Rationale, design and methods of VA-BRAVE: a randomized comparative effectiveness trial of two formulations of buprenorphine for treatment of opioid use disorder in veterans.

Background: To address the US opioid epidemic, there is an urgent clinical need to provide persons with opioid use disorder (OUD) with effective medication treatments for OUD (MOUD). Formulations of sublingual buprenorphine/naloxone (SL-BUP/NLX) are considered the standard of care for OUD including within the Veterans Healthcare Administration (VHA). However, poor retention on MOUD undermines its effectiveness.

Adjunctive Rifampin Therapy For Diabetic Foot Osteomyelitis in the Veterans Health Administration.

Importance: Among patients diagnosed with diabetes, the lifetime incidence of foot ulcers is 15%. Infection is a common complication of foot ulcers, and 20% to 60% of infections result in diabetic foot osteomyelitis (DFO). Current treatment guidelines do not endorse any specific antibiotic agent for DFO, but small clinical trials suggest the addition of rifampin to antimicrobial regimens results in improved cure rates for osteomyelitis.

Assessing the impact of prescribing directives on opioid prescribing practices among Veterans Health Administration providers.

Purpose: The study aimed to test whether directives on opioid prescribing released by the Veterans Health Administration (VHA) or the Food and Drug Administration (FDA) had an impact on prescribing among VHA providers.

Methods: We used the VHA's linked pharmacy and patient medical records database to identify new prescriptions written for propoxyphene, fentanyl, and controlled release (CR) oxycodone between 1/1/2000 and 12/31/2009. We plotted the monthly proportion of these prescriptions that complied with components of four specific safety alerts or directives for these substances issued by the VHA or FDA between 1/1/2001 and 12/31/2008.

Identifying Previously Undetected Harm: Piloting the Institute for Healthcare Improvement's Global Trigger Tool in the Veterans Health Administration.

Background: Adverse event (AE) surveillance may be enhanced by the Institute for Healthcare Improvement's Global Trigger Tool (GTT). A pilot study of the GTT was conducted in one Veterans Health Administration (VA) facility to assess the rates, types, and harm of AEs detected and to examine the overlap in AE detection between the GTT and existing surveillance mechanisms.

Methods: GTT guidelines were followed and medical records were reviewed for 17 weeks of acute care hospitalizations.

Prescription opioid duration of action and the risk of unintentional overdose among patients receiving opioid therapy.

Importance: The unprecedented increase in unintentional overdose events that has occurred in tandem with escalating sales of prescription opioids over the past 2 decades has raised concerns about whether the therapeutic use of opioids has contributed to increases in overdose injury. Few controlled studies have examined the extent to which ecologic measures of increases in opioid prescribing and overdose injuries reflect risk among patients prescribed opioids, let alone whether some opioid regimens are safer than others.

Objective: To examine whether the risk of unintentional overdose injury is associated with the duration of opioid action (ie, long-acting vs short-acting formulations).

Drinking goal choice and outcomes in a Web-based alcohol intervention: results from VetChange.

Objectives: The objectives of the paper are to describe characteristics of participants who chose moderation and abstinence drinking goals, and to examine post-treatment drinking outcomes based on patterns of goal choice during a Web-based alcohol intervention for returning U.S. Veterans.

Retention of black and white participants in the selenium and vitamin E cancer prevention trial (SWOG-coordinated intergroup study S0000).

Background: Disproportionally low retention of minority populations can adversely affect the generalizability of clinical research trials. We determine the overall retention rates for White and Black participants from the Selenium and Vitamin E Cancer Prevention Trial (SELECT) and explore participant and site characteristics associated with retention failure (study disengagement) for these groups.

Methods: A secondary analysis of 28,118 White (age ≥55), and 4,322 Black (age ≥ 50) SELECT participants used multivariate Cox regression to estimate overall retention rates and to calculate HRs and 95% confidence intervals (CI).

Temporal stability of DSM-5 posttraumatic stress disorder criteria in a problem-drinking sample.

The 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) reformulated posttraumatic stress disorder (PTSD) based partially on research showing there were 4 main factors that underlie the symptoms of the disorder. The primary aim of this study was to examine the temporal stability of the DSM-5 factors as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers et al., 2010).

Incident severe thrombocytopenia in veterans treated with pegylated interferon plus ribavirin for chronic hepatitis C infection.

Purpose: We sought to determine the incidence and risks for severe thrombocytopenia (platelets < 50,000/μL) in United States Veteran patients treated with pegylated interferon (PEG-IFN) plus ribavirin for hepatitis C virus-positive (HCV) chronic liver disease (CLD).

Methods: Using a retrospective, observational cohort study design to analyze databases from the New England Veterans Healthcare System, we identified 979 patients diagnosed with HCV-positive CLD treated solely with PEG-IFN plus ribavirin. The cohort was stratified by pre-treatment platelet counts of 50,000-100,000/μL (N = 90), >100,000-150,000/μL (N = 162), and >150,000μL (N = 727).

Veterans Healthcare Administration providers' attitudes and perceptions regarding pragmatic trials embedded at the point of care.

Background The Veterans Healthcare Administration (VA) is implementing an adaptation of a pragmatic trial program, Point of Care Research (POC-R). The goal of POC-R is to embed research into clinical practice, contributing to a Learning Healthcare System. Provider acceptance and participation in POC-R is essential to its successful implementation.

Strategies to address participant misrepresentation for eligibility in Web-based research.

Emerging methodological research suggests that the World Wide Web ("Web") is an appropriate venue for survey data collection, and a promising area for delivering behavioral intervention. However, the use of the Web for research raises concerns regarding sample validity, particularly when the Web is used for recruitment and enrollment. The purpose of this paper is to describe the challenges experienced in two different Web-based studies in which participant misrepresentation threatened sample validity: a survey study and an online intervention study.

Web intervention for OEF/OIF veterans with problem drinking and PTSD symptoms: a randomized clinical trial.

Objective: Veterans who served in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) commonly experience alcohol misuse and symptoms of posttraumatic stress disorder (PTSD) following their return from deployment to a war zone. We conducted a randomized clinical trial to evaluate the efficacy of a newly developed, 8-module, self-management web intervention (VetChange) based on motivational and cognitive-behavioral principles to reduce alcohol consumption, alcohol-related problems, and PTSD symptoms in returning combat veterans.

Method: Six hundred participants, recruited through targeted Facebook ads, were randomized to either an Initial Intervention Group (IIG; n = 404) or a Delayed Intervention Group (DIG; n = 196) that waited 8 weeks for access to VetChange.

Thrombocytopenia and bleeding in veterans with non-hepatitis C-related chronic liver disease.

Background: Thrombocytopenia in chronic liver disease (CLD) typically reflects disease severity and may indicate an increased risk for bleeding.

Aims: To describe the longitudinal course of thrombocytopenia and risks for bleeding in veteran patients with non-hepatitis C-related CLD.

Methods: We identified 2,349 patients with non-hepatitis C-related CLD from databases of the New England Veterans Healthcare System between 1999 and 2008.

A randomized placebo-controlled trial of D-cycloserine and exposure therapy for posttraumatic stress disorder.

D-Cycloserine (DCS) is a partial NMDA receptor agonist that has been shown to enhance therapeutic response to exposure-based treatments for anxiety disorders, but has not been tested in the treatment of combat-related posttraumatic stress disorder (PTSD). The aim of this randomized, double-blind, placebo-controlled trial was to determine whether DCS augments exposure therapy for PTSD in veterans returning from Iraq and Afghanistan and to test whether a brief six-session course of exposure therapy could effectively reduce PTSD symptoms in returning veterans. In contrast to previous trials using DCS to enhance exposure therapy, results indicated that veterans in the exposure therapy plus DCS condition experienced significantly less symptom reduction than those in the exposure therapy plus placebo condition over the course of the treatment.

Risk of community-acquired pneumonia in veteran patients to whom proton pump inhibitors were dispensed.

Background: Observational studies linking proton pump inhibitor (PPI) exposure with community-acquired pneumonia (CAP) have reported either modest or no associations. Accordingly, we studied PPI exposure and CAP in veteran patients, using a retrospective, nested case-control design.

Methods: From linked pharmacy and administrative databases of the New England Veterans Healthcare System, we identified 71985 outpatients newly prescribed PPIs between 1998 and 2007; 1544 patients met criteria for CAP subsequent to PPI initiation; 15440 controls were matched through risk-set sampling by age and time under observation.

Proton pump inhibitor discontinuation in long-term care.

Objectives: To determine factors associated with proton pump inhibitor (PPI) discontinuation in long-term care.

Design: Retrospective cohort analysis.

Setting: Veterans Affairs (VA) long-term care facilities.

A point-of-care clinical trial comparing insulin administered using a sliding scale versus a weight-based regimen.

Background: Clinical trials are widely considered the gold standard in comparative effectiveness research (CER) but the high cost and complexity of traditional trials and concerns about generalizability to broad patient populations and general clinical practice limit their appeal. Unsuccessful implementation of CER results limits the value of even the highest quality trials. Planning for a trial comparing two standard strategies of insulin administration for hospitalized patients led us to develop a new method for a clinical trial designed to be embedded directly into the clinical care setting thereby lowering the cost, increasing the pragmatic nature of the overall trial, strengthening implementation, and creating an integrated environment of research-based care.

Proton pump inhibitors and risk for recurrent Clostridium difficile infection.

Background: Proton pump inhibitors (PPIs) are widely used gastric acid suppressants, but they are often prescribed without clear indications and may increase risk of Clostridium difficile infection (CDI). We sought to determine the association between PPI use and the risk of recurrent CDI.

Methods: Retrospective, cohort study using administrative databases of the New England Veterans Healthcare System from October 1, 2003, through September 30, 2008.

The effects of binge drinking on college students' next-day academic test-taking performance and mood state.

Aim: To assess the effects of binge drinking on students' next-day academic test-taking performance.

Design: A placebo-controlled cross-over design with randomly assigned order of conditions. Participants were randomized to either alcoholic beverage [mean = 0.