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Meta-Analysis
. 2023 Jul 4;21(1):244.
doi: 10.1186/s12916-023-02936-1.

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs

Peter Knapp  1 , Thirimon Moe-Byrne  2 , Jacqueline Martin-Kerry  2 , Rebecca Sheridan  2 , Jenny Roche  3 , Elizabeth Coleman  3 , Peter Bower  4 , Steven Higgins  5 , Catherine Stones  6 , Jonathan Graffy  7 , Jenny Preston  8 , Carrol Gamble  9 , Bridget Young  10 , Daniel Perry  11 , Annegret Dahlmann-Noor  12 , Mohamed Abbas  12 , Payal Khandelwal  13 , Siobhan Ludden  14 , Augusto Azuara-Blanco  15 , Emma McConnell  15 , Nicky Mandall  16 , Anna Lawson  17 , Chris A Rogers  18 , Helena J M Smartt  18 , Rachael Heys  18 , Simon R Stones  19 , Danielle Horton Taylor  20 , Sophie Ainsworth  21 , Jenny Ainsworth  21
Affiliations
Meta-Analysis

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs

Peter Knapp et al. BMC Med. .

Abstract

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.

Keywords: Children; Consent; Multimedia information; Recruitment; Retention; Trial.

PubMed Disclaimer

Conflict of interest statement

SRS is an employee of Envision Pharma Group, owns stock options in Envision Pharma Group, is a member of Savvy Cooperative, and is a trustee of RAiISE, a charitable incorporated organisation registered in England and Wales.

No other authors have any competing interests to add.

Figures

Fig. 1
Fig. 1
Logic model for the projected effects of multimedia information in trial recruitment
Fig. 2
Fig. 2
Pathway through each SWAT. Note: In the FORCE SWAT, only two allocations were used (MMI-only and PIS-only)
Fig. 3
Fig. 3
Flow of participants through each SWAT
Fig. 4
Fig. 4
Forest plot of trial recruitment in the MMI-only and PIS-only arms for the mITT
See this image and copyright information in PMC

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