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Displaying 601 - 610 of 6736 in Annals of Internal Medicine
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Ethical Guidance for Physicians and Health Care Institutions on Grateful Patient Fundraising: A Position Paper From the American College of Physicians
Physician solicitation of charitable contributions from patients—also known among other things as grateful patient fundraising—raises significant ethical concerns. These include pressure on patients to donate and the effects of this on the patient–physician relationship, potential expectations of donor patients for treatment that is not indicated or preferential care, justice and fairness issues, disclosure and use of confidential patient information for nontreatment purposes, and conflicts of interest. The patient–physician relationship and knowledge of the patient’s medical history, clinical status, personal information, and financial circumstances are some of the reasons development and administrative officials might see physicians as strong potential fundraisers. But those are among the reasons grateful patient fundraising is ethically problematic. This American College of Physicians position paper explores these issues and offers guidance.
Outpatient Treatment of Confirmed COVID-19: Living, Rapid Practice Points From the American College of Physicians (Version 2)
An update is available for this article. Description: Evidence for the use of outpatient treatments in adults with confirmed COVID-19 continues to evolve with new data. This is version 2 of the American College of Physicians (ACP) living, rapid practice points focusing on 22 outpatient treatments for COVID-19, specifically addressing the dominant SARS-CoV-2 Omicron variant. Methods: The Population Health and Medical Science Committee (formerly the Scientific Medical Policy Committee) developed this version of the living, rapid practice points on the basis of a living, rapid review done by the ACP Center for Evidence Reviews at Cochrane Austria at the University for Continuing Education Krems (Danube University Krems). This topic will be maintained as living and rapid by continually monitoring and assessing the impact of new evidence. Practice Point 1: Consider molnupiravir to treat symptomatic patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at a high risk for progressing to severe disease. Practice Point 2: Consider nirmatrelvir–ritonavir combination therapy to treat symptomatic patients with confirmed mild to moderate COVID-19 in the outpatient setting who are within 5 days of the onset of symptoms and at a high risk for progressing to severe disease. Practice Point 3: Do not use ivermectin to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting. Practice Point 4: Do not use sotrovimab to treat patients with confirmed mild to moderate COVID-19 in the outpatient setting.
Outpatient Treatment of Confirmed COVID-19: A Living, Rapid Evidence Review for the American College of Physicians (Version 2)
An update is available for this article. Background: Clinicians and patients want to know the benefits and harms of outpatient treatment options for the Omicron variant of SARS-CoV-2. Purpose: To assess the benefits and harms of 22 different COVID-19 treatments. Data Sources: The Epistemonikos COVID-19 L·OVE platform, the iSearch COVID-19 portfolio, and the World Health Organization (WHO) COVID-19 Research Database from 26 November 2021 to 2 March 2023. Study Selection: Two reviewers independently screened abstracts and full texts against a priori–defined criteria. Data Extraction: One reviewer extracted the data and assessed the risk of bias and certainty of evidence (COE). A second reviewer verified the data abstraction and assessments. Data Synthesis: Two randomized controlled trials and 6 retrospective cohort studies were included. Nirmatrelvir–ritonavir was associated with a reduction in hospitalization due to COVID-19 (for example, 0.7% vs. 1.2%; moderate COE) and all-cause mortality (for example, <0.1% vs. 0.2%; moderate COE). Molnupiravir led to a higher recovery rate (31.8% vs. 22.6%; moderate COE) and reduced time to recovery (9 vs. 15 median days; moderate COE) but had no effect on all-cause mortality (0.02% vs. 0.04%; moderate COE) and the incidence of serious adverse events (0.4% vs. 0.3%; moderate COE). Ivermectin had no effect on time to recovery (moderate COE) and resulted in no difference in adverse events compared with placebo (low COE). Sotrovimab resulted in no difference in all-cause mortality compared with no treatment (low COE). No eligible studies for all other treatments of interest were identified. Limitation: Evidence for nirmatrelvir–ritonavir and sotrovimab is based on nonrandomized studies only. Conclusion: Nirmatrelvir–ritonavir and molnupiravir probably improve outcomes for outpatients with mild to moderate COVID-19. Primary Funding Source: American College of Physicians. (PROSPERO: CRD42023406456)
Changes in Induced Medical and Procedural Abortion Rates in a Commercially Insured Population, 2018 to 2022: An Interrupted Time-Series Analysis: Annals of Internal Medicine: Vol 176, No 11
Background: During the COVID-19 pandemic, access to in-person care was limited, and regulations requiring in-person dispensing of mifepristone for medical abortions were relaxed. The effect of the pandemic and accompanying regulatory changes on abortion use is unknown. Objective: To estimate changes in the incidence rate of induced medical and procedural abortions. Design: Serial cross-sectional study with interrupted time-series analyses. Setting: Commercially insured persons in the United States. Participants: Reproductive-aged women. Intervention: Onset of the COVID-19 pandemic in March 2020 and subsequent regulatory changes affecting the in-person dispensing requirement for mifepristone. Measurements: Monthly age-adjusted incidence rates of medical and procedural abortions were measured among women aged 15 to 44 years from January 2018 to June 2022. Medical abortions were classified as in-person or telehealth. Linear segmented time-series regression was used to calculate changes in abortion rates after March 2020. Results: In January 2018, the estimated age-adjusted monthly incidence rate of abortions was 151 per million women (95% CI, 142 to 161 per million women), with equal rates of medical and procedural abortions. After March 2020, there was an immediate 14% decrease in the monthly incidence rate of abortions (21 per million women [CI, 7 to 35 per million women]; P = 0.004), driven by a 31% decline in procedural abortions (22 per million women [CI, 16 to 28 per million women]; P < 0.001). Fewer than 4% of medical abortions each month were administered via telehealth. Limitation: Only abortions reimbursed by commercial insurance were measured. Conclusion: The incidence rate of procedural abortions declined during the COVID-19 pandemic, and this lower rate persisted after other elective procedures rebounded to prepandemic rates. Despite removal of the in-person dispensing requirement for mifepristone, the use of telehealth for insurance-covered medical abortions remained rare. Amid increasing state restrictions, commercial insurers have the opportunity to increase access to abortion care, particularly via telehealth. Primary Funding Source: Health Resources and Services Administration.
Clinical Effectiveness of Cognitively Enhanced Tai Ji Quan Training on Global Cognition and Dual-Task Performance During Walking in Older Adults With Mild Cognitive Impairment or Self-Reported Memory Concerns: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 176, No 11
Background: Mild cognitive impairment (MCI) negatively impacts cognition and dual-task abilities. A physical–cognitive integrated treatment approach could mitigate this risk for dementia. Objective: To compare the effectiveness of cognitively enhanced tai ji quan versus standard tai ji quan or stretching exercise in improving global cognition and reducing dual-task walking costs in older adults with MCI or self-reported memory concerns. Design: 3-group, randomized (1:1:1), superiority trial. (ClinicalTrials.gov: NCT04070703) Setting: Community residential homes. Participants: 318 older adults with self-reported memory decline or concern and a Clinical Dementia Rating (CDR) global score of 0.5 or lower at baseline. Intervention: Cognitively enhanced tai ji quan (n = 105), standard tai ji quan (n = 107), or stretching (n = 106). All groups exercised at home via real-time videoconferencing, 1 hour semiweekly for 24 weeks. Measurements: The co–primary endpoints were change in Montreal Cognitive Assessment (MoCA; range, 0 to 30) and dual-task walking costs (difference between single- and dual-task gait speed, expressed in percentage) from baseline to 24 weeks. Secondary outcomes included CDR–Sum of Boxes (CDR-SB), Trail Making Test B, Digit Span Backward (DSB), and physical performance tests. Outcomes were assessed at 16, 24 (primary endpoint), and 48 weeks (6 months after intervention). Results: A total of 304 participants (96%) completed the 24-week assessment. Cognitively enhanced tai ji quan outperformed standard tai ji quan and stretching with a greater improvement in MoCA score (mean difference, 1.5 points [98.75% CI, 0.7 to 2.2 points] and 2.8 points [CI, 2.1 to 3.6 points], respectively) and in dual-task walking (mean difference, 9.9% [CI, 2.8% to 16.6%] and 22% [CI, 13% to 31%], respectively). The intervention effects persisted at 48-week follow-up. Limitation: There was no nonexercise control group; participants had subjective or mild cognitive impairment. Conclusion: Among community-dwelling older adults with MCI, cognitively enriched tai ji quan therapy was superior to standard tai ji quan and stretching exercise in improving global cognition and reducing dual-task gait interference, with outcomes sustained at 48 weeks. Primary Funding Source: National Institute on Aging.
Adoption of Internal Medicine Milestone Ratings and Changes in Bias Against Black, Latino, and Asian Internal Medicine Residents
Background: The 2014 adoption of the Milestone ratings system may have affected evaluation bias against minoritized groups. Objective: To assess bias in internal medicine (IM) residency knowledge ratings against Black or Latino residents—who are underrepresented in medicine (URiM)—and Asian residents before versus after Milestone adoption in 2014. Design: Cross-sectional and interrupted time-series comparisons. Setting: U.S. IM residencies. Participants: 59 835 IM residents completing residencies during 2008 to 2013 and 2015 to 2020. Intervention: Adoption of the Milestone ratings system. Measurements: Pre-Milestone (2008 to 2013) and post-Milestone (2015 to 2020) bias was estimated as differences in standardized knowledge ratings between U.S.-born and non–U.S.-born minoritized groups versus non-Latino U.S.-born White (NLW) residents, with adjustment for performance on the American Board of Internal Medicine IM certification examination and other physician characteristics. Interrupted time-series analysis measured deviations from pre-Milestone linear bias trends. Results: During the pre-Milestone period, ratings biases against minoritized groups were large (−0.40 SDs [95% CI, −0.48 to −0.31 SDs; P < 0.001] for URiM residents, −0.24 SDs [CI, −0.30 to −0.18 SDs; P < 0.001] for U.S.-born Asian residents, and −0.36 SDs [CI, −0.45 to −0.27 SDs; P < 0.001] for non–U.S.-born Asian residents). These estimates decreased to less than −0.15 SDs after adoption of Milestone ratings for all groups except U.S.-born Black residents, among whom substantial (though lower) bias persisted (−0.26 SDs [CI, −0.36 to −0.17 SDs; P < 0.001]). Substantial deviations from pre-Milestone linear bias trends coincident with adoption of Milestone ratings were also observed. Limitations: Unobserved variables correlated with ratings bias and Milestone ratings adoption, changes in identification of race/ethnicity, and generalizability to Milestones 2.0. Conclusion: Knowledge ratings bias against URiM and Asian residents was ameliorated with the adoption of the Milestone ratings system. However, substantial ratings bias against U.S.-born Black residents persisted. Primary Funding Source: None.
Gene Therapy Versus Common Care for Eligible Individuals With Sickle Cell Disease in the United States: A Cost-Effectiveness Analysis: Annals of Internal Medicine: Vol 177, No 2
Background: Sickle cell disease (SCD) and its complications contribute to high rates of morbidity and early mortality and high cost in the United States and African heritage community. Objective: To evaluate the cost-effectiveness of gene therapy for SCD and its value-based prices (VBPs). Design: Comparative modeling analysis across 2 independently developed simulation models (University of Washington Model for Economic Analysis of Sickle Cell Cure [UW-MEASURE] and Fred Hutchinson Institute Sickle Cell Disease Outcomes Research and Economics Model [FH-HISCORE]) using the same databases. Data Sources: Centers for Medicare & Medicaid Services claims data, 2008 to 2016; published literature. Target Population: Persons eligible for gene therapy. Time Horizon: Lifetime. Perspective: U.S. health care sector and societal. Intervention: Gene therapy versus common care. Outcome Measures: Incremental cost-effectiveness ratios (ICERs), equity-informed VBPs, and price acceptability curves. Results of Base-Case Analysis: At an assumed $2 million price for gene therapy, UW-MEASURE and FH-HISCORE estimated ICERs of $193 000 per QALY and $427 000 per QALY, respectively, under the health care sector perspective. Corresponding estimates from the societal perspective were $126 000 per QALY and $281 000 per QALY. The difference in results between models stemmed primarily from considering a slightly different target population and incorporating the quality-of-life (QOL) effects of splenic sequestration, priapism, and acute chest syndrome in the UW model. From a societal perspective, acceptable (>90% confidence) VBPs ranged from $1 million to $2.5 million depending on the use of alternative effective metrics or equity-informed threshold values. Results of Sensitivity Analysis: Results were sensitive to the costs of myeloablative conditioning before gene therapy, effect on caregiver QOL, and effect of gene therapy on long-term survival. Limitation: The short-term effects of gene therapy on vaso-occlusive events were extrapolated from 1 study. Conclusion: Gene therapy for SCD below a $2 million price tag is likely to be cost-effective when applying a societal perspective at an equity-informed threshold for cost-effectiveness analysis. Primary Funding Source: National Heart, Lung, and Blood Institute.