Evidence map›Paper›PMID 25133065›Full record

ArticleJournal of clinical research & bioethics2014

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

Muhammed Olanrewaju Afolabi, Kalifa Bojang, Umberto D'Alessandro, Egeruan Babatunde Imoukhuede, Raffaella M Ravinetto, Heidi Jane Larson, Nuala McGrath, Daniel Chandramohan

Abstract read
In one paragraph

Article in Journal of clinical research & bioethics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  17. Moving Forward on Consent Practices in Australia.Journal of bioethical inquiry · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Muhammed Olanrewaju AfolabiMedical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK ; London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
Kalifa BojangMedical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
Umberto D'AlessandroMedical Research Council Unit, Atlantic Road, Fajara, the Gambia and London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
Egeruan Babatunde ImoukhuedeCentre for Clinical Vaccinology and Tropical Medicine, the Jenner Institute, Oxford University Churchill Hospital, Oxford, OX3 7LJ, UK.
Raffaella M RavinettoInstitute of Tropical Medicine, Antwerp & KU Leuven, Belgium.
Heidi Jane LarsonLondon School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.
Nuala McGrathUniversity of Southampton, Southampton, Mailpoint 805, C floor, South Academic Block, Southampton General Hospital, Southampton, SO16 6YD, UK.
Daniel ChandramohanLondon School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, UK.

Funding

Medical Research Council MC_UP_A900_1118Medical Research Council MC_UP_A900_1119Wellcome Trust 083495Wellcome Trust 097410
6 · The paper itself

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.

Indexed as

DevelopmentInformed consentTechnologyThe GambiaVideoVulnerable population

Identifiers

PMID25133065
PMCPMC4133653

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.