Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme
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 tri...
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BMJ Publishing Group
2017-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/7/3/e015276.full |
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| author | Stephen J Walters Daniel Hind Richard M Jacques Steven A Julious Joanne Rothwell Oscar Bortolami Laura Flight Inês Bonacho dos Anjos Henriques-Cadby Christopher Knox Ben Nadin Michael Surtees |
| author_facet | Stephen J Walters Daniel Hind Richard M Jacques Steven A Julious Joanne Rothwell Oscar Bortolami Laura Flight Inês Bonacho dos Anjos Henriques-Cadby Christopher Knox Ben Nadin Michael Surtees |
| author_sort | Stephen J Walters |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-2bf5ee856c384ab99969a5336935d6de |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2017-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-2bf5ee856c384ab99969a5336935d6de2025-02-09T13:30:09ZengBMJ Publishing GroupBMJ Open2044-60552017-03-017310.1136/bmjopen-2016-015276Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment ProgrammeStephen J Walters0Daniel Hind1Richard M Jacques2Steven A Julious3Joanne RothwellOscar BortolamiLaura Flight4Inês Bonacho dos Anjos Henriques-CadbyChristopher KnoxBen NadinMichael SurteesMedical Statistics Group, ScHARR, University of Sheffield, Sheffield, UKSchool of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UKSchool of Health and Related Research, The University of Sheffield, Sheffield, UKprofessorSchool of Health and Related Research, The University of Sheffield, Sheffield, UKBackground 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.https://bmjopen.bmj.com/content/7/3/e015276.full |
| spellingShingle | Stephen J Walters Daniel Hind Richard M Jacques Steven A Julious Joanne Rothwell Oscar Bortolami Laura Flight Inês Bonacho dos Anjos Henriques-Cadby Christopher Knox Ben Nadin Michael Surtees Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme BMJ Open |
| title | Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme |
| title_full | Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme |
| title_fullStr | Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme |
| title_full_unstemmed | Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme |
| title_short | Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme |
| title_sort | recruitment and retention of participants in randomised controlled trials a review of trials funded and published by the united kingdom health technology assessment programme |
| url | https://bmjopen.bmj.com/content/7/3/e015276.full |
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