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Displaying 641 - 650 of 1907 in Annals of Internal Medicine
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Predicting Inflammatory Arthritis in At-Risk Persons: Development of Scores for Risk Stratification
Background: Inflammatory arthritis (IA) is an immune-related condition defined by the presence of clinical synovitis. Its most common form is rheumatoid arthritis. Objective: To develop scores for predicting IA in at-risk persons using multidimensional biomarkers. Design: Prospective observational cohort study. Setting: Single-center, Leeds, United Kingdom. Participants: Persons with new musculoskeletal symptoms, a positive test result for anticitrullinated protein antibodies, and no clinical synovitis and followed for 48 weeks or more or until IA occurred. Measurements: A simple score was developed using logistic regression, and a comprehensive score was developed using the least absolute shrinkage and selection operator Cox proportional hazards regression. Internal validation with bootstrapping was estimated, and a decision curve analysis was done. Results: Of 455 participants, 32.5% (148 of 455) developed IA, and 15.4% (70 of 455) developed it within 1 year. The simple score identified 249 low-risk participants with a false negative rate of 5% (and 206 high-risk participants with a false-positive rate of 72%). The comprehensive score identified 119 high-risk participants with a false-positive rate of 29% (and 336 low-risk participants with a false-negative rate of 19%); 40% of high-risk participants developed IA within 1 year and 71% within 5 years. Limitations: External validation is required. Recruitment occurred over 13 years, with lower rates of IA in later years. There was geographic variation in laboratory testing and recruitment availability. Conclusion: The simple score identified persons at low risk for IA who were less likely to need secondary care. The comprehensive score identified high-risk persons who could benefit from risk stratification and preventive measures. Both scores may be useful in clinical care and should also be useful in clinical trials. Primary Funding Source: National Institute for Health and Care Research Leeds Biomedical Research Centre.
Estimating Breast Cancer Overdiagnosis After Screening Mammography Among Older Women in the United States
Background: Overdiagnosis is increasingly recognized as a harm of breast cancer screening, particularly for older women. Objective: To estimate overdiagnosis associated with breast cancer screening among older women by age. Design: Retrospective cohort study comparing the cumulative incidence of breast cancer among older women who continued screening in the next interval with those who did not. Analyses used competing risk models, stratified by age. Setting: Fee-for-service Medicare claims, linked to the SEER (Surveillance, Epidemiology, and End Results) program. Patients: Women 70 years and older who had been recently screened. Measurements: Breast cancer diagnoses and breast cancer death for up to 15 years of follow-up. Results: This study included 54 635 women. Among women aged 70 to 74 years, the adjusted cumulative incidence of breast cancer was 6.1 cases (95% CI, 5.7 to 6.4) per 100 screened women versus 4.2 cases (CI, 3.5 to 5.0) per 100 unscreened women. An estimated 31% of breast cancer among screened women were potentially overdiagnosed. For women aged 75 to 84 years, cumulative incidence was 4.9 (CI, 4.6 to 5.2) per 100 screened women versus 2.6 (CI, 2.2 to 3.0) per 100 unscreened women, with 47% of cases potentially overdiagnosed. For women aged 85 and older, the cumulative incidence was 2.8 (CI, 2.3 to 3.4) among screened women versus 1.3 (CI, 0.9 to 1.9) among those not, with up to 54% overdiagnosis. We did not see statistically significant reductions in breast cancer–specific death associated with screening. Limitations: This study was designed to estimate overdiagnosis, limiting our ability to draw conclusions on all benefits and harms of screening. Unmeasured differences in risk for breast cancer and differential competing mortality between screened and unscreened women may confound results. Results were sensitive to model specifications and definition of a screening mammogram. Conclusion: Continued breast cancer screening was associated with greater incidence of breast cancer, suggesting overdiagnosis may be common among older women who are diagnosed with breast cancer after screening. Whether harms of overdiagnosis are balanced by benefits and for whom remains an important question. Primary Funding Source: National Cancer Institute.
Incidence of and Factors Associated With Recurrent Firearm Injury Among Patients Presenting to St. Louis Trauma Centers, 2010 to 2019: A Cohort Study: Annals of Internal Medicine: Vol 176, No 9
Background: Firearm injuries are a public health crisis in the United States. Objective: To examine the incidence and factors associated with recurrent firearm injuries and death among patients presenting with an acute (index), nonfatal firearm injury. Design: Multicenter, observational, cohort study. Setting: Four adult and pediatric level I trauma hospitals in St. Louis, Missouri, 2010 to 2019. Participants: Consecutive adult and pediatric patients (n = 9553) presenting to a participating hospital with a nonfatal acute firearm injury. Measurements: Data on firearm-injured patient demographics, hospital and diagnostic information, health insurance status, and death were collected from the St. Louis Region-Wide Hospital-Based Violence Intervention Program Data Repository. The Centers for Disease Control and Prevention (CDC) Social Vulnerability Index was used to characterize the social vulnerability of the census tracts of patients’ residences. Analysis included descriptive statistics and time-to-event analyses estimating the probability of experiencing a recurrent firearm injury. Results: We identified 10 293 acutely firearm-injured patients of whom 9553 survived the injury and comprised the analytic sample. Over a median follow-up of 3.5 years (IQR, 1.5 to 6.4 years), 1155 patients experienced a recurrent firearm injury including 5 firearm suicides and 149 fatal firearm injuries. Persons experiencing recurrent firearm injury were young (25.3 ± 9.5 years), predominantly male (93%), Black (96%), and uninsured (50%), and resided in high social vulnerability regions (65%). The estimated risk for firearm reinjury was 7% at 1 year and 17% at 8 years. Limitations: Limited data on comorbidities and patient-level social determinants of health. Inability to account for recurrent injuries presenting to nonstudy hospitals. Conclusion: Recurrent injury and death are frequent among survivors of firearm injury, particularly among patients from socially vulnerable areas. Our findings highlight the need for interventions to prevent recurrence. Primary Funding Source: Emergency Medicine Foundation–AFFIRM and Missouri Foundation for Health.
Effects of Implementation of a Supervised Walking Program in Veterans Affairs Hospitals: A Stepped-Wedge, Cluster Randomized Trial: Annals of Internal Medicine: Vol 176, No 6
Background: In trials, hospital walking programs have been shown to improve functional ability after discharge, but little evidence exists about their effectiveness under routine practice conditions. Objective: To evaluate the effect of implementation of a supervised walking program known as STRIDE (AssiSTed EaRly MobIlity for HospitalizeD VEterans) on discharge to a skilled-nursing facility (SNF), length of stay (LOS), and inpatient falls. Design: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT03300336) Setting: 8 Veterans Affairs hospitals from 20 August 2017 to 19 August 2019. Patients: Analyses included hospitalizations involving patients aged 60 years or older who were community dwelling and admitted for 2 or more days to a participating medicine ward. Intervention: Hospitals were randomly assigned in 2 stratified blocks to a launch date for STRIDE. All hospitals received implementation support according to the Replicating Effective Programs framework. Measurements: The prespecified primary outcomes were discharge to a SNF and hospital LOS, and having 1 or more inpatient falls was exploratory. Generalized linear mixed models were fit to account for clustering of patients within hospitals and included patient-level covariates. Results: Patients in pre-STRIDE time periods (n = 6722) were similar to post-STRIDE time periods (n = 6141). The proportion of patients with any documented walk during a potentially eligible hospitalization ranged from 0.6% to 22.7% per hospital. The estimated rates of discharge to a SNF were 13% pre-STRIDE and 8% post-STRIDE. In adjusted models, odds of discharge to a SNF were lower among eligible patients hospitalized in post-STRIDE time periods (odds ratio [OR], 0.6 [95% CI, 0.5 to 0.8]) compared with pre-STRIDE. Findings were robust to sensitivity analyses. There were no differences in LOS (rate ratio, 1.0 [CI, 0.9 to 1.1]) or having an inpatient fall (OR, 0.8 [CI, 0.5 to 1.1]). Limitation: Direct program reach was low. Conclusion: Although the reach was limited and variable, hospitalizations occurring during the STRIDE hospital walking program implementation period had lower odds of discharge to a SNF, with no change in hospital LOS or inpatient falls. Primary Funding Source: U.S. Department of Veterans Affairs Quality Enhancement Research Initiative (Optimizing Function and Independence QUERI).
Comparative Efficacy and Safety of Wakefulness-Promoting Agents for Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnea: A Systematic Review and Network Meta-analysis: Annals of Internal Medicine: Vol 176, No 5
Background: Excessive daytime sleepiness (EDS) is common among patients with obstructive sleep apnea (OSA). The comparative effectiveness of pharmacologic agents is unknown. Purpose: To compare the effectiveness of drugs for EDS in OSA using network meta-analysis. Data Sources: MEDLINE, CENTRAL, EMBASE, and ClinicalTrials.gov to 7 November 2022. Study Selection: Reviewers identified randomized trials that enrolled patients with EDS-associated OSA on or eligible for conventional therapy assigned to any pharmacologic intervention. Data Extraction: Paired reviewers independently extracted data addressing effects of drugs on the Epworth Sleepiness Scale (ESS), Maintenance of Wakefulness Test (MWT), and adverse events at the longest reported follow-up. The certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Data Synthesis: Fourteen trials (3085 patients) were eligible. At 4 weeks, compared with placebo, solriamfetol improves ESS scores (mean difference [MD], −3.85 [95% CI, −5.24 to −2.50]; high certainty), and armodafinil–modafinil (MD, −2.25 [CI, −2.85 to −1.64]; moderate certainty) and pitolisant–H3-autoreceptor blockers (MD, −2.78 [CI, −4.03 to −1.51]; moderate certainty) probably improve ESS scores. At 4 weeks, compared with placebo, solriamfetol (standardized mean difference [SMD], 0.9 [CI, 0.64 to 1.17]) and armodafinil–modafinil (SMD, 0.41 [CI, 0.27 to 0.55]) improve MWT (both high certainty), whereas pitolisant–H3-autoreceptor blockers probably do not (moderate certainty). At 4 weeks, armodafinil–modafinil probably increases the risk for discontinuation due to adverse events (relative risk [RR], 2.01 [CI, 1.14 to 3.51]; moderate certainty); solriamfetol may increase the risk for discontinuation due to adverse events (RR, 2.07 [CI, 0.67 to 6.25]; low certainty). Low certainty evidence suggests these interventions may not increase the risk for serious adverse events. Limitations: There is limited evidence on long term or effectiveness among patients nonadherent or with mixed adherence to conventional OSA therapies. Conclusion: Solriamfetol, armodafinil–modafinil, and pitolisant reduce daytime sleepiness for patients with OSA already on conventional therapy, with solriamfetol likely superior. Adverse events probably increase the risk for discontinuation of armodafinil–modafinil and may increase the risk for discontinuation with solriamfetol. Primary Funding Source: None.
Reproductive Health Policy in the United States: An American College of Physicians Policy Brief
The legal landscape around access to reproductive health care services was substantially altered after the Supreme Court decision in Dobbs v Jackson Women's Health Organization. In the aftermath of the decision, some state governments have begun to impose stringent restrictions and complete bans on the provision of abortion, whereas others have sought to protect and expand access. Some have gone as far as imposing criminal and civil penalties on physicians and other clinicians who provide evidence-based, clinically indicated reproductive health care services and information that is guided by biomedical ethics and provided in the best interest of the patient's health and well-being. In several states, lawmakers have attempted and successfully used new approaches to enforcing and achieving these prohibitions, including prohibitions on crossing state lines to obtain abortion care, prohibitions on the mailing of medication abortion, and the authorization of third-party civil lawsuits. In this policy brief, the American College of Physicians (ACP) updates and expands on its previous public policy positions on abortion from its 2018 policy paper, “Women's Health Policy in the United States,” to reflect this new reality. The College also offers policymakers and payers recommendations to promote equitable access to reproductive health care services and safeguard maternal health. ACP reaffirms its opposition to undue and unnecessary governmental interference in the patient–physician relationship that criminalizes the provision of health care made in the physician's clinical judgment and based on clinical evidence and the standard of care.
Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19: A Randomized Platform Trial: Annals of Internal Medicine: Vol 176, No 5
Background: Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19. Objective: To determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population. Design: Randomized, placebo-controlled, adaptive platform trial. (ClinicalTrials.gov: NCT04727424) Setting: 12 clinical sites in Brazil. Participants: Symptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease. Intervention: Patients were randomly assigned to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos. Measurements: The primary outcome was a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalization, and/or suspected complications due to clinical progression of COVID-19 within 28 days of randomization. Secondary outcomes included health care attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours), time to hospitalization, mortality, patient-reported outcomes, and adverse drug reactions. Results: Randomization occurred from 15 January to 6 July 2022. A total of 738 participants were allocated to oral fluvoxamine plus inhaled budesonide, and 738 received placebo. The proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to COVID-19 was lower in the treatment group than the placebo group (1.8% [95% credible interval {CrI}, 1.1% to 3.0%] vs. 3.7% [95% CrI, 2.5% to 5.3%]; relative risk, 0.50 [95% CrI, 0.25 to 0.92]), with a probability of superiority of 98.7%. No relative effects were found between groups for any of the secondary outcomes. More adverse events occurred in the intervention group than the placebo group, but no important differences between the groups were detected. Limitation: Low event rate overall, consistent with contemporary trials in vaccinated populations. Conclusion: Treatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care. Primary Funding Source: Latona Foundation, FastGrants, and Rainwater Charitable Foundation.
Risk for Bleeding-Related Hospitalizations During Use of Amiodarone With Apixaban or Rivaroxaban in Patients With Atrial Fibrillation: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 176, No 6
Background: Amiodarone, the most effective antiarrhythmic drug in atrial fibrillation, inhibits apixaban and rivaroxaban elimination, thus possibly increasing anticoagulant-related risk for bleeding. Objective: For patients receiving apixaban or rivaroxaban, to compare risk for bleeding-related hospitalizations during treatment with amiodarone versus flecainide or sotalol, antiarrhythmic drugs that do not inhibit these anticoagulants’ elimination. Design: Retrospective cohort study. Setting: U.S. Medicare beneficiaries aged 65 years or older. Patients: Patients with atrial fibrillation began anticoagulant use between 1 January 2012 and 30 November 2018 and subsequently initiated treatment with study antiarrhythmic drugs. Measurements: Time to event for bleeding-related hospitalizations (primary outcome) and ischemic stroke, systemic embolism, and death with or without recent (past 30 days) evidence of bleeding (secondary outcomes), adjusted with propensity score overlap weighting. Results: There were 91 590 patients (mean age, 76.3 years; 52.5% female) initiating use of study anticoagulants and antiarrhythmic drugs, 54 977 with amiodarone and 36 613 with flecainide or sotalol. Risk for bleeding-related hospitalizations increased with amiodarone use (rate difference [RD], 17.5 events [95% CI, 12.0 to 23.0 events] per 1000 person-years; hazard ratio [HR], 1.44 [CI, 1.27 to 1.63]). Incidence of ischemic stroke or systemic embolism did not increase (RD, −2.1 events [CI, −4.7 to 0.4 events] per 1000 person-years; HR, 0.80 [CI, 0.62 to 1.03]). The risk for death with recent evidence of bleeding (RD, 9.1 events [CI, 5.8 to 12.3 events] per 1000 person-years; HR, 1.66 [CI, 1.35 to 2.03]) was greater than that for other deaths (RD, 5.6 events [CI, 0.5 to 10.6 events] per 1000 person-years; HR, 1.15 [CI, 1.00 to 1.31]) (HR comparison: P = 0.003). The increased incidence of bleeding-related hospitalizations for rivaroxaban (RD, 28.0 events [CI, 18.4 to 37.6 events] per 1000 person-years) was greater than that for apixaban (RD, 9.1 events [CI, 2.8 to 15.3 events] per 1000 person-years) (P = 0.001). Limitation: Possible residual confounding. Conclusion: In this retrospective cohort study, patients aged 65 years or older with atrial fibrillation treated with amiodarone during apixaban or rivaroxaban use had greater risk for bleeding-related hospitalizations than those treated with flecainide or sotalol. Primary Funding Source: National Heart, Lung, and Blood Institute.
Effect of Medicare Advantage on Hospital Readmission and Mortality Rankings
Background: Medicare links hospital performance on readmissions and mortality to payment solely on the basis of outcomes among fee-for-service (FFS) beneficiaries. Whether including Medicare Advantage (MA) beneficiaries, who account for nearly half of all Medicare beneficiaries, in the evaluation of hospital performance affects rankings is unknown. Objective: To determine if the inclusion of MA beneficiaries in readmission and mortality measures reclassifies hospital performance rankings compared with current measures. Design: Cross-sectional. Setting: Population-based. Participants: Hospitals participating in the Hospital Readmissions Reduction Program or Hospital Value-Based Purchasing Program. Measurements: Using the 100% Medicare files for FFS and MA claims, the authors calculated 30-day risk-adjusted readmissions and mortality for acute myocardial infarction, heart failure, chronic obstructive pulmonary disease, and pneumonia on the basis of only FFS beneficiaries and then both FFS and MA beneficiaries. Hospitals were divided into quintiles of performance based on FFS beneficiaries only, and the proportion of hospitals that were reclassified to a different performance group with the inclusion of MA beneficiaries was calculated. Results: Of the hospitals in the top-performing quintile for readmissions and mortality based on FFS beneficiaries, between 21.6% and 30.2% were reclassified to a lower-performing quintile with the inclusion of MA beneficiaries. Similar proportions of hospitals were reclassified from the bottom performance quintile to a higher one across all measures and conditions. Hospitals with a higher proportion of MA beneficiaries were more likely to improve in performance rankings. Limitation: Hospital performance measurement and risk adjustment differed slightly from those used by Medicare. Conclusion: Approximately 1 in 4 top-performing hospitals is reclassified to a lower performance group when MA beneficiaries are included in the evaluation of hospital readmissions and mortality. These findings suggest that Medicare's current value-based programs provide an incomplete picture of hospital performance. Primary Funding Source: Laura and John Arnold Foundation.
Tecovirimat Treatment of People With HIV During the 2022 Mpox Outbreak: A Retrospective Cohort Study: Annals of Internal Medicine: Vol 176, No 5
Background: The recent mpox outbreak has disproportionately affected people with HIV (PWH) and resulted in the first widespread use of the novel antiviral tecovirimat. Whether treatment outcomes differ between PWH and those without HIV is unknown. Objective: To compare the clinical presentation and treatment outcomes of PWH and HIV-negative persons with mpox virus (MPXV) infection treated with tecovirimat. Design: Retrospective cohort study of patients treated with tecovirimat for confirmed MPXV infection from June to August 2022. Setting: Two academic medical centers in New York City. Participants: The study included 196 persons treated with tecovirimat from 20 June to 29 August 2022. Of 154 testing positive for MPXV, 72 were PWH and 4 had a CD4 count lower than 0.20 × 109 cells/L. Measurements: Patient demographic characteristics, clinical presentation, treatment outcomes, and safety data for tecovirimat. Results: Indications for tecovirimat treatment were similar between the PWH and HIV-negative groups. Four participants had serious adverse events; none were attributed to tecovirimat. Three of these 4 participants had HIV infection, and 2 had CD4 counts less than 0.20 × 109 cells/L. Twenty-two percent of participants had nonsevere adverse effects. Groups had similar rates of hospitalization, indications for treatment, and co-occurring infections, but PWH had fewer days from symptom onset to treatment (7.5 vs. 10). There was no difference in treatment outcomes, including days to improvement or rate of persistent symptoms. Limitation: Patients with mpox who were not treated with tecovirimat were not followed routinely and therefore lacked comparable outcome data, limiting evaluation of efficacy. Conclusion: In our cohort of patients treated with tecovirimat for severe mpox, HIV status did not seem to affect treatment outcomes. Primary Funding Source: National Institutes of Health.