Trial reportClinical trials (London, England)2019
Recruitment and retention: A randomized controlled trial of video-enhanced versus standard consent processes within the E-OPTIMAL study.
Trial report in Clinical trials (London, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pooled it
- Do recruitment SWAT interventions have an impact on participant retention in randomised controlled trials? A systematic review.Clinical trials (London, England) · 2024Pooled it
- Recruitment and retention interventions in surgical and wound care trials: A systematic review.PloS one · 2023Pooled it
- Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021Pooled it
- Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial.JAMA network open · 2026Trial
- Using Participatory Methods to Create Informational Videos for Inclusive Brain Stimulation Research Recruitment: Action Research Study and Pilot Randomized Controlled Trial.Journal of participatory medicine · 2026Article
- Patient engagement and shared decision-making in trial recruitment intervention studies: a systematic review.Research involvement and engagement · 2025Review
- Describing the content of trial recruitment interventions using the TIDieR reporting checklist: a systematic methodology review.BMC medical research methodology · 2024Article
- Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK.Trials · 2024Article
- Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.Pilot and feasibility studies · 2024Article
- Educational video while "waiting-to-be-seen" in a cardiology outpatient clinic promotes opt-in self-consent for biobanking of remnant clinical biospecimens: A randomized-controlled trial.Journal of clinical and translational science · 2023Article
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
BACKGROUND/
aimsIn this study, we compared two research consent techniques: a standardized video plus usual consent and usual consent alone.
methodsIndividuals who completed 24-month outcomes (completers) in the Operations and Pelvic Muscle Training in the Management of Apical Support Loss study were invited to participate in an extended, longitudinal follow-up study (extended Operations and Pelvic Muscle Training in the Management of Apical Support Loss). Potential participants who were (1) able to provide consent and (2) not in long-term care facilities were randomized 1:1 to a standardized video detailing the importance of long-term follow-up studies of pelvic floor disorders followed by the usual institutional consent process versus the usual consent process alone. Randomization, stratified by site, used randomly permuted blocks. The primary outcome was the proportion of participants who enrolled in the extended study
resultsOf the 327 Operations and Pelvic Muscle Training in the Management of Apical Support Loss completers, 305 were randomized to the consent process study (153 video vs 152 no video). Groups were similar in demographics, surgical treatment, and outcomes. The overall rate of extended study enrollment was high, without significant differences between groups (video 92.8% vs no video 94.1%, p = 0.65). There were no significant differences in the primary outcome (video 79.1% vs no video 75.7%, p = 0.47) or in any secondary outcomes. Being "very satisfied" overall with study information (97.7% vs 88.5%, p = 0.01); "strong agreement" for feeling informed about the study (81.3% vs 70.8%, p = 0.06), understanding the study purpose (83.6% vs 71.0%, p = 0.02), nature and extent (82.8% vs 70.2%, p = 0.02), and potential societal benefits (82.8% vs 67.9%, p = 0.01); and research coordinator/study nurse relationship being "very important" (72.7% vs 63.4%, p = 0.03) were better in the video compared to the no video consent group.
conclusionThe extended study had high enrollment; most participants completed most study tasks during the 3-year observational extension, regardless of the use of video to augment research consent. The video was associated with a higher proportion of participants reporting improved study understanding and relationship with study personnel.
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