1862. Drug Repurposing and Observational Studies: The Case of Antivirals for the Treatment of COVID-19.
Remdesivir and molnupiravir were the only 2 repurposed antivirals that were approved for emergency use during the COVID-19 pandemic. Both drugs received their emergency use authorization on the basis of a single industry-funded phase 3 trial, which was launched after evidence of in vitro activity against SARS-CoV-2. In contrast, for tenofovir disoproxil fumarate (TDF), little in vitro evidence was generated, no randomized trials for early treatment were done, and the drug was not considered for authorization. Yet, by the summer of 2020, observational evidence suggested a substantially lower risk for severe COVID-19 in TDF users compared with nonusers. The decision-making process for the launching of randomized trials for these 3 drugs is reviewed. Observational data in favor of TDF was systematically dismissed, even though no viable alternative explanations were proposed for the lower risk for severe COVID-19 among TDF users. Lessons learned from the TDF example during the first 2 years of the COVID-19 pandemic are described, and the use of observational clinical data to guide decisions about the launch of randomized trials during the next public health emergency is proposed. The goal is that gatekeepers of randomized trials make better use of the available observational evidence for the repurposing of drugs without commercial value.
1863. Effect of Medicare Advantage on Hospital Readmission and Mortality Rankings.
作者: Andrew S Oseran.;Rishi K Wadhera.;E John Orav.;Jose F Figueroa.
来源: Ann Intern Med. 2023年176卷4期480-488页
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.
1864. Cases in Precision Medicine: Is There an Obligation to Return Reinterpreted Genetic Results to Former Patients?
作者: Paul S Appelbaum.;Wylie Burke.;Erik Parens.;Jessica Roberts.;Sara M Berger.;Wendy K Chung.
来源: Ann Intern Med. 2023年176卷4期563-567页
Interpretation of many genetic test results can change over time as new data accumulate. Hence, physicians who order genetic tests may subsequently receive revised reports with important implications for patients' medical treatment-even for patients who are no longer in their care. Several of the ethical principles underlying medical practice suggest an obligation to reach out to former patients with this information. Discharging that obligation can be accomplished, at a minimum, by attempting to contact the former patient with their last known contact information.
1866. Subclinical Coronary Atherosclerosis and Risk for Myocardial Infarction in a Danish Cohort : A Prospective Observational Cohort Study.
作者: Andreas Fuchs.;Jørgen Tobias Kühl.;Per Ejlstrup Sigvardsen.;Shoaib Afzal.;Andreas Dehlbæk Knudsen.;Mathias Bech Møller.;Martina Chantal de Knegt.;Mathias Holm Sørgaard.;Børge Grønne Nordestgaard.;Lars Valeur Køber.;Klaus Fuglsang Kofoed.
来源: Ann Intern Med. 2023年176卷4期433-442页
Coronary atherosclerosis may develop at an early age and remain latent for many years.
1869. Web Exclusive. Annals for Hospitalists Inpatient Notes - Clinical Pearls-Outpatient Parenteral Antimicrobial Therapy for Infective Endocarditis in Persons Who Inject Drugs.1878. Effect of Thromboprophylaxis on Clinical Outcomes After COVID-19 Hospitalization.
作者: Tracy Y Wang.;Abdus S Wahed.;Alison Morris.;Lisa Baumann Kreuziger.;John G Quigley.;Gervasio A Lamas.;Alexandra J Weissman.;Jose Lopez-Sendon.;M Margaret Knudson.;Deborah M Siegal.;Raj S Kasthuri.;Andrew J Alexander.;Lana Wahid.;Bassel Atassi.;Peter J Miller.;Janice W Lawson.;Bela Patel.;Jerry A Krishnan.;Nancy L Shapiro.;Deborah E Martin.;Andrei L Kindzelski.;Eric S Leifer.;Jungnam Joo.;Lingyun Lyu.;Annie Pennella.;Brendan M Everett.;Mark W Geraci.;Kevin J Anstrom.;Thomas L Ortel.; .
来源: Ann Intern Med. 2023年176卷4期515-523页
Patients hospitalized with COVID-19 have an increased incidence of thromboembolism. The role of extended thromboprophylaxis after hospital discharge is unclear.
1879. Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine-Topiramate to Prevent Exposure During Pregnancy.
作者: Amir Sarayani.;William Troy Donahoo.;Christian Hampp.;Joshua D Brown.;Almut G Winterstein.
来源: Ann Intern Med. 2023年176卷4期443-454页
The U.S. Food and Drug Administration approved phentermine-topiramate for obesity in 2012 and required a Risk Evaluation and Mitigation Strategy (REMS) to prevent prenatal exposure. No such requirement was introduced for topiramate.
1880. Worsening Spread of Candida auris in the United States, 2019 to 2021.
作者: Meghan Lyman.;Kaitlin Forsberg.;D Joseph Sexton.;Nancy A Chow.;Shawn R Lockhart.;Brendan R Jackson.;Tom Chiller.
来源: Ann Intern Med. 2023年176卷4期489-495页
Candida auris is an emerging fungal threat that has been spreading in the United States since it was first reported in 2016.
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