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Effect of Starting Dialysis Versus Continuing Medical Management on Survival and Home Time in Older Adults With Kidney Failure: A Target Trial Emulation Study: Annals of Internal Medicine: Vol 177, No 9
Background: For older adults with kidney failure who are not referred for transplant, medical management is an alternative to dialysis. Objective: To compare survival and home time between older adults who started dialysis at an estimated glomerular filtration rate (eGFR) less than 12 mL/min/1.73 m2 and those who continued medical management. Design: Observational cohort study using target trial emulation. Setting: U.S. Department of Veterans Affairs, 2010 to 2018. Participants: Adults aged 65 years or older with chronic kidney failure and eGFR below 12 mL/min/1.73 m2 who were not referred for transplant. Intervention: Starting dialysis within 30 days versus continuing medical management. Measurements: Mean survival and number of days at home. Results: Among 20 440 adults (mean age, 77.9 years [SD, 8.8]), the median time to dialysis start was 8.0 days in the group starting dialysis and 3.0 years in the group continuing medical management. Over a 3-year horizon, the group starting dialysis survived 770 days and the group continuing medical management survived 761 days (difference, 9.3 days [95% CI, −17.4 to 30.1 days]). Compared with the group continuing medical management, the group starting dialysis had 13.6 fewer days at home (CI, 7.7 to 20.5 fewer days at home). Compared with the group continuing medical management and forgoing dialysis completely, the group starting dialysis had longer survival by 77.6 days (CI, 62.8 to 91.1 days) and 14.7 fewer days at home (CI, 11.2 to 16.5 fewer days at home). Limitation: Potential for unmeasured confounding due to lack of symptom assessments at eligibility; limited generalizability to women and nonveterans. Conclusion: Older adults starting dialysis when their eGFR fell below 12 mL/min/1.73 m2 who were not referred for transplant had modest gains in life expectancy and less time at home. Primary Funding Source: U.S. Department of Veterans Affairs and National Institutes of Health.
The Management of Posttraumatic Stress Disorder and Acute Stress Disorder: Synopsis of the 2023 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline
Description: The U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) worked together to revise the 2017 VA/DoD Clinical Practice Guideline for the Management of Posttraumatic Stress Disorder and Acute Stress Disorder. This article summarizes the 2023 clinical practice guideline (CPG) and its development process, focusing on assessments and treatments for which evidence was sufficient to support a recommendation for or against. Methods: Subject experts from both departments developed 12 key questions and reviewed the published literature after a systematic search using the PICOTS (population, intervention, comparator, outcomes, timing of outcomes measurement, and setting) method. The evidence was then evaluated using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method. Recommendations were made after consensus was reached; they were based on quality and strength of evidence and informed by other factors, including feasibility and patient perspectives. Once the draft was peer reviewed by an external group of experts and their inputs were incorporated, the final document was completed. Recommendations: The revised CPG includes 34 recommendations in the following 5 topic areas: assessment and diagnosis, prevention, treatment, treatment of nightmares, and treatment of posttraumatic stress disorder (PTSD) with co-occurring conditions. Six recommendations on PTSD treatment were rated as strong. The CPG recommends use of specific manualized psychotherapies over pharmacotherapy; prolonged exposure, cognitive processing therapy, or eye movement desensitization and reprocessing psychotherapy; paroxetine, sertraline, or venlafaxine; and secure video teleconferencing to deliver recommended psychotherapy when that therapy has been validated for use with video teleconferencing or when other options are unavailable. The CPG also recommends against use of benzodiazepines, cannabis, or cannabis-derived products. Providers are encouraged to use this guideline to support evidence-based, patient-centered care and shared decision making to optimize individuals’ health outcomes and quality of life.
Effects of U.S. State Medical Cannabis Laws on Treatment of Chronic Noncancer Pain
Background: State medical cannabis laws may lead patients with chronic noncancer pain to substitute cannabis in place of prescription opioid or clinical guideline–concordant nonopioid prescription pain medications or procedures. Objective: To assess effects of state medical cannabis laws on receipt of prescription opioids, nonopioid prescription pain medications, and procedures for chronic noncancer pain. Design: Using data from 12 states that implemented medical cannabis laws and 17 comparison states, augmented synthetic control analyses estimated laws’ effects on receipt of chronic noncancer pain treatment, relative to predicted treatment receipt in the absence of the law. Setting: United States, 2010 to 2022. Participants: 583 820 commercially insured adults with chronic noncancer pain. Measurements: Proportion of patients receiving any opioid prescription, nonopioid prescription pain medication, or procedure for chronic noncancer pain; volume of each treatment type; and mean days’ supply and mean morphine milligram equivalents per day of prescribed opioids, per patient in a given month. Results: In a given month during the first 3 years of law implementation, medical cannabis laws led to an average difference of 0.05 percentage points (95% CI, −0.12 to 0.21 percentage points), 0.05 percentage points (CI, −0.13 to 0.23 percentage points), and −0.17 percentage points (CI, −0.42 to 0.08 percentage points) in the proportion of patients receiving any opioid prescription, any nonopioid prescription pain medication, or any chronic pain procedure, respectively, relative to what we predict would have happened in that month had the law not been implemented. Limitations: This study used a strong nonexperimental design but relies on untestable assumptions involving parallel counterfactual trends. Statistical power is limited by the finite number of states. Results may not generalize to noncommercially insured populations. Conclusion: This study did not identify important effects of medical cannabis laws on receipt of opioid or nonopioid pain treatment among patients with chronic noncancer pain. Primary Funding Source: National Institute on Drug Abuse.
High- Versus Low-Dose Exercise Therapy for Knee Osteoarthritis: A Randomized Controlled Multicenter Trial: Annals of Internal Medicine: Vol 176, No 2
Background: The benefits of exercise in patients with knee osteoarthritis are well documented, but the optimal exercise dose remains unknown. Objective: To compare high-dose versus low-dose exercise therapy with regard to knee function, pain, and quality of life (QoL) in patients with long-term symptomatic knee osteoarthritis. Design: A Swedish and Norwegian multicenter randomized controlled superiority trial with multiple follow-ups up to 12 months after the intervention. (ClinicalTrials.gov: NCT02024126) Setting: Primary health care facilities. Patients: 189 patients with diagnosed knee osteoarthritis and a history of pain and decreased knee function were assigned to high-dose therapy (n = 98; 11 exercises; 70 to 90 minutes) or low-dose therapy (n = 91; 5 exercises; 20 to 30 minutes). Intervention: Patient-tailored exercise programs according to the principles of medical exercise therapy. Global (aerobic), semiglobal (multisegmental), and local (joint-specific) exercises were performed 3 times a week for 12 weeks under supervision of a physiotherapist. Measurements: The Knee Injury and Osteoarthritis Outcome Score (KOOS) was measured biweekly during the 3-month intervention period and at 6 and 12 months after the intervention. The primary end point was the mean difference in KOOS scores between groups at the end of the intervention (3 months). Secondary outcomes included pain intensity and QoL. The proportion of patients with minimal clinically important changes in primary and secondary outcomes was compared between groups. Results: Both groups improved over time, but there were no benefits of high-dose therapy in most comparisons. One exception was the KOOS score for function in sports and recreation, where high-dose therapy was superior at the end of treatment and at 6-month follow-up. A small benefit in QoL at 6 and 12 months was also observed. Limitation: There was no control group that did not exercise. Conclusion: The results do not support the superiority of high-dose exercise over low-dose exercise for most outcomes. However, small benefits with high-dose exercise were found for knee function in sports and recreation and for QoL. Primary Funding Source: Swedish Rheumatic Fund.
Effectiveness of an Unsupervised Online Yoga Program on Pain and Function in People With Knee Osteoarthritis: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 175, No 10
Background: Yoga is a mind–body exercise typically done in groups in person, but this delivery method can be inconvenient, inaccessible, and costly. Effective online programs may increase access to exercise for knee osteoarthritis. Objective: To evaluate the effectiveness of an unsupervised 12-week online yoga program. Design: Two-group superiority randomized trial. (Australian New Zealand Clinical Trials Registry: ACTRN12620000012976) Setting: Community. Participants: 212 adults with symptomatic knee osteoarthritis. Intervention: Both groups received online osteoarthritis information (control). The yoga group also received access to an unsupervised online yoga program delivered via prerecorded videos over 12 weeks (1 video per week, with each session to be performed 3 times per week), with optional continuation thereafter. Measurements: Primary outcomes were changes in knee pain during walking (0 to 10 on a numerical rating scale) and physical function (0 to 68 on the Western Ontario and McMaster Universities Osteoarthritis Index) at 12 weeks (primary time point) and 24 weeks, analyzed using mixed-effects linear regression models. Secondary outcomes were self-reported overall knee pain, stiffness, depression, anxiety, stress, global change, quality of life, self-efficacy, fear of movement, and balance confidence. Adverse events were also collected. Results: A total of 195 (92%) and 189 (89%) participants provided 12- and 24-week primary outcomes, respectively. Compared with control at 12 weeks, yoga improved function (between-group mean difference in change, −4.0 [95% CI, −6.8 to −1.3]) but not knee pain during walking (between-group mean difference in change, −0.6 [CI, −1.2 to 0.1]), with more yoga participants than control participants achieving the minimal clinically important difference (MCID) for both outcomes. At 12 weeks, knee stiffness, quality of life, and arthritis self-efficacy improved more with yoga than the control intervention. Benefits were not maintained at 24 weeks. Adverse events were minor. Limitation: Participants were unblinded. Conclusion: Compared with online education, an unsupervised online yoga program improved physical function but not knee pain at 12 weeks in people with knee osteoarthritis, although the improvement did not reach the MCID and was not sustained at 24 weeks. Primary Funding Source: National Health and Medical Research Council and Centres of Research Excellence.
Cannabis-Based Products for Chronic Pain: A Systematic Review: Annals of Internal Medicine: Vol 175, No 8
Background: Contemporary data are needed about the utility of cannabinoids in chronic pain. Purpose: To evaluate the benefits and harms of cannabinoids for chronic pain. Data Sources: Ovid MEDLINE, PsycINFO, EMBASE, the Cochrane Library, and Scopus to January 2022. Study Selection: English-language, randomized, placebo-controlled trials and cohort studies (≥1 month duration) of cannabinoids for chronic pain. Data Extraction: Data abstraction, risk of bias, and strength of evidence assessments were dually reviewed. Cannabinoids were categorized by THC-to-CBD ratio (high, comparable, or low) and source (synthetic, extract or purified, or whole plant). Data Synthesis: Eighteen randomized, placebo-controlled trials (n = 1740) and 7 cohort studies (n = 13 095) assessed cannabinoids. Studies were primarily short term (1 to 6 months); 56% enrolled patients with neuropathic pain, with 3% to 89% female patients. Synthetic products with high THC-to-CBD ratios (>98% THC) may be associated with moderate improvement in pain severity and response (≥30% improvement) and an increased risk for sedation and are probably associated with a large increased risk for dizziness. Extracted products with high THC-to-CBD ratios (range, 3:1 to 47:1) may be associated with large increased risk for study withdrawal due to adverse events and dizziness. Sublingual spray with comparable THC-to-CBD ratio (1.1:1) probably is associated with small improvement in pain severity and overall function and may be associated with large increased risk for dizziness and sedation and moderate increased risk for nausea. Evidence for other products and outcomes, including longer-term harms, were not reported or were insufficient. Limitation: Variation in interventions; lack of study details, including unclear availability in the United States; and inadequate evidence for some products. Conclusion: Oral, synthetic cannabis products with high THC-to-CBD ratios and sublingual, extracted cannabis products with comparable THC-to-CBD ratios may be associated with short-term improvements in chronic pain and increased risk for dizziness and sedation. Studies are needed on long-term outcomes and further evaluation of product formulation effects. Primary Funding Source: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. (PROSPERO: CRD42021229579)
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.S. Department of Defense (DoD) approved a joint clinical practice guideline (CPG) for the management of substance use disorders (SUDs). This synopsis summarizes key recommendations. Methods: In March 2020, the VA/DoD Evidence-Based Practice Work Group assembled a team to update the 2015 VA/DoD Clinical Practice Guideline for the Management of Substance Use Disorders that included clinical stakeholders and conformed to the National Academy of Medicine's tenets for trustworthy CPGs. The guideline panel developed key questions, systematically searched and evaluated the literature, created two 1-page algorithms, and distilled 35 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. This synopsis presents the recommendations that were believed to be the most clinically impactful. Recommendations: The scope of the CPG is broad; however, this synopsis focuses on key recommendations for the management of alcohol use disorder, use of buprenorphine in opioid use disorder, contingency management, and use of technology and telehealth to manage patients remotely.