Trial reportBulletin of the World Health Organization2015
A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.
Trial report in Bulletin of the World Health Organization, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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
16 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review.Trials · 2026Pooled it
- Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023Pooled it
- Pooled it
- Towards a more patient-centered clinical trial process: A systematic review of interventions incorporating health literacy best practices.Contemporary clinical trials · 2022Pooled it
- Digital tools in the informed consent process: a systematic review.BMC medical ethics · 2021Pooled it
- Acceptability and effectiveness of a study information video in improving the research consent process for youth: a non-inferiority trial.BMJ global health · 2025Trial
- Does the use of video improve patient satisfaction in the consent process for local-anaesthetic urological procedures?International urology and nephrology · 2021Trial
- Trial
- Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.Patient education and counseling · 2019Trial
- Video consent is preferred over written informed consent in pediatric rheumatology research.PLOS digital health · 2025Article
- Article
- Article
- Bioethical reflexivity and requirements of valid consent: conceptual tools.BMC medical ethics · 2019Article
- Engaging populations underrepresented in research through novel approaches to consent.American journal of medical genetics. Part C, Seminars in medical genetics · 2018Article
- Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia.Human vaccines & immunotherapeutics · 2017Article
- Clinical Research in Neglected Tropical Diseases: The Challenge of Implementing Good Clinical (Laboratory) Practices.PLoS neglected tropical diseases · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
objectiveTo assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia.
methodsAdults eligible for inclusion in a malaria treatment trial (n = 311) were randomized to receive information needed for informed consent using either a multimedia tool (intervention arm) or a standard procedure (control arm). A computerized, audio questionnaire was used to assess participants' comprehension of informed consent. This was done immediately after consent had been obtained (at day 0) and at subsequent follow-up visits (days 7, 14, 21 and 28). The acceptability and ease of use of the multimedia tool were assessed in focus groups.
findingsOn day 0, the median comprehension score in the intervention arm was 64% compared with 40% in the control arm (P = 0.042). The difference remained significant at all follow-up visits. Poorer comprehension was independently associated with female sex (odds ratio, OR: 0.29; 95% confidence interval, CI: 0.12-0.70) and residing in Jahaly rather than Basse province (OR: 0.33; 95% CI: 0.13-0.82). There was no significant independent association with educational level. The risk that a participant's comprehension score would drop to half of the initial value was lower in the intervention arm (hazard ratio 0.22, 95% CI: 0.16-0.31). Overall, 70% (42/60) of focus group participants from the intervention arm found the multimedia tool clear and easy to understand.
conclusionA multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy.
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Registered trials
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