228. Vaporized Nicotine Products for Smoking Cessation Among People Experiencing Social Disadvantage : A Randomized Clinical Trial.
作者: Ryan J Courtney.;Bridget C Howard.;Daniel Barker.;Dennis Petrie.;Ron Borland.;Anthony Shakeshaft.;Coral Gartner.;Colin Mendelsohn.;Veronica C Boland.;Alexandra Henderson.;Robyn L Richmond.;Piotr Tutka.;Felix Naughton.;Wayne Hall.;Nicholas Zwar.;Michael Farrell.;Richard P Mattick.;Hayden McRobbie.
来源: Ann Intern Med. 2025年178卷8期1085-1094页
Vaporized nicotine products (VNPs) are more effective than nicotine replacement therapy (NRT) for smoking cessation in general populations, but their effectiveness among low socioeconomic groups is largely unknown.
229. Glucagon-Like Peptide-1 Receptor Agonists and Risk for Gastroesophageal Reflux Disease in Patients With Type 2 Diabetes : A Population-Based Cohort Study.
作者: Yunha Noh.;Hui Yin.;Oriana H Y Yu.;Alain Bitton.;Laurent Azoulay.
来源: Ann Intern Med. 2025年178卷9期1268-1278页
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), medications used to treat type 2 diabetes and obesity, are associated with delayed gastric emptying, which is a risk factor for gastroesophageal reflux disease (GERD). However, evidence linking these drugs to GERD is limited.
230. Aluminum-Adsorbed Vaccines and Chronic Diseases in Childhood : A Nationwide Cohort Study.
作者: Niklas Worm Andersson.;Ingrid Bech Svalgaard.;Stine Skovbo Hoffmann.;Anders Hviid.
来源: Ann Intern Med. 2025年178卷10期1369-1377页
Aluminum is used as an adjuvant in nonlive vaccines administered in early childhood. Concerns persist about potential associations between vaccination with aluminum-adsorbed vaccines and increased risk for chronic autoimmunity, atopy or allergy, and neurodevelopmental disorders. Large-scale safety data remain limited.
231. Single-Arm Trials Can Provide Randomized Real-World Evidence: The Random Invitation Single-Arm Trial Design.
作者: Perrine Janiaud.;John P A Ioannidis.;Benjamin Kasenda.;Atle Fretheim.;Steven N Goodman.;Lars G Hemkens.
来源: Ann Intern Med. 2025年178卷8期1150-1156页
Single-arm trials can be used to explore the feasibility, implementation, and effects of treatment. They typically use opportunistic convenience sampling to find potential participants. Their main limitations for health care decision making are lack of generalizability and the poor quality of the comparative evidence they produce. The authors propose a single-arm trial design that can provide greater generalizability and higher quality of comparative evidence than traditional single-arm trials, called a random invitation single-arm trial or RISAT. A RISAT has 4 essential components. First, it has a data infrastructure for routinely collected real-world data (RWD) where participants have provided consent to have their data used for research (for example, a registry or electronic medical record database). Second, a subset of those participants are randomly invited to take part in the RISAT. Those not invited are not contacted. Third, invitees are offered the specific intervention (such as a novel treatment), to which they consent or not. Fourth, all invitees are followed prospectively regardless of their acceptance of the intervention. For an optional randomized comparison, RISATs can use the RWD infrastructure to measure outcomes from invitees and noninvitees. The authors describe the advantages and challenges of this approach, including inferential issues and biases and comparison with other designs. They show how RISATs allow fairer access to participation, improve applicability and generalizability of results compared with traditional single-arm trials, and provide a form of randomized real-world evidence. At negligible added cost beyond already existing infrastructure, this approach may catalyze the early generation of evidence of higher value than that produced with traditional single-arm trials, increasing the credibility and validity of accelerated drug approval processes and enabling better health care decisions.
232. Evaluation of a Region-Wide Hospital-Based Violence Intervention Program : A Pilot Cohort Study.
作者: Kristen L Mueller.;Taylor M Kaser.;Benjamin P Cooper.;Daphne Lew.;Vicki Moran.;Rachel M Ancona.;Kateri Chapman-Kramer.;Melik Coffey.;Keyria Page.;Abigail Batha.;Stephanie Harris.;Larita Rice-Barnes.;Marsha Williams.;Lindsay M Kranker.;Marguerite W Spruce.;Christopher Behr.;Michael A Mancini.;Douglas J E Schuerer.;Lindsay D Clukies.;Nicole Santucci.;Anne Trolard.;Victoria Anwuri.;Megan L Ranney.;Randi E Foraker.;Matt Vogel.
来源: Ann Intern Med. 2025年178卷8期1116-1126页
Violent injury survivors are at risk for revictimization. The St. Louis area hospital-based violence intervention program (HVIP), Life Outside of Violence (LOV), is the first multisystem, region-wide HVIP in the United States.
233. Development and Validation of Body Mass Index-Specific Waist Circumference Thresholds in Postmenopausal Women : A Prospective Cohort Study.
作者: Aaron K Aragaki.;JoAnn E Manson.;Erin S LeBlanc.;Rowan T Chlebowski.;Lesley F Tinker.;Matthew A Allison.;Bernhard Haring.;Andrew O Odegaard.;Sylvia Wassertheil-Smoller.;Nazmus Saquib.;Kamal Masaki.;Holly R Harris.;Leah R Jager.;Jennifer W Bea.;Jean Wactawski-Wende.;Garnet L Anderson.
来源: Ann Intern Med. 2025年178卷8期1073-1084页
A 2020 consensus statement proposed body mass index (BMI)-specific waist circumference (WC) thresholds to improve patient care.
235. Differences Between Trial Populations and Approved Label Populations of New Drugs in the United States and Europe (2012 to 2023) : A Cross-Sectional Study.
作者: Kerstin N Vokinger.;Miquel Serra-Burriel.;Camille E G Glaus.;Lara Welti.;Joseph S Ross.;Aaron S Kesselheim.
来源: Ann Intern Med. 2025年178卷8期1127-1137页
Drugs are approved when their benefits outweigh their risks based on the results of clinical trials. It remains unclear how often regulatory agencies extrapolate or restrict the approval compared with the trial.
238. Implications of the European Association for the Study of Obesity's New Framework Definition of Obesity: Prevalence and Association With All-Cause Mortality.
作者: Dror Dicker.;Tomas Karpati.;Sara Promislow.;Orna Reges.
来源: Ann Intern Med. 2025年178卷8期1065-1072页
The European Association for the Study of Obesity (EASO) recently introduced a new framework to define obesity that incorporates anthropometric measures beyond body mass index (BMI) and clinical comorbidities. However, this framework has not been validated.
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