{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T08:07:33Z","timestamp":1780387653215,"version":"3.54.1"},"reference-count":10,"publisher":"Oxford University Press (OUP)","issue":"Supplement_5","license":[{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100001352","name":"National University of Singapore Start-Up","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001352","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["227155\/Z\/23\/Z"],"award-info":[{"award-number":["227155\/Z\/23\/Z"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,6,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Obtaining consent in antibiotic trials targeting patients with severe infections can be challenging due to time sensitivity and the frequent lack of decision-making capacity among these patients. This study reviews (1) the current common informed consent procedures and (2) recruitment loss due to consent failures in randomized controlled trials (RCTs) that involve critically ill patients with severe infections.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a scoping review of RCTs published between 2010 and 2023. Antibiotic RCTs involving patients with severe infections were identified in databases including PubMed, Embase, CINAHL, PsycINFO, Cochrane Central, Web of Science, and Scopus. Title and abstract screening and full-text review were performed by 2 independent reviewers. Information relating to consent procedures and enrolled participants was extracted and summarized in a tabulated format.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 926 records were identified, and 112 eligible RCTs were included. Of these, 107 RCTs stated that consent was required, and the majority reported obtaining consent before study procedures (74.8%), requiring written consent (82%), and allowing for surrogate consent (85%). Substantial underreporting of consent rate information was observed, with only 58% of the RCTs reporting details of consent failure before randomization. Substantial heterogeneity in consent failure rates among these studies was also observed, with the rate being up to 66% and a median of 13%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>There is substantial heterogeneity in consent failure rates across antibiotic RCTs involving critically ill patients. Understanding and addressing barriers in recruitment and consent in those trials requires more standardized reporting of consent rate information.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciaf715","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T12:33:41Z","timestamp":1766406821000},"page":"S147-S153","source":"Crossref","is-referenced-by-count":0,"title":["Consent Modes and Consent Rates in Randomized Controlled Trials for Severe Infections: A Scoping Review"],"prefix":"10.1093","volume":"82","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7386-0031","authenticated-orcid":false,"given":"Yiyun","family":"Shou","sequence":"first","affiliation":[{"name":"Saw Swee Hock School of Public Health, National University of Singapore and National University Health System ,","place":["Singapore"]},{"name":"Lloyd's Register Foundation Institute for the Public Understanding of Risk, National University of Singapore ,","place":["Singapore"]},{"name":"School of Medicine and Psychology, Australian National University , Canberra, ACT ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukiko","family":"Ezure","sequence":"additional","affiliation":[{"name":"School of Public Health, University of Queensland , Brisbane, QLD ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan Precious","family":"Kang","sequence":"additional","affiliation":[{"name":"Infectious Diseases Translational Research Programme, Yong Loo Lin School of Medicine, National University of Singapore ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5436-0149","authenticated-orcid":false,"given":"Joey Elizabeth","family":"Yeo","sequence":"additional","affiliation":[{"name":"Saw Swee Hock School of Public Health, National University of Singapore and National University Health System ,","place":["Singapore"]},{"name":"Lloyd's Register Foundation Institute for the Public Understanding of Risk, National University of Singapore ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vignesh Kathiresan","family":"Muthiah","sequence":"additional","affiliation":[{"name":"Lee Kong Chian School of Medicine, Nanyang Technological University ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin Quan Daryl","family":"Tan","sequence":"additional","affiliation":[{"name":"Lee Kong Chian School of Medicine, Nanyang Technological University ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yin","family":"Mo","sequence":"additional","affiliation":[{"name":"Saw Swee Hock School of Public Health, National University of Singapore and National University Health System ,","place":["Singapore"]},{"name":"Infectious Diseases Translational Research Programme, Yong Loo Lin School of Medicine, National University of Singapore ,","place":["Singapore"]},{"name":"Division of Infectious Diseases, Department of Medicine, National University Hospital ,","place":["Singapore"]},{"name":"Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University , Bangkok ,","place":["Thailand"]},{"name":"Oxford Centre for Global Health Research, Nuffield Department of Medicine, University of Oxford , Oxford ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L","family":"Paterson","sequence":"additional","affiliation":[{"name":"Saw Swee Hock School of Public Health, National University of Singapore and National University Health System ,","place":["Singapore"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,6,2]]},"reference":[{"key":"2026060203211581700_ciaf715-B1","doi-asserted-by":"crossref","first-page":"807","DOI":"10.1007\/s00134-007-0582-6","article-title":"Ability of family members to predict patient's consent to critical care research","volume":"33","author":"Ciroldi","year":"2007","journal-title":"Intensive Care Med"},{"key":"2026060203211581700_ciaf715-B2","doi-asserted-by":"crossref","first-page":"93","DOI":"10.1177\/1740774512464727","article-title":"Obtaining surrogate consent for a minimal-risk research study in the intensive care unit setting","volume":"10","author":"Larkin","year":"2013","journal-title":"Clin Trials"},{"key":"2026060203211581700_ciaf715-B3","doi-asserted-by":"crossref","first-page":"106054","DOI":"10.1016\/j.cct.2020.106054","article-title":"Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: a decade in review","volume":"95","author":"Shepherd","year":"2020","journal-title":"Contemp Clin Trials"},{"key":"2026060203211581700_ciaf715-B4","doi-asserted-by":"crossref","first-page":"e059230","DOI":"10.1136\/bmjopen-2021-059230","article-title":"Recruitment, consent and retention of participants in randomised controlled trials: a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997\u20132020)","volume":"12","author":"Jacques","year":"2022","journal-title":"BMJ Open"},{"key":"2026060203211581700_ciaf715-B5","doi-asserted-by":"crossref","first-page":"e015276","DOI":"10.1136\/bmjopen-2016-015276","article-title":"Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme","volume":"7","author":"Walters","year":"2017","journal-title":"BMJ 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review","volume":"16","author":"Patterson","year":"2021","journal-title":"PLoS One"},{"key":"2026060203211581700_ciaf715-B9","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1016\/j.jclinepi.2015.11.015","article-title":"Reporting of consent rates in critical care studies: room for improvement","volume":"74","author":"Garde","year":"2016","journal-title":"J Clin Epidemiol"},{"key":"2026060203211581700_ciaf715-B10","doi-asserted-by":"crossref","first-page":"855","DOI":"10.1007\/s43441-024-00667-w","article-title":"New estimates on the cost of a delay day in drug development","volume":"58","author":"Smith","year":"2024","journal-title":"Ther Innov Regul Sci"}],"container-title":["Clinical Infectious 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