Abstract
BackgroundInternational 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.ObjectivesThis 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.MethodsWe 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.ResultsThe 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.ConclusionsOur 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.
Highlights
Informed consent is a practical application of respect for person which is a fundamental principle of research [1]
In previous studies [6,25] conducted in Gambian communities, the local ethic committees recommended that oral interpretations of the English version of written informed consent documents should be provided to potential participants by trained field staff who are native speakers of the local languages [26]
Each playing session of the multimedia tool lasted an average of 20 minutes, while questionnaire administration through Digitised Audio Informed Consent Comprehension Questionnaire (DICCQ) took an average of 32 minutes
Summary
Informed consent is a practical application of respect for person which is a fundamental principle of research [1]. Comprehensive systematic reviews [4,5] of clinical research conducted in sub-Sahara Africa showed that participants often demonstrated poor comprehension of various domains of informed consent. Participants from Ivory Coast [8], Nigeria [9], Senegal [10], Kenya [11], Uganda [12] and Ethiopia [13] had sub-optimal comprehension of voluntary participation, autonomy, risks/benefits, randomisation and blinding. These unacceptably low levels of comprehension may be due to a combination of factors. 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
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