Julian F Daza, Tyler R Chesney, Juan F Morales, Yuanxin Xue, Sandra Lee, Leandra A Amado, Bianca Pivetta, Arnaud R Mbadjeu Hondjeu, Rachel Jolley, Calvin Diep, Shabbir M H Alibhai, Peter M Smith, Erin D Kennedy, Elizabeth Racz, Luke Wilmshurst, Duminda N Wijeysundera
{"title":"Clinical Tools to Assess Functional Capacity During Risk Assessment Before Elective Noncardiac Surgery : A Scoping Review.","authors":"Julian F Daza, Tyler R Chesney, Juan F Morales, Yuanxin Xue, Sandra Lee, Leandra A Amado, Bianca Pivetta, Arnaud R Mbadjeu Hondjeu, Rachel Jolley, Calvin Diep, Shabbir M H Alibhai, Peter M Smith, Erin D Kennedy, Elizabeth Racz, Luke Wilmshurst, Duminda N Wijeysundera","doi":"10.7326/ANNALS-24-00413","DOIUrl":"https://doi.org/10.7326/ANNALS-24-00413","url":null,"abstract":"<p><strong>Background: </strong>Functional capacity is critical to preoperative risk assessment, yet guidance on its measurement in clinical practice remains lacking.</p><p><strong>Purpose: </strong>To identify functional capacity assessment tools studied before surgery and characterize the extent of evidence regarding performance, including in populations where assessment is confounded by noncardiopulmonary reasons.</p><p><strong>Data sources: </strong>MEDLINE, EMBASE, and EBM Reviews (until July 2024).</p><p><strong>Study selection: </strong>Studies evaluating performance of functional capacity assessment tools administered before elective noncardiac surgery to stratify risk for postoperative outcomes.</p><p><strong>Data extraction: </strong>Study details, measurement properties, pragmatic qualities, and/or clinical utility metrics.</p><p><strong>Data synthesis: </strong>6 categories of performance-based tests and 5 approaches using patient-reported exercise tolerance were identified. Cardiopulmonary exercise testing (CPET) was the most studied tool (132 studies, 32 662 patients) followed by field walking tests (58 studies, 9393 patients) among performance-based tests. Among patient-reported assessments, the Duke Activity Status Index (14 studies, 3303 patients) and unstructured assessments (19 studies, 28 520 patients) were most researched. Most evidence focused on predictive validity (92% of studies), specifically accuracy in predicting cardiorespiratory complications. Several tools lacked evidence on reliability (test consistency across similar measurements), pragmatic qualities (feasibility of implementation), or concurrent criterion validity (correlation to gold standard). Only CPET had evidence on clinical utility (whether administration improved postoperative outcomes). Older adults (≥65 years) were well represented across studies, whereas there were minimal data in patients with obesity, lower-limb arthritis, and disability.</p><p><strong>Limitation: </strong>Synthesis focused on reported data without requesting missing information.</p><p><strong>Conclusion: </strong>Though several tools for preoperative functional capacity assessment have been studied, research has overwhelmingly focused on CPET and only 1 aspect of validity (predictive validity). Important evidence gaps remain among vulnerable populations with obesity, arthritis, and physical disability.</p><p><strong>Primary funding source: </strong>None. (Open Science Framework: https://osf.io/ah7u5).</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":""},"PeriodicalIF":19.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Annals Video Summary - Clinical Tools to Assess Functional Capacity During Risk Assessment Before Elective Noncardiac Surgery.","authors":"","doi":"10.7326/ANNALS-24-02418-VS","DOIUrl":"https://doi.org/10.7326/ANNALS-24-02418-VS","url":null,"abstract":"","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"e2402418VS"},"PeriodicalIF":19.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Divya Ayyala-Somayajula, Jennifer L Dodge, Adam M Leventhal, Norah A Terrault, Brian P Lee
{"title":"Trends in Alcohol Use After the COVID-19 Pandemic: A National Cross-Sectional Study.","authors":"Divya Ayyala-Somayajula, Jennifer L Dodge, Adam M Leventhal, Norah A Terrault, Brian P Lee","doi":"10.7326/ANNALS-24-02157","DOIUrl":"https://doi.org/10.7326/ANNALS-24-02157","url":null,"abstract":"","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":""},"PeriodicalIF":19.6,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bernardo Sousa-Pinto, Rafael José Vieira, Manuel Marques-Cruz, Antonio Bognanni, Sara Gil-Mata, Slava Jankin, Joana Amaro, Liliane Pinheiro, Marta Mota, Mattia Giovannini, Leticia de Las Vecillas, Ana Margarida Pereira, Justyna Lityńska, Boleslaw Samolinski, Jonathan Bernstein, Mark Dykewicz, Martin Hofmann-Apitius, Marc Jacobs, Nikolaos Papadopoulos, Sian Williams, Torsten Zuberbier, João A Fonseca, Ricardo Cruz-Correia, Jean Bousquet, Holger J Schünemann
{"title":"Artificial Intelligence-Supported Development of Health Guideline Questions.","authors":"Bernardo Sousa-Pinto, Rafael José Vieira, Manuel Marques-Cruz, Antonio Bognanni, Sara Gil-Mata, Slava Jankin, Joana Amaro, Liliane Pinheiro, Marta Mota, Mattia Giovannini, Leticia de Las Vecillas, Ana Margarida Pereira, Justyna Lityńska, Boleslaw Samolinski, Jonathan Bernstein, Mark Dykewicz, Martin Hofmann-Apitius, Marc Jacobs, Nikolaos Papadopoulos, Sian Williams, Torsten Zuberbier, João A Fonseca, Ricardo Cruz-Correia, Jean Bousquet, Holger J Schünemann","doi":"10.7326/ANNALS-24-00363","DOIUrl":"10.7326/ANNALS-24-00363","url":null,"abstract":"<p><strong>Background: </strong>Guideline questions are typically proposed by experts.</p><p><strong>Objective: </strong>To assess how large language models (LLMs) can support the development of guideline questions, providing insights on approaches and lessons learned.</p><p><strong>Design: </strong>Two approaches for guideline question generation were assessed: 1) identification of questions conveyed by online search queries and 2) direct generation of guideline questions by LLMs. For the former, the researchers retrieved popular queries on allergic rhinitis using Google Trends (GT) and identified those conveying questions using both manual and LLM-based methods. They then manually structured as guideline questions the queries that conveyed relevant questions. For the second approach, they tasked an LLM with proposing guideline questions, assuming the role of either a patient or a clinician.</p><p><strong>Setting: </strong>Allergic Rhinitis and its Impact on Asthma (ARIA) 2024 guidelines.</p><p><strong>Participants: </strong>None.</p><p><strong>Measurements: </strong>Frequency of relevant questions generated.</p><p><strong>Results: </strong>The authors retrieved 3975 unique queries using GT. From these, they identified 37 questions, of which 22 had not been previously posed by guideline panel members and 2 were eventually prioritized by the panel. Direct interactions with LLMs resulted in the generation of 22 unique relevant questions (11 not previously suggested by panel members), and 4 were eventually prioritized by the panel. In total, 6 of 39 final questions prioritized for the 2024 ARIA guidelines were not initially thought of by the panel. The researchers provide a set of practical insights on the implementation of their approaches based on the lessons learned.</p><p><strong>Limitation: </strong>Single case study (ARIA guidelines).</p><p><strong>Conclusion: </strong>Approaches using LLMs can support the development of guideline questions, complementing traditional methods and potentially augmenting questions prioritized by guideline panels.</p><p><strong>Primary funding source: </strong>Fraunhofer Cluster of Excellence for Immune-Mediated Diseases.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"1518-1529"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142306975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Annals for Hospitalists - November 2024.","authors":"David A Fried","doi":"10.7326/ANNALS-24-03263-HO","DOIUrl":"10.7326/ANNALS-24-03263-HO","url":null,"abstract":"","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":"177 11","pages":"e2403263HO"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142666928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Moving Beyond Aggregation: Seeking Effective Tools to Advance Health Equity.","authors":"Marjorie K Mau, Sela Panapasa","doi":"10.7326/M24-0897","DOIUrl":"10.7326/M24-0897","url":null,"abstract":"","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"1584-1585"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"In symptomatic knee OA, adding oral methotrexate to usual analgesia reduced pain at 6 mo.","authors":"David S Pisetsky","doi":"10.7326/ANNALS-24-02769-JC","DOIUrl":"10.7326/ANNALS-24-02769-JC","url":null,"abstract":"<p><strong>Source citation: </strong>Kingsbury SR, Tharmanathan P, Keding A, et al. <b>Pain reduction with oral methotrexate in knee osteoarthritis: a randomized, placebo-controlled clinical trial.</b> Ann Intern Med. 2024;177:1145-1156. 39074374.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"JC130"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574762","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maria P Velez, Marina Ivanova, Jonas Shellenberger, Jessica Pudwell, Joel G Ray
{"title":"Severe Maternal and Neonatal Morbidity Among Gestational Carriers : A Cohort Study.","authors":"Maria P Velez, Marina Ivanova, Jonas Shellenberger, Jessica Pudwell, Joel G Ray","doi":"10.7326/M24-0417","DOIUrl":"10.7326/M24-0417","url":null,"abstract":"<p><strong>Background: </strong>Use of a gestational (\"surrogate\") carrier is increasingly common. Risk for maternal and neonatal adversity is largely unknown in this birthing population.</p><p><strong>Objective: </strong>To determine the risk for severe maternal morbidity (SMM) and severe neonatal morbidity (SNM) in gestational carriers.</p><p><strong>Design: </strong>Population-based cohort study.</p><p><strong>Setting: </strong>All of Ontario, Canada.</p><p><strong>Participants: </strong>All singleton births at more than 20 weeks' gestation, from 2012 to 2021.</p><p><strong>Measurements: </strong>Exposure was type of conception, namely, gestational carriage (main exposure), unassisted conception (comparison group 1), and in vitro fertilization (IVF) (comparison group 2). Main composite outcomes were SMM and SNM. Modified Poisson regression models generated weighted relative risks (wRRs) using propensity score-based overlap weighting. Secondary outcomes included hypertensive disorders of pregnancy, cesarean delivery, preterm birth, and postpartum hemorrhage.</p><p><strong>Results: </strong>Of all eligible singleton births, 846 124 (97.6%) were by unassisted conception, 16 087 (1.8%) by IVF, and 806 (0.1%) by gestational carriage. Respective risks for SMM were 2.3%, 4.3%, and 7.8%. The wRRs were 3.30 (95% CI, 2.59 to 4.20) comparing gestational carriage with unassisted conception and 1.86 (CI, 1.36 to 2.55) comparing gestational carriage with IVF. Respective risks for SNM were 5.9%, 8.9%, and 6.6%, generating wRRs of 1.20 (CI, 0.92 to 1.55) for gestational carriage versus unassisted conception and 0.81 (CI, 0.61 to 1.08) for gestational carriage versus IVF. Hypertensive disorders, postpartum hemorrhage, and preterm birth at less than 37 weeks were also significantly higher contrasting gestational carriers to either comparison group.</p><p><strong>Limitation: </strong>Absence of information about indications for choosing a gestational carrier, and oocyte or sperm donor source.</p><p><strong>Conclusion: </strong>Among singleton births of more than 20 weeks' gestation, a higher risk for SMM and adverse pregnancy outcomes was seen among gestational carriers compared with women who conceived with and without assistance. Although gestational carriage was associated with preterm birth, there was less clear evidence of severe neonatal morbidity. Potential mechanisms for higher maternal morbidity among gestational carriers require elucidation, alongside developing special care plans for gestational carriers.</p><p><strong>Primary funding source: </strong>The Canadian Institutes of Health Research.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"1482-1488"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142306978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A New Horizon: The Promise of the National Institutes of Health's Landmark Designation of Persons With Disabilities as a Population With Health Disparities.","authors":"Shahin A Saberi, Angela Zhang, Dorothy W Tolchin","doi":"10.7326/ANNALS-24-00676","DOIUrl":"10.7326/ANNALS-24-00676","url":null,"abstract":"","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"1577-1579"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142520766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kushal T Kadakia, Vinay K Rathi, Sanket S Dhruva, Joseph S Ross, Harlan M Krumholz
{"title":"Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.","authors":"Kushal T Kadakia, Vinay K Rathi, Sanket S Dhruva, Joseph S Ross, Harlan M Krumholz","doi":"10.7326/ANNALS-24-00728","DOIUrl":"10.7326/ANNALS-24-00728","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":" ","pages":"1558-1565"},"PeriodicalIF":19.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142387407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}