Follow-Up Care for Older Women With Breast Cancer

DTIC Science & Technology

1998-08-01

and node status (positive/negative); and breast cancer treatments received. For the breast cancer treatments variables , we used two different ...interview. Independent Variables . We constructed five different measures of comorbidity. The first was a self-reported measure of cardiopulmonary...Candidate variables for our multivariate models included: baseline measures of the relevant outcome, age, stage, comorbidity, primary tumor therapy

Temperature variability during targeted temperature management is not associated with neurological outcomes following cardiac arrest.

PubMed

Nayeri, Arash; Bhatia, Nirmanmoh; Holmes, Benjamin; Borges, Nyal; Armstrong, William; Xu, Meng; Farber-Eger, Eric; Wells, Quinn S; McPherson, John A

2017-06-01

Recent studies on comatose survivors of cardiac arrest undergoing targeted temperature management (TTM) have shown similar outcomes at multiple target temperatures. However, details regarding core temperature variability during TTM and its prognostic implications remain largely unknown. We sought to assess the association between core temperature variability and neurological outcomes in patients undergoing TTM following cardiac arrest. We analyzed a prospectively collected cohort of 242 patients treated with TTM following cardiac arrest at a tertiary care hospital between 2007 and 2014. Core temperature variability was defined as the statistical variance (i.e. standard deviation squared) amongst all core temperature recordings during the maintenance phase of TTM. Poor neurological outcome at hospital discharge, defined as a Cerebral Performance Category (CPC) score>2, was the primary outcome. Death prior to hospital discharge was assessed as the secondary outcome. Multivariable logistic regression was used to examine the association between temperature variability and neurological outcome or death at hospital discharge. A poor neurological outcome was observed in 147 (61%) patients and 136 (56%) patients died prior to hospital discharge. In multivariable logistic regression, increased core temperature variability was not associated with increased odds of poor neurological outcomes (OR 0.38, 95% CI 0.11-1.38, p=0.142) or death (OR 0.43, 95% CI 0.12-1.53, p=0.193) at hospital discharge. In this study, individual core temperature variability during TTM was not associated with poor neurological outcomes or death at hospital discharge. Copyright © 2017 Elsevier Inc. All rights reserved.

Adult Outcomes, Reported Self-Aptitude, and Perceived Training: A Follow-Up Study of Individuals with Visual Impairment

ERIC Educational Resources Information Center

Lawson, Holly Michelle

2010-01-01

The purpose of this study was to examine factors that relate to successful adult outcomes for 28 individuals with visual impairment ages 23-30. The primary dependent variable was current employment. Independent living and completion of postsecondary educational program were secondary, related outcome measures. A secondary goal of this research was…

Is the quality of brief motivational interventions for drug use in primary care associated with subsequent drug use?

PubMed

Palfai, Tibor P; Cheng, Debbie M; Bernstein, Judith A; Palmisano, Joseph; Lloyd-Travaglini, Christine A; Goodness, Tracie; Saitz, Richard

2016-05-01

Although a number of brief intervention approaches for drug use are based on motivational interviewing (MI), relatively little is known about whether the quality of motivational interviewing skills is associated with intervention outcomes. The current study examined whether indices of motivational interviewing skill were associated with subsequent drug use outcomes following two different MI-based brief interventions delivered in primary care; a 15 min Brief Negotiated Interview (BNI) and a 45 min adaptation of motivational interviewing (MOTIV). Audio recordings from 351 participants in a randomized controlled trial for drug use in primary care were coded using the Motivational Interviewing Treatment Integrity Scale, (MITI Version 3.1.1). Separate negative binomial regression analyses, stratified by intervention condition, were used to examine the associations between six MITI skill variables and the number of days that the participant used his/her main drug 6 weeks after study entry. Only one of the MITI variables (% reflections to questions) was significantly associated with the frequency of drug use in the MOTIV condition and this was opposite to the hypothesized direction (global p=0.01, adjusted IRR 1.50, 95%CI: 1.03-2.20 for middle vs. lowest tertile [higher skill, more drug use]. None were significantly associated with drug use in the BNI condition. Secondary analyses similarly failed to find consistent predictors of better drug outcomes. Overall, this study provides little evidence to suggest that the level of MI intervention skills are linked with better drug use outcomes among people who use drugs and receive brief interventions in primary care. Findings should be considered in light of the fact that data from the study are from negative trial of SBI and was limited to primary care patients. Future work should consider alternative ways of examining these process variables (i.e., comparing thresholds of proficient versus non-proficient skills) or considering alternative methods of coding intervention skills. Copyright © 2016 Elsevier Ltd. All rights reserved.

Elective neck dissection for primary oral cavity squamous cell carcinoma involving the tongue should include sublevel IIb.

PubMed

Maher, Nigel Gordon; Hoffman, Gary Russell

2014-11-01

The surgical clearance of sublevel IIb lymph nodes, facilitated by neck dissection, increases the risk of postoperative shoulder dysfunction. Our study purpose was to determine the value of including sublevel IIb in elective neck dissections for primary oral cavity squamous cell carcinoma (OCSCC). A retrospective cohort study based on a review of the pathology records accumulated by 1 head and neck surgeon was conducted for 71 patients with clinically node-negative, primary OCSCC treated from 2006 to June 2013. The predictor variables were the oral cavity subsite and tumor clinicopathologic characteristics (ie, perineural, perivascular, and perilymphatic invasion, tumor depth, and T stage). The primary outcome variable was the presence of sublevel IIb metastasis. The secondary outcome variables were the survival and tumor recurrence rates and metastases to any cervical level. Descriptive statistics were calculated for the categorical and continuous variables. A comparison of categorical variables was performed using Fisher's exact test; for continuous variables, t tests or the Mann-Whitney U test were used for 2 groups and analysis of variance or Kruskal-Wallis tests (with Bonferroni's correction) were used for more than 2 groups, depending on the distribution. Disease-specific survival (DSS) analyses were plotted for the predictor variables and patients with sublevel IIb metastasis. Competing risks models were created using the Fine and Gray method (SAS macro %PSHREG) to provide estimates of the crude and adjusted subhazard ratios for DSS for all variables. A total of 71 patients were included in the present study, of whom 69% were male. The greatest proportion of oral cavity subsites was from the tongue and floor of mouth. The overall frequency of sublevel IIb lymphatic metastases at neck dissection was 5.6% of the patient cohort. Sublevel IIb metastases occurred from the primary sites involving the tongue (n = 3) and retromolar trigone (n = 1). The incidence of perilymphatic and perivascular invasion was significantly associated with sublevel IIb lymphatic metastases (P < .02). Sublevel IIb is likely to be an important region to incorporate in elective neck dissections for primary OCSCC involving the tongue. More studies are needed, with greater numbers, to clarify the risk of metastasis to sublevel IIb from oral cavity subsites in primary OCSCC with clinically node-negative necks. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Measures of Social Deprivation That Predict Health Care Access and Need within a Rational Area of Primary Care Service Delivery

PubMed Central

Butler, Danielle C; Petterson, Stephen; Phillips, Robert L; Bazemore, Andrew W

2013-01-01

Objective To develop a measure of social deprivation that is associated with health care access and health outcomes at a novel geographic level, primary care service area. Data Sources/Study Setting Secondary analysis of data from the Dartmouth Atlas, AMA Masterfile, National Provider Identifier data, Small Area Health Insurance Estimates, American Community Survey, Area Resource File, and Behavioural Risk Factor Surveillance System. Data were aggregated to primary care service areas (PCSAs). Study Design Social deprivation variables were selected from literature review and international examples. Factor analysis was used. Correlation and multivariate analyses were conducted between index, health outcomes, and measures of health care access. The derived index was compared with poverty as a predictor of health outcomes. Data Collection/Extraction Methods Variables not available at the PCSA level were estimated at block level, then aggregated to PCSA level. Principal Findings Our social deprivation index is positively associated with poor access and poor health outcomes. This pattern holds in multivariate analyses controlling for other measures of access. A multidimensional measure of deprivation is more strongly associated with health outcomes than a measure of poverty alone. Conclusions This geographic index has utility for identifying areas in need of assistance and is timely for revision of 35-year-old provider shortage and geographic underservice designation criteria used to allocate federal resources. PMID:22816561

A clinical return-to-work rule for patients with back pain.

PubMed

Dionne, Clermont E; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R; Larocque, Isabelle

2005-06-07

Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18-64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was "return to work in good health" at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%- 94%). A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome.

A clinical return-to-work rule for patients with back pain

PubMed Central

Dionne, Clermont E.; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R.; Larocque, Isabelle

2005-01-01

Background Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. Methods This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18–64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was “return to work in good health” at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. Results The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%– 94%). Interpretation A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome. PMID:15939915

Predicting Outcome in Computerized Cognitive Behavioral Therapy for Depression in Primary Care: A Randomized Trial

ERIC Educational Resources Information Center

de Graaf, L. Esther; Hollon, Steven D.; Huibers, Marcus J. H.

2010-01-01

Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated…

Non-traditional Serum Lipid Variables and Recurrent Stroke Risk

PubMed Central

Park, Jong-Ho; Lee, Juneyoung; Ovbiagele, Bruce

2014-01-01

Background and Purpose Expert consensus guidelines recommend low-density lipoprotein cholesterol (LDL-C) as the primary serum lipid target for recurrent stroke risk reduction. However, mounting evidence suggests that other lipid parameters might be additional therapeutic targets or at least also predict cardiovascular risk. Little is known about the effects of non-traditional lipid variables on recurrent stroke risk. Methods We analyzed the Vitamin Intervention for Stroke Prevention study database comprising 3680 recent (<120 days) ischemic stroke patients followed up for 2 years. Independent associations of baseline serum lipid variables with recurrent ischemic stroke (primary outcome) and the composite endpoint of ischemic stroke/coronary heart disease (CHD)/vascular death (secondary outcomes) were assessed. Results Of all variables evaluated, only triglycerides (TG)/high-density lipoprotein cholesterol (HDL-C) ratio was consistently and independently related to both outcomes: compared with the lowest quintile, the highest TG/HDL-C ratio quintile was associated with stroke (adjusted hazard ratio, 1.56; 95% CI, 1.05−2.32) and stroke/CHD/vascular death (1.39; 1.05−1.83), including adjustment for lipid modifier use. Compared with the lowest quintile, the highest total cholesterol/HDL-C ratio quintile was associated with stroke/CHD/vascular death (1.45; 1.03−2.03). LDL-C/HDL-C ratio, non-HDL-C, elevated TG alone, and low HDL-C alone were not independently linked to either outcome. Conclusions Of various non-traditional lipid variables, elevated baseline TG/HDL-C and TC/HDL-C ratios predict future vascular risk after a stroke, but only elevated TG/HDL-C ratio is related to risk of recurrent stroke. Future studies should assess the role of TG/HDL as a potential therapeutic target for global vascular risk reduction after stroke. PMID:25236873

Systolic blood pressure variability in patients with early severe sepsis or septic shock: a prospective cohort study.

PubMed

Tang, Yi; Sorenson, Jeff; Lanspa, Michael; Grissom, Colin K; Mathews, V J; Brown, Samuel M

2017-06-17

Severe sepsis and septic shock are often lethal syndromes, in which the autonomic nervous system may fail to maintain adequate blood pressure. Heart rate variability has been associated with outcomes in sepsis. Whether systolic blood pressure (SBP) variability is associated with clinical outcomes in septic patients is unknown. The propose of this study is to determine whether variability in SBP correlates with vasopressor independence and mortality among septic patients. We prospectively studied patients with severe sepsis or septic shock, admitted to an intensive care unit (ICU) with an arterial catheter. We analyzed SBP variability on the first 5-min window immediately following ICU admission. We performed principal component analysis of multidimensional complexity, and used the first principal component (PC 1 ) as input for Firth logistic regression, controlling for mean systolic pressure (SBP) in the primary analyses, and Acute Physiology and Chronic Health Evaluation (APACHE) II score or NEE dose in the ancillary analyses. Prespecified outcomes were vasopressor independence at 24 h (primary), and 28-day mortality (secondary). We studied 51 patients, 51% of whom achieved vasopressor independence at 24 h. Ten percent died at 28 days. PC 1 represented 26% of the variance in complexity measures. PC 1 was not associated with vasopressor independence on Firth logistic regression (OR 1.04; 95% CI: 0.93-1.16; p = 0.54), but was associated with 28-day mortality (OR 1.16, 95% CI: 1.01-1.35, p = 0.040). Early SBP variability appears to be associated with 28-day mortality in patients with severe sepsis and septic shock.

Measure of functional independence dominates discharge outcome prediction after inpatient rehabilitation for stroke.

PubMed

Brown, Allen W; Therneau, Terry M; Schultz, Billie A; Niewczyk, Paulette M; Granger, Carl V

2015-04-01

Identifying clinical data acquired at inpatient rehabilitation admission for stroke that accurately predict key outcomes at discharge could inform the development of customized plans of care to achieve favorable outcomes. The purpose of this analysis was to use a large comprehensive national data set to consider a wide range of clinical elements known at admission to identify those that predict key outcomes at rehabilitation discharge. Sample data were obtained from the Uniform Data System for Medical Rehabilitation data set with the diagnosis of stroke for the years 2005 through 2007. This data set includes demographic, administrative, and medical variables collected at admission and discharge and uses the FIM (functional independence measure) instrument to assess functional independence. Primary outcomes of interest were functional independence measure gain, length of stay, and discharge to home. The sample included 148,367 people (75% white; mean age, 70.6±13.1 years; 97% with ischemic stroke) admitted to inpatient rehabilitation a mean of 8.2±12 days after symptom onset. The total functional independence measure score, the functional independence measure motor subscore, and the case-mix group were equally the strongest predictors for any of the primary outcomes. The most clinically relevant 3-variable model used the functional independence measure motor subscore, age, and walking distance at admission (r(2)=0.107). No important additional effect for any other variable was detected when added to this model. This analysis shows that a measure of functional independence in motor performance and age at rehabilitation hospital admission for stroke are predominant predictors of outcome at discharge in a uniquely large US national data set. © 2015 American Heart Association, Inc.

Nonspecific abdominal pain in pediatric primary care: evaluation and outcomes.

PubMed

Wallis, Elizabeth M; Fiks, Alexander G

2015-01-01

To describe the characteristics of children with nonspecific abdominal pain (AP) in primary care, their evaluation, and their outcomes. Between 2007 and 2009, a retrospective cohort of children from 5 primary care practices was followed from an index visit with AP until a well-child visit 6 to 24 months later (outcome visit). Using International Classification of Disease, 9th Revision (ICD-9), codes and chart review, we identified afebrile children between 4 and 12 years old with AP. Use of diagnostic testing was assessed. Multivariable logistic regression was used to model the association of index visit clinical and demographic variables with persistent pain at the outcome visit, and receipt of a specific diagnosis. Three hundred seventy-five children presented with AP, representing 1% of the total population of 4- to 12-year-olds during the study period. Eighteen percent of children had persistent pain, and 70% of the study cohort never received a specific diagnosis for their pain. Seventeen percent and 14% of children had laboratory and radiology testing at the index visit, respectively. Only 3% of laboratory evaluations helped to yield a diagnosis. Among variables considered, only preceding pain of more than 7 days at the index visit was associated with persistent pain (odds ratio 2.15, 95% confidence interval 1.19-3.89). None of the variables considered was associated with receiving a specific diagnosis. Most children with AP do not receive a diagnosis, many have persistent pain, and very few receive a functional AP diagnosis. Results support limited use of diagnostic testing and conservative management consistent with national policy statements. Copyright © 2015 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

Variability in primary productivity determines metapopulation dynamics

PubMed Central

2016-01-01

Temporal variability in primary productivity can change habitat quality for consumer species by affecting the energy levels available as food resources. However, it remains unclear how habitat-quality fluctuations may determine the dynamics of spatially structured populations, where the effects of habitat size, quality and isolation have been customarily assessed assuming static habitats. We present the first empirical evaluation on the effects of stochastic fluctuations in primary productivity—a major outcome of ecosystem functions—on the metapopulation dynamics of a primary consumer. A unique 13-year dataset from an herbivore rodent was used to test the hypothesis that inter-annual variations in primary productivity determine spatiotemporal habitat occupancy patterns and colonization and extinction processes. Inter-annual variability in productivity and in the growing season phenology significantly influenced habitat colonization patterns and occupancy dynamics. These effects lead to changes in connectivity to other potentially occupied habitat patches, which then feed back into occupancy dynamics. According to the results, the dynamics of primary productivity accounted for more than 50% of the variation in occupancy probability, depending on patch size and landscape configuration. Evidence connecting primary productivity dynamics and spatiotemporal population processes has broad implications for metapopulation persistence in fluctuating and changing environments. PMID:27053739

Variability in primary productivity determines metapopulation dynamics.

PubMed

Fernández, Néstor; Román, Jacinto; Delibes, Miguel

2016-04-13

Temporal variability in primary productivity can change habitat quality for consumer species by affecting the energy levels available as food resources. However, it remains unclear how habitat-quality fluctuations may determine the dynamics of spatially structured populations, where the effects of habitat size, quality and isolation have been customarily assessed assuming static habitats. We present the first empirical evaluation on the effects of stochastic fluctuations in primary productivity--a major outcome of ecosystem functions--on the metapopulation dynamics of a primary consumer. A unique 13-year dataset from an herbivore rodent was used to test the hypothesis that inter-annual variations in primary productivity determine spatiotemporal habitat occupancy patterns and colonization and extinction processes. Inter-annual variability in productivity and in the growing season phenology significantly influenced habitat colonization patterns and occupancy dynamics. These effects lead to changes in connectivity to other potentially occupied habitat patches, which then feed back into occupancy dynamics. According to the results, the dynamics of primary productivity accounted for more than 50% of the variation in occupancy probability, depending on patch size and landscape configuration. Evidence connecting primary productivity dynamics and spatiotemporal population processes has broad implications for metapopulation persistence in fluctuating and changing environments. © 2016 The Authors.

Variations in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review.

PubMed

du Bois, Andreas; Rochon, Justine; Pfisterer, Jacobus; Hoskins, William J

2009-02-01

Ovarian cancer outcome varies among different institutions, regions, and countries. This systematic review summarizes the available data evaluating the impact of different physician and hospital characteristics on outcome in ovarian cancer patients. A MEDLINE database search for pertinent publications was conducted and reference lists of each relevant article were screened. Experts in the field were contacted. Selected studies assessed the relationship between physician and/or hospital specialty or volume and at least one of the outcomes of interest. The primary outcome was survival. Additional parameters included surgical outcome (debulking), completeness of staging, and quality of chemotherapy. The authors independently reviewed each article and applied the inclusion/exclusion criteria. The quality of each study was assessed by focusing on strategies to control for important prognostic factors. Forty-four articles met inclusion criteria. Discipline and sub-specialization of the primary treating physician were identified as the most important variable associated with superior outcome. Evidence showing a beneficial impact of institutional factors was weaker, but followed the same trend. Hospital volume was hardly related to any outcome parameter. The limited evidence available showed considerable heterogeneity and has to be interpreted cautiously. Better utilization of knowledge about institutional factors and well-established board certifications may improve outcome in ovarian cancer. Patients and primary-care physicians should select gynecologic oncologists for primary treatment in countries with established sub-specialty training. Policymakers, insurance companies, and lay organizations should support development of respective programs.

Psychological contract breach and outcomes: Combining meta-analysis and structural equation models.

PubMed

Topa Cantisano, Gabriela; Morales Domínguez, J Francisco; Depolo, Marco

2008-08-01

In this study, meta-analytic procedures were used to examine the relationships between psychological contract perceived breach and certain outcome variables, such as organizational commitment, job satisfaction and organizational citizenship behaviours (OCB). Our review of the literature generated 41 independent samples in which perceived breach was used as a predictor of these personal and organizational outcomes. A medium effect size (ES) for desirable outcomes (job satisfaction, organizational commitment, organizational trust, OCB and performance) was obtained (r=-.35). For undesirable outcomes (neglect in role duties and intention to leave), ES were also medium (r=.31). When comparing attitudinal (job satisfaction, organizational commitment, organizational trust) and behavioural outcomes (OCB, neglect in role duties and performance), a stronger ES was found for attitudinal (r=-.24) than for behavioural outcomes (r=-.11). Potential moderator variables were examined, and it was found that they explained only a percentage of variability of primary studies. Structural equation analysis of the pooled meta-analytical correlation matrix indicated that the relationships of perceived breach with satisfaction, OCB, intention to leave and performance are fully mediated by organizational trust and commitment. Results are discussed in order to suggest theoretical and empirical implications.

Gender as a Moderator between Having an Anxiety Disorder Diagnosis and Coronary Artery Bypass Grafting Surgery (CABG) Outcomes in Rural Patients

ERIC Educational Resources Information Center

Dao, Tam K.; Voelkel, Emily; Presley, Sherine; Doss, Brendel; Huddleston, Cashuna; Gopaldas, Raja

2012-01-01

Purpose: This paper examines gender as a moderating variable between having an anxiety disorder diagnosis and coronary artery bypass grafting surgery (CABG) outcomes in rural patients. Methods: Using the 2008 Nationwide Inpatient Sample (NIS) database, 17,885 discharge records of patients who underwent a primary CABG surgery were identified.…

Technical efficiency of women's health prevention programs in Bucaramanga, Colombia: a four-stage analysis.

PubMed

Ruiz-Rodriguez, Myriam; Rodriguez-Villamizar, Laura A; Heredia-Pi, Ileana

2016-10-13

Primary Health Care (PHC) is an efficient strategy to improve health outcomes in populations. Nevertheless, studies of technical efficiency in health care have focused on hospitals, with very little on primary health care centers. The objective of the present study was to use the Data Envelopment Analysis to estimate the technical efficiency of three women's health promotion and disease prevention programs offered by primary care centers in Bucaramanga, Colombia. Efficiency was measured using a four-stage data envelopment analysis with a series of Tobit regressions to account for the effect of quality outcomes and context variables. Input/output information was collected from the institutions' records, chart reviews and personal interviews. Information about contextual variables was obtained from databases from the primary health program in the municipality. A jackknife analysis was used to assess the robustness of the results. The analysis was based on data from 21 public primary health care centers. The average efficiency scores, after adjusting for quality and context, were 92.4 %, 97.5 % and 86.2 % for the antenatal care (ANC), early detection of cervical cancer (EDCC) and family planning (FP) programs, respectively. On each program, 12 of the 21 (57.1 %) health centers were found to be technically efficient; having had the best-practice frontiers. Adjusting for context variables changed the scores and reference rankings of the three programs offered by the health centers. The performance of the women's health prevention programs offered by the centers was found to be heterogeneous. Adjusting for context and health care quality variables had a significant effect on the technical efficiency scores and ranking. The results can serve as a guide to strengthen management and organizational and planning processes related to local primary care services operating within a market-based model such as the one in Colombia.

Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women.

PubMed

Brubaker, Linda; Litman, Heather J; Kim, Hae-Young; Zimmern, Philippe; Dyer, Keisha; Kusek, John W; Richter, Holly E; Stoddard, Anne

2015-08-01

Missing data is frequently observed in clinical trials; high rates of missing data may jeopardize trial outcome validity. We determined the rates of missing data over time, by type of data collected and compared demographic and clinical factors associated with missing data among women who participated in two large randomized clinical trials of surgery for stress urinary incontinence, the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Sling (TOMUS). The proportions of subjects who attended and missed each follow-up visit were calculated. The chi-squared test, Fisher's exact test and t test were used to compare women with and without missing data, as well as the completeness of the data for each component of the composite primary outcome. Data completeness for the primary outcome computation in the TOMUS trial (62.3%) was nearly double that in the SISTEr trial (35.7%). The follow-up visit attendance rate decreased over time. A higher proportion of subjects attended all follow-up visits in the TOMUS trial and overall there were fewer missing data for the period that included the primary outcome assessment at 12 months. The highest levels of complete data for the composite outcome variables were for the symptoms questionnaire (SISTEr 100 %, TOMUS 99.8%) and the urinary stress test (SISTEr 96.1%, TOMUS 96.7%). In both studies, the pad test was associated with the lowest levels of complete data (SISTEr 85.1%, TOMUS 88.3%) and approximately one in ten subjects had incomplete voiding diaries at the time of primary outcome assessment. Generally, in both studies, a higher proportion of younger subjects had missing data. This analysis lacked a patient perspective as to the reasons for missing data that could have provided additional information on subject burden, motivations for adherence and study design. In addition, we were unable to compare the effects of the different primary outcome assessment time-points in an identically designed trial. Missing visits and data increased with time. Questionnaire data and physical outcome data (urinary stress test) that could be assessed during a visit were least prone to missing data, whereas data for variables that required subject effort while away from the research team (pad test, voiding diary) were more likely to be missing. Older subjects were more likely to provide complete data.

Predictors of contemporary coronary artery bypass grafting outcomes.

PubMed

Weisel, Richard D; Nussmeier, Nancy; Newman, Mark F; Pearl, Ronald G; Wechsler, Andrew S; Ambrosio, Giuseppe; Pitt, Bertram; Clare, Robert M; Pieper, Karen S; Mongero, Linda; Reece, Tammy L; Yau, Terrence M; Fremes, Stephen; Menasché, Philippe; Lira, Armando; Harrington, Robert A; Ferguson, T Bruce

2014-12-01

The study objective was to identify the predictors of outcomes in a contemporary cohort of patients from the Reduction in cardiovascular Events by acaDesine in patients undergoing CABG (RED-CABG) trial. Despite the increasing risk profile of patients who undergo coronary artery bypass grafting, morbidity and mortality have remained low, and identification of the current predictors of adverse outcomes may permit new treatments to further improve outcomes. The RED-CABG trial was a multicenter, randomized, double-blind, placebo-controlled study that determined that acadesine did not reduce adverse events in moderately high-risk patients undergoing nonemergency coronary artery bypass grafting. The primary efficacy end point was a composite of all-cause death, nonfatal stroke, or the need for mechanical support for severe left ventricular dysfunction through postoperative day 28. Logistic regression modeling with stepwise variable selection identified which prespecified baseline characteristics were associated with the primary outcome. A second logistic model included intraoperative variables as potential covariates. The 4 independent preoperative risk factors predictive of the composite end point were (1) a history of heart failure (odds ratio, 2.9); (2) increasing age (odds ratio, 1.033 per decade); (3) a history of peripheral vascular disease (odds ratio, 1.6); and (4) receiving aspirin before coronary artery bypass grafting (odds ratio, 0.5), which was protective. The duration of the cardiopulmonary bypass (odds ratio, 1.8) was the only intraoperative variable that contributed to adverse outcomes. Patients who had heart failure and preserved systolic function had a similar high risk of adverse outcomes as those with low ejection fractions, and new approaches may mitigate this risk. Recognition of patients with excessive atherosclerotic burden may permit perioperative interventions to improve their outcomes. The contemporary risks of coronary artery bypass grafting have changed, and their identification may permit new methods to improve outcomes. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol.

PubMed

Hattar, Anne; Hagger, Martin S; Pal, Sebely

2015-02-27

Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of goal-reminder text messages to augment intervention effects will also be tested. The trial will determine the effects of a brief, low cost, theory-based weight-loss intervention to improve dietary intake and physical activity behaviour and facilitate weight-loss in overweight and obese individuals. Overweight or obese participants will be randomly allocated to one of three conditions: (1) a psycho-education plus an implementation intentions and mental imagery condition; (2) a psycho-education plus an implementation intentions and mental imagery condition with text messages; or (3) a psycho-education control condition. The intervention will be delivered via video presentation to increase the intervention's applicability in multiple contexts and keep costs low. We hypothesise that the intervention conditions will lead to statistically-significant changes in the primary and secondary outcome variables measured at 6 and 12 weeks post-intervention relative to the psycho-education control condition after controlling for baseline values. The primary outcome variable will be body weight and secondary outcome variables will be biomedical (body mass, body fat percentage, muscle mass, waist-hip circumference ratio, systolic and diastolic blood pressure, low-density lipoprotein, high-density lipoprotein, total cholesterol, triglycerides, blood glucose and insulin levels), psychological (quality of life, motivation, risk perception, outcome expectancy, intention, action self-efficacy, maintenance self-efficacy, goal setting and planning), and behavioural (self-reported diet intake, and physical activity involvement) measures. We also expect the intervention condition augmented with text messages to lead to statistically significant differences in the primary and secondary outcome variables at the follow up periods after controlling for baseline values. The planned trial will test the effectiveness of the theory-based HEALTHI program intervention to reduce weight and salient psychological, biomedical, and behavioural outcomes in overweight and obese adults. The study has been designed to maximise applicability to real world settings and could be integrated into existing weight management practices. ACTRN: ACTRN12613001274763. Registration date 19/11/2013.

Maternal nutrition and birth outcomes.

PubMed

Abu-Saad, Kathleen; Fraser, Drora

2010-01-01

In this review, the authors summarize current knowledge on maternal nutritional requirements during pregnancy, with a focus on the nutrients that have been most commonly investigated in association with birth outcomes. Data sourcing and extraction included searches of the primary resources establishing maternal nutrient requirements during pregnancy (e.g., Dietary Reference Intakes), and searches of Medline for "maternal nutrition"/[specific nutrient of interest] and "birth/pregnancy outcomes," focusing mainly on the less extensively reviewed evidence from observational studies of maternal dietary intake and birth outcomes. The authors used a conceptual framework which took both primary and secondary factors (e.g., baseline maternal nutritional status, socioeconomic status of the study populations, timing and methods of assessing maternal nutritional variables) into account when interpreting study findings. The authors conclude that maternal nutrition is a modifiable risk factor of public health importance that can be integrated into efforts to prevent adverse birth outcomes, particularly among economically developing/low-income populations.

The Use of Intraoperative Sensors Significantly Increases the Patient-Reported Rate of Improvement in Primary Total Knee Arthroplasty.

PubMed

Chow, James C; Breslauer, Leigh

2017-07-01

Albeit multifactorial, patient satisfaction is predominantly driven by postoperative pain and function. Unfortunately, approximately 20% of total knee arthroplasty (TKA) recipients are dissatisfied with the outcome of their surgery. Objective balancing of the soft tissue envelope may contribute to significant decrease in pain and increase in function when compared with traditional subjective methods. In an effort to confirm this, a cohort of manual TKA patient outcomes was compared with sensor-assisted TKA outcomes. One hundred fourteen patients (57 manual, 57 sensor assisted) received primary TKA. Both cohorts were matched for confounding variables. The dependent variables in this study were 6-month patient-reported outcome measures, including Knee Society Score and Oxford Knee Score. The range of motion and incidence of arthrofibrosis were also captured for both cohorts. The rate of improvement of all patient-reported outcome scores and subscores and range of motion was significantly higher in the sensor-assisted cohort. The rate of arthrofibrosis was lower in the sensor-assisted cohort but not statistically significant. The authors rejected the null hypothesis and concluded that the rate of improvement in objective, patient-reported outcome measures was higher in the sensor-assisted cohort than the manual cohort from preoperatively to 6 months postoperatively. [Orthopedics. 2017; 40(4):e648-e651.]. Copyright 2017, SLACK Incorporated.

Contribution of primary care to health: an individual level analysis from Tibet, China.

PubMed

Wang, Wenhua; Shi, Leiyu; Yin, Aitian; Mao, Zongfu; Maitland, Elizabeth; Nicholas, Stephen; Liu, Xiaoyun

2015-11-30

There have been significant improvements in health outcomes in Tibet, health disparities between Tibet and the rest of China has been greatly reduced. This paper tests whether there was a positive association between good primary care and better health outcomes in Tibet. A validated Tibetan version of the Primary Care Assessment Tool (PCAT-T) was used to collect data on 1386 patients aged over 18 years old accessing primary care. Self-rated health (SRH) was employed to measure health outcomes. A multiple binary logistic regression model was used to explore the association between primary care quality and self-rated health status after controlling for socio-demographic and lifestyle variables. This study found that primary care quality had a significant positive association with self-rated health status. Among the nine domains of PCAT-T, family centeredness domain had the highest Odds Ratio (OR = 1.013) with SRH. Patients located in rural area, with higher education levels, without depression, and less frequent drinking were more likely to self-rate as "good health" compared with the reference group. In Tibet, higher quality primary care was associated with better self-rated health status. Primary care should be much strengthened in future health system reform in Tibet.

Patient preferences and treatment safety for uncomplicated vulvovaginal candidiasis in primary health care

PubMed Central

2011-01-01

Background Vaginitis is a common complaint in primary care. In uncomplicated candidal vaginitis, there are no differences in effectiveness between oral or vaginal treatment. Some studies describe that the preferred treatment is the oral one, but a Cochrane's review points out inconsistencies associated with the report of the preferred way that limit the use of such data. Risk factors associated with recurrent vulvovaginal candidiasis still remain controversial. Methods/Design This work describes a protocol of a multicentric prospective observational study with one year follow up, to describe the women's reasons and preferences to choose the way of administration (oral vs topical) in the treatment of not complicated candidal vaginitis. The number of women required is 765, they are chosen by consecutive sampling. All of whom are aged 16 and over with vaginal discharge and/or vaginal pruritus, diagnosed with not complicated vulvovaginitis in Primary Care in Madrid. The main outcome variable is the preferences of the patients in treatment choice; secondary outcome variables are time to symptoms relief and adverse reactions and the frequency of recurrent vulvovaginitis and the risk factors. In the statistical analysis, for the main objective will be descriptive for each of the variables, bivariant analysis and multivariate analysis (logistic regression).. The dependent variable being the type of treatment chosen (oral or topical) and the independent, the variables that after bivariant analysis, have been associated to the treatment preference. Discussion Clinical decisions, recommendations, and practice guidelines must not only attend to the best available evidence, but also to the values and preferences of the informed patient. PMID:21281464

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

PubMed Central

Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

2015-01-01

Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed. PMID:26581079

Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

PubMed

Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

2015-01-01

Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is suboptimal. Greater attention to proper trial registration and outcome analysis definition in published reports is needed.

Does additional cone beam computed tomography decrease the risk of inferior alveolar nerve injury in high-risk cases undergoing third molar surgery?Does CBCT decrease the risk of IAN injury?

PubMed

Korkmaz, Y T; Kayıpmaz, S; Senel, F C; Atasoy, K T; Gumrukcu, Z

2017-05-01

The objectives of this study were to evaluate the efficacy of additional cone beam computed tomography (CBCT) imaging on decreasing the risk of inferior alveolar nerve (IAN) injury during third molar removal in patients at high risk and to assess the surgical outcomes. The study sample included patients considered at high risk for IAN injury based on panoramic radiography (PAN) evaluation. The primary predictor was the type of imaging method (PAN only or with additional CBCT). The other variables were demographic and anatomical/radiographic factors. The primary outcome variable was IAN injury. The secondary outcome variables were the preoperative surgical plan and surgical results including IAN exposure and duration of surgery. The sample comprised 122 patients (139 teeth) aged 18-48 years. Postoperative temporary IAN injury was present in three (4.2%) cases in the CBCT group and 11 (16.4%) in the PAN group at 7 days after surgery. However, none of the patients had a permanent IAN injury at the 6-month follow-up. Additional CBCT imaging was not superior to PAN in reducing IAN injury after third molar surgery during long-term follow-up. Nonetheless, CBCT may decrease the prevalence of temporary IAN injury and improve the surgical outcomes in high-risk patients. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Recent progresses in outcome-dependent sampling with failure time data.

PubMed

Ding, Jieli; Lu, Tsui-Shan; Cai, Jianwen; Zhou, Haibo

2017-01-01

An outcome-dependent sampling (ODS) design is a retrospective sampling scheme where one observes the primary exposure variables with a probability that depends on the observed value of the outcome variable. When the outcome of interest is failure time, the observed data are often censored. By allowing the selection of the supplemental samples depends on whether the event of interest happens or not and oversampling subjects from the most informative regions, ODS design for the time-to-event data can reduce the cost of the study and improve the efficiency. We review recent progresses and advances in research on ODS designs with failure time data. This includes researches on ODS related designs like case-cohort design, generalized case-cohort design, stratified case-cohort design, general failure-time ODS design, length-biased sampling design and interval sampling design.

Recent progresses in outcome-dependent sampling with failure time data

PubMed Central

Ding, Jieli; Lu, Tsui-Shan; Cai, Jianwen; Zhou, Haibo

2016-01-01

An outcome-dependent sampling (ODS) design is a retrospective sampling scheme where one observes the primary exposure variables with a probability that depends on the observed value of the outcome variable. When the outcome of interest is failure time, the observed data are often censored. By allowing the selection of the supplemental samples depends on whether the event of interest happens or not and oversampling subjects from the most informative regions, ODS design for the time-to-event data can reduce the cost of the study and improve the efficiency. We review recent progresses and advances in research on ODS designs with failure time data. This includes researches on ODS related designs like case–cohort design, generalized case–cohort design, stratified case–cohort design, general failure-time ODS design, length-biased sampling design and interval sampling design. PMID:26759313

Some Psychological Benefits of Gardening

ERIC Educational Resources Information Center

Kaplan, Rachel

1973-01-01

Psychological benefits derived from gardening, a leisure activity intimately involved with the natural environment, are examined. Three areas of benefits (tangible outcomes, primary gardening experiences, and sustained interest) were identified and related to the kind of garden, attitudinal, and role variables. (BL)

Follow-Up Care for Older Women With Breast Cancer

DTIC Science & Technology

1999-08-01

range of patient outcomes, including primary tumor therapy and mortality, self -reported upper body function, and overall physical function. Methods...mor therapy, all cause mortality, self -reported function and overall physical function than upper body function, and overall physical was the interview...Major Analytic Variables mor therapy and all cause mortality, as well as self -reported upper body and overall physical Dependent Variables. Our first

Hospitalizations for ambulatory care sensitive conditions and quality of primary care: their relation with socioeconomic and health care variables in the Madrid regional health service (Spain).

PubMed

Magán, Purificación; Alberquilla, Angel; Otero, Angel; Ribera, José Manuel

2011-01-01

Hospitalizations for ambulatory care sensitive conditions (ACSH) have been proposed as an indirect indicator of the effectiveness and quality of care provided by primary health care. To investigate the association of ACSH rates with population socioeconomic factors and with characteristics of primary health care. Cross-sectional, ecologic study. Using hospital discharge data, ACSH were selected from the list of conditions validated for Spain. All 34 health districts in the Region of Madrid, Spain. Individuals aged 65 years or older residing in the region of Madrid between 2001 and 2003, inclusive. Age- and gender-adjusted ACSH rates in each health district. The adjusted ACSH rate per 1000 population was 35.37 in men and 20.45 in women. In the Poisson regression analysis, an inverse relation was seen between ACSH rates and the socioeconomic variables. Physician workload was the only health care variable with a statistically significant relation (rate ratio of 1.066 [95% CI; 1.041-1.091]). These results were similar in the analyses disaggregated by gender. In the multivariate analyses that included health care variables, none of the health care variables were statistically significant. ACSH may be more closely related with socioeconomic variables than with characteristics of primary care activity. Therefore, other factors outside the health system must be considered to improve health outcomes in the population.

Access to primary care for socio-economically disadvantaged older people in rural areas: exploring realist theory using structural equation modelling in a linked dataset.

PubMed

Ford, John A; Jones, Andy; Wong, Geoff; Clark, Allan; Porter, Tom; Steel, Nick

2018-06-19

Realist approaches seek to answer questions such as 'how?', 'why?', 'for whom?', 'in what circumstances?' and 'to what extent?' interventions 'work' using context-mechanism-outcome (CMO) configurations. Quantitative methods are not well-established in realist approaches, but structural equation modelling (SEM) may be useful to explore CMO configurations. Our aim was to assess the feasibility and appropriateness of SEM to explore CMO configurations and, if appropriate, make recommendations based on our access to primary care research. Our specific objectives were to map variables from two large population datasets to CMO configurations from our realist review looking at access to primary care, generate latent variables where needed, and use SEM to quantitatively test the CMO configurations. A linked dataset was created by merging individual patient data from the English Longitudinal Study of Ageing and practice data from the GP Patient Survey. Patients registered in rural practices and who were in the highest deprivation tertile were included. Three latent variables were defined using confirmatory factor analysis. SEM was used to explore the nine full CMOs. All models were estimated using robust maximum likelihoods and accounted for clustering at practice level. Ordinal variables were treated as continuous to ensure convergence. We successfully explored our CMO configurations, but analysis was limited because of data availability. Two hundred seventy-six participants were included. We found a statistically significant direct (context to outcome) or indirect effect (context to outcome via mechanism) for two of nine CMOs. The strongest association was between 'ease of getting through to the surgery' and 'being able to get an appointment' with an indirect mediated effect through convenience (proportion of the indirect effect of the total was 21%). Healthcare experience was not directly associated with getting an appointment, but there was a statistically significant indirect effect through convenience (53% mediated effect). Model fit indices showed adequate fit. SEM allowed quantification of CMO configurations and could complement other qualitative and quantitative techniques in realist evaluations to support inferences about strengths of relationships. Future research exploring CMO configurations with SEM should aim to collect, preferably continuous, primary data.

Trends in Utilization of Surrogate Endpoints in Contemporary Cardiovascular Clinical Trials.

PubMed

Patel, Ravi B; Vaduganathan, Muthiah; Samman-Tahhan, Ayman; Kalogeropoulos, Andreas P; Georgiopoulou, Vasiliki V; Fonarow, Gregg C; Gheorghiade, Mihai; Butler, Javed

2016-06-01

Surrogate endpoints facilitate trial efficiency but are variably linked to clinical outcomes, and limited data are available exploring their utilization in cardiovascular clinical trials over time. We abstracted data regarding primary clinical, intermediate, and surrogate endpoints from all phase II to IV cardiovascular clinical trials from 2001 to 2012 published in the 8 highest Web of Science impact factor journals. Two investigators independently classified the type of primary endpoint. Of the 1,224 trials evaluated, 677 (55.3%) primary endpoints were clinical, 165 (13.5%) intermediate, and 382 (31.2%) surrogate. The relative proportions of these endpoints remained constant over time (p = 0.98). Trials using surrogate endpoints were smaller (187 vs 1,028 patients) and enrolled patients more expeditiously (1.4 vs 0.9 patients per site per month) compared with trials using clinical endpoints (p <0.001 for both comparisons). Surrogate endpoint trials were independently more likely to meet their primary endpoint compared to trials with clinical endpoints (adjusted odds ratio 1.56, 95% CI 1.05 to 2.34; p = 0.03). Rates of positive results in clinical endpoint trials have decreased over time from 66.1% in 2001 to 2003 to 47.2% in 2010 to 2012 (p = 0.001), whereas these rates have remained stable over the same period for surrogate (72.0% to 69.3%, p = 0.27) and intermediate endpoints (74.4% to 71.4%, p = 0.98). In conclusion, approximately a third of contemporary cardiovascular trials use surrogate endpoints. These trials are completed more expeditiously and are more likely to meet their primary outcomes. The overall scientific contribution of these surrogate endpoint trials requires further attention given their variable association with definitive outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

Comprehensive stroke centers may be associated with improved survival in hemorrhagic stroke.

PubMed

McKinney, James S; Cheng, Jerry Q; Rybinnik, Igor; Kostis, John B

2015-05-06

Comprehensive stroke centers (CSCs) provide a full spectrum of neurological and neurosurgical services to treat complex stroke patients. CSCs have been shown to improve clinical outcomes and mitigate disparities in ischemic stroke patients. It is believed that CSCs also improve outcomes in hemorrhagic stroke. We used the Myocardial Infarction Data Acquisition System (MIDAS) database, which includes data on patients discharged with a primary diagnosis of intracerebral hemorrhage (ICH; International Classification of Diseases, Ninth Revision [ICD-9] 431) and subarachnoid hemorrhage (SAH; ICD-9 430) from all nonfederal acute care hospitals in New Jersey (NJ) between 1996 and 2012. Out-of-hospital deaths were assessed by matching MIDAS records with NJ death registration files. The primary outcome variable was 90-day all-cause mortality. The primary independent variable was CSC versus primary stroke center (PSC) and nonstroke center (NSC) admission. Multivariate logistic models were used to measure the effects of available covariates. Overall, 36 981 patients were admitted with a primary diagnosis of ICH or SAH during the study period, of which 40% were admitted to a CSC. Patients admitted to CSCs were more likely to have neurosurgical or endovascular interventions than those admitted to a PSC/NSC (18.9% vs. 4.7%; P<0.0001). CSC admission was associated with lower adjusted 90-day mortality (35.0% vs. 40.3%; odds ratio, 0.93; 95% confidence interval, 0.89 to 0.97) for hemorrhagic stroke. This was particularly true for those admitted with SAH. Hemorrhagic stroke patients admitted to CSCs are more likely to receive neurosurgical and endovascular treatments and be alive at 90 days than patients admitted to other hospitals. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Comprehensive Stroke Centers May Be Associated With Improved Survival in Hemorrhagic Stroke

PubMed Central

McKinney, James S; Cheng, Jerry Q; Rybinnik, Igor; Kostis, John B

2015-01-01

Background Comprehensive stroke centers (CSCs) provide a full spectrum of neurological and neurosurgical services to treat complex stroke patients. CSCs have been shown to improve clinical outcomes and mitigate disparities in ischemic stroke patients. It is believed that CSCs also improve outcomes in hemorrhagic stroke. Methods and Results We used the Myocardial Infarction Data Acquisition System (MIDAS) database, which includes data on patients discharged with a primary diagnosis of intracerebral hemorrhage (ICH; International Classification of Diseases, Ninth Revision [ICD-9] 431) and subarachnoid hemorrhage (SAH; ICD-9 430) from all nonfederal acute care hospitals in New Jersey (NJ) between 1996 and 2012. Out-of-hospital deaths were assessed by matching MIDAS records with NJ death registration files. The primary outcome variable was 90-day all-cause mortality. The primary independent variable was CSC versus primary stroke center (PSC) and nonstroke center (NSC) admission. Multivariate logistic models were used to measure the effects of available covariates. Overall, 36 981 patients were admitted with a primary diagnosis of ICH or SAH during the study period, of which 40% were admitted to a CSC. Patients admitted to CSCs were more likely to have neurosurgical or endovascular interventions than those admitted to a PSC/NSC (18.9% vs. 4.7%; P<0.0001). CSC admission was associated with lower adjusted 90-day mortality (35.0% vs. 40.3%; odds ratio, 0.93; 95% confidence interval, 0.89 to 0.97) for hemorrhagic stroke. This was particularly true for those admitted with SAH. Conclusions Hemorrhagic stroke patients admitted to CSCs are more likely to receive neurosurgical and endovascular treatments and be alive at 90 days than patients admitted to other hospitals. PMID:25950185

Fine-grain analysis of the treatment effect of topiramate on methamphetamine addiction with latent variable analysis.

PubMed

Ma, Jennie Z; Johnson, Bankole A; Yu, Elmer; Weiss, David; McSherry, Frances; Saadvandi, Jim; Iturriaga, Erin; Ait-Daoud, Nassima; Rawson, Richard A; Hrymoc, Mark; Campbell, Jan; Gorodetzky, Charles; Haning, William; Carlton, Barry; Mawhinney, Joseph; Weis, Dennis; McCann, Michael; Pham, Tony; Stock, Christopher; Dickinson, Ruth; Elkashef, Ahmed; Li, Ming D

2013-06-01

As reported previously, 140 methamphetamine-dependent participants at eight medical centers in the U.S. were assigned randomly to receive topiramate (N=69) or placebo (N=71) in a 13-week clinical trial. The study found that topiramate did not appear to reduce methamphetamine use significantly for the primary outcome (i.e., weekly abstinence from methamphetamine in weeks 6-12). Given that the treatment responses varied considerably among subjects, the objective of this study was to identify the heterogeneous treatment effect of topiramate and determine whether topiramate could reduce methamphetamine use effectively in a subgroup of subjects. Latent variable analysis was used for the primary and secondary outcomes during weeks 6-12 and 1-12, adjusting for age, sex, and ethnicity. Our analysis of the primary outcome identified 30 subjects as responders, who either reduced methamphetamine use consistently over time or achieved abstinence. Moreover, topiramate recipients had a significantly steeper slope in methamphetamine reduction and accelerated to abstinence faster than placebo recipients. For the secondary outcomes in weeks 6-12, we identified 40 subjects as responders (who had significant reductions in methamphetamine use) and 65 as non-responders; topiramate recipients were more than twice as likely as placebo recipients to be responders (odds ratio=2.67; p=0.019). Separate analyses of the outcomes during weeks 1-12 yielded similar results. Methamphetamine users appear to respond to topiramate treatment differentially. Our findings show an effect of topiramate on the increasing trend of abstinence from methamphetamine, suggesting that a tailored intervention strategy is needed for treating methamphetamine addiction. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Impact of age, sex, therapeutic intent, race and severity of advanced heart failure on short-term principal outcomes in the MOMENTUM 3 trial.

PubMed

Goldstein, Daniel J; Mehra, Mandeep R; Naka, Yoshifumi; Salerno, Christopher; Uriel, Nir; Dean, David; Itoh, Akinobu; Pagani, Francis D; Skipper, Eric R; Bhat, Geetha; Raval, Nirav; Bruckner, Brian A; Estep, Jerry D; Cogswell, Rebecca; Milano, Carmelo; Fendelander, Lahn; O'Connell, John B; Cleveland, Joseph

2018-01-01

Primary outcomes analysis of the Multicenter Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 (MOMENTUM 3) trial short-term cohort demonstrated a higher survival rate free of debilitating stroke and reoperation to replace/remove the device (primary end-point) in patients receiving the HeartMate 3 (HM3) compared with the HeartMate (HMII). In this study we sought to evaluate the individual and interactive effects of pre-specified patient subgroups (age, sex, race, therapeutic intent [bridge to transplant/bridge to candidacy/destination therapy] and severity of illness) on primary end-point outcomes in MOMENTUM 3 patients implanted with HM3 and HMII devices. Cox proportional hazard models were used to analyze patients enrolled in the "as-treated cohort" (n = 289) of the MOMENTUM 3 trial to: (1) determine interaction of various subgroups on primary end-point outcomes; and (2) identify independent variables associated with primary end-point success. Baseline characteristics were well balanced among HM3 (n = 151) and HMII (n = 138) cohorts. No significant interaction between the sub-groups on primary end-point outcomes was observed. Cox multivariable modeling identified age (≤65 years vs >65 years, hazard ratio 0.42 [95% confidence interval 0.22 to 0.78], p = 0.006]) and pump type (HM3 vs HMII, hazard ratio 0.53 [95% confidence interval 0.30 to 0.96], p = 0.034) to be independent predictors of primary outcomes success. After adjusting for age, no significant impact of sex, race, therapeutic intent and INTERMACS profiles on primary outcomes were observed. This analysis of MOMENTUM 3 suggests that younger age (≤65 years) at implant and pump choice are associated with a greater likelihood of primary end-point success. These findings further suggest that characterization of therapeutic intent into discrete bridge-to-transplant and destination therapy categories offers no clear clinical advantage, and should ideally be abandoned. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Does Receiving a Blood Transfusion Predict for Length of Stay in Children Undergoing Cranial Vault Remodeling for Craniosynostosis? Outcomes Using the Pediatric National Surgical Quality Improvement Program Dataset.

PubMed

Markiewicz, Michael R; Alden, Tord; Momin, Mohmed Vasim; Olsson, Alexis B; Jurado, Ray J; Abdullah, Fizan; Miloro, Michael

2017-08-01

Recent interventions have aimed at reducing the need for blood transfusions in the perioperative period in patients with craniosynostosis undergoing cranial vault remodeling. However, little is known regarding whether the receipt of a blood transfusion influences the length of hospital stay. The purpose of this study was to assess whether the receipt of a blood transfusion in patients undergoing cranial vault remodeling is associated with an increased length of stay. To address the research purposes, we designed a retrospective cohort study using the 2014 Pediatric National Surgical Quality Improvement Program (NSQIP Peds) dataset. The primary predictor variable was whether patients received a blood transfusion during cranial vault remodeling. The primary outcome variable was length of hospital stay after the operation. The association between the receipt of blood transfusions and length of stay was assessed using the Student t test. The association between other covariates and the outcome variable was assessed using linear regression, analysis of variance, and the Tukey test for post hoc pair-wise comparisons. The sample was composed of 756 patients who underwent cranial vault remodeling: 503 who received blood transfusions and 253 who did not. The primary predictor variable of blood transfusion was associated with an increased length of stay (4.1 days vs 3.0 days, P = .03). Other covariates associated with an increased length of stay included race, American Society of Anesthesiologists status, premature birth, presence of a congenital malformation, and number of sutures involved in craniosynostosis. The receipt of a blood transfusion in the perioperative period in patients with craniosynostosis undergoing cranial vault remodeling was associated with an increased length of stay. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Bifurcating effects of hope and support in short- and long-term health outcomes among primary care patients without mental illness.

PubMed

Katerndahl, David

2014-08-01

Adverse life events and stressors can lead to symptoms, increased alcohol intake, and impaired functional status, while hope and social support can mitigate such adverse effects. Yet, there is reason to question such simple, linear relationships among healthy adults. The purpose of this study was to assess whether short-term or long-term changes in alcohol intake, psychological symptoms or functional status were better modelled as cusp catastrophic or linear processes among primary care patients without mental illness. This secondary analysis of a study on the stability of psychological symptoms among primary care patients without mental disorders included 38 subjects who completed baseline, and 2-month and/or 6-month assessments of psychological symptoms, functional status and stressors as well as hope and social support. The analyses modelled short-term and long-term changes in alcohol intake, psychological symptoms and functional status using cusp catastrophe (CCM) and linear modelling. Overall, four of the nine 2-month analyses found CCM superior to linear models; however, only one 6-month analysis (alcohol intake) found that CCM was superior. The 2-month cusp phenomena included both symptomatology and functional status. The asymmetry variables were often not significant in the CCM models; in fact, only distress was significant at all. While hope was a significant bifurcation variable at both the 2-month and 6-month levels, social support was a significant bifurcation variable for three of the four 2-month CCMs. In conclusion, while 6-month outcomes were rarely explained through CCM, half of 2-month outcomes were. Hope and support demonstrated bifurcation effects. © 2013 John Wiley & Sons, Ltd.

The Empirical Foundations of Telemedicine Interventions in Primary Care.

PubMed

Bashshur, Rashid L; Howell, Joel D; Krupinski, Elizabeth A; Harms, Kathryn M; Bashshur, Noura; Doarn, Charles R

2016-05-01

This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world.

The Empirical Foundations of Telemedicine Interventions in Primary Care

PubMed Central

Howell, Joel D.; Krupinski, Elizabeth A.; Harms, Kathryn M.; Bashshur, Noura; Doarn, Charles R.

2016-01-01

Abstract Introduction: This article presents the scientific evidence for the merits of telemedicine interventions in primary care. Although there is no uniform and consistent definition of primary care, most agree that it occupies a central role in the healthcare system as first contact for patients seeking care, as well as gatekeeper and coordinator of care. It enables and supports patient-centered care, the medical home, managed care, accountable care, and population health. Increasing concerns about sustainability and the anticipated shortages of primary care physicians have sparked interest in exploring the potential of telemedicine in addressing many of the challenges facing primary care in the United States and the world. Materials and Methods: The findings are based on a systematic review of scientific studies published from 2005 through 2015. The initial search yielded 2,308 articles, with 86 meeting the inclusion criteria. Evidence is organized and evaluated according to feasibility/acceptance, intermediate outcomes, health outcomes, and cost. Results: The majority of studies support the feasibility/acceptance of telemedicine for use in primary care, although it varies significantly by demographic variables, such as gender, age, and socioeconomic status, and telemedicine has often been found more acceptable by patients than healthcare providers. Outcomes data are limited but overall suggest that telemedicine interventions are generally at least as effective as traditional care. Cost analyses vary, but telemedicine in primary care is increasingly demonstrated to be cost-effective. Conclusions: Telemedicine has significant potential to address many of the challenges facing primary care in today's healthcare environment. Challenges still remain in validating its impact on clinical outcomes with scientific rigor, as well as in standardizing methods to assess cost, but patient and provider acceptance is increasingly making telemedicine a viable and integral component of primary care around the world. PMID:27128779

Does Intravenous Midazolam Dose Influence the Duration of Recovery Room Stay Following Outpatient Third Molar Surgery?

PubMed

Ettinger, Kyle S; Jacob, Adam K; Viozzi, Christopher F; Van Ess, James M; Fillmore, W Jonathan; Arce, Kevin

2015-12-01

To evaluate the impact of intravenous midazolam dose on the duration of recovery room stay for patients undergoing outpatient third molar surgery. Using a retrospective cohort study design, a sample of patients undergoing outpatient third molar surgery under intravenous sedation at Mayo Clinic from 2010 to 2014 was identified. All patients underwent extraction of all 4 third molars during a single operative procedure and the age range was limited to 14 to 29 years. The primary predictor variable was the total dose of intravenous midazolam administered during sedation. The primary outcome variable was recovery room length of stay (LOS) after completion of surgery. Multiple covariates also abstracted included patient age, gender, American Society of Anesthesiologists (ASA) score, duration of surgical procedure, complexity of surgical procedure, types and dosages of all intravenous medications administered during sedation, and volume of crystalloid fluid administered perioperatively. Univariable and multivariable models were developed to evaluate associations between the primary predictor variable and covariates relative to the primary outcome variable. The study sample was composed of 2,610 patients. Mean age was 18.3 years (SD, 3.0 yr; range, 14 to 29 yr) and gender distribution was 52% female. Mean dosage of midazolam administered was 4.1 mg (SD, 1.1 mg; range, 0.5 to 10.0 mg). Variables predicting shorter LOS at multivariable analysis included older age (P < .001), male gender (P = .004), and administration of larger crystalloid fluid volumes (P < .001). Variables predicting longer LOS included higher ASA score (P < .001), administration of ketamine (P < .001), and administration of ketorolac (P < .001). The dose of midazolam administered during sedation was not found to be significantly associated with prolonged recovery room LOS in univariable or multivariable settings. Dosage of intravenous midazolam does not appear to significantly impact the duration of recovery room stay in the prototypical patients undergoing sedation for outpatient third molar surgery. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Variability in the performance of preventive services and in the degree of control of identified health problems: A primary care study protocol

PubMed Central

Bolíbar, Bonaventura; Pareja, Clara; Astier-Peña, M Pilar; Morán, Julio; Rodríguez-Blanco, Teresa; Rosell-Murphy, Magdalena; Iglesias, Manuel; Juncosa, Sebastián; Mascort, Juanjo; Violan, Concepció; Magallón, Rosa; Apezteguia, Javier

2008-01-01

Background Preventive activities carried out in primary care have important variability that makes necessary to know which factors have an impact in order to establish future strategies for improvement. The present study has three objectives: 1) To describe the variability in the implementation of 7 preventive services (screening for smoking status, alcohol abuse, hypertension, hypercholesterolemia, obesity, influenza and tetanus immunization) and to determine their related factors; 2) To describe the degree of control of 5 identified health problems (smoking, alcohol abuse, hypertension, hypercholesterolemia and obesity); 3) To calculate intraclass correlation coefficients. Design Multi-centered cross-sectional study of a randomised sample of primary health care teams from 3 regions of Spain designed to analyse variability and related factors of 7 selected preventive services in years 2006 and 2007. At the end of 2008, we will perform a cross-sectional study of a cohort of patients attended in 2006 or 2007 to asses the degree of control of 5 identified health problems. All subjects older than16 years assigned to a randomised sample of 22 computerized primary health care teams and attended during the study period are included in each region providing a sample with more than 850.000 subjects. The main outcome measures will be implementation of 7 preventive services and control of 5 identified health problems. Furthermore, there will be 3 levels of data collection: 1) Patient level (age, gender, morbidity, preventive services, attendance); 2) Health-care professional level (professional characteristics, years working at the team, workload); 3) Team level (characteristics, electronic clinical record system). Data will be transferred from electronic clinical records to a central database with prior encryption and dissociation of subject, professional and team identity. Global and regional analysis will be performed including standard analysis for primary health care teams and health-care professional level. Linear and logistic regression multilevel analysis adjusted for individual and cluster variables will also be performed. Variability in the number of preventive services implemented will be calculated with Poisson multilevel models. Team and health-care professional will be considered random effects. Intraclass correlation coefficients, standard error and variance components for the different outcome measures will be calculated. PMID:18691407

The effect of leg preference on postural stability in healthy athletes.

PubMed

Huurnink, Arnold; Fransz, Duncan P; Kingma, Idsart; Hupperets, Maarten D W; van Dieën, Jaap H

2014-01-03

In research regarding postural stability, leg preference is often tested and controlled for. However, leg preference may vary between tasks. As athletes are a group of interest for postural stability testing, we evaluated the effect of five leg preference tasks categorization (step up, hop, ball kick, balance, pick up) on single-leg postural stability of 16 field hockey athletes. The 'center of pressure speed' was calculated as the primary outcome variable of single-leg postural stability. Secondary variables were 'mean length of the GRF vector in the horizontal plane', 'mean length of the ankle angular velocity vector', and 'mean length of the hip angular velocity vector', as well as the separate outcomes per degree of freedom. Results showed that leg preference was inconsistent between leg preference tasks. Moreover, the primary and secondary variables yielded no significant difference between the preferred and non-preferred legs, regardless of the applied leg preference task categorization (p>0.05). The present findings do not support the usability of leg preference tasks in controlling for bias of postural stability. In conclusion, none of the applied leg preference tasks revealed a significant effect on postural stability in healthy field hockey athletes. © 2013 Published by Elsevier Ltd.

Primary care physician workforce and Medicare beneficiaries' health outcomes.

PubMed

Chang, Chiang-Hua; Stukel, Therese A; Flood, Ann Barry; Goodman, David C

2011-05-25

Despite a widespread interest in increasing the numbers of primary care physicians to improve care and to moderate costs, the relationship of the primary care physician workforce to patient-level outcomes remains poorly understood. To measure the association between the adult primary care physician workforce and individual patient outcomes. A cross-sectional analysis of the outcomes of a 2007 20% sample of fee-for-service Medicare beneficiaries aged 65 years or older (N = 5,132,936), which used 2 measures of adult primary care physicians (general internists and family physicians) across Primary Care Service Areas (N = 6542): (1) American Medical Association (AMA) Masterfile nonfederal, office-based physicians per total population and (2) office-based primary care clinical full-time equivalents (FTEs) per Medicare beneficiary derived from Medicare claims. Annual individual-level outcomes (mortality, ambulatory care sensitive condition [ACSC] hospitalizations, and Medicare program spending), adjusted for individual patient characteristics and geographic area variables. Marked variation was observed in the primary care physician workforce across areas, but low correlation was observed between the 2 primary care workforce measures (Spearman r = 0.056; P < .001). Compared with areas with the lowest quintile of primary care physician measure using AMA Masterfile counts, beneficiaries in the highest quintile had fewer ACSC hospitalizations (74.90 vs 79.61 per 1000 beneficiaries; relative rate [RR], 0.94; 95% confidence interval [CI], 0.93-0.95), lower mortality (5.38 vs 5.47 per 100 beneficiaries; RR, 0.98; 95% CI, 0.97-0.997), and no significant difference in total Medicare spending ($8722 vs $8765 per beneficiary; RR, 1.00; 95% CI, 0.99-1.00). Beneficiaries residing in areas with the highest quintile of primary care clinician FTEs compared with those in the lowest quintile had lower mortality (5.19 vs 5.49 per 100 beneficiaries; RR, 0.95; 95% CI, 0.93-0.96), fewer ACSC hospitalizations (72.53 vs 79.48 per 1000 beneficiaries; RR, 0.91; 95% CI, 0.90-0.92), and higher overall Medicare spending ($8857 vs $8769 per beneficiary; RR, 1.01; 95% CI, 1.004-1.02). A higher level of primary care physician workforce, particularly with an FTE measure that may more accurately reflect ambulatory primary care, was generally associated with favorable patient outcomes.

Motivational and neurocognitive deficits are central to the prediction of longitudinal functional outcome in schizophrenia.

PubMed

Fervaha, G; Foussias, G; Agid, O; Remington, G

2014-10-01

Functional impairment is characteristic of most individuals with schizophrenia; however, the key variables that undermine community functioning are not well understood. This study evaluated the association between selected clinical variables and one-year longitudinal functional outcomes in patients with schizophrenia. The sample included 754 patients with schizophrenia who completed both baseline and one-year follow-up visits in the CATIE study. Patients were evaluated with a comprehensive battery of assessments capturing symptom severity and cognitive performance among other variables. The primary outcome variable was functional status one-year postbaseline measured using the Heinrichs-Carpenter Quality of Life Scale. Factor analysis of negative symptom items revealed two factors reflecting diminished expression and amotivation. Multivariate regression modeling revealed several significant independent predictors of longitudinal functioning scores. The strongest predictors were baseline amotivation and neurocognition. Both amotivation and neurocognition also had independent predictive value for each of the domains of functioning assessed (e.g., vocational). Both motivational and neurocognitive deficits independently contribute to longitudinal functional outcomes assessed 1 year later among patients with schizophrenia. Both of these domains of psychopathology impede functional recovery; hence, it follows that treatments ameliorating each of these symptoms should promote community functioning among individuals with schizophrenia. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

FACTOR ANALYTIC MODELS OF CLUSTERED MULTIVARIATE DATA WITH INFORMATIVE CENSORING

EPA Science Inventory

This paper describes a general class of factor analytic models for the analysis of clustered multivariate data in the presence of informative missingness. We assume that there are distinct sets of cluster-level latent variables related to the primary outcomes and to the censorin...

Dysglycemia, Glycemic Variability, and Outcome After Cardiac Arrest and Temperature Management at 33°C and 36°C.

PubMed

Borgquist, Ola; Wise, Matt P; Nielsen, Niklas; Al-Subaie, Nawaf; Cranshaw, Julius; Cronberg, Tobias; Glover, Guy; Hassager, Christian; Kjaergaard, Jesper; Kuiper, Michael; Smid, Ondrej; Walden, Andrew; Friberg, Hans

2017-08-01

Dysglycemia and glycemic variability are associated with poor outcomes in critically ill patients. Targeted temperature management alters blood glucose homeostasis. We investigated the association between blood glucose concentrations and glycemic variability and the neurologic outcomes of patients randomized to targeted temperature management at 33°C or 36°C after cardiac arrest. Post hoc analysis of the multicenter TTM-trial. Primary outcome of this analysis was neurologic outcome after 6 months, referred to as "Cerebral Performance Category." Thirty-six sites in Europe and Australia. All 939 patients with out-of-hospital cardiac arrest of presumed cardiac cause that had been included in the TTM-trial. Targeted temperature management at 33°C or 36°C. Nonparametric tests as well as multiple logistic regression and mixed effects logistic regression models were used. Median glucose concentrations on hospital admission differed significantly between Cerebral Performance Category outcomes (p < 0.0001). Hyper- and hypoglycemia were associated with poor neurologic outcome (p = 0.001 and p = 0.054). In the multiple logistic regression models, the median glycemic level was an independent predictor of poor Cerebral Performance Category (Cerebral Performance Category, 3-5) with an odds ratio (OR) of 1.13 in the adjusted model (p = 0.008; 95% CI, 1.03-1.24). It was also a predictor in the mixed model, which served as a sensitivity analysis to adjust for the multiple time points. The proportion of hyperglycemia was higher in the 33°C group compared with the 36°C group. Higher blood glucose levels at admission and during the first 36 hours, and higher glycemic variability, were associated with poor neurologic outcome and death. More patients in the 33°C treatment arm had hyperglycemia.

Prediction of Primary Care Depression Outcomes at Six Months: Validation of DOC-6 ©.

PubMed

Angstman, Kurt B; Garrison, Gregory M; Gonzalez, Cesar A; Cozine, Daniel W; Cozine, Elizabeth W; Katzelnick, David J

2017-01-01

The goal of this study was to develop and validate an assessment tool for adult primary care patients diagnosed with depression to determine predictive probability of clinical outcomes at 6 months. We retrospectively reviewed 3096 adult patients enrolled in collaborative care management (CCM) for depression. Patients enrolled on or before December 31, 2013, served as the training set (n = 2525), whereas those enrolled after that date served as the preliminary validation set (n = 571). Six variables (2 demographic and 4 clinical) were statistically significant in determining clinical outcomes. Using the validation data set, the remission classifier produced the receiver operating characteristics (ROC) curve with a c-statistic or area under the curve (AUC) of 0.62 with predicted probabilities than ranged from 14.5% to 79.1%, with a median of 50.6%. The persistent depressive symptoms (PDS) classifier produced an ROC curve with a c-statistic or AUC of 0.67 and predicted probabilities that ranged from 5.5% to 73.1%, with a median of 23.5%. We were able to identify readily available variables and then validated these in the prediction of depression remission and PDS at 6 months. The DOC-6 tool may be used to predict which patients may be at risk for worse outcomes. © Copyright 2017 by the American Board of Family Medicine.

Meta-analysis of workplace physical activity interventions.

PubMed

Conn, Vicki S; Hafdahl, Adam R; Cooper, Pamela S; Brown, Lori M; Lusk, Sally L

2009-10-01

Most adults do not achieve adequate physical activity levels. Despite the potential benefits of worksite health promotion, no previous comprehensive meta-analysis has summarized health and physical activity behavior outcomes from such programs. This comprehensive meta-analysis integrated the extant wide range of worksite physical activity intervention research. Extensive searching located published and unpublished intervention studies reported from 1969 through 2007. Results were coded from primary studies. Random-effects meta-analytic procedures, including moderator analyses, were completed in 2008. Effects on most variables were substantially heterogeneous because diverse studies were included. Standardized mean difference (d) effect sizes were synthesized across approximately 38,231 subjects. Significantly positive effects were observed for physical activity behavior (0.21); fitness (0.57); lipids (0.13); anthropometric measures (0.08); work attendance (0.19); and job stress (0.33). The significant effect size for diabetes risk (0.98) is less robust given small sample sizes. The mean effect size for fitness corresponds to a difference between treatment minus control subjects' means on VO2max of 3.5 mL/kg/min; for lipids, -0.2 on the ratio of total cholesterol to high-density lipoprotein; and for diabetes risk, -12.6 mg/dL on fasting glucose. These findings document that some workplace physical activity interventions can improve both health and important worksite outcomes. Effects were variable for most outcomes, reflecting the diversity of primary studies. Future primary research should compare interventions to confirm causal relationships and further explore heterogeneity.

Bayesian methods to determine performance differences and to quantify variability among centers in multi-center trials: the IHAST trial.

PubMed

Bayman, Emine O; Chaloner, Kathryn M; Hindman, Bradley J; Todd, Michael M

2013-01-16

To quantify the variability among centers and to identify centers whose performance are potentially outside of normal variability in the primary outcome and to propose a guideline that they are outliers. Novel statistical methodology using a Bayesian hierarchical model is used. Bayesian methods for estimation and outlier detection are applied assuming an additive random center effect on the log odds of response: centers are similar but different (exchangeable). The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) is used as an example. Analyses were adjusted for treatment, age, gender, aneurysm location, World Federation of Neurological Surgeons scale, Fisher score and baseline NIH stroke scale scores. Adjustments for differences in center characteristics were also examined. Graphical and numerical summaries of the between-center standard deviation (sd) and variability, as well as the identification of potential outliers are implemented. In the IHAST, the center-to-center variation in the log odds of favorable outcome at each center is consistent with a normal distribution with posterior sd of 0.538 (95% credible interval: 0.397 to 0.726) after adjusting for the effects of important covariates. Outcome differences among centers show no outlying centers. Four potential outlying centers were identified but did not meet the proposed guideline for declaring them as outlying. Center characteristics (number of subjects enrolled from the center, geographical location, learning over time, nitrous oxide, and temporary clipping use) did not predict outcome, but subject and disease characteristics did. Bayesian hierarchical methods allow for determination of whether outcomes from a specific center differ from others and whether specific clinical practices predict outcome, even when some centers/subgroups have relatively small sample sizes. In the IHAST no outlying centers were found. The estimated variability between centers was moderately large.

A Meta-Analysis of Interventions to Reduce Adolescent Cannabis Use

ERIC Educational Resources Information Center

Bender, Kimberly; Tripodi, Stephen J.; Sarteschi, Christy; Vaughn, Michael G.

2011-01-01

Objective: This meta-analytic review assesses the effectiveness of substance abuse interventions to reduce adolescent cannabis use. Method: A systematic search identified 15 randomized controlled evaluations of interventions to reduce adolescent cannabis use published between 1960 and 2008. The primary outcome variables, frequency of cannabis use,…

A valuable approach to the use of electronic medical data in primary care research: Panning for gold.

PubMed

Barnett, Stephen; Henderson, Joan; Hodgkins, Adam; Harrison, Christopher; Ghosh, Abhijeet; Dijkmans-Hadley, Bridget; Britt, Helena; Bonney, Andrew

2017-05-01

Electronic medical data (EMD) from electronic health records of general practice computer systems have enormous research potential, yet many variables are unreliable. The aim of this study was to compare selected data variables from general practice EMD with a reliable, representative national dataset (Bettering the Evaluation and Care of Health (BEACH)) in order to validate their use for primary care research. EMD variables were compared with encounter data from the nationally representative BEACH program using χ 2 tests and robust 95% confidence intervals to test their validity (measure what they reportedly measure). The variables focused on for this study were patient age, sex, smoking status and medications prescribed at the visit. The EMD sample from six general practices in the Illawarra region of New South Wales, Australia, yielded data on 196,515 patient encounters. Details of 90,553 encounters were recorded in the 2013 BEACH dataset from 924 general practitioners. No significant differences in patient age ( p = 0.36) or sex ( p = 0.39) were found. EMD had a lower rate of current smokers and higher average scripts per visit, but similar prescribing distribution patterns. Validating EMD variables offers avenues for improving primary care delivery and measuring outcomes of care to inform clinical practice and health policy.

ISCHEMIC CENTRAL RETINAL VEIN OCCLUSION IN THE ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR ERA.

PubMed

Tam, Emily K; Golchet, Pamela; Yung, Madeline; DeCroos, Francis C; Spirn, Marc; Lehmann-Clarke, Lydia; Ambresin, Aude; Tsui, Irena

2018-02-01

Anti-vascular endothelial growth factor therapy has improved the prognosis for patients with central retinal vein occlusion (CRVO). However, most studies published to date exclude ischemic CRVO. The purpose of this study was to describe the outcome in eyes with ischemic CRVO treated with anti-vascular endothelial growth factor therapy. Thirty-seven patients with ischemic CRVO from 3 centers were followed for at least 6 months. Data on patient demographic, vision status, and anti-vascular endothelial growth factor treatments were collected. Average number of injections during the study period was 5. Younger age was associated with improved vision (P = 0.006). Patients with improved visual outcomes tended to have macular edema as the primary indication for treatment, whereas patients with worse outcomes tended to have neovascularization as the primary indication for treatment. This study highlights significant variability in the use of anti-vascular endothelial growth factor therapy for ischemic CRVO and underscores that eyes with neovascularization tend to have worse visual outcomes.

Respiratory support in oncology ward setting: a prospective descriptive study.

PubMed

Mishra, Seema; Bhatnagar, Sushma; Gupta, Deepak; Goyal, Gaurav Nirvani; Agrawal, Ravi; Jain, Roopesh; Chauhan, Himanshu

2009-01-01

Mechanical ventilation in cancer patients is a critical issue The present prospective descriptive study was designed (1) to assess the patient population needing respirator support in ward setting at a premier state-run oncology institute in India, (2) to observe and analyze the course of their disease while on respirator, and (3) to coordinate better quality of life measures in cancer patients at the institute based on the present study's outcomes. Beginning from March 2005 to March 2006, all cancer patients who were connected to respirator in the wards were enrolled in the current study. Our anesthesiology department at the cancer institute also has primary responsibility for airway management and mechanical ventilation in high dependency units of oncology wards. Preventilation variables in cancer patients were assessed to judge the futility of mechanical ventilation in ward setting. Subsequently, patients were observed for disease course while on respirator. Final outcome with its etio-pathogenesis was correlated with predicted futility of mechanical ventilation. Over a period of 1 year, 132 (46 men and 86 women) cancer patients with median age 40 years (range 1-75 years) were connected to respirator in oncology wards. Based on the preventilation variables and indications for respirator support, right prediction of medical futility and hospital discharge was made in 77% of patients. Underestimation and overestimation of survival to hospital discharge was made in 10% cases and 13% cases, respectively. Based on preventilation variables, prediction of outcome in cancer patients needing respirator support can be made in 77% cases. This high probability of prediction can be used to educate patients, and their families and primary physicians, for well-informed and documented advance directives, formulated and regularly revised DNAR policies, and judicious use of respirator support for better quality-of-life outcomes.

The Origin of Variation in Primary Care Process and Outcome Indicators: Patients, Professionals, Centers, and Health Districts.

PubMed

Orueta, Juan F; García-Alvarez, Arturo; Grandes, Gonzalo; Nuño-Solinís, Roberto

2015-08-01

Healthcare providers are often evaluated by studying variability in their indicators. However, the usefulness of this analysis may be limited if we do not distinguish the variability attributable to health professionals and organizations from that associated with their patients.Our objectives are to describe the main process and outcome indicators of primary healthcare services, analyzing the contribution to variability in these indicators from different levels: individual, health professional, health center, and health district.This is a cross-sectional study that includes all.All the individuals covered by the public Basque Health Service (children [age 0-13], n = 247,493; adults [≥14 years old], n = 1,959,682) over a 12-month period.We calculated the number of visits to primary care doctors, number of referrals, prescription costs, and potentially avoidable hospitalizations for ambulatory care sensitive conditions (ACSCs). Using multilevel analysis, we determined the percentage of variance attributable to each level.After adjusting for the characteristics of patients (demographic, socioeconomic, and morbidity), doctors (panel size), health center (size, staff satisfaction, demographic structure of the community), and health district, the variance in the indicators was mainly attributable to differences between patients, independently of the attending health professional, the center, or the healthcare organization, both in children (94.21% for visits to the doctor; 96.66% for referrals; 98.57% for prescription costs; 90.02% for potentially avoidable hospitalizations for ACSCs) and in adults (88.10%; 96.26%; 97.92%; and 93.77%, respectively).The limited contribution of health professionals and organizations to variability in indicators should be taken into account when performing evaluations and planning quality improvement strategies.

The Origin of Variation in Primary Care Process and Outcome Indicators

PubMed Central

Orueta, Juan F.; García-Alvarez, Arturo; Grandes, Gonzalo; Nuño-Solinís, Roberto

2015-01-01

Abstract Healthcare providers are often evaluated by studying variability in their indicators. However, the usefulness of this analysis may be limited if we do not distinguish the variability attributable to health professionals and organizations from that associated with their patients. Our objectives are to describe the main process and outcome indicators of primary healthcare services, analyzing the contribution to variability in these indicators from different levels: individual, health professional, health center, and health district. This is a cross-sectional study that includes all. All the individuals covered by the public Basque Health Service (children [age 0–13], n = 247,493; adults [≥14 years old], n = 1,959,682) over a 12-month period. We calculated the number of visits to primary care doctors, number of referrals, prescription costs, and potentially avoidable hospitalizations for ambulatory care sensitive conditions (ACSCs). Using multilevel analysis, we determined the percentage of variance attributable to each level. After adjusting for the characteristics of patients (demographic, socioeconomic, and morbidity), doctors (panel size), health center (size, staff satisfaction, demographic structure of the community), and health district, the variance in the indicators was mainly attributable to differences between patients, independently of the attending health professional, the center, or the healthcare organization, both in children (94.21% for visits to the doctor; 96.66% for referrals; 98.57% for prescription costs; 90.02% for potentially avoidable hospitalizations for ACSCs) and in adults (88.10%; 96.26%; 97.92%; and 93.77%, respectively). The limited contribution of health professionals and organizations to variability in indicators should be taken into account when performing evaluations and planning quality improvement strategies. PMID:26252315

The Impact of Tic Severity, Comorbidity and Peer Attachment on Quality of Life Outcomes and Functioning in Tourette's Syndrome: Parental Perspectives.

PubMed

O'Hare, Deirdre; Helmes, Edward; Eapen, Valsamma; Grove, Rachel; McBain, Kerry; Reece, John

2016-08-01

The aim of this controlled, community-based study based on data from parents of youth (aged 7-16 years) with Tourette's syndrome (TS; n = 86) and parents of age and gender matched peers (n = 108) was to test several hypotheses involving a range of variables salient to the TS population, including peer attachment, quality of life, severity of tics, comorbidity, and psychological, behavioural and social dysfunction. Multivariate between-group analyses confirmed that TS group youth experienced lower quality of life, increased emotional, behavioural and social difficulties, and elevated rates of insecure peer attachment relative to controls, as reported by their primary caregiver. Results also confirmed the main hypothesis that security of peer attachment would be associated with individual variability in outcomes for youth with TS. As predicted, multivariate within-TS group analyses determined strong relationships among adverse quality of life outcomes and insecure attachment to peers, increased tic severity, and the presence of comorbid disorder. Findings suggest that youth with TS are at increased risk for insecure peer attachment and that this might be an important variable impacting the quality of life outcomes for those diagnosed.

Initial fractal exponent of heart-rate variability is associated with success of early resuscitation in patients with severe sepsis or septic shock: a prospective cohort study

PubMed Central

Brown, Samuel M.; Tate, Quinn; Jones, Jason P.; Knox, Daniel; Kuttler, Kathryn G.; Lanspa, Michael; Rondina, Matthew T.; Grissom, Colin K.; Behera, Subhasis; Mathews, V.J.; Morris, Alan

2013-01-01

Introduction Heart-rate variability reflects autonomic nervous system tone as well as the overall health of the baroreflex system. We hypothesized that loss of complexity in heart-rate variability upon ICU admission would be associated with unsuccessful early resuscitation of sepsis. Methods We prospectively enrolled patients admitted to ICUs with severe sepsis or septic shock from 2009 to 2011. We studied 30 minutes of EKG, sampled at 500 Hz, at ICU admission and calculated heart-rate complexity via detrended fluctuation analysis. Primary outcome was vasopressor independence at 24 hours after ICU admission. Secondary outcome was 28-day mortality. Results We studied 48 patients, of whom 60% were vasopressor independent at 24 hours. Five (10%) died within 28 days. The ratio of fractal alpha parameters was associated with both vasopressor independence and 28-day mortality (p=0.04) after controlling for mean heart rate. In the optimal model, SOFA score and the long-term fractal alpha parameter were associated with vasopressor independence. Conclusions Loss of complexity in heart rate variability is associated with worse outcome early in severe sepsis and septic shock. Further work should evaluate whether complexity of heart rate variability (HRV) could guide treatment in sepsis. PMID:23958243

Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review

PubMed Central

Morris, Tom; Gray, Laura

2017-01-01

Objectives To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. Setting Any, not limited to healthcare settings. Participants Any taking part in an SW-CRT published up to March 2016. Primary and secondary outcome measures The primary outcome is the variability in cluster sizes, measured by the coefficient of variation (CV) in cluster size. Secondary outcomes include the difference between the cluster sizes assumed during the sample size calculation and those observed during the trial, any reported variability in cluster sizes and whether the methods of sample size calculation and methods of analysis accounted for any variability in cluster sizes. Results Of the 101 included SW-CRTs, 48% mentioned that the included clusters were known to vary in size, yet only 13% of these accounted for this during the calculation of the sample size. However, 69% of the trials did use a method of analysis appropriate for when clusters vary in size. Full trial reports were available for 53 trials. The CV was calculated for 23 of these: the median CV was 0.41 (IQR: 0.22–0.52). Actual cluster sizes could be compared with those assumed during the sample size calculation for 14 (26%) of the trial reports; the cluster sizes were between 29% and 480% of that which had been assumed. Conclusions Cluster sizes often vary in SW-CRTs. Reporting of SW-CRTs also remains suboptimal. The effect of unequal cluster sizes on the statistical power of SW-CRTs needs further exploration and methods appropriate to studies with unequal cluster sizes need to be employed. PMID:29146637

Risk factors for poor outcomes in patients with open-globe injuries

PubMed Central

Page, Rita D; Gupta, Sumeet K; Jenkins, Thomas L; Karcioglu, Zeynel A

2016-01-01

Purpose The aim of this study was to identify the risk factors that are predictive of poor outcomes in penetrating globe trauma. Patients and methods This retrospective case series evaluated 103 eyes that had been surgically treated for an open-globe injury from 2007 to 2010 at the eye clinic of the University of Virginia. A total of 64 eyes with complete medical records and at least 6 months of follow-up were included in the study. Four risk factors (preoperative best-corrected visual acuity [pre-op BCVA], ocular trauma score [OTS], zone of injury [ZOI], and time lapse [TL] between injury and primary repair) and three outcomes (final BCVA, monthly rate of additional surgeries [MRAS], and enucleation) were identified for analysis. Results Pre-op BCVA was positively associated with MRAS, final BCVA, and enucleation. Calculated OTS was negatively associated with the outcome variables. No association was found between TL and ZOI with the outcome variables. Further, age and predictor variable-adjusted analyses showed pre-op BCVA to be independently positively associated with MRAS (P=0.008) and with final BCVA (P<0.001), while the calculated OTS was independently negatively associated with final BCVA (P<0.001), but not uniquely associated with MRAS (P=0.530). Conclusion Pre-op BCVA and OTS are best correlated with prognosis in open-globe injuries. However, no conventional features reliably predict the outcome of traumatized eyes. PMID:27536059

Outcomes of Medically Indicated Preterm Births Differ by Indication.

PubMed

Wang, Michelle J; Kuper, Spencer G; Steele, Robin; Sievert, Rachel A; Tita, Alan T; Harper, Lorie M

2018-07-01

 We aim to examine whether outcomes of preterm birth (PTB) are further modified by the indication for delivery.  We performed a retrospective cohort study of all singletons delivered at 23 to 34 weeks from 2011 to 2014. Women were classified by their primary indication for delivery: maternal (preeclampsia) or fetal/obstetric (growth restriction, nonreassuring fetal status, and vaginal bleeding). The primary neonatal outcome was a composite of neonatal death, cord pH <7 or base excess < - 12, 5-minute Apgar ≤3, C-reactive protein during resuscitation, culture-proven sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. Secondary outcomes included the individual components of the primary outcome. Groups were compared using Student's t -test and chi-squared tests. Logistic regression was used to adjust for confounding variables.  Of 528 women, 395 (74.8%) were delivered for maternal and 133 (25.2%) for fetal/obstetric indications. Compared with those delivered for a maternal indication, those with a fetal/obstetric indication for delivery had an increased risk of the composite neonatal outcome (adjusted odds ratio [AOR]: 1.9, 95% confidence interval [CI]: 1.13-3.21) and acidemia at birth (AOR: 4.2, 95% CI: 1.89-9.55).  Preterm infants delivered for fetal/obstetric indications have worsened outcomes compared with those delivered for maternal indications. Additional research is needed to further tailor counseling specific to the indication for delivery. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Logic regression and its extensions.

PubMed

Schwender, Holger; Ruczinski, Ingo

2010-01-01

Logic regression is an adaptive classification and regression procedure, initially developed to reveal interacting single nucleotide polymorphisms (SNPs) in genetic association studies. In general, this approach can be used in any setting with binary predictors, when the interaction of these covariates is of primary interest. Logic regression searches for Boolean (logic) combinations of binary variables that best explain the variability in the outcome variable, and thus, reveals variables and interactions that are associated with the response and/or have predictive capabilities. The logic expressions are embedded in a generalized linear regression framework, and thus, logic regression can handle a variety of outcome types, such as binary responses in case-control studies, numeric responses, and time-to-event data. In this chapter, we provide an introduction to the logic regression methodology, list some applications in public health and medicine, and summarize some of the direct extensions and modifications of logic regression that have been proposed in the literature. Copyright © 2010 Elsevier Inc. All rights reserved.

Exposure and response prevention process predicts treatment outcome in youth with OCD.

PubMed

Kircanski, Katharina; Peris, Tara S

2015-04-01

Recent research on the treatment of adults with anxiety disorders suggests that aspects of the in-session exposure therapy process are relevant to clinical outcomes. However, few comprehensive studies have been conducted with children and adolescents. In the present study, 35 youth diagnosed with primary obsessive-compulsive disorder (OCD; M age = 12.9 years, 49% male, 63% Caucasian) completed 12 sessions of exposure and response prevention (ERP) in one of two treatment conditions as part of a pilot randomized controlled testing of a family focused intervention for OCD. Key exposure process variables, including youth self-reported distress during ERP and the quantity and quality of ERP completed, were computed. These variables were examined as predictors of treatment outcomes assessed at mid-treatment, post-treatment, and three-month follow-up, partialing treatment condition. In general, greater variability of distress during ERP and completing a greater proportion of combined exposures (i.e., exposures targeting more than one OC symptom at once) were predictive of better outcomes. Conversely, greater distress at the end of treatment was generally predictive of poorer outcomes. Finally, several variables, including within- and between-session decreases in distress during ERP, were not consistently predictive of outcomes. Findings signal potentially important facets of exposure for youth with OCD and have implications for treatment. A number of results also parallel recent findings in the adult literature, suggesting that there may be some continuity in exposure processes from child to adult development. Future work should examine additional measures of exposure process, such as psychophysiological arousal during exposure, in youth.

Harnessing demographic differences in organizations: What moderates the effects of workplace diversity?

PubMed

Guillaume, Yves R F; Dawson, Jeremy F; Otaye-Ebede, Lilian; Woods, Stephen A; West, Michael A

2017-02-01

To account for the double-edged nature of demographic workplace diversity (i.e,. relational demography, work group diversity, and organizational diversity) effects on social integration, performance, and well-being-related variables, research has moved away from simple main effect approaches and started examining variables that moderate these effects. While there is no shortage of primary studies of the conditions under which diversity leads to positive or negative outcomes, it remains unclear which contingency factors make it work. Using the Categorization-Elaboration Model as our theoretical lens, we review variables moderating the effects of workplace diversity on social integration, performance, and well-being outcomes, focusing on factors that organizations and managers have control over (i.e., strategy, unit design, human resource, leadership, climate/culture, and individual differences). We point out avenues for future research and conclude with practical implications. © 2015 The Authors. Journal of Organizational Behavior published by John Wiley & Sons, Ltd.

Harnessing demographic differences in organizations: What moderates the effects of workplace diversity?

PubMed Central

Dawson, Jeremy F.; Otaye‐Ebede, Lilian; Woods, Stephen A.; West, Michael A.

2015-01-01

Summary To account for the double‐edged nature of demographic workplace diversity (i.e,. relational demography, work group diversity, and organizational diversity) effects on social integration, performance, and well‐being‐related variables, research has moved away from simple main effect approaches and started examining variables that moderate these effects. While there is no shortage of primary studies of the conditions under which diversity leads to positive or negative outcomes, it remains unclear which contingency factors make it work. Using the Categorization‐Elaboration Model as our theoretical lens, we review variables moderating the effects of workplace diversity on social integration, performance, and well‐being outcomes, focusing on factors that organizations and managers have control over (i.e., strategy, unit design, human resource, leadership, climate/culture, and individual differences). We point out avenues for future research and conclude with practical implications. © 2015 The Authors. Journal of Organizational Behavior published by John Wiley & Sons, Ltd PMID:28239234

No Variation in Patient Care Outcomes After Implementation of Resident Shift Work Duty Hour Limitations and a Hospitalist Model System.

PubMed

Hollier, John M; Wilson, Stephen D

This study examines whether implementing a resident shift work schedule (RSWS) alone or combined with a hospitalist-led model system (HMS/RSWS) affects patient care outcomes or costs at a pediatric tertiary care teaching hospital. A retrospective sample compared pre- and postintervention groups for the most common primary discharge diagnoses, including asthma and cellulitis (RSWS intervention) and inflammatory bowel disease and diabetic ketoacidosis (HMS/RSWS intervention). Outcome variables included length of stay, number of subspecialty consultations, and hospitalization charges. For the RSWS intervention, the preintervention (n = 107) and postintervention (n = 92) groups showed no difference in any of the outcome variables. For the HMS/RSWS intervention, the preintervention (n = 98) and postintervention (n = 69) groups did not differ in demographics or length of stay. However, subspecialty consultations increased significantly during postintervention from 0.83 to 1.52 consults/hospitalization ( P < .01) without significantly increasing hospitalization charges. Neither the RSWS nor HMS/RSWS intervention affected patient care outcomes at a pediatric tertiary care teaching hospital.

Factors affecting exits from homelessness among persons with serious mental illness and substance use disorders.

PubMed

Gabrielian, Sonya; Bromley, Elizabeth; Hellemann, Gerhard S; Kern, Robert S; Goldenson, Nicholas I; Danley, Megan E; Young, Alexander S

2015-04-01

We sought to understand the housing trajectories of homeless consumers with serious mental illness (SMI) and co-occurring substance use disorders (SUD) and to identify factors that best predicted achievement of independent housing. Using administrative data, we identified homeless persons with SMI and SUD admitted to a residential rehabilitation program from December 2008 to November 2011. Our primary outcome measure was independent housing status. On a random sample (N = 36), we assessed a range of potential predictors of housing outcomes, including symptoms, cognition, and social/community supports. We used the Residential Time-Line Follow-Back (TLFB) Inventory to gather housing histories since exiting rehabilitation and to identify housing outcomes. We used Recursive Partitioning (RP) to identify variables that best differentiated participants by these outcomes. We identified 3 housing trajectories: stable housing (n = 14), unstable housing (n = 15), and continuously engaged in housing services (n = 7). In RP analysis, 2 variables (Symbol Digit Modalities Test [SDMT], a neurocognitive speed of processing measure, and Behavior and Symptom Identification Scale [BASIS-24] Relationships subscale, which quantifies symptoms affecting relationships) were sufficient to capture information provided by 26 predictors to classify participants by housing outcome. Participants predicted to continuously engage in services had impaired processing speeds (SDMT score < 32.5). Among consumers with SDMT score ≥ 32.5, those predicted to achieve stable housing had fewer interpersonal symptoms (BASIS-24 Relationships subscale score < 0.81) than those predicted to have unstable housing. This model explains 57% of this sample's variability and 14% of this population's variability in housing outcomes. Because cognition and symptoms influencing relationships predicted housing outcomes for homeless adults with SMI and SUD, cognitive and social skills training may be useful for this population. © Copyright 2015 Physicians Postgraduate Press, Inc.

Psychobiologic correlates of treatment response in schizophrenia.

PubMed

Lieberman, J A; Alvir, J M; Koreen, A; Geisler, S; Chakos, M; Sheitman, B; Woerner, M

1996-03-01

In studies conducted on largely treatment naive patients in their first episode of psychosis, we have found that treatment outcome is quite good and that most patients recover or at least achieve a substantial degree of symptom remission. However, over the course of their illness and in the context of subsequent psychotic episodes, they may experience some decrease in their treatment response from illness progression. In addition, the heterogeneity of treatment outcome is associated with specific clinical (gender, primary negative symptoms of the deficit state, duration of psychosis) and biological variables (pHVA, ventricular volume). It is unclear whether these variables represent aspects of discrete subtypes of schizophrenia or dimensional measures of pathology within the broad context of a unitary disease entity.

The impact of social deprivation on the response to a randomised controlled trial of a weight management intervention (BeWEL) for people at increased risk of colorectal cancer.

PubMed

Fisher, A; Craigie, A M; Macleod, M; Steele, R J C; Anderson, A S

2018-06-01

Although 45% of colorectal cancer (CRC) cases may be avoidable through appropriate lifestyle and weight management, health promotion interventions run the risk of widening health inequalities. The BeWEL randomised controlled trial assessed the impact of a diet and activity programme in overweight adults who were diagnosed with a colorectal adenoma, demonstrating a significantly greater weight loss at 12 months in intervention participants than in controls. The present study aimed to compare BeWEL intervention outcomes by participant deprivation status. The intervention group of the BeWEL trial (n = 163) was classified by the Scottish Index of Multiple Deprivation (SIMD) quintiles into 'more deprived' (SIMD 1-2, n = 58) and 'less deprived' (SIMD 3-5, n = 105). Socio-economic and lifestyle variables were compared at baseline to identify potential challenges to intervention adherence in the more deprived. Between group differences at 12 months in primary outcome (change in body weight) and secondary outcomes (cardiovascular risk factors, diet, physical activity, knowledge of CRC risk and psychosocial variables) were assessed by deprivation status. At baseline, education (P = 0.001), income (P < 0.001), spending on physical activity (P = 0.003) and success at previous weight loss attempts (P = 0.007) were significantly lower in the most deprived. At 12 months, no between group differences by deprivation status were detected for changes in primary and main secondary outcomes. Despite potential barriers faced by the more deprived participants, primary and most secondary outcomes were comparable between groups, indicating that this intervention is unlikely to worsen health inequalities and is equally effective across socio-economic groups. © 2017 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association.

Tai Chi for Reducing Dual-task Gait Variability, a Potential Mediator of Fall Risk in Parkinson's Disease: A Pilot Randomized Controlled Trial.

PubMed

Vergara-Diaz, Gloria; Osypiuk, Kamila; Hausdorff, Jeffrey M; Bonato, Paolo; Gow, Brian J; Miranda, Jose Gv; Sudarsky, Lewis R; Tarsy, Daniel; Fox, Michael D; Gardiner, Paula; Thomas, Cathi A; Macklin, Eric A; Wayne, Peter M

2018-01-01

To assess the feasibility and inform design features of a fully powered randomized controlled trial (RCT) evaluating the effects of Tai Chi (TC) in Parkinson's disease (PD) and to select outcomes most responsive to TC assessed during off-medication states. Two-arm, wait-list controlled RCT. Tertiary care hospital. Thirty-two subjects aged 40-75 diagnosed with idiopathic PD within 10 years. Six-month TC intervention added to usual care (UC) versus UC alone. Primary outcomes were feasibility-related (recruitment rate, adherence, and compliance). Change in dual-task (DT) gait stride-time variability (STV) from baseline to 6 months was defined, a priori, as the clinical outcome measure of primary interest. Other outcomes included: PD motor symptom progression (Unified Parkinson's Disease Rating Scale [UPDRS]), PD-related quality of life (PDQ-39), executive function (Trail Making Test), balance confidence (Activity-Specific Balance Confidence Scale, ABC), and Timed Up and Go test (TUG). All clinical assessments were made in the off-state for PD medications. Thirty-two subjects were enrolled into 3 sequential cohorts over 417 days at an average rate of 0.08 subjects per day. Seventy-five percent (12/16) in the TC group vs 94% (15/16) in the UC group completed the primary 6-month follow-up assessment. Mean TC exposure hours overall: 52. No AEs occurred during or as a direct result of TC exercise. Statistically nonsignificant improvements were observed in the TC group at 6 months in DT gait STV (TC [20.1%] vs UC [-0.1%] group [effect size 0.49; P = .47]), ABC, TUG, and PDQ-39. UPDRS progression was modest and very similar in TC and UC groups. Conducting an RCT of TC for PD is feasible, though measures to improve recruitment and adherence rates are needed. DT gait STV is a sensitive and logical outcome for evaluating the combined cognitive-motor effects of TC in PD.

Reduced Myocardial Flow Reserve by Positron Emission Tomography Predicts Cardiovascular Events After Cardiac Transplantation.

PubMed

Konerman, Matthew C; Lazarus, John J; Weinberg, Richard L; Shah, Ravi V; Ghannam, Michael; Hummel, Scott L; Corbett, James R; Ficaro, Edward P; Aaronson, Keith D; Colvin, Monica M; Koelling, Todd M; Murthy, Venkatesh L

2018-06-01

We evaluated the diagnostic and prognostic value of quantification of myocardial flow reserve (MFR) with positron emission tomography (PET) in orthotopic heart transplant patients. We retrospectively identified orthotopic heart transplant patients who underwent rubidium-82 cardiac PET imaging. The primary outcome was the composite of cardiovascular death, acute coronary syndrome, coronary revascularization, and heart failure hospitalization. Cox regression was used to evaluate the association of MFR with the primary outcome. The relationship of MFR and cardiac allograft vasculopathy severity in patients with angiography within 1 year of PET imaging was assessed using Spearman rank correlation and logistic regression. A total of 117 patients (median age, 60 years; 71% men) were identified. Twenty-one of 62 patients (34%) who underwent angiography before PET had cardiac allograft vasculopathy. The median time from orthotopic heart transplant to PET imaging was 6.4 years (median global MFR, 2.31). After a median of 1.4 years, 22 patients (19%) experienced the primary outcome. On an unadjusted basis, global MFR (hazard ratio, 0.22 per unit increase; 95% confidence interval, 0.09-0.50; P <0.001) and stress myocardial blood flow (hazard ratio, 0.48 per unit increase; 95% confidence interval, 0.29-0.79; P =0.004) were associated with the primary outcome. Decreased MFR independently predicted the primary outcome after adjustment for other variables. In 42 patients who underwent angiography within 12 months of PET, MFR and stress myocardial blood flow were associated with moderate-severe cardiac allograft vasculopathy (International Society of Heart and Lung Transplantation grade 2-3). MFR assessed by cardiac rubidium-82 PET imaging is a predictor of cardiovascular events after orthotopic heart transplant and is associated with cardiac allograft vasculopathy severity. © 2018 American Heart Association, Inc.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study.

PubMed

Judge, A; Batra, R N; Thomas, G E; Beard, D; Javaid, M K; Murray, D W; Dieppe, P A; Dreinhoefer, K E; Peter-Guenther, K; Field, R; Cooper, C; Arden, N K

2014-03-01

To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery. Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (EPOS) (n = 1431); EUROHIP (n = 1327); Elective Orthopaedic Centre (n = 2832); and St. Helier (n = 787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27-1.28), P-value 0.001. Compared to people of normal BMI (20-25), those in the obese class II (BMI 35-40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. Copyright © 2014 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

PubMed Central

Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

2014-01-01

Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

Lipid Profiles, Inflammatory Markers, and Insulin Therapy in Youth with Type 2 Diabetes.

PubMed

Levitt Katz, Lorraine E; Bacha, Fida; Gidding, Samuel S; Weinstock, Ruth S; El Ghormli, Laure; Libman, Ingrid; Nadeau, Kristen J; Porter, Kristin; Marcovina, Santica

2018-05-01

Data regarding atherogenic dyslipidemia and the inflammation profile in youth with type 2 diabetes is limited and the effect of insulin therapy on these variables has not previously been studied in youth. We determined the impact of insulin therapy on lipid and inflammatory markers in youth with poorly controlled type 2 diabetes. In the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) multicenter trial, 285 participants failed to sustain glycemic control on randomized treatment (primary outcome, glycated hemoglobin A1c [HbA1c] at ≥8% for 6 months); 363 maintained glycemic control (never reached primary outcome). Statins were used for a low-density lipoprotein cholesterol of ≥130 mg/dL. Upon reaching the primary outcome, insulin was started. Changes in lipids and inflammatory markers (slopes over time) were examined. Progression of dyslipidemia was related to glycemic control. In those with the primary outcome, insulin therapy impacted HbA1c modestly, and dampened the increase in total cholesterol, low-density lipoprotein cholesterol, and total apolipoprotein B, although statin use increased from 8.6% to 22% year after the primary outcome. The increase in triglycerides and plasma nonesterified fatty acids stabilized after insulin was started, independent of HbA1c. There was an increase in high-sensitivity C-reactive protein that continued after insulin initiation, related to HbA1c and percent overweight. Worsening dyslipidemia and inflammation over time raise concern regarding premature development of atherosclerosis in youth with type 2 diabetes. Insulin therapy has a limited benefit in the absence of glycemic control. Strategies to achieve better glycemic control are needed. ClinicalTrials.gov: NCT00081328. Copyright © 2017 Elsevier Inc. All rights reserved.

After Superficial Ablation for Superficial Reflux Associated with Primary Deep Axial Reflux, Can Variable Outcomes be Caused by Deep Venous Valve Anomalies?

PubMed

Maleti, O; Lugli, M; Perrin, M

2017-02-01

To identify which deep anatomical anomalies can explain variable hemodynamic outcomes in patients with superficial reflux associated with primary deep axial reflux who underwent isolated superficial vein ablation without improvement. This is a retrospective study of deep venous valve anomalies in patients who underwent superficial vein ablation for superficial and associated deep reflux. A group of 21 patients who were diagnosed with saphenous reflux associated with primary deep axial reflux, were submitted to great saphenous vein ablation. In 17 patients the deep reflux was not abolished. In this subgroup, surgical exploration of the deep valve was carried out using venotomy for possible valve repair. Among the 17 subgroup patients, four post-thrombotic lesions were discovered intra-operatively in four patients; they underwent different surgical procedures. In 13 of the subgroup patients, primary valve incompetence was confirmed intra-operatively. In 11 cases the leaflets were asymmetrical and in only two were they symmetrical. After valvuloplasty, deep reflux was abolished in all 13 patients. Clinical improvement was obtained in 12/13 patients (92%). It is noteworthy that abolition of deep reflux was associated with significant improvement in air plethysmography data as well as with improvement in clinical status measured on CEAP class, VCSS and the SF-36 questionnaire. Failure to correct deep axial reflux by superficial ablation in patients with superficial and associated primary deep axial reflux may be related to asymmetry in the leaflets of the incompetent deep venous valve. Copyright © 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Positive Psychological Strengths and School Engagement in Primary School Children

ERIC Educational Resources Information Center

Wilkins, Bronwyn; Boman, Peter; Mergler, Amanda

2015-01-01

A sizeable body of research has investigated the impact of specific character strengths or traits on significant outcomes. Some recent research is beginning to consider the effects of groups of strengths, combined as a higher order variable and termed covitality. This study investigated the combined influence of four positive character traits,…

Factors That Help and Hinder Scientific Training in Counseling and Clinical Psychology Students

ERIC Educational Resources Information Center

Marks, Margaret M.

2011-01-01

The purpose of this dissertation is to better understand scientific training within clinical and counseling psychology doctoral programs. A primary goal is to extend previous research by expanding the scientific training outcome variables from research interest and productivity to include additional characteristics of scientific mindedness such as…

Population characteristics, mechanisms of primary care and premature mortality in England: a cross-sectional study.

PubMed

Baker, Richard; Honeyford, Kate; Levene, Louis S; Mainous, Arch G; Jones, David R; Bankart, M John; Stokes, Tim

2016-02-11

Health systems with strong primary care tend to have better population outcomes, but in many countries demand for care is growing. We sought to identify mechanisms of primary care that influence premature mortality. We developed a conceptual model of the mechanisms by which primary care influences premature mortality, and undertook a cross-sectional study in which population and primary care variables reflecting the model were used to explain variations in mortality of those aged under 75 years. The premature standardised mortality ratios (SMRs) for each practice, available from the Department of Health, had been calculated from numbers of deaths in the 5 years from 2006 to 2010. A regression model was undertaken with explanatory variables for the year 2009/2010, and repeated to check stability using data for 2008/2009 and 2010/2011. All general practices in England were eligible for inclusion and, of the total of 8290, complete data were available for 7858. Population variables, particularly deprivation, were the most powerful predictors of premature mortality, but the mechanisms of primary care depicted in our model also affected mortality. The number of GPs/1000 population and detection of hypertension were negatively associated with mortality. In less deprived practices, continuity of care was also negatively associated with mortality. Greater supply of primary care is associated with lower premature mortality even in a health system that has strong primary care (England). Health systems need to sustain the capacity of primary care to deliver effective care, and should assist primary care providers in identifying and meeting the needs of socioeconomically deprived groups. 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/

Short-term stability of sleep and heart rate variability in good sleepers and patients with insomnia: for some measures, one night is enough.

PubMed

Israel, Benjamin; Buysse, Daniel J; Krafty, Robert T; Begley, Amy; Miewald, Jean; Hall, Martica

2012-09-01

Quantify the short-term stability of multiple indices of sleep and nocturnal physiology in good sleeper controls and primary insomnia patients. Intra-class correlation coefficients (ICC) were used to quantify the short-term stability of study outcomes. Sleep laboratory. Fifty-four adults with primary insomnia (PI) and 22 good sleeper controls (GSC). Visually scored sleep outcomes included indices of sleep duration, continuity, and architecture. Quantitative EEG outcomes included power in the delta, theta, alpha, sigma, and beta bands during NREM sleep. Power spectral analysis was used to estimate high-frequency heart rate variability (HRV) and the ratio of low- to high-frequency HRV power during NREM and REM sleep. With the exception of percent stage 3+4 sleep; visually scored sleep outcomes did not exhibit short-term stability across study nights. Most QEEG outcomes demonstrated short-term stability in both groups. Although power in the beta band was stable in the PI group (ICC = 0.75), it tended to be less stable in GSCs (ICC = 0.55). Both measures of cardiac autonomic tone exhibited short-term stability in GSCs and PIs during NREM and REM sleep. Most QEEG bandwidths and HRV during sleep show high short-term stability in good sleepers and patients with insomnia alike. One night of data is, thus, sufficient to derive reliable estimates of these outcomes in studies focused on group differences or correlates of QEEG and/or HRV. In contrast, one night of data is unlikely to generate reliable estimates of PSG-assessed sleep duration, continuity or architecture, with the exception of slow wave sleep.

Goal orientation, perceived task outcome and task demands in mathematics tasks: effects on students' attitude in actual task settings.

PubMed

Seegers, Gerard; van Putten, Cornelis M; de Brabander, Cornelis J

2002-09-01

In earlier studies, it has been found that students' domain-specific cognitions and personal learning goals (goal orientation) influence task-specific appraisals of actual learning tasks. The relations between domain-specific and task-specific variables have been specified in the model of adaptive learning. In this study, additional influences, i.e., perceived task outcome on a former occasion and variations in task demands, were investigated. The purpose of this study was to identify personality and situational variables that mediate students' attitude when confronted with a mathematics task. Students worked on a mathematics task in two subsequent sessions. Effects of perceived task outcome at the first session on students' attitude at the second session were investigated. In addition, we investigated how differences in task demands influenced students' attitude. Variations in task demands were provoked by different conditions in task-instruction. In one condition, students were told that the result on the test would add to their mark on mathematics. This outcome orienting condition was contrasted with a task-orienting condition where students were told that the results on the test would not be used to give individual grades. Participants were sixth grade students (N = 345; aged 11-12 years) from 14 primary schools. Multivariate and univariate analyses of (co)variance were applied to the data. Independent variables were goal orientation, task demands, and perceived task outcome, with task-specific variables (estimated competence for the task, task attraction, task relevance, and willingness to invest effort) as the dependent variables. The results showed that previous perceived task outcome had a substantial impact on students' attitude. Additional but smaller effects were found for variation in task demands. Furthermore, effects of previous perceived task outcome and task demands were related to goal orientation. The resulting pattern confirmed that, in general, performance-oriented learning goals emphasised the negative impact of failure experiences, whereas task-oriented learning goals had a strengthening effect on how success experiences influenced students' attitude.

Correlational analysis and predictive validity of psychological constructs related with pain in fibromyalgia

PubMed Central

2011-01-01

Background Fibromyalgia (FM) is a prevalent and disabling disorder characterized by a history of widespread pain for at least three months. Pain is considered a complex experience in which affective and cognitive aspects are crucial for prognosis. The aim of this study is to assess the importance of pain-related psychological constructs on function and pain in patients with FM. Methods Design Multicentric, naturalistic, one-year follow-up study. Setting and study sample. Patients will be recruited from primary care health centres in the region of Aragon, Spain. Patients considered for inclusion are those aged 18-65 years, able to understand Spanish, who fulfil criteria for primary FM according to the American College of Rheumatology, with no previous psychological treatment. Measurements The variables measured will be the following: main variables (pain assessed with a visual analogue scale and with sphygmomanometer and general function assessed with Fibromyalgia Impact Questionnaire, and), psychological constructs (pain catastrophizing, pain acceptance, mental defeat, psychological inflexibility, perceived injustice, mindfulness, and positive and negative affect), and secondary variables (sociodemographic variables, anxiety and depression assessed with Hospital Anxiety and Depression Scale, and psychiatric interview assessed with MINI). Assessments will be carried at baseline and at one-year follow-up. Main outcome Pain Visual Analogue Scale. Analysis The existence of differences in socio-demographic, main outcome and other variables regarding pain-related psychological constructs will be analysed using Chi Square test for qualitative variables, or Student t test or variance analysis, respectively, for variables fulfilling the normality hypothesis. To assess the predictive value of pain-related psychological construct on main outcome variables at one-year follow-up, use will be made of a logistic regression analysis adjusted for socio-demographic and clinical variables. A Spearman Rho non-parametric correlation matrix will be developed to determine possible overlapping between pain-related psychological constructs. Discussion In recent years, the relevance of cognitive and affective aspects for the treatment of chronic pain, not only in FM but also in other chronic pain diseases, has been widely acknowledged. However, the relative importance of these psychological constructs, the relationship and possible overlapping between them, or the exact meaning of them in pain are not enough known. PMID:21214948

Use of social adaptability index to explain self-care and diabetes outcomes.

PubMed

Campbell, Jennifer A; Walker, Rebekah J; Smalls, Brittany L; Egede, Leonard E

2017-06-20

To examine whether the social adaptability index (SAI) alone or components of the index provide a better explanatory model for self-care and diabetes outcomes. Six hundred fifteen patients were recruited from two primary care settings. A series of multiple linear regression models were run to assess (1) associations between the SAI and diabetes self-care/outcomes, and (2) associations between individual SAI indicator variables and diabetes self-care/outcomes. Separate models were run for each self-care behavior and outcome. Two models were run for each dependent variable to compare associations with the SAI and components of the index. The SAI has a significant association with the mental component of quality of life (0.23, p < 0.01). In adjusted analyses, the SAI score did not have a significant association with any of the self-care behaviors. Individual components from the index had significant associations between self-care and multiple SAI indicator variables. Significant associations also exist between outcomes and the individual SAI indicators for education and employment. In this population, the SAI has low explanatory power and few significant associations with diabetes self-care/outcomes. While the use of a composite index to predict outcomes within a diabetes population would have high utility, particularly for clinical settings, this SAI lacks statistical and clinical significance in a representative diabetes population. Based on these results, the index does not provide a good model fit and masks the relationship of individual components to diabetes self-care and outcomes. These findings suggest that five items alone are not adequate to explain or predict outcomes for patients with type 2 diabetes.

A Partial Least-Squares Analysis of Health-Related Quality-of-Life Outcomes After Aneurysmal Subarachnoid Hemorrhage.

PubMed

Young, Julia M; Morgan, Benjamin R; Mišić, Bratislav; Schweizer, Tom A; Ibrahim, George M; Macdonald, R Loch

2015-12-01

Individuals who have aneurysmal subarachnoid hemorrhages (SAHs) experience decreased health-related qualities of life (HRQoLs) that persist after the primary insult. To identify clinical variables that concurrently associate with HRQoL outcomes by using a partial least-squares approach, which has the distinct advantage of explaining multidimensional variance where predictor variables may be highly collinear. Data collected from the CONSCIOUS-1 trial was used to extract 29 clinical variables including SAH presentation, hospital procedures, and demographic information in addition to 5 HRQoL outcome variables for 256 individuals. A partial least-squares analysis was performed by calculating a heterogeneous correlation matrix and applying singular value decomposition to determine components that best represent the correlations between the 2 sets of variables. Bootstrapping was used to estimate statistical significance. The first 2 components accounting for 81.6% and 7.8% of the total variance revealed significant associations between clinical predictors and HRQoL outcomes. The first component identified associations between disability in self-care with longer durations of critical care stay, invasive intracranial monitoring, ventricular drain time, poorer clinical grade on presentation, greater amounts of cerebral spinal fluid drainage, and a history of hypertension. The second component identified associations between disability due to pain and discomfort as well as anxiety and depression with greater body mass index, abnormal heart rate, longer durations of deep sedation and critical care, and higher World Federation of Neurosurgical Societies and Hijdra scores. By applying a data-driven, multivariate approach, we identified robust associations between SAH clinical presentations and HRQoL outcomes. EQ-VAS, EuroQoL visual analog scaleHRQoL, health-related quality of lifeICU, intensive care unitIVH, intraventricular hemorrhagePLS, partial least squaresSAH, subarachnoid hemorrhageSVD, singular value decompositionWFNS, World Federation of Neurosurgical Societies.

Model-based recursive partitioning to identify risk clusters for metabolic syndrome and its components: findings from the International Mobility in Aging Study

PubMed Central

Pirkle, Catherine M; Wu, Yan Yan; Zunzunegui, Maria-Victoria; Gómez, José Fernando

2018-01-01

Objective Conceptual models underpinning much epidemiological research on ageing acknowledge that environmental, social and biological systems interact to influence health outcomes. Recursive partitioning is a data-driven approach that allows for concurrent exploration of distinct mixtures, or clusters, of individuals that have a particular outcome. Our aim is to use recursive partitioning to examine risk clusters for metabolic syndrome (MetS) and its components, in order to identify vulnerable populations. Study design Cross-sectional analysis of baseline data from a prospective longitudinal cohort called the International Mobility in Aging Study (IMIAS). Setting IMIAS includes sites from three middle-income countries—Tirana (Albania), Natal (Brazil) and Manizales (Colombia)—and two from Canada—Kingston (Ontario) and Saint-Hyacinthe (Quebec). Participants Community-dwelling male and female adults, aged 64–75 years (n=2002). Primary and secondary outcome measures We apply recursive partitioning to investigate social and behavioural risk factors for MetS and its components. Model-based recursive partitioning (MOB) was used to cluster participants into age-adjusted risk groups based on variabilities in: study site, sex, education, living arrangements, childhood adversities, adult occupation, current employment status, income, perceived income sufficiency, smoking status and weekly minutes of physical activity. Results 43% of participants had MetS. Using MOB, the primary partitioning variable was participant sex. Among women from middle-incomes sites, the predicted proportion with MetS ranged from 58% to 68%. Canadian women with limited physical activity had elevated predicted proportions of MetS (49%, 95% CI 39% to 58%). Among men, MetS ranged from 26% to 41% depending on childhood social adversity and education. Clustering for MetS components differed from the syndrome and across components. Study site was a primary partitioning variable for all components except HDL cholesterol. Sex was important for most components. Conclusion MOB is a promising technique for identifying disease risk clusters (eg, vulnerable populations) in modestly sized samples. PMID:29500203

Neutrophil-to-lymphocyte ratio as a predictor of worsening renal function in diabetic patients (3-year follow-up study).

PubMed

Azab, Basem; Daoud, Jacques; Naeem, Fahad Ben; Nasr, Rabih; Ross, Jennifer; Ghimire, Pratima; Siddiqui, Ayesha; Azzi, Nadine; Rihana, Nancy; Abdallah, Marie; Azzi, Nassif; Patel, Parishram; Kleiner, Morton; El-Sayegh, Suzanne

2012-01-01

Previous studies have demonstrated the role of inflammation in diabetic nephropathy (DN). Neutrophil to lymphocyte ratio (NLR) rather than other white cell parameters was found to be a useful inflammatory marker to predict adverse outcomes in medical and surgical conditions. Nevertheless, the value of NLR in predicting DN has not been elucidated. An observational study included 338 diabetic patients, who were followed at our clinic between 2007 and 2009. We arranged our patients into tertiles according to their 2007 NLR. The primary outcome was continuous decrease of GFR >12 mL/min between 2007 and 2009 with the last GFR <60 mL/min. The lowest NLR tertile had fewer patients (2.7%) with primary outcome (i.e., worsening renal function) compared with middle and highest NLR tertiles, which had more patients with primary outcomes (8.7% and 11.5%, respectively) with a significant p-value 0.0164. When other potential confounders were individually analyzed with NLR tertile, the NLR tertiles remained a significant predictor of poor GFR outcome in the presence of other variables (hemoglobin A1C, systolic blood pressure, diastolic blood pressure, age, and congestive heart failure with p-values 0.018, 0.019, 0.017, 0.033, and 0.022, respectively). NLR predicted the worsening of the renal function in diabetic patients. Further studies are needed to confirm this result.

A Study of Clinical Coding Accuracy in Surgery: Implications for the Use of Administrative Big Data for Outcomes Management.

PubMed

Nouraei, S A R; Hudovsky, A; Frampton, A E; Mufti, U; White, N B; Wathen, C G; Sandhu, G S; Darzi, A

2015-06-01

Clinical coding is the translation of clinical activity into a coded language. Coded data drive hospital reimbursement and are used for audit and research, and benchmarking and outcomes management purposes. We undertook a 2-center audit of coding accuracy across surgery. Clinician-auditor multidisciplinary teams reviewed the coding of 30,127 patients and assessed accuracy at primary and secondary diagnosis and procedure levels, morbidity level, complications assignment, and financial variance. Postaudit data of a randomly selected sample of 400 cases were reaudited by an independent team. At least 1 coding change occurred in 15,402 patients (51%). There were 3911 (13%) and 3620 (12%) changes to primary diagnoses and procedures, respectively. In 5183 (17%) patients, the Health Resource Grouping changed, resulting in income variance of £3,974,544 (+6.2%). The morbidity level changed in 2116 (7%) patients (P < 0.001). The number of assigned complications rose from 2597 (8.6%) to 2979 (9.9%) (P < 0.001). Reaudit resulted in further primary diagnosis and procedure changes in 8.7% and 4.8% of patients, respectively. The coded data are a key engine for knowledge-driven health care provision. They are used, increasingly at individual surgeon level, to benchmark performance. Surgical clinical coding is prone to subjectivity, variability, and error (SVE). Having a specialty-by-specialty understanding of the nature and clinical significance of informatics variability and adopting strategies to reduce it, are necessary to allow accurate assumptions and informed decisions to be made concerning the scope and clinical applicability of administrative data in surgical outcomes improvement.

Meta-Analysis of Workplace Physical Activity Interventions

PubMed Central

Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Brown, Lori M.; Lusk, Sally L.

2009-01-01

Context Most adults do not achieve adequate physical activity. Despite the potential benefits of worksite health promotion, no previous comprehensive meta-analysis has summarized health and physical activity behavior outcomes from these programs. This comprehensive meta-analysis integrated the extant wide range of worksite physical activity intervention research. Evidence acquisition Extensive searching located published and unpublished intervention studies reported from 1969 through 2007. Results were coded from primary studies. Random-effects meta-analytic procedures, including moderator analyses, were completed in 2008. Evidence synthesis Effects on most variables were substantially heterogeneous because diverse studies were included. Standardized mean difference (d) effect sizes were synthesized across approximately 38,231 subjects. Significantly positive effects were observed for physical activity behavior (0.21), fitness (0.57), lipids (0.13), anthropometric measures (0.08), work attendance (0.19), and job stress (0.33). The significant effect size for diabetes risk (0.98) is more tentative given small sample sizes. Significant heterogeneity documents intervention effects varied across studies. The mean effect size for fitness corresponds to a difference between treatment minus control subjects' means on V02max of 3.5 mL/kg/min; for lipids, −0.2 on total cholesterol:HDL; and for diabetes risk, −12.6 mg/dL on fasting glucose. Conclusions These findings document that some workplace physical activity interventions can improve both health and important worksite outcomes. Effects were variable for most outcomes, reflecting the diversity of primary studies. Future primary research should compare interventions to confirm causal relationships and further explore heterogeneity. PMID:19765506

Surgical outcome of mesh and suture repair in primary umbilical hernia: postoperative complications and recurrence.

PubMed

Winsnes, A; Haapamäki, M M; Gunnarsson, U; Strigård, K

2016-08-01

To compare recurrence and surgical complications following two dominating techniques: the use of suture and mesh in umbilical hernia repair. 379 consecutive umbilical hernia repair procedures performed between 1 January 2005 and 14 March 2014 in a university setting were included. Gathering was made using International Classification of Diseases codes for both procedure and diagnosis. Each patient record was scrutinized with respect to 45 variables, and the results entered in a database. Exclusion <18 years-of-age (32), non-primary umbilical hernia (25), wrong diagnosis (7), concomitant major abdominal surgery (5), double registration (3) and pregnancy (1) left 306 patients eligible for analysis. Gender distribution was 97 women and 209 men. There was no difference between mesh and suture with regard to the primary outcome variable, cumulative recurrence rate, 8.4 %. Recurrence was both self-reported and found on clinical revisit and defined as recurrence when verified by a clinician and/or radiologist. Results presented as odds ratio (OR) with 95 % confidence interval (CI) show a significantly higher risk for recurrence in patients with a coexisting hernia OR 2.84, 95 % CI 1.24-6.48. Secondary outcome, postoperative surgical complication (n = 51 occurrences), included an array of postoperative surgical events commencing within 30 days after surgery. Complication rate was significantly higher in patients receiving mesh repair OR 6.63, 95 % CI 2.29-20.38. Suture repair decreases the risk for surgical complications, especially infection without an increase in recurrence rate. The risk for recurrence is increased in patients with a history of another hernia.

A single-centre cohort study of National Early Warning Score (NEWS) and near patient testing in acute medical admissions.

PubMed

Abbott, Tom E F; Torrance, Hew D T; Cron, Nicholas; Vaid, Nidhi; Emmanuel, Julian

2016-11-01

The utility of an early warning score may be improved when used with near patient testing. However, this has not yet been investigated for National Early Warning Score (NEWS). We hypothesised that the combination of NEWS and blood gas variables (lactate, glucose or base-excess) was more strongly associated with clinical outcome compared to NEWS alone. This was a prospective cohort study of adult medical admissions to a single-centre over 20days. Blood gas results and physiological observations were recorded at admission. NEWS was calculated retrospectively and combined with the biomarkers in multivariable logistic regression models. The primary outcome was a composite of mortality or critical care escalation within 2days of hospital admission. The secondary outcome was hospital length of stay. After accounting for missing data, 15 patients out of 322 (4.7%) died or were escalated to the critical care unit. The median length of stay was 4 (IQR 7) days. When combined with lactate or base excess, NEWS was associated with the primary outcome (OR 1.18, p=0.01 and OR 1.13, p=0.03). However, NEWS alone was more strongly associated with the primary outcome measure (OR 1.46, p<0.01). The combination of NEWS with glucose was not associated with the primary outcome. Neither NEWS nor any combination of NEWS and a biomarker were associated with hospital length of stay. Admission NEWS is more strongly associated with death or critical care unit admission within 2days of hospital admission, compared to combinations of NEWS and blood-gas derived biomarkers. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Outcomes of Extremely Low Birth Weight Infants with Acidosis at Birth

PubMed Central

Randolph, David A.; Nolen, Tracy L.; Ambalavanan, Namasivayam; Carlo, Waldemar A.; Peralta-Carcelen, Myriam; Das, Abhik; Bell, Edward F.; Davis, Alexis S.; Laptook, Abbot R.; Stoll, Barbara J.; Shankaran, Seetha; Higgins, Rosemary D.

2014-01-01

OBJECTIVES To test the hypothesis that acidosis at birth is associated with the combined primary outcome of death or neurodevelopmental impairment (NDI) in extremely low birth weight (ELBW) infants, and to develop a predictive model of death/NDI exploring perinatal acidosis as a predictor variable. STUDY DESIGN The study population consisted of ELBW infants born between 2002-2007 at NICHD Neonatal Research Network hospitals. Infants with cord blood gas data and documentation of either mortality prior to discharge or 18-22 month neurodevelopmental outcomes were included. Multiple logistic regression analysis was used to determine the contribution of perinatal acidosis, defined as a cord blood gas with a pH<7 or base excess (BE)<-12, to death/NDI in ELBW infants. In addition, a multivariable model predicting death/NDI was developed. RESULTS 3979 patients were identified of whom 249 had a cord gas pH<7 or BE<-12 mEq/L. 2124 patients (53%) had the primary outcome of death/NDI. After adjustment for confounding variables, pH<7 and BE<-12 mEq/L were each significantly associated with death/NDI (OR=2.5[1.6,4.2]; and OR=1.5[1.1,2.0], respectively). However, inclusion of pH or BE did not improve the ability of the multivariable model to predict death/NDI. CONCLUSIONS Perinatal acidosis is significantly associated with death/NDI in ELBW infants. Perinatal acidosis is infrequent in ELBW infants, however, and other factors are more important in predicting death/NDI. PMID:24554564

Longitudinal associations between children’s dental caries and risk factors

PubMed Central

Chankanka, Oitip; Cavanaugh, Joseph E.; Levy, Steven M.; Marshall, Teresa A.; Warren, John J; Broffitt, Barbara; Kolker, Justine L.

2015-01-01

Dental caries is a common disease in children of all ages. It is desirable to know whether children with primary, mixed and permanent dentitions share risk factors for cavitated and non-cavitated caries. Objective To assess the longitudinal associations between caries outcomes and modifiable risk factors. Methods One hundred and fifty-six children in the Iowa Fluoride Study met inclusion criteria of three dental examinations and caries-related risk factor assessments preceding each examination. Surface-specific counts of new non-cavitated caries and cavitated caries at the primary (Exam 1: age 5), mixed (Exam 2: age 9) and permanent (Exam 3: age 13) dentition examinations were outcome variables. Explanatory variables were caries-related factors, including averaged beverage exposure frequencies, toothbrushing frequencies, and composite water fluoride levels collected from 3–5, 6–8, and 11–13 years, dentition category, socioeconomic status and gender. Generalized linear mixed models (GLMMs) were used to explore the relationships between new non-cavitated or cavitated caries and caries-related variables. Results Greater frequency of 100% juice exposure was significantly associated with fewer non-cavitated and cavitated caries surfaces. Greater toothbrushing frequency and high SES were significantly associated with fewer new non-cavitated caries. Children had significantly more new cavitated caries surfaces at the mixed dentition examination than at the primary and permanent dentition examinations. Conclusions There were common caries-related factors for more new non-cavitated caries across the three exams, including less frequent 100% juice exposure, lower toothbrushing frequency and lower socioeconomic status. Less frequent 100% juice exposures might be associated with higher exposures to several other cariogenic beverages. PMID:22320287

Tai Chi for Reducing Dual-task Gait Variability, a Potential Mediator of Fall Risk in Parkinson’s Disease: A Pilot Randomized Controlled Trial

PubMed Central

Vergara-Diaz, Gloria; Osypiuk, Kamila; Hausdorff, Jeffrey M; Bonato, Paolo; Gow, Brian J; Miranda, Jose GV; Sudarsky, Lewis R; Tarsy, Daniel; Fox, Michael D; Gardiner, Paula; Thomas, Cathi A; Macklin, Eric A; Wayne, Peter M

2018-01-01

Objectives To assess the feasibility and inform design features of a fully powered randomized controlled trial (RCT) evaluating the effects of Tai Chi (TC) in Parkinson’s disease (PD) and to select outcomes most responsive to TC assessed during off-medication states. Design Two-arm, wait-list controlled RCT. Settings Tertiary care hospital. Subjects Thirty-two subjects aged 40–75 diagnosed with idiopathic PD within 10 years. Interventions Six-month TC intervention added to usual care (UC) versus UC alone. Outcome Measures Primary outcomes were feasibility-related (recruitment rate, adherence, and compliance). Change in dual-task (DT) gait stride-time variability (STV) from baseline to 6 months was defined, a priori, as the clinical outcome measure of primary interest. Other outcomes included: PD motor symptom progression (Unified Parkinson’s Disease Rating Scale [UPDRS]), PD-related quality of life (PDQ-39), executive function (Trail Making Test), balance confidence (Activity-Specific Balance Confidence Scale, ABC), and Timed Up and Go test (TUG). All clinical assessments were made in the off-state for PD medications. Results Thirty-two subjects were enrolled into 3 sequential cohorts over 417 days at an average rate of 0.08 subjects per day. Seventy-five percent (12/16) in the TC group vs 94% (15/16) in the UC group completed the primary 6-month follow-up assessment. Mean TC exposure hours overall: 52. No AEs occurred during or as a direct result of TC exercise. Statistically nonsignificant improvements were observed in the TC group at 6 months in DT gait STV (TC [20.1%] vs UC [−0.1%] group [effect size 0.49; P = .47]), ABC, TUG, and PDQ-39. UPDRS progression was modest and very similar in TC and UC groups. Conclusions Conducting an RCT of TC for PD is feasible, though measures to improve recruitment and adherence rates are needed. DT gait STV is a sensitive and logical outcome for evaluating the combined cognitive-motor effects of TC in PD.

Exploring indicators of use of costly health services in community-dwelling adults with multiple chronic conditions.

PubMed

Holland, Diane E; Vanderboom, Catherine E; Lohse, Christine M; Mandrekar, Jay; Targonski, Paul V; Madigan, Elizabeth; Powell, Suzanne K

2015-01-01

Although experts recognize that including patient functional and social variables would improve models predicting risk of using costly health services, these self-reported variables are not widely used. Explore differences in predisposing characteristics, enabling resources, patient-perceived need for care and professionally evaluated need for care variables between patients receiving primary care within a Health Care Home who did and did not use hospital, emergency department, or skilled nursing facility services in a 3-month period of time. Primary care. Guided by the Behavioral Model of Health Service Use, a secondary analysis was conducted on data from a study that included 57 community-dwelling older adults receiving primary care in a Health Care Home. Because of the exploratory nature of the study, group differences in the use of costly care services were compared at the 0.10 level of statistical significance. Seventeen patients (29.8%) experienced costly care services. The greatest number of differences in variables between groups was in the category of patient-perceived need for care (functional impairments, dependencies, difficulties). Targeting case management services using evidence-based decision support tools such as prediction models enhances the opportunity to maximize outcomes and minimize waste of resources. Patient-perceived and clinician-evaluated need for care may need to be combined to fully describe the contextual needs that drive the use of health services. Difficulty with Activities with Daily Living and Instrumental Activities of Daily Living should be considered in future studies as candidate predictor variables for need for case management services in primary care settings.

Predictors and moderators of response to cognitive behavioral therapy and medication for the treatment of binge eating disorder.

PubMed

Grilo, Carlos M; Masheb, Robin M; Crosby, Ross D

2012-10-01

To examine predictors and moderators of response to cognitive behavioral therapy (CBT) and medication treatments for binge-eating disorder (BED). 108 BED patients in a randomized double-blind placebo-controlled trial testing CBT and fluoxetine treatments were assessed prior, throughout, and posttreatment. Demographic factors, psychiatric and personality disorder comorbidity, eating disorder psychopathology, psychological features, and 2 subtyping methods (negative affect, overvaluation of shape/weight) were tested as predictors and moderators for the primary outcome of remission from binge eating and 4 secondary dimensional outcomes (binge-eating frequency, eating disorder psychopathology, depression, and body mass index). Mixed-effects models analyzed all available data for each outcome variable. In each model, effects for baseline value and treatment were included with tests of both prediction and moderator effects. Several demographic and clinical variables significantly predicted and/or moderated outcomes. One demographic variable signaled a statistical advantage for medication only (younger participants had greater binge-eating reductions), whereas several demographic and clinical variables (lower self-esteem, negative affect, and overvaluation of shape/weight) signaled better improvements if receiving CBT. Overvaluation was the most salient predictor/moderator of outcomes. Overvaluation significantly predicted binge-eating remission (29% of participants with vs. 57% of participants without overvaluation remitted). Overvaluation was especially associated with lower remission rates if receiving medication only (10% vs. 42% for participants without overvaluation). Overvaluation moderated dimensional outcomes: Participants with overvaluation had significantly greater reductions in eating disorder psychopathology and depression levels if receiving CBT. Overvaluation predictor/moderator findings persisted after controlling for negative affect. Our findings have clinical utility for prescription of CBT and medication and implications for refinement of the BED diagnosis. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Predictors and Moderators of Response to Cognitive Behavioral Therapy and Medication for the Treatment of Binge Eating Disorder

PubMed Central

Grilo, Carlos. M.; Masheb, Robin M.; Crosby, Ross D.

2012-01-01

Objective To examine predictors and moderators of response to cognitive-behavioral therapy (CBT) and medication treatments for binge-eating disorder (BED). Method 108 BED patients in a randomized double-blind placebo-controlled trial testing CBT and fluoxetine treatments were assessed prior, throughout-, and post-treatment. Demographic factors, psychiatric and personality-disorder co-morbidity, eating-disorder psychopathology, psychological features, and two sub-typing methods (negative-affect, overvaluation of shape/weight) were tested as predictors and moderators for the primary outcome of remission from binge-eating and four secondary dimensional outcomes (binge-eating frequency, eating-disorder psychopathology, depression, and body mass index). Mixed-effects-models analyzed all available data for each outcome variable. In each model, effects for baseline value and treatment were included with tests of both prediction and moderator effects. Results Several demographic and clinical variables significantly predicted and/or moderated outcomes. One demographic variable signaled a statistical advantage for medication-only (younger participants had greater binge-eating reductions) whereas several demographic and clinical variables (lower self-esteem, negative-affect, and overvaluation of shape/weight) signaled better improvements if receiving CBT. Overvaluation was the most salient predictor/moderator of outcomes. Overvaluation significantly predicted binge-eating remission (29% of participants with versus 57% of participants without overvaluation remitted). Overvaluation was especially associated with lower remission rates if receiving medication-only (10% versus 42% for participants without overvaluation). Overvaluation moderated dimensional outcomes: participants with overvaluation had significantly greater reductions in eating-disorder psychopathology and depression levels if receiving CBT. Overvaluation predictor/moderator findings persisted after controlling for negative-affect. Conclusions Our findings have clinical utility for prescription of CBT and medication and implications for refinement of the BED diagnosis. PMID:22289130

Physiotherapy program through home visits for community-dwelling elderly Japanese women with mild knee pain.

PubMed

Konishi, Isamu; Tanabe, Naohito; Seki, Nao; Suzuki, Hiroshi; Okamura, Taro; Shinoda, Kunihiko; Hoshino, Emiko

2009-10-01

Knee pain is extremely common among the elderly, particularly women. Hence, there is an urgent need for applicable community-based intervention models for halting the progression of knee pain and related disabilities in elderly women. We aimed to assess the efficacy of home-visit physiotherapy as a new intervention model. This non-randomized 5-month-long controlled trial enrolled elderly community-dwelling women (aged 60-83 years) with mild knee pain. The intervention consisted of two home visits by a physiotherapist, with instructions on routinely performing muscle-strengthening exercises at home and implementing simple environmental modifications when necessary. Outcome measures were assessed at baseline and 5 months later. The primary outcomes were measured as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and a newly devised seiza-style sitting score. People in Japan, especially elderly women, are accustomed to seiza-style sitting that involves kneeling on one's lower legs while resting the buttocks on the heels. The secondary outcomes included quadriceps isometric strength, knee alignment in the frontal and sagittal planes, and passive knee extension range. Forty-two subjects (20 in the intervention group and 22 in the control group) completed the study. At baseline, characteristics and the primary outcomes did not significantly differ between the 2 groups. At 5 months, the primary outcomes improved significantly in the intervention group. Estimated differences in the change from baseline for each outcome between the 2 groups were computed, adjusting for outcome variables imbalanced at baseline. Even after the adjustment, the home-visit physiotherapy regimen provides favorable improvement in the seiza-style sitting score.

Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT)

DTIC Science & Technology

2013-10-01

proceed with the formal Department of the Army review. 15. SUBJECT TERMS Trauma, hemorrhagic shock, cardiac arrest, cardiopulmonary resuscitation ...n/a Introduction Cardiopulmonary resuscitation (CPR) can save victims of normovolemic cardiac arrest (CA), e.g., ventricular...delayed resuscitation with cardiopulmonary bypass. The primary outcome variable will be survival to hospital discharge with minimal neurologic dysfunction

Caregiver Burden after Receiving a Diagnosis of an Autism Spectrum Disorder

ERIC Educational Resources Information Center

Stuart, Melissa; McGrew, John H.

2009-01-01

The study examined factors impacting caregiver burden following diagnosis of an autism spectrum disorder (ASD). Primary caregivers of children diagnosed with an ASD within the past 6 months (n = 78) were assessed on variables thought to influence outcomes associated with family stress as proposed within the double ABCX model of family adaptation,…

Narcissism, Perceived Social Status, and Social Cognition and Their Influence on Aggression

ERIC Educational Resources Information Center

Gumpel, Thomas P.; Wiesenthal, Vered; Söderberg, Patrik

2015-01-01

This study had three primary goals: to explore the relationship between narcissism, participant roles, and aggression; to examine the role of gender as a moderating influence on narcissism-based aggression; and to examine how these variables work together to influence aggressive outcomes in a sample of aggressive middle and high school students.…

National Efforts to Bring Reform to Scale in High-Poverty Schools: Outcomes and Implications

ERIC Educational Resources Information Center

Borman, Geoffrey D.

2005-01-01

Education in the United States is a decentralized system composed of highly variable practices, programs, and school contexts. The primary technology of education, teaching, is highly complex and is typically designed and implemented by teachers who have traditionally enjoyed a great deal of autonomy and independence from regular inspection. The…

Take It Personally: Incorporating Personality Traits as Input Covariates in College Impact Research

ERIC Educational Resources Information Center

Mayhew, Matthew J.; Selznick, Benjamin S.; Lo, Marc A.; Vassallo, Stephen J.

2016-01-01

The primary aim of college impact research is to isolate the extent to which outcomes associated with college attendance are influenced by higher education experiences. As part of this process, researchers draw from theory and the literature base to identify variables that have been shown to influence both the higher education experience and the…

Actual Instructional Time in African Primary Schools: Factors that Reduce School Quality in Developing Countries

ERIC Educational Resources Information Center

Benavot, Aaron; Gad, Limor

2004-01-01

Educational theorists and researchers have long considered time a key component of individual learning. Caroll, in his classic model of school-based learning, conceptualized achievement as an outcome of two time variables: first, the amount of time a learner is engaged in learning; and second, an individual's learning rate. Caroll's ideas…

Motor and cognitive outcomes in children after functional hemispherectomy.

PubMed

Samargia, Sharyl A; Kimberley, Teresa Jacobson

2009-01-01

Medically intractable epilepsy is a chronic recurrence of seizures that often requires surgery to reduce or eliminate them. Although a reduction of seizures is the primary goal of hemispherectomy, the effect of surgery on motor and cognitive skills is also of importance. This review will provide a discussion of (1) evidence regarding motor and cognitive outcomes, (2) predictors of these outcomes, and (3) neural mechanisms responsible for preservation of function after hemispherectomy. Motor and cognitive outcomes after hemispherectomy are variable and depend on many predictors including etiology and duration of seizure disorder, age at the time of surgery, premorbid status, and postsurgical seizure control. A refined ipsilateral pathway may explain the preservation of motor function in some children. A clear understanding of outcome predictors is important for planning effective rehabilitative programs after surgery.

Global Sensitivity Analysis as Good Modelling Practices tool for the identification of the most influential process parameters of the primary drying step during freeze-drying.

PubMed

Van Bockstal, Pieter-Jan; Mortier, Séverine Thérèse F C; Corver, Jos; Nopens, Ingmar; Gernaey, Krist V; De Beer, Thomas

2018-02-01

Pharmaceutical batch freeze-drying is commonly used to improve the stability of biological therapeutics. The primary drying step is regulated by the dynamic settings of the adaptable process variables, shelf temperature T s and chamber pressure P c . Mechanistic modelling of the primary drying step leads to the optimal dynamic combination of these adaptable process variables in function of time. According to Good Modelling Practices, a Global Sensitivity Analysis (GSA) is essential for appropriate model building. In this study, both a regression-based and variance-based GSA were conducted on a validated mechanistic primary drying model to estimate the impact of several model input parameters on two output variables, the product temperature at the sublimation front T i and the sublimation rate ṁ sub . T s was identified as most influential parameter on both T i and ṁ sub , followed by P c and the dried product mass transfer resistance α Rp for T i and ṁ sub , respectively. The GSA findings were experimentally validated for ṁ sub via a Design of Experiments (DoE) approach. The results indicated that GSA is a very useful tool for the evaluation of the impact of different process variables on the model outcome, leading to essential process knowledge, without the need for time-consuming experiments (e.g., DoE). Copyright © 2017 Elsevier B.V. All rights reserved.

Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial.

PubMed

Salemyr, Mats; Muren, Olle; Eisler, Thomas; Bodén, Henrik; Chammout, Ghazi; Stark, André; Sköldenberg, Olof

2015-05-01

The purpose of this study was to determine if a new titanium cup with increased porosity resulted in different periacetabular bone loss and migration compared to a porous coated cup. Fifty-one patients with primary hip osteoarthritis were randomized to either a cup with porous titanium construct backside (porous titanium group, n = 25) or a conventional porous coated titanium cup (control group, n = 26). The primary outcome variable was change in periacetabular bone mineral density two years after surgery measured with dual energy X-ray absorptiometry (DXA). Secondary outcomes were implant fixation measured with radiostereometry (RSA) and clinical outcome scores. The pattern of bone remodelling was similar in the two groups with almost complete restoration to baseline values. BMD diminished in the two proximal zones and increased in the two distal zones. After minimal migration up to six months all implants in both groups became stable. We found no difference between the two groups in clinical outcome scores. In this prospective, randomized, controlled trial on a new porous titanium cup we found, compared to the control group, no clinically relevant differences regarding periacetabular bone preservation, implant fixation or clinical outcome up to two years postoperatively.

Team structure and culture are associated with lower burnout in primary care.

PubMed

Willard-Grace, Rachel; Hessler, Danielle; Rogers, Elizabeth; Dubé, Kate; Bodenheimer, Thomas; Grumbach, Kevin

2014-01-01

Burnout is a threat to the primary care workforce. We investigated the relationship between team structure, team culture, and emotional exhaustion of clinicians and staff in primary care practices. We surveyed 231 clinicians and 280 staff members of 10 public and 6 university-run primary care clinics in San Francisco in 2012. Predictor variables included team structure, such as working in a tight teamlet, and perception of team culture. The outcome variable was the Maslach emotional exhaustion scale. Generalized estimation equation models were used to account for clustering at the clinic level. Working in a tight team structure and perceptions of a greater team culture were associated with less clinician exhaustion. Team structure and team culture interacted to predict exhaustion: among clinicians reporting low team culture, team structure seemed to have little effect on exhaustion, whereas among clinicians reporting high team culture, tighter team structure was associated with less exhaustion. Greater team culture was associated with less exhaustion among staff. However, unlike for clinicians, team structure failed to predict exhaustion among staff. Fostering team culture may be an important strategy to protect against exhaustion in primary care and enhance the benefit of tight team structures.

Comparing initial diagnostic excision biopsy of cutaneous malignant melanoma in primary versus secondary care: A study of Irish National data.

PubMed

Doherty, Sarah M; Jackman, Louise M; Kirwan, John F; Dunne, Deirdre; O'Connor, Kieran G; Rouse, John M

2016-12-01

The incidence of melanoma is rising worldwide. Current Irish guidelines from the National Cancer Control Programme state suspicious pigmented lesions should not be removed in primary care. There are conflicting guidelines and research advising who should remove possible melanomas. To determine whether initial diagnostic excision biopsy of cutaneous malignant melanoma in primary versus secondary care leads to poorer survival. Analysis of data comprising 7116 cases of cutaneous malignant melanoma from the National Cancer Registry Ireland between January 2002 and December 2011. Single predictor variables were examined by the chi-square or Mann-Whitney U test. The effects of single predictor variables on survival were examined by Cox proportionate hazards modelling and a multivariate Cox model of survival based on excision in a non-hospital setting versus hospital setting was derived with adjusted and unadjusted hazard ratios. Over a 10-year period 8.5% of melanomas in Ireland were removed in a non-hospital setting. When comparing melanoma death between the hospital and non-hospital groups, the adjusted hazard ratio was 1.56 (95%CI: 1.08-2.26); (P = .02), indicating a non-inferior outcome for the melanoma cases initially treated in the non-hospital group, after adjustment for significant covariates. This study suggests that initial excision biopsy carried out in general practice does not lead to a poorer outcome. [Box: see text].

A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

PubMed Central

Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

2016-01-01

Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

Can Preoperative Psychological Assessment Predict Outcomes After Temporomandibular Joint Arthroscopy?

PubMed

Bouloux, Gary F; Zerweck, Ashley G; Celano, Marianne; Dai, Tian; Easley, Kirk A

2015-11-01

Psychological assessment has been used successfully to predict patient outcomes after cardiothoracic and bariatric surgery. The purpose of this study was to determine whether preoperative psychological assessment could be used to predict patient outcomes after temporomandibular joint arthroscopy. Consecutive patients with temporomandibular dysfunction (TMD) who could benefit from arthroscopy were enrolled in a prospective cohort study. All patients completed the Millon Behavior Medicine Diagnostic survey before surgery. The primary predictor variable was the preoperative psychological scores. The primary outcome variable was the difference in pain between the pre- and postoperative periods. The Spearman rank correlation coefficient and the Pearson product-moment correlation were used to determine the association between psychological factors and change in pain. Univariable and multivariable analyses were performed using a mixed-effects linear model and multiple linear regression. A P value of .05 was considered significant. Eighty-six patients were enrolled in the study. Seventy-five patients completed the study and were included in the final analyses. The mean change in visual analog scale (VAS) pain score 1 month after arthroscopy was -15.4 points (95% confidence interval, -6.0 to -24.7; P < .001). Jaw function also improved after surgery (P < .001). No association between change in VAS pain score and each of the 5 preoperative psychological factors was identified with univariable correlation analyses. Multivariable analyses identified that a greater pain decrease was associated with a longer duration of preoperative symptoms (P = .054) and lower chronic anxiety (P = .064). This study has identified a weak association between chronic anxiety and the magnitude of pain decrease after arthroscopy for TMD. Further studies are needed to clarify the role of chronic anxiety in the outcome after surgical procedures for the treatment of TMD. Copyright © 2015. Published by Elsevier Inc.

Explanatory variables for adult patients' self-reported recovery after acute lateral ankle sprain.

PubMed

van Rijn, Rogier M; Willemsen, Sten P; Verhagen, Arianne P; Koes, Bart W; Bierma-Zeinstra, Sita M A

2011-01-01

Longitudinal research on musculoskeletal disorders often makes use of a single measure of recovery, despite the large variation in reported recovery that exists. Patients with an acute ankle sprain often experience no pain or functional disability following treatment, yet report not being fully recovered, or vice versa. The purpose of this study was to find explanatory variables for reporting recovery by analyzing the extent to which different outcomes (eg, pain intensity) were associated with recovery and how baseline scores of different variables influence this association in adult patients after acute lateral ankle sprain. This was a cohort study based on data collected in a randomized controlled trial (RCT). This study was constructed within the framework of an RCT. One hundred two patients who incurred an acute ankle sprain were included. Recovery, pain intensity, giving way of the ankle, and Ankle Function Score (AFS) were assessed during the RCT at baseline and at 4 weeks, 8 weeks, 3 months, and 12 months postinjury. Mean differences were calculated between baseline and follow-up. Associations were calculated using linear mixed models, and the influence of baseline scores on these associations was determined using linear regression with interaction. Associations were found between recovery and the mean differences of pain during running on flat and rough surfaces (4 and 8 weeks, 3 months) and between recovery and the mean difference of giving way of the ankle during walking on a rough surface (8 weeks, 3 months). This study used data collected from an RCT. Therefore, the study was limited to the outcomes measured in that trial, and some explanatory factors easily could have been missed. This study is the first to identify explanatory variables for reporting recovery in adults after ankle sprain. Pain intensity and giving way of the ankle measured during high ankle load activities make it easier to measure and to generalize recovery in this population and should be the primary outcome measures of interest. This study indicates the huge need to reach consensus about primary outcome measures for research in patients sustaining ankle sprains.

Prognostic Performance and Reproducibility of the 1973 and 2004/2016 World Health Organization Grading Classification Systems in Non-muscle-invasive Bladder Cancer: A European Association of Urology Non-muscle Invasive Bladder Cancer Guidelines Panel Systematic Review.

PubMed

Soukup, Viktor; Čapoun, Otakar; Cohen, Daniel; Hernández, Virginia; Babjuk, Marek; Burger, Max; Compérat, Eva; Gontero, Paolo; Lam, Thomas; MacLennan, Steven; Mostafid, A Hugh; Palou, Joan; van Rhijn, Bas W G; Rouprêt, Morgan; Shariat, Shahrokh F; Sylvester, Richard; Yuan, Yuhong; Zigeuner, Richard

2017-11-01

Tumour grade is an important prognostic indicator in non-muscle-invasive bladder cancer (NMIBC). Histopathological classifications are limited by interobserver variability (reproducibility), which may have prognostic implications. European Association of Urology NMIBC guidelines suggest concurrent use of both 1973 and 2004/2016 World Health Organization (WHO) classifications. To compare the prognostic performance and reproducibility of the 1973 and 2004/2016 WHO grading systems for NMIBC. A systematic literature search was undertaken incorporating Medline, Embase, and the Cochrane Library. Studies were critically appraised for risk of bias (QUIPS). For prognosis, the primary outcome was progression to muscle-invasive or metastatic disease. Secondary outcomes were disease recurrence, and overall and cancer-specific survival. For reproducibility, the primary outcome was interobserver variability between pathologists. Secondary outcome was intraobserver variability (repeatability) by the same pathologist. Of 3593 articles identified, 20 were included in the prognostic review; three were eligible for the reproducibility review. Increasing tumour grade in both classifications was associated with higher disease progression and recurrence rates. Progression rates in grade 1 patients were similar to those in low-grade patients; progression rates in grade 3 patients were higher than those in high-grade patients. Survival data were limited. Reproducibility of the 2004/2016 system was marginally better than that of the 1973 system. Two studies on repeatability showed conflicting results. Most studies had a moderate to high risk of bias. Current grading classifications in NMIBC are suboptimal. The 1973 system identifies more aggressive tumours. Intra- and interobserver variability was slightly less in the 2004/2016 classification. We could not confirm that the 2004/2016 classification outperforms the 1973 classification in prediction of recurrence and progression. This article summarises the utility of two different grading systems for non-muscle-invasive bladder cancer. Both systems predict progression and recurrence, although pathologists vary in their reporting; suggestions for further improvements are made. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Unicystic Ameloblastoma Revisited: Comparison of Massachusetts General Hospital Outcomes With Original Robinson and Martinez Report.

PubMed

Chouinard, Anne-Frédérique; Peacock, Zachary S; Faquin, William C; Kaban, Leonard B

2017-11-01

Robinson and Martinez established unicystic ameloblastoma (UA) as a distinct pathologic entity in 1977. Using their original description, the aims of this study were to compare the clinical presentation and outcomes of UA treated at Massachusetts General Hospital (MGH) with outcomes reported in the original article. This was a retrospective cohort study of MGH patients treated for UA during a 15-year period. Patients were included if they had a confirmed clinical and histologic diagnosis of UA. The primary predictor variable was the source of the study sample (MGH vs Robinson and Martinez). Secondary variables included age, gender, radiographic appearance, treatment, and histologic subtype. The primary outcome variable was the number of recurrences over time comparing the 2 groups. There were 19 patients (10 female and 9 male patients) in the MGH group and 20 patients (10 female and 10 male patients) in the Robinson and Martinez study. The lesions were predominantly unilocular (13 in MGH group and 19 in Robinson and Martinez group), located in the mandible (18 in MGH group and 20 in Robinson and Martinez group), and tooth associated (12 in MGH group and 14 in Robinson and Martinez group). No statistically significant demographic differences were noted between the 2 groups. In the MGH group, 13 cases (68%) exhibited mural or intramural ameloblastic epithelium, 4 (21%) were luminal or intraluminal, and 2 were unknown. However, histologic configuration was not reported in the Robinson and Martinez group. MGH patients were treated by enucleation (n = 7, 37%) or resection (n = 12, 63%) compared with enucleation in 100% cases in the Robinson and Martinez group. Overall, the disease-free survival rate was higher in the Robinson and Martinez group, but the difference was not statistically significant (P = .089). Within the MGH group, 100% of recurrences occurred in patients with mural invasion treated by enucleation. The results of this study support UA as a distinct entity based on demographic, clinical, and radiographic criteria. Outcomes in the MGH group were influenced by the degree of ameloblastic epithelial invasion and suggest that this variable should be considered when planning treatment. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Entropy of cardiac repolarization predicts ventricular arrhythmias and mortality in patients receiving an implantable cardioverter-defibrillator for primary prevention of sudden death.

PubMed

DeMazumder, Deeptankar; Limpitikul, Worawan B; Dorante, Miguel; Dey, Swati; Mukhopadhyay, Bhasha; Zhang, Yiyi; Moorman, J Randall; Cheng, Alan; Berger, Ronald D; Guallar, Eliseo; Jones, Steven R; Tomaselli, Gordon F

2016-12-01

The need for a readily available, inexpensive, non-invasive method for improved risk stratification of heart failure (HF) patients is paramount. Prior studies have proposed that distinct fluctuation patterns underlying the variability of physiological signals have unique prognostic value. We tested this hypothesis in an extensively phenotyped cohort of HF patients using EntropyX QT , a novel non-linear measure of cardiac repolarization dynamics. In a prospective, multicentre, observational study of 852 patients in sinus rhythm undergoing clinically indicated primary prevention implantable cardioverter-defibrillator (ICD) implantation (2003-10), exposures included demographics, history, physical examination, medications, laboratory results, serum biomarkers, ejection fraction, conventional electrocardiographic (ECG) analyses of heart rate and QT variability, and EntropyX QT . The primary outcome was first 'appropriate' ICD shock for ventricular arrhythmias. The secondary outcome was composite events (appropriate ICD shock and all-cause mortality). After exclusions, the cohort (n = 816) had a mean age of 60 ± 13 years, 28% women, 36% African Americans, 56% ischaemic cardiomyopathy, and 29 ± 16% Seattle HF risk score (SHFS) 5-year predicted mortality. Over 45 ± 24 months, there were 134 appropriate shocks and 166 deaths. After adjusting for 30 exposures, the hazard ratios (comparing the 5th to 1st quintile of EntropyX QT ) for primary and secondary outcomes were 3.29 (95% CI 1.74-6.21) and 2.28 (1.53-3.41), respectively. Addition of EntropyX QT to a model comprised of the exposures or SHFS significantly increased net reclassification and the ROC curve area. EntropyX QT measured during ICD implantation strongly and independently predicts appropriate shock and all-cause mortality over follow-up. EntropyX QT complements conventional risk predictors and has the potential for broad clinical application. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Cost-Effectiveness of Buprenorphine and Naltrexone Treatments for Heroin Dependence in Malaysia

PubMed Central

Ruger, Jennifer Prah; Chawarski, Marek; Mazlan, Mahmud; Ng, Nora; Schottenfeld, Richard

2012-01-01

Aims To aid public health policymaking, we studied the cost-effectiveness of buprenorphine, naltrexone, and placebo interventions for heroin dependence in Malaysia. Design We estimated the cost-effectiveness ratios of three treatments for heroin dependence. We used a microcosting methodology to determine fixed, variable, and societal costs of each intervention. Cost data were collected from investigators, staff, and project records on the number and type of resources used and unit costs; societal costs for participants’ time were estimated using Malaysia’s minimum wage. Costs were estimated from a provider and societal perspective and reported in 2004 US dollars. Setting Muar, Malaysia. Participants 126 patients enrolled in a randomized, double-blind, placebo-controlled clinical trial in Malaysia (2003–2005) receiving counseling and buprenorphine, naltrexone, or placebo for treatment of heroin dependence. Measurements Primary outcome measures included days in treatment, maximum consecutive days of heroin abstinence, days to first heroin use, and days to heroin relapse. Secondary outcome measures included treatment retention, injection drug use, illicit opiate use, AIDS Risk Inventory total score, and drug risk and sex risk subscores. Findings Buprenorphine was more effective and more costly than naltrexone for all primary and most secondary outcomes. Incremental cost-effectiveness ratios were below $50 for primary outcomes, mostly below $350 for secondary outcomes. Naltrexone was dominated by placebo for all secondary outcomes at almost all endpoints. Incremental treatment costs were driven mainly by medication costs, especially the price of buprenorphine. Conclusions Buprenorphine appears to be a cost-effective alternative to naltrexone that might enhance economic productivity and reduce drug use over a longer term. PMID:23226534

Cost-effectiveness of buprenorphine and naltrexone treatments for heroin dependence in Malaysia.

PubMed

Ruger, Jennifer Prah; Chawarski, Marek; Mazlan, Mahmud; Ng, Nora; Schottenfeld, Richard

2012-01-01

To aid public health policymaking, we studied the cost-effectiveness of buprenorphine, naltrexone, and placebo interventions for heroin dependence in Malaysia. We estimated the cost-effectiveness ratios of three treatments for heroin dependence. We used a microcosting methodology to determine fixed, variable, and societal costs of each intervention. Cost data were collected from investigators, staff, and project records on the number and type of resources used and unit costs; societal costs for participants' time were estimated using Malaysia's minimum wage. Costs were estimated from a provider and societal perspective and reported in 2004 US dollars. Muar, Malaysia. 126 patients enrolled in a randomized, double-blind, placebo-controlled clinical trial in Malaysia (2003-2005) receiving counseling and buprenorphine, naltrexone, or placebo for treatment of heroin dependence. Primary outcome measures included days in treatment, maximum consecutive days of heroin abstinence, days to first heroin use, and days to heroin relapse. Secondary outcome measures included treatment retention, injection drug use, illicit opiate use, AIDS Risk Inventory total score, and drug risk and sex risk subscores. Buprenorphine was more effective and more costly than naltrexone for all primary and most secondary outcomes. Incremental cost-effectiveness ratios were below $50 for primary outcomes, mostly below $350 for secondary outcomes. Naltrexone was dominated by placebo for all secondary outcomes at almost all endpoints. Incremental treatment costs were driven mainly by medication costs, especially the price of buprenorphine. Buprenorphine appears to be a cost-effective alternative to naltrexone that might enhance economic productivity and reduce drug use over a longer term.

Process Predictors of the Outcome of Group Drug Counseling

PubMed Central

Crits-Christoph, Paul; Johnson, Jennifer E.; Gibbons, Mary Beth Connolly; Gallop, Robert

2012-01-01

Objective This study examined the relation of process variables to the outcome of group drug counseling, a commonly used community treatment, for cocaine dependence. Method Videotaped group drug counseling sessions from 440 adult patients (23% female, 41% minority) were rated for member alliance, group cohesion, participation, self-disclosure, positive and non-positive feedback and advice, during the 6-month treatment of cocaine dependence. Average, session-level, and slopes of process scores were evaluated. Primary outcomes were monthly cocaine use (days using out of 30), next session cocaine use, and duration of sustained abstinence from cocaine. Secondary outcomes were endorsement of 12-step philosophy and beliefs about substance abuse. Results More positive alliances (with counselor) were associated with reductions in days using cocaine per month and next-session cocaine use, and increases in endorsement of 12-step philosophy. Patient self-disclosure about the past and degree of participation in the group were generally not predictive of group drug counseling outcomes. More advice from counselor and other group members were consistently associated with poorer outcomes in all categories. Individual differences in changes in process variables over time (linear slopes) were generally not predictive of treatment outcomes. Conclusions Some group behaviors widely believed to be associated with outcome, such as self-disclosure and participation, were not generally predictive of outcomes of group drug counseling, but alliance with the group counselor was positively associated, and advice giving negatively associated, with the outcome of treatments for cocaine dependence. PMID:23106760

Does Technical Success of Angioplasty in Dysfunctional Hemodialysis Accesses Correlate with Access Patency?

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

Sidhu, Arshdeep; Tan, Kong T.; Noel-Lamy, Maxime

2016-10-15

PurposeTo study if <30 % residual stenosis post angioplasty (PTA) correlates with primary access circuit patency, and if any variables predict technical success.Materials and MethodsA prospective observational study was performed between January 2009 and December 2012, wherein 76 patients underwent 154 PTA events in 56 prosthetic grafts (AVG) and 98 autogenous fistulas (AVF). Data collected included patient age, gender, lesion location and laterality, access type and location, number of prior interventions, and transonic flow rates pre- and postintervention. Impact of technical outcome on access patency was assessed. Univariate logistic regression was used to assess the impact of variables on technical success withmore » significant factors assessed with a multiple variable model.ResultsTechnical success rates of PTA in AVFs and AVGs were 79.6 and 76.7 %, respectively. Technical failures of PTA were associated with an increased risk of patency loss among circuits with AVFs (p < 0.05), but not with AVGs (p = 0.7). In AVFs, primary access patency rates between technical successes and failures at three and 6 months were 74.4 versus 61.9 % (p = 0.3) and 53.8 versus 23.8 % (p < 0.05), respectively. In AVGs, primary access patency rates between technical successes and failures at three and six months were 72.1 versus 53.9 % (p = 0.5) and 33.6 versus 38.5 % (p = 0.8), respectively. Transonic flow rates did not significantly differ among technically successful or failed outcomes at one or three months.ConclusionTechnical failures of PTA had a significant impact on access patency among AVFs with a trend toward poorer access patency within AVGs.« less

Uterine Artery Embolization in 101 Cases of Uterine Fibroids: Do Size, Location, and Number of Fibroids Affect Therapeutic Success and Complications?

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

Firouznia, Kavous, E-mail: k_firouznia@yahoo.com; Ghanaati, Hossein; Sanaati, Mina

The purpose of this study was to evaluate whether the size, location, or number of fibroids affects therapeutic efficacy or complications of uterine artery embolization (UAE). Patients with symptomatic uterine fibroids (n = 101) were treated by selective bilateral UAE using 500- to 710-{mu}m polyvinyl alcohol (PVA) particles. Baseline measures of clinical symptoms, sonography, and MRI taken before the procedure were compared to those taken 1, 3, 6, and 12 months later. Complications and outcomes were analyzed for associations with fibroid size, location, and number. Reductions in mean fibroid volume were similar in patients with single (66.6 {+-} 21.5%) andmore » multiple (67.4 {+-} 25.0%) fibroids (p-value = 0.83). Menstrual improvement occurred in patients with single (93.3%) and multiple (72.2%) fibroids (p = 0.18). Changes in submucosal and other fibroids were not significantly different between the two groups (p's > 0.56). Linear regression analysis between primary fibroid volume as independent variable and percentage reduction of fibroid volume after 1 year yielded an R{sup 2} of 0.083 and the model coefficient was not statistically significant (p = 0.072). Multivariate regression models revealed no statistically or clinically significant coefficients or odds ratios for three independent variables (primary fibroid size, total number, and fibroid location) and all outcome variables (percent reduction of uterus and fibroid volumes in 1 year, improvement of clinical symptoms [menstrual, bulk related, and urinary] in 1 year, and complications after UAE). In conclusion, neither the success rate nor the probability of complications was affected by the primary fibroid size, location, or total number of fibroids.« less

Does Technical Success of Angioplasty in Dysfunctional Hemodialysis Accesses Correlate with Access Patency?

PubMed

Sidhu, Arshdeep; Tan, Kong T; Noel-Lamy, Maxime; Simons, Martin E; Rajan, Dheeraj K

2016-10-01

To study if <30 % residual stenosis post angioplasty (PTA) correlates with primary access circuit patency, and if any variables predict technical success. A prospective observational study was performed between January 2009 and December 2012, wherein 76 patients underwent 154 PTA events in 56 prosthetic grafts (AVG) and 98 autogenous fistulas (AVF). Data collected included patient age, gender, lesion location and laterality, access type and location, number of prior interventions, and transonic flow rates pre- and postintervention. Impact of technical outcome on access patency was assessed. Univariate logistic regression was used to assess the impact of variables on technical success with significant factors assessed with a multiple variable model. Technical success rates of PTA in AVFs and AVGs were 79.6 and 76.7 %, respectively. Technical failures of PTA were associated with an increased risk of patency loss among circuits with AVFs (p < 0.05), but not with AVGs (p = 0.7). In AVFs, primary access patency rates between technical successes and failures at three and 6 months were 74.4 versus 61.9 % (p = 0.3) and 53.8 versus 23.8 % (p < 0.05), respectively. In AVGs, primary access patency rates between technical successes and failures at three and six months were 72.1 versus 53.9 % (p = 0.5) and 33.6 versus 38.5 % (p = 0.8), respectively. Transonic flow rates did not significantly differ among technically successful or failed outcomes at one or three months. Technical failures of PTA had a significant impact on access patency among AVFs with a trend toward poorer access patency within AVGs.

Maternal Depressive and Anxiety Symptoms, Self-Esteem, Body Dissatisfaction and Preschooler Obesity: A Cross-Sectional Study

ERIC Educational Resources Information Center

Benton, Pree; Skouteris, Helen; Hayden, Melissa

2016-01-01

The primary aim of the present study was to cross-sectionally examine the associations between maternal psychosocial variables, child feeding practices, and preschooler body mass index z-score (BMI-z) in children (aged 2-4 years). A secondary aim was to examine differences in child weight outcomes between mothers scoring above and below specified…

Individual Differences in Early Language Learning: A Study of English Learners of French

ERIC Educational Resources Information Center

Courtney, Louise; Graham, Suzanne; Tonkyn, Alan; Marinis, Theodoros

2017-01-01

The present longitudinal study examines the interaction of learner variables (gender, motivation, self-efficacy, and first language literacy) and their influence on second language learning outcomes. The study follows English learners of French from Year 5 in primary school (aged 9-10) to the first year in secondary school (Year 7; aged 11-12).…

The Role and Impact of Animals with Pediatric Patients.

PubMed

Goddard, Anna Tielsch; Gilmer, Mary Jo

2015-01-01

Animal-facilitated therapy (AFT), more specifically known as animal-assisted therapy (AAT) or "pet therapy," has had an increased presence in the literature with a surge of recent research methodologies exploring this complementary alternative medicine (CAM) intervention. However, limited studies have been conducted in the pediatric population, with many articles anecdotal in nature. A literature review included primary data sources PubMed, PsychINFO, Medline, and CINAHL, and yielded positive and beneficial outcomes to be gained through AAT in the pediatric population. Primary outcome variables of decreased anxiety and pain are the most commonly reported results. Further research studies are indicated to include the effects of AFT with children with different diseases and diagnoses. Exploration of other psychosocial and physical variables, such as self-esteem, would be useful. Interdisciplinary strategies are needed to develop interventions to help reduce patient symptoms and treatment-associated stress, as well as to facilitate healing and wellness beyond traditional medical treatment plans. Complementary therapies are of continued interest to the health care community, especially for pediatric nurses. Effective use of animals to facilitate conversation, lead discussion, or break communication barriers has been demonstrated through both research and anecdotal reports.

Tumor Volume Is a Prognostic Factor in Non-Small-Cell Lung Cancer Treated With Chemoradiotherapy

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

Alexander, Brian M.; Othus, Megan; Caglar, Hale B.

2011-04-01

Purpose: To investigate whether primary tumor and nodal volumes defined on radiotherapy planning scans are correlated with outcome (survival and recurrence) after combined-modality treatment. Methods and Materials: A retrospective review of patients with Stage III non-small-cell lung cancer treated with chemoradiation at Brigham and Women's Hospital/Dana-Farber Cancer Institute from 2000 to 2006 was performed. Tumor and nodal volume measurements, as computed by Eclipse (Varian, Palo Alto, CA), were used as independent variables, along with existing clinical factors, in univariate and multivariate analyses for association with outcomes. Results: For patients treated with definitive chemoradiotherapy, both nodal volume (hazard ratio [HR], 1.09;more » p < 0.01) and tumor volume (HR, 1.03; p < 0.01) were associated with overall survival on multivariate analysis. Both nodal volume (HR, 1.10; p < 0.01) and tumor volume (HR, 1.04; p < 0.01) were also associated with local control but not distant metastases. Conclusions: In addition to traditional surgical staging variables, disease burden, measured by primary tumor and nodal metastases volume, provides information that may be helpful in determining prognosis and identifying groups of patients for which more aggressive local therapy is warranted.« less

Multinomial logistic regression modelling of obesity and overweight among primary school students in a rural area of Negeri Sembilan

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

Ghazali, Amirul Syafiq Mohd; Ali, Zalila; Noor, Norlida Mohd

Multinomial logistic regression is widely used to model the outcomes of a polytomous response variable, a categorical dependent variable with more than two categories. The model assumes that the conditional mean of the dependent categorical variables is the logistic function of an affine combination of predictor variables. Its procedure gives a number of logistic regression models that make specific comparisons of the response categories. When there are q categories of the response variable, the model consists of q-1 logit equations which are fitted simultaneously. The model is validated by variable selection procedures, tests of regression coefficients, a significant test ofmore » the overall model, goodness-of-fit measures, and validation of predicted probabilities using odds ratio. This study used the multinomial logistic regression model to investigate obesity and overweight among primary school students in a rural area on the basis of their demographic profiles, lifestyles and on the diet and food intake. The results indicated that obesity and overweight of students are related to gender, religion, sleep duration, time spent on electronic games, breakfast intake in a week, with whom meals are taken, protein intake, and also, the interaction between breakfast intake in a week with sleep duration, and the interaction between gender and protein intake.« less

Multinomial logistic regression modelling of obesity and overweight among primary school students in a rural area of Negeri Sembilan

NASA Astrophysics Data System (ADS)

Ghazali, Amirul Syafiq Mohd; Ali, Zalila; Noor, Norlida Mohd; Baharum, Adam

2015-10-01

Multinomial logistic regression is widely used to model the outcomes of a polytomous response variable, a categorical dependent variable with more than two categories. The model assumes that the conditional mean of the dependent categorical variables is the logistic function of an affine combination of predictor variables. Its procedure gives a number of logistic regression models that make specific comparisons of the response categories. When there are q categories of the response variable, the model consists of q-1 logit equations which are fitted simultaneously. The model is validated by variable selection procedures, tests of regression coefficients, a significant test of the overall model, goodness-of-fit measures, and validation of predicted probabilities using odds ratio. This study used the multinomial logistic regression model to investigate obesity and overweight among primary school students in a rural area on the basis of their demographic profiles, lifestyles and on the diet and food intake. The results indicated that obesity and overweight of students are related to gender, religion, sleep duration, time spent on electronic games, breakfast intake in a week, with whom meals are taken, protein intake, and also, the interaction between breakfast intake in a week with sleep duration, and the interaction between gender and protein intake.

The importance of extreme weight percentile in postoperative morbidity in children.

PubMed

Stey, Anne M; Moss, R Lawrence; Kraemer, Kari; Cohen, Mark E; Ko, Clifford Y; Lee Hall, Bruce

2014-05-01

Anthropometric data are important indicators of child health. This study sought to determine whether anthropometric data of extreme weight were significant predictors of perioperative morbidity in pediatric surgery. This was a cohort study of children 29 days up to 18 years of age undergoing surgical procedures at participating American College of Surgeons' NSQIP Pediatric hospitals in 2011 and 2012. The primary outcomes were composite morbidity and surgical site infection. The primary predictor of interest was weight percentile, which was divided into the following categories: ≤5(th) percentile, 6(th) to 94(th), or ≥95(th) percentile. A hierarchical multivariate logistic model, adjusting for procedure case mix, demographic, and clinical patient characteristic variables, was used to quantify the relationship between weight percentile category and outcomes. Children in the ≤5th weight percentile had 1.19-fold higher odds of overall postoperative morbidity developing than children in the nonextreme range (95% CI, 1.10-1.30) when controlling for clinical variables. Yet these children did not have higher odds of surgical site infection developing. Children in the ≥95(th) weight percentile did not have a significant increase in overall postoperative morbidity. However, they were at 1.35-fold increased odds of surgical site infection compared with those in the nonextreme range when controlling for clinical variables (95% CI, 1.16-1.57). Both extremely high and extremely low weight percentile scores can be associated with increased postoperative complications after controlling for clinical variables. Copyright © 2014 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Ten problems and solutions when predicting individual outcome from lesion site after stroke.

PubMed

Price, Cathy J; Hope, Thomas M; Seghier, Mohamed L

2017-01-15

In this paper, we consider solutions to ten of the challenges faced when trying to predict an individual's functional outcome after stroke on the basis of lesion site. A primary goal is to find lesion-outcome associations that are consistently observed in large populations of stroke patients because consistent associations maximise confidence in future individualised predictions. To understand and control multiple sources of inter-patient variability, we need to systematically investigate each contributing factor and how each factor depends on other factors. This requires very large cohorts of patients, who differ from one another in typical and measurable ways, including lesion site, lesion size, functional outcome and time post stroke (weeks to decades). These multivariate investigations are complex, particularly when the contributions of different variables interact with one another. Machine learning algorithms can help to identify the most influential variables and indicate dependencies between different factors. Multivariate lesion analyses are needed to understand how the effect of damage to one brain region depends on damage or preservation in other brain regions. Such data-led investigations can reveal predictive relationships between lesion site and outcome. However, to understand and improve the predictions we need explanatory models of the neural networks and degenerate pathways that support functions of interest. This will entail integrating the results of lesion analyses with those from functional imaging (fMRI, MEG), transcranial magnetic stimulation (TMS) and diffusor tensor imaging (DTI) studies of healthy participants and patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Ten problems and solutions when predicting individual outcome from lesion site after stroke

PubMed Central

Price, Cathy J.; Hope, Thomas M.; Seghier, Mohamed L.

2016-01-01

In this paper, we consider solutions to ten of the challenges faced when trying to predict an individual’s functional outcome after stroke on the basis of lesion site. A primary goal is to find lesion-outcome associations that are consistently observed in large populations of stroke patients because consistent associations maximise confidence in future individualised predictions. To understand and control multiple sources of inter-patient variability, we need to systematically investigate each contributing factor and how each factor depends on other factors. This requires very large cohorts of patients, who differ from one another in typical and measurable ways, including lesion site, lesion size, functional outcome and time post stroke (weeks to decades). These multivariate investigations are complex, particularly when the contributions of different variables interact with one another. Machine learning algorithms can help to identify the most influential variables and indicate dependencies between different factors. Multivariate lesion analyses are needed to understand how the effect of damage to one brain region depends on damage or preservation in other brain regions. Such data-led investigations can reveal predictive relationships between lesion site and outcome. However, to understand and improve predictions we need explanatory models of the neural networks and degenerate pathways that support functions of interest. This will entail integrating the results of lesion analyses with those from functional imaging (fMRI, MEG), transcranial magnetic stimulation (TMS) and diffusor tensor imaging (DTI) studies of healthy participants and patients. PMID:27502048

Systematic review of SMART Recovery: Outcomes, process variables, and implications for research.

PubMed

Beck, Alison K; Forbes, Erin; Baker, Amanda L; Kelly, Peter J; Deane, Frank P; Shakeshaft, Anthony; Hunt, David; Kelly, John F

2017-02-01

Clinical guidelines recommend Self-Management and Recovery Training (SMART Recovery) and 12-step models of mutual aid as important sources of long-term support for addiction recovery. Methodologically rigorous reviews of the efficacy and potential mechanisms of change are available for the predominant 12-step approach. A similarly rigorous exploration of SMART Recovery has yet to be undertaken. We aim to address this gap by providing a systematic overview of the evidence for SMART Recovery in adults with problematic alcohol, substance, and/or behavioral addiction, including (i) a commentary on outcomes assessed, process variables, feasibility, current understanding of mental health outcomes, and (ii) a critical evaluation of the methodology. We searched six electronic peer-reviewed and four gray literature databases for English-language SMART Recovery literature. Articles were classified, assessed against standardized criteria, and checked by an independent assessor. Twelve studies (including three evaluations of effectiveness) were identified. Alcohol-related outcomes were the primary focus. Standardized assessment of nonalcohol substance use was infrequent. Information about behavioral addiction was restricted to limited prevalence data. Functional outcomes were rarely reported. Feasibility was largely indexed by attendance. Economic analysis has not been undertaken. Little is known about the variables that may influence treatment outcome, but attendance represents a potential candidate. Assessment and reporting of mental health status was poor. Although positive effects were found, the modest sample and diversity of methods prevent us from making conclusive remarks about efficacy. Further research is needed to understand the clinical and public health utility of SMART as a viable recovery support option. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Practice context affects efforts to improve diabetes care for primary care patients: a pragmatic cluster randomized trial.

PubMed

Dickinson, L Miriam; Dickinson, W Perry; Nutting, Paul A; Fisher, Lawrence; Harbrecht, Marjie; Crabtree, Benjamin F; Glasgow, Russell E; West, David R

2015-04-01

Efforts to improve primary care diabetes management have assessed strategies across heterogeneous groups of patients and practices. However, there is substantial variability in how well practices implement interventions and achieve desired outcomes. To examine practice contextual features that moderate intervention effectiveness. Secondary analysis of data from a cluster randomized trial of three approaches for implementing the Chronic Care Model to improve diabetes care. Forty small to mid-sized primary care practices participated, with 522 clinician and staff member surveys. Outcomes were assessed for 822 established patients with a diagnosis of type 2 diabetes who had at least one visit to the practice in the 18 months following enrollment. The primary outcome was a composite measure of diabetes process of care, ascertained by chart audit, regarding nine quality measures from the American Diabetes Association Physician Recognition Program: HgA1c, foot exam, blood pressure, dilated eye exam, cholesterol, nephropathy screen, flu shot, nutrition counseling, and self-management support. Data from practices included structural and demographic characteristics and Practice Culture Assessment survey subscales (Change Culture, Work Culture, Chaos). Across the three implementation approaches, demographic/structural characteristics (rural vs. urban + .70(p = .006), +2.44(p < .001), -.75(p = .004)); Medicaid: < 20 % vs. ≥ 20 % (-.20(p = .48), +.75 (p = .08), +.60(p = .02)); practice size: < 4 clinicians vs. ≥ 4 clinicians (+.56(p = .02), +1.96(p < .001), +.02(p = .91)); practice Change Culture (high vs. low: -.86(p = .048), +1.71(p = .005), +.34(p = .22)), Work Culture (high vs. low: -.67(p = .18), +2.41(p < .001), +.67(p = .005)) and variability in practice Change Culture (high vs. low: -.24(p = .006), -.20(p = .0771), -.44(p = .0019) and Work Culture (high vs. low: +.56(p = .3160), -1.0(p = .008), -.25 (p = .0216) were associated with trajectories of change in diabetes process of care, either directly or differentially by study arm. This study supports the need for broader use of methodological approaches to better examine contextual effects on implementation and effectiveness of quality improvement interventions in primary care settings.

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia.

PubMed

Chow, Philip I; Ingersoll, Karen S; Thorndike, Frances P; Lord, Holly R; Gonder-Frederick, Linda; Morin, Charles M; Ritterband, Lee M

2018-07-01

The aim of this study was to investigate in a randomized clinical trial the role of sleep-related cognitive variables in the long-term efficacy of an online, fully automated cognitive behavioral therapy intervention for insomnia (CBT-I) (Sleep Healthy Using the Internet [SHUTi]). Three hundred and three participants (M age  = 43.3 years; SD = 11.6) were randomly assigned to SHUTi or an online patient education condition and assessed at baseline, postintervention (nine weeks after baseline), and six and 12 months after the intervention period. Cognitive variables were self-reported internal and chance sleep locus of control, dysfunctional beliefs and attitudes about sleep (DBAS), sleep specific self-efficacy, and insomnia knowledge. Primary outcomes were self-reported online ratings of insomnia severity (Insomnia Severity Index), and sleep onset latency and wake after sleep onset from online sleep diaries, collected 12 months after the intervention period. Those who received SHUTi had, at postassessment, higher levels of insomnia knowledge (95% confidence interval [CI] = 0.10-0.16) and internal sleep locus of control (95% CI = 0.04-0.55) as well as lower DBAS (95% CI = 1.52-2.39) and sleep locus of control attributed to chance (95% CI = 0.15-0.71). Insomnia knowledge, chance sleep locus of control, and DBAS mediated the relationship between condition and at least one 12-month postassessment sleep outcome. Within the SHUTi condition, changes in each cognitive variable (with the exception of internal sleep locus of control) predicted improvement in at least one sleep outcome one year later. Online CBT-I may reduce the enormous public health burden of insomnia by changing underlying cognitive variables that lead to long-term changes in sleep outcomes. Published by Elsevier B.V.

Designing clinical trials of interventions for mobility disability: results from the lifestyle interventions and independence for elders pilot (LIFE-P) trial.

PubMed

Espeland, Mark A; Gill, Thomas M; Guralnik, Jack; Miller, Michael E; Fielding, Roger; Newman, Anne B; Pahor, Marco

2007-11-01

Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Results are described from a pilot clinical trial in which 424 volunteers aged 70-89 years were randomly assigned to one of two interventions-physical activity or a healthy aging education program-and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in < or =10 seconds, a physical performance battery, and a questionnaire focused on physical function. Changes in all four outcomes were interrelated over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e., appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A 4-year trial based on the outcome of the 400-meter walk is projected to require N = 962-2234 to detect an intervention effect of 30%-20% with 90% power. Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400-meter walk as their primary outcome.

Does the Rotator Cuff Tear Pattern Influence Clinical Outcomes After Surgical Repair?

PubMed Central

Watson, Scott; Allen, Benjamin; Robbins, Chris; Bedi, Asheesh; Gagnier, Joel J.; Miller, Bruce

2018-01-01

Background: Limited literature exists regarding the influence of rotator cuff tear morphology on patient outcomes. Purpose: To determine the effect of rotator cuff tear pattern (crescent, U-shape, L-shape) on patient-reported outcomes after rotator cuff repair. Study Design: Cohort study; Level of evidence, 3. Methods: Patients undergoing arthroscopic repair of known full-thickness rotator cuff tears were observed prospectively at regular intervals from baseline to 1 year. The tear pattern was classified at the time of surgery as crescent, U-shaped, or L-shaped. Primary outcome measures were the Western Ontario Rotator Cuff Index (WORC), the American Shoulder and Elbow Surgeons (ASES), and a visual analog scale (VAS) for pain. The tear pattern was evaluated as the primary predictor while controlling for variables known to affect rotator cuff outcomes. Mixed-methods regression and analysis of variance (ANOVA) were used to examine the effects of tear morphology on patient-reported outcomes after surgical repair from baseline to 1 year. Results: A total of 82 patients were included in the study (53 male, 29 female; mean age, 58 years [range, 41-75 years]). A crescent shape was the most common tear pattern (54%), followed by U-shaped (25%) and L-shaped tears (21%). There were no significant differences in outcome scores between the 3 groups at baseline. All 3 groups showed statistically significant improvement from baseline to 1 year, but analysis failed to show any predictive effect in the change in outcome scores from baseline to 1 year for the WORC, ASES, or VAS when tear pattern was the primary predictor. Further ANOVA also failed to show any significant difference in the change in outcome scores from baseline to 1 year for the WORC (P = .96), ASES (P = .71), or VAS (P = .86). Conclusion: Rotator cuff tear pattern is not a predictor of functional outcomes after arthroscopic rotator cuff repair. PMID:29623283

Does the Rotator Cuff Tear Pattern Influence Clinical Outcomes After Surgical Repair?

PubMed

Watson, Scott; Allen, Benjamin; Robbins, Chris; Bedi, Asheesh; Gagnier, Joel J; Miller, Bruce

2018-03-01

Limited literature exists regarding the influence of rotator cuff tear morphology on patient outcomes. To determine the effect of rotator cuff tear pattern (crescent, U-shape, L-shape) on patient-reported outcomes after rotator cuff repair. Cohort study; Level of evidence, 3. Patients undergoing arthroscopic repair of known full-thickness rotator cuff tears were observed prospectively at regular intervals from baseline to 1 year. The tear pattern was classified at the time of surgery as crescent, U-shaped, or L-shaped. Primary outcome measures were the Western Ontario Rotator Cuff Index (WORC), the American Shoulder and Elbow Surgeons (ASES), and a visual analog scale (VAS) for pain. The tear pattern was evaluated as the primary predictor while controlling for variables known to affect rotator cuff outcomes. Mixed-methods regression and analysis of variance (ANOVA) were used to examine the effects of tear morphology on patient-reported outcomes after surgical repair from baseline to 1 year. A total of 82 patients were included in the study (53 male, 29 female; mean age, 58 years [range, 41-75 years]). A crescent shape was the most common tear pattern (54%), followed by U-shaped (25%) and L-shaped tears (21%). There were no significant differences in outcome scores between the 3 groups at baseline. All 3 groups showed statistically significant improvement from baseline to 1 year, but analysis failed to show any predictive effect in the change in outcome scores from baseline to 1 year for the WORC, ASES, or VAS when tear pattern was the primary predictor. Further ANOVA also failed to show any significant difference in the change in outcome scores from baseline to 1 year for the WORC ( P = .96), ASES ( P = .71), or VAS ( P = .86). Rotator cuff tear pattern is not a predictor of functional outcomes after arthroscopic rotator cuff repair.

Satisfaction With Knee Function After Primary Anterior Cruciate Ligament Reconstruction Is Associated With Self-Efficacy, Quality of Life, and Returning to the Preinjury Physical Activity.

PubMed

Ardern, Clare L; Österberg, Annika; Sonesson, Sofi; Gauffin, Håkan; Webster, Kate E; Kvist, Joanna

2016-08-01

To assess whether patient-reported outcomes (psychological factors, appraisals of knee function, and physical activity participation) were associated with satisfaction with knee function after anterior cruciate ligament (ACL) reconstruction. Participants who were aged 18 to 45 years and a minimum 12 months post primary ACL reconstruction completed a questionnaire battery evaluating knee self-efficacy, knee-related quality of life, self-reported function, and physical activity participation. Participants' responses to the question "If you were to spend the rest of your life with your knee just the way it has been in the last week, would you feel . . . (7-point ordinal scale; 1 = happy, 7 = unhappy)" were categorized as satisfied, mostly satisfied, or dissatisfied and used as the primary outcome. Ordinal regression was used to examine associations between independent variables and the primary outcome. A total of 177 participants were included at an average of 3 years after primary ACL reconstruction. At follow-up, 44% reported they would be satisfied, 28% mostly satisfied, and 28% dissatisfied with the outcome of ACL reconstruction. There were significant differences in psychological responses and appraisal of knee function between the 3 groups (P = .001), and significantly more people in the satisfied group had returned to their preinjury activity (58%) than in the mostly satisfied (28%) and dissatisfied (26%) groups (P = .001). Multivariable analysis demonstrated that the odds of being satisfied increased by a factor of 3 with higher self-efficacy, greater knee-related quality of life, and returning to the preinjury activity. People who had returned to their preinjury physical activity and who reported higher knee-related self-efficacy and quality of life were more likely to be satisfied with the outcome of ACL reconstruction. Level IV, prognostic case series. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

PubMed Central

2012-01-01

Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve quality of life, and reduce frequency of medical consultations. Trial registration The trial was registered with ClinicalTrials.gov, number NCT01484223 [ http://ClinicalTrials.gov]. PMID:22551252

Decision for Retransplantation of the Liver

PubMed Central

Azoulay, Daniel; Linhares, Marcello M.; Huguet, Emmanuel; Delvart, Valérie; Castaing, Denis; Adam, René; Ichai, Philippe; Saliba, Faouzi; Lemoine, Antoinette; Samuel, Didier; Bismuth, Henri

2002-01-01

Objective To determine the patient factors affecting patient outcome of first liver retransplantation at a single center to help in the decision process for retransplantation. Summary Background Data Given the critical organ shortage, one of the most controversial questions is whether hepatic retransplantation, the only chance of survival for patients with a failing first organ, should be offered liberally despite its greater cost, worse survival, and the inevitable denial of access to primary transplantation to other patients due to the depletion of an already-limited organ supply. The authors’ experience of 139 consecutive retransplantations was reviewed to evaluate the results of retransplantation and to identify the factors that could improve the results. Methods From 1986 to 2000, 1,038 patients underwent only one liver transplant and 139 patients underwent a first retransplant at the authors’ center (first retransplantation rate = 12%). Multivariate analysis was performed to identify variables, excluding intraoperative and donor variables, associated with graft and patient long-term survival following first retransplantation. Lengths of hospital and intensive care unit stay and hospital charges incurred during the transplantation admissions were compared for retransplanted patients and primary-transplant patients. Results One-year, 5-year, and 10-year graft and patient survival rates following retransplantation were 54.0%, 42.5%, 36.8% and 61.2%, 53.7%, and 50.1%, respectively. These percentages were significantly less than those following a single hepatic transplantation at the authors’ center during the same period (82.3%, 72.1%, and 66.9%, respectively). On multivariate analysis, three patient variables were significantly associated with a poorer patient outcome: urgency of retransplantation (excluding primary nonfunction), age, and creatinine. Primary nonfunction as an indication for retransplantation, total bilirubin, and factor II level were associated with a better prognosis. The final model was highly predictive of survival: according to the combination of the factors affecting outcome, 5-year patient survival rates varied from 15% to 83%. Retransplant patients had significantly longer hospital and intensive care unit stays and accumulated significantly higher total hospital charges than those receiving only one transplant. Conclusions These data confirm the utility of retransplantation in the elective situation. In the emergency setting, retransplantation should be used with discretion, and it should be avoided in subgroups of patients with little chance of success. PMID:12454509

Life after total laryngectomy: a measure of long-term survival, function, and quality of life.

PubMed

Woodard, Troy D; Oplatek, Agnes; Petruzzelli, Guy J

2007-06-01

To analyze postoperative clinical, functional, and quality-of-life (QOL) outcomes in patients after total laryngectomy (TL) and to determine the effect of preoperative variables (including age, sex, comorbidities, prior chemotherapy or radiation therapy, and tumor site and stage) on long-term survival and quality of life. We performed a retrospective cohort follow-up study of patients who underwent TL for cancer between July 28, 1994, and August 11, 2005. University tertiary care facility. One hundred forty-three patients who underwent TL were identified, and their hospital medical records were reviewed. Ninety-one patients (63.6%) underwent TL for primary carcinoma and 52 (36.4%) for recurrent cancer. At follow-up, 58 patients (40.6%) were alive. Baseline characteristics and preoperative clinical variables were collected. Follow-up data on function and QOL were collected from patients who were alive at the time of study via the Head and Neck Cancer Inventory, a previously validated questionnaire. Survival was estimated using the Kaplan-Meier method. Univariate and multivariate analysis was used to determine factors significant for survival. The overall median survival for the cohort was 23.0 months (mean +/- SD, 50 +/- 29 months). On univariate analysis, the following 5 factors were significant predictors of long-term survival: cancer site in the larynx, T3 stage, N0 to N1 stage, presence of no more than 2 comorbidities, and absence of cardiovascular comorbidities at the time of cancer diagnosis (P<.05). On multivariate analysis, only T stage maintained significance as a predictor of survival (P =.04), while cancer site was nonsignificant at P =.07. For patients alive at the time of study, functional and QOL outcomes for 5 domains (speech, eating, social disruption, aesthetics, and overall QOL) ranged from intermediate (score, 31-69) to high (score, 70-100) categories. Pretreatment patient-related factors that correlated with notably better functional and QOL outcomes in at least 1 domain were age older than 65 years at diagnosis, presence of no more than 2 comorbidities, no history of previous chemoradiation therapy, and primary tracheoesophageal puncture placement. Pretreatment clinical variables (including primary tumor site, tumor stage, regional metastases, and number and type of comorbidities) have an effect on long-term survival after TL. Despite common belief, many patients who have undergone TL maintain a good QOL overall. This study sheds light on which patient-related factors may affect health-related QOL outcomes after TL. These findings may be used to select patients who are good candidates for TL based on anticipated functional and QOL outcomes.

Populations and outcome measures used in ongoing research in sarcopenia.

PubMed

Peña Ordóñez, Gloria Gabriela; Bustamante Montes, Lilia Patricia; Ramírez Duran, Ninfa; Sánchez Castellano, Carmen; Cruz-Jentoft, Alfonso J

2017-08-01

Sarcopenia research may be hampered by the heterogeneity of populations and outcome measures used in clinical studies. The aim of this study was to describe the inclusion/exclusion criteria and outcome measures used in ongoing research in sarcopenia. All active intervention studies registered in the World Health Organization with the keyword sarcopenia were included. Study design, type of intervention, inclusion/exclusion criteria and outcome measures were registered and classified. In April 2014, 151 studies on sarcopenia were registered in the WHO database. One hundred twenty-three were intervention studies. Most trials (94.3 %) were single centre and randomized (93.5 %), 51.2 % were double blind. Nutritional interventions (36.6 %), physical exercise (12.2 %) or both (19.5 %) were the most common interventions tested. Only 54.4 % included subjects of both genders, and 46.3 % had an upper age limit. Definition of the target populations was heterogeneous, with 57.7 % including healthy subjects and none using recent definitions of sarcopenia. Lifestyle and the degree of physical activity of subjects were not described or considered in most cases (79.7 %). Subjects with cardiovascular, neuropsychiatric or metabolic disorders and those with physical disability were usually excluded. Muscle mass and muscle strength were the primary outcome variables in 28.5 and 29.5 % of studies and physical performance in 19.5 %, but only 4.1 % used the three variables used the three of them. An additional 26.8 % used biological outcome variables. Little information and agreement existed in the way muscle and physical performance parameters were measured. We found a large heterogeneity in trial design, definition of populations and outcome measures in present research.

Correlational analysis and predictive validity of psychological constructs related with pain in fibromyalgia.

PubMed

Maurel, Sara; Rodero, Baltasar; Lopez-del-Hoyo, Yolanda; Luciano, Juan V; Andrés, Eva; Roca, Miquel; Bergos, Raquel del Moral; Ruiz-Lancina, Yolanda; García-Campayo, Javier

2011-01-08

Fibromyalgia (FM) is a prevalent and disabling disorder characterized by a history of widespread pain for at least three months. Pain is considered a complex experience in which affective and cognitive aspects are crucial for prognosis. The aim of this study is to assess the importance of pain-related psychological constructs on function and pain in patients with FM. Multicentric, naturalistic, one-year follow-up study. SETTING AND STUDY SAMPLE: Patients will be recruited from primary care health centres in the region of Aragon, Spain. Patients considered for inclusion are those aged 18-65 years, able to understand Spanish, who fulfil criteria for primary FM according to the American College of Rheumatology, with no previous psychological treatment. The variables measured will be the following: main variables (pain assessed with a visual analogue scale and with sphygmomanometer and general function assessed with Fibromyalgia Impact Questionnaire, and), psychological constructs (pain catastrophizing, pain acceptance, mental defeat, psychological inflexibility, perceived injustice, mindfulness, and positive and negative affect), and secondary variables (sociodemographic variables, anxiety and depression assessed with Hospital Anxiety and Depression Scale, and psychiatric interview assessed with MINI). Assessments will be carried at baseline and at one-year follow-up. Pain Visual Analogue Scale. The existence of differences in socio-demographic, main outcome and other variables regarding pain-related psychological constructs will be analysed using Chi Square test for qualitative variables, or Student t test or variance analysis, respectively, for variables fulfilling the normality hypothesis. To assess the predictive value of pain-related psychological construct on main outcome variables at one-year follow-up, use will be made of a logistic regression analysis adjusted for socio-demographic and clinical variables. A Spearman Rho non-parametric correlation matrix will be developed to determine possible overlapping between pain-related psychological constructs. In recent years, the relevance of cognitive and affective aspects for the treatment of chronic pain, not only in FM but also in other chronic pain diseases, has been widely acknowledged. However, the relative importance of these psychological constructs, the relationship and possible overlapping between them, or the exact meaning of them in pain are not enough known.

Association of total serum cholesterol with functional outcome following home care rehabilitation in Italian patients with stroke.

PubMed

Cataldo, Maria Concetta; Calcara, Maria Luisa; Caputo, Giuseppe; Mammina, Caterina

2012-04-01

Stroke is a disabling disease. In elderly populations, stroke is the third leading cause of death and the primary cause of reduction in or loss of functional ability and personal autonomy. Possible associations between levels of total serum cholesterol (TC) and both incidence of stroke and functional outcomes after rehabilitation are still under study. To detect positive and negative prognostic factors associated with functional outcomes in first-time stroke patients admitted to an integrated home care rehabilitative program. This study enrolled 141 patients with a first-time stroke who were admitted to a home care rehabilitation program. Primary outcome measures were the Barthel activities of daily living (ADL) and mobility indices at the beginning and end of the rehabilitative treatment. The impact of TC and other demographic and clinical variables was analyzed using bivariate and multivariate logistic regression analyses. Age and Short Portable Mental Status Questionnaire (SPMSQ) score were negatively associated with functional outcome. In contrast, elevated TC was positively associated with a better home rehabilitative treatment outcome. Barthel index score at admission was negatively associated with outcomes assessed by the Barthel ADL index and age with outcomes assessed by the Barthel mobility index. In a multivariate logistic regression analysis, SPMSQ score and elevated TC were significantly associated with outcome. Specifically, higher SPMSQ scores were negatively associated with better rehabilitative treatment outcomes, whereas elevated TC was positively associated. Elevated TC seems to be associated with better functional outcomes in patients with first-time stroke. Copyright © 2012 Elsevier Inc. All rights reserved.

[Predicting the outcome in severe injuries: an analysis of 2069 patients from the trauma register of the German Society of Traumatology (DGU)].

PubMed

Rixen, D; Raum, M; Bouillon, B; Schlosser, L E; Neugebauer, E

2001-03-01

On hospital admission numerous variables are documented from multiple trauma patients. The value of these variables to predict outcome are discussed controversially. The aim was the ability to initially determine the probability of death of multiple trauma patients. Thus, a multivariate probability model was developed based on data obtained from the trauma registry of the Deutsche Gesellschaft für Unfallchirurgie (DGU). On hospital admission the DGU trauma registry collects more than 30 variables prospectively. In the first step of analysis those variables were selected, that were assumed to be clinical predictors for outcome from literature. In a second step a univariate analysis of these variables was performed. For all primary variables with univariate significance in outcome prediction a multivariate logistic regression was performed in the third step and a multivariate prognostic model was developed. 2069 patients from 20 hospitals were prospectively included in the trauma registry from 01.01.1993-31.12.1997 (age 39 +/- 19 years; 70.0% males; ISS 22 +/- 13; 18.6% lethality). From more than 30 initially documented variables, the age, the GCS, the ISS, the base excess (BE) and the prothrombin time were the most important prognostic factors to predict the probability of death (P(death)). The following prognostic model was developed: P(death) = 1/1 + e(-[k + beta 1(age) + beta 2(GCS) + beta 3(ISS) + beta 4(BE) + beta 5(prothrombin time)]) where: k = -0.1551, beta 1 = 0.0438 with p < 0.0001, beta 2 = -0.2067 with p < 0.0001, beta 3 = 0.0252 with p = 0.0071, beta 4 = -0.0840 with p < 0.0001 and beta 5 = -0.0359 with p < 0.0001. Each of the five variables contributed significantly to the multifactorial model. These data show that the age, GCS, ISS, base excess and prothrombin time are potentially important predictors to initially identify multiple trauma patients with a high risk of lethality. With the base excess and prothrombin time value, as only variables of this multifactorial model that can be therapeutically influenced, it might be possible to better guide early and aggressive therapy.

Quality of Life: Literature Review and Recommendations for Measurement of Military Outcomes (Computer Diskette).

DTIC Science & Technology

Quality of Life (QOL) programs, meeting service member’s QOL need is of primary concern to the Navy. The purpose of this report is to review the literature in regards to the relationship of QOL and its impact on such military outcome variables as retention attrition performance readiness, and recruitment. Conclusions from the review were that (1) Intent to reenlist was found to be one of the most potent predictors of retention, with other factors such as pay, services, housing, and job satisfaction, also, exerting their influence; (2) certain demographics,

Do windows or natural views affect outcomes or costs among patients in ICUs?

PubMed

Kohn, Rachel; Harhay, Michael O; Cooney, Elizabeth; Small, Dylan S; Halpern, Scott D

2013-07-01

To determine whether potential exposure to natural light via windows or to more pleasing views through windows affects outcomes or costs among critically ill patients. Retrospective cohort study. An academic hospital in Philadelphia, PA. Six thousand one hundred thirty-eight patients admitted to a 24-bed medical ICU and 6,631 patients admitted to a 24-bed surgical ICU from July 1, 2006, to June 30, 2010. Assignment to medical ICU rooms with vs. without windows and to surgical ICU rooms with natural vs. industrial views based on bed availability. In primary analyses adjusting for patient characteristics, medical ICU patients admitted to rooms with (n = 4,093) versus without (n = 2,243) windows did not differ in rates of ICU (p = 0.25) or in-hospital (p = 0.94) mortality, ICU readmissions (p = 0.37), or delirium (p = 0.56). Surgical ICU patients admitted to rooms with natural (n = 3,072) versus industrial (n = 3,588) views experienced slightly shorter ICU lengths of stay and slightly lower variable costs. Instrumental variable analyses based on initial bed assignment and exposure time did not show any differences in any outcomes in either the medical ICU or surgical ICU cohorts, and none of the differences noted in primary analyses remained statistically significant when adjusting for multiple comparisons. In a prespecified subgroup analysis among patients with ICU length of stay greater than 72 hours, MICU windows were associated with reduced ICU (p = 0.02) and hospital mortality (p = 0.04); these results did not meet criteria for significance after adjustment for multiple comparisons. ICU rooms with windows or natural views do not improve outcomes or reduce costs of in-hospital care for general populations of medical and surgical ICU patients. Future work is needed to determine whether targeting light from windows directly toward patients influences outcomes and to explore these effects in patients at high risk for adverse outcomes.

The impact of the Brazilian family health on selected primary care sensitive conditions: A systematic review

PubMed Central

Menzies, Dick; Hone, Thomas; Dehghani, Kianoush; Trajman, Anete

2017-01-01

Background Brazil has the largest public health-system in the world, with 120 million people covered by its free primary care services. The Family Health Strategy (FHS) is the main primary care model, but there is no consensus on its impact on health outcomes. We systematically reviewed published evidence regarding the impact of the Brazilian FHS on selective primary care sensitive conditions (PCSC). Methods We searched Medline, Web of Science and Lilacs in May 2016 using key words in Portuguese and English, without language restriction. We included studies if intervention was the FHS; comparison was either different levels of FHS coverage or other primary health care service models; outcomes were the selected PCSC; and results were adjusted for relevant sanitary and socioeconomic variables, including the national conditional cash transfer program (Bolsa Familia). Due to differences in methods and outcomes reported, pooling of results was not possible. Results Of 1831 records found, 31 met our inclusion criteria. Of these, 25 were ecological studies. Twenty-one employed longitudinal quasi-experimental methods, 27 compared different levels the FHS coverage, whilst four compared the FHS versus other models of primary care. Fourteen studies found an association between higher FHS coverage and lower post-neonatal and child mortality. When the effect of Bolsa Familia was accounted for, the effect of the FHS on child mortality was greater. In 13 studies about hospitalizations due to PCSC, no clear pattern of association was found. In four studies, there was no effect on child and elderly vaccination or low-birth weight. No included studies addressed breast-feeding, dengue, HIV/AIDS and other neglected infectious diseases. Conclusions Among these ecological studies with limited quality evidence, increasing coverage by the FHS was consistently associated with improvements in child mortality. Scarce evidence on other health outcomes, hospitalization and synergies with cash transfer was found. PMID:28786997

Factors Affecting Outcomes in Cochlear Implant Recipients Implanted With a Perimodiolar Electrode Array Located in Scala Tympani.

PubMed

Holden, Laura K; Firszt, Jill B; Reeder, Ruth M; Uchanski, Rosalie M; Dwyer, Noël Y; Holden, Timothy A

2016-12-01

To identify primary biographic and audiologic factors contributing to cochlear implant (CI) performance variability in quiet and noise by controlling electrode array type and electrode position within the cochlea. Although CI outcomes have improved over time, considerable outcome variability still exists. Biographic, audiologic, and device-related factors have been shown to influence performance. Examining CI recipients with consistent array type and electrode position may allow focused investigation into outcome variability resulting from biographic and audiologic factors. Thirty-nine adults (40 ears) implanted for at least 6 months with a perimodiolar electrode array known (via computed tomography [CT] imaging) to be in scala tympani participated. Test materials, administered CI only, included monosyllabic words, sentences in quiet and noise, and spectral ripple discrimination. In quiet, scores were high with mean word and sentence scores of 76 and 87%, respectively; however, sentence scores decreased by an average of 35 percentage points when noise was added. A principal components (PC) analysis of biographic and audiologic factors found three distinct factors, PC1 Age, PC2 Duration, and PC3 Pre-op Hearing. PC1 Age was the only factor that correlated, albeit modestly, with speech recognition in quiet and noise. Spectral ripple discrimination strongly correlated with speech measures. For these recipients with consistent electrode position, PC1 Age was related to speech recognition performance. Consistent electrode position may have contributed to high speech understanding in quiet. Inter-subject variability in noise may have been influenced by auditory/cognitive processing, known to decline with age, and mechanisms that underlie spectral resolution ability.

Understanding how pain education causes changes in pain and disability: protocol for a causal mediation analysis of the PREVENT trial.

PubMed

Lee, Hopin; Moseley, G Lorimer; Hübscher, Markus; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; McAuley, James H

2015-07-01

Pain education is a complex intervention developed to help clinicians manage low back pain. Although complex interventions are usually evaluated by their effects on outcomes, such as pain or disability, most do not directly target these outcomes; instead, they target intermediate factors that are presumed to be associated with the outcomes. The mechanisms underlying treatment effects, or the effect of an intervention on an intermediate factor and its subsequent effect on outcome, are rarely investigated in clinical trials. This leaves a gap in the evidence for understanding how treatments exert their effects on outcomes. Mediation analysis provides a method for identifying and quantifying the mechanisms that underlie interventions. To determine whether the effect of pain education on pain and disability is mediated by changes in self-efficacy, catastrophisation and back pain beliefs. Causal mediation analysis of the PREVENT randomised controlled trial. Two hundred and two participants with acute low back pain from primary care clinics in the Sydney metropolitan area. Participants will be randomised to receive either 'pain education' (intervention group) or 'sham education' (control group). All outcome measures (including patient characteristics), primary outcome measures (pain and disability), and putative mediating variables (self-efficacy, catastrophisation and back pain beliefs) will be measured prior to randomisation. Putative mediators and primary outcome measures will be measured 1 week after the intervention, and primary outcome measures will be measured 3 months after the onset of low back pain. Causal mediation analysis under the potential outcomes framework will be used to test single and multiple mediator models. A sensitivity analysis will be conducted to evaluate the robustness of the estimated mediation effects on the influence of violating sequential ignorability--a critical assumption for causal inference. Mediation analysis of clinical trials can estimate how much the total effect of the treatment on the outcome is carried through an indirect path. Using mediation analysis to understand these mechanisms can generate evidence that can be used to tailor treatments and optimise treatment effects. In this study, the causal mediation effects of a pain education intervention for acute non-specific low back pain will be estimated. This knowledge is critical for further development and refinement of interventions for conditions such as low back pain. Copyright © 2015 Australian Physiotherapy Association. Published by Elsevier B.V. All rights reserved.

Reporting of methodological features in observational studies of pre-harvest food safety.

PubMed

Sargeant, Jan M; O'Connor, Annette M; Renter, David G; Kelton, David F; Snedeker, Kate; Wisener, Lee V; Leonard, Erin K; Guthrie, Alessia D; Faires, Meredith

2011-02-01

Observational studies in pre-harvest food safety may be useful for identifying risk factors and for evaluating potential mitigation strategies to reduce foodborne pathogens. However, there are no structured reporting guidelines for these types of study designs in livestock species. Our objective was to evaluate the reporting of observational studies in the pre-harvest food safety literature using guidelines modified from the human healthcare literature. We identified 100 pre-harvest food safety studies published between 1999 and 2009. Each study was evaluated independently by two reviewers using a structured checklist. Of the 38 studies that explicitly stated the observational study design, 27 were described as cross-sectional studies, eight as case-control studies, and three as cohort studies. Study features reported in over 75% of the selected studies included: description of the geographic location of the studies, definitions and sources of data for outcomes, organizational level and source of data for independent variables, description of statistical methods and results, number of herds enrolled in the study and included in the analysis, and sources of study funding. However, other features were not consistently reported, including details related to eligibility criteria for groups (such as barn, room, or pen) and individuals, numbers of groups and individuals included in various stages of the study, identification of primary outcomes, the distinction between putative risk factors and confounding variables, the identification of a primary exposure variable, the referent level for evaluation of categorical variable associations, methods of controlling confounding variables and missing variables, model fit, details of subset analysis, demographic information at the sampling unit level, and generalizability of the study results. Improvement in reporting of observational studies of pre-harvest food safety will aid research readers and reviewers in interpreting and evaluating the results of such studies. Copyright © 2010 Elsevier B.V. All rights reserved.

Examining the Feasibility and Impact of a Graduate Public Administration Course in Evidence-Informed Policy

ERIC Educational Resources Information Center

Ouimet, Mathieu; Lapointe, Luc; Léon, Grégory

2015-01-01

A pilot controlled before-and-after design was used to assess the impact of a new master-level course in evidence-informed policy making on students' basic knowledge in evidence-based practice. The primary outcome variable was the mean percentage of pre-post improvement on the knowledge test. In the treatment group, the mean percentage of pre-post…

EDUCORE project: a clinical trial, randomised by clusters, to assess the effect of a visual learning method on blood pressure control in the primary healthcare setting

PubMed Central

2010-01-01

Background High blood pressure (HBP) is a major risk factor for cardiovascular disease (CVD). European hypertension and cardiology societies as well as expert committees on CVD prevention recommend stratifying cardiovascular risk using the SCORE method, the modification of lifestyles to prevent CVD, and achieving good control over risk factors. The EDUCORE (Education and Coronary Risk Evaluation) project aims to determine whether the use of a cardiovascular risk visual learning method - the EDUCORE method - is more effective than normal clinical practice in improving the control of blood pressure within one year in patients with poorly controlled hypertension but no background of CVD; Methods/Design This work describes a protocol for a clinical trial, randomised by clusters and involving 22 primary healthcare clinics, to test the effectiveness of the EDUCORE method. The number of patients required was 736, all between 40 and 65 years of age (n = 368 in the EDUCORE and control groups), all of whom had been diagnosed with HBP at least one year ago, and all of whom had poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic ≥ 90 mmHg). All personnel taking part were explained the trial and trained in its methodology. The EDUCORE method contemplates the visualisation of low risk SCORE scores using images embodying different stages of a high risk action, plus the receipt of a pamphlet explaining how to better maintain cardiac health. The main outcome variable was the control of blood pressure; secondary outcome variables included the SCORE score, therapeutic compliance, quality of life, and total cholesterol level. All outcome variables were measured at the beginning of the experimental period and again at 6 and 12 months. Information on sex, age, educational level, physical activity, body mass index, consumption of medications, change of treatment and blood analysis results was also recorded; Discussion The EDUCORE method could provide a simple, inexpensive means of improving blood pressure control, and perhaps other health problems, in the primary healthcare setting; Trial registration The trial was registered with ClinicalTrials.gov, number NCT01155973 [http://ClinicalTrials.gov]. PMID:20673325

Publication bias in animal research presented at the 2008 Society of Critical Care Medicine Conference.

PubMed

Conradi, Una; Joffe, Ari R

2017-07-07

To determine a direct measure of publication bias by determining subsequent full-paper publication (P) of studies reported in animal research abstracts presented at an international conference (A). We selected 100 random (using a random-number generator) A from the 2008 Society of Critical Care Medicine Conference. Using a data collection form and study manual, we recorded methodology and result variables from A. We searched PubMed and EMBASE to June 2015, and DOAJ and Google Scholar to May 2017 to screen for subsequent P. Methodology and result variables were recorded from P to determine changes in reporting from A. Predictors of P were examined using Fisher's Exact Test. 62% (95% CI 52-71%) of studies described in A were subsequently P after a median 19 [IQR 9-33.3] months from conference presentation. Reporting of studies in A was of low quality: randomized 27% (the method of randomization and allocation concealment not described), blinded 0%, sample-size calculation stated 0%, specifying the primary outcome 26%, numbers given with denominators 6%, and stating number of animals used 47%. Only being an orally presented (vs. poster presented) A (14/16 vs. 48/84, p = 0.025) predicted P. Reporting of studies in P was of poor quality: randomized 39% (the method of randomization and allocation concealment not described), likely blinded 6%, primary outcome specified 5%, sample size calculation stated 0%, numbers given with denominators 34%, and number of animals used stated 56%. Changes in reporting from A to P occurred: from non-randomized to randomized 19%, from non-blinded to blinded 6%, from negative to positive outcomes 8%, from having to not having a stated primary outcome 16%, and from non-statistically to statistically significant findings 37%. Post-hoc, using publication data, P was predicted by having positive outcomes (published 62/62, unpublished 33/38; p = 0.003), or statistically significant results (published 58/62, unpublished 20/38; p < 0.001). Only 62% (95% CI 52-71%) of animal research A are subsequently P; this was predicted by oral presentation of the A, finally having positive outcomes, and finally having statistically significant results. Publication bias is prevalent in critical care animal research.

Social support is a primary influence on home fruit, 100% juice, and vegetable availability.

PubMed

Baranowski, Tom; Watson, Kathy; Missaghian, Mariam; Broadfoot, Alison; Cullen, Karen; Nicklas, Theresa; Fisher, Jennifer; Baranowski, Janice; O'Donnell, Sharon

2008-07-01

Children tend to eat more fruit and vegetables when more are available in the home. We proposed and tested a model that predicts the availability at home (hereinafter termed "home availability") of fruit, 100% juice, and vegetables, using new measures of frequency of food shopping, purchase, and comparative purchase outcome expectancies (ie, the perceived benefits and costs of purchasing fruit and vegetables), home food pantry management practices, family social support for purchasing fruit and vegetables, food shopping practices, and body mass index (BMI). Participants (N=98) were recruited in 2004 in front of grocery stores and completed two telephone interviews. Cross-sectional hierarchical regression was employed with backward deletion of nonsignificant variables. Despite many statistically significant bivariate correlations between the new variables and home fruit, 100% juice, and vegetable availability, social support was the primary predictor of home fruit availability in multivariate regression. BMI and home 100% juice pantry management were the primary predictors of home 100% juice availability. Social support, BMI, and shopping practices were the primary predictors of home vegetable availability. Social support for purchasing fruit, 100% juice, and vegetables was an important, consistent predictor of home availability. These findings need to be replicated in larger samples.

Using Meta-analyses for Comparative Effectiveness Research

PubMed Central

Ruppar, Todd M.; Phillips, Lorraine J.; Chase, Jo-Ana D.

2012-01-01

Comparative effectiveness research seeks to identify the most effective interventions for particular patient populations. Meta-analysis is an especially valuable form of comparative effectiveness research because it emphasizes the magnitude of intervention effects rather than relying on tests of statistical significance among primary studies. Overall effects can be calculated for diverse clinical and patient-centered variables to determine the outcome patterns. Moderator analyses compare intervention characteristics among primary studies by determining if effect sizes vary among studies with different intervention characteristics. Intervention effectiveness can be linked to patient characteristics to provide evidence for patient-centered care. Moderator analyses often answer questions never posed by primary studies because neither multiple intervention characteristics nor populations are compared in single primary studies. Thus meta-analyses provide unique contributions to knowledge. Although meta-analysis is a powerful comparative effectiveness strategy, methodological challenges and limitations in primary research must be acknowledged to interpret findings. PMID:22789450

Long-term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic.

PubMed

Linder, Brian J; Rivera, Marcelino E; Ziegelmann, Matthew J; Elliott, Daniel S

2015-09-01

To evaluate long-term device outcomes following primary artificial urinary sphincter (AUS) implantation. We identified 1802 male patients with stress urinary incontinence that underwent AUS placement from 1983 to 2011. Of these, 1082 (60%) were involving primary implantations and comprise the study cohort. Multiple clinical and surgical variables were evaluated for potential association with treatment failure, defined as any secondary surgery. Patient follow-up was obtained through office examination, operative report, and written or telephone correspondence. Patients undergoing AUS implantation had a median age of 71 years (interquartile range 66-76) and median follow-up of 4.1 years (interquartile range 0.8-7.7). Overall, 338 of 1082 patients (31.2%) underwent secondary surgery, including 89 for device infection and/or erosion, 131 for device malfunction, 89 for urethral atrophy, and 29 for pump malposition or tubing complications. No patient-related risk factors were independently associated with an increased risk of secondary surgery on multivariable analysis. Secondary surgery-free survival was 90% at 1 year, 74% at 5 years, 57% at 10 years, and 41% at 15 years. Primary AUS implantation is associated with acceptable long-term outcomes. Recognition of long-term success is important for preoperative patient counseling. Copyright © 2015 Elsevier Inc. All rights reserved.

Awareness and attitude of the public toward personalized medicine in Korea

PubMed Central

Lee, Iyn-Hyang; Kang, Hye-Young; Suh, Hae Sun; Lee, Sukhyang; Oh, Eun Sil

2018-01-01

Objectives As personalized medicine (PM) is expected to greatly improve health outcomes, efforts have recently been made for its clinical implementation in Korea. We aimed to evaluate public awareness and attitude regarding PM. Methods We performed a self-administered questionnaire survey to 703 adults, who participated in the survey on a voluntary basis. The primary outcome measures included public knowledge, attitude, and acceptance of PM. We conducted multinomial multivariate logistic analysis for outcome variables with three response categories and performed multivariate logistic regression analyses for dichotomous outcome variables. Results Only 28% of participants had knowledge that genetic factors can contribute to inter-individual variations in drug response and the definition of PM (199 out of 702). Higher family income was correlated with greater knowledge concerning PM (OR = 3.76, p = 0.034). A majority of respondents preferred integrated pharmacogenomic testing over drug-specific testing and agreed to inclusion of pharmacogenomic testing in the national health examination (64% and 77%, respectively), but only 51% were willing to pay for it. Discussion Our results identify the urgent need for public education as well as the potential health disparities in access to PM. This study helps to frame policies for implementing PM in clinical practice. PMID:29451916

[The Brazilian Hospital Information System and the acute myocardial infarction hospital care].

PubMed

Escosteguy, Claudia Caminha; Portela, Margareth Crisóstomo; Medronho, Roberto de Andrade; de Vasconcellos, Maurício Teixeira Leite

2002-08-01

To analyze the applicability of the Brazilian Unified Health System's national hospital database to evaluate the quality of acute myocardial infarction hospital care. It was evaluated 1,936 hospital admission forms having acute myocardial infarction (AMI) as primary diagnosis in the municipal district of Rio de Janeiro, Brazil, in 1997. Data was collected from the national hospital database. A stratified random sampling of 391 medical records was also evaluated. AMI diagnosis agreement followed the literature criteria. Variable accuracy analysis was performed using kappa index agreement. The quality of AMI diagnosis registered in hospital admission forms was satisfactory according to the gold standard of the literature. In general, the accuracy of the variables demographics (sex, age group), process (medical procedures and interventions), and outcome (hospital death) was satisfactory. The accuracy of demographics and outcome variables was higher than the one of process variables. Under registration of secondary diagnosis was high in the forms and it was the main limiting factor. Given the study findings and the widespread availability of the national hospital database, it is pertinent its use as an instrument in the evaluation of the quality of AMI medical care.

Pattern of tumour growth of the primary colon cancer predicts long-term outcome after resection of liver metastases.

PubMed

Spelt, Lidewij; Sasor, Agata; Ansari, Daniel; Andersson, Roland

2016-10-01

To identify significant predictive factors for overall survival (OS) and disease-free survival (DFS) after liver resection for colon cancer metastases, with special focus on features of the primary colon cancer, such as lymph node ratio (LNR), vascular invasion, and perineural invasion. Patients operated for colonic cancer liver metastases between 2006 and 2014 were included. Details on patient characteristics, the primary colon cancer operation and metastatic disease were collected. Multivariate analysis was performed to select predictive variables for OS and DFS. Median OS and DFS were 67 and 20 months, respectively. 1-, 3- and 5-year OS were 97, 76, and 52%. 1-, 3- and 5-year DFS were 65, 42, and 37%. Multivariate analysis showed LNR to be an independent predictive factor for DFS but not for OS. Other identified predictive factors were vascular and perineural invasion of the primary colon cancer, size of the largest metastasis and severe complications after liver surgery for OS, and perineural invasion, number of liver metastases and preoperative CEA-level for DFS. Traditional N-stage was also considered to be an independent predictive factor for DFS in a separate multivariate analysis. LNR and perineural invasion of the primary colon cancer can be used as a prognostic variable for DFS after a concomitant liver resection for colon cancer metastases. Vascular and perineural invasion of the primary colon cancer are predictive for OS.

The effects of organization on medical utilization: an analysis of service line organization.

PubMed

Byrne, Margaret M; Charns, Martin P; Parker, Victoria A; Meterko, Mark M; Wray, Nelda P

2004-01-01

To determine whether clinical service lines in primary care and mental health reduces inpatient and urgent care utilization. All VHA medical centers were surveyed to determine whether service lines had been established in primary care or mental health care prior to the beginning of fiscal year 1997 (FY97). Facility-level data on medical utilization from Veterans Health Affairs (VHA) administrative databases were used for descriptive and multivariate regression analyses of utilization and of changes in measures between FY97 and FY98. Nine primary care-related and 5 mental health-related variables were analyzed. Primary care and mental health service lines had been established in approximately half of all facilities. Service lines varied in duration and extent of restructuring. Mere presence of a service line had no positive and several negative effects on measured outcome variables. More detailed analyses showed that some types of service lines have statistically significant and mostly negative effects on both mental health and primary care-related measures. Newly implemented service lines had significantly less improvement in measures over time than facilities with no service line. Health care organizations are implementing innovative organizational structures in hopes of improving quality of care and reducing resource utilization. We found that service lines in primary care and mental health may lead to an initial period of disruption, with little evidence of a beneficial effect on performance for longer duration service lines.

Treatment of specific phobia in older adults

PubMed Central

Pachana, Nancy A; Woodward, Rana M; Byrne, Gerard JA

2007-01-01

Phobias are common in later life, yet treatment research in this population remains scant. The efficacy of exposure therapy, in combination with other Cognitive-Behavioral Therapy (CBT) components, in the treatment of specific phobia with a middle and older aged sample was examined. Sixteen adults aged 45–68 with DSM-IV diagnosis of a specific phobia received a manualized intervention over ten weeks, and were compared with a control group. Results indicated significant time effects in the treatment group for the primary outcome variables of phobic severity and avoidance as well as secondary outcome variables including depression and anxiety. Symptom presence and severity also significantly declined in the treatment group. No significant changes in state anxiety were noted across the treatment period. Such results provide support for the efficacy of exposure combined with CBT treatment for specific phobia in middle to older aged adults. PMID:18044196

Developing, delivering and evaluating primary mental health care: the co-production of a new complex intervention.

PubMed

Reeve, Joanne; Cooper, Lucy; Harrington, Sean; Rosbottom, Peter; Watkins, Jane

2016-09-06

Health services face the challenges created by complex problems, and so need complex intervention solutions. However they also experience ongoing difficulties in translating findings from research in this area in to quality improvement changes on the ground. BounceBack was a service development innovation project which sought to examine this issue through the implementation and evaluation in a primary care setting of a novel complex intervention. The project was a collaboration between a local mental health charity, an academic unit, and GP practices. The aim was to translate the charity's model of care into practice-based evidence describing delivery and impact. Normalisation Process Theory (NPT) was used to support the implementation of the new model of primary mental health care into six GP practices. An integrated process evaluation evaluated the process and impact of care. Implementation quickly stalled as we identified problems with the described model of care when applied in a changing and variable primary care context. The team therefore switched to using the NPT framework to support the systematic identification and modification of the components of the complex intervention: including the core components that made it distinct (the consultation approach) and the variable components (organisational issues) that made it work in practice. The extra work significantly reduced the time available for outcome evaluation. However findings demonstrated moderately successful implementation of the model and a suggestion of hypothesised changes in outcomes. The BounceBack project demonstrates the development of a complex intervention from practice. It highlights the use of Normalisation Process Theory to support development, and not just implementation, of a complex intervention; and describes the use of the research process in the generation of practice-based evidence. Implications for future translational complex intervention research supporting practice change through scholarship are discussed.

Efficacy of self-help manuals for anxiety disorders in primary care: a systematic review.

PubMed

van Boeijen, Christine A; van Balkom, Anton J L M; van Oppen, Patricia; Blankenstein, Nettie; Cherpanath, Ammani; van Dyck, Richard

2005-04-01

The purpose of this study was to review effectiveness studies of self-help manuals for anxiety disorders in primary care. A systematic review of six identified randomized controlled trials was carried out. In addition to outcome, the articles were coded on quality variables. The studies included differed with respect to the methodological quality, measurements used and size of the study population. Despite these differences, global results suggest that a self-help manual is an effective treatment possibility for primary care patients with anxiety disorders. The more time that was spent on guidance on the use of the self-help manual the greater was its effectiveness. Treatment with a self-help manual for anxiety disorders may be effective in primary care. Data are lacking on the feasibility and cost-effectiveness of these manuals.

Clinico-pathological and biological prognostic variables in squamous cell carcinoma of the vulva.

PubMed

Gadducci, Angiolo; Tana, Roberta; Barsotti, Cecilia; Guerrieri, Maria Elena; Genazzani, Andrea Riccardo

2012-07-01

Several clinical-pathological parameters have been related to survival of patients with invasive squamous cell carcinoma of the vulva, whereas few studies have investigated the ability of biological variables to predict the clinical outcome of these patients. The present paper reviews the literature data on the prognostic relevance of lymph node-related parameters, primary tumor-related parameters, FIGO stage, blood variables, and tissue biological variables. Regarding these latter, the paper takes into account the analysis of DNA content, cell cycle-regulatory proteins, apoptosis-related proteins, epidermal growth factor receptor [EGFR], and proteins that are involved in tumor invasiveness, metastasis and angiogenesis. At present, the lymph node status and FIGO stage according to the new 2009 classification system are the main predictors for vulvar squamous cell carcinoma, whereas biological variables do not have yet a clinical relevance and their role is still investigational. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Cognitive-behavioral therapy for body dysmorphic disorder: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Harrison, Amy; Fernández de la Cruz, Lorena; Enander, Jesper; Radua, Joaquim; Mataix-Cols, David

2016-08-01

Body dysmorphic disorder (BDD) is a chronic and disabling psychiatric disorder unlikely to remit without treatment. A systematic review and meta-analysis of randomized controlled trials (RCTs) of cognitive-behavioral therapy (CBT) for BDD was conducted, including published and unpublished trials to 26th November 2015. Primary outcomes were validated BDD measures; secondary outcomes included depression and insight. Meta-regressions were conducted to examine potential effects of variables on the primary outcome, including socio-demographic variables, comorbidity, symptom severity/duration, concomitant medication, treatment duration, and methodological quality of the RCTs. Seven RCTs (N=299) met inclusion criteria. CBT was superior to waitlist or credible psychological placebo in reducing BDD (7 studies; delta=-1.22, 95% CI=-1.66 to -0.79) and depression symptoms (5 studies; delta=-0.49, 95% CI=-0.76 to -0.22). CBT was associated with improvements in insight/delusionality (4 studies; delta=-0.56, 95% CI=-0.93 to -0.19). Improvement in BDD was maintained after 2-4months follow-up (3 studies; delta=-0.89, 95% CI=-1.24 to -0.54). Meta-regression analyses did not reveal any significant predictors of outcome. CBT is an efficacious treatment for BDD but there is substantial room for improvement. The specificity and long-term effects of CBT for BDD require further evaluation using credible control conditions. Additional trials comparing CBT with pharmacological therapies, as well as their combination, are warranted. Tele-care options, such as Internet-based CBT, hold great promise to increase access to evidence-based treatment for a majority of patients who need it and should be evaluated further. Copyright © 2016 Elsevier Ltd. All rights reserved.

CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol

PubMed Central

2013-01-01

Background Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children and adolescents. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to improve the evidence base regarding the effectiveness of conservative treatments for preventing curve progression in idiopathic scoliosis. Methods/design Patients: Previously untreated girls and boys with idiopathic scoliosis, 9 to 17 years of age with at least one year of remaining growth and a curve Cobb angle of 25–40 degrees will be included. A total of 135 participants will be randomly allocated in groups of 45 patients each to receive one of the three interventions. Interventions: All three groups will receive a physical activity prescription according to the World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Outcome: Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. Outcome variables will be measured every 6 months. The primary outcome variable, failure of treatment, is defined as progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays taken with 6 months interval. Secondary outcome measures include the SRS-22r and EQ5D-Y quality of life questionnaires, the International Physical Activity Questionnaire (IPAQ) short form, and Cobb angle at end of the study. Discussion This trial will evaluate which of the tested conservative treatment approaches that is the most effective for patients with adolescent idiopathic scoliosis. Trial registration NCT01761305 PMID:24007599

Change in blood pressure variability in patients with acute ischemic stroke and its effect on early neurologic outcome

PubMed Central

Hong, Jeong-Ho; Jang, Min Uk; Choi, Nack Cheon; Lee, Ji Sung; Kim, Beom Joon; Han, Moon-Ku; Bae, Hee-Joon

2017-01-01

Background How short-term blood pressure variability (BPV) is affected in the acute stage of ischemic stroke and whether BPV is associated with early neurologic outcomes remains unclear. Methods Patients who admitted for ischemic stroke within 24 h of symptom onset were consecutively identified between January 2010 and January 2015. BP profiles measured in real-time were summarized into short-term, 24-h time intervals, based on standard deviation (SD) and mean of systolic BP (SBPSD) during the first 3 days. The primary outcome was daily assessment of early neurological deterioration (END). The associations between short-term SBPSD values and the secular trend for primary outcome were examined. Results A total of 2,545 subjects (mean age, 67.1 ± 13.5 years old and median baseline National Institutes of Health Stroke Scale score, 3) arrived at the hospital an average of 6.1 ± 6.6 h after symptom onset. SBPSD values at day 1 (SD#D1), SD#D2, and SD#D3 were 14.4 ± 5.0, 12.5 ± 4.5, and 12.2 ± 4.6 mmHg, respectively. Multivariable analyses showed that SD#D2 was independently associated with onset of END at day 2 (adjusted odds ratio, 1.08; 95% confidence interval, 1.03–1.13), and SD#D3 was independently associated with END#D3 (1.07, 1.01–1.14), with adjustments for predetermined covariates, SBPmean, and interactions with daily SBPSD. Conclusion Short-term BPV changed and stabilized from the first day of ischemic stroke. Daily high BPV may be associated with neurological deterioration independent of BPV on the previous day. PMID:29252991

Thalamic DBS with a constant-current device in essential tremor: A controlled clinical trial.

PubMed

Wharen, Robert E; Okun, Michael S; Guthrie, Barton L; Uitti, Ryan J; Larson, Paul; Foote, Kelly; Walker, Harrison; Marshall, Frederick J; Schwalb, Jason; Ford, Blair; Jankovic, Joseph; Simpson, Richard; Dashtipour, Khashayar; Phibbs, Fenna; Neimat, Joseph S; Stewart, R Malcolm; Peichel, DeLea; Pahwa, Rajesh; Ostrem, Jill L

2017-07-01

This study of thalamic deep brain stimulation (DBS) investigated whether a novel constant-current device improves tremor and activities of daily living (ADL) in patients with essential tremor (ET). A prospective, controlled, multicenter study was conducted at 12 academic centers. We investigated the safety and efficacy of unilateral and bilateral constant-current DBS of the ventralis intermedius (VIM) nucleus of the thalamus in patients with essential tremor whose tremor was inadequately controlled by medications. The primary outcome measure was a rater-blinded assessment of the change in the target limb tremor score in the stimulation-on versus stimulation-off state six months following surgery. Multiple secondary outcomes were assessed at one-year follow-up, including motor, mood, and quality-of-life measures. 127 patients were implanted with VIM DBS. The blinded, primary outcome variable (n = 76) revealed a mean improvement of 1.25 ± 1.26 points in the target limb tremor rating scale (TRS) score in the arm contralateral to DBS (p < 0.001). Secondary outcome variables at one year revealed significant improvements (p ≤ 0.001) in quality of life, depression symptoms, and ADL scores. Forty-seven patients had a second contralateral VIM-DBS, and this group demonstrated reduction in second-sided tremor at 180 days (p < 0.001). Serious adverse events related to the surgery included infection (n = 3), intracranial hemorrhage (n = 3), and device explantation (n = 3). Unilateral and bilateral constant-current VIM DBS significantly improves upper extremity tremor, ADL, quality of life, and depression in patients with severe ET. Copyright © 2017 Elsevier Ltd. All rights reserved.

Is the American Society of Shoulder and Elbow Therapists' rehabilitation guideline better than standard care when applied to Bankart-operated patients? A controlled study.

PubMed

Damkjær, Lars; Petersen, Tom; Juul-Kristensen, Birgit

2015-02-01

To determine whether there is a difference in shoulder-related physical function and quality of life between postoperative rehabilitation patients receiving standard care and those receiving care according to the American Society of Shoulder and Elbow Therapists' rehabilitation guideline for arthroscopic anterior capsulolabral repair of the shoulder. Descriptive studies with comparison between a retrospective and a prospective cohort. Municipal outpatient rehabilitation centre. A total of 96 arthroscopic Bankart-operated patients. A total of 52 patients received standard care; 44 patients underwent rehabilitation according to the American Society of Shoulder and Elbow Therapists' rehabilitation guideline. Primary outcome variable was Western Ontario Shoulder Instability Index. Secondary outcome measures were Patient-Specific Functional Scale, shoulder range of motion, return to work, return to sports, and costs. There was no significant difference in adjusted mean change scores between the standard care group and the guideline group in the primary outcome variable (Western Ontario Shoulder Instability Index total = 574.85 vs. 644.48) or the secondary outcomes (Patient-Specific Functional Scale = 4.6 vs. 5.0; range of motion in forward flexion = 46.49° vs. 49.58°; external rotation in adduction = 28.58° vs. 34.18°; external rotation in abduction = 51.29° vs. 47.55°; weeks until return to work = 5.2 vs. 6.9; weeks until return to sports =13.9 vs. 13.1; costs = number of visits; 18.5 vs. 15.9). There were no significant between-group differences in shoulder-related physical function and quality of life between the standard care group and the guideline group, following Bankart operations. © The Author(s) 2014.

Semiparametric methods for estimation of a nonlinear exposure-outcome relationship using instrumental variables with application to Mendelian randomization.

PubMed

Staley, James R; Burgess, Stephen

2017-05-01

Mendelian randomization, the use of genetic variants as instrumental variables (IV), can test for and estimate the causal effect of an exposure on an outcome. Most IV methods assume that the function relating the exposure to the expected value of the outcome (the exposure-outcome relationship) is linear. However, in practice, this assumption may not hold. Indeed, often the primary question of interest is to assess the shape of this relationship. We present two novel IV methods for investigating the shape of the exposure-outcome relationship: a fractional polynomial method and a piecewise linear method. We divide the population into strata using the exposure distribution, and estimate a causal effect, referred to as a localized average causal effect (LACE), in each stratum of population. The fractional polynomial method performs metaregression on these LACE estimates. The piecewise linear method estimates a continuous piecewise linear function, the gradient of which is the LACE estimate in each stratum. Both methods were demonstrated in a simulation study to estimate the true exposure-outcome relationship well, particularly when the relationship was a fractional polynomial (for the fractional polynomial method) or was piecewise linear (for the piecewise linear method). The methods were used to investigate the shape of relationship of body mass index with systolic blood pressure and diastolic blood pressure. © 2017 The Authors Genetic Epidemiology Published by Wiley Periodicals, Inc.

Semiparametric methods for estimation of a nonlinear exposure‐outcome relationship using instrumental variables with application to Mendelian randomization

PubMed Central

Staley, James R.

2017-01-01

ABSTRACT Mendelian randomization, the use of genetic variants as instrumental variables (IV), can test for and estimate the causal effect of an exposure on an outcome. Most IV methods assume that the function relating the exposure to the expected value of the outcome (the exposure‐outcome relationship) is linear. However, in practice, this assumption may not hold. Indeed, often the primary question of interest is to assess the shape of this relationship. We present two novel IV methods for investigating the shape of the exposure‐outcome relationship: a fractional polynomial method and a piecewise linear method. We divide the population into strata using the exposure distribution, and estimate a causal effect, referred to as a localized average causal effect (LACE), in each stratum of population. The fractional polynomial method performs metaregression on these LACE estimates. The piecewise linear method estimates a continuous piecewise linear function, the gradient of which is the LACE estimate in each stratum. Both methods were demonstrated in a simulation study to estimate the true exposure‐outcome relationship well, particularly when the relationship was a fractional polynomial (for the fractional polynomial method) or was piecewise linear (for the piecewise linear method). The methods were used to investigate the shape of relationship of body mass index with systolic blood pressure and diastolic blood pressure. PMID:28317167

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

Opportunities for social workers in the patient centered medical home.

PubMed

Hawk, Mary; Ricci, Edmund; Huber, George; Myers, Marcella

2015-01-01

The Patient Centered Medical Home (PCMH) has been hailed as one method of improving chronic care outcomes in the United States. A number of studies have underscored the importance of the social work role within the PCMH, yet little existing research explores the social worker as a driver of improved patient care. The Pennsylvania Chronic Care Initiative was created with a primary goal of increasing the number of practices that were recognized as PCMH by the National Committee for Quality Assurance. This article describes findings from in-depth qualitative interviews with representatives from seven primary care practices, in which the authors examined barriers and facilitators to implementation of the initiative. Barriers to implementation included small practice size, payer-driven care, not having a strong physician champion, variability within patient populations, and high implementation costs. Facilitators included having a social worker coordinate behavioral health services, clinical nurse case managers, preexisting models of outcomes-driven care, and being part of an integrated health delivery and financing system. Recommendations strengthening the role of medical social workers in primary care practices are discussed.

Unpacking cultural factors in adaptation to type 2 diabetes mellitus.

PubMed

Walsh, Michele E; Katz, Murray A; Sechrest, Lee

2002-01-01

Race and ethnicity are used as predictors of outcome in health services research. Often, however, race and ethnicity serve merely as proxies for the resources, values, beliefs, and behaviors (ie, ecology and culture) that are assumed to correlate with them. "Unpacking" proxy variables-directly measuring the variables believed to underlie them-would provide a more reliable and more interpretable way of looking at group differences. To assess the use of a measure of ecocultural domains that is correlated with ethnicity in accounting for variance in adherence, quality of life, clinical outcomes, and service utilization. A cross-sectional observational study. Twenty-six Hispanic and 29 non-Hispanic white VA primary care patients with type 2 diabetes mellitus. The independent variables were patient ethnicity and a summed score of ecocultural domains representing patient adaptation to illness. The outcomes were adherence to treatment, health-related quality of life, clinical indicators of disease management, and utilization of urgent health care services. Patient adaptation was correlated with ethnicity and accounted for more variance in all outcomes than did ethnicity. The unique variance accounted for by adaptation was small to moderate, whereas that accounted for by ethnicity was negligible. It is possible to identify and measure ecocultural domains that better account for variation in important health services outcomes for patients with type 2 diabetes than does ethnicity. Going beyond the study of ethnic differences alone and measuring the correlated factors that play a role in disease management can advance understanding of the phenomena involved in this variation and provide better direction for service design and delivery.

Effect of day of the week of primary total hip arthroplasty on length of stay at a university-based teaching medical center.

PubMed

Rathi, Pranav; Coleman, Sheldon; Durbin-Johnson, Blythe; Giordani, Mauro; Pereira, Gavin; Di Cesare, Paul E

2014-12-01

Length of hospital stay (LHS) after primary total hip arthroplasty (THA) constitutes a critical outcome measure, as prolonged LHS implies increased resource expenditure. Investigations have highlighted factors that affect LHS after THA. These factors include advanced age, medical comorbidities, obesity, intraoperative time, anesthesia technique, surgical site infection, and incision length. We retrospectively analyzed the effect of day of the week of primary THA on LHS. We reviewed the surgery and patient factors of 273 consecutive patients who underwent THA at our institution, a tertiary-care teaching hospital. There was a 15% increase in LHS for patients who underwent THA on Thursday versus Monday when controlling for other covariates that can affect LHS. Other statistically significant variables associated with increased LHS included American Society of Anesthesiologists grade, transfusion requirements, and postoperative complications. The day of the week of THA may be an independent variable affecting LHS. Institutions with reduced weekend resources may want to perform THA earlier in the week to try to reduce LHS.

Effect of Day of the Week of Primary Total Hip Arthroplasty on Length of Stay at a University-Based Teaching Medical Center

PubMed Central

Rathi, Pranav; Coleman, Sheldon; Durbin-Johnson, Blythe; Giordani, Mauro; Pereira, Gavin; Di Cesare, Paul E.

2016-01-01

Length of hospital stay (LHS) after primary total hip arthroplasty (THA) constitutes a critical outcome measure, as prolonged LHS implies increased resource expenditure. Investigations have highlighted factors that affect LHS after THA. These factors include advanced age, medical comorbidities, obesity, intraoperative time, anesthesia technique, surgical site infection, and incision length. We retrospectively analyzed the effect of day of the week of primary THA on LHS. We reviewed the surgery and patient factors of 273 consecutive patients who underwent THA at our institution, a tertiary-care teaching hospital. There was a 15% increase in LHS for patients who underwent THA on Thursday versus Monday when controlling for other covariates that can affect LHS. Other statistically significant variables associated with increased LHS included American Society of Anesthesiologists grade, transfusion requirements, and post-operative complications. The day of the week of THA may be an independent variable affecting LHS. Institutions with reduced weekend resources may want to perform THA earlier in the week to try to reduce LHS. PMID:25490016

Designing Clinical Trials of Interventions for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) Trial

PubMed Central

Espeland, Mark A.; Gill, Thomas M.; Guralnik, Jack; Miller, Michael E.; Fielding, Roger; Newman, Anne B.; Pahor, Marco

2008-01-01

Background Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Methods Results are described from a pilot clinical trial in which 424 volunteers aged 70–89 years were randomly assigned to one of two interventions -- physical activity or a healthy aging education program -- and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in ≤10 seconds, a physical performance battery, and a questionnaire focused on physical function. Results Changes in all four outcomes were inter-related over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e. appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A four-year trial based on the outcome of 400 meter walk is projected to require N = 962 to 2,234 to detect an intervention effect of 30% to 20% with 90% power. Conclusions Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400 meter walk as their primary outcome. PMID:18000143

Primary Cryotherapy for High-Grade Clinically Localized Prostate Cancer: Oncologic and Functional Outcomes from the COLD Registry.

PubMed

Tay, Kae Jack; Polascik, Thomas J; Elshafei, Ahmed; Cher, Michael L; Given, Robert W; Mouraviev, Vladimir; Ross, Ashley E; Jones, J Stephen

2016-01-01

To evaluate the oncological and functional outcomes of primary cryotherapy in men with clinically localized, high-grade prostate cancer. We included all men with biopsy Gleason score ≥8, localized (cT1-2) disease with a serum prostate-specific antigen (PSA) ≤50 ng/mL from the Cryo On-Line Data (COLD) registry. The primary outcome was biochemical progression free survival (BPFS) as defined by the Phoenix criteria (nadir PSA +2 ng/mL). Secondary outcomes of continence (defined as strictly no leak) and potency (able to have intercourse) were patient reported. Factors influencing BPFS were evaluated individually using Kaplan Meier and in a multivariate model using Cox regression. Altogether, 300 men were included for analysis. The median follow-up was 18.2 months (mean 28.4) and median BPFS was 69.8 months. Based on Kaplan-Meier analysis, the estimated 2- and 5-year BPFS rate was 77.2% and 59.1%, respectively. Neoadjuvant hormonal therapy was administered to 41% of men and this tended to occur in men with larger prostates, likely as a technical consideration for downsizing before cryosurgery. At multivariate analysis, the presence of Gleason score 9 or 10 (Hazard Ratio [HR] 1.9) and a posttreatment PSA nadir of ≥0.4 ng/mL (HR 5.7) were the only significant variables associated with biochemical progression using Cox regression. Complete continence was noted in 90.5% of men and potency in 17% of men at the 12-month follow-up. The incidence of rectourethral fistulae and urinary retention requiring intervention beyond temporary catheterization was 1.3% and 3.3%, respectively. Primary cryotherapy appears to be effective and safe in the community setting for high-grade, clinically localized prostate cancer in the short term.

Endoscopic repair of primary versus recurrent male unilateral inguinal hernias: Are there differences in the outcome?

PubMed

Köckerling, F; Jacob, D; Wiegank, W; Hukauf, M; Schug-Pass, C; Kuthe, A; Bittner, R

2016-03-01

To date, there are no prospective randomized studies that compare the outcome of endoscopic repair of primary versus recurrent inguinal hernias. It is therefore now attempted to answer that key question on the basis of registry data. In total, 20,624 patients were enrolled between September 1, 2009, and April 31, 2013. Of these patients, 18,142 (88.0%) had a primary and 2482 (12.0%) had a recurrent endoscopic repair. Only patients with male unilateral inguinal hernia and with a 1-year follow-up were included. The dependent variables were intra- and postoperative complications, reoperations, recurrence, and chronic pain rates. The results of unadjusted analyses were verified via multivariable analyses. Unadjusted analysis did not reveal any significant differences in the intraoperative complications (1.28 vs 1.33%; p = 0.849); however, there were significant differences in the postoperative complications (3.20 vs 4.03%; p = 0.036), the reoperation rate due to complications (0.84 vs 1.33%; p = 0.023), pain at rest (4.08 vs 6.16%; p < 0.001), pain on exertion (8.03 vs 11.44%; p < 0.001), chronic pain requiring treatment (2.31 vs 3.83%; p < 0.001), and the recurrence rates (0.94 vs 1.45%; p = 0.0023). Multivariable analysis confirmed the significant impact of endoscopic repair of recurrent hernia on the outcome. Comparison of perioperative and 1-year outcome for endoscopic repair of primary versus recurrent male unilateral inguinal hernia showed significant differences to the disadvantage of the recurrent operation. Therefore, endoscopic repair of recurrent inguinal hernias calls for particular competence on the part of the hernia surgeon.

Is Heart Rate Variability Better Than Routine Vital Signs for Prehospital Identification of Major Hemorrhage

DTIC Science & Technology

2015-01-01

different PRBC transfusion volumes. We performed multivariate regression analysis using HRV metrics and routine vital signs to test the hypothesis that...study sponsors did not have any role in the study design, data collection, analysis and interpretation of data, report writing, or the decision to...primary outcome was hemorrhagic injury plus different PRBC transfusion volumes. We performed multivariate regression analysis using HRV metrics and

Long-term survival outcomes in patients with surgically treated oropharyngeal cancer and defined human papilloma virus status.

PubMed

Dale, O T; Sood, S; Shah, K A; Han, C; Rapozo, D; Mehanna, H; Winter, S C

2016-11-01

This study investigated long-term survival outcomes in surgically treated oropharyngeal cancer patients with known human papilloma virus status. A case note review was performed of all patients undergoing primary surgery for oropharyngeal cancer in a single centre over a 10-year period. Human papilloma virus status was determined via dual modality testing. Associations between clinicopathological variables and survival were identified using a log-rank test. Of the 107 cases in the study, 40 per cent (n = 41) were human papilloma virus positive. The positive and negative predictive values of p16 immunohistochemistry for human papilloma virus status were 57 per cent and 100 per cent, respectively. At a mean follow up of 59.5 months, 5-year overall and disease-specific survival estimates were 78 per cent and 69 per cent, respectively. Human papilloma virus status (p = 0.014), smoking status (p = 0.021) and tumour stage (p = 0.03) were significant prognostic indicators. The long-term survival rates in surgically treated oropharyngeal cancer patients were comparable to other studies. Variables including human papilloma virus status and tumour stage were associated with survival in patients treated with primary surgery; however, nodal stage and presence of extracapsular spread were non-prognostic.

Preparedness of lower-level health facilities and the associated factors for the outpatient primary care of hypertension: Evidence from Tanzanian national survey.

PubMed

Bintabara, Deogratius; Mpondo, Bonaventura C T

2018-01-01

Sub-Saharan Africa is experiencing a rapid rise in the burden of non-communicable diseases in both urban and rural areas. Data on health system preparedness to manage hypertension and other non-communicable diseases remains scarce. This study aimed to assess the preparedness of lower-level health facilities for outpatient primary care of hypertension in Tanzania. This study used data from the 2014-2015 Tanzania Service Provision Assessment survey. The facility was considered as prepared for the outpatient primary care of hypertension if reported at least half (≥50%) of the items listed from each of the three domains (staff training and guideline, basic diagnostic equipment, and basic medicines) as identified by World Health Organization-Service Availability and Readiness Assessment manual. Data were analyzed using Stata 14. An unadjusted logistic regression model was used to assess the association between outcome and explanatory variables. All variables with a P value < 0.2 were fitted into the multiple logistic regression models using a 5% significance level. Out of 725 health facilities involved in the current study, about 68% were public facilities and 73% located in rural settings. Only 28% of the assessed facilities were considered prepared for the outpatient primary care of hypertension. About 9% and 42% of the assessed facilities reported to have at least one trained staff and guidelines for hypertension respectively. In multivariate analysis, private facilities [AOR = 2.7, 95% CI; 1.2-6.1], urban location [AOR = 2.2, 95% CI; 1.2-4.2], health centers [AOR = 5.2, 95% CI; 3.1-8.7] and the performance of routine management meetings [AOR = 2.6, 95% CI; 1.1-5.9] were significantly associated with preparedness for the outpatient primary care of hypertension. The primary healthcare system in Tanzania is not adequately equipped to cope with the increasing burden of hypertension and other non-communicable diseases. Rural location, public ownership, and absence of routine management meetings were associated with being not prepared. There is a need to strengthen the primary healthcare system in Tanzania for better management of chronic diseases and curb their rising impact on health outcomes.

Head and neck cutaneous squamous cell carcinoma metastatic to cervical sublevel IIb lymph nodes occurred from primary sites involving the auricle and adjacent neck.

PubMed

Maher, Nigel Gordon; Hoffman, Gary Russell

2014-03-01

Neck dissections that include sublevel IIb increase the risk of postoperative shoulder dysfunction. The purpose of this investigation was to document the incidence of level IIb metastatic lymphatic spread in a group of patients undergoing neck dissection as part of the surgical management of cutaneous squamous cell carcinoma of the head and neck. A retrospective review of the pathology records taken from 1 surgeon from June 2006 through June 2013 was carried out. The predictor variable was the primary tumor site. The outcome variable was the metastatic nodal involvement according to neck level and sublevel. Secondary variables included T stage, pathologist, tumor depth, and the presence of perineural, perilymphatic, and perivascular invasion. Data analyses were by descriptive statistics. Thirty-six patients with a total of 40 neck dissections met the inclusion criteria. The average primary site tumor depth was 14.7 mm, and there were 16 cases of poorly differentiated squamous cell carcinoma. Sublevel IIb was involved in 7.5% of cases, all of which occurred from lateralized primary sites of the head and neck. Cutaneous squamous cell carcinoma arising from the auricle and neck sites adjacent to sublevel IIb may have increased risk of metastatic involvement of sublevel IIb nodes. Further studies with larger numbers are required to determine the risk of metastasis to sublevel IIb from midline sites of the face. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

Is Bone Morphogenetic Protein-2 as Effective as Alveolar Distraction Osteogenesis for Vertical Bone Regeneration?

PubMed

Reuss, Jose M; Pi-Anfruns, Joan; Moy, Peter K

2018-04-01

The aim of this study was to assess the clinical effectiveness of alveolar distraction osteogenesis (ADO) versus recombinant human bone morphogenetic protein-2 (rh-BMP-2) for vertical ridge augmentation. Few data have been published on vertical bone regeneration using rh-BMP-2. The authors implemented a retrospective cohort study and enrolled a sample composed of patients with deficient alveolar vertical bone height. The primary predictor variable was vertical augmentation with BMP-2 and a titanium mesh or ADO. The primary outcome variable was gain in vertical bone height (millimeters) measured using computed tomography. The secondary outcome variable was postoperative complications, namely need for further grafting before or simultaneous with implant placement, soft tissue dehiscence, paresthesia, infection, implant failure, and pain. Other outcomes included implant stability at time of placement and follow-up (implant stability quotient by resonance frequency analysis), surgical time (minutes), and total treatment time until implant placement (weeks). Other study variables included location of reconstruction (maxilla or mandible). Appropriate bivariate statistics were computed and statistical significance was set a P value less than .05. The retrospective review yielded 21 patients in the BMP group and 19 in the ADO group. For the BMP-2 group, the average vertical bone gain was 2.96 ± 1.8 mm overall (maxilla, mean 3.6 ± 3.1 mm; mandible, mean 2.32 ± 1.8 mm). For the ADO group, this gain was 4 ± 1.69 mm overall (maxilla, mean 2.8 ± 1.94 mm; mandible, mean 5.2 ± 4.67 mm). For complications, group BMP showed a statistically minor tendency for more postoperative problems, such as wound dehiscence. For implant survival, group BMP showed a 92.2% survival rate versus 96.3% in group ADO at 3 to 45 months after delivery of the prosthesis (average, 22 months). The 2 techniques showed similar values in absolute vertical bone gain. Group ADO showed a slightly better outcome in outright vertical regenerative potential, albeit with a more frequent need for regrafting before and simultaneous with implant placement. Group BMP showed a lesser need for regrafting, despite having a higher postoperative complication rate. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Rate of hepatitis C viral clearance by human livers in human patients: Liver transplantation modeling primary infection and implications for studying entry inhibition.

PubMed

Hughes, Michael G; Tucker, William W; Reddy, Sreelatha; Brier, Michael E; Koch, David; McClain, Craig J; Jonsson, Colleen B; Matoba, Nobuyuki; Chung, Donghoon

2017-01-01

To better understand the dynamics of early hepatitis C virus (HCV) infection, we determined how rapidly non-cirrhotic HCV-uninfected liver allografts clear HCV from the circulation of cirrhotic HCV-infected patients at the time of transplantation but before administration of immunosuppression. Specifically, we characterized serum HCV kinetics during the first 90 min of reperfusion for 19 chronically HCV-infected patients transplanted with an HCV-uninfected liver by measuring serum viral load immediately prior to reperfusion (t = 0) and then every 15 min for a total of 90 min (t = 90). Immunosuppression was withheld until all samples were taken to better model primary infection. During this period, rates of viral clearance varied more than 20-fold with a median rate constant of 0.0357 1/min, range 0.0089-0.2169; half-life (minutes) median 19.4, range 3.2-77.8. The majority of viral clearance occurred within the first 60 min. The amount of blood transfused during this 90-min period (a potential confounding variable of this human liver transplant model of primary infection) accounted for 53% and 59% of k (r = 0.53, p = 0.05) and half-life (r = 0.59, p = 0.03) variability, respectively. No other clinical variables tested (age, allograft weight, and degree of reperfusion injury as assessed by peak postoperative ALT or AST) accounted for the remaining variability (p>0.05). In a human liver transplant model of primary infection, HCV rapidly clears the bloodstream. With approximately 90% of clearance occurring in the first 90 minutes of reperfusion, studies of HCV entry inhibition could utilize rate of clearance during this early period as an outcome measure.

Cleft Lip Repair, Nasoalveolar Molding, and Primary Cleft Rhinoplasty.

PubMed

Bhuskute, Aditi A; Tollefson, Travis T

2016-11-01

Cleft lip and palate are the fourth most common congenital birth defect. Management requires multidisciplinary care owing to the complexity of these clefts on midface growth, dentition, Eustachian tube function, and lip and nasal cosmesis. Repair requires planning, but can be performed systematically to reduce variability of outcomes. The use of primary rhinoplasty at the time of cleft lip repair can improve nose symmetry and reduce nasal deformity. Use of nasoalveolar molding ranging from lip taping to the use of preoperative infant orthopedics has played an important role in improving functional and cosmetic results of cleft lip repair. Copyright © 2016 Elsevier Inc. All rights reserved.

Fatal EBV infection and variable clinical manifestations in an XLP-1 pedigree - rapid diagnosis of primary immunodeficiencies may save lives.

PubMed

Sperl, D; Benesch, M; Urban, C; Lackner, H; Sovinz, P; Speicher, M R; Uhrig, S; Schwarzbraun, T; Schwinger, W; zur Stadt, U; Beutel, K; Janka, G; Scarpatetti, M; Seidel, M G

2012-10-01

Two related boys who died from fulminant infectious mononucleosis were diagnosed with X-linked lymphoproliferative disease type 1 (XLP-1). Family screening (n=17) identified 6 female mutation carriers and 2 more XLP-1 patients in whom, despite recurrent infections, agammaglobulinemia, and Hodgkin's Disease, the genetic basis had been unknown; demonstrating that awareness and early genetic testing are crucial to reveal underlying primary immunodeficiencies and improve outcome. Furthermore, XLP should be included routinely in the differential diagnosis of severe hypogammaglobulinemia and/or lymphoma in males. © Georg Thieme Verlag KG Stuttgart · New York.

Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial.

PubMed

Tello-Bernabé, Eugenia; Sanz-Cuesta, Teresa; del Cura-González, Isabel; de Santiago-Hernando, María L; Jurado-Sueiro, Montserrat; Fernández-Girón, Mercedes; García-de Blas, Francisca; Pensado-Freire, Higinio; Góngora-Maldonado, Francisco; de la Puente-Chamorro, María J; Rodríguez-Pasamontes, Carmen; Martín-Iglesias, Susana

2011-12-01

Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive. ISRCTN: ISRCTN83365316.

Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial

PubMed Central

2011-01-01

Background Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. Method/design This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive. Trial registration ISRCTN: ISRCTN83365316 PMID:22132861

Multidisciplinary treatment in children with problematic severe asthma: A prospective evaluation.

PubMed

Verkleij, Marieke; Beelen, Anita; van Ewijk, Bart E; Geenen, Rinie

2017-05-01

For children with problematic severe asthma, achieving adequate control of asthma is difficult. The aim of this prospective observational study was to evaluate the effects of intensive multidisciplinary inpatient treatment on multiple outcome variables in children with problematic severe asthma. Participants were 89 children with problematic severe asthma (mean age 13.6 ± 2.5 years) treated in tertiary care clinics at high altitude (Switzerland) or sea level (Netherlands) and their parents (85 mothers, 55 fathers). The primary outcome variable was the Childhood Asthma Control Test (C-ACT). Other outcome variables were forced expiratory volume in 1 sec (FEV 1 ), fractional concentration of exhaled nitric oxide (FeNO), quality of life [PAQLQ(S)], children's coping (UCL-A), parents' report of behavioral problems (CBCL), and parenting stress (PSI/NOSI). Evaluations were taken pre-treatment, post-treatment, and 3-6 months follow-up. Median [P25;P75] treatment duration 74 [56;80] days; Median follow-up interval 131 [103;177] days. The percentages of children showing controlled asthma (C-ACT) were 18% (pre-treatment), 69% (post-treatment), and 44% (follow-up). The vast majority of the children (80%) showed an improvement on C-ACT with 4% showing a deterioration. On C-ACT, FeNO, quality of life, and behavioral problems, improvements at post-treatment were highly significant. Improvements generally remained at a functional level at follow-up. Children's coping and parenting stress in parents did not change. The improvement in asthma control and other outcome variables suggests that multidisciplinary inpatient treatment is an effective approach for a heterogeneous group of children with asthma that remained uncontrolled in secondary care. Pediatr Pulmonol. 2017;52:588-597. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Second Primary Head and Neck Cancers After Non-Head and Neck Primary Cancers.

PubMed

Schlieve, Thomas; Heidel, R Eric; Carlson, Eric R

2016-12-01

The purpose of the present study was to determine the rate of second primary head and neck cancer development among patients with a primary cancer diagnosed outside the head and neck region, to present the clinical characteristics of this population, and to determine whether any variables are associated with survival. We designed a case series based on a sample of patients diagnosed with head and neck cancer who had previously been diagnosed with cancer located outside the head and neck region. The primary predictor variable was a diagnosis of cancer outside the head and neck region. The primary outcome variable was the diagnosis of a second cancer in the head and neck region. χ 2  Goodness-of-fit tests were used to test for differences between the observed and expected rates. A total of 19,406 cancers were diagnosed at the University of Tennessee Cancer Institute during the study period from July 1, 2004 to June 30, 2014. The rate of second primary head and neck cancer among patients with a non-head and neck primary cancer was 0.2%. These 40 cancers occurred among a total of 849 head and neck squamous cell carcinoma (HNSCC) cases (5%) diagnosed during the study period. The most common location for a second primary HNSCC was the gingiva (27.5%), followed by the oral tongue (17.5%). Significantly more gingival cancers were diagnosed than expected (P < .001) and significantly fewer tongue cancers than expected (P = .01). The most common primary cancer was prostate (27.5%), followed by breast (25%). The median survival was 28.5 months after the second primary diagnosis. A nonsignificant effect was found for age (P = .30), tobacco use (P = .12), gender (P = .60), TNM stage (P = .29), and treatment protocol (P = .96) on survival. The development of a second primary HNSCC in a population of patients with non-head and neck primary cancers is associated with decreased overall survival. The most common presentation of a second primary HNSCC in our study was in the gingiva and the most common primary cancer was in the prostate. Clinicians should consider the increased proportion of gingival cancers in this population when examining patients and be aware of the decrease in overall survival. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Study protocol: a multi-professional team intervention of physical activity referrals in primary care patients with cardiovascular risk factors—the Dalby lifestyle intervention cohort (DALICO) study

PubMed Central

2012-01-01

Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling. Discussions By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication. PMID:22726659

Parental Decisional Regret after Primary Distal Hypospadias Repair: Family and Surgery Variables, and Repair Outcomes.

PubMed

Ghidini, Filippo; Sekulovic, Sasa; Castagnetti, Marco

2016-03-01

Decisional regret is defined as distress after making a health care choice and can be an issue for parents electing distal hypospadias repair for their sons. We assessed the influence on decisional regret of variables related to the family, surgery and outcomes. Charts for 372 patients undergoing primary distal hypospadias repair between 2005 and 2012 were reviewed, and validated questionnaires, including the Decisional Regret Scale, Pediatric Penile Perception Score and Dysfunctional Voiding and Incontinence Scoring System, were administered to parents. Data were available for 172 of 372 families (response rate 46.2%). Of 323 parents 128 (39.6%) presented with moderately strong decisional regret, with good agreement within couples. Predictors of decisional regret included intermediate parental educational level (OR 3.19, 95% CI 1.52-6.69), patient not being the first born (OR 2.01, 95% CI 1.07-3.78), family history of hypospadias (OR 4.42, 95% CI 1.96-9.97), initial desire to avoid surgery (OR 2.07, 95% CI 1.04-4.12), younger age at followup (OR 0.81, 95% CI 0.72-0.91), presence of lower urinary tract symptoms (OR 4.92, 95% CI 1.53-15.81) and lower Pediatric Penile Perception Score (OR 0.86, 95% CI 0.75-0.99). Decisional regret was unrelated to parental desire to avoid circumcision, surgical variables, development of complications and duration of followup. Decisional regret is a problem in a significant proportion of parents electing distal hypospadias repair for their sons. In our experience family variables seemed to be predictors of decisional regret, while surgical variables did not. Predictors of decisional regret included worse parental perception of penile appearance and the presence of lower urinary tract symptoms. However, the latter could be unrelated to surgery. Irrespective of the duration of followup, decisional regret seems decreased in parents of older patients. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Results from a prospective acute inpatient rehabilitation database: clinical characteristics and functional outcomes using the Functional Independence Measure.

PubMed

Ng, Yee Sien; Jung, Heeyoune; Tay, San San; Bok, Chek Wai; Chiong, Yi; Lim, Peter A C

2007-01-01

Rehabilitation improves functional outcomes, but there is little data on the profiles and outcomes of patients undergoing inpatient rehabilitation in Singapore. The aims of this paper were to document the clinical characteristics and functional outcomes, using the Functional Independence Measure (FIM), of all patients admitted to an inpatient rehabilitation unit in a tertiary teaching hospital, and to identify and analyse factors significantly associated with better discharge functional scores and higher functional gains. In this prospective cohort study over a 4-year period, clinical and functional data for 1502 patients admitted consecutively to the Singapore General Hospital inpatient rehabilitation unit were charted into a custom-designed rehabilitation database. The primary outcome measures were the discharge total FIM scores, FIM gain and FIM efficiency. Multiple linear regression analysis was used to identify independent variables associated with better discharge FIM scores and FIM gain. The mean age was 61.3 +/- 15.0 years and 57.2% of the patients were male. Stroke (57.9%) followed by spinal cord injury (9.7%) were the most common diagnoses. The average rehabilitation length of stay was 21.5 +/- 19.0 days. The mean admission total FIM score was 70.3 +/- 23.2 and the mean discharge total FIM score was 87.3 +/- 23.0, with this gain being highly significant (P <0.001). The mean FIM gain was 17.0 +/- 13.4 and FIM efficiency was 0.95 +/- 0.90 points/day. Factors associated with better functional outcomes were higher admission motor and cognitive FIM scores, male gender, a longer rehabilitation length of stay and the use of acupuncture. Factors associated with poorer functional outcomes were older age, clinical deconditioning, ischaemic heart disease, depression, pressure sores and the presence of a domestic worker as a caregiver. The FIM is an easy-to-use, standardised and robust general measure of functional disability. Multiple demographic, clinical and socio-cultural variables are associated with the primary functional outcomes and should be taken into account in rehabilitation and discharge planning. Nevertheless, rehabilitation improves functional outcomes across a wide range of diagnoses. Further research should be aimed at evaluating long-term disability postdischarge from inpatient rehabilitation and translating these findings into improving rehabilitation and healthcare resource utilisation.

Practical Suicide-Risk Management for the Busy Primary Care Physician

PubMed Central

McDowell, Anna K.; Lineberry, Timothy W.; Bostwick, J. Michael

2011-01-01

Suicide is a public health problem and a leading cause of death. The number of people thinking seriously about suicide, making plans, and attempting suicide is surprisingly high. In total, primary care clinicians write more prescriptions for antidepressants than mental health clinicians and see patients more often in the month before their death by suicide. Treatment of depression by primary care physicians is improving, but opportunities remain in addressing suicide-related treatment variables. Collaborative care models for treating depression have the potential both to improve depression outcomes and decrease suicide risk. Alcohol use disorders and anxiety symptoms are important comorbid conditions to identify and treat. Management of suicide risk includes understanding the difference between risk factors and warning signs, developing a suicide risk assessment, and practically managing suicidal crises. PMID:21709131

Alkaline phosphatase for treatment of sepsis-induced acute kidney injury: a prospective randomized double-blind placebo-controlled trial

PubMed Central

2012-01-01

Introduction To evaluate whether alkaline phosphatase (AP) treatment improves renal function in sepsis-induced acute kidney injury (AKI), a prospective, double-blind, randomized, placebo-controlled study in critically ill patients with severe sepsis or septic shock with evidence of AKI was performed. Methods Thirty-six adult patients with severe sepsis or septic shock according to Systemic Inflammatory Response Syndrome criteria and renal injury defined according to the AKI Network criteria were included. Dialysis intervention was standardized according to Acute Dialysis Quality Initiative consensus. Intravenous infusion of alkaline phosphatase (bolus injection of 67.5 U/kg body weight followed by continuous infusion of 132.5 U/kg/24 h for 48 hours, or placebo) starting within 48 hours of AKI onset and followed up to 28 days post-treatment. The primary outcome variable was progress in renal function variables (endogenous creatinine clearance, requirement and duration of renal replacement therapy, RRT) after 28 days. The secondary outcome variables included changes in circulating inflammatory mediators, urinary excretion of biomarkers of tubular injury, and safety. Results There was a significant (P = 0.02) difference in favor of AP treatment relative to controls for the primary outcome variable. Individual renal parameters showed that endogenous creatinine clearance (baseline to Day 28) was significantly higher in the treated group relative to placebo (from 50 ± 27 to 108 ± 73 mL/minute (mean ± SEM) for the AP group; and from 40 ± 37 to 65 ± 30 mL/minute for placebo; P = 0.01). Reductions in RRT requirement and duration did not reach significance. The results in renal parameters were supported by significantly more pronounced reductions in the systemic markers C-reactive protein, Interleukin-6, LPS-binding protein and in the urinary excretion of Kidney Injury Molecule-1 and Interleukin-18 in AP-treated patients relative to placebo. The Drug Safety Monitoring Board did not raise any issues throughout the trial. Conclusions The improvements in renal function suggest alkaline phosphatase is a promising new treatment for patients with severe sepsis or septic shock with AKI. Trial Registration www.clinicaltrials.gov: NCTNCT00511186 PMID:22269279

Influence of frailty-related diagnoses, high-risk prescribing in elderly adults, and primary care use on readmissions in fewer than 30 days for veterans aged 65 and older.

PubMed

Pugh, Jacqueline A; Wang, Chen-Pin; Espinoza, Sara E; Noël, Polly H; Bollinger, Mary; Amuan, Megan; Finley, Erin; Pugh, Mary Jo

2014-02-01

To determine the effect of two variables not previously studied in the readmissions literature (frailty-related diagnoses and high-risk medications in the elderly (HRME)) and one understudied variable (volume of primary care visits in the prior year). Retrospective cohort study using data from a study designed to examine outcomes associated with inappropriate prescribing in elderly adults. All Veterans Affairs (VA) facilities with acute inpatient beds in fiscal year 2006 (FY06). All veterans aged 65 and older by October 1, 2005, who received VA care at least once per year between October 1, 2004, and September 30, 2006, and were hospitalized at least once during FY06 on a medical or surgical unit. A generalized linear interactive risk prediction model included demographic and clinical characteristics (mental health and chronic medical conditions, frailty-related diagnoses, number of medications) in FY05; incident HRME in FY06 before index hospitalization or readmission; chronic HRME in FY05; and FY05 emergency department (ED), hospital, geriatric, palliative, or primary care use. Facility-level variables were complexity, rural versus urban, and FY06 admission rate. The mean adjusted readmission rate was 18.3%. The new frailty-related diagnoses variable is a risk factor for readmission in addition to Charlson comorbidity score. Incident HRME use was associated with lower rates of readmission, as were higher numbers of primary care visits in the prior year. Frailty-related diagnoses may help to target individuals at higher risk of readmission to receive more-intensive care transition services. HRME use does not help in this targeting. A higher number of face-to-face primary care visits in the prior year, unlike ED and hospital use, correlates with fewer readmissions and may be another avenue for targeting prevention strategies. Published 2014. This article is a U.S. Government work and is in the public domain in the U.S.A.

Age and Preoperative Knee Society Score Are Significant Predictors of Outcomes Among Asians Following Total Knee Arthroplasty.

PubMed

Bin Abd Razak, Hamid Rahmatullah; Tan, Chuen-Seng; Chen, Yongqiang Jerry Delphi; Pang, Hee-Nee; Tay, Keng-Jin Darren; Chin, Pak-Lin; Chia, Shi-Lu; Lo, Ngai-Nung; Yeo, Seng-Jin

2016-05-04

The ability to predict patients' functional outcomes will add value to preoperative counseling. The purpose of this study was to evaluate predictors of good outcomes following total knee arthroplasty (TKA) among Asian patients. Registry data from 2006 to 2010 were extracted. The Oxford Knee Score (OKS) and the Short Form (SF)-36 physical component summary (PCS) were used to evaluate outcomes. A "good outcome" was defined as an improvement in scores of greater than or equal to the minimal clinically important difference (MCID) in the primary analysis. The MCID for the OKS was 5, and the MCID for the PCS was 10. For the sensitivity analyses, a "good outcome" was defined as an OKS of <30 and a PCS score of >50. Clinical variables were used to develop a multiple logistic regression model for a good outcome following total knee arthroplasty at 5 years. Follow-up data were available for 3,062 patients who underwent primary TKA (mean age of 66.4 years; 79.5% female). Eighty-five percent had a good outcome on the basis of the OKS and 83%, on the basis of the SF-36 PCS. Age and preoperative Knee Society score (KSS) were found to be significant predictors. When outcomes were assessed by the MCID, lesser age and lower (worse) preoperative KSS predicted a good outcome at 5 years. When outcomes were assessed by absolute criteria (postoperative scores measured against OKS and PCS thresholds), a higher (better) preoperative KSS predicted a good outcome at 5 years. Body mass index, preoperative flexion range, SF-36 mental component summary (MCS) score, mechanical alignment, sex, education level, ethnicity, operative side, number of comorbidities, type of anesthesia, and type of implant were found not to be significant predictors. The majority of Asian patients with osteoarthritis had good outcomes according to the MCID criterion and benefitted from primary TKA. On the basis of our findings, we believe that older patients with a lower (worse) preoperative KSS can be informed that they have a high likelihood of improvement but a lower likelihood of achieving as good a functional outcome as those with better scores. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2016 by The Journal of Bone and Joint Surgery, Incorporated.

Presence of Genes Encoding Panton-Valentine Leukocidin Is Not the Primary Determinant of Outcome in Patients with Hospital-Acquired Pneumonia Due to Staphylococcus aureus

PubMed Central

Sharma-Kuinkel, Batu K.; Ahn, Sun H.; Rude, Thomas H.; Zhang, Yurong; Tong, Steven Y. C.; Ruffin, Felicia; Genter, Fredric C.; Braughton, Kevin R.; DeLeo, Frank R.; Barriere, Steven L.

2012-01-01

The impact of Panton-Valentine leukocidin (PVL) on the outcome in Staphylococcus aureus pneumonia is controversial. We genotyped S. aureus isolates from patients with hospital-acquired pneumonia (HAP) enrolled in two registrational multinational clinical trials for the genetic elements carrying pvl and 30 other virulence genes. A total of 287 isolates (173 methicillin-resistant S. aureus [MRSA] and 114 methicillin-susceptible S. aureus [MSSA] isolates) from patients from 127 centers in 34 countries for whom clinical outcomes of cure or failure were available underwent genotyping. Of these, pvl was detected by PCR and its product confirmed in 23 isolates (8.0%) (MRSA, 18/173 isolates [10.4%]; MSSA, 5/114 isolates [4.4%]). The presence of pvl was not associated with a higher risk for clinical failure (4/23 [17.4%] versus 48/264 [18.2%]; P = 1.00) or mortality. These findings persisted after adjustment for multiple potential confounding variables. No significant associations between clinical outcome and (i) presence of any of the 30 other virulence genes tested, (ii) presence of specific bacterial clone, (iii) levels of alpha-hemolysin, or (iv) delta-hemolysin production were identified. This study suggests that neither pvl presence nor in vitro level of alpha-hemolysin production is the primary determinant of outcome among patients with HAP caused by S. aureus. PMID:22205797

School performance from primary education in the adolescent offspring of parents with schizophrenia and bipolar disorder- a national, register-based study.

PubMed

Ranning, Anne; Laursen, Thomas; Agerbo, Esben; Thorup, Anne; Hjorthøj, Carsten; Jepsen, Jens Richardt Møllegaard; Nordentoft, Merete

2017-12-14

Schizophrenia (SZ) and bipolar disorder (BP) are causes of severe disability worldwide and parents' severe mental illness (SMI) is associated with childhood adversity, and socio-emotional and cognitive problems in children. Yet, how parental BP and SZ affect educational attainment in offspring is still unclear. We included all children (N = 684.248) born and living in Denmark between 1986 and 1996 and their parents. Our follow-up lasted from 1986 until children's graduation in 2014. The main outcome variable was their school grades following their primary education. School outcomes were divided into four categories: not graduated, low-grade point average (GPA), medium GPA and high GPA. We then performed a multiple logistic regression with medium GPA as the reference category, with the children of parents without SZ or BP as the reference group. Children of parents with SZ faced higher odds than their peers of not graduating primary education (OR 2.6), along with low GPA (odds ratios (OR) 1.6) and lower odds for a high GPA (OR 0.7). Moreover, it was the children of mothers rather than fathers with BP who had higher odds of not graduating primary education (OR 1.6). Lastly, child placement was associated with lower grades and lower graduation rates, and outcomes for children of parents with SMI were favorable compared with other children placed in care. For children, parental SZ is associated with lower grades and lower chances for graduating primary education. In contrast, the children of parents with BP were indistinguishable from the reference group regarding school grades. This signifies that specificity of parental severe mental illness is important in relation to educational achievement of children.

Team dynamics, clinical work satisfaction, and patient care coordination between primary care providers: A mixed methods study.

PubMed

Song, Hummy; Ryan, Molly; Tendulkar, Shalini; Fisher, Josephine; Martin, Julia; Peters, Antoinette S; Frolkis, Joseph P; Rosenthal, Meredith B; Chien, Alyna T; Singer, Sara J

Team-based care is essential for delivering high-quality, comprehensive, and coordinated care. Despite considerable research about the effects of team-based care on patient outcomes, few studies have examined how team dynamics relate to provider outcomes. The aim of this study was to examine relationships among team dynamics, primary care provider (PCP) clinical work satisfaction, and patient care coordination between PCPs in 18 Harvard-affiliated primary care practices participating in Harvard's Academic Innovations Collaborative. First, we administered a cross-sectional survey to all 548 PCPs (267 attending clinicians, 281 resident physicians) working at participating practices; 65% responded. We assessed the relationship of team dynamics with PCPs' clinical work satisfaction and perception of patient care coordination between PCPs, respectively, and the potential mediating effect of patient care coordination on the relationship between team dynamics and work satisfaction. In addition, we embedded a qualitative evaluation within the quantitative evaluation to achieve a convergent mixed methods design to help us better understand our findings and illuminate relationships among key variables. Better team dynamics were positively associated with clinical work satisfaction and quality of patient care coordination between PCPs. Coordination partially mediated the relationship between team dynamics and satisfaction for attending clinicians, suggesting that higher satisfaction depends, in part, on better teamwork, yielding more coordinated patient care. We found no mediating effects for resident physicians. Qualitative results suggest that sources of satisfaction from positive team dynamics for PCPs may be most relevant to attending clinicians. Improving primary care team dynamics could improve clinical work satisfaction among PCPs and patient care coordination between PCPs. In addition to improving outcomes that directly concern health care providers, efforts to improve aspects of team dynamics may also help resolve critical challenges in workforce planning in primary care.

Imaging Surveillance After Primary Breast Cancer Treatment

PubMed Central

Lam, Diana L.; Houssami, Nehmat; Lee, Janie M.

2017-01-01

OBJECTIVE Current clinical guidelines are consistent in supporting annual mammography for women after treatment of primary breast cancer. Surveillance imaging beyond standard digital mammography, including digital breast tomosynthesis (DBT), breast ultrasound, and MRI, may improve outcomes. This article reviews the evidence on the performance and effectiveness of breast imaging modalities available for surveillance after treatment of sporadic unilateral primary breast cancer and identifies additional factors to be considered when selecting an imaging surveillance regimen. CONCLUSION Evidence review supports the use of mammography for surveillance after primary breast cancer treatment. Variability exists in guideline recommendations for surveillance initiation, interval, and cessation. DBT offers the most promise as a potential modality to replace standard digital mammography as a front-line surveillance test; a single published study to date has shown a significant decrease in recall rates compared with standard digital mammography alone. Most guidelines do not support the use of whole-breast ultrasound in breast cancer surveillance, and further studies are needed to define the characteristics of women who may benefit from MRI surveillance. The emerging evidence about surveillance imaging outcomes suggests that additional factors, including patient and imaging characteristics, tumor biology and gene expression profile, and choice of treatment, warrant consideration in selecting personalized posttreatment imaging surveillance regimens. PMID:28075622

Use of Proton-Pump Inhibitors Predicts Heart Failure and Death in Patients with Coronary Artery Disease

PubMed Central

Pello Lázaro, Ana María; Cristóbal, Carmen; Franco-Peláez, Juan Antonio; Tarín, Nieves; Aceña, Álvaro; Carda, Rocío; Huelmos, Ana; Martín-Mariscal, María Luisa; Fuentes-Antras, Jesús; Martínez-Millá, Juan; Alonso, Joaquín; Lorenzo, Óscar; Egido, Jesús; López-Bescós, Lorenzo; Tuñón, José

2017-01-01

Objectives Proton-pump inhibitors (PPIs) seem to increase the incidence of cardiovascular events in patients with coronary artery disease (CAD), mainly in those using clopidogrel. We analysed the impact of PPIs on the prognosis of patients with stable CAD. Methods We followed 706 patients with CAD. Primary outcome was the combination of secondary outcomes. Secondary outcomes were 1) acute ischaemic events (any acute coronary syndrome, stroke, or transient ischaemic attack) and 2) heart failure (HF) or death. Results Patients on PPIs were older [62.0 (53.0–73.0) vs. 58.0 (50.0–70.0) years; p = 0.003] and had a more frequent history of stroke (4.9% vs. 1.1%; p = 0.004) than those from the non-PPI group, and presented no differences in any other clinical variable, including cardiovascular risk factors, ejection fraction, and therapy with aspirin and clopidogrel. Follow-up was 2.2±0.99 years. Seventy-eight patients met the primary outcome, 53 developed acute ischaemic events, and 33 HF or death. PPI use was an independent predictor of the primary outcome [hazard ratio (HR) = 2.281 (1.244–4.183); p = 0.008], along with hypertension, body-mass index, glomerular filtration rate, atrial fibrillation, and nitrate use. PPI use was also an independent predictor of HF/death [HR = 5.713 (1.628–20.043); p = 0.007], but not of acute ischaemic events. A propensity score showed similar results. Conclusions In patients with CAD, PPI use is independently associated with an increased incidence of HF and death but not with a high rate of acute ischaemic events. Further studies are needed to confirm these findings. PMID:28103324

Use of Proton-Pump Inhibitors Predicts Heart Failure and Death in Patients with Coronary Artery Disease.

PubMed

Pello Lázaro, Ana María; Cristóbal, Carmen; Franco-Peláez, Juan Antonio; Tarín, Nieves; Aceña, Álvaro; Carda, Rocío; Huelmos, Ana; Martín-Mariscal, María Luisa; Fuentes-Antras, Jesús; Martínez-Millá, Juan; Alonso, Joaquín; Lorenzo, Óscar; Egido, Jesús; López-Bescós, Lorenzo; Tuñón, José

2017-01-01

Proton-pump inhibitors (PPIs) seem to increase the incidence of cardiovascular events in patients with coronary artery disease (CAD), mainly in those using clopidogrel. We analysed the impact of PPIs on the prognosis of patients with stable CAD. We followed 706 patients with CAD. Primary outcome was the combination of secondary outcomes. Secondary outcomes were 1) acute ischaemic events (any acute coronary syndrome, stroke, or transient ischaemic attack) and 2) heart failure (HF) or death. Patients on PPIs were older [62.0 (53.0-73.0) vs. 58.0 (50.0-70.0) years; p = 0.003] and had a more frequent history of stroke (4.9% vs. 1.1%; p = 0.004) than those from the non-PPI group, and presented no differences in any other clinical variable, including cardiovascular risk factors, ejection fraction, and therapy with aspirin and clopidogrel. Follow-up was 2.2±0.99 years. Seventy-eight patients met the primary outcome, 53 developed acute ischaemic events, and 33 HF or death. PPI use was an independent predictor of the primary outcome [hazard ratio (HR) = 2.281 (1.244-4.183); p = 0.008], along with hypertension, body-mass index, glomerular filtration rate, atrial fibrillation, and nitrate use. PPI use was also an independent predictor of HF/death [HR = 5.713 (1.628-20.043); p = 0.007], but not of acute ischaemic events. A propensity score showed similar results. In patients with CAD, PPI use is independently associated with an increased incidence of HF and death but not with a high rate of acute ischaemic events. Further studies are needed to confirm these findings.

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.

Race, obesity, and the renin-angiotensin-aldosterone system: treatment response in children with primary hypertension.

PubMed

South, Andrew M; Arguelles, Lester; Finer, Gal; Langman, Craig B

2017-09-01

Pediatric primary hypertension (HTN) is increasingly recognized, but the effect of patient characteristics such as obesity and race on treatment outcomes is not well described. The renin-angiotensin-aldosterone system (RAAS) may also contribute to HTN. We hypothesized patient parameters of these factors, including baseline RAAS, influence blood pressure (BP) response to pharmacological treatment in HTN. This was a retrospective cohort of 102 consecutive patients with HTN. Primary outcomes were changes per year in systolic and diastolic BP (SBP, DBP). Secondary outcome was change per year in left ventricular mass index (LVMI). We evaluated whether baseline plasma renin activity (PRA), aldosterone, renin-to-aldosterone ratio, overweight/obesity, race, initial drug choice, and multidrug therapy were associated with the outcomes using general linear regression models adjusted for confounding variables. Racially diverse (43% Hispanic, 28% black, 25% white) and predominantly overweight/obese (75%) patients were studied. Median length of follow-up was 14.5 months. Higher baseline aldosterone was associated with decreased SBP (-1.03 mmHg/year), DBP (-0.95 mmHg/year), and DBP z score (-0.07/year) during the study period. Higher baseline PRA was associated with decreased SBP z score (-0.04/year) and LVMI (-2.89 g/m 2.7 /year). Stratified analyses revealed the relationships between baseline aldosterone and PRA, and annual reductions in outcomes were strengthened in nonobese and white patients. Pretreatment aldosterone and PRA predicted short-term follow-up BP and LVMI, especially in nonobese and white patients. The RAAS profile could guide treatment of HTN and suggests consideration of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers as first-line treatment options.

Predicting declines in perceived relationship continuity using practice deprivation scores: a longitudinal study in primary care.

PubMed

Levene, Louis S; Baker, Richard; Walker, Nicola; Williams, Christopher; Wilson, Andrew; Bankart, John

2018-06-01

Increased relationship continuity in primary care is associated with better health outcomes, greater patient satisfaction, and fewer hospital admissions. Greater socioeconomic deprivation is associated with lower levels of continuity, as well as poorer health outcomes. To investigate whether deprivation scores predicted variations in the decline over time of patient-perceived relationship continuity of care, after adjustment for practice organisational and population factors. An observational study in 6243 primary care practices with more than one GP, in England, using a longitudinal multilevel linear model, 2012-2017 inclusive. Patient-perceived relationship continuity was calculated using two questions from the GP Patient Survey. The effect of deprivation on the linear slope of continuity over time was modelled, adjusting for nine confounding variables (practice population and organisational factors). Clustering of measurements within general practices was adjusted for by using a random intercepts and random slopes model. Descriptive statistics and univariable analyses were also undertaken. Relationship continuity declined by 27.5% between 2012 and 2017, and at all deprivation levels. Deprivation scores from 2012 did not predict variations in the decline of relationship continuity at practice level, after accounting for the effects of organisational and population confounding variables, which themselves did not predict, or weakly predicted with very small effect sizes, the decline of continuity. Cross-sectionally, continuity and deprivation were negatively correlated within each year. The decline in relationship continuity of care has been marked and widespread. Measures to maximise continuity will need to be feasible for individual practices with diverse population and organisational characteristics. © British Journal of General Practice 2018.

Assessing Impacts on Unplanned Hospitalisations of Care Quality and Access Using a Structural Equation Method: With a Case Study of Diabetes

PubMed Central

Congdon, Peter

2016-01-01

Background: Enhanced quality of care and improved access are central to effective primary care management of long term conditions. However, research evidence is inconclusive in establishing a link between quality of primary care, or access, and adverse outcomes, such as unplanned hospitalisation. Methods: This paper proposes a structural equation model for quality and access as latent variables affecting adverse outcomes, such as unplanned hospitalisations. In a case study application, quality of care (QOC) is defined in relation to diabetes, and the aim is to assess impacts of care quality and access on unplanned hospital admissions for diabetes, while allowing also for socio-economic deprivation, diabetes morbidity, and supply effects. The study involves 90 general practitioner (GP) practices in two London Clinical Commissioning Groups, using clinical quality of care indicators, and patient survey data on perceived access. Results: As a single predictor, quality of care has a significant negative impact on emergency admissions, and this significant effect remains when socio-economic deprivation and morbidity are allowed. In a full structural equation model including access, the probability that QOC negatively impacts on unplanned admissions exceeds 0.9. Furthermore, poor access is linked to deprivation, diminished QOC, and larger list sizes. Conclusions: Using a Bayesian inference methodology, the evidence from the analysis is weighted towards negative impacts of higher primary care quality and improved access on unplanned admissions. The methodology of the paper is potentially applicable to other long term conditions, and relevant when care quality and access cannot be measured directly and are better regarded as latent variables. PMID:27598184

Assessing Impacts on Unplanned Hospitalisations of Care Quality and Access Using a Structural Equation Method: With a Case Study of Diabetes.

PubMed

Congdon, Peter

2016-09-01

Enhanced quality of care and improved access are central to effective primary care management of long term conditions. However, research evidence is inconclusive in establishing a link between quality of primary care, or access, and adverse outcomes, such as unplanned hospitalisation. This paper proposes a structural equation model for quality and access as latent variables affecting adverse outcomes, such as unplanned hospitalisations. In a case study application, quality of care (QOC) is defined in relation to diabetes, and the aim is to assess impacts of care quality and access on unplanned hospital admissions for diabetes, while allowing also for socio-economic deprivation, diabetes morbidity, and supply effects. The study involves 90 general practitioner (GP) practices in two London Clinical Commissioning Groups, using clinical quality of care indicators, and patient survey data on perceived access. As a single predictor, quality of care has a significant negative impact on emergency admissions, and this significant effect remains when socio-economic deprivation and morbidity are allowed. In a full structural equation model including access, the probability that QOC negatively impacts on unplanned admissions exceeds 0.9. Furthermore, poor access is linked to deprivation, diminished QOC, and larger list sizes. Using a Bayesian inference methodology, the evidence from the analysis is weighted towards negative impacts of higher primary care quality and improved access on unplanned admissions. The methodology of the paper is potentially applicable to other long term conditions, and relevant when care quality and access cannot be measured directly and are better regarded as latent variables.

The Effect of Immunologically Safe Plasma Rich in Growth Factor Eye Drops in Patients with Sjögren Syndrome.

PubMed

Sanchez-Avila, Ronald Mauricio; Merayo-Lloves, Jesus; Riestra, Ana Cristina; Anitua, Eduardo; Muruzabal, Francisco; Orive, Gorka; Fernández-Vega, Luis

2017-06-01

The objective was to provide preliminary information about the efficacy and safety of immunologically safe plasma rich in growth factor (immunosafe PRGF) eye drops in the treatment of moderate to severe dry eye in patients with primary and secondary Sjögren's syndrome (SS) and to analyze the influence of several variables on treatment outcomes. This retrospective study included patients with SS. All patients were treated with previously immunosafe PRGF eye drops to reduce the immunologic component contents. Ocular Surface Disease Index (OSDI) scale, best-corrected visual acuity (BCVA), visual analog scale (VAS) frequency, and VAS severity outcome measures were evaluated before and after treatment with immunosafe PRGF. The potential influence of some patient clinical variables on results was also assessed. Safety assessment was also performed reporting all adverse events. Twenty-six patients (12 patients with primary SS, and 14 patients suffering secondary SS) with a total of 52 affected eyes were included and evaluated. Immunosafe PRGF treatment showed a significant reduction (P < 0.05) in OSDI scale (41.86%), in BCVA (62.97%), in VAS frequency (34.75%), and in VAS severity (41.50%). BCVA and VAS frequency scores improved significantly (P < 0.05) after concomitant treatment of PRGF with corticosteroids. Only 2 adverse events were reported in 2 patients (7.7% of patients). Signs and symptoms of dry eye syndrome in patients with SS were reduced after treatment with PRGF-Endoret eye drops. Immunosafe PRGF-Endoret is safe and effective for treating patients with primary and secondary SS.

Low-level exposure to air pollution and risk of adverse birth outcomes in Hillsborough County, Florida.

PubMed

Mainolfi, Maria B; Salihu, Hamisu M; Wilson, Roneé E; Mbah, Alfred K

2013-05-01

In this retrospective cohort (1998 to 2007), 145,445 singleton live births in Hillsborough, Florida, were analyzed to elucidate the relationship between fetal morbidity and prenatal exposure to six criteria air pollutants. This study was based on three linked databases: Florida Hospital Discharge, vital statistics records, and air pollution meteorological data from the Environmental Protection Agency. The primary outcomes of interest were low birth weight, preterm births, and small for gestational age. This study used structural equation modeling and trimester groupings to evaluate the relationship between air pollution and birth outcomes of pregnant residents. The latent variables of structural equation modeling yielded a significant B value of 0.35, indicating that exposure to the criteria pollutants in pregnancy may have a significant relationship to fetal morbidity. Exposure to criteria air pollutants in pregnancy is associated with fetal morbidity outcomes.

Occupational Stress: A Comprehensive Review of the Top 50 Annual and Lifetime Cited Articles.

PubMed

Nowrouzi, Behdin; Nguyen, Christine; Casole, Jennifer; Nowrouzi-Kia, Behnam

2017-05-01

This study determined the impact and influence of published articles on the field of occupational stress. A transdisciplinary approach was used to identify the 50 work-related stress articles with the most lifetime citations and the 50 work-related stress articles with the highest annual citation rates. Studies were categorized based on their primary focus: (a) etiology, (b) predictor of outcome for which occupational stress is the outcome or predictor of outcome for which occupational stress is an independent variable, (c) management/intervention, (d) theory/model/framework, or (e) methodologies. The majority of studies with the highest number of lifetime citations as well as the highest annual citation rates used stress as a predictor or outcome of another factor. The proportion of studies that were categorized by etiology, intervention/management, theory/model/framework, or methodologies was relatively low for both lifetime and annual citations.

Deep brain stimulation for psychiatric disorders: Is there an impact on social functioning?

PubMed Central

Saleh, Christian; Hasler, Gregor

2017-01-01

Background: Deep brain stimulation (DBS) for refractory psychiatric disorders shows promising effects on symptom-reduction, however, little is known regarding the effects of DBS on social outcome. Methods: A PubMed search based on original studies of DBS for psychiatric disorders [treatment resistant depression (TRD), Gilles de la Tourette's syndrome (GTS), and obsessive compulsive disorder (OCD)] was conducted. Data on social outcome following surgery were extracted and analyzed. Results: Social functioning was not a primary outcome measure in the reviewed article. The literature is incomplete and inconclusive on this variable, however from the reported data, there is some evidence that DBS has the potential to improve social functioning. Conclusions: More systematic and detailed data gathering and reporting on social outcome with longer follow-ups are needed to evaluate more exhaustively the role of DBS in refractory psychiatric disorders. PMID:28781911

Effectiveness of a smartphone-based worry-reduction training for stress reduction: A randomized-controlled trial.

PubMed

Versluis, Anke; Verkuil, Bart; Spinhoven, Philip; F Brosschot, Jos

2018-04-03

Perseverative cognition (e.g. worry) and unconscious stress are suggested to be important mediators in the relation between stressors and physiological health. We examined whether a smartphone-based worry-reduction training improved a physiological marker of stress (i.e. increased heart rate variability [HRV]) and unconscious stress. Randomised-controlled trial was conducted with individuals reporting work stress (n = 136). Participants were randomised to the experimental, control or waitlist condition (resp. EC, CC, WL). The EC and CC registered emotions five times daily for four weeks. The EC additionally received a worry-reduction training with mindfulness exercises. Primary outcome was 24-h assessments of HRV measured at pre-, mid- and post-intervention. Secondary outcomes were implicit affect and stress. Effects on heart rate and other psychological outcomes were explored. A total of 118 participants completed the study. No change from pre- to post-intervention was observed for the primary or secondary outcomes. The change over time was not different between conditions. Findings suggest that the training was ineffective for improving HRV or psychological stress. Future studies may focus on alternative smartphone-based stress interventions, as stress levels are high in society. There is need for easy interventions and smartphones offer possibilities for this.

Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

PubMed Central

Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

2016-01-01

To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

Parents’ Primary Professional Sources of Parenting Advice Moderate Predictors of Parental Attitudes toward Corporal Punishment

PubMed Central

Taylor, Catherine A.; McKasson, Sarah; Hoy, Guenevere; DeJong, William

2016-01-01

Despite the risk it poses to children’s mental and physical health, approval and use of corporal punishment (CP) remains high in the United States. Informed by the Theory of Planned Behavior, we examined potential predictors of attitudes supportive of CP while assessing the moderating effects of parents’ (N=500) chosen primary professional source of advice regarding child discipline: pediatricians (47.8%), religious leaders (20.8%), mental health professionals (MHPs) (n=18.4%), or other identified professionals (13.0%). We conducted a random-digit-dial telephone survey among parents ages 18 and over within New Orleans, LA. The main outcome measure was derived from the Attitudes Toward Spanking scale (ATS). The main “predictors” were: perceived injunctive norms (i.e., perceived approval of CP by professionals; and by family and friends), perceived descriptive norms of family and friends regarding CP, and expected outcomes of CP use. We used multivariate OLS models to regress ATS scores on the predictor variables for each subset of parents based on their chosen professional source of advice. Perceived approval of CP by professionals was the strongest predictor of parental attitudes supportive of CP, except for those seeking advice from MHPs. Perceived injunctive and descriptive norms of family and friends were important, but only for those seeking advice from pediatricians or religious leaders. Positive expected outcomes of CP mattered, but only for those seeking advice from religious leaders or MHPs. In conclusion, the strength and relevance of variables predicting attitudes toward CP varied according to the professional from which the parent was most likely to seek advice. PMID:28529440

The variability in Oxford hip and knee scores in the preoperative period: is there an ideal time to score?

PubMed

Quah, C; Holmes, D; Khan, T; Cockshott, S; Lewis, J; Stephen, A

2018-01-01

Background All NHS-funded providers are required to collect and report patient-reported outcome measures for hip and knee arthroplasty. Although there are established guidelines for timing such measures following arthroplasty, there are no specific time-points for collection in the preoperative period. The primary aim of this study was to identify whether there was a significant amount of variability in the Oxford hip and knee scores prior to surgical intervention when completed in the outpatient clinic at the time of listing for arthroplasty or when completed at the preoperative assessment clinic. Methods A prospective cohort study of patients listed for primary hip or knee arthroplasty was conducted. Patients were asked to fill in a preoperative Oxford score in the outpatient clinic at the time of listing. They were then invited to fill in the official outcome measures questionnaire at the preoperative assessment clinic. The postoperative Oxford score was then completed when the patient was seen again at their postoperative follow up in clinic. Results Of the total of 109 patients included in this study period, there were 18 (17%) who had a worse score of 4 or more points difference and 43 (39.4%) who had an improvement of 4 or more points difference when the scores were compared between time of listing at the outpatient and at the preoperative assessment clinic. There was a statistically significant difference (P = 0.0054) in the mean Oxford scores. Conclusions The results of our study suggest that there should be standardisation of timing for completing the preoperative patient-reported outcome measures.

Parents' Primary Professional Sources of Parenting Advice Moderate Predictors of Parental Attitudes toward Corporal Punishment.

PubMed

Taylor, Catherine A; McKasson, Sarah; Hoy, Guenevere; DeJong, William

2017-02-01

Despite the risk it poses to children's mental and physical health, approval and use of corporal punishment (CP) remains high in the United States. Informed by the Theory of Planned Behavior, we examined potential predictors of attitudes supportive of CP while assessing the moderating effects of parents' (N=500) chosen primary professional source of advice regarding child discipline: pediatricians (47.8%), religious leaders (20.8%), mental health professionals (MHPs) (n=18.4%), or other identified professionals (13.0%). We conducted a random-digit-dial telephone survey among parents ages 18 and over within New Orleans, LA. The main outcome measure was derived from the Attitudes Toward Spanking scale (ATS). The main "predictors" were: perceived injunctive norms (i.e., perceived approval of CP by professionals; and by family and friends), perceived descriptive norms of family and friends regarding CP, and expected outcomes of CP use. We used multivariate OLS models to regress ATS scores on the predictor variables for each subset of parents based on their chosen professional source of advice. Perceived approval of CP by professionals was the strongest predictor of parental attitudes supportive of CP, except for those seeking advice from MHPs. Perceived injunctive and descriptive norms of family and friends were important, but only for those seeking advice from pediatricians or religious leaders. Positive expected outcomes of CP mattered, but only for those seeking advice from religious leaders or MHPs. In conclusion, the strength and relevance of variables predicting attitudes toward CP varied according to the professional from which the parent was most likely to seek advice.

Prostate Active Surveillance Study — EDRN Public Portal

Cancer.gov

Primary Objective: To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. Secondary Objectives: To determine the proportion of patients on active surveillance who progress based on the above criteria. To determine the clinical predictors of disease progression. To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Aviation Selection Test Battery Component Predictiveness of Primary Flight Training Outcomes Among Diverse Groups

DTIC Science & Technology

2011-03-01

variability of the volunteers and draftees being inducted. The military use of aircraft led to an emerging need to systematically train pilots for...shown to be the least effective factor in deciding who would perform well . In another study, the U.S. Army developed a computer-based simulation... reviewing instruction, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of

Learning primary care in medical school: does specialty or geographic location of the teaching site make a difference?

PubMed

Irigoyen, M M; Kurth, R J; Schmidt, H J

1999-05-01

The Liaison Committee on Medical Education mandates a core curriculum in primary care but does not specify its content or structure. In this study, we explored the question of whether primary care specialty or geographic location affects student learning and satisfaction. From 1994 to 1996, 294 third-year medical students at one medical school in New York state were randomly assigned to multiple teaching sites for a required 5-week primary care clerkship. Independent predictor variables were primary care specialty of the preceptor (family medicine, medicine, pediatrics, or joint medicine and pediatrics) and geographic location of the site (urban, suburban, rural). Outcome measures included four areas of student satisfaction, one of patient volume, and two of student performance. Primary care specialty had no detectable association with the outcome measures, except for a lower rating of patient diversity in pediatric experiences (P <0.001). Geographic location of the site had a significant association with all measures of student satisfaction and patient volume (all P values <0.001). Students at rural sites rated the experience more highly and saw on average 15 more patients per rotation. Ratings of student satisfaction remained high after adjusting for patient volume. Primary care specialty and geographic location did not influence student performance in the clerkship or scores on standardized patient examination. Rural geographic location of teaching site, but not primary care specialty, was associated with higher student satisfaction. However, higher student satisfaction ratings did not correspond to better student performance. Provided that all sites meet the screening criteria for inclusion in a teaching program, these findings support the continued development of high-quality, heterogeneous, interdisciplinary, primary care experiences.

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

Emergency department visits and primary care among adults with chronic conditions.

PubMed

McCusker, Jane; Roberge, Danièle; Lévesque, Jean-Frédéric; Ciampi, Antonio; Vadeboncoeur, Alain; Larouche, Danielle; Sanche, Steven

2010-11-01

An emergency department (ED) visit may be a marker for limited access to primary medical care, particularly among those with ambulatory care sensitive chronic conditions (ACSCC). In a population with universal health insurance, to examine the relationships between primary care characteristics and location of last general physician (GP) contact (in an ED vs. elsewhere) among those with and without an ACSCC. A cross-sectional survey using data from 2 cycles of the Canadian Community Health Survey carried out in 2003 and 2005. The study sample comprised Québec residents aged ≥18 who reported at least one GP contact during the previous 12 months, and were not hospitalized (n = 33,491). The primary outcome was place of last GP contact: in an ED versus elsewhere. Independent variables included the following: lack of a regular physician, perceived unmet healthcare needs, perceived availability of health care, number of contacts with doctors and nurses, and diagnosis of an ACSCC (hypertension, heart disease, chronic respiratory disease, diabetes). Using multiple logistic regression, with adjustment for sociodemographic, health status, and health services variables, lack of a regular GP and perceptions of unmet needs were associated with last GP contact in an ED; there was no interaction with ACSCC or other chronic conditions. Primary care characteristics associated with GP contact in an ED rather than another site reflect individual characteristics (affiliation with a primary GP and perceived needs) rather than the geographic availability of healthcare, both among those with and without chronic conditions.

Effectiveness of a stepped primary care smoking cessation intervention: cluster randomized clinical trial (ISTAPS study).

PubMed

Cabezas, Carmen; Advani, Mamta; Puente, Diana; Rodriguez-Blanco, Teresa; Martin, Carlos

2011-09-01

To evaluate the effectiveness in primary care of a stepped smoking cessation intervention based on the transtheoretical model of change. Cluster randomized trial; unit of randomization: basic care unit (family physician and nurse who care for the same group of patients); and intention-to-treat analysis. All interested basic care units (n = 176) that worked in 82 primary care centres belonging to the Spanish Preventive Services and Health Promotion Research Network in 13 regions of Spain. A total of 2,827 smokers (aged 14-85 years) who consulted a primary care centre for any reason, provided written informed consent and had valid interviews. The outcome variable was the 1-year continuous abstinence rate at the 2-year follow-up. The main variable was the study group (intervention/control). Intervention involved 6-month implementation of recommendations from a Clinical Practice Guideline which included brief motivational interviews for smokers at the precontemplation-contemplation stage, brief intervention for smokers in preparation-action who do not want help, intensive intervention with pharmacotherapy for smokers in preparation-action who want help and reinforcing intervention in the maintenance stage. Control group involved usual care. Among others, characteristics of tobacco use and motivation to quit variables were also collected. The 1-year continuous abstinence rate at the 2-year follow-up was 8.1% in the intervention group and 5.8% in the control group (P = 0.014). In the multivariate logistic regression, the odds of quitting of the intervention versus control group was 1.50 (95% confidence interval = 1.05-2.14). A stepped smoking cessation intervention based on the transtheoretical model significantly increased smoking abstinence at a 2-year follow-up among smokers visiting primary care centres. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

Effectiveness of the Epley’s maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV), which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers. The objective of this study is to evaluate the effectiveness of Epley’s maneuver performed by general practitioners (GPs) in the treatment of BPPV. Methods/Design This study is a randomized clinical trial conducted in the primary care setting. The study’s scope will include two urban primary care centers which provide care for approximately 49,400 patients. All patients attending these two primary care centers, who are newly diagnosed with benign paroxysmal positional vertigo, will be invited to participate in the study and will be randomly assigned either to the treatment group (Epley’s maneuver) or to the control group (a sham maneuver). Both groups will receive betahistine. Outcome variables will be: response to the D-H test, patients’ report on presence or absence of vertigo during the previous week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert-type scale in the previous week, total score on the Dizziness Handicap Inventory (DHI) and quantity of betahistine taken. We will use descriptive statistics of all variables collected. Groups will be compared using the intent-to-treat approach and either parametric or nonparametric tests, depending on the nature and distribution of the variables. Chi-square test or Fisher’s exact test will be conducted to compare categorical measures and Student’s t-test or Mann–Whitney U-test will be used for intergroup comparison variables. Discussion Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners (GPs) and, therefore, its widespread practice may contribute to improve the quality of life of BPPV patients. Trial registration ClinicalTrials.gov Identifier: NCT01969513. PMID:24886338

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis

PubMed Central

Perl, Jeffrey; Davies, Simon J.; Lambie, Mark; Pisoni, Ronald L.; McCullough, Keith; Johnson, David W.; Sloand, James A.; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M.

2016-01-01

♦ Background: Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ Methods: The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ Results: A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ Conclusion: The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. PMID:26526049

The Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS): Unifying Efforts to Inform Practice and Improve Global Outcomes in Peritoneal Dialysis.

PubMed

Perl, Jeffrey; Davies, Simon J; Lambie, Mark; Pisoni, Ronald L; McCullough, Keith; Johnson, David W; Sloand, James A; Prichard, Sarah; Kawanishi, Hideki; Tentori, Francesca; Robinson, Bruce M

2016-01-01

♦ Extending technique survival on peritoneal dialysis (PD) remains a major challenge in optimizing outcomes for PD patients while increasing PD utilization. The primary objective of the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) is to identify modifiable practices associated with improvements in PD technique and patient survival. In collaboration with the International Society for Peritoneal Dialysis (ISPD), PDOPPS seeks to standardize PD-related data definitions and provide a forum for effective international collaborative clinical research in PD. ♦ The PDOPPS is an international prospective cohort study in Australia, Canada, Japan, the United Kingdom (UK), and the United States (US). Each country is enrolling a random sample of incident and prevalent patients from national samples of 20 to 80 sites with at least 20 patients on PD. Enrolled patients will be followed over an initial 3-year study period. Demographic, comorbidity, and treatment-related variables, and patient-reported data, will be collected over the study course. The primary outcome will be all-cause PD technique failure or death; other outcomes will include cause-specific technique failure, hospitalizations, and patient-reported outcomes. ♦ A high proportion of the targeted number of study sites has been recruited to date in each country. Several ancillary studies have been funded with high momentum toward expansion to new countries and additional participation. ♦ The PDOPPS is the first large, international study to follow PD patients longitudinally to capture clinical practice. With data collected, the study will serve as an invaluable resource and research platform for the international PD community, and provide a means to understand variation in PD practices and outcomes, to identify optimal practices, and to ultimately improve outcomes for PD patients. Copyright © 2016 International Society for Peritoneal Dialysis.

Dimensional personality traits and alcohol treatment outcome: a systematic review and meta-analysis.

PubMed

Foulds, James; Newton-Howes, Giles; Guy, Nicola H; Boden, Joseph M; Mulder, Roger T

2017-08-01

To identify dimensional personality traits associated with treatment outcome for patients with an alcohol use disorder (AUD). Systematic review and meta-analysis of clinical trials and longitudinal studies of ≥ 8 weeks in patients receiving treatment for AUD, in which the association between personality dimensions and treatment outcome was reported. Primary outcomes were relapse and alcohol consumption measures. Treatment retention was a secondary outcome. Eighteen studies, including 4783 subjects, were identified. Twelve studies used Cloninger's Temperament and Personality Questionnaire (TPQ) or Temperament and Character Inventory (TCI). Remaining studies used a broad range of other personality measures. Compared with non-relapsers, patients who relapsed had higher novelty-seeking [standardized mean difference in novelty-seeking score 0.28; 95% confidence interval (CI) = 0.12, 0.44], lower persistence (-0.30, 95% = CI -0.48, -0.12), lower reward dependence (-0.16, 95% CI = -0.31, -0.01) and lower cooperativeness (-0.23, 95% CI = -0.41, -0.04). Few studies reported on alcohol consumption outcomes, therefore findings for those outcomes were inconclusive. Lower novelty-seeking predicted better retention in treatment in two of three studies. Most studies reported findings only for those retained in treatment, and did not attempt to account for missing data; therefore, findings for the primary outcomes cannot be generalized to patients who dropped out of treatment. Studies using personality instruments other than the TCI or TPQ reported no consistent findings on the association between personality variables and treatment outcome. Among patients receiving treatment for an alcohol use disorder, those who relapse during follow-up have higher novelty-seeking, lower persistence, lower reward dependence and lower cooperativeness than those who do not relapse. © 2017 Society for the Study of Addiction.

The Epidemiology of Primary and Revision Total Hip Arthroplasty in Teaching and Nonteaching Hospitals in the United States.

PubMed

Kowalik, Thomas D; DeHart, Matthew; Gehling, Hanne; Gehling, Paxton; Schabel, Kathryn; Duwelius, Paul; Mirza, Amer

2016-06-01

The purpose of this study was to examine the epidemiology of primary and revision total hip arthroplasty (THA) in teaching and nonteaching hospitals. The Healthcare Cost and Utilization Project Nationwide Inpatient Sample was queried from 2006 to 2010 to identify primary and revision THAs at teaching and nonteaching hospitals. A total of 1,336,396 primary and 223,520 revision procedures were identified. Forty-six percent of all primary and 54% of all revision procedures were performed at teaching hospitals. Teaching hospitals performed 17% of their THAs as revisions; nonteaching hospitals performed 12% as revisions. For primary and revision THAs, teaching hospitals had fewer patients aged >65 years, fewer Medicare patients, similar gender rates, more nonwhite patients, and more patients in the highest income quartile compared with nonteaching hospitals. Costs, length of stay, and Charlson Comorbidity Index scores were similar; however, the mortality rate was lower at teaching hospitals. This study found small but significant differences in key epidemiologic and outcome variables in examining primary and revision THA at teaching and nonteaching hospitals. Level III.

Variable compensation in Primary Healthcare: a report on the experience in Curitiba, Rio de Janeiro, Brazil, and Lisbon, Portugal.

PubMed

Poli Neto, Paulo; Faoro, Nilza Teresinha; Prado Júnior, José Carlos do; Pisco, Luís Augusto Coelho

2016-05-01

How professionals are compensated may affect how they perform their tasks. Fixed compensation may take the form of wages, payment for productivity or capitation. In addition to fixed compensation, there are numerous mechanisms for variable compensation. This article describes the experience of Curitiba and Rio de Janeiro in Brazil, and Lisbon in Portugal, using different models of performance-based compensation. In all three of these examples, management felt the need to offer monetary reward to achieve certain goals. The indicators analyzed the structure, processes and outcomes, and assessed professionals individual and as part of healthcare teams. In Lisbon, variable compensation can be as high as 40% of the base wage, while in Curitiba and Rio de Janeiro it is limited to 10%. Despite the growing use of this management tool in Brazil and the world, further studies are required to analyze the effectiveness of variable compensation.

Cognitive-behavioral therapy for women with lifelong vaginismus: process and prognostic factors.

PubMed

ter Kuile, Moniek M; van Lankveld, Jacques J D M; de Groot, Ellen; Melles, Reinhilde; Neffs, Janneke; Zandbergen, Maartje

2007-02-01

Cognitive-behavioral therapy (CBT) seems an effective treatment of lifelong vaginismus, but mechanisms of action have not yet been established. The present study explored whether the effect of CBT for lifelong vaginismus is mediated by changes in fear of penetration and avoidance behavior, which CBT explicitly aims to alter. A second aim of this study was to predict treatment outcome on the basis of pre-treatment variables. Participants with lifelong vaginismus were allocated at random to a 3-months CBT (n=81) or a waiting-list control condition (n=36). Full vaginal penetration with the penis of the partner constituted the primary outcome measure. Change scores in successful 'non-coital penetrative-behavior' and 'fear of coitus' were used to measure the mediating variables. Treatment resulted in an increase of intercourse (outcome), a decrease in fear of coitus, and an enhancement of successful non-coital penetration behavior, compared with no treatment. Outcome (intercourse) was partly mediated by changes in fear of coitus and changes in avoidance behavior. No treatment predictors could be detected in this study sample. It is concluded that techniques such as gradual exposure, aimed at decreasing avoidance behavior and penetration fear, constitute an important avenue of change in the treatment of lifelong vaginismus.

Employment outcomes of transition-aged adults with autism spectrum disorders: a state of the States report.

PubMed

Burgess, Sloane; Cimera, Robert E

2014-01-01

The primary purpose of this study was to evaluate the employment outcomes of transition-aged adults with autism spectrum disorders (ASD) served by vocational rehabilitation services (VR) over the last 10 years by state. A secondary purpose was to compare employment outcomes of individuals with ASD to those of the overall transition-aged population served by VR for the same time period. Although there was variability both within and among states, the results of this study indicate that, over time, the number of young adults with ASD seeking VR services has increased; however, employment outcomes including the percent of adults with ASD achieving employment, the number of hours worked, and wages earned have not improved for this group. The cost to provide VR services to transition-aged adults with ASD was relatively stable over time. Transition-aged adults with ASD were more likely to become successfully employed as a result of receiving VR services than the overall population of transition-aged adults served by VR. However, the employed transition-aged adults consistently worked fewer hours and earned lower wages than those in the overall population. Factors that may influence variability within and among states, and between groups, and implications for research and practice are discussed.

Effects of person-centred care on health outcomes-A randomized controlled trial in patients with acute coronary syndrome.

PubMed

Pirhonen, Laura; Olofsson, Elisabeth Hansson; Fors, Andreas; Ekman, Inger; Bolin, Kristian

2017-02-01

To study the effects of person-centred care provided to patients with acute coronary syndrome, using four different health-related outcome measures. Also, to examine the performance of these outcomes when measuring person-centred care. The data used in this study consists of primary data from a multicentre randomized parallel group, controlled intervention study for patients with acute coronary syndrome at Sahlgrenska University Hospital in Gothenburg, Sweden. The intervention and control group consisted of 94 and 105 patients, respectively. The effect of the intervention on health-related outcomes was estimated, controlling for socio-economic and disease-related variables. Patients in the intervention group reported significantly higher general self-efficacy than those in the control group six months after intervention start-up. Moreover, the intervention group returned to work in a greater extent than controls; their physical activity level had increased more and they had a higher EQ-5D score, meaning higher health-related quality of life. These latter effects are not significant but are all pointing towards the beneficial effects of person-centred care. All the effects were estimated while controlling for important socio-economic and disease-related variables. The effectiveness of person-centred care varies between different outcomes considered. A statistically significant beneficial effect was found for one of the four outcome measures (self-efficacy). The other measures all captured beneficial, but not significant, effects. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial

PubMed Central

2014-01-01

Background Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. Methods/design The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. Discussion The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. Trial registration NCT01967797. PMID:24947045

Implementation and evaluation of the 5As framework of obesity management in primary care: design of the 5As Team (5AsT) randomized control trial.

PubMed

Campbell-Scherer, Denise L; Asselin, Jodie; Osunlana, Adedayo M; Fielding, Sheri; Anderson, Robin; Rueda-Clausen, Christian F; Johnson, Jeffrey A; Ogunleye, Ayodele A; Cave, Andrew; Manca, Donna; Sharma, Arya M

2014-06-19

Obesity is a pressing public health concern, which frequently presents in primary care. With the explosive obesity epidemic, there is an urgent need to maximize effective management in primary care. The 5As of Obesity Management™ (5As) are a collection of knowledge tools developed by the Canadian Obesity Network. Low rates of obesity management visits in primary care suggest provider behaviour may be an important variable. The goal of the present study is to increase frequency and quality of obesity management in primary care using the 5As Team (5AsT) intervention to change provider behaviour. The 5AsT trial is a theoretically informed, pragmatic randomized controlled trial with mixed methods evaluation. Clinic-based multidisciplinary teams (RN/NP, mental health, dietitians) will be randomized to control or the 5AsT intervention group, to participate in biweekly learning collaborative sessions supported by internal and external practice facilitation. The learning collaborative content addresses provider-identified barriers to effective obesity management in primary care. Evidence-based shared decision making tools will be co-developed and iteratively tested by practitioners. Evaluation will be informed by the RE-AIM framework. The primary outcome measure, to which participants are blinded, is number of weight management visits/full-time equivalent (FTE) position. Patient-level outcomes will also be assessed, through a longitudinal cohort study of patients from randomized practices. Patient outcomes include clinical (e.g., body mass index [BMI], blood pressure), health-related quality of life (SF-12, EQ5D), and satisfaction with care. Qualitative data collected from providers and patients will be evaluated using thematic analysis to understand the context, implementation and effectiveness of the 5AsT program. The 5AsT trial will provide a wide range of insights into current practices, knowledge gaps and barriers that limit obesity management in primary practice. The use of existing resources, collaborative design, practice facilitation, and integrated feedback loops cultivate an applicable, adaptable and sustainable approach to increasing the quantity and quality of weight management visits in primary care. NCT01967797.

Temperature variability during delirium in ICU patients: an observational study.

PubMed

van der Kooi, Arendina W; Kappen, Teus H; Raijmakers, Rosa J; Zaal, Irene J; Slooter, Arjen J C

2013-01-01

Delirium is an acute disturbance of consciousness and cognition. It is a common disorder in the intensive care unit (ICU) and associated with impaired long-term outcome. Despite its frequency and impact, delirium is poorly recognized by ICU-physicians and -nurses using delirium screening tools. A completely new approach to detect delirium is to use monitoring of physiological alterations. Temperature variability, a measure for temperature regulation, could be an interesting component to monitor delirium, but whether temperature regulation is different during ICU delirium has not yet been investigated. The aim of this study was to investigate whether ICU delirium is related to temperature variability. Furthermore, we investigated whether ICU delirium is related to absolute body temperature. We included patients who experienced both delirium and delirium free days during ICU stay, based on the Confusion Assessment method for the ICU conducted by a research- physician or -nurse, in combination with inspection of medical records. We excluded patients with conditions affecting thermal regulation or therapies affecting body temperature. Daily temperature variability was determined by computing the mean absolute second derivative of the temperature signal. Temperature variability (primary outcome) and absolute body temperature (secondary outcome) were compared between delirium- and non-delirium days with a linear mixed model and adjusted for daily mean Richmond Agitation and Sedation Scale scores and daily maximum Sequential Organ Failure Assessment scores. Temperature variability was increased during delirium-days compared to days without delirium (β(unadjuste)d=0.007, 95% confidence interval (CI)=0.004 to 0.011, p<0.001). Adjustment for confounders did not alter this result (β(adjusted)=0.005, 95% CI=0.002 to 0.008, p<0.001). Delirium was not associated with absolute body temperature (β(unadjusted)=-0.03, 95% CI=-0.17 to 0.10, p=0.61). This did not change after adjusting for confounders (β(adjusted)=-0.03, 95% CI=-0.17 to 0.10, p=0.63). Our study suggests that temperature variability is increased during ICU delirium.

Primary Intracerebral Hemorrhage: A Closer Look at Hypertension and Cerebral Amyloid Angiopathy.

PubMed

Roh, David; Sun, Chung-Huan; Schmidt, J Michael; Gurol, Edip; Murthy, Santosh; Park, Soojin; Agarwal, Sachin; Connolly, E Sander; Claassen, Jan

2018-03-19

Primary intracerebral hemorrhage (ICH) studies often use hematoma location rather than ICH etiologies when assessing outcome. Characterizing ICH using hematoma location is effective/reproducible, but may miss heterogeneity among these ICH locations, particularly lobar ICH where competing primary ICH etiologies are possible. We subsequently investigated baseline characteristics/outcome differences of spontaneous, primary ICH by their etiologies: cerebral amyloid angiopathy (CAA) and hypertension. Primary ICH clinical/outcomes data were prospectively collected between 2009 and 2015. Modified Boston criteria were used to identify "probable/definite" and "possible" CAA-ICH, which were evaluated separately. SMASH-U criteria were used to identify hypertension ICH. Medication and systemic disease coagulopathy ICH were excluded. Baseline characteristics/outcomes among "probable/definite" CAA-ICH, "possible" CAA-ICH, and hypertension ICH were compared using logistic regression. Mortality models using ICH etiologies compared to hematoma location as predictor variables were assessed. Two hundred and four hypertension ICHs, 55 "probable/definite" CAA-ICHs, and 46 "possible" CAA-ICHs were identified. Despite older age and larger ICH volumes, lower hospital mortality was seen in "probable/definite" CAA-ICH versus hypertension ICH (OR 0.2; 95% CI 0.05-0.8; p = 0.02) after adjusting for female gender, components of ICH score, and EVD placement. There were no mortality differences between "possible" CAA-ICH and hypertension ICH. However, lower hospital mortality was seen in "probable/definite" versus "possible" CAA-ICH (OR 0.2; 95% CI 0.04-0.7; p = 0.02). When using ICH etiology rather than hematoma location, hospital mortality models significantly improved (χ 2 : [df = 2, N = 305] = 6.2; p = 0.01). Further investigation is required to confirm the mortality heterogeneity seen within our primary ICH cohort. Hematoma location may play a role for these findings, but the mortality differences seen among lobar ICH using CAA-ICH subtypes and a failure to identify mortality differences between "possible" CAA-ICH and hypertension ICH suggest the limitations of accounting for hematoma location alone.

The impacts of implementation of National Essential Medicines Policies on primary healthcare institutions: a cross-sectional study in China.

PubMed

Guo, Zhigang; Guan, Xiaodong; Shi, Luwen

2017-11-13

In 2009, China implemented the National Essential Medicines Policies (NEMPs) as part of a new round of medical system reforms. This study aims to evaluate the impacts of the NEMPs on primary healthcare institutions and discuss the roles of the policies in the new healthcare reforms of China. The study selected a total of six representative provinces of China, generating a sample of 261 primary healthcare institutions from August to December in 2010. A questionnaire survey developed by the study team was distributed to all of the primary healthcare institutions. Nine indicators from three dimensions as the outcome variables were used and calculated to evaluate the impacts of implementation of policies. All of the outcome variables were tested using independent-samples T test between the treatment group (with the NEMPs implemented) and the control group (without the NEMPs implemented). The ratio of drug sales and institution revenues at primary healthcare institutions was 42.99% in the treatment group, which was significantly lower than the control group (53.90%, p < 0.01), while the ratio of financial subsidies of the treatment group was shown to be higher (30.78% VS 20.82%, p < 0.01). The rate of healthcare workers income growth was greater in the treatment group (15.35% VS 5.79%, p = 0.006). The treatment group exhibited higher outpatient and emergency visits per month in urban areas (2720 VS 1763 visits per month) and rural areas (3830 VS 3633), and higher prescriptions per month in urban areas (2048 VS 1025, p = 0.005) and rural areas (3806 VS 3251). The treatment group used more essential medicines and received greater income from essential medicines while the drug price markup rate was lower. The NEMPs appear to affect the transformation of the operation mechanisms of primary healthcare institutions, the improvement of the mechanisms for government investment, and the healthcare pricing system. Meanwhile, the gaps between urban and rural areas need to be addressed. In conclusion, the NEMPs of China are instrumental to the aim of providing basic healthcare services to every citizen.

Study protocol: intervention in maternal perception of preschoolers' weight among Mexican and Mexican-American mothers.

PubMed

Flores-Peña, Yolanda; He, Meizi; Sosa, Erica T; Avila-Alpirez, Hermelinda; Trejo-Ortiz, Perla M

2018-05-30

Childhood obesity is a public health issue negatively affecting children's physical and psychosocial health. Mothers are children's primary caregivers, thus key players in childhood obesity prevention. Studies have indicated that mothers underestimate their children's weight. If mothers are unaware of their children's weight problem, they are less likely to participate in activities preventing and treating excess weight. The "Healthy Change" intervention is designed to change maternal perception of child's weight (MPCW) through peer-led group health education in childcare settings. The "Healthy Change" is a multicenter two-arm randomized trial in four centers. Three centers are in Mexican States (Nuevo Leon, Tamaulipas, and Zacatecas). The fourth center is in San Antonio, Texas, USA. A total of 360 mother-child pairs (90 pairs per center) are to be randomly and evenly allocated to either the intervention or the control group. Intervention group will receive four-session group obesity prevention education. Control group will receive a four-session personal and food hygiene education. The education is delivered by trained peer-mother promotoras. Data will be collected using questionnaires and focus groups. The primary outcome is a change in proportion of mothers with accurate MPCW. Secondary outcomes include change in maternal feeding styles and practices, maternal self-efficacy and actions for managing child excessive weight gain. McNemar's Test will be used to test the primary outcome. The GLM Univariate procedure will be used to determine intervention effects on secondary outcomes. The models will include the secondary outcome measures as the dependent variables, treatment condition (intervention/control) as the fixed factor, and confounding factors (e.g., mother's education, children's gender and age) as covariates. Sub-analyses will be performed to compare intervention effects on primary and secondary outcomes between the samples from Mexico and Texas, USA. Qualitative data will be analyzed through analysis of inductive content. A combined coding model will be developed and used to code transcripts using the NVivo software. Healthy Change intervention could help change MPCW, an initial step for obesity prevention among preschoolers. This study presents a first of its kind intervention available in Spanish and English targeting Mexican and Mexican-American mothers in Mexico and USA. ISRCTN12281648.

Admission glycemic variability correlates with in-hospital outcomes in diabetic patients with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention

PubMed Central

Su, Gong; Zhang, Tao; Yang, Hongxia; Dai, Wenlong; Tian, Lei; Tao, Hong; Wang, Tao; Mi, Shuhua

2018-01-01

Objective The aim of this study is to evaluate the effects of admission glycemic variability (AGV) on in-hospital outcomes in diabetic patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI). Methods We studied 759 diabetic patients with NSTE-ACS undergoing PCI. AGV was accessed based on the mean amplitude of glycemic excursions (MAGEs) in the first 24 hours after admission. Primary outcome was a composite of in-hospital events, all-cause mortality, new-onset myocardial infarction, acute heart failure, and stroke. Secondary outcomes were each of these considered separately. Predictive effects of AGV on the in-hospital outcomes in patients were analyzed. Results Patients with high MAGE levels had significantly higher incidence of total outcomes (9.9% vs. 4.8%, p=0.009) and all-cause mortality (2.3% vs. 0.4%, p=0.023) than those with low MAGE levels during hospitalization. Multivariable analysis revealed that AGV was significantly associated with incidence of in-hospital outcomes (Odds ratio=2.024, 95% CI 1.105-3.704, p=0.022) but hemoglobin A1c (HbA1c) was not. In the receiver-operating characteristic curve analysis for MAGE and HbA1c in predicting in-hospital outcomes, the area under the curve for MAGE (0.608, p=0.012) was superior to that for HbA1c (0.556, p=0.193). Conclusion High AGV levels may be closely correlated with increased in-hospital poor outcomes in diabetic patients with NSTE-ACS following PCI. PMID:29848920

A pilot cluster randomised trial to assess the effect of a structured communication approach on quality of life in secure mental health settings: The Comquol Study.

PubMed

MacInnes, Douglas; Kinane, Catherine; Parrott, Janet; Mansfield, Jacqueline; Craig, Tom; Eldridge, Sandra; Marsh, Ian; Chan, Claire; Hounsome, Natalia; Harrison, George; Priebe, Stefan

2016-09-29

There is a lack of research in forensic settings examining therapeutic relationships. A structured communication approach, placing patients' perspectives at the heart of discussions about their care, was used to improve patients' quality of life in secure settings. The objectives were to: • Establish the feasibility of the trial design • Determine the variability of the outcomes of interest • Estimate the costs of the intervention • If necessary, refine the intervention METHODS: A pilot cluster randomised controlled trial was conducted. Data was collected from July 2012 to January 2015 from participants in 6 medium secure in-patient services in London and Southern England. 55 patients and 47 nurses were in the intervention group with 57 patients and 45 nurses in the control group. The intervention comprised 6 nurse-patient meetings over a 6 month period. Patients rated their satisfaction with a range of domains followed by discussions on improving patient identified problems. Assessments took place at baseline, 6 months, and 12 months. Participants were not blind to their allocated group. The primary outcome was self-reported quality of life collected by a researcher blind to participants' allocation status. The randomisation procedures and intervention approach functioned well. The measures used were understood by the participants and gave relevant outcome information. The response rates were good with low patient withdrawal rates. The quality of life estimated treatment effect was 0.2 (95 % CI: -0.4 to 0.8) at 6 months and 0.4 (95 % CI: -0.3 to 1.1) indicating the likely extreme boundaries of effect in the main trial. The estimated treatment effect of the primary outcome is clinically important, and a positive effect of the intervention is not ruled out. The estimate of the ICC for the primary outcome at 6 and 12 months was 0.04 (0.00 to 0.17) and 0.05 (0.00 to 0.18). The cost of the intervention was £529 per patient. The trial design was viable as the basis for a full-scale trial. A full trial is justified to estimate the effect of the intervention with greater certainty. The variability of the outcomes could be used to calculate numbers needed for a full-scale trial. Ratings of need for therapeutic security may be useful in any future study. Current Controlled Trials ISRCTN34145189 . Retrospectively registered 22 June 2012.

Neuropsychological and socio-occupational functioning in young psychiatric outpatients: a longitudinal investigation.

PubMed

Lee, Rico S C; Hermens, Daniel F; Redoblado-Hodge, M Antoinette; Naismith, Sharon L; Porter, Melanie A; Kaur, Manreena; White, Django; Scott, Elizabeth M; Hickie, Ian B

2013-01-01

Clinical symptoms and neuropsychological deficits are longitudinally associated with functional outcome in chronic psychiatric cohorts. The current study extended these findings to young and early-course psychiatric outpatients, with the aim of identifying cognitive markers that predict later socio-occupational functioning. At baseline, 183 young psychiatric outpatients were assessed. Ninety-three returned for follow-up (M = 21.6 years old; SD = 4.5) with an average re-assessment interval of 21.6 months (SD = 7.0), and primary diagnoses of major depressive disorder (n = 34), bipolar disorder (n = 29), or psychosis (n = 30). The primary outcome measure was cross-validated with various other functional measures and structural equation modelling was used to map out the interrelationships between predictors and later functional outcome. Good socio-occupational functioning at follow-up was associated with better quality of life, less disability, current employment and being in a romantic relationship. The final structural equation model explained 47.5% of the variability in functional outcome at follow-up, with baseline neuropsychological functioning (a composite of memory, working memory and attentional switching) the best independent predictor of later functional outcome. Notably, depressive and negative symptoms were only associated with functioning cross-sectionally. Diagnosis at follow-up was not associated with functional outcome. Neuropsychological functioning was the single best predictor of later socio-occupational outcome among young psychiatric outpatients. Therefore, framing psychiatric disorders along a neuropsychological continuum is likely to be more useful in predicting functional trajectory than traditional symptom-based classification systems. The current findings also have implications for early intervention utilising cognitive remediation approaches.

Primordial and primary prevention programs for cardiovascular diseases: from risk assessment through risk communication to risk reduction. A review of the literature

PubMed Central

Lancarotte, Inês; Nobre, Moacyr Roberto

2016-01-01

The aim of this study was to identify and reflect on the methods employed by studies focusing on intervention programs for the primordial and primary prevention of cardiovascular diseases. The PubMed, EMBASE, SciVerse Hub-Scopus, and Cochrane Library electronic databases were searched using the terms ‘effectiveness AND primary prevention AND risk factors AND cardiovascular diseases’ for systematic reviews, meta-analyses, randomized clinical trials, and controlled clinical trials in the English language. A descriptive analysis of the employed strategies, theories, frameworks, applied activities, and measurement of the variables was conducted. Nineteen primary studies were analyzed. Heterogeneity was observed in the outcome evaluations, not only in the selected domains but also in the indicators used to measure the variables. There was also a predominance of repeated cross-sectional survey design, differences in community settings, and variability related to the randomization unit when randomization was implemented as part of the sample selection criteria; furthermore, particularities related to measures, limitations, and confounding factors were observed. The employed strategies, including their advantages and limitations, and the employed theories and frameworks are discussed, and risk communication, as the key element of the interventions, is emphasized. A methodological process of selecting and presenting the information to be communicated is recommended, and a systematic theoretical perspective to guide the communication of information is advised. The risk assessment concept, its essential elements, and the relevant role of risk perception are highlighted. It is fundamental for communication that statements targeting other people’s understanding be prepared using systematic data. PMID:27982169

An organizing framework for informal caregiver interventions: detailing caregiving activities and caregiver and care recipient outcomes to optimize evaluation efforts

PubMed Central

2011-01-01

Background Caregiver interventions may help improve the quality of informal care. Yet the lack of a systematic framework specifying the targets and outcomes of caregiver interventions hampers our ability to understand what has been studied, to evaluate existing programs, and to inform the design of future programs. Our goal was to develop an organizing framework detailing the components of the caregiving activities and the caregiver and care recipient outcomes that should be affected by an intervention. In so doing, we characterize what has been measured in the published literature to date and what should be measured in future studies to enable comparisons across interventions and across time. Methods Our data set comprises 121 reports of caregiver interventions conducted in the United States and published between 2000 and 2009. We extracted information on variables that have been examined as primary and secondary outcomes. These variables were grouped into categories, which then informed the organizing framework. We calculated the frequency with which the interventions examined each framework component to identify areas about which we have the most knowledge and under-studied areas that deserve attention in future research. Results The framework stipulates that caregiver interventions seek to change caregiving activities, which in turn affect caregiver and care recipient outcomes. The most frequently assessed variables have been caregiver psychological outcomes (especially depression and burden) and care recipient physical and health care use outcomes. Conclusions Based on the organizing framework, we make three key recommendations to guide interventions and inform research and policy. First, all intervention studies should assess quality and/or quantity of caregiving activities to help understand to what extent and how well the intervention worked. Second, intervention studies should assess a broad range of caregiver and care recipient outcomes, including considering whether expanding to economic status and health care use of the caregiver can be accommodated, to ease subsequent economic evaluations of caregiving. Third, intervention studies should measure a common set of outcomes to facilitate cross-time and cross-study comparisons of effectiveness. PMID:22107600

Primary care models for treating opioid use disorders: What actually works? A systematic review

PubMed Central

Klasa, Katarzyna; Bush, Christopher; Heisler, Michele; Chopra, Vineet; Bohnert, Amy

2017-01-01

Background Primary care-based models for Medication-Assisted Treatment (MAT) have been shown to reduce mortality for Opioid Use Disorder (OUD) and have equivalent efficacy to MAT in specialty substance treatment facilities. Objective The objective of this study is to systematically analyze current evidence-based, primary care OUD MAT interventions and identify program structures and processes associated with improved patient outcomes in order to guide future policy and implementation in primary care settings. Data sources PubMed, EMBASE, CINAHL, and PsychInfo. Methods We included randomized controlled or quasi experimental trials and observational studies evaluating OUD treatment in primary care settings treating adult patient populations and assessed structural domains using an established systems engineering framework. Results We included 35 interventions (10 RCTs and 25 quasi-experimental interventions) that all tested MAT, buprenorphine or methadone, in primary care settings across 8 countries. Most included interventions used joint multi-disciplinary (specialty addiction services combined with primary care) and coordinated care by physician and non-physician provider delivery models to provide MAT. Despite large variability in reported patient outcomes, processes, and tasks/tools used, similar key design factors arose among successful programs including integrated clinical teams with support staff who were often advanced practice clinicians (nurses and pharmacists) as clinical care managers, incorporating patient “agreements,” and using home inductions to make treatment more convenient for patients and providers. Conclusions The findings suggest that multidisciplinary and coordinated care delivery models are an effective strategy to implement OUD treatment and increase MAT access in primary care, but research directly comparing specific structures and processes of care models is still needed. PMID:29040331

A contemporary approach to the prevention of peritoneal dialysis-related peritonitis in children: the role of improvement science.

PubMed

Redpath Mahon, Allison; Neu, Alicia M

2017-08-01

Peritonitis is a leading cause of hospitalizations, morbidity, and modality change in pediatric chronic peritoneal dialysis (CPD) patients. Despite guidelines published by the International Society for Peritoneal Dialysis aimed at reducing the risk of peritonitis, registry data have revealed significant variability in peritonitis rates among centers caring for children on CPD, which suggests variability in practice. Improvement science methods have been used to reduce a variety of healthcare-associated infections and are also being applied successfully to decrease rates of peritonitis in children. A successful quality improvement program with the goal of decreasing peritonitis will not only include primary drivers directly linked to the outcome of peritonitis, but will also direct attention to secondary drivers that are important for the achievement of primary drivers, such as health literacy and patient and family engagement strategies. In this review, we describe a comprehensive improvement science model for the reduction of peritonitis in pediatric patients on CPD.

Primary central nervous system lymphoma in immunocompetent individuals: a single center experience.

PubMed

Aki, Hilal; Uzunaslan, Didem; Saygin, Caner; Batur, Sebnem; Tuzuner, Nukhet; Kafadar, Ali; Ongoren, Seniz; Oz, Buge

2013-01-01

Primary central nervous system lymphoma (PCNSL) is defined as the involvement of brain, leptomeninges, eyes or spinal cord by non-Hodgkin lymphoma. The role of various prognostic markers in predicting adverse outcome is debated. To investigate the clinical and immunohistochemical findings of immunocompetent PCNSL cases (39 cases) diagnosed at the study center, and evaluate the influence of potential prognostic factors on overall survival (OS) of patients. Data regarding patient characteristics, neuroimaging, pathological and immunohistochemical features and follow-up were obtained from patient records. The influence of potential prognostic parameters on OS was investigated by log-rank test and Cox regression analysis. Patients who received combined chemotherapy and radiotherapy had a significantly better OS when compared to chemotherapy alone. Other variables included in this study were not associated with a significant survival advantage. In this study, we failed to demonstrate a relationship between different clinicopathological variables and OS of patients. Prospective studies with large patient series are needed to investigate other potential prognostic factors.

Extreme intrafamilial variability of Saudi brothers with primary hyperoxaluria type 1.

PubMed

Alfadhel, Majid; Alhasan, Khalid A; Alotaibi, Mohammed; Al Fakeeh, Khalid

2012-01-01

Primary hyperoxaluria type 1 (PH1) is characterized by progressive renal insufficiency culminating in end-stage renal disease, and a wide range of clinical features related to systemic oxalosis in different organs. It is caused by autosomal recessive deficiency of alanine:glyoxylate aminotransferase due to a defect in AGXT gene. Two brothers (one 6 months old; the other 2 years old) presented with acute renal failure and urinary tract infection respectively. PH1 was confirmed by high urinary oxalate level, demonstration of oxalate crystals in bone biopsy, and pathogenic homozygous known AGXT gene mutation. Despite the same genetic background, same sex, and shared environment, the outcome of the two siblings differs widely. While one of them died earlier with end-stage renal disease and multiorgan failure caused by systemic oxalosis, the older brother is pyridoxine responsive with normal development and renal function. Clinicians should be aware of extreme intrafamilial variability of PH1 and international registries are needed to characterize the genotype-phenotype correlation in such disorder.

Effectiveness of Splanchnic Nerve Neurolysis for Targeting Location of Cancer Pain: Using the Pain Drawing as an Outcome Variable.

PubMed

Novy, Diane M; Engle, Mitchell P; Lai, Emily A; Cook, Christina; Martin, Emily C; Trahan, Lisa; Yu, Jun; Koyyalagunta, Dhanalakshmi

2016-07-01

The effectiveness of splanchnic nerve neurolysis (SNN) for cancer-related abdominal pain has been investigated using numeric pain intensity rating as an outcome variable. The outcome variable in this study used the grid method for obtaining a targeted pain drawing score on 60 patients with pain from pancreatic or gastro-intestinal primary cancers or metastatic disease to the abdominal region. Results demonstrate excellent inter-rater agreement (intra-class correlation [ICC] coefficient at pre-SNN = 0.97 and ICC at within one month post-SNN = 0.98) for the grid method of scoring the pain drawing and demonstrate psychometric generalizability among patients with cancer-related pain. Using the Wilcoxon signed rank test and associated effect sizes, results show significant improvement in dispersion of pain following SNN. Effect sizes for the difference in pre-SNN to 2 post-SNN time points were higher for the pain drawing than for pain intensity rating. Specifically, the effect size difference from pre- to within one month post-SNN was r = 0.42 for pain drawing versus r = 0.23 for pain intensity rating. Based on a smaller subset of patients who were seen within 1 - 6 months following SNN, the effect size difference from pre-SNN was r = 0.46 for pain drawing versus r = 0.00 for pain intensity rating. Collectively, these data support the use of the pain drawing as a reliable outcome measure among patients with cancer pain for procedures such as SNN that target specific location and dispersion of pain.

Genetic variation in alpha2-adrenoreceptors and heart rate recovery after exercise

PubMed Central

Kohli, Utkarsh; Diedrich, André; Kannankeril, Prince J.; Muszkat, Mordechai; Sofowora, Gbenga G.; Hahn, Maureen K.; English, Brett A.; Blakely, Randy D.; Stein, C. Michael

2015-01-01

Heart rate recovery (HRR) after exercise is an independent predictor of adverse cardiovascular outcomes. HRR is mediated by both parasympathetic reactivation and sympathetic withdrawal and is highly heritable. We examined whether common genetic variants in adrenergic and cholinergic receptors and transporters affect HRR. In our study 126 healthy subjects (66 Caucasians, 56 African Americans) performed an 8 min step-wise bicycle exercise test with continuous computerized ECG recordings. We fitted an exponential curve to the postexercise R-R intervals for each subject to calculate the recovery constant (kr) as primary outcome. Secondary outcome was the root mean square residuals averaged over 1 min (RMS1min), a marker of parasympathetic tone. We used multiple linear regressions to determine the effect of functional candidate genetic variants in autonomic pathways (6 ADRA2A, 1 ADRA2B, 4 ADRA2C, 2 ADRB1, 3 ADRB2, 2 NET, 2 CHT, and 1 GRK5) on the outcomes before and after adjustment for potential confounders. Recovery constant was lower (indicating slower HRR) in ADRA2B 301–303 deletion carriers (n = 54, P = 0.01), explaining 3.6% of the interindividual variability in HRR. ADRA2A Asn251Lys, ADRA2C rs13118771, and ADRB1 Ser49Gly genotypes were associated with RMS1min. Genetic variability in adrenergic receptors may be associated with HRR after exercise. However, most of the interindividual variability in HRR remained unexplained by the variants examined. Noncandidate gene-driven approaches to study genetic contributions to HRR in larger cohorts will be of interest. PMID:26058836

Reciprocal Interaction of 24-Hour Blood Pressure Variability and Systolic Blood Pressure on Outcome in Stroke Thrombolysis.

PubMed

Kellert, Lars; Hametner, Christian; Ahmed, Niaz; Rauch, Geraldine; MacLeod, Mary J; Perini, Francesco; Lees, Kennedy R; Ringleb, Peter A

2017-07-01

Significance and management of blood pressure (BP) changes in acute stroke care are unclear. Here, we aimed to investigate the impact of 24-hour BP variability (BPV) on outcome in patients with acute ischemic stroke treated with intravenous thrombolysis. From the Safe Implementation of Treatment in Stroke International Stroke Thrombolysis registry, 28 976 patients with documented pre-treatment systolic BP at 2 and 24 hours were analyzed. The primary measure of BP variability was successive variability. Data were preprocessed using coarsened exact matching. We assessed early neurological improvement, symptomatic intracerebral hemorrhage (SICH), and long-term functional outcome (modified Rankin Scale [mRS] at 90 days) by binary and ordinal regression analyses. Attempts to explain successive variation for analysis of BPV with patients characteristics at admission found systolic BP (5.5% variance) to be most influential, yet 92% of BPV variance remained unexplained. Independently from systolic BP, successive variation for analysis of BPV was associated with poor functional outcome mRS score of 0 to 2 (odds ratio [OR], 0.94; 95% confidence interval [CI], 0.90-0.98), disadvantage across the shift of mRS (OR, 1.04; 95% CI, 1.01-1.08), mortality (OR, 1.10; 95% CI, 1.01-1.08), SICH SITS (OR, 1.14; 95% CI, 1.06-1.23), and SICH ECASS (OR, 1.24; 95% CI, 1.10-1.40; ECASS [European Cooperative Acute Stroke Study 2]). Analyzing successive variation for analysis of BPV as a function of pre-treatment, systolic BP significantly improved the prediction of functional outcome (mRS score of 0-1, mRS score of 0-2, neurological improvement, mRS-shift: all P interaction <0.01). Excluding patients with atrial fibrillation in a sensitivity analysis gave consistent results overall. This study suggests the need for a more individual BP management accounting for pre-treatment BP and the acute BP course (ie, BPV) to achieve best possible outcome for the patient. © 2017 American Heart Association, Inc.

Management of orthodontic emergencies in primary care - self-reported confidence of general dental practitioners.

PubMed

Popat, H; Thomas, K; Farnell, D J J

2016-07-08

Objective To determine general dental practitioners' (GDPs) confidence in managing orthodontic emergencies.Design Cross-sectional study.Setting Primary dental care.Subjects and methods An online survey was distributed to dentists practicing in Wales. The survey collected basic demographic information and included descriptions of ten common orthodontic emergency scenarios.Main outcome measure Respondents' self-reported confidence in managing the orthodontic emergency scenarios on a 5-point Likert scale. Differences between the Likert responses and the demographic variables were investigated using chi-squared tests.Results The median number of orthodontic emergencies encountered by respondents over the previous six months was 1. Overall, the self-reported confidence of respondents was high with 7 of the 10 scenarios presented scoring a median of 4 indicating that GDPs were 'confident' in their management. Statistical analysis revealed that GDPs who saw more orthodontic emergencies in the previous six months were more confident when managing the presented scenarios. Other variables such as age, gender, geographic location of practice and number of years practising dentistry were not associated with self-reported confidence.Conclusions Despite GDPs encountering very few orthodontic emergencies in primary care, they appear to be confident in dealing with commonly arising orthodontic emergency situations.

[Factors associated with cross-nursing].

PubMed

von Seehausen, Mariana Pujól; Oliveira, Maria Inês Couto de; Boccolini, Cristiano Siqueira

2017-05-01

This article aims to estimate the prevalence and analyze the factors associated with cross-nursing. A cross-sectional study was conducted in 2013 with interviews with a representative sample of mothers of infants less than one-year-old (n' = 695) attended in nine primary health units in Rio de Janeiro, Brazil. Sociodemographic characteristics were studied; pregnancy, childbirth and primary care assistance; maternal habits and baby features. Adjusted prevalence ratios (PR) were obtained by Poisson Regression, retaining variables associated with the outcome in the final model (p ≤ 0.05). Cross-nursing was practiced by 29.4% of the mothers. Most practitioner mothers were relatives or friends. The following variables were directly associated with cross-nursing: being an adolescent mother (PR' = 1.595), smoking (PR' = 1.396), alcohol consumption (PR' = 1.613), inappropriate baby feeding habits (PR' = 1.371) and infant's age in months (PR' = 1.066). Maternal formal employment was inversely associated with the practice (PR' = 0.579). Cross-nursing has a relevant prevalence among mothers assisted by primary health care units in Rio de Janeiro City. This issue should be addressed, especially among the most vulnerable groups, due to the association with adolescence and with unhealthy habits.

Fatigue reduction during aggregated and distributed sequential stimulation.

PubMed

Bergquist, Austin J; Babbar, Vishvek; Ali, Saima; Popovic, Milos R; Masani, Kei

2017-08-01

Transcutaneous neuromuscular electrical stimulation (NMES) can generate muscle contractions for rehabilitation and exercise. However, NMES-evoked contractions are limited by fatigue when they are delivered "conventionally" (CONV) using a single active electrode. Researchers have developed "sequential" (SEQ) stimulation, involving rotation of pulses between multiple "aggregated" (AGGR-SEQ) or "distributed" (DISTR-SEQ) active electrodes, to reduce fatigue (torque-decline) by reducing motor unit discharge rates. The primary objective was to compare fatigue-related outcomes, "potentiation," "variability," and "efficiency" between CONV, AGGR-SEQ, and DISTR-SEQ stimulation of knee extensors in healthy participants. Torque and current were recorded during testing with fatiguing trains using each NMES type under isometric and isokinetic (180°/s) conditions. Compared with CONV stimulation, SEQ techniques reduced fatigue-related outcomes, increased potentiation, did not affect variability, and reduced efficiency. SEQ techniques hold promise for reducing fatigue during NMES-based rehabilitation and exercise; however, optimization is required to improve efficiency. Muscle Nerve 56: 271-281, 2017. © 2016 Wiley Periodicals, Inc.

Does the thyroid-stimulating hormone measured concurrently with first trimester biochemical screening tests predict adverse pregnancy outcomes occurring after 20 weeks gestation?

PubMed

Ong, Gregory S Y; Hadlow, Narelle C; Brown, Suzanne J; Lim, Ee Mun; Walsh, John P

2014-12-01

Maternal hypothyroidism in early pregnancy is associated with adverse outcomes, but not consistently across studies. First trimester screening for chromosomal anomalies is routine in many centers and provides an opportunity to test thyroid function. To determine if thyroid function tests performed with first trimester screening predicts adverse pregnancy outcomes. A cohort study of 2411 women in Western Australia with singleton pregnancies attending first trimester screening between 9 and 14 weeks gestation. We evaluated the association between TSH, free T4, free T3, thyroid antibodies, free beta human chorionic gonadotrophin (β-hCG) and pregnancy associated plasma protein A (PAPP-A) with a composite of adverse pregnancy events as the primary outcome. Secondary outcomes included placenta previa, placental abruption, pre-eclampsia, pregnancy loss after 20 weeks gestation, threatened preterm labor, preterm birth, small size for gestational age, neonatal death, and birth defects. TSH exceeded the 97.5th percentile for the first trimester (2.15 mU/L) in 133 (5.5%) women, including 22 (1%) with TSH above the nonpregnant reference range (4 mU/L) and 5 (0.2%) above 10 mU/L. Adverse outcomes occurred in 327 women (15%). TSH and free T4 did not differ significantly between women with or without adverse pregnancy events. On the multivariate analysis, neither maternal TSH >2.15 mU/L nor TSH as a continuous variable predicted primary or secondary outcomes. Testing maternal TSH as part of first trimester screening does not predict adverse pregnancy outcomes. This may be because in the community setting, mainly mild abnormalities in thyroid function are detected.

Comparison between publicly accessible publications, registries, and protocols of phase III trials indicated persistence of selective outcome reporting.

PubMed

Zhang, Sheng; Liang, Fei; Li, Wenfeng

2017-11-01

The decision to make protocols of phase III randomized controlled trials (RCTs) publicly accessible by leading journals was a landmark event in clinical trial reporting. Here, we compared primary outcomes defined in protocols with those in publications describing the trials and in trial registration. We identified phase III RCTs published between January 1, 2012, and June 30, 2015, in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The BMJ with available protocols. Consistency in primary outcomes between protocols and registries (articles) was evaluated. We identified 299 phase III RCTs with available protocols in this analysis. Out of them, 25 trials (8.4%) had some discrepancy for primary outcomes between publications and protocols. Types of discrepancies included protocol-defined primary outcome reported as nonprimary outcome in publication (11 trials, 3.7%), protocol-defined primary outcome omitted in publication (10 trials, 3.3%), new primary outcome introduced in publication (8 trials, 2.7%), protocol-defined nonprimary outcome reported as primary outcome in publication (4 trials, 1.3%), and different timing of assessment of primary outcome (4 trials, 1.3%). Out of trials with discrepancies in primary outcome, 15 trials (60.0%) had discrepancies that favored statistically significant results. Registration could be seen as a valid surrogate of protocol in 237 of 299 trials (79.3%) with regard to primary outcome. Despite unrestricted public access to protocols, selective outcome reporting persists in a small fraction of phase III RCTs. Only studies from four leading journals were included, which may cause selection bias and limit the generalizability of this finding. Copyright © 2017 Elsevier Inc. All rights reserved.

Dexamethasone in head and neck cancer patients with microvascular reconstruction: No benefit, more complications.

PubMed

Kainulainen, S; Törnwall, J; Koivusalo, A M; Suominen, A L; Lassus, P

2017-02-01

Glucocorticoids are widely used in association with major surgery of the head and neck to improve postoperative rehabilitation, shorten intensive care unit and hospital stay, and reduce neck swelling. This study aimed to clarify whether peri- and postoperative use of dexamethasone in reconstructive head and neck cancer surgery is associated with any advantages or disadvantages. This prospective double-blind randomized controlled trial comprised 93 patients. A total dose of 60mg of dexamethasone was administered to 51 patients over three days peri- and postoperatively. The remaining 42 patients served as controls. The main primary outcome variables were neck swelling, length of intensive care unit and hospital stay, duration of intubation or tracheostomy, and delay to start of possible radiotherapy. Complications were also recorded. No statistical differences emerged between the two groups in any of the main primary outcome variables. However, there were more major complications, especially infections, needing secondary surgery within three weeks of the operation in patients receiving dexamethasone than in control patients (27% vs. 7%, p=0.012). The use of dexamethasone in oral cancer patients with microvascular reconstruction did not provide a benefit. More major complications, especially infections, occurred in patients receiving dexamethasone. Our data thus do not support the use of peri- and postoperative dexamethasone in oropharyngeal cancer patients undergoing microvascular reconstruction. Copyright © 2016 Elsevier Ltd. All rights reserved.

Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial.

PubMed

Mihuta, Mary E; Green, Heather J; Shum, David H K

2018-04-01

Cognitive dysfunction associated with cancer is frequently reported and can reduce quality of life. This study evaluated a Web-based cognitive rehabilitation therapy program (eReCog) in cancer survivors compared with a waitlist control group. Adult cancer survivors with self-reported cognitive symptoms who had completed primary treatment at least 6 months prior were recruited. Participants completed telephone screening and were randomly allocated to the 4-week online intervention or waitlist. Primary outcome was perceived cognitive impairment assessed with the Functional Assessment of Cancer Therapy-Cognitive Function version 3. Secondary outcomes were additional measures of subjective cognitive functioning, objective cognitive functioning, and psychosocial variables. Seventy-six women were allocated to the intervention (n = 40) or waitlist (n = 36). A significant interaction was found on the instrumental activities of daily living measure of self-reported prospective memory whereby the intervention group reported a greater reduction in prospective memory failures than the waitlist group. Interaction trends were noted on perceived cognitive impairments (P = .089) and executive functioning (P = .074). No significant interactions were observed on other measures of objective cognitive functioning or psychosocial variables. The Web-based intervention shows promise for improving self-reported cognitive functioning in adult cancer survivors. Further research is warranted to better understand the mechanisms by which the intervention might contribute to improved self-reported cognition. Copyright © 2017 John Wiley & Sons, Ltd.

A cluster randomised controlled trial protocol of an adapted intervention for alcohol use disorders in people living with HIV and AIDS: impact on alcohol use, general functional ability, quality of life and adherence to HAART.

PubMed

Madhombiro, Munyaradzi; Dube-Marimbe, Bazondlile; Dube, Michelle; Chibanda, Dixon; Zunza, Moleen; Rusakaniko, Simbarashe; Stewart, David; Seedat, Soraya

2017-01-28

Interventions for alcohol use disorders (AUDs) in HIV infected individuals have been primarily targeted at HIV risk reduction and improved antiretroviral treatment adherence. However, reduction in alcohol use is an important goal. Alcohol use affects other key factors that may influence treatment course and outcome. In this study the authors aim to administer an adapted intervention for AUDs to reduce alcohol use in people living with HIV/AIDS (PLWHA). This study is a cluster randomised controlled trial at 16 HIV care clinics. A motivational interviewing and cognitive behavioural therapy based intervention for AUDs, developed through adaptation and piloted in Zimbabwe, will be administered to PLWHA with AUDs recruited at HIV clinics. The intervention will be administered over 16 sessions at 8 HIV clinics. This intervention will be compared with an equal attention control in the form of the World Health Organization Mental Health Gap Action Programme (WHO mhGAP) guide, adapted for the Zimbabwean context. General function, quality of life, and adherence to highly active antiretroviral treatment (HAART) will be secondary outcomes. Booster sessions will be administered to both groups at 3 and 6 months respectively. The primary outcome measure will be the Alcohol Use Disorder Identification Test (AUDIT) score. The World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0), World Health Organisation Quality of Life (WHOQoL) HIV, viral load, and CD4 counts will be secondary outcome measures. Outcome assessments will be administered at baseline, 3, 6, and 12 months. Moderating factors such as perceived social support, how people cope with difficult situations and post-traumatic exposure and experience will be assessed at baseline. Trained research assistants will recruit participants. The outcome assessors who will be trained in administering the outcome and moderating tools will be blinded to the treatment arms allocated to the participants. However, the principal investigator, participants and intervention staff will be unblinded. Data will be analysed using STATA Version 14. Primary and secondary outcomes will be measured at four time points that is; at baseline, 3, 6, and 12 months respectively. All participants will be included in the analysis of primary and secondary outcome measures. The mean AUDIT scores will be compared between groups using student t-tests. Multilevel logistic regression analysis will be performed for binominal variables and multilevel linear regression for continuous variables. Descriptive statistics will be computed for baseline and follow-up assessments. The study will be the first to address problematic alcohol use in PLWHA in Zimbabwe. It seeks to use local resources in delivering a modified, brief, evidence-based, and culturally contextualised intervention. The study results will determine the effectiveness of adapting psychological interventions for AUDs in HIV infected adults using a task-sharing framework. Pan African Clinical Trial Registry, PACTR201509001211149 . Registered 22 July 2015.

Factors that distinguish college students with depressive symptoms with and without suicidal thoughts

PubMed Central

Nyer, Maren; Holt, Daphne J.; Pedrelli, Paola; Fava, Maurizio; Ameral, Victoria; Cassiello, Clair F.; Nock, Matthew K.; Ross, Margaret; Hutchinson, Dori; Farabaugh, Amy

2013-01-01

BACKGROUND Suicide among college students is a significant public health concern. Although suicidality is linked to depression, not all depressed college students experience suicidal ideation (SI). The primary aim of this study was to determine potential factors that may distinguish college students with depressive symptoms with and without SI. METHODS A total of 287 undergraduate college students with substantial depressive symptoms (Beck Depression Inventory [BDI] total score >13) with and without SI were compared across psychiatric and functional outcome variables. Independent sample t tests were conducted for each outcome variable using the suicide item of the BDI as a dichotomous (ie, zero vs nonzero score) grouping variable. RESULTS Relative to students with substantial depressive symptoms without SI, those with SI were more symptomatic overall, having significantly higher levels of depressive symptoms, hopelessness, and anxiety. However, contrary to our expectations, nonsuicidal and suicidal students did not differ on measures of everyday functioning (ie, cognitive and physical functioning and grade point average). CONCLUSIONS Our findings suggest that SI among college students is associated with increased subjective distress but may not adversely impact physical or cognitive functioning or academic performance. PMID:23376869

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

PubMed Central

Adie, Sam; Harris, Ian A.; Naylor, Justine M.; Mittal, Rajat

2017-01-01

Background The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes. Methods We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63–1.1, I2 = 21%). Conclusion A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study. PMID:28234219

The effect of smoking on surgical outcomes in ventral hernia repair: a propensity score matched analysis of the National Surgical Quality Improvement Program data.

PubMed

Borad, N P; Merchant, A M

2017-12-01

Although studies have implicated smoking as a positive predictor of post-operative outcomes in inguinal hernia repair, its impact on ventral hernia repair (VHR) is not as clear. This study aims to fill this gap by investigating the impact of smoking on developing adverse 30-day post-operative outcomes in VHR. Patients undergoing VHR between 2005 and 2014 were extracted from the American College of Surgeons National Surgical Quality Improvement Program database. Patients were stratified by smoking status and compared for significant differences in baseline characteristics. Logistic regression modeled the impact of smoking on the primary outcome variable of 30-day mortality and the secondary outcome variables of 30-day overall, cardiac, respiratory, or wound morbidity. To evaluate the influence of smoking in comparable groups undergoing VHR, a propensity score matched analysis was performed. Out of 169,458 patients identified, 32,973 (19.5%) were classified as current smokers. Smokers and non/ex-smokers differed significantly in multiple pre-operative baseline characteristics. Unmatched univariate analyses revealed smoking status as a positive predictor of every post-operative outcome. These findings were validated with propensity score matching analyses, which found current smokers have an increased likelihood of 30-day mortality (OR 1.42), overall morbidity (OR 1.39), wound (OR 1.40), respiratory (OR 1.14), or cardiac morbidity (OR 1.88) compared to non/ex-smokers (p < 0.05 for all). Smoking is a modifiable risk factor with a detrimental impact on outcomes in patients undergoing ventral hernia repair. Delaying VHR and promoting smoking cessation prior to surgery may help reduce the odds of adverse 30-day post-operative outcomes.

A preliminary investigation of daily variability of stuttering in adults.

PubMed

Constantino, Christopher D; Leslie, Paula; Quesal, Robert W; Yaruss, J Scott

2016-01-01

Variability in frequency of stuttering has made the results of treatment outcome studies difficult to interpret. Many factors that affect variability have been investigated; yet the typical range of variability experienced by speakers remains unknown. This study examined the day-to-day variability in the percentage of syllables containing stuttered and nonstuttered disfluencies in the speech of six adult speakers in three spontaneous speaking situations and two reading tasks. The frequency of moments stuttering during the tasks were compared within and between speakers and days to document the degree of variability in stuttering frequency and explore whether there were any consistent patterns. The Stuttering Severity Instrument-Fourth Edition (SSI-4) and Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A) were also tested for day-to-day variability. Correlations between frequency, severity, and life impact were made. The primary result of this study was the large range over which frequency of stuttering varied from day to day for the same individual. This variability did not correlate with any measures of stuttering severity but did correlate with life impact as measured by the OASES-A. No global pattern was detected in variability from day to day within or between participants. However, there were significantly more nonstuttered disfluencies present during the spontaneous speaking tasks than during the reading tasks. The day-to-day variability in the life impact of the disorder (OASES-A) was less than the day-to-day variability in observable stuttering behavior (percentage of syllables stuttered and SSI-4). Frequency of stuttering varies significantly from situation to situation and day to day, with observed variability exceeding the degree of change often reported in treatment outcomes studies from before to after treatment. This variability must be accounted for in future clinical and scientific work. Copyright © 2016 Elsevier Inc. All rights reserved.

The role of androgen receptor CAG repeat polymorphism and other factors which affect the clinical response to testosterone replacement in metabolic syndrome and type 2 diabetes: TIMES2 sub-study.

PubMed

Stanworth, R D; Akhtar, S; Channer, K S; Jones, T H

2014-02-01

The TIMES2 (testosterone replacement in hypogonadal men with either metabolic syndrome or type 2 diabetes) study reported beneficial effects of testosterone replacement therapy (TRT) on insulin resistance and other variables in men with diabetes or metabolic syndrome. The androgen receptor CAG repeat polymorphism (AR CAG) is known to affect stimulated AR activity and has been linked to various clinically relevant variables. To assess the role of AR CAG in the alteration of clinical response to TRT in the TIMES2 study. Subgroup analysis from a multicentre, randomised, double-blind, placebo-controlled and parallel group study. Outpatient study recruiting from secondary and primary care. A total of 139 men with hypogonadism and type 2 diabetes or metabolic syndrome, of which 73 received testosterone during the TIMES2 study. Testosterone 2% transdermal gel vs placebo. Regression coefficient of AR CAG from linear regression models for each variable. AR CAG was independently positively associated with change in fasting insulin, triglycerides and diastolic blood pressure during TRT with a trend to association with HOMA-IR - the primary outcome variable. There was a trend to negative association between AR CAG and change in PSA. There was no association of AR CAG with change in other glycaemic variables, other lipid variables or obesity. AR CAG affected the response of some variables to TRT in the TIMES2 study, although the association with HOMA-IR did not reach significance. Various factors may have limited the power of our study to detect the significant associations between AR CAG, testosterone levels and change in variables with testosterone treatment. Analysis of similar data sets from other clinical trials is warranted.

Perceived effects and recovery in Oklahoma City firefighters.

PubMed

Nixon, S J; Schorr, J; Boudreaux, A; Vincent, R D

1999-04-01

This survey of 325 Oklahoma City Firefighters examined their perceptions of the effect of the bombing, their recovery and their sources of support. Other variables that were considered in this analysis included age, usefulness of the Critical Incidence Stress Management (CISM) procedures, and attitude, an aggregate variable that accounted for job satisfaction. Of particular importance in this analysis was the finding that support from "faith" was a primary predictor of positive outcome and positive attitude over the one-year period. However, the effect of the variable differed for older and younger firefighters. That is, there was a greater proportion of younger firefighters among those reporting greater support from faith. These data suggest that, at least in this geographic area, chaplains, and other spiritual leaders may play a particularly important role in the aftermath of such a disaster.

A third of systematic reviews changed or did not specify the primary outcome: a PROSPERO register study.

PubMed

Tricco, Andrea C; Cogo, Elise; Page, Matthew J; Polisena, Julie; Booth, Alison; Dwan, Kerry; MacDonald, Heather; Clifford, Tammy J; Stewart, Lesley A; Straus, Sharon E; Moher, David

2016-11-01

To examine outcome reporting bias of systematic reviews registered in PROSPERO. Retrospective cohort study. The primary outcomes from systematic review publications were compared with those reported in the corresponding PROSPERO records; discrepancies in the primary outcomes were assessed as upgrades, additions, omissions, or downgrades. Relative risks (RRs) and 95% confidence intervals (CI) were calculated to determine the likelihood of having a change in primary outcome when the meta-analysis result was favorable and statistically significant. Ninety-six systematic reviews were published. A discrepancy in the primary outcome occurred in 32% of the included reviews and 39% of the reviews did not explicitly specify a primary outcome(s); 6% of the primary outcomes were omitted. There was no significant increased risk of adding/upgrading (RR, 2.14; 95% CI: 0.53, 8.63) or decreased risk of downgrading (RR, 0.76; 95% CI: 0.27, 2.17) an outcome when the meta-analysis result was favorable and statistically significant. As well, there was no significant increased risk of adding/upgrading (RR, 0.89; 95% CI: 0.31, 2.53) or decreased risk of downgrading (RR, 0.56; 95% CI: 0.29, 1.08) an outcome when the conclusion was positive. We recommend review authors carefully consider primary outcome selection, and journals are encouraged to focus acceptance on registered systematic reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

What Can the First 2 Months Tell Us About Outcomes After Anterior Cruciate Ligament Reconstruction?

PubMed Central

Christensen, Jesse C.; Goldfine, Laura R.; Barker, Tyler; Collingridge, Dave S.

2015-01-01

Context: Substantial research has been conducted on anterior cruciate ligament reconstruction (ACLR) to evaluate patient outcomes. However, little attention has been given to outcomes during the early phase of recovery and how early deficits affect both short- and long-term outcomes. Objective: To identify relationships between demographic (age, sex, and body mass index [BMI]) and intraoperative (isolated ACLR versus primary ACLR + secondary procedures), and postoperative (range-of-motion [ROM] and peak isometric knee-extension force [PIF]) variables during the first 2 months after ACLR using self-reported outcomes. Design: Cohort study. Setting: Outpatient orthopaedic hospital. Patients or Other Participants: A total of 63 patients (38 men, 25 women; age = 33.0 ± 12.1 years; BMI = 26.3 ± 6.5 kg/m2) who underwent ACLR. Main Outcome Measure(s): Demographic, intraoperative, and postoperative variables were collected at 1 and 2 months after ACLR and were compared with International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form scores at 1, 2, and ≥12 months. Results: Significant relationships were identified between ≥12-month IKDC scores and the 1-month (Pearson correlation, r = 0.283, r2 = 0.08; P = .025) and 2-month (r = 0.301, r2 = 0.09; P = .017) IKDC scores. After controlling for other variables, we found that the PIF ratio measures at 1 and 2 months were positively associated with 1- and 2-month IKDC scores (P < .001) and BMI was negatively associated with both 1- and 2-month IKDC scores (P < .05). One-month IKDC scores were related to the 1-month difference in knee-flexion ROM (P = .04). Conclusions: The IKDC scores during the first 2 months were positively correlated with patients' perceptions of function on long-term IKDC scores. It also appears that improvements in lower extremity strength and flexion ROM deficits were positively associated with short-term IKDC scores. Higher BMI was negatively associated with patients' perceptions of function on short-term IKDC scores. PMID:25594914

Preparedness of lower-level health facilities and the associated factors for the outpatient primary care of hypertension: Evidence from Tanzanian national survey

PubMed Central

Mpondo, Bonaventura C. T.

2018-01-01

Introduction Sub-Saharan Africa is experiencing a rapid rise in the burden of non-communicable diseases in both urban and rural areas. Data on health system preparedness to manage hypertension and other non-communicable diseases remains scarce. This study aimed to assess the preparedness of lower-level health facilities for outpatient primary care of hypertension in Tanzania. Methods This study used data from the 2014–2015 Tanzania Service Provision Assessment survey. The facility was considered as prepared for the outpatient primary care of hypertension if reported at least half (≥50%) of the items listed from each of the three domains (staff training and guideline, basic diagnostic equipment, and basic medicines) as identified by World Health Organization-Service Availability and Readiness Assessment manual. Data were analyzed using Stata 14. An unadjusted logistic regression model was used to assess the association between outcome and explanatory variables. All variables with a P value < 0.2 were fitted into the multiple logistic regression models using a 5% significance level. Results Out of 725 health facilities involved in the current study, about 68% were public facilities and 73% located in rural settings. Only 28% of the assessed facilities were considered prepared for the outpatient primary care of hypertension. About 9% and 42% of the assessed facilities reported to have at least one trained staff and guidelines for hypertension respectively. In multivariate analysis, private facilities [AOR = 2.7, 95% CI; 1.2–6.1], urban location [AOR = 2.2, 95% CI; 1.2–4.2], health centers [AOR = 5.2, 95% CI; 3.1–8.7] and the performance of routine management meetings [AOR = 2.6, 95% CI; 1.1–5.9] were significantly associated with preparedness for the outpatient primary care of hypertension. Conclusion The primary healthcare system in Tanzania is not adequately equipped to cope with the increasing burden of hypertension and other non-communicable diseases. Rural location, public ownership, and absence of routine management meetings were associated with being not prepared. There is a need to strengthen the primary healthcare system in Tanzania for better management of chronic diseases and curb their rising impact on health outcomes. PMID:29447231

Common mental disorder and its association with academic performance among Debre Berhan University students, Ethiopia.

PubMed

Haile, Yohannes Gebreegziabhere; Alemu, Sisay Mulugeta; Habtewold, Tesfa Dejenie

2017-01-01

Common mental disorder (CMD) is prevalent in industrialized and non-industrialized countries. The prevalence of CMD among university students was 28.8-44.7% and attributed to several risk factors, such as schooling. The aim of this study was to assess the prevalence and risk factors of CMD. In addition, the association between CMD and academic performance was tested. Institution based cross-sectional study was conducted with 422 students at Debre Berhan university from March to April 2015. CMD was the primary outcome variable whereas academic performance was the secondary outcome variable. Kessler psychological distress (K10) scale was used to assess CMD. Bivariate and multiple logistic regression analysis were performed for modeling the primary outcome variable; independent samples T test and linear regression analysis were carried out for modeling the secondary outcome variable. The strength of association was interpreted using odds ratio and regression coefficient (β) and decision on statistical significance was made at a p value of 0.05. Data were entered using EPI-data version 3.1 software and analyzed using the Statistical Package for the Social Sciences (SPSS) version 20.01 software. The prevalence of CMD was 63.1%. Field of study (p = 0.008, OR = 0.2, 95% CI 0.04-0.61), worshiping (p = 0.04, OR = 1.8, 95% CI 1.02-3.35), insomnia (p < 0.001, OR = 3.8, 95% CI 2.21-6.57), alcohol drinking (p = 0.006, OR = 2.7, 95% CI 1.33-5.66), and headache (p = 0.02, OR = 2.1, 95% CI 1.10-3.86) were identified risk factors for CMD. The mean cumulative grade point average of students with CMD was lower by 0.02 compared to those without CMD, but not statistically significant (p = 0.70, β = -0.02, 95% CI -0.15 to 0.10). CMD explained only 0.8% (r 2  = 0.008) of the difference in academic performance between students. At least three out of five students fulfilled CMD diagnostic criteria. The statistically significant risk factors were field of study, worshiping, insomnia, alcohol drinking, and headache. Moreover, there was no statistically significant association between CMD and academic performance. Undertaking integrated evidence-based intervention focusing on students with poor sleep quality, poor physical health, and who drink alcohol is essential if the present finding confirmed by a longitudinal study.

A Low-Effort, Clinic-Wide Intervention Improves Attendance for HIV Primary Care

PubMed Central

Gardner, Lytt I.; Marks, Gary; Craw, Jason A.; Wilson, Tracey E.; Drainoni, Mari-Lynn; Moore, Richard D.; Mugavero, Michael J.; Rodriguez, Allan E.; Bradley-Springer, Lucy A.; Holman, Susan; Keruly, Jeanne C.; Sullivan, Meg; Skolnik, Paul R.; Malitz, Faye; Metsch, Lisa R.; Raper, James L.; Giordano, Thomas P.

2012-01-01

Background. Retention in care for human immunodeficiency virus (HIV)–infected patients is a National HIV/AIDS Strategy priority. We hypothesized that retention could be improved with coordinated messages to encourage patients' clinic attendance. We report here the results of the first phase of the Centers for Disease Control and Prevention/Health Resources and Services Administration Retention in Care project. Methods. Six HIV-specialty clinics participated in a cross-sectionally sampled pretest-posttest evaluation of brochures, posters, and messages that conveyed the importance of regular clinic attendance. 10 018 patients in 2008–2009 (preintervention period) and 11 039 patients in 2009–2010 (intervention period) were followed up for clinic attendance. Outcome variables were the percentage of patients who kept 2 consecutive primary care visits and the mean proportion of all primary care visits kept. Stratification variables were: new, reengaging, and active patients, HIV RNA viral load, CD4 cell count, age, sex, race or ethnicity, risk group, number of scheduled visits, and clinic site. Data were analyzed by multivariable log-binomial and linear models using generalized estimation equation methods. Results. Clinic attendance for primary care was significantly higher in the intervention versus preintervention year. Overall relative improvement was 7.0% for keeping 2 consecutive visits and 3.0% for the mean proportion of all visits kept (P < .0001). Larger relative improvement for both outcomes was observed for new or reengaging patients, young patients and patients with elevated viral loads. Improved attendance among the new or reengaging patients was consistent across the 6 clinics, and less consistent across clinics for active patients. Conclusion. Targeted messages on staying in care, which were delivered at minimal effort and cost, improved clinic attendance, especially for new or reengaging patients, young patients, and those with elevated viral loads. PMID:22828593

Physical activity differences between children from migrant and native origin.

PubMed

Labree, Wim; Lötters, Freek; van de Mheen, Dike; Rutten, Frans; Rivera Chavarría, Ana; Neve, Madelon; Rodenburg, Gerda; Machielsen, Honorine; Koopmans, Gerrit; Foets, Marleen

2014-08-09

Children from migrant origin are at higher risk for overweight and obesity. As limited physical activity is a key factor in this overweight and obesity risk, in general, the aim of this study is to assess to what degree children from migrant and native Dutch origin differ with regard to levels of physical activity and to determine which home environment aspects contribute to these differences. A cross-sectional survey among primary caregivers of primary school children at the age of 8-9 years old (n = 1943) from 101 primary schools in two urban areas in The Netherlands. We used bivariate correlation and multivariate regression techniques to examine the relationship between physical and social environment aspects and the child's level of physical activity. All outcomes were reported by primary caregivers. Outcome measure was the physical activity level of the child. Main independent variables were migrant background, based on country of birth of the parents, and variables in the physical and social home environment which may enhance or restrict physical activity: the availability and the accessibility of toys and equipment, as well as sport club membership (physical environment), and both parental role modeling, and supportive parental policies (social environment). We controlled for age and sex of the child, and for socio-economic status, as indicated by educational level of the parents. In this sample, physical activity levels were significantly lower in migrant children, as compared to children in the native population. Less physical activity was most often seen in Turkish, Moroccan, and other non-western children (p < .05). Although traditional home characteristics in both the physical, and the social environment are often associated with child's physical activity, these characteristics provided only modest explanation of the differences in physical activity between migrant and non-migrant children in this study. The question arises whether interventions aimed at overweight and obesity should have to focus on home environmental characteristics with regard to physical activity.

An Overview of Systematic Reviews on Prognostic Factors in Neck Pain: Results from the International Collaboration on Neck Pain (ICON) Project

PubMed Central

Walton, David M; Carroll, Linda J; Kasch, Helge; Sterling, Michele; Verhagen, Arianne P; MacDermid, Joy C; Gross, Anita; Santaguida, P. Lina; Carlesso, Lisa

2013-01-01

Given the challenges of chronic musculoskeletal pain and disability, establishing a clear prognosis in the acute stage has become increasingly recognized as a valuable approach to mitigate chronic problems. Neck pain represents a condition that is common, potentially disabling, and has a high rate of transition to chronic or persistent problems. As a field of research, prognosis in neck pain has stimulated several empirical primary research papers, and a number of systematic reviews. As part of the International Consensus on Neck (ICON) project, we sought to establish the general state of knowledge in the area through a structured, systematic review of systematic reviews (overview). An exhaustive search strategy was created and employed to identify the 13 systematic reviews (SRs) that served as the primary data sources for this overview. A decision algorithm for data synthesis, which incorporated currency of the SR, risk of bias assessment of the SRs using AMSTAR scoring and consistency of findings across SRs, determined the level of confidence in the risk profile of 133 different variables. The results provide high confidence that baseline neck pain intensity and baseline disability have a strong association with outcome, while angular deformities of the neck and parameters of the initiating trauma have no effect on outcome. A vast number of predictors provide low or very low confidence or inconclusive results, suggesting there is still much work to be done in this field. Despite the presence of multiple SR and this overview, there is insufficient evidence to make firm conclusions on many potential prognostic variables. This study demonstrates the challenges in conducting overviews on prognosis where clear synthesis critieria and a lack of specifics of primary data in SR are barriers. PMID:24115971

Sex differences in left main coronary artery stenting: Different characteristics but similar outcomes for women compared with men.

PubMed

Shin, Eun-Seok; Lee, Cheol Whan; Ahn, Jung-Min; Lee, Pil Hyung; Chang, Mineok; Kim, Min-Ju; Yoon, Sung-Han; Park, Duk-Woo; Kang, Soo-Jin; Lee, Seung-Whan; Kim, Young-Hak; Park, Seong-Wook; Park, Seung-Jung

2018-02-15

The clinical outcomes for women compared with men undergoing left main PCI were sparse. We compared the characteristics and long-term outcomes in women versus men after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for unprotected left main CAD. We identified 2328 patients (545 women; 1783 men) with unprotected left main CAD who received PCI with DES between January 2007 and December 2013 in the Interventional Cardiology Research In-cooperation Society-left MAIN revascularization (IRIS-MAIN) registry. The primary outcome was a composite of death from any cause, myocardial infarction, or stroke. The median follow-up time was 2.9years (interquartile range: 1.0-4.1years). Women were older, had a higher incidence of insulin-requiring diabetes mellitus and hypertension, and more commonly presented with acute coronary syndrome than men. Left main ostial lesion was more common in women, whereas left main bifurcation lesion with more extensive CAD was more common in men. The incidence of primary outcome was similar between the two groups (10.8% vs. 10.8%, respectively, log-rank p=0.587). The results were similar after adjustment for baseline variables and consistent across major subgroups. The need for target lesion revascularization was significantly higher in women than in men (8.8% vs. 5.7%, respectively, p<0.05) but the sex bias was not confirmed after adjusting for confounders. Women, as compared to men, had different clinical and lesion characteristics but similar long-term outcomes after PCI with DES for left main CAD. Copyright © 2017 Elsevier B.V. All rights reserved.

Evaluation of an intervention to reduce adolescent sitting time during the school day: The 'Stand Up for Health' randomised controlled trial.

PubMed

Parrish, Anne-Maree; Trost, Stewart G; Howard, Steven J; Batterham, Marijka; Cliff, Dylan; Salmon, Jo; Okely, Anthony D

2018-05-22

Adolescents spend large proportions of the school day sitting; potentially increasing their health risks. This study aimed to evaluate the feasibility, acceptability and potential efficacy of a school-based intervention to reduce adolescent sitting time during the school day. Two-arm parallel-group randomised controlled trial. Adolescents (13-16 years) were recruited from four private high schools in New South Wales, Australia. Schools were pair-matched and randomised to treatment or control. Research assistants were blinded to intervention aims and treatment allocation. Intervention initiatives included classroom and outdoor environmental measures to break up and reduce the proportion of adolescent school time spent sitting. Teacher and students surveys assessed intervention feasibility, acceptability and potential efficacy. Proportional sitting time was the primary outcome, measured by activPAL monitors, worn for one week during the school day. Secondary outcomes included body mass index, body fatness, working memory and non-verbal reasoning. Data were analysed using a general linear model for continuous variables and adjusted for clustering. While teachers and students supported the program, process evaluation results indicate aspects of the intervention were not implemented with fidelity. Eighty-eight adolescents (M age =14.7±0.7, 50% male) participated in the trial. Eighty-six had valid data for all variables (43 controls, 43 intervention). There was no significant intervention effect on the primary outcome. There was a significant effect on working memory (adjusted difference ±SD=-0.42±1.37; p=0.048 (Cohen's d)=0.31). These findings contribute to limited research in this area, providing guidance for future interventions in the high school environment. The study was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN 12614001001684). Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

Neonatal Outcomes of Low-Risk, Late-Preterm Twins Compared With Late-Preterm Singletons.

PubMed

Salem, Shimrit Yaniv; Kibel, Mia; Asztalos, Elizabeth; Zaltz, Arthur; Barrett, Jon; Melamed, Nir

2017-09-01

To test the hypothesis that the risk of neonatal morbidity among late-preterm twins is similar to that of late-preterm singletons. We conducted a retrospective cohort study of all women with twin or singleton pregnancy who gave birth during the late-preterm period in a single tertiary center between 2008 and 2015. Neonatal outcomes of low-risk, late-preterm twins were compared with those of low-risk, late-preterm singletons. The primary outcome was the same primary composite respiratory morbidity variable that was used in the randomized controlled trial of Gyamfi-Bannerman et al on the administration of antenatal corticosteroids during the late-preterm period. A total of 922 singleton and 721 twin late-preterm neonates met the inclusion criteria. The rates of composite respiratory morbidity and severe composite respiratory morbidity were similar for twins and singletons (8.3% compared with 7.4%, P=.5 and 6.8% compared with 6.0%, P=.5, respectively), but were lower than the rates of the same composite respiratory morbidity variable in the randomized controlled study described previously. The odds for respiratory morbidity were similar for twins and singletons for both composite respiratory morbidity (adjusted odds ratio [OR] 0.73, 95% CI 0.48-1.12) and severe composite respiratory morbidity (adjusted OR 0.79, 95% CI 0.50-1.24). The risk of respiratory morbidity among late-preterm twins is similar to that of late-preterm singletons. Still, the low absolute rates of the composite respiratory morbidity in our population suggest that administration of antenatal corticosteroids may be mostly justified among neonates born closer to 34 weeks of gestation.

Identification of extremely premature infants at high risk of rehospitalization.

PubMed

Ambalavanan, Namasivayam; Carlo, Waldemar A; McDonald, Scott A; Yao, Qing; Das, Abhik; Higgins, Rosemary D

2011-11-01

Extremely low birth weight infants often require rehospitalization during infancy. Our objective was to identify at the time of discharge which extremely low birth weight infants are at higher risk for rehospitalization. Data from extremely low birth weight infants in Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers from 2002-2005 were analyzed. The primary outcome was rehospitalization by the 18- to 22-month follow-up, and secondary outcome was rehospitalization for respiratory causes in the first year. Using variables and odds ratios identified by stepwise logistic regression, scoring systems were developed with scores proportional to odds ratios. Classification and regression-tree analysis was performed by recursive partitioning and automatic selection of optimal cutoff points of variables. A total of 3787 infants were evaluated (mean ± SD birth weight: 787 ± 136 g; gestational age: 26 ± 2 weeks; 48% male, 42% black). Forty-five percent of the infants were rehospitalized by 18 to 22 months; 14.7% were rehospitalized for respiratory causes in the first year. Both regression models (area under the curve: 0.63) and classification and regression-tree models (mean misclassification rate: 40%-42%) were moderately accurate. Predictors for the primary outcome by regression were shunt surgery for hydrocephalus, hospital stay of >120 days for pulmonary reasons, necrotizing enterocolitis stage II or higher or spontaneous gastrointestinal perforation, higher fraction of inspired oxygen at 36 weeks, and male gender. By classification and regression-tree analysis, infants with hospital stays of >120 days for pulmonary reasons had a 66% rehospitalization rate compared with 42% without such a stay. The scoring systems and classification and regression-tree analysis models identified infants at higher risk of rehospitalization and might assist planning for care after discharge.

Identification of Extremely Premature Infants at High Risk of Rehospitalization

PubMed Central

Carlo, Waldemar A.; McDonald, Scott A.; Yao, Qing; Das, Abhik; Higgins, Rosemary D.

2011-01-01

OBJECTIVE: Extremely low birth weight infants often require rehospitalization during infancy. Our objective was to identify at the time of discharge which extremely low birth weight infants are at higher risk for rehospitalization. METHODS: Data from extremely low birth weight infants in Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers from 2002–2005 were analyzed. The primary outcome was rehospitalization by the 18- to 22-month follow-up, and secondary outcome was rehospitalization for respiratory causes in the first year. Using variables and odds ratios identified by stepwise logistic regression, scoring systems were developed with scores proportional to odds ratios. Classification and regression-tree analysis was performed by recursive partitioning and automatic selection of optimal cutoff points of variables. RESULTS: A total of 3787 infants were evaluated (mean ± SD birth weight: 787 ± 136 g; gestational age: 26 ± 2 weeks; 48% male, 42% black). Forty-five percent of the infants were rehospitalized by 18 to 22 months; 14.7% were rehospitalized for respiratory causes in the first year. Both regression models (area under the curve: 0.63) and classification and regression-tree models (mean misclassification rate: 40%–42%) were moderately accurate. Predictors for the primary outcome by regression were shunt surgery for hydrocephalus, hospital stay of >120 days for pulmonary reasons, necrotizing enterocolitis stage II or higher or spontaneous gastrointestinal perforation, higher fraction of inspired oxygen at 36 weeks, and male gender. By classification and regression-tree analysis, infants with hospital stays of >120 days for pulmonary reasons had a 66% rehospitalization rate compared with 42% without such a stay. CONCLUSIONS: The scoring systems and classification and regression-tree analysis models identified infants at higher risk of rehospitalization and might assist planning for care after discharge. PMID:22007016

Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures.

PubMed

Ingalls, Nichole K; Horton, Zachary A; Bettendorf, Matthew; Frye, Ira; Rodriguez, Carlos

2010-02-01

The lidocaine patch 5% was developed to treat postherpetic neuralgia. Anecdotal experience at our institution suggests the lidocaine patch 5% decreases narcotic usage in patients with traumatic rib fractures. This trial was developed to define the patch's efficacy. Patients with rib fractures admitted to the trauma service at our Level I trauma center were enrolled and randomized in a 1 to 1 double-blind manner to receive a lidocaine patch 5% or placebo patch. Fifty-eight patients who met the inclusion criteria were enrolled from January 2007 to August 2008. Demographic and clinical information were recorded. The primary outcomes variable was total narcotic use, analyzed using the 1-tailed Mann-Whitney test. The secondary outcomes variables included non-narcotic pain medication, average pain score, pulmonary complications, and length of stay. Significance was defined based on a 1-sided test for the primary outcome and 2-sided tests for other comparisons, at p < 0.05. Thirty-three patients received the lidocaine patch 5% and 25 received the placebo patch. There were no significant differences in age, number of rib fractures, gender, trauma mechanism, preinjury lung disease, smoking history, percent of current smokers, and need for placement of chest tube between the lidocaine patch 5% and placebo groups. There was no difference between the lidocaine patch 5% and placebo groups, respectively, with regard to total IV narcotic usage: median, 0.23 units versus 0.26 units; total oral narcotics: median, 4 units versus 7 units; pain score: 5.6 +/- 0.4 versus 6.0 +/- 0.3 (mean +/- SEM); length of stay: 7.8 +/- 1.1 versus 6.2 +/- 0.7; or percentage of patients with pulmonary complications: 72.7% versus 72.0%. The lidocaine patch 5% does not significantly improve pain control in polytrauma patients with traumatic rib fractures.

CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol.

PubMed

Abbott, Allan; Möller, Hans; Gerdhem, Paul

2013-09-05

Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children and adolescents. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to improve the evidence base regarding the effectiveness of conservative treatments for preventing curve progression in idiopathic scoliosis. Previously untreated girls and boys with idiopathic scoliosis, 9 to 17 years of age with at least one year of remaining growth and a curve Cobb angle of 25-40 degrees will be included. A total of 135 participants will be randomly allocated in groups of 45 patients each to receive one of the three interventions. All three groups will receive a physical activity prescription according to the World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. OUTCOME variables will be measured every 6 months. The primary outcome variable, failure of treatment, is defined as progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays taken with 6 months interval. Secondary outcome measures include the SRS-22r and EQ5D-Y quality of life questionnaires, the International Physical Activity Questionnaire (IPAQ) short form, and Cobb angle at end of the study. This trial will evaluate which of the tested conservative treatment approaches that is the most effective for patients with adolescent idiopathic scoliosis. NCT01761305.

The association between a living wage and subjective social status and self-rated health: a quasi-experimental study in the Dominican Republic.

PubMed

Landefeld, John C; Burmaster, Katharine B; Rehkopf, David H; Syme, S Leonard; Lahiff, Maureen; Adler-Milstein, Sarah; Fernald, Lia C H

2014-11-01

Poverty, both absolute and relative, is associated with poorer health. This is of particular concern in middle- and low-income countries facing a significant and growing burden of disease. There has been limited research specifically on whether interventions that increase income may foster better health outcomes. The establishment of a "living wage" apparel factory in the Dominican Republic provided a minimum income standard for factory workers, thus creating a natural experiment through which to study the effects of increased income on health indicators. The primary component of the intervention was a 350% wage increase, but apparel workers in the intervention factory also received education and professional development and were exposed to an enhanced occupational health and safety program. Workers at the intervention factory (n = 99) were compared with workers at a matched apparel factory (n = 105). Data were collected via in-person interviews in July and August of 2011, which was 15-16 months after workers were initially hired at the intervention site. Primary analyses used employment at the intervention factory as the independent variable and examined associations with two dependent variables: subjective social status and self-rated health. Results showed that receiving a 350% higher wage was associated with substantially higher subjective social status scores, as well as higher global and comparative self-rated health scores; effects were strongest in women. Subjective social status and self-rated health are associated with future health outcomes, so these results indicate that income increases for apparel workers may have positive long-term health outcomes, particularly for women. Copyright © 2014. Published by Elsevier Ltd.

The impact of virus in N3 node dissection for head and neck cancer.

PubMed

Armas, Gian Luca; Su, Chih-Ying; Huang, Chao-Cheng; Fang, Fu-Min; Chen, Ching-Mei; Chien, Chih-Yen

2008-11-01

This study is to determine the impact of virus in surgical outcomes among patients of head and neck cancer with N3 lymph node metastasis. A retrospective analysis was conducted for 32 patients with operable N3 neck metastasis undergoing surgical treatment between January 1987 and October 2006. The nuclei of the tumor cells were investigated for the presence of human papillomavirus (HPV) and Epstein-Barr virus (EBV) DNAs and were taken into account as the variable for survival analysis. The primary sites were oropharynx in 11 patients, tongue in 3, buccal mucosa in 1, hypopharynx in 8 and unknown primary in 9. The five-year cumulative overall survival rate was 40.7% and 5-year cumulative regional control rate was 55.8%. The 5-year cumulative overall survival rate of patients with unknown primary site (72.9%) and HPV or EBV positive in the tumor (77.8%) were significantly higher than those patients with known primary site (31.3%) and HPV or EBV negative in the tumor (27.4%), respectively (P = 0.0335 and P = 0.0348, log rank test). In conclusion, surgery with adjuvant therapy offers reasonable outcomes for operable N3 node in head and neck cancer in our cohort. In addition, patients with HPV or EBV positive in the tumor have a better survival.

Physician styles of patient management as a potential source of disparities: cluster analysis from a factorial experiment.

PubMed

Lutfey, Karen E; Gerstenberger, Eric; McKinlay, John B

2013-06-01

To identify styles of physician decision making (as opposed to singular clinical actions) and to analyze their association with variations in the management of a vignette presentation of coronary heart disease (CHD). Primary data were collected from primary care physicians in North and South Carolina. In a balanced factorial experimental design, primary care physicians viewed one of 16 (2(4)) video vignette presentations of CHD and provided detailed information about how they would manage the case. 256 MD primary care physicians were interviewed face-to-face in North and South Carolina. We identify three clusters depicting unique styles of CHD management that are robust to controls for physician (gender and level of experience) and patient characteristics (age, gender, socioeconomic status, and race) as well as key organizational features of physicians' work settings. Physicians in Cluster 1 "Cardiac" (N = 92) were more likely to focus on cardiac issues compared with their counterparts; physicians in Cluster 2 "Talkers" (N = 93) were more likely to give advice and take additional medical history; whereas physicians in Cluster 3 "Minimalists" (N = 71) were less likely than their counterparts to take action on any of the types of management behavior. Variations in styles of decision making, which encompass multiple outcome variables and extend beyond individual-level demographic predictors, may add to our understanding of disparities in health quality and outcomes. © Health Research and Educational Trust.

Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine.

PubMed

Meador, Kimford J; Loring, David W; Boyd, Alan; Echauz, Javier; LaRoche, Suzette; Velez-Ruiz, Naymee; Korb, Pearce; Byrnes, William; Dilley, Deanne; Borghs, Simon; De Backer, Marc; Story, Tyler; Dedeken, Peter; Webster, Elizabeth

2016-09-01

Differential effectiveness of antiepileptic drugs (AEDs) is more commonly determined by tolerability than efficacy. Cognitive effects of AEDs can adversely affect tolerability and quality of life. This study evaluated cognitive and EEG effects of lacosamide (LCM) compared with carbamazepine immediate-release (CBZ-IR). A randomized, double-blind, double-dummy, two-period crossover, fixed-dose study in healthy subjects compared neuropsychological and EEG effects of LCM (150mg, b.i.d.) and CBZ-IR (200mg, t.i.d.). Testing was conducted at screening, predrug baseline, the end of each treatment period (3-week titration; 3-week maintenance), and the end of each washout period (4weeks after treatment). A composite Z-score was derived for the primary outcome variable (computerized cognitive tests and traditional neuropsychological measures) and separately for the EEG measures. Other variables included individual computer, neuropsychological, and EEG scores and adverse events (AEs). Subjects included 60 healthy adults (57% female; mean age: 34.4years [SD: 10.5]); 44 completed both treatments; 41 were per protocol subjects. Carbamazepine immediate-release had worse scores compared with LCM for the primary composite neuropsychological outcome (mean difference=0.33 [SD: 1.36], p=0.011) and for the composite EEG score (mean difference=0.92 [SD: 1.77], p=0.003). Secondary analyses across the individual variables revealed that CBZ-IR was statistically worse than LCM on 36% (4/11) of the neuropsychological tests (computerized and noncomputerized) and 0% of the four EEG measures; none favored CBZ-IR. Drug-related AEs occurred more with CBZ-IR (49%) than LCM (22%). Lacosamide had fewer untoward neuropsychological and EEG effects and fewer AEs and AE-related discontinuations than CBZ-IR in healthy subjects. Lacosamide exhibits a favorable cognitive profile. Copyright © 2016 Elsevier Inc. All rights reserved.

Cost-efficiency and outcomes in the treatment of perforated peptic ulcer disease: laparoscopic versus open approach.

PubMed

Wright, G Paul; Davis, Alan T; Koehler, Tracy J; Scheeres, David E

2014-10-01

Laparoscopic treatment of perforated peptic ulcer disease (perfPUD) has demonstrated comparable operative outcomes with an open approach though the cost-efficiency of this method has not been studied. Data were obtained from the Nationwide Inpatient Sample (2007-2010). Patients who underwent operation for perfPUD were divided on the basis of laparoscopic or open approach. The primary outcome measures were hospital duration of stay, mortality, and total charges. A total of 5,361 patients with perfPUD were identified: 5,219 in the open group and 142 in the laparoscopic group. Patients in the laparoscopic group were younger (50.5 vs 60.0, P < .001) and had a lesser incidence at presentation of sepsis (8.5 vs 14.8%, P = .034) and shock (2.1 vs 7.7%, P = .012). On univariate analysis, the laparoscopic group had decreased duration of stay (7.0 vs 8.0 days, P < .001), lesser rates of mortality (3.5 vs 8.1%, P = .048), and were discharged to home more frequently (79.6 vs 68.1%, P = .025). Mean total charges were less in the laparoscopic group ($44,095 vs $52,055, P = .019). Multivariate analyses failed to show a difference between groups for any of the outcome variables. The laparoscopic treatment of perfPUD is associated with equivalent costs and outcomes compared with the open technique when we corrected for presentation variables. Copyright © 2014 Elsevier Inc. All rights reserved.

Can early postoperative intraocular pressure predict success following mitomycin-C augmented trabeculectomy in primary angle-closure glaucoma.

PubMed

Rong, S S; Feng, M Y; Wang, N; Meng, H; Thomas, R; Fan, S; Wang, R; Wang, X; Tang, X; Liang, Y B

2013-03-01

To evaluate the association between early and late postoperative intraocular pressure (IOP) and determine if early postoperative IOP can predict the surgical outcome. A total of 165 consecutive patients with primary angle-closure glaucoma (PACG) undergoing primary mitomycin-C-augmented trabeculectomy underwent a comprehensive eye examination before surgery and were followed-up on days 1, 7, 14, and 30, and months 3, 6, 12, and 18. IOPs on days 1, 7, 14, and 30 were stratified into groups A (<10 mm Hg), B (≥10 and <15 mm Hg), C (≥15 and <20 mm Hg), and D (≥20 mm Hg). Differences between groups were analyzed using analysis of variance (ANOVA) and Fisher's exact test. Multivariable regression was used to exam the predictive ability of early IOP for final outcome. The mean age was 62.5±7.9 years and 41.21% (n=68) were males. Stratified by IOP on days 1, 7, 14, and 30, respectively, mean IOPs at month 18 were different among groups A, B, C, and D (ANOVA, P=0.047, P=0.033, P=0.008, and P<0.001, respectively). Once the IOPs were settled with interventions on day 7 a higher IOP level was associated with decreasing success rate under different outcome definitions, final IOP <15 mm Hg (Fisher's exact P=0.001) and <20 mm Hg (P=0.039) without medication. Multiple regression showed early IOP predicted final IOP independently from baseline variables. A cutoff value of 13.5 mm Hg on day 7 achieved an accuracy of 80.0 and 57.1% in predicting IOP<15 mm Hg without medication and failure after surgery, respectively. The IOP at 18 months following primary antifibrotic-augmented trabeculectomy in PACG patients is associated with and predicted by the postoperative IOPs at 1 month. Control of early IOP to 13.5 or less may provide better outcomes.

Effects of the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) on biomedical outcomes, observed cardiovascular events and cardiovascular risks in primary care: a longitudinal comparative study.

PubMed

Jiao, Fang Fang; Fung, Colman Siu Cheung; Wong, Carlos King Ho; Wan, Yuk Fai; Dai, Daisy; Kwok, Ruby; Lam, Cindy Lo Kuen

2014-08-21

To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus (RAMP-DM) led to improvements in biomedical outcomes, observed cardiovascular events and predicted cardiovascular risks after 12-month intervention in the primary care setting. A random sample of 1,248 people with diabetes enrolled to RAMP-DM for at least 12 months was selected and 1,248 people with diabetes under the usual primary care were matched by age, sex, and HbA1c level at baseline as the usual care group. Biomedical and cardiovascular outcomes were measured at baseline and at 12-month after the enrollment. Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes, proportion of subjects reaching treatment targets, observed and predicted cardiovascular risks. Compared to the usual care group, RAMP-DM group had lower cardiovascular events incidence (1.21% vs 2.89%, P = 0.003), and net decrease in HbA1c (-0.20%, P < 0.01), SBP (-3.62 mmHg, P < 0.01) and 10-year cardiovascular disease (CVD) risks (total CVD risk, -2.06%, P < 0.01; coronary heart disease (CHD) risk, -1.43%, P < 0.01; stroke risk, -0.71%, P < 0.01). The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA1c, and SBP/DBP. After adjusting for confounding variables, the significance remained for HbA1c, predicted CHD and stroke risks. The RAMP-DM resulted in greater improvements in HbA1c and reduction in observed and predicted cardiovascular risks at 12 months follow-up, which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting. ClinicalTrials.gov, NCT02034695.

The efficacy of cognitive behavioral therapy for Chinese people: A meta-analysis.

PubMed

Ng, Ting Kin; Wong, Daniel Fu Keung

2018-07-01

Over the past decade, cognitive behavioral therapy has been applied to an increasingly wider range of disorders and problems in Chinese societies. However, no meta-analysis has been conducted to synthesize the studies on cognitive behavioral therapy for Chinese clients. The purpose of this meta-analytic study was to examine the overall efficacy of cognitive behavioral therapy for Chinese people. A literature search was conducted using electronic databases, including Web of Science, PsycINFO and PubMed. Pooled mean effect sizes were calculated using the random-effects model. The literature search identified 55 studies with 6763 Chinese participants. The overall short-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Effect sizes were medium for anxiety, depression/well-being and caregiving stress and small for psychotic symptoms and addictive behaviors. The effects of cognitive behavioral therapy on process variables, dysfunctional thoughts and coping, were in the small range. The overall longer-term effect of cognitive behavioral therapy on the primary outcome was medium in size. Moderator analyses showed that the short-term effect was stronger for culturally adapted cognitive behavioral therapy than for unadapted cognitive behavioral therapy. Type of primary outcome, type of control group, recruitment method, study design, the format of delivery and region were found to moderate the efficacy of cognitive behavioral therapy. The findings of this study provide evidence for the overall efficacy of cognitive behavioral therapy for Chinese people and the benefit of cultural adaptation of cognitive behavioral therapy to Chinese culture.

A national study of the association between food environments and county-level health outcomes.

PubMed

Ahern, Melissa; Brown, Cheryl; Dukas, Stephen

2011-01-01

This national, county-level study examines the relationship between food availability and access, and health outcomes (mortality, diabetes, and obesity rates) in both metro and non-metro areas. This is a secondary, cross-sectional analysis using Food Environment Atlas and CDC data. Linear regression models estimate relationships between food availability and access variables (direct-to-consumer farm sales, per capita grocery stores, full-service restaurants, fast food restaurants, and convenience stores) with health outcomes. Controls include smoking, race/ethnicity, gender, age, education, poverty, primary care availability, recreational facility availability, and mobility/distance-from-grocery-store. Non-metro findings: Lower adjusted mortality rates were associated with more per capita full-service restaurants and grocery stores, and greater per capita direct farm sales. Lower adjusted diabetes rates were associated with a lower per capita supply of fast food restaurants and convenience stores, and more per capita full-service restaurants and grocery stores. Lower adjusted obesity rates were associated with more per capita full-service restaurants and grocery stores. Unexpectedly, obesity rates were positively associated with per capita grocery stores and negatively associated with fast food restaurants. Metro findings: More per capita full-service restaurants, grocery stores, and direct farm sales are associated with positive health outcomes; fast food restaurants and convenience stores are associated with negative health outcomes. The food access/availability environment is an important determinant of health outcomes in metro and non-metro areas. Future research should focus on more refined specifications that capture variability across non-metro settings. © 2011 National Rural Health Association.

Impact of gastrectomy procedural complexity on surgical outcomes and hospital comparisons.

PubMed

Mohanty, Sanjay; Paruch, Jennifer; Bilimoria, Karl Y; Cohen, Mark; Strong, Vivian E; Weber, Sharon M

2015-08-01

Most risk adjustment approaches adjust for patient comorbidities and the primary procedure. However, procedures done at the same time as the index case may increase operative risk and merit inclusion in adjustment models for fair hospital comparisons. Our objectives were to evaluate the impact of surgical complexity on postoperative outcomes and hospital comparisons in gastric cancer surgery. Patients who underwent gastric resection for cancer were identified from a large clinical dataset. Procedure complexity was characterized using secondary procedure CPT codes and work relative value units (RVUs). Regression models were developed to evaluate the association between complexity variables and outcomes. The impact of complexity adjustment on model performance and hospital comparisons was examined. Among 3,467 patients who underwent gastrectomy for adenocarcinoma, 2,171 operations were distal and 1,296 total. A secondary procedure was reported for 33% of distal gastrectomies and 59% of total gastrectomies. Six of 10 secondary procedures were associated with adverse outcomes. For example, patients who underwent a synchronous bowel resection had a higher risk of mortality (odds ratio [OR], 2.14; 95% CI, 1.07-4.29) and reoperation (OR, 2.09; 95% CI, 1.26-3.47). Model performance was slightly better for nearly all outcomes with complexity adjustment (mortality c-statistics: standard model, 0.853; secondary procedure model, 0.858; RVU model, 0.855). Hospital ranking did not change substantially after complexity adjustment. Surgical complexity variables are associated with adverse outcomes in gastrectomy, but complexity adjustment does not affect hospital rankings appreciably. Copyright © 2015 Elsevier Inc. All rights reserved.

Modulators of Response to Tumor Necrosis-Related Apoptosis-Inducing Ligand (TRAIL) Therapy in Ovarian Cancer

DTIC Science & Technology

2009-04-01

expression. REPORTABLE OUTCOMES: The following abstracts have been presented at national meetings as a result of this research: 1. Qamar L...108(2008) page S130. 2. Qamar L, Syed N, Ford HL, Thorburn A and Behbakht K. The Six1 homeobox gene is associated with increased Tumor Necrosis...Primary ovarian cancers are variably sensitive to TRAIL and lexatumumab/the agonistic antibody to TRAIL death receptor 5, but not to Maptumumab L. Qamar , T

Orion - Super Koropon(Registered Trademark) Torque/Tension Report

NASA Technical Reports Server (NTRS)

Hemminger, Edgar G.; McLeod, Christopher; Peil, John

2012-01-01

The primary objective of this testing was to obtain torque tension data for the use of Super Koropon Primer Base which was proposed for use on the Orion project. This compound is a corrosion inhibitor/sealer used on threaded fasteners and inserts as specified per NASA/JSC PRC-4004, Sealing of Joints and Faying Surfaces. Some secondary objectives of this testing, were to identify the effect on torque coefficient of several variables. This document contains the outcome of the testing.

Using ClinicalTrials.gov to supplement information in ophthalmology conference abstracts about trial outcomes: a comparison study.

PubMed

Scherer, Roberta W; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching "new" outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned.

Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

PubMed

Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

2015-07-01

Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

Bupropion for the treatment of apathy in Huntington’s disease: A multicenter, randomised, double-blind, placebo-controlled, prospective crossover trial

PubMed Central

Gelderblom, Harald; Wüstenberg, Torsten; McLean, Tim; Mütze, Lisanne; Fischer, Wilhelm; Saft, Carsten; Hoffmann, Rainer; Süssmuth, Sigurd; Schlattmann, Peter; van Duijn, Erik; Landwehrmeyer, Bernhard; Priller, Josef

2017-01-01

Objective To evaluate the efficacy and safety of bupropion in the treatment of apathy in Huntington’s disease (HD). Methods In this phase 2b multicentre, double-blind, placebo-controlled crossover trial, individuals with HD and clinical signs of apathy according to the Structured Clinical Interview for Apathy—Dementia (SCIA-D), but not depression (n = 40) were randomized to receive either bupropion 150/300mg or placebo daily for 10 weeks. The primary outcome parameter was a significant change of the Apathy Evaluation Scale (AES) score after ten weeks of treatment as judged by an informant (AES-I) living in close proximity with the study participant. The secondary outcome parameters included changes of 1. AES scores determined by the patient (AES-S) or the clinical investigator (AES-C), 2. psychiatric symptoms (NPI, HADS-SIS, UHDRS-Behavior), 3. cognitive performance (SDMT, Stroop, VFT, MMSE), 4. motor symptoms (UHDRS-Motor), 5. activities of daily function (TFC, UHDRS-Function), and 6. caregiver distress (NPI-D). In addition, we investigated the effect of bupropion on brain structure as well as brain responses and functional connectivity during reward processing in a gambling task using magnetic resonance imaging (MRI). Results At baseline, there were no significant treatment group differences in the clinical primary and secondary outcome parameters. At endpoint, there was no statistically significant difference between treatment groups for all clinical primary and secondary outcome variables. Study participation, irrespective of the intervention, lessened symptoms of apathy according to the informant and the clinical investigator. Conclusion Bupropion does not alleviate apathy in HD. However, study participation/placebo effects were observed, which document the need for carefully controlled trials when investigating therapeutic interventions for the neuropsychiatric symptoms of HD. Trial registration ClinicalTrials.gov 01914965 PMID:28323838

Internet versus face-to-face group cognitive-behavioral therapy for fibromyalgia: A randomized control trial.

PubMed

Vallejo, Miguel A; Ortega, José; Rivera, Javier; Comeche, María I; Vallejo-Slocker, Laura

2015-09-01

The aim of this study was to explore the effectiveness of Internet-delivered cognitive-behavioral therapy (iCBT) in treating fibromyalgia (FM) compared with an identical protocol using conventional group face-to-face CBT. Sixty participants were assigned to either (a) the waiting list group, (b) the CBT group, or (c) the iCBT group. The groups were assessed at baseline, after 10 weeks of treatment, and at 3-, 6-, and 12-month follow-ups. The primary outcome measured was the impact of FM on daily functioning, as measured by the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcomes were psychological distress, depression, and cognitive variables, including self-efficacy, catastrophizing, and coping strategies. In post-treatment, only the CBT group showed improvement in the primary outcome. The CBT and iCBT groups both demonstrated improvement in psychological distress, depression, catastrophizing, and utilizing relaxation as a coping strategy. The iCBT group showed an improvement in self-efficacy that was not obtained in the CBT group. CBT and iCBT were dissimilar in efficacy at follow-up. The iCBT group members improved their post-treatment scores at their 6- and 12-month follow-ups. At the 12-month follow-up, the iCBT group showed improvement over their primary outcome and catastrophizing post-treatment scores. A similar effect of CBT was expected, but the positive results observed at the post-treatment assessment were not maintained at follow-up. The results suggest that some factors, such as self-efficacy or catastrophizing, could be enhanced by iCBT. Specific characteristics of iCBT may potentiate the social support needed to improve treatment adherence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Acculturation and Outcomes among Patients with Heart Failure

PubMed Central

Peterson, Pamela N.; Campagna, Elizabeth J.; Maravi, Moises; Allen, Larry A.; Bull, Sheana; Steiner, John F.; Havranek, Edward P.; Dickinson, L. Miriam; Masoudi, Frederick A

2013-01-01

Background Acculturation to U.S. society among minority patients may influence health outcomes beyond race and ethnicity alone. In particular, those who are foreign-born and who do not speak English as their primary language may have greater challenges interacting with the health care system and thus be at greater risk for adverse outcomes. Methods and Results We studied patients hospitalized with a principal discharge diagnosis of HF between January 2000 and December 2007 in an integrated delivery system that cares for minority patients. Individuals were defined as having low acculturation if their primary language was not English and their country of birth was outside of the U.S. Multivariable logistic regression and Cox proportional hazards regression were used to determine the independent risk of 30-day rehospitalization and 1-year mortality, respectively. Candidate adjustment variables included demographics (age, gender, race/ethnicity), coexisting illnesses, laboratory values, left ventricular systolic function, and characteristics of the index admission. Of 1,268 patients, 30% (n=379) were Black, 39% (n=498) Hispanic, and 27% (n= 348) White. Eighteen percent (n=228) had low acculturation. After adjustment, low acculturation was associated with a higher risk of readmission at 30 days (OR 1.70; 95% CI 1.07-2.68) but not 1-year all-cause mortality (HR 0.69; 95% CI 0.42-1.14). Conclusions Patients with HF who are foreign-born and do not speak English as their primary language have a greater risk of rehospitalization, independent of clinical factors and race/ethnicity. Future studies should evaluate whether culturally concordant interventions focusing on such patients may improve outcomes for this patient population. PMID:22247483

Rationale and design of the Staying Positive with Arthritis (SPA) Study: A randomized controlled trial testing the impact of a positive psychology intervention on racial disparities in pain.

PubMed

Hausmann, Leslie R M; Ibrahim, Said A; Kwoh, C Kent; Youk, Ada; Obrosky, D Scott; Weiner, Debra K; Vina, Ernest; Gallagher, Rollin M; Mauro, Genna T; Parks, Acacia

2018-01-01

Knee osteoarthritis is a painful, disabling condition that disproportionately affects African Americans. Existing arthritis treatments yield small to moderate improvements in pain and have not been effective at reducing racial disparities in the management of pain. The biopsychosocial model of pain and evidence from the positive psychology literature suggest that increasing positive psychological skills (e.g., gratitude, kindness) could improve pain and functioning and reduce disparities in osteoarthritis pain management. Activities to cultivate positive psychological skills have been developed and validated; however, they have not been tested in patients with osteoarthritis, their effects on racial differences in health outcomes have not been examined, and evidence of their effects on health outcomes in patients with other chronic illnesses is of limited quality. In this article we describe the rationale and design of Staying Positive with Arthritis (SPA) study, a randomized controlled trial in which 180 African American and 180 White primary care patients with chronic pain from knee osteoarthritis will be randomized to a 6-week program of either positive skill-building activities or neutral control activities. The primary outcomes will be self-reported pain and functioning as measured by the WOMAC Osteoarthritis Index. We will assess these primary outcomes and potential, exploratory psychosocial mediating variables at an in-person baseline visit and by telephone at 1, 3, and 6months following completion of the assigned program. If effective, the SPA program would be a novel, theoretically-informed psychosocial intervention to improve quality and equity of care in the management of chronic pain from osteoarthritis. Published by Elsevier Inc.

Double blind randomised controlled trial of two different breathing techniques in the management of asthma

PubMed Central

Slader, C A; Reddel, H K; Spencer, L M; Belousova, E G; Armour, C L; Bosnic‐Anticevich, S Z; Thien, F C K; Jenkins, C R

2006-01-01

Background Previous studies have shown that breathing techniques reduce short acting β2 agonist use and improve quality of life (QoL) in asthma. The primary aim of this double blind study was to compare the effects of breathing exercises focusing on shallow nasal breathing with those of non‐specific upper body exercises on asthma symptoms, QoL, other measures of disease control, and inhaled corticosteroid (ICS) dose. This study also assessed the effect of peak flow monitoring on outcomes in patients using breathing techniques. Methods After a 2 week run in period, 57 subjects were randomised to one of two breathing techniques learned from instructional videos. During the following 30 weeks subjects practised their exercises twice daily and as needed for relief of symptoms. After week 16, two successive ICS downtitration steps were attempted. The primary outcome variables were QoL score and daily symptom score at week 12. Results Overall there were no clinically important differences between the groups in primary or secondary outcomes at weeks 12 or 28. The QoL score remained unchanged (0.7 at baseline v 0.5 at week 28, p = 0.11 both groups combined), as did lung function and airway responsiveness. However, across both groups, reliever use decreased by 86% (p<0.0001) and ICS dose was reduced by 50% (p<0.0001; p>0.10 between groups). Peak flow monitoring did not have a detrimental effect on asthma outcomes. Conclusion Breathing techniques may be useful in the management of patients with mild asthma symptoms who use a reliever frequently, but there is no evidence to favour shallow nasal breathing over non‐specific upper body exercises. PMID:16517572

Double blind randomised controlled trial of two different breathing techniques in the management of asthma.

PubMed

Slader, C A; Reddel, H K; Spencer, L M; Belousova, E G; Armour, C L; Bosnic-Anticevich, S Z; Thien, F C K; Jenkins, C R

2006-08-01

Previous studies have shown that breathing techniques reduce short acting beta(2) agonist use and improve quality of life (QoL) in asthma. The primary aim of this double blind study was to compare the effects of breathing exercises focusing on shallow nasal breathing with those of non-specific upper body exercises on asthma symptoms, QoL, other measures of disease control, and inhaled corticosteroid (ICS) dose. This study also assessed the effect of peak flow monitoring on outcomes in patients using breathing techniques. After a 2 week run in period, 57 subjects were randomised to one of two breathing techniques learned from instructional videos. During the following 30 weeks subjects practised their exercises twice daily and as needed for relief of symptoms. After week 16, two successive ICS downtitration steps were attempted. The primary outcome variables were QoL score and daily symptom score at week 12. Overall there were no clinically important differences between the groups in primary or secondary outcomes at weeks 12 or 28. The QoL score remained unchanged (0.7 at baseline v 0.5 at week 28, p = 0.11 both groups combined), as did lung function and airway responsiveness. However, across both groups, reliever use decreased by 86% (p<0.0001) and ICS dose was reduced by 50% (p<0.0001; p>0.10 between groups). Peak flow monitoring did not have a detrimental effect on asthma outcomes. Breathing techniques may be useful in the management of patients with mild asthma symptoms who use a reliever frequently, but there is no evidence to favour shallow nasal breathing over non-specific upper body exercises.

Food insecurity, depression and the modifying role of social support among people living with HIV/AIDS in rural Uganda.

PubMed

Tsai, Alexander C; Bangsberg, David R; Frongillo, Edward A; Hunt, Peter W; Muzoora, Conrad; Martin, Jeffrey N; Weiser, Sheri D

2012-06-01

Depression is common among people living with HIV/AIDS and contributes to a wide range of worsened HIV-related outcomes, including AIDS-related mortality. Targeting modifiable causes of depression, either through primary or secondary prevention, may reduce suffering as well as improve HIV-related outcomes. Food insecurity is a pervasive source of uncertainty for those living in resource-limited settings, and cross-sectional studies have increasingly recognized it as a critical determinant of poor mental health. Using cohort data from 456 men and women living with HIV/AIDS initiating HIV antiretroviral therapy in rural Uganda, we sought to (a) estimate the association between food insecurity and depression symptom severity, (b) assess the extent to which social support may serve as a buffer against the adverse effects of food insecurity, and (c) determine whether the buffering effects are specific to certain types of social support. Quarterly data were collected by structured interviews and blood draws. The primary outcome was depression symptom severity, measured by a modified Hopkins Symptom Checklist for Depression. The primary explanatory variables were food insecurity, measured with the Household Food Insecurity Access Scale, and social support, measured with a modified version of the Functional Social Support Questionnaire. We found that food insecurity was associated with depression symptom severity among women but not men, and that social support buffered the impacts of food insecurity on depression. We also found that instrumental support had a greater buffering influence than emotional social support. Interventions aimed at improving food security and strengthening instrumental social support may have synergistic beneficial effects on both mental health and HIV outcomes among PLWHA in resource-limited settings. Copyright © 2012 Elsevier Ltd. All rights reserved.

Is balneotherapy effective for fibromyalgia? Results from a 6-month double-blind randomized clinical trial.

PubMed

Fioravanti, Antonella; Manica, Patrizia; Bortolotti, Roberto; Cevenini, Gabriele; Tenti, Sara; Paolazzi, Giuseppe

2018-05-05

The aim of this study was to assess the efficacy and tolerability of balneotherapy (BT) in patients with primary fibromyalgia syndrome (FS). In a prospective, randomized, controlled, double-blind trial with a 6-month follow-up, 100 FS patients were randomized to receive a cycle of BT with highly mineralized sulfate water (BT group) or with tap water (control group). Clinical assessments were performed at screening visit, at basal time, and after treatment (2 weeks, 3 and 6 months). The primary outcome measures were the change of global pain on the Visual Analogue Scale (VAS) and Fibromyalgia Impact Questionnaire total score (FIQ-Total) from baseline to 15 days. Secondary outcomes included Widespread Pain Index, Symptom Severity Scale Score, Short Form Health Survey, State-Trait Anxiety Inventory (STAI), and Center for Epidemiologic Studies Depression Scale. We performed an intent-to-treat analysis. The Kolmogorov-Smirnov test was applied to verify the normality distribution of all quantitative variables and the Student's t test to compare sample data. In the BT group, we observed a significant improvement of VAS and FIQ-Total at the end of the treatment that persisted until 6 months, while no significant differences were found in the control group. The differences between groups were significant for primary parameters at each time point. Similar results were obtained for the other secondary outcomes except for the STAI outcome. Adverse events were reported by 10 patients in the BT group and by 22 patients in the control group. Our results support the short- and long-term therapeutic efficacy of BT in FS. NCT02548065.

Characteristics, management, and depression outcomes of primary care patients who endorse thoughts of death or suicide on the PHQ-9.

PubMed

Bauer, Amy M; Chan, Ya-Fen; Huang, Hsiang; Vannoy, Steven; Unützer, Jürgen

2013-03-01

With increasing emphasis on integrating behavioral health services, primary care providers play an important role in managing patients with suicidal thoughts. To evaluate whether Patient Health Questionnaire-9 (PHQ-9) Item 9 scores are associated with patient characteristics, management, and depression outcomes in a primary care-based mental health program. Observational analysis of data collected from a patient registry. Eleven thousand fifteen adults enrolled in the Mental Health Integration Program (MHIP). MHIP provides integrated mental health services for safety-net populations in over 100 community health centers across Washington State. Key elements of the team-based model include: a disease registry; integrated care management; and organized psychiatric case review. The independent variable, suicidal ideation (SI), was assessed by PHQ-9 Item 9. Depression severity was assessed with the PHQ-8. Outcomes included four indicators of depression treatment process (care manager contact, psychiatric case review, psychotropic medications, and specialty mental health referral), and two indicators of depression outcomes (50 % reduction in PHQ-9 score and PHQ-9 score < 10). SI was common (45.2 %) at baseline, with significantly higher rates among men and patients with greater psychopathology. Few patients with SI (5.4 %) lacked substantial current depressive symptoms. After adjusting for age, gender, and severity of psychopathology, patients with SI received follow-up earlier (care manager contact HR = 1.05, p < 0.001; psychiatric review HR = 1.02, p < 0.05), and were more likely to receive psychotropic medications (OR = 1.11, p = 0.001) and specialty referral (OR = 1.23, p < 0.001), yet were less likely to achieve a PHQ-9 score < 10 (HR = 0.87, p < 0.001). Suicidal thoughts are common among safety-net patients referred by primary care providers for behavioral health care. Scores on Item 9 of the PHQ-9 are easily obtainable in primary care, may help providers initiate conversations about suicidality, and serve as useful markers of psychiatric complexity and treatment-resistance. Patients with positive scores should receive timely and comprehensive psychiatric evaluation and follow-up.

Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. Methods/Design This will be an unblinded, two-group, parallel randomised controlled trial (RCT). The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland: Galway University Hospital and Mayo General Hospital. Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care (n = 392) or secondary care (n = 392) locations. The primary outcome variable is the uptake rate of screening. Secondary outcomes include indicators of clinical effectiveness of screening at each screening site (primary and secondary) including gestational week at time of screening, time to access antenatal diabetes services for women diagnosed with GDM, and pregnancy and neonatal outcomes for women with GDM. In addition, parallel economic and qualitative evaluations will be conducted. The trial will cover the period from the woman’s first hospital antenatal visit at 12 to 18 weeks gestation, until the completion of the pregnancy. Trial registration Current Controlled Trials: ISRCTN02232125 PMID:24438478

A Family-Based Randomized Controlled Trial of Pain Intervention for Adolescents with Sickle Cell Disease

PubMed Central

Barakat, Lamia P.; Schwartz, Lisa A.; Salamon, Katherine S.; Radcliffe, Jerilynn

2010-01-01

The study had two aims--to determine the efficacy of a family-based cognitive-behavioral pain management intervention for adolescents with sickle cell disease (SCD) in (1) reducing pain and improving health-related variables and (2) improving psychosocial outcomes. Each adolescent and a family support person were randomly assigned to receive a brief pain intervention (PAIN) (n = 27) or a disease education attention control intervention (DISEASE ED) (n = 26) delivered at home. Assessment of primary pain and health-related variables (health service use, pain coping, pain-related hindrance of goals) and secondary psychosocial outcomes (disease knowledge, disease self-efficacy, and family communication) occurred at baseline (prior to randomization), post-intervention, and one-year follow-up. Change on outcomes did not differ significantly by group at either time point. When groups were combined in exploratory analyses, there was evidence of small to medium effects of intervention on health-related and psychosocial variables. Efforts to address barriers to participation and improve feasibility of psychosocial interventions for pediatric SCD are critical to advancing development of effective treatments for pain. Sample size was insufficient to adequately test efficacy, and analyses did not support this focused cognitive-behavioral pain management intervention in this sample of adolescents with SCD. Exploratory analyses suggest that comprehensive interventions, that address a broad range of skills related to disease management and adolescent health concerns, may be more effective in supporting teens during healthcare transition. PMID:20686425

Social skills treatment for people with severe, chronic acquired brain injuries: a multicenter trial.

PubMed

McDonald, Skye; Tate, Robyn; Togher, Leanne; Bornhofen, Cristina; Long, Esther; Gertler, Paul; Bowen, Rebecca

2008-09-01

To determine whether social skills deficits including unskilled, inappropriate behavior, problems reading social cues (social perception), and mood disturbances (such as depression and anxiety) could be remediated after severe traumatic brain injuries. Randomized controlled trial comparing a social skills program with social activity alone or with waitlist control. Several participants were reassigned after randomization. Hospital outpatient and community facilities. Fifty-one outpatients from 3 brain injury units in Sydney, Australia, with severe, chronic acquired brain injuries were recruited. A total of 39 people (13 in skills training, 13 in social activity, 13 in waitlist) completed all phases of the study. Twelve-week social skills treatment program encompassing weekly 3-hour group sessions focused on shaping social behavior and remediating social perception and 1-hour individual sessions to address psychologic issues with mood, self-esteem, etc. Primary outcomes were: (1) social behavior during encounters with a confederate as rated on the Behaviorally Referenced Rating System of Intermediary Social Skills-Revised (BRISS-R), (2) social perception as measured by The Awareness of Social Inference Test, and (3) depression and anxiety as measured by the Depression, Anxiety and Stress Scale. Secondary outcomes were: relative report on social behavior and participation using: the Katz Adjustment Scale-R1; the Social Performance Survey Schedule; the La Trobe Communication Questionnaire; and the Sydney Psychosocial Reintegration Scale (both relative and self-report). Repeated-measures analysis of variance indicated that social activity alone did not lead to improved performance relative to waitlist (placebo effect) on any outcome variable. On the other hand, the skills training group improved differentially on the Partner Directed Behavior Scale of the BRISS-R, specifically the self-centered behavior and partner involvement behavior subscales. No treatment effects were found for the remaining primary outcomes (social perception, emotional adjustment) or for secondary outcome variables (relative and self-report measures of social function). This study suggested that treatment effects after social skills training in people with severe, chronic brain injuries are modest and are limited to direct measures of social behavior.

A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes).

PubMed

Biddle, Stuart J H; Edwardson, Charlotte L; Wilmot, Emma G; Yates, Thomas; Gorely, Trish; Bodicoat, Danielle H; Ashra, Nuzhat; Khunti, Kamlesh; Nimmo, Myra A; Davies, Melanie J

2015-01-01

Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time. Adults aged 18-40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables. 187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures. A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change. Moreover, some participants reported a focus on physical activity rather than reductions in sitting per se. The habitual nature of sedentary behaviour means that behaviour change is challenging. Controlled-Trials.com ISRCTN08434554.

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Effects of housing circumstances on health, quality of life and healthcare use for people with severe mental illness: a review.

PubMed

Kyle, Tania; Dunn, James R

2008-01-01

Individuals with severe and persistent mental illness (SPMI) identify housing as an important factor in achieving and maintaining their health. However, many live in substandard accommodations that are physically inadequate, crowded, noisy and located in undesirable neighbourhoods. In much of the research on housing for persons with SPMI, the central outcome of interest is remaining housed; however, it is worth investigating whether housing has other benefits. This paper is a systematic review of studies that investigated the relationship between housing-related independent variables and health-related dependent variables. Ten online databases were searched for studies published since 1980 that had study populations of adults with SPMI, analysed primary or secondary empirical data, and measured housing-related independent variables and health-related dependent variables. Clearly defined epidemiological criteria were used to assess the strength of evidence of the selected studies. Twenty-nine studies met the suitability criteria, of which 14 reported healthcare utilisation outcomes; 12 examined mental status outcomes; and 9 reported quality-of-life outcomes. The findings of the review suggest that there is good evidence that housing interventions benefit the homeless population; however more research is needed about housing solutions for individuals with SPMI who are housed, but in precarious or inappropriate housing situations. Study methodologies could be improved by emphasising longitudinal designs that focus on participant retention and by implementing matched control groups or randomised interventions to strengthen internal validity. Ensuring that a person is adequately housed upon discharge from hospital should be a treatment priority. When housing eligibility is not dependent on psychiatric treatment compliance and sobriety, providing permanent housing minimises harm and may free people to voluntarily seek treatment. Housing that offers an unlimited length of stay is recommended because SPMI is a chronic and fluctuating condition that requires stable surroundings to maintain health.

Age differences in the associations between sick leave and aspects of health, psychosocial workload and family life: a cross-sectional study

PubMed Central

Bos, Judith T; van der Velden, Koos; van der Gulden, Joost W J

2012-01-01

Objectives To investigate differences in associations between sick leave and aspects of health, psychosocial workload, family life and work–family interference between four age groups (<36, 36–45, 46–55 and 55+ years). Design A cross-sectional study; a questionnaire was sent to the home addresses of all employees of a university. Setting A Dutch university. Participants 1843 employees returned the questionnaire (net response: 49.1%). The age distribution was as follows: <36: 32%; 36–45: 26%; 46–55: 27% and 55+: 12%. Primary outcomes Frequent sick leave (FSL, ≥3 times in the past 12 months) and prolonged sick leave (PSL, >2 weeks in total in the past 12 months). Differences between the age groups in independent variables and outcomes were investigated. Logistic regression analysis was used to calculate associations between various variables and the sick leave outcomes. Interaction terms were included to detect differences between the age groups. Results Age differences were found for many work- and family-related characteristics but not in the mean scores for health-related aspects. Presence of chronic disease was reported more frequently with increasing age. The 55+ age group had almost two times less chance of FSL, but 1.6 times more chance of PSL than the <36 age group. Age moderates the associations between career opportunities, partner's contribution in domestic tasks and sex, and FSL. Job security and pay, support from supervisor, challenging work and being breadwinner have different associations with PSL. However, life events in private lives and perceived health complaints are important in all age groups. FSL and PSL have some determinants in common, but there are differences between the outcomes as well. Conclusions Age should be treated as a variable of interest instead of a control variable. Employers and occupational physicians need to be aware that each phase in life has specific difficulties that can lead to FSL and PSL. PMID:22855622

Fournier's gangrene: an analysis of repeated surgical debridement.

PubMed

Chawla, Sam N; Gallop, Christina; Mydlo, Jack H

2003-05-01

We wanted to determine if there was a difference in outcome for those patients with Fournier's disease who underwent numerous debridements as opposed to only one initial debridement. The records of 19 patients with the diagnosis of Fournier's gangrene were reviewed retrospectively at our institution. Special attention was placed on demographic data, primary managing service, as well as wound cultures, and the number and timing of surgical debridements. Patients were also classified by a collection of variables at presentation and given a score named the Fournier's Severity Index. We utilised the Fournier's Severity Index (FSI) as developed by Laor et al. which included a number of vital sign data as well as laboratory values collected at admission in the emergency room. The average FSI was 9.1 ranging from 0 to 15. The mean FSI of survivors was 8.6 versus 12.4 of non-survivors. The surgical management of this disease process was also critically examined. The average number of repeated debridements was 3.5 ranging from 1 to 8. Both the FSI and the number of debridements were attempted to be used to predict outcome. Outcome was measured in the variables length of stay (days) and survival. A regression analysis revealed the number of debridements to be positively related to the length of stay (LOS). This was the opposite as expected at the beginning of the study. Also FSI was not predictive of LOS. Fournier's gangrene is a disease process with a wide variability in presentation. The FSI does give some indication about the likelihood of survival based on variables which can be recorded upon presentation. It also provides an efficient way to characterize the acuity of presentation and compare patients. While the repeated nature of debridements may be considered the accepted standard of care in these patients, this was not found to be predictive of outcome.

A systematic review of preoperative determinants of patient-reported pain and physical function up to 2 years following primary unilateral total hip arthroplasty.

PubMed

Lungu, E; Maftoon, S; Vendittoli, P-A; Desmeules, F

2016-05-01

Although generally considered successful, total hip arthroplasty (THA) can yield suboptimal results in terms of pain and function in up to one forth of patients suffering from hip osteoarthritis (OA). A thorough understanding of the determinants of patient-reported pain and function following THA can help plan interventions directed at improving surgical results. Previously published systematic reviews do not permit to confidently identify the determinants of THA outcomes because of unsatisfactory methodological designs. Therefore, we aimed to answer: (1) which preoperative factors are most consistently associated with postoperative patient-reported pain and function up to 2 years following primary unilateral THA for hip OA. Medline, Pubmed, Embase and CINAHL were screened from their respective inception dates until April 2015 using a combination of keywords and MESH terms. Criteria for inclusion were: (1) participants with primary unilateral THA for hip OA followed for at least 3 months with a maximal follow-up of 2 years; (2) validated disease-specific patient-reported outcome measures assessing pain and/or disability; (3) identification of determinants obtained via multivariate analyses. Methodological quality was assessed using a modified version of the methodology checklist for prognostic studies. Twenty-two manuscripts were included. Mean score of the methodological quality was 81.0±10.3% (66.7% to 100%). Among socioeconomic determinants, a lower educational level was significantly related to worse pain and function (3 out of 3 studies evaluating the relationship). Clinical determinants of poor outcomes included preoperative levels of pain and physical function (9 out of 12 studies), higher body mass index (6 out of 10 studies), presence/greater level of comorbidities (7 out of 8), worse general health (4 out of 4 studies) and lower radiographic OA severity (3 out of 4 studies). Study heterogeneity limited the pooled assessment of the strength of associations between the preoperative variables and THA outcomes. Studies with moderate-to-high methodological quality allowed to identify 6 preoperative variables consistently associated with medium term pain and function following THA. This knowledge may assist the management of patients at risk of poor results. Further research is required to clarify the force of associations between determinants and THA outcomes. Level II. Systematic review of cohort studies. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

The use of errorless learning strategies for patients with Alzheimer's disease: a literature review.

PubMed

Li, Ruijie; Liu, Karen P Y

2012-12-01

The aim of this article was to review the evidence of errorless learning on learning outcomes in patients with early-stage Alzheimer's disease. A computer-aided literature search from 1999 to 2011 was carried out using MEDLINE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and PsycArticles. Keywords included 'errorless learning or practice' and 'Alzheimer's disease'. Four studies that fulfilled the inclusion criteria were selected and reviewed. Two of the studies were clinical controlled trials: one was a single-group pretest-post-test trial and the other was a multiple single-participant study. Demographic variables, design, treatment and outcome measures were summarized. Recall trials were used as the primary outcome measure. Results indicate that the use of errorless learning promotes better retention of specific types of information. Errorless learning is effective in memory rehabilitation of older adults with Alzheimer's disease. However, it would require more studies with unified outcome measures to allow for the formulation of standardized clinical protocol and recommendations.

The business case for nursing in long-term care.

PubMed

Horn, Susan D

2008-05-01

Lower nurse staffing in hospitals has been associated with adverse patient outcomes; results in nursing homes (NHs) are less clear. We examined the association between nurses' direct care time and outcomes in long-stay NH residents and potential cost savings from decreased adverse outcomes versus additional wages for adequate nurse staffing. Data were from the National Pressure Ulcer Long-Term Care Study of 1,376 at-risk residents from 82 NHs. Primary data came from medical records. Hospital, pressure ulcer (PrU) treatment, and urinary tract infection (UTI) costs were from national statistics or cost-identification studies. Time horizon was 1 year. More registered nurse (RN) direct care time/resident/day was associated with fewer PrUs, hospitalizations, and UTIs. Annual net societal benefit was $3,191/resident/year in high-risk NH units with 30-40 min of RN time/resident/day versus units with <10 min. Thus, after controlling for important variables, more RN time/day was strongly associated with better outcomes and lower societal cost.

Intraindividual Cognitive Variability in Middle Age Predicts Cognitive Impairment 8-10 Years Later: Results from the Wisconsin Registry for Alzheimer's Prevention.

PubMed

Koscik, Rebecca L; Berman, Sara E; Clark, Lindsay R; Mueller, Kimberly D; Okonkwo, Ozioma C; Gleason, Carey E; Hermann, Bruce P; Sager, Mark A; Johnson, Sterling C

2016-11-01

Intraindividual cognitive variability (IICV) has been shown to differentiate between groups with normal cognition, mild cognitive impairment (MCI), and dementia. This study examined whether baseline IICV predicted subsequent mild to moderate cognitive impairment in a cognitively normal baseline sample. Participants with 4 waves of cognitive assessment were drawn from the Wisconsin Registry for Alzheimer's Prevention (WRAP; n=684; 53.6(6.6) baseline age; 9.1(1.0) years follow-up; 70% female; 74.6% parental history of Alzheimer's disease). The primary outcome was Wave 4 cognitive status ("cognitively normal" vs. "impaired") determined by consensus conference; "impaired" included early MCI (n=109), clinical MCI (n=11), or dementia (n=1). Primary predictors included two IICV variables, each based on the standard deviation of a set of scores: "6 Factor IICV" and "4 Test IICV". Each IICV variable was tested in a series of logistic regression models to determine whether IICV predicted cognitive status. In exploratory analyses, distribution-based cutoffs incorporating memory, executive function, and IICV patterns were used to create and test an MCI risk variable. Results were similar for the IICV variables: higher IICV was associated with greater risk of subsequent impairment after covariate adjustment. After adjusting for memory and executive functioning scores contributing to IICV, IICV was not significant. The MCI risk variable also predicted risk of impairment. While IICV in middle-age predicts subsequent impairment, it is a weaker risk indicator than the memory and executive function scores contributing to its calculation. Exploratory analyses suggest potential to incorporate IICV patterns into risk assessment in clinical settings. (JINS, 2016, 22, 1016-1025).

Socioeconomic factors and effect of evidence-based patient information about primary prevention of type 2 diabetes mellitus--are there interactions?

PubMed

Genz, Jutta; Haastert, Burkhard; Müller, Hardy; Verheyen, Frank; Cole, Dennis; Rathmann, Wolfgang; Nowotny, Bettina; Roden, Michael; Giani, Guido; Ohmann, Christian; Icks, Andrea

2014-08-18

Having shown in a recent randomized controlled trial that evidence-based patient information (EBPI) significantly increased knowledge on primary prevention of diabetes compared to standard patient information, we now investigated interaction between socioeconomic status (SES) and the effect of an EBPI. 1,120 visitors (aged 40-70 years, without known diabetes) to the "Techniker Krankenkasse" and the "German Diabetes Center" websites were randomized. The intervention group received a newly developed on-line EBPI, the control group standard on-line information. The primary outcome measure was knowledge, classified as "good/average/poor". We analyzed associations of knowledge with socioeconomic variables (education, vocational training, employment, subjective social status) combined with intervention effect including interactions, adjusted for possible confounding by knowledge before intervention, self-reported blood glucose measurements, blood pressure, blood lipid levels, age and gender. Logistic regression models were fitted to the subpopulation (n = 647) with complete values in these variables.Education (high vs. low) was significantly associated with knowledge (good vs. average/poor); however, there was no significant interaction between education and intervention. After adjustment, the other socioeconomic variables were not significantly associated with knowledge. Socioeconomic variables did not significantly change the effect of the intervention. There was a tendency towards a lower effect where lower educated individuals were concerned. Possibly the power was too low to detect interaction effects. Larger studies using SES-specific designs are needed to clarify the effect of SES. We suggest considering the socioeconomic status when evaluating a decision aid, e.g. an EBPI, to ensure its effectiveness not only in higher socioeconomic groups. Current Controlled Trials ISRCTN22060616 (Date assigned: 12 September 2008).

A group-randomized controlled trial for health promotion in Girl Scouts: healthier troops in a SNAP (Scouting Nutrition & Activity Program).

PubMed

Rosenkranz, Richard R; Behrens, Timothy K; Dzewaltowski, David A

2010-02-19

Girl Scouting may offer a viable channel for health promotion and obesity prevention programs. This study evaluated the effectiveness of an intervention program delivered through Girl Scout Junior troops that was designed to foster healthful troop meeting environments and increase obesity prevention behaviors at home. Seven Girl Scout troops were randomized to intervention (n = 3, with 34 girls) or standard-care control (n = 4, with 42 girls) conditions. Girls ranged in age from 9 to 13 years (mean 10.5 years). Intervention troop leaders were trained to implement policies promoting physical activity (PA) and healthful eating opportunities at troop meetings, and to implement a curriculum promoting obesity-prevention behaviors at home. The primary outcome variable was child body mass index (BMI) z-score. Secondary outcomes included accelerometer-assessed PA levels in troop meetings, direct observations of snack offerings, time spent in physically active meeting content, and leader encouragement of PA and healthful eating. The intervention was delivered with good fidelity, and intervention troops provided greater opportunities for healthful eating and PA (x2 = 210.8, p < .001), relative to control troops. In troop meetings, intervention troop leaders promoted PA (x2 = 23.46, p < .001) and healthful eating (x2 = 18.14, p < .001) more frequently, and discouraged healthful eating and PA less frequently (x2 = 9.63, p = .002) compared to control troop leaders. Most effects of the intervention on individual-level variables of girls and parents were not significantly different from the control condition, including the primary outcome of child BMI z-score (F1, 5 = 0.42, p = .544), parent BMI (F1, 5 = 1.58, p = .264), and related behavioral variables. The notable exception was for objectively assessed troop PA, wherein girls in intervention troops accumulated significantly less sedentary (x2 = 6.3, p = .011), significantly more moderate (x2 = 8.2, p = .004), and more moderate-to-vigorous physical activity, (x2 = 18.4, p < .001), than girls in control troops. Implementing a health promotion curriculum and supporting policies to provide more healthful environments in Girl Scout troop meetings appears feasible on a broader scale. Additional work is needed to bridge health promotion from such settings to other environments if lasting individual-level behavior change and obesity prevention remain targeted outcomes. NCT00949637.

Role of tear location on outcomes of open primary repair of the anterior cruciate ligament: A systematic review of historical studies.

PubMed

van der List, Jelle P; DiFelice, Gregory S

2017-10-01

The general opinion is that outcomes of open primary repair of the anterior cruciate ligament (ACL) in the historical literature were disappointing. Since good outcomes of primary repair of proximal tears have recently been reported, we aimed to assess the role of tear location on open primary repair outcomes in the historical literature. All studies reporting outcomes of open primary ACL repair published between the inception of PubMed, Embase and Cochrane and 2000 were identified. Studies were included if tear location was reported. Outcome scores, return to sports, stability examinations, failures and patient satisfaction were collected and reviewed in the total study cohort and in a subgroup of studies treating only proximal tears. Spearman correlation analysis was performed between the percentage of proximal tears in the studies and all outcomes. Twenty-nine studies were included reporting outcomes of open primary in 1457 patients of which 72% had proximal and 23% midsubstance tears. Mean age was 30years, 65% were males, and mean follow-up was 3.6years. Good outcomes were noted in the total cohort, and excellent outcomes were noted following repair of proximal tears. Positive correlation was found between the percentage proximal tears in the studies and percentage satisfied patients (p=0.010). Tear location seems to have played a role on the outcomes of open primary ACL repair. Outcomes of open primary repair in patients with proximal tears were excellent, which confirms there may be a potential role for primary repair as treatment for proximal ACL tears. Copyright © 2017 Elsevier B.V. All rights reserved.

Resident Participation in Fixation of Intertrochanteric Hip Fractures: Analysis of the NSQIP Database.

PubMed

Neuwirth, Alexander L; Stitzlein, Russell N; Neuwirth, Madalyn G; Kelz, Rachel K; Mehta, Samir

2018-01-17

Future generations of orthopaedic surgeons must continue to be trained in the surgical management of hip fractures. This study assesses the effect of resident participation on outcomes for the treatment of intertrochanteric hip fractures. The National Surgical Quality Improvement Program (NSQIP) database (2010 to 2013) was queried for intertrochanteric hip fractures (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] code 820.21) treated with either extramedullary (Current Procedural Terminology [CPT] code 27244) or intramedullary (CPT code 27245) fixation. Demographic variables, including resident participation, as well as primary (death and serious morbidity) and secondary outcome variables were extracted for analysis. Univariate, propensity score-matched, and multivariate logistic regression analyses were performed to evaluate outcome variables. Data on resident participation were available for 1,764 cases (21.0%). Univariate analyses for all intertrochanteric hip fractures demonstrated no significant difference in 30-day mortality (6.3% versus 7.8%; p = 0.264) or serious morbidity (44.9% versus 43.2%; p = 0.506) between the groups with and without resident participation. Multivariate and propensity score-matched analyses gave similar results. Resident involvement was associated with prolonged operating-room time, length of stay, and time to discharge when a prolonged case was defined as one above the 90th percentile for time parameters. Resident participation was not associated with an increase in morbidity or mortality but was associated with an increase in time-related secondary outcome measures. While attending surgeon supervision is necessary, residents can and should be involved in the care of these patients without concern that resident involvement negatively impacts perioperative morbidity and mortality. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Psychosocial work environment and prediction of quality of care indicators in one Canadian health center.

PubMed

Paquet, Maxime; Courcy, François; Lavoie-Tremblay, Mélanie; Gagnon, Serge; Maillet, Stéphanie

2013-05-01

Few studies link organizational variables and outcomes to quality indicators. This approach would expose operant mechanisms by which work environment characteristics and organizational outcomes affect clinical effectiveness, safety, and quality indicators. What are the predominant psychosocial variables in the explanation of organizational outcomes and quality indicators (in this case, medication errors and length of stay)? The primary objective of this study was to link the fields of evidence-based practice to the field of decision making, by providing an effective model of intervention to improve safety and quality. The study involved healthcare workers (n = 243) from 13 different care units of a university affiliated health center in Canada. Data regarding the psychosocial work environment (10 work climate scales, effort/reward imbalance, and social support) was linked to organizational outcomes (absenteeism, turnover, overtime), to the nurse/patient ratio and quality indicators (medication errors and length of stay) using path analyses. The models produced in this study revealed a contribution of some psychosocial factors to quality indicators, through an indirect effect of personnel- or human resources-related variables, more precisely: turnover, absenteeism, overtime, and nurse/patient ratio. Four perceptions of work environment appear to play an important part in the indirect effect on both medication errors and length of stay: apparent social support from supervisors, appreciation of the workload demands, pride in being part of one's work team, and effort/reward balance. This study reveals the importance of employee perceptions of the work environment as an indirect predictor of quality of care. Working to improve these perceptions is a good investment for loyalty and attendance. In general, better personnel conditions lead to fewer medication errors and shorter length of stay. © Sigma Theta Tau International.

CuidaCare: effectiveness of a nursing intervention on the quality of life’s caregiver: cluster-randomized clinical trial

PubMed Central

2014-01-01

Background In Spain, family is the main source of care for dependent people. Numerous studies suggest that providing informal (unpaid) care during a prolonged period of time results in a morbidity-generating burden. Caregivers constitute a high-risk group that experiences elevated stress levels, which reduce their quality of life. Different strategies have been proposed to improve management of this phenomenon in order to minimize its impact, but definitive conclusions regarding their effectiveness are lacking. Methods/Design A community clinical trial is proposed, with a 1-year follow-up period, that is multicentric, controlled, parallel, and with randomized allocation of clusters in 20 health care centers within the Community of Madrid. The study's objective is to evaluate the effectiveness of a standard care intervention in primary health care (intervention CuidaCare) to improve the quality of life of the caregivers, measured at 0, 6, and 12 months after the intervention. One hundred and forty two subjects (71 from each group) ≥65 years, identified by the nurse as the main caregivers, and who provide consent to participate in the study will be included. The main outcome variable will be perceived quality of life as measured by the Visual Analogue Scale (VAS) of EuroQol-5D (EQ-5D). The secondary outcome variables will be EQ-5D Dimensions, EQ-5D Index, nursing diagnosis, and Zarit's test. Prognostic variables will be recorded for the dependent patient and the caregiver. The principle analysis will be done by comparing the average change in EQ-5D VAS value before and after intervention between the two groups. All statistical tests will be performed as intention-to-treat. Prognostic factors' estimates will be adjusted by mixed-effects regression models. Possible confounding or effect-modifying factors will be taken into account. Discussion Assistance for the caregiver should be integrated into primary care services. In order to do so, incorporating standard, effective interventions with relevant outcome variables such as quality of life is necessary. Community care nurses are at a privileged position to develop interventions like the proposed one. Trial registration This trial has been registered in ClinicalTrials.gov under code number NCT 01478295. PMID:24467767

Variability of antibiotic prescribing in patients with chronic obstructive pulmonary disease exacerbations: a cohort study.

PubMed

Boggon, Rachael; Hubbard, Richard; Smeeth, Liam; Gulliford, Martin; Cassell, Jackie; Eaton, Susan; Pirmohamed, Munir; van Staa, Tjeerd-Pieter

2013-05-31

The role of antibiotics in treating mild or moderate exacerbations in patients with acute chronic obstructive pulmonary disease (COPD) is unclear. The aims were to: (i) describe patient characteristics associated with acute exacerbations amongst a representative COPD population, (ii) explore the relationship between COPD severity and outcomes amongst patients with exacerbations, and (iii) quantify variability by general practice in prescribing of antibiotics for COPD exacerbations. A cohort of 62,747 patients with COPD was identified from primary care general practices (GP) in England, and linked to hospital admission and death certificate data. Exacerbation cases were matched to three controls and characteristics compared using conditional logistic regression. Outcomes were compared using incidence rates and Cox regression, stratified by disease severity. Variability of prescribing at the GP level was evaluated graphically and by using multilevel models. COPD severity was found to be associated with exacerbation and subsequent mortality (very severe vs. mild, odds ratio for exacerbation 2.12 [95%CI 19.5-2.32]), hazard ratio for mortality 2.14 [95%CI 1.59-2.88]). Whilst 61% of exacerbation cases were prescribed antibiotics, this proportion varied considerably between GP practices (interquartile range, 48-73%). This variation is greater than can be explained by patient characteristics alone. There is significant variability between GP practices in the prescribing of antibiotics to COPD patients experiencing exacerbations. Combined with a lack of evidence on the effects of treatment, this supports the need and opportunity for a large scale pragmatic randomised trial of the prescribing of antibiotics for COPD patients with exacerbations, in order to clarify their effectiveness and long term outcomes whilst ensuring the representativeness of subjects.

Variability of antibiotic prescribing in patients with chronic obstructive pulmonary disease exacerbations: a cohort study

PubMed Central

2013-01-01

Background The role of antibiotics in treating mild or moderate exacerbations in patients with acute chronic obstructive pulmonary disease (COPD) is unclear. The aims were to: (i) describe patient characteristics associated with acute exacerbations amongst a representative COPD population, (ii) explore the relationship between COPD severity and outcomes amongst patients with exacerbations, and (iii) quantify variability by general practice in prescribing of antibiotics for COPD exacerbations. Method A cohort of 62,747 patients with COPD was identified from primary care general practices (GP) in England, and linked to hospital admission and death certificate data. Exacerbation cases were matched to three controls and characteristics compared using conditional logistic regression. Outcomes were compared using incidence rates and Cox regression, stratified by disease severity. Variability of prescribing at the GP level was evaluated graphically and by using multilevel models. Results COPD severity was found to be associated with exacerbation and subsequent mortality (very severe vs. mild, odds ratio for exacerbation 2.12 [95%CI 19.5–2.32]), hazard ratio for mortality 2.14 [95%CI 1.59–2.88]). Whilst 61% of exacerbation cases were prescribed antibiotics, this proportion varied considerably between GP practices (interquartile range, 48–73%). This variation is greater than can be explained by patient characteristics alone. Conclusions There is significant variability between GP practices in the prescribing of antibiotics to COPD patients experiencing exacerbations. Combined with a lack of evidence on the effects of treatment, this supports the need and opportunity for a large scale pragmatic randomised trial of the prescribing of antibiotics for COPD patients with exacerbations, in order to clarify their effectiveness and long term outcomes whilst ensuring the representativeness of subjects. PMID:23724907

Exact tests using two correlated binomial variables in contemporary cancer clinical trials.

PubMed

Yu, Jihnhee; Kepner, James L; Iyer, Renuka

2009-12-01

New therapy strategies for the treatment of cancer are rapidly emerging because of recent technology advances in genetics and molecular biology. Although newer targeted therapies can improve survival without measurable changes in tumor size, clinical trial conduct has remained nearly unchanged. When potentially efficacious therapies are tested, current clinical trial design and analysis methods may not be suitable for detecting therapeutic effects. We propose an exact method with respect to testing cytostatic cancer treatment using correlated bivariate binomial random variables to simultaneously assess two primary outcomes. The method is easy to implement. It does not increase the sample size over that of the univariate exact test and in most cases reduces the sample size required. Sample size calculations are provided for selected designs.

Hyperchloremia Is Associated With Complicated Course and Mortality in Pediatric Patients With Septic Shock.

PubMed

Stenson, Erin K; Cvijanovich, Natalie Z; Anas, Nick; Allen, Geoffrey L; Thomas, Neal J; Bigham, Michael T; Weiss, Scott L; Fitzgerald, Julie C; Checchia, Paul A; Meyer, Keith; Quasney, Michael; Hall, Mark; Gedeit, Rainer; Freishtat, Robert J; Nowak, Jeffrey; Raj, Shekhar S; Gertz, Shira; Grunwell, Jocelyn R; Wong, Hector R

2018-02-01

Hyperchloremia is associated with poor outcome among critically ill adults, but it is unknown if a similar association exists among critically ill children. We determined if hyperchloremia is associated with poor outcomes in children with septic shock. Retrospective analysis of a pediatric septic shock database. Twenty-nine PICUs in the United States. Eight hundred ninety children 10 years and younger with septic shock. None. We considered the minimum, maximum, and mean chloride values during the initial 7 days of septic shock for each study subject as separate hyperchloremia variables. Within each category, we considered hyperchloremia as a dichotomous variable defined as a serum concentration greater than or equal to 110 mmol/L. We used multivariable logistic regression to determine the association between the hyperchloremia variables and outcome, adjusted for illness severity. We considered all cause 28-day mortality and complicated course as the primary outcome variables. Complicated course was defined as mortality by 28 days or persistence of greater than or equal to two organ failures at day 7 of septic shock. Secondarily, we conducted a stratified analysis using a biomarker-based mortality risk stratification tool. There were 226 patients (25%) with a complicated course and 93 mortalities (10%). Seventy patients had a minimum chloride greater than or equal to 110 mmol/L, 179 had a mean chloride greater than or equal to 110 mmol/L, and 514 had a maximum chloride greater than or equal to 110 mmol/L. A minimum chloride greater than or equal to 110 mmol/L was associated with increased odds of complicated course (odds ratio, 1.9; 95% CI, 1.1-3.2; p = 0.023) and mortality (odds ratio, 3.7; 95% CI, 2.0-6.8; p < 0.001). A mean chloride greater than or equal to 110 mmol/L was also associated with increased odds of mortality (odds ratio, 2.1; 95% CI, 1.3-3.5; p = 0.002). The secondary analysis yielded similar results. Hyperchloremia is independently associated with poor outcomes among children with septic shock.

Depression care management for adults older than 60 years in primary care clinics in urban China: a cluster-randomised trial.

PubMed

Chen, Shulin; Conwell, Yeates; He, Jin; Lu, Naiji; Wu, Jiayan

2015-04-01

China's national health policy classifies depression as a chronic disease that should be managed in primary care settings. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression; however, this approach has not yet been tested in China. We aimed to assess whether use of a collaborative-care depression care management (DCM) intervention could improve outcomes for Chinese adults with depression aged 60 years and older. Between Jan 17, 2011, [corrected] and Nov 30, 2013, we did a cluster-randomised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China. We randomly assigned (1:1) clinics to either DCM (involving training for physicians in use of treatment guidelines, training for primary care nurses to function as care managers, and consultation with psychiatrists as support) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder. Clinics were chosen randomly for inclusion from all primary care clinics in the district by computer algorithm and then randomly allocated depression care interventions remotely by computer algorithm. Physicians, study personnel, and patients were not masked to clinic assignment. Our primary outcome was difference in Hamilton Depression Rating Scale (HAMD) score using data for clusters at baseline and 3, 6, and 12 month follow-up in a mixed-effects model of the intention-to-treat population. We originally aimed to analyse outcomes at 24 months, however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months, therefore we decided to end the trial at 12 months. This trial is registered with ClinicalTrials.gov, number NCT01287494. Of 34 primary care clinics in Shangcheng district, 16 were randomly chosen. We randomly assigned eight clinics to the DCM intervention (164 patients enrolled) and eight primary care clinics to enhanced care as usual (162 patients). There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention. Over the 12 months, patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practices assigned to enhanced care as usual (estimated between group difference -6·5 [95% CI -7·1 to -5·9]; Cohen's d 0·8 [95% CI 0·8-0·9]; p<0·0001). The intercluster correlation for change in HAMD total score was 0·07 (95% CI 0·06-0·08). There were no study-related adverse events in either group. Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM. Primary care-based collaborative management of depression is promising to address this pressing public health need in China. National Institutes of Health, Program for New Century Excellent Talents in Universities of China, Ministry of Education, China. Copyright © 2015 Elsevier Ltd. All rights reserved.

Latent class analysis derived subgroups of low back pain patients - do they have prognostic capacity?

PubMed

Molgaard Nielsen, Anne; Hestbaek, Lise; Vach, Werner; Kent, Peter; Kongsted, Alice

2017-08-09

Heterogeneity in patients with low back pain is well recognised and different approaches to subgrouping have been proposed. One statistical technique that is increasingly being used is Latent Class Analysis as it performs subgrouping based on pattern recognition with high accuracy. Previously, we developed two novel suggestions for subgrouping patients with low back pain based on Latent Class Analysis of patient baseline characteristics (patient history and physical examination), which resulted in 7 subgroups when using a single-stage analysis, and 9 subgroups when using a two-stage approach. However, their prognostic capacity was unexplored. This study (i) determined whether the subgrouping approaches were associated with the future outcomes of pain intensity, pain frequency and disability, (ii) assessed whether one of these two approaches was more strongly or more consistently associated with these outcomes, and (iii) assessed the performance of the novel subgroupings as compared to the following variables: two existing subgrouping tools (STarT Back Tool and Quebec Task Force classification), four baseline characteristics and a group of previously identified domain-specific patient categorisations (collectively, the 'comparator variables'). This was a longitudinal cohort study of 928 patients consulting for low back pain in primary care. The associations between each subgroup approach and outcomes at 2 weeks, 3 and 12 months, and with weekly SMS responses were tested in linear regression models, and their prognostic capacity (variance explained) was compared to that of the comparator variables listed above. The two previously identified subgroupings were similarly associated with all outcomes. The prognostic capacity of both subgroupings was better than that of the comparator variables, except for participants' recovery beliefs and the domain-specific categorisations, but was still limited. The explained variance ranged from 4.3%-6.9% for pain intensity and from 6.8%-20.3% for disability, and highest at the 2 weeks follow-up. Latent Class-derived subgroups provided additional prognostic information when compared to a range of variables, but the improvements were not substantial enough to warrant further development into a new prognostic tool. Further research could investigate if these novel subgrouping approaches may help to improve existing tools that subgroup low back pain patients.

Measuring individual differences in responses to date-rape vignettes using latent variable models.

PubMed

Tuliao, Antover P; Hoffman, Lesa; McChargue, Dennis E

2017-01-01

Vignette methodology can be a flexible and powerful way to examine individual differences in response to dangerous real-life scenarios. However, most studies underutilize the usefulness of such methodology by analyzing only one outcome, which limits the ability to track event-related changes (e.g., vacillation in risk perception). The current study was designed to illustrate the dynamic influence of risk perception on exit point from a date-rape vignette. Our primary goal was to provide an illustrative example of how to use latent variable models for vignette methodology, including latent growth curve modeling with piecewise slopes, as well as latent variable measurement models. Through the combination of a step-by-step exposition in this text and corresponding model syntax available electronically, we detail an alternative statistical "blueprint" to enhance future violence research efforts using vignette methodology. Aggr. Behav. 43:60-73, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

[Different Health Impairments at the Beginning of Medical Rehab: Possibilities of more Flexibility using the Example of Rehab Aftercare].

PubMed

Walther, A L; Deck, R

2015-08-01

The aftercare-program new credo was developed interdisciplinary and with practical orientation for rehabilitation patients with chronic back pain. The concept focuses on rehabilitation aftercare from the beginning of rehabilitation treatment and includes a long-term support of rehabilitation patients after inpatient rehabilitation. A multi-center, controlled longitudinal study demonstrated that participants in the intervention group (IG) implemented significantly better rehabilitation contents and objectives in everyday life and had significant better long-term effects. Anyway, there are participants who don't benefit from the new credo as they begin rehabilitation treatment with low impairments. Assuming that rehabilitation patients with lower impairments need a less comprehensive rehabilitation aftercare compared to those with higher impairments, a follow-up study including a flexible aftercare strategy was conducted. Thereby it is investigated whether the IG achieves more sustainable effects despite of less aftercare compared to the control group (CG) without the aftercare program. A prospective controlled longitudinal study in 2 rehabilitation clinics with 3 points of measurement was conducted. The flexibilization of the aftercare program was based on the level of impairment in the main outcome variable functional limitation in activities of daily living (FFbH-R) and restriction in participation (IMET) at the beginning of rehabilitation. Both questionnaires have been used in numerous studies successfully. Rehabilitation patients with low impairments received only the elements of the new credo during inpatient rehabilitation, rehabilitation patients with relevant impairments received the entire new credo over a period of 12 month after inpatient rehabilitation. The effects were evaluated with data from the CG of the primary study [Deck et al., 2012]. This sample was also divided according to their impairments. Rehabilitation patients with no relevant impairments were included in the analysis (IG N=81, KG N=157). Regarding the long-term effects for the primary outcome variable FFbH-R a significant positive intragroup-effect was detected for the IG, the CG reached the initial value 12 month after inpatient rehabilitation. For the IMET a significant intragroup-effect is also visible in the IG, the CG does not change over the period of time. For both primary outcomes, there are no significant interaction effects to be observed. With respect to the secondary outcomes, in the IG significant small to moderate intragroup-effects were determined in all outcomes, the CG achieved for half of those outcomes significant small intragroup-effects. Rehabilitation patients, who begin rehabilitation with rather low impairments perpetuate their rehabilitation effects with an even reduced aftercare. Aftercare-programs should therefore be adapted to the individual needs. Rehabilitation patient, who start the rehabilitation with relative good health, seem not to have an added value from an intensive aftercare-program. © Georg Thieme Verlag KG Stuttgart · New York.

The impact of HIV clinical pharmacists on HIV treatment outcomes: a systematic review

PubMed Central

Saberi, Parya; Dong, Betty J; Johnson, Mallory O; Greenblatt, Ruth M; Cocohoba, Jennifer M

2012-01-01

Objective Due to the rapid proliferation of human immunodeficiency virus (HIV) treatment options, there is a need for health care providers with knowledge of antiretroviral therapy intricacies. In a HIV multidisciplinary care team, the HIV pharmacist is well-equipped to provide this expertise. We conducted a systematic review to assess the impact of HIV pharmacists on HIV clinical outcomes. Methods We searched six electronic databases from January 1, 1980 to June 1, 2011 and included all quantitative studies that examined pharmacist’s roles in the clinical care of HIV-positive adults. Primary outcomes were antiretroviral adherence, viral load, and CD4+ cell count and secondary outcomes included health care utilization parameters, antiretroviral modifications, and other descriptive variables. Results Thirty-two publications were included. Despite methodological limitation, the involvement of HIV pharmacists was associated with statistically significant adherence improvements and positive impact on viral suppression in the majority of studies. Conclusion This systematic review provides evidence of the beneficial impact of HIV pharmacists on HIV treatment outcomes and offers suggestions for future research. PMID:22536064

Substance Use, Education, Employment, and Criminal Activity Outcomes of Adolescents in Outpatient Chemical Dependency Programs

PubMed Central

Balsa, Ana I.; Homer, Jenny F.; French, Michael T.; Weisner, Constance M.

2010-01-01

Although the primary outcome of interest in clinical evaluations of addiction treatment programs is usually abstinence, participation in these programs can have a wide range of consequences. This study evaluated the effects of treatment initiation on substance use, school attendance, employment, and involvement in criminal activity at 12 months post-admission for 419 adolescents (aged 12 to 18) enrolled in chemical dependency recovery programs in a large managed care health plan. Instrumental variables estimation methods were used to account for unobserved selection into treatment by jointly modeling the likelihood of participation in treatment and the odds of attaining a certain outcome or level of an outcome. Treatment initiation significantly increased the likelihood of attending school, promoted abstinence, and decreased the probability of adolescent employment, but it did not significantly affect participation in criminal activity at the 12-month follow-up. These findings highlight the need to address selection in a non-experimental study and demonstrate the importance of considering multiple outcomes when assessing the effectiveness of adolescent treatment. PMID:18064572

Predictors for adverse outcome after iliac angioplasty and stenting for limb-threatening ischemia.

PubMed

Timaran, Carlos H; Stevens, Scott L; Freeman, Michael B; Goldman, Mitchell H

2002-09-01

The role of iliac artery angioplasty and stenting (IAS) for the treatment of limb-threatening ischemia is not defined. IAS has been used primarily for patients with disabling claudication. Because poorer results have been shown in patients with critical ischemia after iliac artery angioplasty, the purpose of this study was to estimate the influence of risk factors on the outcome of iliac angioplasty and stent placement in patients with limb-threatening ischemia. During a 5-year period (from 1996 to 2001), 85 iliac angioplasty and stent placement procedures (107 stents) were performed in 31 women and 43 men with limb-threatening ischemia. Patients with claudication were specifically excluded. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery) were followed to define the variables. The TransAtlantic InterSociety Consensus classification was used to characterize the type of iliac lesions. Both univariate (Kaplan-Meier [KM]) and multivariate analyses (Cox proportional hazards model) were used to determine the association between variables, cumulative patency, limb salvage, and survival. Indications for iliac angioplasty with stenting were ischemic rest pain (56%) and tissue loss (44%). Primary stenting was performed in 36 patients (42%). Stents were placed selectively after iliac angioplasty mainly for residual stenosis or pressure gradient (43%). Overall, primary stent patency rate was 90% at 1 year, 74% at 3 years, and 69% at 5 years. Primary stent patency rate was significantly reduced in women compared with men (KM, log-rank test, P <.001). Primary patency rates at 1, 3, and 5 years were 79%, 57%, and 38% for women and 92%, 88%, and 88% for men. Primary stent patency rate also was significantly reduced in patients with renal insufficiency (creatinine level, >1.6 mg/dL; KM, log-rank test, P <.001). Cox regression analysis identified female gender (relative risk, 5.1; 95% CI, 1.8 to 7.9; P =.002) and renal insufficiency (relative risk, 6.6; 95% CI, 1.6 to 14.2; P =.01) as independent predictors of decreased primary stent patency. No independent predictors for limb salvage and survival were identified. Women undergoing iliac angioplasty and stenting for limb-threatening ischemia have significantly reduced primary stent patency rates and may need additional procedures to obtain satisfactory clinical improvement and limb salvage. Patients with renal insufficiency and critical ischemia also have reduced primary stent patency rates after IAS. Limb salvage, as shown in this study, is not affected by previous iliac stent failure.

Is inertial flywheel resistance training superior to gravity-dependent resistance training in improving muscle strength? A systematic review with meta-analyses.

PubMed

Vicens-Bordas, J; Esteve, E; Fort-Vanmeerhaeghe, A; Bandholm, T; Thorborg, K

2018-01-01

The primary aim of this systematic review was to determine if inertial flywheel resistance training is superior to gravity-dependent resistance training in improving muscle strength. The secondary aim was to determine whether inertial flywheel resistance training is superior to gravity-dependent resistance training in improving other muscular adaptations. A systematic review with meta-analyses of randomised and non-randomised controlled trials. We searched MEDLINE, Scopus, SPORTDiscus, Web of Science and Cochrane Central Register of Controlled Trials with no publication date restrictions until November 2016. We performed meta-analyses on randomised and non-randomised controlled trials to determine the standardized mean difference between the effects of inertial flywheel and gravity-dependent resistance training on muscle strength. A total of 76 and 71 participants were included in the primary and secondary analyses, respectively. After systematic review, we included three randomised and four non-randomised controlled trials. In the primary analysis for the primary outcome muscle strength, the pooled results from randomised controlled trials showed no difference (SMD=-0.05; 95%CI -0.51 to 0.40; p=0.82; I 2 =0%). In the secondary analyses of the primary outcome, the pooled results from non-randomised controlled trials showed no difference (SMD=0.02; 95%CI -0.45 to 0.49; p=0.93; I 2 =0%; and SMD=0.03; 95%CI -0.43 to 0.50; p=0.88; I 2 =0%). Meta-analysis on secondary outcomes could not be performed. Based on the available data, inertial flywheel resistance training was not superior to gravity-dependent resistance training in enhancing muscle strength. Data for other strength variables and other muscular adaptations was insufficient to draw firm conclusions from. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Examining multi-session brief intervention for substance use in primary care: research methods of a randomized controlled trial.

PubMed

Chambers, Jaclyn E; Brooks, Adam C; Medvin, Rachel; Metzger, David S; Lauby, Jennifer; Carpenedo, Carolyn M; Favor, Kevin E; Kirby, Kimberly C

2016-04-18

Brief interventions such as Screening, a single session of Brief Intervention, and Referral to Treatment (SBIRT) have shown mixed effectiveness in primary care. However, there are indications that multi-session brief interventions may demonstrate more consistently positive outcomes, and perhaps a more intensive approach would be of benefit in addressing substance use in primary care. This study compared the effectiveness of SBIRT with a single BI session (BI/RT) to a multi-session brief-treatment intervention (BI/RT+) in primary care. We also developed easy-to-use, evidence-based materials to assist clinicians in delivering these interventions. This study was conducted in three Federally Qualified Healthcare Centers (FQHCs). A total of 10,935 patients were screened, and 600 individuals were recruited. The sample was primarily Black/African American (82 %) with a mean age of 40. Patients who attended a healthcare appointment were screened for substance use via the AUDIT and DAST. Patients were eligible for the study if they scored 8 or higher on the AUDIT, were using only marijuana and scored 2 or higher on the DAST, or were using other illicit drugs and scored 1 or higher on the DAST. Participants were randomly assigned to receive one-session BI/RT, or two to six sessions of brief intervention that incorporated elements of motivational enhancement therapy and cognitive-behavioral therapy (BI/RT+). Both interventions were delivered by behavioral health consultants at the FQHCs. Participants completed follow-up assessments every 3 months for 1 year. Primary outcome variables included substance use treatment sessions attended and days of substance use. Secondary outcomes included measures of health, employment, legal, and psychiatric functioning and HIV risk behaviors. Additionally, we will conduct an economic evaluation examining cost-effectiveness and will analyze outcomes from a process evaluation examining patient and provider experiences. The ability of brief interventions to impact substance use has great potential, but research findings have been mixed. By conducting a large-scale randomized controlled trial in real-world health centers, this study will answer important questions about the effectiveness of expanded BIs for patients who screen positive for risky substance use in primary care. Trial registration NCT01751672.

A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease.

PubMed

McGarry, Andrew; McDermott, Michael; Kieburtz, Karl; de Blieck, Elisabeth A; Beal, Flint; Marder, Karen; Ross, Christopher; Shoulson, Ira; Gilbert, Peter; Mallonee, William M; Guttman, Mark; Wojcieszek, Joanne; Kumar, Rajeev; LeDoux, Mark S; Jenkins, Mary; Rosas, H Diana; Nance, Martha; Biglan, Kevin; Como, Peter; Dubinsky, Richard M; Shannon, Kathleen M; O'Suilleabhain, Padraig; Chou, Kelvin; Walker, Francis; Martin, Wayne; Wheelock, Vicki L; McCusker, Elizabeth; Jankovic, Joseph; Singer, Carlos; Sanchez-Ramos, Juan; Scott, Burton; Suchowersky, Oksana; Factor, Stewart A; Higgins, Donald S; Molho, Eric; Revilla, Fredy; Caviness, John N; Friedman, Joseph H; Perlmutter, Joel S; Feigin, Andrew; Anderson, Karen; Rodriguez, Ramon; McFarland, Nikolaus R; Margolis, Russell L; Farbman, Eric S; Raymond, Lynn A; Suski, Valerie; Kostyk, Sandra; Colcher, Amy; Seeberger, Lauren; Epping, Eric; Esmail, Sherali; Diaz, Nancy; Fung, Wai Lun Alan; Diamond, Alan; Frank, Samuel; Hanna, Philip; Hermanowicz, Neal; Dure, Leon S; Cudkowicz, Merit

2017-01-10

To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD. We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach. An interim analysis for futility revealed a conditional power of <5% for the primary analysis, prompting premature conclusion in July 2014. No statistically significant differences were seen between treatment groups for the primary or secondary outcome measures. CoQ was generally safe and well-tolerated throughout the study. These data do not justify use of CoQ as a treatment to slow functional decline in HD. NCT00608881. This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD. © 2016 American Academy of Neurology.

Using ClinicalTrials.gov to Supplement Information in Ophthalmology Conference Abstracts about Trial Outcomes: A Comparison Study

PubMed Central

Scherer, Roberta W.; Huynh, Lynn; Ervin, Ann-Margret; Dickersin, Kay

2015-01-01

Background Including results from unpublished randomized controlled trials (RCTs) in a systematic review may ameliorate the effect of publication bias in systematic review results. Unpublished RCTs are sometimes described in abstracts presented at conferences, included in trials registers, or both. Trial results may not be available in a trials register and abstracts describing RCT results often lack study design information. Complementary information from a trials register record may be sufficient to allow reliable inclusion of an unpublished RCT only available as an abstract in a systematic review. Methods We identified 496 abstracts describing RCTs presented at the 2007 to 2009 Association for Research in Vision and Ophthalmology (ARVO) meetings; 154 RCTs were registered in ClinicalTrials.gov. Two persons extracted verbatim primary and non-primary outcomes reported in the abstract and ClinicalTrials.gov record. We compared each abstract outcome with all ClinicalTrials.gov outcomes and coded matches as complete, partial, or no match. Results We identified 800 outcomes in 152 abstracts (95 primary [51 abstracts] and 705 [141 abstracts] non-primary outcomes). No outcomes were reported in 2 abstracts. Of 95 primary outcomes, 17 (18%) agreed completely, 53 (56%) partially, and 25 (26%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among 705 non-primary outcomes, 56 (8%) agreed completely, 205 (29%) agreed partially, and 444 (63%) had no match with a ClinicalTrials.gov primary or non-primary outcome. Among the 258 outcomes partially agreeing, we found additional information on the time when the outcome was measured more often in ClinicalTrials.gov than in the abstract (141/258 (55%) versus 55/258 (21%)). We found no association between the presence of non-matching “new” outcomes and year of registration, time to registry update, industry sponsorship, or multi-center status. Conclusion Conference abstracts may be a valuable source of information about results for outcomes of unpublished RCTs that have been registered in ClinicalTrials.gov. Complementary additional descriptive information may be present for outcomes reported in both sources. However, ARVO abstract authors also present outcomes not reported in ClinicalTrials.gov and these may represent analyses not originally planned. PMID:26107924

Temperature Variability during Delirium in ICU Patients: An Observational Study

PubMed Central

van der Kooi, Arendina W.; Kappen, Teus H.; Raijmakers, Rosa J.; Zaal, Irene J.; Slooter, Arjen J. C.

2013-01-01

Introduction Delirium is an acute disturbance of consciousness and cognition. It is a common disorder in the intensive care unit (ICU) and associated with impaired long-term outcome. Despite its frequency and impact, delirium is poorly recognized by ICU-physicians and –nurses using delirium screening tools. A completely new approach to detect delirium is to use monitoring of physiological alterations. Temperature variability, a measure for temperature regulation, could be an interesting component to monitor delirium, but whether temperature regulation is different during ICU delirium has not yet been investigated. The aim of this study was to investigate whether ICU delirium is related to temperature variability. Furthermore, we investigated whether ICU delirium is related to absolute body temperature. Methods We included patients who experienced both delirium and delirium free days during ICU stay, based on the Confusion Assessment method for the ICU conducted by a research- physician or –nurse, in combination with inspection of medical records. We excluded patients with conditions affecting thermal regulation or therapies affecting body temperature. Daily temperature variability was determined by computing the mean absolute second derivative of the temperature signal. Temperature variability (primary outcome) and absolute body temperature (secondary outcome) were compared between delirium- and non-delirium days with a linear mixed model and adjusted for daily mean Richmond Agitation and Sedation Scale scores and daily maximum Sequential Organ Failure Assessment scores. Results Temperature variability was increased during delirium-days compared to days without delirium (βunadjusted=0.007, 95% confidence interval (CI)=0.004 to 0.011, p<0.001). Adjustment for confounders did not alter this result (βadjusted=0.005, 95% CI=0.002 to 0.008, p<0.001). Delirium was not associated with absolute body temperature (βunadjusted=-0.03, 95% CI=-0.17 to 0.10, p=0.61). This did not change after adjusting for confounders (βadjusted=-0.03, 95% CI=-0.17 to 0.10, p=0.63). Conclusions Our study suggests that temperature variability is increased during ICU delirium. PMID:24194955

Fluid Overload is Associated with Late Poor Outcomes in Neonates Following Cardiac Surgery

PubMed Central

Wilder, Nicole S; Yu, Sunkyung; Donohue, Janet E; Goldberg, Caren S; Blatt, Neal B

2016-01-01

Objective Acute kidney injury (AKI) is a severe complication of cardiac surgery associated with increased morbidity and mortality, yet AKI classification for neonates remains challenging. We characterized patterns of post-operative fluid overload (FO) as a surrogate marker for AKI and as a risk factor of poor post-operative outcomes in neonates undergoing cardiac surgery. Design Retrospective cohort study. Setting Single, congenital heart center destination program. Patients 435 neonates undergoing cardiac surgery with cardiopulmonary bypass from January 2006 through December 2010. Interventions None Measurements and Main Results Demographics, diagnosis, and perioperative clinical variables were collected, including daily weights and serum creatinine (SCr) levels. A composite poor clinical outcome (death, need for renal replacement therapy (RRT), or extracorporeal life support (ECLS) within 30 post-operative days) was considered the primary outcome measure. Twenty-one neonates (5%) had a composite poor outcome with 7 (2%) requiring RRT, 8 (2%) requiring ECLS, and 14 (3%) dying between 3 and 30 days post-surgery. Neonates with a composite poor outcome had significantly higher maximum FO (>20%) and were slower to diurese. A receiver-operating characteristic curve determined that FO ≥ 16% and SCr ≥ 0.9 on post-operative day 3 were the optimal cutoffs for significant discrimination on the primary outcome (area under the curve = 0.71 and 0.76, respectively). In multivariable analysis, FO ≥ 16% (adjusted odds ratio [AOR] = 3.7) and SCr ≥ 0.9 (AOR = 6.6) on post-operative day 3 remained an independent risk factor for poor outcome. FO ≥ 16% was also significantly associated with cardiac arrest requiring cardiopulmonary resuscitation, prolonged intensive care unit stay, and chest re-exploration. Conclusions This study highlights the importance of monitoring fluid balance in the neonatal cardiac surgical population, and suggests that daily FO, a readily-available, non-invasive marker of renal function, may be a sensitive and specific predictor of adverse outcomes. PMID:27028790

Subconjunctival PRGF Fibrin Membrane as an Adjuvant to Nonpenetrating Deep Sclerectomy: A 2-Year Pilot Study.

PubMed

Rodríguez-Agirretxe, Iñaki; Freire, Vanesa; Muruzabal, Francisco; Orive, Gorka; Anitua, Eduardo; Díez-Feijóo, Elio; Acera, Arantxa

2018-01-01

To evaluate the potential role of the autologous PRGF (plasma rich in growth factors) fibrin membrane in tissue regeneration after glaucoma filtering surgery. Ten patients with medically uncontrolled primary open-angle glaucoma underwent nonpenetrating deep sclerectomy and were treated with PRGF fibrin membrane as adjuvant. Intraocular pressure reduction was the primary outcome. This variable was measured preoperatively and also at each follow-up visit. Secondary outcomes included the number of antiglaucoma medications, anterior segment optical coherence tomography bleb examination, photographic bleb evaluation, and subjective clinical symptomatology evaluation. The surgical technique showed a significant reduction (p < 0.05) in intraocular pressure in relation to preoperative values at each time of the study, decreasing from 23.3 ± 6.4 to 15.2 ± 4.6 mm Hg at 2 years. Furthermore, the number of antiglaucoma medications consumed showed a significant reduction at the end point of the study compared with the preoperative situation. Optical coherence tomography and photographic filtering bleb variables experienced a progressive reduction during the follow-up. Subjective symptoms showed a reduction from 8.3 ± 4.5 to 4.2 ± 5.3 at 2 years. PRGF-Endoret treatment could promote ocular surface regeneration after glaucoma surgery, enhancing the surgery success rates and reducing the need for postoperative medications. It is important to highlight that this is a preliminary study and some large clinical studies are necessary to verify these results. © 2017 S. Karger AG, Basel.

Conversion-to-open in laparoscopic appendectomy: A cohort analysis of risk factors and outcomes.

PubMed

Finnerty, Brendan M; Wu, Xian; Giambrone, Gregory P; Gaber-Baylis, Licia K; Zabih, Ramin; Bhat, Akshay; Zarnegar, Rasa; Pomp, Alfons; Fleischut, Peter; Afaneh, Cheguevara

2017-04-01

Identifying risk factors for conversion from laparoscopic to open appendectomy could select patients who may benefit from primary open appendectomy. We aimed to develop a predictive scoring model for conversion from laparoscopic to open based on pre-operative patient characteristics. A retrospective review of the State Inpatient Database (2007-2011) was performed using derivation (N = 71,617) and validation (N = 143,235) cohorts of adults ≥ 18 years with acute appendicitis treated by laparoscopic-only (LA), conversion from laparoscopic to open (CA), or primary open (OA) appendectomy. Pre-operative variables independently associated with CA were identified and reported as odds ratios (OR) with 95% confidence intervals (CI). A weighted integer-based scoring model to predict CA was designed based on pre-operative variable ORs, and complications between operative subgroups were compared. Independent predictors of CA in the derivation cohort were age ≥40 (OR 1.67; CI 1.55-1.80), male sex (OR 1.25; CI 1.17-1.34), black race (OR 1.46; CI 1.28-1.66), diabetes (OR 1.47; CI 1.31-1.65), obesity (OR 1.56; CI 1.40-1.74), and acute appendicitis with abscess or peritonitis (OR 7.00; CI 6.51-7.53). In the validation cohort, the CA predictive scoring model had an optimal cutoff score of 4 (range 0-9). The risk of conversion-to-open was ≤5% for a score <4, compared to 10-25% for a score ≥4. On composite outcomes analysis controlling for all pre-operative variables, CA had a higher likelihood of infectious/inflammatory (OR 1.44; CI 1.31-1.58), hematologic (OR 1.31; CI 1.17-1.46), and renal (OR 1.22; CI 1.06-1.39) complications compared to OA. Additionally, CA had a higher likelihood of infectious/inflammatory, respiratory, cardiovascular, hematologic, and renal complications compared to LA. CA patients have an unfavorable complication profile compared to OA. The predictors identified in this scoring model could help select for patients who may benefit from primary open appendectomy. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Is Le Fort I Osteotomy Associated With Maxillary Sinusitis?

PubMed

Nocini, Pier Francesco; D'Agostino, Antonio; Trevisiol, Lorenzo; Favero, Vittorio; Pessina, Mattia; Procacci, Pasquale

2016-02-01

The purpose of the present study was to investigate the association between Le Fort I osteotomy and the anatomic, radiologic, and symptomatic modifications of the maxillary sinus. Subjects who had undergone Le Fort I osteotomy from January 2008 to December 2013 were enrolled in a retrospective cohort study. The eligibility criteria were the availability of a cone beam computed tomography (CBCT) scan taken before and 12 to 24 months after the procedure. The exclusion criteria were the unavailability of CBCT scans, the use of tobacco, and previous orthognathic procedures. The primary predictor variable was time (pre-vs postoperative). The primary outcome variables were the sinus volume, mucosal thickening, iatrogenic alterations in the sinus anatomy, and rhinosinusitis symptoms, evaluated using the Sino-Nasal Outcome 20-item Test (SNOT-20). Descriptive statistics were computed for each variable, and paired analyses were used to compare the pre- and postoperative values. The data from 64 subjects (mean age 27; 59.4% were female; median follow-up 32.4 months, range 13 to 66 months) were studied. Postoperatively, 1.6% of the sample (0% preoperatively) had moderate-to-severe and 15.6% (3.1% preoperatively) had mild-to-moderate sinusitis symptoms. The rest of the sample presented with mild to no symptoms. The increase in the SNOT scores after surgery was statistically significant (P = .016). Radiologic evidence of postoperative inflammatory processes affecting the paranasal sinuses was found in 27.3% of the sinuses (9.4% preoperatively). The postoperative Lund-Mackay scores were significantly greater (P = .0005). A 19% decrease was found in the mean postoperative sinus volume, with a 37% incidence of iatrogenic injury. The study results indicate that Le Fort I osteotomies can have an important impact on sinus health. The postoperative radiologic evidence of maxillary sinus inflammatory processes and the incidence of rhinosinusitis symptoms and iatrogenic damage in these patients have led us to conclude that CBCT scans and the SNOT-20 questionnaire should be used routinely during postoperative monitoring. Larger long-term studies are warranted to clarify the postoperative outcomes and complications. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Observed intra-cluster correlation coefficients in a cluster survey sample of patient encounters in general practice in Australia

PubMed Central

Knox, Stephanie A; Chondros, Patty

2004-01-01

Background Cluster sample study designs are cost effective, however cluster samples violate the simple random sample assumption of independence of observations. Failure to account for the intra-cluster correlation of observations when sampling through clusters may lead to an under-powered study. Researchers therefore need estimates of intra-cluster correlation for a range of outcomes to calculate sample size. We report intra-cluster correlation coefficients observed within a large-scale cross-sectional study of general practice in Australia, where the general practitioner (GP) was the primary sampling unit and the patient encounter was the unit of inference. Methods Each year the Bettering the Evaluation and Care of Health (BEACH) study recruits a random sample of approximately 1,000 GPs across Australia. Each GP completes details of 100 consecutive patient encounters. Intra-cluster correlation coefficients were estimated for patient demographics, morbidity managed and treatments received. Intra-cluster correlation coefficients were estimated for descriptive outcomes and for associations between outcomes and predictors and were compared across two independent samples of GPs drawn three years apart. Results Between April 1999 and March 2000, a random sample of 1,047 Australian general practitioners recorded details of 104,700 patient encounters. Intra-cluster correlation coefficients for patient demographics ranged from 0.055 for patient sex to 0.451 for language spoken at home. Intra-cluster correlations for morbidity variables ranged from 0.005 for the management of eye problems to 0.059 for management of psychological problems. Intra-cluster correlation for the association between two variables was smaller than the descriptive intra-cluster correlation of each variable. When compared with the April 2002 to March 2003 sample (1,008 GPs) the estimated intra-cluster correlation coefficients were found to be consistent across samples. Conclusions The demonstrated precision and reliability of the estimated intra-cluster correlations indicate that these coefficients will be useful for calculating sample sizes in future general practice surveys that use the GP as the primary sampling unit. PMID:15613248

Internet-based individually versus group guided self-help treatment for social anxiety disorder: protocol of a randomized controlled trial.

PubMed

Schulz, Ava; Stolz, Timo; Berger, Thomas

2014-04-15

Social anxiety disorder (SAD) is one of the most common mental disorders and causes subjective suffering and economic burden worldwide. Although effective treatments are available, a lot of cases go untreated. Internet-based self-help is a low-threshold and flexible treatment alternative for SAD. Various studies have already shown that internet-based self-help can be effective to reduce social phobic symptoms significantly. Most of the interventions tested include therapist support, whereas the role of peer support within internet-based self-help has not yet been fully understood. There is evidence suggesting that patients' mutual exchange via integrated discussion forums can increase the efficacy of internet-based treatments. This study aims at investigating the added value of therapist-guided group support on the treatment outcome of internet-based self-help for SAD. The study is conducted as a randomized controlled trial. A total of 150 adults with a diagnosis of SAD are randomly assigned to either a waiting-list control group or one of the active conditions. The participants in the two active conditions use the same internet-based self-help program, either with individual support by a psychologist or therapist-guided group support. In the group guided condition, participants can communicate with each other via an integrated, protected discussion forum. Subjects are recruited via topic related websites and links; diagnostic status will be assessed with a telephone interview. The primary outcome variables are symptoms of SAD and diagnostic status after the intervention. Secondary endpoints are general symptomology, depression, quality of life, as well as the primary outcome variables 6 months later. Furthermore, process variables such as group processes, the change in symptoms and working alliance will be studied. The results of this study should indicate whether group-guided support could enhance the efficacy of an internet-based self-help treatment for SAD. This novel treatment format, if shown effective, could represent a cost-effective option and could further be modified to treat other conditions, as well. ISRCTN75894275.

Emetogenicity-risk procedures in same day surgery center of an academic university hospital in United States: a retrospective cost-audit of postoperative nausea vomiting management.

PubMed

Gupta, Deepak; Haber, Halim

2014-06-01

Despite the variable results of published studies, it is imperative for ambulatory surgery centers to self-audit local cost-implications for post-operative nausea and vomiting (PONV) management. Our retrospective cost-audit assessed if there were comparative peri-anesthesia care cost-trends among patients who had undergone Low-Emetogenicity-Risk Procedures (LERP), Moderate-Emetogenicity-Risk Procedures (MERP) and Severe-Emetogenicity-Risk Procedures (SERP). This study was a review of Same Day Surgery Center practices in an academic university hospital setting during a three-year period (2010-2012). The patient lists were accessed from CIS and CITRIX App Bar for time audit and OR (operating room) schedule reports. Subsequently, OR pharmacy department ran a search for peri-operative anti-emetics and opioids that were billed for the patients at Same Day Surgery Center for the review period. The primary outcomes were the comparative costs/charges of these medications and comparative durations/ charges for these patients' stay in the post-anesthesia care unit (PACU). Secondary outcomes analyzed in the study included peri-anesthesia durations. A total of 8,657 patient records were analyzed. Almost all analyzed variables revealed statistically significant inter-variable positive correlations. The patients' age was significantly (P < 0.001) different among LERP/MERP/SERP patients (LERP: 48.8 +/- 14.7 years; MERP: 61.8 +/- 14.6 years; SERP: 51.3 +/- 14.5 years). In regards to primary and secondary outcomes, the statistical significant differences among LERP/MERP/SERP patients (after correcting for both patients' age as well as patients' sex) were only achieved for preoperative times (P = 0.002; Power = 0.9), operating room recovery times (P = 0.003; Power = 0.9), PACU stay times (P < 0.001; Power = 1.0), and PACU charges (P < 0.001; Power = 1.0). PACU stay times and PACU charges were significantly higher in patients who had undergone SERP as compared to patients who had undergone LERP or MERP at our Same Day Surgery Center.

Abnormal liver function in common variable immunodeficiency disorders due to nodular regenerative hyperplasia.

PubMed

Ward, C; Lucas, M; Piris, J; Collier, J; Chapel, H

2008-09-01

Patients with common variable immunodeficiency disorders are monitored for liver function test abnormalities. A proportion of patients develop deranged liver function and some also develop hepatomegaly. We investigated the prevalence of abnormalities and types of liver disease, aiming to identify those at risk and determine outcomes. The local primary immunodeficiency database was searched for patients with a common variable immunodeficiency disorder and abnormal liver function and/or a liver biopsy. Patterns of liver dysfunction were determined and biopsies reviewed. A total of 47 of 108 patients had deranged liver function, most commonly raised alkaline phosphatase levels. Twenty-three patients had liver biopsies. Nodular regenerative hyperplasia was found in 13 of 16 with unexplained pathology. These patients were more likely to have other disease-related complications of common variable immunodeficiency disorders, in particular non-coeliac (gluten insensitive) lymphocytic enteropathy. However, five had no symptoms of liver disease and only one died of liver complications. Nodular regenerative hyperplasia is a common complication of common variable immunodeficiency disorders but was rarely complicated by portal hypertension.

Heart rate variability: Pre-deployment predictor of post-deployment PTSD symptoms

PubMed Central

Pyne, Jeffrey M.; Constans, Joseph I.; Wiederhold, Mark D.; Gibson, Douglas P.; Kimbrell, Timothy; Kramer, Teresa L.; Pitcock, Jeffery A.; Han, Xiaotong; Williams, D. Keith; Chartrand, Don; Gevirtz, Richard N.; Spira, James; Wiederhold, Brenda K.; McCraty, Rollin; McCune, Thomas R.

2017-01-01

Heart rate variability is a physiological measure associated with autonomic nervous system activity. This study hypothesized that lower pre-deployment HRV would be associated with higher post-deployment post-traumatic stress disorder (PTSD) symptoms. Three-hundred-forty-three Army National Guard soldiers enrolled in the Warriors Achieving Resilience (WAR) study were analyzed. The primary outcome was PTSD symptom severity using the PTSD Checklist – Military version (PCL) measured at baseline, 3- and 12-month post-deployment. Heart rate variability predictor variables included: high frequency power (HF) and standard deviation of the normal cardiac inter-beat interval (SDNN). Generalized linear mixed models revealed that the pre-deployment PCL*ln(HF) interaction term was significant (p < 0.0001). Pre-deployment SDNN was not a significant predictor of post-deployment PCL. Covariates included age, pre-deployment PCL, race/ethnicity, marital status, tobacco use, childhood abuse, pre-deployment traumatic brain injury, and previous combat zone deployment. Pre-deployment heart rate variability predicts post-deployment PTSD symptoms in the context of higher pre-deployment PCL scores. PMID:27773678

Biomarker progressions explain higher variability in stage-specific cognitive decline than baseline values in Alzheimer disease.

PubMed

Dodge, Hiroko H; Zhu, Jian; Harvey, Danielle; Saito, Naomi; Silbert, Lisa C; Kaye, Jeffrey A; Koeppe, Robert A; Albin, Roger L

2014-11-01

It is unknown which commonly used Alzheimer disease (AD) biomarker values-baseline or progression-best predict longitudinal cognitive decline. 526 subjects from the Alzheimer's Disease Neuroimaging Initiative (ADNI). ADNI composite memory and executive scores were the primary outcomes. Individual-specific slope of the longitudinal trajectory of each biomarker was first estimated. These estimates and observed baseline biomarker values were used as predictors of cognitive declines. Variability in cognitive declines explained by baseline biomarker values was compared with variability explained by biomarker progression values. About 40% of variability in memory and executive function declines was explained by ventricular volume progression among mild cognitive impairment patients. A total of 84% of memory and 65% of executive function declines were explained by fluorodeoxyglucose positron emission tomography (FDG-PET) score progression and ventricular volume progression, respectively, among AD patients. For most biomarkers, biomarker progressions explained higher variability in cognitive decline than biomarker baseline values. This has important implications for clinical trials targeted to modify AD biomarkers. Copyright © 2014 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Gun orientation in self-inflicted craniomaxillofacial gunshot wounds: risk factors associated with fatality.

PubMed

Johnson, J; Markiewicz, M R; Bell, R B; Potter, B E; Dierks, E J

2012-08-01

The purpose of this study was to evaluate whether orientation of a firearm predicts survival, and to identify risk factors associated with fatality in subjects with self-inflicted craniomaxillofacial gunshot wounds. A retrospective cohort study design was used. The primary predictor variable was orientation of the weapon, defined as in the coronal (lateral) or sagittal (anterior-posterior) trajectory pattern. The primary outcome variable was death for subjects on arrival or during their hospital stay. Other covariates measured include demographic, firearm-related, and psychosocial variables. Risk factors for fatality were identified using multivariate logistic regression. Of the 92 subjects that met study inclusion criteria, 47 (67.2) held the firearm in the coronal position. In the full multivariate model, coronal gun orientation (OR=7.7, 95% CI: 2.0, 30.1, p=0.003) and the absence of a psychiatric diagnosis were associated with an increased risk of fatality (OR=0.1, 95% CI: 0.04, 0.5, p=0.002). Coronal firearm orientation was associated with an increased risk of fatality following self-inflicted craniomaxillofacial gunshot injuries. A patient with a documented psychiatric disorder was not found to be more likely to succumb to this type of injury. Copyright © 2012 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Reward Size Informs Repeat-Switch Decisions and Strongly Modulates the Activity of Neurons in Parietal Cortex

PubMed Central

Kubanek, Jan; Snyder, Lawrence H.

2017-01-01

Abstract Behavior is guided by previous experience. Good, positive outcomes drive a repetition of a previous behavior or choice, whereas poor or bad outcomes lead to an avoidance. How these basic drives are implemented by the brain has been of primary interest to psychology and neuroscience. We engaged animals in a choice task in which the size of a reward outcome strongly governed the animals' subsequent decision whether to repeat or switch the previous choice. We recorded the discharge activity of neurons implicated in reward-based choice in 2 regions of parietal cortex. We found that the tendency to retain previous choice following a large (small) reward was paralleled by a marked decrease (increase) in the activity of parietal neurons. This neural effect is independent of, and of sign opposite to, value-based modulations reported in parietal cortex previously. This effect shares the same basic properties with signals previously reported in the limbic system that detect the size of the recently obtained reward to mediate proper repeat-switch decisions. We conclude that the size of the obtained reward is a decision variable that guides the decision between retaining a choice or switching, and neurons in parietal cortex strongly respond to this novel decision variable. PMID:26491065

Treatment of gingival recession with coronally advanced flap procedures: a systematic review.

PubMed

Cairo, Francesco; Pagliaro, Umberto; Nieri, Michele

2008-09-01

The treatment of buccal gingival recessions is a common requirement due to aesthetic concern or root sensitivity. The aim of this manuscript was to systematically review the literature on coronally advanced flap (CAF) alone or in combination with tissue grafts, barrier membranes (BM), enamel matrix derivative (EMD) or other material for treating gingival recession. Randomized clinical trials on treatment of Miller Class I and II gingival recessions with at least 6 months of follow-up were identified. Data sources included electronic databases and hand-searched journals. The primary outcome variable was complete root coverage (CRC). The secondary outcome variables were recession reduction, clinical attachment gain, keratinized tissue gain, aesthetic satisfaction, root sensitivity, post-operative patient pain and complications. A total of 794 Miller Class I and II gingival recessions in 530 patients from 25 RCTs were evaluated in this systematic review. CAF was associated with mean recession reduction and CRC. The addition of connective tissue graft (CTG) or EMD enhanced the clinical outcomes of CAF in terms of CRC, while BM did not. The results with respect to the adjunctive use of acellular dermal matrix were controversial. CTG or EMD in conjunction with CAF enhances the probability of obtaining CRC in Miller Class I and II single gingival recessions.

CLINICAL DEMOGRAPHIC CHARACTERISTICS OF TOTAL KNEE ARTHROPLASTY IN A UNIVERSITY HOSPITAL

PubMed Central

Souza, José Miguel Francisco da Silva; Ferreira, Ricardo dos Santos; de Lima, Alexandre José Pereira; de Sá, Airton César Pereira; de Albuquerque, Paulo Cezar Vidal Carneiro

2016-01-01

ABSTRACT Objective: To assess socio-demographic characteristics of patients undergoing total knee arthroplasty (TKA) in a public university hospital, evaluating the outcome infection and associated factors. Method: A retrospective study was carried out with 78 patients undergoing TKA, from 2013 to 2014. The socio-demographic and clinical characteristics of the patients were collected. Comparison between infected and non-infected patients was performed to find out which variables were possibly associated to this complication. Result: Of 81 arthroplasties performed, patients were older (mean age 64 years), women (79%), with primary osteoarthritis as main etiology (87.6%) and most had comorbidities (82.7%). Infection occurred in 16% of patients, and this outcome associated with age older than 65 years (p=0.023) and the occurrence of deep vein thrombosis (p=0.027). Conclusion: Patients undergoing TKA are mostly elderly women with primary osteoarthritis in the knee and comorbidities who developed infection in 16% of cases. More studies need to be conducted aimed at creating specific protocols in order to improve the quality of clinical practice. Level of Evidence III, Retrospective Comparative Study. PMID:28924354

Aquatic Exercise Therapy for People With Parkinson Disease: A Randomized Controlled Trial.

PubMed

Carroll, Louise M; Volpe, Daniele; Morris, Meg E; Saunders, Jean; Clifford, Amanda M

2017-04-01

To evaluate the effects of aquatic exercise therapy on gait variability and disability compared with usual care for people with Parkinson disease (PD). Single-blind randomized controlled trial. Community-based hydrotherapy pool. Individuals with PD (Hoehn-Yahr stages I-III) (N=21). Participants were randomly assigned to either an aquatic exercise therapy group (45min, twice a week for 6wk) or a group that received usual care. The primary outcome measure was gait variability as measured using a motion capture system. Secondary outcomes were quality of life measured on the Parkinson's Disease Questionnaire-39 and freezing of gait and motor disability quantified by the Unified Parkinson's Disease Rating Scale. Feasibility was evaluated by measuring safety, adverse events, and participant satisfaction. People in the aquatic therapy group and usual care group showed similar small improvements in gait variability. The aquatic therapy group showed greater improvements in disability than the usual care group (P<.01). No differences between groups or over time were identified for freezing of gait or quality of life. Aquatic therapy sessions were safe and enjoyable with no adverse events. Aquatic therapy appears feasible and safe for some people in the early stages of PD. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

The influence of blood pressure management on neurological outcome in endovascular therapy for acute ischaemic stroke.

PubMed

Rasmussen, M; Espelund, U S; Juul, N; Yoo, A J; Sørensen, L H; Sørensen, K E; Johnsen, S P; Andersen, G; Simonsen, C Z

2018-06-01

Observational studies have suggested that low blood pressure and blood pressure variability may partially explain adverse neurological outcome after endovascular therapy with general anaesthesia (GA) for acute ischaemic stroke. The aim of this study was to further examine whether blood pressure related parameters during endovascular therapy are associated with neurological outcome. The GOLIATH trial randomised 128 patients to either GA or conscious sedation for endovascular therapy in acute ischaemic stroke. The primary outcome was 90 day modified Rankin Score. The haemodynamic protocol aimed at keeping the systolic blood pressure >140 mm Hg and mean blood pressure >70 mm Hg during the procedure. Blood pressure related parameters of interest included 20% reduction in mean blood pressure; mean blood pressure <70 mm Hg, <80 mm Hg, and <90 mm Hg, respectively; time with systolic blood pressure <140 mm Hg; procedural minimum and maximum mean and systolic blood pressure; mean blood pressure at the time of groin puncture; postreperfusion mean blood pressure; blood pressure variability; and use of vasopressors. Sensitivity analyses were performed in the subgroup of reperfused patients. Procedural average mean and systolic blood pressures were higher in the conscious sedation group (P<0.001). The number of patients with mean blood pressure <70-90 mm Hg and systolic blood pressure <140 mm Hg, blood pressure variability, and use of vasopressors were all higher in the GA group (P<0.001). There was no statistically significant association between any of the examined blood pressure related parameters and the modified Rankin Score in the overall patient population, and in the subgroup of patients with full reperfusion. We found no statistically significant association between blood pressure related parameters during endovascular therapy and neurological outcome. NCT 02317237. Copyright © 2018 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Impact of maternal body mass index and gestational weight gain on neonatal outcomes among healthy Middle-Eastern females

PubMed Central

Papazian, Tatiana; Abi Tayeh, Georges; Sibai, Darine; Hout, Hala; Melki, Imad

2017-01-01

Background Studies on the relative impact of body mass index in women in childbearing age and gestational weight gain on neonatal outcomes are scarce in the Middle East. Objectives The primary objective of this research was to assess the impact of maternal body mass index (BMI) and gestational weight gain (GWG) on neonatal outcomes. The effect of maternal age and folic acid supplementation before and during pregnancy was also examined. Subjects and methods This is a retrospective cross sectional observational study of 1000 full term deliveries of women enrolled thru the National Collaborative Perinatal Neonatal Network, in Lebanon. Maternal characteristics such as age, BMI and GWG and neonatal outcomes such as weight, height, head circumference and Apgar score were the primary studied variables in this study. Total maternal weight gain were compared to the guidelines depicted by the Institute of Medicine (IOM). Results The negative outcomes of newborns such as lean body weight and macrosomia were significantly present in women who gained respectively below or above the IOM’s cut-off points. Pregestational body mass index influenced significantly the infants’ birth weight, in both the underweight and obese categories. Birth height, head circumference and Apgar score were not influenced by pregestational body mass index or gestational weight gain. No significant associations were found between maternal age and pregestational body mass index and gestational weight gain. Conclusion Studies evaluating the impact of weight before and during pregnancy on neonatal outcomes and anthropometrics measurements are lacking in the Middle East. Our results highlight the importance of nutritional counseling in order to shed the extra weights before conceiving and monitor weight gain to avoid the negative impact on feto-maternal health. PMID:28715482

Impact of maternal body mass index and gestational weight gain on neonatal outcomes among healthy Middle-Eastern females.

PubMed

Papazian, Tatiana; Abi Tayeh, Georges; Sibai, Darine; Hout, Hala; Melki, Imad; Rabbaa Khabbaz, Lydia

2017-01-01

Studies on the relative impact of body mass index in women in childbearing age and gestational weight gain on neonatal outcomes are scarce in the Middle East. The primary objective of this research was to assess the impact of maternal body mass index (BMI) and gestational weight gain (GWG) on neonatal outcomes. The effect of maternal age and folic acid supplementation before and during pregnancy was also examined. This is a retrospective cross sectional observational study of 1000 full term deliveries of women enrolled thru the National Collaborative Perinatal Neonatal Network, in Lebanon. Maternal characteristics such as age, BMI and GWG and neonatal outcomes such as weight, height, head circumference and Apgar score were the primary studied variables in this study. Total maternal weight gain were compared to the guidelines depicted by the Institute of Medicine (IOM). The negative outcomes of newborns such as lean body weight and macrosomia were significantly present in women who gained respectively below or above the IOM's cut-off points. Pregestational body mass index influenced significantly the infants' birth weight, in both the underweight and obese categories. Birth height, head circumference and Apgar score were not influenced by pregestational body mass index or gestational weight gain. No significant associations were found between maternal age and pregestational body mass index and gestational weight gain. Studies evaluating the impact of weight before and during pregnancy on neonatal outcomes and anthropometrics measurements are lacking in the Middle East. Our results highlight the importance of nutritional counseling in order to shed the extra weights before conceiving and monitor weight gain to avoid the negative impact on feto-maternal health.

Patient engagement: an investigation at a primary care clinic

PubMed Central

Gill, Preetinder Singh

2013-01-01

Background Engaged employees are an asset to any organization. They are instrumental in ensuring good commercial outcomes through continuous innovation and incremental improvement. A health care facility is similar to a regular work setting in many ways. A health care provider and a patient have roles akin to a team leader and a team member/stakeholder, respectively. Hence it can be argued that the concept of employee engagement can be applied to patients in health care settings in order to improve health outcomes. Methods Patient engagement data were collected using a survey instrument from a primary care clinic in the northern Indian state of Punjab. Canonical correlation equations were formulated to identify combinations which were strongly related to each other. In addition, the cause-effect relationship between patient engagement and patient-perceived health outcomes was described using structural equation modeling. Results Canonical correlation analysis showed that the first set of canonical variables had a fairly strong relationship, ie, a magnitude > 0.80 at the 95% confidence interval, for five dimensions of patient engagement. Structural equation modeling analysis yielded a β ≥ 0.10 and a Student’s t statistic ≥ 2.96 for these five dimensions. The threshold Student’s t statistic was 1.99. Hence it was found the β values were significant at the 95% confidence interval for all census regions. Conclusion A scaled reliable survey instrument was developed to measured patient engagement. Better patient engagement is associated with better patient-perceived health outcomes. This study provides preliminary evidence that patient engagement has a causal relationship with patient-perceived health outcomes. PMID:23515133

Protocols and Hospital Mortality in Critically Ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study.

PubMed

Sevransky, Jonathan E; Checkley, William; Herrera, Phabiola; Pickering, Brian W; Barr, Juliana; Brown, Samuel M; Chang, Steven Y; Chong, David; Kaufman, David; Fremont, Richard D; Girard, Timothy D; Hoag, Jeffrey; Johnson, Steven B; Kerlin, Mehta P; Liebler, Janice; O'Brien, James; O'Keefe, Terence; Park, Pauline K; Pastores, Stephen M; Patil, Namrata; Pietropaoli, Anthony P; Putman, Maryann; Rice, Todd W; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Martin, Greg S

2015-10-01

Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized ICUs have superior patient outcomes compared with less highly protocolized ICUs. Observational study in which participating ICUs completed a general assessment and enrolled new patients 1 day each week. A total of 6,179 critically ill patients. Fifty-nine ICUs in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study. None. The primary exposure was the number of ICU protocols; the primary outcome was hospital mortality. A total of 5,809 participants were followed prospectively, and 5,454 patients in 57 ICUs had complete outcome data. The median number of protocols per ICU was 19 (interquartile range, 15-21.5). In single-variable analyses, there were no differences in ICU and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in ICUs with a high versus low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p = 0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between ICUs with high versus low numbers of protocols for lung protective ventilation in acute respiratory distress syndrome (47% vs 52%; p = 0.28) and for spontaneous breathing trials (55% vs 51%; p = 0.27). Clinical protocols are highly prevalent in U.S. ICUs. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality.

Intolerance of uncertainty and transdiagnostic group cognitive behavioral therapy for anxiety.

PubMed

Talkovsky, Alexander M; Norton, Peter J

2016-06-01

Recent evidence suggests intolerance of uncertainty (IU) is a transdiagnostic variable elevated across anxiety disorders. No studies have investigated IU's response to transdiagnostic group CBT for anxiety (TGCBT). This study evaluated IU outcomes following TGCBT across anxiety disorders. 151 treatment-seekers with primary diagnoses of social anxiety disorder, panic disorder, or GAD were evaluated before and after 12 weeks of TGCBT and completed self-report questionnaires at pre-, mid-, and post-treatment. IU decreased significantly following treatment. Decreases in IU predicted improvements in clinical presentation across diagnoses. IU interacted with time to predict improvement in clinical presentation irrespective of primary diagnosis. IU also interacted with time to predict improvement in clinical presentation although interactions of time with diagnosis-specific measures did not. IUS interacted with time to predict reduction in anxiety and fear symptoms, and inhibitory IU interacted with time to predicted reductions in anxiety symptoms but prospective IU did not. IU appears to be an important transdiagnostic variable in CBT implicated in both initial presentation and treatment change. Further implications are discussed. Published by Elsevier Ltd.

Extreme intrafamilial variability of Saudi brothers with primary hyperoxaluria type 1

PubMed Central

Alfadhel, Majid; Alhasan, Khalid A; Alotaibi, Mohammed; Al Fakeeh, Khalid

2012-01-01

Background Primary hyperoxaluria type 1 (PH1) is characterized by progressive renal insufficiency culminating in end-stage renal disease, and a wide range of clinical features related to systemic oxalosis in different organs. It is caused by autosomal recessive deficiency of alanine:glyoxylate aminotransferase due to a defect in AGXT gene. Case report Two brothers (one 6 months old; the other 2 years old) presented with acute renal failure and urinary tract infection respectively. PH1 was confirmed by high urinary oxalate level, demonstration of oxalate crystals in bone biopsy, and pathogenic homozygous known AGXT gene mutation. Despite the same genetic background, same sex, and shared environment, the outcome of the two siblings differs widely. While one of them died earlier with end-stage renal disease and multiorgan failure caused by systemic oxalosis, the older brother is pyridoxine responsive with normal development and renal function. Conclusion Clinicians should be aware of extreme intrafamilial variability of PH1 and international registries are needed to characterize the genotype-phenotype correlation in such disorder. PMID:22956877

Can a Specific Neck Strengthening Program Decrease Cervical Spine Injuries in a Men's Professional Rugby Union Team? A Retrospective Analysis.

PubMed

Naish, Robert; Burnett, Angus; Burrows, Sally; Andrews, Warren; Appleby, Brendyn

2013-01-01

Cervical spine injuries in Rugby Union are a concerning issue at all levels of the game. The primary aim of this retrospective analysis conducted in a professional Rugby Union squad was to determine whether a 26-week isometric neck strengthening intervention program (13-week strengthening phase and 13-week maintenance phase) was effective in reducing the number and severity of cervical spine injuries. The secondary aim was to determine whether at week five, where the program had been the similar for all players, there was increased isometric neck strength. All 27 players who were common to both the 2007-2008 and 2008-2009 seasons were included in this analysis and data was extracted from a Sports Medicine/Sports Science database which included the squad's injury records. Primary outcome variables included; the number of cervical spine injuries and the severity of these injuries as determined by the total number of days lost from training and competition. Secondary outcome variables included isometric neck strength in flexion, extension and left and right lateral flexion. Using non-parametric statistical methods, no significant differences were evident for the total number of cervical spine injuries (n = 8 in 2007-2008, n = 6 in 2008-2009) or time loss due to these injuries (100 days in 2007-2008, 40 days in 2008-2009). However, a significant (p = 0.03) reduction in the number of match injuries was evident from 2007-2008 (n = 11) to 2008-09 (n = 2). Non-significant increases in isometric neck strength were found in all directions examined. A significant reduction in the number of match injuries was evident in this study. However, no other significant changes to primary outcome variables were achieved. Further, no significant increases in isometric neck strength were found in this well-trained group of professional athletes. Key PointsWhile many authors have proposed that neck strengthening could be an effective strategy in preventing cervical spine injuries in Rugby Union, there is currently little information in the literature pertaining to how such a study might be conducted.A significant decrease in the number of injuries recorded in matches can be achieved using a specific neck strengthening program at the elite level.In an elite rugby union team as investigated in this study a significant increase in neck strength is difficult to achieve in a short period of time such as five weeks.

Can a Specific Neck Strengthening Program Decrease Cervical Spine Injuries in a Men's Professional Rugby Union Team? A Retrospective Analysis

PubMed Central

Naish, Robert; Burnett, Angus; Burrows, Sally; Andrews, Warren; Appleby, Brendyn

2013-01-01

Cervical spine injuries in Rugby Union are a concerning issue at all levels of the game. The primary aim of this retrospective analysis conducted in a professional Rugby Union squad was to determine whether a 26-week isometric neck strengthening intervention program (13-week strengthening phase and 13-week maintenance phase) was effective in reducing the number and severity of cervical spine injuries. The secondary aim was to determine whether at week five, where the program had been the similar for all players, there was increased isometric neck strength. All 27 players who were common to both the 2007-2008 and 2008-2009 seasons were included in this analysis and data was extracted from a Sports Medicine/Sports Science database which included the squad's injury records. Primary outcome variables included; the number of cervical spine injuries and the severity of these injuries as determined by the total number of days lost from training and competition. Secondary outcome variables included isometric neck strength in flexion, extension and left and right lateral flexion. Using non-parametric statistical methods, no significant differences were evident for the total number of cervical spine injuries (n = 8 in 2007-2008, n = 6 in 2008-2009) or time loss due to these injuries (100 days in 2007-2008, 40 days in 2008-2009). However, a significant (p = 0.03) reduction in the number of match injuries was evident from 2007-2008 (n = 11) to 2008-09 (n = 2). Non-significant increases in isometric neck strength were found in all directions examined. A significant reduction in the number of match injuries was evident in this study. However, no other significant changes to primary outcome variables were achieved. Further, no significant increases in isometric neck strength were found in this well-trained group of professional athletes. Key Points While many authors have proposed that neck strengthening could be an effective strategy in preventing cervical spine injuries in Rugby Union, there is currently little information in the literature pertaining to how such a study might be conducted. A significant decrease in the number of injuries recorded in matches can be achieved using a specific neck strengthening program at the elite level. In an elite rugby union team as investigated in this study a significant increase in neck strength is difficult to achieve in a short period of time such as five weeks. PMID:24149163

Predicting depressive symptoms among the mothers of children with leukaemia: a caregiver stress model perspective.

PubMed

Demirtepe-Saygılı, Dilek; Bozo, Ozlem

2011-05-01

The aim of this study was to find out the predictors of depressive symptoms of mothers of children with leukaemia. The potential predictors were chosen in the light of the caregiver stress model [Pearlin, Mullan, Semple, and Skaff, 1990. Caregiving and the stress process: An overview of concepts and their measures. The Gerontologist, 30(5), 583-594.], which examines the caregiver stress as composed of many factors such as the background variables, primary and secondary stressors, mediators and psychological health outcomes. This study included the caregiving tasks, basic needs of the caregivers and role strain as the stressors; coping strategies and perceived social support as mediators and depressive symptoms as the outcome variable. The participants of this study were 90 mothers of children with leukaemia. The results revealed that the satisfaction level of the basic needs and role strain were the predictors of the depressive symptoms. While emotion-focussed coping and perceived social support mediated the stressors and the depressive symptoms relationship, problem-focussed coping did not. The possible explanations of the results were explored and the implications were discussed.

Prediction of Mental Health Services Use One Year After Regular Referral to Specialized Care Versus Referral to Stepped Collaborative Care.

PubMed

van Orden, Mirjam; Leone, Stephanie; Haffmans, Judith; Spinhoven, Philip; Hoencamp, Erik

2017-04-01

Referral to collaborative mental health care within the primary care setting is a service concept that has shown to be as effective as direct referral to specialized mental health care for patients with common mental disorders. Additionally it is more efficient in terms of lower mental health services use. This post-hoc analysis examines if treatment intensity during 1-year of follow-up can be predicted prospectively by baseline characteristics. With multilevel multivariate regression analyses baseline characteristics were examined as potential predictors of visit counts. Results showed that only the enabling factors service concept and referral delay for treatment had a significant association with mental health visit counts, when outcome was dichotomized in five or more visits. Inclusion of the outcome variable as a count variable confirmed the predictive value of service concept and referral delay, but added marital status as a significant predictor. Overall, enabling factors (service concept and referral delay) seem to be important and dominant predictors of mental health services use.

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Outcomes of deliveries by family physicians or obstetricians: a population-based cohort study using an instrumental variable

PubMed Central

Aubrey-Bassler, Kris; Cullen, Richard M.; Simms, Alvin; Asghari, Shabnam; Crane, Joan; Wang, Peizhong Peter; Godwin, Marshall

2015-01-01

Background: Previous research has suggested that obstetric outcomes are similar for deliveries by family physicians and obstetricians, but many of these studies were small, and none of them adjusted for unmeasured selection bias. We compared obstetric outcomes between these provider types using an econometric method designed to adjust for unobserved confounding. Methods: We performed a retrospective population-based cohort study of all Canadian (except Quebec) hospital births with delivery by family physicians and obstetricians at more than 20 weeks gestational age, with birth weight greater than 500 g, between Apr. 1, 2006, and Mar. 31, 2009. The primary outcomes were the relative risks of in-hospital perinatal death and a composite of maternal mortality and major morbidity assessed with multivariable logistic regression and instrumental variable–adjusted multivariable regression. Results: After exclusions, there were 3600 perinatal deaths and 14 394 cases of maternal morbidity among 799 823 infants and 793 053 mothers at 390 hospitals. For deliveries by family physicians v. obstetricians, the relative risk of perinatal mortality was 0.98 (95% confidence interval [CI] 0.85–1.14) and of maternal morbidity was 0.81 (95% CI 0.70–0.94) according to logistic regression. The respective relative risks were 0.97 (95% CI 0.58–1.64) and 1.13 (95% CI 0.65–1.95) according to instrumental variable methods. Interpretation: After adjusting for both observed and unobserved confounders, we found a similar risk of perinatal mortality and adverse maternal outcome for obstetric deliveries by family physicians and obstetricians. Whether there are differences between these groups for other outcomes remains to be seen. PMID:26303244

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

With great control comes great responsibility: the relationship between perceived academic control, student responsibility, and self-regulation.

PubMed

Fishman, Evan J

2014-12-01

Students' perceived control over academic outcomes has been linked to their use of self-regulated strategies. However, students' sense of responsibility, or internal commitment to produce such outcomes, has not often been considered in this relationship. The purpose of this study was to examine the relationships between perceived academic control (PAC), student responsibility (SR), and knowledge building (KB). Participants were 152 undergraduate students enrolled in an educational technology course. An exploratory factor analysis was conducted to demonstrate the distinction between the PAC and SR constructs. A series of regression analyses were conducted to address the research hypotheses, and a bootstrap test was used to assess the mediating role of SR in the relationship between the PAC variables and KB. Initial evidence regarding the uniqueness of the PAC and SR constructs was provided. PAC (both primary control and secondary control [SC]) were positively and significantly related to SR. KB was positively and significantly related to SR, as was SC. Additionally, SR partially mediated the relationship between the PAC variables and KB. The findings showed that those who perceived the capability to achieve academic outcomes were more likely to feel internally obligated to produce such outcomes. The same was true for students who perceived the capability to psychologically adjust to academic situations. The results also demonstrated that students' sense of responsibility for academic outcomes played a partially mediating role in the relationship between their perceptions of control and reported use of self-regulated behaviour. © 2014 The British Psychological Society.

Structure and work process in primary care and hospitalizations for sensitive conditions

PubMed Central

Araujo, Waleska Regina Machado; Queiroz, Rejane Christine de Sousa; Rocha, Thiago Augusto Hernandes; da Silva, Núbia Cristina; Thumé, Elaine; Tomasi, Elaine; Facchini, Luiz Augusto; Thomaz, Erika Barbara Abreu Fonseca

2017-01-01

ABSTRACT OBJECTIVE The objective of this study is to investigate whether the characteristics of the structure of primary health units and the work process of primary care teams are associated with the number of hospitalizations for primary care sensitive conditions. METHODS In this ecological study, we have analyzed data of Brazilian municipalities related to sociodemographic characteristics, coverage of care programs, structure of primary health units, and work process of primary care teams. We have obtained the data from the first cycle of the Brazilian Program for Improving Access and Quality of the Primary Care, of the Department of Information Technology of the Brazilian Unified Health System, the Brazilian Institute of Geography and Statistics, and the United Nations Development Programme. The associations have been estimated using negative binomial regression coefficients (β) and respective 95% confidence intervals, with a hierarchical approach in three levels (alpha = 5%). RESULTS In the adjusted analysis for the outcome in 2013, in the distal level, the coverage of the Bolsa Família Program (β = -0.001) and private insurance (β = -0.01) had a negative association, and the human development index (β = 1.13), the proportion of older adults (β = 0.05) and children under the age of five (β = 0.05), and the coverage of the Community Health Agent Strategy (β = 0.002) showed positive association with hospitalizations for primary care sensitive conditions. In the intermediate level, minimum hours (β = -0.14) and availability of vaccines (β = -0.16) showed a negative association, and availability of medications showed a positive association (β = 0.16). In the proximal level, only the variable of matrix support (β = 0.10) showed a positive association. The variables in the adjusted analysis of the number of hospitalizations for primary care sensitive conditions in 2014 presented the same association as in 2013. CONCLUSIONS The characteristics of the structure of primary health units and the work process of the primary care teams impact the number of hospitalizations for primary care sensitive conditions in Brazilian municipalities. PMID:28832757

Systematic assessment of duration and intensity of anodal transcranial direct current stimulation on primary motor cortex excitability.

PubMed

Tremblay, Sara; Larochelle-Brunet, Félix; Lafleur, Louis-Philippe; El Mouderrib, Sofia; Lepage, Jean-François; Théoret, Hugo

2016-09-01

Since the initial demonstration of linear effects of stimulation duration and intensity on the strength of after-effects associated with transcranial direct current stimulation (tDCS), few studies have systematically assessed how varying these parameters modulates corticospinal excitability. Therefore, the objective of this study was to systematically evaluate the effects of anodal tDCS on corticospinal excitability at two stimulation intensities (1 mA, 2 mA) and durations (10 min, 20 min), and determine the value of several variables in predicting response. Two groups of 20 individuals received, in two separate sessions, 1 and 2 mA anodal tDCS (left primary motor cortex (M1)-right supra-orbital montage) for either 10- or 20-min. Transcranial magnetic stimulation was delivered over left M1 and motor evoked potentials (MEPs) of the contralateral hand were recorded prior to tDCS and every 5 min for 20-min post-tDCS. The following predictive variables were evaluated: I-wave recruitment, stimulation intensity, baseline M1 excitability and inter-trial MEP variability. Results show that anodal tDCS failed to significantly modulate corticospinal excitability in all conditions. Furthermore, low response rates were identified across all parameter combinations. No baseline measure was significantly correlated with increases in MEP amplitude. However, a decrease in inter-trial MEP variability was linked to response to anodal tDCS. In conclusion, the present findings are consistent with recent reports showing high levels of inter-subject variability in the neurophysiological response to tDCS, which may partly explain inconsistent group results. Furthermore, the level of variability in the neurophysiological outcome measure, i.e. MEPs, appears to be related to response. © 2016 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

A Pharmacist-Physician Collaboration to Optimize Benzodiazepine Use for Anxiety and Sleep Symptom Control in Primary Care.

PubMed

Furbish, Shannon M L; Kroehl, Miranda E; Loeb, Danielle F; Lam, Huong Mindy; Lewis, Carmen L; Nelson, Jennifer; Chow, Zeta; Trinkley, Katy E

2017-08-01

Benzodiazepines are prescribed inappropriately in up to 40% of outpatients. The purpose of this study is to describe a collaborative team-based care model in which clinical pharmacists work with primary care providers (PCPs) to improve the safe use of benzodiazepines for anxiety and sleep disorders and to assess the preliminary results of the impact of the clinical service on patient outcomes. Adult patients were eligible if they received care from the academic primary care clinic, were prescribed a benzodiazepine chronically, and were not pregnant or managed by psychiatry. Outcomes included baseline PCP confidence and knowledge of appropriate benzodiazepine use, patient symptom severity, and medication changes. Twenty-five of 57 PCPs responded to the survey. PCPs reported greater confidence in diagnosing and treating generalized anxiety and panic disorders than sleep disorder and had variable knowledge of appropriate benzodiazepine prescribing. Twenty-nine patients had at least 1 visit. Over 44 total patient visits, 59% resulted in the addition or optimization of a nonbenzodiazepine medication and 46% resulted in the discontinuation or optimization of a benzodiazepine. Generalized anxiety symptom severity scores significantly improved (-2.0; 95% confidence interval (CI): -3.57 to -0.43). Collaborative team-based models that include clinical pharmacists in primary care can assist in optimizing high-risk benzodiazepine use. Although these findings suggest improvements in safe medication use and symptoms, additional studies are needed to confirm these preliminary results.

Primary stability and self-tapping blades: biomechanical assessment of dental implants in medium-density bone.

PubMed

Kim, Yung-Soo; Lim, Young-Jun

2011-10-01

The aim of this biomechanical study was to assess the influence of self-tapping blades in terms of primary implant stability between implants with self-tapping blades and implants without self-tapping blades using five different analytic methods, especially in medium-density bone. Two different types of dental implants (4 × 10 mm) were tested: self-tapping and non-self-tapping. The fixture design including thread profiles was exactly the same between the two groups; the only difference was the presence of cutting blades on one half of the apical portion of the implant body. Solid rigid polyurethane blocks with corresponding densities were selected to simulate medium-density bone. Five mechanical assessments (insertion torque, resonance frequency analysis [RFA], reverse torque, pull-out and push in test) were performed for primary stability. Implants without self-tapping blades showed significantly higher values (P<0.001) in four biomechanical assessments, except RFA (P=0.684). However, a statistically significant correlation could not be detected between insertion torque values with the four different outcome variables (P>0.05). The outcomes of the present study indicate that the implant body design without self-tapping blades has a good primary stability compared with that with self-tapping blades in medium-density bone. Considering the RFA, a distinct layer of cortical bone on marginal bone will yield implant stability quotient values similar to those in medium-bone density when implants have the same diameter. © 2011 John Wiley & Sons A/S.

The place of proximity: social support in mother-adult daughter relationships.

PubMed

Scelza, Brooke A

2011-07-01

The mother-adult daughter relationship has been highlighted in both the social sciences and the public health literature as an important facet of social support networks, particularly as they pertain to maternal and child health. Evolutionary anthropologists also have shown positive associations between support from maternal grandmothers and various outcomes related to reproductive success; however, many of these studies rely on proximity as a surrogate measure of support. Here I present data from the Puerto Rican Maternal and Infant Health Survey (PRMIHS) comparing geographic proximity of mother and daughter with a self-reported measure of mother-to-daughter support. These two measures were used to predict infant health outcomes as well as various measures of instrumental and emotional aid provided during pregnancy and after birth. Primary support was shown to have a positive effect across the analyses, whereas geographic proximity was associated with an increased risk of infant mortality and low birth weight as well as reduced odds of receiving support. This paradox was then examined using a combination variable that teased out the interactions of maternal support and proximity. Women who were geographically close to their mothers but who did not consider them a primary source of support had increased odds of infant death and low birth weight, and were less likely to receive either tangible or intangible forms of aid, while women whose mothers were both close and primary showed uniformly positive outcomes. These results place the role of propinquity within the larger context of social support and highlight the need for more detailed studies of social support within evolutionary anthropology.

Survival after in-hospital cardiac arrest among cerebrovascular disease patients.

PubMed

Fehnel, Corey R; Trepman, Alissa; Steele, Dale; Khan, Muhib A; Silver, Brian; Mitchell, Susan L

2018-05-19

Stroke is a leading cause of death and disability, and while preferences for cardiopulmonary resuscitation (CPR) are frequently discussed, there is limited evidence detailing outcomes after CPR among acute cerebrovascular neurology (inclusive of stroke, subarachnoid hemorrhage (SAH)) patients. Systematic review and meta-analysis of PubMed and Cochrane libraries from January 1990 to December 2016 was conducted among stroke patients undergoing in-hospital CPR. Primary data from studies meeting inclusion criteria at two levels were extracted: 1) studies reporting survival to hospital discharge after CPR with cerebrovascular primary admitting diagnosis, and 2) studies reporting survival to hospital discharge after CPR with cerebrovascular comorbidity. Meta-analysis generated weighted, pooled survival estimates for each population. Of 818 articles screened, there were 176 articles (22%) that underwent full review. Three articles met primary inclusion criteria, with an estimated 8% (95% Confidence Interval (CI) 0.01, 0.14) rate of survival to hospital discharge from a pooled sample of 561 cerebrovascular patients after in-hospital CPR. Twenty articles met secondary inclusion criteria, listing a cerebrovascular comorbidity, with an estimated rate of survival to hospital discharge of 16% (95% CI 0.14, 0.19). All studies demonstrated wide variability in adherence to Utstein guidelines, and neurological outcomes were detailed in only 6 (26%) studies. Among the few studies reporting survival to hospital discharge after CPR among acute cerebrovascular patients, survival is lower than general inpatient populations. These findings synthesize the limited empirical basis for discussions about resuscitation among stroke patients, and highlight the need for more disease stratified reporting of outcomes after inpatient CPR. Copyright © 2018 Elsevier Ltd. All rights reserved.

New utility for an old tool: can a simple gait speed test predict ambulatory surgical discharge outcomes?

PubMed

Odonkor, Charles A; Schonberger, Robert B; Dai, Feng; Shelley, Kirk H; Silverman, David G; Barash, Paul G

2013-10-01

The primary aims of this study were to design prediction models based on a functional marker (preoperative gait speed) to predict readiness for home discharge time of 90 mins or less and to identify those at risk for unplanned admissions after elective ambulatory surgery. This prospective observational cohort study evaluated all patients scheduled for elective ambulatory surgery. Home discharge readiness and unplanned admissions were the primary outcomes. Independent variables included preoperative gait speed, heart rate, and total anesthesia time. The relationship between all predictors and each primary outcome was determined in separate multivariable logistic regression models. After adjustment for covariates, gait speed with adjusted odds ratio of 3.71 (95% confidence interval, 1.21-11.26), P = 0.02, was independently associated with early home discharge readiness of 90 mins or less. Importantly, gait speed dichotomized as greater or less than 1 m/sec predicted unplanned admissions, with odds ratio of 0.35 (95% confidence interval, 0.16-0.76, P = 0.008) for those with speeds 1 m/sec or greater in comparison with those with speeds less than 1 m/sec. In a separate model, history of cardiac surgery with adjusted odds ratio of 7.5 (95% confidence interval, 2.34-24.41; P = 0.001) was independently associated with unplanned admissions after elective ambulatory surgery, when other covariates were held constant. This study demonstrates the use of novel prediction models based on gait speed testing to predict early home discharge and to identify those patients at risk for unplanned admissions after elective ambulatory surgery.

Prenatal coke: what's behind the smoke? Prenatal cocaine/alcohol exposure and school-age outcomes: the SCHOO-BE experience.

PubMed

Delaney-Black, V; Covington, C; Templin, T; Ager, J; Martier, S; Compton, S; Sokol, R

1998-06-21

Despite media reports and educators' concerns, little substantive data have been published to document or refute the emerging reports that children prenatally exposed to cocaine have serious behavioral problems in school. Recent pilot data from this institution have indeed demonstrated teacher-reported problem behaviors following prenatal cocaine exposure after controlling for the effects of prenatal alcohol use and cigarette exposure. Imperative in the study of prenatal exposure and child outcome is an acknowledgement of the influence of other control factors such as postnatal environment, secondary exposures, and parenting issues. We report preliminary evaluation from a large ongoing historical prospective study of prenatal cocaine exposure on school-age outcomes. The primary aim of this NIDA-funded study is to determine if a relationship exists between prenatal cocaine/alcohol exposures and school behavior and, if so, to determine if the relationship is characterized by a dose-response relationship. A secondary aim evaluates the relationship between prenatal cocaine/alcohol exposures and school achievement. Both relationships will be assessed in a black, urban sample of first grade students using multivariate statistical techniques for confounding as well as mediating and moderating prenatal and postnatal variables. A third aim is to evaluate the relationship between a general standardized classroom behavioral measure and a tool designed to tap the effects thought to be specific to prenatal cocaine exposure. This interdisciplinary research team can address these aims because of the existence of a unique, prospectively collected perinatal Database, funded in part by NIAAA and NICHD. The database includes repeated measures of cocaine, alcohol, and other substances for over 3,500 births since 1986. Information from this database is combined with information from the database of one of the largest public school systems in the nation. The final sample will be composed of over 600 first grade students for whom the independent variables, prenatal cocaine/alcohol exposures, were prospectively assessed and quantified at the university maternity center. After informed consent, the primary dependent variable, school behavior, is assessed, using the PROBS-14 (a teacher consensus developed instrument), the Child Behavior Check List, and the Conners' Teacher Rating Scale. The secondary dependent measure, school achievement, is measured by the Metropolitan Achievement Text and the Test of Early Reading Ability. Control variables, such as the environment and parenting, are measured by several instruments aimed at capturing the child and family ecology since birth. All analyses will be adjusted as appropriate for prospectively gathered control variables such as perinatal risk, neonatal risk, and other prenatal drug and cigarette exposures. Further adjustment will be made for postnatal social risk factors which may influence outcome. Of particular concern are characteristics of the home (adaptation of HOME), parent (depression, stress), and neighborhood (violence exposure). Finally, postnatal exposure to lead and other drugs is being considered.

Effects of edaravone on early outcomes in acute ischemic stroke patients treated with recombinant tissue plasminogen activator.

PubMed

Wada, Tomoki; Yasunaga, Hideo; Inokuchi, Ryota; Horiguchi, Hiromasa; Fushimi, Kiyohide; Matsubara, Takehiro; Nakajima, Susumu; Yahagi, Naoki

2014-10-15

We investigated whether edaravone could improve early outcomes in acute ischemic stroke patients treated with recombinant tissue plasminogen activator (rtPA). We conducted a retrospective cohort study using the Japanese Diagnosis Procedure Combination database. We identified patients admitted with a primary diagnosis of ischemic stroke from 1 July 2010 to 31 March 2012 and treated with rtPA on the same day of stroke onset or the following day. Thereafter, we selected those who received edaravone on the same day of rtPA administration (edaravone group), and those who received rtPA without edaravone (control group). The primary outcomes were modified Rankin Scale (mRS) scores at discharge. One-to-one propensity-score matching was performed between the edaravone and control groups. An ordinal logistic regression analysis for mRS scores at discharge was performed with adjustment for possible variables as well as clustering of patients within hospitals using a generalized estimating equation. We identified 6336 eligible patients for inclusion in the edaravone group (n=5979; 94%) and the control group (n=357; 6%) as the total population. In 356 pairs of the propensity-matched population, the ordinal logistic regression analysis showed that edaravone was significantly associated with lower mRS scores of patients at discharge (adjusted odds ratio: 0.74; 95% confidence interval: 0.57-0.96). Edaravone may improve early outcomes in acute ischemic stroke patients treated with rtPA. Copyright © 2014 Elsevier B.V. All rights reserved.

A Cluster Randomized Controlled Trial of the MyFamilyPlan Online Preconception Health Education Tool.

PubMed

Batra, Priya; Mangione, Carol M; Cheng, Eric; Steers, W Neil; Nguyen, Tina A; Bell, Douglas; Kuo, Alice A; Gregory, Kimberly D

2018-05-01

To evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits. Cluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome. Urban academic medical center (California). Eligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized. Intervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials. The primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score. Multilevel multivariate logistic regression. After adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected. MyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors.

Switch from aprotinin to ε-aminocaproic acid: impact on blood loss, transfusion, and clinical outcome in neonates undergoing cardiac surgery.

PubMed

Martin, K; Gertler, R; Liermann, H; Mayr, N P; MacGuill, M; Schreiber, C; Vogt, M; Tassani, P; Wiesner, G

2011-12-01

With the withdrawal of aprotinin from worldwide marketing in November 2007, many institutions treating patients at high risk for hyperfibrinolysis had to update their therapeutic protocols. At our institution, the standard was switched from aprotinin to ε-aminocaproic acid (EACA) in all patients undergoing cardiac surgery with extracorporeal circulation including neonates. Although both antifibrinolytic medications have been used widely for many years, there are few data directly comparing their blood-sparing effect and their side-effects especially in neonates. Perioperative data from 235 neonates aged up to 30 days undergoing primary cardiac surgery were analysed. Between July 1, 2006 and November 5, 2007, all patients (n=95) received aprotinin. Starting November 6, 2007 until December 31, 2009, all patients (n=140) were treated with EACA. The primary outcome criterion was blood loss; secondary outcome criteria were transfusion requirements, renal, vascular, and neurological complications and also in-hospital mortality. All descriptive and intraoperative data variable were similar. Blood loss was significantly higher in the EACA group (P=0.001), but there was no difference in the rate of re-operation for bleeding (P=0.218) nor the number of transfusions. There were no differences in the incidences of postoperative renal, neurological, and vascular events or in-hospital mortality. In neonatal patients undergoing cardiac surgery, the switch to EACA treatment led to a higher postoperative blood loss. However, there were no differences in transfusion requirements or major clinical outcomes.

Varenicline for treatment of alcohol dependence: a randomized, placebo-controlled trial.

PubMed

de Bejczy, Andrea; Löf, Elin; Walther, Lisa; Guterstam, Joar; Hammarberg, Anders; Asanovska, Gulber; Franck, Johan; Isaksson, Anders; Söderpalm, Bo

2015-11-01

Alcohol dependence is a devastating illness affecting a large population, and new pharmacological treatments with good efficacy are greatly needed. One potential candidate is varenicline, a smoking cessation agent with partial agonist action at α4 β2 nicotinic acetylcholine receptors. A total of 160 subjects, 30 to 70 years of age, fulfilling DSM-IV criteria for alcohol dependence without any serious physical or mental disorders, were recruited through advertisement at 3 university clinics in Sweden during March 2009 to January 2011. After a 2-week placebo run-in period, subjects received 2 mg varenicline daily (titrated from 0.5 mg during first week) or placebo for 12 weeks in a double-blind manner. The primary outcome was the proportion of heavy drinking days, measured by self-reported alcohol consumption. Primary and secondary outcomes were calculated as a mean over the 10-week steady-state active treatment period. In the primary outcome analysis, no effect of varenicline over placebo was found (p = 0.73 for the intention to treat [ITT] and 0.92 for per protocol [PP]). Secondary outcome analysis found a significant reduction of specific alcohol marker phosphatidylethanol (PEth) in the blood in the varenicline group compared to placebo (p = 0.02 ITT). Craving (p = 0.048 PP) and Alcohol Use Disorders Identification Test (AUDIT) scores (p = 0.015 ITT) were also reduced in the active treatment group. PEth more strongly correlated with self-reported alcohol consumption than carbohydrate-deficient ttransferrin and γ-glutamyl transferase, and correlation coefficients were higher in the varenicline group than in the placebo group for all markers. Although the results of the main outcome of this study did not support an effect of varenicline in alcohol-dependent individuals, the secondary analyses of PEth, craving and AUDIT score support an effect of varenicline on alcohol consumption. The disclosure of a treatment effect and the lack of a clear placebo effect when using PEth as outcome variable, together with a nonsymmetric bias associated with self-reported data, strongly argue for using the specific biomarker PEth in studies of treatments of alcohol dependence. Copyright © 2015 by the Research Society on Alcoholism.

Sensitivity subgroup analysis based on single-center vs. multi-center trial status when interpreting meta-analyses pooled estimates: the logical way forward.

PubMed

Alexander, Paul E; Bonner, Ashley J; Agarwal, Arnav; Li, Shelly-Anne; Hariharan, Abishek; Izhar, Zain; Bhatnagar, Neera; Alba, Carolina; Akl, Elie A; Fei, Yutong; Guyatt, Gordon H; Beyene, Joseph

2016-06-01

Prior studies regarding whether single-center trial estimates are larger than multi-center are equivocal. We examined the extent to which single-center trials yield systematically larger effects than multi-center trials. We searched the 119 core clinical journals and the Cochrane Database of Systematic Reviews for meta-analyses (MAs) of randomized controlled trials (RCTs) published during 2012. In this meta-epidemiologic study, for binary variables, we computed the pooled ratio of ORs (RORs), and for continuous outcomes mean difference in standardized mean differences (SMDs), we conducted weighted random-effects meta-regression and random-effects MA modeling. Our primary analyses were restricted to MAs that included at least five RCTs and in which at least 25% of the studies used each of single trial center (SC) and more trial center (MC) designs. We identified 81 MAs for the odds ratio (OR) and 43 for the SMD outcome measures. Based on our analytic plan, our primary analysis (core) is based on 25 MAs/241 RCTs (binary outcome) and 18 MAs/173 RCTs (continuous outcome). Based on the core analysis, we found no difference in magnitude of effect between SC and MC for binary outcomes [RORs: 1.02; 95% confidence interval (CI): 0.83, 1.24; I(2) 20.2%]. Effect sizes were systematically larger for SC than MC for the continuous outcome measure (mean difference in SMDs: -0.13; 95% CI: -0.21, -0.05; I(2) 0%). Our results do not support prior findings of larger effects in SC than MC trials addressing binary outcomes but show a very similar small increase in effect in SC than MC trials addressing continuous outcomes. Authors of systematic reviews would be wise to include all trials irrespective of SC vs. MC design and address SC vs. MC status as a possible explanation of heterogeneity (and consider sensitivity analyses). Copyright © 2015 Elsevier Inc. All rights reserved.

Social Science Methods for Twins Data: Integrating Causality, Endowments and Heritability

PubMed Central

Kohler, Hans-Peter; Behrman, Jere R.; Schnittker, Jason

2011-01-01

Twins have been extensively used in economics, sociology and behavioral genetics to investigate the role of genetic endowments on a broad range of social, demographic and economic outcomes. However, the focus in these literatures has been distinct: the economic literature has been primarily concerned with the need to control for unobserved endowments—including as an important subset, genetic endowments—in analyses that attempt to establish the impact of one variable, often schooling, on a variety of economic, demographic and health outcomes. Behavioral genetic analyses have mostly been concerned with decomposing the variation in the outcomes of interest into genetic, shared environmental and non-shared environmental components, with recent multivariate analyses investigating the contributions of genes and the environment to the correlation and causation between variables. Despite the fact that twins studies and the recognition of the role of endowments are central to both of these literatures, they have mostly evolved independently. In this paper we develop formally the relationship between the economic and behavioral genetic approaches to the analyses of twins, and we develop an integrative approach that combines the identification of causal effects, which dominates the economic literature, with the decomposition of variances and covariances into genetic and environmental factors that is the primary goal of behavioral genetic approaches. We apply this integrative ACE-β approach to an illustrative investigation of the impact of schooling on several demographic outcomes such as fertility and nuptiality and health. PMID:21845929

Amount of earnings during prize contingency management treatment is associated with posttreatment abstinence outcomes.

PubMed

Petry, Nancy M; Roll, John M

2011-12-01

Contingency management (CM) treatments that provide patients with the opportunity to earn chances of winning prizes of varying magnitudes are becoming increasingly popular. In the CM literature, magnitude of reinforcement is linked with effect sizes, such that CM treatments that provide larger magnitude reinforcement are more efficacious than those that provide lower magnitude reinforcement. With prize CM, even when magnitudes of overall expected prize earnings are constant, some patients win more prizes than others. Thus, patients who win larger overall amounts of prizes during treatment may have better outcomes than those who win fewer prizes. This study evaluated the impact of overall amounts of prizes won on long-term abstinence outcomes. The dollar amount of prizes won during prize CM treatments was determined from 78 cocaine-abusing methadone-maintenance patients who were randomized to prize CM treatments in three clinical trials. Abstinence three months following the end of the CM intervention was the primary dependent variable. The dollar amount of prizes won during CM treatment was a significant predictor of submission of cocaine-negative urine samples and self-reports of cocaine abstinence at the follow-up evaluation, even after controlling for other variables associated with long-term abstinence, such as pretreatment urinalysis results and longest duration of abstinence achieved during treatment. These results suggest that magnitudes of earnings during prize CM may impact outcomes and call for further experimentation of parameters related to the efficacy of prize CM.

Impact of urinary incontinence on medical rehabilitation inpatients.

PubMed

Mallinson, Trudy; Fitzgerald, Colleen M; Neville, Cynthia E; Almagor, Orit; Manheim, Larry; Deutsch, Anne; Heinemann, Allen

2017-01-01

To determine the prevalence of urinary incontinence (UI) and its association with rehabilitation outcomes in patients receiving inpatient medical rehabilitation in the United States. A retrospective, cohort study of 425,547 Medicare patients discharged from inpatient rehabilitation facilities (IRFs) in 2005. We examined prevalence of UI at admission and discharge for 5 impairment groups. We examined the impact of demographics, health, and functional status on the primary outcome, change in continence status, and secondary outcomes of discharge location and 6-month mortality. Approximately one-quarter (26.6%) of men were incontinent at admission compared to 22.2% of women. In all diagnostic groups, continence status remains largely unchanged from admission to discharge. Patients who are older, have cognitive difficulties, less functional improvement, and longer lengths of stay (LOS), are more likely to remain incontinent, compared to those who improved, after controlling for patient factors and clinical variables. UI was significantly associated with discharge to another post-acute setting (PAC). For orthopedic patients, UI was associated with a 71% increase in the likelihood of discharge to an institutional setting after controlling for patient factors and clinical variables. UI was not associated with death at 6 months post-discharge. UI is highly prevalent in IRF patients and is associated with increased likelihood of discharge to institutional care, particularly for orthopedic patients. Greater attention to identifying and treating UI in IRF patients may reduce medical expenditures and improve other outcomes. Neurourol. Urodynam. 36:176-183, 2017. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

Factors affecting outcome in ocular myasthenia gravis.

PubMed

Mazzoli, Marco; Ariatti, Alessandra; Valzania, Franco; Kaleci, Shaniko; Tondelli, Manuela; Nichelli, Paolo F; Galassi, Giuliana

2018-01-01

50%-60% of patients with ocular myasthenia gravis (OMG) progress to generalized myasthenia gravis (GMG) within two years. The aim of our study was to explore factors affecting prognosis of OMG and to test the predictive role of several independent clinical variables. We reviewed a cohort of 168 Caucasian patients followed from September 2000 to January 2016. Several independent variables were considered as prognostic factors: gender, age of onset, results on electrophysiological tests, presence and level of antibodies against acetylcholine receptors (AChR Abs), treatments, thymic abnormalities. The primary outcome was the progression to GMG and/or the presence of bulbar symptoms. Secondary outcomes were either achievement of sustained minimal manifestation status or worsening in ocular quantitative MG subscore (O-QMGS) or worsening in total QMG score (T-QMGS), assessed by Myasthenia Gravis Foundation of America (MGFA) quantitative scores. Changes in mental and physical subscores of health-related quality of life (HRQoL) were assessed with SF-36 questionnaire. Variance analysis was used to interpret the differences between AChR Ab titers at different times of follow up among the generalized and non-generalized patients. Conversion to GMG occurred in 18.4% of patients; it was significantly associated with sex, later onset of disease and anti-AChR Ab positivity. Antibody titer above the mean value of 25.8 pmol/mL showed no significant effect on generalization. Sex and late onset of disease significantly affected T-QMGS worsening. None of the other independent variables significantly affected O-QMGS and HRQoL. Sex, later onset and anti-AChR Ab positivity were significantly associated with clinical worsening.

Depression and Outcome of Fear of Falling in a Falls Prevention Program.

PubMed

Iaboni, Andrea; Banez, Carol; Lam, Robert; Jones, Simon A; Maki, Brian E; Liu, Barbara A; Flint, Alastair J

2015-10-01

To examine whether depression predicts less improvement in fear of falling and falls efficacy in older adults attending a falls prevention program (FPP). Using a prospective observational design in an academic medical center, the authors studied 69 nondemented adults aged 55 years or older (mean age: 77.8±8.9 years) who had experienced at least one fall in the previous year and who attended the FPP. The primary outcome variable was change in severity of fear of falling during the FPP. Secondary outcome variables were change in falls efficacy and fear-related restriction of activities during the FPP. Independent variables were baseline depressive disorders and depressive symptom severity. Twenty-one of 69 study participants (30.4%) had a depressive disorder at baseline. Depressive disorder and depressive symptoms were not associated with change in severity of fear of falling or restriction of activity. On the other hand, depressive disorder was associated with improvement in falls efficacy, although this finding was not significant in multivariate analysis. Among participants with a depressive disorder, improvement in falls efficacy was significantly correlated with improvement in depressive symptoms. There was no association between baseline depression and change in fear of falling in this FPP. The correlation between improvement in depressive symptoms and improvement in falls efficacy raises the question as to whether a cognitive-behavioral intervention that simultaneously targets both depression and falls efficacy would be a useful component of a FPP. Copyright © 2015 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

The Efficacy of a Family-Based Intervention Program on Childhood Obesity: A Quasi-Experimental Design.

PubMed

Chen, Chia-Ying; Kao, Chia-Chan; Hsu, Hsiu-Yueh; Wang, Ruey-Hsia; Hsu, Shu-Hua

2015-10-01

The purpose of this quasi-experimental study was to assess the efficacy of a family-based (FB) weight-loss and behavior-modification intervention among overweight/obese children (age 9-11 years) and their parents in Taiwan. The intervention group (52 child-parent dyads) participated in an FB program for 7 weeks. The control group (55 child-parent dyads) received an educational pamphlet about obesity prevention. The children's body mass index (BMI) z-scores were the primary outcome variable. The parents' BMI, high-calorie (HC) food-intake behaviors, screen-related behaviors, and restrictions on children's consumption of HC foods and screen-related behaviors and the availability of HC foods at home were the secondary outcome variables. Outcome variables were measured at baseline (T0), at the end of the intervention (T1), and 4 weeks after the end of the intervention (T2). A linear mixed model was used to assess the efficacy of the FB program. Results indicated that the children's BMI z-scores decreased significantly more from T0 to T2 in the experimental group than in the control group. The decreases in parents' HC food-intake behaviors and availability of HC foods at home and the increase in parental restrictions on children's consumption of HC foods were significantly greater in the experimental than in the control group from T0 to T1 and T0 to T2. The FB program was effective in modifying parental behaviors and the weight of overweight/obese children in a Taiwanese population. © The Author(s) 2015.

Variations in data collection can influence outcome measures of BMI measuring programmes.

PubMed

Townsend, Nick; Rutter, Harry; Foster, Charlie

2011-10-01

The World Health Organization (WHO) promotes the surveillance of obesity prevalence through standardized and harmonized surveillance systems. However, variations in data collection between countries, or between coordinating regions in countries can affect outcome measures. Multilevel analysis of 2007/08 National Child Measurement Programme (NCMP) data estimating the relationship between BMI z-score and data collection variations within coordinating regions whilst adjusting for individual-level and school-level variables. The 2007/08 NCMP collected height and weight measurements for 478,381 Reception year pupils (4-5-year-olds) and 496,297 year 6 pupils (10-11-year-olds) from 17,279 primary schools in 152 data collection coordinating regions in England. Data collection variables accounted for 29.7% of the regional variation in BMI z-score for Reception year pupils but only 5.3% for the older Year 6 pupils. Digit preference in the rounding of weight measurements had the greatest impact of all the data collection variables, explaining 26.4% of the regional variation in BMI z-score for Reception year pupils and 4.0% for Year 6 pupils. Although variations in data collection may have a small effect on individual measurements their impact can be magnified when scaled up to regional or national figures. All measurement programmes must regularly identify and minimize variations in data collection to improve accuracy of outcome measures. These factors include those identified within this study: participation and opt out rates, the time in the year the measurements are taken and the recording of measurements to the correct decimal place.

Evidence of selective reporting bias in hematology journals: A systematic review

PubMed Central

Scheckel, Caleb; Hicks, Chandler; Nissen, Timothy; Leduc, Linda; Som, Mousumi; Vassar, Matt

2017-01-01

Introduction Selective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored. Methods Our primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included. Results Of 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes. Conclusion Our results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making. PMID:28570573

Public funding of pharmaceuticals in The Netherlands: investigating the effect of evidence, process and context on CVZ decision-making.

PubMed

Cerri, Karin H; Knapp, Martin; Fernandez, Jose-Luis

2014-09-01

The College Voor Zorgverzekeringen (CVZ) provides guidance to the Dutch healthcare system on funding and use of new pharmaceutical technologies. This study examined the impact of evidence, process and context factors on CVZ decisions in 2004-2009. A data set of CVZ decisions pertaining to pharmaceutical technologies was created, including 29 variables extracted from published information. A three-category outcome variable was used, defined as the decision to 'recommend', 'restrict' or 'not recommend' a technology. Technologies included in list 1A/1B or on the expensive drug list were considered recommended; those included in list 2 or for which patient co-payment is required were considered restricted; technologies not included on any reimbursement list were classified as 'not recommended'. Using multinomial logistic regression, the relative contribution of explanatory variables on CVZ decisions was assessed. In all, 244 technology appraisals (256 technologies) were analysed, with 51%, of technologies recommended, 33% restricted and 16% not recommended by CVZ for funding. The multinomial model showed significant associations (p ≤ 0.10) between CVZ outcome and several variables, including: (1) use of an active comparator and demonstration of statistical superiority of the primary endpoint in clinical trials, (2) pharmaceutical budget impact associated with introduction of the technology, (3) therapeutic indication and (4) prevalence of the target population. Results confirm the value of a comprehensive and multivariate approach to understanding CVZ decision-making.

Short-term to seasonal variability in factors driving primary productivity in a shallow estuary: Implications for modeling production

NASA Astrophysics Data System (ADS)

Canion, Andy; MacIntyre, Hugh L.; Phipps, Scott

2013-10-01

The inputs of primary productivity models may be highly variable on short timescales (hourly to daily) in turbid estuaries, but modeling of productivity in these environments is often implemented with data collected over longer timescales. Daily, seasonal, and spatial variability in primary productivity model parameters: chlorophyll a concentration (Chla), the downwelling light attenuation coefficient (kd), and photosynthesis-irradiance response parameters (Pmchl, αChl) were characterized in Weeks Bay, a nitrogen-impacted shallow estuary in the northern Gulf of Mexico. Variability in primary productivity model parameters in response to environmental forcing, nutrients, and microalgal taxonomic marker pigments were analysed in monthly and short-term datasets. Microalgal biomass (as Chla) was strongly related to total phosphorus concentration on seasonal scales. Hourly data support wind-driven resuspension as a major source of short-term variability in Chla and light attenuation (kd). The empirical relationship between areal primary productivity and a combined variable of biomass and light attenuation showed that variability in the photosynthesis-irradiance response contributed little to the overall variability in primary productivity, and Chla alone could account for 53-86% of the variability in primary productivity. Efforts to model productivity in similar shallow systems with highly variable microalgal biomass may benefit the most by investing resources in improving spatial and temporal resolution of chlorophyll a measurements before increasing the complexity of models used in productivity modeling.

All-on-4® Treatment Concept for the Rehabilitation of the Completely Edentulous Mandible: A 7-Year Clinical and 5-Year Radiographic Retrospective Case Series with Risk Assessment for Implant Failure and Marginal Bone Level.

PubMed

Maló, Paulo; de Araújo Nobre, Miguel; Lopes, Armando; Ferro, Ana; Gravito, Inês

2015-10-01

Studies are needed to evaluate long-term outcomes of the All-on-4® treatment concept (Nobel Biocare AB) for rehabilitation of edentulous mandibles by assessing marginal bone levels and risk indicators for implant failure. To evaluate 7-year clinical outcomes and 5-year radiographic outcomes of the All-on-4 treatment concept. This retrospective case series included patients admitted for implant rehabilitations in the mandible, who were followed for 7 years clinically and 5 years radiographically. Primary outcome measures were cumulative prosthetic and implant survival using patient as the unit of analysis (Kaplan-Meier product limit estimator). Secondary outcome measure was marginal bone level (MBL) at 5 years. Variables associated with implant failure were analyzed using the Cox proportional hazards regression model to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Binary logistic regression was used to compute odds ratio (OR) with 95% CIs for variables associated with MBL ≥2.8 mm at 5 years. A total of 324 patients (194 women, 130 men, average age = 58.9 years) were rehabilitated with 1,296 implants supporting 324 full-arch fixed immediately loaded mandibular prostheses. Sixty-four patients (19.8%) were lost to follow-up. Prosthetic survival was 323/324 (99.7%), and 14 patients lost 18 implants, with an estimated cumulative survival rate of 95.4% at 7 years. Variables associated with implant failure were smoking (HR = 5.28; 95% CI: 1.33, 20.91]) and the learning curve effect (0.69 < HR < 0.33 for more experienced levels). Mean MBL at 5 years was 1.81 mm (95% CI: 1.70, 1.92), and smoking was associated with MBL ≥2.8 mm (OR = 2.4; 95% CI: 1.02, 5.62). The high implant and prosthetic survival rates and excellent MBL outcome confirm the predictability and safety of the All-on-4 treatment concept over a longer term than previously reported. © 2014 Wiley Periodicals, Inc.

Outcomes of laparoscopic resection of Meckel's diverticulum are equivalent to open laparotomy.

PubMed

Ezekian, Brian; Leraas, Harold J; Englum, Brian R; Gilmore, Brian F; Reed, Christopher; Fitzgerald, Tamara N; Rice, Henry E; Tracy, Elisabeth T

2018-03-15

Meckel's diverticulum (MD) is a common congenital anomaly caused by failure of involution of the omphalomesenteric duct. Enthusiasm for minimally invasive surgery (MIS) in children has burgeoned as technologies have advanced, but the outcomes of laparoscopic resection in comparison to open laparotomy for MD remain poorly defined. We queried a large national database to compare current practice patterns and clinical outcomes between surgical approaches for MD in the pediatric population. The National Surgical Quality Improvement Program-Pediatric (NSQIP-Ped) database was queried for patients undergoing surgical intervention for MD (2011-2014). Patients were stratified by surgical approach. Baseline characteristics, intraoperative variables, and perioperative complications were compared by univariate analysis using Pearson's χ 2 test for categorical variables and Kruskall-Wallis test for continuous variables. Primary outcomes of interest were length of stay (LOS), rate of readmission, and 30-day mortality. Secondary outcomes included operative time, anesthesia time, postoperative complications, and rates of reoperation. A total of 148 cases of MD were identified, of which 73 (49.3%) were initially managed with a laparoscopic approach and 75 (50.7%) were managed with an open approach. We found a high rate of conversion from laparoscopy to an open approach (20/73 or 27.4%). The median age of the laparoscopic group was higher than the open group (8.3 vs. 2.5years, p<0.001). Operative and anesthesia time, LOS, 30-day mortality, post-operative complications, and rates of reoperation and readmission were similar between groups (all p>0.05). Nearly half of all resections for MD in children are now approached laparoscopically. This approach has equivalent outcomes to traditional open laparotomy. More widespread use of a hybrid approach with laparoscopy and exteriorization of the small bowel through an extended port site may facilitate avoiding open laparotomy. Routine conversion to open for palpation of the MD or segmental small bowel resection should be avoided in the absence of compelling intra-operative findings or operative complications. Level III (retrospective comparative study). Copyright © 2018 Elsevier Inc. All rights reserved.

Postural stability and quality of life after guided and self-training among older adults residing in an institutional setting.

PubMed

Tuunainen, Eeva; Rasku, Jyrki; Jäntti, Pirkko; Moisio-Vilenius, Päivi; Mäkinen, Erja; Toppila, Esko; Pyykkö, Ilmari

2013-01-01

To evaluate whether rehabilitation of muscle force or balance improves postural stability and quality of life (QoL), and whether self-administered training is comparable with guided training among older adults residing in an institutional setting. A randomized, prospective intervention study was undertaken among 55 elderly patients. Three intervention groups were evaluated: a muscle force training group; a balance and muscle force training group; and a self-administered training group. Each group underwent 1-hour-long training sessions, twice a week, for 3 months. Postural stability was measured at onset, after 3 months, and after 6 months. Time-domain-dependent body sway variables were calculated. The fall rate was evaluated for 3 years. General health related quality of life (HRQoL) was measured with a 15D instrument. Postural stability was used as a primary outcome, with QoL and falls used as secondary outcomes. Muscle force trainees were able to undertake training, progressing towards more strenuous exercises. In posturography, the number of spiky oscillations was reduced after training, and stationary fields of torque moments of the ankle increased, providing better postural stability in all groups; in particular, the zero crossing rate of weight signal and the number of low variability episodes in the stabilogram were improved after training. While no difference was found between different training groups in posturography outcomes, a reduction of fall rate was significant in only the guided training groups. A significant part of the variability of the QoL could be explained by the posturography outcome (46%). However, the outcome of training was associated with a reduced QoL. Even moderate or severely demented residents could do exercises in five-person groups under the supervision of a physiotherapist. An improvement in postural stability was observed in all training groups, indicating that even self-administered training could be beneficial. Posturography outcome indicated that training alters the postural strategy by reducing the oscillatory fluctuations of body sway signal. However, only guided training tended to reduce falls. Short training intervention programs may decrease QoL by changing the elderly's daily routine and making it more active and exhausting.

Glucocorticoid Receptor Polymorphisms and Outcomes in Pediatric Septic Shock.

PubMed

Cvijanovich, Natalie Z; Anas, Nick; Allen, Geoffrey L; Thomas, Neal J; Bigham, Michael T; Weiss, Scott L; Fitzgerald, Julie; Checchia, Paul A; Meyer, Keith; Quasney, Michael; Gedeit, Rainer; Freishtat, Robert J; Nowak, Jeffrey; Raj, Shekhar S; Gertz, Shira; Grunwell, Jocelyn R; Opoka, Amy; Wong, Hector R

2017-04-01

Polymorphisms of the glucocorticoid receptor gene are associated with outcome and corticosteroid responsiveness among patients with inflammatory disorders. We conducted a candidate gene association study to test the hypothesis that these polymorphisms are associated with outcome and corticosteroid responsiveness among children with septic shock. We genotyped 482 children with septic shock for the presence of two glucocorticoid receptor polymorphisms (rs56149945 and rs41423247) associated with increased sensitivity and one glucocorticoid receptor polymorphism (rs6198) associated with decreased sensitivity to corticosteroids. The primary outcome variable was complicated course, defined as 28-day mortality or the persistence of two or more organ failures 7 days after a septic shock diagnosis. We used logistic regression to test for an association between corticosteroid exposure and outcome, within genotype group, and adjusted for illness severity. Multiple PICUs in the United States. Standard care. There were no differences in outcome when comparing the various genotype groups. Among patients homozygous for the wild-type glucocorticoid receptor allele, corticosteroids were independently associated with increased odds of complicated course (odds ratio, 2.30; 95% CI, 1.01-5.21; p = 0.047). Based on these glucocorticoid receptor polymorphisms, we could not detect a beneficial effect of corticosteroids among any genotype group. Among children homozygous for the wild-type allele, corticosteroids were independently associated with increased odds of poor outcome.

The behavioral and health consequences of sleep deprivation among U.S. high school students: relative deprivation matters.

PubMed

Meldrum, Ryan Charles; Restivo, Emily

2014-06-01

To evaluate whether the strength of the association between sleep deprivation and negative behavioral and health outcomes varies according to the relative amount of sleep deprivation experienced by adolescents. 2011 Youth Risk Behavior Survey data of high school students (N=15,364) were analyzed. Associations were examined on weighted data using logistic regression. Twelve outcomes were examined, ranging from weapon carrying to obesity. The primary independent variable was a self-reported measure of average number of hours slept on school nights. Participants who reported deprivations in sleep were at an increased risk of a number of negative outcomes. However, this varied considerably across different degrees of sleep deprivation. For each of the outcomes considered, those who slept less than 5h were more likely to report negative outcomes (adjusted odds ratios ranging from 1.38 to 2.72; p<.05 across all models) relative to sleeping 8 or more hours. However, less extreme forms of sleep deprivation were, in many instances, unrelated to the outcomes considered. Among U.S. high school students, deficits in sleep are significantly and substantively associated with a variety of negative outcomes, and this association is particularly pronounced for students achieving fewer than 5h of sleep at night. Copyright © 2014 Elsevier Inc. All rights reserved.

Electronic clinical records in primary care for estimating disease burden and management. An example of COPD.

PubMed

Verde-Remeseiro, Luis; López-Pardo, Estrella; Ruano-Ravina, Alberto; Gude-Sampedro, Francisco; Castro-Calvo, Ramón

2015-01-01

Chronic obstructive pulmonary disease (COPD) is a significant health problem in developed countries. We aimed to estimate the prevalence of COPD in a single Spanish healthcare area. We also aimed to assess if there are any differences in prevalence and spirometry use among primary care services by utilizing already registered information. We designed a cross-sectional study to determine the prevalence of COPD and the performance of spirometries in each primary care service. A total of 8,444 patients were diagnosed with COPD, with a prevalence of 2.6% for individuals older than 39 years. The prevalence increased with age and was much higher in men. Significant heterogeneity was found in the prevalence of COPD and spirometry use among primary care services. COPD was underdiagnosed and there was wide variability in spirometry use in our area. Greater efforts are needed to diagnose COPD in order to improve its clinical outcomes and to refine registries so that they can be used as reliable sources of information. Copyright © 2015 SESPAS. Published by Elsevier Espana. All rights reserved.

Detection of comorbidities and synchronous primary tumours via thoracic radiography and abdominal ultrasonography and their influence on treatment outcome in dogs with soft tissue sarcomas, primary brain tumours and intranasal tumours.

PubMed

Bigio Marcello, A; Gieger, T L; Jiménez, D A; Granger, L Abbigail

2015-12-01

Canine soft tissue sarcomas (STS), primary brain tumours and intranasal tumours are commonly treated with radiotherapy (RT). Given the low metastatic potential of these tumours, recommendations regarding imaging tests as staging are variable among institutions. The purpose of our study was to describe thoracic radiographic and abdominal ultrasonographic findings in dogs with these neoplasms and to investigate association of abnormal findings with alterations in recommended treatment. Medical records from 101 dogs, each having thoracic radiographs and abdominal ultrasound performed as part of their staging, were reviewed. In 98 of 101 (97%), imaging abnormalities were detected, 27% of which were further investigated with fine needle aspiration cytology or biopsy. Nine percent of the detected abnormalities were considered serious comorbidities that altered treatment recommendations, including 3 (3%) which were confirmed as synchronous primary neoplasms. These findings may influence recommendations regarding the decision to perform thoracic radiographs and abdominal ultrasound prior to initiation of RT. © 2013 John Wiley & Sons Ltd.

Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters.

PubMed

Del Cura-González, Isabel; López-Rodríguez, Juan A; Sanz-Cuesta, Teresa; Rodríguez-Barrientos, Ricardo; Martín-Fernández, Jesús; Ariza-Cardiel, Gloria; Polentinos-Castro, Elena; Román-Crespo, Begoña; Escortell-Mayor, Esperanza; Rico-Blázquez, Milagros; Hernández-Santiago, Virginia; Azcoaga-Lorenzo, Amaya; Ojeda-Ruiz, Elena; González-González, Ana I; Ávila-Tomas, José F; Barrio-Cortés, Jaime; Molero-García, José M; Ferrer-Peña, Raul; Tello-Bernabé, María Eugenia; Trujillo-Martín, Mar

2016-05-17

Clinical practice guidelines (CPGs) have been developed with the aim of helping health professionals, patients, and caregivers make decisions about their health care, using the best available evidence. In many cases, incorporation of these recommendations into clinical practice also implies a need for changes in routine clinical practice. Using educational games as a strategy for implementing recommendations among health professionals has been demonstrated to be effective in some studies; however, evidence is still scarce. The primary objective of this study is to assess the effectiveness of a teaching strategy for the implementation of CPGs using educational games (e-learning EDUCAGUIA) to improve knowledge and skills related to clinical decision-making by residents in family medicine. The primary objective will be evaluated at 1 and 6 months after the intervention. The secondary objectives are to identify barriers and facilitators for the use of guidelines by residents of family medicine and to describe the educational strategies used by Spanish teaching units of family and community medicine to encourage implementation of CPGs. We propose a multicenter clinical trial with randomized allocation by clusters of family and community medicine teaching units in Spain. The sample size will be 394 residents (197 in each group), with the teaching units as the randomization unit and the residents comprising the analysis unit. For the intervention, both groups will receive an initial 1-h session on clinical practice guideline use and the usual dissemination strategy by e-mail. The intervention group (e-learning EDUCAGUIA) strategy will consist of educational games with hypothetical clinical scenarios in a virtual environment. The primary outcome will be the score obtained by the residents on evaluation questionnaires for each clinical practice guideline. Other included variables will be the sociodemographic and training variables of the residents and the teaching unit characteristics. The statistical analysis will consist of a descriptive analysis of variables and a baseline comparison of both groups. For the primary outcome analysis, an average score comparison of hypothetical scenario questionnaires between the EDUCAGUIA intervention group and the control group will be performed at 1 and 6 months post-intervention, using 95 % confidence intervals. A linear multilevel regression will be used to adjust the model. The identification of effective teaching strategies will facilitate the incorporation of available knowledge into clinical practice that could eventually improve patient outcomes. The inclusion of information technologies as teaching tools permits greater learning autonomy and allows deeper instructor participation in the monitoring and supervision of residents. The long-term impact of this strategy is unknown; however, because it is aimed at professionals undergoing training and it addresses prevalent health problems, a small effect can be of great relevance. ClinicalTrials.gov: NCT02210442 .

Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol

PubMed Central

Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

2018-01-01

Introduction Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or ‘third -wave’ CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. Methods/analysis This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethics and dissemination Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016–0107). The Ffindings will be used to improve the intervention per user needs and preferences, and inform what amendments and/or information are required before a follow-on trial would be possible. This study contributes to a growing body of innovative, recovery-oriented innovations of psychological treatments for adults with BD. Trial registration number ACTRN12616000887471; Pre-results. PMID:29391366

Exploring the feasibility and acceptability of a recovery-focused group therapy intervention for adults with bipolar disorder: trial protocol.

PubMed

Beck, Alison K; Baker, Amanda; Jones, Steven; Lobban, Fiona; Kay-Lambkin, Frances; Attia, John; Banfield, Michelle

2018-01-31

Improving accessible, acceptable recovery-oriented service provision for people with bipolar disorder (BD) is an important priority. Mindfulness and acceptance-based cognitive and behavioural therapies (or 'third -wave' CBT) may prove fruitful due to the considerable overlap between these approaches and key features of personal recovery. Groups also confer therapeutic benefits consistent with personal recovery and may improve recovery-oriented service provision by adding another modality for accessing support. The primary objective of this trial is to explore the feasibility and acceptability of a new recovery-focused group therapy (RfGT) intervention for adults with BD. This is the first published feasibility assessment of a time-limited RfGTrecovery-focused group therapy intervention for BD. This protocol describes an open feasibility study, utilising a pre-treatment design versus post- treatment design and nested qualitative evaluation. Participants will be recruited from the Central Coast region of New South Wales, Australia, from primary care providers, specialist mental health services, non-government organisations and via self-referral. The primary outcomes are feasibility and acceptability as indexed by recruitment, retention, intervention adherence, adverse events (if any) and detailed consumer feedback. Clinical outcomes and process measures will be assessed to inform future research. Primary outcome data will utiliseuse descriptive statistics (eg, summarizingsummarising recruitment, demographics, attendance, attrition and intervention adherence). Secondary outcomes will be assessed using repeated-measures analysis of covariance across all time points (including change, effect size and variability). Ethical approval has been granted by the Northern Sydney Local Health District HREChuman research ethics committee (HREC) (HREC/16/HAWKE/69) and The University of Newcastle HREC (H-2016-0107). The Ffindings will be used to improve the intervention per user needs and preferences, and inform what amendments and/or information are required before a follow-on trial would be possible. This study contributes to a growing body of innovative, recovery-oriented innovations of psychological treatments for adults with BD. ACTRN12616000887471; Pre-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.

Protocol for determining primary healthcare practice characteristics, models of practice and patient accessibility using an exploratory census survey with linkage to administrative data in Nova Scotia, Canada.

PubMed

Marshall, Emily Gard; Gibson, Richard J; Lawson, Beverley; Burge, Frederick

2017-03-16

There is little evidence on how primary care providers (PCPs) model their practices in Nova Scotia (NS), Canada, what services they offer or what accessibility is like for the average patient. This study will create a database of all family physicians and primary healthcare nurse practitioners in NS, including information about accessibility and the model of care in which they practice, and will link the survey data to administrative health databases. 3 census surveys of all family physicians, primary care nurse practitioners (ie, PCPs) and their practices in NS will be conducted. The first will be a telephone survey conducted during typical daytime business hours. At each practice, the person answering the telephone will be asked questions about the practice's accessibility and model of care. The second will be a telephone survey conducted after typical daytime business hours to determine what out-of-office services PCP practices offer their patients. The final will be a tailored fax survey that will collect information that could not be obtained in the first 2 surveys plus new information on scope of practice, practice model and willingness to participate in research. Survey data will be linked with billing data from administrative health databases. Multivariate regression analysis will be employed to assess whether access and availability outcome variables are associated with PCP and model of practice characteristics. Negative binomial regression analysis will be employed to assess the association between independent variables from the survey data and health system use outcomes from administrative data. This study has received ethical approval from the Nova Scotia Health Authority and the Health Data Nova Scotia Data Access Committee. Dissemination approached will include stakeholder engagement at local and national levels, conference presentations, peer-reviewed publications and a public website. 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/.

Medication adherence and rejection rates in older versus younger adult liver transplant recipients

PubMed Central

Leven, Emily A.; Annunziato, Rachel; Helcer, Jacqueline; Lieber, Sarah R.; Knight, Christopher S.; Wlodarkiewicz, Catherine; Soriano, Rainier P.; Florman, Sander S.; Schiano, Thomas D.; Shemesh, Eyal

2017-01-01

A growing number of older adults are undergoing liver transplantation (LT) in the US. In some settings, it is thought that adherence declines with age. This retrospective study examined adherence and clinical outcomes in older versus younger adult LT recipients. Medical records of adult LT recipients from 2009–2012 from a single urban center were reviewed. The medication level variability index (MLVI) was the pre-defined primary outcome, with nonadherence defined as MLVI >2.5. The secondary outcome was incidence of rejection. Outcomes were evaluated starting one year post-LT until 2015. 42/248 patients were ≥65 at transplant. Older adults had significantly better adherence than younger ones (65% ≥65 were adherent vs. 42% younger adults; Chi-Square two-tailed p=0.02). Survival analyses of rejection between age groups censored by time since transplant showed no difference among the four age groups (χ2 = 0.84, p=0.84). Older age was not found to be a risk factor for reduced adherence or graft rejection in patients surviving at least one year post-LT. PMID:28370346

Anxiety, Depression, and Pain Symptoms: Associations With the Course of Marijuana Use and Drug Use Consequences Among Urban Primary Care Patients.

PubMed

Bertholet, Nicolas; Cheng, Debbie M; Palfai, Tibor P; Lloyd-Travaglini, Christine; Samet, Jeffrey H; Saitz, Richard

This exploratory study aims to investigate whether anxiety, depression, and pain are associated with changes in marijuana use and drug use consequences among primary care patients. In all, 331 adult primary care patients with marijuana as the only drug used were followed prospectively to investigate associations between anxiety/depression symptoms (no/minimal symptoms; anxiety or depression symptoms; symptoms of both) and pain (1-10 scale: none [0]; low [1-3]; medium [4-6]; high [7-10]) (independent variables) and substance use outcomes in regression models. These outcomes were changes (over 6 months) in primary outcomes: marijuana use days (past 30); and drug use consequences (Short Inventory of Problems-Drugs [SIP-D]); secondary outcomes-drug use risk (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] score for drugs). At baseline, 67% reported no/minimal anxiety/depression symptoms, 16% anxiety or depression symptoms, 17% both; 14% reported no pain, 16% low, 23% medium, 47% high pain level. Mean (SD) number of marijuana use days was 16.4 (11.6), mean SIP-D 5.9 (9.0), mean ASSIST 12.5 (7.8); no significant association was found between anxiety/depression and marijuana use changes. Given the same baseline status for SIP-D and ASSIST, respectively, those with anxiety or depression had greater increases in SIP-D (adjusted mean difference [95% confidence interval] +3.26 [1.20; 5.32], P = 0.004) and borderline significant increases in ASSIST (+3.27 [-0.12; 6.65], P = 0.06) compared with those without anxiety or depression; those with both anxiety and depression had greater increases in ASSIST (+5.42 [2.05; 8.79], P = 0.003), but not SIP-D (+1.80 [-0.46; 4.06], P = 0.12). There was no significant association between pain and marijuana use and SIP-D changes. Given the same baseline ASSIST level, those with high pain level had greater increases in ASSIST (+4.89 [1.05; 8.72], P = 0.04) compared with those with no pain. In these exploratory analyses, anxiety, depression, and high pain level appear to be associated with increases in drug-related harm among primary care patients using marijuana.

Global cardiovascular risk assessment in the primary prevention of cardiovascular disease in adults: systematic review of systematic reviews

PubMed Central

Tompson, Alice C; Onakpoya, Igho J; Roberts, Nia; Ward, Alison M; Heneghan, Carl J

2017-01-01

Objective To identify, critically appraise and summarise existing systematic reviews on the impact of global cardiovascular risk assessment in the primary prevention of cardiovascular disease (CVD) in adults. Design Systematic review of systematic reviews published between January 2005 and October 2016 in The Cochrane Library, EMBASE, MEDLINE or CINAHL databases, and post hoc analysis of primary trials. Participants, interventions, outcomes Systematic reviews of interventions involving global cardiovascular risk assessment relative to no formal risk assessment in adults with no history of CVD. The primary outcomes of interest were CVD-related morbidity and mortality and all-cause mortality; secondary outcomes were systolic blood pressure (SBP), cholesterol and smoking. Results We identified six systematic reviews of variable but generally of low quality (mean Assessing the Methodological Quality of Systematic Reviews 4.2/11, range 0/11 to 7/11). No studies identified by the systematic reviews reported CVD-related morbidity or mortality or all-cause mortality. Meta-analysis of reported randomised controlled trials (RCTs) showed small reductions in SBP (mean difference (MD) −2.22 mm Hg (95% CI −3.49 to −0.95); I2=66%; n=9; GRADE: very low), total cholesterol (MD −0.11 mmol/L (95% CI −0.20 to −0.02); I2=72%; n=5; GRADE: very low), low-density lipoprotein cholesterol (MD −0.15 mmol/L (95% CI −0.26 to −0.05), I2=47%; n=4; GRADE: very low) and smoking cessation (RR 1.62 (95% CI 1.08 to 2.43); I2=17%; n=7; GRADE: low). The median follow-up time of reported RCTs was 12 months (range 2–36 months). Conclusions The quality of existing systematic reviews was generally poor and there is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality. There are reductions in SBP, cholesterol and smoking but they may not be clinically significant given their small effect size and short duration. Resources need to be directed to conduct high-quality systematic reviews focusing on hard patient outcomes, and likely further primary RCTs. Trial registration number CRD42015019821. PMID:28341688

Primary outcomes reporting in trials of paediatric type 1 diabetes mellitus: a systematic review.

PubMed

Khanpour Ardestani, Samaneh; Karkhaneh, Mohammad; Yu, Hai Chuan; Hydrie, Muhammad Zafar Iqbal; Vohra, Sunita

2017-12-19

Our objective was to systematically review randomised clinical trials (RCTs) of paediatric type 1 diabetes mellitus (T1DM) to assess reporting of (1) primary outcome, (2) outcome measurement properties and (3) presence or absence of adverse events. Electronic searches in MEDLINE, EMBASE, CINAHL, Cochrane SR and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were undertaken. The search period was between 2001 and 2017. English-language RCTs on children younger than 21 years with T1DM were selected. We excluded studies of diagnostic or screening tools, multiple phase studies, protocols, and follow-up or secondary analysis of data. Of 11 816 unique references, 231 T1DM RCTs were included. Of total 231 included studies, 117 (50.6%) trials failed to report what their primary outcome was. Of 114 (49.4%) studies that reported primary outcome, 88 (77.2%) reported one and 26 (22.8%) more than one primary outcomes. Of 114 studies that clearly stated their primary outcome, 101 (88.6%) used biological/physiological measurements and 13 (11.4%) used instruments (eg, questionnaires, scales, etc) to measure their primary outcome; of these, 12 (92.3%) provided measurement properties or related citation. Of the 231 included studies, 105 (45.5%) reported that adverse events occurred, 39 (16.9%) reported that no adverse events were identified and 87 (37.7%) did not report on the presence or absence of adverse events. Despite tremendous efforts to improve reporting of clinical trials, clear reporting of primary outcomes of RCTs for paediatric T1DM is still lacking. Adverse events due to DM interventions were often not reported in the included trials. Transparent reporting of primary outcome, validity of measurement tools and adverse events need to be improved in paediatric T1DM trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

PubMed Central

2012-01-01

Background The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. Methods The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. Results There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Conclusions Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012. Trial registration Current Controlled Trials ISRCTN68175121 PMID:22769971

The Well London program--a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results.

PubMed

Phillips, Gemma; Renton, Adrian; Moore, Derek G; Bottomley, Christian; Schmidt, Elena; Lais, Shahana; Yu, Ge; Wall, Martin; Tobi, Patrick; Frostick, Caroline; Clow, Angela; Lock, Karen; Petticrew, Mark; Hayes, Richard

2012-07-06

The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT). The baseline survey data are reported here. The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs); ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of physical activity were higher in the Well London adult population but this is likely to be due to the different measurement tools used in the two surveys. Randomization of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well-balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012.

Combining cognitive bias modification training with motivational support in alcohol dependent outpatients: study protocol for a randomised controlled trial.

PubMed

Boffo, Marilisa; Pronk, Thomas; Wiers, Reinout W; Mannarini, Stefania

2015-02-26

Addiction research has hypothesised that automatic and reflective cognitive processes play an important role in the onset and maintenance of alcohol (ab)use, wherein automatic reactions to drug-related cues steer the drug user towards consuming before reflective processes can get over and steer towards a different behavioural response. These automatic processes include the tendency to attend and approach alcohol cues. These biases may be trained away from alcohol via computerised cognitive bias modification (CBM). The present protocol describes the design of a double-blind randomised controlled trial (RCT) testing the effectiveness of attentional bias and approach bias re-training with a 2×2 factorial design, alongside a brief motivational support (MS) program. Participants (n = 120) are adult alcohol dependent outpatients, recruited from a public health service for addiction in Italy, who have been abstinent for at least two months, and with a main diagnosis of alcohol dependence disorder. Participants are randomly assigned to one of four experimental conditions and complete 11 sessions of training after a baseline assessment. The MS takes place before each training session. Post-intervention and three-month follow-up assessments examine the change in clinical outcome variables and attentional and approach biases (measured with the Visual Probe Task and the Approach-Avoidance Task, respectively). Alcohol approach-avoidance implicit memory associations (measured with the Brief Implicit Association Test) are also evaluated at pre- and post-intervention to explore generalisation effects. Primary outcome measure is relapse rate at follow-up. Secondary outcome measures include change in cognitive biases, in alcohol-related implicit memory associations, and in the clinical variables assessed. An exploratory analysis is also planned to detect interaction effects between the CBM modules and possible moderators (interference control capacity, gender, age, number of previous detoxifications) and mediators (change in cognitive bias) of the primary outcome measure. This RCT is the first to test the effectiveness of a combined CBM intervention alongside motivational support in alcohol-dependent outpatients. The results of this study can be extremely valuable for future research in the optimisation of CBM treatment for alcohol addiction. Current Controlled Trials ISRCTN01005959 (registration date: 24 October 2013).

Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: methods of a decision-maker-researcher partnership systematic review.

PubMed

Haynes, R Brian; Wilczynski, Nancy L

2010-02-05

Computerized clinical decision support systems are information technology-based systems designed to improve clinical decision-making. As with any healthcare intervention with claims to improve process of care or patient outcomes, decision support systems should be rigorously evaluated before widespread dissemination into clinical practice. Engaging healthcare providers and managers in the review process may facilitate knowledge translation and uptake. The objective of this research was to form a partnership of healthcare providers, managers, and researchers to review randomized controlled trials assessing the effects of computerized decision support for six clinical application areas: primary preventive care, therapeutic drug monitoring and dosing, drug prescribing, chronic disease management, diagnostic test ordering and interpretation, and acute care management; and to identify study characteristics that predict benefit. The review was undertaken by the Health Information Research Unit, McMaster University, in partnership with Hamilton Health Sciences, the Hamilton, Niagara, Haldimand, and Brant Local Health Integration Network, and pertinent healthcare service teams. Following agreement on information needs and interests with decision-makers, our earlier systematic review was updated by searching Medline, EMBASE, EBM Review databases, and Inspec, and reviewing reference lists through 6 January 2010. Data extraction items were expanded according to input from decision-makers. Authors of primary studies were contacted to confirm data and to provide additional information. Eligible trials were organized according to clinical area of application. We included randomized controlled trials that evaluated the effect on practitioner performance or patient outcomes of patient care provided with a computerized clinical decision support system compared with patient care without such a system. Data will be summarized using descriptive summary measures, including proportions for categorical variables and means for continuous variables. Univariable and multivariable logistic regression models will be used to investigate associations between outcomes of interest and study specific covariates. When reporting results from individual studies, we will cite the measures of association and p-values reported in the studies. If appropriate for groups of studies with similar features, we will conduct meta-analyses. A decision-maker-researcher partnership provides a model for systematic reviews that may foster knowledge translation and uptake.

Practice assistants in primary care in Germany - associations with organizational attributes on job satisfaction.

PubMed

Gavartina, Amina; Zaroti, Stavria; Szecsenyi, Joachim; Miksch, Antje; Ose, Dominik; Campbell, Stephen M; Goetz, Katja

2013-08-05

Job satisfaction and organizational attributes in primary care teams are important issues as they affect clinical outcomes and the quality of health care provided. As practice assistants are an integral part of these teams it is important to gain insight into their views on job satisfaction and organizational attributes. The aim of this study was to evaluate the job satisfaction of practice assistants and the organizational attributes within their general practices in Germany and to explore the existence of possible associations. This observational study was based on a job satisfaction survey and measurement of organizational attributes in general practices in the German federal state of Baden-Wuerttemberg. Job satisfaction was measured with the 10-item 'Warr-Cook-Wall job satisfaction scale'. Organizational attributes were evaluated with the 21-items 'survey of organizational attributes for primary care' (SOAPC). Linear regression analyses were performed in which each of SOAPC scales and the overall score of SOAPC was treated as outcome variables. 586 practice assistants out of 794 respondents (73.8%) from 234 general practices completed the questionnaire. Practice assistants were mostly satisfied with their colleagues and least of all satisfied with their income and recognition for their work. The regression analysis showed that 'freedom of working method' and 'recognition of work', the employment status of practice assistants and the mode of practice were almost always significantly associated with each subscale and overall score of SOAPC. Job satisfaction is highly associated with different aspects of organizational attributes for primary care ('communication', 'decision-making' and 'stress'). Consequently, improved job satisfaction could lead to a better-organized primary care team. This implication should be investigated directly in further intervention studies with a special focus on improving the recognition for work and income.

Power steering: The politics of utility privatization in India

NASA Astrophysics Data System (ADS)

Kale, Sunila Sharatkumar

In this dissertation I offer an explanation for why Indian states are undertaking economic liberalization at different rates, focusing on reforms to the electricity sector. In the period between 1991 and 2003, India's states restructured their electricity systems to vastly different degrees. The dissertation evaluates three variables that feature prominently in the literature on economic policy change: ideological predilections of governing elites, external pressures like those coming from international financial institutions, and state-society interactions. I argue that it is the last explanation, focusing on the degree to which the potential "losers" from reform dominate state politics---that most compellingly accounts for the unevenness in state-level reforms. In my work, I lay greater analytic weight on the role of rural actors than much of the existing literature on the political economy of market reforms. The primary independent variable that explains this variation in reform outcomes is the organization and political strength of societal actors in each state, particularly rural and industrial constituencies, and middle class interests. In some parts of India, the advent of Green Revolution technologies in the late 1960s meant that farmers---chiefly larger landowners---became the primary beneficiaries of extensive development subsidies, including those for electricity. During India's period of economic liberalization in the 1990s, these beneficiaries constituted the main opponents of privatization, which today threatens to change the rules of the game by allocating resources according to market logics. Given these dynamics, where farm sectors are large or well-organized, reform has not proceeded. In the absence of rural political clout, state elites elected to privatize in order to satisfy industrial and urban constituents and signal the state's openness to private capital inflows. By comparing outcomes across states within the single country of India, the research design can control for some variables that are proposed as determinative of government policy, like electoral institutions and macroeconomic shock. I have selected cases to both capture variation of the dependent variable and control for other plausible explanations, such as ideology, financial crisis, and external pressure.

Inequities in access to health care in different health systems: a study in municipalities of central Colombia and north-eastern Brazil

PubMed Central

2014-01-01

Introduction Health system reforms are undertaken with the aim of improving equity of access to health care. Their impact is generally analyzed based on health care utilization, without distinguishing between levels of care. This study aims to analyze inequities in access to the continuum of care in municipalities of Brazil and Colombia. Methods A cross-sectional study was conducted based on a survey of a multistage probability sample of people who had had at least one health problem in the prior three months (2,163 in Colombia and 2,167 in Brazil). The outcome variables were dichotomous variables on the utilization of curative and preventive services. The main independent variables were income, being the holder of a private health plan and, in Colombia, type of insurance scheme of the General System of Social Security in Health (SGSSS). For each country, the prevalence of the outcome variables was calculated overall and stratified by levels of per capita income, SGSSS insurance schemes and private health plan. Prevalence ratios were computed by means of Poisson regression models with robust variance, controlling for health care need. Results There are inequities in favor of individuals of a higher socioeconomic status: in Colombia, in the three different care levels (primary, outpatient secondary and emergency care) and preventive activities; and in Brazil, in the use of outpatient secondary care services and preventive activities, whilst lower-income individuals make greater use of the primary care services. In both countries, inequity in the use of outpatient secondary care is more pronounced than in the other care levels. Income in both countries, insurance scheme enrollment in Colombia and holding a private health plan in Brazil all contribute to the presence of inequities in utilization. Conclusions Twenty years after the introduction of reforms implemented to improve equity in access to health care, inequities, defined in terms of unequal use for equal need, are still present in both countries. The design of the health systems appears to determine access to the health services: two insurance schemes in Colombia with different benefits packages and a segmented system in Brazil, with a significant private component. PMID:24479581

Wound care clinical pathway: a conceptual model.

PubMed

Barr, J E; Cuzzell, J

1996-08-01

A clinical pathway is a written sequence of clinical processes or events that guides a patient with a defined problem toward an expected outcome. Clinical pathways are tools to assist with the cost-effective management of clinical outcomes related to specific problems or disease processes. The primary obstacles to developing clinical pathways for wound care are the chronic natures of some wounds and the many variables that can delay healing. The pathway introduced in this article was modeled upon the three phases of tissue repair: inflammatory, proliferative, and maturation. This physiology-based model allows clinicians to identify and monitor outcomes based on observable and measurable clinical parameters. The pathway design, which also includes educational and behavioral outcomes, allows the clinician to individualize the expected timeframe for outcome achievement based on individual patient criteria and expert judgement. Integral to the pathway are the "4P's" which help standardize the clinical processes by wound type: Protocols, Policies, Procedures, and Patient education tools. Four categories into which variances are categorized based on the cause of the deviation from the norm are patient, process/system, practitioner, and planning/discharge. Additional research is warranted to support the value of this clinical pathway in the clinical arena.

The long-term significance of teacher-rated hyperactivity and reading ability in childhood: findings from two longitudinal studies.

PubMed

McGee, Rob; Prior, Margot; Willams, Sheila; Smart, Diana; Sanson, Anne

2002-11-01

The aims of this study were twofold: first, to examine behavioural and academic outcomes of children with hyperactivity, using data from two longitudinal studies; and second, to examine comparable psychosocial outcomes for children with early reading difficulties. Measures of teacher-rated persistent hyperactivity, and reading ability obtained during early primary school were available for children from the Australian Temperament Project and the Dunedin Multidisciplinary Health and Development Study. Both samples were followed up to assess behavioural and academic outcomes during the adolescent and early adult years. Family background, antisocial behaviour and literacy were controlled in the first set of analyses to examine the influence of early hyperactivity. There were strong linear relationships between early hyperactivity and later adverse outcomes. Adjustment for other childhood variables suggested that early hyperactivity was associated with continuing school difficulties, problems with attention and poor reading in adolescence. Early reading difficulties, after controlling for early hyperactivity, predicted continuing reading problems in high school and leaving school with no qualifications. The findings suggest that there are dual pathways from early inattentive behaviours to later inattention and reading problems, and from early reading difficulties to substantial impairments in later academic outcomes.

Pharmacotherapy for primary delusional jealousy, a retrospective observational study of 32 cases with Othello syndrome.

PubMed

Liu, Chen-Chung; Wang, Yen-Chin; Hwang, Tzung-Jeng

2018-03-01

To determine whether primary delusional jealousy can be treated effectively with antipsychotics or antidepressants, and whether any clinical variables are associated with response to pharmacotherapy, we carried out a retrospective case series observational study by reviewing clinical records of patients with an International Classification of Disease, 9th ed., diagnostic code of 297 (delusional disorders) who were treated at the Department of Psychiatry of a university affiliated hospital from January 2010 to December 2015. Only those records showing obvious delusional jealousy not secondary to other medical conditions, dementia, or schizophrenia were scrutinized thoroughly with respect to types of pharmacotherapy, treatment response, and other demographic and clinical variables likely to be associated with clinical outcomes. All except one of 32 patients, 16 men and 16 women, between 37 and 79 (60.9±10.6) years of age, were treated with low-dose antipsychotics. The general response was favorable as 19 (59.4%) were rated as good and 13 as inadequate responders (seven partial and six limited). Compared with antipsychotic monotherapy, concomitant therapy with antidepressants had a higher rate of good response, although statistically insignificant (75 vs. 53%, P=0.21). Younger age (P=0.01) and presentation at the index visit with their suspected unfaithful spouse were associated with a good response (P=0.036); comorbidity with delusions other than the jealous type was associated with a poor response (P=0.006). The overall outcome for delusional jealousy looks promising if the patients can accept pharmacotherapy in an outpatient setting.

Relationships of work characteristics to job satisfaction, turnover intention, and burnout among doctors in the district public-private mixed health system of Bangladesh.

PubMed

Roy, Ashim; van der Weijden, Trudy; de Vries, Nanne

2017-06-20

Work design integrates work characteristics having organizational, social and job components which influence employees' welfare and also organizational goals. We investigated the effects of work characteristics and other predictors to job satisfaction, turnover intention, and burnout in doctors of the public primary, public secondary and private facilities of the district health system of Bangladesh. A quantitative study using a self-administered questionnaire containing mostly structured items was conducted among the public and private doctors with a sample size of 384 from 29 out of a total 64 districts of Bangladesh during October and November 2015. All variables including work characteristics and outcomes of interest were based on literature and measured on 5-point Likert scale. Multivariate analysis of variance, bivariate correlation, and multiple regression were the models operated through SPSS version-21. A total of 354 doctors responded. No significant differences were found between public primary and secondary level doctors on combined work characteristics and outcomes variables, which however differed significantly between the public and private doctors. Organizational support was the strongest predictor adversely affecting job satisfaction, turnover intention and burnout of both the public and private doctors; private doctors' experienced more support. The effects of health-professional politics on the public doctors were alarming. Work design of the Bangladesh's health system is in need of ample development. Doing so, improvement in organizational supports is crucial; however, other work characteristics components are also important for enhancing doctors' welfare and health system productivity.

Predictors of anxiety and depression among people attending diabetes screening: a prospective cohort study embedded in the ADDITION (Cambridge) randomized control trial.

PubMed

Paddison, C A M; Eborall, H C; French, D P; Kinmonth, A L; Prevost, A T; Griffin, S J; Sutton, S

2011-02-01

This study aimed to identify factors predicting anxiety and depression among people who attend primary care-based diabetes screening. A prospective cohort study embedded in the ADDITION (Cambridge) randomized control trial. Participants (N= 3,240) at risk of diabetes were identified from 10 primary care practices and invited to a stepwise screening programme as part of the ADDITION (Cambridge) trial. Main outcome measures were anxiety and depression at 12 months post-screening assessed using the Hospital Anxiety and Depression Scale (HADS). Hierarchical linear regressions showed that demographic, clinical, and psychological variables collectively accounted for 52% of the variance in HADS anxiety scores and 53% of the variance in HADS depression scores 12 months after diabetes screening. Screening outcome (positive or negative for diabetes) was not related to differences in anxiety or depression at 12 months. Higher number of self-reported (diabetes) symptoms after first attendance was associated with higher anxiety and depression at 12-month follow-up, after controlling for anxiety and depression after first attendance. Participants in a diabetes screening programme showed low scores on anxiety and depression scales after first appointment and 1 year later. Diagnosis of diabetes was shown to have a limited psychological impact and may be less important than symptom perception in determining emotional outcomes after participation in diabetes screening. ©2010 The British Psychological Society.

Improving health and productivity of depressed workers: a pilot randomized controlled trial of telephone cognitive behavioral therapy delivery in workplace settings.

PubMed

Bee, Penny E; Bower, Peter; Gilbody, Simon; Lovell, Karina

2010-01-01

To examine the feasibility of telephone-delivered cognitive behavioral therapy (T-CBT) in an occupational context, with reference to participant recruitment, treatment adherence, follow-up and effect. Eligible participants comprised all employees of a large communications company with authorized work absence due to mild/moderate mental health difficulties over a 10-month period. Fifty-three consenting participants were centrally randomized to 12 weeks T-CBT or usual care, with minimization on age, gender and illness severity. Primary (symptom severity) and secondary outcomes (self-rated work performance and productivity) were measured at baseline and 3-months via postal questionnaires. Intention-to-treat analysis comprised multiple regression modeling with adjustment for missing response predictors, minimization variables and baseline values. Twenty-three employees attended one or more T-CBT sessions. T-CBT was associated with medium-large effects sizes on clinical outcomes (0.63-0.77) and work productivity scores (0.75-0.88). Twenty-one patients failed to return 3-month primary outcome data. Non-respondents were more likely to be male and more severely ill. Delivery of T-CBT in an occupational context is feasible with evidence of potential effect. Larger-scale trials are warranted. These studies demand assertive outreach or telephone-based assessment strategies in order to maximize participant recruitment and follow-up. Copyright 2010 Elsevier Inc. All rights reserved.

The case against primary endoscopic realignment of pelvic fracture urethral injuries

PubMed Central

Tausch, Timothy J.; Morey, Allen F.

2015-01-01

Objectives To review previous reports and present our experience on the outcomes after treating pelvic fracture urethral injuries (PFUIs) with primary endoscopic realignment (PER) vs. placing a suprapubic tube (SPT) with elective bulbomembranous anastomotic urethroplasty (BMAU). Methods We reviewed previous reports and identified articles that reported outcomes after PER vs. SPT and elective BMAU for patients who sustained PFUIs. We also present our institutional experience of treating patients who were referred after undergoing either form of treatment. Results The success rates for PER after PFUI are wide-ranging (11–86%), with variable definitions for a successful outcome. At our institution, for patients treated by SPT/BMAU, the mean time to a definitive resolution of stenosis was dramatically shorter (6 months, range 3–15) than for those treated with PER (122 months, range 4–574; P < 0.01). The vast majority of patients treated by PER required multiple endoscopic urethral interventions (median 4, range 1–36;P < 0.01) and/or had various other adverse events that were rare among the SPT/BMAU group (14/17, 82%, vs. 2/23, 9%;P < 0.05). Conclusion While PER occasionally results in urethral patency with no need for further intervention, the risk of delay in definitive treatment and the potential for adverse events have led to a preference for SPT and elective BMAU at our institution. PMID:26019972

Efficacy of a DVD-Based Smoking Cessation Intervention for African Americans

PubMed Central

Baker, Elizabeth A.; Robinson, Robert G.

2014-01-01

Introduction: Previous research suggests that African American smokers may have improved outcomes if interventions are culturally specific. However, few interventions sufficiently address the unique needs of this population in a format with large reach potential. The purpose of this study was to test the efficacy of a newly developed digital video disc (DVD)-based cessation intervention targeting African Americans. Methods: In a 2-arm randomized trial, smokers (N = 140) were randomly assigned to view either the new Pathways to Freedom (PTF) DVD or a standard control DVD. Participants were assessed at baseline, immediately postviewing the DVD, and at a 1-month follow-up. The primary outcomes were feasibility and process variables, including intervention evaluations, readiness to quit, and risk perceptions, and smoking-related behavior changes were examined as secondary outcomes. Results: Findings demonstrated the hypothesized positive effects of the PTF DVD compared with the control DVD on content evaluations, risk perceptions, and readiness to quit at follow-up. Conclusions: We found initial evidence for the efficacy of the PTF DVD as a stand-alone intervention. Future research will test the efficacy of the DVD for smoking cessation in a larger randomized trial. The ultimate goal of this research is to validate a new intervention for an underserved community of smokers that can be used in multiple settings, such as community health clinics, primary care, quitlines, cessation clinics, and seminars/workshops. PMID:24838844

A quality improvement plan for hypertension control: the INCOTECA Project (INterventions for COntrol of hyperTEnsion in CAtalonia)

PubMed Central

Vallès-Fernandez, Roser; Rosell-Murphy, Magdalena; Correcher-Aventin, Olga; Mengual-Martínez, Lucas; Aznar-Martínez, Núria; Prieto-De Lamo, Gemma; Franzi-Sisó, Alícia; Puig-Manresa, Jordi; Ma Bonet-Simó, Josep

2009-01-01

Background Different studies have shown insufficient blood pressure (BP) control in hypertensive patients. Multiple factors influence hypertension management, and the quality of primary care is one of them. We decided therefore to evaluate the effectiveness of a quality improvement plan directed at professionals of Primary Health Care Teams (PHCT) with the aim to achieve a better control of hypertension. The hypothesis of the study is that the implementation of a quality improvement plan will improve the control of hypertension. The primary aim of this study will be to evaluate the effectiveness of this plan. Methods and design Design: multicentric study quasi-experimental before – after with control group. The non-randomised allocation of the intervention will be done at PHCT level. Setting: 18 PHCT in the Barcelona province (Spain). Sample: all patients with a diagnosis of hypertension (population based study). Exclusion criteria: patients with a diagnosis of hypertension made later than 01/01/2006 and patients younger than 18 years. Intervention: a quality improvement plan, which targets primary health care professionals and includes educational sessions, feedback to health professionals, audit and implementation of recommended clinical practice guidelines for the management of hypertensive patients. Measurements: age, sex, associated co-morbidity (diabetes mellitus type I and II, heart failure and renal failure). The following variables will be recorded: BP measurement, cardiovascular risk and antihypertensive drugs used. Results will be measured before the start of the intervention and twelve months after the start of the study. Dependent variable: prevalence of hypertensive patients with poor BP control. Analysis: Chi-square test and Student's t-test will be used to measure the association between independent qualitative and quantitative variables, respectively. Non-parametric tests will be used for the analysis of non-normally distributed variables. Significance level (α) will be set at < 0.05. Outcomes will be analysed on an intention-to-treat basis. Discussion The implementation of a quality improvement plan might benefit the coordination of different professionals of PHCTs and may also improve blood pressure control. Trial Registration This protocol has been registered at clinicaltrials.gov with the ID number MS: 1998275938244441. PMID:19321009

Patient volume, staffing, and workload in relation to risk-adjusted outcomes in a random stratified sample of UK neonatal intensive care units: a prospective evaluation.

PubMed

Tucker, Janet

2002-01-12

UK recommendations suggest that large neonatal intensive-care units (NICUs) have better outcomes than small units, although this suggestion remains unproven. We assessed whether patient volume, staffing levels, and workload are associated with risk-adjusted outcomes, and with costs or staff wellbeing. 186 UK NICUs were stratified according to volume of patients, nursing provision, and neonatal consultant provision. Primary outcomes were hospital mortality, mortality or cerebral damage, and nosocomial bacteraemia. We studied 13515 infants of all birthweights consecutively admitted to 54 randomly selected NICUs. Multiple logistic regression analyses were done with every primary outcome as the dependent variable. Staff wellbeing and stress were assessed by anonymous mental health index (MHI)-5 questionnaires. Data were available for 13334 (99%) infants. High-volume NICUs treated the sickest infants and had highest crude mortality. Risk-adjusted mortality and mortality or cerebral damage were unrelated to patient volume or staffing provision; however, nosocomial bacteraemia was less frequent in NICUs with low neonatal consultant provision (odds ratio 0.65, 95% CI 0.43-0.98). Mortality was raised with increasing workload in all types of NICUs. Infants admitted at full capacity versus half capacity were about 50% more likely to die, but there was wide uncertainty around this estimate. Most staff had MHI-5 scores that suggested good mental health. The implications of this report for staffing policy, medicolegal risk management, and ethical practice remain to be tested. Centralisation of only the sickest infants could improve efficiency, provided that this does not create excessive workload for staff. Assessment of increased staffing levels that are closer to those in adult intensive care might be appropriate.

Protocols and Hospital Mortality in Critically ill Patients: The United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study

PubMed Central

Sevransky, Jonathan E.; Checkley, William; Herrera, Phabiola; Pickering, Brian W.; Barr, Juliana; Brown, Samuel M; Chang, Steven Y; Chong, David; Kaufman, David; Fremont, Richard D; Girard, Timothy D; Hoag, Jeffrey; Johnson, Steven B; Kerlin, Mehta P; Liebler, Janice; O'Brien, James; O'Keefe, Terence; Park, Pauline K; Pastores, Stephen M; Patil, Namrata; Pietropaoli, Anthony P; Putman, Maryann; Rice, Todd W.; Rotello, Leo; Siner, Jonathan; Sajid, Sahul; Murphy, David J; Martin, Greg S

2015-01-01

Objective Clinical protocols may decrease unnecessary variation in care and improve compliance with desirable therapies. We evaluated whether highly protocolized intensive care units have superior patient outcomes compared with less highly protocolized intensive care units. Design Observational study in which participating intensive care units completed a general assessment and enrolled new patients one day each week. Setting and Patients 6179 critically ill patients across 59 intensive care units in the United States Critical Illness and Injury Trials Group Critical Illness Outcomes Study Interventions: None Measurements and Main Results The primary exposure was the number of intensive care unit protocols; the primary outcome was hospital mortality. 5809 participants were followed prospectively and 5454 patients in 57 intensive care units had complete outcome data. The median number of protocols per intensive care unit was 19 (IQR 15 to 21.5). In single variable analyses, there were no differences in intensive care unit and hospital mortality, length of stay, use of mechanical ventilation, vasopressors, or continuous sedation among individuals in intensive care units with a high vs. low number of protocols. The lack of association was confirmed in adjusted multivariable analysis (p=0.70). Protocol compliance with two ventilator management protocols was moderate and did not differ between intensive care units with high vs. low numbers of protocols for lung protective ventilation in ARDS (47% vs. 52%; p=0.28) and for spontaneous breathing trials (55% vs. 51%; p=0.27). Conclusions Clinical protocols are highly prevalent in United States intensive care units. The presence of a greater number of protocols was not associated with protocol compliance or patient mortality. PMID:26110488

Management of Simple Clavicle Fractures by Primary Care Physicians.

PubMed

Stepanyan, Hayk; Gendelberg, David; Hennrikus, William

2017-05-01

The clavicle is the most commonly fractured bone. Children with simple fractures are often referred to orthopedic surgeons by primary care physician to ensure adequate care. The objective of this study was to show that simple clavicle fractures have excellent outcomes and are within the scope of primary care physician's practice. We performed a retrospective chart review of 16 adolescents with simple clavicle fractures treated with a sling. Primary outcomes were bony union, pain, and function. The patients with simple clavicle fractures had excellent outcomes with no complications or complaints of pain or restriction of their activities of daily living. The outcomes are similar whether treated by an orthopedic surgeon or a primary care physician. The cost to society and the patient is less when the primary care physician manages the fracture. Therefore, primary care physicians should manage simple clavicle fractures.

Influences of acute alcohol consumption, sexual precedence, and relationship motivation on women’s relationship and sex appraisals and unprotected sex intentions

PubMed Central

Jacques-Tiura, Angela J.; Norris, Jeanette; Kiekel, Preston A.; Davis, Kelly Cue; Zawacki, Tina; Morrison, Diane M.; George, William H.; Abdallah, Devon Alisa

2014-01-01

Guided by the cognitive mediation model of sexual decision making (Norris, Masters, & Zawacki, 2004. Cognitive mediation of women’s sexual decision making: The influence of alcohol, contextual factors, and background variables. Annual Review of Sex Research, 15, 258–296), we examined female social drinkers’ (N = 162) in-the-moment risky sexual decision making by testing how individual differences (relationship motivation) and situational factors (alcohol consumption and sexual precedence conditions) influenced cognitive appraisals and sexual outcomes in a hypothetical sexual scenario. In a path model, acute intoxication, sexual precedence, and relationship motivation interactively predicted primary relationship appraisals and independently predicted primary sex appraisals. Primary appraisals predicted secondary appraisals related to relationship and unprotected sex, which predicted unprotected sex intentions. Sexual precedence directly increased unprotected sex intentions. Findings support the cognitive mediation model and suggest that sexual risk reduction interventions should address alcohol, relationship, sexual, and cognitive factors. PMID:25755302

A meta-analysis of the efficacy of fibromyalgia treatment according to level of care

PubMed Central

Garcia-Campayo, Javier; Magdalena, Jesus; Magallón, Rosa; Fernández-García, Esther; Salas, Montserrat; Andrés, Eva

2008-01-01

Introduction The aim of this paper was to compare the efficacy of the treatments for fibromyalgia currently available in both primary care and specialised settings. Methods Published reports of randomised controlled trials (RCTs) researching pharmacological and non-pharmacological treatments in patients with fibromyalgia were found in the MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PsychInfo databases. The most recent electronic search was undertaken in June 2006. Results We identified a total of 594 articles. Based on titles and abstracts, 102 full articles were retrieved, 33 of which met the inclusion criteria. These RCTs assessed 120 treatment interventions in 7789 patients diagnosed with primary fibromyalgia. Of them, 4505 (57.8%) were included in the primary care group of our study and 3284 (42.2%) in the specialised intervention group. The sample was mostly made up of middle-aged women, who have had fibromyalgia for a mean period of 6 to 10 years. The mean effect size of the efficacy of the 120 treatment interventions in patients with fibromyalgia compared with controls was 0.49 (95% confidence interval [CI] = 0.39 to 0.58; p < 0.001). In the primary care group it was 0.46 (95% CI = 0.33 to 0.58) while in specialised care it was 0.53 (95% CI = 0.38 to 0.69), with no statistical significance in the differences. We analysed the efficacy of treatments by comparing primary and specialised care in the different fibromyalgia groups and there were no significant differences. The variables of the studies that affected the improvements in the efficacy of fibromyalgia treatment were low quality of the studies and a shorter duration of treatment. However, both factors were biased by the heterogeneity of the studies. Other variables that also improved outcome and were not biased by the heterogeneity of the studies, were younger age of the patients and shorter duration of the disorder. On the contrary, gender and type of treatment (pharmacological vs. psychological) did not affect outcome. Conclusion Based on this meta-analysis and despite the heterogeneity of specialised care studies and of the other limitations described in this article, treating fibromyalgia in specialised care offers no clear advantages. PMID:18627602

Modeling and forecasting US presidential election using learning algorithms

NASA Astrophysics Data System (ADS)

Zolghadr, Mohammad; Niaki, Seyed Armin Akhavan; Niaki, S. T. A.

2017-09-01

The primary objective of this research is to obtain an accurate forecasting model for the US presidential election. To identify a reliable model, artificial neural networks (ANN) and support vector regression (SVR) models are compared based on some specified performance measures. Moreover, six independent variables such as GDP, unemployment rate, the president's approval rate, and others are considered in a stepwise regression to identify significant variables. The president's approval rate is identified as the most significant variable, based on which eight other variables are identified and considered in the model development. Preprocessing methods are applied to prepare the data for the learning algorithms. The proposed procedure significantly increases the accuracy of the model by 50%. The learning algorithms (ANN and SVR) proved to be superior to linear regression based on each method's calculated performance measures. The SVR model is identified as the most accurate model among the other models as this model successfully predicted the outcome of the election in the last three elections (2004, 2008, and 2012). The proposed approach significantly increases the accuracy of the forecast.

Impact of Medication Adherence on Mortality and Cardiovascular Morbidity: Protocol for a Population-Based Cohort Study

PubMed Central

2018-01-01

Background Cardiovascular disease (CVD) is a group of disorders of the heart and blood vessels, such as coronary heart disease (CHD), cerebrovascular disease, and peripheral artery disease. CVD is the leading threat to global health, whether measured by mortality, morbidity, or economic cost. Long-term administration of aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers improves survival in patients with stablished coronary heart disease. Nevertheless, adherence to prescribed medication is poor for long-term drug treatment. Objective We aim to assess the relationship between adherences to the four pharmacological groups recommended for secondary prevention and the clinical outcomes of cardiovascular morbidity and mortality in patients with established CHD according to the level of adherence to these drugs in a population of incident cases of acute coronary syndrome (ACS). Methods Population-based cohort study of patients with a first episode of ACS during 2006-2015 in the Information System for Research in Primary Care (SIDIAP) database. We will estimate adherence to these drugs. The primary endpoint is a composite of all-cause mortality, ACS, and ischaemic stroke. Bivariate analyses will be performed estimating odds ratios for categorical variables and mean differences for continuous variables. Hazard ratios for adherences will be calculated for outcome events using Cox proportional hazard regression models, and proportionality of hazards assumption will be tested. Results We expect to estimate adherence to all four study treatments, the incidence of MACE, and to analyze if this incidence is associated with the level of drug adherence. Conclusions We expect to find that adherent patients have a lower risk of the primary endpoints compared with nonadherent patients. Trial Registration This study protocol was classified as EPA-OD by the AEMPS (IJG-EST-2017-01-2017-01, 07/04/2017) and registered in the EU PAS register (EUPAS19017, 09/05/2017). PMID:29523501

Density of surgeons is significantly associated with reduced risk of deaths from motor vehicle crashes in US counties.

PubMed

Chang, David C; Eastman, Brent; Talamini, Mark A; Osen, Hayley B; Tran Cao, Hop S; Coimbra, Raul

2011-05-01

The concept of surgery and public health has been introduced in recent years, highlighting the impact of surgeons on improving public health outcomes, a relationship that has traditionally been ascribed to general practitioners. The purpose of this study is to quantify the effect of surgeon availability on deaths from motor vehicle crashes (MVC). Retrospective analysis of the Area Resource File from 2006 was performed. The primary outcome variable was the three-year (2001-2003) average in MVC deaths per 1 million population for each county. The primary independent variable was the density of surgeons per 1 million population in year 2003. Multiple linear regression analysis was performed, adjusting for density of general practitioners, urbanicity of the county, and socioeconomic status of the county. A total of 3,225 counties were analyzed. The median number of MVC deaths per million population was 226 (IQR 158-320). The median number of surgeon per million population was 55 (IQR 0-105), while the median number of general practitioners per million population was 424 (IQR 274-620). On unadjusted analysis, each increase of one surgeon per million population was associated with 0.38 fewer MVC deaths per million population (p < 0.001). On multivariate analysis, each increase of one surgeon per million population was significantly associated with 0.16 fewer MVC deaths per million population (p < 0.001). Rural location, persistent poverty, and low educational level were all associated with significant increases in MVC deaths. Higher density of surgeons is associated with significant reduction in deaths from MVCs. This highlights the need for 1) consideration of surgery as primary care and 2) development of inclusive surgical systems designed to provide care commensurate with patients' degree of injury. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Determinants associated with deprivation in multimorbid patients in primary care—A cross-sectional study in Switzerland

PubMed Central

Déruaz-Luyet, Anouk; N’Goran, A. Alexandra; Pasquier, Jérôme; Streit, Sven; Neuner-Jehle, Stefan; Zeller, Andreas; Haller, Dagmar M.; Herzig, Lilli; Bodenmann, Patrick

2017-01-01

Background Deprivation usually encompasses material, social, and health components. It has been shown to be associated with greater risks of developing chronic health conditions and of worse outcome in multimorbidity. The DipCare questionnaire, an instrument developed and validated in Switzerland for use in primary care, identifies patients subject to potentially higher levels of deprivation. Objectives To identifying determinants of the material, social, and health profiles associated with deprivation in a sample of multimorbid, primary care patients, and thus set priorities in screening for deprivation in this population. Design Secondary analysis from a nationwide cross-sectional study in Switzerland. Participants A random sample of 886 adult patients suffering from at least three chronic health conditions. Main measures The outcomes of interest were the patients’ levels of deprivation as measured using the DipCare questionnaire. Classification And Regression Tree analysis identified the independent variables that separated the examined population into groups with increasing deprivation scores. Finally, a sensitivity analysis (multivariate regression) confirmed the robustness of our results. Key results Being aged under 64 years old was associated with higher overall, material, and health deprivation; being aged over 77 years old was associated with higher social deprivation. Other variables associated with deprivation were the level of education, marital status, and the presence of depression or chronic pain. Conclusion Specific profiles, such as being younger, were associated with higher levels of overall, material, and health deprivation in multimorbid patients. In contrast, patients over 77 years old reported higher levels of social deprivation. Furthermore, chronic pain and depression added to the score for health deprivation. It is important that GPs consider the possibility of deprivation in these multimorbid patients and are able to identify it, both in order to encourage treatment adherence and limit any forgoing of care for financial reasons. PMID:28738070

Distress among women receiving uninformative BRCA1/2 results: 12-month outcomes.

PubMed

O'Neill, Suzanne C; Rini, Christine; Goldsmith, Rachel E; Valdimarsdottir, Heiddis; Cohen, Lawrence H; Schwartz, Marc D

2009-10-01

Few data are available regarding the long-term psychological impact of uninformative BRCA1/2 test results. This study examines change in distress from pretesting to 12-months post-disclosure, with medical, family history, and psychological variables, such as pretesting perceived risk of carrying a deleterious mutation prior to testing and primary and secondary appraisals, as predictors. Two hundred and nine women with uninformative BRCA1/2 test results completed questionnaires at pretesting and 1-, 6-, and 12-month post-disclosure, including measures of anxiety and depression, cancer-specific and genetic testing distress. We used a mixed models approach to predict change in post-disclosure distress. Distress declined from pretesting to 1-month post-disclosure, but remained stable thereafter. Primary appraisals predicted all types of distress at 1-month post-disclosure. Primary and secondary appraisals predicted genetic testing distress at 1-month as well as change over time. Receiving a variant of uncertain clinical significance and entering testing with a high expectation for carrying a deleterious mutation predicted genetic testing distress that persisted through the year after testing. As a whole, women receiving uninformative BRCA1/2 test results are a resilient group. For some women, distress experienced in the month after testing does not dissipate. Variables, such as heightened pretesting perceived risk and cognitive appraisals, predict greater likelihood for sustained distress in this group and could be amenable to intervention.

Sleep duration differences between children of migrant and native origins.

PubMed

Labree, L J W Wim; van de Mheen, H Dike; Rutten, F F H Frans; Rodenburg, G Gerda; Koopmans, G T Gerrit; Foets, M Marleen

To explore whether primary school children of migrant and native Dutch origins differ regarding their sleep duration per night, a risk for overweight and obesity, and to determine to what degree differences in parenting styles contribute to these differences. A cross-sectional survey, including 1,943 children aged 8-9 years old and their primary caregivers, was performed. Data were collected from primary schools in cities and adjacent municipalities in The Netherlands: Eindhoven and Rotterdam. The outcome measure was mean sleep duration per night. The main independent variable was migrant background, based on the country of birth of the parents. A possible mediating variable was parenting style (rejecting, neglecting, permissive, authoritarian, authoritative). Age and sex of the child as well as parental socioeconomic status, as indicated by educational level, were added as confounders. Dutch children have the highest sleep duration: more than 11 h (mean = 670.1; SD = 27.7). All migrant children show less than 11 h of sleep per night. Migrant children of non-Western origin, especially Turkish and Moroccan children, show the lowest sleep duration per night. Parenting styles do not contribute to these differences. Migrant background is associated with sleep duration. As children of migrant origin are, in general, at higher risk for overweight and obesity and sleep duration is regarded as a risk factor for overweight and obesity, further investigation of this association is needed.

Haphazard reporting of deaths in clinical trials: a review of cases of ClinicalTrials.gov records and matched publications–a cross-sectional study

PubMed Central

Earley, Amy; Lau, Joseph; Uhlig,, Katrin

2013-01-01

Context A participant death is a serious event in a clinical trial and needs to be unambiguously and publicly reported. Objective To examine (1) how often and how numbers of deaths are reported in ClinicalTrials.gov records; (2) how often total deaths can be determined per arm within a ClinicalTrials.gov results record and its corresponding publication and (3) whether counts may be discordant. Design Registry-based study of clinical trial results reporting. Setting ClinicalTrials.gov results database searched in July 2011 and matched PubMed publications. Selection criteria A random sample of ClinicalTrials.gov results records. Detailed review of records with a single corresponding publication. Main outcome measure ClinicalTrials.gov records reporting number of deaths under participant flow, primary or secondary outcome or serious adverse events. Consistency in reporting of number of deaths between ClinicalTrials.gov records and corresponding publications. Results In 500 randomly selected ClinicalTrials.gov records, only 123 records (25%) reported a number for deaths. Reporting of deaths across data modules for participant flow, primary or secondary outcomes and serious adverse events was variable. In a sample of 27 pairs of ClinicalTrials.gov records with number of deaths and corresponding publications, total deaths per arm could only be determined in 56% (15/27 pairs) but were discordant in 19% (5/27). In 27 pairs of ClinicalTrials.gov records without any information on number of deaths, 48% (13/27) were discordant since the publications reported absence of deaths in 33% (9/27) and positive death numbers in 15% (4/27). Conclusions Deaths are variably reported in ClinicalTrials.gov records. A reliable total number of deaths per arm cannot always be determined with certainty or can be discordant with number reported in corresponding trial publications. This highlights a need for unambiguous and complete reporting of the number of deaths in trial registries and publications. PMID:23335556

Clinical and angiographic risk factors for stroke and death within 30 days after carotid endarterectomy and stent-protected angioplasty: a subanalysis of the SPACE study.

PubMed

Stingele, Robert; Berger, Jürgen; Alfke, Karsten; Eckstein, Hans-Henning; Fraedrich, Gustav; Allenberg, Jens; Hartmann, Marius; Ringleb, Peter A; Fiehler, Jens; Bruckmann, H; Hennerici, M; Jansen, O; Klein, G; Kunze, A; Marx, P; Niederkorn, K; Schmiedt, W; Solymosi, L; Zeumer, H; Hacke, W

2008-03-01

Carotid endarterectomy (CEA) and carotid artery stenting (CAS) are used to prevent ischaemic stroke in patients with stenosis of the internal carotid artery. Better knowledge of risk factors could improve assignment of patients to these procedures and reduce overall risk. We aimed to assess the risk of stroke or death associated with CEA and CAS in patients with different risk factors. We analysed data from 1196 patients randomised to CAS or CEA in the Stent-Protected Angioplasty versus Carotid Endarterectomy in Symptomatic Patients (SPACE) trial. The primary outcome event was death or ipsilateral stroke (ischaemic or haemorrhagic) with symptoms that lasted more than 24 h between randomisation and 30 days after therapy. Six predefined variables were assessed as potential risk factors for this outcome: age, sex, type of qualifying event, side of intervention, degree of stenosis, and presence of high-grade contralateral stenosis or occlusion. The SPACE trial is registered at Current Controlled Trials, with the international standard randomised controlled trial number ISRCTN57874028. Risk of ipsilateral stroke or death increased significantly with age in the CAS group (p=0.001) but not in the CEA group (p=0.534). Classification and regression tree analysis showed that the age that gave the greatest separation between high-risk and low-risk populations who had CAS was 68 years: the rate of primary outcome events was 2.7% (8/293) in patients who were 68 years old or younger and 10.8% (34/314) in older patients. Other variables did not differ between the CEA and CAS groups. Of the predefined covariates, only age was significantly associated with the risk of stroke and death. The lower risk after CAS versus CEA in patients up to 68 years of age was not detectable in older patients. This finding should be interpreted with caution because of the drawbacks of post-hoc analyses.

A Randomised Controlled Trial to Reduce Sedentary Time in Young Adults at Risk of Type 2 Diabetes Mellitus: Project STAND (Sedentary Time ANd Diabetes)

PubMed Central

Biddle, Stuart J. H.; Edwardson, Charlotte L.; Wilmot, Emma G.; Yates, Thomas; Gorely, Trish; Bodicoat, Danielle H.; Ashra, Nuzhat; Khunti, Kamlesh; Nimmo, Myra A.; Davies, Melanie J.

2015-01-01

Aims Type 2 diabetes mellitus (T2DM), a serious and prevalent chronic disease, is traditionally associated with older age. However, due to the rising rates of obesity and sedentary lifestyles, it is increasingly being diagnosed in the younger population. Sedentary (sitting) behaviour has been shown to be associated with greater risk of cardio-metabolic health outcomes, including T2DM. Little is known about effective interventions to reduce sedentary behaviour in younger adults at risk of T2DM. We aimed to investigate, through a randomised controlled trial (RCT) design, whether a group-based structured education workshop focused on sitting reduction, with self-monitoring, reduced sitting time. Methods Adults aged 18–40 years who were either overweight (with an additional risk factor for T2DM) or obese were recruited for the Sedentary Time ANd Diabetes (STAND) RCT. The intervention programme comprised of a 3-hour group-based structured education workshop, use of a self-monitoring tool, and follow-up motivational phone call. Data were collected at three time points: baseline, 3 and 12 months after baseline. The primary outcome measure was accelerometer-assessed sedentary behaviour after 12 months. Secondary outcomes included other objective (activPAL) and self-reported measures of sedentary behaviour and physical activity, and biochemical, anthropometric, and psycho-social variables. Results 187 individuals (69% female; mean age 33 years; mean BMI 35 kg/m2) were randomised to intervention and control groups. 12 month data, when analysed using intention-to-treat analysis (ITT) and per-protocol analyses, showed no significant difference in the primary outcome variable, nor in the majority of the secondary outcome measures. Conclusions A structured education intervention designed to reduce sitting in young adults at risk of T2DM was not successful in changing behaviour at 12 months. Lack of change may be due to the brief nature of such an intervention and lack of focus on environmental change. Moreover, some participants reported a focus on physical activity rather than reductions in sitting per se. The habitual nature of sedentary behaviour means that behaviour change is challenging. Trial Registration Controlled-Trials.com ISRCTN08434554 PMID:26623654

Exploring the use of mothers' own milk as oral care for mechanically ventilated very low-birth-weight preterm infants.

PubMed

Thibeau, Shelley; Boudreaux, Cynthia

2013-06-01

The purpose of this study was to explore the use of mothers' own milk (colostrums, transitional milk, and mature milk) as oral care in the ventilator-associated pneumonia (VAP)-prevention bundle of mechanically ventilated preterm infants weighing 1500 g or less. Mechanically ventilated preterm infants weighing 1500 g or less admitted to a regional level III NICU in the Gulf South between January 1, 2006, and December 31, 2009. Retrospective descriptive. Oral care with mothers' own milk was implemented as part of the VAP-prevention bundle in the neonatal intensive care unit in the fourth quarter of 2007. Using retrospective deidentified data retrieved from the electronic medical record, the primary and secondary outcome variables were collected among eligible infants (≤1500 g) admitted January 1, 2006, to December 31, 2007 (before implementation) and January 1, 2008, to December 31, 2009 (after implementation). Sample characteristics, including infant gestational age, birth weight, and gender, as well as maternal age, type of delivery, and incidence of maternal chorioamnionitis, were also collected. Data analysis included frequencies and distributions to summarize sample characteristics and variables of interest. Appropriate tests for differences were conducted on outcome variables between the before and after groups of the human milk oral care intervention. The feasibility outcome variable included nursing compliance with the oral care procedure. The safety outcome variable included record of any adverse events associated with the oral care procedure. The efficacy health outcomes included the rate of positive tracheal aspirates, positive blood cultures, the number of ventilator days, and length of stay. Infant age (26.1-26.6 weeks) and weight (840-863 g) were similar in the before (n = 70) and after (n = 68) sample subjects. There were no statistically significant differences in ventilator days, χ² (46, n = 115) = 46.22, P = .46, and length of stay, χ (75, n = 115) = 78.78, P = .36, between groups. Although the rate of positive tracheal aspirates and positive blood cultures reduced after implementation of oral care with mothers' own milk, these differences were not statistically significant (U(47) = 250, z = -7.1, P = .48; U(47) = 217.5, z = -1.44, P = .15). There were no statistically significant differences in the rates of positive tracheal aspirates and blood cultures after implementation of oral care with mothers' own milk. The findings of this study suggest that using mothers' own milk as part of the VAP-prevention bundle is a feasible and safe practice; however, further research is needed to determine the immunological benefits of this practice.

Intracerebral hemorrhage with intraventricular extension and no hydrocephalus may not increase mortality or severe disability.

PubMed

Mahta, Ali; Katz, Paul M; Kamel, Hooman; Azizi, S Ausim

2016-08-01

This paper aimed to test the hypothesis that intraventricular extension of spontaneous intracerebral hemorrhage (ICH) in the absence of hydrocephalus is not associated with increased mortality or severe disability. We performed a retrospective consecutive cohort study of patients with primary spontaneous ICH who were admitted to a single institution. Multivariate logistic regression analysis was used to assess the association of each variable with functional outcome as measured by the modified Rankin Scale (mRS). A total of 164 patients met our inclusion criteria and were included in the study. Only hydrocephalus (p=0.002) and hematoma volume (p=0.006) were significantly associated with mortality or poor functional outcome (mRS of 3 to 6). In contrast, the presence of intraventricular hematoma was not independently associated with poor functional outcome. The presence of intraventricular extension of ICH in the absence of hydrocephalus may not increase mortality or disability. Copyright © 2016 Elsevier Ltd. All rights reserved.

Surrogate Endpoints and Risk Adaptive Strategies in Previously Untreated Follicular Lymphoma.

PubMed

Narkhede, Mayur S; Cheson, Bruce D

2018-05-05

Follicular lymphoma is the second most common subtype of non-Hodgkin lymphoma with an estimated 3.18 cases per 100,000 people. Despite the prolongation of survival with chemoimmunotherapy, variability in response to initial treatment and outcome still exists. Whereas prolonging overall survival is important, it is generally an unreasonable primary endpoint in the front-line setting. The long follow-up needed and the influence of subsequent therapies creates a potential bias. Thus, clinical trials require approximately 5 to 8 years from activation to completion and analysis of outcomes. This duration results in enormous cost and a delay in developing newer therapies. Thus, there is a need to identify markers or surrogate endpoints that can be used in clinical trials to expedite the development of new treatments. This review will discuss various clinical, radiologic, and laboratory measures used to assess outcomes and overall survival in patients with untreated follicular lymphoma, and gauge their utility in clinical trials as surrogate endpoints. Copyright © 2018 Elsevier Inc. All rights reserved.

Primary TKA Patients with Quantifiably Balanced Soft-Tissue Achieve Significant Clinical Gains Sooner than Unbalanced Patients

PubMed Central

Gustke, Kenneth A.; Golladay, Gregory J.; Roche, Martin W.; Elson, Leah C.; Anderson, Christopher R.

2014-01-01

Although total knee arthroplasty has a high success rate, poor outcomes and early revision are associated with ligament imbalance. This multicenter evaluation was performed in order to provide 1-year followup of a previously reported group of patients who had sensor-assisted TKA, comparing the clinical outcomes of quantitatively balanced versus unbalanced patients. At 1 year, the balanced cohort scored 179.3 and 10.4 in KSS and WOMAC, respectively; the unbalanced cohort scored 156.1 and 17.9 in KSS and WOMAC (P < 0.001; P = 0.085). The average activity level scores of quantitatively balanced patients were 68.6 (corresponding to tennis, light jogging, and heavy yard work), while the average activity level of unbalanced patients was 46.7 (corresponding to light housework, and limited walking distances) (P = 0.015). Out of all confounding variables, a balanced articulation was the most significant contributing factor to improved postoperative outcomes (P < 0.001). PMID:25210632

Association of education level with dialysis outcome.

PubMed

Khattak, Muhammad; Sandhu, Gurprataap S; Desilva, Ranil; Goldfarb-Rumyantzev, Alexander S

2012-01-01

The impact of education on health care outcome has been studied in the past, but its role in the dialysis population is unclear. In this report, we evaluated this association. We used the United States Renal Data System data of end-stage renal disease patients aged 18 years. Education level at the time of end-stage renal disease onset was the primary variable of interest. The outcome of the study was patient mortality. We used four categories of education level: 0 = less than 12 years of education; 1 = high school graduate; 2 = some college; 3 = college graduate. Subgroups based on age, race, sex, donor type, and diabetic status were also analyzed. After adjustments for covariates in the Cox model, using individuals with less than 12 years of education as a reference, patients with college education showed decreased mortality with hazard ratio of 0.81 (95% confidence interval 0.69–0.95), P = 0.010. In conclusion, we showed that higher education level is associated with improved survival of patients on dialysis.

A responder analysis of the effects of yoga for individuals with COPD: who benefits and how?

PubMed

Donesky, DorAnne; Melendez, Michelle; Nguyen, Huong Q; Carrieri-Kohlman, Virginia

2012-01-01

We previously reported that a twice-weekly, modified Iyengar yoga program was a safe and viable self-management strategy for patients with chronic obstructive pulmonary disease (COPD). 1 The primary purpose of this exploratory analysis was to classify yoga participants into 1 of 3 responder categories by using minimum clinically important difference (MCID) criteria for each of 3 variables: 6-minute walk distance (6MW), distress related to dyspnea (shortness of breath; DD), and functional performance (FPI). Changes in health-related quality of life (HRQL) and in psychological well-being (anxiety and depression), and participants' self-reported improvements by responder category were also examined. A secondary goal was to identify baseline participant characteristics, including initial randomization assignment that might predict response to treatment. Participants were randomly assigned to either an initial yoga (IY) or an enhanced wait-list control (WLC) group. Those in the WLC group were offered the yoga program immediately following the IY group's participation. Individuals from both groups who completed at least 18 of 24 yoga classes were categorized as responders, partial responders, or non-responders for each of the 3 outcome variables (6MW, DD, FPI) on the basis of MCID criteria. Baseline characteristics and changes in HRQL and psychological well-being were also analyzed. None of the participants demonstrated MCIDs for all 3 outcomes; however, 6 were classified as responders for 2 out-come variables and 4 were classified as non-responders for all 3 outcome variables. Two-thirds of the female participant group and one-third of the male participant group completed the yoga program. DD responders showed increased anxiety levels, whereas anxiety levels of the DD non-responders remained unchanged. FPI responders reported significant improvements in physical function, whereas partial and non-FPI responders noted declined function. Participants assigned to the IY group demonstrated greater benefit from yoga than did those in the W LC group. Although this modified Iyengar yoga program appears to have benefited some individuals with COPD, further studies are required to assess who the intervention works for and under what conditions.

Predicting recovery of voluntary upper extremity movement in subacute stroke patients with severe upper extremity paresis.

PubMed

Koh, Chia-Lin; Pan, Shin-Liang; Jeng, Jiann-Shing; Chen, Bang-Bin; Wang, Yen-Ho; Hsueh, I-Ping; Hsieh, Ching-Lin

2015-01-01

Prediction of voluntary upper extremity (UE) movement recovery is largely unknown in patients with little voluntary UE movement at admission. The present study aimed to investigate (1) the extent and variation of voluntary UE movement recovery, and (2) the best predictive model of the recovery of voluntary UE movement by clinical variables in patients with severe UE paresis. Prospective cohort study. 140 (out of 590) stroke patients with severe UE paresis completed all assessments. Voluntary UE movement was assessed using the UE subscale of the Stroke Rehabilitation Assessment of Movement (STREAM-UE). Two outcome measures, STREAM-UE scores at discharge (DC(STREAM-UE)) and changes between admission and discharge (Δ(STREAM-UE)), were investigated to represent the final states and improvement of the recovery of voluntary UE movement. Stepwise regression analyses were used to investigate 19 clinical variables and to find the best predictive models of the two outcome measures. The participants showed wide variation in both DC(STREAM-UE) and Δ(STREAM-UE). 3.6% of the participants almost fully recovered at discharge (DC(STREAM-UE) > 15). A large improvement (Δ(STREAM-UE) >= 10) occurred in 16.4% of the participants, while 32.9% of the participants did not have any improvement. The four predictors for the DC(STREAM-UE) (R(2) = 35.0%) were 'baseline STREAM-UE score', 'hemorrhagic stroke', 'baseline National Institutes of Health Stroke Scale (NIHSS) score', and 'cortical lesion excluding primary motor cortex'. The three predictors for the Δ(STREAM-UE) (R(2) = 22.0%) were 'hemorrhagic stroke', 'baseline NIHSS score', and 'cortical lesion excluding primary motor cortex'. Recovery of voluntary UE movement varied widely in patients with severe UE paresis after stroke. The predictive power of clinical variables was poor. Both results indicate the complex nature of voluntary UE movement recovery in patients with severe UE paresis after stroke.

Geographic accessibility and utilization of orthodontic services among Medicaid children and adolescents

PubMed Central

McKernan, Susan C.; Kuthy, Raymond A.; Momany, Elizabeth T.; McQuistan, Michelle R.; Hanley, Paul F.; Jones, Michael P.; Damiano, Peter C.

2014-01-01

Objectives To describe rates of Medicaid-funded services provided by orthodontists in Iowa to children and adolescents, identify factors associated with utilization, and describe geographic barriers to care. Methods We analyzed enrollment and claims data from the Iowa Medicaid program for a 3-year period, January 2008 through December 2010. Descriptive, bivariate, and multivariable logistic regression analyses were performed with utilization of orthodontic services as the main outcome variable. Service areas were identified by small area analysis in order to examine regional variability in utilization. Results The overall rate of orthodontic utilization was 3.1 percent. Medicaid enrollees living in small towns and rural areas were more likely to utilize orthodontic services than those living in urban areas. Children who had an oral evaluation by a primary care provider in the year prior to the study period were more likely to receive orthodontic services. Service areas with lower population density and greater mean travel distance to participating orthodontists had higher utilization rates than smaller, more densely populated areas. Conclusions Rural residency and increased travel distances do not appear to act as barriers to orthodontic care for this population. The wide variability of utilization rates seen across service areas may be related to workforce supply in the form of orthodontists who accept Medicaid-insured patients. Referrals to orthodontists from primary care dentists may improve access to specialty care for Medicaid enrollees. PMID:23289856

One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial.

PubMed

Lulic, Martina; Leiggener Görög, Isabelle; Salvi, Giovanni E; Ramseier, Christoph A; Mattheos, Nikolaos; Lang, Niklaus P

2009-08-01

Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.

Feasibility, acceptability, and initial efficacy of an online sexual health promotion program for LGBT youth: the Queer Sex Ed intervention.

PubMed

Mustanski, Brian; Greene, George J; Ryan, Daniel; Whitton, Sarah W

2015-01-01

Lesbian, gay, bisexual, and transgender (LGBT) youth experience multiple sexual health inequities driven, in part, by deficits in parental and peer support, school-based sex education programs, and community services. Research suggests that the Internet may be an important resource in the development of sexual health among LGBT youth. We examined the feasibility of recruiting youth in same-sex relationships into an online sexual health intervention, evaluated intervention acceptability, and obtained initial estimates of intervention efficacy. LGBT youth (16 to 20 years old) completed Queer Sex Ed (QSE), an online, multimedia sexual health intervention consisting of five modules. The final sample (N = 202) completed the pretest, intervention, and posttest assessments. The primary study outcomes were sexual orientation identity and self-acceptance (e.g., coming-out self-efficacy), sexual health knowledge (e.g., sexual functioning), relationship variables (e.g., communication skills), and safer sex (e.g., sexual assertiveness). Analyses indicated that 15 of the 17 outcomes were found to be significant (p < .05). Effect sizes ranged from small for sexual orientation (e.g., internalized homophobia) and relationship variables (e.g., communication skills) to moderate for safer sex (e.g., contraceptive knowledge) outcomes. This study demonstrated the feasibility, acceptability, and initial efficacy of QSE, an innovative online comprehensive sexual health program for LGBT youth.

Admission hyperglycemia predicts poorer short- and long-term outcomes after primary percutaneous coronary intervention for ST-elevation myocardial infarction.

PubMed

Chen, Pei-Chi; Chua, Su-Kiat; Hung, Huei-Fong; Huang, Chung-Yen; Lin, Chiu-Mei; Lai, Shih-Ming; Chen, Yen-Ling; Cheng, Jun-Jack; Chiu, Chiung-Zuan; Lee, Shih-Huang; Lo, Huey-Ming; Shyu, Kou-Gi

2014-02-12

Admission hyperglycemia is associated with poor outcome in patients with myocardial infarction. The present study evaluated the relationship between admission glucose level and other clinical variables in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The 959 consecutive STEMI patients undergoing primary PCI were divided into five groups based on admission glucose levels of <100, 100-139, 140-189, 190-249 and ≥250 mg/dL. Their short- and long-term outcomes were compared. Higher admission glucose levels were associated with significantly higher in-hospital morbidity and mortality, the overall mortality rate at follow up, and the incidence of reinfarction or heart failure requiring admission or leading to mortality at follow up. The odds ratios (95% confidence interval) for in-hospital morbidity, in-hospital mortality, mortality at follow up and re-infarction or heart failure or mortality at follow up of patients with admission glucose levels ≥190 mg/dL, compared with those with admission glucose levels <190 mg/dL, were 2.12 (1.3-3.4, P = 0.001), 2.74 (1.4-5.5, P = 0.004), 2.52 (1.2-5.1, P = 0.01) and 1.70 (1.03-2.8, P = 0.04), respectively. Previously non-diabetic patients with admission glucose levels ≥250 mg/dL had significantly higher in-hospital morbidity or mortality (44 vs 70%, P = 0.03). Known diabetic patients had higher rates of reinfarction, heart failure or mortality at follow up in the 100-139 mg/dL (8 vs 27%, P = 0.04) and 140-189 mg/dL (11 vs 26%, P = 0.02) groups. Admission hyperglycemia, especially at glucose levels ≥190 mg/dL, is a predictor of poor prognosis in STEMI patients undergoing primary PCI.

Association of Dermatology Consultations With Patient Care Outcomes in Hospitalized Patients With Inflammatory Skin Diseases

PubMed Central

Milani-Nejad, Nima; Zhang, Myron

2017-01-01

Importance The value of inpatient dermatology consultations has traditionally been demonstrated with frequency in changes of diagnosis and management; however, the impact of dermatology consultations on metrics such as hospital length of stay and readmission rates remains unknown. Objective To determine the association of dermatology consultations with patient care in hospitalized patients using objective values. Design, Setting, and Participants We retrospectively queried the deidentified database of patients hospitalized between January 1, 2012, and December 31, 2014, at a single university medical center. A total of 413 patients with a primary inflammatory skin condition discharge diagnosis and 647 patients with primary inflammatory skin condition admission diagnosis were selected. Main Outcomes and Measures Hospital length of stay and 1-year readmission with inflammatory skin conditions. Results The 413 patients with a primary inflammatory skin condition discharge diagnosis were 61.0% female and had a mean (SD) age of 55.1 (16.4) years. The 647 patients with primary inflammatory skin condition admission diagnosis were 50.8% female and had a mean (SD) age of 57.8 (15.9) years. Multivariable modeling showed that dermatology consultations were associated with a reduction of 1-year inflammatory skin condition readmissions among patients who were discharged primarily with an inflammatory skin condition (readmission probability, 0.0025; 95% CI, 0.00020-0.030 with dermatology consult vs 0.026; 95% CI, 0.0065-0.10 without; odds ratio, 0.093; 95% CI, 0.010-0.840; P = .03). No other confounding variable was associated with reduction in readmissions. Multivariable modeling also showed that dermatology consultations were associated with a reduction in the adjusted hospital length of stay by 2.64 days (95% CI, 1.75-3.53 days; P < .001). Conclusions and Relevance Dermatology consultations were associated with improvements of outcomes among hospitalized patients. The expansion of the role of dermatology consultation services may improve patient care in a cost-effective manner. PMID:28296992

SU-F-R-14: PET Based Radiomics to Predict Outcomes in Patients with Hodgkin Lymphoma

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

Lee, J; Aristophanous, M; Akhtari, M

Purpose: To identify PET-based radiomics features associated with high refractory/relapsed disease risk for Hodgkin lymphoma patients. Methods: A total of 251 Hodgkin lymphoma patients including 19 primary refractory and 9 relapsed patients were investigated. All patients underwent an initial pre-treatment diagnostic FDG PET/CT scan. All cancerous lymph node regions (ROIs) were delineated by an experienced physician based on thresholding each volume of disease in the anatomical regions to SUV>2.5. We extracted 122 image features and evaluated the effect of ROI selection (the largest ROI, the ROI with highest mean SUV, merged ROI, and a single anatomic region [e.g. mediastinum]) onmore » classification accuracy. Random forest was used as a classifier and ROC analysis was used to assess the relationship between selected features and patient’s outcome status. Results: Each patient had between 1 and 9 separate ROIs, with much intra-patient variability in PET features. The best model, which used features from a single anatomic region (the mediastinal ROI, only volumes>5cc: 169 patients with 12 primary refractory) had a classification accuracy of 80.5% for primary refractory disease. The top five features, based on Gini index, consist of shape features (max 3D-diameter and volume) and texture features (correlation and information measure of correlation1&2). In the ROC analysis, sensitivity and specificity of the best model were 0.92 and 0.80, respectively. The area under the ROC (AUC) and the accuracy were 0.86 and 0.86, respectively. The classification accuracy was less than 60% for other ROI models or when ROIs less than 5cc were included. Conclusion: This study showed that PET-based radiomics features from the mediastinal lymph region are associated with primary refractory disease and therefore may play an important role in predicting outcomes in Hodgkin lymphoma patients. These features could be additive beyond baseline tumor and clinical characteristics, and may warrant more aggressive treatment.« less

Realist evaluation of the antiretroviral treatment adherence club programme in selected primary healthcare facilities in the metropolitan area of Western Cape Province, South Africa: a study protocol

PubMed Central

Mukumbang, Ferdinand C; Van Belle, Sara; Marchal, Bruno; Van Wyk, Brian

2016-01-01

Introduction Suboptimal retention in care and poor treatment adherence are key challenges to antiretroviral therapy (ART) in sub-Saharan Africa. Community-based approaches to HIV service delivery are recommended to improve patient retention in care and ART adherence. The implementation of the adherence clubs in the Western Cape province of South Africa was with variable success in terms of implementation and outcomes. The need for operational guidelines for its implementation has been identified. Therefore, understanding the contexts and mechanisms for successful implementation of the adherence clubs is crucial to inform the roll-out to the rest of South Africa. The protocol outlines an evaluation of adherence club intervention in selected primary healthcare facilities in the metropolitan area of the Western Cape Province, using the realist approach. Methods and analysis In the first phase, an exploratory study design will be used. Document review and key informant interviews will be used to elicit the programme theory. In phase two, a multiple case study design will be used to describe the adherence clubs in five contrastive sites. Semistructured interviews will be conducted with purposively selected programme implementers and members of the clubs to assess the context and mechanisms of the adherence clubs. For the programme's primary outcomes, a longitudinal retrospective cohort analysis will be conducted using routine patient data. Data analysis will involve classifying emerging themes using the context-mechanism-outcome (CMO) configuration, and refining the primary CMO configurations to conjectured CMO configurations. Finally, we will compare the conjectured CMO configurations from the cases with the initial programme theory. The final CMOs obtained will be translated into middle range theories. Ethics and dissemination The study will be conducted according to the principles of the declaration of Helsinki (1964). Ethics clearance was obtained from the University of the Western Cape. Dissemination will be done through publications and curation. PMID:27044575

Comorbid symptomatology moderates response to risperidone, stimulant, and parent training in children with severe aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder.

PubMed

Farmer, Cristan A; Brown, Nicole V; Gadow, Kenneth D; Arnold, L Eugene; Kolko, David G; Findling, Robert L; Molina, Brooke S G; Buchan-Page, Kristin A; Rice, Robert R; Bangalore, Srihari S; Bukstein, Oscar; Rundberg-Rivera, E Victoria; McNamara, Nora; Aman, Michael G

2015-04-01

In this study, we evaluated parent and child characteristics as predictors and moderators of response in the four-site Treatment of Severe Childhood Aggression (TOSCA) study. A total of 168 children with severe aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder (ADHD) were enrolled in a 9-week trial of basic treatment (n=84, stimulant+parent training+placebo) versus augmented treatment (n=84, stimulant+parent training+risperidone). In the initial report, augmented treatment surpassed basic treatment in reducing the primary outcome of disruptive behavior (D-Total) scores. In the current study, we evaluated parent (income, education, family functioning, employment) and child variables (intelligence quotient [IQ], aggression type, comorbid symptomatology) as predictors or moderators, using linear mixed models and the MacArthur guidelines. Higher scores on ADHD symptom severity and callous/unemotional traits predicted better outcome on D-Total regardless of treatment assignment. Two moderators of D-Total were found: Higher anger/irritability symptoms and lower mania scores were associated with faster response, although not better overall effect at endpoint, in the augmented but not the basic group. Several variables moderated response on secondary outcomes (ADHD severity and prosocial behavior), and were characterized by faster response, although not better outcome, in the augmented but not in the basic group. Maternal education moderated outcome on the measure of positive social behavior; children of mothers with less education benefited more from augmented treatment relative to basic than those with more education. Although these findings require validation, they tentatively suggest that augmented treatment works equally well across the entire sample. Nevertheless, certain child characteristics may be useful indicators for the speed of response to augmented treatment.

The Association of Visual Impairment With Clinical Outcomes in Hemodialysis Patients.

PubMed

Hong, Yu Ah; Kim, Suk Young; Kim, Su-Hyun; Kim, Young Ok; Jin, Dong Chan; Song, Ho Chul; Choi, Euy Jin; Kim, Yong-Lim; Kim, Yon-Su; Kang, Shin-Wook; Kim, Nam-Ho; Yang, Chul Woo; Kim, Yong Kyun

2016-05-01

Visual impairment limits people's ability to perform daily tasks and affects their quality of life. We evaluated the impact of visual impairment on clinical outcomes in hemodialysis (HD) patients.HD patients were selected from the Clinical Research Center registry a prospective cohort study on dialysis patients in Korea. Visual impairment was defined as difficulty in daily life due to decreased visual acuity or blindness. The primary outcome was all-cause mortality and the secondary outcomes were cardiovascular and infection-related hospitalization.A total of 3250 patients were included. Seven hundred thirty (22.5%) of the enrolled patients had visual impairment. The median follow-up period was 30 months. The Kaplan-Meier curve and log-rank test showed that all-cause mortality rates (P < 0.001) as well as cardiovascular and infection-related hospitalization rates (P < 0.001 and P < 0.001) were significantly higher in patients with visual impairment than in patients without visual impairment. In the multivariable analysis, visual impairment had significant predictive power for all-cause mortality (Hazard ratio [HR], 1.77, 95% confidence interval [CI], 1.21-2.61, P = 0.004) and cardiovascular hospitalization (HR 1.45 [1.00-1.90], P = 0.008) after adjusting for confounding variables. Of these 3250 patients, 634 patients from each group were matched by propensity scores. In the propensity score matched analysis, patients with visual impairment had independently significant associations with increased all-cause mortality (HR 1.69 [1.12-2.54], P = 0.01) and cardiovascular hospitalization (HR 1.48 [1.08-2.02], P = 0.01) compared with patients without visual impairment after adjustment for confounding variables.Our data demonstrated that visual impairment was an independent risk factor for clinical adverse outcomes in HD patients.

Relationship of physical therapy inpatient rehabilitation interventions and patient characteristics to outcomes following spinal cord injury: The SCIRehab project

PubMed Central

Teeter, Laura; Gassaway, Julie; Taylor, Sally; LaBarbera, Jacqueline; McDowell, Shari; Backus, Deborah; Zanca, Jeanne M.; Natale, Audrey; Cabrera, Jordan; Smout, Randall J.; Kreider, Scott E. D.; Whiteneck, Gale

2012-01-01

Background/objective Examine associations of type and quantity of physical therapy (PT) interventions delivered during inpatient spinal cord injury (SCI) rehabilitation and patient characteristics with outcomes at the time of discharge and at 1 year post-injury. Methods Physical therapists delivering routine care documented details of PT interventions provided. Regression modeling was used to predict outcomes at discharge and 1 year post-injury for a 75% subset; models were validated with the remaining 25%. Injury subgroups also were examined: motor complete low tetraplegia, motor complete paraplegia, and American Spinal Injury Association (ASIA) Impairment Scale (AIS) D motor incomplete tetra-/paraplegia. Results PT treatment variables explain more variation in three functionally homogeneous subgroups than in the total sample. Among patients with motor complete low tetraplegia, higher scores for the transfer component of the discharge motor Functional Independence Measure () are strongly associated with more time spent working on manual wheelchair skills. Being male is the most predictive variable for the motor FIM score at discharge for patients with motor complete paraplegia. Admission ASIA lower extremity motor score (LEMS) and change in LEMS were the factors most predictive for having the primary locomotion mode of “walk” or “both (walk and wheelchair)” on the discharge motor FIM for patients with AIS D injuries. Conclusion Injury classification influences type and quantity of PT interventions during inpatient SCI rehabilitation and is a strong predictor of outcomes at discharge and 1 year post-injury. The impact of PT treatment increases when patient groupings become more homogeneous and outcomes become specific to the groupings. Note This is the second of nine articles in the SCIRehab series. PMID:23318034

Experience by children and adolescents of more than one type of maltreatment: Association of different classes of maltreatment profiles with clinical outcome variables.

PubMed

Witt, Andreas; Münzer, Annika; Ganser, Helene G; Fegert, Jörg M; Goldbeck, Lutz; Plener, Paul L

2016-07-01

Most victims of child abuse have experienced more than one type of maltreatment, yet there is a lack of understanding of the impact of specific combinations of types of maltreatment. This study aimed to identify meaningful classes of maltreatment profiles and to associate them with short-term clinical outcomes. A total of 358 German children and adolescents aged 4-17 with a known history of child maltreatment were included in the study. Through interviews and questionnaires, information was obtained from participants and their primary caregivers on history of maltreatment, sociodemographics, psychopathology, level of psychosocial functioning, and health-related quality of life. Types of abuse were categorized into six major groups: sexual abuse in general, sexual abuse with penetration, physical abuse, emotional abuse, neglect, and exposure to domestic violence. A latent class analysis (LCA) was performed to determine distinct multi-type maltreatment profiles, which were then assessed for their associations with the sociodemographic and clinical outcome variables. The LCA revealed that participants could be categorized into three meaningful classes according to history of maltreatment: (1) experience of multiple types of maltreatment excluding sexual abuse (63.1%), (2) experience of multiple types of maltreatment including sexual abuse (26.5%), and (3) experience of predominantly sexual abuse (10.3%). Members of Class 2 showed significantly worse short-term outcomes on psychopathology, level of functioning, and quality of life compared to the other classes. Three distinct profiles of multiple types of maltreatment were empirically identified in this sample. Exposure to multiple types of abuse was associated with poorer outcomes. Copyright © 2016 Elsevier Ltd. All rights reserved.

An analysis of the predictors of mortality and morbidity in patients admitted after suicidal hanging to an Indian multidisciplinary Intensive Care Unit

PubMed Central

Renuka, MK; Kalaiselvan, MS; Arunkumar, AS

2017-01-01

Background and Aims: Hanging is a frequently used method to attempt suicide in India. There is a lack of data in the Indian population regarding clinical features and outcomes of suicidal hanging. The purpose of this study was to evaluate the factors affecting mortality and morbidity in patients admitted with suicidal hanging to the Intensive Care Unit (ICU). Methods: A 6-year retrospective study of adult patients admitted to the ICU with suicidal hanging was analysed for demographics, mode of hanging, lead time to emergency room (ER) admission, clinical presentation, Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores, admission Glasgow coma scale (GCS) and neurological outcomes. The primary outcome was in-hospital mortality rate. Secondary outcomes were hospital length of stay (LOS), ICU-LOS, time for neurological recovery, organ support and duration of mechanical ventilation. Statistical analysis was performed using the Student's t-test for continuous variables and Chi-square test for categorical variables. Results: We analysed data of 106 patients. The median age was 27 years [Interquartile Range (IQR) (22–34)]. The median lead time to ER admission was 1 h [IQR (0.5–1.4)] with median ICU stay of 3 days [IQR (2–4)]. Vasopressors were administered to 27.4% patients. GCS was ≤7 in 65% patients, and 84.9% patients received mechanical ventilation. Mortality rate was 10.3%. Survivors recovered with normal organ function. Conclusion: Suicidal hanging is associated with significant mortality. Admission GCS, APACHE II and 48 h SOFA score were predictors of poor outcome. PMID:28794524

Intrinsic platelet reactivity before start with clopidogrel as predictor for on-clopidogrel platelet function and long-term clinical outcome.

PubMed

Hochholzer, Willibald; Valina, Christian M; Bömicke, Timo; Amann, Michael; Stratz, Christian; Nührenberg, Thomas; Trenk, Dietmar; Neumann, Franz-Josef

2015-07-01

High on-clopidogrel platelet reactivity is associated with worse clinical outcome. Previous data suggest that intrinsic platelet reactivity before initiation of clopidogrel contributes significantly to on-clopidogrel platelet reactivity. It is unknown whether intrinsic reactivity can sufficiently predict on-clopidogrel reactivity and therefore identify patients with insufficient response to clopidogrel before initiation of treatment and at risk for worse clinical outcome. This analysis included 765 consecutive patients undergoing elective coronary stent implantation. Platelet reactivity was assessed by light transmission aggregometry (5 µM ADP) before administration of clopidogrel 600mg and after intake of first maintenance dose of clopidogrel on day 1 following coronary stenting. Patients were followed for up to seven years. The combined primary endpoint was death of any cause or non-fatal myocardial infarction. Intrinsic and on-clopidogrel platelet reactivity were significant correlated (r=0.31; p < 0.001). Among all tested clinical and genetic factors including the cytochrome P450 2C19*2 polymorphism, intrinsic platelet reactivity was the strongest predictor for on-clopidogrel platelet reactivity. However, intrinsic platelet reactivity could only explain 8 % of variability of on-clopidogrel platelet function. Only on-treatment platelet reactivity was predictive for long-term clinical outcome (HR 1.47, 95 % CI 1.05-2.05; p = 0.02) whereas intrinsic platelet reactivity was not (HR 1.03, 95 % CI 0.74-1.43; p = 0.86). In conclusion, intrinsic platelet reactivity before initiation of clopidogrel is the strongest predictor of early on-clopidogrel platelet reactivity but can only explain a minor proportion of its variability and is not significantly associated with clinical outcome. Thus, baseline testing cannot substitute on-clopidogrel platelet function testing.

Association between severity of untreated sleep apnoea and postoperative complications following major cardiac surgery: a prospective observational cohort study.

PubMed

Mason, Martina; Hernández Sánchez, Jules; Vuylsteke, Alain; Smith, Ian

2017-09-01

To examine whether untreated sleep apnoea is associated with prolonged Intensive Care Unit (ICU) stay and increased frequency of postoperative ICU complications, in patients undergoing major cardiac surgery. Adult patients, undergoing elective coronary artery bypass grafting with or without cardiac valve surgery, between March 2013 and July 2014, were considered. We excluded patients participating in other interventional studies, those who had a tracheostomy before surgery, required emergency surgery or were due to be admitted on the day of surgery. Patients underwent inpatient overnight oximetry on the night prior to their surgery to assess for the presence of sleep apnoea. Since oximetry alone cannot differentiate obstructive from central apnoea, the results are reported as sleep apnoea which was diagnosed in patients with an arterial oxygen desaturation index (ODI) ≥ 5/h. The primary outcome measure was length of stay (LoS) in ICU in days. The secondary outcome was a composite measure of postoperative complications in ICU. Multivariate models were developed to assess associations between ODI and the primary and secondary outcome measures, adjusting for preselected predictor variables, relative to primary and secondary outcomes. There was no significant association between ODI and ICU LoS, HR 1.0, 95% CI 0.99-1.02; p = 0.12. However we did find a significant association between ODI and postoperative complications in the ICU, OR = 1.1; 95% CI 1.02-1.17; p = 0.014. The probability of developing complications rose with higher ODI, reflecting sleep apnoea severity. Acknowledging the limitations of this prospective study, untreated sleep apnoea did not predict an increased length of stay in ICU but we do report an association with postoperative complications in patients undergoing major cardiac surgery. Copyright © 2017 Elsevier B.V. All rights reserved.

Association between trends in clinical variables and outcome in intensive care patients with faecal peritonitis: analysis of the GenOSept cohort.

PubMed

Tridente, Ascanio; Clarke, Geraldine M; Walden, Andrew; Gordon, Anthony C; Hutton, Paula; Chiche, Jean-Daniel; Holloway, Paul A H; Mills, Gary H; Bion, Julian; Stüber, Frank; Garrard, Christopher; Hinds, Charles

2015-05-05

Patients admitted to intensive care following surgery for faecal peritonitis present particular challenges in terms of clinical management and risk assessment. Collaborating surgical and intensive care teams need shared perspectives on prognosis. We aimed to determine the relationship between dynamic assessment of trends in selected variables and outcomes. We analysed trends in physiological and laboratory variables during the first week of intensive care unit (ICU) stay in 977 patients at 102 centres across 16 European countries. The primary outcome was 6-month mortality. Secondary endpoints were ICU, hospital and 28-day mortality. For each trend, Cox proportional hazards (PH) regression analyses, adjusted for age and sex, were performed for each endpoint. Trends over the first 7 days of the ICU stay independently associated with 6-month mortality were worsening thrombocytopaenia (mortality: hazard ratio (HR) = 1.02; 95% confidence interval (CI), 1.01 to 1.03; P < 0.001) and renal function (total daily urine output: HR =1.02; 95% CI, 1.01 to 1.03; P < 0.001; Sequential Organ Failure Assessment (SOFA) renal subscore: HR = 0.87; 95% CI, 0.75 to 0.99; P = 0.047), maximum bilirubin level (HR = 0.99; 95% CI, 0.99 to 0.99; P = 0.02) and Glasgow Coma Scale (GCS) SOFA subscore (HR = 0.81; 95% CI, 0.68 to 0.98; P = 0.028). Changes in renal function (total daily urine output and renal component of the SOFA score), GCS component of the SOFA score, total SOFA score and worsening thrombocytopaenia were also independently associated with secondary outcomes (ICU, hospital and 28-day mortality). We detected the same pattern when we analysed trends on days 2, 3 and 5. Dynamic trends in all other measured laboratory and physiological variables, and in radiological findings, changes in respiratory support, renal replacement therapy and inotrope and/or vasopressor requirements failed to be retained as independently associated with outcome in multivariate analysis. Only deterioration in renal function, thrombocytopaenia and SOFA score over the first 2, 3, 5 and 7 days of the ICU stay were consistently associated with mortality at all endpoints. These findings may help to inform clinical decision making in patients with this common cause of critical illness.

Outcome in early-onset fetal growth restriction is best combining computerized fetal heart rate analysis with ductus venosus Doppler: insights from the Trial of Umbilical and Fetal Flow in Europe.

PubMed

Frusca, Tiziana; Todros, Tullia; Lees, Christoph; Bilardo, Caterina M

2018-02-01

Early-onset fetal growth restriction represents a particular dilemma in clinical management balancing the risk of iatrogenic prematurity with waiting for the fetus to gain more maturity, while being exposed to the risk of intrauterine death or the sequelae of acidosis. The Trial of Umbilical and Fetal Flow in Europe was a European, multicenter, randomized trial aimed to determine according to which criteria delivery should be triggered in early fetal growth restriction. We present the key findings of the primary and secondary analyses. Women with fetal abdominal circumference <10th percentile and umbilical pulsatility index >95th percentile between 26-32 weeks were randomized to 1 of 3 monitoring and delivery protocols. These were: fetal heart rate variability based on computerized cardiotocography; and early or late ductus venosus Doppler changes. A safety net based on fetal heart rate abnormalities or umbilical Doppler changes mandated delivery irrespective of randomized group. The primary outcome was normal neurodevelopmental outcome at 2 years. Among 511 women randomized, 362/503 (72%) had associated hypertensive conditions. In all, 463/503 (92%) of fetuses survived and cerebral palsy occurred in 6/443 (1%) with known outcome. Among all women there was no difference in outcome based on randomized group; however, of survivors, significantly more fetuses randomized to the late ductus venosus group had a normal outcome (133/144; 95%) than those randomized to computerized cardiotocography alone (111/131; 85%). In 118/310 (38%) of babies delivered <32 weeks, the indication was safety-net criteria: 55/106 (52%) in late ductus venosus, 37/99 (37%) in early ductus venosus, and 26/105 (25%) in computerized cardiotocography groups. Higher middle cerebral artery impedance adjusted for gestation was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52) and infant survival without neurodevelopmental impairment at 2 years (odds ratio, 1.33; 95% confidence interval, 1.03-1.72) although birthweight and gestational age were more important determinants. Perinatal and 2-year outcome was better than expected in all randomized groups. Among survivors, 2-year neurodevelopmental outcome was best in those randomized to delivery based on late ductus venosus changes. Given a high rate of delivery based on the safety-net criteria, deciding delivery based on late ductus venosus changes and abnormal computerized fetal heart rate variability seems prudent. There is no rationale for delivery based on cerebral Doppler changes alone. Of note, most women with early-onset fetal growth restriction develop hypertension. Copyright © 2018 Elsevier Inc. All rights reserved.

Serum eotaxin-1 is increased in extremely-low-birth-weight infants with bronchopulmonary dysplasia or death.

PubMed

Kandasamy, Jegen; Roane, Claire; Szalai, Alexander; Ambalavanan, Namasivayam

2015-11-01

Early systemic inflammation in extremely-low-birth-weight (ELBW) infants is associated with an increased risk of bronchopulmonary dysplasia (BPD). Our objective was to identify circulating biomarkers and develop prediction models for BPD/death soon after birth. Blood samples from postnatal day 1 were analyzed for C-reactive protein (CRP) by enzyme-linked immunosorbent assay and for 39 cytokines/chemokines by a multiplex assay in 152 ELBW infants. The primary outcome was physiologic BPD or death by 36 wk. CRP, cytokines, and clinical variables available at ≤24 h were used for forward stepwise regression and Classification and Regression Tree (CART) analysis to identify predictors of BPD/death. Overall, 24% developed BPD and 35% died or developed BPD. Regression analysis identified birth weight and eotaxin (CCL11) as the two most significant variables. CART identified FiO2 at 24 h (11% BPD/death if FiO2 ≤28%, 49% if >28%) and eotaxin in infants with FiO2 > 28% (29% BPD/death if eotaxin was ≤84 pg/ml; 65% if >84) as variables most associated with outcome. Eotaxin measured on the day of birth is useful for identifying ELBW infants at risk of BPD/death. Further investigation is required to determine if eotaxin is involved in lung injury and pathogenesis of BPD.

Associations between weather conditions and clinical symptoms in patients with hip osteoarthritis: a 2-year cohort study.

PubMed

Dorleijn, Desirée M J; Luijsterburg, Pim A J; Burdorf, Alex; Rozendaal, Rianne M; Verhaar, Jan A N; Bos, Pieter K; Bierma-Zeinstra, Sita M A

2014-04-01

The goal of this study was to assess whether there is an association between ambient weather conditions and patients' clinical symptoms in patients with hip osteoarthritis (OA). The design was a cohort study with a 2-year follow-up and 3-monthly measurements and prospectively collected data on weather variables. The study population consisted of 222 primary care patients with hip OA. Weather variables included temperature, wind speed, total amount of sun hours, precipitation, barometric pressure, and relative humidity. The primary outcomes were severity of hip pain and hip disability as measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) pain and function subscales. Associations between hip pain and hip disability and the weather variables were assessed using crude and multivariate adjusted linear mixed-model analysis for repeated measurements. On the day of questionnaire completion, mean relative humidity was associated with WOMAC pain (estimate 0.1; 95% confidence interval=0.0-0.2; P=.02). Relative humidity contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC pain score. Mean barometric pressure was associated with WOMAC function (estimate 0.1; 95% confidence interval=0.0-0.1; P=.02). Barometric pressure contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC function score. The other weather variables were not associated with the WOMAC pain or function score. Our results support the general opinion of OA patients that barometric pressure and relative humidity influence perceived OA symptoms. However, the contribution of these weather variables (< or = 1%) to the severity of OA symptoms is not considered to be clinically relevant. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Influence of physician factors on the effectiveness of a continuing medical education intervention.

PubMed

Flores, Sergio; Reyes, Hortensia; Perez-Cuevas, Ricardo

2006-01-01

Continuing medical education (CME) is essential for improving the quality of care in primary health care settings. This study's objective was to determine how the characteristics of family physicians influenced the effectiveness of a multifaceted CME intervention to improve the management of acute respiratory infection (ARI) or type 2 diabetes (DM2). A secondary analysis was conducted based on data from 121 family physicians, who participated in the educational intervention study. The outcome variable was positive change in physician's performance for treatment of ARI or DM2. The exposure variable was multifaceted CME intervention. Independent variables were professional physicians and organizational characteristics. Analysis included log binomial regression modeling. Factors influencing positive change included, for ARI, participation in the CME intervention and medical director interested in that condition and for DM2, participation in the CME intervention, medical director interested in DM2, and being a teacher. Physicians' characteristics and organizational environment influence the effectiveness of educational intervention and are therefore relevant to the implementation of CME strategies.

Acute postoperative neurological deterioration associated with surgery for ruptured intracranial aneurysm: incidence, predictors, and outcomes.

PubMed

Mahaney, Kelly B; Todd, Michael M; Bayman, Emine O; Torner, James C

2012-06-01

Subarachnoid hemorrhage (SAH) results in significant morbidity and mortality, even among patients who reach medical attention in good neurological condition. Many patients have neurological decline in the perioperative period, which contributes to long-term outcomes. The focus of this study is to characterize the incidence of, characteristics predictive of, and outcomes associated with acute postoperative neurological deterioration in patients undergoing surgery for ruptured intracranial aneurysm. The Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST) was a multicenter randomized clinical trial that enrolled 1001 patients and assesssed the efficacy of hypothermia as neuroprotection during surgery to secure a ruptured intracranial aneurysm. All patients had a radiographically confirmed SAH, were classified as World Federation of Neurosurgical Societies (WFNS) Grade I-III immediately prior to surgery, and underwent surgery to secure the ruptured aneurysm within 14 days of SAH. Neurological assessment with the National Institutes of Health Stroke Scale (NIHSS) was performed preoperatively, at 24 and 72 hours postoperatively, and at time of discharge. The primary outcome variable was a dichotomized scoring based on an IHAST version of the Glasgow Outcome Scale (GOS) in which a score of 1 represents a good outcome and a score > 1 a poor outcome, as assessed at 90-days' follow-up. Data from IHAST were analyzed for occurrence of a postoperative neurological deterioration. Preoperative and intraoperative variables were assessed for associations with occurrence of postoperative neurological deterioration. Differences in baseline, intraoperative, and postoperative variables and in outcomes between patients with and without postoperative neurological deterioration were compared with Fisher exact tests. The Wilcoxon rank-sum test was used to compare variables reported as means. Multiple logistic regression was used to adjust for covariates associated with occurrence of postoperative deficit. Acute postoperative neurological deterioration was observed in 42.6% of the patients. New focal motor deficit accounted for 65% of postoperative neurological deterioration, while 60% was accounted for using the NIHSS total score change and 51% by Glasgow Coma Scale score change. Factors significantly associated with occurrence of postoperative neurological deterioration included: age, Fisher grade on admission, occurrence of a procedure prior to aneurysm surgery (ventriculostomy), timing of surgery, systolic blood pressure during surgery, ST segment depression during surgery, history of abnormality in cardiac valve function, use of intentional hypotension during surgery, duration of anterior cerebral artery occlusion, intraoperative blood loss, and difficulty of aneurysm exposure. Of the 426 patients with postoperative neurological deterioration at 24 hours after surgery, only 46.2% had a good outcome (GOS score of 1) at 3 months, while 77.7% of those without postoperative neurological deterioration at 24 hours had a good outcome (p < 0.05). Neurological injury incurred perioperatively or in the acute postoperative period accounts for a large percentage of poor outcomes in patients with good admission WFNS grades undergoing surgery for aneurysmal SAH. Avoiding surgical factors associated with postoperative neurological deterioration and directing investigative efforts at developing improved neuroprotection for use in aneurysm surgery may significantly improve long-term neurological outcomes in patients with SAH.

Medicaid payer status is linked to increased rates of complications after treatment of proximal humerus fractures.

PubMed

Sabesan, Vani J; Petersen-Fitts, Graysen; Lombardo, Daniel; Briggs, Daniel; Whaley, James

2017-06-01

Low socioeconomic status and Medicaid insurance as a primary payer have been associated with major disparities in resource utilization and risk-adjusted outcomes for patients undergoing total joint arthroplasty. With the expansion of Medicaid through the Affordable Care Act in 2014, examination of these disparities has become increasingly relevant for the treatment of proximal humerus fracture (PHF). The Healthcare Cost and Utilization Project Nationwide Inpatient Sample database was used to identify patients who were treated for PHF from 2002 to 2012. Primary outcomes included treatment type, surgical fixation method, in-hospital complications, mean length of stay, and mean total charges for Medicaid patients vs. a matched privately insured cohort. In an effort to minimize confounding variables, each Medicaid patient was matched to a privately insured patient on the basis of gender, race, year of procedure, and age. Of the 678,831 patients treated with PHF, 4.9% (33,263) had Medicaid as the primary payer during the 10-year period. Medicaid patients were found to have a significantly higher risk (P < .05) of postoperative in-hospital complications, including postoperative infection (odds ratio [OR], 2.00 [1.37-2.93]), wound complications (OR, 1.69 [1.04-2.75]), and acute respiratory distress syndrome (OR, 1.34 [1.15-1.59]). Medicaid patients have a significantly higher risk for certain postoperative hospital complications and consume more resources after treatment for PHFs. Additional work is needed to understand the optimal treatment type for Medicaid patients and to understand the complex interplay between socioeconomic status and outcomes to ensure appropriate resource allocation and risk stratification. Copyright © 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Longitudinal analysis of quality of life, clinical, radiographic, echocardiographic, and laboratory variables in dogs with myxomatous mitral valve disease receiving pimobendan or benazepril: the QUEST study.

PubMed

Häggström, J; Boswood, A; O'Grady, M; Jöns, O; Smith, S; Swift, S; Borgarelli, M; Gavaghan, B; Kresken, J-G; Patteson, M; Åblad, B; Bussadori, C M; Glaus, T; Kovačević, A; Rapp, M; Santilli, R A; Tidholm, A; Eriksson, A; Belanger, M C; Deinert, M; Little, C J L; Kvart, C; French, A; Rønn-Landbo, M; Wess, G; Eggertsdottir, A; Lynne O'Sullivan, M; Schneider, M; Lombard, C W; Dukes-McEwan, J; Willis, R; Louvet, A; DiFruscia, R

2013-01-01

Myxomatous mitral valve disease (MMVD) is an important cause of morbidity and mortality in dogs. To compare, throughout the period of follow-up of dogs that had not yet reached the primary endpoint, the longitudinal effects of pimobendan versus benazepril hydrochloride treatment on quality-of-life (QoL) variables, concomitant congestive heart failure (CHF) treatment, and other outcome variables in dogs suffering from CHF secondary to MMVD. A total of 260 dogs in CHF because of MMVD. A prospective single-blinded study with dogs randomized to receive pimobendan (0.4-0.6 mg/kg/day) or benazepril hydrochloride (0.25-1.0 mg/kg/day). Differences in outcome variables and time to intensification of CHF treatment were compared. A total of 124 dogs were randomized to pimobendan and 128 to benazepril. No difference was found between groups in QoL variables during the trial. Time from inclusion to 1st intensification of CHF treatment was longer in the pimobendan group (pimobendan 98 days, IQR 30-276 days versus benazepril 59 days, IQR 11-121 days; P = .0005). Postinclusion, dogs in the pimobendan group had smaller heart size based on VHS score (P = .013) and left ventricular diastolic (P = .035) and systolic (P = .0044) dimensions, higher body temperature (P = .030), serum sodium (P = .0027), and total protein (P = .0003) concentrations, and packed cell volume (P = .030). Incidence of arrhythmias was similar in treatment groups. Pimobendan versus benazepril resulted in similar QoL during the study, but conferred increased time before intensification of CHF treatment. Pimobendan treatment resulted in smaller heart size, higher body temperature, and less retention of free water. Copyright © 2013 by the American College of Veterinary Internal Medicine.

Predictors of outcome and methodological issues in children with acute lymphoblastic leukaemia in El Salvador.

PubMed

Bonilla, Miguel; Gupta, Sumit; Vasquez, Roberto; Fuentes, Soad L; deReyes, Gladis; Ribeiro, Raul; Sung, Lillian

2010-12-01

Most children with cancer live in low-income countries (LICs) where risk factors in paediatric acute lymphoblastic leukaemia (ALL) developed in high-income countries may not apply. We describe predictors of survival for children in El Salvador with ALL. We included patients <16 years diagnosed with ALL between January 2001 and July 2007 treated with the El Salvador-Guatemala-Honduras II protocol. Demographic, disease-related, socioeconomic and nutritional variables were examined as potential predictors of event-free survival (EFS) and overall survival (OS). 260/443 patients (58.7%) were classified as standard risk. Standard- and high-risk 5-year EFS were 56.3 ± 4.5% and 48.6 ± 5.5%; 5-year OS were 77.7 ± 3.8% and 61.9 ± 5.8%, respectively. Among standard-risk children, socioeconomic variables such as higher monthly income (hazard ratio [HR] per $100 = 0.84 [95% confidence interval (CI) 0.70-0.99; P=0.04]) and parental secondary education (HR = 0.49, 95% CI 0.29-0.84; P = 0.01) were associated with better EFS. Among high-risk children, higher initial white blood cell (HR per 10×10(9)/L = 1.03, 95% CI 1.02-1.05; P<0.001) predicted worse EFS; socioeconomic variables were not predictive. The difference in EFS and OS appeared related to overestimating OS secondary to poor follow-up after abandonment/relapse. Socioeconomic variables predicted worse EFS in standard-risk children while disease-related variables were predictive in high-risk patients. Further studies should delineate pathways through which socioeconomic status affects EFS in order to design effective interventions. EFS should be the primary outcome in LIC studies. Copyright © 2010 Elsevier Ltd. All rights reserved.

Protocol for a prospective collaborative systematic review and meta-analysis of individual patient data from randomized controlled trials of vasoactive drugs in acute stroke: The Blood pressure in Acute Stroke Collaboration, stage-3.

PubMed

Sandset, Else Charlotte; Sanossian, Nerses; Woodhouse, Lisa J; Anderson, Craig; Berge, Eivind; Lees, Kennedy R; Potter, John F; Robinson, Thompson G; Sprigg, Nikola; Wardlaw, Joanna M; Bath, Philip M

2018-01-01

Rationale Despite several large clinical trials assessing blood pressure lowering in acute stroke, equipoise remains particularly for ischemic stroke. The "Blood pressure in Acute Stroke Collaboration" commenced in the mid-1990s focussing on systematic reviews and meta-analysis of blood pressure lowering in acute stroke. From the start, Blood pressure in Acute Stroke Collaboration planned to assess safety and efficacy of blood pressure lowering in acute stroke using individual patient data. Aims To determine the optimal management of blood pressure in patients with acute stroke, including both intracerebral hemorrhage and ischemic stroke. Secondary aims are to assess which clinical and therapeutic factors may alter the optimal management of high blood pressure in patients with acute stroke and to assess the effect of vasoactive treatments on hemodynamic variables. Methods and design Individual patient data from randomized controlled trials of blood pressure management in participants with ischemic stroke and/or intracerebral hemorrhage enrolled during the ultra-acute (pre-hospital), hyper-acute (<6 h), acute (<48 h), and sub-acute (<168 h) phases of stroke. Study outcomes The primary effect variable will be functional outcome defined by the ordinal distribution of the modified Rankin Scale; analyses will also be carried out in pre-specified subgroups to assess the modifying effects of stroke-related and pre-stroke patient characteristics. Key secondary variables will include clinical, hemodynamic and neuroradiological variables; safety variables will comprise death and serious adverse events. Discussion Study questions will be addressed in stages, according to the protocol, before integrating these into a final overreaching analysis. We invite eligible trials to join the collaboration.

Factors Associated with HIV Testing Among Participants from Substance Use Disorder Treatment Programs in the US: A Machine Learning Approach.

PubMed

Pan, Yue; Liu, Hongmei; Metsch, Lisa R; Feaster, Daniel J

2017-02-01

HIV testing is the foundation for consolidated HIV treatment and prevention. In this study, we aim to discover the most relevant variables for predicting HIV testing uptake among substance users in substance use disorder treatment programs by applying random forest (RF), a robust multivariate statistical learning method. We also provide a descriptive introduction to this method for those who are unfamiliar with it. We used data from the National Institute on Drug Abuse Clinical Trials Network HIV testing and counseling study (CTN-0032). A total of 1281 HIV-negative or status unknown participants from 12 US community-based substance use disorder treatment programs were included and were randomized into three HIV testing and counseling treatment groups. The a priori primary outcome was self-reported receipt of HIV test results. Classification accuracy of RF was compared to logistic regression, a standard statistical approach for binary outcomes. Variable importance measures for the RF model were used to select the most relevant variables. RF based models produced much higher classification accuracy than those based on logistic regression. Treatment group is the most important predictor among all covariates, with a variable importance index of 12.9%. RF variable importance revealed that several types of condomless sex behaviors, condom use self-efficacy and attitudes towards condom use, and level of depression are the most important predictors of receipt of HIV testing results. There is a non-linear negative relationship between count of condomless sex acts and the receipt of HIV testing. In conclusion, RF seems promising in discovering important factors related to HIV testing uptake among large numbers of predictors and should be encouraged in future HIV prevention and treatment research and intervention program evaluations.

Prenatal Diagnosis of a Segmental Small Bowel Volvulus with Threatened Premature Labor

PubMed Central

Mottet, Nicolas; Ramanah, Rajeev; Riethmuller, Didier

2017-01-01

Fetal primary small bowel volvulus is extremely rare but represents a serious life-threatening condition needing emergency neonatal surgical management to avoid severe digestive consequences. We report a case of primary small bowel volvulus with meconium peritonitis prenatally diagnosed at 27 weeks and 4 days of gestation during threatened premature labor with reduced fetal movements. Ultrasound showed a small bowel mildly dilated with thickened and hyperechogenic intestinal wall, with a typical whirlpool configuration. Normal fetal development allowed continuation of pregnancy with ultrasound follow-up. Induction of labor was decided at 37 weeks and 2 days of gestation because of a significant aggravation of intestinal dilatation appearing more extensive with peritoneal calcifications leading to the suspicion of meconium peritonitis, associated with reduced fetal movements and reduced fetal heart rate variability, for neonatal surgical management with a good outcome. PMID:29230337

Osteosarcoma of the spine: prognostic variables for local recurrence and overall survival, a multicenter ambispective study.

PubMed

Dekutoski, Mark B; Clarke, Michelle J; Rose, Peter; Luzzati, Alessandro; Rhines, Laurence D; Varga, Peter P; Fisher, Charles G; Chou, Dean; Fehlings, Michael G; Reynolds, Jeremy J; Williams, Richard; Quraishi, Nasir A; Germscheid, Niccole M; Sciubba, Daniel M; Gokaslan, Ziya L; Boriani, Stefano

2016-07-01

OBJECTIVE Primary spinal osteosarcomas are rare and aggressive neoplasms. Poor outcomes can occur, as obtaining marginal margins is technically demanding; further Enneking-appropriate en bloc resection can have significant morbidity. The goal of this study is to identify prognostic variables for local recurrence and mortality in surgically treated patients diagnosed with a primary osteosarcoma of the spine. METHODS A multicenter ambispective database of surgically treated patients with primary spine osteosarcomas was developed by AOSpine Knowledge Forum Tumor. Patient demographic, diagnosis, treatment, perioperative morbidity, local recurrence, and cross-sectional survival data were collected. Tumors were classified in 2 cohorts: Enneking appropriate (EA) and Enneking inappropriate (EI), as defined by pathology margin matching Enneking-recommended surgical margins. Prognostic variables were analyzed in reference to local recurrence and survival. RESULTS Between 1987 and 2012, 58 patients (32 female patients) underwent surgical treatment for primary spinal osteosarcoma. Patients were followed for a mean period of 3.5 ± 3.5 years (range 0.5 days to 14.3 years). The median survival for the entire cohort was 6.7 years postoperative. Twenty-four (41%) patients died, and 17 (30%) patients suffered a local recurrence, 10 (59%) of whom died. Twenty-nine (53%) patients underwent EA resection while 26 (47%) patients underwent EI resection with a postoperative median survival of 6.8 and 3.7 years, respectively (p = 0.048). EI patients had a higher rate of local recurrence than EA patients (p = 0.001). Patient age, previous surgery, biopsy type, tumor size, spine level, and chemotherapy timing did not significantly influence recurrence and survival. CONCLUSIONS Osteosarcoma of the spine presents a significant challenge, and most patients die in spite of aggressive surgery. There is a significant decrease in recurrence and an increase in survival with en bloc resection (EA) when compared with intralesional resection (EI). The effect of adjuvant and neoadjuvant chemotherapeutics, as well as method of biopsy, requires further exploration.

Parental functioning and pediatric sleep disturbance: an examination of factors associated with parenting stress in children clinically referred for evaluation of insomnia.

PubMed

Byars, Kelly C; Yeomans-Maldonado, Gloria; Noll, Jennie G

2011-10-01

Parenting stress is an aspect of parent functioning relevant in clinical settings. Within the context of behavioral sleep medicine, the role of parenting stress is not well understood. Prospective evaluation of patients 1.5-10 years old with insomnia. Subjects were 156 primary caregiver-child pairs who completed the Parenting Stress Index-Short Form (PSI-SF), Child Sleep Habits Questionnaire (CSHQ) and Child Behavior Checklist (CBCL). (1) determine prevalence of clinically significant parenting stress in primary caregivers of children clinically referred for insomnia; (2) identify childhood sleep problems that play a role in parenting stress; (3) identify relevant correlates of parenting stress within the context of a behavioral sleep medicine clinic; and (4) identify the most salient child sleep and behavioral variables associated with parenting stress. Forty-seven percent of primary caregivers had clinically significant parenting stress. When examining the relationship between child sleep problems and parenting stress, bedtime resistance (p=0.030) and daytime sleepiness (p=0.0003) stood alone as having the most salient associations with parenting stress. When considering a broader range of covariates (child age and child gender) and clinically relevant variables (parent history of sleep problems, parent history of psychiatric conditions, child behavior problems and child sleep problems) in a single regression equation, both child externalizing behavior problems (β=0.570, p<0.0001) and child daytime sleepiness (β=0.152, p=0.028) independently explained significant variability in parenting stress. Many primary caregivers of children clinically-referred for insomnia evaluation and treatment have significant parenting stress. Parenting stress is associated with daytime behavioral problems and sleepiness in children with insomnia. Clinicians working with pediatric insomnia patients should carefully evaluate parenting stress and child daytime behavior as these aspects of functioning may have an impact on service delivery and treatment outcomes. Copyright © 2011 Elsevier B.V. All rights reserved.

Pharmacological Strategies to Counteract Antipsychotic-Induced Weight Gain and Metabolic Adverse Effects in Schizophrenia: A Systematic Review and Meta-analysis

PubMed Central

Mizuno, Yuya; Suzuki, Takefumi; Nakagawa, Atsuo; Yoshida, Kazunari; Mimura, Masaru; Fleischhacker, Walter Wolfgang; Uchida, Hiroyuki

2014-01-01

Background: Antipsychotic-induced metabolic adversities are often difficult to manage. Using concomitant medications to counteract these adversities may be a rational option. Objective: To systematically determine the effectiveness of medications to counteract antipsychotic-induced metabolic adversities in patients with schizophrenia. Data Sources: Published articles until November 2013 were searched using 5 electronic databases. Clinical trial registries were searched for unpublished trials. Study Selection: Double-blind randomized placebo-controlled trials focusing on patients with schizophrenia were included if they evaluated the effects of concomitant medications on antipsychotic-induced metabolic adversities as a primary outcome. Data Extraction: Variables relating to participants, interventions, comparisons, outcomes, and study design were extracted. The primary outcome was change in body weight. Secondary outcomes included clinically relevant weight change, fasting glucose, hemoglobin A1c, fasting insulin, insulin resistance, cholesterol, and triglycerides. Data Synthesis: Forty trials representing 19 unique interventions were included in this meta-analysis. Metformin was the most extensively studied drug in regard to body weight, the mean difference amounting to −3.17 kg (95% CI: −4.44 to −1.90 kg) compared to placebo. Pooled effects for topiramate, sibutramine, aripiprazole, and reboxetine were also different from placebo. Furthermore, metformin and rosiglitazone improved insulin resistance, while aripiprazole, metformin, and sibutramine decreased blood lipids. Conclusion: When nonpharmacological strategies alone are insufficient, and switching antipsychotics to relatively weight-neutral agents is not feasible, the literature supports the use of concomitant metformin as first choice among pharmacological interventions to counteract antipsychotic-induced weight gain and other metabolic adversities in schizophrenia. PMID:24636967

Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

PubMed Central

Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

2008-01-01

Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520 PMID:18793398

Overcoming bias in estimating the volume-outcome relationship.

PubMed

Tsai, Alexander C; Votruba, Mark; Bridges, John F P; Cebul, Randall D

2006-02-01

To examine the effect of hospital volume on 30-day mortality for patients with congestive heart failure (CHF) using administrative and clinical data in conventional regression and instrumental variables (IV) estimation models. The primary data consisted of longitudinal information on comorbid conditions, vital signs, clinical status, and laboratory test results for 21,555 Medicare-insured patients aged 65 years and older hospitalized for CHF in northeast Ohio in 1991-1997. The patient was the primary unit of analysis. We fit a linear probability model to the data to assess the effects of hospital volume on patient mortality within 30 days of admission. Both administrative and clinical data elements were included for risk adjustment. Linear distances between patients and hospitals were used to construct the instrument, which was then used to assess the endogeneity of hospital volume. When only administrative data elements were included in the risk adjustment model, the estimated volume-outcome effect was statistically significant (p=.029) but small in magnitude. The estimate was markedly attenuated in magnitude and statistical significance when clinical data were added to the model as risk adjusters (p=.39). IV estimation shifted the estimate in a direction consistent with selective referral, but we were unable to reject the consistency of the linear probability estimates. Use of only administrative data for volume-outcomes research may generate spurious findings. The IV analysis further suggests that conventional estimates of the volume-outcome relationship may be contaminated by selective referral effects. Taken together, our results suggest that efforts to concentrate hospital-based CHF care in high-volume hospitals may not reduce mortality among elderly patients.

Hearing and neurodevelopmental outcomes for children with asymptomatic congenital cytomegalovirus infection: A systematic review.

PubMed

Bartlett, Adam W; McMullan, Brendan; Rawlinson, William D; Palasanthiran, Pamela

2017-09-06

Congenital CMV is one of the commonest congenital infections and a recognised cause of sensorineural hearing loss and neurodevelopmental impairment. Ninety percent are clinically inapparent at birth but are reported to be at risk of developing such abnormalities throughout childhood, the extent of which requires further elucidation. A systematic literature review was conducted using Medline and Embase databases, manual citation review, and personal libraries for articles reporting primary data on hearing and neurodevelopmental outcomes for children with asymptomatic congenital CMV. PROSPERO registration number CRD42015025407. Thirty-seven of 480 articles identified between 1969 and 2016 met the eligibility criteria. Twenty-nine of these contributed primary data on hearing outcomes and 20 on neurodevelopmental outcomes (12 of the 37 studies contributed data on both). Cumulative incidence of sensorineural hearing loss with follow-up to at least 5 years was 7% to 11%, which is more than healthy controls but less than children with symptomatic congenital CMV (34%-41%). The onset, course, and severity of hearing loss was variable with no reliable virological prognostic marker. In comparison to controls, children with asymptomatic congenital CMV did not perform worse than controls in neurodevelopmental assessments and performed better than children with symptomatic congenital CMV. Studies show children with asymptomatic congenital CMV are at increased risk of developing hearing loss but perform equally well on neurodevelopmental assessments when compared with healthy controls. There is no reliable virological marker to determine which infants will develop sequelae. Regular follow-up until school entry is supported by the literature. Copyright © 2017 John Wiley & Sons, Ltd.

Primary care clinicians' experiences with treatment decision making for older persons with multiple conditions.

PubMed

Fried, Terri R; Tinetti, Mary E; Iannone, Lynne

2011-01-10

Clinicians are caring for an increasing number of older patients with multiple diseases in the face of uncertainty concerning the benefits and harms associated with guideline-directed interventions. Understanding how primary care clinicians approach treatment decision making for these patients is critical to the design of interventions to improve the decision-making process. Focus groups were conducted with 40 primary care clinicians (physicians, nurse practitioners, and physician assistants) in academic, community, and Veterans Affairs-affiliated primary care practices. Participants were given open-ended questions about their approach to treatment decision making for older persons with multiple medical conditions. Responses were organized into themes using qualitative content analysis. The participants were concerned about their patients' ability to adhere to complex regimens derived from guideline-directed care. There was variability in beliefs regarding, and approaches to balancing, the benefits and harms of guideline-directed care. There was also variability regarding how the participants involved patients in the process of decision making, with clinicians describing conflicts between their own and their patients' goals. The participants listed a number of barriers to making good treatment decisions, including the lack of outcome data, the role of specialists, patient and family expectations, and insufficient time and reimbursement. The experiences of practicing clinicians suggest that they struggle with the uncertainties of applying disease-specific guidelines to their older patients with multiple conditions. To improve decision making, they need more data, alternative guidelines, approaches to reconciling their own and their patients' priorities, the support of their subspecialist colleagues, and an altered reimbursement system.

Reduced Coffee Consumption Among Individuals with Primary Sclerosing Cholangitis but Not Primary Biliary Cirrhosis

PubMed Central

Lammert, Craig; Juran, Brian D.; Schlicht, Erik; Xie, Xiao; Atkinson, Elizabeth J.; de Andrade, Mariza; Lazaridis, Konstantinos N.

2014-01-01

Background & Aims Coffee consumption has been associated with decreased risk of liver disease and related outcomes. However, coffee drinking has not been investigated among patients with cholestatic autoimmune liver diseases, primary biliary cirrhosis (PBC), or primary sclerosing cholangitis (PSC). We investigated the relationship between coffee consumption and risk of PBC and PSC in a large North American cohort. Methods Lifetime coffee drinking habits were determined from responses to questionnaires from 606 patients with PBC, 480 with PSC, and 564 healthy volunteers (controls). Patients (those with PBC or PSC) were compared to controls utilizing the Wilcoxon rank sum test for continuous variables and c2 method for discrete variables. Logistic regression was used to analyze the estimate the effects of different coffee parameters (time, frequency, and type of coffee consumption) after adjusting for age, sex, smoking status, and education level. Results Patients with PBC and controls did not differ in coffee parameters. However, 24% of patients with PSC had never drank coffee compared to 16% of controls (P<.05), and only 67% were current drinkers compared with 77% of controls (P<.05). Patients with PSC also consumed fewer lifetime cups per month (45 vs 47 for controls, P<.05) and spent a smaller percentage of their lifetime of coffee drinking coffee (46.6% vs 66.7% for controls, P<.05). These differences remained significant in a multivariate model. Among PSC patients with concurrent ulcerative colitis, coffee protected against proctocolectomy (hazard ratio=0.34, P<.001). Conclusions Coffee consumption is lower among patients with PSC, but not PBC, compared to controls. PMID:24440215

A Review of Primary and Secondary Influences on Sport Expertise

ERIC Educational Resources Information Center

Baker, Joseph; Horton, Sean

2004-01-01

Sport scientists have examined numerous factors influencing the acquisition and manifestation of high levels of performance. These factors can be divided into variables having a primary influence on expertise and variables that have a secondary influence through their interaction with other variables. Primary influences on expertise include…

Variations in Mental Health Diagnosis and Prescribing Across Pediatric Primary Care Practices

PubMed Central

Mayne, Stephanie L.; Ross, Michelle E.; Song, Lihai; McCarn, Banita; Steffes, Jennifer; Liu, Weiwei; Margolis, Benyamin; Azuine, Romuladus; Gotlieb, Edward; Grundmeier, Robert W.; Leslie, Laurel K.; Localio, Russell; Wasserman, Richard

2016-01-01

BACKGROUND: Primary care pediatricians increasingly care for children’s mental health problems, but little is known about practice-level variation in diagnosis and psychotropic medication prescribing practices. METHODS: This retrospective review of electronic heath records from 43 US primary care practices included children aged 4 to 18 years with ≥1 office visit from January 1, 2009, to June 30, 2014. We examined variability in diagnosis and psychotropic prescribing across practices using logistic regression with practice fixed effects and evaluated associations of the availability of colocated or community-based mental health providers or the proportion of children in foster care with diagnosis and prescribing using generalized linear mixed models. RESULTS: Among 294 748 children, 40 932 (15%) received a mental health diagnosis and 39 695 (14%) were prescribed psychotropic medication. Attention deficit/hyperactivity disorder was most commonly diagnosed (1%–16% per practice). The proportion of children receiving any psychotropic medication (4%-26%) and the proportion receiving ≥2 medication classes (1%-12%) varied across practices. Prescribing of specific medication classes also varied (stimulants, 3%–18%; antidepressants, 1%–12%; α-agonists, 0%–8%; second-generation antipsychotics, 0%–5%). Variability was partially explained by community availability of psychiatrists (significantly higher odds of a diagnosis or prescription when not available) but not by colocation of mental health professionals or percentage of children in foster care. CONCLUSIONS: The prevalence of mental health diagnosis and psychotropic medication prescribing varies substantially across practices and is only partially explained by psychiatrist availability. Research is needed to better define the causes of variable practice-level diagnosis and prescribing and implications for child mental health outcomes. PMID:27244791

Body-Weight Fluctuations and Outcomes in Coronary Disease.

PubMed

Bangalore, Sripal; Fayyad, Rana; Laskey, Rachel; DeMicco, David A; Messerli, Franz H; Waters, David D

2017-04-06

Body-weight fluctuation is a risk factor for death and coronary events in patients without cardiovascular disease. It is not known whether variability in body weight affects outcomes in patients with coronary artery disease. We determined intraindividual fluctuations in body weight from baseline weight and follow-up visits and performed a post hoc analysis of the Treating to New Targets trial, which involved assessment of the efficacy and safety of lowering low-density lipoprotein cholesterol levels with atorvastatin. The primary outcome was any coronary event (a composite of death from coronary heart disease, nonfatal myocardial infarction, resuscitated cardiac arrest, revascularization, or angina). Secondary outcomes were any cardiovascular event (a composite of any coronary event, a cerebrovascular event, peripheral vascular disease, or heart failure), death, myocardial infarction, or stroke. Among 9509 participants, after adjustment for risk factors, baseline lipid levels, mean body weight, and weight change, each increase of 1 SD in body-weight variability (measured according to average successive variability and used as a time-dependent covariate) was associated with an increase in the risk of any coronary event (2091 events; hazard ratio, 1.04; 95% confidence interval [CI], 1.01 to 1.07; P=0.01), any cardiovascular event (2727 events; hazard ratio, 1.04; 95% CI, 1.02 to 1.07; P<0.001), and death (487 events; hazard ratio,1.09; 95% CI, 1.07 to 1.12; P<0.001). Among patients in the quintile with the highest variation in body weight, the risk of a coronary event was 64% higher, the risk of a cardiovascular event 85% higher, death 124% higher, myocardial infarction 117% higher, and stroke 136% higher than it was among those in the quintile with the lowest variation in body weight in adjusted models. Among participants with coronary artery disease, fluctuation in body weight was associated with higher mortality and a higher rate of cardiovascular events independent of traditional cardiovascular risk factors. (Funded by Pfizer; ClinicalTrials.gov number, NCT00327691 .).