Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial

Knapp, Peter; Mandall, Nicky; Hulse, Wendy; Roche, Jenny; Moe‐Byrne, Thirimon; Martin-Kerry, Jacqueline; Sheridan, Rebecca; Higgins, Steven

doi:10.1177/14653125211024250

Cited by 12 publications

(21 citation statements)

References 42 publications

(54 reference statements)

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“…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.…”

Section: Discussionmentioning

confidence: 91%

“…However, it is little evaluated, particularly in children or adolescents. 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.…”

Section: Discussionmentioning

confidence: 96%

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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

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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.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 96%

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

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“…However, it has not been subject to much evaluation, particularly in children or young people. In two other reported TRECA studies, one in a hypothetical trial setting 35 and the other a SWAT, 36 children were more likely to rate multimedia information as 'easy to understand' than printed information, and the MMIs produced a small but not statistically significant increase in trial recruitment. The MMI also resulted in greater confidence in decision-making in one of the studies.…”

Section: Discussionmentioning

confidence: 91%

“…The MMI also resulted in greater confidence in decision-making in one of the studies. 35 Both studies generated higher rates of positive evaluative comments about the MMI than the printed trial information. Two systematic reviews of trials of multimedia information to inform consent in adults reported that they may increase understanding of consent and the research, and increase information retention.…”

Section: Discussionmentioning

confidence: 98%

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

et al. 2022

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Background: Digital multimedia information (MMI) has potential for use in trial recruitment but there is little formal evaluation. The objectives were to evaluate digital MMI about a trial for its effects on recruitment, retention, participation decisions, and patients’ acceptability, compared with printed information (PIS) alone and when combined with PIS. Methods: SWAT (study within a trial) using random parallel-group individual allocation within the Thermic-3 trial evaluating warm versus cold cardioplegia solution during cardiac surgery. Set in one UK hospital, participants were 147 children (0-16 years) awaiting surgery for congenital heart defects; 38% were female. Participants and their parents/guardian received trial information via multimedia (including text, animated videos and talking-head videos) for viewing at home (MMI group; n=49), or PIS (PIS group; n=47), or both (PIS&MMI group; n=51). Primary outcome was recruitment rate to the Thermic-3 trial comparing PIS-alone and MMI-alone. Secondary outcomes were recruitment rate comparing PIS-alone and combined PIS&MMI; Decision-Making Questionnaire; 3 ‘free-text’ questions (deriving subjective evaluations); trial retention. Results: MMI produced a 14.2% absolute increase in recruitment, which was not statistically significant: 32 (65.3%) participants were recruited from the MMI group; 24 (51.1%) from the PIS group (OR 1.80; 95% CI 0.79 to 4.10, p = 0.16); and 22 from the PIS&MMI group. There was no difference in recruitment through combined PIS&MMI (43.1% vs 51.1%; OR 0.73; 95% CI 0.33 to 1.61; p= 0.43). Questionnaires were returned by 17 (12%) participants and analysed descriptively. Trial retention (at 3 months) was high in all groups (72/77; 93.5% overall) and there was no difference due to information format received before participating. Conclusions: MMI increased recruitment to the Thermic-3 trial but the difference was not statistically significant, and the SWAT was small. Trial registration: TRECA ISRCTN73136092 and NI Hub for Trials Methodology Research SWAT Repository (SWAT 97). Thermic-3: ISRCTN13467772.

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“…Three studies (4 publications) with "limited" validity reported better usability with eConsent than with paper-based ICFs [13,19,20,49], and in 2 of these studies, at least some of the differences were statistically significant [13,19,20]. [49], 2021…”

Section: Patient Usability: Econsenting Versus Papermentioning

confidence: 99%

Comparative Effectiveness of eConsent: Systematic Review

Cohen¹,

Byrom²,

Becher³

et al. 2023

J Med Internet Res

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Background Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns. Objective This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process (“cycle time”) and on-site workload in comparison with traditional paper-based consenting. Methods The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having “high” validity if comprehensive assessments were performed using established instruments. Results Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with “high” validity), acceptability (8/35, 23% of the studies; 1 with “high” validity), and usability (5/35, 14% of the studies; 1 with “high” validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the “high” validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. Conclusions This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.

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Evaluating the use of multimedia information when recruiting adolescents to orthodontics research: A randomised controlled trial

Cited by 12 publications

References 42 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 effects of multimedia information on recruitment and retention in a children’s cardiac surgery trial: a randomised controlled SWAT (study within a trial)

Comparative Effectiveness of eConsent: Systematic Review

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