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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.

Lessons From the Front Line of Fighting Gender Inequity

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.

Ending Medical Complicity With Skilled-Nursing Facility Discrimination Against People With Opioid Use Disorder

Comparative Safety Analysis of Oral Antipsychotics for In-Hospital Adverse Clinical Events in Older Adults After Major Surgery: A Nationwide Cohort Study: Annals of Internal Medicine: Vol 176, No 9

Background: Antipsychotics are commonly used to manage postoperative delirium. Recent studies reported that haloperidol use has declined, and atypical antipsychotic use has increased over time. Objective: To compare the risk for in-hospital adverse events associated with oral haloperidol, olanzapine, quetiapine, and risperidone in older patients after major surgery. Design: Retrospective cohort study. Setting: U.S. hospitals in the Premier Healthcare Database. Patients: 17 115 patients aged 65 years and older without psychiatric disorders who were prescribed an oral antipsychotic drug after major surgery from 2009 to 2018. Interventions: Haloperidol (≤4 mg on the day of initiation), olanzapine (≤10 mg), quetiapine (≤150 mg), and risperidone (≤4 mg). Measurements: The risk ratios (RRs) for in-hospital death, cardiac arrhythmia events, pneumonia, and stroke or transient ischemic attack (TIA) were estimated after propensity score overlap weighting. Results: The weighted population had a mean age of 79.6 years, was 60.5% female, and had in-hospital death of 3.1%. Among the 4 antipsychotics, quetiapine was the most prescribed (53.0% of total exposure). There was no statistically significant difference in the risk for in-hospital death among patients treated with haloperidol (3.7%, reference group), olanzapine (2.8%; RR, 0.74 [95% CI, 0.42 to 1.27]), quetiapine (2.6%; RR, 0.70 [CI, 0.47 to 1.04]), and risperidone (3.3%; RR, 0.90 [CI, 0.53 to 1.41]). The risk for nonfatal clinical events ranged from 2.0% to 2.6% for a cardiac arrhythmia event, 4.2% to 4.6% for pneumonia, and 0.6% to 1.2% for stroke or TIA, with no statistically significant differences by treatment group. Limitation: Residual confounding by delirium severity; lack of untreated group; restriction to oral low-to-moderate dose treatment. Conclusion: These results suggest that atypical antipsychotics and haloperidol have similar rates of in-hospital adverse clinical events in older patients with postoperative delirium who receive an oral low-to-moderate dose antipsychotic drug. Primary Funding Source: National Institute on Aging.

Moving From Idealism to Realism With Data Sharing

Facilitating Shared Decision Making Among Black Patients at Risk for Sudden Cardiac Arrest: A Randomized Clinical Trial: Annals of Internal Medicine: Vol 176, No 5

Background: Racial disparities in implantable cardioverter-defibrillator (ICD) implantation are multifactorial and are partly explained by higher refusal rates. Objective: To assess the effectiveness of a video decision support tool for Black patients eligible for an ICD. Design: Multicenter, randomized clinical trial conducted between September 2016 and April 2020. (ClinicalTrials.gov: NCT02819973) Setting: Fourteen academic and community-based electrophysiology clinics in the United States. Participants: Black adults with heart failure who were eligible for a primary prevention ICD. Intervention: An encounter-based video decision support tool or usual care. Measurements: The primary outcome was the decision regarding ICD implantation. Additional outcomes included patient knowledge, decisional conflict, ICD implantation within 90 days, the effect of racial concordance on outcomes, and the time patients spent with clinicians. Results: Of the 330 randomly assigned patients, 311 contributed data for the primary outcome. Among those randomly assigned to the video group, assent to ICD implantation was 58.6% compared with 59.4% in the usual care group (difference, −0.8 percentage point [95% CI, −13.2 to 11.1 percentage points]). Compared with usual care, participants in the video group had a higher mean knowledge score (difference, 0.7 [CI, 0.2 to 1.1]) and a similar decisional conflict score (difference, −2.6 [CI, −5.7 to 0.4]). The ICD implantation rate within 90 days was 65.7%, with no differences by intervention. Participants randomly assigned to the video group spent less time with their clinician than those in the usual care group (mean, 22.1 vs. 27.0 minutes; difference, −4.9 minutes [CI, −9.4 to −0.3 minutes]). Racial concordance between video and study participants did not affect study outcomes. Limitation: The Centers for Medicare & Medicaid Services implemented a requirement for shared decision making for ICD implantation during the study. Conclusion: A video-based decision support tool increased patient knowledge but did not increase assent to ICD implantation. Primary Funding Source: Patient-Centered Outcomes Research Institute.

Forgiving Physician Debt

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