当前位置: 首页 >> 检索结果
941. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
作者: Kushal T Kadakia.;Vinay K Rathi.;Sanket S Dhruva.;Joseph S Ross.;Harlan M Krumholz.
来源: Ann Intern Med. 2024年177卷11期1558-1565页
Nearly all medical devices reviewed by the U.S. Food and Drug Administration (FDA) are authorized via the 510(k) clearance process. Established in 1976, this review pathway bases authorizations on the comparability of new devices to previously authorized devices ("predicates"). This evaluation usually does not require clinical evidence of safety and effectiveness. Advocates of the 510(k) clearance process tout its support for device innovation and rapid market access, and critics of the 510(k) clearance process express that it may inadequately protect patient safety. In September 2023, the FDA issued 3 guidance documents that, if finalized, would significantly change medical device regulation. This article provides clinical and regulatory context for the proposed guidance documents, which focus on predicate selection, clinical testing requirements, and implantable devices, and identifies opportunities for further reforms that promote transparency and patient safety.
942. HIV Reservoir Landscape in Breast Milk From Long-Term Virally Suppressed Individuals.
作者: Ariel Osegueda.;Lucia Baquero.;Andrea Pereyra Casanova.;Leonel Cruces.;Katie Fisher.;Cintia Mendez.;Yanina Ghiglione.;Sarah Palmer.;Gabriela Turk.;Natalia Laufer.
来源: Ann Intern Med. 2024年177卷11期1595-1598页 943. School Mask Mandates and COVID-19: The Challenge of Using Difference-in-Differences Analysis of Observational Data to Estimate the Effectiveness of a Public Health Intervention.
作者: Ambarish Chandra.;Tracy Beth Høeg.;Shamez Ladhani.;Vinay Prasad.;Ram Duriseti.
来源: Ann Intern Med. 2024年177卷11期1566-1572页
There are considerable challenges when using difference-in-differences (DiD) analysis of ecological data to estimate the effectiveness of public health interventions in rapidly changing situations.
944. How Would You Manage This Patient With Obesity? Grand Rounds Discussion From Beth Israel Deaconess Medical Center.
作者: Risa B Burns.;Melanie R Jay.;Anne N Thorndike.;Zahir Kanjee.
来源: Ann Intern Med. 2024年177卷10期1415-1424页
In 2022, 1 in 8 people in the world were living with obesity, and lifestyle interventions that include diet, exercise, and behavioral modification have been the foundation for management of obesity. Recently, pharmacologic therapies have been developed for management of obesity, the newest of these being glucagon-like peptide 1 receptor agonists. With the development of new pharmacologic options, the American Gastroenterological Association developed a guideline in 2022 to provide evidence-based recommendations for the pharmacologic management of obesity in adults and recommended, for adults with obesity or overweight with weight-related complications who have had an inadequate response to lifestyle interventions, adding pharmacologic agents to lifestyle interventions over continuing lifestyle interventions alone. In this article, 2 experts review the available evidence to answer the following questions: How effective are lifestyle interventions for the treatment of obesity? How effective are pharmacologic interventions for the treatment of obesity? Given these options, how do you engage in a shared decision-making discussion to develop a mutually agreed-on treatment plan?
946. In advanced CKD, ACEis or ARBs reduce kidney failure vs. placebo or non-RAAS inhibitors at 34 mo.
Ku E, Inker LA, Tighiouart H, et al. Angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers for advanced chronic kidney disease: a systematic review and retrospective individual participant-level meta-analysis of clinical trials. Ann Intern Med. 2024;177:953-963. 38950402.
947. Shortfalls in Follow-up Albuminuria Quantification After an Abnormal Result on a Urine Protein Dipstick Test.
作者: Yunwen Xu.;Jung-Im Shin.;Amelia Wallace.;Juan J Carrero.;Lesley A Inker.;Amrita Mukhopadhyay.;Saul B Blecker.;Leora I Horwitz.;Morgan E Grams.;Alexander R Chang.
来源: Ann Intern Med. 2024年177卷11期1593-1595页 948. Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data.
作者: Gerard T Portela.;Jeffrey L Carson.;Sonja A Swanson.;John H Alexander.;Paul C Hébert.;Shaun G Goodman.;Philippe Gabriel Steg.;Marnie Bertolet.;Jordan B Strom.;Dean A Fergusson.;Tabassome Simon.;Harvey D White.;Howard A Cooper.;J Dawn Abbott.;Sunil V Rao.;Bernard R Chaitman.;Christopher B Fordyce.;Renato D Lopes.;Benoit Daneault.;Maria M Brooks.; .
来源: Ann Intern Med. 2024年177卷11期1489-1498页
The optimal hemoglobin threshold to guide red blood cell (RBC) transfusion for patients with acute myocardial infarction (MI) and anemia is uncertain.
949. In persistent uncontrolled asthma, adding azithromycin to standard therapy increased clinical remission rates at 1 y.
Thomas D, McDonald VM, Stevens S, et al. Effect of azithromycin on asthma remission in adults with persistent uncontrolled asthma: a secondary analysis of a randomized, double-anonymized, placebo-controlled trial. Chest. 2024;166:262-270. 38431051.
950. USPSTF recommends biennial mammography for breast cancer screening in women aged 40 to 74 y.
US Preventive Services Task Force; Nicholson WK, Silverstein M, Wong JB, et al. Screening for breast cancer: US Preventive Services Task Force recommendation statement. JAMA. 2024;331:1918-1930. 38687503.
951. In ischemic stroke treated within 4.5 h, reteplase vs. alteplase increased excellent functional outcome at 90 d.
Li S, Gu HQ, Li H, et al; RAISE Investigators. Reteplase versus alteplase for acute ischemic stroke. N Engl J Med. 2024;390:2264-2273. 38884332.
952. In adults with postacute sequelae of COVID-19, nirmatrelvir-ritonavir did not improve symptoms at 10 wk.
Geng LN, Bonilla H, Hedlin H, et al. Nirmatrelvir-ritonavir and symptoms in adults with postacute sequelae of SARS-CoV-2 infection: the STOP-PASC randomized clinical trial. JAMA Intern Med. 2024;184:1024-1034. 38848477.
953. In patients receiving invasive ventilation, PPIs reduce upper GI bleeding but did not affect mortality at 90 d.
Cook D, Deane A, Lauzier F, et al; REVISE Investigators. Stress ulcer prophylaxis during invasive mechanical ventilation. N Engl J Med. 2024;391:9-20. 38875111.
954. In adults with metabolic dysfunction, the MAF-5 score predicted risk for liver fibrosis (AUC range, 0.73 to 0.81).
van Kleef LA, Francque SM, Prieto-Ortiz JE, et al. Metabolic Dysfunction-Associated Fibrosis 5 (MAF-5) score predicts liver fibrosis risk and outcome in the general population with metabolic dysfunction. Gastroenterology. 2024;167:357-367.e9. 38513745.
956. In adults with moderate-to-severe OSA and obesity, tirzepatide reduced apnea-hypopnea events vs. placebo.
Malhotra A, Grunstein RR, Fietze I, et al; SURMOUNT-OSA Investigators. Tirzepatide for the treatment of obstructive sleep apnea and obesity. N Engl J Med. 21 Jun 2024. [Epub ahead of print.] 38912654.
957. RAS blocker effects on first HF hospitalization or CV death does not differ in Black and non-Black patients with HFrEF.
Shen L, Lee MMY, Jhund PS, et al. Revisiting race and the benefit of RAS blockade in heart failure: a meta-analysis of randomized clinical trials. JAMA. 2024;331:2094-2104. 38809561.
958. Effectiveness of Integrating Suicide Care in Primary Care : Secondary Analysis of a Stepped-Wedge, Cluster Randomized Implementation Trial.
作者: Julie Angerhofer Richards.;Maricela Cruz.;Christine Stewart.;Amy K Lee.;Taylor C Ryan.;Brian K Ahmedani.;Gregory E Simon.
来源: Ann Intern Med. 2024年177卷11期1471-1481页
Primary care encounters are common among patients at risk for suicide.
|