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

Peter Knapp; Thirimon Moe-Byrne; Jacqueline Martin-Kerry; Rebecca Sheridan; Jenny Roche; Elizabeth Coleman; Peter Bower; Steven Higgins; Catherine Stones; Jonathan Graffy; Jenny Preston; Carrol Gamble; Bridget Young; Daniel Perry; Annegret Dahlmann-Noor; Mohamed Abbas; Payal Khandelwal; Siobhan Ludden; Augusto Azuara-Blanco; Emma McConnell; Nicky Mandall; Anna Lawson; Chris A Rogers; Helena J M Smartt; Rachael Heys; Simon R Stones; Danielle Horton Taylor; Sophie Ainsworth; Jenny Ainsworth

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^*, Thirimon Moe-Byrne, Jacqueline Martin-Kerry, Rebecca Sheridan, Jenny Roche, Elizabeth Coleman, Peter Bower, Steven Higgins, Catherine Stones, Jonathan Graffy, Jenny Preston, Carrol Gamble, Bridget Young, Daniel Perry, Annegret Dahlmann-Noor, Mohamed Abbas, Payal Khandelwal, Siobhan Ludden, Augusto Azuara-Blanco, Emma McConnellNicky Mandall, Anna Lawson, Chris A Rogers, Helena J M Smartt, Rachael Heys, Simon R Stones, Danielle Horton Taylor, Sophie Ainsworth, Jenny Ainsworth

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	244
Number of pages	16
Journal	BMC Medicine
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12916-023-02936-1
Publication status	Published - 4 Jul 2023

Bibliographical note

Keywords

Adolescent
Humans
Child
Multimedia
Patient Selection
Surveys and Questionnaires
Randomized Controlled Trials as Topic

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10.1186/s12916-023-02936-1Licence: CC BY

Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs
© The Author(s) 2023.
Final published version, 1.61 MBLicence: CC BY

Cite this

Knapp, P., Moe-Byrne, T., Martin-Kerry, J., Sheridan, R., Roche, J., Coleman, E., Bower, P., Higgins, S., Stones, C., Graffy, J., Preston, J., Gamble, C., Young, B., Perry, D., Dahlmann-Noor, A., Abbas, M., Khandelwal, P., Ludden, S., Azuara-Blanco, A., ... Ainsworth, J. (2023). Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs. BMC Medicine, 21(1), Article 244. https://doi.org/10.1186/s12916-023-02936-1

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

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 = "Adolescent, Humans, Child, Multimedia, Patient Selection, Surveys and Questionnaires, Randomized Controlled Trials as Topic",

author = "Peter Knapp and Thirimon Moe-Byrne and Jacqueline Martin-Kerry and Rebecca Sheridan and Jenny Roche and Elizabeth Coleman and Peter Bower and Steven Higgins and Catherine Stones and Jonathan Graffy and Jenny Preston and Carrol Gamble and Bridget Young and Daniel Perry and Annegret Dahlmann-Noor and Mohamed Abbas and Payal Khandelwal and Siobhan Ludden and Augusto Azuara-Blanco and Emma McConnell and Nicky Mandall and Anna Lawson and Rogers, {Chris A} and Smartt, {Helena J M} and Rachael Heys and Stones, {Simon R} and Taylor, {Danielle Horton} and Sophie Ainsworth and Jenny Ainsworth",

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year = "2023",

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doi = "10.1186/s12916-023-02936-1",

language = "English",

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Knapp, P , Moe-Byrne, T , Martin-Kerry, J , Sheridan, R , Roche, J , Coleman, E, Bower, P, Higgins, S, Stones, C, Graffy, J, Preston, J, Gamble, C, Young, B, Perry, D, Dahlmann-Noor, A, Abbas, M, Khandelwal, P, Ludden, S, Azuara-Blanco, A, McConnell, E, Mandall, N, Lawson, A, Rogers, CA, Smartt, HJM, Heys, R, Stones, SR, Taylor, DH, Ainsworth, S & Ainsworth, J 2023, 'Providing multimedia information to children and young people increases recruitment to trials: pre-planned meta-analysis of SWATs', BMC Medicine, vol. 21, no. 1, 244. https://doi.org/10.1186/s12916-023-02936-1

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

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 - Adolescent

KW - Humans

KW - Child

KW - Multimedia

KW - Patient Selection

KW - Surveys and Questionnaires

KW - Randomized Controlled Trials as Topic

U2 - 10.1186/s12916-023-02936-1

DO - 10.1186/s12916-023-02936-1

M3 - Article

C2 - 37403173

SN - 1741-7015

VL - 21

JO - BMC Medicine

JF - BMC Medicine

IS - 1

M1 - 244

ER -