differences between the groups in terms of patient and lesion characteristics. 9.7% of patients in the PS group crossed over to a provisional two-stent strategy. MACEs were not significantly different between groups (MACE at 3-year; PS 28.1% vs. E2S 28.9%, adjusted p=0.99). The rates of target lesion revascularization (TLR) on the circumflex artery (LCX) were numerically high in the E2S group (LCX-TLR at 3-years; PS 11.8% vs. E2S 16.6%, adjusted p=0.51). E2S was associated with a comparable MACE rate to PS for true ULMCA bifurcations. The rates of LCX-TLR tended to be higher in the E2S group although there was no statistical significance. This study sought to compare the clinical outcomes of a provisional strategy (PS) with an elective two-stent strategy (E2S) for the treatment of true unprotected left main coronary artery bifurcations. 377 Patients (PS 216 vs. E2S 161 patients) were evaluated, and 9.7% in the PS group crossed over to a two-stent strategy. E2S was associated with a similar major adverse cardiac event rate at 3-years when compared to the PS strategy (PS 28.1% vs. E2S 28.9%, p=0.99). However, the left circumflex artery TLR rate at 3-year tended to be higher in the E2S group (PS 11.8% vs. E2S 16.6%, p=0.51). Copyright © 2017 Elsevier B.V. All rights reserved.

From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

PubMed

Mortsiefer, Achim; Meysen, Tobias; Schumacher, Martin; Abholz, Heinz-Harald; Wegscheider, Karl; In der Schmitten, Jürgen

2015-05-07

Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p < 0.001. The ICC was 0.026 (p = 0.002). Hypertension control (BP <140/90 mmHg) improved in the same subpopulation from 38.1 to 45.9% in the complex intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. ISRCTN44478543 .

Efficacy of oral ribavirin in hematologic disease patients with paramyxovirus infection: analytic strategy using propensity scores.

PubMed

Park, So-Youn; Baek, Seunghee; Lee, Sang-Oh; Choi, Sang-Ho; Kim, Yang Soo; Woo, Jun Hee; Sung, Heungsup; Kim, Mi-Na; Kim, Dae-Young; Lee, Jung-Hee; Lee, Je-Hwan; Lee, Kyoo-Hyung; Kim, Sung-Han

2013-02-01

Few antiviral agents are available for treating paramyxovirus infections, such as those involving respiratory syncytial virus (RSV), parainfluenza virus (PIV), and human metapneumovirus (hMPV). We evaluated the effect of oral ribavirin on clinical outcomes of paramyxovirus infections in patients with hematological diseases. All adult patients with paramyxovirus were retrospectively reviewed over a 2-year period. Patients who received oral ribavirin were compared to those who received supportive care without ribavirin therapy. A propensity-matched case-control study and a logistic regression model with inverse probability of treatment weighting (IPTW) were performed to reduce the effect of selection bias in assignment for oral ribavirin therapy. A total of 145 patients, including 64 (44%) with PIV, 60 (41%) with RSV, and 21 (15%) with hMPV, were analyzed. Of these 145 patients, 114 (78%) received oral ribavirin and the remaining 31 (21%) constituted the nonribavirin group. Thirty-day mortality and underlying respiratory death rates were 31% (35/114) and 12% (14/114), respectively, for the oral ribavirin group versus 19% (6/31) and 16% (5/31), respectively, for the nonribavirin group (P = 0.21 and P = 0.56). In the case-control study, the 30-day mortality rate in the ribavirin group was 24% (5/21) versus 19% (4/21) in the nonribavirin group (P = 0.71). In addition, the logistic regression model with IPTW revealed no significant difference in 30-day mortality (adjusted hazard ratio of 1.3; 95% confidence interval [95% CI] of 0.3 to 5.8) between the two groups. Steroid use (adjusted odds ratio, 5.67; P = 0.01) and upper respiratory tract infection (adjusted odds ratio, 0.07; P = 0.001) was independently associated with mortality. Our data suggest that oral ribavirin therapy may not improve clinical outcomes in hematologic disease patients infected with paramyxovirus.

Thiol/disulfide homeostasis in postmenopausal osteoporosis.

PubMed

Korkmaz, V; Kurdoglu, Z; Alisik, M; Turgut, E; Sezgın, O O; Korkmaz, H; Ergun, Y; Erel, O

2017-04-01

To evaluate the impact of postmenopausal osteoporosis on thiol/disulfide homeostasis. A total of 75 participants were divided into two groups: Group 1 (n = 40) was composed of healthy postmenopausal women, and group 2 (n = 35) was composed of women with postmenopausal osteoporosis. Clinical findings and thiol/disulfide homeostasis were compared between the two groups. The disulfide/native thiol ratio was 8.6% ± 3.6 in group 1 and 12.7% ± 8.4 in group 2 (p = 0.04). The disulfide/native thiol percent ratio was significantly higher in group 2 after adjustment for the years since menopause and age (p < 0.05). The native thiol/total thiol percent ratio was 85.6% ± 4.8 in group 1 and 73.8% ± 24.9 in group 2 (p = 0.01). The native thiol/total thiol percent ratio was significantly lower in group 2 after adjustment for the years since menopause and age (p < 0.05). Thiol/disulfide homeostasis shifted to the disulfide side independent of age and years since menopause in postmenopausal osteoporosis.

Cancer Specific Mortality in Men Diagnosed with Prostate Cancer before Age 50 Years: A Nationwide Population Based Study.

PubMed

Thorstenson, Andreas; Garmo, Hans; Adolfsson, Jan; Bratt, Ola

2017-01-01

We compared clinical characteristics and cancer specific mortality in men diagnosed with prostate cancer before vs after age 50 years. A total of 919 men 35 to 49 years old and 45,098 men 50 to 66 years old who were diagnosed with prostate cancer between 1998 and 2012 were identified in PCBaSe (Prostate Cancer data Base Sweden). Cancer specific mortality was compared among age groups (35 to 49, 50 to 59, 60 to 63 and 64 to 66 years) with and without adjusting for cancer characteristics, comorbidity and education in a multivariable Cox proportional hazards model. Clinical cancer characteristics indicated that most nonmetastatic cancer in men younger than 50 years was detected after prostate specific antigen testing. The proportion of nonmetastatic vs metastatic disease at diagnosis was similar in all age groups. A strong association between younger age and poor prognosis was apparent in men in whom metastatic disease was diagnosed before age 50 to 55 years. The crude and adjusted HRs of cancer specific mortality were 1.41 (95% CI 1.12-1.79) and 1.28 (95% CI 1.01-1.62) in men diagnosed before age 50 and at age 50 to 59 years, respectively. In men with nonmetastatic disease crude cancer specific mortality increased with older age but adjusted cancer specific mortality was similar in all age groups. Our findings suggest that an aggressive form of metastatic prostate cancer is particularly common in men younger than 50 to 55 years. Genetic studies and trials of intensified systemic treatment are warranted in this patient group. Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Inference of median difference based on the Box-Cox model in randomized clinical trials.

PubMed

Maruo, K; Isogawa, N; Gosho, M

2015-05-10

In randomized clinical trials, many medical and biological measurements are not normally distributed and are often skewed. The Box-Cox transformation is a powerful procedure for comparing two treatment groups for skewed continuous variables in terms of a statistical test. However, it is difficult to directly estimate and interpret the location difference between the two groups on the original scale of the measurement. We propose a helpful method that infers the difference of the treatment effect on the original scale in a more easily interpretable form. We also provide statistical analysis packages that consistently include an estimate of the treatment effect, covariance adjustments, standard errors, and statistical hypothesis tests. The simulation study that focuses on randomized parallel group clinical trials with two treatment groups indicates that the performance of the proposed method is equivalent to or better than that of the existing non-parametric approaches in terms of the type-I error rate and power. We illustrate our method with cluster of differentiation 4 data in an acquired immune deficiency syndrome clinical trial. Copyright © 2015 John Wiley & Sons, Ltd.

The Assessment of Family Functions, Dyadic Adjustment, and Parental Attitude in Adolescents with Substance Use Disorder

PubMed Central

ÖNGEL ATAR, Ayça; YALÇIN, Özhan; UYGUN, Ersin; ÇİFTÇİ DEMİRCİ, Arzu; ERDOĞAN, Ayten

2016-01-01

Introduction Family structure and family attitudes have been reported to be important factors in the development of substance use disorders. In this study, we aimed to assess the relationship between substance use and family functions, parental attitude, and parental dyadic adjustment of adolescents with substance use disorder. Methods The study was conducted on 50 patients, comprising 9 female and 41 male adolescents between the ages of 14 and 18 years, treated at Bakırköy Mental Health Hospital, Substance Abuse Research, Treatment and Education Center for Children Adolescents (ÇEMATEM), Turkey, with the diagnosis of substance use disorder according to DSM-5 and their parents and a control group comprising 50 healthy adolescents without any psychopathology or substance use disorder and their parents. The study was designed as a matched case–control study for age and gender. Sociodemographic Data Form (SDF), Parental Attitude Scale (PAS), Dyadic Adjustment Scale (DAS), and Family Assessment Device (FAD) were applied to both groups. Results When the study and control groups were compared with regard to the PAS, the study group scores determined for “involvement-acceptance,” “psychological autonomy,” and “control-supervision” dimensions were significantly lower than the control group scores. Compared with the control group, dyadic adjustment was lower in terms of “dyadic cohesion,” “dyadic consensus,” and “affectional expression.” Living with biological parents and the togetherness of parents were lower in the study group. “Problem solving,” “communication,” “roles,” “affective responsiveness,” “affective involvement,” “behavior control,” and “general functioning” dimension scores according to FAD were also significantly higher in the study group. Conclusion Compared with togetherness of the controls, the dyadic adjustment of their parents was lower and family functions as perceived by the parents and adolescents were unhealthier in the adolescents using substances. These findings indicate that the family functions, dyadic adjustment, and parental attitude styles need to be assessed in the risk groups to determine familial risk factors and to structure protective measures. These assessments may guide clinicians and policy-makers toward good clinical practice and help build protective measures. PMID:28360764

The vascular surgeon facing clinical ethical dilemmas (the VASCUETHICS Study): 'V'-shaped association between compassionate attitudes and professional seniority.

PubMed

Clará, A; Merino, J; Mateos, E; Ysa, A; Román, B; Vidal-Barraquer, F

2006-06-01

To evaluate the association between compassionate attitudes and seniority in vascular surgeons facing clinical ethical dilemmas (CED). (1) DESIGN: Cross-sectional. (2) SUBJECTS: Vascular surgeons (residents included) from the 28 vascular teaching departments of one European country. (3) MEASUREMENTS: Multidisciplinary team-designed, structured and self-administered questionnaire consisting of five clinical ethical dilemmas, of which four had conflict between compassion towards a 'small' or 'very costly' beneficial action vs. a reasonable but more 'pragmatic' allocation of health resources. Participants stated their degree of agreement with eight answers representing the two attitudes on a continuous scale. (4) STATISTICS: Cluster analysis and logistic regression model adjusted by confounding factors. Two hundred and fifty three vascular surgeons (median age 37 years, 74% male) from the 26 participating teaching vascular departments (public hospitals) completed the questionnaire (88% surgeons/department). Cluster analysis identified two groups of surgeons according to their pattern of answers: Group I (n=63) were mainly compassionate whereas Group II (n=180) were mainly pragmatic. The multivariate analysis disclosed, after adjusting for additional private practice, on call services and career status, a significant V-shaped relationship between the compassionate behaviour and seniority. Surgeons with 8-15 years experience were the least compassionate. The youngest and the most senior vascular surgeons were more prone to favour compassionate attitudes when facing clinical ethical dilemmas. Although both compassionate and pragmatic attitudes may be legitimate ethically, physicians not favouring compassion may be at risk of leaving the patient without an advocate within the health care system.

Ethnic Minority Status, Depression, and Cognitive Failures in Relation to Marital Adjustment in Ethnically Diverse Older Women.

PubMed

Laganá, Luciana; Spellman, Therese; Wakefield, Jennifer; Oliver, Taylor

2011-04-01

The authors investigated the relationship between marital adjustment and ethnic minority status, depressive symptomatology, and cognitive failures among 78 married, community-dwelling, and predominantly non-European-American older women (ages 57-89). Respondents were screened to rule out dementia. Level of depressive symptoms, self-report of cognitive failures, and marital adjustment were obtained. As hypothesized, higher depressive symptomatology and cognitive failures were associated with worse marital adjustment ( p < .05 for both). The same was true for membership in a non-dominant ethnic group, albeit only when ethnic status was considered outside the context of the other two independent variables. These results have clinical implications and fit within the theoretical framework of the socioemotional selectivity theory (Carstensen, 1992) applied to marriage in older age, a conceptualization formulated by Bookwala and Jacobs in 2004.

The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial.

PubMed

Engebretson, Steven P; Hyman, Leslie G; Michalowicz, Bryan S; Schoenfeld, Elinor R; Gelato, Marie C; Hou, Wei; Seaquist, Elizabeth R; Reddy, Michael S; Lewis, Cora E; Oates, Thomas W; Tripathy, Devjit; Katancik, James A; Orlander, Philip R; Paquette, David W; Hanson, Naomi Q; Tsai, Michael Y

2013-12-18

Chronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control. To determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis. The Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers. The treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months. Difference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score. Enrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all). Nonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c. clinicaltrials.gov Identifier: NCT00997178.

Effectiveness of long-acting injectable risperidone versus oral antipsychotics in the treatment of recent-onset schizophrenia: a case-control study.

PubMed

Barrio, Pablo; Batalla, Albert; Castellví, Pere; Hidalgo, Diego; García, Marta; Ortiz, Ana; Grande, Iria; Pons, Alexandre; Parellada, Eduard

2013-07-01

Long-acting injectable antipsychotics may offer a relevant improvement in treatment adherence in recent-onset psychosis, leading to a decreased rate of hospital readmission, a better rate of clinical remission and improved psychosocial adjustment. The aim of the study was to compare the clinical remission rates, number of hospital readmissions and personal and social functioning after 2 years between patients with recent-onset schizophrenia (<2 years) in treatment with risperidone long-acting injectable (RLAI) and patients with recent-onset schizophrenia receiving oral antipsychotics. This is a case-control study comparing patients with recent-onset schizophrenia who initiated RLAI treatment between 2004 and 2008 (n=26) with a control group matched for age and sex, diagnosed with recent-onset schizophrenia and treated with oral antipsychotics (n=26). Study assessments included sociodemographic variables, the Positive and Negative Syndrome Scale, the Personal and Social Functioning Scale, the number of hospital readmissions and the Andreasen remission criteria. To assess the effect of treatment on each dependent variable, separate generalized estimating equations models were constructed. After 2 years of treatment, and adjusting for educational level, the RLAI group showed a greater reduction in the Positive and Negative Syndrome Scale total scale [mean (SD)=47.7 (12.0) vs. 66.2 (18.5); mean difference =-17.56; 95% confidence interval (CI)=-27.11 to -8.00; P<0.001], as well as in the negative [mean (SD) 14.3 (6.1) vs. 19.4 (6.4); mean difference=-5.02; 95% CI=-8.28 to -1.77; P=0.002] and general psychopathology [mean (SD)=23.4 (6.3) vs. 32.7 (8.1); mean difference=-9.16; 95% CI=-13.3 to -5.03; P<0.001] subscales compared with the oral antipsychotic group. Personal and Social Functioning Scale scores were also higher in the RLAI group [mean (SD)=72.4 (14.8) vs. 59.7 (13.5); mean difference=13.41; 95% CI=5.65-21.18; P<0.001]. Although not statistically significant, there were fewer readmissions (adjusted odds ratio 0.28; 95% CI=0.06-1.35; P=0.114) and more illness remissions (adjusted odds ratio 3.24; 95% CI=0.20-11.93; P=0.077) in the RLAI group. Treatment with RLAI instead of oral antipsychotics in recent-onset schizophrenia might improve clinical symptoms and social functioning. The efficacy of RLAI treatment on remission and readmission rates should be researched further.

A cost-effectiveness analysis of two different repositioning strategies for the prevention of pressure ulcers.

PubMed

Marsden, Grace; Jones, Katie; Neilson, Julie; Avital, Liz; Collier, Mark; Stansby, Gerard

2015-12-01

To assess the cost effectiveness of two repositioning strategies and inform the 2014 National Institute for Health and Care Excellence clinical guideline recommendations on pressure ulcer prevention. Pressure ulcers are distressing events, caused when skin and underlying tissues are placed under pressure sufficient to impair blood supply. They can have a substantial impact on quality of life and have significant resource implications. Repositioning is a key prevention strategy, but can be resource intensive, leading to variation in practice. This economic analysis was conducted to identify the most cost-effective repositioning strategy for the prevention of pressure ulcers. The economic analysis took the form of a cost-utility model. The clinical inputs to the model were taken from a systematic review of clinical data. The population in the model was older people in a nursing home. The economic model was developed with members of the guideline development group and included costs borne by the UK National Health Service. Outcomes were expressed as costs and quality adjusted life years. Despite being marginally more clinically effective, alternating 2 and 4 hourly repositioning is not a cost-effective use of UK National Health Service resources (compared with 4 hourly repositioning) for this high risk group of patients at a cost-effectiveness threshold of £20,000 per quality adjusted life years. These results were used to inform the clinical guideline recommendations for those who are at high risk of developing pressure ulcers. © 2015 John Wiley & Sons Ltd.

The importance of surgeon experience for clinical and economic outcomes from thyroidectomy.

PubMed Central

Sosa, J A; Bowman, H M; Tielsch, J M; Powe, N R; Gordon, T A; Udelsman, R

1998-01-01

OBJECTIVE: To determine whether individual surgeon experience is associated with improved short-term clinical and economic outcomes for patients with benign and malignant thyroid disease who underwent thyroid procedures in Maryland between 1991 and 1996. SUMMARY BACKGROUND DATA: There is a prevailing belief that surgeon experience affects patient outcomes in endocrine surgery, but there is a paucity of objective evidence outside of clinical series published by experienced surgeons that supports this view. METHODS: A cross-sectional analysis of all patients who underwent thyroidectomy in Maryland between 1991 and 1996 was conducted using a computerized statewide hospital discharge data base. Surgeons were categorized by volume of thyroidectomies over the 6-year study period: A (1 to 9 cases), B (10 to 29 cases), C (30 to 100 cases), and D (>100 cases). Multivariate regression was used to assess the relation between surgeon caseload and in-hospital complications, length of stay, and total hospital charges, adjusting for case mix and hospital volume. RESULTS: The highest-volume surgeons (group D) performed the greatest proportion of total thyroidectomies among the 5860 discharges, and they were more likely to operate on patients with cancer. After adjusting for case mix and hospital volume, highest-volume surgeons had the shortest length of stay (1.4 days vs. 1.7 days for groups B and C and 1.9 days for group A) and the lowest complication rate (5.1 % vs. 6.1% for groups B and C and 8.6% for group A). Length of stay and complications were more determined by surgeon experience than hospital volume, which had no consistent association with outcomes. CONCLUSIONS: Individual surgeon experience is significantly associated with complication rates and length of stay for thyroidectomy. PMID:9742915

Placebo-controlled clinical trial of use of 10% hydrogen peroxide whitening strips for medication-induced xerostomia.

PubMed

Papas, Athena S; Kugel, Gerard; Singh, Mabi; Barker, Matthew L; Gerlach, Robert W

2009-01-01

A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effectiveness and safety of peroxide-containing strip-based tooth whitening among subjects with medication-induced hyposalivation. Eligibility for this tooth whitening study was limited to dentate adults taking xerogenic medications with an unstimulated salivary flow < or = 0.2 ml/min. After giving informed consent, 42 subjects were randomized using a 2:1 ratio to 10% hydrogen peroxide whitening strips (Crest Whitestrips Premium) or placebo strips without peroxide. Strips were used for 30 min twice daily for a 14-day period. Usage was unsupervised, and only the maxillary arch was treated. On days 8 and 15, efficacy was assessed from standard digital images of the anterior dentition and quantified using the Cielab color system, while safety was assessed from interviews and clinical examinations. At day 8, the peroxide group experienced significant (p < 0.001) color improvement relative to baseline and placebo. Adjusted means +/- standard errors for yellowness reduction were -1.65 +/- 0.115 units for the peroxide group and -0.32 +/- 0.170 units for the placebo group. For the increase in lightness, adjusted means +/- standard errors on day 8 were 1.53 +/- 0.130 units for the peroxide group and 0.37 +/- 0.191 units for the controls. Continued strip use through day 15 yielded incremental color improvement for the peroxide group. Mild and transient tooth sensitivity represented the most common adverse events. No subject discontinued treatment due to a product-related adverse event. Twice daily use of 10% hydrogen peroxide whitening strips by adults with medication-induced xerostomia was well tolerated, with significant tooth color improvement evident within 7 days. Copyright 2009 S. Karger AG, Basel.

Comparing the profile of child patients attending dental general anaesthesia and conscious sedation services.

PubMed

Hariharan, S; Hosey, M T; Bernabe, E

2017-05-12

Aims To compare the profile of paediatric patients receiving dental treatment under general anaesthesia (GA) or conscious sedation (CS). A second aim was to explore whether there is an overlap between the two patient groups.Design This service evaluation study was based on sociodemographic and clinical data extracted from clinical records of patients attending dental appointments for GA or CS services at King's College Hospital. Sociodemographic and clinical differences between GA and CS groups were explored using logistic regression models.Results Data from 113 children (58 GA and 55 CS) were analysed. There were differences between groups in terms of age and numbers of quadrants and teeth treated, but not in terms of sex, ethnicity or deprivation scores. In the adjusted model, older children and those having more teeth treated were more likely to be in the GA than in the CS group. An overlap between the GA and CS groups was found, with 50% of children aged four to nine years having two to four teeth treated in both groups.Conclusion Age and number of teeth treated were the main characteristics associated with receiving care under GA or CS. Some overlap between children receiving dental treatment under GA or CS existed despite demographic and clinical differences between both groups.

The effect of an interactive follow-up program on ostomy adjustment of inpatients after their discharge from surgical wards of the hospitals affiliated to Isfahan University of Medical Sciences.

PubMed

Hamidi, Yaser; Moeini, Mahin; Yousefi, Hojatollah

2018-04-07

Ostomy patients suffer from many physical and mental problems, which can be solved to a large extent with the help of education and follow-up programs. These follow-ups can be done in person or on the telephone by the nurses, or even, by sending a text message that is an easier way for the patients to adapt to their condition. This study aimed to investigate the effect of an interactive follow-up program on the adjustment of ostomy inpatients after being discharged. This study is a clinical trial, conducted on 64 ostomy patients who were discharged from the surgical wards of the hospital affiliated to Isfahan University of Medical Sciences. Subjects in the experimental group participated in a 6-week follow-up program via text message. The information about the patients were collected by Olbrisch Ostomy Adjustment Scale. The obtained results have suggested that 34.4% of the patients in the experimental group and 28.1% of the patients in the control group were female. Before the intervention, comparing the mean score of ostomy adjustment and its dimensions in the two groups showed no significant difference (P > 0.05). However, a significant difference was observed between the two groups immediately after the intervention (P < 0.05) and 1 month after the intervention, except for dimension of negative acceptance (P > 0.05). The findings of this study suggested that using SMS can be considered as a proper tool or method for following up the ostomy patients.

Impact of financial and educational interventions on maternity care: results of cluster randomized trials in rural China, CHIMACA.

PubMed

Hemminki, Elina; Long, Qian; Zhang, Wei-Hong; Wu, Zhuochun; Raven, Joanna; Tao, Fangbiao; Yan, Hong; Wang, Yang; Klemetti, Reija; Zhang, Tuohong; Regushevskaya, Elena; Tang, Shenglan

2013-02-01

To report on the design and basic outcomes of three interventions aimed at improving the use and quality of maternity care in rural China: financial interventions, training in clinical skills, and training in health education. Community-based cluster randomized trials were carried out in one central and two western provinces between 2007 and 2009: (1) financial interventions covered part of women's costs for prenatal and postnatal care, (2) training of midwives in clinical skills was given by local maternity care experts in two- or three-group training courses, (3) health education training for midwives and village doctors were given by local experts in health education in two- or three-group training courses. A survey was conducted in a stratified random sample of women who had been pregnant in the study period. 73% of women (n = 3,673) were interviewed within 1-10 months of giving birth. Outcomes were compared by the different intervention and control groups. Adjusted odds ratios were calculated by logistic regression to adjust for varying maternal characteristics. Most of the differences found between the groups were small and some varied between provinces. The financial intervention did not influence the number of visits, but was associated with increased caesarean sections and a decrease in many ultrasound tests. The clinical intervention influenced some indicators of care content. There was no consistent finding for the health education intervention. Financial and training interventions have the potential to improve maternity care, but better implementation is required. Unintended consequences, including overuse of technology, are possible.

4D.10: CHANGES IN PWV IN PREVIOUSLY UNTREATED MILD HYPERTENSIVES ARE RELATED TO REDUCTION OF BLOOD PRESSURE BY TREATMENT.

PubMed

Rodilla Sala, E; Millasseau, S; Escrivá, M; García, J; Costa, J A; Pascual, J M

2015-06-01

Changes in target organ lesions, even beyond reduction of blood pressure, have been shown to have predictive value. Destiffening of arterial damage seems to be possible but the mechanisms are still elusive. We report changes in pulse wave velocity (PWV) after one year of treatment in new diagnosed previously untreated, hypertensive patients. We included in this longitudinal study 356 consecutive, never-treated patients with suspected hypertension. After standard clinical assessment, including ambulatory blood pressure monitoring (ABPM), pulse wave analysis and PWV (Sphygmocor®, AtcorMedical), 231 showed elevated office and/or ambulatory blood pressure (BP) and received monotherapy treatment accordingly. 125 patients who showed to be normotensive, served as control group. Clinical assessment was repeated after a median of 1.1 years in the whole cohort. PWV was adjusted to BP. In the whole group, 179 patients were female (50.3%), mean age was 48.8 ± 12years. The hypertensive diagnosed group tended to be older (50 vs. 46 years, p < 0,001) and had higher PWV even after mean BP adjustment (8.6 ± 2.0 vs. 8.0 ± 1.4 m/s, p < 0.001), higher baseline office, ambulatory and central BP (145/86, 136/86 and 138/87 mmHg vs. 125/75, 120/76 and 120/79, respectively, p < 0,001). After 1 year of treatment, BP was significantly improved only in the hypertensive group (follow-up office, ambulatory and central BP 128/75, 124/78, 121/79 mmHg, pintragroup < 0.001) and remained constant in the control group (126/74, 120/76, 120/80, pintragroup = ns). The reduction of central and peripheral systolic BP in the hypertensive group was of the same magnitude (-17 vs -17 mmHg, p = ns). PWV was significantly reduced in both groups even after BP adjustment, at follow-up they were similar between groups (7.8 vs. 7.7, p = ns). The reduction of adjusted PWV was significantly higher in the hypertensive group (Delta = 0.86 vs. 0,20 m/s, p = 0.001). There was no differential effect in PWV reduction depending on antihypertensive class, except for patients treated with nebivolol. Blood pressure reduction in newly diagnosed stage 1 hypertensive patients improves PWV within a year of treatment, confirming that rapid tight control of BP is important even in mild hypertensives. Of note, arterial destiffening seems to go beyond BP reductions.

Clinical Research on the Comprehensive Curative Effect of Acupuncture and Traditional Chinese Medicine for Pelvic Inflammatory Sequelae.

PubMed

Mao, Penyuan; Liu, Shujie; Xue, Jianguo; Wu, Yuejun; Wang, Changqing

2018-05-08

BACKGROUND This randomized, controlled trial was designed to assess whether acupuncture plus an oral administration of Chinese herbal medicine provides greater relief of symptoms than oral administration of Chinese herbal medicine alone for treatment of pelvic inflammatory sequelae. MATERIAL AND METHODS Sixty-two patients ages 22 to 45 years with pelvic inflammatory sequelae were randomly assigned into one of 2 groups: an herbal group (n=30) and an herbal with acupuncture group (n=32). Both groups were treated for 3 courses of 3 months each. RESULTS Significant improvement of clinical symptoms and signs of pelvic inflammatory sequelae occurred in both treatment groups. The total effective rate for the herbal group was 83.33%, and for the herbal with acupuncture group it was 100% ([i]P[/i]=0.354 for difference between groups). During treatment, 5 patients had adverse reactions of nausea, loss of appetite, and diarrhea. After adjustment of the herb prescription, all adverse reactions disappeared. CONCLUSIONS Our results highlight the benefit of oral administration of Chinese herbal medicine along with acupuncture; this had a greater clinical curative effect rate than oral administration of Chinese herbal medicine alone when treating pelvic inflammatory sequelae.

Chief medical clinic manager of a university OB/GYN clinic--an innovative job description as management response for increase of profitability, quality of care, and physicians' freedom of action.

PubMed

Jacobs, Volker R; Mallmann, Peter

2010-01-01

Leadership structures in German clinics are adjusting parallel to DRG (diagnose-related groups)-induced economic reorientation of the health care system. A Chief Medical Clinic Manager (CMCM) is a new job description and an innovative approach to combine medical competence and business economics at the operational level of care. The ideal qualification is a medical specialist in the clinical field with practical experience in patient care and leadership as well as in hospital economics and quality control. A CMCM is placed at a superior level in the clinic, with authorizing competence for the entire physician team. Main tasks are cost transparency within the clinic, organizational development by structured processes, and financial and strategic controlling of all business aspects. A CMCM induces change management and financial adjustment of care to reimbursement with maintaining the standard of care. In cooperation with the director of the clinic, a CMCM develops a vision for clinic development, an investment strategy, and a business plan. The success parameters are positive operative results of the clinic, cost-covering care, increased investment rate, employee satisfaction, and implementation of innovations in research and therapy. A CMCM thereby increases financial and organizational freedom of action at the clinic level in a non-profit public health care system.

Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial.

PubMed

Homayouni, Kaynoosh; Foruzi, Shima; Kalhori, Fereshte

2016-09-01

Pes anserinus tendino-bursitis is a condition caused by repetitive friction over the bursa or direct trauma to knee joint and it presents with proximal medial tibial pain and swelling. The aim of this study is to determine the effects of kinesiotaping in comparison with naproxen and physical therapy in treatment of pes anserinus tendino-bursitis. In a randomized comparative clinical trial 56 patients with clinical diagnosis of pes anserinus tendino-bursitis were randomly assigned to kinesiotaping and naproxen/physical therapy (28 patients in each group). Kinesiotaping on the tender area in the form of space-correction (lifting) technique was used and repeated for three times with a one-week interval. Another group received naproxen (250mg TID for 10 days) and ten sessions of daily physical therapy. The visual analog scale (VAS) was used for evaluation of pain. The depth of swelling of the area was measured with sonography before and after treatment. Wilcoxon signed ranks test has been used for determining the influence of interventions on pain (VAS) and swelling scores in each group. The ANCOVA (Analysis of covariance) test was applied for comparing the influence of interventions on VAS and swelling scores after adjustment for co-variables. At end of the study, 27 patients remained in the kinesiotaping group and 19 patients in naproxen/physical therapy group. Treatment with kinesiotaping significantly decreased the pain (P=0.0001) and swelling scores (P=0.0001) in comparison with naproxen/physical therapy after adjustment for baseline characteristics. Kinesiotaping was safe without any complications except for a mild local skin irritation in one patient. Kinesiotaping is more effective than naproxen plus physical therapy in reduction of pain and swelling in patients with pes anserinus tendino-bursitis. www.ClinicalTrials.gov identifier is NCT01680263.

Assessment of Executive Function in Patients With Substance Use Disorder: A Comparison of Inventory- and Performance-Based Assessment.

PubMed

Hagen, Egon; Erga, Aleksander H; Hagen, Katrin P; Nesvåg, Sverre M; McKay, James R; Lundervold, Astri J; Walderhaug, Espen

2016-07-01

Chronic polysubstance abuse (SUD) is associated with neurophysiological and neuroanatomical changes. Neurocognitive impairment tends to affect quality of life, occupational functioning, and the ability to benefit from therapy. Neurocognitive assessment is thus of importance, but costly and not widely available. Therefore, in a busy clinical setting, procedures that include readily available measures targeting core cognitive deficits would be beneficial. This paper investigates the utility of psychometric tests and a questionnaire-based inventory to assess "hot" and "cold" neurocognitive measures of executive functions (EF) in adults with a substance use disorder. Hot decision-making processes are associated with emotional, affective, and visceral responses, while cold executive functions are associated with rational decision-making. Subjects with polysubstance abuse (n=126) and healthy controls (n=32) were compared on hot (Iowa Gambling Task) and cold (Stroop and the Trail Making Test) measures of EF, in addition to a questionnaire assessing everyday EF related problems (BRIEF-A; Behavior Rating Inventory of Executive Function - Adult, self-report version). Information about the substance abuse and social adjustment were assessed by self-report. Logistic regression analyses were applied to assess independent correlates of SUD status and social adjustment. A multiple linear regression was performed to predict the number of previous treatment attempts. The psychometric test of hot EF (the Iowa Gambling Task) did not differentiate the patients with polysubstance abuse from controls, and was not associated with social adjustment. The psychometric tests of cold EF distinguished somewhat between the groups and were associated with one indicator of social adjustment. The BRIEF-A differentiated between groups on all the clinical scales and was associated with three out of five social adjustment indicators ("criminal lifestyle," "conflict with caregiver," and "stable housing."). The BRIEF-A inventory was the most sensitive measure of executive function in patients with substance use disorder, followed by measures of cold executive function. BRIEF-A should therefore be considered as an integral part of the clinical routine when assessing patients with SUD. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Study Comparing Vein Integrity and Clinical Outcomes in Open Vein Harvesting and 2 Types of Endoscopic Vein Harvesting for Coronary Artery Bypass Grafting: The VICO Randomized Clinical Trial (Vein Integrity and Clinical Outcomes)

PubMed Central

Krishnamoorthy, Bhuvaneswari; Critchley, William R.; Thompson, Alexander J.; Payne, Katherine; Morris, Julie; Venkateswaran, Rajamiyer V.; Caress, Ann L.

2018-01-01

Background Current consensus statements maintain that endoscopic vein harvesting (EVH) should be standard care in coronary artery bypass graft surgery, but vein quality and clinical outcomes have been questioned. The VICO trial (Vein Integrity and Clinical Outcomes) was designed to assess the impact of different vein harvesting methods on vessel damage and whether this contributes to clinical outcomes after coronary artery bypass grafting. Methods In this single-center, randomized clinical trial, patients undergoing coronary artery bypass grafting with an internal mammary artery and with 1 to 4 vein grafts were recruited. All veins were harvested by a single experienced practitioner. We randomly allocated 300 patients into closed tunnel CO2 EVH (n=100), open tunnel CO2 EVH (n=100), and traditional open vein harvesting (n=100) groups. The primary end point was endothelial integrity and muscular damage of the harvested vein. Secondary end points included clinical outcomes (major adverse cardiac events), use of healthcare resources, and impact on health status (quality-adjusted life-years). Results The open vein harvesting group demonstrated marginally better endothelial integrity in random samples (85% versus 88% versus 93% for closed tunnel EVH, open tunnel EVH, and open vein harvesting; P<0.001). Closed tunnel EVH displayed the lowest longitudinal hypertrophy (1% versus 13.5% versus 3%; P=0.001). However, no differences in endothelial stretching were observed between groups (37% versus 37% versus 31%; P=0.62). Secondary clinical outcomes demonstrated no significant differences in composite major adverse cardiac event scores at each time point up to 48 months. The quality-adjusted life-year gain per patient was 0.11 (P<0.001) for closed tunnel EVH and 0.07 (P=0.003) for open tunnel EVH compared with open vein harvesting. The likelihood of being cost-effective, at a predefined threshold of £20 000 per quality-adjusted life-year gained, was 75% for closed tunnel EVH, 19% for open tunnel EVH, and 6% for open vein harvesting. Conclusions Our study demonstrates that harvesting techniques affect the integrity of different vein layers, albeit only slightly. Secondary outcomes suggest that histological findings do not directly contribute to major adverse cardiac event outcomes. Gains in health status were observed, and cost-effectiveness was better with closed tunnel EVH. High-level experience with endoscopic harvesting performed by a dedicated specialist practitioner gives optimal results comparable to those of open vein harvesting. Clinical Trial Registration URL: https://www.isrctn.com. International Standard Randomised Controlled Trial Registry Number: 91485426. PMID:28637880

Pilot clinical application of an adaptive robotic system for young children with autism.

PubMed

Bekele, Esubalew; Crittendon, Julie A; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E

2014-07-01

It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. © The Author(s) 2013.

Sex-specific incidence of EGFR mutation and its association with age and obesity in lung adenocarcinomas: a retrospective analysis.

PubMed

Kim, Hye-Ryoun; Kim, Seo Yun; Kim, Cheol Hyeon; Yang, Sung Hyun; Lee, Jae Cheol; Choi, Chang-Min; Na, Im Il

2017-11-01

Age and obesity are well-known risk factors for various cancers, but the potential roles of age and obesity in lung cancer, especially in those with activating EGFR mutations, have not been thoroughly evaluated. The aim of this retrospective study is to evaluate the associations between the sex-specific incidence of EGFR mutations and age and obesity. We conducted a retrospective study based on the data from 1378 lung adenocarcinoma cases. The degree of obesity was categorized by body mass index (BMI). The associations between EGFR mutational status and clinical factors, including stage, smoking history, age group (≤45 years, 46-55, 56-65 and >65), and BMI group (<18.5 kg/m 2 , 18.5-22.9, 23.0-24.9 and ≥25.0) were analyzed using logistic regression models for each sex. In men, the incidence of EGFR mutation was inversely associated with age (adjusted odds ratio [OR] for age group = 0.76, p-trend = 0.003) and positively associated with obesity (adjusted OR for BMI group = 1.23, p-trend = 0.04). In contrast, in women, the incidence of EGFR mutation was positively associated with age (adjusted OR for age group = 1.19, p-trend = 0.02). However, the incidence of EGFR mutation was not statistically associated with obesity (adjusted OR for BMI group = 1.03, p-trend = 0.76). Our data suggests that age and obesity may contribute to the sex-specific incidence of EGFR mutation in lung adenocarcinoma in different manners.

The incidence of primary hip osteoarthritis in active duty US military servicemembers.

PubMed

Scher, Danielle L; Belmont, Philip J; Mountcastle, Sally; Owens, Brett D

2009-04-15

Although multiple studies have reported the prevalence of primary hip osteoarthritis (OA), little has been reported on incidence rates of hip OA. We sought to determine the incidence rate and demographic risk factors of hip OA in an ethnically diverse and physically active population of US military servicemembers. A query was performed using the US Defense Medical Epidemiology Database for the International Classification of Diseases, Ninth Revision, Clinical Modification code for hip OA (715.95). Multivariate Poisson regression analysis was used to estimate the rate of hip OA per 100,000 person-years, controlling for sex, race, age, rank, and service. The overall unadjusted incidence rate of hip OA was 35 per 100,000 person-years. Women, compared with men, had a significantly increased adjusted incidence rate ratio for hip OA of 1.87 (95% confidence interval [95% CI] 1.73-2.01). The adjusted incidence rate ratio for black servicemembers when compared with white servicemembers was 1.32 (95% CI 1.23-1.41). The adjusted incidence rate ratio for the > or =40-year-old age group compared with the 20-year-old group was 22.21 (95% CI 17.54-28.14). With junior officers as the referent category, junior enlisted, senior enlisted, and senior officers rank groups had a significantly increased adjusted incidence rate ratio for hip OA. With the Air Force as the referent category, each service had a significantly increased adjusted incidence rate ratio for hip OA. Female sex; black race; age > or =40 years; junior enlisted, senior enlisted, and senior officer rank groups; and military service in the Navy, Army, or Marines were all risk factors for hip OA.

The 4C framework for making reasonable adjustments for people with learning disabilities.

PubMed

Marsden, Daniel; Giles, Rachel

2017-01-18

Background People with learning disabilities experience significant inequalities in accessing healthcare. Legal frameworks, such as the Equality Act 2010, are intended to reduce such disparities in care, and require organisations to make 'reasonable adjustments' for people with disabilities, including learning disabilities. However, reasonable adjustments are often not clearly defined or adequately implemented in clinical practice. Aim To examine and synthesise the challenges in caring for people with learning disabilities to develop a framework for making reasonable adjustments for people with learning disabilities in hospital. This framework would assist ward staff in identifying and managing the challenges of delivering person-centred, safe and effective healthcare to people with learning disabilities in this setting. Method Fourth-generation evaluation, collaborative thematic analysis, reflection and a secondary analysis were used to develop a framework for making reasonable adjustments in the hospital setting. The authors attended ward manager and matron group meetings to collect their claims, concerns and issues, then conducted a collaborative thematic analysis with the group members to identify the main themes. Findings Four main themes were identified from the ward manager and matron group meetings: communication, choice-making, collaboration and coordination. These were used to develop the 4C framework for making reasonable adjustments for people with learning disabilities in hospital. Discussion The 4C framework has provided a basis for delivering person-centred care for people with learning disabilities. It has been used to inform training needs analyses, develop audit tools to review delivery of care that is adjusted appropriately to the individual patient; and to develop competencies for learning disability champions. The most significant benefit of the 4C framework has been in helping to evaluate and resolve practice-based scenarios. Conclusion Use of the 4C framework may enhance the care of people with learning disabilities in hospital, by enabling reasonable adjustments to be made in these settings.

Adjusting for case mix and social class in examining variation in home visits between practices.

PubMed

Sullivan, Caoimhe O; Omar, Rumana Z; Forrest, Christopher B; Majeed, Azeem

2004-08-01

The purpose of this study was to investigate whether adjusting for clinical case mix and social class explains more of the variation in home visits between general practices than adjusting for age and sex alone. The setting was 60 general practices in England and Wales taking part in the 1 year Fourth National Morbidity Survey. The participants comprised 349 505 patients who were registered with one of the participating general practices for at least 180 days, and who had at least one consultation during the period. The outcome measure is whether or not a patient received a home visit in that year. A clinical case mix category (morbidity class) based on 1 year's diagnostic information was assigned to each patient using the Johns Hopkins Adjusted Clinical Groups (ACG) Case Mix System. The social class measure was derived from occupation and employment status and is similar to that of the 1991 UK census. Variations in home visits between practices were examined using multilevel logistic regression models. The variability between practices before and after adjusting for clinical case mix and social class was estimated using the intracluster correlation coefficient (ICC). The overall percentage of patients receiving a home visit over the 1 year study period was 17%, and this varied from 7 to 31% across the 60 practices. The percentage of the total variation in home visits attributable to differences between practices was 2.5% [95% confidence interval (CI) 1.4-3.2%] after adjusting for age and sex. This reduced to 1.6% (95% CI 1.1-2.4%) after taking into account morbidity class. The results were similar when social class was included instead of morbidity class. Morbidity and social class together reduced variation in home visits between practices to 1.5% (95% CI 1.1-2.2%). Age, sex, social class and clinical case mix are strong determinants of home visits in the UK. Adjusting for morbidity and social class results in a small improvement in explaining the variability in home visits between practices compared with adjusting for age and sex alone. There is far more variation between patients within practices; however, it is not straightforward to examine the factors influencing this variation. In addition to morbidity and social class, there could also be other unmeasured factors such as varying patient demand for home visits, disability or differences in GP home visiting practice style that could influence the large within-practice variability observed in this study.

Diagnostic Testing and Hospital Outcomes of Children with Neurologic Impairment and Bacterial Pneumonia.

PubMed

Thomson, Joanna; Hall, Matt; Berry, Jay G; Stone, Bryan; Ambroggio, Lilliam; Srivastava, Rajendu; Shah, Samir S

2016-11-01

To assess hospital-level variability in diagnostic testing and outcomes for children with neurologic impairment hospitalized with pneumonia. A retrospective cohort study of 27 455 children ages 1-18 years with neurologic impairment hospitalized with pneumonia at 39 children's hospitals. K-means clustering was used to assign each hospital to 1 of 3 groups (termed A, B, and C) based on similar diagnostic testing patterns. Outcomes of hospital-level median length of stay (LOS), 30-day readmissions, and pneumonia-associated complications were compared while controlling for patient differences. Overall, 48.5% had comorbid complex chronic conditions, and 25.4% were assisted with medical technology. Outcomes and diagnostic testing varied across hospitals: median hospital-level LOS, 3.2 days (IQR 2.8-3.8); median readmission, 8.4% (IQR 6.8,-10.0); and median pneumonia-associated complication rate, 23.1% (IQR 18.7-26.8). Despite similar populations, hospitals in group A tended to perform fewer tests than those in groups B and C. Across hospital groups, there was a significant difference in adjusted readmission rates (group A 7.2%, group B 9.0%, group C 7.7%, P = .003). There was no significant difference in adjusted median LOS (group A 3.4 days, group B 3.2 days, group C 3.3 days, P = .3) or adjusted pneumonia-associated complication rates (group A 22.5%, group B 22.5%, group C 25.0%, P = .6). For children with neurologic impairment hospitalized with pneumonia, across hospital differences in diagnostic testing were not associated with clinically meaningful differences in outcomes. High-utilizing hospitals may be able to decrease diagnostic testing for children with neurologic impairment hospitalized with pneumonia without adversely impacting outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

The Relationship of Self-Concept, Objective Appearance and Profile Self-Perception.

ERIC Educational Resources Information Center

Korabik, Karen; Pitt, Edward J.

Two hundred seven parents of patients at the St. Louis University Orthodontic Clinic chose ideal male and female profiles from groups of five profile drawings ranging from severely retregnathic to severely prognathic. In addition, they completed a self concept questionnaire (Bills Index of Adjustment) and picked from the profile drawings of the…

Analysis of memory deficits following chemotherapy in breast cancer survivors: evidence from the doors and people test.

PubMed

Prokasheva, Svetlana; Faran, Yifat; Cwikel, Julie; Geffen, David B

2011-01-01

Studies of cognitive effects of chemotherapy among breast cancer patients show that not all women who are exposed to chemotherapy develop cognitive dysfunction and that the observed declines in cognitive functioning may be quite subtle. The use of measures that are sensitive to subtle cognitive decline are recommended yet rarely used among clinical populations. The purpose of this study is to specify the types of memory changes observed among breast cancer survivors treated with chemotherapy and tamoxifen, by using an analytic test of memory, the Doors and People test, which uses age-adjusted norms. The participants were 40 women who were survivors of breast cancer, 20 of whom had completed chemotherapy treatment and 20 women who were treated only with tamoxifen. There were no significant differences between the two groups in overall scores and in all four subtests: visual memory, verbal memory, recall, and recognition measured by age-adjusted scores. Forty percent of patients in both of the groups were classified as having mild impairment in episodic memory. No between-group differences were found in the frequency of subjective, cognitive complaints. Subjective complaints were reported by 69% of patients but were unrelated to objective performance. Memory deficits were observed in breast cancer patients who receive either chemotherapy or tamoxifen alone compared to age-adjusted norms. The Doors and People Test is a sensitive measure of memory deficits that is feasible for use with clinical populations of breast cancer patients in order to monitor changes in cognitive function.

The prevalence of obesity among clinical students in a Malaysian medical school.

PubMed

Boo, N Y; Chia, G J Q; Wong, L C; Chew, R M; Chong, W; Loo, R C N

2010-02-01

This study aimed to determine the prevalence of obesity among medical students and its relationship with their dietary intake and physical activities. This observational study was carried out on 240 medical students during the clinical phase of their medical course in a private medical school. Their body weight and height were measured, and a standardised questionnaire was used to collect information on their physical activities and dietary intake. The median body weight of the participants was 59.0 kg (interquartile range: 51.3-66.8), the mean body height was 166.1 cm (standard deviation [SD] 8.5 cm), and the mean body mass index (BMI) was 21.8 kg/m2 (SD 3.4 kg/m2). Based on the World Health Organization BMI cut-offs for the Asian population, 30.1 percent (n is equal to 72) of the students were overweight or obese, with a BMI that was equal to or greater than 23.0 kg/m2. Logistic regression analysis showed that, after controlling for various potential confounders, the only significant risk factors associated with overweight/obesity among these students were: male gender (adjusted odds ratio [OR] 2.1; 95 percent confidence intervals [CI] of 1.1 and 4.1; p is equal to 0.03), Malay ethnic group (adjusted OR 2.4; 95 percent CI 1.0 and 5.7; p is equal to 0.04), Indian ethnic group (adjusted OR 3.6; 95 percent CI 1.5 and 8.9; p is equal to 0.005), and the number of soft drinks consumed per week (adjusted OR 1.3; 95 percent CI 1.0 and 1.5; p is equal to 0.02). Skipping breakfast, the frequency of physical exercise per week, the number of hours of sleep per day, and eating noodles or roti canai (a type of Malaysian pancake) for breakfast were not significant risk factors. Obesity remains a common problem among medical students in their clinical years.

Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial.

PubMed

Ibler, Kristina Sophie; Jemec, Gregor B E; Diepgen, Thomas L; Gluud, Christian; Lindschou Hansen, Jane; Winkel, Per; Thomsen, Simon Francis; Agner, Tove

2012-12-12

To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema. Randomised, observer blinded parallel group superiority clinical trial. Three hospitals in Denmark. 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group. Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual. The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up. Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted -3.56 (95% confidence interval -4.92 to -2.14); adjusted -3.47 (-4.80 to -2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted -0.78, non-parametric test P=0.003; adjusted -0.92, -1.48 to -0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema. A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves. ClinicalTrials.gov NCT01012453.

Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

PubMed

McMillan, Matthew T; Soi, Sameer; Asbun, Horacio J; Ball, Chad G; Bassi, Claudio; Beane, Joal D; Behrman, Stephen W; Berger, Adam C; Bloomston, Mark; Callery, Mark P; Christein, John D; Dixon, Elijah; Drebin, Jeffrey A; Castillo, Carlos Fernandez-Del; Fisher, William E; Fong, Zhi Ven; House, Michael G; Hughes, Steven J; Kent, Tara S; Kunstman, John W; Malleo, Giuseppe; Miller, Benjamin C; Salem, Ronald R; Soares, Kevin; Valero, Vicente; Wolfgang, Christopher L; Vollmer, Charles M

2016-08-01

To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P < 0.00001) and octreotide (odds ratio 3.30, P < 0.00001). When adjusting for risk, performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

Impact of masked hypertension on diabetic nephropathy in patients with type II diabetes: a KAMOGAWA-HBP study.

PubMed

Ushigome, Emi; Oyabu, Chikako; Tanaka, Toru; Hasegawa, Goji; Ohnishi, Masayoshi; Tsunoda, Sei; Ushigome, Hidetaka; Yokota, Isao; Nakamura, Naoto; Oda, Yohei; Asano, Mai; Tanaka, Muhei; Yamazaki, Masahiro; Fukui, Michiaki

2018-05-01

The prognostic significance of masked hypertension (MH) on the progression of diabetic nephropathy among patients with type II diabetes is not well documented. We examined the relationship between clinic systolic blood pressure (SBP) and morning home SBP measurements and progression to macroalbuminuria in patients with type II diabetes. We analyzed prospective cohort study data from 712 patients with type II diabetes. We classified the patients into the following four groups according to their clinic (130 mm Hg) and home (125 mm Hg) SBP measurements: controlled blood pressure group, white-coat hypertension group, MH group, and sustained hypertension (SH) group. The patients were instructed to perform triplicate morning and evening blood pressure measurements for 14 consecutive days. During the 2-year follow-up period, 23 patients progressed to macroalbuminuria. The unadjusted odds ratio (95% confidence interval) for progression to macroalbuminuria among the patients with MH was significantly higher than that among the patients with controlled blood pressure (8.89 [1.06-74.88]). No significant relationship was observed between white-coat hypertension or SH and progression to macroalbuminuria. In analyses adjusted for various potential confounders, the adjusted odds ratio for progression to macroalbuminuria in the MH group was more than 8-fold higher than that in the controlled blood pressure group. MH might be a predictor of progression to macroalbuminuria among patients with type II diabetes. This rate of progression is comparable with or greater than the results reported for patients with SH. Copyright © 2018 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

Effect of Inhaled Xenon on Cerebral White Matter Damage in Comatose Survivors of Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial.

PubMed

Laitio, Ruut; Hynninen, Marja; Arola, Olli; Virtanen, Sami; Parkkola, Riitta; Saunavaara, Jani; Roine, Risto O; Grönlund, Juha; Ylikoski, Emmi; Wennervirta, Johanna; Bäcklund, Minna; Silvasti, Päivi; Nukarinen, Eija; Tiainen, Marjaana; Saraste, Antti; Pietilä, Mikko; Airaksinen, Juhani; Valanne, Leena; Martola, Juha; Silvennoinen, Heli; Scheinin, Harry; Harjola, Veli-Pekka; Niiranen, Jussi; Korpi, Kirsi; Varpula, Marjut; Inkinen, Outi; Olkkola, Klaus T; Maze, Mervyn; Vahlberg, Tero; Laitio, Timo

2016-03-15

Evidence from preclinical models indicates that xenon gas can prevent the development of cerebral damage after acute global hypoxic-ischemic brain injury but, thus far, these putative neuroprotective properties have not been reported in human studies. To determine the effect of inhaled xenon on ischemic white matter damage assessed with magnetic resonance imaging (MRI). A randomized single-blind phase 2 clinical drug trial conducted between August 2009 and March 2015 at 2 multipurpose intensive care units in Finland. One hundred ten comatose patients (aged 24-76 years) who had experienced out-of-hospital cardiac arrest were randomized. Patients were randomly assigned to receive either inhaled xenon combined with hypothermia (33°C) for 24 hours (n = 55 in the xenon group) or hypothermia treatment alone (n = 55 in the control group). The primary end point was cerebral white matter damage as evaluated by fractional anisotropy from diffusion tensor MRI scheduled to be performed between 36 and 52 hours after cardiac arrest. Secondary end points included neurological outcome assessed using the modified Rankin Scale (score 0 [no symptoms] through 6 [death]) and mortality at 6 months. Among the 110 randomized patients (mean age, 61.5 years; 80 men [72.7%]), all completed the study. There were MRI data from 97 patients (88.2%) a median of 53 hours (interquartile range [IQR], 47-64 hours) after cardiac arrest. The mean global fractional anisotropy values were 0.433 (SD, 0.028) in the xenon group and 0.419 (SD, 0.033) in the control group. The age-, sex-, and site-adjusted mean global fractional anisotropy value was 3.8% higher (95% CI, 1.1%-6.4%) in the xenon group (adjusted mean difference, 0.016 [95% CI, 0.005-0.027], P = .006). At 6 months, 75 patients (68.2%) were alive. Secondary end points at 6 months did not reveal statistically significant differences between the groups. In ordinal analysis of the modified Rankin Scale, the median (IQR) value was 1 (1-6) in the xenon group and 1 (0-6) in the control group (median difference, 0 [95% CI, 0-0]; P = .68). The 6-month mortality rate was 27.3% (15/55) in the xenon group and 34.5% (19/55) in the control group (adjusted hazard ratio, 0.49 [95% CI, 0.23-1.01]; P = .053). Among comatose survivors of out-of-hospital cardiac arrest, inhaled xenon combined with hypothermia compared with hypothermia alone resulted in less white matter damage as measured by fractional anisotropy of diffusion tensor MRI. However, there was no statistically significant difference in neurological outcomes or mortality at 6 months. These preliminary findings require further evaluation in an adequately powered clinical trial designed to assess clinical outcomes associated with inhaled xenon among survivors of out-of-hospital cardiac arrest. clinicaltrials.gov Identifier: NCT00879892.

Hypercalcemia and hypophosphatemia among preterm infants receiving aggressive parenteral nutrition.

PubMed

Brener Dik, Pablo H; Galletti, María F; Bacigalupo, Leticia T; Fernández Jonusas, Silvia; L Mariani, Gonzalo

2018-06-01

Aggressive parenteral nutrition is the standard of care among very-low-birth weight preterm infants. However, in recent studies, its impact on short-term outcomes, has been evaluated. The objective was to compare the prevalence of hypercalcemia and hypophosphatemia among preterm infants receiving aggressive or standard parenteral nutrition. Observational, retrospective study comparing a group of preterm infants weighing less than 1250 grams who received aggressive parenteral nutrition with a historical control group. The prevalence of hypercalcemia was estimated and its association with aggressive parenteral nutrition was searched adjusting by confounders. The mean phosphate level was estimated for the control group by linear regression and was compared to the value in the other group. Forty patients per group were included. The prevalence of hypercalcemia was higher in the group who received aggressive parenteral nutrition (87.5% versus 35%, p= 0.001). Aggressive parenteral nutrition was associated with hypercalcemia when adjusting by birth weight, intrauterine growth restriction, amino acid, and calorie intake (adjusted odds ratio: 21.8, 95% confidence interval [CI]: 3.7-128). The mean calcium level was different between both groups (p= 0.002). Infants who received aggressive parenteral nutrition had more sepsis without reaching statistical significance and the mean phosphate level was lower than that estimated for the control group (p= 0.04). The prevalence of hypophosphatemia in this group was 90% (95% CI: 76-97%). Our data show an association between hypercalcemia/hypophosphatemia and aggressive parenteral nutrition. It is recommended to frequently monitor calcium and phosphate levels since they might be associated with adverse clinical outcomes. Sociedad Argentina de Pediatría.

Clinical Implications for Muscle Strength Differences in Women of Different Age and Racial Groups: The WIN Study.

PubMed

Trudelle-Jackson, Elaine; Ferro, Emerenciana; Morrow, James R

2011-01-01

BACKGROUND: Reduction in muscle strength is strongly associated with functional decline in women, and women with lower quadriceps strength adjusted for body weight are more likely to develop knee osteoarthritis. OBJECTIVE: To compare body weight--adjusted strength among women of different age/racial groups. STUDY DESIGN: Cross-sectional study of muscle strength in 918 women aged 20--83 (M ± SD = 52 ± 13). METHODS: An orthopedic examination was conducted including measurement of handgrip and lower extremity strength (hip abductors/external rotators, knee flexors/extensors). Data were grouped into young (20--39 years, n = 139), middle (40--54 years, n = 300), and older (55+ years, n = 424) ages for white (n = 699) and African American (AA) (n = 164) women. Means and standard deviations for strength adjusted for body weight were calculated for each age and racial group and compared using 2-way multivariate analysis of variance and post hoc tests. RESULTS: No significant age-by-race interaction (P = .092) but significant main effects for age and race (P < .001). Pairwise comparisons revealed significant differences in knee extensor and flexor strength between all age groups. For grip and hip external rotator strength, significant differences were found between the middle and older groups. Differences in hip abductor strength were found between the young and middle-aged groups. AA women had lower strength than white women in all muscle groups (P < .05) except hip external rotators. CONCLUSIONS: Strength decreased with age in all muscle groups but magnitude of decrease varied by muscle. Strengthening programs should target different muscles, depending on a woman's age and race.

Etifoxine versus alprazolam for the treatment of adjustment disorder with anxiety: a randomized controlled trial.

PubMed

Stein, Dan J

2015-01-01

Adjustment disorder with anxiety (ADWA) is a highly prevalent condition, particularly in primary care practice. There are relatively few systematic treatment trials in the area of ADWA, and there are few data on predictors of treatment response. Etifoxine is a promising agent insofar as it is not associated with dependence, but in primary care settings benzodiazepines continue to be frequently prescribed for psychiatric symptoms. A randomized controlled trial of etifoxine versus alprazolam for ADWA was undertaken, focusing on efficacy and safety measures, and including an investigation of predictors of clinical response. This was a comparative, multicenter, double-blind, randomized trial in two parallel groups of outpatients with ADWA. One group was treated with 150 mg/day for etifoxine, and the other with 1.5 mg/day for alprazolam for 28 days. Patients were followed for 4 weeks of treatment, and for an additional week after treatment discontinuation. The primary outcome measure was the Hamilton Anxiety Rating Scale (HAM-A), while secondary outcome measures included the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Change Scale (CGI-C), and the Self-Report for the Assessment of Adjustment Disorders. Non-inferiority analysis was used to assess the primary outcome measure, and a multivariate logistic regression was employed to investigate predictors of response. Two hundred and two adult outpatients with ADWA were enrolled at 17 primary care sites. One hundred and seventy seven patients completed the study (n = 87 in the etifoxine group; n = 90 in the alprazolam group). Etifoxine and alprazolam were accompanied by decreases in the HAM-A at day 28, with a difference between treatment groups in HAM-A score of 1.78 [90% CI; 0.23, 3.33] in favor of alprazolam. However, after medication discontinuation, HAM-A scores continued to improve in the etifoxine group, but increased in the alprazolam group; the difference between groups in mean change between day 28 and day 35 was significant (p = 0.019). Secondary outcome measures showed similar results for etifoxine and alprazolam at day 35. More treatment-related adverse events were reported in patients treated with alprazolam, particularly central nervous system-related AEs, and especially after medication discontinuation. No significant predictors of treatment response were found. This randomized controlled trial provides support for the efficacy and safety of etifoxine in the management of adjustment disorder with anxiety, particularly when treatment discontinuation data are also assessed. Etifoxine has the important clinical advantage of having anxiolytic effects, which are not being associated with dependence. Pharmacotherapy was equally efficacious in patients with more severe anxiety symptoms at baseline. Additional work using longer-term follow-up and collecting data on cost-efficiency of management options would further advance the field of ADWA. Sponsorship and article processing charges for this study were provided by Biocodex, Gentilly, France.

Clinical factors associated with failed trials of labor in late preterm and term twin pregnancies.

PubMed

Ko, Hyun-Joo; Jun, Jong Kwan

2014-07-01

To evaluate the perinatal outcomes and clinical factors of unsuccessful trials of labor (TOLs) in late preterm and term twin pregnancies. We enrolled 896 consecutive twin pregnancies delivered between 1999 and 2012 in a single center, which met the following inclusion criteria: a vertex first twin, live twins, and attempted TOLs after 34 weeks. Obstetric characteristics and perinatal outcomes were compared between vaginal delivery and cesarean delivery groups. Successful TOLs were carried out in 81% (726/896). Failed TOLs occurred in 15% (37/247) of late preterm twins and 20% (133/649) of term twins. Comparisons of neonatal outcomes between the groups showed no significant differences in NICU admission, ventilator use, and composite morbidity. On univariable analysis, nulliparity, preeclampsia, induced labor, excessive weight gain, and intertwin weight discordance of >30% showed significant associations with failed TOLs. Multivariable analyses revealed nulliparity (adjusted odds ratio 9.89, 95% confidence interval 4.64-21.1) and preeclampsia (adjusted odds ratio 2.17, 95% confidence interval 1.30-3.63) as significantly associated with failed TOLs. In late preterm and term twins, trials of labor can be performed successfully without a significant increase in adverse neonatal outcomes. Nulliparity and preeclampsia are clinical factors associated with failed TOLs in twin pregnancies.

The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

PubMed Central

Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

2015-01-01

Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

Exploring the Relationship Between Resilience and Ostomy Adjustment in Adults With a Permanent Ostomy.

PubMed

Scardillo, Jody; Dunn, Karen S; Piscotty, Ronald

2016-01-01

The aims of this study were to describe the relationship between resilience and ostomy adjustment in adults with permanent stomas and to determine if participants who report higher levels of resilience also report higher levels of adjustment to a permanent ostomy. Descriptive, correlational research design utilizing the Roy Adaptation Model as the theoretical framework was used. Persons with permanent stomas were recruited from ostomy support groups on the East Coast of the United States. The study sample included 48 respondents. Their mean age was 66 ± 12.7 years (mean ± SD); the majority (60.4%) were women, had an ileostomy (62.5%), and had a history of inflammatory bowel disease (62.5%). Respondents completed a questionnaire that queried demographic and pertinent clinical data, along with 2 previously validated instruments, the Resilience Scale and Ostomy Adjustment Inventory-23. The relationships between levels of resilience, levels of adjustment to an ostomy, and demographic characteristics were examined. Participants with higher levels of ostomy adjustment had higher levels of resilience than respondents who reported lower levels of ostomy adjustment (r = 0.65, P ≤ .01). Findings from this study suggest that higher levels of resilience facilitate adjustment to a permanent ostomy.

Effectiveness of nurse home-visiting for disadvantaged families: results of a natural experiment

PubMed Central

Sawyer, Michael Gifford; Frost, Linda; Bowering, Kerrie; Lynch, John

2013-01-01

Objective To evaluate the effects of a postnatal home-visiting programme delivered by community health nurses to socially disadvantaged mothers in South Australia. Design The intervention group of 428 mothers lived in metropolitan Adelaide and the comparison group of 239 mothers lived in regional towns where the programme was not yet available. All participating mothers met health service eligibility criteria for enrolment in the home-visiting programme. Participants in both groups were assessed at baseline (mean child age=14.4 weeks SD=2.3), prior to programme enrolment, and again when the children were aged 9, 18 and 24 months. Setting State-wide community child health service. Participants 667 socially disadvantaged mothers enrolled consecutively. 487 mothers (73%) completed the 24-month assessment. Intervention Two-year postnatal home-visiting programme based on the Family Partnership Model. Primary outcome measures Parent Stress Index (PSI), Kessler Psychological Distress Scale and the Ages and Stages Questionnaire. Results Mixed models adjusting for baseline differences were used to compare outcomes in the two groups. The mothers in the home-visiting group reported greater improvement on the PSI subscales assessing a mother's perceptions on the quality of their relationship with their child (1.10, 95% CI 0.06 to 2.14) and satisfaction with their role as parents (0.46, 95% CI −0.15 to 1.07) than mothers in the comparison group. With the exception of childhood sleeping problems, there were no other significant differences in the outcomes across the two groups. Conclusions The findings suggest that home-visiting programmes delivered by community health nurses as part of routine clinical practice have the potential to improve maternal–child relationships and help mothers adjust to their role as parents. Clinical Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12608000275369. PMID:23619089

Contemporary Treatment Patterns and Outcomes for Clinical Stage IS Testicular Cancer.

PubMed

Kamran, Sophia C; Seisen, Thomas; Markt, Sarah C; Preston, Mark A; Trinh, Quoc-Dien; Frazier, Lindsay A; Choueiri, Toni K; Martin, Neil E; Nguyen, Paul L; Beard, Clair J

2018-02-01

Controversy exists regarding the optimal management strategy for clinical stage IS seminomatous (SGCT) and nonseminomatous germ cell tumors (NSGCT) of the testis. To assess contemporary treatment patterns and outcomes for clinical stage IS testicular cancer. Using the National Cancer Data Base (2004-2012), we identified 1362 patients with clinical stage IS SGCT and NSGCT of the testis, treated with either adjuvant treatment (AT) or observation. We calculated the annual percent change (APC) to assess treatment trends. Inverse probability of treatment weighting (IPTW)-adjusted Kaplan-Meier curves and Cox regression analyses were used to compare overall survival (OS) between AT and observation groups. Analyses were stratified by histologic type. Overall, there were 581 (43%) and 781 (57%) men with SGCT and NSGCT, respectively. Among men with SGCT, the use of AT decreased over the study period (APC=-2.7, 95% confidence interval [CI]: -4.4, -1.1, p=0.001). The 5-yr IPTW-adjusted rates of OS were 99% and 97% in the AT and observation groups, respectively (hazard ratio = 0.36, 95% CI: 0.12, 1.14, p=0.08). Among men with NSGCT, the use of AT remained stable over the study period (APC = +0.8, 95% CI: -0.7, +2.2, p=0.29). The 5-yr IPTW-adjusted rates of OS were 97% and 95% in the AT and observation groups, respectively (HR=0.66, 95% CI: 0.27, 1.61, p=0.36). Limitations include the lack of full treatment details and cancer-specific survival information. Trends in the use of AT significantly decreased over time for SGCT, while it remained stable for NSGCT. Nonetheless, we report 5-yr OS rates of ≥95% for both histologies without any significant benefit with the use of AT. Further studies are warranted to confirm these findings. We evaluated treatment trends and outcomes for stage IS testicular cancer. We found that treatment changed over time for seminoma and remained stable for nonseminoma; there was no significant survival benefit in the use of adjuvant treatment versus observation for both seminomatous and nonseminomatous germ cell tumors. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Temperature control during therapeutic moderate whole-body hypothermia for neonatal encephalopathy.

PubMed

Strohm, B; Azzopardi, D

2010-09-01

The precision of temperature control achieved in clinical practice during therapeutic hypothermia in neonates has not been described. The hourly rectal temperature recordings from 17 infants treated with servo controlled and an equal number treated with manually adjusted cooling equipment were examined. The target rectal temperature for all infants is 33.5 degrees C for 72 h. During 6 to 72 h after start of cooling, the mean (95% CI, variance) of the averaged rectal temperatures was 33.6 degrees C (95% CI 33.4 degrees C to 33.8 degrees C, 0.1 degrees C) in the manually adjusted group and 33.4 degrees C (95% CI 33.3 degrees C to 33.5 degrees C, 0.04 degrees C) in the servo controlled group (means, p=0.08; equality of variance, p=0.03). The variance was also significantly different between infant groups during 1 to 5 h after start of cooling, p=0.01, but not during rewarming. The rectal temperature can be maintained close to the target temperature with either manually adjusted or servo controlled equipment, but there is less temperature variability with the servo controlled system in use in the UK.

Does measuring BHR add to guideline derived clinical measures in determining treatment for patients with persistent asthma?

PubMed

Koenig, Steven M; Murray, John J; Wolfe, James; Andersen, Leslie; Yancey, Steve; Prillaman, Barbara; Stauffer, John; Dorinsky, Paul

2008-05-01

Little is known about the use of biomarkers in guiding treatment decisions in routine asthma management. The objective of this study was to determine whether adding a LABA to an ICS would control bronchial hyperresponsiveness (BHR) at an overall lower dose of ICS when titration of medication was based upon the assessment of routine clinical measures with or without the measurement of BHR. After a 2-week run-in period, subjects (> or = 12 years) were randomized to one of three treatment groups. Two groups followed a BHR treatment strategy (based on clinical parameters [lung function, asthma symptoms, and bronchodilator use] and BHR) and were treated with either fluticasone propionate/salmeterol (FSC(BHR) group) or fluticasone propionate (FP(BHR) group) (n=156 each). The third group followed a clinical treatment algorithm (based on clinical parameters alone) and were treated with fluticasone propionate (FP(REF) group; n=154). All treatments were administered via Diskus. Treatment doses were adjusted as needed every 8 weeks for 40 weeks according to the subject's derived severity class, which was based on clinical measures of asthma control with or without BHR. The mean total daily inhaled corticosteroids (ICS) dose during the double-blind treatment period was lower, although not statistically significant, in the FSC(BHR) group compared with the FP(BHR) group (a difference of -42.9 mcg; p=0.07). Compared with the FP(REF) group, the mean total daily ICS dose was higher in the FSC(BHR) group (a difference of 85.2 mcg) and was significantly higher in the FP(BHR) group (a difference of 131.2 mcg, p=0.037). This study demonstrated that for most subjects, control of BHR was maintained when treatment was directed toward control of clinical parameters. In addition, there was a trend towards control of BHR and clinical measures at a lower dose of ICS when used concurrently with salmeterol.

Ethnic Minority Status, Depression, and Cognitive Failures in Relation to Marital Adjustment in Ethnically Diverse Older Women

PubMed Central

Laganá, Luciana; Spellman, Therese; Wakefield, Jennifer; Oliver, Taylor

2014-01-01

The authors investigated the relationship between marital adjustment and ethnic minority status, depressive symptomatology, and cognitive failures among 78 married, community-dwelling, and predominantly non-European-American older women (ages 57–89). Respondents were screened to rule out dementia. Level of depressive symptoms, self-report of cognitive failures, and marital adjustment were obtained. As hypothesized, higher depressive symptomatology and cognitive failures were associated with worse marital adjustment (p < .05 for both). The same was true for membership in a non-dominant ethnic group, albeit only when ethnic status was considered outside the context of the other two independent variables. These results have clinical implications and fit within the theoretical framework of the socioemotional selectivity theory (Carstensen, 1992) applied to marriage in older age, a conceptualization formulated by Bookwala and Jacobs in 2004. PMID:25632173

Neighborhood socioeconomic disadvantage and 30-day rehospitalization: a retrospective cohort study.

PubMed

Kind, Amy J H; Jencks, Steve; Brock, Jane; Yu, Menggang; Bartels, Christie; Ehlenbach, William; Greenberg, Caprice; Smith, Maureen

2014-12-02

Measures of socioeconomic disadvantage may enable improved targeting of programs to prevent rehospitalizations, but obtaining such information directly from patients can be difficult. Measures of U.S. neighborhood socioeconomic disadvantage are more readily available but are rarely used clinically. To evaluate the association between neighborhood socioeconomic disadvantage at the census block group level, as measured by the Singh validated area deprivation index (ADI), and 30-day rehospitalization. Retrospective cohort study. United States. Random 5% national sample of Medicare patients discharged with congestive heart failure, pneumonia, or myocardial infarction between 2004 and 2009 (n = 255,744). Medicare data were linked to 2000 census data to construct an ADI for each patient's census block group, which were then sorted into percentiles by increasing ADI. Relationships between neighborhood ADI grouping and 30-day rehospitalization were evaluated using multivariate logistic regression models, controlling for patient sociodemographic characteristics, comorbid conditions and severity, and index hospital characteristics. The 30-day rehospitalization rate did not vary significantly across the least disadvantaged 85% of neighborhoods, which had an average rehospitalization rate of 21%. However, within the most disadvantaged 15% of neighborhoods, rehospitalization rates increased from 22% to 27% with worsening ADI. This relationship persisted after full adjustment, with the most disadvantaged neighborhoods having a rehospitalization risk (adjusted risk ratio, 1.09 [95% CI, 1.05 to 1.12]) similar to that of chronic pulmonary disease (adjusted risk ratio, 1.06 [CI, 1.04 to 1.08]) and greater than that of uncomplicated diabetes (adjusted risk ratio, 0.95 [CI, 0.94 to 0.97]). No direct markers of care quality or access. Residence within a disadvantaged U.S. neighborhood is a rehospitalization predictor of magnitude similar to chronic pulmonary disease. Measures of neighborhood disadvantage, such as the ADI, could potentially be used to inform policy and care after hospital discharge. National Institute on Aging and University of Wisconsin School of Medicine and Public Health's Institute for Clinical and Translational Research and Health Innovation Program.

Gender differences in psychotic disorders with concurrent substance use.

PubMed

Caton, Carol L M; Xie, Haiyi; Drake, Robert E; McHugo, Gregory

2014-01-01

We conducted a comparative analysis of gender differences in patients with primary psychotic disorders with concurrent substance use and in those with substance-induced psychoses. A total of 385 individuals admitted to psychiatric emergency departments with early-onset psychosis and recent substance use were interviewed at baseline and at six-month intervals for two years. Using a standardized research diagnostic assessment instrument, we classified patients at baseline into primary and substance-induced psychosis groups and analyzed the effects of gender on demographic, family, and clinical characteristics at baseline, the interaction of gender and diagnosis, and gender main effects on illness course, adjustment, and service use over the two-year follow-up period. Women had better premorbid adjustment, less misattribution of symptoms, and a later age at onset of regular drug use compared to men. Women, however, showed greater depression and histories of abuse compared to men. Men had greater arrest histories. No interactions between gender and diagnosis were significant. Both genders in the primary and substance-induced psychosis groups showed clinical and functional improvement over the follow-up period despite the overall minimal use of mental health and substance abuse treatment services. Women and men with psychosis and substance use differ on several dimensions. Our findings suggest the need for gender-specific treatment programming across both diagnostic groups.

Occupational risk for male infertility: a case-control study of 218 infertile and 227 fertile men.

PubMed

Chia, S E; Tay, S K

2001-11-01

The aim of the study was to determine if certain occupations pose an increased risk for infertility (of no known cause) among a group of infertile men compared with a group of fertile men. A total of 640 consecutive men whose spouses were unable to conceive were recruited from an infertility clinic. Of these, 218 men (cases) were found to have no known cause for their infertility. A total of 227 men whose spouses were pregnant at the time of the study were recruited as controls. The Singapore Standard Occupational Classification was used to code the subjects' occupations. Semen parameters (density, total sperm counts, motility, viability, and normal morphology) in all of the cases were significantly poorer than those in the controls. The risk for infertility is associated with smoking adjusted odds ratio (OR) 2.85 and 95% confidence interval (CI) 1.91 to 4.24. Work, independently, is not a risk factor for infertility. Engineering technicians (adjusted OR, 2.75; 95% CI, 1.36 to 5.54), finance analysts (adjusted OR, 4.66; 95% CI, 1.90 to 11.40), corporate and computing managers (adjusted OR, 2.49; 95% CI, 1.04 to 5.98), and teachers (adjusted OR, 7.72; 95% CI, 1.86 to 32.10) were at a greater risk of infertility compared with "services and clerical workers." Using services and clerical workers as a reference group, certain occupations are at a higher risk for infertility. Higher work demands and possible electromagnetic field exposure could be contributory factors for infertility.

High Peak Estradiol/Mature Oocyte Ratio Predicts Lower Clinical Pregnancy, Ongoing Pregnancy, and Live Birth Rates in GnRH Antagonist Intracytoplasmic Sperm Injection Cycles.

PubMed

Sandoval, Juan S; Steward, Ryan G; Chen, Chen; Li, Yi-Ju; Price, Thomas M; Muasher, Suheil J

2016-01-01

To define the relationship between peak estradiol (E2)/mature oocyte ratio and pregnancy outcomes in gonadotropin-releasing hormone (GnRH) antagonist intracytoplasmic sperm injection (ICSI) cycles. Retrospective cohort study in the setting of an academic reproductive medicine practice. Records from 162 fresh, autologous, GnRH antagonist ICSI cycles performed between 2009 and 2012 .were analyzed. The main outcome measures were rates of clinical pregnancy (CPR), ongoing pregnancy (OPR), and live birth (LBR). For the primary analysis, 4 groups were created based on peak E2/mature oocyte ratio (group 1: <200, group 2: 200-300, group 3: 300-400, and group 4: >400 pg/mL/oocyte). After adjusting for age, basal FSH, and the number of mature oocytes, a significantly lower OPR was seen in group 4 as compared to group I (OR 0.15, 95% CI 0.03-0.86; p=0.032) and group 3 (OR 0.17, 95% CI 0.03-0.98; p=0.048), respectively. The adjusted LBR was also significantly lower in group 4 as compared to group 1 (OR 0.15, 95% CI 0.03-0.83; p=0.030). In a secondary analysis, 3 ranges of peak E2/ mature oocyte ratio (<200, 200-400, and >400 pg/ mL/oocyte) were compared between low, normal, and high responders (<6, 6-15, and >15 mature oocytes, respectively). Clinical pregnancy rate, OPR, and LBR were all lower in normal responders when the E2/oocyte ratio exceeded 400 pg/mL/oocyte as compared to <200 pg/mL/oocyte and 200-300 pg/mL/oocyte (CPR 1% vs. 16% and 32%, respectively, p=0.017; OPR 0 vs. 15% and 27%, respectively, p=0.011; and LBR 0 vs. 13% and 26%, respectively, p=0.018). Very elevated peak E2/mature oocyte ratio is associated with a lower CPR, OPR, and LBR in fresh, autologous, GnRH antagonist ICSI cycles.

Different yet similar: Examining race and ethnicity in treatment-seeking adults with binge eating disorder.

PubMed

Lydecker, Janet A; Grilo, Carlos M

2016-01-01

This study examined racial/ethnic differences in demographic variables and the clinical presentation of treatment-seeking adults with binge eating disorder (BED) who participated in treatment research at a medical school-based program. Participants were 775 (n = 195 men, n = 560 women) treatment-seeking adults with DSM-IV-defined BED who self-identified as Black (n = 121), Hispanic (n = 54), or White (n = 580). Doctoral-level research clinicians assessed participants for BED and for eating disorder psychopathology using the Structured Clinical Interview for DSM-IV Disorders and the Eating Disorder Examination (EDE) interview, and measured height and weight. Participants also completed established self-report measures. Black participants had a greater proportion of women than White participants and White participants had higher education than Black and Hispanic participants. Black participants had higher body mass index (BMI) and reported more frequent binge eating episodes than White participants but eating-disorder psychopathology (EDE scales and Global Severity) did not significantly differ across racial/ethnic groups. Black participants had lower levels of depression than Hispanic and White participants. These differences in clinical presentation remained unchanged after adjusting for age, education, sex, and BMI. White participants had younger ages of onset for dieting, binge eating, and obesity, but not BED, than Black and Hispanic participants. There are some racial/ethnic differences in the developmental trajectories and clinical presentation of treatment-seeking adults with BED that remain unchanged after adjusting for demographic differences. Black participants presented for treatment with higher BMI and binge eating frequency than White participants and with lower depression than White and Hispanic groups, but associated eating disorder psychopathology levels were similar across racial/ethnic groups. (c) 2015 APA, all rights reserved).

Inflammation in Schizophrenia: Cytokine Levels and Their Relationships to Demographic and Clinical Variables.

PubMed

Lee, Ellen E; Hong, Suzi; Martin, Averria Sirkin; Eyler, Lisa T; Jeste, Dilip V

2017-01-01

Inflammation may play a role in the accelerated physical aging reported in schizophrenia, though biomarker findings and associations with demographic and clinical factors are inconsistent. In a cross-sectional, case-control design, 95 outpatients with schizophrenia (mean age ± SD: 48.1 ± 10.2 years) and 95 demographically comparable healthy comparison subjects (HCs) (mean age ± SD: 48.1 ± 12.1 years) were studied. Sociodemographic and clinical data were collected, and plasma levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and interferon-γ (IFN-γ) were assayed. The authors compared cytokine levels, examined demographic and clinical associations, and adjusted for relevant variables with linear models. Individuals with schizophrenia had higher levels of TNF-α and IL-6 but not IFN-γ than HCs. Age was not related to cytokine levels, and age relationships did not differ between diagnostic groups. Women had higher levels of IL-6. TNF-α and IL-6 levels were significantly correlated with depressive symptoms, and adjustment for depression reduced the group effect for both. Within the HCs, TNF-α levels were associated with physical comorbidity and body mass index. IL-6 levels were significantly correlated with body mass index and within schizophrenia patients, with worse mental and physical well-being. Accounting for physical morbidity and mental well-being reduced group differences in TNF-α and IL-6 levels, respectively. Worse positive symptoms were associated with higher IL-6 levels. Higher TNF-α and IL-6 levels in schizophrenia patients were associated with depression, physical comorbidity, and mental well-being. Further longitudinal studies are warranted to assess inflammation as a potential treatment target for a subgroup of schizophrenia. Copyright © 2017 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Professional Fee Ratios for US Hospital Discharge Data.

PubMed

Peterson, Cora; Xu, Likang; Florence, Curtis; Grosse, Scott D; Annest, Joseph L

2015-10-01

US hospital discharge datasets typically report facility charges (ie, room and board), excluding professional fees (ie, attending physicians' charges). We aimed to estimate professional fee ratios (PFR) by year and clinical diagnosis for use in cost analyses based on hospital discharge data. The subjects consisted of a retrospective cohort of Truven Health MarketScan 2004-2012 inpatient admissions (n=23,594,605) and treat-and-release emergency department (ED) visits (n=70,771,576). PFR per visit was assessed as total payments divided by facility-only payments. Using ordinary least squares regression models controlling for selected characteristics (ie, patient age, comorbidities, etc.), we calculated adjusted mean PFR for admissions by health insurance type (commercial or Medicaid) per year overall and by Major Diagnostic Category (MDC), Diagnostic Related Group, Healthcare Cost and Utilization Project Clinical Classification Software, and primary International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis, and for ED visits per year overall and by MDC and primary ICD-9-CM diagnosis. Adjusted mean PFR for 2012 admissions, including preceding ED visits, was 1.264 (95% CI, 1.264, 1.265) for commercially insured admissions (n=2,614,326) and 1.177 (1.176, 1.177) for Medicaid admissions (n=816,503), indicating professional payments increased total per-admission payments by an average 26.4% and 17.7%, respectively, above facility-only payments. Adjusted mean PFR for 2012 ED visits was 1.286 (1.286, 1.286) for commercially insured visits (n=8,808,734) and 1.440 (1.439, 1.440) for Medicaid visits (n=2,994,696). Supplemental tables report 2004-2012 annual PFR estimates by clinical classifications. Adjustments for professional fees are recommended when hospital facility-only financial data from US hospital discharge datasets are used to estimate health care costs.

Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection.

PubMed

Wilcox, Mark H; Gerding, Dale N; Poxton, Ian R; Kelly, Ciaran; Nathan, Richard; Birch, Thomas; Cornely, Oliver A; Rahav, Galia; Bouza, Emilio; Lee, Christine; Jenkin, Grant; Jensen, Werner; Kim, You-Sun; Yoshida, Junichi; Gabryelski, Lori; Pedley, Alison; Eves, Karen; Tipping, Robert; Guris, Dalya; Kartsonis, Nicholas; Dorr, Mary-Beth

2017-01-26

Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively. We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population. In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, -10.1 percentage points; 95% confidence interval [CI], -15.9 to -4.3; P<0.001; MODIFY II: 16% [62 of 395] vs. 26% [97 of 378]; adjusted difference, -9.9 percentage points; 95% CI, -15.5 to -4.3; P<0.001) and was significantly lower with actoxumab plus bezlotoxumab than with placebo (MODIFY I: 16% [61 of 383] vs. 28% [109 of 395]; adjusted difference, -11.6 percentage points; 95% CI, -17.4 to -5.9; P<0.001; MODIFY II: 15% [58 of 390] vs. 26% [97 of 378]; adjusted difference, -10.7 percentage points; 95% CI, -16.4 to -5.1; P<0.001). In prespecified subgroup analyses (combined data set), rates of recurrent infection were lower in both groups that received bezlotoxumab than in the placebo group in subpopulations at high risk for recurrent infection or for an adverse outcome. The rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; the rates of sustained cure (initial clinical cure without recurrent infection in 12 weeks) were 64%, 58%, and 54%, respectively. The rates of adverse events were similar among these groups; the most common events were diarrhea and nausea. Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239 .).

Value-based contracting innovated Medicare advantage healthcare delivery and improved survival.

PubMed

Mandal, Aloke K; Tagomori, Gene K; Felix, Randell V; Howell, Scott C

2017-02-01

In Medicare Advantage (MA) with its CMS Hierarchical Condition Categories (CMS-HCC) payment model, CMS reimburses private plans (Medicare Advantage Organizations [MAOs]) with prospective, monthly, health-based or risk-adjusted, capitated payments. The effect of this payment methodology on healthcare delivery remains debatable. How value-based contracting generates cost efficiencies and improves clinical outcomes in MA is studied. A difference in contracting arrangements between an MAO and 2 provider groups facilitated an intervention-control, preintervention-postintervention, difference-in-differences approach among statistically similar, elderly, community-dwelling MA enrollees within one metropolitan statistical area. Starting in 2009, for intervention-group MA enrollees, the MAO and a provider group agreed to full-risk capitation combined with a revenue gainshare. The gainshare was based on increases in the Risk Adjustment Factor (RAF), which modified the CMS-HCC payments. For the control group, the MAO continued to reimburse another provider group through fee-for-service. RAF, utilization, and survival were followed until December 31, 2012. The intervention group's mean RAF increased significantly (P <.001), estimating $2,519,544 per 1000 members of additional revenue. The intervention increased office-based visits (P <.001). Emergency department visits (P <.001) and inpatient hospital admissions (P = .002) decreased. This change in utilization saved $2,071,293 per 1000 enrollees. By intensifying office-based care for these MA enrollees with multiple comorbidities, a 6% survival benefit with a 32.8% lower hazard of death (P <.001) was achieved. Value-based contracting can drive utilization patterns and improve clinical outcomes among chronically ill, elderly MA members.

Two Groups of University Student Women: Sexual Activity and the Use of Contraception

ERIC Educational Resources Information Center

Belanger, Kathleen; Bradley, Eleanor J.

1971-01-01

The recent reversal in the new patient constituency of the Vancouver Family Planning Clinic from a predominantly married to a single population would appear to reflect a change in social mores without a concommitant adjustment in community and professional attitudes. Almost all the women studied showed gradations of depression and insecurity, in…

Applicability of the Dual-Factor Model of Mental Health for College Students

ERIC Educational Resources Information Center

Eklund, Katie; Dowdy, Erin; Jones, Camille; Furlong, Michael

2011-01-01

This study explores the utility of a dual-factor model of mental health in which the concepts of mental illness and mental wellness are integrated. Life satisfaction, emotional symptoms, personal adjustment, and clinical symptoms were assessed with a sample of 240 college students. Participants were organized into four groups based on levels of…

Bone accretion in adolescents using the combined estrogen and progestin transdermal contraceptive method Ortho Evra: a pilot study.

PubMed

Harel, Zeev; Riggs, Suzanne; Vaz, Rosalind; Flanagan, Patricia; Harel, Dalia; Machan, Jason T

2010-02-01

To date, there are no data regarding the effect of the transdermal combined estrogen and progestin contraceptive Ortho Evra on bone mineral content (BMC) and bone mineral density (BMD). We examined the effects of transdermally delivered ethinyl estradiol and norelgestromin on whole body (WB) BMC and BMD of the hip and lumbar spine (LS) of adolescent girls. In a matched case-control study, girls (n = 5) who applied Ortho Evra for days 1-21 followed by days 22-28 free of medication for 13 cycles (about 12 months) were compared with 5 age- and ethnicity-matched control girls. Evaluations of calcium intake; bone-protective physical activity; bone densitometry (DXA, QDR 4500A, Hologic); bone formation markers serum osteocalcin (OC) and bone-specific alkaline phosphatase (BAP); bone resorption marker urinary N-telopeptide (uNTX); insulin growth factor-1 (IGF-1); and sex hormone binding globulin (SHBG) were carried out at initiation, 6 months, and 12 months. Changes from baseline were compared using mixed models, adjusting for follow-up comparisons using the Holm Test (sequential Bonferroni). There were no significant differences (SD) between groups at baseline in age, gynecologic age, WBBMC, hip BMD, and LSBMD. Girls on Ortho Evra did not change significantly in WBBMC (12-month mean increase 0.2% +/- 0.8%), whereas controls did (3.9% +/- 1.8%, P < or = .001, adjusted P = .002), with SD between the 2 groups (P = .007, adjusted P = .036). Adolescents on Ortho Evra did not change significantly in hip BMD (12-month mean increase 0.5% +/- 0.6%), whereas controls did (2.7% +/- 0.6%, P < or = .001, adjusted P = .004), with SD between the 2 groups (P = .024) prior to adjustment for multiple comparisons, but no SD after adjustment (P = .096). Similarly, although the increase in LSBMD within the control group after 12 months (mean increase 2.8% +/- 1.0%) was statistically significant (P = .009, adjusted P = .044), the change within the treatment group (12-month mean increase 0.8% +/- 0.8%) was not. However, percent LSBMD changes after 12 months did not significantly differ between the 2 groups before or after adjustment for multiple comparisons. Calcium intake and bone-protective physical activity did not significantly predict BMC and BMD changes of study participants. There was a significantly greater increase in SHBG levels in the treatment group after 6 months (P = .003, adjusted P = .013) and 12 months (P < or = .001, adjusted P < or = .001) than in controls. Changes in levels of OC, BAP, uNTX, and IGF-1 were not significantly different between the 2 groups. Ortho Evra use attenuates bone mass acquisition in young women who are still undergoing skeletal maturation. This attenuation may be attributed in part to increased SHBG levels, which reduce the concentrations of free estradiol and free testosterone that are available to interact with receptors on the bone. Clinical implications remain to be determined in studies with a larger number of adolescents. Copyright 2010 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Brief Report: Sexual Attraction and Relationships in Adolescents with Autism.

PubMed

May, Tamara; Pang, Ken C; Williams, Katrina

2017-06-01

Past research suggests more variation in sexual attraction in Autism Spectrum Disorder (ASD) using clinical samples. This study utilised a population representative group of 14/15 year olds from the Longitudinal Study of Australian Children. Ninety-four adolescents (73 males, 21 females) with ASD and 3454 (1685 males, 1675 females) without self-reported on sexual attraction and past sexual relationships. Females with ASD reported lower rates of heterosexual preference (adjusted odds ratio: 0.14, p < .001), higher rates of bisexuality (adjusted odds ratio: 6.05, p < .001) and uncertainty in attraction (adjusted odds ratio: 10.44, p < .001) compared with non-ASD females. ASD males reported fewer prior boyfriends/girlfriends. Findings confirm female adolescents with ASD have differences in sexual attraction compared with non-ASD females.

Using risk-adjustment models to identify high-cost risks.

PubMed

Meenan, Richard T; Goodman, Michael J; Fishman, Paul A; Hornbrook, Mark C; O'Keeffe-Rosetti, Maureen C; Bachman, Donald J

2003-11-01

We examine the ability of various publicly available risk models to identify high-cost individuals and enrollee groups using multi-HMO administrative data. Five risk-adjustment models (the Global Risk-Adjustment Model [GRAM], Diagnostic Cost Groups [DCGs], Adjusted Clinical Groups [ACGs], RxRisk, and Prior-expense) were estimated on a multi-HMO administrative data set of 1.5 million individual-level observations for 1995-1996. Models produced distributions of individual-level annual expense forecasts for comparison to actual values. Prespecified "high-cost" thresholds were set within each distribution. The area under the receiver operating characteristic curve (AUC) for "high-cost" prevalences of 1% and 0.5% was calculated, as was the proportion of "high-cost" dollars correctly identified. Results are based on a separate 106,000-observation validation dataset. For "high-cost" prevalence targets of 1% and 0.5%, ACGs, DCGs, GRAM, and Prior-expense are very comparable in overall discrimination (AUCs, 0.83-0.86). Given a 0.5% prevalence target and a 0.5% prediction threshold, DCGs, GRAM, and Prior-expense captured $963,000 (approximately 3%) more "high-cost" sample dollars than other models. DCGs captured the most "high-cost" dollars among enrollees with asthma, diabetes, and depression; predictive performance among demographic groups (Medicaid members, members over 64, and children under 13) varied across models. Risk models can efficiently identify enrollees who are likely to generate future high costs and who could benefit from case management. The dollar value of improved prediction performance of the most accurate risk models should be meaningful to decision-makers and encourage their broader use for identifying high costs.

Performance evaluation of inpatient service in Beijing: a horizontal comparison with risk adjustment based on Diagnosis Related Groups.

PubMed

Jian, Weiyan; Huang, Yinmin; Hu, Mu; Zhang, Xiumei

2009-04-30

The medical performance evaluation, which provides a basis for rational decision-making, is an important part of medical service research. Current progress with health services reform in China is far from satisfactory, without sufficient regulation. To achieve better progress, an effective tool for evaluating medical performance needs to be established. In view of this, this study attempted to develop such a tool appropriate for the Chinese context. Data was collected from the front pages of medical records (FPMR) of all large general public hospitals (21 hospitals) in the third and fourth quarter of 2007. Locally developed Diagnosis Related Groups (DRGs) were introduced as a tool for risk adjustment and performance evaluation indicators were established: Charge Efficiency Index (CEI), Time Efficiency Index (TEI) and inpatient mortality of low-risk group cases (IMLRG), to reflect respectively work efficiency and medical service quality. Using these indicators, the inpatient services' performance was horizontally compared among hospitals. Case-mix Index (CMI) was used to adjust efficiency indices and then produce adjusted CEI (aCEI) and adjusted TEI (aTEI). Poisson distribution analysis was used to test the statistical significance of the IMLRG differences between different hospitals. Using the aCEI, aTEI and IMLRG scores for the 21 hospitals, Hospital A and C had relatively good overall performance because their medical charges were lower, LOS shorter and IMLRG smaller. The performance of Hospital P and Q was the worst due to their relatively high charge level, long LOS and high IMLRG. Various performance problems also existed in the other hospitals. It is possible to develop an accurate and easy to run performance evaluation system using Case-Mix as the tool for risk adjustment, choosing indicators close to consumers and managers, and utilizing routine report forms as the basic information source. To keep such a system running effectively, it is necessary to improve the reliability of clinical information and the risk-adjustment ability of Case-Mix.

Does 3-Day Course of Oral Amoxycillin Benefit Children of Non-Severe Pneumonia with Wheeze: A Multicentric Randomised Controlled Trial

PubMed Central

Awasthi, Shally; Agarwal, Girdhar; Kabra, Sushil K.; Singhi, Sunit; Kulkarni, Madhuri; More, Vaishali; Niswade, Abhimanyu; Pillai, Raj Mohan; Luke, Ravi; Srivastava, Neeraj M.; Suresh, Saradha; Verghese, Valsan P.; Raghupathy, P.; Lodha, R.; Walter, Stephen D.

2008-01-01

Background WHO-defined pneumonias, treated with antibiotics, are responsible for a significant proportion of childhood morbidity and mortality in the developing countries. Since substantial proportion pneumonias have a viral etiology, where children are more likely to present with wheeze, there is a concern that currently antibiotics are being over-prescribed for it. Hence the current trial was conducted with the objective to show the therapeutic equivalence of two treatments (placebo and amoxycillin) for children presenting with non-severe pneumonia with wheeze, who have persistent fast breathing after nebulisation with salbutamol, and have normal chest radiograph. Methodology This multi-centric, randomised placebo controlled double blind clinical trial intended to investigate equivalent efficacy of placebo and amoxicillin and was conducted in ambulatory care settings in eight government hospitals in India. Participants were children aged 2–59 months of age, who received either oral amoxycillin (31–54 mg/Kg/day, in three divided doses for three days) or placebo, and standard bronchodilator therapy. Primary outcome was clinical failure on or before day- 4. Principal Findings We randomized 836 cases in placebo and 835 in amoxycillin group. Clinical failures occurred in 201 (24.0%) on placebo and 166 (19.9%) on amoxycillin (risk difference 4.2% in favour of antibiotic, 95% CI: 0.2 to 8.1). Adherence for both placebo and amoxycillin was >96% and 98.9% subjects were followed up on day- 4. Clinical failure was associated with (i) placebo treatment (adjusted OR = 1.28, 95% CI: 1.01 to1.62), (ii) excess respiratory rate of >10 breaths per minute (adjusted OR = 1.51, 95% CI: 1.19, 1.92), (iii) vomiting at enrolment (adjusted OR = 1.49, 95% CI: 1.13, 1.96), (iv) history of use of broncho-dilators (adjusted OR = 1.71, 95% CI: 1.30, 2.24) and (v) non-adherence (adjusted OR = 8.06, 95% CI: 4.36, 14.92). Conclusions Treating children with non-severe pneumonia and wheeze with a placebo is not equivalent to treatment with oral amoxycillin. Trial Registration ClinicalTrials.gov NCT00407394 PMID:18431478

Public Reporting of Primary Care Clinic Quality: Accounting for Sociodemographic Factors in Risk Adjustment and Performance Comparison.

PubMed

Wholey, Douglas R; Finch, Michael; Kreiger, Rob; Reeves, David

2018-01-03

Performance measurement and public reporting are increasingly being used to compare clinic performance. Intended consequences include quality improvement, value-based payment, and consumer choice. Unintended consequences include reducing access for riskier patients and inappropriately labeling some clinics as poor performers, resulting in tampering with stable care processes. Two analytic steps are used to maximize intended and minimize unintended consequences. First, risk adjustment is used to reduce the impact of factors outside providers' control. Second, performance categorization is used to compare clinic performance using risk-adjusted measures. This paper examines the effects of methodological choices, such as risk adjusting for sociodemographic factors in risk adjustment and accounting for patients clustering by clinics in performance categorization, on clinic performance comparison for diabetes care, vascular care, asthma, and colorectal cancer screening. The population includes all patients with commercial and public insurance served by clinics in Minnesota. Although risk adjusting for sociodemographic factors has a significant effect on quality, it does not explain much of the variation in quality. In contrast, taking into account the nesting of patients within clinics in performance categorization has a substantial effect on performance comparison.

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Clinical Characteristics of the Suicide Attempters Who Refused to Participate in a Suicide Prevention Case Management Program.

PubMed

Park, Soyoung; Choi, Kyoung Ho; Oh, Youngmin; Lee, Hae-Kook; Kweon, Yong-Sil; Lee, Chung Tai; Lee, Kyoung-Uk

2015-10-01

Case management interventions for suicide attempters aimed at helping adjust their social life to prevent reattempts have high nonparticipation and dropout rates. We analyzed the clinical characteristics of the group who refused to participate in the suicide prevention program in Korea. A total of 489 patients with a suicide attempt who visited Uijeongbu St. Mary's Hospital, the Catholic University of Korea, from December 2009 to December 2013 were analyzed. All patients were divided into the participation group (n = 262) and the refusal group (n = 227) according to their participation in the case management program. Demographic and clinical characteristics of each group were examined. Results showed that the refusal group had low risks for suicide in terms of risk factors related with psychopathologies and presenting suicide behavior. That is, the refusal group had less patients with co-morbid medical illnesses and more patients with mild severity of depression compared to the participation group. However, the refusal group had more interpersonal conflict, more isolation of social integrity, and more impaired insight about suicide attempt. The results suggest that nonparticipation in the case management program may depend upon the patient's impaired insight about the riskiness of suicide and lack of social support.

The effect of clinical characteristics and dietary habits on the relationship between education status and 5-year incidence of cardiovascular disease: the ATTICA study.

PubMed

Panagiotakos, Demosthenes B; Pitsavos, Christos; Chrysohoou, Christina; Vlismas, Konstantinos; Skoumas, Yannis; Palliou, Konstantina; Stefanadis, Christodoulos

2008-08-01

The aim of this work was to investigate whether clinical characteristics and dietary habits influence the association between education status and 5-year incidence of cardiovascular disease (CVD). From 2001 to 2002, 1,514 men and 1,528 women (>18 year) without known CVD were enrolled. In 2006, the 5-year follow-up was performed (31% participants were lost to follow-up). Development of fatal or non-fatal CVD (coronary heart disease, acute coronary syndromes, stroke, or other CVD) was defined according to WHO-ICD-10 criteria. Education status was measured in years of school, while baseline dietary habits were assessed through a semi-quantitative food-frequency questionnaire (EPIC-Greek). The Mediterranean-Diet-Score was applied to assess overall adherence to this pattern using scores of 11 food-variables and alcohol, according to the principles of the Mediterranean-diet. The 5-year incidence of CVD was 108 (11.0%) cases in men and 62 (6.1%) cases in women (P < 0.001); 32 (1.6%) of these events were fatal (21 in men). People in the low education group had significantly higher prevalence of hypertension, diabetes, and dyslipidemias, were more likely to be sedentary and smokers, compared to high group. Moreover, compared to high, people in low education group had less healthy dietary habits, as assessed using the diet score (P < 0.001). Multi-adjusted analysis revealed that low education was positively associated with 5-year incidence of CVD, after adjusting for age and sex (HR = 1.64; 95%CI 1.05-2.55); however this association lost its significance when clinical characteristics and dietary habits were taken into account (HR = 1.31; 95%CI 0.63-2.74). Low education seems to increase CVD risk, an observation that was partially explained by baseline clinical characteristics and unhealthy dietary choices of people belonging into this group.

Short-term Resource Utilization and Cost-Effectiveness of Comprehensive Geriatric Assessment in Acute Hospital Care for Severely Frail Elderly Patients.

PubMed

Ekerstad, Niklas; Karlson, Björn W; Andersson, David; Husberg, Magnus; Carlsson, Per; Heintz, Emelie; Alwin, Jenny

2018-05-18

The objective of this study was to estimate the 3-month within-trial cost-effectiveness of comprehensive geriatric assessment (CGA) in acute medical care for frail elderly patients compared to usual medical care, by estimating health-related quality of life and costs from a societal perspective. Clinical, prospective, controlled, 1-center intervention trial with 2 parallel groups. Structured, systematic interdisciplinary CGA-based care in an acute elderly care unit. If the patient fulfilled the inclusion criteria, and there was a bed available at the CGA unit, the patient was included in the intervention group. If no bed was available at the CGA unit, the patient was included in the control group and admitted to a conventional acute medical care unit. A large county hospital in western Sweden. The trial included 408 frail elderly patients, 75 years or older, in need of acute in-hospital treatment. The patients were allocated to the intervention group (n = 206) or control group (n = 202). Mean age of the patients was 85.7 years, and 56% were female. The primary outcome was the adjusted incremental cost-effectiveness ratio associated with the intervention compared to the control at the 3-month follow-up. We undertook cost-effectiveness analysis, adjusted by regression analyses, including hospital, primary, and municipal care costs and effects. The difference in the mean adjusted quality-adjusted life years gained between groups at 3 months was 0.0252 [95% confidence interval (CI): 0.0082-0.0422]. The incremental cost, that is, the difference between the groups, was -3226 US dollars (95% CI: -6167 to -285). The results indicate that the care in a CGA unit for acutely ill frail elderly patients is likely to be cost-effective compared to conventional care after 3 months. Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Ethnicity and sexual risk in heterosexual people attending sexual health clinics in England: a cross-sectional, self-administered questionnaire study.

PubMed

Coyle, Rachel Margaret; Miltz, Ada Rose; Lampe, Fiona C; Sewell, Janey; Phillips, Andrew N; Speakman, Andrew; Dhar, Jyoti; Sherr, Lorraine; Sadiq, S Tariq; Taylor, Stephen; Ivens, Daniel R; Collins, Simon; Elford, Jonathan; Anderson, Jane; Rodger, Alison

2018-03-08

In the UK, people of black ethnicity experience a disproportionate burden of HIV and STI. We aimed to assess the association of ethnicity with sexual behaviour and sexual health among women and heterosexual men attending genitourinary medicine (GUM) clinics in England. The Attitudes to and Understanding of Risk of Acquisition of HIV is a cross-sectional, self-administered questionnaire study of HIV negative people recruited from 20 GUM clinics in England, 2013-2014. Modified Poisson regression with robust SEs was used to calculate adjusted prevalence ratios (aPR) for the association between ethnicity and various sexual risk behaviours, adjusted for age, study region, education and relationship status. Questionnaires were completed by 1146 individuals, 676 women and 470 heterosexual men. Ethnicity was recorded for 1131 (98.8%) participants: 550 (48.6%) black/mixed African, 168 (14.9%) black/mixed Caribbean, 308 (27.2%) white ethnic groups, 105 (9.3%) other ethnicity. Compared with women from white ethnic groups, black/mixed African women were less likely to report condomless sex with a non-regular partner (aPR (95% CI) 0.67 (0.51 to 0.88)), black/mixed African and black/mixed Caribbean women were less likely to report two or more new partners (0.42 (0.32 to 0.55) and 0.44 (0.29 to 0.65), respectively), and black/mixed Caribbean women were more likely to report an STI diagnosis (1.56 (1.00 to 2.42)). Compared with men from white ethnic groups, black/mixed Caribbean men were more likely to report an STI diagnosis (1.91 (1.20 to 3.04)), but did not report risk behaviours more frequently. Men and women of black/mixed Caribbean ethnicity remained more likely to report STI history after adjustment for sexual risk behaviours. Risk behaviours were reported less frequently by women of black ethnicity; however, history of STI was more prevalent among black/mixed Caribbean women. In black/mixed Caribbean men, higher STI history was not explained by ethnic variation in reported risk behaviours. The association between STI and black/mixed Caribbean ethnicity remained after adjustment for risk behaviours. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effect of chronic kidney disease on warfarin management in a pharmacist-managed anticoagulation clinic.

PubMed

Kleinow, Megan E; Garwood, Candice L; Clemente, Jennifer L; Whittaker, Peter

2011-09-01

There is growing evidence that kidney disease affects hepatically cleared drugs. Accordingly, we hypothesized that chronic kidney disease (CKD) would disrupt anticoagulation of warfarin-treated patients and thereby increase the amount of management required to maintain appropriate anticoagulation. Specifically, we anticipated that more dose manipulations (both dose changes and transient dose adjustments) and shorter times between scheduled clinic visits would be required for anticoagulation patients with CKD. To determine how CKD affected warfarin maintenance dose, anticoagulation stability, the proportion of clinic visits that necessitated a dose manipulation (either a change in the prescribed weekly dose or a transient dose adjustment), and the length of time between scheduled visits in 2 pharmacist-managed anticoagulation clinics. Our retrospective, cohort chart review investigated warfarin response in anticoagulation clinic patients. From the clinic database of patients with an international normalized ratio (INR) target range of 2.0-3.0, we matched 20 of 24 patients with CKD (estimated creatinine clearance less than 60 mL per minute) to 20 comparison group patients (estimated creatinine clearance greater than 60 mL per minute) based on parameters demonstrated to affect warfarin dose: ethnicity, gender, age, body surface area, and simvastatin use. We calculated the average weekly dose used to maintain target INR (assessment period range=116-1,408 days). To evaluate anticoagulation stability and patient management, we quantified several parameters, including the percentage of total time in therapeutic range, the proportion of clinic visits that required a dose change, and the time between scheduled visits. We compared group means using t-tests, and categorical data were compared using Fisher's exact test. Our population was predominantly female (75%) and of African ancestry (95%); average age 60 years. Patients with CKD required a 24% lower dose than the comparison group (mean [SD]=35.9 [10.7] vs. 47.0 [11.2] mg per week, P=0.003) and spent less time in therapeutic range required increased clinic management versus the comparison group, as indicated by a significantly higher proportion of clinic visits at which dose changes occurred (22% vs. 12%, P<0.001) and a decreased time between scheduled visits (mean [SD] of 16.0 [3.2] days vs. 19.7 [3.4] days, respectively, P=0.001). CKD was associated with both decreased warfarin maintenance dose and decreased anticoagulation stability which, in turn, required more frequent and intensive anticoagulation clinic management.

Comparative Outcome Analysis of Penicillin-Based Versus Fluoroquinolone-Based Antibiotic Therapy for Community-Acquired Pneumonia

PubMed Central

Wang, Chi-Chuan; Lin, Chia-Hui; Lin, Kuan-Yin; Chuang, Yu-Chung; Sheng, Wang-Huei

2016-01-01

Abstract Community-acquired pneumonia (CAP) is a common but potentially life-threatening condition, but limited information exists on the effectiveness of fluoroquinolones compared to β-lactams in outpatient settings. We aimed to compare the effectiveness and outcomes of penicillins versus respiratory fluoroquinolones for CAP at outpatient clinics. This was a claim-based retrospective cohort study. Patients aged 20 years or older with at least 1 new pneumonia treatment episode were included, and the index penicillin or respiratory fluoroquinolone therapies for a pneumonia episode were at least 5 days in duration. The 2 groups were matched by propensity scores. Cox proportional hazard models were used to compare the rates of hospitalizations/emergence service visits and 30-day mortality. A logistic model was used to compare the likelihood of treatment failure between the 2 groups. After propensity score matching, 2622 matched pairs were included in the final model. The likelihood of treatment failure of fluoroquinolone-based therapy was lower than that of penicillin-based therapy (adjusted odds ratio [AOR], 0.88; 95% confidence interval [95%CI], 0.77–0.99), but no differences were found in hospitalization/emergence service (ES) visits (adjusted hazard ratio [HR], 1.27; 95% CI, 0.92–1.74) and 30-day mortality (adjusted HR, 0.69; 95% CI, 0.30–1.62) between the 2 groups. The likelihood of treatment failure of fluoroquinolone-based therapy was lower than that of penicillin-based therapy for CAP on an outpatient clinic basis. However, this effect may be marginal. Further investigation into the comparative effectiveness of these 2 treatment options is warranted. PMID:26871827

Chronic discrimination and bodily pain in a multiethnic cohort of midlife women in the Study of Women's Health Across the Nation.

PubMed

Dugan, Sheila A; Lewis, Tené T; Everson-Rose, Susan A; Jacobs, Elizabeth A; Harlow, Siobán D; Janssen, Imke

2017-09-01

A growing literature links discrimination to key markers of biobehavioral health. While racial or ethnic differences in pain are seen in experimental and clinical studies, the authors were interested in how chronic discrimination contributes to pain within multiple racial or ethnic groups over time. Participants were 3056 African American, Caucasian, Chinese, Hispanic, and Japanese women from the Study of Women's Health Across the Nation. The Everyday Discrimination Scale was assessed from baseline through 13 follow-up examinations. The bodily pain subscale of the MOS 36-Item Short-Form Health Survey (SF-36) was assessed annually. There were large racial or ethnic differences in reports of discrimination and pain. Discrimination attributions also varied by race or ethnicity. In linear mixed model analyses, initially adjusted for age, education, and pain medications, chronic everyday discrimination was associated with more bodily pain in all ethnic groups (beta = -5.84; P < 0.002 for Japanese; beta = -6.17; P < 0.001 for African American; beta = -8.74; P < 0.001 for Chinese; beta = -10.54; P < 0.001 for Caucasians; beta = -12.82; P < 0.001 for Hispanic). Associations remained significant in all ethnic groups after adjusting for additional covariates in subsequent models until adding depressive symptoms as covariate; in the final fully-adjusted models, discrimination remained a significant predictor of pain for African American (beta = -4.50; P < 0.001), Chinese (beta = -6.62; P < 0.001), and Caucasian (beta = -7.86; P < 0.001) women. In this longitudinal study, experiences of everyday discrimination were strongly linked to reports of bodily pain for the majority of women. Further research is needed to determine if addressing psychosocial stressors, such as discrimination, with patients can enhance clinical management of pain symptoms.

Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial.

PubMed

Huffman, Mark D; Mohanan, Padinhare P; Devarajan, Raji; Baldridge, Abigail S; Kondal, Dimple; Zhao, Lihui; Ali, Mumtaj; Krishnan, Mangalath N; Natesan, Syam; Gopinath, Rajesh; Viswanathan, Sunitha; Stigi, Joseph; Joseph, Johny; Chozhakkat, Somanathan; Lloyd-Jones, Donald M; Prabhakaran, Dorairaj

2018-02-13

Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016. During 5 predefined steps over the study period, hospitals were randomly selected to move in a 1-way crossover from the control group to the intervention group. Consecutively presenting patients with acute myocardial infarction were offered participation. Hospitals provided either usual care (control group; n = 10 066 participants [step 0: n = 2915; step 1: n = 2649; step 2: n = 2251; step 3: n = 1422; step 4; n = 829; step 5: n = 0]) or care using a quality improvement tool kit (intervention group; n = 11 308 participants [step 0: n = 0; step 1: n = 662; step 2: n = 1265; step 3: n = 2432; step 4: n = 3214; step 5: n = 3735]) that consisted of audit and feedback, checklists, patient education materials, and linkage to emergency cardiovascular care and quality improvement training. The primary outcome was the composite of all-cause death, reinfarction, stroke, or major bleeding using standardized definitions at 30 days. Secondary outcomes included the primary outcome's individual components, 30-day cardiovascular death, medication use, and tobacco cessation counseling. Mixed-effects logistic regression models were used to account for clustering and temporal trends. Among 21 374 eligible randomized participants (mean age, 60.6 [SD, 12.0] years; n = 16 183 men [76%] ; n = 13 689 [64%] with ST-segment elevation myocardial infarction), 21 079 (99%) completed the trial. The primary composite outcome was observed in 5.3% of the intervention participants and 6.4% of the control participants. The observed difference in 30-day major adverse cardiovascular event rates between the groups was not statistically significant after adjustment (adjusted risk difference, -0.09% [95% CI, -1.32% to 1.14%]; adjusted odds ratio, 0.98 [95% CI, 0.80-1.21]). The intervention group had a higher rate of medication use including reperfusion but no effect on tobacco cessation counseling. There were no unexpected adverse events reported. Among patients with acute myocardial infarction in Kerala, India, use of a quality improvement intervention compared with usual care did not decrease a composite of 30-day major adverse cardiovascular events. Further research is needed to understand the lack of efficacy. clinicaltrials.gov Identifier: NCT02256657.

Observational Study to Assess the Therapeutic Value of Four Ovarian Hyperstimulation Protocols in IVF After Pituitary Suppression with GnRH Antagonists in Normally Responding Women.

PubMed

Ana, Monzó; Vicente, Montañana; María, Rubio José; Trinidad, García-Gimeno; Alberto, Romeu

2011-02-22

To compare the clinical results of four different protocols of COH for IVF-ICSI in normovulatory women, using in all cases pituitary suppression with GnRH antagonists. A single center, open label, parallel-controlled, prospective, post-authorization study under the approved conditions for use where 305 normal responders women who were candidates to COH were assigned to r-FSH +hp-hMG (n = 51, Group I), hp-hMG (n = 61, Group II), fixed-dose r-FSH (n = 118, Group III), and r-FSH with potential dose adjustment (n = 75, Group IV) to subsequently undergo IVF-ICSI. During stimulation, Group IV needed significantly more days of stimulation as compared to Group II [8.09 ± 1.25 vs. 7.62 ± 1.17; P < 0.05], but was the group in which more oocytes were recovered [Group I: 9.43 ± 4.99 vs. Group II: 8.96 ± 4.82 vs. Group III: 8.78 ± 3.72 vs. Group IV: 11.62 ± 5.80; P < 0.05]. No significant differences were seen between the groups in terms of clinical and ongoing pregnancy, but among patients in whom two embryos with similar quality parameters (ASEBIR) were transferred, the group treated with hp-hMG alone achieved a significantly greater clinical pregnancy rate as compared to all other groups [Group I: 31.6%, Group II: 56.4%, Group III: 28.7%, Group IV: 32.7%; P < 0.05]. Although randomized clinical trials should be conducted to achieve a more reliable conclusion, these observations support the concept that stimulation with hp-hMG could be beneficial in normal responders women undergoing pituitary suppression with GnRH antagonists.

The effect of expedited rotator cuff surgery in injured workers: a case-control study.

PubMed

Razmjou, Helen; Lincoln, Sandra; Boljanovic, Dragana; Gallay, Stephen; Henry, Patrick; Richards, Robin R; Holtby, Richard

2017-07-01

Expediting rotator cuff surgery is expected to facilitate recovery and return to work in injured workers. This case-control study examined the effect of expedited rotator cuff surgery on recovery and work status in injured workers. Injured workers who had undergone an expedited rotator cuff surgery funded by parallel-pay insurance (study group) were compared with workers who had used the public health insurance (control group) while adjusting for sex, age, severity of pathology, and follow-up period. Disability was measured by the American Shoulder and Elbow Surgeons (ASES) Standardized Assessment Form score. The percentage of patients who exceeded the minimal clinically important difference of 17 points in the ASES was calculated. The study group waited less time to have surgery than the control group (P < .0001), reported less disability after surgery, and had a higher number of patients whose improvement exceeded the minimal clinically important difference (119 vs. 65, P < .0001). The study group was more likely to be working at the time of the final follow-up (P < .0001). The final multivariable regressions, which adjusted for unmatched variables, such as dominant side involvement, mechanism of injury, and associated operations that were different between groups, were consistent with univariable analyses indicating superior results in the study group. Injured workers who underwent expedited rotator cuff surgery reported less disability and had a more successful return to work after surgery than injured workers who waited longer for specialist assessment and surgery within the public health system. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Utilization of small changes in serum creatinine with clinical risk factors to assess the risk of AKI in critically lll adults.

PubMed

Cruz, Dinna N; Ferrer-Nadal, Asunción; Piccinni, Pasquale; Goldstein, Stuart L; Chawla, Lakhmir S; Alessandri, Elisa; Belluomo Anello, Clara; Bohannon, Will; Bove, Tiziana; Brienza, Nicola; Carlini, Mauro; Forfori, Francesco; Garzotto, Francesco; Gramaticopolo, Silvia; Iannuzzi, Michele; Montini, Luca; Pelaia, Paolo; Ronco, Claudio

2014-04-01

Disease biomarkers require appropriate clinical context to be used effectively. Combining clinical risk factors, in addition to small changes in serum creatinine, has been proposed to improve the assessment of AKI. This notion was developed in order to identify the risk of AKI early in a patient's clinical course. We set out to assess the performance of this combination approach. A secondary analysis of data from a prospective multicenter intensive care unit cohort study (September 2009 to April 2010) was performed. Patients at high risk using this combination approach were defined as an early increase in serum creatinine of 0.1-0.4 mg/dl, depending on number of clinical factors predisposing to AKI. AKI was defined and staged using the Acute Kidney Injury Network criteria. The primary outcome was evolution to severe AKI (Acute Kidney Injury Network stages 2 and 3) within 7 days in the intensive care unit. Of 506 patients, 214 (42.2%) patients had early creatinine elevation and were deemed at high risk for AKI. This group was more likely to subsequently develop the primary endpoint (16.4% versus 1.0% [not at high risk], P<0.001). The sensitivity of this grouping for severe AKI was 92%, the specificity was 62%, the positive predictive value was 16%, and the negative predictive value was 99%. After adjustment for Sequential Organ Failure Assessment score, serum creatinine, and hazard tier for AKI, early creatinine elevation remained an independent predictor for severe AKI (adjusted relative risk, 12.86; 95% confidence interval, 3.52 to 46.97). Addition of early creatinine elevation to the best clinical model improved prediction of the primary outcome (area under the receiver operating characteristic curve increased from 0.75 to 0.83, P<0.001). Critically ill patients at high AKI risk, based on the combination of clinical factors and early creatinine elevation, are significantly more likely to develop severe AKI. As initially hypothesized, the high-risk combination group methodology can be used to identify patients at low risk for severe AKI in whom AKI biomarker testing may be expected to have low yield. The high risk combination group methodology could potentially allow clinicians to optimize biomarker use.

Quantitative Assessment of Neovascularization after Indirect Bypass Surgery: Color-Coded Digital Subtraction Angiography in Pediatric Moyamoya Disease.

PubMed

Cho, H-H; Cheon, J-E; Kim, S-K; Choi, Y H; Kim, I-O; Kim, W S; Lee, S-M; You, S K; Shin, S-M

2016-05-01

For the postoperative follow-up in pediatric patients with Moyamoya disease, it is essential to evaluate the degree of neovascularization status. Our aim was to quantitatively assess the neovascularization status after bypass surgery in pediatric Moyamoya disease by using color-coded digital subtraction angiography. Time-attenuation intensity curves were generated at ROIs corresponding to surgical flap sites from color-coded DSA images of the common carotid artery, internal carotid artery, and external carotid artery angiograms obtained pre- and postoperatively in 32 children with Moyamoya disease. Time-to-peak and area under the curve values were obtained. Postoperative changes in adjusted time-to-peak (ΔTTP) and ratios of adjusted area under the curve changes (ΔAUC ratio) of common carotid artery, ICA, and external carotid artery angiograms were compared across clinical and angiographic outcome groups. To analyze diagnostic performance, we categorized clinical outcomes into favorable and unfavorable groups. The ΔTTP at the common carotid artery increased among clinical and angiographic outcomes, in that order, with significant differences (P = .003 and .005, respectively). The ΔAUC ratio at the common carotid artery and external carotid artery also increased, in that order, among clinical and angiographic outcomes with a significant difference (all, P = .000). The ΔAUC ratio of ICA showed no significant difference among clinical and angiographic outcomes (P = .418 and .424, respectively). The ΔTTP for the common carotid artery of >1.27 seconds and the ΔAUC ratio of >33.5% for the common carotid artery and 504% for the external carotid artery are revealed as optimal cutoff values between favorable and unfavorable groups. Postoperative changes in quantitative values obtained with color-coded DSA software showed a significant correlation with outcome scores and can be used as objective parameters for predicting the outcome in pediatric Moyamoya disease, with an additional cutoff value calculated through the receiver operating characteristic curve. © 2016 by American Journal of Neuroradiology.

Association of the magnitude of weight loss and changes in physical fitness with long-term cardiovascular disease outcomes in overweight or obese people with type 2 diabetes: a post-hoc analysis of the Look AHEAD randomised clinical trial.

PubMed

Gregg, Edward; Jakicic, John; Blackburn, George; Bloomquist, Paul; Bray, George; Clark, Jeanne; Coday, Mace; Curtis, Jeffrey; Egan, Caitlin; Evans, Mary; Foreyt, John; Foster, Gary; Hazuda, Helen; Hill, James; Horton, Edward; Hubbard, Van; Jeffery, Robert; Johnson, Karen; Kitabchi, Abbas; Knowler, William; Kriska, Andrea; Lang, Wei; Lewis, Cora; Montez, Maria; Nathan, David; Neiberg, Rebecca; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Redmon, Bruce; Regensteiner, Judith; Rejeski, Jack; Ribisl, Paul; Safford, Monika; Stewart, Kerry; Trence, Dace; Wadden, Thomas; Wing, Rena; Yanovski, Susan

2016-11-01

Findings from the Look AHEAD trial showed no significant reductions in the primary outcome of cardiovascular disease incidence in adults with type 2 diabetes randomly assigned to an intensive lifestyle intervention for weight loss compared with those randomly assigned to diabetes support and education (control). We examined whether the incidence of cardiovascular disease in Look AHEAD varied by changes in weight or fitness. Look AHEAD was a randomised clinical trial done at 16 clinical sites in the USA, recruiting patients from Aug 22, 2001, to April 30, 2004. In the trial, 5145 overweight or obese adults aged 45-76 years with type 2 diabetes were assigned (1:1) to an intensive lifestyle intervention or diabetes support and education. In this observational, post-hoc analysis, we examined the association of magnitude of weight loss and fitness change over the first year with incidence of cardiovascular disease. The primary outcome of the trial and of this analysis was a composite of death from cardiovascular causes, non-fatal acute myocardial infarction, non-fatal stroke, or admission to hospital for angina. The secondary outcome included the same indices plus coronary artery bypass grafting, carotid endartectomy, percutaneous coronary intervention, hospitalisation for congestive heart failure, peripheral vascular disease, or total mortality. We adjusted analyses for baseline differences in weight or fitness, demographic characteristics, and risk factors for cardiovascular disease. The Look AHEAD trial is registered with ClinicalTrials.gov, number NCT00017953. For the analyses related to weight change, we excluded 311 ineligible participants, leaving a population of 4834; for the analyses related to fitness change, we excluded 739 participants, leaving a population of 4406. In analyses of the full cohort (ie, combining both study groups), over a median 10·2 years of follow-up (IQR 9·5-10·7), individuals who lost at least 10% of their bodyweight in the first year of the study had a 21% lower risk of the primary outcome (adjusted hazard ratio [HR] 0·79, 95% CI 0·64-0·98; p=0·034) and a 24% reduced risk of the secondary outcome (adjusted HR 0·76, 95% CI 0·63-0·91; p=0·003) compared with individuals with stable weight or weight gain. Achieving an increase of at least 2 metabolic equivalents in fitness change was associated with a significant reduction in the secondary outcome (adjusted HR 0·77, 95% CI 0·61-0·96; p=0·023) but not the primary outcome (adjusted HR 0·78, 0·60-1·03; p=0·079). In analyses treating the control group as the reference group, participants in the intensive lifestyle intervention group who lost at least 10% of their bodyweight had a 20% lower risk of the primary outcome (adjusted HR 0·80, 95% CI 0·65-0·99; p=0·039), and a 21% lower risk of the secondary outcome (adjusted HR 0·79, 95% CI 0·66-0·95; p=0·011); however, change in fitness was not significantly associated with a change in the primary outcome. The results of this post-hoc analysis of Look AHEAD suggest an association between the magnitude of weight loss and incidence of cardiovascular disease in people with type 2 diabetes. These findings suggest a need to continue to refine approaches to identify individuals who are most likely to benefit from lifestyle interventions and to develop strategies to improve the magnitude of sustained weight loss with lifestyle interventions. US National Institute of Diabetes and Digestive and Kidney Diseases. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of ergonomic and education interventions to reduce occupational sitting in office-based university workers: study protocol for a randomized controlled trial.

PubMed

Radas, Antonia; Mackey, Martin; Leaver, Andrew; Bouvier, Anna-Louise; Chau, Josephine Y; Shirley, Debra; Bauman, Adrian

2013-10-12

Prolonged sitting is a specific occupational hazard in office workers. There is growing evidence that prolonged sitting is detrimental to metabolic health. The aim of this study is to determine whether providing office workers with education along with adjustable sit-stand workstations leads to reduction in sitting behavior. A randomized control trial (RCT) with three groups (one control group and two intervention groups) will be conducted in an office workplace setting. The education intervention group will receive an education package that encourages reduction in sitting behaviors. The sit-stand desk intervention group will receive the same education package along with an adjustable sit-stand desk. Participants will be included in the study if they are currently employed in a full-time academic or administrative role that involves greater than 15 hours per week or greater than 4 hours per day computer-based work. Baseline data will include participant's age, gender, weight, height, smoking habit, employment position, level of education, and baseline self-reported leisure time physical activity. The primary outcome is the average daily sedentary time during work hours, measured by an accelerometer. Participant recruitment commenced in March 2013 and will be completed by December 2013. This study will determine whether providing office workers with an adjustable sit-stand desk and individually targeted education, or education alone, is more effective in decreasing sitting behaviors than no intervention. Australian New Zealand Clinical Trials Registry: ACTRN12613000366752.

FLAIR vascular hyperintensities predict early ischemic recurrence in TIA.

PubMed

Nam, Ki-Woong; Kim, Chi Kyung; Kim, Tae Jung; Oh, Kyungmi; Han, Moon-Ku; Ko, Sang-Bae; Yoon, Byung-Woo

2018-02-27

To evaluate the relationship between fluid-attenuated inversion recovery (FLAIR) vascular hyperintensity (FVH) and early ischemic lesion recurrence (follow-up diffusion-weighted imaging [FU-DWI] [+]) in patients with lesion-negative TIA. We recruited consecutive patients with lesion-negative TIA within 24 hours of symptom onset, who underwent follow-up MRI during the acute period. FVH was defined as a focal or serpentine high signal intensity on FLAIR images. Other potential confounders were adjusted to evaluate the relationship between FVH and FU-DWI (+). Furthermore, to compare clinical outcomes between the FU-DWI (+) and FU-DWI (-) groups, we assessed 1-year recurrent ischemic stroke or TIA. Among 392 patients with lesion-negative TIA, 82 patients had FU-DWI (+) on the follow-up MRI. In the multivariate analysis, FVH remained an independent predictor of FU-DWI (+) (adjusted odds ratio [aOR] = 4.77, 95% confidence interval [CI] 2.45-9.29, p < 0.001). The time to initial MRI (aOR = 0.49, 95% CI = 0.33-0.70, p < 0.001) and intracranial atherosclerosis (aOR = 2.07, 95% CI = 1.10-3.92, p = 0.025) were also associated with FU-DWI (+), independent of FVH. In clinical outcomes, the FU-DWI (+) group showed more frequent 1-year recurrent ischemic stroke events than the FU-DWI (-) group (10.7% vs 3.1%, respectively, p = 0.007). FVH is associated with FU-DWI (+) in patients with lesion-negative TIA. As FU-DWI (+) frequently occurs during the acute period and has a subsequent worse outcome after discharge, additional radiologic or clinical markers for it are necessary. © 2018 American Academy of Neurology.

Multicenter Analysis of Clinical Follow-Ups in Patients with a Star GK Cardiac Valve Replacement for More than One Year.

PubMed

Li, Mingwen; Xiao, Yingbin; Chen, Daozhong; Liu, Liming; Ma, Liming; Wang, Pingfan; Jia, Kui; Yang, Kai; Chen, Lin

2016-05-18

Star GK valves were widely used in China, and we studied the clinical follow-up results of patients with Star GK valve implants for more than one year.  Clinical data were collected from those patients who had Star GK valve implants for over one year. Patients were divided into three groups: (1) AVR group: received aortic valve replacement surgery. Based on the valve model this group was further sub-divided into two groups: 21A group, and 23A group; (2) MVR group: received mitral valve replacement surgery. Based on the valve model this group was further sub-divided into three groups: 25M group, 27M group, and 29M group; (3) DVR group: received combined replacement surgeries including AVR + MVR. According to postoperative follow-up time these patients were divided into two groups: 1-year group and 3-year group. Follow-up data were collected by telephone, outpatient visits, or correspondence. Clinical data were aggregated by professional data scientists to conduct independent analyses.  959 patients were included in the study following Star GK valve implant. Follow-up after 1 year found that thrombosis occurred in 4 cases, hemorrhage in 15 cases, left heart failure in 13 cases, paravalvular leakage in 5 cases, and death due to cardiac causes in 2 cases.  The long-term efficacy of Star GK valve implants was satisfactory with low incidence of valve-related complications, and following Star GK valve implant, valve and blood were highly compatible and blood component damage was minor. Very low incidence rate of thrombosis was observed following Star GK valve implant, however, attention should be paid to adjust the anticoagulation intensity.

Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct.

PubMed

Nogueira, Raul G; Jadhav, Ashutosh P; Haussen, Diogo C; Bonafe, Alain; Budzik, Ronald F; Bhuva, Parita; Yavagal, Dileep R; Ribo, Marc; Cognard, Christophe; Hanel, Ricardo A; Sila, Cathy A; Hassan, Ameer E; Millan, Monica; Levy, Elad I; Mitchell, Peter; Chen, Michael; English, Joey D; Shah, Qaisar A; Silver, Frank L; Pereira, Vitor M; Mehta, Brijesh P; Baxter, Blaise W; Abraham, Michael G; Cardona, Pedro; Veznedaroglu, Erol; Hellinger, Frank R; Feng, Lei; Kirmani, Jawad F; Lopes, Demetrius K; Jankowitz, Brian T; Frankel, Michael R; Costalat, Vincent; Vora, Nirav A; Yoo, Albert J; Malik, Amer M; Furlan, Anthony J; Rubiera, Marta; Aghaebrahim, Amin; Olivot, Jean-Marc; Tekle, Wondwossen G; Shields, Ryan; Graves, Todd; Lewis, Roger J; Smith, Wade S; Liebeskind, David S; Saver, Jeffrey L; Jovin, Tudor G

2018-01-04

The effect of endovascular thrombectomy that is performed more than 6 hours after the onset of ischemic stroke is uncertain. Patients with a clinical deficit that is disproportionately severe relative to the infarct volume may benefit from late thrombectomy. We enrolled patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, with mismatch criteria defined according to age (<80 years or ≥80 years). Patients were randomly assigned to thrombectomy plus standard care (the thrombectomy group) or to standard care alone (the control group). The coprimary end points were the mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days. A total of 206 patients were enrolled; 107 were assigned to the thrombectomy group and 99 to the control group. At 31 months, enrollment in the trial was stopped because of the results of a prespecified interim analysis. The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999). The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00). Among patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were better with thrombectomy plus standard care than with standard care alone. (Funded by Stryker Neurovascular; DAWN ClinicalTrials.gov number, NCT02142283 .).

The influence of corticosteroid treatment on the outcome of influenza A(H1N1pdm09)-related critical illness.

PubMed

Delaney, Jesse W; Pinto, Ruxandra; Long, Jennifer; Lamontagne, François; Adhikari, Neill K; Kumar, Anand; Marshall, John C; Cook, Deborah J; Jouvet, Philippe; Ferguson, Niall D; Griesdale, Donald; Burry, Lisa D; Burns, Karen E A; Hutchison, Jamie; Mehta, Sangeeta; Menon, Kusum; Fowler, Robert A

2016-03-30

Patients with 2009 pandemic influenza A(H1N1pdm09)-related critical illness were frequently treated with systemic corticosteroids. While observational studies have reported significant corticosteroid-associated mortality after adjusting for baseline differences in patients treated with corticosteroids or not, corticosteroids have remained a common treatment in subsequent influenza outbreaks, including avian influenza A(H7N9). Our objective was to describe the use of corticosteroids in these patients and investigate predictors of steroid prescription and clinical outcomes, adjusting for both baseline and time-dependent factors. In an observational cohort study of adults with H1N1pdm09-related critical illness from 51 Canadian ICUs, we investigated predictors of steroid administration and outcomes of patients who received and those who did not receive corticosteroids. We adjusted for potential baseline confounding using multivariate logistic regression and propensity score analysis and adjusted for potential time-dependent confounding using marginal structural models. Among 607 patients, corticosteroids were administered to 280 patients (46.1%) at a median daily dose of 227 (interquartile range, 154-443) mg of hydrocortisone equivalents for a median of 7.0 (4.0-13.0) days. Compared with patients who did not receive corticosteroids, patients who received corticosteroids had higher hospital crude mortality (25.5% vs 16.4%, p = 0.007) and fewer ventilator-free days at 28 days (12.5 ± 10.7 vs 15.7 ± 10.1, p < 0.001). The odds ratio association between corticosteroid use and hospital mortality decreased from 1.85 (95% confidence interval 1.12-3.04, p = 0.02) with multivariate logistic regression, to 1.71 (1.05-2.78, p = 0.03) after adjustment for propensity score to receive corticosteroids, to 1.52 (0.90-2.58, p = 0.12) after case-matching on propensity score, and to 0.96 (0.28-3.28, p = 0.95) using marginal structural modeling to adjust for time-dependent between-group differences. Corticosteroids were commonly prescribed for H1N1pdm09-related critical illness. Adjusting for only baseline between-group differences suggested a significant increased risk of death associated with corticosteroids. However, after adjusting for time-dependent differences, we found no significant association between corticosteroids and mortality. These findings highlight the challenges and importance in adjusting for baseline and time-dependent confounders when estimating clinical effects of treatments using observational studies.

Differences in Hemoglobin A1c Between Hispanics/Latinos and Non-Hispanic Whites: An Analysis of the Hispanic Community Health Study/Study of Latinos and the 2007–2012 National Health and Nutrition Examination Survey

PubMed Central

Hsu, Lucy L.; Arredondo, Mario; Menke, Andy; Werner, Ellen; Thyagarajan, Bharat; Heiss, Gerardo; Teng, Yanping; Schneiderman, Neil; Giachello, Aida L.; Gallo, Linda C.; Talavera, Gregory A.; Cowie, Catherine C.

2016-01-01

OBJECTIVE To determine whether, after adjustment for glycemia and other selected covariates, hemoglobin A1c (HbA1c) differed among adults from six Hispanic/Latino heritage groups (Central American, Cuban, Dominican, Mexican, Puerto Rican, and South American) and between Hispanic/Latino and non-Hispanic white adults without self-reported diabetes. RESEARCH DESIGN AND METHODS We performed a cross-sectional analysis of data from 13,083 individuals without self-reported diabetes from six Hispanic/Latino heritage groups, enrolled from 2008 to 2011 in the Hispanic Community Health Study/Study of Latinos, and 2,242 non-Hispanic white adults enrolled during the 2007–2012 cycles of the National Health and Nutrition Examination Survey. We compared HbA1c levels among Hispanics/Latinos and between Hispanics/Latinos and non-Hispanic whites before and after adjustment for age, sex, fasting (FPG) and 2-h post–oral glucose tolerance test (2hPG) glucose, anthropometric measurements, and selected biochemical and hematologic variables and after stratification by diabetes status: unrecognized diabetes (FPG ≥7.1 mmol/L or 2hPG ≥11.2 mmol/L), prediabetes (FPG 5.6–7.0 mmol/L or 2hPG 7.8–11.1 mmol/L), and normal glucose tolerance (FPG <5.6 mmol/L and 2hPG <7.8 mmol/L). RESULTS Adjusted mean HbA1c differed significantly across all seven groups (P < 0.001). Non-Hispanic whites had significantly lower HbA1c (P < 0.05) than each individual Hispanic/Latino heritage group. Upon stratification by diabetes status, statistically significant differences (P < 0.001) in adjusted mean HbA1c persisted across all seven groups. CONCLUSIONS HbA1c differs among Hispanics/Latinos of diverse heritage groups and between non-Hispanic whites and Hispanics/Latinos after adjustment for glycemia and other covariates. The clinical significance of these differences is unknown. PMID:27208330

Cardiology or primary care for heart failure in the community setting: process of care and clinical outcomes.

PubMed

Philbin, E F; Weil, H F; Erb, T A; Jenkins, P L

1999-08-01

Severity of illness, treatment choices, and clinical outcomes may vary with physician training. This study was performed to determine whether such differences exist among patients with congestive heart failure (CHF) treated by cardiologists and by noncardiologists in the community hospital setting. Prospective cohort study. Ten acute-care community hospitals. PATIENTS, MEASUREMENTS, AND RESULTS: Two thousand four hundred fifty-four patients with CHF were identified and followed up for 6 months after hospital discharge. Patients who were not treated by a cardiologist (group I; n = 977) were compared with patients whose attending physician was a cardiologist (group II; n = 419) and patients who received consultative care from a cardiologist (group III; n = 1,058). When compared with group I patients, group II patients were more likely to receive the recommended diagnostic tests and treatment strategies, although some of these differences could be explained by variations in the case mix. Group II patients had higher hospital charges, but lower CHF readmission rates and better postdischarge quality-of-life measures. No differences in adjusted mortality rates were observed. In the community-hospital setting, the clinical practices of cardiologists are more compatible with published treatment guidelines than the clinical practices of other physicians. The benefits of cardiology specialty care include lower CHF readmission rates and better postdischarge quality-of-life measures, rather than lower mortality rates, fewer hospital charges, or shorter length of stay.

Waist-hip ratio and 1-year clinical outcome in patients with non-ST-elevation myocardial infarctions.

PubMed

Lee, Hye Won; Hong, Taek Jong; Hong, Ju Young; Choi, Jong Hyun; Kim, Bo Won; Ahn, Jinhee; Park, Jin Sup; Oh, Jun-Hyok; Choi, Jung Hyun; Lee, Han Cheol; Cha, Kwang Soo

2016-08-01

Obesity is a well-known cardiovascular disease risk factor. We evaluated the relationship between the waist-hip ratio (WHR), as a surrogate marker of central obesity, and clinical outcomes in patients with non-ST-segment elevation myocardial infarctions (NSTEMIs) undergoing percutaneous coronary interventions (PCIs). Between 2008 and 2010, NSTEMI patients who underwent PCI and who had available anthropometric data were divided into three groups according to their WHR tertile range. Clinical outcomes in the groups were analyzed. Increasing incidences of hypertension and diabetes mellitus were associated with increasing WHR. As the WHR increased, a disintegration of patient metabolic patterns was documented in laboratory findings. There was no difference in the 1-year mortality rates between the three groups. However, increasing 1-year major adverse cardiovascular event rates were documented as the WHR increased (13, 14.7, and 19.4% in tertile groups 1-3, respectively; P=0.005). After adjusting for confounding variables, the highest tertile group was associated with increased 1-year mortality and major adverse cardiovascular event rates compared with the lowest tertile group. These differences arose from the female subgroup, suggesting that the magnitude of the central obesity effect might be greater in female than in male patients. Central obesity, represented by WHR, was associated with poor clinical outcomes in NSTEMI patients undergoing PCI, particularly among women.

Does neoadjuvant/perioperative chemotherapy improve overall survival for T2N0 gastric adenocarcinoma?

PubMed

Gabriel, Emmanuel; Attwood, Kristopher; Narayanan, Sumana; Brady, Maureen; Nurkin, Steven; Hochwald, Steven; Kukar, Moshim

2018-03-01

The purpose of this study was to determine whether neoadjuvant and/or perioperative chemotherapy (NAC) has an overall survival (OS) benefit for patients with T2N0 gastric adenocarcinoma. We performed retrospective analyses using the National Cancer Data Base, 2004-2013. Patients with T2N0 gastric adenocarcinoma were divided into two treatment groups: (1) NAC plus surgery (NA + S) and (2) surgery alone (S). Of 1,704 patients included, 277 (16.3%) received NAC, and 1,427 (83.7%) were treated with surgery alone. Patients in the NA + S group were more likely to be younger, have fewer comorbidities, and have larger tumors located in the proximal stomach. Although in an unadjusted analysis of OS, the NA + S group had improved survival compared to the S group (HR = 0.81, 95% CI 0.67-0.99, P < 0.0001), this was not maintained in a propensity adjusted analysis (HR = 0.89, 95% CI 0.68-1.18, P = 0.42). Similarly, propensity adjusted analyses accounting for potential bias from clinical misstaging or treatment effect from NAC did not show any OS benefit from NAC. Based on the largest cohort of clinically staged T2N0 gastric adenocarcinoma, there was no OS benefit derived from NAC compared to surgery alone. For select patients with reliable preoperative staging, NAC may be omitted. © 2017 Wiley Periodicals, Inc.

The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients.

PubMed

Mauri Llerda, J A; Suller Marti, A; de la Peña Mayor, P; Martínez Ferri, M; Poza Aldea, J J; Gomez Alonso, J; Mercadé Cerdá, J M

2015-10-01

The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups. Copyright © 2014 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

Cognitive Training Program to Improve Working Memory in Older Adults with MCI.

PubMed

Hyer, Lee; Scott, Ciera; Atkinson, Mary Michael; Mullen, Christine M; Lee, Anna; Johnson, Aaron; Mckenzie, Laura C

2016-01-01

Deficits in working memory (WM) are associated with age-related decline. We report findings from a clinical trial that examined the effectiveness of Cogmed, a computerized program that trains WM. We compare this program to a Sham condition in older adults with Mild Cognitive Impairment (MCI). Older adults (N = 68) living in the community were assessed. Participants reported memory impairment and met criteria for MCI, either by poor delayed memory or poor performance in other cognitive areas. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS, Delayed Memory Index) and the Clinical Dementia Rating scale (CDR) were utilized. All presented with normal Mini Mental State Exams (MMSE) and activities of daily living (ADLs). Participants were randomized to Cogmed or a Sham computer program. Twenty-five sessions were completed over five to seven weeks. Pre, post, and follow-up measures included a battery of cognitive measures (three WM tests), a subjective memory scale, and a functional measure. Both intervention groups improved over time. Cogmed significantly outperformed Sham on Span Board and exceeded in subjective memory reports at follow-up as assessed by the Cognitive Failures Questionnaire (CFQ). The Cogmed group demonstrated better performance on the Functional Activities Questionnaire (FAQ), a measure of adjustment and far transfer, at follow-up. Both groups, especially Cogmed, enjoyed the intervention. Results suggest that WM was enhanced in both groups of older adults with MCI. Cogmed was better on one core WM measure and had higher ratings of satisfaction. The Sham condition declined on adjustment.

Ethnic Differences in Gestational Weight Gain: A Population-Based Cohort Study in Norway.

PubMed

Kinnunen, Tarja I; Waage, Christin W; Sommer, Christine; Sletner, Line; Raitanen, Jani; Jenum, Anne Karen

2016-07-01

Objectives To explore ethnic differences in gestational weight gain (GWG). Methods This was a population-based cohort study conducted in primary care child health clinics in Groruddalen, Oslo, Norway. Participants were healthy pregnant women (n = 632) categorised to six ethnic groups (43 % were Western European women, the reference group). Body weight was measured at 15 and 28 weeks' gestation on average. Data on pre-pregnancy weight and total GWG until delivery were self-reported. The main method of analysis was linear regression adjusting for age, weeks' gestation, pre-pregnancy body mass index, education and severe nausea. Results No ethnic differences were observed in GWG by 15 weeks' gestation. By 28 weeks' gestation, Eastern European women had gained 2.71 kg (95 % confidence interval, CI 1.10-4.33) and Middle Eastern women 1.32 kg (95 % CI 0.14-2.50) more weight on average than the Western European women in the fully adjusted model. Among Eastern European women, the total adjusted GWG was 3.47 kg (95 % CI 1.33-5.61) above the reference group. Other ethnic groups (South Asian, East Asian and African) did not differ from the reference group. When including non-smokers (n = 522) only, observed between-group differences increased and Middle Eastern women gained more weight than the reference group by all time points. Conclusions Eastern European and Middle Eastern women had higher GWG on average than Western European women, especially among the non-smokers. Although prevention of excessive GWG is important for all pregnant women, these ethnic groups might need special attention during pregnancy.

Group Sex and Prevalent Sexually Transmitted Infections Among Men Who Have Sex with Men.

PubMed

Rice, Cara E; Lynch, Courtney D; Norris, Alison H; Davis, John A; Fields, Karen S; Ervin, Melissa; Turner, Abigail Norris

2016-08-01

We evaluated the direct relation between group sex and prevalent sexually transmitted infections (STI) in a cross-sectional study of men who have sex with men (MSM) presenting at an urban STI clinic in the Midwestern US. Among 231 men who enrolled and reported that they have sex with men, we collected behavioral data using a combination of interviewer and self-administered surveys and extracted STI data from electronic health records. We used modified Poisson regression to examine the unadjusted and adjusted associations between group sex participation and prevalent STI. One-quarter of participants (n = 58) reported group sex participation in the last 3 months. Eighteen percent of participants (n = 42) had gonorrhea and 19 % (n = 45) had chlamydial infection. Men who reported recent group sex were more likely to be HIV-positive, to report recent drug use, and to report unprotected receptive anal intercourse in the past 3 months. After adjustment for age, race, and recent drug use, recent participation in group sex was associated with prevalent gonorrhea infection (prevalence ratio [PR] = 2.11, 95 % confidence interval [CI] = [1.13, 3.95]) but not chlamydia infection (PR = 1.03, 95 % CI = [0.58, 1.84]). We performed a sensitivity analysis in which we also adjusted for unprotected receptive anal intercourse and the results were not substantively changed. In summary, participation in group sex in the past 3 months was associated with a more than twofold increased prevalence of gonorrhea, but not with chlamydia. These findings support group sex participation as a potential contributor to increased STI prevalence.

Influence of embryo culture medium on incidence of ectopic pregnancy in in vitro fertilization.

PubMed

Lin, Shengli; Li, Rong; Zheng, Xiaoying; Chi, Hongbin; Ren, Xiulian; Yang, Rui; Liu, Ping; Qiao, Jie

2015-12-01

To explore the effect of type of media used to culture embryos for IVF on the incidence of ectopic pregnancy (EP). Retrospective analysis. University-affiliated IVF center. The retrospective analysis involved 23,481 women who underwent IVF-ET cycles between 2011 and 2013. None. There was an association between EP and the culture medium. During 23,481 fresh transfer cycles, 364 patients were diagnosed with EP. The EP to clinical pregnancy rate was 3.01% in the G5 group, 3.89% in the G5 Plus group, and 4.04% in the Global group. The EP to clinical pregnancy rates were significantly higher in the G5 Plus and Global groups than in the G5 group. After adjusting for confounding factors, the incidence of EP was significantly associated with the G5 Plus and Global media. Our results showed that there is an association between incidence of EP and the culture medium. The rates of EP to clinical pregnancy were significantly higher in the G5 Plus and Global media than in the G5 medium. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effects of Education and Income on Treatment and Outcome in Patients With Acute Myeloid Leukemia in a Tax-Supported Health Care System: A National Population-Based Cohort Study.

PubMed

Østgård, Lene Sofie Granfeldt; Nørgaard, Mette; Medeiros, Bruno C; Friis, Lone Smidstrup; Schoellkopf, Claudia; Severinsen, Marianne Tang; Marcher, Claus Werenberg; Nørgaard, Jan Maxwell

2017-11-10

Purpose Previous US studies have shown that socioeconomic status (SES) affects survival in acute myeloid leukemia (AML). However, no large study has investigated the association between education or income and clinical characteristics, treatment, and outcome in AML. Methods To investigate the effects of education and income in a tax-supported health care system, we conducted a population-based study using individual-level SES and clinical data on all Danish patients with AML (2000 to 2014). We compared treatment intensity, allogeneic transplantation, and response rates by education and income level using logistic regression (odds ratios). We used Cox regression (hazard ratios [HRs]) to compare survival, adjusting for age, sex, SES, and clinical prognostic markers. Results Of 2,992 patients, 1,588 (53.1%) received intensive chemotherapy. Compared with low-education patients, highly educated patients more often received allogeneic transplantation (16.3% v 8.7%). In intensively treated patients younger than 60 years of age, increased mortality was observed in those with lower and medium education (1-year survival, 66.7%; adjusted HR, 1.47; 95% CI, 1.11 to 1.93; and 1-year survival, 67.6%; adjusted HR, 1.55; CI, 1.21 to 1.98, respectively) compared with higher education (1-year survival, 76.9%). Over the study period, 5-year survival improvements were limited to high-education patients (from 39% to 58%), increasing the survival gap between groups. In older patients, low-education patients received less intensive therapy (30% v 48%; adjusted odds ratio, 0.65; CI, 0.44 to 0.98) compared with high-education patients; however, remission rates and survival were not affected in those intensively treated. Income was not associated with therapy intensity, likelihood of complete remission, or survival (high income: adjusted HR, 1.0; medium income: adjusted HR, 0.96; 95% CI, 0.82 to 1.12; low income: adjusted HR, 1.06; CI, .88 to 1.27). Conclusion In a universal health care system, education level, but not income, affects transplantation rates and survival in younger patients with AML. Importantly, recent survival improvement has exclusively benefitted highly educated patients.

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

PubMed

Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

2004-08-01

The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

Early return visits by pediatric primary care patients with otitis media: a retail nurse practitioner clinic versus standard medical office care.

PubMed

Rohrer, James E; Garrison, Gregory M; Angstman, Kurt B

2012-01-01

To compare outpatient return visits within 2 weeks experienced by pediatric patients diagnosed with otitis media using retail nurse practitioner clinics to similar patients using standard medical office clinics. The impact of retail clinics on return visit rates has not been extensively studied. Electronic medical records of pediatric primary care patients seen in a large group practice in Minnesota in 2009 for otitis media. Patients seen in retail walk-in clinics staffed by nurse practitioners (N = 627) or regular office clinics (N = 2353). A return visit to any site within 2 weeks. The percentage returning was higher in standard care patients than in retail medicine patients (21.0 vs 11.2, P < .001). The odds of a return visit within 2 weeks were higher in standard care patients than in retail medicine patients after adjusting for propensity to use services, age, and gender (odds ratio = 1.54, P < 0.01). In this group practice, the odds of return visits within 2 weeks for pediatric patients treated for otitis media were lower in retail medicine clinics than in standard office clinics.

Basal metabolic rate is decreased in women with polycystic ovary syndrome and biochemical hyperandrogenemia and is associated with insulin resistance.

PubMed

Georgopoulos, Neoklis A; Saltamavros, Alexandros D; Vervita, Vasiliki; Karkoulias, Kyriakos; Adonakis, George; Decavalas, George; Kourounis, George; Markou, Kostas B; Kyriazopoulou, Venetsana

2009-07-01

To evaluate basal metabolic rate (BMR) in women with PCOS and to determine its association with insulin resistance (IR). Prospective assessment of BMR in women with PCOS. Outpatient clinic of the Division of Reproductive Endocrinology. The study included 91 Greek women with PCOS and biochemical hyperandrogenemia, with mean age 24.03 +/- 0.55 years and mean body mass index (BMI) 26.67 +/- 0.69 kg/m(2), and 48 matched regularly menstruating women, with mean age 26.33 +/- 0.93 years and mean BMI 23.35 +/- 0.85 kg/m(2), as control subjects. Assessment of BMR by indirect calorimetry, IR by HOMA and QUICKI indices, fasting insulin, and fasting glucose/insulin ratio. Reduced BMR in PCOS with or without IR. Adjusted BMR was 1,868 +/- 41 kcal/day in the control group, 1,445.57 +/- 76 in all PCOS women, 1,590 +/- 130 in PCOS women without IR and 1,116 +/- 106 in PCOS women with IR. Adjusted BMR showed a statistically significant difference between women with PCOS and control subjects, with lowest values in the group of PCOS women with IR, even after adjusting all groups for age and BMI. Women with PCOS, particularly those with IR, present a significantly decreased BMR.

Does stage of cancer, comorbidity or lifestyle factors explain educational differences in survival after endometrial cancer? A cohort study among Danish women diagnosed 2005-2009.

PubMed

Seidelin, Ulla Holten; Ibfelt, Else; Andersen, Ingelise; Steding-Jessen, Marianne; Høgdall, Claus; Kjær, Susanne Krüger; Dalton, Susanne Oksbjerg

2016-06-01

Several studies have documented an association between socioeconomic position and survival from gynaecological cancer, but the mechanisms are unclear. The aim of this study was to examine the association between level of education and survival after endometrial cancer among Danish women; and whether differences in stage at diagnosis and comorbidity contribute to the educational differences in survival. Women with endometrial cancer diagnosed between 2005 and 2009 were identified in the Danish Gynaecological Cancer Database, with information on clinical characteristics, surgery, body mass index (BMI) and smoking status. Information on highest attained education, cohabitation and comorbidity was obtained from nationwide administrative registries. Logistic regression models were used to determine the association between level of education and cancer stage and Cox proportional hazards model for analyses of overall survival. Of the 3638 patients identified during the study period, 787 had died by the end of 2011. The group of patients with short education had a higher odds ratio (OR) for advanced stage at diagnosis, but this was not statistically significant (adjusted OR 1.20; 95% CI 0.97-1.49). The age-adjusted hazard ratio (HR) for dying of patients with short education was 1.47 (CI 95% 1.17-1.80). Adjustment for cohabitation status, BMI, smoking and comorbidity did not change HRs, but further adjustment for cancer stage yielded a HR of 1.36 (1.11-1.67). Early detection in all educational groups might reduce social inequalities in survival, however, the unexplained increased risk for death after adjustment for prognostic factors, warrants increased attention to patients with short education in all age groups throughout treatment and rehabilitation.

Evaluating variation in use of definitive therapy and risk-adjusted prostate cancer mortality in England and the USA.

PubMed

Sachdeva, Ashwin; van der Meulen, Jan H; Emberton, Mark; Cathcart, Paul J

2015-02-24

Prostate cancer mortality (PCM) in the USA is among the lowest in the world, whereas PCM in England is among the highest in Europe. This paper aims to assess the association of variation in use of definitive therapy on risk-adjusted PCM in England as compared with the USA. Observational study. Cancer registry data from England and the USA. Men diagnosed with non-metastatic prostate cancer (PCa) in England and the USA between 2004 and 2008. Competing-risks survival analyses to estimate subhazard ratios (SHR) of PCM adjusted for age, ethnicity, year of diagnosis, Gleason score (GS) and clinical tumour (cT) stage. 222,163 men were eligible for inclusion. Compared with American patients, English patients were more likely to present at an older age (70-79 years: England 44.2%, USA 29.3%, p<0.001), with higher tumour stage (cT3-T4: England 25.1%, USA 8.6%, p<0.001) and higher GS (GS 8-10: England 20.7%, USA 11.2%, p<0.001). They were also less likely to receive definitive therapy (England 38%, USA 77%, p<0.001). English patients were more likely to die of PCa (SHR=1.9, 95% CI 1.7 to 2.0, p<0.001). However, this difference was no longer statistically significant when also adjusted for use of definitive therapy (SHR=1.0, 95% CI 1.0 to 1.1, p=0.3). Risk-adjusted PCM is significantly higher in England compared with the USA. This difference may be explained by less frequent use of definitive therapy in England. 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.

Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

PubMed

Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

2016-07-01

To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

Telomeric repeat-containing RNA (TERRA) related to polycystic ovary syndrome (PCOS).

PubMed

Wang, Caiqin; Shen, Fengxian; Zhu, Yuning; Fang, Yuying; Lu, Shiming

2017-04-01

Telomeric repeat-containing RNA (TERRA) participates in the regulation of telomere length, and leucocyte telomere length (LTL) plays an important role in the pathophysiology of polycystic ovary syndrome (PCOS), but little is known about the role of TERRA in PCOS. To evaluate the role of TERRA and peripheral blood LTL in PCOS. Forty women with PCOS and 35 healthy women without PCOS were recruited. A prospective case-control study was performed. RNA fluorescence in situ hybridization (FISH) was used to detect TERRA expression in peripheral blood leucocyte. Quantitative PCR was used to measure TERRA expression and the mean LTL in the PCOS and control groups. We analysed the association between related clinical parameters and the age-adjusted ratio of the telomere repeat length (T/S ratio) or TERRA. Telomeric repeat-containing RNA was expressed in human peripheral blood leucocytes, and the signal was abolished after culture with RNase A. The age-adjusted LTLs were significantly longer in the PCOS group than in the control group (P < 0·01). The age-adjusted TERRA level was significantly lower in the PCOS group than in the control group (P < 0·01). Testosterone (TTE) was related positively to LTL and negatively to TERRA in the PCOS group (r = 0·532, P = 0·002; r = -0·477, P = 0·017). We found TERRA expression in human peripheral blood leucocytes, and LTLs were positively associated with PCOS. TERRA and testosterone play an important role in the LTL regulation in PCOS. © 2016 John Wiley & Sons Ltd.

The performance of the new prognostic grade and stage groups in conservatively treated prostate cancer.

PubMed

Chen, Cheng; Chen, Ye; Hu, Lin-Kun; Jiang, Chang-Chuan; Xu, Ren-Fang; He, Xiao-Zhou

2018-02-27

We evaluated the prognosis of the new grade groups and American Joint Committee on Cancer (AJCC) stage groups in men with prostate cancer (PCa) who were treated conservatively. A total of 13 798 eligible men were chosen from the Surveillance Epidemiology and End Results database. The new grade and AJCC stage groups were investigated on prostate biopsy specimens. Kaplan-Meier survival analysis and multivariable hazards models were applied to estimate the association of new grade and stage groups with overall survival (OS) and PCa-specific survival (CSS). Mean follow-up was 42.65 months (95% confidence interval: 42.47-42.84) in the entire cohort. The 3-year OS and CSS rates stepped down for grade groups 1-5 and AJCC stage groups I-IVB, respectively. After adjusting for clinical and pathological characteristics, all grade groups and AJCC stage groups were associated with higher all-cause and PCa-specific mortality compared to the reference group (all P ≤ 0.003). In conclusion, we evaluated the oncological outcome of the new grade and AJCC stage groups on biopsy specimens of conservatively treated PCa. These two novel clinically relevant classifications can assist physicians to determine different therapeutic strategies for PCa patients.

Children's adjustment in conflicted marriage and divorce: a decade review of research.

PubMed

Kelly, J B

2000-08-01

To review important research of the past decade in divorce, marital conflict, and children's adjustment and to describe newer divorce interventions. Key empirical studies from 1990 to 1999 were surveyed regarding the impact of marital conflict, parental violence, and divorce on the psychological adjustment of children, adolescents, and young adults. Recent studies investigating the impact of divorce on children have found that many of the psychological symptoms seen in children of divorce can be accounted for in the years before divorce. The past decade also has seen a large increase in studies assessing complex variables within the marriage which profoundly affect child and adolescent adjustment, including marital conflict and violence and related parenting behaviors. This newer literature provides provocative and helpful information for forensic and clinical psychiatrists in their work with both married and divorcing families. While children of divorced parents, as a group, have more adjustment problems than do children of never-divorced parents, the view that divorce per se is the major cause of these symptoms must be reconsidered in light of newer research documenting the negative effects of troubled marriages on children.

Use of Epidural Analgesia as an Adjunct in Elective Abdominal Wall Reconstruction: A Review of 4983 Cases.

PubMed

Karamanos, Efstathios; Dream, Sophie; Falvo, Anthony; Schmoekel, Nathan; Siddiqui, Aamir

2017-01-01

Use of epidural analgesia in patients undergoing elective abdominal wall reconstruction is common. To assess the impact of epidural analgesia in patients undergoing abdominal wall reconstruction. All patients who underwent elective ventral hernia repair from 2005 to 2014 were retrospectively identified. Patients were divided into two groups by the postoperative use of epidural analgesics as an adjunct analgesic method. Preoperative comorbidities, American Society of Anesthesiologists status, operative findings, postoperative pain management, and venothromboembolic prophylaxis were extracted from the database. Logistic regressions were performed to assess the impact of epidural use. Severity of pain on postoperative days 1 and 2. During the study period, 4983 patients were identified. Of those, 237 patients (4.8%) had an epidural analgesic placed. After adjustment for differences between groups, use of epidural analgesia was associated with significantly lower rates of 30-day presentation to the Emergency Department (adjusted odds ratio [AOR] = 0.53, 95% confidence interval [CI] = 0.32-0.87, adjusted p = 0.01). Use of epidural analgesia resulted in higher odds of abscess development (AOR = 5.89, CI = 2.00-17.34, adjusted p < 0.01) and transfusion requirement (AOR = 2.92, CI = 1.34-6.40, adjusted p < 0.01). Use of epidural analgesia resulted in a significantly lower pain score on postoperative day 1 (3 vs 4, adjusted p < 0.01). Use of epidural analgesia in patients undergoing abdominal wall reconstruction may result in longer hospital stay and higher incidence of complications while having no measurable positive clinical impact on pain control.

Estimating restricted mean treatment effects with stacked survival models

PubMed Central

Wey, Andrew; Vock, David M.; Connett, John; Rudser, Kyle

2016-01-01

The difference in restricted mean survival times between two groups is a clinically relevant summary measure. With observational data, there may be imbalances in confounding variables between the two groups. One approach to account for such imbalances is estimating a covariate-adjusted restricted mean difference by modeling the covariate-adjusted survival distribution, and then marginalizing over the covariate distribution. Since the estimator for the restricted mean difference is defined by the estimator for the covariate-adjusted survival distribution, it is natural to expect that a better estimator of the covariate-adjusted survival distribution is associated with a better estimator of the restricted mean difference. We therefore propose estimating restricted mean differences with stacked survival models. Stacked survival models estimate a weighted average of several survival models by minimizing predicted error. By including a range of parametric, semi-parametric, and non-parametric models, stacked survival models can robustly estimate a covariate-adjusted survival distribution and, therefore, the restricted mean treatment effect in a wide range of scenarios. We demonstrate through a simulation study that better performance of the covariate-adjusted survival distribution often leads to better mean-squared error of the restricted mean difference although there are notable exceptions. In addition, we demonstrate that the proposed estimator can perform nearly as well as Cox regression when the proportional hazards assumption is satisfied and significantly better when proportional hazards is violated. Finally, the proposed estimator is illustrated with data from the United Network for Organ Sharing to evaluate post-lung transplant survival between large and small-volume centers. PMID:26934835

Acculturation attitudes, perceived attitudes of the majority, and adjustment of Israeli-Arab and Jewish-Ethiopian students to an Israeli University.

PubMed

Kurman, Jenny; Eshel, Yohanan; Sbeit, Khalil

2005-10-01

The authors investigated adjustment to an Israeli university by students from two minority groups, Israeli Arabs and Jewish Ethiopians, as a function of their different acculturation attitudes (J. W. Berry, 1990). Social adjustment of both Arabs and Ethiopians was contingent on acculturation attitudes supporting participation with the majority. Psychological adjustment of both groups was negatively associated with personal acculturation preferences that deviated from the shared acculturation attitudes of the respective in-group (i.e., assimilation in the Arab group, and separation in the Ethiopian group). The perceived attitude of the majority also contributed to the psychological adjustment of both groups. Major theoretical implications are that both attitudes of the majority and adjustment to the in-group play an important role in psychological adjustment of immigrants.

The bizzare phenomenon of smokers' paradox in the immediate outcome post acute myocardial infarction: an insight into the Malaysian National Cardiovascular Database-Acute Coronary Syndrome (NCVD-ACS) registry year 2006-2013.

PubMed

Venkatason, Padmaa; Salleh, Norsabihin Mohd; Zubairi, Yong; Hafidz, Imran; Ahmad, Wan Azman Wan; Han, Sim Kui; Zuhdi, Ahmad Syadi Mahmood

2016-01-01

'Smoker's paradox' is a controversial phenomenon of an unexpected favourable outcome of smokers post acute myocardial infarction. There are conflicting evidences from the literature so far. We investigate for the existence of this phenomenon in our post acute myocardial infarction patients. We analysed 12,442 active smokers and 10,666 never-smokers diagnosed with STEMI and NSTEMI from the Malaysian National Cardiovascular Database-Acute Coronary Syndrome (NCVD-ACS) year 2006-2013 from 18 hospitals across Malaysia. Comparisons in the baseline characteristics, clinical presentation, in-hospital treatment and short term clinical outcome were made between the two groups. To compare the clinical outcome, an extensive multivariate adjustment was made to estimate the allcause mortality risk ratios for both groups. The active smokers were younger (smokers 53.7 years vs non-smokers 62.3 years P < 0.001) and had lower cardiovascular risk burden and other co-morbidities. STEMI is more common in smokers and intravenous thrombolysis was the main reperfusion therapy in both groups. Smokers had a higher rate of in-hsopital coronary revascularisation in NSTEMI group (21.6 % smokers vs 16.7 % non-smokers P < 0.001) but similar to non-smokers in the STEMI group. Multivariate adjusted mortality risk ratios showed significantly lower mortality risks of smokers at both in-hospital (RR 0.510 [95 % CI 0.442-0.613]) and 30-day post discharge (RR 0.534 [95 % CI 0.437-0.621]). Smoking seems to be associated with a favourable outcome post myocardial infarction. The phenomenon of 'smoker's paradox' is in fact a reality in our patients population. The definitive explanation for this unexpected protective effect of smoking remains unclear.

Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case–control study in a clinical cohort

PubMed Central

Nerum, H; Halvorsen, L; Straume, B; Sørlie, T; Øian, P

2013-01-01

Objective To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). Design Case–control study in a clinical cohort. Setting University Hospital of North Norway. Sample In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. Methods Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. Main outcome measures Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. Results As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4–29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4–33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. Conclusions There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies. PMID:23157417

Trivalent inactivated influenza vaccine and spontaneous abortion.

PubMed

Irving, Stephanie A; Kieke, Burney A; Donahue, James G; Mascola, Maria A; Baggs, James; DeStefano, Frank; Cheetham, T Craig; Jackson, Lisa A; Naleway, Allison L; Glanz, Jason M; Nordin, James D; Belongia, Edward A

2013-01-01

To estimate the association between spontaneous abortion and influenza vaccine receipt with a case-control study utilizing data from six health care organizations in the Vaccine Safety Datalink. Women aged 18-44 years with spontaneous abortion during the autumn of 2005 or 2006 were identified using International Classification of Diseases, 9th Revision, Clinical Modification codes. Cases of spontaneous abortion at 5-16 weeks of gestation were confirmed by medical record review; date of fetal demise was based on ultrasound information when available. Control group individuals with a live birth were individually matched to case group individuals by health care organization and date of last menstrual period (LMP). The primary exposure of interest was influenza vaccination during the 28 days preceding the date of spontaneous abortion of the matched pair. Conditional logistic regression models adjusted for maternal age, health care utilization, maternal diabetes, and parity. Our final analysis included 243 women with spontaneous abortion and 243 matched control group women; 82% of women with spontaneous abortion had ultrasound confirmation of fetal demise. Using clinical diagnosis and ultrasound data, the mean gestational age at fetal demise was 7.8 weeks. Mean ages at LMP of case group women and control group women were 31.7 and 29.3 years, respectively (P<.001). Sixteen women with spontaneous abortion (7%) and 15 (6%) matched control group women received influenza vaccine within the 28-day exposure window. There was no association between spontaneous abortion and influenza vaccination in the 28-day exposure window (adjusted matched odds ratio 1.23, 95% confidence interval 0.53-2.89; P=.63). There was no statistically significant increase in the risk of pregnancy loss in the 4 weeks after seasonal inactivated influenza vaccination. II.

Ethnic variations in pathways to acute care and compulsory detention for women experiencing a mental health crisis.

PubMed

Lawlor, Caroline; Johnson, Sonia; Cole, Laura; Howard, Louise M

2012-01-01

Much recent debate on excess rates of compulsory detention and coercive routes to care has focused on young black men; evidence is less clear regarding ethnic variations among women and factors that may mediate these. To explore ethnic variations in compulsory detentions of women, and to explore the potential role of immediate pathways to admission and clinician-rated reasons for admission as mediators of these differences. All women admitted to an acute psychiatric inpatient ward or a women's crisis house in four London boroughs during a 12-week period were included. Data were collected regarding their pathways to care, clinician-rated reasons for admission, hospital stays, and social and clinical characteristics. Two hundred and eighty seven (287) women from white British, white other, black Caribbean, black African and black other groups were included. Adjusting for social and clinical characteristics, all groups of black patients and white other patients were significantly more likely to have been compulsorily admitted than white British patients; white British patients were more likely than other groups to be admitted to a crisis house and more likely than all the black groups to be admitted because of perceived suicide risk. Immediate pathways to care differed: white other, black African and black other groups were less likely to have referred themselves in a crisis and more likely to have been in contact with the police. When adjustment was made for differences in pathways to care, the ethnic differences in compulsory admission were considerably reduced. There are marked ethnic inequities not only between white British and black women, but also between white British and white other women in experiences of acute admission. Differences between groups in help-seeking behaviours in a crisis may contribute to explaining differences in rates of compulsory admission.

Prolonging the duration of masseter muscle reduction by adjusting the masticatory movements after the treatment of masseter muscle hypertrophy with botulinum toxin type a injection.

PubMed

Wei, Jiao; Xu, Hua; Dong, Jiasheng; Li, Qingfeng; Dai, Chuanchang

2015-01-01

Botulinum toxin type A (BTX-A) is widely used for the clinical treatment of masseteric hypertrophy. Until now, few reports have discussed how to prolong the duration of its effectiveness. This study evaluated that purposely adjusting the masticatory movements is possible of postponing the masseter muscle rehypertrophy. Ninety-eight patients were randomly and equally divided into 2 groups, and 35 U BTX-A per side was injected into the masseters. The thickness and volume of the masticatory muscles were measured by ultrasound and computerized tomography, respectively. Patients in Group 1 were instructed to strengthen their masticatory effort during the denervated atrophic stage of the masseter (the interval was evaluated by real-time ultrasound monitoring), whereas patients in Group 2 were not given this instruction. When the masseter muscle began to recover, patients in both groups were instructed to reduce their chewing. The duration of the masseter muscle rehypertrophy was significantly prolonged in Group 1 patients. The thickness and the volume of the other masticatory muscles were significantly increased in Group 1 but were either slightly decreased or insignificantly different in Group 2. Purposely strengthening masticatory muscle movement during the denervated atrophic stage of the masseter can prolong the duration of masseter rehypertrophy.

Gender Differences in Psychotic Disorders with Concurrent Substance Use

PubMed Central

Caton, Carol L.M.; Xie, Haiyi; Drake, Robert E.; McHugo, Gregory

2015-01-01

Objective We conducted a comparative analysis of gender differences in patients with primary psychotic disorders with concurrent substance use and in those with substance-induced psychoses. Methods A total of 385 individuals admitted to psychiatric emergency departments with early onset psychosis and recent substance use were interviewed at baseline and at 6-month intervals for two years. Using a standardized research diagnostic assessment instrument, we classified patients at baseline into primary and substance-induced psychosis groups and analyzed the effects of gender on demographic, family, and clinical characteristics at baseline, the interaction of gender and diagnosis, and gender main effects on illness course, adjustment, and service use over the two-year follow-up period. Results Women had better premorbid adjustment, less misattribution of symptoms, and a later age of onset of regular drug use compared to men. Women, however, showed greater depression and histories of abuse compared to men. Men had greater arrest histories. No interactions between gender and diagnosis were significant. Both genders in the primary and substance-induced psychosis groups showed clinical and functional improvement over the follow-up period despite the overall minimal use of mental health and substance abuse treatment services. Conclusions Women and men with psychosis and substance use differ on several dimensions. Our findings suggest the need for gender-specific treatment programming across both diagnostic groups. PMID:25391275

Vitamin B-6 Supplementation Could Mediate Antioxidant Capacity by Reducing Plasma Homocysteine Concentration in Patients with Hepatocellular Carcinoma after Tumor Resection

PubMed Central

Cheng, Shao-Bin; Lin, Ping-Ting; Liu, Hsiao-Tien; Peng, Yi-Shan; Huang, Shih-Chien

2016-01-01

Vitamin B-6 has a strong antioxidative effect. It would be useful to determine whether vitamin B-6 supplementation had effects on antioxidant capacities in patients with hepatocellular carcinoma (HCC) who had recently undergone tumor resection. Thirty-three HCC patients were randomly assigned to either the placebo (n = 16) group or the vitamin B-6 50 mg/d (n = 17) group for 12 weeks. Plasma pyridoxal 5′-phosphate, homocysteine, indicators of oxidative stress, and antioxidant capacities were measured. Plasma homocysteine in the vitamin B-6 group was significantly decreased at week 12, while the level of trolox equivalent antioxidant capacity (TEAC) was significantly increased at the end of the intervention period. Vitamin B-6 supplementation had a significant reducing effect on the change of plasma homocysteine (β = −2.4, p = 0.02) but not on the change of TEAC level after adjusting for potential confounders. The change of plasma homocysteine was significantly associated with the change of TEAC after adjusting for potential confounders (β = −162.0, p = 0.03). Vitamin B-6 supplementation seemed to mediate antioxidant capacity via reducing plasma homocysteine rather than having a direct antioxidative effect in HCC patients who had recently undergone tumor resection. The clinical trial number is NCT01964001, ClinicalTrials.gov. PMID:27051670

[Morbidity observed in a health area: Impact on professionals and funding].

PubMed

de Miguel, Pablo; Caballero, Isabel; Rivas, Francisco Javier; Manera, Jaime; de Vicente, María Auxiliadora; Gómez, Ángel

2015-05-01

To analyze morbidity, in the context of a health area, and broken down by health centre, of patients who made contact with healthcare services, in order to propose an adjustment to finance the payment per capita. A descriptive study of morbidity observed in citizens assigned a health area during year 2010. SITE: Health Area 9. Autonomous Community of Madrid. Formed by the municipalities of Fuenlabrada, Humanes, and Moraleja de Enmedio. All levels of health care included. All citizens with health card assigned to a health center in the area who has maintained contact with the public health service's own area. Coded contact of patients are grouped using the Population Grouping Clinical Risk 3M TM Software (CRG). Each patient is included in a homogeneous and exclusive group with a numerical morbidity and clinical sense. Through the health card is known primary care centre, physician, age and sex. The distribution of morbidity is obtained by primary care centre, primary care physician, age and sex analyzing differences and combinations. It was found that the average values of the population morbidity are different in each primary care centre. In order to maintain the principle of equity in health care, it is suggested that an adjustment is made to the per capita payment based on the morbidity rate of the population. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

Obstetric and perinatal outcomes of singletons after single blastocyst transfer: is there any difference according to blastocyst morphology?

PubMed

Bouillon, Céline; Celton, Noémie; Kassem, Sandra; Frapsauce, Cynthia; Guérif, Fabrice

2017-08-01

A strong correlation between blastocyst morphology and implantation has been shown by many studies. The consequences and effects of assisted reproductive techniques on children's short and long-term health have always been a source of discussion. The obstetric and perinatal outcome of singletons according to blastocyst morphology has rarely been evaluated. The aim of this observational study is to determine whether a relationship exists between blastocyst morphology and obstetric and perinatal outcomes. A total of 799 singleton clinical pregnancies were analysed after transfer of a single fresh blastocyst on day 5 between 2006 and 2013. Blastocysts were divided into four groups based on their morphology on day 5: group 1 = good morphology blastocysts; group 2 = fair morphology blastocysts; group 3 = poor morphology blastocysts and group 4 = early (B1/B2) blastocysts. Obstetric and perinatal outcomes were compared between the four groups. After adjustment for some confounding variables, main obstetric and perinatal outcomes after transfer of blastocysts with poor morphological characteristics were not associated with increased adverse obstetric and perinatal events. Sex ratio was significantly higher in group 1 compared with groups 2, 3 and 4, and in Group 2 compared with Group 3 (P < 0.001) even after adjustment (P < 0.05). Copyright © 2017 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Psychological Intervention in Primary Care After Earthquakes in Lorca, Spain

PubMed Central

Garriga, Ascensión; Egea, Carmen

2015-01-01

Objective: After the earthquakes that occurred in Lorca, Spain, on May 11, 2011, the regional mental health management employed 2 clinical psychologists for 6 months to provide care to people referred by primary care physicians. The objective was to address the expected increased demand for treatment of mental disorders, notably posttraumatic stress disorder (PTSD) and adjustment disorders. Method: Referred individuals were evaluated and treated according to a clinical protocol designed ad hoc from June 12, 2011, to November 30, 2011. The protocol provided a stepped intervention guided by clinical and psychometric assessment using “normalization” for those with no psychiatric diagnosis, brief group treatment for mild to moderate PTSD or adjustment disorders, individual treatment for more severe PTSD, and referral to the local mental health center for other mental health disorders. Standard adult and child scales to assess posttraumatic, depression, and anxiety symptoms and resilience were used at initial assessment to guide treatment allocation and repeated to assess outcome status. Psychologists also provided a clinical assessment of symptom resolution at the end of the study. Results: Rates of symptom resolution and improvements on all scales (PTSD, depression, anxiety, and resilience) demonstrated clinically and statistically significant improvement in all treatment groups (P = .000). Dropout was low. Medications were prescribed frequently to adults; no child received medication as a result of the earthquakes. No case of mental disorder related to the earthquakes was referred to the local mental health center during the 6 months of psychologist intervention. Conclusion:The structured intervention resulted in a high resolution of cases and low dropout, allowing treatment of a larger number of people with optimal frequency (weekly), devoting more time to the most severe cases and less to those moderately or mildly affected. PMID:26137356

Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis.

PubMed

Pichler, Lukas; Poeran, Jashvant; Zubizarreta, Nicole; Cozowicz, Crispiana; Sun, Eric C; Mazumdar, Madhu; Memtsoudis, Stavros G

2018-05-21

Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes. The study included data on 88,830 total knee arthroplasties performed with a peripheral nerve block (Premier Healthcare Database 2013 to 2016). Multilevel multivariable regressions measured associations between use of liposomal bupivacaine and (1) inpatient opioid prescription (extracted from billing) and (2) length of stay, cost of hospitalization, as well as opioid-related complications. To reflect the difference between statistical and clinical significance, a relative change of -15% in outcomes was assumed to be clinically important. Overall, liposomal bupivacaine was used in 21.2% (n = 18,817) of patients that underwent a total knee arthroplasty with a peripheral nerve block. Liposomal bupivacaine use was not associated with a clinically meaningful reduction in inpatient opioid prescription (group median, 253 mg of oral morphine equivalents, adjusted effect -9.3% CI -11.1%, -7.5%; P < 0.0001) and length of stay (group median, 3 days, adjusted effect -8.8% CI -10.1%, -7.5%; P < 0.0001) with no effect on cost of hospitalization. Most importantly, liposomal bupivacaine use was not associated with decreased odds for opioid-related complications. Liposomal bupivacaine was not associated with a clinically relevant improvement in inpatient opioid prescription, resource utilization, or opioid-related complications in patients who received modern pain management including a peripheral nerve block.

Testing for clinical inertia in medication treatment of bipolar disorder.

PubMed

Hodgkin, Dominic; Merrick, Elizabeth L; O'Brien, Peggy L; McGuire, Thomas G; Lee, Sue; Deckersbach, Thilo; Nierenberg, Andrew A

2016-11-15

Clinical inertia has been defined as lack of change in medication treatment at visits where a medication adjustment appears to be indicated. This paper seeks to identify the extent of clinical inertia in medication treatment of bipolar disorder. A second goal is to identify patient characteristics that predict this treatment pattern. Data describe 23,406 visits made by 1815 patients treated for bipolar disorder during the STEP-BD practical clinical trial. Visits were classified in terms of whether a medication adjustment appears to be indicated, and also whether or not one occurred. Multivariable regression analyses were conducted to find which patient characteristics were predictive of whether adjustment occurred. 36% of visits showed at least 1 indication for adjustment. The most common indications were non-response to medication, side effects, and start of a new illness episode. Among visits with an indication for adjustment, no adjustment occurred 19% of the time, which may be suggestive of clinical inertia. In multivariable models, presence of any indication for medication adjustment was a predictor of receiving one (OR=1.125, 95% CI =1.015, 1.246), although not as strong as clinical status measures. The associations observed are not necessarily causal, given the study design. The data also lack information about physician-patient communication. Many patients remained on the same medication regimen despite indications of side effects or non-response to treatment. Although lack of adjustment does not necessarily reflect clinical inertia in all cases, the reasons for this treatment pattern merit further examination. Copyright © 2016 Elsevier B.V. All rights reserved.

Testing for Clinical Inertia in Medication Treatment of Bipolar Disorder

PubMed Central

Hodgkin, Dominic; Merrick, Elizabeth L.; O'Brien, Peggy L.; McGuire, Thomas G.; Lee, Sue; Deckersbach, Thilo; Nierenberg, Andrew A.

2016-01-01

Background Clinical inertia has been defined as lack of change in medication treatment at visits where a medication adjustment appears to be indicated. This paper seeks to identify the extent of clinical inertia in medication treatment of bipolar disorder. A second goal is to identify patient characteristics that predict this treatment pattern. Method Data describe 23,406 visits made by 1,815 patients treated for bipolar disorder during the STEP-BD practical clinical trial. Visits were classified in terms of whether a medication adjustment appears to be indicated, and also whether or not one occurred. Multivariable regression analyses were conducted to find which patient characteristics were predictive of whether adjustment occurred. Results 36% of visits showed at least 1 indication for adjustment. The most common indications were non-response to medication, side effects, and start of a new illness episode. Among visits with an indication for adjustment, no adjustment occurred 19% of the time, which may be suggestive of clinical inertia. In multivariable models, presence of any indication for medication adjustment was a predictor of receiving one (OR=1.125, 95% CI = 1.015, 1.246), although not as strong as clinical status measures. Limitations The associations observed are not necessarily causal, given the study design. The data also lack information about physician-patient communication. Conclusions Many patients remained on the same medication regimen despite indications of side effects or non-response to treatment. Although lack of adjustment does not necessarily reflect clinical inertia in all cases, the reasons for this treatment pattern merit further examination. PMID:27391267

Intraclass correlation estimates for cancer screening outcomes: estimates and applications in the design of group-randomized cancer screening studies.

PubMed

Hade, Erinn M; Murray, David M; Pennell, Michael L; Rhoda, Dale; Paskett, Electra D; Champion, Victoria L; Crabtree, Benjamin F; Dietrich, Allen; Dignan, Mark B; Farmer, Melissa; Fenton, Joshua J; Flocke, Susan; Hiatt, Robert A; Hudson, Shawna V; Mitchell, Michael; Monahan, Patrick; Shariff-Marco, Salma; Slone, Stacey L; Stange, Kurt; Stewart, Susan L; Strickland, Pamela A Ohman

2010-01-01

Screening has become one of our best tools for early detection and prevention of cancer. The group-randomized trial is the most rigorous experimental design for evaluating multilevel interventions. However, identifying the proper sample size for a group-randomized trial requires reliable estimates of intraclass correlation (ICC) for screening outcomes, which are not available to researchers. We present crude and adjusted ICC estimates for cancer screening outcomes for various levels of aggregation (physician, clinic, and county) and provide an example of how these ICC estimates may be used in the design of a future trial. Investigators working in the area of cancer screening were contacted and asked to provide crude and adjusted ICC estimates using the analysis of variance method estimator. Of the 29 investigators identified, estimates were obtained from 10 investigators who had relevant data. ICC estimates were calculated from 13 different studies, with more than half of the studies collecting information on colorectal screening. In the majority of cases, ICC estimates could be adjusted for age, education, and other demographic characteristics, leading to a reduction in the ICC. ICC estimates varied considerably by cancer site and level of aggregation of the groups. Previously, only two articles had published ICCs for cancer screening outcomes. We have complied more than 130 crude and adjusted ICC estimates covering breast, cervical, colon, and prostate screening and have detailed them by level of aggregation, screening measure, and study characteristics. We have also demonstrated their use in planning a future trial and the need for the evaluation of the proposed interval estimator for binary outcomes under conditions typically seen in GRTs.

Severity of illness and ambulatory care-sensitive conditions.

PubMed

Yuen, Elaine J

2004-09-01

This study describes how severity of illness may refine the definition of ambulatory care-sensitive conditions, or ACSCs. Hospital discharge abstract data from Philadelphia were combined with census data to develop population-based adjusted rates of hospitalization for diabetes and asthma, two ACSCs. By stratifying ACSC hospitalization by severity of illness, variations were observed by age, race, and gender. Minority groups may be at higher risk for less access to outpatient primary care and were observed to have higher rates of more severely ill, Stage 3 hospitalization. Geographic map displays indicated wide ranges of age-sex-adjusted rates for high-severity hospitalization in the five-county Philadelphia region. This refined ACSC measure may help to identify specific groups and clinical conditions within a population to assist health care planners estimate health care resources such as facilities, manpower, and programs, as well as to evaluate their outcomes.

Psychosocial and seizure factors related to depression and neurotic-disorders among patients with chronic epilepsy in Nigeria.

PubMed

Olley, B O

2004-03-01

To establish the effect of psychosocial and seizure factors on Depression and Neurotic Disorders among clinically diagnosed Nigerian patients, with epilepsy. This study utilized the multivariate statistical design to evaluate the associations between some psychosocial and seizure factors on increase depression and neurotic disorders. The Neurology outpatient clinics of two tertiary facilities in Nigeria: Aro Neuro-psychiatric Hospital/World Health Organization Collaborating Centre, Abeokuta and the University College Hospital Ibadan, were used for the study. Two hundred and sixty four (264) consecutive clinic attendees with a clinical diagnosis of epilepsy participated in the study. Perceived Stigma Scale (PSS); Washington Psychosocial Seizure Inventory (WPSI-Modified): Becks Depression Inventory (BDI) and Crown-Crisp Experiential Index (CCEI). Significant main effect for seizure control, stigma, emotional adjustment, vocational adjustment, interpersonal adjustment, adjustment to seizures but not for age at onset of epilepsy, financial adjustment and gender, were recorded on depression. Similarly significant main effect for seizure control, stigma, emotional adjustment, adjustment to seizures but not for age at onset of epilepsy, gender, vocational adjustment, financial adjustment and interpersonal adjustment were recorded for neurotic disorders. The study highlights some of the factors, which may contribute to the understanding of epilepsy-related psychopathologies and implication for psychotherapeutic intervention among individuals with epilepsy in Nigeria.

Increased vulnerability of rural children on antiretroviral therapy attending public health facilities in South Africa: a retrospective cohort study

PubMed Central

2010-01-01

Background A large proportion of the 340,000 HIV-positive children in South Africa live in rural areas, yet there is little sub-Saharan data comparing rural paediatric antiretroviral therapy (ART) programme outcomes with urban facilities. We compared clinical, immunological and virological outcomes between children at seven rural and 37 urban facilities across four provinces in South Africa. Methods We conducted a retrospective cohort study of routine data of children enrolled on ART between November 2003 and March 2008 in three settings, namely: urban residence and facility attendance (urban group); rural residence and facility attendance (rural group); and rural residents attending urban facilities (rural/urban group). Outcome measures were: death, loss to follow up (LTFU), virological suppression, and changes in CD4 percentage and weight-for-age-z (WAZ) scores. Kaplan-Meier estimates, logrank tests, multivariable Cox regression and generalized estimating equation models were used to compare outcomes between groups. Results In total, 2332 ART-naïve children were included, (1727, 228 and 377 children in the urban, rural and rural/urban groups, respectively). At presentation, rural group children were older (6.7 vs. 5.6 and 5.8 years), had lower CD4 cell percentages (10.0% vs. 12.8% and 12.7%), lower WAZ scores (-2.06 vs. -1.46 and -1.41) and higher proportions with severe underweight (26% vs.15% and 15%) compared with the urban and rural/urban groups, respectively. Mortality was significantly higher in the rural group and LTFU significantly increased in the rural/urban group. After 24 months of ART, mortality probabilities were 3.4% (CI: 2.4-4.8%), 7.7% (CI: 4.5-13.0%) and 3.1% (CI: 1.7-5.6%) p = 0.0137; LTFU probabilities were 11.5% (CI: 9.3-14.0%), 8.8% (CI: 4.5-16.9%) and 16.6% (CI: 12.4-22.6%), p = 0.0028 in the urban, rural and rural/urban groups, respectively. The rural group had an increased adjusted mortality probability, adjusted hazards ratio 2.41 (CI: 1.25-4.67) and the rural/urban group had an increased adjusted LTFU probability, aHR 2.85 (CI: 1.41-5.79). The rural/urban group had a decreased adjusted probability of virological suppression compared with the urban group at any timepoint on treatment, adjusted odds ratio 0.67 (CI: 0.48-0.93). Conclusions Rural HIV-positive children are a vulnerable group, exhibiting delayed access to ART and an increased risk of poor outcomes while on ART. Expansion of rural paediatric ART programmes, with future research exploring improvements to rural health system effectiveness, is required. PMID:21108804

A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers

PubMed Central

MacIntyre, Chandini Raina; Wang, Quanyi; Cauchemez, Simon; Seale, Holly; Dwyer, Dominic E.; Yang, Peng; Shi, Weixian; Gao, Zhanhai; Pang, Xinghuo; Zhang, Yi; Wang, Xiaoli; Duan, Wei; Rahman, Bayzidur; Ferguson, Neil

2011-01-01

Please cite this paper as: MacIntyre et al. (2011) A cluster randomized clinical trial comparing fit‐tested and non‐fit‐tested N95 respirators to medical masks to prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses DOI: 10.1111/j.1750‐2659.2010.00198.x. Background  We compared the efficacy of medical masks, N95 respirators (fit tested and non fit tested), in health care workers (HCWs). Methods  A cluster randomized clinical trial (RCT) of 1441 HCWs in 15 Beijing hospitals was performed during the 2008/2009 winter. Participants wore masks or respirators during the entire work shift for 4 weeks. Outcomes included clinical respiratory illness (CRI), influenza‐like illness (ILI), laboratory‐confirmed respiratory virus infection and influenza. A convenience no‐mask/respirator group of 481 health workers from nine hospitals was compared. Findings  The rates of CRI (3·9% versus 6·7%), ILI (0·3% versus 0·6%), laboratory‐confirmed respiratory virus (1·4% versus 2·6%) and influenza (0·3% versus 1%) infection were consistently lower for the N95 group compared to medical masks. By intention‐to‐treat analysis, when P values were adjusted for clustering, non‐fit‐tested N95 respirators were significantly more protective than medical masks against CRI, but no other outcomes were significant. The rates of all outcomes were higher in the convenience no‐mask group compared to the intervention arms. There was no significant difference in outcomes between the N95 arms with and without fit testing. Rates of fit test failure were low. In a post hoc analysis adjusted for potential confounders, N95 masks and hospital level were significant, but medical masks, vaccination, handwashing and high‐risk procedures were not. Interpretation  Rates of infection in the medical mask group were double that in the N95 group. A benefit of respirators is suggested but would need to be confirmed by a larger trial, as this study may have been underpowered. The finding on fit testing is specific to the type of respirator used in the study and cannot be generalized to other respirators. Trial registration  Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: ACTRN12609000257268 (http://www.anzctr.org.au). PMID:21477136

Analysis of flexural strength and contact pressure after simulated chairside adjustment of pressed lithium disilicate glass-ceramic.

PubMed

Ramadhan, Ali; Thompson, Geoffrey A; Maroulakos, Georgios; Berzins, David

2018-04-30

Research evaluating load-to-failure of pressed lithium disilicate glass-ceramic (LDGC) with a clinically validated test after adjustment and repair procedures is scarce. The purpose of this in vitro study was to investigate the effect of the simulated chairside adjustment of the intaglio surface of monolithic pressed LDGC and procedures intended to repair damage. A total of 423 IPS e.max Press (Ivoclar Vivadent AG) disks (15 mm diameter, 1 mm height) were used in the study. The material was tested by using an equibiaxial loading arrangement (n≥30/group) and a contact pressure test (n≥20/group). Specimens were assigned to 1 of 14 groups. One-half was assigned to the equibiaxial load test and the other half underwent contact pressure testing. Testing was performed in 2 parts, before glazing and after glazing. Before-glazing specimens were devested and entered in the test protocol, while after-glazing specimens were devested and glazed before entering the test protocol. Equibiaxial flexure test specimens were placed on a ring-on-ring apparatus and loaded until failure. Contact pressure specimens were cemented to epoxy resin blocks with a resin cement and loaded with a 50-mm diameter hemisphere until failure. Tests were performed on a universal testing machine with a crosshead speed of 0.5 mm/min. Weibull statistics and likelihood ratio contour plots determined intergroup differences (95% confidence bounds). Before glazing, the equibiaxial flexural strength test and the Weibull and likelihood ratio contour plots demonstrated a significantly higher failure strength for 1EC (188 MPa) than that of the damaged and/or repaired groups. Glazing following diamond-adjustment (1EGG) was the most beneficial post-damage procedure (176 MPa). Regarding the contact pressure test, the Weibull and likelihood ratio contour plots revealed no significant difference between the 1PC (98 MPa) and 1PGG (98 MPa) groups. Diamond-adjustment, without glazing (1EG and 1PG), resulted in the next-to-lowest equibiaxial flexure strength and the lowest contact pressure. After glazing, the strength of all the groups, when subjected to glazing following devesting, increased in comparison with corresponding groups in the before-glazing part of the study. A glazing treatment improved the mechanical properties of diamond-adjusted IPS e.max Press disks when evaluated by equibiaxial flexure and contact pressure tests. Copyright © 2018 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis.

PubMed

Dougados, Maxime; Maksymowych, Walter P; Landewé, Robert B M; Moltó, Anna; Claudepierre, Pascal; de Hooge, Manouk; Lambert, Robert G; Bonin, Randi; Bukowski, Jack F; Jones, Heather E; Logeart, Isabelle; Pedersen, Ron; Szumski, Annette; Vlahos, Bonnie; van der Heijde, Désirée

2018-02-01

To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates. At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: -0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was -0.22 (95% CI -0.38 to -0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: -1.9% versus 1.6% (adjusted difference for etanercept minus control: -4.7%,95% CI -9.9 to 0.5, p=0.07) for change in mNY criteria; -1.9% versus 7.8% (adjusted difference: -18.2%,95% CI -30.9 to -5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and -0.6% versus 6.7% (adjusted difference: -16.4%,95% CI -27.9 to -5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change. Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. NCT01258738, NCT01648907; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis

PubMed Central

Dougados, Maxime; Maksymowych, Walter P; Landewé, Robert B M; Moltó, Anna; Claudepierre, Pascal; de Hooge, Manouk; Lambert, Robert G; Bonin, Randi; Bukowski, Jack F; Jones, Heather E; Logeart, Isabelle; Pedersen, Ron; Szumski, Annette; Vlahos, Bonnie

2018-01-01

Objective To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). Methods Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates. Results At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: –0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was –0.22 (95% CI –0.38 to –0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: –1.9% versus 1.6% (adjusted difference for etanercept minus control: –4.7%,95% CI –9.9 to 0.5, p=0.07) for change in mNY criteria; –1.9% versus 7.8% (adjusted difference: –18.2%,95% CI –30.9 to –5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and –0.6% versus 6.7% (adjusted difference: –16.4%,95% CI –27.9 to –5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change. Conclusion Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. Trial registration numbers NCT01258738, NCT01648907; Post-results. PMID:28970213

Sacroiliac joint dysfunction in patients with herniated lumbar disc: a cross-sectional study.

PubMed

Madani, Seyed Pezhman; Dadian, Mohammad; Firouznia, Keykavous; Alalawi, Salah

2013-01-01

To determine the relative frequency of sacroiliac joint dysfunction in a sample of patients with image proven lumbar disc herniation. A single group cross-sectional study was conducted in a three year period from 2007 in an outpatient clinic at a university hospital. Overall, 202 patients aged more than or equal to 18 years with image proven herniated lumbar disc and with physical findings suggestive of lumbosacral root irritation were included. Overall, 146 (72.3%) participants had sacroiliac joint dysfunction. The dysfunction was significantly more prevalent in females (p< 0.001, adjusted OR=2.46, 95% CI=1.00 to 6.03), patients with recurrent pain (p< 0.005, adjusted OR=2.33 with 95% CI=1.10 to 4.89) and patients with positive straight leg raising provocative test (p< 0.0001, adjusted OR=5.07, 95% CI=2.37 to 10.85). There was no significant relationship between the prevalence of SIJD, and working hours, duration of low back pain, or body mass index. Sacroiliac joint dysfunction is a significant pathogenic factor with high possibility of occurrence in low back pain. Thus, regardless of intervertebral disc pathology, sacroiliac joint dysfunction must be considered in clinical decision making.

Self-esteem, social adjustment and suicidality in affective disorders.

PubMed

Daskalopoulou, E G; Dikeos, D G; Papadimitriou, G N; Souery, D; Blairy, S; Massat, I; Mendlewicz, J; Stefanis, C N

2002-09-01

Self-esteem (SE) and social adjustment (SA) are often impaired during the course of affective disorders; this impairment is associated with suicidal behaviour. The aim of the present study was to investigate SE and SA in unipolar or bipolar patients in relation to demographic and clinical characteristics, especially the presence of suicidality (ideation and/or attempt). Forty-four patients, 28 bipolar and 16 unipolar, in remission for at least 3 months, and 50 healthy individuals were examined through a structured clinical interview. SE and SA were assessed by the Rosenberg self-esteem scale and the social adjustment scale, respectively. The results have shown that bipolar patients did not differ from controls in terms of SE, while unipolar patients had lower SE than bipolars and controls. No significant differences in the mean SA scores were found between the three groups. Suicidality during depression was associated only in bipolar patients with lower SE at remission; similar but not as pronounced was the association of suicidality with SA. It is concluded that low SE lasting into remission seems to be related to the expression of suicidality during depressive episodes of bipolar patients, while no similar pattern is evident in unipolar patients.

Accounting for interim safety monitoring of an adverse event upon termination of a clinical trial.

PubMed

Dallas, Michael J

2008-01-01

Upon termination of a clinical trial that uses interim evaluations to determine whether the trial can be stopped, a proper statistical analysis must account for the interim evaluations. For example, in a group-sequential design where the efficacy of a treatment regimen is evaluated at interim stages, and the opportunity to stop the trial based on positive efficacy findings exists, the terminal p-value, point estimate, and confidence limits of the outcome of interest must be adjusted to eliminate bias. While it is standard practice to adjust terminal statistical analyses due to opportunities to stop for "positive" findings, adjusting due to opportunities to stop for "negative" findings is also important. Stopping rules for negative findings are particularly useful when monitoring a specific rare serious adverse event in trials designed to show safety with respect to the event. In these settings, establishing conservative stopping rules are appropriate, and therefore accounting for the interim monitoring can have a substantial effect on the final results. Here I present a method to account for interim safety monitoring and illustrate its usefulness. The method is demonstrated to have advantages over methodology that does not account for interim monitoring.

Self-rated driving habits among older adults with clinically-defined mild cognitive impairment, clinically-defined dementia, and normal cognition.

PubMed

O'Connor, Melissa L; Edwards, Jerri D; Bannon, Yvonne

2013-12-01

Older adults with clinically-defined dementia may report reducing their driving more than cognitively normal controls. However, it is unclear how these groups compare to individuals with clinically-defined mild cognitive impairment (MCI) in terms of driving behaviors. The current study investigated self-reported driving habits among adults age 60 and older with clinical MCI (n=41), clinical mild dementia (n=40), and normal cognition (n=43). Participants reported their driving status, driving frequency (days per week), and how often they avoided accessing the community, making left turns, driving at night, driving in unfamiliar areas, driving on high-traffic roads, and driving in bad weather. After adjusting for education, a MANCOVA revealed that participants with MCI and dementia avoided unfamiliar areas and high-traffic roads significantly more than normal participants. Participants with dementia also avoided left turns and accessing the community more than those with normal cognition and MCI (p<0.05 for all). The other driving variables did not significantly differ between groups. Thus, older adults with clinically-defined MCI, as well as those with dementia, avoided some complex driving situations more than cognitively intact adults. However, all diagnostic groups had similar rates of driving cessation and frequency. Future research should examine the safety implications of such findings. Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of autoCPAP devices in home treatment of sleep apnea/hypopnea syndrome.

PubMed

Meurice, J C; Cornette, A; Philip-Joet, F; Pepin, J L; Escourrou, P; Ingrand, P; Veale, D

2007-11-01

Quality of life (QOL) and sleepiness for patients with sleep apnea/hypopnea syndrome (SAHS) might improve with continuous positive airway pressure devices working in auto-adjust mode (autoCPAP) by allowing pressure modulations following patient needs. Clinical comparisons between devices driven by different algorithms are needed. We compared the clinical effectiveness of fixed pressure CPAP and four different autoCPAP devices by assessing compliance and QOL (36-item short-form health survey [SF-36]). SAHS patients were randomly allocated to five groups. Polysomnography (PSG) was performed to titrate the effective pressure in the constant CPAP group and evaluate residual apnea/hypopnea index (AHI) under autoCPAP. Follow-up consisted of clinical visits at three and six months by homecare technicians who assessed compliance, symptom scores and SF-36 scores. A laboratory-based PSG using the same CPAP/autoCPAP device as at home was performed at six months. Eighty-three patients (mean age 56+/-10 yrs) with mean body mass index (BMI) 30.8+/-5.3 kg/m(2) and severe SAHS (mean AHI: 52.3+/-17.8/h) were included. There were no differences in clinical symptoms or QOL scores, and similar clinical and PSG improvements were seen in all groups. CPAP use was >5 h per night, without any significant difference between groups. AutoCPAP is equally as effective as fixed CPAP for long-term home treatment in severe SAHS patients.

The clinical outcomes of oldest old patients with tuberculosis treated by regimens containing rifampicin, isoniazid, and pyrazinamide.

PubMed

Lin, Huang-Shen; Cheng, Chun-Wen; Lin, Ming-Shyan; Chou, Yen-Li; Chang, Pey-Jium; Lin, Jing-Chi; Ye, Jung-Jr

2016-01-01

To investigate the clinical characteristics, adverse drug reactions, and outcomes of the oldest old patients (aged ≥80 years) with tuberculosis (TB) treated with rifampicin, isoniazid, and pyrazinamide (RIP)-containing regimens. A retrospective chart review study. A 1,200-bed tertiary teaching hospital in southwest Taiwan. We conducted a retrospective observational study between January 1, 2005 and December 31, 2011. Seven hundred adult patients (aged ≥18 years) with TB treated with RIP-containing anti-TB regimens were reviewed, including 161 oldest old patients. Clinical outcomes included clinical responsiveness and microbiological eradication. Adverse outcomes included drug-induced hepatitis, and other symptoms included gastrointestinal upset (eg, abdominal pain, vomiting, diarrhea, or dyspepsia), skin rash, joint pain, and hyperuricemia. Compared with the non-oldest old adult patients, the oldest old patients more frequently had hepatitis (P=0.014), gastrointestinal upset (P=0.029), and unfavorable outcomes (P<0.001). In a multivariate analysis, hepatitis during treatment (adjusted odds ratio: 3.482, 95% confidence interval: 1.537-7.885; P<0.003) and oldest old age (adjusted odds ratio: 5.161, 95% confidence interval: 2.294-11.613; P<0.010) were independent risk factors for unfavorable outcomes. In the oldest old patients with hepatitis, rifampicin use was more common in the favorable outcome group than in the unfavorable outcome group (100% vs 37.5%; P=0.001). The oldest old age and hepatitis during RIP treatment were associated with unfavorable outcomes. For the oldest old patients with TB having hepatitis during treatment, rifampicin rechallenge and use might benefit the treatment outcome.

A Comparison of Motor Adaptations to Robotically Facilitated Upper Extremity Task Practice Demonstrated by Children with Cerebral Palsy and Adults with Stroke

PubMed Central

Qiu, Qinyin; Adamovich, Sergei; Saleh, Soha; Lafond, Ian; Merians, Alma S.; Fluet, Gerard G.

2015-01-01

Nine children with cerebral palsy and nine adults with stroke were trained using 5 different upper extremity simulations using the NJIT-RAVR system for approximately nine to twelve hours over a three week period. Both groups made improvements in clinical measurements of upper extremity function and reaching kinematics. Patterns and magnitudes of improvement differ between the two groups. Responses to training required adjustment of the robotic system to accommodate the rehabilitation needs of children with cerebral palsy. PMID:22275632

Impact of a Clinical Pharmacy Specialist in an Emergency Department for Seniors.

PubMed

Shaw, Paul B; Delate, Thomas; Lyman, Alfred; Adams, Jody; Kreutz, Heather; Sanchez, Julia K; Dowd, Mary Beth; Gozansky, Wendolyn

2016-02-01

This study assesses outcomes associated with the implementation of an emergency department (ED) for seniors in which a clinical pharmacy specialist, with specialized geriatric training that included medication management training, is a key member of the ED care team. This was a retrospective cohort analysis of patients aged 65 years or older who presented at an ED between November 1, 2012, and May 31, 2013. Three groups of seniors were assessed: treated by the clinical pharmacy specialist in the ED for seniors, treated in the ED for seniors but not by the clinical pharmacy specialist, and not treated in the ED for seniors. Outcomes included rates of an ED return visit, mortality and hospital admissions, and follow-up total health care costs. Multivariable regression modeling was used to adjust for any potential confounders in the associations between groups and outcomes. A total of 4,103 patients were included, with 872 (21%) treated in the ED for seniors and 342 (39%) of these treated by the clinical pharmacy specialist. Groups were well matched overall in patient characteristics. Patients who received medication review and management by the clinical pharmacy specialist did not experience a reduction in ED return visits, mortality, cost of follow-up care, or hospital admissions compared with the other groups. Of the patients treated by the clinical pharmacy specialist, 154 (45.0%) were identified as having at least 1 medication-related problem. Although at least 1 medication-related problem was identified in almost half of patients treated by the clinical pharmacy specialist in the ED for seniors, incorporation of a clinical pharmacy specialist into the ED staff did not improve clinical outcomes. Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Clinical and Pharmacogenetic Predictors of Circulating Atorvastatin and Rosuvastatin Concentration in Routine Clinical Care

PubMed Central

DeGorter, Marianne K.; Tirona, Rommel G.; Schwarz, Ute I.; Choi, Yun-Hee; Dresser, George K.; Suskin, Neville; Myers, Kathryn; Zou, GuangYong; Iwuchukwu, Otito; Wei, Wei-Qi; Wilke, Russell A.; Hegele, Robert A.; Kim, Richard B.

2014-01-01

Background A barrier to statin therapy is myopathy associated with elevated systemic drug exposure. Our objective was to examine the association between clinical and pharmacogenetic variables and statin concentrations in patients. Methods and Results In total, 299 patients taking atorvastatin or rosuvastatin were prospectively recruited at an outpatient referral center. The contribution of clinical variables and transporter gene polymorphisms to statin concentration was assessed using multiple linear regression. We observed 45-fold variation in statin concentration among patients taking the same dose. After adjustment for gender, age, body mass index, ethnicity, dose, and time from last dose, SLCO1B1 c.521T>C (p < 0.001) and ABCG2 c.421C>A (p < 0.01) were important to rosuvastatin concentration (adjusted R2 = 0.56 for the final model). Atorvastatin concentration was associated with SLCO1B1 c.388A>G (p < 0.01) and c.521T>C (p < 0.05), and 4β-hydroxycholesterol, a CYP3A activity marker (adjusted R2 = 0.47). A second cohort of 579 patients from primary and specialty care databases were retrospectively genotyped. In this cohort, genotypes associated with statin concentration were not differently distributed among dosing groups, implying providers had not yet optimized each patient's risk-benefit ratio. Nearly 50% of patients in routine practice taking the highest doses were predicted to have statin concentrations greater than the 90th percentile. Conclusions Interindividual variability in statin exposure in patients is associated with uptake and efflux transporter polymorphisms. An algorithm incorporating genomic and clinical variables to avoid high atorvastatin and rosuvastatin levels is described; further study will determine if this approach reduces incidence of statin-myopathy. PMID:23876492

Factors Associated With Pressure Ulcers in Individuals With Spina Bifida

PubMed Central

Kim, Sunkyung; Ward, Elisabeth; Dicianno, Brad E.; Clayton, Gerald H.; Sawin, Kathleen J.; Beierwaltes, Patricia; Thibadeau, Judy

2015-01-01

Objective To describe factors associated with pressure ulcers in individuals with spina bifida (SB) enrolled in the National Spina Bifida Patient Registry (NSBPR). Design Unbalanced longitudinal multicenter cohort study. Setting Nineteen SB clinics. Participants Individuals with SB (N=3153) enrolled in 19 clinic sites that participate in the NSBPR. Interventions Not applicable. Main Outcome Measures Pressure ulcer status (yes/no) at the annual visit between 2009 and 2012. Results Of 3153 total participants, 19% (n=603) reported ulcers at their most recent annual clinic visit. Seven factors–level of lesion, wheelchair use, urinary incontinence, shunt presence, above the knee orthopedic surgery, recent surgery, and male sex–were significantly associated with the presence of pressure ulcers. Of these factors, level of lesion, urinary incontinence, recent surgery, and male sex were included in the final logistic regression model. The 3 adjusting variables–SB type, SB clinic, and age group–were significant in all analyses (all P<.001). Conclusions By adjusting for SB type, SB clinic, and age group, we found that 7 factors–level of lesion, wheelchair use, urinary incontinence, shunt presence, above the knee orthopedic surgery, recent surgery, and male sex–were associated with pressure ulcers. Identifying key factors associated with the onset of pressure ulcers can be incorporated into clinical practice in ways that prevent and enhance treatment of pressure ulcers in the population with SB. PMID:25796136

Effect of Adding Interferential Current in an Exercise and Manual Therapy Program for Patients With Unilateral Shoulder Impingement Syndrome: A Randomized Clinical Trial.

PubMed

Gomes, Cid André Fidelis de Paula; Dibai-Filho, Almir Vieira; Moreira, William Arruda; Rivas, Shirley Quispe; Silva, Emanuela Dos Santos; Garrido, Ana Claudia Bogik

The purpose of this study was to measure the additional effect of adding interferential current (IFC) to an exercise and manual therapy program for patients with unilateral shoulder impingement syndrome. Forty-five participants were randomly assigned to group 1 (exercise and manual therapy), group 2 (exercise and manual therapy + IFC), or group 3 (exercise and manual therapy + placebo ultrasound). Individuals participated in 16 treatment sessions, twice a week for 8 weeks. The primary outcome of the study was total score of the Shoulder Pain and Disability Index (SPADI). The secondary outcomes were the pain and disability subscales of SPADI, Numeric Rating Scale, and Pain-Related Self-Statement Scale. Adjusted between-group mean differences (MDs) and 95% confidence intervals (CIs) were calculated using linear mixed models. After 16 treatment sessions, statistically significant but not clinically important differences were identified in favor of the exercise and manual therapy program alone in the SPADI-total (group 1 vs group 2, MD 11.12 points, 95% CI 5.90-16.35; group 1 vs group 3, MD 13.43 points, 95% CI 8.21-18.65). Similar results were identified for secondary outcomes. The addition of IFC does not generate greater clinical effects in an exercise and manual therapy program for individuals with unilateral shoulder impingement syndrome. Copyright © 2018. Published by Elsevier Inc.

Do first impressions count? Frailty judged by initial clinical impression predicts medium-term mortality in vascular surgical patients.

PubMed

O'Neill, B R; Batterham, A M; Hollingsworth, A C; Durrand, J W; Danjoux, G R

2016-06-01

Recognising frailty during pre-operative assessment is important. Frail patients experience higher mortality rates and are less likely to return to baseline functional status following the physiological insult of surgery. We evaluated the association between an initial clinical impression of frailty and all-cause mortality in 392 patients attending our vascular pre-operative assessment clinic. Prevalence of frailty assessed by the initial clinical impression was 30.6% (95% CI 26.0-35.2%). There were 133 deaths in 392 patients over a median follow-up period of 4 years. Using Cox regression, adjusted for age, sex, revised cardiac risk index and surgery (yes/no), the hazard ratio for mortality for frail vs. not-frail was 2.14 (95% CI 1.51-3.05). The time to 20% mortality was 16 months in the frail group and 33 months in the not-frail group. The initial clinical impression is a useful screening tool to identify frail patients in pre-operative assessment. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

Comparison of the incidence of postoperative pain after using a continuous rotary system, a reciprocating system, and a Self-Adjusting File system in single-visit endodontics: A prospective randomized clinical trial.

PubMed

Saha, Suparna Ganguly; Gupta, Rudra Kumar; Bhardwaj, Anuj; Misuriya, Abhinav; Saha, Mainak Kanti; Nirwan, Amit Singh

2018-01-01

The aim of this study is to compare the incidence of postoperative pain using the ProTaper Next (PTN), WaveOne Gold (WOG), and Self-Adjusting File (SAF) systems. Two hundred and fourteen patients with irreversible pulpitis were selected for single-visit endodontics. The teeth were blindly assigned to three groups based on the instrumentation system used: Group A (PTN), Group B (WOG), and Group C (SAF). Participants were asked to note the incidence of the pre- and postoperative pain on a visual analog scale at different time intervals. Paired t -test and one-way ANOVA were used along with post hoc Tukey's test. The greatest mean pain in Group A (PTN) and Group B (WOG) was found to be maximum in the first 24 h with a significant reduction in pain at the subsequent observation time points of 48 h, 72 h, and 7 days. Group C (SAF) showed minimum pain followed by Group B followed by Group A which showed comparatively higher pain scores even at the end of 7 days. In single-visit endodontics, SAF system may prove to be a better system compared with PTN and WOG as it produces minimal postoperative pain, thus improving the overall acceptance of endodontic treatment.

Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study.

PubMed

Marik, Paul E; Khangoora, Vikramjit; Rivera, Racquel; Hooper, Michael H; Catravas, John

2017-06-01

The global burden of sepsis is estimated as 15 to 19 million cases annually, with a mortality rate approaching 60% in low-income countries. In this retrospective before-after clinical study, we compared the outcome and clinical course of consecutive septic patients treated with intravenous vitamin C, hydrocortisone, and thiamine during a 7-month period (treatment group) with a control group treated in our ICU during the preceding 7 months. The primary outcome was hospital survival. A propensity score was generated to adjust the primary outcome. There were 47 patients in both treatment and control groups, with no significant differences in baseline characteristics between the two groups. The hospital mortality was 8.5% (4 of 47) in the treatment group compared with 40.4% (19 of 47) in the control group (P < .001). The propensity adjusted odds of mortality in the patients treated with the vitamin C protocol was 0.13 (95% CI, 0.04-0.48; P = .002). The Sepsis-Related Organ Failure Assessment score decreased in all patients in the treatment group, with none developing progressive organ failure. All patients in the treatment group were weaned off vasopressors, a mean of 18.3 ± 9.8 h after starting treatment with the vitamin C protocol. The mean duration of vasopressor use was 54.9 ± 28.4 h in the control group (P < .001). Our results suggest that the early use of intravenous vitamin C, together with corticosteroids and thiamine, are effective in preventing progressive organ dysfunction, including acute kidney injury, and in reducing the mortality of patients with severe sepsis and septic shock. Additional studies are required to confirm these preliminary findings. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Leukocyte telomere length and depression, anxiety and stress and adjustment disorders in primary health care patients.

PubMed

Wang, Xiao; Sundquist, Kristina; Hedelius, Anna; Palmér, Karolina; Memon, Ashfaque A; Sundquist, Jan

2017-04-24

The primary aim was to examine possible differences in telomere length between primary health care patients, with depression, anxiety or stress and adjustment disorders, and healthy controls. The second aim was to examine the association between telomere length and baseline characteristics in the patients. The third aim was to examine the potential effects of the 8-week treatments (mindfulness-based group therapy or treatment as usual, i.e. mostly cognitive-based therapy) on telomere length, and to examine whether there was a difference in the potential effect on telomere length between the two groups. A total of 501 individuals including 181 patients (aged 20-64 years), with depression, anxiety and stress and adjustment disorders, and 320 healthy controls (aged 19-70 years) were recruited in the study. Patient data were collected from a randomized controlled trial comparing mindfulness-based group therapy with treatment as usual. We isolated genomic DNA from blood samples, collected at baseline and after the 8-week follow-up. Telomere length was measured by quantitative real-time (qRT)-PCR. Telomere length was significantly shorter in the patients (mean = 0.77 ± 0.12,), compared to the controls (mean = 0.81 ± 0.14) (p = 0.006). The difference in telomere length remained significant after controlling for age and sex. Old age, male sex and being overweight were associated with shorter telomere length. There was no significant difference in telomere length between baseline and at the 8-week follow-up in any of the treatment groups and no difference between the two groups. Our findings confirm that telomere length, as compared with healthy controls, is shortened in patients with depression, anxiety and stress and adjustment disorders. In both groups (mindfulness-based group therapy or treatment as usual), the telomere length remained unchanged after the 8-week treatment/follow-up and there was no difference between the two groups. (ClinicalTrials.gov ID: NCT01476371 ) Registered November 11, 2011.

BMI, Overweight Status and Obesity Adjusted by Various Factors in All Age Groups in the Population of a City in Northeastern Brazil

PubMed Central

Ataíde Lima, Raquel Patrícia; de Carvalho Pereira, Danielle; Cristhine Pordeus Luna, Rafaella; Rodrigues Gonçalves, Maria da Conceição; Teixeira de Lima, Roberto; Batista Filho, Malaquias; Gouveia Filizola, Rosália; de Moraes, Ronei Marcos; Rios Asciutti, Luiza Sonia; de Carvalho Costa, Maria José

2015-01-01

Objective: In Brazil, demographic, socioeconomic and epidemiological changes over time have led to a transition in nutritional standards, resulting in a gradual reduction of malnutrition and an increased prevalence of overweight and obese individuals, similar to the situation in developed countries in previous decades. This study assessed the body mass index (BMI) and the prevalence of an overweight status and obesity, adjusted for various factors, in a population in northeastern Brazil including all age groups. Methods: This is a cross-sectional population-based epidemiological study using single sampling procedure composed of levels. Given the heterogeneity of the variable “income” and the relationship between income, prevalence of diseases and nutrition, a stratified sampling on blocks in the first level was used. In this, city districts were classified by income into 10 strata, according to information obtained from IBGE. A systematic sampling was applied on randomly selected blocks in order to choose the residences that would be part of the sample (second level), including 1165 participants from all age groups. Results and Discussion: The prevalence of an overweight status or obesity was adjusted for demographic, socioeconomic and lifestyle variables. When the Chi-square test was applied, a relationship was observed between the prevalence of an overweight status or obesity and the age group, gender, educational level and income of the participants. Regarding lifestyle parameters, only smoking was associated with the prevalence of an overweight status or obesity, in both adults and in the total sample. The results for the following groups were significant (p < 0.05): the age group from 20 to 59 years, when the individual presented an educational level greater than or equal to high school; and the age group ≥ 60 years, when the individual was female. It is noteworthy that educational level and being female were significant in adjusting for the total population as major factors influencing an increased BMI, followed by the variables physical activity and family income. Conclusions: The adjusted results justify the adoption of intervention and prevention policies to combat these clinical conditions for the study population as a whole, particularly directed toward adults with higher education level as well as elderly females. PMID:25913186

A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO).

PubMed

Quinnell, Timothy G; Bennett, Maxine; Jordan, Jake; Clutterbuck-James, Abigail L; Davies, Michael G; Smith, Ian E; Oscroft, Nicholas; Pittman, Marcus A; Cameron, Malcolm; Chadwick, Rebecca; Morrell, Mary J; Glover, Matthew J; Fox-Rushby, Julia A; Sharples, Linda D

2014-10-01

Mandibular advancement devices (MADs) are used to treat obstructive sleep apnoea-hypopnoea syndrome (OSAHS) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease. To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS. This open-label, randomised, controlled, crossover trial was undertaken at a UK sleep centre. Adults with Apnoea-Hypopnoea Index (AHI) 5-<30/h and Epworth Sleepiness Scale (ESS) score ≥9 underwent 6 weeks of treatment with three non-adjustable MADs: self-moulded (SleepPro 1; SP1); semi-bespoke (SleepPro 2; SP2); fully-bespoke MAD (bMAD); and 4 weeks no treatment. Primary outcome was AHI scored by a polysomnographer blinded to treatment. Secondary outcomes included ESS, quality of life, resource use and cost. 90 patients were randomised and 83 were analysed. All devices reduced AHI compared with no treatment by 26% (95% CI 11% to 38%, p=0.001) for SP1, 33% (95% CI 24% to 41%) for SP2 and 36% (95% CI 24% to 45%, p<0.001) for bMAD. ESS was 1.51 (95% CI 0.73 to 2.29, p<0.001, SP1) to 2.37 (95% CI 1.53 to 3.22, p<0.001, bMAD) lower than no treatment (p<0.001 for all). Compliance was lower for SP1, which was the least preferred treatment at trial exit. All devices were cost-effective compared with no treatment at a £20,000/quality-adjusted life year (QALY) threshold. SP2 was the most cost-effective up to £39,800/QALY. Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective. Of those trialled, the semi-bespoke MAD is an appropriate first choice. ISRCTN02309506. 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.

Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study.

PubMed

Gundersen, Guri Holmen; Norekval, Tone M; Haug, Hilde Haugberg; Skjetne, Kyrre; Kleinau, Jens Olaf; Graven, Torbjorn; Dalen, Havard

2016-01-01

Medical history, physical examination and laboratory testing are not optimal for the assessment of volume status in heart failure (HF) patients. We aimed to study the clinical influence of focused ultrasound of the pleural cavities and inferior vena cava (IVC) performed by specialised nurses to assess volume status in HF patients at an outpatient clinic. HF outpatients were prospectively included and underwent laboratory testing, history recording and clinical examination by two nurses with and without an ultrasound examination of the pleural cavities and IVC using a pocket-size imaging device, in random order. Each nurse worked in a team with a cardiologist. The influence of the different diagnostic tests on diuretic dosing was assessed descriptively and in linear regression analyses. Sixty-two patients were included and 119 examinations were performed. Mean±SD age was 74±12 years, EF was 34±14%, and N-terminal pro-brain natriuretic peptide (NT-proBNP) value was 3761±3072 ng/L. Dosing of diuretics differed between the teams in 31 out of 119 consultations. Weight change and volume status assessed clinically with and without ultrasound predicted dose adjustment of diuretics at follow-up (p<0.05). Change of oedema, NT-proBNP, creatinine, and symptoms did not (p≥0.10). In adjusted analyses, only volume status based on ultrasound predicted dose adjustments of diuretics at first visit and follow-up (all ultrasound p≤0.01, all other p≥0.2). Ultrasound examinations of the pleural cavities and IVC by nurses may improve diagnostics and patient care in HF patients at an outpatient clinic, but more studies are needed to determine whether these examinations have an impact on clinical outcomes. NCT01794715. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

The clinical epidemiology of pediatric patients with measles from 2000 to 2009 in shanghai, china.

PubMed

Ye, Yingzi; Wang, Wenjie; Wang, Xiaohong; Yu, Hui

2011-10-01

Measles remains a leading vaccine-preventable cause of child mortality worldwide. The incidence has increased recently in some areas. The authors retrospectively analyzed the epidemiological and clinical characteristics of 2473 measles patients in Shanghai from 2000 to 2009. There were 1909 measles cases during 2005-2009 (group II), whereas only 564 cases were reported during 2000-2004 (group I). In total, 60.87% patients in group II were younger than 9 months, which was significantly higher than that in group I (35.28%; P < .001). More complications, death cases, and less atypical rashes were found in recent years. In addition, 2181 of all the 2473 patients (88.19%) and 1112 of 1328 hospitalized children (83.73%) had not been vaccinated; most of them were immigrants. The results indicated that the rising number of immigrants accounted for the increased measles morbidity in Shanghai. The tendency of more young patients and increased complications suggest that some adjustments might be needed in vaccination administration and therapeutic strategy.

Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management).

PubMed

Little, Paul; Hobbs, F D Richard; Moore, Michael; Mant, David; Williamson, Ian; McNulty, Cliodna; Cheng, Ying Edith; Leydon, Geraldine; McManus, Richard; Kelly, Joanne; Barnett, Jane; Glasziou, Paul; Mullee, Mark

2013-10-10

To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. Open adaptive pragmatic parallel group randomised controlled trial. Primary care in United Kingdom. Patients aged ≥ 3 with acute sore throat. An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN). Symptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics. For score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (-0.33, 95% confidence interval -0.64 to -0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (-0.30, -0.61 to -0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the antigen test group (58/164) was 27% lower (0.73, 0.52 to 0.98; P=0.03). There were no significant differences in complications or reconsultations. Targeted use of antibiotics for acute sore throat with a clinical score improves reported symptoms and reduces antibiotic use. Antigen tests used according to a clinical score provide similar benefits but with no clear advantages over a clinical score alone. ISRCTN32027234.

Association between tinnitus retraining therapy and a tinnitus control instrument.

PubMed

Ito, Mari; Soma, Keiko; Ando, Reiko

2009-10-01

Tinnitus retraining therapy (TRT), which is an adaptation therapy for tinnitus based on the neurophysiological model proposed by Jastreboff in 1990,consists of directive counseling and acoustic therapy with a tinnitus control instrument (TCI) or other devices. For the past 5 years, our hospital has administered TRT characterized by the use of a TCI. In this study, we reviewed the clinical course of patients with tinnitus who presented to our outpatient clinic for tinnitus and hearing loss during the 3-year period from April 2004 to March 2007 and underwent TRT with a TCI. Among 188 patients with tinnitus (105 males and 83 females), 88 patients (51 males and 37 females, excluding dropouts) who purchased a TCI and continued therapy were included in the study. Significant improvement in Tinnitus Handicap Inventory (THI) and Visual Analogue Scale (VAS) scores was found as early as 1 month of treatment and later compared with those on initial examination, suggesting that TRT with a TCI may be an effective treatment for tinnitus. Among the noises generated by the TCI, the sound pressure output from the TCI was set at just below tinnitus loudness level both of the first adjustment and the second adjustment. Speech noise and white noise were frequently selected, whereas high-frequency noise and pink noise were infrequently selected. Speech noise was most frequently selected at the first adjustment, and the number of patients selecting white noise increased at the second adjustment. The results that we compared the two also revealed that the mean hearing level and tinnitus loudness levels were higher in the white noise group than in the speech noise group, which suggested that the inner ear disorder was more harder in the white noise group. Both the THI score and VAS grade improved after 1 month of treatment in the speech noise group, whereas improvement in these parameters was observed in the white noise group after 6 months of treatment. These results suggest that it took much longer the patients in the white noise group to improve. : Significant improvement in THI and VAS scores was found as early as 1 month of treatment and later compared with those on initial examination, suggesting that TRT with a TCI may be an effective treatment for tinnitus. It resulted that many patients chose the speech noise or the white noise. And also it was indicated that noise generators set at just below mixing point with tinnitus are more effective. In this study, however, speech noise was often selected probably because of the reduced output at high frequencies and the level of comfort. As white noise produces greater sound volume, patients tended to switch from other therapeutic sound to white noise at the second adjustment. These findings may help administer acoustic therapy in the future.

Specialized survivor clinic attendance increases adherence to cardiomyopathy screening guidelines in adult survivors of childhood cancer.

PubMed

Marr, Kristin C; Agha, Mohammad; Sutradhar, Rinku; Pole, Jason D; Hodgson, David; Guttmann, Astrid; Greenberg, Mark; Nathan, Paul C

2017-10-01

To determine if attendance at a specialized clinic for adult survivors of childhood cancer is associated with better rates of adherence to the Children's Oncology Group (COG) Long-term Follow-up (LTFU) guidelines for cardiomyopathy screening. We conducted a retrospective population-based study using administrative data in Ontario, Canada of 5-year survivors diagnosed between 1986 and 2005 at risk of therapy-related late cardiomyopathy. Patients were classified into three groups based on the recommended frequency of screening: annual, every 2 years, and every 5 years. Of 1811 eligible survivors followed for median 7.8 years (range 0-14.0), patients were adherent to screening for only 8.6% of their period of follow-up. Survivor clinic utilization had the strongest association with increased rates of adherence: when compared to no attendance, ≥ 5 clinic visits/10-year period had RR of adherence of 10.6 (95% CI 5.7-19.5) in the annual group, 3.3 (95% CI 2.3-4.8) in the every 2-year group, and 2.3 (95% CI 1.6-3.2) in the every 5-year group. Additional factors associated with increased adherence after adjusting for clinic attendance included annual assessment by a general practioner, female sex, diagnosis prior to 2003, and living in a rural area. In a model of specialized survivor care, increased clinic utilization is associated with improved patient adherence to COG LTFU cardiomyopathy screening guidelines. Specialized survivor clinics may improve health outcomes in survivors through improved adherence to screening. However, rates of adherence remain suboptimal and further multifacetted strategies need to be explored to improve overall rates of screening in adult survivors of childhood cancer.

Adjustable suture strabismus surgery in infants and children: a 19-year experience.

PubMed

Kassem, Ahmed; Xue, Gilbert; Gandhi, Niral B; Tian, Jing; Guyton, David L

2018-06-01

To evaluate the success rate of adjustable suture techniques in horizontal eye muscle surgery in children ≤15 years of age over a 19-year period by a single surgeon. The medical records of all consecutive patients in this age group who underwent horizontal eye muscle surgery from 1989 through 2012 were reviewed retrospectively. Patients were divided into two groups: those in whom a nonadjustable suture technique was used and those in whom adjustable sutures were used. The following data were collected: type of strabismus, preoperative measurements, postoperative results, and reoperation rates. A total of 116 cases in the nonadjustable group and 521 cases in the adjustable group were included. In the adjustable group, adjustment was performed in 63% of the cases, because of either an under- (41%) or overcorrection (22%). The adjustment procedure was performed under topical proparacaine in 15% of cases and under intravenous propofol in 85%. For the adjustable group, 3-5 minutes more per muscle intraoperatively and 15-20 minutes for adjustment were required. No complications were encountered during the adjustment procedures. Early success rate, defined as alignment within 8 Δ of straight at 3 to 6 months' postoperative follow-up, was significantly greater in the adjustable group than in the nonadjustable group (77.7% vs 64.6% [P ≤ 0.03]). Of the adjustable patients, 15% required reoperation compared with 21% of the nonadjustable patients. Use of adjustable sutures in horizontal eye muscle surgery in children ≤15 years of age provided an improved success rate and fewer reoperations compared with nonadjustable sutures. Copyright © 2018 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Pertuzumab for the Neoadjuvant Treatment of Early-Stage HER2-Positive Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.

PubMed

Squires, Hazel; Pandor, Abdullah; Thokala, Praveen; Stevens, John W; Kaltenthaler, Eva; Clowes, Mark; Coleman, Robert; Wyld, Lynda

2018-01-01

As part of its single technology appraisal process, the National Institute for Health and Care Excellence invited the manufacturer of pertuzumab (Perjeta ® ; Roche Products Limited) to submit evidence of its clinical and cost- effectiveness for the neoadjuvant treatment of women with high-risk, early-stage, HER2-positive breast cancer when used in combination with trastuzumab and chemotherapy. High-risk women included those with locally advanced (including inflammatory) breast cancer and women with high-risk early-stage breast cancer (classified as T2/3 or N1). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group. This article presents the critical review of the company's submission by the Evidence Review Group and the outcome of the National Institute for Health and Care Excellence guidance. The clinical data were mainly taken from a phase II, randomised, open-label, active controlled study (NeoSphere), which reported a significant advantage in terms of pathological complete response rates of pertuzumab in combination with trastuzumab and chemotherapy, compared with trastuzumab alone with chemotherapy (45.8 vs. 29.0%, p = 0.0141). The company did not make any indirect comparisons. A meta-analysis of 12 neoadjuvant studies investigating the relationship between pathological complete response and event-free survival was used to extrapolate the outcomes reported in the NeoSphere study. A cardiac safety study (TRYPHAENA) demonstrated the safety of pertuzumab. The company undertook a model-based economic evaluation of neoadjuvant pertuzumab plus trastuzumab and docetaxel compared with neoadjuvant trastuzumab and docetaxel over a lifetime horizon from the National Health Service and Personal Social Services perspective. The probabilistic incremental cost-effectiveness ratio was estimated to be £20,104 per quality-adjusted life-year gained for pertuzumab alongside trastuzumab and docetaxel compared with trastuzumab and docetaxel, which was revised to £21,869 per quality-adjusted life-year gained following the clarification process. The Evidence Review Group corrected an error in the digitisation of the survivor functions and modified the clinically inappropriate assumption that recurrence is zero after 7 years. The Evidence Review Group's probabilistic base case was £23,962 per quality-adjusted life-year gained. During the appraisal, to mitigate the uncertainties associated with the evidence, the company offered a patient access scheme, which led to the National Institute for Health and Care Excellence Appraisal Committee recommending pertuzumab in this patient group, subject to the company providing the agreed discount in the patient access scheme.

Suicide Risk Among Holocaust Survivors Following Psychiatric Hospitalizations: A Historic Cohort Study.

PubMed

Lurie, Ido; Gur, Adi; Haklai, Ziona; Goldberger, Nehama

2018-01-01

The association between Holocaust experience, suicide, and psychiatric hospitalization has not been unequivocally established. The aim of this study was to determine the risk of suicide among 3 Jewish groups with past or current psychiatric hospitalizations: Holocaust survivors (HS), survivors of pre-Holocaust persecution (early HS), and a comparison group of similar European background who did not experience Holocaust persecution. In a retrospective cohort study based on the Israel National Psychiatric Case Register (NPCR) and the database of causes of death, all suicides in the years 1981-2009 were found for HS (n = 16,406), early HS (n = 1,212) and a comparison group (n = 4,286). Age adjusted suicide rates were calculated for the 3 groups and a logistic regression model was built to assess the suicide risk, controlling for demographic and clinical variables. The number of completed suicides in the study period was: HS-233 (1.4%), early HS-34 (2.8%), and the comparison group-64 (1.5%). Age adjusted rates were 106.7 (95% CI 93.0-120.5) per 100,000 person-years for HS, 231.0 (95% CI 157.0-327.9) for early HS and 150.7 (95% CI 113.2-196.6) for comparisons. The regression models showed significantly higher risk for the early HS versus comparisons (multivariate model adjusted OR = 1.68, 95% CI 1.09-2.60), but not for the HS versus comparisons. These results may indicate higher resilience among the survivors of maximal adversity compared to others who experienced lesser persecution.

Comparison of the Mortality and In-Hospital Outcomes of Preterm Infants Treated with Ibuprofen for Patent Ductus Arteriosus with or without Clinical Symptoms Attributable to the Patent Ductus Arteriosus at the Time of Ibuprofen Treatment

PubMed Central

2017-01-01

The aim of this study was to assess the differences in the mortality and in-hospital outcomes of preterm infants with < 28 weeks of gestation who received ibuprofen treatment according to the presence of clinical symptoms (any of oliguria, hypotension, or moderate to severe respiratory difficulty) attributable to hemodynamically-significant patent ductus arteriosus (hsPDA) at the time of first ibuprofen treatment. In total, 91 infants born from April 2010 to March 2015 were included. Fourteen infants (15.4%) received ibuprofen treatment when there were clinical symptoms due to hsPDA (clinical symptoms group). In clinical symptoms group, infants were younger (25 [23–27] vs. 26 [23–27] weeks; P = 0.012) and lighter (655 [500–930] vs. 880 [370–1,780] grams; P < 0.001). Also, the clinical risk index for babies (CRIB)-II scores were higher and more infants received invasive ventilator care ≤ 2 postnatal days. More infants received multiple courses of ibuprofen in clinical symptoms group. Although the frequency of secondary patent ductus arteriosus (PDA) ligation and the incidence of bronchopulmonary dysplasia (BPD) was higher in the clinical symptoms group in the univariate analysis, after multivariate logistic regression analysis adjusting for the CRIB-II score, birthweight, birth year, and the invasive ventilator care ≤ 2 postnatal days, there were no significant differences in mortality, frequency of secondary ligation and in-hospital outcomes including necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), BPD or death. Our data suggest that we can hold off on PDA treatment until the clinical symptoms become prominent. PMID:27914140

First Postpubertal Male Same-Sex Sexual Experience in the National Health and Social Life Survey: Current Functioning in Relation to Age at Time of Experience and Partner Age.

PubMed

Rind, Bruce

2017-07-17

This study used an important data set to examine long-term adjustment and functioning in men, who as adolescents had sexual experiences with men. The data came from the National Health and Social Life Survey, which used a national probability sample (Laumann, Gagnon, Michael, & Michaels, 1994). Three perspectives were considered, which offered different predictions. From the "child sexual abuse" (CSA) paradigm, which dominates clinical, legal, and lay views, expected was robust evidence for poorer adjustment, given that intense harm is assumed to be intrinsic. From the "mainstream psychological" perspective, derived from the CSA paradigm but more scientifically based, poorer adjustment was also expected, but with less magnitude, given that minor-adult sex is seen as posing a serious risk of harm, which may not universally apply. From the "relevant-empirical" perspective, which infers response to male adolescent-adult same-sex sex from relevant prior empirical research (as opposed to clinical cases or the female experience), expected was little or no evidence for poorer adjustment. Results supported the relevant-empirical perspective. Compared to several control groups (i.e., men whose first postpubertal same-sex sex was as men with other men; men with no postpubertal same-sex sexual experience or child-adult sex), men whose first postpubertal same-sex sex was as adolescents with men were just as well adjusted in terms of health, happiness, sexual functioning, and educational and career achievement. Results are discussed in relation to cultural influences, other cultures, and comparative data from primates.

On poverty, politics and psychology: the socioeconomic gradient of mental healthcare utilisation and outcomes.

PubMed

Delgadillo, Jaime; Asaria, Miqdad; Ali, Shehzad; Gilbody, Simon

2016-11-01

Since 2008, the Improving Access to Psychological Therapies (IAPT) programme has disseminated evidence-based interventions for depression and anxiety problems. In order to maintain quality standards, government policy in England sets the expectation that 50% of treated patients should meet recovery criteria according to validated patient-reported outcome measures. Using national IAPT data, we found evidence suggesting that the prevalence of mental health problems is greater in poorer areas and that these areas had lower average recovery rates. After adjusting benchmarks for local index of multiple deprivation, we found significant differences between unadjusted (72.5%) and adjusted (43.1%) proportions of underperforming clinical commissioning group areas. © The Royal College of Psychiatrists 2016.

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

A direct comparison of quality of life in obese and Cushing’s syndrome patients

PubMed Central

Abraham, Smita Baid; Abel, Brent S; Rubino, Domenica; Nansel, Tonja; Ramsey, Sheila; Nieman, Lynnette K

2014-01-01

Objective Obese (OB) individuals and patients with Cushing’s syndrome (CS) often have similar clinical presentations. While each group has reduced health-related quality of life (HRQL), it is not known whether the degree of impairment is different and might distinguish between them. The objective of this study was to compare HRQL in these two populations. Design Cross-sectional study. Methods Three hundred and twenty-seven OB patients (48.1±11.7 years; 72.5% women) with weight gain and at least two features of CS were recruited from an outpatient weight management clinic. Sixty-six untreated patients with CS (41.6±13.2 years; 78.8% women) presented to the NIH Clinical Center for evaluation. Subjects completed the SF-36 survey and a locally created symptom questionnaire. Results After adjusting for symptom count, OB patients had a significantly higher (better HRQL) mean physical component summary (PCS) score than CS patients (44.9±0.6 vs 35.4±1.5, P<0.0001). However, the mean mental component summary (MCS) score was lower (worse HRQL) in the OB group (41.6±0.6 vs 50.7±1.6, P<0.0001). Symptom count showed significant correlations with PCS and MCS scores. BMI correlated with PCS (r=−0.29) in OB but not in CS patients. BMI was not associated with MCS in either group. Conclusion HRQL is significantly different between OB and CS patients. Surprisingly, after adjusting for symptom count, OB patients showed worse mental health scores than the CS population. Significant differences in HRQL and symptom count may suggest which OB patients should be screened for CS. PMID:23444412

Variations in depression care and outcomes among high-risk mothers from different racial/ethnic groups.

PubMed

Huang, Hsiang; Chan, Ya-Fen; Katon, Wayne; Tabb, Karen; Sieu, Nida; Bauer, Amy M; Wasse, Jessica Knaster; Unützer, Jürgen

2012-08-01

PURPOSE. To examine variations in depression care and outcomes among high-risk pregnant and parenting women from different racial/ethnic groups served in community health centres. As part of a collaborative care programme that provides depression treatment in primary care clinics for high-risk mothers, 661 women with probable depression (Patient Health Questionnaire-9 ≥ 10), who self-reported race/ethnicity as Latina (n = 393), White (n = 126), Black (n = 75) or Asian (n = 67), were included in the study. Primary outcomes include quality of depression care and improvement in depression. A Cox proportional hazard model adjusting for sociodemographic and clinical characteristics was used to examine time to treatment response. We observed significant differences in both depression processes and outcomes across ethnic groups. After adjusting for other variables, Blacks were found to be significantly less likely to improve than Latinas [hazard ratio (HR): 0.53, 95% confidence interval (CI): 0.44-0.65]. Other factors significantly associated with depression improvement were pregnancy (HR: 1.52, 95% CI: 1.27-1.82), number of clinic visits (HR: 1.26, 95% CI: 1.17-1.36) and phone contacts (HR: 1.45, 95% CI: 1.32-1.60) by the care manager in the first month of treatment. After controlling for depression severity, having suicidal thoughts at baseline was significantly associated with a decreased likelihood of depression improvement (HR: 0.75, 95% CI: 0.67-0.83). In this racially and ethnically diverse sample of pregnant and parenting women treated for depression in primary care, the intensity of care management was positively associated with improved depression. There was also appreciable variation in depression outcomes between Latina and Black patients.

The relationship between shared decision-making and health-related quality of life among patients in Hong Kong SAR, China.

PubMed

Xu, Richard H; Cheung, Annie W L; Wong, Eliza L Y

2017-08-01

To elucidate the association between health-related quality of life and shared decision-making among patients in Hong Kong after adjustment for potential confounding variables. A telephone survey was conducted with patients attending all public specialist outpatient clinics in Hong Kong between July and December 2014. The Specialist Outpatient Patient Experience Questionnaire and EQ-5D questionnaire were used to evaluate shared decision-making and quality of life, respectively. We performed a Tobit regression analysis to examine the associations between shared decision-making and quality of life after adjustment for known social, economic and health-related factors. Twenty-six of the Hospital Authority's specialist outpatient clinics. Patients aged 18 years or older who attended one of the Hospital Authority's specialist outpatient clinics between July and November 2014. Shared decision-making and quality of life score. Overall, 13 966 patients completed the study. The group reporting partial involvement in decision-making had slightly higher EQ-5D scores than the 'not involved' group and the 'fully involved' group. EQ-5D scores were higher among subjects who were younger, male, and had a higher level of education. Respondents living alone and living in institutions scored lower on the EQ-5D than patients living with families. Important differences in the relationship between the attitudes towards shared decision-making and quality of life were identified among patients. These associations should be taken into consideration when promoting patient-centred care and improving health professional-patient communication. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Effectiveness of a combination of ezetimibe and statins in patients with acute coronary syndrome and multiple comorbidities: A 6-year population-based cohort study.

PubMed

Lin Wu, Fe-Lin; Wang, Jui; Ho, Wei; Chou, Chia-Hung; Wu, Yi-Jung; Choo, Dan-Wei; Wang, Yu-Wen; Chen, Po-Yu; Chien, Kuo-Liong; Lin, Zhen-Fang

2017-04-15

The clinical benefits of a combination of statins and ezetimibe in patients with acute coronary syndrome (ACS) were observed in a clinical trial. However, little is known regarding the effectiveness of using statins with or without ezetimibe in patients with ACS and multiple comorbidities in real-world clinical practice. This is a nationwide population-based cohort study using Taiwan National Health Insurance Research Database. A total of 212,110 patients with ACS who had been discharged after their first ACS events between 2006 and 2010 were enrolled. A propensity score matching approach was used to create matched cohorts for adjusting potential confounders. Cox proportional hazards regressions were performed to estimate the risk of re-hospitalization for ACS and revascularization. Patients in the statins-plus-ezetimibe group had a significantly lower risk of re-hospitalization for ACS (adjusted hazard ratio [HR]=0.64, 95% confidence interval [CI]: 0.60-0.69) and revascularization (HR=0.69, 95% CI: 0.63-0.76) than those in the statins-alone group. In the statins-plus-ezetimibe group, female patients had a lower risk of re-hospitalization for ACS than male patients did, and patients without diabetes mellitus had a lower risk of re-hospitalization for ACS than did patients with diabetes mellitus. Patients with ACS and multiple comorbidities receiving a combination therapy of statins and ezetimibe had a lower risk of re-hospitalization for ACS and revascularization than those receiving statins alone. Significant interaction effects were observed between combination with ezetimibe, sex, and diabetes mellitus. Copyright © 2017 Elsevier B.V. All rights reserved.

Analysis of Observational Studies in the Presence of Treatment Selection Bias: Effects of Invasive Cardiac Management on AMI Survival Using Propensity Score and Instrumental Variable Methods

PubMed Central

Stukel, Thérèse A.; Fisher, Elliott S; Wennberg, David E.; Alter, David A.; Gottlieb, Daniel J.; Vermeulen, Marian J.

2007-01-01

Context Comparisons of outcomes between patients treated and untreated in observational studies may be biased due to differences in patient prognosis between groups, often because of unobserved treatment selection biases. Objective To compare 4 analytic methods for removing the effects of selection bias in observational studies: multivariable model risk adjustment, propensity score risk adjustment, propensity-based matching, and instrumental variable analysis. Design, Setting, and Patients A national cohort of 122 124 patients who were elderly (aged 65–84 years), receiving Medicare, and hospitalized with acute myocardial infarction (AMI) in 1994–1995, and who were eligible for cardiac catheterization. Baseline chart reviews were taken from the Cooperative Cardiovascular Project and linked to Medicare health administrative data to provide a rich set of prognostic variables. Patients were followed up for 7 years through December 31, 2001, to assess the association between long-term survival and cardiac catheterization within 30 days of hospital admission. Main Outcome Measure Risk-adjusted relative mortality rate using each of the analytic methods. Results Patients who received cardiac catheterization (n=73 238) were younger and had lower AMI severity than those who did not. After adjustment for prognostic factors by using standard statistical risk-adjustment methods, cardiac catheterization was associated with a 50% relative decrease in mortality (for multivariable model risk adjustment: adjusted relative risk [RR], 0.51; 95% confidence interval [CI], 0.50–0.52; for propensity score risk adjustment: adjusted RR, 0.54; 95% CI, 0.53–0.55; and for propensity-based matching: adjusted RR, 0.54; 95% CI, 0.52–0.56). Using regional catheterization rate as an instrument, instrumental variable analysis showed a 16% relative decrease in mortality (adjusted RR, 0.84; 95% CI, 0.79–0.90). The survival benefits of routine invasive care from randomized clinical trials are between 8% and 21 %. Conclusions Estimates of the observational association of cardiac catheterization with long-term AMI mortality are highly sensitive to analytic method. All standard risk-adjustment methods have the same limitations regarding removal of unmeasured treatment selection biases. Compared with standard modeling, instrumental variable analysis may produce less biased estimates of treatment effects, but is more suited to answering policy questions than specific clinical questions. PMID:17227979

Predictors of clinical success among a national Veterans Affairs cohort with methicillin-resistant Staphylococcus aureus pneumonia.

PubMed

Caffrey, Aisling R; Morrill, Haley J; Puzniak, Laura A; LaPlante, Kerry L

2014-04-01

The treatment of methicillin-resistant Staphylococcus aureus (MRSA) pneumonia is exceedingly complicated, which is concerning because of the high mortality rate associated with the infection. Identification of independent predictors of clinical success can optimize patient care by assisting clinicians in treatment decisions. Our goal was to identify independent predictors of clinical success in a national Veterans Affairs (VA) cohort of patients with MRSA pneumonia. A nested case-control study was conducted among a cohort of VA patients with MRSA pneumonia receiving linezolid or vancomycin between January 2002 and September 2010. Cases included those demonstrating clinical success, defined as discharge from the hospital or intensive care unit by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Control subjects represented nonsuccess, defined as therapy change, intubation, intensive care unit admission, readmission, or death between treatment initiation and day 14. The potential predictors assessed included treatment, patient demographic and admission characteristics, previous health care and medication exposures, comorbidities, and medical history. Odds ratios (ORs) and 95% CIs were calculated from logistic regression. Our study included 2442 cases of clinical success and 1290 control subjects. Demographic characteristics varied between the clinical success and nonsuccess groups, including age, race, and region of facility. A current diagnosis of chronic respiratory disease (46% vs 42%) and diagnosis of pneumonia in the year before the MRSA pneumonia admission (37% vs 32%) were both more common in the clinical success group. Despite these significant differences, only 2 predictors of clinical success were identified in our study: previous complication of an implant or graft, including mechanical complications and infections, in the year before the MRSA pneumonia admission (adjusted OR, 1.55 [95% CI, 1.17-2.06]) and treatment with linezolid (adjusted OR, 1.53 [95% CI, 1.12-2.10]). Predictors of nonsuccess (adjusted OR [95% CI) included diagnosis of concomitant urinary tract infection (0.82 [0.70-0.96]), intravenous line (0.76 [0.66-0.89]), previous coagulopathy (0.74 [0.56-0.96]), previous amputation procedure (0.72 [0.53-0.98]), current coagulopathy diagnosis (0.71 [0.53-0.96]), dialysis (0.54 [0.38-0.76]), multiple inpatient procedures (0.53 [0.45-0.62]), inpatient surgery (0.48 [0.41-0.57]), and previous endocarditis (0.24 [0.07-0.81]). MRSA pneumonia tends to affect patients with complex care, and identification of the predictors of clinical success is useful when considering different therapeutic approaches. In this national cohort of VA patients with MRSA pneumonia, treatment was the only modifiable variable predicting clinical success. Published by EM Inc USA.

Performance evaluation of inpatient service in Beijing: a horizontal comparison with risk adjustment based on Diagnosis Related Groups

PubMed Central

Jian, Weiyan; Huang, Yinmin; Hu, Mu; Zhang, Xiumei

2009-01-01

Background The medical performance evaluation, which provides a basis for rational decision-making, is an important part of medical service research. Current progress with health services reform in China is far from satisfactory, without sufficient regulation. To achieve better progress, an effective tool for evaluating medical performance needs to be established. In view of this, this study attempted to develop such a tool appropriate for the Chinese context. Methods Data was collected from the front pages of medical records (FPMR) of all large general public hospitals (21 hospitals) in the third and fourth quarter of 2007. Locally developed Diagnosis Related Groups (DRGs) were introduced as a tool for risk adjustment and performance evaluation indicators were established: Charge Efficiency Index (CEI), Time Efficiency Index (TEI) and inpatient mortality of low-risk group cases (IMLRG), to reflect respectively work efficiency and medical service quality. Using these indicators, the inpatient services' performance was horizontally compared among hospitals. Case-mix Index (CMI) was used to adjust efficiency indices and then produce adjusted CEI (aCEI) and adjusted TEI (aTEI). Poisson distribution analysis was used to test the statistical significance of the IMLRG differences between different hospitals. Results Using the aCEI, aTEI and IMLRG scores for the 21 hospitals, Hospital A and C had relatively good overall performance because their medical charges were lower, LOS shorter and IMLRG smaller. The performance of Hospital P and Q was the worst due to their relatively high charge level, long LOS and high IMLRG. Various performance problems also existed in the other hospitals. Conclusion It is possible to develop an accurate and easy to run performance evaluation system using Case-Mix as the tool for risk adjustment, choosing indicators close to consumers and managers, and utilizing routine report forms as the basic information source. To keep such a system running effectively, it is necessary to improve the reliability of clinical information and the risk-adjustment ability of Case-Mix. PMID:19402913

Mortality in American Veterans with the HLA-B27 gene.

PubMed

Walsh, Jessica A; Zhou, Xi; Clegg, Daniel O; Teng, Chiachen; Cannon, Grant W; Sauer, Brian

2015-04-01

To compare survival in American veterans with and without the HLA-B27 (B27) gene. Mortality was evaluated in a national cohort of veterans with clinically available B27 test results between October 1, 1999, and December 31, 2011. The primary outcome was the mortality difference between B27-positive and B27-negative veterans, adjusted for age, sex, race, and diagnoses codes for diseases that may have influenced both B27 testing and mortality, including psoriasis, inflammatory bowel disease, spondyloarthritis (SpA), and other types of inflammatory arthritis. The secondary outcomes were the adjusted mortality HR for B27+ and B27- veterans, in subgroups with and without SpA. Among veterans with available B27 test results, 27,652 (84.7%) were B27- and 4978 (15.3%) were B27+. The mean followup time was 4.6 years. Mortality was higher in the B27+ group than in the B27- group (HR 1.15, 95% CI 1.03-1.27). Mortality was also higher in the B27+ subgroups with SpA (HR 1.35, 95% CI 1.06-1.72) and without SpA (HR 1.11, 95% CI 0.99-1.24), but the difference was significant only in the subgroup with SpA. B27 positivity was associated with an increased mortality rate in a cohort of veterans clinically selected for B27 testing, after adjustment for SpA. In the subgroup with SpA, the mortality rate was associated with B27 positivity, and in the subgroup without SpA, there was a nonsignificant association between B27+ and mortality.

The association between systemic sclerosis disease manifestations and esophageal high-resolution manometry parameters

PubMed Central

Kimmel, Jessica N.; Carlson, Dustin A.; Hinchcliff, Monique; Carns, Mary A.; Aren, Kathleen A; Lee, Jungwha; Pandolfino, John E.

2016-01-01

Background/Aims We aimed to evaluate the associations between SSc-related systemic manifestations and esophageal function using high-resolution manometry (HRM). Methods Patients with SSc that had undergone HRM between 1/2004 and 9/2014 were identified and HRMs were analyzed according to the Chicago Classification. Clinical characteristics were identified via retrospective chart review and compared among motility diagnoses while adjusting for age, gender, race, and SSc-disease duration. Results 79 patients (85% female, ages 25–77) were included. Clinical characteristics were compared between patients with absent contractility (AC, n = 40), ineffective esophageal motility (IEM; n = 15), and normal motility (n = 19); the 5 remaining patients met criteria for other motility diagnoses. Groups differed in severity of skin involvement measured by the modified Rodnan skin score (0–51): AC (adjusted mean 12.6), IEM (4.4), normal (4.3), p = 0.043. Pulmonary function tests [percent predicted FVC and DLCO) were lower in AC (adjusted mean, FVC: 70.3, DLCO 51.1), than IEM (FVC: 92.0; DLCO: 76.9) and normal motility (FVC: 80.0; DLCO: 67.2), p-values 0.057 (FVC) and 0.007 (DLCO). Groups did not differ by SSc-disease duration, autoantibodies, or reported symptoms of dysphagia or reflux. Conclusions In patients with SSc, absent esophageal contractility on HRM was associated with increased skin disease severity and worse lung function. Obtaining HRM to identify SSc patients with more severe esophageal dysfunction could be considered to enable implementation of management strategies in patients potentially at risk for increased morbidity and mortality. PMID:26921101

Pupillometer-based Neurofeedback Cognitive Training to Improve Processing Speed and Social Functioning in Individuals at Clinical High Risk for Psychosis

PubMed Central

Choi, Jimmy; Stevens, Michael; Deasy, Melissa; Haber, Lawrence C.; Dewberry, Michael J.; Pearlson, Godfrey D.; Corcoran, Cheryl M.; Javitt, Daniel C.; Fiszdon, Joanna M.

2016-01-01

Objective Among individuals at clinical high risk (CHR) for psychosis, processing speed (PS) has been related to social and role functioning regardless of conversion to schizophrenia. This information processing dysfunction is a gateway to broader behavioral deficits such as difficulty executing social behaviors. We examined the feasibility of improving information processing relevant to social situations in CHR, including its sustainability at 2-month follow-up, and its association with concurrent social function. Methods This was a double-blind RCT in which 62 CHR participants were randomized to Processing Speed Training (PST) or an active control matched for training format and the same dose and duration of treatment. PST is a tablet-based program that uses pupillometry-based neurofeedback to continually adjust training parameters for an optimal neurocognitive load and to improve visual scanning efficiency by inhibiting selection of non-essential targets and discriminating figure-ground details. Results The PST group showed faster motoric and non-motoric PS at post training and 2-month follow-up. At 2 month follow-up, the PST group reported better overall social adjustment. Changes in PS from baseline to 2 months were correlated with overall social adjustment and social avoidance in the entire sample. Conclusions and Implications for Practice This is the first study to test focal neurofeedback-based cognitive training for PS deficits in the putatively prodromal phase of schizophrenia to address associated social morbidity. Targeting PS appears to be a promising pathway to decreasing co-morbidity and mitigating a risk factor for psychosis. PMID:27560455

Professional Fee Ratios for US Hospital Discharge Data

PubMed Central

Peterson, Cora; Xu, Likang; Florence, Curtis; Grosse, Scott D.; Annest, Joseph L.

2015-01-01

Background US hospital discharge datasets typically report facility charges (ie, room and board), excluding professional fees (ie, attending physicians’ charges). Objectives We aimed to estimate professional fee ratios (PFR) by year and clinical diagnosis for use in cost analyses based on hospital discharge data. Subjects The subjects consisted of a retrospective cohort of Truven Health MarketScan 2004–2012 inpatient admissions (n = 23,594,605) and treat-and-release emergency department (ED) visits (n = 70,771,576). Measures PFR per visit was assessed as total payments divided by facility-only payments. Research Design Using ordinary least squares regression models controlling for selected characteristics (ie, patient age, comorbidities, etc.), we calculated adjusted mean PFR for admissions by health insurance type (commercial or Medicaid) per year overall and by Major Diagnostic Category (MDC), Diagnostic Related Group, Healthcare Cost and Utilization Project Clinical Classification Software, and primary International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) diagnosis, and for ED visits per year overall and by MDC and primary ICD-9-CM diagnosis. Results Adjusted mean PFR for 2012 admissions, including preceding ED visits, was 1.264 (95% CI, 1.264, 1.265) for commercially insured admissions (n = 2,614,326) and 1.177 (1.176, 1.177) for Medicaid admissions (n = 816,503), indicating professional payments increased total per-admission payments by an average 26.4% and 17.7%, respectively, above facility-only payments. Adjusted mean PFR for 2012 ED visits was 1.286 (1.286, 1.286) for commercially insured visits (n = 8,808,734) and 1.440 (1.439, 1.440) for Medicaid visits (n = 2,994,696). Supplemental tables report 2004–2012 annual PFR estimates by clinical classifications. Conclusions Adjustments for professional fees are recommended when hospital facility-only financial data from US hospital discharge datasets are used to estimate health care costs. PMID:26340662

Prevention of lingual calculus formation with daily use of 6% H2O2/2% pyrophosphate whitening strips.

PubMed

Farrell, S; Barker, M L; Gerlach, R W; Putt, M S; Milleman, J L

2009-01-01

This randomized controlled clinical trial was conducted to evaluate whether daily use of a hydrogen peroxide/ pyrophosphate-containing antitartar whitening strip might safely yield clinical reductions in post-prophylaxis calculus accumulation. A three-month, randomized controlled trial was conducted to compare calculus accumulation with a daily 6% hydrogen peroxide/pyrophosphate strip versus regular brushing. After an eight-week run-in phase to identify calculus formers, a prophylaxis was administered, and 77 subjects were randomly assigned to daily strip or brushing only groups. All subjects received an anticavity dentifrice (Crest Cavity Protection) and manual brush for use throughout the three-month study; for subjects assigned to the experimental group, strip application was once daily for five minutes on the facial and lingual surfaces of the mandibular teeth. Efficacy was measured as mm calculus (VMI) before prophylaxis and after six and 12 weeks of treatment, while safety was assessed from examination and interview. Subjects ranged in age from 21-87 years, with groups balanced (p > 0.26) on pertinent demographic and behavioral parameters, and pre-prophylaxis calculus baseline mean scores (16.0 mm). At Week 6, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 12.0 (0.87) for the strip group and 17.0 (0.88) for the brushing control. At Week 12, calculus accumulation was lower in the strip group, with adjusted mean (SE) lingual VMI of 14.3 (0.85) for the strip group and 17.2 (0.86) for the brushing control. Treatments differed significantly (p < 0.02) on calculus accumulation at both time points. A total of three subjects (8%) in the strip group and two subjects (5%) in the brushing control had mild oral irritation or tooth sensitivity during treatment; no one discontinued early due to an adverse event. Daily use of hydrogen peroxide whitening strips with pyrophosphate reduced calculus formation by up to 29% versus regular brushing, without meaningful adverse events.

Betamethasone and dexamethasone in adult community-acquired bacterial meningitis: a quality registry study from 1995 to 2014.

PubMed

Glimåker, M; Brink, M; Naucler, P; Sjölin, J

2016-09-01

Acute bacterial meningitis (ABM) is a highly lethal disease. Available data support the use of corticosteroids in high-income countries, but the effect on mortality is still controversial. The effects of corticosteroids on mortality and sequelae were evaluated in the national Swedish quality registry. In total, during 1995-2014 1746 adults with ABM were included, of whom 989 were treated with corticosteroids (betamethasone, n = 766; dexamethasone, n = 248; methylprednisolone, n = 2), 498 were not given corticosteroids and in 259 patients data for corticosteroids were missing. Fatal outcome was observed in 8.9% of the patients in the corticosteroid-treated group vs. 17.9% in the non-corticosteroid-treated group (p <0.001), resulting in an odds ratio (OR) of 0.57 with a 95% confidence interval (CI) of 0.40-0.81 adjusted for age, sex, mental status, and door-to-antibiotic time. In patients with meningitis caused by S. pneumoniae, mortality was 10.2% in the corticosteroid-treated group and 21.3% in the non-corticosteroid-treated group (p <0.001) with an adjusted OR of 0.50 (95% CI 0.31-0.80). In ABM patients with non-pneumococcal aetiology the adjusted OR was 0.71 (95% CI 0.40-1.26). Lower mortality was observed in the corticosteroid-treated group with impaired mental status, whereas no significant difference was found in patients with unaffected mental status. The adjusted ORs for betamethasone and dexamethasone were 0.49 (95% CI 0.28-0.84) and 0.61 (95% CI 0.37-1.01), respectively. Corticosteroid treatment decreases mortality in ABM and should be administered initially with antibiotics in adult ABM patients with impaired mental status regardless of presumed aetiology. Betamethasone seems to be at least as effective as dexamethasone. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Immediate versus early non-occlusal loading of dental implants placed flapless in partially edentulous patients: a 3-year randomized clinical trial.

PubMed

Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Piemontese, Matteo; Nieri, Michele

2012-02-01

To compare immediate versus early non-occlusal loading of dental implants placed flapless in a 3-year, parallel group, randomized clinical trial. The study was conducted in a private dental clinic between July 2005 and July 2010. Patients 18 years or older were randomized to receive implants for fixed partial dentures in cases of partial edentulism. The test group was represented by immediate non-occlusal implant loading, whereas the control group was represented by early non-occlusal implant loading. The outcome variables were implant failure, complications and radiographic bone level at implant sites 3 years after loading, measured from the implant-abutment junction to the most coronal point of bone-to-implant contact. Randomization was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes, and the measurer was blinded to group assignment. Sixty patients were randomized: 30 to the immediately loaded group and 30 to the early loaded group. Four patients dropped out; however, the data of all patients were included in the analysis. No implant failure occurred. Two complications occurred in the control group and one in the test group. The mean bone level at 3 years was 1.91 mm for test group and 1.59 mm for control group. The adjusted difference in bone level was 0.26 mm (CI 95% -0.08 to 0.59, p = 0.1232). The null hypothesis of no difference in failure rates, complications and bone level between implants that were loaded immediately or early at 3 years cannot be rejected in this randomized clinical trial. © 2011 John Wiley & Sons A/S.

Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial

PubMed Central

Levine, Lisa D.; Downes, Katheryne L.; Elovitz, Michal A.; Parry, Samuel; Sammel, Mary D.; Srinivas, Sindhu K

2016-01-01

Objective To evaluate the effectiveness of four commonly used induction methods. Methods This randomized trial compared four induction methods: Misoprostol alone, Foley alone, Misoprostol–cervical Foley concurrently, and Foley–oxytocin concurrently,. Women undergoing labor induction with full term (≥37 weeks), singleton, vertex presenting gestations, with no contraindication to vaginal delivery, intact membranes, Bishop score ≤6, and cervical dilation ≤2cm were included. Women were enrolled only once during the study period. Our primary outcome was time to delivery. Neither patients nor providers were blinded to assigned treatment group since examinations are required for placement of all methods; however, research personnel were blinded during data abstraction. A sample size of 123 per group (N=492) was planned to compare the four groups pairwise (P≤.008), with a 4-hour reduction in delivery time considered clinically meaningful. Results From May 2013 through June 2015, 997 women were screened and 491 were randomized and analyzed. Demographic and clinical characteristics were similar among the four treatment groups. When comparing all induction method groups, combination methods achieved a faster median time to delivery than single-agent methods, (misoprostol–Foley: 13.1 hours, Foley–oxytocin: 14.5 hours, misoprostol: 17.6 hours, Foley: 17.7 hours, p<0.001). When censored for cesarean and adjusting for parity, women who received misoprostol–Foley delivered almost twice as likely to deliver before women who received misoprostol alone (hazard ratio (HR, 95% CI) 1.92 [1.42–2.59]) or Foley alone (HR, 95%CI: 1.87 [1.39–2.52]), whereas Foley–oxytocin was not statistically different from single-agent methods. Conclusion After censoring for cesarean and adjusting for parity, misoprostol–cervical Foley resulted in twice the chance of delivering before either single-agent method. PMID:27824758

Cross-cultural differences in knee functional status outcomes in a polyglot society represented true disparities not biased by differential item functioning.

PubMed

Deutscher, Daniel; Hart, Dennis L; Crane, Paul K; Dickstein, Ruth

2010-12-01

Comparative effectiveness research across cultures requires unbiased measures that accurately detect clinical differences between patient groups. The purpose of this study was to assess the presence and impact of differential item functioning (DIF) in knee functional status (FS) items administered using computerized adaptive testing (CAT) as a possible cause for observed differences in outcomes between 2 cultural patient groups in a polyglot society. This study was a secondary analysis of prospectively collected data. We evaluated data from 9,134 patients with knee impairments from outpatient physical therapy clinics in Israel. Items were analyzed for DIF related to sex, age, symptom acuity, surgical history, exercise history, and language used to complete the functional survey (Hebrew versus Russian). Several items exhibited DIF, but unadjusted FS estimates and FS estimates that accounted for DIF were essentially equal (intraclass correlation coefficient [2,1]>.999). No individual patient had a difference between unadjusted and adjusted FS estimates as large as the median standard error of the unadjusted estimates. Differences between groups defined by any of the covariates considered were essentially unchanged when using adjusted instead of unadjusted FS estimates. The greatest group-level impact was <0.3% of 1 standard deviation of the unadjusted FS estimates. Complete data where patients answered all items in the scale would have been preferred for DIF analysis, but only CAT data were available. Differences in FS outcomes between groups of patients with knee impairments who answered the knee CAT in Hebrew or Russian in Israel most likely reflected true differences that may reflect societal disparities in this health outcome.

Two decision aids for mode of delivery among women with previous caesarean section: randomised controlled trial.

PubMed

Montgomery, Alan A; Emmett, Clare L; Fahey, Tom; Jones, Claire; Ricketts, Ian; Patel, Roshni R; Peters, Tim J; Murphy, Deirdre J

2007-06-23

To determine the effects of two computer based decision aids on decisional conflict and mode of delivery among pregnant women with a previous caesarean section. Randomised trial, conducted from May 2004 to August 2006. Four maternity units in south west England, and Scotland. 742 pregnant women with one previous lower segment caesarean section and delivery expected at >or=37 weeks. Non-English speakers were excluded. Usual care: standard care given by obstetric and midwifery staff. Information programme: women navigated through descriptions and probabilities of clinical outcomes for mother and baby associated with planned vaginal birth, elective caesarean section, and emergency caesarean section. Decision analysis: mode of delivery was recommended based on utility assessments performed by the woman combined with probabilities of clinical outcomes within a concealed decision tree. Both interventions were delivered via a laptop computer after brief instructions from a researcher. Total score on decisional conflict scale, and mode of delivery. Women in the information programme (adjusted difference -6.2, 95% confidence interval -8.7 to -3.7) and the decision analysis (-4.0, -6.5 to -1.5) groups had reduced decisional conflict compared with women in the usual care group. The rate of vaginal birth was higher for women in the decision analysis group compared with the usual care group (37% v 30%, adjusted odds ratio 1.42, 0.94 to 2.14), but the rates were similar in the information programme and usual care groups. Decision aids can help women who have had a previous caesarean section to decide on mode of delivery in a subsequent pregnancy. The decision analysis approach might substantially affect national rates of caesarean section. Trial Registration Current Controlled Trials ISRCTN84367722.

Clinical indicators for recurrent cardiovascular events in acute coronary syndrome patients treated with statins under routine practice in Thailand: an observational study.

PubMed

Chinwong, Dujrudee; Patumanond, Jayanton; Chinwong, Surarong; Siriwattana, Khanchai; Gunaparn, Siriluck; Hall, John Joseph; Phrommintikul, Arintaya

2015-06-16

Acute coronary syndrome (ACS) patients are at very high cardiovascular risk and tend to have recurrent cardiovascular events. The clinical indicators for subsequent cardiovascular events are limited and need further investigation. This study aimed to explore clinical indicators that were associated with recurrent cardiovascular events following index hospitalization. The data of patients hospitalized with ACS at a tertiary care hospital in northern Thailand between January 2009 and December 2012 were retrospectively reviewed from medical charts and the electronic hospital database. The patients were classified into three groups based on the frequency of recurrent cardiovascular events (nonfatal ACS, nonfatal stroke, or all-cause death) they suffered: no recurrent events (0), single recurrent event (1), and multiple recurrent events (≥2). Ordinal logistic regression was performed to explore the clinical indicators for recurrent cardiovascular events. A total of 405 patients were included; 60 % were male; the average age was 64.9 ± 11.5 years; 40 % underwent coronary revascularization during admission. Overall, 359 (88.6 %) had no recurrent events, 36 (8.9 %) had a single recurrent event, and 10 (2.5 %) had multiple recurrent events. The significant clinical indicators associated with recurrent cardiovascular events were achieving an LDL-C goal of < 70 mg/dL (Adjusted OR = 0.43; 95 % CI = 0.27-0.69, p-value < 0.001), undergoing revascularization during admission (Adjusted OR = 0.44; 95 % CI = 0.24-0.81, p-value = 0.009), being male (Adjusted OR = 1.85; 95 % CI = 1.29-2.66, p-value = 0.001), and decrease estimated glomerular filtration rate (Adjusted OR = 2.46; 95 % CI = 2.21-2.75, p-value < 0.001). The routine clinical practice indicators assessed in ACS patients that were associated with recurrent cardiovascular events were that achieving the LDL-C goal and revascularization are protective factors, while being male and having decreased estimated glomerular filtration rate are risk factors for recurrent cardiovascular events. These clinical indicators should be used for routinely monitoring patients to prevent recurrent cardiovascular events in ACS patients.

Improving the quality of primary care by allocating performance-based targets, in a diverse insured population.

PubMed

Peled, Ronit; Porath, Avi; Wilf-Miron, Rachel

2016-11-21

Primary Care Health organizations, operating under universal coverage and a regulated package of benefits, compete mainly over quality of care. Monitoring, primary care clinical performance, has been repeatedly proven effective in improving the quality of care. In 2004, Maccabi Healthcare Services (MHS), the second largest Israeli HMO, launched its Performance Measurement System (PMS) based on clinical quality indicators. A unique module was built in the PMS to adjust for case mix while tailoring targets to the local units. This article presents the concept and formulas developed to adjust targets to the units' current performance, and analyze change in clinical indicators over a six year period, between sub-population groups. Six process and intermediate outcome indicators, representing screening for breast and colorectal cancer and care for patients with diabetes and cardiovascular disease, were selected and analyzed for change over time (2003-2009) in overall performance, as well as the difference between the lowest and the highest socio-economic ranks (SERs) and Arab and non-Arab members. MHS demonstrated a significant improvement in the selected indicators over the years. Performance of members from low SERs and Arabs improved to a greater extent, as compared to members from high ranks and non-Arabs, respectively. The performance measurement system, with its module for tailoring of units' targets, served as a managerial vehicle for bridging existing gaps by allocating more resources to lower performing units. This concept was proven effective in improving performance while reducing disparities between diverse population groups.

TREATMENT SWITCHING: STATISTICAL AND DECISION-MAKING CHALLENGES AND APPROACHES.

PubMed

Latimer, Nicholas R; Henshall, Chris; Siebert, Uwe; Bell, Helen

2016-01-01

Treatment switching refers to the situation in a randomized controlled trial where patients switch from their randomly assigned treatment onto an alternative. Often, switching is from the control group onto the experimental treatment. In this instance, a standard intention-to-treat analysis does not identify the true comparative effectiveness of the treatments under investigation. We aim to describe statistical methods for adjusting for treatment switching in a comprehensible way for nonstatisticians, and to summarize views on these methods expressed by stakeholders at the 2014 Adelaide International Workshop on Treatment Switching in Clinical Trials. We describe three statistical methods used to adjust for treatment switching: marginal structural models, two-stage adjustment, and rank preserving structural failure time models. We draw upon discussion heard at the Adelaide International Workshop to explore the views of stakeholders on the acceptability of these methods. Stakeholders noted that adjustment methods are based on assumptions, the validity of which may often be questionable. There was disagreement on the acceptability of adjustment methods, but consensus that when these are used, they should be justified rigorously. The utility of adjustment methods depends upon the decision being made and the processes used by the decision-maker. Treatment switching makes estimating the true comparative effect of a new treatment challenging. However, many decision-makers have reservations with adjustment methods. These, and how they affect the utility of adjustment methods, require further exploration. Further technical work is required to develop adjustment methods to meet real world needs, to enhance their acceptability to decision-makers.

Physician and patient characteristics associated with clinical inertia in blood pressure control.

PubMed

Harle, Christopher A; Harman, Jeffrey S; Yang, Shuo

2013-11-01

Clinical inertia, the failure to adjust antihypertensive medications during patient visits with uncontrolled hypertension, is thought to be a common problem. This retrospective study used 5 years of electronic medical records from a multispecialty group practice to examine the association between physician and patient characteristics and clinical inertia. Hierarchical linear models (HLMs) were used to examine (1) differences in physician and patient characteristics among patients with and without clinical inertia, and (2) the association between clinical inertia and future uncontrolled hypertension. Overall, 66% of patients experienced clinical inertia. Clinical inertia was associated with one physician characteristic, patient volume (odds ratio [OR]=0.998). However, clinical inertia was associated with multiple patient characteristics, including patient age (OR=1.021), commercial insurance (OR=0.804), and obesity (OR=1.805). Finally, patients with clinical inertia had 2.9 times the odds of uncontrolled hypertension at their final visit in the study period. These findings may aid the design of interventions to reduce clinical inertia. ©2013 Wiley Periodicals, Inc.

The association between tinnitus and the risk of ischemic cerebrovascular disease in young and middle-aged patients: A secondary case-control analysis of a nationwide, population-based health claims database.

PubMed

Huang, Yung-Sung; Koo, Malcolm; Chen, Jin-Cherng; Hwang, Juen-Haur

2017-01-01

Tinnitus and ischemic cerebrovascular disease (ICVD) may share common pathophysiologic mechanisms. Nevertheless, no studies have investigated whether tinnitus is associated with a higher risk of ICVD. The aim of this study was to evaluate the risk of ICVD among young and middle-aged patients with tinnitus. Using the Taiwan's National Health Insurance Research Database, we identified 3,474 patients 20-45 years old with incident ICVD diagnosed between January 1, 2000 and December 31, 2010 and 17,370 controls, frequency matched on age interval, sex, and year of the index date. Risk of ICVD associated with tinnitus was assessed using multiple logistic regression analyses. Tinnitus was significantly associated with a higher risk of incident ICVD among young and middle-aged patients (adjusted odds ratio [OR] 1.66, 95% confidence interval [CI] 1.34-2.04), adjusting for sex, age, and comorbidities. In addition, sex-stratified analysis showed that the associations were significant in both male (adjusted OR 1.55, 95% CI 1.16-2.07) and female patients (adjusted OR 1.77, 95% CI 1.30-2.41). Furthermore, tinnitus was significantly associated with a higher risk of ICVD in the 20.0-29.9 years (adjusted OR 4.11, 95% CI 1.98-8.52) and 30.0-39.9 years (adjusted OR 2.19, 95% CI 1.57-3.05) age groups, but not in the 40.0-45.0 years age group. Tinnitus could be a novel risk factor or clinical indicator for young ischemic stroke, and further investigations are warranted.

Predictors of physical therapy clinic performance in the treatment of patients with low back pain syndromes.

PubMed

Resnik, Linda; Liu, Dawei; Mor, Vince; Hart, Dennis L

2008-09-01

Little is known about organizational and service delivery factors related to quality of care in physical therapy. This study sought to identify characteristics related to differences in practice outcomes and service utilization. The sample comprised 114 outpatient clinics and 1,058 therapists who treated 16,281 patients with low back pain syndromes during the period 2000-2001. Clinics participated with the Focus on Therapeutic Outcomes, Inc (FOTO) database. Hierarchical linear models were used to risk adjust treatment outcomes and number of visits per treatment episode. Aggregated residual scores from these models were used to classify each clinic into 1 of 3 categories in each of 3 types of performance groups: (1) effectiveness, (2) utilization, and (3) overall performance (ie, composite measure of effectiveness and utilization). Relationships between clinic classification and the following independent variables were examined by multinomial logistic regression: years of therapist experience, number of physical therapists, ratio of physical therapists to physical therapist assistants, proportion of patients with low back pain syndromes, number of new patients per physical therapist per month, utilization of physical therapist assistants, and setting. Clinics that were lower utilizers of physical therapist assistants were 6.6 times more likely to be classified into the high effectiveness group compared with the low effectiveness group, 6.7 times more likely to be classified in the low utilization group compared with the high utilization group, and 12.4 times more likely to be classified in the best performance group compared with the worst performance group. Serving a higher proportion of patients with low back pain syndromes was associated with an increased likelihood of being classified in the lowest or middle group. Years of physical therapist experience was inversely associated with being classified in the middle utilization group compared with the highest utilization group. These findings suggest that, in the treatment of patients with low back pain syndromes, clinics that are low utilizers of physical therapist assistants are more likely to provide superior care (ie, better patient outcomes and lower service use).

Validation of a noninvasive test routinely used in otology for the diagnosis of cerebrospinal fluid shunt malfunction in patients with normal pressure hydrocephalus.

PubMed

Sakka, Laurent; Chomicki, Alexandre; Gabrillargues, Jean; Khalil, Toufic; Chazal, Jean; Avan, Paul

2016-02-01

Ventriculoperitoneal shunting is the first-line treatment for normal pressure hydrocephalus. Noninvasive auditory tests based on recorded otoacoustic emissions were assessed, as currently used for universal neonatal hearing screenings, for the diagnosis of cerebrospinal fluid shunt malfunction. The test was designed based on previous works, which demonstrated that an intracranial pressure change induces a proportional, characteristic, otoacoustic-emission phase shift. Forty-four patients with normal pressure hydrocephalus (23 idiopathic and 21 secondary cases) were included in this prospective observational study. The male:female sex ratio was 1.44, the age range was 21-87 years (mean age 64.3 years), and the range of the follow-up period was 1-3 years (mean 20 months). Patients were implanted with a Sophy SU8 adjustable-pressure valve as the ventriculoperitoneal shunt. The phase shifts of otoacoustic emissions in response to body tilt were measured preoperatively, immediately postoperatively, and at 3-6 months, 7-15 months, 16-24 months, and more than 24 months postoperatively. Three groups were enrolled: Group 1, 19 patients who required no valve opening-pressure adjustment; Group 2, 18 patients who required valve opening-pressure adjustments; and Group 3, 7 patients who required valve replacement. In Group 1, phase shift, which was positive before surgery, became steadily negative after surgery and during the follow-up. In Group 2, phase shift, which was positive before surgery, became negative immediately after surgery and increasingly negative after a decrease in the valve-opening pressure. In Group 3, phase shift was positive in 6 cases and slightly negative in 1 case before revision, but after revision phase shift became significantly negative in all cases. Otoacoustic emissions noninvasively reflect cerebrospinal fluid shunt function and are impacted by valve-opening pressure adjustments. Otoacoustic emissions consistently diagnosed shunt malfunction and predicted the need for surgical revision. The authors' diagnostic test, which can be repeated without risk or discomfort by an unskilled operator, may address the crucial need of detecting valve dysfunction in patients with poor clinical outcome after shunt surgery.

Hepatitis B Vaccination Status among Japanese Travelers.

PubMed

Yaita, Kenichiro; Yahara, Koji; Sakai, Yoshiro; Iwahashi, Jun; Masunaga, Kenji; Hamada, Nobuyuki; Watanabe, Hiroshi

2017-05-08

This study clarified the characteristics of travelers who received hepatitis B vaccinations. Subjects were 233 Japanese travelers who visited our clinic prior to travel. We summarized the characteristics of the clients and performed two comparative studies: first, we compared a hepatitis B-vaccinated group with an unvaccinated group; second, we compared a group that had completed the hepatitis B vaccine series with a group that did not complete the series. The hepatitis B vaccine was administered to 152 clients. Factors positively associated with the hepatitis B vaccination (after adjusting for age and sex) included the following: travel for business or travel as an accompanying family member; travel to Asia; travel for a duration of a month or more; and, inclusion of the vaccine in a company or organization's payment plan. Meanwhile, factors negatively associated with the vaccination were travel for leisure or education, and travel to North America or Africa. Among 89 record-confirmed cases, only 53 completed 3 doses. The completion rate was negatively associated with the scheduled duration of travel if it was from a month to less than a year (after adjusting for age and sex). The present study provides a basis for promoting vaccination compliance more vigorously among Japanese adults.

Out of the picture: a study of family drawings by children from step-, single-parent, and non-step families.

PubMed

Dunn, Judy; O'Connor, Thomas G; Levy, Irit

2002-12-01

Investigated the family drawings of 180 children ages 5 to 7 years in various family settings, including stepfather, single-parent, complex stepfamilies, and 2-parent control families. The relations of family type and biological relatedness to omission of family members and grouping of parents were examined. Children from step- and single-parent families were more likely to exclude family members than children from "control" non-step families, and exclusion was predicted from biological relatedness. Children who were biologically related to both resident parents were also more likely to group their parents together. Omission of family members was found to be associated with children's adjustment (specifically more externalizing and internalizing behavior) as reported by teachers and parents. The results indicate that biological relatedness is a salient aspect of very young children's representations of their families. The association between adjustment and exclusion of family members and grouping of parents indicates that family drawings may be useful research and clinical tools, when used in combination with other methods of assessment.

Polychlorinated biphenyl exposure and effects in transformer repair workers.

PubMed Central

Emmett, E A

1985-01-01

Fifty-five present and past transformer repair workers exposed to polychlorinated biphenyls (PCBs) and 56 unexposed comparison workers were evaluated in a clinical-epidemiologic study. The groups were similar in most demographic variables. Adipose tissue lipid and serum PCBs concentrations were higher in current exposed workers (geometric means adipose 2.1 ppm, serum 12.2 ppb). Concentrations in comparison (0.6 ppm and 4.6 ppb) and previously exposed (0.83 ppm and 5.9 ppb) workers were lower. Statistically significant differences in serum albumin and lactic dehydrogenase, but not in other liver function tests, were seen between the exposed and comparison groups; however, after adjustment for confounding variables, no correlations were observed between liver function tests and either adipose or serum PCBs concentrations. Statistically significant correlation both before and after adjustment for confounding variables were seen with adipose PCBs and 24-hr urinary 17-hydroxycorticosteroid excretion and with serum PCBs and serum gamma-glutamyl transpeptidase. Both associations could reflect microsomal enzyme induction among other possibilities. No differences were seen in fasting serum triglycerides, total cholesterol, LDL, HDL or VLDL cholesterol between the two exposure groups. A statistically significant correlation between serum PCBs and serum triglycerides, total cholesterol, and VLDL cholesterol was removed by adjusting for confounding variables. No correlation was seen between adipose PCBs concentrations and any serum lipid component. Partition phenomena could account for these findings.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2863134

Obtaining the mean relative weights of the cost of care in Catalonia (Spain): retrospective application of the adjusted clinical groups case-mix system in primary health care.

PubMed

Sicras-Mainar, Antoni; Velasco-Velasco, Soledad; Navarro-Artieda, Ruth; Aguado Jodar, Alba; Plana-Ripoll, Oleguer; Hermosilla-Pérez, Eduardo; Bolibar-Ribas, Bonaventura; Prados-Torres, Alejandra; Violan-Fors, Concepción

2013-04-01

The study aims to obtain the mean relative weights (MRWs) of the cost of care through the retrospective application of the adjusted clinical groups (ACGs) in several primary health care (PHC) centres in Catalonia (Spain) in routine clinical practice. This is a retrospective study based on computerized medical records. All patients attended by 13 PHC teams in 2008 were included. The principle measurements were: demographic variables (age and sex), dependent variables (number of diagnoses and total costs), and case-mix or co-morbidity variables (International Classification of Primary Care). The costs model for each patient was established by differentiating the fix costs from the variable costs. In the bivariate analysis, the Student's t, analysis of variance, chi-squared, Pearson's linear correlation and Mann-Whitney-Wilcoxon tests were used. In order to compare the MRW of the present study with those of the United States (US), the concordance [intraclass correlation coefficient (ICC) and concordance correlation coefficient (CCC)] and the correlation (coefficient of determination: R²) were measured. The total number of patients studied was 227,235, and the frequentation was 5.9 visits/habitant/year) and with a mean diagnoses number of 4.5 (3.2). The distribution of costs was €148.7 million, of which 29.1% were fixed costs. The mean total cost per patient/year was €654.2 (851.7), which was considered to be the reference MRW. Relationship between study-MRW and US-MRW: ICC was 0.40 [confidential interval (CI) 95%: 0.21-0.60] and the CCC was 0.42 (CI 95%: 0.35-0.49). The correlation between the US MRW and the MRW of the present study can be seen; the adjusted R² value is 0.691. The explanatory power of the ACG classification was 36.9% for the total costs. The R² of the total cost without considering outliers was 56.9%. The methodology has been shown appropriate for promoting the calculation of the MRW for each category of the classification. The results provide a possible practical application in PHC clinical management. © 2012 Blackwell Publishing Ltd.

Are comparisons of patient experiences across hospitals fair? A study in Veterans Health Administration hospitals.

PubMed

Cleary, Paul D; Meterko, Mark; Wright, Steven M; Zaslavsky, Alan M

2014-07-01

Surveys are increasingly used to assess patient experiences with health care. Comparisons of hospital scores based on patient experience surveys should be adjusted for patient characteristics that might affect survey results. Such characteristics are commonly drawn from patient surveys that collect little, if any, clinical information. Consequently some hospitals, especially those treating particularly complex patients, have been concerned that standard adjustment methods do not adequately reflect the challenges of treating their patients. To compare scores for different types of hospitals after making adjustments using only survey-reported patient characteristics and using more complete clinical and hospital information. We used clinical and survey data from a national sample of 1858 veterans hospitalized for an initial acute myocardial infarction (AMI) in a Department of Veterans Affairs (VA) medical center during fiscal years 2003 and 2004. We used VA administrative data to characterize hospitals. The survey asked patients about their experiences with hospital care. The clinical data included 14 measures abstracted from medical records that are predictive of survival after an AMI. Comparisons of scores across hospitals adjusted only for patient-reported health status and sociodemographic characteristics were similar to those that also adjusted for patient clinical characteristics; the Spearman rank-order correlations between the 2 sets of adjusted scores were >0.97 across 9 dimensions of inpatient experience. This study did not support concerns that measures of patient care experiences are unfair because commonly used models do not adjust adequately for potentially confounding patient clinical characteristics.

Impact of intra-aortic balloon pump on long-term mortality of unselected patients with ST-segment elevation myocardial infarction complicated by cardiogenic shock

PubMed Central

Dziewierz, Artur; Siudak, Zbigniew; Rakowski, Tomasz; Kleczyński, Paweł; Zasada, Wojciech

2014-01-01

Introduction A large, randomised trial (IABP-SHOCK II) confirmed no benefit of intra-aortic balloon pump (IABP) on clinical outcomes of patients with ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock. However, the ‘sickest’ patients are often excluded from randomised clinical trials, so it is difficult to generalise expected outcomes from randomized clinical trials to the real life setting. Aim We sought to evaluate the impact of IABP on 1-year mortality of unselected patients with STEMI presenting in cardiogenic shock. Material and methods Data were gathered for 1,650 consecutive patients with STEMI transferred for primary angioplasty from hospital networks in 7 countries in Europe from November 2005 to January 2007 (the EUROTRANSFER registry population). Of them, 51 patients with cardiogenic shock on admission were identified and stratified based on the use of IABP. Outcome results were adjusted for age and sex, to control possible selection bias. Results At the discretion of the operators, IABP was applied in 30 patients (58.8%, IABP group). The remaining 21 patients were treated without IABP (no-IABP group). The use of IABP was more frequent among males, younger patients, and patients with STEMI of the anterior wall. There was no difference in 30-day mortality in patients with and without IABP (no-IABP vs. IABP: 38.1% vs. 33.3%; adjusted OR 1.79 (95% CI 0.43–7.52); p = 0.43). Similarly, IABP had no impact on 1-year mortality (42.9% vs. 33.3%; adjusted OR 1.27 (95% CI 0.32–5.09); p = 0.74). One-year mortality was comparable among patients who survived hospitalisation (14.3% vs. 13%; p = 0.64). Conclusions We observed no benefit of IABP on short – and long-term mortality of unselected patients with STEMI complicated by cardiogenic shock. PMID:25489303

[A pilot clinical study of immediate provisionalization with a chairside computer aided design and computer aided manufacture monolithic crown for single tooth immediate implant placement].

PubMed

Tian, J H; Di, P; Lin, Y; Zhang, Y; Wei, D H; Cui, H Y

2017-01-09

Objective: To evaluate the primary clinical outcomes of immediate provisionalization with a monolithic crown utilizing a novel chairside computer aided design and computer aided manufacture (CAD/CAM) workflow for single tooth immediate implant placement. Methods: This pilot study was a prospective within-subjects design. Thirteen consecutive patients were included and diagnosed with untreatable single incisor or premolar with fine general and local anatomical conditions. The trial was conducted at Department of Implantology, Peking University School and Hospital of Stomatology, Beijing, between January 2016 and June 2016. The teeth were extracted atraumatically and implants were immediately placed in the fresh sockets. Two screw-retained interim crowns were fabricated for the same site utilizing different workflows, a monolithic lithium disilicate (LS2) crown produced by CEREC (Sirona, Germany) chairside CAD/CAM system (CER group) and a manually fabricated resin crown utilizing conventional workflow (CONV group) respectively. The patients were blinded to the group allocation of the two interim crowns. After the clinical try-in for both crowns in a randomized sequence, the patients ' level of satisfaction was assessed with a virtual analogue scale (VAS) questionnaire. The restorations chosen by patients themselves were seated in the implants by one experienced prosthodontist. The accuracy, aesthetic effect and clinical time consumption of both groups were compared. Statistical analyses were performed with the Wilcoxon signed rank test. Results: All patients were treated with atraumatic tooth extraction, immediate implant placement using flapless surgery and immediate provisionalization in a single visit. The interim crowns of both groups could be fitted with or without slight adjustments. For each patient, the interim crown of CER group was chosen to be seated with a relatively higher VAS result. The white esthetic score (WES) results demonstrated no statistically significant difference between CER group (7.5±1.1) and CONV group (7.9±0.9) ( P> 0.05). The mean total work time was significantly different resulting in (131.9±5.0) min for CER group and (205.2±6.3) min( P< 0.05). The major difference lied in the laboratory work time, resulting in (113.5±6.3) min for CER group which was significantly shorter than (185.6±6.6) min for CONV group. As for impression taking time, the CER group (7.5±0.8) min was significantly shorter than CONV group (11.7± 1.1) min ( P< 0.05). However, analysis for clinical adjustment time showed a significantly longer time for CER group [(11.0±2.1) min vs (8.0±2.8) min, P< 0.05]. After 3-6 months of observation, the overall survival rate was 100%. Screw loosening occurred in 4 patients and was tightened again. No other major complication soccurred. Conclusions: The full digital workflow utilizing CEREC chairside CAD/CAM system to fabricate interim crowns after immediate implant placement in one single visit was feasible. It was more time-efficient and could effectively shorten the laboratory work time compared to the conventional workflow. Patients demonstrated high satisfaction and there was no statistical difference in WES results compared to the conventional workflow. Favorable clinical outcomes were gained in this short-term follow-up study.

Short stature--the role of intelligence in psychosocial adjustment.

PubMed Central

Gilmour, J; Skuse, D

1996-01-01

Short children are often described as having psychosocial problems. These reports may be inaccurate as former studies have relied largely on parental report. Psychosocial functioning of short children was assessed with the aim of using them and their peers as informants. Twenty two short (mean (SD) height -2.53 (0.28) SD score) prepubertal children aged between 6 and 11 years were recruited from growth clinics. Comparison children were recruited from each case child's class at school. Cognitive and psychosocial functioning was assessed. Peer relationships were measured using sociometry. There were no significant group differences in terms of peer acceptance, self perception, and social competence. Although cases described themselves as receiving less social support from teachers, no differences were evident in other areas of social support. Little evidence was found to suggest clinic referred prepubertal short children are psychosocially maladjusted. Further analysis revealed cognitive ability was a better predictor than height for most aspects of behavioural and emotional adjustment. PMID:8813866

Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR).

PubMed

Evans, Scott R; Rubin, Daniel; Follmann, Dean; Pennello, Gene; Huskins, W Charles; Powers, John H; Schoenfeld, David; Chuang-Stein, Christy; Cosgrove, Sara E; Fowler, Vance G; Lautenbach, Ebbing; Chambers, Henry F

2015-09-01

Clinical trials that compare strategies to optimize antibiotic use are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. The Antibacterial Resistance Leadership Group strives to overcome these challenges through innovative trial design. Response adjusted for duration of antibiotic risk (RADAR) is a novel methodology utilizing a superiority design and a 2-step process: (1) categorizing patients into an overall clinical outcome (based on benefits and harms), and (2) ranking patients with respect to a desirability of outcome ranking (DOOR). DOORs are constructed by assigning higher ranks to patients with (1) better overall clinical outcomes and (2) shorter durations of antibiotic use for similar overall clinical outcomes. DOOR distributions are compared between antibiotic use strategies. The probability that a randomly selected patient will have a better DOOR if assigned to the new strategy is estimated. DOOR/RADAR represents a new paradigm in assessing the risks and benefits of new strategies to optimize antibiotic use. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Diet-induced thermogenesis in postoperatve Roux-en-Y gastric bypass patients with weight regain.

PubMed

Cardeal, Mariane de Almeida; Faria, Silvia Leite; Faria, Orlando Pereira; Facundes, Marcela; Ito, Marina Kiyomi

2016-06-01

Bariatric surgery has been shown to be an effective treatment for obesity. Changes in energy expenditure, especially through diet-induced thermogenesis (DIT), have been identified as one of the mechanisms to explain this success. However, not all patients are able to maintain healthy postoperative weight loss. Therefore, a question arises: In the weight regain after bariatric surgery, are these changes in energy metabolism still active? To investigate if weight regain after Roux-en-Y gastric bypass (RYGB) surgery is associated with a lower diet-induced thermogenesis in the late postoperative period. A cross-sectional study with the participants chosen from among the patients from a private practice. This was a cross-sectional study where 3 groups of female patients were evaluated: (1) 20 patients with a RYGB postoperative time period of at least 2 years, who kept a healthy weight after surgery (loss of at least 50% of excess weight; Healthy group); (2) 19 patients with clinically severe obesity (BMI>40 kg/m(2), without co-morbidities and>35 kg/m(2), with co-morbidities; Pre group); (3) 18 patients who experienced weight regain after RYGB (Regain group). The 3 groups were submitted to indirect calorimetry to measure resting metabolic rate (RMR), respiratory quotient (RQ), and DIT. Immediately after the RMR measurement, a mixed meal of regular consistency was offered. Ten minutes after the food intake began, energy expenditure measurements were initiated continuing throughout the following 3 postprandial hours. Body composition was evaluated using multifrequency bioelectrical impedance. In subgroups of the studied population, glucose and insulin levels were measured at baseline and at 30, 60, 90, 120, and 180 minutes after feeding. The mean area under the curve (AUC) between the 3 groups and measurements at baseline were compared using the analysis of variance (ANOVA). The Healthy group had the highest weight adjusted RMR value compared with both the Pre and Regain group (23.03±3.02 kcal/kg; 16.18±2.94 kcal/kg; 17.11±3.28 kcal/kg, respectively; P<.0001). The Regain and Pre groups showed no difference for this variable. The weight-adjusted DIT (AUC 0-180 min) was about 42% and 34% higher in the Healthy group compared with the Pre and Regain groups, respectively (P<.0001). Lean body mass (kg) showed a positive correlation with the AUC of weight-adjusted DIT in the 3 groups. Multiple regression revealed that lean body mass was the only variable related to weight adjusted DIT, independent of group and other selected variables. Weight-adjusted DIT in the Regain group was smaller compared with the Healthy group, and with no difference compared with the Pre group. The lean body mass seems to have a positive association with diet-induced thermogenesis. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Neuropathologic features associated with Alzheimer disease diagnosis

PubMed Central

Grinberg, L.T.; Miller, B.; Kawas, C.; Yaffe, K.

2011-01-01

Objective: To examine whether the association between clinical Alzheimer disease (AD) diagnosis and neuropathology and the precision by which neuropathology differentiates people with clinical AD from those with normal cognition varies by age. Methods: We conducted a cross-sectional analysis of 2,014 older adults (≥70 years at death) from the National Alzheimer's Coordinating Center database with clinical diagnosis of normal cognition (made ≤1 year before death, n = 419) or AD (at ≥65 years, n = 1,595) and a postmortem neuropathologic examination evaluating AD pathology (neurofibrillary tangles, neuritic plaques) and non-AD pathology (diffuse plaques, amyloid angiopathy, Lewy bodies, macrovascular disease, microvascular disease). We used adjusted logistic regression to analyze the relationship between clinical AD diagnosis and neuropathologic features, area under the receiver operating characteristic curve (c statistic) to evaluate how precisely neuropathology differentiates between cognitive diagnoses, and an interaction to identify effect modification by age group. Results: In a model controlling for coexisting neuropathologic features, the relationship between clinical AD diagnosis and neurofibrillary tangles was significantly weaker with increasing age (p < 0.001 for interaction). The aggregate of all neuropathologic features more strongly differentiated people with clinical AD from those without in younger age groups (70–74 years: c statistic, 95% confidence interval: 0.93, 0.89–0.96; 75–84 years: 0.95, 0.87–0.95; ≥85 years: 0.83, 0.80–0.87). Non-AD pathology significantly improved precision of differentiation across all age groups (p < 0.004). Conclusion: Clinical AD diagnosis was more weakly associated with neurofibrillary tangles among the oldest old compared to younger age groups, possibly due to less accurate clinical diagnosis, better neurocompensation, or unaccounted pathology among the oldest old. PMID:22031532

Protocol for economic evaluation alongside a cluster-randomised controlled trial of a psychoeducational intervention for the primary prevention of postnatal mental health problems in first-time mothers.

PubMed

Ride, Jemimah; Rowe, Heather; Wynter, Karen; Fisher, Jane; Lorgelly, Paula

2014-10-03

Postnatal mental health problems, which are an international public health priority, are a suitable target for preventive approaches. The financial burden of these disorders is borne across sectors in society, including health, early childhood, education, justice and the workforce. This paper describes the planned economic evaluation of What Were We Thinking, a psychoeducational intervention for the prevention of postnatal mental health problems in first-time mothers. The evaluation will be conducted alongside a cluster-randomised controlled trial of its clinical effectiveness. Cost-effectiveness and costs-utility analyses will be conducted, resulting in estimates of cost per percentage point reduction in combined 30-day prevalence of depression, anxiety and adjustment disorders and cost per quality-adjusted life year gained. Uncertainty surrounding these estimates will be addressed using non-parametric bootstrapping and represented using cost-effectiveness acceptability curves. Additional cost analyses relevant for implementation will also be conducted. Modelling will be employed to estimate longer term cost-effectiveness if the intervention is found to be clinically effective during the period of the trial. Approval to conduct the study was granted by the Southern Health (now Monash Health) Human Research Ethics Committee (24 April 2013; 11388B). The study was registered with the Monash University Human Research Ethics Committee (30 April 2013; CF12/1022-2012000474). The Education and Policy Research Committee, Victorian Government Department of Education and Early Childhood Development approved the study (22 March 2012; 2012_001472). Use of the EuroQol was registered with the EuroQol Group; 16 August 2012. The trial was registered with the Australian New Zealand Clinical Trials Registry on 7 May 2012 (registration number ACTRN12613000506796). 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.

Adaptive capacity of the Adjusted Clinical Groups Case-Mix System to the cost of primary healthcare in Catalonia (Spain): a observational study.

PubMed

Sicras-Mainar, Antoni; Velasco-Velasco, Soledad; Navarro-Artieda, Ruth; Prados-Torres, Alexandra; Bolibar-Ribas, Buenaventura; Violan-Fors, Concepción

2012-01-01

To describe the adaptive capacity of the Adjusted Clinical Groups (ACG) system to the cost of care in primary healthcare centres in Catalonia (Spain). Retrospective study (multicentres) conducted using computerised medical records. 13 primary care teams in 2008 were included. All patients registered in the study centres who required care between 1 January and 31 December 2008 were finally studied. Patients not registered in the study centres during the study period were excluded. Demographic (age and sex), dependent (cost of care) and case-mix variables were studied. The cost model for each patient was established by differentiating the fixed and variable costs. To evaluate the adaptive capacity of the ACG system, Pearson's coefficient of variation and the percentage of outliers were calculated. To evaluate the explanatory power of the ACG system, the authors used the coefficient of determination (R(2)). The number of patients studied was 227 235 (frequency: 5.9 visits per person per year), with a mean of 4.5 (3.2) episodes and 8.1 (8.2) visits per patient per year. The mean total cost was €654.2. The explanatory power of the ACG system was 36.9% for costs (56.5% without outliers). 10 ACG categories accounted for 60.1% of all cases and 19 for 80.9%. 5 categories represented 71% of poor performance (N=78 887, 34.7%), particularly category 0300-Acute Minor, Age 6+ (N=26 909, 11.8%), which had a coefficient of variation =139% and 6.6% of outliers. The ACG system is an appropriate manner of classifying patients in routine clinical practice in primary healthcare centres in Catalonia, although improvements to the adaptive capacity through disaggregation of some categories according to age groups and, especially, the number of acute episodes in paediatric patients would be necessary to reduce intra-group variation.

Recommendations for clinical staging (cTNM) of cancer of the esophagus and esophagogastric junction for the 8th edition AJCC/UICC staging manuals.

PubMed

Rice, Thomas W; Ishwaran, Hemant; Blackstone, Eugene H; Hofstetter, Wayne L; Kelsen, David P; Apperson-Hansen, Carolyn

2016-11-01

We report analytic and consensus processes that produced recommendations for clinical stage groups (cTNM) of esophageal and esophagogastric junction cancer for the AJCC/UICC cancer staging manuals, 8th edition. The Worldwide Esophageal Cancer Collaboration (WECC) provided data on 22,123 clinically staged patients with epithelial esophageal cancers. Risk-adjusted survival for each patient was developed using random survival forest analysis from which (1) data-driven clinical stage groups were identified wherein survival decreased monotonically and was distinctive between and homogeneous within groups and (2) data-driven anatomic clinical stage groups based only on cTNM. The AJCC Upper GI Task Force, by smoothing, simplifying, expanding, and assessing clinical applicability, produced (3) consensus clinical stage groups. Compared with pTNM, cTNM survival was "pinched," with poorer survival for early cStage groups and better survival for advanced ones. Histologic grade was distinctive for data-driven grouping of cT2N0M0 squamous cell carcinoma (SCC) and cT1-2N0M0 adenocarcinoma, but consensus removed it. Grouping was different by histopathologic cell type. For SCC, cN0-1 was distinctive for cT3 but not cT1-2, and consensus removed cT4 subclassification and added subgroups 0, IVA, and IVB. For adenocarcinoma, N0-1 was distinctive for cT1-2 but not cT3-4a, cStage II subgrouping was necessary (T1N1M0 [IIA] and T2N0M0 [IIB]), advanced cancers cT3-4aN0-1M0 plus cT2N1M0 comprised cStage III, and consensus added subgroups 0, IVA, and IVB. Treatment decisions require accurate cStage, which differs from pStage. Understaging and overstaging are problematic, and additional factors, such as grade, may facilitate treatment decisions and prognostication until clinical staging techniques are uniformly applied and improved. © 2016 International Society for Diseases of the Esophagus.

Recommendations for clinical staging (cTNM) of cancer of the esophagus and esophagogastric junction for the 8th edition AJCC/UICC staging manuals

PubMed Central

Rice, Thomas W.; Ishwaran, Hemant; Blackstone, Eugene H.; Hofstetter, Wayne L.; Kelsen, David P.; Apperson-Hansen, Carolyn

2017-01-01

SUMMARY We report analytic and consensus processes that produced recommendations for clinical stage groups (cTNM) of esophageal and esophagogastric junction cancer for the AJCC/UICC cancer staging manuals, 8th edition. The Worldwide Esophageal Cancer Collaboration (WECC) provided data on 22,123 clinically staged patients with epithelial esophageal cancers. Risk-adjusted survival for each patient was developed using random survival forest analysis from which (1) data-driven clinical stage groups were identified wherein survival decreased monotonically and was distinctive between and homogeneous within groups and (2) data-driven anatomic clinical stage groups based only on cTNM. The AJCC Upper GI Task Force, by smoothing, simplifying, expanding, and assessing clinical applicability, produced (3) consensus clinical stage groups. Compared with pTNM, cTNM survival was “pinched,” with poorer survival for early cStage groups and better survival for advanced ones. Histologic grade was distinctive for data-driven grouping of cT2N0M0 squamous cell carcinoma (SCC) and cT1-2N0M0 adenocarcinoma, but consensus removed it. Grouping was different by histopathologic cell type. For SCC, cN0-1 was distinctive for cT3 but not cT1-2, and consensus removed cT4 subclassification and added subgroups 0, IVA, and IVB. For adenocarcinoma, N0-1 was distinctive for cT1-2 but not cT3-4a, cStage II subgrouping was necessary (T1N1M0 [IIA] and T2N0M0 [IIB]), advanced cancers cT3-4aN0-1M0 plus cT2N1M0 comprised cStage III, and consensus added subgroups 0, IVA, and IVB. Treatment decisions require accurate cStage, which differs from pStage. Understaging and overstaging are problematic, and additional factors, such as grade, may facilitate treatment decisions and prognostication until clinical staging techniques are uniformly applied and improved. PMID:27905171

Perinatal and maternal outcomes in planned home and obstetric unit births in women at ‘higher risk’ of complications: secondary analysis of the Birthplace national prospective cohort study

PubMed Central

Li, Y; Townend, J; Rowe, R; Brocklehurst, P; Knight, M; Linsell, L; Macfarlane, A; McCourt, C; Newburn, M; Marlow, N; Pasupathy, D; Redshaw, M; Sandall, J; Silverton, L; Hollowell, J

2015-01-01

Objective To explore and compare perinatal and maternal outcomes in women at ‘higher risk’ of complications planning home versus obstetric unit (OU) birth. Design Prospective cohort study. Setting OUs and planned home births in England. Population 8180 ‘higher risk’ women in the Birthplace cohort. Methods We used Poisson regression to calculate relative risks adjusted for maternal characteristics. Sensitivity analyses explored possible effects of differences in risk between groups and alternative outcome measures. Main outcome measures Composite perinatal outcome measure encompassing ‘intrapartum related mortality and morbidity’ (intrapartum stillbirth, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus or clavicle) and neonatal admission within 48 hours for more than 48 hours. Two composite maternal outcome measures capturing intrapartum interventions/adverse maternal outcomes and straightforward birth. Results The risk of ‘intrapartum related mortality and morbidity’ or neonatal admission for more than 48 hours was lower in planned home births than planned OU births [adjusted relative risks (RR) 0.50, 95% CI 0.31–0.81]. Adjustment for clinical risk factors did not materially affect this finding. The direction of effect was reversed for the more restricted outcome measure ‘intrapartum related mortality and morbidity’ (RR adjusted for parity 1.92, 95% CI 0.97–3.80). Maternal interventions were lower in planned home births. Conclusions The babies of ‘higher risk’ women who plan birth in an OU appear more likely to be admitted to neonatal care than those whose mothers plan birth at home, but it is unclear if this reflects a real difference in morbidity. Rates of intrapartum related morbidity and mortality did not differ statistically significantly between settings at the 5% level but a larger study would be required to rule out a clinically important difference between the groups. PMID:25603762

Factors associated with recovery from acute optic neuritis in patients with multiple sclerosis.

PubMed

Malik, Muhammad Taimur; Healy, Brian C; Benson, Leslie A; Kivisakk, Pia; Musallam, Alexander; Weiner, Howard L; Chitnis, Tanuja

2014-06-17

To identify clinical and demographic features associated with the severity and recovery from acute optic neuritis (AON) episodes in patients with multiple sclerosis (MS). Adult (n = 253) and pediatric (n = 38) patients whose first symptom was AON were identified from our MS database. Severity measured by loss of visual acuity (mild attack ≤20/40, moderate attack 20/50-20/190, and severe attack ≥20/200) and recovery in visual acuity at 1 year after the attack (complete recovery ≤20/20, fair recovery 20/40, and poor recovery ≥20/50) were recorded. Demographic and clinical features associated with attack severity and recovery were identified using proportional odds logistic regression. For another group of patients, blood samples were available within 6 months of an AON attack. In this group, the impact of vitamin D level on the severity/recovery was also assessed. Men (adjusted odds ratio [OR] = 2.28, p = 0.03) and subjects with severe attacks (adjusted OR = 5.24, p < 0.001) had worse recovery. AON severity was similar between the pediatric and adult subjects, but recovery was significantly better in pediatric subjects in the unadjusted analysis (p = 0.041) and the analysis adjusted for sex (p = 0.029). Season-adjusted vitamin D level was significantly associated with attack severity (OR for 10-U increase in vitamin D level = 0.47; 95% confidence interval: 0.32, 0.68; p < 0.001). Vitamin D level was not associated with recovery from the attack (p = 0.98) in univariate analysis or after accounting for attack severity (p = 0.10). Vitamin D levels affect AON severity, whereas younger age, attack severity, and male sex affect AON recovery. Underlying mechanisms and potential therapeutic targets may identify new measures to mitigate disability accrual in MS. © 2014 American Academy of Neurology.

Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes.

PubMed

Scott, Andrew V; Stonemetz, Jerry L; Wasey, Jack O; Johnson, Daniel J; Rivers, Richard J; Koch, Colleen G; Frank, Steven M

2015-07-01

In an effort to measure and improve the quality of perioperative care, the Surgical Care Improvement Project (SCIP) was introduced in 2003. The SCIP guidelines are evidence-based process measures designed to reduce preventable morbidity, but it remains to be determined whether SCIP-measure compliance is associated with improved outcomes. The authors retrospectively analyzed the electronic medical record data from 45,304 inpatients at a single institution to assess whether compliance with SCIP Inf-10 (body temperature management) was associated with a reduced incidence of morbidity and mortality. The primary outcomes were hospital-acquired infection and ischemic cardiovascular events. Secondary outcomes were mortality and hospital length of stay. Body temperature on admission to the postoperative care unit was higher in the SCIP-compliant group (36.6° ± 0.5°C; n = 44,064) compared with the SCIP-noncompliant group (35.5° ± 0.5°C; n = 1,240) (P < 0.0001). SCIP compliance was associated with improved outcomes in both nonadjusted and risk-adjusted analyses. SCIP compliance was associated with a reduced incidence of hospital-acquired infection (3,312 [7.5%] vs.160 [12.9%] events; risk-adjusted odds ratio [OR], 0.68; 95% CI, 0.54 to 0.85), ischemic cardiovascular events (602 [1.4%] vs. 38 [3.1%] events; risk-adjusted OR, 0.60; 95% CI, 0.41 to 0.92), and mortality (617 [1.4%] vs. 60 [4.8%] events; risk-adjusted OR, 0.41; 95% CI, 0.29 to 0.58). Median (interquartile range) hospital length of stay was also decreased: 4 (2 to 8) versus 5 (2 to 14) days; P < 0.0001. Compliance with SCIP Inf-10 body temperature management guidelines during surgery is associated with improved clinical outcomes and can be used as a quality measure.

The Association of Frailty With Outcomes and Resource Use After Emergency General Surgery: A Population-Based Cohort Study.

PubMed

McIsaac, Daniel I; Moloo, Husein; Bryson, Gregory L; van Walraven, Carl

2017-05-01

Older patients undergoing emergency general surgery (EGS) experience high rates of postoperative morbidity and mortality. Studies focused primarily on elective surgery indicate that frailty is an important predictor of adverse outcomes in older surgical patients. The population-level effect of frailty on EGS is poorly described. Therefore, our objective was to measure the association of preoperative frailty with outcomes in a population of older patients undergoing EGS. We created a population-based cohort study using linked administrative data in Ontario, Canada, that included community-dwelling individuals aged >65 years having EGS. Our main exposure was preoperative frailty, as defined by the Johns Hopkins Adjusted Clinical Groups frailty-defining diagnoses indicator. The Adjusted Clinical Groups frailty-defining diagnoses indicator is a binary variable that uses 12 clusters of frailty-defining diagnoses. Our main outcome measures were 1-year all-cause mortality (primary), intensive care unit admission, length of stay, institutional discharge, and costs of care (secondary). Of 77,184 patients, 19,779 (25.6%) were frail. Death within 1 year occurred in 6626 (33.5%) frail patients compared with 11,366 (19.8%) nonfrail patients. After adjustment for sociodemographic and surgical confounders, this resulted in a hazard ratio of 1.29 (95% confidence interval [CI] 1.25-1.33). The risk of death for frail patients varied significantly across the postoperative period and was particularly high immediately after surgery (hazard ratio on postoperative day 1 = 23.1, 95% CI 22.3-24.1). Frailty was adversely associated with all secondary outcomes, including a 5.82-fold increase in the adjusted odds of institutional discharge (95% CI 5.53-6.12). After EGS, frailty is associated with increased rates of mortality, institutional discharge, and resource use. Strategies that might improve perioperative outcomes in frail EGS patients need to be developed and tested.

Contraceptive Use among Women with Chronic Medical Conditions and Factors Associated with Its Non-Use in Malaysia

PubMed Central

Manaf, Rosliza Abdul; Ismail, Irmi Zarina; Latiff, Latiffah A.

2012-01-01

Introduction: Women with chronic medical conditions are at higher risk of adverse pregnancy outcomes, which may be minimized through optimal preconception care and appropriate contraceptive use. This study aimed to describe contraceptive use among women with chronic medical conditions and factors associated with its non-use. Methods: This study used cross-sectional data from a family planning survey among women with chronic medical conditions conducted in three health facilities in a southern state of Malaysia. A total of 450 married women in reproductive age (18-50 year) with intact uterus, and do not plan to conceive were analysed for contraceptive use. Both univariate and multivariate analysis was conducted to identify factors associated with contraceptive non-use among the study participants. Results: A total of 312 (69.3%) of the study participants did not use contraceptive. Contraceptive non-use was highest among the diabetics (71.2%), connective tissue disease patients (68.6%) and hypertensive patients (65.3%). Only 26.3% of women with heart disease did not use contraceptive. In the multivariate analysis, contraceptive non-use was significantly more common among women who received their medical treatment in the health clinics as compared to those who received treatment in the hospital (adjusted odds ratio [OR]=1.75, 95% confidence interval [CI]: 1.09, 2.79), being in older age group of 41-50 year (adjusted OR=2.31, 95% CI: 1.19, 4.48), having children (adjusted OR=4.57, 95% CI: 1.66, 12.57) and having lower education (adjusted OR=2.87, 95% CI: 1.43, 5.77). Conclusion: About two-third of women with chronic medical conditions who needed contraceptive did not use them despite the higher risk of pregnancy related complications. The high unmet need warrant an effective health promotion programme to encourage the uptake of contraceptives especially targeting women of older age group, low education and those who received their medical treatment at health clinics. PMID:22980381

SU-E-I-68: Practical Considerations On Implementation of the Image Gently Pediatric CT Protocols

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

Zhang, J; Adams, C; Lumby, C

Purpose: One limitation associated with the Image Gently pediatric CT protocols is practical implementation of the recommended manual techniques. Inconsistency as a result of different practice is a possibility among technologist. An additional concern is the added risk of data error that would result in over or underexposure. The Automatic Exposure Control (AEC) features automatically reduce radiation for children. However, they do not work efficiently for the patients of very small size and relative large size. This study aims to implement the Image Gently pediatric CT protocols in the practical setting while maintaining the use of AEC features for pediatricmore » patients of varying size. Methods: Anthropomorphological abdomen phantoms were scanned in a CT scanner using the Image Gently pediatric protocols, the AEC technique with a fixed adult baseline, and automatic protocols with various baselines. The baselines were adjusted corresponding to patient age, weight and posterioranterior thickness to match the Image Gently pediatric CT manual techniques. CTDIvol was recorded for each examination. Image noise was measured and recorded for image quality comparison. Clinical images were evaluated by pediatric radiologists. Results: By adjusting vendor default baselines used in the automatic techniques, radiation dose and image quality can match those of the Image Gently manual techniques. In practice, this can be achieved by dividing pediatric patients into three major groups for technologist reference: infant, small child, and large child. Further division can be done but will increase the number of CT protocols. For each group, AEC can efficiently adjust acquisition techniques for children. This implementation significantly overcomes the limitation of the Image Gently manual techniques. Conclusion: Considering the effectiveness in clinical practice, Image Gently Pediatric CT protocols can be implemented in accordance with AEC techniques, with adjusted baselines, to achieve the goal of providing the most appropriate radiation dose for pediatric patients of varying sizes.« less

Measuring health-related quality of life in population-based studies of coronary heart disease: comparing six generic indexes and a disease-specific proxy score.

PubMed

Garster, Noelle C; Palta, Mari; Sweitzer, Nancy K; Kaplan, Robert M; Fryback, Dennis G

2009-11-01

To compare HRQoL differences with CHD in generic indexes and a proxy CVD-specific score in a nationally representative sample of U.S. adults. The National Health Measurement Study, a cross-sectional random-digit-dialed telephone survey of adults aged 35-89, administered the EQ-5D, QWB-SA, HUI2, HUI3, SF-36v2 (yielding PCS, MCS, and SF-6D), and HALex. Analyses compared 3,350 without CHD (group 1), 265 with CHD not taking chest pain medication (group 2), and 218 with CHD currently taking chest pain medication (group 3), with and without adjustment for demographic variables and comorbidities. Data on 154 patients from heart failure clinics were used to construct a proxy score utilizing generic items probing CVD symptoms. Mean scores differed between CHD groups for all indexes with and without adjustment (P < 0.0001 for all except MCS P = 0.018). Unadjusted group 3 versus 1 differences were about three times larger than for group 2 versus 1. Standardized differences for the proxy score were similar to those for generic indexes, and were about 1.0 for all except MCS for group 3 versus 1. Generic indexes capture differences in HRQoL in population-based studies of CHD similarly to a score constructed from questions probing CVD-specific symptoms.

75 FR 7035 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-16

... adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met. I... issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility... eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section...

78 FR 21152 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met. I... issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility... eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section...

[Analysis of the causes and determinants of reaction to severe stress and adjustment disorder patients on mental health clinics].

PubMed

Golinowska, Danuta; Florkowski, Antoni; Juszczak, Dariusz

2010-05-01

In everyday life there are many obstacles that prevent the creation of many important needs. They require a skillful adaptation and may be the cause of stress. Stress of considerable intensity can receive the joy of life and even lead to a temporary mental disorder. To present the main causes and frequency of disturbance determined according to the ICD-10 as a reaction to severe stress and adaptive disorders among patients in psychiatric and psychological counseling and to establish whether the causes of the disorder are dependent on factors such as age, sex or level of education. Analysis was done on a separate group of 754 persons from among patients seeking psychiatric counseling--Psychological Outpatient Mental Health in the 10th Military Clinical Hospital in Bydgoszcz, in 2005. This group were qualified person, who according to the criteria of ICD-10 were found to respond to severe stress and abnormal adaptation. In addition, during the interview determines whether they are long-term somatic illness. They have not been included in the study group. Also excluded persons who were found difficulties in operation prior to the stressful situation and those that have already been treated with psychiatric or psychological benefit from therapy. The collected data were statistically analyzed. The analysis identifies three main causes of adjustment disorder. The first group of reasons is related to difficulties in the workplace, which represents 59% of all patients with the disorder described. In this group identifies three major stressful situations: bullying, job loss, unemployment. Another reason relates to family problems. They are the reason for the emergence of abnormalities in 23% of patients analyzed group. Among these difficulties was divided into four main types of situation causing disorder presented. There are family conflicts, death of spouse, parent death, divorce. The last group of factors are stressful events or incidents which contributed to the disorder in 16% of patients in the group described. In this category were observed four major groups analyzed the causes of the disorder. This is due to the difficulty of adapting to the compulsory military service, traffic accidents, participation in missions abroad, the situation of rape. Making a detailed analysis by category of difficulty is shown that in this group of subjects, age, educational level and gender are significant factors in influencing the formation of these disorders. The main causes of this disorder are closely related to everyday human activity and especially on employment. Harassment and bad relationships in the workplace, job loss, unemployment are the factors most often causing disorder in question. The analysis made also clear that the situations of family conflict is also a frequent cause of severe reactions to stress and adjustment disorder. Not without significance is the impact of factors such as level of education, age and sex. Analysis by specific categories of causes of reactions to stress and adjustment disorder indicates that these factors significantly correlate with the formation of these disorders in the group of people.

Has the Reform of the Japanese Healthcare Provision System Improved the Value in Healthcare? A Cost-Consequence Analysis of Organized Care for Hip Fracture Patients.

PubMed

Fukuda, Haruhisa; Shimizu, Sayuri; Ishizaki, Tatsuro

2015-01-01

To assess the value of organized care by comparing the clinical outcomes and healthcare expenditure between the conventional Japanese "integrated care across specialties within one hospital" mode of providing healthcare and the prospective approach of "organized care across separate facilities within a community". Retrospective cohort study. Two groups of hospitals were categorized according to healthcare delivery approach: the first group included 3 hospitals autonomously providing integrated care across specialties, and the second group included 4 acute care hospitals and 7 rehabilitative care hospitals providing organized care across separate facilities. Patients aged 65 years and above who had undergone hip fracture surgery. Regression models adjusting for patient characteristics and clinical variables were used to investigate the impact of organized care on the improvements to the mobility capability of patients before and after hospitalization and the differences in healthcare resource utilization. The sample for analysis included 837 hip fracture surgery cases. The proportion of patients with either unchanged or improved mobility capability was not statistically associated with the healthcare delivery approaches. Total adjusted mean healthcare expenditure for integrated care and organized care were US$28,360 (95% confidence interval: 27,787-28,972) and US$21,951 (21,511-22,420), respectively, indicating an average increase of US$6,409 in organized care. Our cost-consequence analysis underscores the need to further investigate the actual contribution of organized care to the provision of efficient and high-quality healthcare.

Characteristics of Perimenstrual Asthma and Its Relation to Asthma Severity and Control

PubMed Central

Rao, Chitra K.; Moore, Charity G.; Bleecker, Eugene; Busse, William W.; Calhoun, William; Castro, Mario; Chung, Kian Fan; Erzurum, Serpil C.; Israel, Elliot; Curran-Everett, Douglas

2013-01-01

Background: Although perimenstrual asthma (PMA) has been associated with severe and difficult-to-control asthma, it remains poorly characterized and understood. The objectives of this study were to identify clinical, demographic, and inflammatory factors associated with PMA and to assess the association of PMA with asthma severity and control. Methods: Women with asthma recruited to the National Heart, Lung, and Blood Institute Severe Asthma Research Program who reported PMA symptoms on a screening questionnaire were analyzed in relation to basic demographics, clinical questionnaire data, immunoinflammatory markers, and physiologic parameters. Univariate comparisons between PMA and non-PMA groups were performed. A severity-adjusted model predicting PMA was created. Additional models addressed the role of PMA in asthma control. Results: Self-identified PMA was reported in 17% of the subjects (n = 92) and associated with higher BMI, lower FVC % predicted, and higher gastroesophageal reflux disease rates. Fifty-two percent of the PMA group met criteria for severe asthma compared with 30% of the non-PMA group. In multivariable analyses controlling for severity, aspirin sensitivity and lower FVC % predicted were associated with the presence of PMA. Furthermore, after controlling for severity and confounders, PMA remained associated with more asthma symptoms and urgent health-care utilization. Conclusions: PMA is common in women with severe asthma and associated with poorly controlled disease. Aspirin sensitivity and lower FVC % predicted are associated with PMA after adjusting for multiple factors, suggesting that alterations in prostaglandins may contribute to this phenotype. PMID:23632943

Effect of Internet-Based Guided Self-help vs Individual Face-to-Face Treatment on Full or Subsyndromal Binge Eating Disorder in Overweight or Obese Patients: The INTERBED Randomized Clinical Trial.

PubMed

de Zwaan, Martina; Herpertz, Stephan; Zipfel, Stephan; Svaldi, Jennifer; Friederich, Hans-Christoph; Schmidt, Frauke; Mayr, Andreas; Lam, Tony; Schade-Brittinger, Carmen; Hilbert, Anja

2017-10-01

Although cognitive behavioral therapy (CBT) represents the criterion standard for treatment of binge eating disorder (BED), most individuals do not have access to this specialized treatment. To evaluate the efficacy of internet-based guided self-help (GSH-I) compared with traditional, individual face-to-face CBT. The Internet and Binge Eating Disorder (INTERBED) study is a prospective, multicenter, randomized, noninferiority clinical trial (treatment duration, 4 months; follow-ups, 6 months and 1.5 years). A volunteer sample of 178 adult outpatients with full or subsyndromal BED were recruited from 7 university-based outpatient clinics from August 1, 2010, through December 31, 2011; final follow-up assessment was in April 2014. Data analysis was performed from November 30, 2014, to May 27, 2015. Participants received 20 individual face-to-face CBT sessions of 50 minutes each or sequentially completed 11 internet modules and had weekly email contacts. The primary outcome was the difference in the number of days with objective binge eating episodes (OBEs) during the previous 28 days between baseline and end of treatment. Secondary outcomes included OBEs at follow-ups, eating disorder and general psychopathologic findings, body mass index, and quality of life. A total of 586 patients were screened, 178 were randomized, and 169 had at least one postbaseline assessment and constituted the modified intention-to-treat analysis group (mean [SD] age, 43.2 [12.3] years; 148 [87.6%] female); the 1.5-year follow-up was available in 116 patients. The confirmatory analysis using the per-protocol sample (n = 153) failed to show noninferiority of GSH-I (adjusted effect, 1.47; 95% CI, -0.01 to 2.91; P = .05). Using the modified intention-to-treat sample, GSH-I was inferior to CBT in reducing OBE days at the end of treatment (adjusted effect, 1.63; 95% CI, 0.17-3.05; P = .03). Exploratory longitudinal analyses also showed the superiority of CBT over GSH-I by the 6-month (adjusted effect, 0.36; 95% CI, 0.23-0.55; P < .001) but not the 1.5-year follow-up (adjusted effect, 0.91; 95% CI, 0.54-1.50; P = .70). Reductions in eating disorder psychopathologic findings were significantly higher in the CBT group than in the GSH-I group at 6-month follow-up (adjusted effect, -0.4; 95% CI, -0.68 to -0.13; P = .005). No group differences were found for body mass index, general psychopathologic findings, and quality of life. Face-to-face CBT leads to quicker and greater reductions in the number of OBE days, abstinence rates, and eating disorder psychopathologic findings and may be a better initial treatment option than GSH-I. Internet-based guided self-help remains a viable, slower-acting, low-threshold treatment alternative compared with CBT for adults with BED. isrctn.org Identifier: ISRCTN40484777 and germanctr.de Identifier: DRKS00000409.

Development of a risk-adjustment model for antimicrobial utilization data in 21 public hospitals in Queensland, Australia (2006-11).

PubMed

Rajmokan, M; Morton, A; Marquess, J; Playford, E G; Jones, M

2013-10-01

Making valid comparisons of antimicrobial utilization between hospitals requires risk adjustment for each hospital's case mix. Data on individual patients may be unavailable or difficult to process. Therefore, risk adjustment for antimicrobial usage frequently needs to be based on a hospital's services. This study evaluated such a strategy for hospital antimicrobial utilization. Data were obtained on five broad subclasses of antibiotics [carbapenems, β-lactam/β-lactamase inhibitor combinations (BLBLIs), fluoroquinolones, glycopeptides and third-generation cephalosporins] from the Queensland pharmacy database (MedTrx) for 21 acute public hospitals (2006-11). Eleven clinical services and a variable for hospitals from the tropical region were employed for risk adjustment. Multivariable regression models were used to identify risk and protective services for these antibiotics. Funnel plots were used to display hospitals' antimicrobial utilization. Total inpatient antibiotic utilization for these antibiotics increased from 130.6 defined daily doses (DDDs)/1000 patient-days in 2006 to 155.8 DDDs/1000 patient-days in 2011 (P < 0.0001). Except for third-generation cephalosporins, the average utilization rate was higher for intensive care, renal/nephrology, cardiac, burns/plastic surgery, neurosurgery, transplant and acute spinal services than for the respective reference group (no service). In addition, oncology, high-activity infectious disease and coronary care services were associated with higher utilization of carbapenems, BLBLIs and glycopeptides. Our model predicted antimicrobial utilization rates by hospital services. The funnel plots displayed hospital utilization data after adjustment for variation among the hospitals. However, the methodology needs to be validated in other populations, ideally using a larger group of hospitals.

Non-alcoholic fatty liver disease is associated with high prevalence of gastro-oesophageal reflux symptoms.

PubMed

Miele, Luca; Cammarota, Giovanni; Vero, Vittoria; Racco, Simona; Cefalo, Consuelo; Marrone, Giuseppe; Pompili, Maurizio; Rapaccini, Gianlodovico; Bianco, Alessandro; Landolfi, Raffaele; Gasbarrini, Antonio; Grieco, Antonio

2012-12-01

Gastro-oesophageal reflux symptoms are usually reported by patients with obesity and metabolic syndrome. Aim of this study was to assess the prevalence and clinical characteristics of gastro-oesophageal reflux symptoms in subjects with non-alcoholic fatty liver disease. Cross-sectional, case-control study of 185 consecutive patients with non-alcoholic fatty liver disease and an age- and sex-matched control group of 112 healthy volunteers. Participants were interviewed with the aid of a previously validated questionnaire to assess lifestyle and reflux symptoms in the 3 months preceding enrolment. Odds ratios were determined before and after adjustment for body mass index, increased waist circumference, physical activity, metabolic syndrome and proton pump inhibitors and/or antiacid medication. The prevalence of heartburn and/or regurgitation and of at least one of gastro-oesophageal reflux symptoms was significantly higher in the non-alcoholic fatty liver disease group. Non-alcoholic fatty liver disease subjects were associated to higher prevalence of heartburn (adjusted odds ratios: 2.17, 95% confidence intervals: 1.16-4.04), regurgitation (adjusted odds ratios: 2.61, 95% confidence intervals: 1.24-5.48) and belching (adjusted odds ratios: 2.01, 95% confidence intervals: 1.12-3.59) and had higher prevalence of at least one GER symptom (adjusted odds ratios: 3.34, 95% confidence intervals: 1.76-6.36). Non-alcoholic fatty liver disease is associated with a higher prevalence of gastro-oesophageal reflux symptoms. Copyright © 2012 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Significant association between renal function and area of amyloid deposition in kidney biopsy specimens in both AA amyloidosis associated with rheumatoid arthritis and AL amyloidosis.

PubMed

Kuroda, Takeshi; Tanabe, Naohito; Hasegawa, Eriko; Wakamatsu, Ayako; Nozawa, Yukiko; Sato, Hiroe; Nakatsue, Takeshi; Wada, Yoko; Ito, Yumi; Imai, Naofumi; Ueno, Mitsuhiro; Nakano, Masaaki; Narita, Ichiei

2017-06-01

The kidney is a major target organ for systemic amyloidosis, which results in proteinuria and an elevated serum creatinine level. The clinical manifestations and precursor proteins of amyloid A (AA) and light-chain (AL) amyloidosis are different, and the renal damage due to amyloid deposition also seems to differ. The purpose of this study was to clarify haw the difference in clinical features between AA and AL amyloidosis are explained by the difference in the amount and distribution of amyloid deposition in the renal tissues. A total of 119 patients participated: 58 patients with an established diagnosis of AA amyloidosis (AA group) and 61 with AL amyloidosis (AL group). We retrospectively investigated the correlation between clinical data, pathological manifestations, and the area occupied by amyloid in renal biopsy specimens. In most of the renal specimens the percentage area occupied by amyloid was less than 10%. For statistical analyses, the percentage area of amyloid deposition was transformed to a common logarithmic value (Log 10 %amyloid). The results of sex-, age-, and Log 10 %amyloid-adjusted analyses showed that systolic blood pressure (SBP) was higher in the AA group. In terms of renal function parameters, serum creatinine, creatinine clearance (Ccr) and estimated glomerular filtration rate (eGFR) indicated significant renal impairment in the AA group, whereas urinary protein indicated significant renal impairment in the AL group. Pathological examinations revealed amyloid was predominantly deposited at glomerular basement membrane (GBM) and easily transferred to the mesangial area in the AA group, and it was predominantly deposited at in the AL group. The degree of amyloid deposition in the glomerular capillary was significantly more severe in AL group. The frequency of amyloid deposits in extraglomerular mesangium was not significantly different between the two groups, but in AA group, the degree amyloid deposition was significantly more severe, and the deposition pattern in the glomerulus was nodular. Nodular deposition in extraglomerular mesangium leads to renal impairment in AA group. There are significant differences between AA and AL amyloidosis with regard to the renal function, especially in terms of Ccr, eGFR and urinary protein, even after Log10%amyloid was adjusted; showing that these inter-group differences in renal function would not be depend on the amount of renal amyloid deposits. These differences could be explained by the difference in distribution and morphological pattern of amyloid deposition in the renal tissue.

Use of Valtrac™-Secured Intracolonic Bypass in Laparoscopic Rectal Cancer Resection

PubMed Central

Ye, Feng; Chen, Dong; Wang, Danyang; Lin, Jianjiang; Zheng, Shusen

2014-01-01

Abstract The occurrence of anastomotic leakage (AL) remains a major concern in the early postoperative stage. Because of the relatively high morbidity and mortality of AL in patients with laparoscopic low rectal cancer who receive an anterior resection, a fecal diverting method is usually introduced. The Valtrac™-secured intracolonic bypass (VIB) was used in open rectal resection, and played a role of protecting the anastomotic site. This study was designed to assess the efficacy and safety of the VIB in protecting laparoscopic low rectal anastomosis and to compare the efficacy and complications of VIB with those of loop ileostomy (LI). Medical records of the 43 patients with rectal cancer who underwent elective laparoscopic low anterior resection and received VIB procedure or LI between May 2011 and May 2013 were retrospectively analyzed, including the patients’ demographics, clinical features, and operative data. Twenty-four patients received a VIB and 19 patients a LI procedure. Most of the demographics and clinical features of the groups, including Dukes stages, were similar. However, the median distance of the tumor edge from the anus verge in the VIB group was significantly longer (7.5 cm; inter-quartile range [IQR] 7.0–9.5 cm) than that of the L1 group (6.0 cm; IQR 6.0–7.0 cm). None of the patients developed clinical AL. The comparisons between the LI and the VIB groups were adjusted for the significant differences in the tumor level of the groups. After adjustment, the LI group experienced longer overall postoperative hospital stay (14.0 days, IQR: 12.0, 16.0 days; P < 0.001) and incurred higher costs ($6300 (IQR: $5900, $6600)) than the VIB group (7.0 days, $4800; P < 0.05). Stoma-related complications in the ileostomy group included dermatitis (n = 2), stoma bleeding (n = 1), and wound infection after closure (n = 2). No BAR-related complications occurred. The mean time to Valtrac™ ring loosening was 14.1 ± 3.2 days. The VIB procedure, as a good partner with the laparoscopic rectal cancer resection, appears to be a safe and effective, but time-limited, diverting technique to protect an elective low colorectal anastomosis. PMID:25546660

Delayed systolic blood pressure recovery following exercise as a mechanism of masked uncontrolled hypertension in chronic kidney disease.

PubMed

Agarwal, Rajiv; Pappas, Maria K

2017-10-01

Among people treated for hypertension, the presence of elevated blood pressure (BP) out of the clinic but normal BP in the clinic is called masked uncontrolled hypertension (MUCH). What causes MUCH remains unknown. The purpose of this study was to answer the question of whether patients with MUCH have an increased hemodynamic reactivity to exercise and delayed hemodynamic recovery following exercise. Four groups were compared: controlled hypertension (CH, n = 58), MUCH (n = 34) and uncontrolled hypertension (UCH, n = 12), all of which had chronic kidney disease (CKD), and a group of healthy normal volunteers who did not have hypertension or CKD (n = 16). All participants underwent assessment of 24-h ambulatory BP monitoring, BP measurement during a graded symptom-limited exercise using a cycle ergometer and BP recovery over 7 min following exercise. Exercise-induced increase in systolic BP was similar among the four groups. When compared with healthy controls, recovery of systolic BP following termination of exercise was blunted among the CKD groups in unadjusted (P < 0.0001) and adjusted (P < 0.001) models. During recovery, the healthy control group had 5.9% decline in systolic BP per minute. In contrast, MUCH had only 3.3% per minute reduction and the UCH group had 0.3% reduction per minute. A test of linear trend was significant (P = 0.002, adjusted model). Because there was no impairment in the heart rate recovery among groups, we speculate that the parasympathetic pathway appears intact among treated hypertensives with CKD. However, the failure to withdraw sympathetic tone upon termination of exercise causes ongoing vasoconstriction and delayed systolic BP recovery providing a biological basis for MUCH. Delayed recovery from exercise-induced hypertension in those with poorly controlled BP provides potentially a new target to assure round-the-clock BP control. Published by Oxford University Press on behalf of ERA-EDTA 2016. This work is written by US Government employees and is in the public domain in the US.

Cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure.

PubMed

Wong, Frances Kam Yuet; So, Ching; Ng, Alina Yee Man; Lam, Po-Tin; Ng, Jeffrey Sheung Ching; Ng, Nancy Hiu Yim; Chau, June; Sham, Michael Mau Kwong

2018-02-01

Studies have shown positive clinical outcomes of specialist palliative care for end-stage heart failure patients, but cost-effectiveness evaluation is lacking. To examine the cost-effectiveness of a transitional home-based palliative care program for patients with end-stage heart failure patients as compared to the customary palliative care service. A cost-effectiveness analysis was conducted alongside a randomized controlled trial (Trial number: NCT02086305). The costs included pre-program training, intervention, and hospital use. Quality of life was measured using SF-6D. The study took place in three hospitals in Hong Kong. The inclusion criteria were meeting clinical indicators for end-stage heart failure patients including clinician-judged last year of life, discharged to home within the service area, and palliative care referral accepted. A total of 84 subjects (study = 43, control = 41) were recruited. When the study group was compared to the control group, the net incremental quality-adjusted life years gain was 0.0012 (28 days)/0.0077 (84 days) and the net incremental costs per case was -HK$7935 (28 days)/-HK$26,084 (84 days). The probability of being cost-effective was 85% (28 days)/100% (84 days) based on the cost-effectiveness thresholds recommended both by National Institute for Health and Clinical Excellence (£20,000/quality-adjusted life years) and World Health Organization (Hong Kong gross domestic product/capita in 2015, HK$328117). Results suggest that a transitional home-based palliative care program is more cost-effective than customary palliative care service. Limitations of the study include small sample size, study confined to one city, clinic consultation costs, and societal costs including patient costs and unpaid care-giving costs were not included.

The clinical outcomes of oldest old patients with tuberculosis treated by regimens containing rifampicin, isoniazid, and pyrazinamide

PubMed Central

Lin, Huang-Shen; Cheng, Chun-Wen; Lin, Ming-Shyan; Chou, Yen-Li; Chang, Pey-Jium; Lin, Jing-Chi; Ye, Jung-Jr

2016-01-01

Objectives To investigate the clinical characteristics, adverse drug reactions, and outcomes of the oldest old patients (aged ≥80 years) with tuberculosis (TB) treated with rifampicin, isoniazid, and pyrazinamide (RIP)-containing regimens. Design A retrospective chart review study. Setting A 1,200-bed tertiary teaching hospital in southwest Taiwan. Participants We conducted a retrospective observational study between January 1, 2005 and December 31, 2011. Seven hundred adult patients (aged ≥18 years) with TB treated with RIP-containing anti-TB regimens were reviewed, including 161 oldest old patients. Outcome measures Clinical outcomes included clinical responsiveness and microbiological eradication. Adverse outcomes included drug-induced hepatitis, and other symptoms included gastrointestinal upset (eg, abdominal pain, vomiting, diarrhea, or dyspepsia), skin rash, joint pain, and hyperuricemia. Results Compared with the non-oldest old adult patients, the oldest old patients more frequently had hepatitis (P=0.014), gastrointestinal upset (P=0.029), and unfavorable outcomes (P<0.001). In a multivariate analysis, hepatitis during treatment (adjusted odds ratio: 3.482, 95% confidence interval: 1.537–7.885; P<0.003) and oldest old age (adjusted odds ratio: 5.161, 95% confidence interval: 2.294–11.613; P<0.010) were independent risk factors for unfavorable outcomes. In the oldest old patients with hepatitis, rifampicin use was more common in the favorable outcome group than in the unfavorable outcome group (100% vs 37.5%; P=0.001). Conclusion The oldest old age and hepatitis during RIP treatment were associated with unfavorable outcomes. For the oldest old patients with TB having hepatitis during treatment, rifampicin rechallenge and use might benefit the treatment outcome. PMID:27042029

Impact on seniors of the patient-centered medical home: evidence from a pilot study.

PubMed

Fishman, Paul A; Johnson, Eric A; Coleman, Kathryn; Larson, Eric B; Hsu, Clarissa; Ross, Tyler R; Liss, David; Tufano, James; Reid, Robert J

2012-10-01

To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic compared with seniors enrolled at the remaining 19 primary care clinics owned and operated by Group Health. Analyses of secondary data on quality and cost were conducted for 1,947 seniors in the PCMH clinic and 39,396 seniors in the 19 control clinics. Patient experience with care was based on survey data collected from 487 seniors in the PCMH clinic and of 668 in 2 specific control clinics that were selected for their similarities in organization and patient composition to the pilot clinic. After adjusting for baseline, seniors in the PCMH clinic reported higher ratings than controls on 3 of 7 patient experience scales. Seniors in the PCMH clinic had significantly greater quality outcomes over time, but this difference was not significant relative to control. PCMH patients used more e-mail, phone, and specialist visits but fewer emergency services and inpatient admissions for ambulatory care sensitive conditions. At 1 and 2 years, the PCMH and control clinics did not differ significantly in overall costs. A PCMH redesign can be associated with improvements in patient experience and quality without increasing overall cost.

I thought we were good: social cognition, figurative language, and adolescent psychopathology.

PubMed

Im-Bolter, Nancie; Cohen, Nancy J; Farnia, Fataneh

2013-07-01

Language has been shown to play a critical role in social cognitive reasoning in preschool and school-aged children, but little research has been conducted with adolescents. During adolescence, the ability to understand figurative language becomes increasingly important for social relationships and may affect social adjustment. This study investigated the contribution of structural and figurative language to social cognitive skills in adolescents who present for mental health services and those who do not. One hundred and thirty-eight adolescents referred to mental health centers (clinic group) and 186 nonreferred adolescents (nonclinic group) aged 12-17 were administered measures of structural and figurative language, working memory, and social cognitive problem solving. We found that adolescents in the clinic group demonstrated less mature social problem solving overall, but particularly with respect to anticipating and overcoming potential obstacles and conflict resolution compared with the nonclinic group. In addition, results demonstrated that age, working memory, and structural and figurative language predicted social cognitive maturity in the clinic group, but only structural language was a predictor in the nonclinic group. Social problem solving may be particularly difficult for adolescents referred for mental health services and places higher demands on their cognitive and language skills compared with adolescents who have never been referred for mental health services. © 2013 The Authors. Journal of Child Psychology and Psychiatry © 2013 Association for Child and Adolescent Mental Health.

Impact of clinical audits on cesarean section rate.

PubMed

Peng, Fu-Shiang; Lin, Hsien-Ming; Lin, Ho-Hsiung; Tu, Fung-Chao; Hsiao, Chin-Fen; Hsiao, Sheng-Mou

2016-08-01

Many countries have noted a substantial increase in the cesarean section rate (CSR). Several methods for lowering the CSR have been described. Understanding the impact of clinical audits on the CSR may aid in lowering CSR. Thus, our aim is to elucidate the effect of clinical audits on the CSR. We retrospectively analyzed 3781 pregnant women who gave birth in a medical center between January 2008 and January 2011. Pregnant women who delivered between January 2008 and July 2009 were enrolled as the pre-audit group (n = 1592). After August 2009, all cesarean section cases that were audited were enrolled in the audit group (n = 2189). The CSR was compared between groups. The overall CSR (34.5% vs. 31.1%, adjusted odds ratio [OR] = 0.83, p = 0.008) and the cesarean section rate due to dystocia (9.6% vs. 6.2%, p < 0.001) were significantly lower in the audit group than the pre-audit group. However, there was no significant difference in the rate of operative vaginal delivery between groups. Consensus on the unnecessity for cesarean section was achieved in 16 (8.2%) of 195 audit cases in the monthly audit conference. In nulliparous pregnant women (n = 2148), multivariate analysis revealed that clinical audit (OR = 0.78), maternal age (OR = 1.10), gestational age at delivery (OR = 0.80), and fetal body weight at birth (OR = 1.0005) were independent predictors of cesarean section (all p < 0.05). Most variables of maternal and perinatal morbidity and mortality did not differ before and after audits were implemented. Clinical audits appear to be an effective strategy for reducing the CSR. Therefore, we recommend strict monitoring of the indications in dystocia for cesarean section to reduce the CSR. Copyright © 2016. Published by Elsevier B.V.

Dose Adjustment for Normal Eating (DAFNE) in routine clinical practice: who benefits?

PubMed

Keen, A J A; Duncan, E; McKillop-Smith, A; Evans, N D; Gold, A E

2012-05-01

To explore the effectiveness of Dose Adjustment for Normal Eating in routine clinical practice in the UK. Participants were 124 adults with Type 1 diabetes who had completed a Dose Adjustment for Normal Eating course. Data were collected before the course and again 1 year later on a variety of biological, psychological and social measures. There were a range of significant benefits consistent with Dose Adjustment for Normal Eating aims, including: better control among those with baseline HbA(1c) ≥ 81 mmol/mol (9.6%) (z = -2.8, P = 0.004); reduced number of participants reporting severe hypoglycaemia (χ² = 4.27, P = 0.039); total eradication of diabetic ketoacidosis (χ² = 4.17, P = 0.041) and lower diabetes-related distress (z = -4.5, P < 0.001). The most deprived of the clinic population were significantly under-represented (χ² = 17.8, P = 0.001) and the levels of clinical depression were unusually low. These results indicate that Dose Adjustment for Normal Eating delivered in routine clinical practice is associated with a range of benefits and that certain clinical and psychosocial characteristics are associated with better outcomes. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Adjusting case mix payment amounts for inaccurately reported comorbidity data.

PubMed

Sutherland, Jason M; Hamm, Jeremy; Hatcher, Jeff

2010-03-01

Case mix methods such as diagnosis related groups have become a basis of payment for inpatient hospitalizations in many countries. Specifying cost weight values for case mix system payment has important consequences; recent evidence suggests case mix cost weight inaccuracies influence the supply of some hospital-based services. To begin to address the question of case mix cost weight accuracy, this paper is motivated by the objective of improving the accuracy of cost weight values due to inaccurate or incomplete comorbidity data. The methods are suitable to case mix methods that incorporate disease severity or comorbidity adjustments. The methods are based on the availability of detailed clinical and cost information linked at the patient level and leverage recent results from clinical data audits. A Bayesian framework is used to synthesize clinical data audit information regarding misclassification probabilities into cost weight value calculations. The models are implemented through Markov chain Monte Carlo methods. An example used to demonstrate the methods finds that inaccurate comorbidity data affects cost weight values by biasing cost weight values (and payments) downward. The implications for hospital payments are discussed and the generalizability of the approach is explored.

Telehealth Management of Parkinson's Disease Using Wearable Sensors: An Exploratory Study.

PubMed

Heldman, Dustin A; Harris, Denzil A; Felong, Timothy; Andrzejewski, Kelly L; Dorsey, E Ray; Giuffrida, Joseph P; Goldberg, Barry; Burack, Michelle A

2017-09-01

Parkinson's disease (PD) motor symptoms can fluctuate and may not be accurately reflected during a clinical evaluation. In addition, access to movement disorder specialists is limited for many with PD. The objective was to assess the impact of motion sensor-based telehealth diagnostics on PD clinical care and management. Eighteen adults with PD were randomized to control or experimental groups. All participants were instructed to use a motion sensor-based monitoring system at home one day per week, for seven months. The system included a finger-worn motion sensor and tablet-based software interface that guided patients through tasks to quantify tremor, bradykinesia, and dyskinesia. Data were processed into motor symptom severity reports, which were reviewed by a movement disorders neurologist for experimental group participants. After three months and six months, control group participants visited the clinic for a routine appointment, while experimental group participants had a videoconference or phone call instead. Home based assessments were completed with median compliance of 95.7%. For a subset of participants, the neurologist successfully used information in the reports such as quantified response to treatment or progression over time to make therapy adjustments. Changes in clinical characteristics from study start to end were not significantly different between groups. Individuals with PD were able and willing to use remote monitoring technology. Patient management aided by telehealth diagnostics provided comparable outcomes to standard care. Telehealth technologies combined with wearable sensors have the potential to improve care for disparate PD populations or those unable to travel.

Posttraumatic stress symptom trajectories among children exposed to violence.

PubMed

Miller-Graff, Laura E; Howell, Kathryn H

2015-02-01

Little research has examined the developmental course of posttraumatic stress symptoms (PTSS) in children. The current study aimed to identify developmental trajectories of PTSS in childhood and to examine predictors of symptom presentation in 1,178 children from the Longitudinal Studies of Child Abuse and Neglect (LONGSCAN) studies, a consortium of studies focusing on the causes and effects of child maltreatment. Most children had a history of documented reports with Child Protective Services (CPS) and all were identified as living in high-risk environments. Using group-based trajectory modeling, 3 unique developmental trajectories were identified: Resilient, Clinical-Improving (PTSS in the clinical range at baseline then declining over time), and Borderline-Stable (chronically subclinical PTSS). Children in the Clinical-Improving group were more likely than children in the Resilient group to have reports of physical abuse (RRR = 1.76), emotional abuse (RRR = 2.55), neglect (RRR = 1.57), and exposure to violence at home and in the community (RRR = 1.04). Children in the Borderline-Stable group were more likely than children in the Resilient group to have a CPS history of neglect (RRR = 2.44) and exposure to violence at home and in the community (RRR = 1.04). Many children living in high-risk environments exhibit resilience to PTSS, but exposure to witnessed violence and neglect appear to put children at chronic risk for poor adjustment. These children may require more intensive, integrated clinical services that attend to multiple adverse experiences. Copyright © 2015 International Society for Traumatic Stress Studies.

Are we comparing frontotemporal dementia and Alzheimer disease patients with the right measures?

PubMed

Deutsch, Mariel B; Liang, Li-Jung; Jimenez, Elvira E; Mather, Michelle J; Mendez, Mario F

2016-09-01

Clinical research studies of behavioral variant frontotemporal dementia (bvFTD) often use Alzheimer disease (AD) as a comparison group for control of dementia variables, using tests of cognitive function to match the groups. These two dementia syndromes, however, are very different in clinical manifestations, and the comparable severity of these dementias may not be reflected by commonly used cognitive scales such as the Mini-Mental State Examination (MMSE). We evaluated different measures of dementia severity and symptoms among 20 people with bvFTD compared to 24 with early-onset AD. Despite similar ages, disease-duration, education, and cognitive performance on two tests of cognitive function, the MMSE and the Montreal Cognitive Assessment (MoCA), the bvFTD participants, compared to the AD participants, were significantly more impaired on other measures of disease severity, including function (Functional Assessment Questionnaire (FAQ)), neuropsychiatric symptoms (Neuropsychiatric Inventory (NPI)), and global dementia stage (Clinical Dementia Rating Scales (CDRs)). However, when we adjusted for the frontotemporal lobar degeneration-CDR (FTLD-CDR) in the analyses, the two dementia groups were comparable across all measures despite significant differences on the cognitive scales. We found tests of cognitive functions (MMSE and MoCA) to be insufficient measures for ensuring comparability between bvFTD and AD groups. In clinical studies, the FTLD-CDR, which includes additional language and behavior items, may be a better overall way to match bvFTD and AD groups on dementia severity.

Are we comparing frontotemporal dementia and Alzheimer disease patients with the right measures?

PubMed Central

Deutsch, Mariel B.; Liang, Li-Jung; Jimenez, Elvira E.; Mather, Michelle J.; Mendez, Mario F.

2016-01-01

Background Clinical research studies of behavioral variant frontotemporal dementia (bvFTD) often use Alzheimer disease (AD) as a comparison group for control of dementia variables, using tests of cognitive function to match the groups. These two dementia syndromes, however, are very different in clinical manifestations, and the comparable severity of these dementias may not be reflected by commonly used cognitive scales such as the Mini-Mental State Examination (MMSE). Methods We evaluated different measures of dementia severity and symptoms among 20 people with bvFTD compared to 24 with early-onset AD. Results Despite similar ages, disease-duration, education, and cognitive performance on two tests of cognitive function, the MMSE and the Montreal Cognitive Assessment (MoCA), the bvFTD participants, compared to the AD participants, were significantly more impaired on other measures of disease severity, including function (Functional Assessment Questionnaire (FAQ)), neuropsychiatric symptoms (Neuropsychiatric Inventory (NPI)), and global dementia stage (Clinical Dementia Rating Scales (CDRs)). However, when we adjusted for the frontotemporal lobar degeneration-CDR (FTLD-CDR) in the analyses, the two dementia groups were comparable across all measures despite significant differences on the cognitive scales. Conclusion We found tests of cognitive functions (MMSE and MoCA) to be insufficient measures for ensuring comparability between bvFTD and AD groups. In clinical studies, the FTLD-CDR, which includes additional language and behavior items, may be a better overall way to match bvFTD and AD groups on dementia severity. PMID:27079571

Using activity-based costing to track resource use in group practices.

PubMed

Zeller, T L; Siegel, G; Kaciuba, G; Lau, A H

1999-09-01

Research shows that understanding how resources are consumed can help group practices control costs. An American Academy of Orthopaedic Surgeons study used an activity-based costing (ABC) system to measure how resources are consumed in providing medical services. Teams of accounting professors observed 18 diverse orthopedic surgery practices. The researchers identified 17 resource-consuming business processes performed by nonphysician office staff. They measured resource consumption by assigning costs to each process according to how much time is spent on related work activities. When group practices understand how their resources are being consumed, they can reduce costs and optimize revenues by making adjustments in how administrative and clinical staff work.

Performance Differences in Year 1 of Pioneer Accountable Care Organizations

PubMed Central

McWilliams, J. Michael; Chernew, Michael E.; Landon, Bruce E.; Schwartz, Aaron L.

2015-01-01

BACKGROUND In 2012, a total of 32 organizations entered the Pioneer accountable care organization (ACO) program, in which providers can share savings with Medicare if spending falls below a financial benchmark. Performance differences associated with characteristics of Pioneer ACOs have not been well described. METHODS In a difference-in-differences analysis of Medicare fee-for-service claims, we compared Medicare spending for beneficiaries attributed to Pioneer ACOs (ACO group) with other beneficiaries (control group) before (2009 through 2011) and after (2012) the start of Pioneer ACO contracts, with adjustment for geographic area and beneficiaries’ sociodemographic and clinical characteristics. We estimated differential changes in spending for several subgroups of ACOs: those with and those without clear financial integration between hospitals and physician groups, those with higher and those with lower baseline spending, and the 13 ACOs that withdrew from the Pioneer program after 2012 and the 19 that did not. RESULTS Adjusted Medicare spending and spending trends were similar in the ACO group and the control group during the precontract period. In 2012, the total adjusted per-beneficiary spending differentially changed in the ACO group as compared with the control group (−$29.2 per quarter, P = 0.007), consistent with a 1.2% savings. Savings were significantly greater for ACOs with baseline spending above the local average, as compared with those with baseline spending below the local average (P = 0.05 for interaction), and for those serving high-spending areas, as compared with those serving low-spending areas (P = 0.04). Savings were similar in ACOs with financial integration between hospitals and physician groups and those without, as well as in ACOs that withdrew from the program and those that did not. CONCLUSIONS Year 1 of the Pioneer ACO program was associated with modest reductions in Medicare spending. Savings were greater for ACOs with higher baseline spending than for those with lower baseline spending and were unrelated to withdrawal from the program. (Funded by the National Institute on Aging and others.) PMID:25875195

19 CFR 351.413 - Disregarding insignificant adjustments.

Code of Federal Regulations, 2010 CFR

2010-04-01

... any group of adjustments having an ad valorem effect of less than 1.0 percent, of the export price, constructed export price, or normal value, as the case may be. Groups of adjustments are adjustments for differences in circumstances of sale under § 351.410, adjustments for differences in the physical...

The efficacy of a single continuous nylon suture for control of post keratoplasty astigmatism.

PubMed Central

Van Meter, W

1996-01-01

PURPOSE: Post operative adjustment of a single continuous suture is an effective means of reducing post keratoplasty astigmatism. This study evaluates post keratoplasty keratometry following suture adjustment with an adjusted suture in place and after the suture is removed. METHODS: Average keratometric astigmatism was measured over 24 months time in 26 patients with an adjusted continuous suture and 24 patients with a continuous suture that was not adjusted. Average keratometry in 43 patients with an adjusted continuous suture was compared with 37 patients with combined continuous and interrupted sutures. Finally, suture out astigmatism in 19 adjusted patients was compared to six patients with no adjustment. RESULTS: There was an increase in average corneal astigmatism over two years of 2.2 diopters in the adjusted group and 1.7 diopters in the non-adjusted group with sutures in place. One year following surgery, average keratometry flattened from 47.5 to 42.9 diopters in the adjusted continuous group and from 47.0 to 46.0 diopters in the group with combined continuous and interrupted sutures. Following suture removal, average astigmatism in patients who had suture adjustment was 4.4 diopters +/- 2.5 diopters (range 1-10 diopters), and 6.01 diopters (range 4-7) in the non-adjusted group. CONCLUSIONS: Average post keratoplasty astigmatism increases after a continuous suture is adjusted but the increase is comparable to patients with acceptable astigmatism who do not require adjustment. More progressive corneal flattening over 12 months time is seen with a continuous suture than which combined sutures. Average suture out astigmatism was 4.0 diopters following suture adjustment, compared to an average of 8.4 diopters prior to adjustment. Images FIGURE 1 FIGURE 2 FIGURE 3 FIGURE 4 FIGURE 7A FIGURE 7B PMID:8981721

African Caribbeans have greater subclinical cerebrovascular disease than Europeans: this is associated with both their elevated resting and ambulatory blood pressure and their hyperglycaemia.

PubMed

Shibata, Dean; Tillin, Therese; Beauchamp, Norman; Heasman, John; Hughes, Alun D; Park, Chloe; Gedroyc, Wady; Chaturvedi, Nish

2013-12-01

Stroke is elevated in people of black African descent, but evidence for excess subclinical cerebrovascular disease is conflicting, and the role of risk factors in determining any ethnic differences observed unexplored. We compared prevalence of brain infarcts, and severe white matter hyperintensities (WMHs) on cerebral MRI, in a community-based sample of men and women aged 58-86 of African Caribbean (214) and European (605) descent, in London, UK. Resting, central and ambulatory blood pressure (BP) were measured; diabetes was assessed by blood testing and questionnaire. Mean age was 70. Multiple (≥4) brain infarcts and severe WMH occurred more frequently in African Caribbeans (18/43%), than Europeans (7/33%, P=0.05/0.008). Separately, clinic and night-time ambulatory BP were significantly associated with severe WMH in both ethnic groups; when both were entered into the model, the association for clinic SBP was attenuated and lost statistical significance [1.00 (0.98-1.02) P=0.9 in Europeans, 1.00 (0.97-1.04) P=0.9 in African Caribbeans], whereas the association for night-time SBP was retained [1.04 (1.02-1.07) P<0.001 in Europeans, 1.08 (1.03-1.12), P=0.001 in African Caribbeans]. The greater age-adjusted and sex-adjusted risk of severe WMH in African Caribbeans compared with Europeans [2.08 (1.15-3.76) P=0.02], was attenuated to 1.45 [(0.74-2.83) P=0.3] on adjustment for clinic and night-time systolic pressure, antihypertensive medication use and glycated haemoglobin. African Caribbeans have a greater burden of subclinical cerebrovascular disease than Europeans. This excess is related to elevated clinic and ambulatory BP, and to hyperglycaemia.

Clinical associations of delirium in hospitalized adult patients and the role of on admission presentation.

PubMed

Lin, Robert Y; Heacock, Laura C; Bhargave, Geeta A; Fogel, Joyce F

2010-10-01

To describe clinical associations of delirium in hospitalized patients and relationships to on admission presentation. Retrospective analysis of an administrative hospitalization database 1998-2007. Acute care hospitalizations in the New York State (NYS). Four categories of diagnosis related group (DRG) hospitalizations were extracted from a NYS administrative database: pneumonia, congestive heart failure, urinary tract/kidney infection (UTI), and lower extremity orthopedic surgery (LEOS) DRGs. These hospitalizations were examined for clinical associations with delirium coding both on and after admission. Delirium was coded in 0.8% of the cohort, of which an on admission diagnosis was present in 59%. On admission delirium was strongly associated with dementia (adjusted odds ratio 0, 95%CI 5.8-6.3) and with adverse drug effects (ADEs) (adjusted odds ratio 4.6, 95%CI 4.3, 5.0). After admission delirium was even more highly associated with ADEs (adjusted odds ratio 22.2, 95%CI 20.7-23.7). The UTI DRG category had the greatest proportion of on admission delirium. However after admission delirium was more common in the LEOS DRG category. Over time, there was a greater increase in delirium proportions in the UTI DRG category, and an overall increase in coding for encephalopathy states (potential alternative delirium descriptors). ADEs play an important role in delirium regardless of whether or not it is present on admission. While the finding that most delirium hospitalizations presented on admission suggests that delirium impacts more as a clinical admitting determinant, in-hospital prevention strategies may still have benefit in targeted settings where after admission delirium is more frequent, such as patients with LEOS. Copyright © 2010 John Wiley & Sons, Ltd.

[Clinical applications of dosing algorithm in the predication of warfarin maintenance dose].

PubMed

Huang, Sheng-wen; Xiang, Dao-kang; An, Bang-quan; Li, Gui-fang; Huang, Ling; Wu, Hai-li

2011-12-27

To evaluate the feasibility of clinical application for genetic based dosing algorithm in the predication of warfarin maintenance dose in Chinese population. The clinical data were collected and blood samples harvested from a total of 126 patients undergoing heart valve replacement. The genotypes of VKORC1 and CYP2C9 were determined by melting curve analysis after PCR. They were divided randomly into the study and control groups. In the study group, the first three doses of warfarin were prescribed according to the predicted warfarin maintenance dose while warfarin was initiated at 2.5 mg/d in the control group. The warfarin doses were adjusted according to the measured international normalized ratio (INR) values. And all subjects were followed for 50 days after an initiation of warfarin therapy. At the end of a 50-day follow-up period, the proportions of the patients on a stable dose were 82.4% (42/51) and 62.5% (30/48) for the study and control groups respectively. The mean durations of reaching a stable dose of warfarin were (27.5 ± 1.8) and (34.7 ± 1.8) days and the median durations were (24.0 ± 1.7) and (33.0 ± 4.5) days in the study and control groups respectively. Significant differences existed in the durations of reaching a stable dose between the two groups (P = 0.012). Compared with the control group, the hazard ratio (HR) for the duration of reaching a stable dose was 1.786 in the study group (95%CI 1.088 - 2.875, P = 0.026). The predicted dosing algorithm incorporating genetic and non-genetic factors may shorten the duration of achieving efficiently a stable dose of warfarin. And the present study validates the feasibility of its clinical application.

School-age outcomes of infants at risk for autism spectrum disorder.

PubMed

Miller, Meghan; Iosif, Ana-Maria; Young, Gregory S; Hill, Monique; Phelps Hanzel, Elise; Hutman, Ted; Johnson, Scott; Ozonoff, Sally

2016-06-01

Studies of infants at risk for autism spectrum disorder (ASD) have proliferated, but few of these samples have been followed longer-term. We conducted a follow-up study, at age 5.5-9 years, of younger siblings of children with ASD (high-risk group, n = 79) or typical development (low-risk group, n = 60), originally recruited as infants. Children with ASD were excluded because of the focus on understanding the range of non-ASD outcomes among high-risk siblings. Using examiner ratings, parent ratings, and standardized assessments, we evaluated differences in clinical outcomes, psychopathology symptoms, autism symptoms, language skills, and nonverbal cognitive abilities. After adjusting for covariates, the high-risk group had increased odds of any clinically elevated/impaired score across measures relative to the low-risk group (43% vs. 12%, respectively). The high-risk group also had increased odds of examiner-rated Clinical Concerns (CC) outcomes (e.g., ADHD concerns, broader autism phenotype, speech-language difficulties, anxiety/mood problems, learning problems) relative to the low-risk group (38% vs. 13%, respectively). The high-risk group with CC outcomes had higher parent-reported psychopathology and autism symptoms, and lower directly-assessed language skills, than the Low-Risk Typically Developing (TD) and High-Risk TD groups, which did not differ. There were no differences in nonverbal cognitive skills. For some in the high-risk group, clinical concerns persisted from early childhood, whereas for others clinical concerns were first evident at school-age. Results suggest continued vulnerability in at least a subgroup of school-age children with a family history of ASD and suggest that this population may benefit from continued screening and monitoring into the school-age years. Autism Res 2016, 9: 632-642. © 2015 International Society for Autism Research, Wiley Periodicals, Inc. © 2015 International Society for Autism Research, Wiley Periodicals, Inc.

Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials.

PubMed

Atri, Alireza; Frölich, Lutz; Ballard, Clive; Tariot, Pierre N; Molinuevo, José Luis; Boneva, Neli; Windfeld, Kristian; Raket, Lars L; Cummings, Jeffrey L

2018-01-09

New therapeutic approaches for Alzheimer disease (AD) are needed. To assess whether idalopirdine, a selective 5-hydroxytryptamine-6 receptor antagonist, is effective for symptomatic treatment of mild to moderate AD. Three randomized clinical trials that included 2525 patients aged 50 years or older with mild to moderate AD (study 1: n = 933 patients at 119 sites; study 2: n = 858 at 158 sites; and study 3: n = 734 at 126 sites). The 24-week studies were conducted from October 2013 to January 2017; final follow-up on January 12, 2017. Idalopirdine (10, 30, or 60 mg/d) or placebo added to cholinesterase inhibitor treatment (donepezil in studies 1 and 2; donepezil, rivastigmine, or galantamine in study 3). Primary end point in all 3 studies: change in cognition total score (range, 0-70; a lower score indicates less impairment) from baseline to 24 weeks measured by the 11-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog); key secondary end points: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change Scale and 23-item Activities of Daily Living Inventory scores. Dose group efficacy required a significant benefit over placebo for the primary end point and 1 or more key secondary end points. Safety data and adverse event profiles were recorded. Among 2525 patients randomized in the 3 trials (mean age, 74 years; mean baseline ADAS-Cog total score, 26; between 62% and 65% of participants were women), 2254 (89%) completed the studies. In study 1, the mean change in ADAS-Cog total score between baseline and 24 weeks was 0.37 for the 60-mg dose of idalopirdine group, 0.61 for the 30-mg dose group, and 0.41 for the placebo group (adjusted mean difference vs placebo, 0.05 [95% CI, -0.88 to 0.98] for the 60-mg dose group and 0.33 [95% CI, -0.59 to 1.26] for the 30-mg dose group). In study 2, the mean change in ADAS-Cog total score between baseline and 24 weeks was 1.01 for the 30-mg dose of idalopirdine group, 0.53 for the 10-mg dose group, and 0.56 for the placebo group (adjusted mean difference vs placebo, 0.63 [95% CI, -0.38 to 1.65] for the 30-mg dose group; given the gated testing strategy and the null findings at the 30-mg dose, statistical comparison of the 10-mg dose was not performed). In study 3, the mean change in ADAS-Cog total score between baseline and 24 weeks was 0.38 for the 60-mg dose of idalopirdine group and 0.82 for the placebo group (adjusted mean difference vs placebo, -0.55 [95% CI, -1.45 to 0.36]). Treatment-emergent adverse events occurred in between 55.4% and 69.7% of participants in the idalopirdine groups vs between 56.7% and 61.4% of participants in the placebo groups. In patients with mild to moderate AD, the use of idalopirdine compared with placebo did not improve cognition over 24 weeks of treatment. These findings do not support the use of idalopirdine for the treatment of AD. clinicaltrials.gov Identifiers: NCT01955161, NCT02006641, and NCT02006654.

Internet-based modular program BADI for adjustment disorder: protocol of a randomized controlled trial.

PubMed

Skruibis, Paulius; Eimontas, Jonas; Dovydaitiene, Migle; Mazulyte, Egle; Zelviene, Paulina; Kazlauskas, Evaldas

2016-07-26

Adjustment disorder is one of the most common mental health diagnoses. Still it receives relatively little attention from researchers trying to establish best interventions to treat it. With high prevalence of stressful life events, which might be leading to adjustment disorder, and limited resources of mental health service providers, online interventions could be a very practical way of helping people who have these disorders or are in the risk to develop them. The proposed study protocol is aimed to describe a randomized controlled trial of an internet-based modular intervention for adjustment disorder as it is defined in a proposal for the ICD-11. This study is a two-armed Randomized Controlled Trial (RCT) to examine the effectiveness of a web-based intervention BADI (Brief Adjustment Disorder Intervention) for adjustment disorder symptoms. BADI has four modules: Relaxation, Time management, Mindfulness and Strengthening relationships. It is based on stress and coping research and integrates evidence-based treatment approaches such as Cognitive Behavioural therapy (CBT), mindfulness and body-mind practices, as well as exercises for enhancing social support. Primary outcome of the study are symptoms of adjustment disorder and well-being. Engagement into the program and motivation for change is a secondary outcome. All participants after completing the baseline assessment are randomly assigned to one of the two groups: either to the one in which participant will instantly gain access to the BADI intervention or a group in which participants will be given access to the BADI program after waiting one month. Participants of BADI can choose exercises of the program flexibly. There is no particular order in which the exercises should be completed. Study will provide new insights of modular internet-based interventions efficacy for adjustment disorders. The study will also provide information about the role of motivation and expectancies on engagement in modular internet-based interventions. In case this RCT supports effectiveness of fully automated version of BADI, it could be used very broadly. It could become a cost-effective and accessible intervention for adjustment disorder. The study was retrospectively registered with the Australian and New Zealand Clinical Trials Registry with the registration number ACTRN12616000883415 . Registered 5 July, 2016.

Are Comparisons of Patient Experiences Across Hospitals Fair? A Study in Veterans Health Administration Hospitals

PubMed Central

Cleary, Paul D.; Meterko, Mark; Wright, Steven M.; Zaslavsky, Alan M.

2015-01-01

Background Surveys are increasingly used to assess patient experiences with health care. Comparisons of hospital scores based on patient experience surveys should be adjusted for patient characteristics that might affect survey results. Such characteristics are commonly drawn from patient surveys that collect little, if any, clinical information. Consequently some hospitals, especially those treating particularly complex patients, have been concerned that standard adjustment methods do not adequately reflect the challenges of treating their patients. Objectives To compare scores for different types of hospitals after making adjustments using only survey-reported patient characteristics and using more complete clinical and hospital information. Research Design We used clinical and survey data from a national sample of 1858 veterans hospitalized for an initial acute myocardial infarction (AMI) in a Department of Veterans Affairs (VA) medical center during fiscal years 2003 and 2004. We used VA administrative data to characterize hospitals. The survey asked patients about their experiences with hospital care. The clinical data included 14 measures abstracted from medical records that are predictive of survival after an AMI. Results Comparisons of scores across hospitals adjusted only for patient-reported health status and sociodemographic characteristics were similar to those that also adjusted for patient clinical characteristics; the Spearman rank-order correlations between the 2 sets of adjusted scores were >0.97 across 9 dimensions of inpatient experience. Conclusions This study did not support concerns that measures of patient care experiences are unfair because commonly used models do not adjust adequately for potentially confounding patient clinical characteristics. PMID:24926709

Covariate Imbalance and Adjustment for Logistic Regression Analysis of Clinical Trial Data

PubMed Central

Ciolino, Jody D.; Martin, Reneé H.; Zhao, Wenle; Jauch, Edward C.; Hill, Michael D.; Palesch, Yuko Y.

2014-01-01

In logistic regression analysis for binary clinical trial data, adjusted treatment effect estimates are often not equivalent to unadjusted estimates in the presence of influential covariates. This paper uses simulation to quantify the benefit of covariate adjustment in logistic regression. However, International Conference on Harmonization guidelines suggest that covariate adjustment be pre-specified. Unplanned adjusted analyses should be considered secondary. Results suggest that that if adjustment is not possible or unplanned in a logistic setting, balance in continuous covariates can alleviate some (but never all) of the shortcomings of unadjusted analyses. The case of log binomial regression is also explored. PMID:24138438

Comparison between laparotomy first versus angiographic embolization first in patients with pelvic fracture and hemoperitoneum: a nationwide observational study from the Japan Trauma Data Bank

PubMed Central

2013-01-01

Background A common dilemma in the management of pelvic fractures is recognizing the presence of associated abdominal injury. The purpose of this study was to determine the association between initial therapeutic intervention (laparotomy or transcatheter arterial embolization (TAE)) and mortality. Methods This was a cohort study using the Japan Trauma Data Bank between 2004 and 2010, including blunt trauma patients with pelvic fractures and positive Focused Assessment with Sonography in Trauma (FAST) results. Eligible patients were restricted to those who underwent laparotomy or TAE/angiography as the initial therapeutic intervention. Crude and adjusted odds ratio (AOR) for in-hospital mortality were compared between the laparotomy first and TAE first groups (reference group). Multiple logistic regression analysis and propensity score adjusted analysis were used to adjust for clinically relevant confounders, including the severity of injury. Results Of the 317 participants, 123 patients underwent laparotomy first and 194 patients underwent TAE first. The two groups were similar in terms of age, although the laparotomy first group had higher mean Injury Severity Scores (ISS) and higher mean scores based on the abdominal Abbreviated Injury Scale (AIS), as well as lower mean pelvic AIS and systolic blood pressure (SBP). Half of the patients who were hypotensive (SBP < 90 mmHg) on arrival underwent TAE first. The laparotomy first group had a significantly higher crude in-hospital mortality (41% vs. 27%; P < 0.01). After adjusting for confounders, the choice of initial therapeutic intervention did not affect the in-hospital mortality (AOR, 1.20; 95% Confidence Interval (CI), 0.61-2.39). Even in the limited subgroup of hypotensive patients (SBP 66–89 mmHg and SBP < 65 mmHg subgroup), the effect was similar (AOR, 1.50; 95% CI, 0.56-4.05 and AOR, 1.05; 95% CI, 0.44-3.03). Conclusions In Japan, laparotomy and TAE are equally chosen as the initial therapeutic intervention regardless of hemodynamic status. No significant difference was seen between the laparotomy first and TAE first groups regarding in-hospital mortality. PMID:24299060

High-dose rifapentine with moxifloxacin for pulmonary tuberculosis.

PubMed

Jindani, Amina; Harrison, Thomas S; Nunn, Andrew J; Phillips, Patrick P J; Churchyard, Gavin J; Charalambous, Salome; Hatherill, Mark; Geldenhuys, Hennie; McIlleron, Helen M; Zvada, Simbarashe P; Mungofa, Stanley; Shah, Nasir A; Zizhou, Simukai; Magweta, Lloyd; Shepherd, James; Nyirenda, Sambayawo; van Dijk, Janneke H; Clouting, Heather E; Coleman, David; Bateson, Anna L E; McHugh, Timothy D; Butcher, Philip D; Mitchison, Denny A

2014-10-23

Tuberculosis regimens that are shorter and simpler than the current 6-month daily regimen are needed. We randomly assigned patients with newly diagnosed, smear-positive, drug-sensitive tuberculosis to one of three regimens: a control regimen that included 2 months of ethambutol, isoniazid, rifampicin, and pyrazinamide administered daily followed by 4 months of daily isoniazid and rifampicin; a 4-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for 2 months followed by moxifloxacin and 900 mg of rifapentine administered twice weekly for 2 months; or a 6-month regimen in which isoniazid was replaced by daily moxifloxacin for 2 months followed by one weekly dose of both moxifloxacin and 1200 mg of rifapentine for 4 months. Sputum specimens were examined on microscopy and after culture at regular intervals. The primary end point was a composite treatment failure and relapse, with noninferiority based on a margin of 6 percentage points and 90% confidence intervals. We enrolled a total of 827 patients from South Africa, Zimbabwe, Botswana, and Zambia; 28% of patients were coinfected with the human immunodefiency virus. In the per-protocol analysis, the proportion of patients with an unfavorable response was 4.9% in the control group, 3.2% in the 6-month group (adjusted difference from control, -1.8 percentage points; 90% confidence interval [CI], -6.1 to 2.4), and 18.2% in the 4-month group (adjusted difference from control, 13.6 percentage points; 90% CI, 8.1 to 19.1). In the modified intention-to-treat analysis these proportions were 14.4% in the control group, 13.7% in the 6-month group (adjusted difference from control, 0.4 percentage points; 90% CI, -4.7 to 5.6), and 26.9% in the 4-month group (adjusted difference from control, 13.1 percentage points; 90% CI, 6.8 to 19.4). The 6-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen. The 4-month regimen was not noninferior to the control regimen. (Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust; RIFAQUIN Current Controlled Trials number, ISRCTN44153044.).

[Late effects of massive psychic trauma. Holocaust survivors 50 years later].

PubMed

Robinson, S; Rebaudengo-Rosca, P; Rapaport, M

1993-03-01

The authors report the results of a study aimed at examining the present mental state, adjustment and lifestyle of a non-clinical sample of Holocaust survivors aged 60 and over. Most the interviewees have suffered since the war from various psychic symptoms, the so-called "survivor syndrome". Concentration camp survivors form a special group whose level of suffering appears greater and more severe than other survivors. In spite of continuous mental suffering Holocaust survivors have succeeded in adjusting well. They hold top positions at work, are socially successful and have stable family nuclei. They behave as if they need to fulfil the expectations of all those who perished in the Holocaust. Only 4 subjects reported a latency period before the appearance of symptoms.

Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches

PubMed Central

Browning, Colette; Chapman, Anna; Yang, Hui; Liu, Shuo; Zhang, Tuohong; Enticott, Joanne C; Thomas, Shane A

2016-01-01

Objective To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. Design Pragmatic cluster randomised controlled trial (RCT). Setting Community Health Stations (CHSs) in Fengtai district, Beijing, China. Participants Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. Outcome measures Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. Results At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI −0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference −2.38, 95% CI −4.64 to −0.12, p=0.039) and systolic BP (adjusted difference −3.57, 95% CI −6.08 to −1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. Conclusions In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. Trial registration number ISRCTN01010526; Pre-results. PMID:26944692

Hydrotherapy improves pain and function in older women with knee osteoarthritis: a randomized controlled trial.

PubMed

Dias, João Marcos; Cisneros, Lígia; Dias, Rosângela; Fritsch, Carolina; Gomes, Wellington; Pereira, Leani; Santos, Mary Luci; Ferreira, Paulo Henrique

Currently, there is poor evidence of the effect of hydrotherapy alone on patients with hip or knee osteoarthritis. The study aimed to assess the impact of hydrotherapy on pain, function, and muscle function in older women with knee osteoarthritis. A randomized controlled trial was conducted to evaluate the efficacy of hydrotherapy in women with knee osteoarthritis. Seventy-three women aged 65 and older were randomized to hydrotherapy (n=36) or a control group (n=37). The hydrotherapy group received the intervention program in a heated pool (twice per week for six weeks) and an educational protocol while the control group received an educational protocol only. Primary outcomes (before and post-treatment) were pain intensity (0-100) and function (0-100), assessed with the WOMAC questionnaire. Secondary outcomes (before and post-treatment) were knee extensor and knee flexor muscle performance (strength, power, and endurance), assessed by an isokinetic dynamometer. The magnitude of change between the groups for the outcomes was calculated using linear regression models adjusted by baseline outcome values. The hydrotherapy group had better outcomes for pain (adjusted mean difference=11 points, 95% CI: 3-18) and function (adjusted mean difference=12 points, 95% CI: 5-18). Patients receiving hydrotherapy had better performance for knee flexor and extensor strength, knee flexor power, and knee extensor endurance. Older women with knee osteoarthritis are likely to have benefits from a course of hydrotherapy exercises. Registry of clinical trials (Trial number RBR-8F57KR) - http://www.ensaiosclinicos.gov.br/rg/RBR-8f57kr/. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Cost-effectiveness of a multicomponent primary care program targeting frail elderly people.

PubMed

Ruikes, Franca G H; Adang, Eddy M; Assendelft, Willem J J; Schers, Henk J; Koopmans, Raymond T C M; Zuidema, Sytse U

2018-05-16

Over the last 20 years, integrated care programs for frail elderly people aimed to prevent functional dependence and reduce hospitalization and institutionalization. However, results have been inconsistent and merely modest. To date, evidence on the cost-effectiveness of these programs is scarce. We evaluated the cost-effectiveness of the CareWell program, a multicomponent integrated care program for frail elderly people. Economic evaluation from a healthcare perspective embedded in a cluster controlled trial of 12 months in 12 general practices in (the region of) Nijmegen. Two hundred and four frail elderly from 6 general practices in the intervention group received care according to the CareWell program, consisting of multidisciplinary team meetings, proactive care planning, case management, and medication reviews; 165 frail elderly from 6 general practices in the control group received usual care. In cost-effectiveness analyses, we related costs to daily functioning (Katz-15 change score i.e. follow up score minus baseline score) and quality adjusted life years (EQ-5D-3 L). Adjusted mean costs directly related to the intervention were €456 per person. Adjusted mean total costs, i.e. intervention costs plus healthcare utilization costs, were €1583 (95% CI -4647 to 1481) higher in the intervention group than in the control group. Incremental Net Monetary Benefits did not show significant differences between groups, but on average tended to favour usual care. The CareWell primary program was not cost-effective after 12 months. From a cost-effectiveness perspective, widespread implementation of the program in its current form cannot be recommended. The study was registered in the ClinicalTrials.govProtocol Registration System: ( NCT01499797 ; December 26, 2011). Retrospectively registered.

Prediction of arterial oxygen partial pressure after changes in FIO₂: validation and clinical application of a novel formula.

PubMed

Al-Otaibi, H M; Hardman, J G

2011-11-01

Existing methods allow prediction of Pa(O₂) during adjustment of Fi(O₂). However, these are cumbersome and lack sufficient accuracy for use in the clinical setting. The present studies aim to extend the validity of a novel formula designed to predict Pa(O₂) during adjustment of Fi(O₂) and to compare it with the current methods. Sixty-seven new data sets were collected from 46 randomly selected, mechanically ventilated patients. Each data set consisted of two subsets (before and 20 min after Fi(O₂) adjustment) and contained ventilator settings, pH, and arterial blood gas values. We compared the accuracy of Pa(O₂) prediction using a new formula (which utilizes only the pre-adjustment Pa(O₂) and pre- and post-adjustment Fi(O₂) with prediction using assumptions of constant Pa(O₂)/Fi(O₂) or constant Pa(O₂)/Pa(O₂). Subsequently, 20 clinicians predicted Pa(O₂) using the new formula and using Nunn's isoshunt diagram. The accuracy of the clinician's predictions was examined. The 95% limits of agreement (LA(95%)) between predicted and measured Pa(O₂) in the patient group were: new formula 0.11 (2.0) kPa, Pa(O₂)/Fi(O₂) -1.9 (4.4) kPa, and Pa(O₂)/Pa(O₂) -1.0 (3.6) kPa. The LA(95%) of clinicians' predictions of Pa(O₂) were 0.56 (3.6) kPa (new formula) and -2.7 (6.4) kPa (isoshunt diagram). The new formula's prediction of changes in Pa(O₂) is acceptably accurate and reliable and better than any other existing method. Its use by clinicians appears to improve accuracy over the most popular existing method. The simplicity of the new method may allow its regular use in the critical care setting.

Timing of Radiotherapy and Outcome in Patients Receiving Adjuvant Endocrine Therapy

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

Karlsson, Per, E-mail: per.karlsson@oncology.gu.s; Cole, Bernard F.; International Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA

2011-06-01

Purpose: To evaluate the association between the interval from breast-conserving surgery (BCS) to radiotherapy (RT) and the clinical outcome among patients treated with adjuvant endocrine therapy. Patients and Methods: Patient information was obtained from three International Breast Cancer Study Group trials. The analysis was restricted to 964 patients treated with BCS and adjuvant endocrine therapy. The patients were divided into two groups according to the median number of days between BCS and RT and into four groups according to the quartile of time between BCS and RT. The endpoints were the interval to local recurrence, disease-free survival, and overall survival.more » Proportional hazards regression analysis was used to perform comparisons after adjustment for baseline factors. Results: The median interval between BCS and RT was 77 days. RT timing was significantly associated with age, menopausal status, and estrogen receptor status. After adjustment for these factors, no significant effect of a RT delay {<=}20 weeks was found. The adjusted hazard ratio for RT within 77 days vs. after 77 days was 0.94 (95% confidence interval [CI], 0.47-1.87) for the interval to local recurrence, 1.05 (95% CI, 0.82-1.34) for disease-free survival, and 1.07 (95% CI, 0.77-1.49) for overall survival. For the interval to local recurrence the adjusted hazard ratio for {<=}48, 49-77, and 78-112 days was 0.90 (95% CI, 0.34-2.37), 0.86 (95% CI, 0.33-2.25), and 0.89 (95% CI, 0.33-2.41), respectively, relative to {>=}113 days. Conclusion: A RT delay of {<=}20 weeks was significantly associated with baseline factors such as age, menopausal status, and estrogen-receptor status. After adjustment for these factors, the timing of RT was not significantly associated with the interval to local recurrence, disease-free survival, or overall survival.« less

Prehospital sodium bicarbonate use could worsen long term survival with favorable neurological recovery among patients with out-of-hospital cardiac arrest.

PubMed

Kawano, Takahisa; Grunau, Brian; Scheuermeyer, Frank X; Gibo, Koichiro; Dick, William; Fordyce, Christopher B; Dorian, Paul; Stenstrom, Robert; Straight, Ronald; Christenson, Jim

2017-10-01

Sodium bicarbonate (SB) is widely used for resuscitation in out-of- hospital cardiac arrest (OHCA); however, its effect on long term outcomes is unclear. From 2005-2016, we prospectively conducted a province-wide population-based observational study including adult non-traumatic OHCA patients managed by paramedics. SB was administered by paramedics based on their clinical assessments. To examine the association of SB administration and survival and favorable neurological outcome to hospital discharge, defined as modified Rankin scale of 3 or less, we performed a multivariable logistic regression analysis: (1) within propensity score matched comparison groups, and; (2) within the full cohort with missing variables addressed by multiple imputation techniques. Of 15 601 OHCA patients, 13,865 were included in this study with 5165 (37.3%) managed with SB. In the SB treated group, 118 (2.3%) patients survived and 62 (1.2%) had favorable neurological outcomes to hospital discharge, compared to 1699 (19.8%) and 831 (10.6%) in the non-SB treated group, respectively. In the 1:1 propensity matched cohort including 5638 OHCA patients, SB was associated with decreased probability of outcomes (adjusted OR for survival: 0.64, 95% CI 0.45-0.91, and adjusted OR for favorable neurological outcome: 0.59, 95% CI 0.39-0.88, respectively). The association remained consistent in the multiply imputed cohort (adjusted OR 0.48, 95 CI 0.36-0.64, and adjusted OR 0.54, 95% CI 0.38-0.76, respectively). In OHCA patients, prehospital SB administration was associated with worse survival rate and neurological outcomes to hospital discharge. Copyright © 2017 Elsevier B.V. All rights reserved.

Preventive Effects of Safety Helmets on Traumatic Brain Injury after Work-Related Falls.

PubMed

Kim, Sang Chul; Ro, Young Sun; Shin, Sang Do; Kim, Joo Yeong

2016-10-29

Work-related traumatic brain injury (TBI) caused by falls is a catastrophic event that leads to disabilities and high socio-medical costs. This study aimed to measure the magnitude of the preventive effect of safety helmets on clinical outcomes and to compare the effect across different heights of fall. We collected a nationwide, prospective database of work-related injury patients who visited the 10 emergency departments between July 2010 and October 2012. All of the adult patients who experienced work-related fall injuries were eligible, excluding cases with unknown safety helmet use and height of fall. Primary and secondary endpoints were intracranial injury and in-hospital mortality. We calculated adjusted odds ratios (AORs) of safety helmet use and height of fall for study outcomes, and adjusted for any potential confounders. A total of 1298 patients who suffered from work-related fall injuries were enrolled. The industrial or construction area was the most common place of fall injury occurrence, and 45.0% were wearing safety helmets at the time of fall injuries. The safety helmet group was less likely to have intracranial injury comparing with the no safety helmet group (the adjusted odds ratios (ORs) (95% confidence interval (CI)): 0.42 (0.24-0.73)), however, there was no statistical difference of in-hospital mortality between two groups (the adjusted ORs (95% CI): 0.83 (0.34-2.03). In the interaction analysis, preventive effects of safety helmet on intracranial injury were significant within 4 m height of fall. A safety helmet is associated with prevention of intracranial injury resulting from work-related fall and the effect is preserved within 4 m height of fall. Therefore, wearing a safety helmet can be an intervention for protecting fall-related intracranial injury in the workplace.

Children and young adults with CF in the USA have better lung function compared with the UK.

PubMed

Goss, Christopher H; MacNeill, Stephanie J; Quinton, Hebe B; Marshall, Bruce C; Elbert, Alexander; Knapp, Emily A; Petren, Kristofer; Gunn, Elaine; Osmond, Joanne; Bilton, Diana

2015-03-01

People with cystic fibrosis (CF) are managed differently in the USA and UK providing an opportunity to learn from differences in practice patterns. To compare cross-sectional demographics, practice patterns and clinical outcomes between US and UK CF patients. This was a cross-sectional study using 2010 data from patients in the US Cystic Fibrosis Foundation and the UK Cystic Fibrosis patient registries. The a priori outcome measures of interest were lung function and nutritional status. Descriptive statistics and two sample comparisons were performed. Stratification and multivariable linear regression were used to adjust for confounding. The study cohort included 13 777 children and 11 058 adults from the USA and 3968 children and 3965 adults from the UK. In children, mean body mass index centiles were similar. Lung function (FEV1 and FVC% predicted) was significantly higher in US patients ages 6-25 years of age. In a regression model adjusted for only age, FEV1% predicted was on average 3.31% of predicted (95% CI 2.65 to 3.96) higher in the USA compared with the UK. When adjusted for age, age at diagnosis, gender, pancreatic insufficiency and genotype, FEV1% predicted was on average 3.03% of predicted (95% CI 2.37 to 3.69) higher in the USA compared with the UK These differences persisted despite adjustment for possible confounders. Hypertonic saline and dornase alfa were much more commonly prescribed in US children. Children and young adults with CF have better lung function in the USA compared with the UK despite similar nutritional status. 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.

Relationship between bisphenol A exposure and attention-deficit/ hyperactivity disorder: A case-control study for primary school children in Guangzhou, China.

PubMed

Li, Yanru; Zhang, Haibin; Kuang, Hongxuan; Fan, Ruifang; Cha, Caihui; Li, Guanyong; Luo, Zhiwei; Pang, Qihua

2018-04-01

Bisphenol A (BPA) is an endocrine-disrupting chemical. Studies have shown that the exposure to BPA is associated with attention-deficit/hyperactivity disorder (ADHD) during adolescent development. However the direct clinical evidence is limited. To investigate the possible association between environmental BPA exposure and the altered behavior of children, a case-control study was conducted with children aged 6-12 years in Guangzhou, China. Two hundred fifteen children diagnosed with ADHD and 253 healthy children from Guangzhou were recruited as the case and control groups, respectively. Urinary BPA and 8-hydroxy-2'-deoxyguanosine (8-OHdG, a biomarker of oxidative DNA damage) concentrations were determined by high-performance liquid chromatography/tandem spectrometry. The results showed that concentrations of urinary BPA for the case group were significantly higher than those for the control group (3.44 vs 1.70 μg/L; 4.63 vs 1.71 μg/g Crt. p < .001). A stepwise increase in the odds ratios for ADHD was observed with the increasing quartiles of children's urinary BPA (first quartile: reference category; second quartile adjusted OR: 1.79, 95% CI: 0.95-3.37; third quartile adjusted OR: 7.44, 95% CI: 3.91-14.1; fourth quartile adjusted OR: 9.41, 95% CI: 4.91-18.1). When the BPA levels were stratified by gender, the odds of ADHD among boys and girls increased significantly with urinary BPA concentrations (adjusted OR: 4.58, 95% CI: 2.84-7.37; adjusted OR: 2.83, 95% CI: 1.17-6.84). Urinary 8-OHdG concentrations in the ADHD children were significantly higher than those in the control group. Furthermore, the linear regression analysis results indicated that a significant relationship existed between BPA exposure and 8-OHdG levels (R = 0.257, p < .001). Our findings provide direct evidence that childhood BPA exposure may be related to ADHD and 8-OHdG concentrations for children. Moreover, BPA exposure could increase the higher occurrence of ADHD for boy than for girls. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cranioplasty prosthesis manufacturing based on reverse engineering technology

PubMed Central

Chrzan, Robert; Urbanik, Andrzej; Karbowski, Krzysztof; Moskała, Marek; Polak, Jarosław; Pyrich, Marek

2012-01-01

Summary Background Most patients with large focal skull bone loss after craniectomy are referred for cranioplasty. Reverse engineering is a technology which creates a computer-aided design (CAD) model of a real structure. Rapid prototyping is a technology which produces physical objects from virtual CAD models. The aim of this study was to assess the clinical usefulness of these technologies in cranioplasty prosthesis manufacturing. Material/Methods CT was performed on 19 patients with focal skull bone loss after craniectomy, using a dedicated protocol. A material model of skull deficit was produced using computer numerical control (CNC) milling, and individually pre-operatively adjusted polypropylene-polyester prosthesis was prepared. In a control group of 20 patients a prosthesis was manually adjusted to each patient by a neurosurgeon during surgery, without using CT-based reverse engineering/rapid prototyping. In each case, the prosthesis was implanted into the patient. The mean operating times in both groups were compared. Results In the group of patients with reverse engineering/rapid prototyping-based cranioplasty, the mean operating time was shorter (120.3 min) compared to that in the control group (136.5 min). The neurosurgeons found the new technology particularly useful in more complicated bone deficits with different curvatures in various planes. Conclusions Reverse engineering and rapid prototyping may reduce the time needed for cranioplasty neurosurgery and improve the prosthesis fitting. Such technologies may utilize data obtained by commonly used spiral CT scanners. The manufacturing of individually adjusted prostheses should be commonly used in patients planned for cranioplasty with synthetic material. PMID:22207125

A randomized trial comparing treatments for varicose veins.

PubMed

Brittenden, Julie; Cotton, Seonaidh C; Elders, Andrew; Ramsay, Craig R; Norrie, John; Burr, Jennifer; Campbell, Bruce; Bachoo, Paul; Chetter, Ian; Gough, Michael; Earnshaw, Jonothan; Lees, Tim; Scott, Julian; Baker, Sara A; Francis, Jill; Tassie, Emma; Scotland, Graham; Wileman, Samantha; Campbell, Marion K

2014-09-25

Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001). Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

PubMed

Patel, Manesh R; Mahaffey, Kenneth W; Garg, Jyotsna; Pan, Guohua; Singer, Daniel E; Hacke, Werner; Breithardt, Günter; Halperin, Jonathan L; Hankey, Graeme J; Piccini, Jonathan P; Becker, Richard C; Nessel, Christopher C; Paolini, John F; Berkowitz, Scott D; Fox, Keith A A; Califf, Robert M

2011-09-08

The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).

The development of a comprehensive multidisciplinary care pathway for patients with a hip fracture: design and results of a clinical trial.

PubMed

Flikweert, Elvira R; Izaks, Gerbrand J; Knobben, Bas A S; Stevens, Martin; Wendt, Klaus

2014-05-30

Hip fractures frequently occur in older persons and severely decrease life expectancy and independence. Several care pathways have been developed to lower the risk of negative outcomes but most pathways are limited to only one aspect of care. The aim of this study was therefore to develop a comprehensive care pathway for older persons with a hip fracture and to conduct a preliminary analysis of its effect. A comprehensive multidisciplinary care pathway for patients aged 60 years or older with a hip fracture was developed by a multidisciplinary team. The new care pathway was evaluated in a clinical trial with historical controls. The data of the intervention group were collected prospectively. The intervention group included all patients with a hip fracture who were admitted to University Medical Center Groningen between 1 July 2009 and 1 July 2011. The data of the control group were collected retrospectively. The control group comprised all patients with a hip fracture who were admitted between 1 January 2006 and 1 January 2008. The groups were compared with the independent sample t-test, the Mann-Whitney U-test or the Chi-squared test (Phi test). The effect of the intervention on fasting time and length of stay was adjusted by linear regression analysis for differences between the intervention and control group. The intervention group included 256 persons (women, 68%; mean age (SD), 78 (9) years) and the control group 145 persons (women, 72%; mean age (SD), 80 (10) years). Median preoperative fasting time and median length of hospital stay were significantly lower in the intervention group: 9 vs. 17 hours (p < 0.001), and 7 vs. 11 days (p < 0.001), respectively. A similar result was found after adjustment for age, gender, living condition and American Society of Anesthesiologists (ASA) classification. In-hospital mortality was also lower in the intervention group: 2% vs. 6% (p < 0.05). There were no statistically significant differences in other outcome measures. The new comprehensive care pathway was associated with a significant decrease in preoperative fasting time and length of hospital stay.

Are Characteristics of the Medical Home Associated with Diabetes Care Costs?

PubMed Central

Flottemesch, Thomas J.; Scholle, Sarah Hudson; O’Connor, Patrick J.; Solberg, Leif I.; Asche, Steve; Pawlson, L. Gregory

2015-01-01

Objective To examine the relationship between primary care medical home clinical practice systems (PCMH clinical practice systems) corresponding to the domains of the Chronic Care Model and diabetes-related healthcare costs incurred by members of a health plan who have diagnosed Type 2 diabetes and received care at one of 27 Minnesota-based medical groups over a 12-month period. Study Design Cross-sectional analysis of patient-level cost data in relation to the presence of PCMH clinical practice systems by Chronic Care Model domain using the Physician Practice Connections Readiness Survey (PPC-RS). Methods Multivariate regressions adjusting for patient demographics, health status and comorbidities estimated the relationship between the presence of PCMH clinical practice systems as measured by the PPC-RS and three outcomes: total diabetes-related healthcare costs, ambulatory care management costs, and potentially avoidable costs (e.g. unscheduled inpatient and emergency care). Results Two domains of PCMH clinical practice systems as measured by the PPC-RS were significantly associated with reductions in potentially avoidable costs. These were Health Care Organization (p=.04) and clinical reminder systems in the Decision Support domain (p=.01). Compared to medical groups with only quality improvement, those with improved Health Care Organization defined as performance measurement and individual provider feedback averaged $245/patient less. Similarly, medical groups with clinical reminders for counseling averaged $338/patient less. Conclusions PCMH clinical practice systems that correspond to some domains of the Chronic Care Model are related to reduced inpatient and emergency care costs. Further research is needed about how these systems impact costs over time. PMID:22710277

Injunctive and Descriptive Peer Group Norms and the Academic Adjustment of Rural Early Adolescents

ERIC Educational Resources Information Center

Hamm, Jill V.; Schmid, Lorrie; Farmer, Thomas W.; Locke, Belinda

2011-01-01

This study integrates diverse literatures on peer group influence by conceptualizing and examining the relationship of peer group injunctive norms to the academic adjustment of a large and ethnically diverse sample of rural early adolescents' academic adjustment. Results of three-level hierarchical linear modeling indicated that peer groups were…

An Electronic Patient-Reported Outcome Measures System in UK Chiropractic Practices: A Feasibility Study of Routine Collection of Outcomes and Costs.

PubMed

Newell, Dave; Diment, Emily; Bolton, Jenni E

2016-01-01

The purpose of this study was to test the feasibility of collecting valid and widely used health outcomes, including information concerning cost of care, using a Web-based patient-driven patient-reported outcome measure (PROM) collection process within a cohort of UK chiropractic practices. A Web-based PROM system (Care Response) was used. Patients with low back and neck pain were recruited from a group of chiropractic practices located in the United Kingdom. Information collected included demographic data, generic and condition-specific PROMs at the initial consultation and 90 days later, patient-reported experience measures, and additional health seeking to estimate costs of care. A group of 33 clinics provided information from a total of 1895 patients who completed baseline questionnaires with 844 (45%) completing the measures at 90-day follow-up. Subsequent outcomes suggest that more than 70% of patients improved over the course of treatment regardless of the outcome used. Using the baseline as a virtual counterfactual with respect to follow-up, we calculated quality-adjusted life years and the cost thereof resulting in a mean quality-adjusted life years gained of 0.8 with an average cost of £895 per quality-adjusted life year. Routine collection of PROMs, including information about cost, is feasible and can be achieved using an online system within a clinical practice environment. We describe a Web-based collection system and discuss the choice of measures leading to a comprehensive understanding of outcomes and costs in routine practice. Copyright © 2016 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

Does rectal indomethacin eliminate the need for prophylactic pancreatic stent placement in patients undergoing high-risk ERCP? Post hoc efficacy and cost-benefit analyses using prospective clinical trial data.

PubMed

Elmunzer, B Joseph; Higgins, Peter D R; Saini, Sameer D; Scheiman, James M; Parker, Robert A; Chak, Amitabh; Romagnuolo, Joseph; Mosler, Patrick; Hayward, Rodney A; Elta, Grace H; Korsnes, Sheryl J; Schmidt, Suzette E; Sherman, Stuart; Lehman, Glen A; Fogel, Evan L

2013-03-01

A recent large-scale randomized controlled trial (RCT) demonstrated that rectal indomethacin administration is effective in addition to pancreatic stent placement (PSP) for preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk cases. We performed a post hoc analysis of this RCT to explore whether rectal indomethacin can replace PSP in the prevention of PEP and to estimate the potential cost savings of such an approach. We retrospectively classified RCT subjects into four prevention groups: (1) no prophylaxis, (2) PSP alone, (3) rectal indomethacin alone, and (4) the combination of PSP and indomethacin. Multivariable logistic regression was used to adjust for imbalances in the prevalence of risk factors for PEP between the groups. Based on these adjusted PEP rates, we conducted an economic analysis comparing the costs associated with PEP prevention strategies employing rectal indomethacin alone, PSP alone, or the combination of both. After adjusting for risk using two different logistic regression models, rectal indomethacin alone appeared to be more effective for preventing PEP than no prophylaxis, PSP alone, and the combination of indomethacin and PSP. Economic analysis revealed that indomethacin alone was a cost-saving strategy in 96% of Monte Carlo trials. A prevention strategy employing rectal indomethacin alone could save approximately $150 million annually in the United States compared with a strategy of PSP alone, and $85 million compared with a strategy of indomethacin and PSP. This hypothesis-generating study suggests that prophylactic rectal indomethacin could replace PSP in patients undergoing high-risk ERCP, potentially improving clinical outcomes and reducing healthcare costs. A RCT comparing rectal indomethacin alone vs. indomethacin plus PSP is needed.

Variation in 'fast-track' referrals for suspected cancer by patient characteristic and cancer diagnosis: evidence from 670 000 patients with cancers of 35 different sites.

PubMed

Zhou, Y; Mendonca, S C; Abel, G A; Hamilton, W; Walter, F M; Johnson, S; Shelton, J; Elliss-Brookes, L; McPhail, S; Lyratzopoulos, G

2018-01-01

In England, 'fast-track' (also known as 'two-week wait') general practitioner referrals for suspected cancer in symptomatic patients are used to shorten diagnostic intervals and are supported by clinical guidelines. However, the use of the fast-track pathway may vary for different patient groups. We examined data from 669 220 patients with 35 cancers diagnosed in 2006-2010 following either fast-track or 'routine' primary-to-secondary care referrals using 'Routes to Diagnosis' data. We estimated the proportion of fast-track referrals by sociodemographic characteristic and cancer site and used logistic regression to estimate respective crude and adjusted odds ratios. We additionally explored whether sociodemographic associations varied by cancer. There were large variations in the odds of fast-track referral by cancer (P<0.001). Patients with testicular and breast cancer were most likely to have been diagnosed after a fast-track referral (adjusted odds ratios 2.73 and 2.35, respectively, using rectal cancer as reference); whereas patients with brain cancer and leukaemias least likely (adjusted odds ratios 0.05 and 0.09, respectively, for brain cancer and acute myeloid leukaemia). There were sex, age and deprivation differences in the odds of fast-track referral (P<0.013) that varied in their size and direction for patients with different cancers (P<0.001). For example, fast-track referrals were least likely in younger women with endometrial cancer and in older men with testicular cancer. Fast-track referrals are less likely for cancers characterised by nonspecific presenting symptoms and patients belonging to low cancer incidence demographic groups. Interventions beyond clinical guidelines for 'alarm' symptoms are needed to improve diagnostic timeliness.

Variation in ‘fast-track’ referrals for suspected cancer by patient characteristic and cancer diagnosis: evidence from 670 000 patients with cancers of 35 different sites

PubMed Central

Zhou, Y; Mendonca, S C; Abel, G A; Hamilton, W; Walter, F M; Johnson, S; Shelton, J; Elliss-Brookes, L; McPhail, S; Lyratzopoulos, G

2018-01-01

Background: In England, ‘fast-track’ (also known as ‘two-week wait’) general practitioner referrals for suspected cancer in symptomatic patients are used to shorten diagnostic intervals and are supported by clinical guidelines. However, the use of the fast-track pathway may vary for different patient groups. Methods: We examined data from 669 220 patients with 35 cancers diagnosed in 2006–2010 following either fast-track or ‘routine’ primary-to-secondary care referrals using ‘Routes to Diagnosis’ data. We estimated the proportion of fast-track referrals by sociodemographic characteristic and cancer site and used logistic regression to estimate respective crude and adjusted odds ratios. We additionally explored whether sociodemographic associations varied by cancer. Results: There were large variations in the odds of fast-track referral by cancer (P<0.001). Patients with testicular and breast cancer were most likely to have been diagnosed after a fast-track referral (adjusted odds ratios 2.73 and 2.35, respectively, using rectal cancer as reference); whereas patients with brain cancer and leukaemias least likely (adjusted odds ratios 0.05 and 0.09, respectively, for brain cancer and acute myeloid leukaemia). There were sex, age and deprivation differences in the odds of fast-track referral (P<0.013) that varied in their size and direction for patients with different cancers (P<0.001). For example, fast-track referrals were least likely in younger women with endometrial cancer and in older men with testicular cancer. Conclusions: Fast-track referrals are less likely for cancers characterised by nonspecific presenting symptoms and patients belonging to low cancer incidence demographic groups. Interventions beyond clinical guidelines for ‘alarm’ symptoms are needed to improve diagnostic timeliness. PMID:29182609

Depressive symptoms are doubled in older British South Asian and Black Caribbean people compared with Europeans: associations with excess co-morbidity and socioeconomic disadvantage.

PubMed

Williams, E D; Tillin, T; Richards, M; Tuson, C; Chaturvedi, N; Hughes, A D; Stewart, R

2015-07-01

Despite elevated risk profiles for depression among South Asian and Black Caribbean people in the UK, prevalences of late-life depressive symptoms across the UK's three major ethnic groups have not been well characterized. Data were collected at baseline and 20-year follow-up from 632 European, 476 South Asian and 181 Black Caribbean men and women (aged 58-88 years), of a community-based cohort study from north-west London. The 10-item Geriatric Depression Scale was interviewer-administered during a clinic visit (depressive symptoms defined as a score of ⩾4 out of 10), with clinical data (adiposity, diabetes, cardiovascular disease, cognitive function) also collected. Sociodemographic, psychosocial, behavioural, disability, and medical history information was obtained by questionnaire. Prevalence of depressive symptoms varied by ethnic group, affecting 9.7% of White European, 15.5% of South Asian, and 17.7% of Black Caribbean participants. Compared with White Europeans, South Asian and Black Caribbean participants were significantly more likely to have depressive symptoms (odds ratio 1.79, 95% confidence interval 1.24-2.58 and 1.80, 1.11-2.92, respectively). Adjustment for co-morbidities had most effect on the excess South Asian odds, and adjustment for socioeconomic position had most effect on the elevated Black Caribbean odds. Higher prevalence of depressive symptoms observed among South Asian people were attenuated after adjustment for physical health, whereas the Black Caribbean increased prevalence was most explained by socioeconomic disadvantage. It is important to understand the reasons for these ethnic differences to identify opportunities for interventions to address inequalities.

Real-World Adverse Effects of Capecitabine Toxicity in an Elderly Population.

PubMed

van Beek, Michiel W H; Roukens, Monique; Jacobs, Wilco C H; Timmer-Bonte, Johanna N H; Kramers, Cees

2018-06-22

Few studies have assessed the safety and effectiveness of the numerous available chemotherapeutic therapies for geriatric oncology patients. Most safety studies are conducted in large trials, and there is some uncertainty surrounding whether the results would be the same in typical daily use. This retrospective study aims to assess the adverse effects of real-world capecitabine use in elderly patients. We reviewed the records of patients treated with capecitabine in an oncology department of a University Clinic in Nijmegen, The Netherlands. We scored adverse effects such as hand-foot syndrome and diarrhea, and dosage adjustments and the reasons for them. In total, 132 patients were included, 69 of whom were aged 70 years or below (mean age: 57 years), while 63 were aged older than 70 years (mean age: 74 years). Patients aged over 70 years experienced more serious adverse effects than younger patients. Grade 2 or 3 hand-foot syndrome toxicity was experienced by 20.2% of patients aged younger than 70 years and by 34.9% of patients older than 70 years (p = 0.059). Grade 2, 3, or 4 diarrhea was experienced by 17.4% of the patients aged younger than 70 years but by 31.7% of the patients aged older than 70 years (p = 0.044). Dosage was adjusted for 27/69 patients in the younger group and 52/63 patients in the older group (p = 0.001). The difference in observed adverse effects cannot be the sole explanation for the high incidence of observed dose adjustments. A prospective follow-up study of elderly patients using capecitabine outside clinical trials is needed to evaluate the optimum balance between adverse effects and efficacy.

Cost-effectiveness of thrombolysis within 4.5 hours of acute ischemic stroke: experience from Australian stroke center.

PubMed

Tan Tanny, Sharman P; Busija, Lucy; Liew, Danny; Teo, Sarah; Davis, Stephen M; Yan, Bernard

2013-08-01

Previous economic studies outside Australia have demonstrated that patients treated with tissue-type plasminogen activator (tPA) within 4.5 hours of stroke onset have lower healthcare costs than those not. We aim to perform cost-effectiveness analysis of intravenous tPA in an Australian setting. Data on clinical outcomes and costs were derived for 378 patients who received intravenous tPA within 4.5 hours of stroke onset at Royal Melbourne Hospital (Australia) between January 2003 and December 2011. To simulate clinical outcomes and costs for a hypothetical control group assumed not to have received tPA, we applied efficacy data from a meta-analysis of randomized trials to outcomes observed in the tPA group. During a 1-year time-horizon, net costs, years of life lived, and quality-adjusted life-years were compared and incremental cost-effectiveness ratios derived for tPA versus no tPA. In the study population, mean (SD) age was 68.2 (13.5) years and 206 (54.5%) were men. Median National Institutes of Health Stroke Scale score (interquartile range) at presentation was 12.5 (8-18). Compared with no tPA, we estimated that tPA would result in 0.02 life-years and 0.04 quality-adjusted life-years saved per person>1 year. The net cost of tPA was AUD $55.61 per patient. The incremental cost-effectiveness ratios were AUD $2377 per life-year saved and AUD $1478 per quality-adjusted life-years saved. Because the costs of tPA are incurred only once, the incremental cost-effectiveness ratios would decrease with increasing time-horizon. Uncertainty analyses indicated the results to be robust. Intravenous tPA within 4.5 hours represents a cost-effective intervention for acute ischemic stroke.

A 12-week clinical comparison of an oscillating-rotating power brush versus a marketed sonic brush with self-adjusting technology in reducing plaque and gingivitis.

PubMed

Klukowska, Malgorzata; Grender, Julie M; Conde, Erinn; Goyal, C Ram

2013-01-01

The aim of this investigation was to assess the comparative gingivitis and plaque reduction efficacy of a leading oscillating-rotating power toothbrush and a recently introduced sonic toothbrush in adults with gingivitis. This was a 12-week, randomized and controlled, parallel group, examiner-blind, single-center clinical study of 130 adults with pre-existing gingivitis and plaque. At baseline, the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and total number of bleeding sites were assessed, along with plaque levels (whole mouth, gingival margin, and interproximal) via the Rustogi Modified Navy Plaque Index (RMNPI). Qualified subjects were randomly assigned to one of two power toothbrush test groups: the Oral-B Triumph with SmartGuide (marketed in the United States as the Oral-B Professional Care SmartSeries 5000 [D34]) oscillating-rotating brush, or the Colgate ProClinical A1500 (also marketed as elmex ProClinical) sonic brush. Subjects brushed at home for two minutes twice daily with their assigned power toothbrush and a marketed sodium fluoride dentifrice, and were reevaluated for gingivitis at Week 4 and Week 12 via the MGI, GBI, and total number of bleeding sites, and for plaque reduction via the RMNPI. Ninety-seven percent (97%) of the 130 enrolled subjects completed the trial and 62 and 65 subjects in the oscillating-rotating and sonic brush groups, respectively, had evaluable data for analysis. Statistically significant mean reductions in all three gingivitis parameters and plaque relative to baseline were seen at both Weeks 4 and 12 with unsupervised use of both test toothbrushes (p < 0.001). The oscillating-rotating power brush provided statistically significantly superior reductions compared to the sonic brush in mean adjusted MGI (31% and 29% at Weeks 4 and 12, respectively; p < 0.001), GBI (17% at Week 12; p = 0.047), and total number of bleeding sites (48% and 30% at Weeks 4 and 12, respectively; p = 0.002), and produced statistically significantly greater relative mean adjusted plaque reductions for RMNPI whole mouth plaque (38% and 24% at Weeks 4 and 12, respectively; p < 0.001), gingival margin plaque (36% at Week 4; p = 0.004), and interproximal plaque (39% and 26% at Weeks 4 and 12, respectively; p < 0.001). Both power toothbrushes were well-tolerated. An advanced oscillating-rotating power toothbrush produced substantial, statistically superior reductions in plaque and gingivitis via multiple outcome measures compared to a new sonic toothbrush after both four weeks and 12 weeks of tooth brushing.

Developing a manual for strengthening mental health nurses' clinical supervision.

PubMed

Buus, Niels; Cassedy, Paul; Gonge, Henrik

2013-05-01

In this article, we report findings from a study aimed at developing the content and implementation of a manual for a research-based intervention on clinical supervision of mental health nursing staff. The intervention was designed to strengthen already existing supervision practices through educational preparation for supervision and systematic reflection on supervision. The intervention consists of three sessions and was implemented on two groups of mental health hospital staff. We present an outline of the manual and explain how the trial sessions made us adjust the preliminary manual. The effects of implementing the manual will subsequently be analysed in an independent randomised controlled trial.

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.

Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at standard surgical risk: results from the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST).

PubMed

Vilain, Katherine R; Magnuson, Elizabeth A; Li, Haiyan; Clark, Wayne M; Begg, Richard J; Sam, Albert D; Sternbergh, W Charles; Weaver, Fred A; Gray, William A; Voeks, Jenifer H; Brott, Thomas G; Cohen, David J

2012-09-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) demonstrated similar rates of the primary composite end point between carotid artery stenting (CAS) and carotid endarterectomy (CEA), although the risk of stroke was higher with CAS, and the risk of myocardial infarction was higher with CEA. Given the large number of patients who are candidates for these procedures, an understanding of their relative cost and cost-effectiveness may have important implications for health care policy and treatment guidelines. We performed a formal economic evaluation alongside the CREST trial. Costs were estimated from all trial participants over the first year of follow-up using a combination of resource use data and hospital billing data. Patient-level health use scores were obtained using data from the SF-36. We then used a Markov disease-simulation model calibrated to the CREST results to project 10-year costs and quality-adjusted life expectancy for the 2 treatment groups. Although initial procedural costs were $1025/patient higher with CAS, postprocedure costs and physician costs were lower such that total costs for the index hospitalization were similar for the CAS and CEA groups ($15 055 versus $14 816; mean difference, $239/patient; 95% CI for difference, -$297 to $775). Neither follow-up costs after discharge nor total 1-year costs differed significantly. For the CREST population, model-based projections over a 10-year time horizon demonstrated that CAS would result in a mean incremental cost of $524/patient and a reduction in quality-adjusted life expectancy of 0.008 years compared with CEA. Probabilistic sensitivity analysis demonstrated that CEA was economically attractive at an incremental cost-effectiveness threshold of $50 000/quality-adjusted life-year gained in 54% of samples, whereas CAS was economically attractive in 46%. Despite slightly lower in-trial costs and lower rates of stroke with CEA compared with CAS, projected 10-year outcomes from this controlled clinical trial demonstrate only trivial differences in overall healthcare costs and quality-adjusted life expectancy between the 2 strategies. If the CREST results can be replicated in clinical practice, these findings suggest that factors other than cost-effectiveness should be considered when deciding between treatment options for carotid artery stenosis in patients at standard risk for surgical complications. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique Identifier: NCT00004732.

Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism.

PubMed

Stott, David J; Rodondi, Nicolas; Kearney, Patricia M; Ford, Ian; Westendorp, Rudi G J; Mooijaart, Simon P; Sattar, Naveed; Aubert, Carole E; Aujesky, Drahomir; Bauer, Douglas C; Baumgartner, Christine; Blum, Manuel R; Browne, John P; Byrne, Stephen; Collet, Tinh-Hai; Dekkers, Olaf M; den Elzen, Wendy P J; Du Puy, Robert S; Ellis, Graham; Feller, Martin; Floriani, Carmen; Hendry, Kirsty; Hurley, Caroline; Jukema, J Wouter; Kean, Sharon; Kelly, Maria; Krebs, Danielle; Langhorne, Peter; McCarthy, Gemma; McCarthy, Vera; McConnachie, Alex; McDade, Mairi; Messow, Martina; O'Flynn, Annemarie; O'Riordan, David; Poortvliet, Rosalinde K E; Quinn, Terence J; Russell, Audrey; Sinnott, Carol; Smit, Jan W A; Van Dorland, H Anette; Walsh, Kieran A; Walsh, Elaine K; Watt, Torquil; Wilson, Robbie; Gussekloo, Jacobijn

2017-06-29

The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 μg daily, or 25 μg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 μg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], -2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, -2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST ClinicalTrials.gov number, NCT01660126 .).

Preventive Effects of Seat Belt on Clinical Outcomes for Road Traffic Injuries

PubMed Central

2015-01-01

Proper seat belt use saves lives; however, the use rate decreased in Korea. This study aimed to measure the magnitude of the preventive effect of seat belt on case-fatality across drivers and passengers. We used the Emergency Department based Injury In-depth Surveillance (EDIIS) database from 17 EDs between 2011 and 2012. All of adult injured patients from road traffic injuries (RTI) in-vehicle of less than 10-seat van were eligible, excluding cases with unknown seat belt use and outcomes. Primary and secondary endpoints were in-hospital mortality and intracranial injury. We calculated adjusted odds ratios (AORs) of seat belt use and driving status for study outcomes adjusting for potential confounders. Among 23,698 eligible patients, 15,304 (64.6%) wore seat belts. Driver, middle aged (30-44 yr), male, daytime injured patients were more likely to use seat belts (all P < 0.001). In terms of clinical outcome, no seat belt group had higher proportions of case-fatality and intracranial injury compared to seat belt group (both P < 0.001). Compared to seat belt group, AORs (95% CIs) of no seat belt group were 10.43 (7.75-14.04) for case-fatality and 2.68 (2.25-3.19) for intracranial injury respectively. In the interaction model, AORs (95% CIs) of no seat belt use for case-fatality were 11.71 (8.45-16.22) in drivers and 5.52 (2.83-14.76) in non-driving passengers, respectively. Wearing seat belt has significantly preventive effects on case-fatality and intracranial injury. Public health efforts to increase seat belt use are needed to reduce health burden from RTIs. PMID:26713066

The impact of text message reminders on adherence to antimalarial treatment in northern Ghana: a randomized trial.

PubMed

Raifman, Julia R G; Lanthorn, Heather E; Rokicki, Slawa; Fink, Günther

2014-01-01

Low rates of adherence to artemisinin-based combination therapy (ACT) regimens increase the risk of treatment failure and may lead to drug resistance, threatening the sustainability of current anti-malarial efforts. We assessed the impact of text message reminders on adherence to ACT regimens. Health workers at hospitals, clinics, pharmacies, and other stationary ACT distributors in Tamale, Ghana provided flyers advertising free mobile health information to individuals receiving malaria treatment. The messaging system automatically randomized self-enrolled individuals to the control group or the treatment group with equal probability; those in the treatment group were further randomly assigned to receive a simple text message reminder or the simple reminder plus an additional statement about adherence in 12-hour intervals. The main outcome was self-reported adherence based on follow-up interviews occurring three days after treatment initiation. We estimated the impact of the messages on treatment completion using logistic regression. 1140 individuals enrolled in both the study and the text reminder system. Among individuals in the control group, 61.5% took the full course of treatment. The simple text message reminders increased the odds of adherence (adjusted OR 1.45, 95% CI [1.03 to 2.04], p-value 0.028). Receiving an additional message did not result in a significant change in adherence (adjusted OR 0.77, 95% CI [0.50 to 1.20], p-value 0.252). The results of this study suggest that a simple text message reminder can increase adherence to antimalarial treatment and that additional information included in messages does not have a significant impact on completion of ACT treatment. Further research is needed to develop the most effective text message content and frequency. ClinicalTrials.gov NCT01722734.

The impact of real-world cardiovascular-related pharmacogenetic testing in an insured population.

PubMed

Billings, Jennifer; Racsa, Patrick N; Bordenave, Kristine; Long, Charron L; Ellis, Jeffrey J

2018-06-01

Pharmacogenomics is intended to help clinicians provide the right drug to the right patient at an appropriate dose. However, limited evidence of clinical utility has slowed uptake of pharmacogenomic testing (PGT). To evaluate the impact of real-world cardiovascular (CV)-related PGT on clinical outcomes, healthcare resource utilisation (HCRU) and cost in a large, heterogeneous population. Individuals with Medicare Advantage Prescription Drug, Medicaid, or commercial coverage between 1/1/2011 and 9/30/2015 and ≥1 atherosclerotic CV-related diagnosis were identified. Those with ≥1 claim for CV-related PGT were included in the test group (index date = 1st PGT claim) and matched 1:2 to controls without PGT. Individuals aged <22 or ≥90 years old on the index date, with <12 months continuous enrollment before and after the index date, or without an ASCVD-related diagnosis in the 12-month pre-index period were excluded. The primary outcome was occurrence of a major CV event during the 12-month post-index period. After adjustment, the PGT group was significantly more likely to experience ischaemic stroke, pulmonary embolism, deep vein thrombosis or a composite event compared with controls. Adjusting for baseline characteristics, HCRU was significantly higher for the test group across all measured outcomes except all-cause and ASCVD-related inpatient admissions. Median all-cause and ASCVD-related healthcare costs were significantly higher for the test group. Real world PGT in a large population did not improve outcomes. Tailoring medication therapy to each patient holds great promise for providing quality care but a deeper understanding of how widespread utilisation of PGT might impact objective health outcomes is needed. © 2018 John Wiley & Sons Ltd.

Antivenom therapy for crotaline snakebites: has the poison control center provided effective guidelines?

PubMed

Chen, Yen-Chia; Chen, Min-Hui; Wang, Lee-Min; Wu, Jackson Jer-Kan; Huang, Chun-I; Lee, Chen-Hsen; Yen, David Hung-Tsang; Yang, Chen-Chang

2007-12-01

Crotaline snakebites (Protobothrops mucrosquamatus and Trimeresurus stejnegeri) are a common medical emergency in Taiwan that can be effectively treated by a bivalent F(ab)2 antivenom. We investigated the differences in the clinical outcomes of patients who received different therapeutic regimens of antivenom in a medical center where clinical toxicologists followed the poison control center (PCC) guidelines (medical group) and surgeons did not (surgical group). The medical records of inpatients with crotaline snakebites between 1991 and 2005 were reviewed and information on demographics, treatments, adverse effects of antivenom, and complications was abstracted and analyzed. A total of 179 patients (90 medical, 89 surgical) were eligible for study. There was no significant intergroup difference in baseline characteristics except that the dose of antivenom and the probability of antibiotic use were both higher in the surgical group (5.9 +/- 4.2 vials vs. 2.7 +/- 1.6 vials; 93% vs. 60%). Multiple logistic regression adjusting for age, gender, calendar year of envenomation, severity of envenomation, and antibiotic use did not disclose evidence of any difference in various clinical outcomes between medical and surgical patients. The lower dose of antivenom recommended by the PCC may be as effective and safe as the higher dose used in the surgical group for the treatment of crotaline snakebites.

The effect of an automated clinical reminder on weight loss in primary care.

PubMed

O'Grady, Jason S; Thacher, Tom D; Chaudhry, Rajeev

2013-01-01

Overweight and obese individuals have increased health risks. Clinical reminders positively affect health outcomes in diabetes and osteoporosis, but the effect of automated prompts on weight loss in obesity has not been studied. Our objective was to determine whether an automatic prompt for the clinician to recommend lifestyle changes to patients with a body mass index (BMI) >25 kg/m(2) led to greater weight loss over a 3- to 6-month interval compared with the absence of a clinical reminder. We conducted a retrospective analysis of electronic medical records of obese adult patients with a BMI >25 kg/m(2) who were seen in 2009 and 2010, before and after implementation of an automated printed clinical reminder, respectively. We evaluated 1600 patients in each of the control and intervention groups. The primary outcome was the mean change in BMI between the control and intervention groups. Multiple linear regression was used to assess the effect of the clinical reminder on the change in BMI while adjusting for baseline BMI and potential confounding factors. The reduction in BMI (mean ± standard deviation) in the group with the clinical reminder (-0.084 ± 1.56 kg/m(2)) was not significantly greater than the control group (-0.053 ± 1.49 kg/m(2); P = .56). A regression model incorporating the clinical reminder, age, baseline BMI, obesity diagnosis, diabetes, and hyperlipidemia found that baseline BMI (P < .001), obesity diagnosis (P < .001), age (P = .001), and hyperlipidemia diagnosis (P = .02) were significant predictors of weight loss, but the clinical reminder was not (P = .78). There was a significant interaction between the clinical reminder and baseline BMI (P = .005), as the prompt increased weight loss more in those with lower baseline BMI. Automated clinical reminders alone do not improve weight loss in overweight and obese patients. Physician diagnoses of obesity or hyperlipidemia were associated with weight loss, suggesting that formally noting these diagnoses contributes to successful weight loss.

Neurodevelopmental Outcomes of Extremely Low Birth Weight Infants with Spontaneous Intestinal Perforation or Surgical Necrotizing Enterocolitis

PubMed Central

Wadhawan, Rajan; Oh, William; Hintz, Susan R; Blakely, Martin L; Das, Abhik; Bell, Edward F.; Saha, Shampa; Laptook, Abbot R.; Shankaran, Seetha; Stoll, Barbara J.; Walsh, Michele C.; Higgins, Rosemary D.

2013-01-01

Objective To determine if extremely low birth weight infants with surgical necrotizing enterocolitis have a higher risk of death or neurodevelopmental impairment and neurodevelopmental impairment among survivors (secondary outcome) at 18–22 months corrected age compared to infants with spontaneous intestinal perforation and infants without necrotizing enterocolitis or spontaneous intestinal perforation. Study Design Retrospective analysis of the Neonatal Research Network very low birth weight registry, evaluating extremely low birth weight infants born between 2000–2005. The study infants were designated into 3 groups: 1) Spontaneous intestinal perforation without necrotizing enterocolitis; 2) Surgical necrotizing enterocolitis (Bell's stage III); and 3) Neither spontaneous intestinal perforation nor necrotizing enterocolitis. Multivariate logistic regression analysis was performed to evaluate the association between the clinical group and death or neurodevelopmental impairment, controlling for multiple confounding factors including center. Results Infants with surgical necrotizing enterocolitis had the highest rate of death prior to hospital discharge (53.5%) and death or neurodevelopmental impairment (82.3%) compared to infants in the spontaneous intestinal perforation group (39.1% and 79.3%) and no necrotizing enterocolitis/no spontaneous intestinal perforation group (22.1% and 53.3%; p<0.001). Similar results were observed for neurodevelopmental impairment among survivors. On logistic regression analysis, both spontaneous intestinal perforation and surgical necrotizing enterocolitis were associated with increased risk of death or neurodevelopmental impairment (adjusted OR 2.21, 95% CI: 1.5, 3.2 and adjusted OR 2.11, 95% CI: 1.5, 2.9 respectively) and neurodevelopmental impairment among survivors (adjusted OR 2.17, 95% CI: 1.4, 3.2 and adjusted OR 1.70, 95% CI: 1.2, 2.4 respectively). Conclusions Spontaneous intestinal perforation and surgical necrotizing enterocolitis are associated with a similar increase in the risk of death or neurodevelopmental impairment and neurodevelopmental impairment among extremely low birth weight survivors at 18–22 months corrected age. PMID:24135709

Polycystic ovarian syndrome and the risk of subsequent primary ovarian insufficiency: a nationwide population-based study.

PubMed

Pan, Mei-Lien; Chen, Li-Ru; Tsao, Hsiao-Mei; Chen, Kuo-Hu

2017-07-01

To evaluate the risk of subsequent primary ovarian insufficiency (POI) amongst patients with a history of polycystic ovarian syndrome (PCOS). This nationwide, population-based study is an inspection and review of data from the 1998 to 2012 Taiwan National Health Insurance Research Database. In a sample of 1,000,000 randomly sampled individuals, women with PCOS (exposure group; n = 7,049) and women without PCOS (contrast group; n = 70,490) were compared. Women initially diagnosed with PCOS at less than 15 or more than 35 years of age were excluded. Each woman with PCOS was age-matched to 10 women without PCOS. The diagnoses of PCOS and POI (coded using International Classification of Diseases, 9th Revision, Clinical Modification) were further confirmed with blood test results and ultrasonographic findings to ensure the accuracy of the diagnoses. POI occurred more among women with PCOS compared with women without PCOS (3.73% vs 0.44%; P < 0.001). Using Kaplan-Meier survival analysis, the POI-free survival rates were significantly different between the exposure and contrast groups (P < 0.001). During 10 years of follow-up, Cox proportional-hazard analysis revealed that the risk for POI was significantly higher in the exposure than in the contrast group (hazard ratio [HR] 8.64, 95% confidence interval [CI] 7.33-10.18) and remained similar after adjustment for covariates (adjusted HR 8.31, 95% CI 7.05-9.81). Compared with that of women without PCOS, the risk of POI was even higher for women with PCOS who did not receive metformin treatment (adjusted HR 9.93, 95% CI 8.28-11.90). However, the risk for POI was significantly reduced for women with PCOS who received metformin treatment (adjusted HR 5.66, 95% CI 4.36-7.35). As a possible precursor stage, prior PCOS is a significant and independent risk factor for development of POI. The use of metformin reduces the risk of POI.

Ethnic variations in pathways to acute care and compulsory detention for women experiencing a mental health crisis

PubMed Central

Lawlor, Caroline; Cole, Laura; Howard, Louise M.

2012-01-01

Background: Much recent debate on excess rates of compulsory detention and coercive routes to care has focused on young black men; evidence is less clear regarding ethnic variations among women and factors that may mediate these. Aim: To explore ethnic variations in compulsory detentions of women, and to explore the potential role of immediate pathways to admission and clinician-rated reasons for admission as mediators of these differences. Method: All women admitted to an acute psychiatric inpatient ward or a women’s crisis house in four London boroughs during a 12-week period were included. Data were collected regarding their pathways to care, clinician-rated reasons for admission, hospital stays, and social and clinical characteristics. Results: Two hundred and eighty seven (287) women from white British, white other, black Caribbean, black African and black other groups were included. Adjusting for social and clinical characteristics, all groups of black patients and white other patients were significantly more likely to have been compulsorily admitted than white British patients; white British patients were more likely than other groups to be admitted to a crisis house and more likely than all the black groups to be admitted because of perceived suicide risk. Immediate pathways to care differed: white other, black African and black other groups were less likely to have referred themselves in a crisis and more likely to have been in contact with the police. When adjustment was made for differences in pathways to care, the ethnic differences in compulsory admission were considerably reduced. Discussion: There are marked ethnic inequities not only between white British and black women, but also between white British and white other women in experiences of acute admission. Differences between groups in help-seeking behaviours in a crisis may contribute to explaining differences in rates of compulsory admission. PMID:21059630

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

Chronic Kidney Disease Awareness Among Individuals with Clinical Markers of Kidney Dysfunction

PubMed Central

Plantinga, Laura C.; Hsu, Chi-yuan; Jordan, Regina; Burrows, Nilka Ríos; Hedgeman, Elizabeth; Yee, Jerry; Saran, Rajiv; Powe, Neil R.

2011-01-01

Summary Background and objectives Awareness of chronic kidney disease (CKD) among providers and patients is low. Whether clinical cues prompt recognition of CKD is unknown. We examined whether markers of kidney disease that should trigger CKD recognition among providers are associated with higher individual CKD awareness. Design, setting, participants, & measurements CKD awareness was assessed in 1852 adults with an estimated GFR <60 ml/min per 1.73 m2 using 1999 to 2008 National Health and Nutrition Examination Survey data. CKD awareness was a “yes” answer to “Have you ever been told you have weak or failing kidneys?” Participants were grouped by distribution of the following abnormal markers of CKD: hyperkalemia, acidosis, hyperphosphatemia, elevated blood urea nitrogen, anemia, albuminuria, and uncontrolled hypertension. Odds of CKD awareness associated with each abnormal marker and groupings of markers were estimated by multivariable logistic regression. Results Among individuals with kidney disease, only those with albuminuria had greater odds of CKD awareness (adjusted odds ratio, 4.0, P < 0.01) than those without. Odds of CKD awareness increased with each additional manifested clinical marker of CKD (adjusted odds ratio, 1.3, P = 0.05). Nonetheless, 90% of individuals with two to four markers of CKD and 84% of individuals with ≥5 markers of CKD were unaware of their disease. Conclusions Although individuals who manifest many markers of kidney dysfunction are more likely to be aware of their CKD, their CKD awareness remains low. A better understanding of mechanisms of awareness is required to facilitate earlier detection of CKD and implement therapy to minimize associated complications. PMID:21784832

Clinical efficacy of polyspecific intravenous immunoglobulin therapy in patients with streptococcal toxic shock syndrome: a comparative observational study.

PubMed

Linnér, Anna; Darenberg, Jessica; Sjölin, Jan; Henriques-Normark, Birgitta; Norrby-Teglund, Anna

2014-09-15

Streptococcal toxic shock syndrome (STSS) and necrotizing fasciitis are the 2 most severe invasive manifestations caused by group A Streptococcus (GAS). Intravenous immunoglobulin (IVIG) therapy has been suggested as adjunctive treatment with a beneficial effect on mortality. However the clinical evidence is limited. Here we aim to further document the clinical efficacy of administered IVIG therapy in a comparative observational study of well-defined patients with STSS. The effect of IVIG was evaluated in patients with STSS prospectively identified in a nationwide Swedish surveillance study conducted between April 2002 and December 2004. Detailed data on symptoms, severity of disease, treatment, and outcome were obtained from 67 patients. Crude and adjusted analyses with logistic regression were performed. Twenty-three patients received IVIG therapy compared with 44 who did not. No significant difference in comorbidities, severity of disease, organ failures, or sex was seen, but the IVIG group was slightly younger and had a higher degree of necrotizing fasciitis (56% vs 14%). The primary endpoint was 28-day survival. Adjusted analysis revealed that factors influencing survival in STSS were Simplified Acute Physiology Score II (odds ratio [OR], 1.1; P = .007), clindamycin (OR, 8.6; P = .007), and IVIG (OR, 5.6; P = .030). This comparative observational study of prospectively identified STSS patients demonstrates that both IVIG and clindamycin therapy contribute to a significantly improved survival in STSS. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

20 CFR 229.49 - Adjustment of benefits under family maximum for change in family group.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for change in family group. 229.49 Section 229.49 Employees' Benefits RAILROAD RETIREMENT BOARD... Overall Minimum Rate § 229.49 Adjustment of benefits under family maximum for change in family group. (a) Increase in family group. If an overall minimum rate is adjusted for the family maximum and an additional...

Racial disparities in cancer survival among randomized clinical trials patients of the Southwest Oncology Group.

PubMed

Albain, Kathy S; Unger, Joseph M; Crowley, John J; Coltman, Charles A; Hershman, Dawn L

2009-07-15

Racial disparities in cancer outcomes have been observed in several malignancies. However, it is unclear if survival differences persist after adjusting for clinical, demographic, and treatment variables. Our objective was to determine whether racial disparities in survival exist among patients enrolled in consecutive trials conducted by the Southwest Oncology Group (SWOG). We identified 19 457 adult cancer patients (6676 with breast, 2699 with lung, 1244 with colon, 1429 with ovarian, and 1843 with prostate cancers; 1291 with lymphoma; 2067 with leukemia; and 2208 with multiple myeloma) who were treated on 35 SWOG randomized phase III clinical trials from October 1, 1974, through November 29, 2001. Patients were grouped according to studies of diseases with similar histology and stage. Cox regression was used to evaluate the association between race and overall survival within each disease site grouping, controlling for available prognostic factors plus education and income, which are surrogates for socioeconomic status. Median and ten-year overall survival estimates were derived by the Kaplan-Meier method. All statistical tests were two-sided. Of 19 457 patients registered, 2308 (11.9%, range = 3.9%-21.6%) were African American. After adjustment for prognostic factors, African American race was associated with increased mortality in patients with early-stage premenopausal breast cancer (hazard ratio [HR] for death = 1.41, 95% confidence interval [CI] = 1.10 to 1.82; P = .007), early-stage postmenopausal breast cancer (HR for death = 1.49, 95% CI = 1.28 to 1.73; P < .001), advanced-stage ovarian cancer (HR for death = 1.61, 95% CI = 1.18 to 2.18; P = .002), and advanced-stage prostate cancer (HR for death = 1.21, 95% CI = 1.08 to 1.37; P = .001). No statistically significant association between race and survival for lung cancer, colon cancer, lymphoma, leukemia, or myeloma was observed. Additional adjustments for socioeconomic status did not substantially change these observations. Ten-year (and median) overall survival rates for African American vs all other patients were 68% (not reached) vs 77% (not reached), respectively, for early-stage, premenopausal breast cancer; 52% (10.2 years) vs 62% (13.5 years) for early-stage, postmenopausal breast cancer; 13% (1.3 years) vs 17% (2.3 years) for advanced ovarian cancer; and 6% (2.2 years) vs 9% (2.7 years) for advanced prostate cancer. African American patients with sex-specific cancers had worse survival than white patients, despite enrollment on phase III SWOG trials with uniform stage, treatment, and follow-up.

"Subthreshold" depression: is the distinction between depressive disorder not otherwise specified and adjustment disorder valid?

PubMed

Zimmerman, Mark; Martinez, Jennifer H; Dalrymple, Kristy; Chelminski, Iwona; Young, Diane

2013-05-01

Patients with clinically significant symptoms of depression who do not meet the criteria for major depressive disorder or dysthymic disorder are considered to have subthreshold depression. According to DSM-IV, such patients should be diagnosed with depressive disorder not otherwise specified (NOS) if the development of the symptoms is not attributable to a stressful event or with adjustment disorder if the symptoms follow a stressor. Research on the treatment of subthreshold depression rarely addresses the distinction between depressive disorder NOS and adjustment disorder. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we examined the validity of this distinction. From December 1995 to June 2011, 3,400 psychiatric patients presenting to the Rhode Island Hospital outpatient practice were evaluated with semistructured diagnostic interviews for DSM-IV Axis I and Axis II disorders and measures of psychosocial morbidity. Slightly less than 10% (n = 300) of the 3,400 patients were diagnosed with depressive disorder NOS or adjustment disorder with depressed mood. The patients with depressive disorder NOS were significantly more often diagnosed with social phobia (P < .05) and a personality disorder (P < .01). The patients with depressive disorder NOS reported more anhedonia, increased appetite, increased sleep, and indecisiveness, whereas the patients with adjustment disorder reported more weight loss, reduced appetite, and insomnia. There was no significant difference between the groups in overall level of severity of depression or impaired functioning. The patients with depressive disorder NOS had a nonsignificantly elevated morbid risk of depression in their first-degree relatives. Clinically significant subthreshold depression was common in psychiatric outpatients, and the present results support the validity of distinguishing between depressive disorder NOS and adjustment disorder with depressed mood. Future studies of the treatment of subthreshold depression should account for this diagnostic distinction. © Copyright 2013 Physicians Postgraduate Press, Inc.

Relapse insomnia increases greater risk of anxiety and depression: evidence from a population-based 4-year cohort study.

PubMed

Chen, Ping-Jen; Huang, Charles Lung-Cheng; Weng, Shih-Feng; Wu, Ming-Ping; Ho, Chung-Han; Wang, Jhi-Joung; Tsai, Wan-Chi; Hsu, Ya-Wen

2017-10-01

We investigated the longitudinal impacts of insomnia on the subsequent developments of anxiety and depression during a four-year follow-up. We further categorized individuals with insomnia into different insomnia subgroups to examine whether the risk of anxiety and depression varies by subtype. Participants were identified from National Health Insurance enrollees in Taiwan during 2002-2009. The study included 19,273 subjects with insomnia and 38,546 matched subjects without insomnia. All subjects did not have previous diagnosis of insomnia, sleep apnea, anxiety, or depression. Compared with non-insomniacs, insomniacs had a higher risk of developing anxiety only [adjusted hazard ratio (HR) = 8.83, 95% CI = 7.59-10.27], depression only (adjusted HR = 8.48, 95% CI = 6.92-10.39), and both anxiety and depression (adjusted HR = 17.98, 95% CI = 12.65-25.56). When breaking down the insomnia subgroups, individuals with a relapse of insomnia (adjusted HR = 10.42-26.80) had the highest risk of anxiety only, depression only, and both anxiety and depression, followed by persistent insomnia (adjusted HR = 9.82-18.98), then remitted insomnia (adjusted HR = 4.50-8.27). All three insomnia subgroups had a greater four-year cumulative incidence rate than the non-insomnia group for anxiety only, depression only, and both anxiety and depression (p < 0.0001). Our findings reinforce the clinical predictor role of insomnia in the future onset of anxiety or/and depression. Awareness of insomnia and treatment of insomnia should be recommended at clinics, and patterns of insomnia should be monitored to help treatment and control of subsequent psychiatric disorders. Future research with comprehensive data collection is needed to identify factors that contribute to different insomnia subtypes. Copyright © 2017 Elsevier B.V. All rights reserved.

Albuminuria and masked uncontrolled hypertension in chronic kidney disease.

PubMed

Agarwal, Rajiv

2017-12-01

Masked uncontrolled hypertension (MUCH) is associated with greater target organ damage such as left ventricular hypertrophy, increased arterial stiffness and albuminuria. Whether MUCH independently associates with greater cardiovascular end-organ damage or kidney damage is unclear. The objective of this study was to assess the strength of the relationship of MUCH (awake ambulatory blood pressure ≥135/85 mmHg and clinic blood pressure <140/90 mmHg) with target organ damage. In a cross-sectional study at a veterans' administration medical center, clinically normotensive veterans without chronic kidney disease (CKD) (n = 29) and 287 patients with CKD and controlled hypertension (CH, n = 193), MUCH (n = 67) and uncontrolled hypertension (UCH, n = 27) had evaluation of target organ damage. Target organ damage was measured by echocardiography [left ventricular mass index (LVMI)], arterial ultrasonography [aortic pulse wave velocity (PWV)] and 24-h urine collection [albuminuria (urine albumin to creatinine ratio)] in all participants. Compared to that of controls, LVMI was higher by 21.8 g/m2 (CI, 4.0-39.7 g/m2) in CH, 27.9 (CI, 8-47.8) in MUCH and 39.5 (CI, 15.7-63.2) in UCH (P < 0.01 for group differences, P < 0.01 for linear trend). Although differences persisted after adjustment for age, sex and race, they lost significance after adjustments for cardiovascular risk factors and their treatment. Compared to that of controls, PWV was different among CH, MUCH and UCH (P = 0.04 for group differences, P = 0.02 for linear trend). However, differences lost significance after adjustments for age, sex and race. Compared to that of controls, log2 UACR was higher by 2.40 mg/mg (CI, 1.28-3.52) in CH, 4.94 (CI, 3.70-6.18) in MUCH and 6.01 (CI, 4.49-7.53) in UCH (P < 0.0001 for group difference, P < 0.0001 for linear trend). Differences persisted after adjustment for age, sex and race, cardiovascular risk factors and their treatment and cardiovascular disease (P < 0.0001 for group difference, P < 0.0001 for linear trend). MUCH is more strongly related to albuminuria compared with cardiovascular damage as assessed by left ventricular mass and PWV. A graded and an independent relationship of blood pressure classification status with albuminuria is consistent with the hypothesis that renal mechanisms may be more important than cardiovascular disease in mediating the pathogenesis of MUCH. Published by Oxford University Press on behalf of ERA-EDTA 2016. This work is written by a US Government employee and is in the public domain in the US.

Effectiveness of Tai Chi on Physical and Psychological Health of College Students: Results of a Randomized Controlled Trial

PubMed Central

Li, Moyi; Ling, Kun; Lin, Hui; Chen, Lidian; Tao, Jing; Li, Junzhe; Zheng, Xin; Chen, Bai; Fang, Qianying

2015-01-01

Objective To investigate the effectiveness and safety of Tai Chi Chuan (TCC) on physical and psychological health of college students. Methods Two hundred six college students were recruited and randomly allocated to a control group or a TCC exercise group in an equal ratio. Participants in the control group were instructed to maintain their original activity level and those in the TCC exercise group received 12 weeks of TCC exercise training based on their original activity level. Physical and psychological outcomes were evaluated at baseline, 13 weeks and 25 weeks. Intention-to-treat analysis was performed for the above outcomes. Results Compared with the control group, the TCC exercise group showed significant improvements at the end of the 12-week intervention period for flexibility (length of Sit and Reach (cm): TCC group 14.09±7.40 versus control 12.88±6.57, P = 0.039 adjusted for its baseline measures using a general linear model) and balance ability (open eyes perimeter: TCC group 235.6(191~314) versus control 261(216~300); closed eyes perimeter: TCC group 370.5 (284~454) versus control 367 (293~483); P = 0.0414, 0.008, respectively, adjusted for corresponding baseline measures using a general linear model). No significant changes in other physical and mental outcomes were found between the two groups. No adverse events were reported during the study period. Conclusion TCC exercise was beneficial in college students for improving flexibility and balance capability to some extent, compared with usual exercise. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-13003328 PMID:26147842

Impairment in Occupational Functioning and Adult ADHD: The Predictive Utility of Executive Function (EF) Ratings Versus EF Tests

PubMed Central

Barkley, Russell A.; Murphy, Kevin R.

2010-01-01

Attention deficit hyperactivity disorder (ADHD) is associated with deficits in executive functioning (EF). ADHD in adults is also associated with impairments in major life activities, particularly occupational functioning. We investigated the extent to which EF deficits assessed by both tests and self-ratings contributed to the degree of impairment in 11 measures involving self-reported occupational problems, employer reported workplace adjustment, and clinician rated occupational adjustment. Three groups of adults were recruited as a function of their severity of ADHD: ADHD diagnosis (n = 146), clinical controls self-referring for ADHD but not diagnosed with it (n = 97), and community controls (n = 109). Groups were combined and regression analyses revealed that self-ratings of EF were significantly predictive of impairments in all 11 measures of occupational adjustment. Although several tests of EF also did so, they contributed substantially less than did the EF ratings, particularly when analyzed jointly with the ratings. We conclude that EF deficits contribute to the impairments in occupational functioning that occur in conjunction with adult ADHD. Ratings of EF in daily life contribute more to such impairments than do EF tests, perhaps because, as we hypothesize, each assesses a different level in the hierarchical organization of EF as a meta-construct. PMID:20197297

Elevated levels of cerebrospinal fluid neuron-specific enolase (NSE), but not S100B in major depressive disorder.

PubMed

Schmidt, Frank Martin; Mergl, Roland; Stach, Barbara; Jahn, Ina; Schönknecht, Peter

2015-02-01

Alterations in neuronal and glial integrity are considered to be of pathogenic impact on major depressive disorder (MDD). For MDD, data on cerebrospinal fluid (CSF) levels of neuron-specific enolase (NSE) are lacking and scarce for glial protein S100B. We measured CSF levels of NSE and S100B in 31 patients with MDD and 32 mentally healthy controls using electrochemiluminescence immunoassays (ECLIA). Adjusted means of NSE were significantly elevated in the MDD patients (11.73 ng/ml (9.95-13.52 95% CI) compared to the controls (6.17 ng/ml (4.55-7.78), F = 9.037, P = 0.004. Effect size for adjusted mean group difference of 5.57 ng/ml was found invariably high (Cohen's d = 1.23). Differentiating MDD from controls, a NSE cut-off of 7.94 ng/ml showed sensitivity of 81% (95% CI 63.7-90.8) and specificity of 75% (95% CI 57.9-86.7). Adjusted levels of S100B did not differ significantly between the two groups (1.12 ng/ml (0.77-1.48) in MDD, 0.97 ng/ml (0.64-1.30) in controls). Our results of elevated CSF-NSE levels support neuronal pathology in MDD and the potential use of CSF-NSE as marker in clinical diagnostics. Missing group differences in S100B do not promote a specific glial pathology in depressive disorders.

Infant formula supplementation with long-chain polyunsaturated fatty acids has no effect on Bayley developmental scores at 18 months of age--IPD meta-analysis of 4 large clinical trials.

PubMed

Beyerlein, Andreas; Hadders-Algra, Mijna; Kennedy, Katherine; Fewtrell, Mary; Singhal, Atul; Rosenfeld, Eva; Lucas, Alan; Bouwstra, Hylco; Koletzko, Berthold; von Kries, Rüdiger

2010-01-01

To find out whether supplementation of formula milk by long-chain polyunsaturated fatty acids (LCPUFA) affects neurodevelopment at 18 months of age in term or preterm infants by an individual patient data (IPD) meta-analysis. Data of 870 children from 4 large randomised clinical trials for formula milk with and without LCPUFAs allowed for assessing the effect of LCPUFA with adjustment for potential confounders and extensive subgroup analysis on prematurity, LCPUFA source, and dosage. Any additional clinical trials examining the effect of LCPUFA supplementation on Bayley Scales of Infant Development at 18 months were regarded as relevant. Two relevant studies were identified by MEDLINE, but were not available to us. An IPD meta-analysis was performed with subgroup analyses by preterm delivery, very low birth weight (<1500 g), trials with higher amounts of docosahexaenoic acid (DHA) and arachidonic acid (AA), and specific sources of LCPUFA. The sample size of 870 children was sufficient to detect clinically relevant differences in Bayley Scales even in subgroups. There were no significant differences in mental or psychomotor developmental indexes between LCPUFA-supplemented and control groups for all children or in subgroups. This was confirmed with adjustment for the possible confounders: sex, gestational age, birth weight, maternal age, and maternal smoking. The adjusted mean differences in mental developmental index and psychomotor developmental index for all of the children were -0.8 (95% confidence interval -2.8 to 1.2) and -1.0 (-2.7 to 0.7), respectively. These data based on considerable sample size provide substantial evidence that LCPUFA supplementation of infant formula does not have a clinically meaningful effect on the neurodevelopment as assessed by Bayley scores at 18 months. Inclusion of all relevant data should not have led to differing conclusions except, possibly, for very-low-birth-weight infants.

Time to clinical investigation for Indigenous and non-Indigenous Queensland women after a high grade abnormal Pap smear, 2000-2009.

PubMed

Whop, Lisa J; Baade, Peter D; Brotherton, Julia Ml; Canfell, Karen; Cunningham, Joan; Gertig, Dorota; Lokuge, Kamalini; Garvey, Gail; Moore, Suzanne P; Diaz, Abbey; O'Connell, Dianne L; Valery, Patricia; Roder, David M; Condon, John R

2017-02-06

To investigate time to follow-up (clinical investigation) for Indigenous and non-Indigenous women in Queensland after a high grade abnormality (HGA) being detected by Pap smear. Population-based retrospective cohort analysis of linked data from the Queensland Pap Smear Register (PSR), the Queensland Hospital Admitted Patient Data Collection, and the Queensland Cancer Registry. 34 980 women aged 20-68 years (including 1592 Indigenous women) with their first HGA Pap smear result recorded on the PSR (index smear) during 2000-2009 were included and followed to the end of 2010. Time from the index smear to clinical investigation (histology test or cancer diagnosis date), censored at 12 months. The proportion of women who had a clinical investigation within 2 months of a HGA finding was lower for Indigenous (34.1%; 95% CI, 31.8-36.4%) than for non-Indigenous women (46.5%; 95% CI, 46.0-47.0%; unadjusted incidence rate ratio [IRR], 0.65; 95% CI, 0.60-0.71). This difference remained after adjusting for place of residence, area-level disadvantage, and age group (adjusted IRR, 0.74; 95% CI, 0.68-0.81). However, Indigenous women who had not been followed up within 2 months were subsequently more likely to have a clinical investigation than non-Indigenous women (adjusted IRR for 2-4 month interval, 1.21; 95% CI, 1.08-1.36); by 6 months, a similar proportion of Indigenous (62.2%; 95% CI, 59.8-64.6%) and non-Indigenous women (62.8%; 95% CI, 62.2-63.3%) had been followed up. Prompt follow-up after a HGA Pap smear finding needs to improve for Indigenous women. Nevertheless, slow follow-up is a smaller contributor to their higher cervical cancer incidence and mortality than their lower participation in cervical screening.

Knowledge of carbohydrate counting and insulin dose calculations in paediatric patients with type 1 diabetes mellitus.

PubMed

Finner, Natalie; Quinn, Anne; Donovan, Anna; O'Leary, Orla; O'Gorman, Clodagh S

2015-12-01

Patients with type 1 diabetes mellitus (T1DM) who are able to adjust their insulin doses according to the carbohydrate content of a meal, as well as their blood glucose, are likely to have improved glycaemic control (Silverstein et al., 2005). With improved glycaemic control, patients have a lower risk of developing long-term microvascular complications associated with T1DM (Diabetes Control and Complications Trial Research Group, 1993). To assess the carbohydrate and insulin knowledge of patients attending our paediatric diabetes clinic at the University Hospital Limerick (UHL), the validated PedCarbQuiz (PCQ) was applied to our clinic population. This study was completed by applying a questionnaire called the PedCarbQuiz (PCQ) to children exclusively attending our paediatric diabetes clinic at UHL. Of the clinic's 220 patients, 81 participated in the study. The average total PCQ score (%) was higher in the continuous subcutaneous insulin infusion (CSII) group compared with the multiple daily insulin (MDI) injection user group (79.1 ± 12.1 versus 65.9 ± 6.6 p = 0.005). The CSII group also had a higher average carbohydrate score (%) compared with the MDI group (79.4 ± 12.4 versus 66.3 ± 16.2, p = 0.004). This study demonstrates that in a representative Irish regional paediatric T1DM clinic, knowledge of carbohydrates and insulin is better among patients treated with CSII compared with MDI. However, knowledge in both groups is poorer than in the original US sample. This study demonstrates that in a representative Irish regional paediatric T1DM clinic, knowledge of carbohydrates and insulin is poorer than in a US based sample, although this knowledge is better among patients treated with CSII compared with MDI. This highlights the need for improved resources for diabetes and carbohydrate counting education for patients with T1DM.

Morgellons disease: Analysis of a population with clinically confirmed microscopic subcutaneous fibers of unknown etiology.

PubMed

Savely, Virginia R; Stricker, Raphael B

2010-05-13

Morgellons disease is a controversial illness in which patients complain of stinging, burning, and biting sensations under the skin. Unusual subcutaneous fibers are the unique objective finding. The etiology of Morgellons disease is unknown, and diagnostic criteria have yet to be established. Our goal was to identify prevalent symptoms in patients with clinically confirmed subcutaneous fibers in order to develop a case definition for Morgellons disease. Patients with subcutaneous fibers observed on physical examination (designated as the fiber group) were evaluated using a data extraction tool that measured clinical and demographic characteristics. The prevalence of symptoms common to the fiber group was then compared with the prevalence of these symptoms in patients with Lyme disease and no complaints of skin fibers. The fiber group consisted of 122 patients. Significant findings in this group were an association with tick-borne diseases and hypothyroidism, high numbers from two states (Texas and California), high prevalence in middle-aged Caucasian women, and an increased prevalence of smoking and substance abuse. Although depression was noted in 29% of the fiber patients, pre-existing delusional disease was not reported. After adjusting for nonspecific symptoms, the most common symptoms reported in the fiber group were: crawling sensations under the skin; spontaneously appearing, slow-healing lesions; hyperpigmented scars when lesions heal; intense pruritus; seed-like objects, black specks, or "fuzz balls" in lesions or on intact skin; fine, thread-like fibers of varying colors in lesions and intact skin; lesions containing thick, tough, translucent fibers that are highly resistant to extraction; and a sensation of something trying to penetrate the skin from the inside out. This study of the largest clinical cohort reported to date provides the basis for an accurate and clinically useful case definition for Morgellons disease.

Evaluating linguistic equivalence of patient-reported outcomes in a cancer clinical trial.

PubMed

Hahn, Elizabeth A; Bode, Rita K; Du, Hongyan; Cella, David

2006-01-01

In order to make meaningful cross-cultural or cross-linguistic comparisons of health-related quality of life (HRQL) or to pool international research data, it is essential to create unbiased measures that can detect clinically important differences. When HRQL scores differ between cultural/linguistic groups, it is important to determine whether this reflects real group differences, or is the result of systematic measurement variability. To investigate the linguistic measurement equivalence of a cancer-specific HRQL questionnaire, and to conduct a sensitivity analysis of treatment differences in HRQL in a clinical trial. Patients with newly diagnosed chronic myelogenous leukemia (n = 1049) completed serial HRQL assessments in an international Phase III trial. Two types of differential item functioning (uniform and non-uniform) were evaluated using item response theory and classical test theory approaches. A sensitivity analysis was conducted to compare HRQL between treatment arms using items without evidence of differential functioning. Among 27 items, nine (33%) did not exhibit any evidence of differential functioning in both linguistic comparisons (English versus French, English versus German). Although 18 items functioned differently, there was no evidence of systematic bias. In a sensitivity analysis, adjustment for differential functioning affected the magnitude, but not the direction or interpretation of clinical trial treatment arm differences. Sufficient sample sizes were available for only three of the eight language groups. Identification of differential functioning in two-thirds of the items suggests that current psychometric methods may be too sensitive. Enhanced methodologies are needed to differentiate trivial from substantive differential item functioning. Systematic variability in HRQL across different groups can be evaluated for its effect upon clinical trial results; a practice recommended when data are pooled across cultural or linguistic groups to make conclusions about treatment effects.

Routine Angiographic Follow-Up versus Clinical Follow-Up after Percutaneous Coronary Intervention in Acute Myocardial Infarction

PubMed Central

Kim, Yong Hoon; Her, Ae-Young; Choi, Byoung Geol; Shim, Minsuk; Choi, Se Yeon; Byun, Jae Kyeong; Li, Hu; Kim, Woohyeun; Kang, Jun Hyuk; Choi, Jah Yeon; Park, Eun Jin; Park, Sung Hun; Lee, Sunki; Na, Jin Oh; Choi, Cheol Ung; Lim, Hong Euy; Kim, Eung Ju; Park, Chang Gyu; Seo, Hong Seog; Oh, Dong Joo

2017-01-01

Purpose Differences in the utility of routine angiographic follow-up (RAF) and clinical follow-up (CF) after percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are not well understood. The present study aimed to compare the 3-year clinical outcomes of RAF and CF in AMI patients who underwent PCI with drug-eluting stents (DES). Materials and Methods A total of 774 consecutive AMI patients who underwent PCI with DES were enrolled. RAF was performed at 6 to 9 months after index PCI (n=425). The remaining patients were medically managed and clinically followed (n=349); symptom-driven events were captured. To adjust for any potential confounders, a propensity score matched analysis was performed using a logistic regression model, and two propensity-matched groups (248 pairs, n=496, C-statistic=0.739) were generated. Cumulative clinical outcomes up to 3 years were compared between RAF and CF groups. Results During the 3-year follow-up period, the cumulative incidences of revascularization [target lesion revascularization: hazard ratio (HR), 2.40; 95% confidence interval (CI), 1.18–4.85; p=0.015, target vessel revascularization (TVR): HR, 3.33; 95% CI, 1.69–6.58; p=0.001, non-TVR: HR, 5.64; 95% CI, 1.90–16.6; p=0.002] and major adverse cardiac events (MACE; HR, 3.32; 95% CI, 1.92–5.73; p<0.001) were significantly higher in the RAF group than the CF group. However, the 3-year incidences of death and myocardial infarction were not different between the two groups. Conclusion RAF following index PCI with DES in AMI patients was associated with increased incidences of revascularization and MACE. Therefore, CF seems warranted for asymptomatic patients after PCI for AMI. PMID:28540983

Recreational Marijuana Use and Acute Myocardial Infarction: Insights from Nationwide Inpatient Sample in the United States.

PubMed

Desai, Rupak; Patel, Upenkumar; Sharma, Shobhit; Amin, Parth; Bhuva, Rushikkumar; Patel, Malav S; Sharma, Nitin; Shah, Manan; Patel, Smit; Savani, Sejal; Batra, Neha; Kumar, Gautam

2017-11-03

Background Marijuana is a widely used recreational substance. Few cases have been reported of acute myocardial infarction following marijuana use. To our knowledge, this is the first ever study analyzing the lifetime odds of acute myocardial infarction (AMI) with marijuana use and the outcomes in AMI patients with versus without marijuana use. Methods We queried the 2010-2014 National Inpatient Sample (NIS) database for 11-70-year-old AMI patients. Pearson Chi-square test for categorical variables and Student T-test for continuous variables were used to compare the baseline demographic and hospital characteristics between two groups (without vs. with marijuana) of AMI patients. The univariate and multivariate analyses were used to assess and compare the clinical outcomes between two groups. We used Cochran-Armitage test to measure the trends. All statistical analyses were executed by IBM SPSS Statistics 22.0 (IBM Corp., Armonk, NY). We used weighted data to produce national estimates in our study. Results Out of 2,451,933 weighted hospitalized AMI patients, 35,771 patients with a history of marijuana and 2,416,162 patients without a history of marijuana use were identified. The AMI-marijuana group consisted more of younger, male, African American patients. The length of stay and mortality rate were lower in the AMI-marijuana group with more patients being discharged against medical advice. Multivariable analysis showed that marijuana use was a significant risk factor for AMI development when adjusted for age, sex, race (adjusted OR 1.079, 95% CI 1.065-1.093, p<0.001); adjusted for age, female, race, smoking, cocaine abuse (adjusted OR 1.041, 95% CI 1.027-1.054, p<0.001); and also when adjusted for age, female, race, payer status, smoking, cocaine abuse, amphetamine abuse and alcohol abuse (adjusted OR: 1.031, 95% CI: 1.018-1.045, p<0.001). Complications such as respiratory failure (OR 18.9, CI 15.6-23.0, p<0.001), cerebrovascular disease (OR 9.0, CI 7.0-11.7, p<0.001), cardiogenic shock (OR 6.0, CI 4.9-7.4, p<0.001), septicemia (OR 1.8, CI 1.5-2.2, p<0.001), and dysrhythmia (OR 1.8, CI 1.5-2.1, p<0.001) were independent predictors of mortality in AMI-marijuana group. Conclusion The lifetime AMI odds were increased in recreational marijuana users. Overall odds of mortality were not increased significantly in AMI-marijuana group. However, marijuana users showed higher trends of AMI prevalence and related mortality from 2010-2014. It is crucial to assess cardiovascular effects related to marijuana overuse and educate patients for the same.

Recreational Marijuana Use and Acute Myocardial Infarction: Insights from Nationwide Inpatient Sample in the United States

PubMed Central

Patel, Upenkumar; Sharma, Shobhit; Amin, Parth; Bhuva, Rushikkumar; Patel, Malav S; Sharma, Nitin; Shah, Manan; Patel, Smit; Savani, Sejal; Batra, Neha; Kumar, Gautam

2017-01-01

Background Marijuana is a widely used recreational substance. Few cases have been reported of acute myocardial infarction following marijuana use. To our knowledge, this is the first ever study analyzing the lifetime odds of acute myocardial infarction (AMI) with marijuana use and the outcomes in AMI patients with versus without marijuana use. Methods We queried the 2010-2014 National Inpatient Sample (NIS) database for 11-70-year-old AMI patients. Pearson Chi-square test for categorical variables and Student T-test for continuous variables were used to compare the baseline demographic and hospital characteristics between two groups (without vs. with marijuana) of AMI patients. The univariate and multivariate analyses were used to assess and compare the clinical outcomes between two groups. We used Cochran–Armitage test to measure the trends. All statistical analyses were executed by IBM SPSS Statistics 22.0 (IBM Corp., Armonk, NY). We used weighted data to produce national estimates in our study. Results Out of 2,451,933 weighted hospitalized AMI patients, 35,771 patients with a history of marijuana and 2,416,162 patients without a history of marijuana use were identified. The AMI-marijuana group consisted more of younger, male, African American patients. The length of stay and mortality rate were lower in the AMI-marijuana group with more patients being discharged against medical advice. Multivariable analysis showed that marijuana use was a significant risk factor for AMI development when adjusted for age, sex, race (adjusted OR 1.079, 95% CI 1.065-1.093, p<0.001); adjusted for age, female, race, smoking, cocaine abuse (adjusted OR 1.041, 95% CI 1.027-1.054, p<0.001); and also when adjusted for age, female, race, payer status, smoking, cocaine abuse, amphetamine abuse and alcohol abuse (adjusted OR: 1.031, 95% CI: 1.018-1.045, p<0.001). Complications such as respiratory failure (OR 18.9, CI 15.6-23.0, p<0.001), cerebrovascular disease (OR 9.0, CI 7.0-11.7, p<0.001), cardiogenic shock (OR 6.0, CI 4.9-7.4, p<0.001), septicemia (OR 1.8, CI 1.5–2.2, p<0.001), and dysrhythmia (OR 1.8, CI 1.5-2.1, p<0.001) were independent predictors of mortality in AMI-marijuana group. Conclusion The lifetime AMI odds were increased in recreational marijuana users. Overall odds of mortality were not increased significantly in AMI-marijuana group. However, marijuana users showed higher trends of AMI prevalence and related mortality from 2010-2014. It is crucial to assess cardiovascular effects related to marijuana overuse and educate patients for the same. PMID:29312837

Disease-Specific Trends of Comorbidity Coding and Implications for Risk Adjustment in Hospital Administrative Data.

PubMed

Nimptsch, Ulrike

2016-06-01

To investigate changes in comorbidity coding after the introduction of diagnosis related groups (DRGs) based prospective payment and whether trends differ regarding specific comorbidities. Nationwide administrative data (DRG statistics) from German acute care hospitals from 2005 to 2012. Observational study to analyze trends in comorbidity coding in patients hospitalized for common primary diseases and the effects on comorbidity-related risk of in-hospital death. Comorbidity coding was operationalized by Elixhauser diagnosis groups. The analyses focused on adult patients hospitalized for the primary diseases of heart failure, stroke, and pneumonia, as well as hip fracture. When focusing the total frequency of diagnosis groups per record, an increase in depth of coding was observed. Between-hospital variations in depth of coding were present throughout the observation period. Specific comorbidity increases were observed in 15 of the 31 diagnosis groups, and decreases in comorbidity were observed for 11 groups. In patients hospitalized for heart failure, shifts of comorbidity-related risk of in-hospital death occurred in nine diagnosis groups, in which eight groups were directed toward the null. Comorbidity-adjusted outcomes in longitudinal administrative data analyses may be biased by nonconstant risk over time, changes in completeness of coding, and between-hospital variations in coding. Accounting for such issues is important when the respective observation period coincides with changes in the reimbursement system or other conditions that are likely to alter clinical coding practice. © Health Research and Educational Trust.

Effects of Exercise on Cognition: The Finnish Alzheimer Disease Exercise Trial: A Randomized, Controlled Trial.

PubMed

Öhman, Hannareeta; Savikko, Niina; Strandberg, Timo E; Kautiainen, Hannu; Raivio, Minna M; Laakkonen, Marja-Liisa; Tilvis, Reijo; Pitkälä, Kaisu H

2016-04-01

To examine whether a regular, long-term exercise program performed by individuals with Alzheimer's disease (AD) at home or as group-based exercise at an adult daycare center has beneficial effects on cognition; to examine secondary outcomes of a trial that has been published earlier. Randomized, controlled trial. Community. Community-dwelling dyads (N = 210) of individuals with AD and their spousal caregivers randomized into three groups. Two types of intervention comprising customized home-based exercise (HE) and group-based exercise (GE), each twice a week for 1 year, were compared with a control group (CG) receiving usual community care. Cognitive function was measured using the Clock Drawing Test (CDT), Verbal Fluency (VF), Clinical Dementia Rating (CDR), and Mini-Mental State Examination (MMSE) at baseline and 3, 6, and 12 months of follow-up. Executive function, measured using CDT, improved in the HE group, and changes in the score were significantly better than those of the CG at 12 months (adjusted for age, sex, and CDR, P = .03). All groups deteriorated in VF and MMSE score during the intervention, and no significant differences between the groups were detected at 12-month follow-up when analyses were adjusted for age, sex, and CDR. Regular, long-term, customized HE improved the executive function of community-dwelling older people with memory disorders, but the effects were mild and were not observed in other domains of cognition. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Expert advice provided through telemedicine improves healing of chronic wounds: prospective cluster controlled study.

PubMed

Zarchi, Kian; Haugaard, Vibeke B; Dufour, Deirdre N; Jemec, Gregor B E

2015-03-01

Telemedicine is widely considered as an efficient approach to manage the growing problem of chronic wounds. However, to date, there is no convincing evidence to support the clinical efficacy of telemedicine in wound management. In this prospective cluster controlled study, we tested the hypothesis that advice on wound management provided by a team of wound-care specialists through telemedicine would significantly improve the likelihood of wound healing compared with the best available conventional practice. A total of 90 chronic wound patients in home care met all study criteria and were included: 50 in the telemedicine group and 40 in the conventional group. Patients with pressure ulcers, surgical wounds, and cancer wounds were excluded. During the 1-year follow-up, complete wound healing was achieved in 35 patients (70%) in the telemedicine group compared with 18 patients (45%) in the conventional group. After adjusting for important covariates, offering advice on wound management through telemedicine was associated with significantly increased healing compared with the best available conventional practice (telemedicine vs. conventional practice: adjusted hazard ratio 2.19; 95% confidence interval: 1.15-4.17; P=0.017). This study strongly supports the use of telemedicine to connect home-care nurses to a team of wound experts in order to improve the management of chronic wounds.

Continuous glucose monitoring in acute coronary syndrome.

PubMed

Rodríguez-Quintanilla, Karina Alejandra; Lavalle-González, Fernando Javier; Mancillas-Adame, Leonardo Guadalupe; Zapata-Garrido, Alfonso Javier; Villarreal-Pérez, Jesús Zacarías; Tamez-Pérez, Héctor Eloy

2013-01-01

Diabetes mellitus is an independent risk factor for cardiovascular disease. To compare the efficacy of devices for continuous glucose monitoring and capillary glucose monitoring in hospitalized patients with acute coronary syndrome using the following parameters: time to achieve normoglycemia, period of time in normoglycemia, and episodes of hypoglycemia. We performed a pilot, non-randomized, unblinded clinical trial that included 16 patients with acute coronary artery syndrome, a capillary or venous blood glucose ≥ 140 mg/dl, and treatment with a continuous infusion of fast acting human insulin. These patients were randomized into 2 groups: a conventional group, in which capillary measurement and recording as well as insulin adjustment were made every 4h, and an intervention group, in which measurement and recording as well as insulin adjustment were made every hour with a subcutaneous continuous monitoring system. Student's t-test was applied for mean differences and the X(2) test for qualitative variables. We observed a statistically significant difference in the mean time for achieving normoglycemia, favoring the conventional group with a P = 0.02. Continuous monitoring systems are as useful as capillary monitoring for achieving normoglycemia. Copyright © 2012 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

Comparison of clinical outcomes in diabetic and non-diabetic burns patients in a national burns referral centre in southeast Asia: A 3-year retrospective review.

PubMed

Low, Zhao-Kai; Ng, Wai-Yee; Fook-Chong, Stephanie; Tan, Bien-Keem; Chong, Si-Jack; Hwee, Jolie; Tay, Sook-Muay

2017-03-01

Diabetic burns patients may be at risk of worse clinical outcomes. This study aims to further investigate the impact of diabetes mellitus on clinical outcomes in burns patients in Singapore. A 3-year retrospective review was performed at the Singapore General Hospital Burns Centre (2011-2013). Pure inhalational burns were excluded. Diabetic (N=53) and non-diabetic (N=533) patients were compared, and the impact of diabetes on clinical outcomes, adjusting for confounders, was investigated using multivariate logistic regression. The diabetic group had a significantly higher incidence of wound infection and severe renal impairment, as well as a longer length of stay, higher number of operations and higher rate of unplanned readmission. ICU admission was significantly associated with hyperglycaemia (OR 5.44 [2.61-11.35], p<0.001) and a higher total body surface area of burn (OR per 1% TBSA 1.07 [1.05-1.09], p<0.001). Unplanned readmission was significantly associated with wound infection (OR 4.29 [1.70-10.83], p=0.002), and mortality associated with a higher TBSA (OR per 1% TBSA 1.1 [1.07-1.14], p<0.001). After adjusting for confounders, diabetes mellitus was not significantly associated with unplanned readmission or mortality. Diabetic burns patients have an increased risk of worse clinical outcomes, including wound infections, renal impairment and longer length of stay. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

Comparison of the outcome following the fixation of osteotomies or fractures associated with total hip replacement using cables or wires: the results at five years.

PubMed

Berton, C; Puskas, G J; Christofilopoulos, P; Stern, R; Hoffmeyer, P; Lübbeke, A

2012-11-01

There are no recent studies comparing cable with wire for the fixation of osteotomies or fractures in total hip replacement (THR). Our objective was to evaluate the five-year clinical and radiological outcomes and complication rates of the two techniques. We undertook a review including all primary and revision THRs performed in one hospital between 1996 and 2005 using cable or wire fixation. Clinical and radiological evaluation was performed five years post-operatively. Cables were used in 51 THRs and wires in 126, and of these, 36 THRs with cable (71%) and 101 with wire (80%) were evaluated at follow-up. The five-year radiographs available for 33 cable and 91 wire THRs revealed rates of breakage of fixation of 12 of 33 (36%) and 42 of 91 (46%), respectively. With cable there was a significantly higher risk of metal debris (68% vs. 9%; adjusted relative risk (RR) 6.6; 95% confidence interval (CI) 3.0 to 14.1), nonunion (36% vs. 21%; adjusted RR 2.0; 95% CI 1.0 to 3.9) and osteolysis around the material, acetabulum or femur (61% vs 19%; adjusted RR 3.9; 95% CI 2.3 to 6.5). Cable breakage increased the risk of osteolysis to 83%. There was a trend towards foreign-body reaction and increased infection with cables. Clinical results did not differ between the groups. In conclusion, we found a higher incidence of complications and a trend towards increased infection and foreign-body reaction with the use of cables.

Differences in clinical characteristics between patients assessed for NHS specialist psychotherapy and primary care counselling.

PubMed

Chiesa, Marco; Fonagy, Peter; Bateman, Anthony W

2007-12-01

Although several studies have described patient populations in primary care counselling settings and NHS (National Health Service) specialist psychotherapy settings, there is a paucity of studies specifically comparing differences in clinical characteristics between the two groups of patients. The aim of this study is to ascertain if specialist psychotherapy referrals represent a more challenging client group than primary care counselling patients. We compare the socio-demographic features and severity of presentation in the symptomatic, interpersonal problems and global adjustment dimensions of a sample of patients (N=384) assessed by a primary care counselling service located in North London and a sample of patients (N=853) assessed in eight NHS psychotherapy centres located within urban settings in England. Both the groups completed the Brief Symptom Inventory, the Inventory of Interpersonal Problems and Clinical Outcomes in Routine Evaluation Outcome Measure. Patients referred for specialist psychotherapy services were more dysfunctional than those referred for primary care counselling. The linear function constructed to discriminate the groups showed that a combination of more psychotic symptoms, social inhibitions and higher risk of self-harm effectively identified those referred to psychotherapy services, while patients exhibiting greater levels of somatic and anxiety symptoms and non-assertiveness were more likely to be seen in primary care settings. However, similarities between the two samples were also marked, as shown by the overlap in the distribution of clinical outcomes in routine evaluation clinical scores in the two samples. The findings are discussed in terms of their implications for policy and service delivery of these two types of psychological therapy services.

Participant-Informant Relationships Affect Quality of Life Ratings in Incipient and Clinical Alzheimer Disease.

PubMed

Lin, Amy; Brook, Jenny; Grill, Joshua D; Teng, Edmond

2017-03-01

Clinical trials in incipient and clinical Alzheimer disease (AD) often include informant-reported outcomes. Whereas informant reports in AD dementia may be modulated by the nature of participant-informant relationships, whether informant type affects reporting at earlier disease stages is less certain. We sought to determine the effects of participant-informant relationships on informant assessments of quality of life (QOL), functional abilities, and behavioral symptoms in individuals with normal cognition (NC), mild cognitive impairment (MCI), and mild-to-moderate AD dementia. Cross-sectional. Easton Center for Alzheimer Disease Research at the University of California, Los Angeles. A total of 399 individuals who met criteria for NC (N = 100), MCI [amnestic (N = 125) and nonamnestic (N = 61)], and AD (N = 113). Participants were subdivided into groups based on informant-participant relationships (spouse versus other). We examined informant effects on the Quality of Life-Alzheimer's Disease (QOL-AD) scale, the Functional Activities Questionnaire (FAQ), and the Neuropsychiatric Inventory (NPI). After adjustments for demographic and cognitive factors, spouse informants reported higher participant QOL in the amnestic MCI and AD groups than did other informants. No informant effects were seen on QOL-AD ratings in the nonamnestic MCI or NC groups or on the FAQ or NPI in the MCI and AD groups. Participant-informant relationships may modulate informant responses on subjective measures such as the QOL-AD in both incipient and clinical AD. Clinical trials that use informant measures may need to address these effects. Published by Elsevier Inc.

The impact of precancerous cervical lesions on functioning at work and work productivity.

PubMed

Lerner, Debra; Parsons, Susan K; Justicia-Linde, Faye; Chelmow, David; Chang, Hong; Rogers, William H; Greenhill, Annabel M; Perch, Katherine; Kruzikas, Denise

2010-09-01

To assess the work performance and productivity impact of human papillomavirus (HPV). A cross-sectional study compared 94 employed women with clinically significant HPV-related cervical lesions with 118 healthy controls. Data were collected by self-administered web-based questionnaire. At-work performance limitations and productivity loss (presenteeism) and absenteeism were measured. Univariate and multivariate case-control group and clinical subgroup differences were tested. Based on adjusted mean scores, the HPV group had significantly more at-work limitations and productivity loss than controls (P = 0.009), higher absence rates (P = 0.002), and significantly more productivity loss because of absences (P = 0.007). At-work limitations varied in association with martial status (P = 0.025); at-work productivity loss was associated with years of education (P = 0.039). HPV is costly for working women, their employers, and the economy.

Depressed suicide attempters with posttraumatic stress disorder.

PubMed

Ramberg, Maria; Stanley, Barbara; Ystgaard, Mette; Mehlum, Lars

2015-01-01

Posttraumatic stress disorder and major depressive disorder are well-established risk factors for suicidal behavior. This study compared depressed suicide attempters with and without comorbid posttraumatic stress disorder with respect to additional diagnoses, global functioning, depressive symptoms, substance abuse, history of traumatic exposure, and suicidal behavior. Adult patients consecutively admitted to a general hospital after a suicide attempt were interviewed and assessed for DSM-IV diagnosis and clinical correlates. Sixty-four patients (71%) were diagnosed with depression; of them, 21 patients (32%) had posttraumatic stress disorder. There were no group differences in social adjustment, depressive symptoms, or suicidal intent. However, the group with comorbid depression and posttraumatic stress disorder had more additional Axis I diagnoses, a higher degree of childhood trauma exposure, and more often reported previous suicide attempts, non-suicidal self-harm, and vengeful suicidal motives. These findings underline the clinical importance of diagnosis and treatment of posttraumatic stress disorder in suicide attempters.

Self-Concept and Psychological Adjustment Differences Between Self-Identified Male Transexuals and Male Homosexuals

ERIC Educational Resources Information Center

Roback, Howard B.; And Others

1977-01-01

Self-concept and adjustment data from anatomical males seeking sexual reassignment surgery were compared with that from a male homosexual group. Findings indicated that the homosexual group had a better self-image and was better adjusted than the sex change group. (Author)

Influenza vaccine text message reminders for urban, low-income pregnant women: a randomized controlled trial.

PubMed

Stockwell, Melissa S; Westhoff, Carolyn; Kharbanda, Elyse Olshen; Vargas, Celibell Y; Camargo, Stewin; Vawdrey, David K; Castaño, Paula M

2014-02-01

We evaluated the impact of influenza vaccine text message reminders in a low-income obstetric population. We conducted a randomized controlled trial that enrolled 1187 obstetric patients from 5 community-based clinics in New York City. The intervention group received 5 weekly text messages regarding influenza vaccination starting mid-September 2011 and 2 text message appointment reminders. Both groups received standard automated telephone appointment reminders. The prespecified endpoints were receipt of either pre- or postpartum influenza vaccination calculated cumulatively at the end of each month (September-December 2011). After adjusting for gestational age and number of clinic visits, women who received the intervention were 30% more likely to be vaccinated as of December 2011 (adjusted odds ratio [AOR] = 1.30; 95% confidence interval [CI] = 1.003, 1.69 end of September: AOR = 1.34; 95% CI = 0.98, 1.85; October: AOR = 1.35; 95% CI = 1.05, 1.75; November: AOR = 1.27; 95% CI = 0.98, 1.65). The subgroup of women early in the third trimester at randomization showed the greatest intervention effect (December 31: 61.9% intervention vs 49.0% control; AOR = 1.88; 95% CI = 1.12, 3.15). In this low-income obstetric population, text messaging was associated with increased influenza vaccination, especially in those who received messages early in their third trimester.

Heart failure in primary care: co-morbidity and utilization of health care resources.

PubMed

Carmona, Montserrat; García-Olmos, Luis M; García-Sagredo, Pilar; Alberquilla, Ángel; López-Rodríguez, Fernando; Pascual, Mario; Muñoz, Adolfo; Salvador, Carlos H; Monteagudo, José L; Otero-Puime, Ángel

2013-10-01

In order to ensure proper management of primary care (PC) services, the efficiency of the health professionals tasked with such services must be known. Patients with heart failure (HF) are characterized by advanced age, high co-morbidity and high resource utilization. To ascertain PC resource utilization by HF patients and variability in the management of such patients by GPs. Descriptive, cross-sectional study targeting a population attended by 129 GPs over the course of 1 year. All patients with diagnosis of HF in their clinical histories were included, classified using the Adjusted Clinical Group system and then grouped into six resource utilization bands (RUBs). Resource utilization and Efficiency Index were both calculated. One hundred per cent of patients with HF were ranked in RUBs 3, 4 and 5. The highest GP visit rate was 20 and the lowest in excess of 10 visits per year. Prescription drug costs for these patients ranged from €885 to €1422 per patient per year. Health professional efficiency varied notably, even after adjustment for co-morbidity (Efficiency Index Variation Ratio of 28.27 for visits and 404.29 for prescription drug cost). Patients with HF register a high utilization of resources, and there is great variability in the management of such patients by health professionals, which cannot be accounted for by the degree of case complexity.

Effect of Early Statin Treatment in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction

PubMed Central

Sim, Doo Sun; Cho, Kyung Hoon; Ahn, Youngkeun; Kim, Young Jo; Chae, Shung Chull; Hong, Taek Jong; Seong, In Whan; Chae, Jei Keon; Kim, Chong Jin; Cho, Myeong Chan; Rha, Seung-Woon; Bae, Jang Ho; Seung, Ki Bae; Park, Seung Jung

2013-01-01

Background and Objectives The benefit of early statin treatment following acute myocardial infarction (MI) complicated with cardiogenic shock (CS) has not been well studied. We sought to assess the effect of early statin therapy in patients with CS complicating acute MI. Subjects and Methods We studied 553 statin-naive patients with acute MI and CS (Killip class IV) who underwent revascularization therapy between November 2005 and January 2008 at 51 hospitals in the Korea Acute Myocardial Infarction Registry. Patients were divided into 2 groups: those who received statins during hospitalization (n=280) and those who did not (n=273). The influence of statin treatment on a 12-month clinical outcome was examined using a matched-pairs analysis (n=200 in each group) based on the propensity for receiving statin therapy during hospitalization. Results Before adjustment, patients receiving statin, compared to those not receiving statin, had a more favorable clinical profile, were less likely to suffer procedural complications, and more likely to receive adequate medical therapy. Patients receiving statin had lower unadjusted in-hospital mortality and composite rate of mortality, MI, and repeat revascularization at 12 months, which remained significantly lower after adjustment for patient risk, procedural characteristics, and treatment propensity. Conclusion In CS patients with acute MI undergoing revascularization therapy, early statin treatment initiated during hospitalization was associated with lower rates of in-hospital death and 12-month adverse cardiac events. PMID:23508129

Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial

PubMed Central

2011-01-01

Background Sexually transmitted infections (STIs) are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI) and the provision of condoms on the engagement in unprotected casual sex. Methods 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. Results 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66%) completed the study. 184/1115 (17%) had a casual sexual relationship abroad and overall 46/1115 (4.1%) had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6]) and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4]) had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40) in the motivational BI group, 24% (95%CI10-37) in the condoms group and 24% (95%CI14-33) in the control group (p = 0.7). Conclusion This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected Trial Registration Number ClinicalTrials.gov: NCT01056536 PMID:22044609

Prevalence, risk, and correlates of posttraumatic stress disorder across ethnic and racial minority groups in the United States.

PubMed

Alegría, Margarita; Fortuna, Lisa R; Lin, Julia Y; Norris, Fran H; Gao, Shan; Takeuchi, David T; Jackson, James S; Shrout, Patrick E; Valentine, Anne

2013-12-01

We assess whether posttraumatic stress disorder (PTSD) varies in prevalence, diagnostic criteria endorsement, and type and frequency of potentially traumatic events (PTEs) among a nationally representative US sample of 5071 non-Latino whites, 3264 Latinos, 2178 Asians, 4249 African Americans, and 1476 Afro-Caribbeans. PTSD and other psychiatric disorders were evaluated using the World Mental Health-Composite International Diagnostic Interview (WMH-CIDI) in a national household sample that oversampled ethnic/racial minorities (n=16,238) but was weighted to produce results representative of the general population. Asians have lower prevalence rates of probable lifetime PTSD, whereas African Americans have higher rates as compared with non-Latino whites, even after adjusting for type and number of exposures to traumatic events, and for sociodemographic, clinical, and social support factors. Afro-Caribbeans and Latinos seem to demonstrate similar risk to non-Latino whites, adjusting for these same covariates. Higher rates of probable PTSD exhibited by African Americans and lower rates for Asians, as compared with non-Latino whites, do not appear related to differential symptom endorsement, differences in risk or protective factors, or differences in types and frequencies of PTEs across groups. There appears to be marked differences in conditional risk of probable PTSD across ethnic/racial groups. Questions remain about what explains risk of probable PTSD. Several factors that might account for these differences are discussed, as well as the clinical implications of our findings. Uncertainty of the PTSD diagnostic assessment for Latinos and Asians requires further evaluation.

Has the Reform of the Japanese Healthcare Provision System Improved the Value in Healthcare? A Cost-Consequence Analysis of Organized Care for Hip Fracture Patients

PubMed Central

Fukuda, Haruhisa; Shimizu, Sayuri; Ishizaki, Tatsuro

2015-01-01

Objectives To assess the value of organized care by comparing the clinical outcomes and healthcare expenditure between the conventional Japanese “integrated care across specialties within one hospital” mode of providing healthcare and the prospective approach of “organized care across separate facilities within a community”. Design Retrospective cohort study. Setting Two groups of hospitals were categorized according to healthcare delivery approach: the first group included 3 hospitals autonomously providing integrated care across specialties, and the second group included 4 acute care hospitals and 7 rehabilitative care hospitals providing organized care across separate facilities. Participants Patients aged 65 years and above who had undergone hip fracture surgery. Measurements Regression models adjusting for patient characteristics and clinical variables were used to investigate the impact of organized care on the improvements to the mobility capability of patients before and after hospitalization and the differences in healthcare resource utilization. Results The sample for analysis included 837 hip fracture surgery cases. The proportion of patients with either unchanged or improved mobility capability was not statistically associated with the healthcare delivery approaches. Total adjusted mean healthcare expenditure for integrated care and organized care were US$28,360 (95% confidence interval: 27,787-28,972) and US$21,951 (21,511-22,420), respectively, indicating an average increase of US$6,409 in organized care. Conclusion Our cost-consequence analysis underscores the need to further investigate the actual contribution of organized care to the provision of efficient and high-quality healthcare. PMID:26208322

Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial.

PubMed

Senn, Nicolas; de Valliere, Serge; Berdoz, Didier; Genton, Blaise

2011-11-01

Sexually transmitted infections (STIs) are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI) and the provision of condoms on the engagement in unprotected casual sex. 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66%) completed the study. 184/1115 (17%) had a casual sexual relationship abroad and overall 46/1115 (4.1%) had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6]) and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4]) had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40) in the motivational BI group, 24% (95%CI10-37) in the condoms group and 24% (95%CI14-33) in the control group (p = 0.7). This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected ClinicalTrials.gov: NCT01056536.

Psychosocial adjustment and life satisfaction until 5 years after severe brain damage.

PubMed

Sörbo, Ann K; Blomqvist, Maritha; Emanuelsson, Ingrid M; Rydenhag, Bertil

2009-06-01

The objectives of this study were to describe psychosocial adjustment and outcome over time for severely brain-injured patients and to find suitable outcome measures for clinical practice during the rehabilitation process and for individual rehabilitation planning after discharge from hospital. The methods include a descriptive, prospective, population-based study. The participants were assessed at 6 months and annually until 5 years after traumatic brain injury or nontraumatic subarachnoid haemorrhage. Inclusion criteria were age 16-65 years, severe traumatic brain injury or nontraumatic subarachnoid haemorrhage defined as Glasgow Coma Scale 8 or worse and need for neurointensive care for at least 5 days. The main outcome measures were Head Injury Evaluation Chart, Glasgow Outcome Scale Extended (GOSE) and Life Satisfaction Questionnaire (LiSat)-11 checklist. Change over time for the group and the individuals, as measured with the GOSE, was analyzed by a statistical method that is suitable for small datasets and takes into account the nonmetric properties of the data. Eighteen patients were included. Three died and one was excluded for the long-term follow-up (n=14). The group had a good outcome with no participant remaining in a vegetative state, 93% (12 of 13) went home and 60% (six of 10) returned to work. Eighty percent (eight of 10) of participants rated 'life as a whole' as satisfactory 5 years after the injury. The change at group level was significant (GOSE) until 1 year after the injury. The GOSE and the LiSat-11 were most clinically useful as they were easy to use for the rater/participants.

Pain Sensitivity Subgroups in Individuals With Spine Pain: Potential Relevance to Short-Term Clinical Outcome

PubMed Central

Bialosky, Joel E.; Robinson, Michael E.

2014-01-01

Background Cluster analysis can be used to identify individuals similar in profile based on response to multiple pain sensitivity measures. There are limited investigations into how empirically derived pain sensitivity subgroups influence clinical outcomes for individuals with spine pain. Objective The purposes of this study were: (1) to investigate empirically derived subgroups based on pressure and thermal pain sensitivity in individuals with spine pain and (2) to examine subgroup influence on 2-week clinical pain intensity and disability outcomes. Design A secondary analysis of data from 2 randomized trials was conducted. Methods Baseline and 2-week outcome data from 157 participants with low back pain (n=110) and neck pain (n=47) were examined. Participants completed demographic, psychological, and clinical information and were assessed using pain sensitivity protocols, including pressure (suprathreshold pressure pain) and thermal pain sensitivity (thermal heat threshold and tolerance, suprathreshold heat pain, temporal summation). A hierarchical agglomerative cluster analysis was used to create subgroups based on pain sensitivity responses. Differences in data for baseline variables, clinical pain intensity, and disability were examined. Results Three pain sensitivity cluster groups were derived: low pain sensitivity, high thermal static sensitivity, and high pressure and thermal dynamic sensitivity. There were differences in the proportion of individuals meeting a 30% change in pain intensity, where fewer individuals within the high pressure and thermal dynamic sensitivity group (adjusted odds ratio=0.3; 95% confidence interval=0.1, 0.8) achieved successful outcomes. Limitations Only 2-week outcomes are reported. Conclusions Distinct pain sensitivity cluster groups for individuals with spine pain were identified, with the high pressure and thermal dynamic sensitivity group showing worse clinical outcome for pain intensity. Future studies should aim to confirm these findings. PMID:24764070

Effects of an Antioxidant-enriched Multivitamin in Cystic Fibrosis: Randomized, Controlled, Multicenter Trial.

PubMed

Sagel, Scott D; Khan, Umer; Jain, Raksha; Graff, Gavin; Daines, Cori L; Dunitz, Jordan M; Borowitz, Drucy; Orenstein, David M; Abdulhamid, Ibrahim; Noe, Julie; Clancy, John P; Slovis, Bonnie; Rock, Michael J; McCoy, Karen S; Strausbaugh, Steven; Livingston, Floyd R; Papas, Konstantinos A; Shaffer, Michele L

2018-04-24

Cystic fibrosis (CF) is characterized by dietary antioxidant deficiencies, which may contribute to an oxidant-antioxidant imbalance and oxidative stress. Evaluate the effects of an oral antioxidant-enriched multivitamin supplement on antioxidant concentrations, markers of inflammation and oxidative stress, and clinical outcomes. In this investigator-initiated, multicenter, randomized, double-blind, controlled trial, 73 pancreatic insufficient CF subjects 10 years of age and older with an FEV1 between 40-100% predicted were randomized to 16 weeks of an antioxidant-enriched multivitamin or control multivitamin without antioxidant enrichment. Endpoints included systemic antioxidant concentrations, markers of inflammation and oxidative stress, clinical outcomes (pulmonary exacerbations, anthropometric measures, pulmonary function), safety and tolerability. Change in sputum myeloperoxidase concentration over 16 weeks, the primary efficacy endpoint, was not significantly different between the treated and control groups. Systemic antioxidant concentrations (β-carotene, CoQ10, γ-tocopherol, lutein) significantly increased in the antioxidant treated group (p<0.001 for each), while circulating calprotectin and myeloperoxidase decreased in the treated group compared to the control group at week 4. The treated group had a lower risk of first pulmonary exacerbation requiring antibiotics than the control group (adjusted hazard ratio=0.50, p=0.04). Lung function and growth endpoints did not differ between groups. Adverse events and tolerability were similar between groups. Antioxidant supplementation was safe and well tolerated, resulting in increased systemic antioxidant concentrations and modest reductions in systemic inflammation after 4 weeks. Antioxidant treatment was also associated with a lower risk of first pulmonary exacerbation. Clinical trial registration available at www.clinicaltrials.gov, ID NCT01859390.

Field test of the feasibility and validity of using the Hoosier Assurance Plan Instrument for Adults in a state mental health program.

PubMed

Newman, Frederick L; McGrew, John; Deliberty, Richard N

2009-08-01

The current paper reports on the feasibility of using the HAPI-A, an instrument designed to assess a person's level of functioning in the community: (1) to help determine eligibility to receive behavioral health services, (2) to assign reimbursement case rates; and (3) to provide data for a service provider report card. A 3-year field study of the use of the instrument across an entire state mental health system explored the effectiveness of methods to enhance data accuracy, including annual training and a professional clinical record audit, and the ability of the test to detect differences in improvement rates within risk-adjusted groupings. The combination of training and auditing produced statistically significant, cumulative reductions in data errors across all 3 years of the field test. The HAPI-A also was sensitive in detecting differences among service providers in outcome improvements for six of six risk-adjusted groups rated at the moderate level of impairment and for five of six groups rated at the mild level of impairment, but was inconsistent in detecting outcome differences for persons rated at the severe level of impairment.

Modelling the impact of new patient visits on risk adjusted access at 2 clinics.

PubMed

Kolber, Michael A; Rueda, Germán; Sory, John B

2018-06-01

To evaluate the effect new outpatient clinic visits has on the availability of follow-up visits for established patients when patient visit frequency is risk adjusted. Diagnosis codes for patients from 2 Internal Medicine Clinics were extracted through billing data. The HHS-HCC risk adjusted scores for each clinic were determined based upon the average of all clinic practitioners' profiles. These scores were then used to project encounter frequencies for established patients, and for new patients entering the clinic based on risk and time of entry into the clinics. A distinct mean risk frequency distribution for physicians in each clinic could be defined providing model parameters. Within the model, follow-up visit utilization at the highest risk adjusted visit frequencies would require more follow-up slots than currently available when new patient no-show rates and annual patient loss are included. Patients seen at an intermediate or lower visit risk adjusted frequency could be accommodated when new patient no-show rates and annual patient clinic loss are considered. Value-based care is driven by control of cost while maintaining quality of care. In order to control cost, there has been a drive to increase visit frequency in primary care for those patients at increased risk. Adding new patients to primary care clinics limits the availability of follow-up slots that accrue over time for those at highest risk, thereby limiting disease and, potentially, cost control. If frequency of established care visits can be reduced by improved disease control, closing the practice to new patients, hiring health care extenders, or providing non-face to face care models then quality and cost of care may be improved. © 2018 John Wiley & Sons, Ltd.

The influence of pelvic adjustment on vertical jump height in female university students with functional leg length inequality.

PubMed

Gong, Wontae

2015-01-01

[Purpose] This study aimed to investigate the effect of pelvic adjustment on vertical jump height (VJH) in female university students with functional leg length inequality (FLLI). [Subjects] Thirty female university students with FLLI were divided into a pelvic adjustment group (n = 15) and a stretching (control) group (n = 15). [Methods] VJH was measured using an OptoGait. [Results] After the intervention, jump height improved significantly compared with the pre-intervention height only in the pelvic adjustment group, while FLLI showed statistically significant improvement in both groups. [Conclusion] Pelvic adjustment as per the Gonstead method can be applied as a method of reducing FLLI and increasing VJH.

Personality, cognitive appraisal and adjustment in chronic pain patients.

PubMed

Herrero, Ana M; Ramírez-Maestre, Carmen; González, Vanessa

2008-11-01

This study investigated the relationship between clinical personality patterns and cognitive appraisal as well as their repercussions on adjustment to chronic pain in a sample of 91 patients. It was predicted that clinical personality patterns would be related to adjustment and cognitive appraisal processes, whereas cognitive appraisals would be related to anxiety, depression and levels of perceived pain. The instruments used were as follows: the Millon Clinical Multiaxial Inventory, the Cognitive Appraisal Questionnaire, the Hospital Anxiety and Depression Scale, and the McGill Pain Questionnaire. Multiple regression analyses, the Kruskal-Wallis test, and the Mann Whitney U-test were used to analyse the data obtained. The results show that certain clinical personality patterns were associated with poor adjustment to chronic pain. The use of cognitive appraisal of harm predicted higher anxiety levels and greater perceived pain in chronic pain patients. The use of cognitive appraisals of challenge predicted lower depression levels.

The American College of Surgeons National Surgical Quality Improvement Program: achieving better and safer surgery.

PubMed

Ko, Clifford Y; Hall, Bruce L; Hart, Amy J; Cohen, Mark E; Hoyt, David B

2015-05-01

The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP), in operation since late 2004, evaluates surgical quality and safety by feeding back valid, timely, risk-adjusted outcomes, which providers use to improve care. A number of components have been developed and refined in the more than a decade since ACS NSQIP's initiation. These items can be grouped into areas of data collection, case sampling, risk adjustment, feedback reporting, the expansion into procedure-targeted sampling, development of improvement collaboratives, and the development of improvement tools. Although ACS NSQIP was originally designed as a hospital-based program, it now also allows for surgeon-specific reporting that can be used by individual surgeons as a feedback tool to improve their performance. There are more than 600 ACS NSQIP hospitals in 49 of the 50 states of the United States and in 13 other countries. Virtually all surgical (sub)specialties are touched by ACS NSQIP, which contains several million patient records and more than 100 statistically risk-adjusted models. In studies that have used ACS NSQIP clinical data, demonstrable improvement has been reported in local hospitals, in regional collaboratives, and across the program overall. Concomitantly, substantial cost savings for individual hospitals, as well as at regional and national levels, have been reported. ACS NSQIP has not only demonstrated how and why the use of accurate clinical data is crucial, but also how the program, through its risk-adjusted feedback, improvement tools, and hospital collaboratives, helps hospitals and providers to achieve safer surgery and better patient care.

Association of Intradialytic Hypertension with Left Ventricular Mass in Hypertensive Hemodialysis Patients Enrolled in the Blood Pressure in Dialysis (BID) Study.

PubMed

Shamir, Amith Roy; Karembelkar, Ameet; Yabes, Jonathan; Yao, Yi; Miskulin, Dana; Gassman, Jennifer; Ploth, David; Negrea, Lavinia; Paine, Susan; Rahman, Mahboob; Kwong, Raymond Y; Zager, Philip; Jhamb, Manisha

2018-05-30

Intradialytic hypertension (IDH), or paradoxical rise in blood pressure (BP) during hemodialysis (HD) is associated with increased morbidity and mortality. The association between IDH and increased left ventricular mass (LVM), a well-known risk factor for adverse cardiovascular outcomes in HD patients, has not been studied. The aim of our study is to evaluate the cross-sectional association of intradialytic change in BP with cardiac structure and function measured by cardiac MRI in hypertensive HD patients enrolled in the multi-center Blood Pressure in Dialysis (BID) clinical trial. Participants in the BID study were categorized into 3 groups based on average change (Δ) in systolic blood pressure (SBP) (post-HD SBP minus pre-HD SBP) during HD over a 1 month period: group 1 - patients with an increase in SBP ≥ 10mm Hg during HD (IDH); group 2 -patients with SBP decrease of greater ≥10mm Hg during HD; group 3 - patients with SBP increase or decrease by < 10mm Hg during HD. LVM index (LVMI) was measured using cardiac MRI, which were centrally read. Baseline characteristics were compared in the 3 groups and multivariable regression models were fitted for the adjusted association of IDH with LVMI. Among the 80 participants, 7 (8.8%) had IDH and had average Δ SBP 17.0 ± 10.1 mmHg during HD. Patients with IDH were less likely to be diabetic, had lower pre-dialysis SBP and lower percent interdialytic weight gain as compared to the other 2 groups (p=0.02, p< 0.001 and p=0.02 respectively). In multivariable regression analyses, IDH was significantly associated with LVMI (adjusted mean difference relative to SBP decreased group [95% confidence interval (CI)] = 12.5 [3.6, 21.5], p=0.01) after adjusting for age, sex, diabetes, IDWG%, pre-HD SBP and beta blocker use. Every 1 mm rise in ΔSBP during HD was associated with 0.2 g/m2 increase in LVMI in adjusted models (p=0.04). IDH is independently associated with higher LVMI in hypertensive HD patients and may contribute to increased cardiovascular events. © 2018 The Author(s). Published by S. Karger AG, Basel.

Matching-adjusted comparisons demonstrate better clinical outcomes with SC peginterferon beta-1a every two weeks than with SC interferon beta-1a three times per week.

PubMed

Coyle, Patricia K; Shang, Shulian; Xiao, Zhen; Dong, Qunming; Castrillo-Viguera, Carmen

2018-05-01

Subcutaneous (SC) peginterferon beta-1a and SC interferon beta-1a (IFN beta-1a) have demonstrated efficacy in treating relapsing-remitting multiple sclerosis (RRMS) but have never been compared in direct head-to-head clinical trials, the gold-standard comparison. A well-balanced matching-adjusted comparison of weighted individual patient data on SC peginterferon beta-1a, and aggregate data from published phase 3 clinical trials of SC IFN beta-1a, was conducted to provide additional information on the comparative efficacy of these two agents. Individual patient data from a study of SC peginterferon beta-1a 125 mcg every two weeks (ADVANCE) and pooled summary data from four published studies of SC IFN beta-1a 44 mcg three times per week (OPERA I and II, CARE-MS I and II) with similar populations were utilized. A comparison was conducted by weighting individual peginterferon beta-1a-treated patients, using estimated propensity of enrolling in SC IFN beta-1a treatment to match multiple key aggregate baseline characteristics of SC IFN beta-1a-treated patients. After matching, weighted annualized relapse rate (ARR), 24-week confirmed disability worsening (CDW), and clinical no evidence of disease activity (clinical-NEDA) were calculated and compared for peginterferon beta-1a and SC IFN beta-1a. After matching, baseline characteristics were well balanced across treatment groups. At 2 years, ARR after matching was 0.256 for patients receiving peginterferon beta-1a (effective n = 376) and 0.335 for those receiving SC IFN beta-1a (n = 1218) (P = 0.0901). The percentage of patients who were relapse free over 2 years was significantly higher with peginterferon beta-1a than with SC IFN beta-1a (75.1% vs. 57.4% [after matching], P < 0.0001). The peginterferon beta-1a treatment group had a significantly lower proportion of patients with 24-week CDW compared with SC IFN beta-1a (after matching 6.5% vs. 13.2%; P = 0.0007). Clinical-NEDA occurred in a significantly higher proportion of patients treated with SC peginterferon beta-1a versus SC IFN beta-1a (74.1% vs. 48.1%; P < 0.0001). This matching-adjusted comparison using data from four phase 3 trials with SC IFN beta-1a formulations demonstrated that patients with RRMS treated with SC peginterferon beta-1a 125 mcg every two weeks achieved better clinical outcomes than patients who received SC IFN beta-1a 44 mcg three times per week. Copyright © 2018 The Authors. Published by Elsevier B.V. All rights reserved.

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a.

PubMed

Rudick, R A; Pace, A; Rani, M R S; Hyde, R; Panzara, M; Appachi, S; Shrock, J; Maurer, S L; Calabresi, P A; Confavreux, C; Galetta, S L; Lublin, F D; Radue, E-W; Ransohoff, R M

2009-06-09

Findings from a small clinical study suggested that statins may counteract the therapeutic effects of interferon beta (IFNbeta) in patients with relapsing-remitting multiple sclerosis (RRMS). We conducted a post hoc analysis of data from the Safety and Efficacy of Natalizumab in Combination With IFNbeta-1a in Patients With Relapsing-Remitting Multiple Sclerosis (SENTINEL) study to determine the effects of statins on efficacy of IFNbeta. SENTINEL was a prospective trial of patients with RRMS treated with natalizumab (Tysabri, Biogen Idec, Inc., Cambridge, MA) plus IM IFNbeta-1a (Avonex, Biogen Idec, Inc.) 30 microg compared with placebo plus IM IFNbeta-1a 30 microg. Clinical and MRI outcomes in patients treated with IM IFNbeta-1a only (no-statins group, n = 542) were compared with those of patients taking IM IFNbeta-1a and statins at doses used to treat hyperlipidemia (statins group, n = 40). No significant differences were observed between treatment groups in adjusted annualized relapse rate (p = 0.937), disability progression (p = 0.438), number of gadolinium-enhancing lesions (p = 0.604), or number of new or enlarging T2-hyperintense lesions (p = 0.802) at 2 years. More patients in the statins group reported fatigue, extremity pain, muscle aches, and increases in hepatic transaminases compared with patients in the no-statins group. Statin treatment had no ex vivo or in vitro effect on induction of IFN-stimulated genes. Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment.

Does reducing gamete co-incubation time improve clinical outcomes: a retrospective study.

PubMed

Li, Rui-Qi; Ouyang, Neng-Yong; Ou, Song-Bang; Ni, Ren-Min; Mai, Mei-Qi; Zhang, Qing-Xue; Yang, Dong-Zi; Wang, Wen-Jun

2016-01-01

The objective of this retrospective study was to determine whether patients undergoing in vitro fertilization (IVF) benefit from reducing the gamete co-incubation time. Patients (n = 570) were enrolled, including 281 patients in the reduced incubation time group (2-h incubation) and 289 patients in the standard IVF group (18-h incubation). The observed outcomes, including the clinical pregnancy rate (CPR), implantation rate (IR), live birth rate (LBR), and miscarriage rate (MR), were similar between the two groups. When the data were divided into two subgroups based on the maternal age (≤30 and >30 years), the rates of top-quality embryos (30.83 vs. 25.89 %; p = 0.028), CPR (66.67 vs. 42.11 %; p = 0.013), and IR (41.90 vs. 31.25 %, p = 0.019) of the 2-h incubation group were significantly higher in the younger subgroup. However, for older patients, only a lower MR (7.59 vs. 20.83 %; p = 0.019) was achieved. Reducing the time of incubation still improved the CPR (OR = 1.993, 95 % CI 1.141-3.480) and MR (OR = 3.173, 95 % CI 1.013-9.936) in the younger and older subgroups, respectively, after it was adjusted for potential confounders. Reducing incubation time improves the clinical results of IVF, although the LBR is not statistically different between the 2- and 18-h incubation time groups. And the specific clinical outcomes of reducing incubation time varied between the >30-year-old and the ≤30-year-old.

Shortened length of stay and hospital cost reduction with implementation of an accelerated clinical care pathway after elective colon resection.

PubMed

Stephen, Antonia E; Berger, David L

2003-03-01

Patient care pathways have been developed for operative procedures with documented improvements in length of stay and cost without compromising outcome. The average hospital stay after colonic resection is 5 to 10 days. This study describes a clinical pathway for colon resections and examines patient outcome before and after institution of the pathway. One hundred thirty-eight patients underwent elective colon resections at our institution by a single surgeon before (n = 52) and after (n = 86) introduction of a clinical pathway. Length of stay, postoperative complications, readmissions, and cost per patient were compared between the 2 groups. Mean total length of stay (+/- standard deviation [SD]) was less in the postclinical pathway patients (3.7 +/- 1.5 days) compared to preclinical pathway patients (6.6 +/- 3.3 days) (P <.001). When adjusted for age, sex, diagnosis, and type of operation, the difference in length of stay remains statistically significant (P <.001). There was 1 readmission in the prepathway group and 8 readmissions in the postpathway group. When the readmissions were added to the original admissions, the mean length of stay in the postpathway patients was 4.2 +/- 2.8 days and in the prepathway patients was 6.9 +/- 4.1 days (P <.001). The average cost per patient (+/- standard error of the mean), with readmission costs added, was 9310 +/- 5170 US dollars in the prepathway group and 7070 +/- 3670 US dollars in the postpathway group (P =.002). The institution of a clinical pathway for elective, open colon resections can be done safely with improvements in cost and length of stay.

Comparative efficacy of two battery-powered toothbrushes on dental plaque removal.

PubMed

Ruhlman, C Douglas; Bartizek, Robert D; Biesbrock, Aaron R

2002-01-01

A number of clinical studies have consistently demonstrated that power toothbrushes deliver superior plaque removal compared to manual toothbrushes. Recently, a new power toothbrush (Crest SpinBrush) has been marketed with a design that fundamentally differs from other marketed power toothbrushes. Other power toothbrushes feature a small, round head designed to oscillate for enhanced cleaning between the teeth and below the gumline. The new power toothbrush incorporates a similar round oscillating head in conjunction with fixed bristles, which allows the user to brush with optimal manual brushing technique. The objective of this randomized, examiner-blind, parallel design study was to compare the plaque removal efficacy of a positive control power toothbrush (Colgate Actibrush) to an experimental toothbrush (Crest SpinBrush) following a single use among 59 subjects. Baseline plaque scores were 1.64 and 1.40 for the experimental toothbrush and control toothbrush treatment groups, respectively. With regard to all surfaces examined, the experimental toothbrush delivered an adjusted (via analysis of covariance) mean difference between baseline and post-brushing plaque scores of 0.47, while the control toothbrush delivered an adjusted mean difference of 0.33. On average, the difference between toothbrushes was statistically significant (p = 0.013). Because the covariate slope for the experimental group was statistically significantly greater (p = 0.001) than the slope for the control group, a separate slope model was used. Further analysis demonstrated that the experimental group had statistically significantly greater plaque removal than the control group for baseline plaque scores above 1.43. With respect to buccal surfaces, using a separate slope analysis of covariance, the experimental toothbrush delivered an adjusted mean difference between baseline and post-brushing plaque scores of 0.61, while the control toothbrush delivered an adjusted mean difference of 0.39. This difference between toothbrushes was also statistically significant (p = 0.002). On average, the results on lingual surfaces demonstrated similar directional scores favoring the experimental toothbrush; however these results did not achieve statistical significance. In conclusion, the experimental Crest SpinBrush, with its novel fixed and oscillating bristle design, was found to be more effective than the positive control Colgate Actibrush, which is designed with a small round oscillating cluster of bristles.

Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study – a randomized controlled trial

PubMed Central

Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

2016-01-01

Objective: Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. Methods: A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Results: Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were −17.9 mmHg (95%CI −30.9 to −4.9); P = 0.010 and −6.6 mmHg (95%CI −12.9 to −0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were −12.1 mmHg (95%CI −29.1 to 5.1); P = 0.158 and of −5.3 mmHg (95%CI −16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was −10.7 ml/min per 1.73 m2 (95%CI −20.1 to −1.4); P = 0.027. Conclusion: We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated’ in all patients with resistant hypertension before considering RDN. PMID:27327441

Spironolactone versus sympathetic renal denervation to treat true resistant hypertension: results from the DENERVHTA study - a randomized controlled trial.

PubMed

Oliveras, Anna; Armario, Pedro; Clarà, Albert; Sans-Atxer, Laia; Vázquez, Susana; Pascual, Julio; De la Sierra, Alejandro

2016-09-01

Both renal denervation (RDN) and spironolactone have been proposed for the treatment of resistant hypertension. However, they have not been compared in a randomized clinical trial. We aimed to compare the efficacy of spironolactone versus RDN in patients with resistant hypertension. A total of 24 patients with office SBP at least 150 mmHg and 24-h SBP at least 140 mmHg despite receiving at least three full-dose antihypertensive drugs, one a diuretic, but without aldosterone antagonists, were randomized to receive RDN or spironolactone (50 mg) as add-on therapy. Primary endpoint was change in 24-h SBP at 6 months. Comparisons between treatment groups were performed using generalized linear models adjusted by age, sex, and baseline values. Spironolactone was more effective than RDN in reducing 24-h SBP and 24-h DBP: mean baseline-adjusted differences between the two groups were -17.9 mmHg (95%CI -30.9 to -4.9); P = 0.010 and -6.6 mmHg (95%CI -12.9 to -0.3); P = 0.041, for 24-h SBP and 24-h DBP, respectively. As regards changes in office blood pressure, mean baseline-adjusted differences between the two groups were -12.1 mmHg (95%CI -29.1 to 5.1); P = 0.158 and of -5.3 mmHg (95%CI -16.3 to 5.8); P = 0.332, for office SBP and office DBP, respectively. Otherwise, the decrease of estimated glomerular filtration rate was greater in the spironolactone group; mean baseline-adjusted difference between the two groups was -10.7 ml/min per 1.73 m (95%CI -20.1 to -1.4); P = 0.027. We conclude that spironolactone is more effective than RDN to reduce 24-h SBP and 24-h DBP in patients with resistant hypertension. Therefore, spironolactone should be the fourth antihypertensive drug to prescribe if deemed well tolerated' in all patients with resistant hypertension before considering RDN.

[Factors influencing nurses' clinical decision making--focusing on critical thinking disposition].

PubMed

Park, Seungmi; Kwon, In Gak

2007-10-01

The purpose of this study was to investigate the factors influencing nurses' clinical decision making focusing on critical thinking disposition. The subjects of this study consisted of 505 nurses working at one of the general hospitals located in Seoul. Data was collected by a self-administered questionnaire between December 2006 and January 2007. Data was analyzed by one way ANOVA, Pearson correlation coefficients, and stepwise multiple regression using SPSS Win 14.0. The mean scores of critical thinking disposition and clinical decision making were 99.10 and 134.32 respectively. Clinical decision making scores were significantly higher in groups under continuing education, with a master or higher degree, with clinical experience more than 5 years, or with experts. Critical thinking disposition and its subscales have a significant correlation with clinical decision making. Intellectual eagerness/curiosity, prudence, clinical experience, intellectual honesty, self-confidence, and healthy skepticism were important factors influencing clinical decision making(adjusted R(2)=33%). Results of this study suggest that various strategies such as retaining experienced nurses, encouraging them to continue with education and enhancing critical thinking disposition are warranted for development of clinical decision making.

Shared clinical decision making

PubMed Central

AlHaqwi, Ali I.; AlDrees, Turki M.; AlRumayyan, Ahmad; AlFarhan, Ali I.; Alotaibi, Sultan S.; AlKhashan, Hesham I.; Badri, Motasim

2015-01-01

Objectives: To determine preferences of patients regarding their involvement in the clinical decision making process and the related factors in Saudi Arabia. Methods: This cross-sectional study was conducted in a major family practice center in King Abdulaziz Medical City, Riyadh, Saudi Arabia, between March and May 2012. Multivariate multinomial regression models were fitted to identify factors associated with patients preferences. Results: The study included 236 participants. The most preferred decision-making style was shared decision-making (57%), followed by paternalistic (28%), and informed consumerism (14%). The preference for shared clinical decision making was significantly higher among male patients and those with higher level of education, whereas paternalism was significantly higher among older patients and those with chronic health conditions, and consumerism was significantly higher in younger age groups. In multivariate multinomial regression analysis, compared with the shared group, the consumerism group were more likely to be female [adjusted odds ratio (AOR) =2.87, 95% confidence interval [CI] 1.31-6.27, p=0.008] and non-dyslipidemic (AOR=2.90, 95% CI: 1.03-8.09, p=0.04), and the paternalism group were more likely to be older (AOR=1.03, 95% CI: 1.01-1.05, p=0.04), and female (AOR=2.47, 95% CI: 1.32-4.06, p=0.008). Conclusion: Preferences of patients for involvement in the clinical decision-making varied considerably. In our setting, underlying factors that influence these preferences identified in this study should be considered and tailored individually to achieve optimal treatment outcomes. PMID:26620990

No effect of 2008/09 seasonal influenza vaccination on the risk of pandemic H1N1 2009 influenza infection in England.

PubMed

Pebody, Richard; Andrews, Nick; Waight, Pauline; Malkani, Rashmi; McCartney, Christine; Ellis, Joanna; Miller, Elizabeth

2011-03-21

This study reports effectiveness of trivalent influenza vaccine (TIV) against confirmed pandemic influenza infection in England using a retrospective test-negative case-control study. Cases and controls were frequency matched by age, swabbing-week and region. On univariable and multivariable analysis adjusted for underlying clinical risk factors, cases were no more or less likely than controls to be vaccinated with 2008-09 or 2007-08 season TIV. Adjusted vaccine effectiveness for the former was -6% (-43% to 22%). Vaccine effectiveness did not differ significantly by age-group or hospitalisation status. There was no evidence prior vaccination with TIV significantly altered subsequent risk of pandemic influenza H1N1 2009 infection. Copyright © 2011 Elsevier Ltd. All rights reserved.

Recovery from work-related stress: a randomized controlled trial of a stress management intervention in a clinical sample.

PubMed

Glasscock, David J; Carstensen, Ole; Dalgaard, Vita Ligaya

2018-05-28

Randomized controlled trials (RCTs) of interventions aimed at reducing work-related stress indicate that cognitive behavioural therapy (CBT) is more effective than other interventions. However, definitions of study populations are often unclear and there is a lack of interventions targeting both the individual and the workplace. The aim of this study was to determine whether a stress management intervention combining individual CBT and a workplace focus is superior to no treatment in the reduction of perceived stress and stress symptoms and time to lasting return to work (RTW) in a clinical sample. Patients with work-related stress reactions or adjustment disorders were randomly assigned to an intervention group (n = 57, 84.2% female) or a control group (n = 80, 83.8% female). Subjects were followed via questionnaires and register data. The intervention contained individual CBT and the offer of a workplace meeting. We examined intervention effects by analysing group differences in score changes on the Perceived Stress Scale (PSS-10) and the General Health Questionnaire (GHQ-30). We also tested if intervention led to faster lasting RTW. Mean baseline values of PSS were 24.79 in the intervention group and 23.26 in the control group while the corresponding values for GHQ were 21.3 and 20.27, respectively. There was a significant effect of time. 10 months after baseline, both groups reported less perceived stress and improved mental health. 4 months after baseline, we found significant treatment effects for both perceived stress and mental health. The difference in mean change in PSS after 4 months was - 3.09 (- 5.47, - 0.72), while for GHQ it was - 3.91 (- 7.15, - 0.68). There were no group differences in RTW. The intervention led to faster reductions in perceived stress and stress symptoms amongst patients with work-related stress reactions and adjustment disorders. 6 months after the intervention ended there were no longer differences between the groups.

Considerations for automated machine learning in clinical metabolic profiling: Altered homocysteine plasma concentration associated with metformin exposure.

PubMed

Orlenko, Alena; Moore, Jason H; Orzechowski, Patryk; Olson, Randal S; Cairns, Junmei; Caraballo, Pedro J; Weinshilboum, Richard M; Wang, Liewei; Breitenstein, Matthew K

2018-01-01

With the maturation of metabolomics science and proliferation of biobanks, clinical metabolic profiling is an increasingly opportunistic frontier for advancing translational clinical research. Automated Machine Learning (AutoML) approaches provide exciting opportunity to guide feature selection in agnostic metabolic profiling endeavors, where potentially thousands of independent data points must be evaluated. In previous research, AutoML using high-dimensional data of varying types has been demonstrably robust, outperforming traditional approaches. However, considerations for application in clinical metabolic profiling remain to be evaluated. Particularly, regarding the robustness of AutoML to identify and adjust for common clinical confounders. In this study, we present a focused case study regarding AutoML considerations for using the Tree-Based Optimization Tool (TPOT) in metabolic profiling of exposure to metformin in a biobank cohort. First, we propose a tandem rank-accuracy measure to guide agnostic feature selection and corresponding threshold determination in clinical metabolic profiling endeavors. Second, while AutoML, using default parameters, demonstrated potential to lack sensitivity to low-effect confounding clinical covariates, we demonstrated residual training and adjustment of metabolite features as an easily applicable approach to ensure AutoML adjustment for potential confounding characteristics. Finally, we present increased homocysteine with long-term exposure to metformin as a potentially novel, non-replicated metabolite association suggested by TPOT; an association not identified in parallel clinical metabolic profiling endeavors. While warranting independent replication, our tandem rank-accuracy measure suggests homocysteine to be the metabolite feature with largest effect, and corresponding priority for further translational clinical research. Residual training and adjustment for a potential confounding effect by BMI only slightly modified the suggested association. Increased homocysteine is thought to be associated with vitamin B12 deficiency - evaluation for potential clinical relevance is suggested. While considerations for clinical metabolic profiling are recommended, including adjustment approaches for clinical confounders, AutoML presents an exciting tool to enhance clinical metabolic profiling and advance translational research endeavors.

Cytosolic 5'-nucleotidase 1A autoantibody profile and clinical characteristics in inclusion body myositis.

PubMed

Lilleker, J B; Rietveld, A; Pye, S R; Mariampillai, K; Benveniste, O; Peeters, M T J; Miller, J A L; Hanna, M G; Machado, P M; Parton, M J; Gheorghe, K R; Badrising, U A; Lundberg, I E; Sacconi, S; Herbert, M K; McHugh, N J; Lecky, B R F; Brierley, C; Hilton-Jones, D; Lamb, J A; Roberts, M E; Cooper, R G; Saris, C G J; Pruijn, G J M; Chinoy, H; van Engelen, B G M

2017-05-01

Autoantibodies directed against cytosolic 5'-nucleotidase 1A have been identified in many patients with inclusion body myositis. This retrospective study investigated the association between anticytosolic 5'-nucleotidase 1A antibody status and clinical, serological and histopathological features to explore the utility of this antibody to identify inclusion body myositis subgroups and to predict prognosis. Data from various European inclusion body myositis registries were pooled. Anticytosolic 5'-nucleotidase 1A status was determined by an established ELISA technique. Cases were stratified according to antibody status and comparisons made. Survival and mobility aid requirement analyses were performed using Kaplan-Meier curves and Cox proportional hazards regression. Data from 311 patients were available for analysis; 102 (33%) had anticytosolic 5'-nucleotidase 1A antibodies. Antibody-positive patients had a higher adjusted mortality risk (HR 1.89, 95% CI 1.11 to 3.21, p=0.019), lower frequency of proximal upper limb weakness at disease onset (8% vs 23%, adjusted OR 0.29, 95% CI 0.12 to 0.68, p=0.005) and an increased prevalence of excess of cytochrome oxidase deficient fibres on muscle biopsy analysis (87% vs 72%, adjusted OR 2.80, 95% CI 1.17 to 6.66, p=0.020), compared with antibody-negative patients. Differences were observed in clinical and histopathological features between anticytosolic 5'-nucleotidase 1A antibody positive and negative patients with inclusion body myositis, and antibody-positive patients had a higher adjusted mortality risk. Stratification of inclusion body myositis by anticytosolic 5'-nucleotidase 1A antibody status may be useful, potentially highlighting a distinct inclusion body myositis subtype with a more severe phenotype. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Determinants of treatment plan implementation in multidisciplinary team meetings for patients with chronic diseases: a mixed-methods study

PubMed Central

Raine, Rosalind; Xanthopoulou, Penny; Wallace, Isla; Nic a’ Bháird, Caoimhe; Lanceley, Anne; Clarke, Alex; Livingston, Gill; Prentice, Archie; Ardron, Dave; Harris, Miriam; King, Michael; Michie, Susan; Blazeby, Jane M; Austin-Parsons, Natalie; Gibbs, Simon; Barber, Julie

2014-01-01

Objective Multidisciplinary team (MDT) meetings are assumed to produce better decisions and are extensively used to manage chronic disease in the National Health Service (NHS). However, evidence for their effectiveness is mixed. Our objective was to investigate determinants of MDT effectiveness by examining factors influencing the implementation of MDT treatment plans. This is a proxy measure of effectiveness, because it lies on the pathway to improvements in health, and reflects team decision making which has taken account of clinical and non-clinical information. Additionally, this measure can be compared across MDTs for different conditions. Methods We undertook a prospective mixed-methods study of 12 MDTs in London and North Thames. Data were collected by observation of 370 MDT meetings, interviews with 53 MDT members, and from 2654 patient medical records. We examined the influence of patient-related factors (disease, age, sex, deprivation, whether their preferences and other clinical/health behaviours were mentioned) and MDT features (as measured using the ‘Team Climate Inventory’ and skill mix) on the implementation of MDT treatment plans. Results The adjusted odds (or likelihood) of implementation was reduced by 25% for each additional professional group represented at the MDT meeting. Implementation was more likely in MDTs with clear goals and processes and a good ‘Team Climate’ (adjusted OR 1.96; 95% CI 1.15 to 3.31 for a unit increase in Team Climate Inventory (TCI) score). Implementation varied by disease category, with the lowest adjusted odds of implementation in mental health teams. Implementation was also lower for patients living in more deprived areas (adjusted odds of implementation for patients in the most compared with least deprived areas was 0.60, 95% CI 0.39 to 0.91). Conclusions Greater multidisciplinarity is not necessarily associated with more effective decision making. Explicit goals and procedures are also crucial. Decision implementation should be routinely monitored to ensure the equitable provision of care. PMID:24915539

Does duration of abstinence affect the live-birth rate after assisted reproductive technology? A retrospective analysis of 1,030 cycles.

PubMed

Periyasamy, Anurekha J; Mahasampath, Gowri; Karthikeyan, Muthukumar; Mangalaraj, Ann M; Kunjummen, Aleyamma T; Kamath, Mohan S

2017-12-01

To study influence of abstinence period on the live-birth rate after assisted reproductive technology (ART). Retrospective cohort study. Reproductive medicine unit, university-level hospital. A total 1,030 ART cycles evaluated from 2011 to 2015. Group I, abstinence period 2-7 days, and group II, abstinence period >7 days, were compared. Two subgroups Ia (2-4 days) and Ib (5-7 days) were also compared with group II. Primary outcome was live birth per ET. Secondary outcomes included implantation, clinical pregnancy, and miscarriage rates. The live-birth rate (34.1 % vs. 24.1%; odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.4), clinical pregnancy rate (44.4 % vs. 32.7%; OR, 1.6; 95% CI, 1.1-2.3), and implantation rate (26.4% vs. 18.2%) were significantly higher in group I compared with group II. Other secondary outcomes of fertilization rate and miscarriage rate did not differ between groups I and II. The adjusted odds ratio (aOR) for live birth (aOR, 1.6; 95% CI, 1.1-2.5) and clinical pregnancy rates (aOR, 1.7; 95% CI, 1.2-2.5) were significantly higher for group I compared with group II. The live-birth rate was significantly higher in group Ia (36.1% vs. 24.1%) compared with group II. An abstinence period of more than 7 days may impact ART outcomes adversely when compared with an abstinence period of 2-7 days. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Evaluation of the incidence of microcracks caused by Mtwo and ProTaper Next rotary file systems versus the self-adjusting file: A scanning electron microscopic study

PubMed Central

Saha, Suparna Ganguly; Vijaywargiya, Neelam; Saxena, Divya; Saha, Mainak Kanti; Bharadwaj, Anuj; Dubey, Sandeep

2017-01-01

Introduction: To evaluate the incidence of microcrack formation canal preparation with two rotary nickel–titanium systems Mtwo and ProTaper Next along with the self-adjusting file system. Materials and Methods: One hundred and twenty mandibular premolar teeth were selected. Standardized access cavities were prepared and the canals were manually prepared up to size 20 after coronal preflaring. The teeth were divided into three experimental groups and one control group (n = 30). Group 1: The canals were prepared using Mtwo rotary files. Group 2: The canals were prepared with ProTaper Next files. Group 3: The canals were prepared with self-adjusting files. Group 4: The canals were unprepared and used as a control. The roots were sectioned horizontally 3, 6, and 9 mm from the apex and examined under a scanning electron microscope to check for the presence of microcracks. The Pearson's Chi-square test was applied. Results: The highest incidence of microcracks were associated with the ProTaper Next group, 80% (P = 0.00), followed by the Mtwo group, 70% (P = 0.000), and the least number of microcracks was noted in the self-adjusting file group, 10% (P = 0.068). No significant difference was found between the ProTaper Next and Mtwo groups (P = 0.368) while a significant difference was observed between the ProTaper Next and self-adjusting file groups (P = 0.000) as well as the Mtwo and self-adjusting file groups (P = 0.000). Conclusion: All nickel–titanium rotary instrument systems were associated with microcracks. However, the self-adjusting file system had significantly fewer microcracks when compared with the Mtwo and ProTaper Next. PMID:29386786

Evaluation of the incidence of microcracks caused by Mtwo and ProTaper Next rotary file systems versus the self-adjusting file: A scanning electron microscopic study.

PubMed

Saha, Suparna Ganguly; Vijaywargiya, Neelam; Saxena, Divya; Saha, Mainak Kanti; Bharadwaj, Anuj; Dubey, Sandeep

2017-01-01

To evaluate the incidence of microcrack formation canal preparation with two rotary nickel-titanium systems Mtwo and ProTaper Next along with the self-adjusting file system. One hundred and twenty mandibular premolar teeth were selected. Standardized access cavities were prepared and the canals were manually prepared up to size 20 after coronal preflaring. The teeth were divided into three experimental groups and one control group ( n = 30). Group 1: The canals were prepared using Mtwo rotary files. Group 2: The canals were prepared with ProTaper Next files. Group 3: The canals were prepared with self-adjusting files. Group 4: The canals were unprepared and used as a control. The roots were sectioned horizontally 3, 6, and 9 mm from the apex and examined under a scanning electron microscope to check for the presence of microcracks. The Pearson's Chi-square test was applied. The highest incidence of microcracks were associated with the ProTaper Next group, 80% ( P = 0.00), followed by the Mtwo group, 70% ( P = 0.000), and the least number of microcracks was noted in the self-adjusting file group, 10% ( P = 0.068). No significant difference was found between the ProTaper Next and Mtwo groups ( P = 0.368) while a significant difference was observed between the ProTaper Next and self-adjusting file groups ( P = 0.000) as well as the Mtwo and self-adjusting file groups ( P = 0.000). All nickel-titanium rotary instrument systems were associated with microcracks. However, the self-adjusting file system had significantly fewer microcracks when compared with the Mtwo and ProTaper Next.

[Effect of 2 methods of occlusion adjustment on occlusal balance and muscles of mastication in patient with implant restoration].

PubMed

Wang, Rong; Xu, Xin

2015-12-01

To compare the effect of 2 methods of occlusion adjustment on occlusal balance and muscles of mastication in patients with dental implant restoration. Twenty patients, each with a single edentulous posterior dentition with no distal dentition were selected, and divided into 2 groups. Patients in group A underwent original occlusion adjustment method and patients in group B underwent occlusal plane reduction technique. Ankylos implants were implanted in the edentulous space in each patient and restored with fixed prosthodontics single unit crown. Occlusion was adjusted in each restoration accordingly. Electromyograms were conducted to determine the effect of adjustment methods on occlusion and muscles of mastication 3 months and 6 months after initial restoration and adjustment. Data was collected and measurements for balanced occlusal measuring standards were obtained, including central occlusion force (COF), asymmetry index of molar occlusal force(AMOF). Balanced muscles of mastication measuring standards were also obtained including measurements from electromyogram for the muscles of mastication and the anterior bundle of the temporalis muscle at the mandibular rest position, average electromyogram measurements of the anterior bundle of the temporalis muscle at the intercuspal position(ICP), Astot, masseter muscle asymmetry index, and anterior temporalis asymmetry index (ASTA). Statistical analysis was performed using Student 's t test with SPSS 18.0 software package. Three months after occlusion adjustment, parameters of the original occlusion adjustment method were significantly different between group A and group B in balanced occlusal measuring standards and balanced muscles of mastication measuring standards. Six months after occlusion adjustment, parameters of the original occlusion adjustment methods were significantly different between group A and group B in balanced muscles of mastication measuring standards, but was no significant difference in balanced occlusal measuring standards. Using occlusion plane reduction adjustment technique, it is possible to obtain occlusion index and muscles of mastication's electromyogram index similar to the opposite side's natural dentition in patients with single unit fix prosthodontics crown and single posterior edentulous dentition without distal dentitions.

Study on the social adaptation of Chinese children with down syndrome.

PubMed

Wang, Yan-Xia; Mao, Shan-Shan; Xie, Chun-Hong; Qin, Yu-Feng; Zhu, Zhi-Wei; Zhan, Jian-Ying; Shao, Jie; Li, Rong; Zhao, Zheng-Yan

2007-06-30

To evaluate social adjustment and related factors among Chinese children with Down syndrome (DS). A structured interview and Peabody Picture Vocabulary Test (PPVT) were conducted with a group of 36 DS children with a mean age of 106.28 months, a group of 30 normally-developing children matched for mental age (MA) and a group of 40 normally-developing children matched for chronological age (CA). Mean scores of social adjustment were compared between the three groups, and partial correlations and stepwise multiple regression models were used to further explore related factors. There was no difference between the DS group and the MA group in terms of communication skills. However, the DS group scored much better than the MA group in self-dependence, locomotion, work skills, socialization and self-management. Children in the CA group achieved significantly higher scores in all aspects of social adjustment than the DS children. Partial correlations indicate a relationship between social adjustment and the PPVT raw score and also between social adjustment and age (significant r ranging between 0.24 and 0.92). A stepwise linear regression analysis showed that family structure was the main predictor of social adjustment. Newborn history was also a predictor of work skills, communication, socialization and self-management. Parental education was found to account for 8% of self-dependence. Maternal education explained 6% of the variation in locomotion. Although limited by the small sample size, these results indicate that Chinese DS children have better social adjustment skills when compared to their mental-age-matched normally-developing peers, but that the Chinese DS children showed aspects of adaptive development that differed from Western DS children. Analyses of factors related to social adjustment suggest that effective early intervention may improve social adaptability.

Antenatal peer support workers and initiation of breast feeding: cluster randomised controlled trial.

PubMed

MacArthur, Christine; Jolly, Kate; Ingram, Lucy; Freemantle, Nick; Dennis, Cindy-Lee; Hamburger, Ros; Brown, Julia; Chambers, Jackie; Khan, Khalid

2009-01-30

To assess the effectiveness of an antenatal service using community based breastfeeding peer support workers on initiation of breast feeding. Cluster randomised controlled trial. Community antenatal clinics in one primary care trust in a multiethnic, deprived population. 66 antenatal clinics with 2511 pregnant women: 33 clinics including 1140 women were randomised to receive the peer support worker service and 33 clinics including 1371 women were randomised to receive standard care. An antenatal peer support worker service planned to comprise a minimum of two contacts with women to provide advice, information, and support from approximately 24 weeks' gestation within the antenatal clinic or at home. The trained peer support workers were of similar ethnic and sociodemographic backgrounds to their clinic population. Initiation of breast feeding obtained from computerised maternity records of the hospitals where women from the primary care trust delivered. The sample was multiethnic, with only 9.4% of women being white British, and 70% were in the lowest 10th for deprivation. Most of the contacts with peer support workers took place in the antenatal clinics. Data on initiation of breast feeding were obtained for 2398 of 2511 (95.5%) women (1083/1140 intervention and 1315/1371 controls). The groups did not differ for initiation of breast feeding: 69.0% (747/1083) in the intervention group and 68.1% (896/1315) in the control groups; cluster adjusted odds ratio 1.11 (95% confidence interval 0.87 to 1.43). Ethnicity, parity, and mode of delivery independently predicted initiation of breast feeding, but randomisation to the peer support worker service did not. A universal service for initiation of breast feeding using peer support workers provided within antenatal clinics serving a multiethnic, deprived population was ineffective in increasing initiation rates. Current Controlled Trials ISRCTN16126175.

The Effect of Coded Healing Abutments on Treatment Duration and Clinical Outcome: A Randomized Controlled Clinical Trial Comparing Encode and Conventional Impression Protocols.

PubMed

Abduo, Jaafar; Chen, Chen; Le Breton, Eugene; Radu, Alexandra; Szeto, Josephine; Judge, Roy; Darby, Ivan

To compare the Encode impression protocol (Biomet 3i) with the conventional impression protocol in terms of treatment duration, clinical accuracy, and outcome up to the first postplacement review of single-implant crowns. A total of 45 implants were included in this study. The implants were randomly allocated to the Encode group (23 implants) or the conventional group (22 implants). At the time of surgery, all implants received two-piece Encode healing abutments. The implants were restored 3 months after insertion. In the conventional protocol, open-tray implant-level impressions were taken and the implants were restored with prefabricated abutments and porcelain-fused-to-metal (PFM) crowns. For the implants in the Encode group, closed-tray impressions of the healing abutments were taken. The generated casts were sent to the Biomet 3i scanning/milling center for custom abutment manufacturing on which PFM crowns were fabricated. Treatment duration (laboratory and clinical), clinical accuracy of occlusal and proximal contacts, and outcome (esthetics, patient satisfaction, and crown contour) were evaluated with the aid of a series of questionnaires. The Encode protocol required significantly less laboratory time (18 minutes) than the conventional protocol for adjustment of the abutments. The impression pour time, time for the laboratory to return the crown, time for crown insertion at the final appointment, and total clinical time for crown insertion did not differ significantly between the two protocols. Likewise, clinical accuracy, esthetics, and patient satisfaction were similar for the two protocols. The two protocols were clinically comparable. The Encode protocol is advantageous in reducing the laboratory time before crown fabrication.

Incremental costs associated with physician and pharmacist collaboration to improve blood pressure control.

PubMed

Kulchaitanaroaj, Puttarin; Brooks, John M; Ardery, Gail; Newman, Dana; Carter, Barry L

2012-08-01

To compare costs associated with a physician-pharmacist collaborative intervention with costs of usual care. Cost analysis using health care utilization and outcome data from two prospective, cluster-randomized, controlled clinical trials. Eleven community-based medical offices. A total of 496 patients with hypertension; 244 were in the usual care (control) group and 252 were in the intervention group. To compare the costs, we combined cost data from the two trials. Total costs included costs of provider time, laboratory tests, and antihypertensive drugs. Provider time was calculated based on an online survey of intervention pharmacists and the National Ambulatory Medical Care Survey. Cost parameters were taken from the Bureau of Labor Statistics for average wage rates, the Medicare laboratory fee schedule, and a publicly available Web site for drug prices. Total costs were adjusted for patient characteristics. Adjusted total costs were $774.90 in the intervention group and $445.75 in the control group (difference $329.16, p<0.001). In a sensitivity analysis, the difference in adjusted total costs between the two groups ranged from $224.27-515.56. The intervention cost required to have one additional patient achieve blood pressure control within 6 months was $1338.05, determined by the difference in costs divided by the difference in hypertension control rates between the groups ($329.16/24.6%). The cost over 6 months to lower systolic and diastolic blood pressure 1 mm Hg was $36.25 and $94.32, respectively. The physician-pharmacist collaborative intervention increased not only blood pressure control but also the cost of care. Additional research, such as a cost-benefit or a cost-minimization analysis, is needed to assess whether financial savings related to reduced morbidity and mortality achieved from better blood pressure control outweigh the cost of the intervention. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

Circulating natriuretic peptide concentrations reflect changes in insulin sensitivity over time in the Diabetes Prevention Program.

PubMed

Walford, Geoffrey A; Ma, Yong; Christophi, Costas A; Goldberg, Ronald B; Jarolim, Petr; Horton, Edward; Mather, Kieren J; Barrett-Connor, Elizabeth; Davis, Jaclyn; Florez, Jose C; Wang, Thomas J

2014-05-01

We aimed to study the relationship between measures of adiposity, insulin sensitivity and N-terminal pro-B-type natriuretic peptide (NT-proBNP) in the Diabetes Prevention Program (DPP). The DPP is a completed clinical trial. Using stored samples from this resource, we measured BMI, waist circumference (WC), an insulin sensitivity index (ISI; [1/HOMA-IR]) and NT-proBNP at baseline and at 2 years of follow-up in participants randomised to placebo (n = 692), intensive lifestyle intervention (n = 832) or metformin (n = 887). At baseline, log NT-proBNP did not differ between treatment arms and was correlated with baseline log ISI (p < 0.0001) and WC (p = 0.0003) but not with BMI (p = 0.39). After 2 years of treatment, BMI decreased in the lifestyle and metformin groups (both p < 0.0001); WC decreased in all three groups (p < 0.05 for all); and log ISI increased in the lifestyle and metformin groups (both p < 0.001). The change in log NT-proBNP did not differ in the lifestyle or metformin group vs the placebo group (p > 0.05 for both). In regression models, the change in log NT-proBNP was positively associated with the change in log ISI (p < 0.005) in all three study groups after adjusting for changes in BMI and WC, but was not associated with the change in BMI or WC after adjusting for changes in log ISI. Circulating NT-proBNP was associated with a measure of insulin sensitivity before and during preventive interventions for type 2 diabetes in the DPP. This relationship persisted after adjustment for measures of adiposity and was consistent regardless of whether a participant was treated with placebo, intensive lifestyle intervention or metformin.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection.

PubMed

Maki, Kevin C; Kaspar, Kerrie L; Khoo, Christina; Derrig, Linda H; Schild, Arianne L; Gupta, Kalpana

2016-06-01

Urinary tract infections (UTIs) are among the most common bacterial infections and are often treated with antibiotics. Concerns about multidrug-resistant uropathogens have pointed to the need for safe and effective UTI-prevention strategies such as cranberry consumption. We assessed the effects of the consumption of a cranberry beverage on episodes of clinical UTIs. In this randomized, double-blind, placebo-controlled, multicenter clinical trial, women with a history of a recent UTI were assigned to consume one 240-mL serving of cranberry beverage/d (n = 185) or a placebo (n = 188) beverage for 24 wk. The primary outcome was the clinical UTI incidence density, which was defined as the total number of clinical UTI events (including multiple events per subject when applicable) per unit of observation time. The dates of the random assignment of the first subject and the last subject's final visit were February 2013 and March 2015, respectively. The mean age was 40.9 y, and characteristics were similar in both groups. Compliance with study product consumption was 98%, and 86% of subjects completed the treatment period in both groups. There were 39 investigator-diagnosed episodes of clinical UTI in the cranberry group compared with 67 episodes in the placebo group (antibiotic use-adjusted incidence rate ratio: 0.61; 95% CI: 0.41, 0.91; P = 0.016). Clinical UTI with pyuria was also significantly reduced (incidence rate ratio: 0.63; 95% CI: 0.40, 0.97; P = 0.037). One clinical UTI event was prevented for every 3.2 woman-years (95% CI: 2.0, 13.1 woman-years) of the cranberry intervention. The time to UTI with culture positivity did not differ significantly between groups (HR: 0.97; 95% CI: 0.56, 1.67; P = 0.914). The consumption of a cranberry juice beverage lowered the number of clinical UTI episodes in women with a recent history of UTI. This study was registered at clinicaltrials.gov as NCT01776021. © 2016 American Society for Nutrition.

Cost analysis of enhanced recovery after surgery in microvascular breast reconstruction.

PubMed

Oh, Christine; Moriarty, James; Borah, Bijan J; Mara, Kristin C; Harmsen, William S; Saint-Cyr, Michel; Lemaine, Valerie

2018-06-01

Enhanced recovery after surgery (ERAS) pathways have been shown in multiple surgical specialties to decrease hospital length of stay (LOS) after surgery. ERAS in breast reconstruction has been found to decrease hospital LOS and inpatient opioid use. ERAS protocols can facilitate a patient's recovery and can potentially increase the quality of care while decreasing costs. A standardized ERAS pathway was developed through multidisciplinary collaboration. It addressed all phases of surgical care for patients undergoing free-flap breast reconstruction utilizing an abdominal donor site. In this retrospective cohort study, clinical variables associated with hospitalization costs for patients who underwent free-flap breast reconstruction with the ERAS pathway were compared with those of historical controls, termed traditional recovery after surgery (TRAS). All patients included in the study underwent surgery between September 2010 and September 2014. Predicted costs of the study groups were compared using generalized linear modeling. A total of 200 patients were analyzed: 82 in the ERAS cohort and 118 in the TRAS cohort. Clinical variables that were identified to potentially affect costs were found to have a statistically significant difference between groups and included unilateral versus bilateral procedures (p = 0.04) and the need for postoperative blood transfusion (p = 0.03). The cost regression analysis on the two cohorts was adjusted for these significant variables. Adjusted mean costs of patients with ERAS were found to be $4,576 lesser than those of the TRAS control group ($38,688 versus $43,264). Implementation of the ERAS pathway was associated with significantly decreased costs when compared to historical controls. There has been a healthcare focus toward prudent resource allocation, which dictates the need for plastic surgeons to recognize economic evaluation of clinical practice. The ERAS pathway can increase healthcare accountability by improving quality of care while simultaneously decreasing the costs associated with autologous breast reconstruction. Copyright © 2018 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Parental bonding and hoarding in obsessive-compulsive disorder.

PubMed

Chen, David; Bienvenu, O Joseph; Krasnow, Janice; Wang, Ying; Grados, Marco A; Cullen, Bernadette; Goes, Fernando S; Maher, Brion; Greenberg, Benjamin D; McLaughlin, Nicole C; Rasmussen, Steven A; Fyer, Abby J; Knowles, James A; McCracken, James T; Piacentini, John; Geller, Dan; Pauls, David L; Stewart, S Evelyn; Murphy, Dennis L; Shugart, Yin-Yao; Riddle, Mark A; Nestadt, Gerald; Samuels, Jack

2017-02-01

Hoarding behavior may indicate a clinically and possibly etiologically distinct subtype of obsessive-compulsive disorder (OCD). Empirical evidence supports a relationship between hoarding and emotional over-attachment to objects. However, little is known about the relationship between hoarding and parental attachment in OCD. The study sample included 894 adults diagnosed with DSM-IV OCD who had participated in family and genetic studies of OCD. Participants were assessed for Axis I disorders, personality disorders, and general personality dimensions. The Parental Bonding Instrument (PBI) was used to assess dimensions of perceived parental rearing (care, overprotection, and control). We compared parental PBI scores in the 334 hoarding and 560 non-hoarding participants, separately in men and women. We used logistic regression to evaluate the relationship between parenting scores and hoarding in women, adjusting for other clinical features associated with hoarding. In men, there were no significant differences between hoarding and non-hoarding groups in maternal or paternal parenting scores. In women, the hoarding group had a lower mean score on maternal care (23.4 vs. 25.7, p<0.01); a higher mean score on maternal protection (9.4 vs. 7.7, p<0.001); and a higher mean score on maternal control (7.0 vs. 6.2, p<0.05), compared to the non-hoarding group. The magnitude of the relationships between maternal bonding dimensions and hoarding in women did not change after adjustment for other clinical features. Women who reported low maternal care/high maternal protection had significantly greater odds of hoarding compared to women with high maternal care/low maternal protection (OR=2.54, 95% CI=1.60-4.02, p<0.001). Perceived poor maternal care, maternal overprotection, and maternal overcontrol are associated with hoarding in women with OCD. Parenting dimensions are not related to hoarding in men. These findings provide further support for a hoarding subtype of OCD and for sex-specific differences in etiologic pathways for hoarding in OCD. Copyright © 2016 Elsevier Inc. All rights reserved.

Chronic low back pain is associated with reduced vertebral bone mineral measures in community-dwelling adults

PubMed Central

2012-01-01

Background Chronic low back pain (CLBP) experienced in middle-age may have important implications for vertebral bone health, although this issue has not been investigated as a primary aim previously. This study investigated the associations between CLBP and dual energy X-ray absorptiometry (DXA)-derived vertebral bone mineral measures acquired from postero-anterior and lateral-projections, among community-dwelling, middle-aged adults. Methods Twenty-nine adults with CLBP (11 male, 18 female) and 42 adults with no history of LBP in the preceding year (17 male, 25 female) were evaluated. Self-reported demographic and clinical data were collected via questionnaires. Areal bone mineral density (aBMD) was measured in the lumbar spine by DXA. Apparent volumetric (ap.v) BMD in the lumbar spine was also calculated. Multiple linear regression models were used to examine associations between study group (CLBP and control) and vertebral DXA variables by gender, adjusting for height, mass and age. Results There was no difference between groups by gender in anthropometrics or clinical characteristics. In the CLBP group, the mean (SD) duration of CLBP was 13.3 (10.4) years in males and 11.6 (9.9) years in females, with Oswestry Disability Index scores of 16.2 (8.7)% and 15.4 (9.1)%, respectively. Males with CLBP had significantly lower adjusted lateral-projection aBMD and lateral-projection ap.vBMD than controls at L3 with mean differences (standard error) of 0.09 (0.04) g/cm2 (p = 0.03) and 0.02 (0.01) g/cm3 (p = 0.04). These multivariate models accounted for 55% and 53% of the variance in lateral-projection L3 aBMD and lateral-projection L3 ap.vBMD. Conclusions CLBP in males is associated with some lumbar vertebral BMD measures, raising important questions about the mechanism and potential clinical impact of this association. PMID:22458361