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
Abstract Background Participant 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...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2025-06-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-025-08931-6 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849685922569781248 |
|---|---|
| author | L. Miller A. Hart F. Cléirigh-Büttner C. Arundel T. Hamborg S. McGuinness R. Moss-Morris A. Parker C. Relton I. Stagg L. Sweeney V. Wileman Z. Zenasni C. Norton |
| author_facet | L. Miller A. Hart F. Cléirigh-Büttner C. Arundel T. Hamborg S. McGuinness R. Moss-Morris A. Parker C. Relton I. Stagg L. Sweeney V. Wileman Z. Zenasni C. Norton |
| author_sort | L. Miller |
| collection | DOAJ |
| description | Abstract Background Participant 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. Aim To evaluate the efficacy of a shortened vs standard-length PIL on trial recruitment and retention rates. Methods This 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. Results Four 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. Conclusion We 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 registration A 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). |
| format | Article |
| id | doaj-art-987e83d0a2b14da184f6f90afa4a5422 |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-987e83d0a2b14da184f6f90afa4a54222025-08-20T03:22:54ZengBMCTrials1745-62152025-06-012611910.1186/s13063-025-08931-6What 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 trialL. Miller0A. Hart1F. Cléirigh-Büttner2C. Arundel3T. Hamborg4S. McGuinness5R. Moss-Morris6A. Parker7C. Relton8I. Stagg9L. Sweeney10V. Wileman11Z. Zenasni12C. Norton13Unit for Social and Community Psychiatry, Centre for Psychiatry and Mental Health (CPMH), Wolfson Institute of Population Health, Queen Mary University of LondonSt Mark’s HospitalPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of LondonYork Trials Unit, Department of Health Sciences - Faculty of Science, ARRC Building, University of YorkPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of LondonBristol Vaccine Centre, University of BristolDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, Guy’s Hospital CampusYork Trials Unit, Department of Health Sciences - Faculty of Science, ARRC Building, University of YorkPragmatic Clinical Trials Unit, Centre for Evaluation and Methods, Wolfson Institute of Population Health, Queen Mary University of LondonNIHR Royal Free Clinical Research Facility, Royal Free London NHS Foundation Trust, Royal Free HospitalInstitute of Psychiatry, Psychology and Neuroscience, King’s College LondonDepartment of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London, Guy’s Hospital CampusSchool of Public Health, Imperial Clinical Trials Unit, Imperial College London, Stadium House, White City CampusFlorence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King’s College LondonAbstract Background Participant 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. Aim To evaluate the efficacy of a shortened vs standard-length PIL on trial recruitment and retention rates. Methods This 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. Results Four 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. Conclusion We 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 registration A 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).https://doi.org/10.1186/s13063-025-08931-6SWATStudy within a trialRecruitment methodsResearch methodsTrial designParticipant Information Leaflet |
| spellingShingle | L. Miller A. Hart F. Cléirigh-Büttner C. Arundel T. Hamborg S. McGuinness R. Moss-Morris A. Parker C. Relton I. Stagg L. Sweeney V. Wileman Z. Zenasni C. Norton 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 Trials SWAT Study within a trial Recruitment methods Research methods Trial design Participant Information Leaflet |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | SWAT Study within a trial Recruitment methods Research methods Trial design Participant Information Leaflet |
| url | https://doi.org/10.1186/s13063-025-08931-6 |
| work_keys_str_mv | AT lmiller whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT ahart whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT fcleirighbuttner whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT carundel whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT thamborg whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT smcguinness whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT rmossmorris whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT aparker whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT crelton whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT istagg whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT lsweeney whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT vwileman whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT zzenasni whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial AT cnorton whatistheimpactonrecruitmentofashortenedcomparedwithastandardlengthparticipantinformationleafletprometheusinibdbooststudywithinatrialadecentralisedukrandomisedcontrolledtrial |