1. A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.
- Author
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Afolabi, Muhammed Olanrewaju, McGrath, Nuala, D'Alessandro, Umberto, Kampmann, Beate, Imoukhuede, Egeruan B., Ravinetto, Raffaella M., Alexander, Neal, Larson, Heidi J., Chandramohan, Daniel, and Bojang, Kalifa
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MALARIA diagnosis , *ACHIEVEMENT tests , *COMPUTER adaptive testing , *PATIENT aftercare , *INFORMED consent (Medical law) , *LITERACY , *MEDICAL care , *MEMORY , *MULTIMEDIA systems , *PATIENTS , *QUESTIONNAIRES , *VIDEO recording , *PATIENTS' rights , *DATA analysis , *ACCESS to information , *RANDOMIZED controlled trials , *CONTROL groups , *HUMAN research subjects , *PATIENT selection , *DATA analysis software , *MANN Whitney U Test , *KRUSKAL-Wallis Test - Abstract
Objective To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. Methods Adults 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. Findings On 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. Conclusion A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. [ABSTRACT FROM AUTHOR]
- Published
- 2015
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