Title |
A multimedia consent tool for research participants in the Gambia: a randomized controlled trial
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Published in |
Bulletin of the World Health Organization, March 2015
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DOI | 10.2471/blt.14.146159 |
Pubmed ID | |
Authors |
Muhammed Olanrewaju Afolabi, Nuala McGrath, Umberto D’Alessandro, Beate Kampmann, Egeruan B Imoukhuede, Raffaella M Ravinetto, Neal Alexander, Heidi J Larson, Daniel Chandramohan, Kalifa Bojang |
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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | 1% |
Gambia | 1 | 1% |
Unknown | 80 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 18 | 22% |
Researcher | 14 | 17% |
Student > Ph. D. Student | 7 | 9% |
Student > Bachelor | 6 | 7% |
Student > Postgraduate | 6 | 7% |
Other | 12 | 15% |
Unknown | 19 | 23% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 21 | 26% |
Nursing and Health Professions | 12 | 15% |
Social Sciences | 9 | 11% |
Biochemistry, Genetics and Molecular Biology | 4 | 5% |
Psychology | 3 | 4% |
Other | 11 | 13% |
Unknown | 22 | 27% |