Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme

BackgroundSubstantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and tria...

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Bibliographic Details
Published in:	BMJ open Vol. 7; no. 3; p. e015276
Main Authors:	Walters, Stephen J, Bonacho dos Anjos Henriques-Cadby, Inês, Bortolami, Oscar, Flight, Laura, Hind, Daniel, Jacques, Richard M, Knox, Christopher, Nadin, Ben, Rothwell, Joanne, Surtees, Michael, Julious, Steven A
Format:	Journal Article
Language:	English
Published:	England BMJ Publishing Group LTD 01-03-2017 BMJ Publishing Group
Subjects:	Cardiovascular disease Catheters Clinical trials Cost analysis Cost-Benefit Analysis - economics Evidence-based medicine Health technology assessment Human subjects Humans Medical research Multicenter Studies as Topic - economics Multicenter Studies as Topic - statistics & numerical data Older people Participation Patient Dropouts - statistics & numerical data Patient Selection Patients Randomized Controlled Trials as Topic - economics Randomized Controlled Trials as Topic - statistics & numerical data Recruitment Research Methods Retention Streptococcus infections Technology Assessment, Biomedical - economics Technology Assessment, Biomedical - methods United Kingdom United Kingdom > UK Randomised Controlled Trials Retention recruitment Publicly funded Health Technology Assessment review
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Summary:	BackgroundSubstantial amounts of public funds are invested in health research worldwide. Publicly funded randomised controlled trials (RCTs) often recruit participants at a slower than anticipated rate. Many trials fail to reach their planned sample size within the envisaged trial timescale and trial funding envelope.ObjectivesTo review the consent, recruitment and retention rates for single and multicentre randomised control trials funded and published by the UK's National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme.Data sources and study selectionHTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed.Data extractionInformation was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers.Main outcome measuresTarget sample size and whether it was achieved; recruitment rates (number of participants recruited per centre per month) and retention rates (randomised participants retained and assessed with valid primary outcome data).ResultsThis review identified 151 individually RCTs from 787 NIHR HTA reports. The final recruitment target sample size was achieved in 56% (85/151) of the RCTs and more than 80% of the final target sample size was achieved for 79% of the RCTs (119/151). The median recruitment rate (participants per centre per month) was found to be 0.92 (IQR 0.43–2.79) and the median retention rate (proportion of participants with valid primary outcome data at follow-up) was estimated at 89% (IQR 79–97%).ConclusionsThere is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 ObjectType-Review-3 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2016-015276