Evidence map›Paper›PMID 34551765›Full record

SynthesisBMC medicine2021

Can we achieve better recruitment by providing better information? Meta-analysis of 'studies within a trial' (SWATs) of optimised participant information sheets.

Vichithranie W Madurasinghe, Peter Bower, Sandra Eldridge, David Collier, Jonathan Graffy, Shaun Treweek, Peter Knapp, Adwoa Parker, Jo Rick, Chris Salisbury and 6 more

Registry-linked trialAbstract readMeta-Analysis
In one paragraph

Synthesis in BMC medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01925625 (Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 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.

NCT01925625 nacompletednot on this map

Detection in Blood of Autoantibodies to Tumour Antigens as a Case-finding Method in Lung Cancer Using the EarlyCDT-Lung Test

TypeinterventionalSponsorStuart SchembriRan2013 to 2018Enrolled12,210ConditionsLung CancerArmsEarly CDT Lung blood test
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2026
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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

16 authors.

Vichithranie W MadurasingheNuffield Department of Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7L, UK.
Peter BowerNIHR School for Primary Care Research, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL, UK. peter.bower@manchester.ac.uk.ORCID 0000-0001-9558-3349
Sandra EldridgeCentre for Clinical Trials and Methodology, Institute of Population Health Sciences, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
David CollierBarts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, EC1M 6BQ, UK.
Jonathan GraffyArbury Road Surgery 114, Arbury Road, Cambridge, CB4 2JG, UK.
Shaun TreweekHealth Services Research Unit, University of Aberdeen, Room 306, 3rd Floor, Health Sciences Building Foresterhill, Aberdeen, AB25 2ZD, UK.
Peter KnappDepartment of Health Sciences, University of York & the Hull York Medical School, York, UK.
Adwoa ParkerYork Trials Unit, Department of Health Sciences, University of York, York, UK.
Jo RickNational Institute of Health Research School for Primary Care Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Chris SalisburyCentre for Academic Primary Care, Department of Population Health Sciences, Bristol Medical School University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Mei See ManNorwich Clinical Trials Unit, Norwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
David TorgersonDepartment of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Rebecca SheridanDepartment of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Frank SullivanUniversity of St. Andrews North Haugh, St. Andrews, Fife, KY16 9T, UK.
Sarah CockayneDepartment of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
Charlotte DackDepartment of Psychology, University of Bath, Bath, BA2 7AY, UK.

Funding

Medical Research Council G1002325
6 · The paper itself

Abstract

backgroundThe information given to people considering taking part in a trial needs to be easy to understand if those people are to become, and then remain, trial participants. However, there is a tension between providing comprehensive information and providing information that is comprehensible. User-testing is one method of developing better participant information, and there is evidence that user-tested information is better at informing participants about key issues relating to trials. However, it is not clear if user-testing also leads to changes in the rates of recruitment in trials, compared to standard trial information. As part of a programme of research, we embedded 'studies within a trial' (SWATs) across multiple ongoing trials to see if user-tested materials led to better rates of recruitment.

methodsSeven 'host' trials included a SWAT evaluation and randomised their participants to receive routine information sheets generated by the research teams, or information sheets optimised through user-testing. We collected data on trial recruitment and analysed the results across these trials using random effects meta-analysis, with the primary outcome defined as the proportion of participants randomised in a host trial following an invitation to take part.

resultsSix SWATs (n=27,805) provided data on recruitment. Optimised participant information sheets likely result in little or no difference in recruitment rates (7.2% versus 6.8%, pooled odds ratio = 1.03, 95% CI 0.90 to 1.19, p-value = 0.63, I

conclusionsParticipant information sheets developed through user testing did not improve recruitment rates. The programme of work showed that co-ordinated testing of recruitment strategies using SWATs is feasible and can provide both definitive and timely evidence on the effectiveness of recruitment strategies.

trial registrationHealthlines Depression (ISRCTN14172341) Healthlines CVD (ISRCTN27508731) CASPER (ISRCTN02202951) ISDR (ISRCTN87561257) ECLS (NCT01925625) REFORM (ISRCTN68240461) HeLP Diabetes (ISRCTN02123133).

Indexed as

Research DesignHumansOdds RatioPatient SelectionInformationRandomised controlled trialRecruitmentResearch methodologySWATsUser-testing

Identifiers

PMID34551765
PMCPMC8459527

What OpenQuestion holds

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Registered trials

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.