Randomised trials conducted using cohorts: a scoping review.

Journal: BMJ open

Volume: 14

Issue: 3

Year of Publication: 2024

Affiliated Institutions:  Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK b.nickolls@qmul.ac.uk. Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK. Research Center for Clinical Neuroimmunology and Neuroscience Basel (RCNB), University Hospital Basel, Basel, Switzerland. Department of Family Medicine, Western University, London, Ontario, Canada. National Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Bone and Joint Health, Blizard Institute, Queen Mary University of London, London, UK. Centre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK. University Medical Centre Utrecht, Utrecht, The Netherlands. University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada. Independent Researcher, Basel, Switzerland.

Abstract summary 

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.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.Scoping review.Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews-Cochrane Methodology Registry (Final issue, third Quarter 2012).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.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.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.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.Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.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.

Authors & Co-authors:  Nickolls Relton Hemkens Zwarenstein Eldridge McCall Griffin Sohanpal Verkooijen Maguire McCord

Study Outcome 

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Statistics
Citations :  Barría RM. Introductory chapter: the contribution of cohort studies to health sciences. In: Cohort studies in health sciences. InTech, 2018.
Authors :  11
Identifiers
Doi : e075601
SSN : 2044-6055
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
Clinical Trial;Decision Making;Patient Participation;Patient-Centered Care;Randomized Controlled Trial;STATISTICS & RESEARCH METHODS
Study Design
Study Approach
Country of Study
Publication Country
England