Evidence map›Paper›PMID 40528252›Full record

Trial reportTrials2025

What is the impact on recruitment of a shortened compared with a standard-length participant information leaflet? PROMETHEUS in IBD-BOOST: study within a trial, a decentralised UK randomised controlled trial.

L Miller, A Hart, F Cléirigh-Büttner, C Arundel, T Hamborg, S McGuinness, R Moss-Morris, A Parker, C Relton, I Stagg and 4 more

Abstract readRandomized Controlled TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

14 authors.

L MillerUnit for Social and Community Psychiatry, Centre for Psychiatry and Mental Health (CPMH), Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK. l.miller@qmul.ac.uk.
A HartSt Mark's Hospital, Acton Lane, Central Middlesex, London, NW10 7NS, UK.
F Cléirigh-BüttnerPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
C ArundelYork Trials Unit, Department of Health Sciences - Faculty of Science, ARRC Building, University of York, York, YO10 5DD, UK.
T HamborgPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
S McGuinnessBristol Vaccine Centre, University of Bristol, 39-41 St Michaels Hill, Bristol, BS2 8DX, UK.
R Moss-MorrisDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Guy's Hospital Campus, 5 Floor Bermondsey Wing, London Bridge, London, SE1 9RT, UK.
A ParkerYork Trials Unit, Department of Health Sciences - Faculty of Science, ARRC Building, University of York, York, YO10 5DD, UK.
C ReltonPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
I StaggNIHR Royal Free Clinical Research Facility, Royal Free London NHS Foundation Trust, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.
L SweeneyInstitute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, Denmark Hill, London, SE5 8AB, UK.
V WilemanDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Guy's Hospital Campus, 5 Floor Bermondsey Wing, London Bridge, London, SE1 9RT, UK.
Z ZenasniSchool of Public Health, Imperial Clinical Trials Unit, Imperial College London, Stadium House, White City Campus, 80 Wood Lane, London, W12 7TA, UK.
C NortonFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, 57 Waterloo Road, London, SE1 8WA, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundParticipant Information Leaflets (PILs) are lengthy and increasingly complex, and could deter research participation. A shortened PIL may be more appealing as it is likely to provide a more a manageable volume of information. Previous research has found that shortened PILs are no less effective for recruitment outcomes, and we deemed it useful to replicate this in an online setting. We also decided to compare retention rates, given the potential for more information to increase participants' motivation.

aimTo evaluate the efficacy of a shortened vs standard-length PIL on trial recruitment and retention rates.

methodsThis two-arm study within a trial (SWAT) was embedded in a host randomised controlled trial (RCT)-IBD-BOOST. Potential participants were randomised to receive a standard-length or shortened PIL electronically for recruitment to the host RCT. An ethics committee approved potential participants being blinded to this randomisation. PRIMARY OUTCOME: The percentage of SWAT participants receiving the shortened vs standard PIL who were recruited to the RCT.

resultsFour thousand two hundred one participants were randomised to the standard-length (n = 2099) and shortened (n = 2102) PIL arms. Thirty-four email queries were received about the PILs-18 from those who received the standard and 16 from those receiving the shortened. Seven hundred eight SWAT participants were recruited to the RCT-333 (15.86%) who received the standard-length PIL and 375 (17.84%) who received the shortened (OR = 1.15, (95%CI = 0.98, 1.35), p = 0.09). Retention rates in the RCT were not statistically different between groups.

conclusionWe did not find evidence of a significant difference between RCT recruitment and retention rates in participants randomised to the standard-length PIL compared with the shortened. It may be that a shortened PIL has the same effect on recruitment and retention outcomes, providing that the trial does not require extensive information for other reasons (e.g. safety). Therefore, it could be argued that researchers have a choice about how long to make PILs, perhaps with a link to more detail. Alternatively, given that there was no benefit of the shortened PIL, it may be worth comparing written PILs with other methods of conveying information to determine optimal means of encouraging participation and retention in decentralised trials. HOST

trial registrationA randomised controlled trial of supported, online, self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial (ISRCTN71618461 on ISRCTN registry).

Indexed as

Inflammatory Bowel DiseasesPamphletsPatient Education as TopicPatient SelectionResearch SubjectsAdultFemaleHealth Knowledge, Attitudes, PracticeHumansMaleMiddle AgedMotivationSample SizeTime FactorsUnited KingdomYoung AdultClinical trialsEmbedded randomised controlled trialEthicsInformed consentParticipant Information LeafletPILRecruitment methodsResearch methodsStudy within a trialSWATTrial design

Identifiers

PMID40528252
PMCPMC12175447

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.