Evidence map›Paper›PMID 35165116›Full record

ReviewBMJ open2022

Recruitment, consent and retention of participants in randomised controlled trials: a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997-2020).

Richard M Jacques, Rashida Ahmed, James Harper, Adya Ranjan, Isra Saeed, Rebecca M Simpson, Stephen J Walters

Abstract readReview
In one paragraph

Review in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 5 pooled it
–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

79 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026
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19 more citing papers are in PubMed but not listed here.

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

7 authors.

Richard M JacquesSchool of Health and Related Research, The University of Sheffield, Sheffield, UK r.jacques@sheffield.ac.uk.ORCID 0000-0001-6710-5403
Rashida AhmedSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.
James HarperSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.
Adya RanjanSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.
Isra SaeedSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.
Rebecca M SimpsonSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.ORCID 0000-0003-1677-5938
Stephen J WaltersSchool of Health and Related Research, The University of Sheffield, Sheffield, UK.ORCID 0000-0001-9000-8126

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo review the consent, recruitment and retention rates for randomised controlled trials (RCTs) funded by the UK's National Institute for Health Research (NIHR) and published in the online NIHR Journals Library between January 1997 and December 2020.

designComprehensive review.

settingRCTs funded by the NIHR and published in the NIHR Journals Library. DATA EXTRACTION: Information relating to the trial characteristics, sample size, recruitment and retention. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the recruitment rate (number of participants recruited per centre per month). Secondary outcomes were the target sample size and whether it was achieved; consent rates (percentage of eligible participants who consented and were randomised) and retention rates (percentage of randomised participants retained and assessed with valid primary outcome data).

resultsThis review identified 388 individual RCTs from 379 reports in the NIHR Journals Library. The final recruitment target sample size was achieved in 63% (245/388) of the RCTs. The original recruitment target was revised in 30% (118/388) of trials (downwards in 67% (79/118)). The median recruitment rate (participants per centre per month) was found to be 0.95 (IQR: 0.42-2.60); the median consent rate was 72% (IQR: 50%-88%) and the median retention rate was estimated at 88% (IQR: 80%-97%).

conclusionsThere is considerable variation in the consent, recruitment and retention rates in publicly funded RCTs. Although the majority of (6 out of 10) trials in this review achieved their final target sample; 3 out of 10 trials revised their original target sample size (downwards in 7 out of 10 trials). Investigators should bear this in mind at the planning stage of their study and not be overly optimistic about their recruitment projections.

Indexed as

Periodicals as TopicCost-Benefit AnalysisHumansInformed ConsentPublicationsRandomized Controlled Trials as TopicResearch Reportauditpublic healthstatistics & research methods

Identifiers

PMID35165116
PMCPMC8845327

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.