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Effect of Social Vulnerability on Efficacy of Bariatric Surgery Versus Medical and Lifestyle Intervention for Type 2 Diabetes: Analysis of the ARMMS-T2D Consortium of Randomized Trials
Background: Social determinants of health (SDOH) can affect metabolic health. Objective: To determine the effect of social vulnerability on the comparative effectiveness of metabolic bariatric surgery or medical and lifestyle intervention on glycemia and weight outcomes in people with type 2 diabetes (T2D). Design: Analysis of the effect modification of baseline Area Deprivation Index (ADI; a metric of social vulnerability) on longitudinal outcomes between randomized treatment groups using linear mixed-effects models. (ClinicalTrials.gov: NCT02328599) Setting: 4 U.S. academic centers. Participants: 258 participants with T2D enrolled in 4 randomized controlled trials of surgical versus medical management and a longitudinal observational follow-up study. Measurements: ADI linked to ZIP code data at randomization; weight loss and hemoglobin A1c (HbA1c) level at the end of the active intervention period (7 to 12 years). Results: Baseline characteristics were well balanced between the surgical and medical therapy groups after adjustment for study site and stratification by high versus low ADI. Surgery was more effective than medical therapy in reducing HbA1c level among persons with high ADI (net difference, −1.29% [95% CI, −1.95% to −0.63%]) and those with low ADI (net difference, −0.95% [CI, −1.29% to −0.62%]). Surgery was also more effective than medical therapy at producing weight loss across ADIs, with respective net differences of −10.6% (CI, −15.2% to −5.9%) for high ADI and −13.3% (CI, −15.7% to −10.9%) for low ADI. The interaction between ADI and intervention group was not significant for either HbA1c (P = 0.37) or weight loss (P = 0.31). Limitations: Small sample size; parent trials were not designed to address effect modification by ADI. Conclusion: Surgery was superior to medical therapy for people with T2D regardless of social deprivation. This study did not detect statistically significant differences in the comparative advantage of surgery over medical therapy by ADI. Primary Funding Source: National Institutes of Health.
The Effect of 4:3 Intermittent Fasting on Weight Loss at 12 Months: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 178, No 5
Background: Long-term (≥12 months) randomized trials evaluating the efficacy of intermittent fasting (IMF) as a dietary weight loss strategy are limited. Furthermore, no studies have compared IMF versus daily caloric restriction (DCR) when both interventions are provided in the context of a guidelines-based behavioral weight loss program. Objective: To compare the effects of 4:3 IMF versus DCR on changes in weight at 12 months, with comprehensive behavioral support provided to both groups. Design: Randomized clinical trial. (ClinicalTrials.gov: NCT03411356) Setting: Denver, Colorado, and surrounding metropolitan area. Participants: Adults aged 18 to 60 years with body mass index (BMI) of 27 to 46 kg/m2. Intervention: The IMF group was instructed to restrict energy intake by 80% on 3 nonconsecutive days per week, with ad libitum intake (no restriction) the other 4 days (4:3 IMF). The DCR group was instructed to reduce daily energy intake by 34% to match the weekly energy deficit of 4:3 IMF. Both groups received a high-intensity comprehensive behavioral weight loss program that included group-based behavioral support and a recommendation to increase moderate-intensity physical activity to 300 minutes per week. Measurements: The primary outcome was change in body weight (in kilograms) at 12 months. Results: Of the 165 (4:3 IMF, n = 84; DCR, n = 81) randomly assigned participants (mean age, 42 years [SD, 9]; mean BMI, 34.1 kg/m2 [SD, 4.4]; 73.9% female), 125 completed the trial. In an intention-to-treat analysis, 4:3 IMF showed greater reductions in weight than DCR at 12 months (mean difference, 2.89 kg [95% CI, 5.65 to 0.14 kg]; P = 0.040). Limitation: Limited generalizability. Conclusion: Compared with DCR, 4:3 IMF resulted in modestly greater weight loss among adults with overweight or obesity enrolled in a 12-month, high-intensity, comprehensive behavioral weight loss program. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases.
Availability of Cardioprotective Medications for Type 2 Diabetes in the Medicaid Program
Background: Sodium–glucose cotransporter-2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are the only type 2 diabetes medications that reduce cardiovascular disease and death, yet their availability in Medicaid is unclear. Objective: To assess the unrestricted availability of SGLT2is and GLP-1 RAs, using dipeptidyl peptidase-4 inhibitors (DPP4is) as a benchmark. Design: National cross-sectional study using publicly available data. Setting: All 50 state Medicaid fee-for-service (FFS) plans and 273 nonelderly adult managed care organization (MCO) plans with comprehensive coverage in March 2024. Participants: Medicaid plans and enrollees with diabetes in those plans as of March 2024. Measurements: Unrestricted availability was defined as having at least 1 medication in each class listed on the preferred drug list without prior authorization or step therapy. Results: Of 50 FFS plans (including Washington, DC, and excluding 1 state, which had 5 MCO plans), 40 (80%) had unrestricted availability of SGLT2is, 30 (60%) of GLP-1 RAs, 41 (82%) of either, 29 (58%) of both, and 42 (84%) of DPP4is. Among 273 MCO plans (39 states; median, 6 plans [range, 2 to 24 plans]), 182 (67%) had availability of SGLT2is, 131 (48%) of GLP-1 RAs, 184 (67%) of either, 129 (47%) of both, and 204 (75%) of DPP4is. The proportion of MCO enrollees with availability varied markedly among states (SGLT2i range, 24% to 100%; GLP-1 RA range, 0% to 99%; DPP4i range, 41% to 100%). Primarily because of more MCO restrictions, 1.7 million enrollees (lower to upper bound, 1.33 million to 2.17 million enrollees; 25%) had restricted SGLT2i availability, 2.72 million (lower to upper bound, 2.12 million to 3.45 million; 40%) had restricted GLP-1 RA availability, and 1.5 million (lower to upper bound, 1.17 million to 1.90 million; 22%) had restricted DPP4i availability. Availability increased from 2020 to 2024, especially in FFS, but MCO GLP-1 RA availability has plateaued at below 60% since 2022. Tirzepatide was almost entirely restricted. Limitations: Diabetes enrollment was estimated using plan size and state and national prevalence data. The appropriateness of prior authorization restrictions was unknown. Conclusion: Many Medicaid enrollees have restricted access to cardioprotective medications, particularly in MCO plans for GLP-1 RA medications, with substantial state variation. Formulary coverage is a potential lever to increase availability of these medications while balancing pharmaceutical costs. Primary Funding Source: University of California, San Francisco, Action Research Center for Health Equity.
Screening for Anal Cancer Among Men Who Have Sex With Men With HIV: Benefits, Harms, and Cost-Effectiveness Analyses
Background: Following the success of the ANCHOR (Anal Cancer–HSIL Outcomes Research) trial, the U.S. Department of Health and Human Services recommends anal cancer screening for high-risk persons, particularly men who have sex with men (MSM) with HIV. Objective: To quantify the cost-effectiveness and benefits versus harms of different anal cancer screening strategies. Design: Microsimulation model. Data Sources: The ANCHOR trial and published literature. Target Population: MSM with HIV. Time Horizon: Lifetime. Perspective: Health care sector. Intervention: Cytology alone and human papillomavirus (HPV) testing (high-risk HPV [hrHPV], HPV16/18, and HPV16), co-testing, and triage options; ages at which to begin screening (≥35, ≥40, or ≥45 years); screening interval (annual, biennial, triennial, or quadrennial). Outcome Measures: Incremental cost-effectiveness ratios (ICERs) of dollars per quality-adjusted life-year (QALY) and the tradeoff of harms (high-resolution anoscopies [HRAs]) versus benefits (cancer cases averted and life-years gained). Results of Base-Case Analysis: Screening initiation at age 35 years or older using cytology dominated initiation at ages 40 and 45 years or older, with ICERs ranging from $87 731 for a quadrennial interval to $350 100 for an annual interval. In the comparative analysis, the following unique strategies were on the cost-effectiveness frontier: quadrennial HPV16, quadrennial HPV16/18, triennial HPV16/18, triennial hrHPV, biennial HPV16/18, biennial hrHPV, annual cytology with hrHPV triage, and annual hrHPV; ICERs ranged from $81 341 to $2 510 847. In the harm-to-benefit analysis, triage options offered the most efficient HRA use. Results of Sensitivity Analysis: ICERs decreased for newly eligible persons. For 35-year-old newly eligible MSM with HIV, ICERs for cytology ranged from $70 750 (quadrennial) to $223 895 (annual). Limitation: Findings are not generalizable to other high-risk populations. Conclusion: Anal cancer screening among MSM with HIV aged 35 years or older is cost-effective, but value-based prioritization of strategies is needed to optimize screening use. Primary Funding Source: National Cancer Institute.
Glucagon-Like Peptide-1 Receptor Agonists and Risk for Depression in Older Adults With Type 2 Diabetes: A Target Trial Emulation Study: Annals of Internal Medicine: Vol 178, No 3
Background: Although glucagon-like peptide-1 receptor agonists (GLP-1RAs) have shown potential antidepressant effects, population studies yield inconsistent results. Objective: To compare the risk for depression in older adults with type 2 diabetes (T2D) initiating treatment with GLP-1RAs versus sodium–glucose cotransporter-2 inhibitors (SGLT2is) or dipeptidyl peptidase-4 inhibitors (DPP4is). Design: Target trial emulation study. Setting: U.S. National Medicare administrative data from January 2014 to December 2020. Patients: Adults aged 66 years or older with T2D initiating treatment with a GLP-1RA were matched 1:1 on propensity score with those initiating treatment with either an SGLT2i or a DPP4i. Measurements: The primary end point was incident depression. Cox proportional hazards regression models were used to estimate the hazard ratio (HR) with 95% CI within matched groups. Results: A total of 14 665 matched pairs of older adults were included in the cohort for GLP-1RAs versus SGLT2is; the rate difference of depression between GLP-1RA users and SGLT2i users was 3.48 (95% CI, −0.81 to 7.78) per 1000 person-years, with an HR of 1.07 (CI, 0.98 to 1.18). In the cohort for GLP-1RAs versus DPP4is (13 711 matched pairs), the rate difference was −5.78 (CI, −10.49 to −1.07) per 1000 person-years, with an HR of 0.90 (CI, 0.82 to 0.98). Limitation: Unmeasured confounders (such as hemoglobin A1c levels and body mass index), outcome misclassification, and limited generalizability to all GLP-1RA users (for example, younger populations or those without T2D receiving the drug for obesity treatment). Conclusion: Among older adults with T2D, the incidence of depression was relatively low. Use of GLP-1RAs was associated with a modestly lower risk for depression compared with use of DPP4is, but not SGLT2is. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.
Sexual Trauma, Suicide, and Overdose in a National Cohort of Older Veterans
Background: Little is known about the association between military sexual trauma (MST) and risk for suicide-related outcomes later in life. Objective: To determine the association between MST and risk for suicide, overdose, and related mortality among older men and women at specific age landmarks and to investigate whether posttraumatic stress disorder (PTSD) modifies risk. Design: Longitudinal cohort study; baseline in 2012 to 2013, with follow-up through 31 December 2020. Setting: All U.S. Department of Veterans Affairs (VA) medical centers in the United States. Participants: 5 059 526 veterans aged 50 years or older. Measurements: Positive MST screening result, nonfatal suicide attempt, death by suicide, or overdose death. Results: MST was documented for 15.7% of older women and 1.3% of older men. The adjusted cumulative incidence of any suicide attempt was higher for those with MST (men, 18.67%; women, 8.66%) than for those without MST (men, 6.25%; women, 2.92%) at age 90 years. The adjusted risk differences among men and women were 12.41% (95% CI, 11.72% to 13.10%) and 5.74% (CI, 5.22% to 6.26%) for any late-life suicide attempt, 11.92% (CI, 11.27% to 12.57%) and 5.58% (CI, 5.08% to 6.08%) for nonfatal suicide attempt, 0.27% (CI, 0.00% to 0.54%) and 0.15% (CI, 0.00% to 0.30%) for fatal suicide attempt, and 1.05% (CI, 0.79% to 1.31%) and 0.48% (CI, 0.28% to 0.68%) for any drug overdose at age 90 years. MST remained a significant risk factor for any suicide attempt among people with and without PTSD. Limitations: Selection bias, generalizability to non-VA veterans, possible unmeasured confounding, and missingness. Conclusion: Late-life suicide attempt and death by suicide or overdose are associated with prior MST. These findings advance our understanding of the lasting effect of sexual trauma on suicide risk and mortality and suggest that monitoring and treatment of MST-related conditions are vital over the long term. Primary Funding Source: VA Office of Research and Development.
Prevention of Episodic Migraine Headache Using Pharmacologic Treatments in Outpatient Settings: A Clinical Guideline From the American College of Physicians
Description: The American College of Physicians (ACP) developed this clinical guideline for clinicians caring for adults with episodic migraine headache (defined as 1 to 14 headache days per month) in outpatient settings. Methods: ACP based these recommendations on systematic reviews of the comparative benefits and harms of pharmacologic treatments to prevent episodic migraine, patients’ values and preferences, and economic evidence. ACP evaluated the comparative effectiveness of the following interventions: angiotensin-converting enzyme inhibitors (lisinopril), angiotensin II–receptor blockers (candesartan and telmisartan), antiseizure medications (valproate and topiramate), β-blockers (metoprolol and propranolol), calcitonin gene-related peptide (CGRP) antagonist-gepants (atogepant or rimegepant), CGRP monoclonal antibodies (eptinezumab, erenumab, fremanezumab, or galcanezumab), selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors (fluoxetine and venlafaxine), and a tricyclic antidepressant (amitriptyline). ACP used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to analyze the effects of pharmacologic treatment on the following outcomes: migraine frequency and duration, number of days medication was taken for acute treatment of migraine, frequency of migraine-related emergency department visits, migraine-related disability, quality of life and physical functioning, and discontinuations due to adverse events. In addition, adverse events were captured through U.S. Food and Drug Administration medication labels and eligible studies. Recommendations: In this guideline, ACP makes recommendations for clinicians to initiate monotherapy for episodic migraine prevention in nonpregnant adults in the outpatient setting as well as alternative approaches if initial treatments are not tolerated or result in an inadequate response. All 3 ACP recommendations have conditional strength and low-certainty evidence. Clinical considerations provide additional context for physicians and other clinicians.
Effectiveness of the 2023-to-2024 XBB.1.5 COVID-19 Vaccines Over Long-Term Follow-up: A Target Trial Emulation: Annals of Internal Medicine: Vol 178, No 3
Background: Monovalent COVID-19 vaccines targeting the XBB.1.5 Omicron variant were introduced in September 2023. In the absence of randomized controlled trials demonstrating their efficacy, information on real-world vaccine effectiveness (VE) is needed. Objective: To determine XBB.1.5 COVID-19 VE and the extent to which it declines over time. Design: Target trial emulation. Setting: U.S. Veterans Health Administration. Participants: Eligible XBB.1.5 vaccine recipients were matched 1:1 to unvaccinated persons in 7 sequential biweekly trials with enrollment from 2 October 2023 through 3 January 2024. Intervention: XBB.1.5 COVID-19 vaccination versus no XBB.1.5 vaccination. Measurements: Outcomes were ascertained through 10 May 2024 and included any positive result on a SARS-CoV-2 test from day 10 after the matched index date, subsequent hospitalization within 1 day before or 10 days after the positive result, or death within 30 days after the positive result. Vaccine effectiveness was estimated as 100 × (1 − risk ratio). Results: Participants (91.3% male; mean age, 69.9 years) included 587 137 pairs of vaccinated and matched unvaccinated persons. Over a mean follow-up of 176 days (range, 118 to 211 days), VE was −3.26% (95% CI, −6.78% to −0.22%) against documented SARS-CoV-2 infection, 16.64% (CI, 6.47% to 25.77%) against SARS-CoV-2–associated hospitalization, and 26.61% (CI, 5.53% to 42.32%) against SARS-CoV-2–associated death. When estimated at 60, 90, and 120 days, respectively, VE against documented infection (14.21%, 7.29%, and 3.15%), hospitalization (37.57%, 30.84%, and 25.25%), or death (54.24%, 44.33%, and 30.25%) showed substantial waning. Limitation: Potential for residual confounding and incomplete capture of COVID-19 vaccination and SARS-CoV-2–related outcomes. Conclusion: COVID-19 vaccines targeting the XBB.1.5 variant of Omicron were not effective in preventing infection and had relatively low VE against hospitalization and death, which declined rapidly over time. Primary Funding Source: U.S. Department of Veterans Affairs.
Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention: A Randomized Trial: Annals of Internal Medicine: Vol 177, No 11
Background: REPRIEVE (Randomized Trial to Prevent Vascular Events in HIV) led to new guidelines for statin use among people with HIV (PWH) with low to moderate risk for atherosclerotic cardiovascular disease (ASCVD). Little is known about the natural history of diabetes mellitus (DM) or mechanisms contributing to statin effects on DM among this population. Objective: To determine the contribution of known DM risk factors to excess risk for DM with pitavastatin in REPRIEVE. Design: Phase 3, primary ASCVD prevention trial over a median of 5.6 years of follow-up. (ClinicalTrials.gov: NCT02344290) Setting: Global, multicenter trial. Participants: 7731 PWH aged 40 to 75 years with low to moderate ASCVD risk (by the pooled cohort equations from the American College of Cardiology and American Heart Association) without DM at study entry. Intervention: Random 1:1 assignment to pitavastatin, 4 mg daily, or placebo. Measurements: New-onset DM was determined at each visit by clinical diagnosis requiring initiation of medication treatment for DM. The incidence of new-onset DM was assessed in relation to predefined demographic and metabolic risk factors, stratified by treatment group. Treatment effects of pitavastatin on progression to new DM in key subgroups were determined. Results: Participants with at least 3 DM risk factors (vs. no risk factors) had increased risk for DM in each treatment group (incidence rate, 3.24 per 100 person-years [PY] vs. 0.34 per 100 PY [pitavastatin] and 2.66 per 100 PY vs. 0.27 per 100 PY [placebo]). The incidence of DM was highest in South Asia. In adjusted analyses, high body mass index, prediabetes, and metabolic syndrome components were strongly associated with new-onset DM (all P < 0.005). Limitation: Pitavastatin was the only statin assessed; DM was assessed clinically. Conclusion: Metabolic risk factors, including prediabetes and obesity, contributed to new-onset DM in statin- and placebo-treated participants. A clinically significant effect of pitavastatin on DM was seen primarily among those with multiple risk factors for DM at entry. Strategies targeting key metabolic risk factors, like obesity and prediabetes, may help protect against DM among PWH. Primary Funding Source: National Heart, Lung, and Blood Institute of the National Institutes of Health.
The Effect of the “Safety in Dementia” Online Tool to Assist Decision Making for Caregivers of Persons With Dementia and Access to Firearms: A Randomized Trial: Annals of Internal Medicine: Vol 177, No 12
Background: Caregivers face challenges (including competing desires to prevent injury, respect autonomy, and avoid conflict) when addressing firearm access by community-dwelling persons with Alzheimer disease and related dementias (ADRD). Objective: To test the effect of the online Safety in Dementia (SiD) decision aid on caregivers’ decision making about firearm access for people with ADRD. Design: Prospective 2-group randomized trial with longitudinal follow-up. (ClinicalTrials.gov: NCT05173922) Setting: United States. Participants: English- or Spanish-speaking caregivers (aged ≥18 years) of community-dwelling adults with ADRD and firearm access. Intervention: SiD versus a web-based information control. Measurements: The primary outcome was preparation for decision making about firearm access. The secondary outcome at follow-up was self-reported action to reduce access. Results: Among 500 participants enrolled between June 2022 and February 2024, the mean age was 47 years, 69% identified as female, half were the adult child or stepchild of the person with ADRD, and 99% chose study participation in English. Participant characteristics were similar by study group. For the primary outcome, SiD significantly increased preparation for decision making versus the control (69.8 vs. 64.8 out of 100; mean difference, 4.80 [95% CI, 0.53 to 9.07]; P = 0.024). There was no significant effect on actions to reduce firearm access at 2 weeks or 2 months. Limitation: The results may not be generalizable to non–English-speaking populations. Conclusion: The online SiD decision aid increased preparation for decision making about firearm access in this sample of ADRD caregivers in the United States. Use of such resources in clinical or community settings may support caregivers and people with ADRD in avoiding firearm injury or death. Primary Funding Source: National Institute on Aging, National Institutes of Health.