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

作者信息

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

机构信息

School of Health and Related Research, University of Sheffield, Sheffield, UK.

出版信息

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


DOI:10.1136/bmjopen-2016-015276
PMID:28320800
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5372123/
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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc7f/5372123/830e46bfddcd/bmjopen2016015276f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc7f/5372123/361bf9dd2d10/bmjopen2016015276f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc7f/5372123/830e46bfddcd/bmjopen2016015276f02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc7f/5372123/361bf9dd2d10/bmjopen2016015276f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc7f/5372123/830e46bfddcd/bmjopen2016015276f02.jpg

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本文引用的文献

[1]
Projection of participant recruitment to primary care research: a qualitative study.

Trials. 2015-10-20

[2]
A rapid review indicated higher recruitment rates in treatment trials than in prevention trials.

J Clin Epidemiol. 2014-12-6

[3]
Randomised controlled trial and health economic evaluation of the impact of diagnostic testing for influenza, respiratory syncytial virus and Streptococcus pneumoniae infection on the management of acute admissions in the elderly and high-risk 18- to 64-year-olds.

Health Technol Assess. 2014-5

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The trials methodological research agenda: results from a priority setting exercise.

Trials. 2014-1-23

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Asia's ascent--global trends in biomedical R&D expenditures.

N Engl J Med. 2014-1-2

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A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

Health Technol Assess. 2013-12

[7]
Strategies to improve retention in randomised trials.

Cochrane Database Syst Rev. 2013-12-3

[8]
A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies.

Trials. 2013-6-9

[9]
Publication rate for funded studies from a major UK health research funder: a cohort study.

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[10]
The CRASH-2 trial: a randomised controlled trial and economic evaluation of the effects of tranexamic acid on death, vascular occlusive events and transfusion requirement in bleeding trauma patients.

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