Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.


Afolabi, MO; Bojang, K; D'Alessandro, U; Imoukhuede, EB; Ravinetto, RM; Larson, HJ; McGrath, N; Chandramohan, D; (2014) Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing. J Clin Res Bioeth, 5 (3). p. 178. ISSN 2155-9627 DOI: 10.4172/2155-9627.1000178

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Abstract

BACKGROUND International guidelines recommend the use of appropriate informed consent procedures in low literacy research settings because written information is not known to guarantee comprehension of study information. OBJECTIVES This study developed and evaluated a multimedia informed consent tool for people with low literacy in an area where a malaria treatment trial was being planned in The Gambia. METHODS We developed the informed consent document of the malaria treatment trial into a multimedia tool integrating video, animations and audio narrations in three major Gambian languages. Acceptability and ease of use of the multimedia tool were assessed using quantitative and qualitative methods. In two separate visits, the participants' comprehension of the study information was measured by using a validated digitised audio questionnaire. RESULTS The majority of participants (70%) reported that the multimedia tool was clear and easy to understand. Participants had high scores on the domains of adverse events/risk, voluntary participation, study procedures while lowest scores were recorded on the question items on randomisation. The differences in mean scores for participants' 'recall' and 'understanding' between first and second visits were statistically significant (F (1,41)=25.38, p<0.00001 and (F (1, 41) = 31.61, p<0.00001 respectively. CONCLUSIONS Our locally developed multimedia tool was acceptable and easy to administer among low literacy participants in The Gambia. It also proved to be effective in delivering and sustaining comprehension of study information across a diverse group of participants. Additional research is needed to compare the tool to the traditional consent interview, both in The Gambia and in other sub-Saharan settings.

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
PubMed ID: 25133065
URI: http://researchonline.lshtm.ac.uk/id/eprint/1883895

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