Evidence map›Paper›PMID 38458814›Full record

ArticleBMJ open2024

Randomised trials conducted using cohorts: a scoping review.

Beverley Jane Nickolls, Clare Relton, Lars Hemkens, Merrick Zwarenstein, Sandra Eldridge, Stephen J McCall, Xavier Luke Griffin, Ratna Sohanpal, Helena M Verkooijen, Jonathon L Maguire and 1 more

Abstract readScoping Review
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Beverley Jane NickollsCentre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK b.nickolls@qmul.ac.uk.ORCID 0000-0002-9844-2493
Clare ReltonCentre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Lars HemkensResearch Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), University Hospital Basel, Basel, Switzerland.ORCID 0000-0002-3444-1432
Merrick ZwarensteinDepartment of Family Medicine, Western University, London, Ontario, Canada.
Sandra EldridgeCentre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Stephen J McCallNational Perinatal Epidemiology Unit, Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0003-0078-7010
Xavier Luke GriffinBone and Joint Health, Blizard Institute, Queen Mary University of London, London, UK.ORCID 0000-0003-2976-7523
Ratna SohanpalCentre for Primary Care, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
Helena M VerkooijenUniversity Medical Centre Utrecht, Utrecht, The Netherlands.
Jonathon L MaguireUniversity of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada.ORCID 0000-0002-4083-8612
Kimberly A McCordIndependent Researcher, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCohort 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.

objectiveTo examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

designScoping review. DATA SOURCES: Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews-Cochrane Methodology Registry (Final issue, third Quarter 2012). ELIGIBILITY CRITERIA: 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 EXTRACTION AND SYNTHESIS: 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.

resultsA 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.

conclusionThis 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.

Indexed as

Randomized Controlled Trials as TopicResearch DesignCohort StudiesHumansRegistriesClinical TrialDecision MakingPatient-Centered CarePatient ParticipationRandomized Controlled TrialSTATISTICS & RESEARCH METHODS

Identifiers

PMID38458814
PMCPMC10928784

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.