Optimizing Informed Consent for Participants in Randomised Controlled

Optimizing Informed Consent for Participants in Randomised Controlled Trials: a Comparison of Three Different Methods James Ditai 1, 2, Macreen Mudoola 1, Brian Faragher 3, Julian Abeso 4, John Dusabe-Richards 3, Peter Olupot-Olupot 3, Enitan Carrol 2, Melissa Gladstone 2, Antonieta Medina-Lara 5, Julie Storr 6, Andrew Weeks 2 1 Sanyu Africa Research Institute, Uganda; 2 Sanyu Unit, University of Liverpool, UK; 3 Liverpool School of Tropical Medicine, UK; 4 Mbale Regional Referral Hospital, Uganda; 5 University of Exeter, UK; 6 WHO, Switzerland. Background Informed Consent is a fundamental ethical requirement for medical research. However poor participant understanding of the research information continues to be reported. This can be particularly a problem in community interventional studies in rural African women, where levels of illiteracy, dependency and compliance are high. There have been calls for research into innovations to improve the informed consent process. The recent systematic review by Synnot et al (2014) of 16 studies involving data from 1884 participants revealed that there is still uncertainty about the effect of audio-visual informed consent interventions on a range of patient outcomes. In this study we tested an improved informed consent process, developed for women of low or no literacy in a low-income setting in rural eastern Uganda. Methods v A nested consent study within the pilot of a cluster randomised trial in rural eastern Uganda v 3 methods of informed consent were used over 3 weeks to recruit pregnant women in their homes from 13 villages v Each method was used for 1 week of recruitment in addition to the standard participant information sheet (PIS) for every participant. Objective To assess the impact of alternative consent models on participant’s understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda Results § A total of 30 pregnant women were recruited in their homes over 3 weeks during November 2015 § 21 from 6 trial clusters/villages, and 9 were from 7 villages outside the trial clusters § All participants were followed up after 48 hours and assessed recall for information and preference § 93. 3% (28/30) were evaluated at 48 hrs § 6. 7% (2/30) were not at home on the 48 hours visit and were evaluated 72 hours later § Most women preferred slide show consent [63% (19/30) vs video 20% (6/30) and researcher- read 17% (5/30)] Typical comments from women were: “For me who has not gone to school, I am able to understand better…” “It’s because the explanations were being demonstrated at the same time. . ”. “You can ask questions if you have not understood, while in the video you cannot. ” “…it has shown me how serious it is when the baby falls sick…” Discussion Week 1: Researcher-Read Consent: • Researcher read study information to participant +/family member • Participant receives PIS Week 2: Slide Show Consent: • Researcher verbally presented slide show in a double sided flip-like Calendar • Participant receives PIS Week 3: Video Message Consent: • participant +/- family member watched a pre-recorded video on a smart phone • Participant receives PIS Woman visited at home after 48 hrs of Consent: • Researcher assessed recall of information • Shown other 2 consent methods • Established preference In this study, the majority of pregnant women preferred slide show consent method. They liked having pictures in the slides to aid their understanding, and the logical progression of information. The slides were developed from the Participant Information Sheet by a consensus of scientists from Uganda and the United Kingdom in English and translated into the local language for use during recruitment, and pictures included that directly related to the study information. Women may not have valued the video-message method as it was simply a recording of the researcher reading out the study information Conclusion The slide show consent model is preferred model for recruitment of pregnant women into randomised controlled trials in rural Ugandan settings. Reference Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B. Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database of Systematic Reviews 2014, Issue 5. Art. No. : CD 003717. DOI: 10. 1002/14651858. CD 003717. pub 3 This study was funded by the UK MRC/Wellcome Trust/Df. ID Global Health Trials Scheme