Lifestyle Modification in Blood Pressure Study II (LIMBS): study protocol of a randomized controlled trial assessing the efficacy of a 24 week structured yoga program versus lifestyle modification on blood pressure reduction.

Hypertension is a major public health issue affecting 68 million adults in the United States. Lifestyle modifications including complementary therapies such as the movement based mind body practice of yoga have become increasingly popular in the United States and have been considered as a potential alternative to medication in blood pressure reduction. We completed a pilot study in 2009 which showed meaningful decreases in 24-hour ambulatory blood pressure readings after a 12 week period of yoga participation.

Crohn's disease and ulcerative colitis are associated with elevated standardized mortality ratios: a meta-analysis.

Background: Evidence regarding all-cause and cause-specific mortality in inflammatory bowel disease (IBD) is conflicting, and debate exists over appropriate study design to examine these important outcomes. We conducted a comprehensive meta-analysis of all-cause and cause-specific mortality in both Crohn's disease (CD) and ulcerative colitis (UC), and additionally examined various effects of study design on this outcome.

Methods: A systematic search of PubMed and EMBASE was conducted to identify studies examining mortality rates relative to the general population.

Methods for linking community views to measureable outcomes in a youth violence prevention program.

Background: All parties in community-academic partnerships have a vested interest prevention program success. Markers of success that reflect community's experiences of programmatic prevention success are not always measurable, but critically speak to community-defined needs.

Objective: The purpose of this manuscript was to (1) describe our systematic process for linking locally relevant community views (community-defined indicators) to measurable outcomes in the context of a youth violence prevention program and (2) discuss lessons learned, next steps, and recommendations for others trying to replicate a similar process.

The impact of 24-hr, in-hospital pediatric critical care attending physician presence on process of care and patient outcomes*.

Objective: Attending physicians are only required to provide in-hospital coverage during daytime hours in many pediatric intensive care units. An in-hospital 24-hr pediatric intensive care unit attending coverage model has been increasingly popular, but the impact of 24-hr, in-hospital attending coverage on care processes and outcomes has not been reported. We compared processes of care and outcomes before and after the implementation of a 24-hr in-hospital pediatric intensive care unit attending physician model.

Effect of rotavirus vaccine on reducing acute gastroenteritis in a large outpatient pediatric network.

Objectives: To measure the effect of rotavirus vaccine (RVV) on acute gastroenteritis (AGE) managed by primary care physicians in the first 2 rotatvirus seasons following the introduction of RVV.

Design: Retrospective cohort study.

Setting: Practice-based network composed of 33 ambulatory pediatric practices in Philadelphia, Pennsylvania.

The analysis of binary longitudinal data with time-dependent covariates.

We consider longitudinal studies with binary outcomes that are measured repeatedly on subjects over time. The goal of our analysis was to fit a logistic model that relates the expected value of the outcomes with explanatory variables that are measured on each subject. However, additional care must be taken to adjust for the association between the repeated measurements on each subject.

Response to antimalarial agents in cutaneous lupus erythematosus: a prospective analysis.

Objective: To demonstrate response to antimalarial agents in patients with cutaneous lupus erythematosus (CLE) using activity scores from the Cutaneous Lupus Erythematosus Disease Area and Severity Index, a validated outcome measure.

Design: Prospective, longitudinal cohort study.

Setting: University cutaneous autoimmune disease clinic.

Temporal and within practice variability in the health improvement network.

Background: The Health Improvement Network (THIN) database is a primary care electronic medical record database in the UK designed for pharmacoepidemiologic research. Matching on practice and calendar year often is used to account for secular trends in time and differences across practices. However, little is known about the consistency within practices across observation years and among practices within a given year, in THIN or other large medical record databases.

Depression symptom ratings in geriatric patients with bipolar mania.

Objective: Given the paucity of information available regarding standardized ratings of depression symptoms in bipolar manic states, and in particular those in older adults, we explored depression ratings in symptomatic participants in a multicenter study of treatment of bipolar I disorder in late life.

Methods: Baseline data was obtained from the first 100 patients enrolled in an NIMH-funded, 9-week, randomized, double-blind RCT comparing treatment with lithium or valproate in patients of age 60 years and older with Type I Bipolar mania or hypomania. This multi-site study was conducted at six academic medical centers in the United States and enrolled inpatients and outpatients with a total Young Mania Rating Scale (YMRS) score of 18 or greater.

Weight and metabolic outcomes after 2 years on a low-carbohydrate versus low-fat diet: a randomized trial.

Background: Previous studies comparing low-carbohydrate and low-fat diets have not included a comprehensive behavioral treatment, resulting in suboptimal weight loss.

Objective: To evaluate the effects of 2-year treatment with a low-carbohydrate or low-fat diet, each of which was combined with a comprehensive lifestyle modification program.

Design: Randomized parallel-group trial.

TOWARDS PATIENT-CENTERED CARE FOR DEPRESSION: CONJOINT METHODS TO TAILOR TREATMENT BASED ON PREFERENCES.

BACKGROUND: Although antidepressants and counseling have been shown to be effective in treating patients with depression, non-treatment or under-treatment for depression is common especially among the elderly and minorities. Previous work on patient preferences has focused on medication versus counseling, but less is known about the value patients place on attributes of medication and counseling. OBJECTIVE: Conjoint analysis has been recognized as a valuable means of assessing patient treatment preferences.

A comparison of several approaches for choosing between working correlation structures in generalized estimating equation analysis of longitudinal binary data.

The method of generalized estimating equations (GEE) models the association between the repeated observations on a subject with a patterned correlation matrix. Correct specification of the underlying structure is a potentially beneficial goal, in terms of improving efficiency and enhancing scientific understanding. We consider two sets of criteria that have previously been suggested, respectively, for selecting an appropriate working correlation structure, and for ruling out a particular structure(s), in the GEE analysis of longitudinal studies with binary outcomes.

Mediation analysis: a retrospective snapshot of practice and more recent directions.

R. Baron and D. A.

Previously undetected metabolic syndromes and infectious diseases among psychiatric inpatients.

Objective: This study identified previously undetected metabolic and infectious disease among persons with serious mental illness who were admitted to psychiatric inpatient units.

Methods: Observational-naturalistic methods were used to simulate universal screening in order to document evidence of undetected disease among 588 adult psychiatric patients. Data were obtained from medical records and laboratory tests.

Lack of association between retrospectively collected pharmacy refill data and electronic drug monitoring of antiretroviral adherence.

Antiretroviral medication refill adherence has not been compared directly to electronic drug monitoring (EDM) in any identifiable published study. We retrospectively studied adults with undetectable HIV titers on highly active antiretroviral therapy. We used Pearson correlation coefficients and receiver operating characteristic curves to relate the two adherence measures, and we used the Wilcoxon rank-sum test to assess the relation between adherence and viral load.

How redesigning AD clinical trials might increase study partners' willingness to participate.

Background: Timely recruiting and retaining participants into Alzheimer disease (AD) clinical trials is a challenge. We used conjoint analysis to identify how alterations in attributes of clinical trial design improve willingness to participate: risk, home visits, car service, or increased chance of receiving intervention.

Method: A total of 108 study partners of patients with very mild to severe stage AD rated willingness to allow their relative to participate in eight clinical trials that varied combinations of the four attributes.

A randomized controlled trial of a close monitoring program for minor depression and distress.

Background: Minor depression is almost twice as common in primary care (PC) as major depression. Despite the high prevalence, few evidence-based algorithms exist for managing patients with minor depression or patients presenting solely with distress.

Objectives: The aim of this study was to test the effectiveness of a telephone-based close monitoring program to manage PC patients with minor depression or distress.

Longitudinal course of substance treatment benefits in older male veteran at-risk drinkers.

Background: This investigation aims to determine the 12-month drinking trajectory of older at-risk drinkers in treatment. Furthermore, the drinking trajectory between at-risk drinkers who had met the threshold suggestive of alcohol dependence (problem at-risk drinkers) and those who did not meet this threshold (nonproblematic at-risk drinkers) were compared.

Methods: This investigation is a component of the PRISM-E (Primary Care Research in Substance Abuse and Mental Health for the Elderly) Study, a multisite randomized trial comparing service use, outcomes, and cost between Integrated (IC) versus Enhanced Specialty Referral (ESR) care models for older (65+ years) adults with depression, anxiety, and/or at-risk alcohol consumption.

Mediators of telephone-based continuing care for alcohol and cocaine dependence.

A previous randomized trial with 224 alcohol and/or cocaine addicts who had completed an initial phase of treatment indicated that 12 weeks of telephone-based continuing care yielded higher abstinence rates over 24 months than did group counseling continuing care. The current study examined mediators of this treatment effect. Results suggested that self-help involvement during treatment and self-efficacy and commitment to abstinence 3 months after treatment mediated subsequent abstinence outcomes.

Developing adaptive treatment strategies in substance abuse research.

For many individuals, substance abuse possesses characteristics of chronic disorders in that individuals experience repeated cycles of cessation and relapse; hence viewing drug dependence as a chronic, relapsing disorder is increasingly accepted. The development of a treatment for a chronic disorder requires consideration of the ordering of treatments, the timing of changes in treatment, and the use of measures of response, burden and adherence collected during treatment to make further treatment decisions. Adaptive treatment strategies provide a vehicle through which these issues can be addressed and thus provide a means toward improving and informing the clinical management of chronic substance abuse disorders.

An extension of the Early Treatment Diabetic Retinopathy Study (ETDRS) system for grading of diabetic macular edema in the Astemizole Retinopathy Trial.

Purpose: To compare the effects of astemizole, an antihistamine, versus placebo on the 1-year course of diabetic macular edema (DME) and to illustrate use of a modified ETDRS system for grading areas of retinal thickening and hard exudates that may be useful in clinical trials of treatments for this disorder.

Methods: Between June 1994 and September 1997, at 2 clinics, 63 patients who had, in at least one eye (the study eye), DME that had not previously been treated with macular photocoagulation, and for which photocoagulation was not currently recommended by the investigator, were enrolled and randomly assigned to astemizole or placebo. Fifty-four of the 63 patients (86%, 26 in Clinic 1 and 28 in Clinic 2) completed 1 year of followup and had adequate 7-field stereoscopic film-based color fundus photographs of the study eye at the baseline and 1-year visits.

Simvastatin causes changes in affective processes in elderly volunteers.

Objectives: To test for simvastatin-induced changes in affect and affective processes in elderly volunteers.

Design: Randomized, clinical trial.

Setting: The Geriatric Behavioral Psychopharmacology Laboratory at the University of Pennsylvania.