{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T03:14:47Z","timestamp":1783566887757,"version":"3.55.0"},"reference-count":124,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T00:00:00Z","timestamp":1709856000000},"content-version":"unspecified","delay-in-days":7,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009148","name":"Queen Mary University of London","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100009148","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,11,24]]},"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Scoping review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data sources<\/jats:title>\n                    <jats:p>Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews\u2014Cochrane Methodology Registry (Final issue, third Quarter 2012).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Eligibility criteria<\/jats:title>\n                    <jats:p>Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and\/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data extraction and synthesis<\/jats:title>\n                    <jats:p>Data were extracted on the condition being studied, age group, setting, country\/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.<\/jats:p>\n                    <jats:p>The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.<\/jats:p>\n                    <jats:p>Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075601","type":"journal-article","created":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T21:55:25Z","timestamp":1709934925000},"page":"e075601","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["Randomised trials conducted using cohorts: a scoping review"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9844-2493","authenticated-orcid":false,"given":"Beverley Jane","family":"Nickolls","sequence":"first","affiliation":[{"name":"Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clare","family":"Relton","sequence":"additional","affiliation":[{"name":"Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3444-1432","authenticated-orcid":false,"given":"Lars","family":"Hemkens","sequence":"additional","affiliation":[{"name":"Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, Basel, Switzerland"},{"name":"Department of Clinical Research, University of Basel, Basel, Switzerland"},{"name":"Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Stanford, California, USA"},{"name":"Meta-Research Innovation Center Berlin (METRICS-B), Berlin Institute of Health, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merrick","family":"Zwarenstein","sequence":"additional","affiliation":[{"name":"Department of Family Medicine, Western University, London, Ontario, Canada"},{"name":"Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Eldridge","sequence":"additional","affiliation":[{"name":"Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0078-7010","authenticated-orcid":false,"given":"Stephen J","family":"McCall","sequence":"additional","affiliation":[{"name":"National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK"},{"name":"Center for Research on Population and Health, Faculty of Health Sciences, American University of Beirut, Ras Beirut, Lebanon"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2976-7523","authenticated-orcid":false,"given":"Xavier Luke","family":"Griffin","sequence":"additional","affiliation":[{"name":"Bone and Joint Health, Blizard Institute, Queen Mary University of London, London, UK"},{"name":"Barts Health NHS Trust, Royal London Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ratna","family":"Sohanpal","sequence":"additional","affiliation":[{"name":"Centre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena M","family":"Verkooijen","sequence":"additional","affiliation":[{"name":"University Medical Centre Utrecht, Utrecht, The Netherlands"},{"name":"University of Utrecht, Utrecht, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4083-8612","authenticated-orcid":false,"given":"Jonathon L","family":"Maguire","sequence":"additional","affiliation":[{"name":"University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly A","family":"McCord","sequence":"additional","affiliation":[{"name":"Independent Researcher, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,3,8]]},"reference":[{"key":"2025121600362382000_14.3.e075601.1","doi-asserted-by":"crossref","unstructured":"Barr\u00eda RM . 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