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Review
. 2017 Mar 20;7(3):e015276.
doi: 10.1136/bmjopen-2016-015276.

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

Stephen J Walters  1 , Inês Bonacho Dos Anjos Henriques-Cadby  1 , Oscar Bortolami  1 , Laura Flight  1 , Daniel Hind  1 , Richard M Jacques  1 , Christopher Knox  1 , Ben Nadin  1 , Joanne Rothwell  1 , Michael Surtees  1 , Steven A Julious  1
Affiliations
Review

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

Stephen J Walters et al. BMJ Open. .

Abstract

Background: Substantial 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.

Objectives: To 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 selection: HTA reports of individually randomised single or multicentre RCTs published from the start of 2004 to the end of April 2016 were reviewed.

Data extraction: Information was extracted, relating to the trial characteristics, sample size, recruitment and retention by two independent reviewers.

Main outcome measures: Target 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).

Results: This 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%).

Conclusions: There 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.

Keywords: Health Technology Assessment; Publicly funded; Randomised Controlled Trials; Retention; recruitment; review.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.

Figures

Figure 1
Figure 1
Flow diagram of search process for a review of trial reports published in the Health Technology Assessment Journal between 2004 and end of April 2016. RCT, randomised controlled trials.
Figure 2
Figure 2
Recruitment Rates by clinical area for the 151 Health Technology Assessment trials considered.
See this image and copyright information in PMC

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