The effects of multimedia information on recruitment and retention in a children’s cardiac surgery trial: a randomised controlled SWAT (study within a trial)

Knapp, Peter; Heys, Rachael; Dabner, Lucy; Sheehan, Karen; Smartt, Helena J.M.; Walker-Smith, Terrie; Rogers, Chris A; Stoica, Șerban; Roche, Jenny; Moe‐Byrne, Thirimon; Martin-Kerry, Jacqueline; Sheridan, Rebecca; Coleman, Elizabeth Ann; Higgins, Steve

doi:10.12688/f1000research.110083.1

Cited by 3 publications

(6 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In two other reported TRECA-embedded studies: first, more adolescents rated MMI as ‘easy to understand’ than those who saw printed information; multimedia also resulted in greater confidence in decision-making 38. Second, MMI resulted in higher rates of recruitment than PIS to a children’s cardiac surgery trial, although the difference was not statistically significant 39. Two systematic reviews of trials of MMI to inform consent decisions in adults reported that they may increase comprehension of the research and consent, and retention of information 40 41.…”

Section: Discussionmentioning

confidence: 95%

“… 38 Second, MMI resulted in higher rates of recruitment than PIS to a children’s cardiac surgery trial, although the difference was not statistically significant. 39 Two systematic reviews of trials of MMI to inform consent decisions in adults reported that they may increase comprehension of the research and consent, and retention of information. 40 41 There has been more evaluation of MMI in healthcare delivery, showing a number of benefits for patients, for example, on knowledge, self-management of health condition, satisfaction with care, and anxiety and pain.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

et al. 2022

Self Cite

View full text Add to dashboard Cite

ObjectivesTo evaluate digital, multimedia information (MMI) for its effects on trial recruitment, retention, decisions about participation and acceptability by patients, compared with printed information.DesignStudy Within A Trial using random cluster allocation within the Forearm Fracture Recovery in Children Evaluation (FORCE) study.SettingEmergency departments in 23 UK hospitals.Participants1409 children aged 4–16 years attending with a torus (buckle) fracture, and their parents/guardian. Children’s mean age was 9.2 years, 41.0% were female, 77.4% were ethnically White and 90.0% spoke English as a first language.InterventionsParticipants and their parents/guardian received trial information either via multimedia, including animated videos, talking head videos and text (revised for readability and age appropriateness when needed) on tablet computer (MMI group; n=681), or printed participant information sheet (PIS group; n=728).Outcome measuresPrimary outcome was recruitment rate to FORCE. Secondary outcomes were Decision-Making Questionnaire (nine Likert items, analysed summatively and individually), three ‘free text’ questions (deriving subjective evaluations) and trial retention.ResultsMMI produced a small, not statistically significant increase in recruitment: 475 (69.8%) participants were recruited from the MMI group; 484 (66.5%) from the PIS group (OR=1.35; 95% CI 0.76 to 2.40, p=0.31). A total of 324 (23.0%) questionnaires were returned and analysed. There was no difference in total Decision-Making Questionnaire scores: adjusted mean difference 0.05 (95% CI −1.23 to 1.32, p=0.94). The MMI group was more likely to report the information ‘very easy’ to understand (89; 57.8% vs 67; 39.4%; Z=2.60, p=0.01) and identify information that was explained well (96; 62.3% vs 71; 41.8%). Almost all FORCE recruits were retained at the 6 weeks’ timepoint and there was no difference in retention rate between the information groups: MMI (473; 99.6%); PIS (481; 99.4%).ConclusionsMMI did not increase recruitment or retention in the FORCE trial, but participants rated multimedia as easier to understand and were more likely to evaluate it positively.Trial registration numberISRCTN73136092 and ISRCTN13955395.

show abstract

Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

et al. 2022

Self Cite

View full text Add to dashboard Cite

show abstract

“…(The figure includes data from a published study. 154 ) Table 25 presents the analysis of DMQ total scores, including only those participants who fully completed the measure (i.e. when no imputation was used).…”

Section: Decision-making Questionnairesmentioning

confidence: 99%

“…FIGURE 8Forest plot of the modified ITT trial recruitment analysis for MMI-only compared with PIS-only. (The figure includes data from two published studies 154,155 ). …”

mentioning

confidence: 99%

See 1 more Smart Citation

The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs

Knapp,

Martin-Kerry,

Moe-Byrne

et al. 2023

Health Soc Care Deliv Res

Self Cite

View full text Add to dashboard Cite

Background The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people. Objectives The study objectives were as follows: to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets. Design Two-phase study: multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement multimedia information resources’ evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people. Setting United Kingdom trials involving patients aged under 18. Participants Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials). Interventions Multimedia information resources (comprising text, audio, ‘talking heads’ video, trial-specific and trial-generic animations). Printed participant information sheets. Main outcome measures Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis. Results Phase 1 generated two multimedia information resource templates: (1) for children aged 6–11 years; (2) for children aged 12–18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of ‘information was easy to understand’ (Z = 3.03; p = 0.003) and ‘I had confidence in decision-making’ (Z = 2.00; p = 0.044) than printed participant information sheet-only provision. Limitations It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings. Conclusions Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets. Future work There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents. Study registration This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97). Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.

show abstract

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

Knapp

Moe‐Byrne

Martin-Kerry

et al. 2023

BMC Med

Self Cite

View full text Add to dashboard Cite

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.

show abstract

The effects of multimedia information on recruitment and retention in a children’s cardiac surgery trial: a randomised controlled SWAT (study within a trial)

Cited by 3 publications

References 35 publications

Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

Does digital, multimedia information increase recruitment and retention in a children’s wrist fracture treatment trial, and what do people think of it? A randomised controlled Study Within A Trial (SWAT)

The effectiveness and acceptability of multimedia information when recruiting children and young people to trials: the TRECA meta-analysis of SWATs

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

Contact Info

Product

Resources

About