Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi [Book Review]
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
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BMC Medical Ethics 13 (1):29- (2012)
Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms ( n =18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.
|Keywords||Assessment Comprehension Double-blinding Informed consent Intervention Randomisation Placebo Malawi Understanding|
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References found in this work BETA
Howard Brody & Franklin G. Miller (2003). The Clinician-Investigator: Unavoidable but Manageable Tension. Kennedy Institute of Ethics Journal 13 (4):329-346.
M. Stead (2005). “Hello, Hello—It's English I Speak!”: A Qualitative Exploration of Patients' Understanding of the Science of Clinical Trials. Journal of Medical Ethics 31 (11):664-669.
C. Kerr (2004). Randomisation in Trials: Do Potential Trial Participants Understand It and Find It Acceptable? Journal of Medical Ethics 30 (1):80-84.
Citations of this work BETA
Bridget Haire, Morenike Oluwatoyin Folayan, Catherine Hankins, Jeremy Sugarman, Sheena McCormack, Gita Ramjee & Mitchell Warren (2013). Ethical Considerations in Determining Standard of Prevention Packages for HIV Prevention Trials: Examining PrEP. Developing World Bioethics 13 (2):87-94.
Esther Munalula‐Nkandu, Paul Ndebele, Seter Siziya & J. C. Munthali (2015). To What Did They Consent? Understanding Consent Among Low Literacy Participants in a Microbicide Feasibility Study in Mazabuka, Zambia. Developing World Bioethics 15 (3):248-256.
Marion Kalabuanga, Raffaella Ravinetto, Vivi Maketa, Hypolite Muhindo Mavoko, Blaise Fungula, Raquel Inocêncio da Luz, Jean‐Pierre Van Geertruyden & Pascal Lutumba (2015). The Challenges of Research Informed Consent in Socio‐Economically Vulnerable Populations: A Viewpoint From the Democratic Republic of Congo. Developing World Bioethics 16 (1).
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