Justice and equity in pragmatic clinical trials: Considerations for pain research within integrated health systems.

Introduction: Pragmatic clinical trials (PCTs) can overcome implementation challenges for bringing evidence-based therapies to people living with pain and co-occurring conditions, providing actionable information for patients, providers, health systems, and policy makers. All studies, including those conducted within health systems that have a history of advancing equitable care, should make efforts to address justice and equity.

Methods: Drawing from collective experience within pragmatic pain clinical trials networks, and synthesizing relevant literature, our multidisciplinary working group examined challenges related to integrating justice and equity into pragmatic pain management research conducted in large, integrated health systems.

The Management of Substance Use Disorders: Synopsis of the 2021 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline.

Description: In August 2021, leadership within the U.S. Department of Veterans Affairs (VA) and U.

Dose-related effects of ketamine for antidepressant-resistant symptoms of posttraumatic stress disorder in veterans and active duty military: a double-blind, randomized, placebo-controlled multi-center clinical trial.

This study tested the efficacy of repeated intravenous ketamine doses to reduce symptoms of posttraumatic stress disorder (PTSD). Veterans and service members with PTSD (n = 158) who failed previous antidepressant treatment were randomized to 8 infusions administered twice weekly of intravenous placebo (n = 54), low dose (0.2 mg/kg; n = 53) or standard dose (0.

Comparison of Prolonged Exposure vs Cognitive Processing Therapy for Treatment of Posttraumatic Stress Disorder Among US Veterans: A Randomized Clinical Trial.

Importance: Posttraumatic stress disorder (PTSD) is a prevalent and serious mental health problem. Although there are effective psychotherapies for PTSD, there is little information about their comparative effectiveness.

Objective: To compare the effectiveness of prolonged exposure (PE) vs cognitive processing therapy (CPT) for treating PTSD in veterans.

Updates on Age to Start and Stop Colorectal Cancer Screening: Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer.

This document is a focused update to the 2017 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy.

Updates on age to start and stop colorectal cancer screening: recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer.

This document is a focused update to the 2017 colorectal cancer (CRC) screening recommendations from the U.S. Multi-Society Task Force on Colorectal Cancer, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy.

Shifting the National Consciousness about Pain Treatment: The Critical Need for a National Public Education Campaign.

The failure of past practices and policies related to opioid prescribing for chronic pain has led federal agencies and professional organizations to recommend multimodal approaches that prioritize evidence-based nonpharmacological pain treatments (NPTs). These multimodal approaches, which include both traditional and complementary/integrative approaches, hold great promise for reducing the burden of chronic pain and reducing opioid use. Unfortunately, NPT approaches are underutilized due to a daunting array of interrelated barriers including the public's attitudes and beliefs about chronic pain and its treatment.

Self-Management to Improve Function After Amputation: A Randomized Controlled Trial of the VETPALS Intervention.

Objective: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system.

Design: Randomized controlled trial with masked outcome assessment.

Setting: Five Veterans Affairs medical centers geographically dispersed across the United States.

SACRED: Effect of simvastatin on hepatic decompensation and death in subjects with high-risk compensated cirrhosis: Statins and Cirrhosis: Reducing Events of Decompensation.

Background/aims: The development of decompensation in cirrhosis demarcates a marked change in the natural history of chronic liver disease. HMG-CoA reductase inhibitors (statins) exert pleiotropic effects that reduce inflammation and fibrosis as well as improve vascular reactivity. Retrospective studies uniformly have associated statin utilization with improved outcomes for patients with cirrhosis.

When and How To Use Endoscopic Tattooing in the Colon: An International Delphi Agreement.

Background & Aims: There is a lack of clinical studies to establish indications and methodology for tattooing, therefore technique and practice of tattooing is very variable. We aimed to establish a consensus on the indications and appropriate techniques for colonic tattoo through a modified Delphi process.

Methods: The baseline questionnaire was classified into 3 areas: where tattooing should not be used (1 domain, 6 questions), where tattooing should be used (4 domains, 20 questions), and how to perform tattooing (1 domain 20 questions).

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain.

Background: Mindfulness-based interventions (MBIs) are evidence-based nonpharmacological treatments for treating chronic pain. However, the predominant MBI, mindfulness-based stress reduction, has features that pose significant implementation barriers.

Objectives: This study will test two approaches to delivering MBIs for improving Veterans' chronic pain and mental health comorbidities.

Changes in Drug List Prices and Amounts Paid by Patients and Insurers.

Importance: High out-of-pocket drug costs can cause patients to skip treatment and worsen outcomes, and high insurer drug payments could increase premiums. Drug wholesale list prices have doubled in recent years. However, because of manufacturer discounts and rebates, the extent to which increases in wholesale list prices are associated with amounts paid by patients and insurers is poorly characterized.

Deprescribing for Community-Dwelling Older Adults: a Systematic Review and Meta-analysis.

Background: Polypharmacy and use of inappropriate medications have been linked to increased risk of falls, hospitalizations, cognitive impairment, and death. The primary objective of this review was to evaluate the effectiveness, comparative effectiveness, and harms of deprescribing interventions among community-dwelling older adults.

Methods: We searched OVID MEDLINE Embase, CINAHL, and the Cochrane Library from 1990 through February 2019 for controlled clinical trials comparing any deprescribing intervention to usual care or another intervention.

Effects of Metformin Exposure on Survival in a Large National Cohort of Patients With Diabetes and Cirrhosis.

Background & Aims: Type II diabetes mellitus worsens the prognosis of cirrhosis. Multiple medications including metformin and statins often are co-administered to manage patients with diabetes. The aim of this study was to assess the impact of metformin exposure on mortality, hepatic decompensation, and hepatocellular carcinoma in individuals with diabetes and cirrhosis, controlling for multiple concomitant exposures.

State of the Science on Quality Indicators for Colonoscopy and How to Achieve Them.

Colonoscopy is a safe and effective tool, but operator dependent. Room for improvement in the quality of colonoscopy is the impetus for the development and measurement of colonoscopy quality indicators and the focus of many efforts to improve colonoscopy quality indicator prevention and control in provider practices and health systems. We present the preprocedural, intraprocedural, and postprocedural quality indicators and benchmarks for colonoscopy.

Effect of Frequency of Changing Point-of-Use Reminder Signs on Health Care Worker Hand Hygiene Adherence: A Cluster Randomized Clinical Trial.

Importance: Although hand hygiene (HH) is considered the most effective strategy for preventing hospital-acquired infections, HH adherence rates remain poor.

Objective: To examine whether the frequency of changing reminder signs affects HH adherence among health care workers.

Design, Setting, And Participants: This cluster randomized clinical trial in 9 US Department of Veterans Affairs acute care hospitals randomly assigned 58 inpatient units to 1 of 3 schedules for changing signs designed to promote HH adherence among health care workers: (1) no change; (2) weekly; and (3) monthly.

Decision support needs of kidney transplant candidates regarding the deceased donor waiting list: A qualitative study and conceptual framework.

Background: Kidney transplant candidates face complex decisions about transplant options such as living donation or acceptance of lower quality kidneys. We sought to characterize knowledge and decision support needs regarding kidney transplant outcomes and options.

Methods: We conducted 10 interviews and four focus groups of 28 adult kidney transplant candidates from two centers in Minnesota.