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
Learn more about PhilPapers
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|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
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).
Similar books and articles
Andrew Vallely, Shelley Lees, Charles Shagi, Stella Kasindi & Selephina Soteli (2010). How Informed is Consent in Vulnerable Populations? Experience Using a Continuous Consent Process During the MDP301 Vaginal Microbicide Trial in Mwanza, Tanzania. BMC Medical Ethics 11 (1):10-.
Howard B. Degenholtz, Lisa S. Parker & Charles F. Reynolds (2002). Trial Design and Informed Consent for a Clinic-Based Study with a Treatment as Usual Control Arm. Ethics and Behavior 12 (1):43 – 62.
Emma R. M. Cohen, Jennifer M. O'neill, Michel Joffres, Ross E. G. Upshur & Edward Mills (2009). Reporting of Informed Consent, Standard of Care and Post-Trial Obligations in Global Randomized Intervention Trials: A Systematic Survey of Registered Trials. Developing World Bioethics 9 (2):74-80.
P. Allmark (2006). Improving the Quality of Consent to Randomised Controlled Trials by Using Continuous Consent and Clinician Training in the Consent Process. Journal of Medical Ethics 32 (8):439-443.
Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine & Ethics 38 (2):257-266.
H. Mann (2005). Controversial Choice of a Control Intervention in a Trial of Ventilator Therapy in ARDS: Standard of Care Arguments in a Randomised Controlled Trial. Journal of Medical Ethics 31 (9):548-553.
R. Macklin (2010). Intertwining Biomedical Research and Public Health in HIV Microbicide Research. Public Health Ethics 3 (3):199-209.
Jessica Masty & Celia Fisher (2008). A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research. Ethics and Behavior 18 (2 & 3):139 – 160.
Charles Weijer, Characterizing the Population in Clinical Trials: Barriers, Comparability, and Implications for Review.
Ayodele S. Jegede (2009). Understanding Informed Consent for Participation in International Health Research. Developing World Bioethics 9 (2):81-87.
Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Juhana E. Idänpään-Heikkilä & Sev Fluss (2004). The CIOMS View on the Use of Placebo in Clinical Trials. Science and Engineering Ethics 10 (1):23-28.
Laura Buccini, Donald Iverson, Peter Caputi & Caroline Jones (2010). An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents. Journal of Bioethical Inquiry 7 (3):313-319.
Laura Weiss Roberts, Teddy D. Warner, Laura B. Dunn, Janet L. Brody, Katherine Green Hammond & Brian B. Roberts (2007). Shaping Medical Students' Attitudes Toward Ethically Important Aspects of Clinical Research: Results of a Randomized, Controlled Educational Intervention. Ethics and Behavior 17 (1):19 – 50.
Added to index2012-11-09
Total downloads5 ( #505,679 of 1,796,251 )
Recent downloads (6 months)1 ( #468,795 of 1,796,251 )
How can I increase my downloads?