A multimedia consent tool for research participants in the Gambia: a randomized controlled trial.


Afolabi, MO; McGrath, N; D'Alessandro, U; Kampmann, B; Imoukhuede, EB; Ravinetto, RM; Alexander, N; Larson, HJ; Chandramohan, D; Bojang, K; (2015) A multimedia consent tool for research participants in the Gambia: a randomized controlled trial. Bulletin of the World Health Organization, 93 (5). 320-328A. ISSN 0042-9686 DOI: 10.2471/BLT.14.146159

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Abstract

To assess the effectiveness of a multimedia informed consent tool for adults participating in a clinical trial in the Gambia. 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. 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. A multimedia informed consent tool significantly improved comprehension and retention of consent information by research participants with low levels of literacy. Abstract available from the publisher. Abstract available from the publisher. Abstract available from the publisher. Abstract available from the publisher. Abstract available from the publisher.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Disease Control
Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Tropical Epidemiology Group
PubMed ID: 26229203
Web of Science ID: 356640900014
URI: http://researchonline.lshtm.ac.uk/id/eprint/2255431

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