TY - JOUR
T1 - Providing multimedia information to children and young people increases recruitment to trials
T2 - pre-planned meta-analysis of SWATs
AU - Knapp, Peter
AU - Moe-Byrne, Thirimon
AU - Martin-Kerry, Jacqueline
AU - Sheridan, Rebecca
AU - Roche, Jenny
AU - Coleman, Elizabeth
AU - Bower, Peter
AU - Higgins, Steven
AU - Stones, Catherine
AU - Graffy, Jonathan
AU - Preston, Jenny
AU - Gamble, Carrol
AU - Young, Bridget
AU - Perry, Daniel
AU - Dahlmann-Noor, Annegret
AU - Abbas, Mohamed
AU - Khandelwal, Payal
AU - Ludden, Siobhan
AU - Azuara-Blanco, Augusto
AU - McConnell, Emma
AU - Mandall, Nicky
AU - Lawson, Anna
AU - Rogers, Chris A.
AU - Smartt, Helena J.M.
AU - Heys, Rachael
AU - Stones, Simon R.
AU - Taylor, Danielle Horton
AU - Ainsworth, Sophie
AU - Ainsworth, Jenny
N1 - Funding Information:
This study was funded by the NIHR Health and Social Care Delivery Research Programme (14/21/21). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/7/4
Y1 - 2023/7/4
N2 - Background: Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. Methods: We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. Results: Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. Conclusions: Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.
AB - Background: Randomised controlled trials are often beset by problems with poor recruitment and retention. Information to support decisions on trial participation is usually provided as printed participant information sheets (PIS), which are often long, technical, and unappealing. Multimedia information (MMI), including animations and videos, may be a valuable alternative or complement to a PIS. The Trials Engagement in Children and Adolescents (TRECA) study compared MMI to PIS to investigate the effects on participant recruitment, retention, and quality of decision-making. Methods: We undertook six SWATs (Study Within A Trial) within a series of host trials recruiting children and young people. Potential participants in the host trials were randomly allocated to receive MMI-only, PIS-only, or combined MMI + PIS. We recorded the rates of recruitment and retention (varying between 6 and 26 weeks post-randomisation) in each host trial. Potential participants approached about each host trial were asked to complete a nine-item Decision-Making Questionnaire (DMQ) to indicate their evaluation of the information and their reasons for participation/non-participation. Odds ratios were calculated and combined in a meta-analysis. Results: Data from 3/6 SWATs for which it was possible were combined in a meta-analysis (n = 1758). Potential participants allocated to MMI-only were more likely to be recruited to the host trial than those allocated to PIS-only (OR 1.54; 95% CI 1.05, 2.28; p = 0.03). Those allocated to combined MMI + PIS compared to PIS-only were no more likely to be recruited to the host trial (OR = 0.89; 95% CI 0.53, 1.50; p = 0.67). Providing MMI rather than PIS did not impact on DMQ scores. Once children and young people had been recruited to host trials, their trial retention rates did not differ according to intervention allocation. Conclusions: Providing MMI-only increased the trial recruitment rate compared to PIS-only but did not affect DMQ scores. Combined MMI + PIS instead of PIS had no effect on recruitment or retention. MMIs are a useful tool for trial recruitment in children and young people, and they could reduce trial recruitment periods.
KW - Children
KW - Consent
KW - Multimedia information
KW - Recruitment
KW - Retention
KW - Trial
UR - http://www.scopus.com/inward/record.url?scp=85163937607&partnerID=8YFLogxK
U2 - 10.1186/s12916-023-02936-1
DO - 10.1186/s12916-023-02936-1
M3 - Article
C2 - 37403173
AN - SCOPUS:85163937607
SN - 1741-7015
VL - 21
JO - BMC Medicine
JF - BMC Medicine
IS - 1
M1 - 244
ER -