Search Results for: "american academy"

Description: In May 2022, leadership within the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved a joint clinical practice guideline for the use of opioids when managing chronic pain. This synopsis summarizes the recommendations that the authors believe are the most important to highlight. Methods: In December 2020, the VA/DoD Evidence-Based Practice Work Group assembled a team to update the 2017 VA/DoD Clinical Practice Guideline for Opioid Therapy for Chronic Pain. The guideline development team included clinical stakeholders and conformed to the National Academy of Medicine's tenets for trustworthy clinical practice guidelines. The guideline team developed key questions to guide a systematic evidence review that was done by an independent third party and distilled 20 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. The guideline team also created 3 one-page algorithms to help guide clinical decision making. This synopsis presents the recommendations and highlights selected recommendations on the basis of clinical relevance. Recommendations: This guideline is intended for clinicians who may be considering opioid therapy to manage patients with chronic pain. This synopsis reviews updated recommendations for the initiation and continuation of opioid therapy; dose, duration, and taper of opioids; screening, assessment, and evaluation; and risk mitigation. New additions are highlighted, including recommendations about the use of buprenorphine instead of full agonist opioids; assessing for behavioral health conditions and factors associated with higher risk for harm, such as pain catastrophizing; and the use of pain and opioid education to reduce the risk for prolonged opioid use for postsurgical pain.

Incremental Health Care Costs of Self-Reported Functional Impairments and Phenotypic Frailty in Community-Dwelling Older Adults: A Prospective Cohort Study: Annals of Internal Medicine: Vol 176, No 4

Background: Health care systems need better strategies to identify older adults at risk for costly care to select target populations for interventions to reduce health care burden. Objective: To determine whether self-reported functional impairments and phenotypic frailty are associated with incremental health care costs after accounting for claims-based predictors. Design: Prospective cohort study. Setting: Index examinations (2002 to 2011) of 4 prospective cohort studies linked with Medicare claims. Participants: 8165 community-dwelling fee-for-service beneficiaries (4318 women, 3847 men). Measurements: Weighted (Centers for Medicare & Medicaid Services Hierarchical Condition Category index) and unweighted (count of conditions) multimorbidity and frailty indicators derived from claims. Self-reported functional impairments (difficulty performing 4 activities of daily living) and frailty phenotype (operationalized using 5 components) derived from cohort data. Health care costs ascertained for 36 months after index examinations. Results: Average annualized costs (2020 U.S. dollars) were $13 906 among women and $14 598 among men. After accounting for claims-based indicators, average incremental costs of functional impairments versus no impairment in women (men) were $3328 ($2354) for 1 impairment increasing to $7330 ($11 760) for 4 impairments; average incremental costs of phenotypic frailty versus robust in women (men) were $8532 ($6172). Mean predicted costs adjusted for claims-based indicators in women (men) varied by both functional impairments and the frailty phenotype ranging from $8124 ($11 831) among robust persons without impairments to $18 792 ($24 713) among frail persons with 4 impairments. Compared with the model with claims-derived indicators alone, this model resulted in more accurate cost prediction for persons with multiple impairments or phenotypic frailty. Limitation: Cost data limited to participants enrolled in the Medicare fee-for-service program. Conclusion: Self-reported functional impairments and phenotypic frailty are associated with higher subsequent health care expenditures in community-dwelling beneficiaries after accounting for several claims-based indicators of costs. Primary Funding Source: National Institutes of Health.

Effect of Yoga on Frailty in Older Adults: A Systematic Review: Annals of Internal Medicine: Vol 176, No 4

Background: Yoga, a multicomponent mind–body practice, improves several domains of physical and psychological health and may affect frailty in older adults. Purpose: To evaluate the available trial evidence on the effect of yoga-based interventions on frailty in older adults. Data Sources: MEDLINE, EMBASE, and Cochrane Central from their inception to 12 December 2022. Study Selection: Randomized controlled trials evaluating the effect of yoga-based interventions, including at least 1 session of physical postures, on a validated frailty scale or single-item markers of frailty in adults aged 65 years or older. Data Extraction: Two authors independently screened articles and extracted data; 1 author assessed risk of bias with review from a second author. Disagreements were resolved through consensus and as-needed input from a third author. Data Synthesis: Thirty-three studies (n = 2384 participants) were identified in varied populations, including community dwellers, nursing home residents, and those with chronic disease. Yoga styles were primarily based on Hatha yoga and most often included Iyengar or chair-based methods. Single-item frailty markers included measures of gait speed, handgrip strength, balance, lower-extremity strength and endurance, and multicomponent physical performance measures; no studies included a validated definition of frailty. When compared with education or inactive control, there was moderate-certainty evidence that yoga improved gait speed and lower-extremity strength and endurance, low-certainty evidence for balance and multicomponent physical function measures, and very low-certainty evidence for handgrip strength. Limitation: Heterogeneity in study design and yoga style, small sample sizes, and reporting deficiencies leading to concerns for selection bias. Conclusion: Yoga may affect frailty markers that are associated with clinically meaningful outcomes in older adult populations but may not offer benefit over active interventions (for example, exercise). Primary Funding Source: None. (PROSPERO: CRD42020130303)

Effectiveness of Opioid Analgesic Medicines Prescribed in or at Discharge From Emergency Departments for Musculoskeletal Pain: A Systematic Review and Meta-analysis: Annals of Internal Medicine: Vol 175, No 11

Background: The comparative benefits and harms of opioids for musculoskeletal pain in the emergency department (ED) are uncertain. Purpose: To evaluate the comparative effectiveness and harms of opioids for musculoskeletal pain in the ED setting. Data Sources: Electronic databases and registries from inception to 7 February 2022. Study Selection: Randomized controlled trials of any opioid analgesic compared with placebo or a nonopioid analgesic administered or prescribed to adults in or on discharge from the ED. Data Extraction: Pain and disability were rated on a scale of 0 to 100 and pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. Data Synthesis: Forty-two articles were included (n = 6128). In the ED, opioids were statistically but not clinically more effective in reducing pain in the short term (about 2 hours) than placebo and paracetamol (acetaminophen) but were not clinically or statistically more effective than nonsteroidal anti-inflammatory drugs (NSAIDs) or local or systemic anesthetics. Opioids may carry higher risk for harms than placebo, paracetamol, or NSAIDs, although evidence is very uncertain. There was no evidence of difference in harms associated with local or systemic anesthetics. Limitations: Low or very low GRADE ratings for some outcomes, unexplained heterogeneity, and little information on long-term outcomes. Conclusion: The risk–benefit balance of opioids versus placebo, paracetamol, NSAIDs, and local or systemic anesthetics is uncertain. Opioids may have equivalent pain outcomes compared with NSAIDs, but evidence on comparisons of harms is very uncertain and heterogeneous. Although factors such as route of administration or dosage may explain some heterogeneity, more work is needed to identify which subgroups will have a more favorable benefit–risk balance for one analgesic over another. Longer-term pain management once dose thresholds are reached is also uncertain. Primary Funding Source: None. (PROSPERO: CRD42021275293)

Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 1

Background: It remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated. Objective: To investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet. Design: 6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078) Setting: Odense University Hospital in Denmark from November 2016 until June 2020. Participants: 165 participants with T2DM. Intervention: Two calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins. Measurements: Glycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD. Results: The mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A1c (mean difference in change, −6.1 mmol/mol [95% CI, −9.2 to −3.0 mmol/mol] or −0.59% [CI, −0.87% to −0.30%]) and lost more weight (mean difference in change, −3.8 kg [CI, −6.2 to −1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up. Limitation: Open-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons. Conclusion: Persons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention. Primary Funding Source: Novo Nordisk Foundation.

The Management of Major Depressive Disorder: Synopsis of the 2022 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guideline

Description: In February 2022, 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 major depressive disorder (MDD). This synopsis summarizes key recommendations. Methods: Senior leaders within the VA and the DoD assembled a team to update the 2016 CPG for the management of MDD 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 36 recommendations for care using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. Select recommendations that were identified by the authors to represent key changes from the prior CPG are presented in this synopsis. Recommendations: The scope of the CPG is diverse; however, this synopsis focuses on key recommendations that the authors identified as important new evidence and changes to prior recommendations on pharmacologic management, pharmacogenomics, psychotherapy, complementary and alternative therapies, and the use of telemedicine.

Evaluation of Harms Reporting in U.S. Cancer Screening Guidelines

Background: Cancer screening should be recommended only when the balance between benefits and harms is favorable. This review evaluated how U.S. cancer screening guidelines reported harms, within and across organ-specific processes to screen for cancer. Objective: To describe current reporting practices and identify opportunities for improvement. Design: Review of guidelines. Setting: United States. Patients: Patients eligible for screening for breast, cervical, colorectal, lung, or prostate cancer according to U.S. guidelines. Measurements: Information was abstracted on reporting of patient-level harms associated with screening, diagnostic follow-up, and treatment. The authors classified harms reporting as not mentioned, conceptual, qualitative, or quantitative and noted whether literature was cited when harms were described. Frequency of harms reporting was summarized by organ type. Results: Harms reporting was inconsistent across organ types and at each step of the cancer screening process. Guidelines did not report all harms for any specific organ type or for any category of harm across organ types. The most complete harms reporting was for prostate cancer screening guidelines and the least complete for colorectal cancer screening guidelines. Conceptualization of harms and use of quantitative evidence also differed by organ type. Limitations: This review considers only patient-level harms. The authors did not verify accuracy of harms information presented in the guidelines. Conclusion: The review identified opportunities for improving conceptualization, assessment, and reporting of screening process–related harms in guidelines. Future work should consider nuances associated with each organ-specific process to screen for cancer, including which harms are most salient and where evidence gaps exist, and explicitly explore how to optimally weigh available evidence in determining net screening benefit. Improved harms reporting could aid informed decision making, ultimately improving cancer screening delivery. Primary Funding Source: National Cancer Institute.

Population Genomic Screening for Three Common Hereditary Conditions: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 176, No 5

Background: The cost-effectiveness of screening the U.S. population for Centers for Disease Control and Prevention (CDC) Tier 1 genomic conditions is unknown. Objective: To estimate the cost-effectiveness of simultaneous genomic screening for Lynch syndrome (LS), hereditary breast and ovarian cancer syndrome (HBOC), and familial hypercholesterolemia (FH). Design: Decision analytic Markov model. Data Sources: Published literature. Target Population: Separate age-based cohorts (ages 20 to 60 years at time of screening) of racially and ethnically representative U.S. adults. Time Horizon: Lifetime. Perspective: U.S. health care payer. Intervention: Population genomic screening using clinical sequencing with a restricted panel of high-evidence genes, cascade testing of first-degree relatives, and recommended preventive interventions for identified probands. Outcome Measures: Incident breast, ovarian, and colorectal cancer cases; incident cardiovascular events; quality-adjusted survival; and costs. Results of Base-Case Analysis: Screening 100 000 unselected 30-year-olds resulted in 101 (95% uncertainty interval [UI], 77 to 127) fewer overall cancer cases and 15 (95% UI, 4 to 28) fewer cardiovascular events and an increase of 495 quality-adjusted life-years (QALYs) (95% UI, 401 to 757) at an incremental cost of $33.9 million (95% UI, $27.0 million to $41.1 million). The incremental cost-effectiveness ratio was $68 600 per QALY gained (95% UI, $41 800 to $88 900). Results of Sensitivity Analysis: Screening 30-, 40-, and 50-year-old cohorts was cost-effective in 99%, 88%, and 19% of probabilistic simulations, respectively, at a $100 000-per-QALY threshold. The test costs at which screening 30-, 40-, and 50-year-olds reached the $100 000-per-QALY threshold were $413, $290, and $166, respectively. Variant prevalence and adherence to preventive interventions were also highly influential parameters. Limitations: Population averages for model inputs, which were derived predominantly from European populations, vary across ancestries and health care environments. Conclusion: Population genomic screening with a restricted panel of high-evidence genes associated with 3 CDC Tier 1 conditions is likely to be cost-effective in U.S. adults younger than 40 years if the testing cost is relatively low and probands have access to preventive interventions. Primary Funding Source: National Human Genome Research Institute.

Periconception Red Blood Cell Folate and Offspring Congenital Heart Disease: Nested Case–Control and Mendelian Randomization Studies: Annals of Internal Medicine: Vol 175, No 9

Background: Periconception folic acid supplementation has been suggested to protect against congenital heart disease (CHD), but the association between maternal red blood cell (RBC) folate, the gold-standard biomarker of folate exposure, and subsequent offspring CHD risk is lacking. Objective: To quantify the association between periconception maternal RBC folate and offspring CHD risk. Design: Prospective, nested, case–control study and 1-sample Mendelian randomization. (ClinicalTrials.gov: NCT02737644) Setting: 29 maternity institutions in 12 districts of Greater Shanghai, China. Participants: All 197 mothers of offspring with CHD and 788 individually matched mothers of unaffected offspring from the SPCC (Shanghai Preconception Cohort). Measurements: Maternal RBC folate was measured before or at early pregnancy. Odds ratios [ORs] were estimated using conditional logistic regression after adjustment for covariates. Mendelian randomization was done using the methylenetetrahydrofolate reductase (MTHFR) C677T as the genetic instrument. Results: Case patients had lower median maternal RBC folate concentrations than control participants (714 nmol/L [interquartile range, 482 to 1008 nmol/L] vs. 788 nmol/L [557 to 1094 nmol/L]). Maternal RBC folate concentrations were inversely associated with offspring CHD (adjusted OR per 100 nmol/L, 0.93 [95% CI, 0.89 to 0.99]). The adjusted OR for mothers with periconception RBC folate of 906 nmol/L or more (vs. <906 nmol/L) was 0.61 (CI, 0.40 to 0.93). Mendelian randomization showed that each 100-nmol increase in maternal RBC folate concentrations was significantly associated with reduced offspring CHD risk (OR, 0.75 [CI, 0.61 to 0.92]). Limitation: Potential confounding due to unmeasured covariates in the nested case–control study. Conclusion: Higher maternal RBC folate is associated with reduced offspring CHD risk. For primary CHD prevention, higher target RBC folate levels than currently recommended for neural tube defect prevention may be needed and warrant further study. Primary Funding Source: National Key Research and Development Program of China, National Natural Science Foundation of China, China Postdoctoral Science Foundation, and Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences.

Direct-to-Consumer Generic Drugs: A Maverick Approach or Another Exposure of Market Failures?

Previous See more results in Annals of Internal Medicine

Clinical Information Search