Piloting a tool for informed consent comprehension in a cardiovascular clinical trial in South Africa: An IMPI-2 pilot trial substudy (ICC Study)

Background. Informed consent is a key requirement in research. However, the comprehension of information presented is rarely evaluated prior to or during the research. Ensuring that participants understand the key issues in trials is important, not just for ethical reasons, but also because it can help set patient expectations. We evaluated the feasibility of using the University of California Brief Assessment of Capacity to Consent (UBACC) questionnaire to guide informed consent comprehension in the pilot study for the second Investigation of the Management of Pericarditis in Africa (IMPI-2) trial. IMPI-2 is a randomised control trial (RCT) on the use of alteplase-facilitated pericardial drainage, compared with routine care among patients with large pericardial effusion. We used an abbreviated version of the UBACC to evaluate participant comprehension of key elements of the consent documentation and to guide discussions. Method. Comprehension was assessed using a 10-item UBACC at baseline, 6 weeks, 3 months and 6 months follow-up to reiterate the information about the trial. Each response was scored from 0 to 3 and the sum at each visit was recorded to represent comprehension. A UBACC score of >= 25 was considered adequate comprehension. Bivariate logistic regression was performed to evaluate comprehension over time. A multivariate analysis was conducted to identify predictors of UBACC score. Results. The Informed Consent Comprehension (ICC) Study included 71 participants with a median age of 42 years; 45% were females and 49% had at least a secondary level of education. Level of comprehension improved with time; the odds of passing the evaluation at baseline compared with 6 months was higher (odds ratio (OR) 1.39, 95% confidence interval (CI) 1.17 - 1.65, p<0.001). Not using interpreters and having a secondary level of education were associated with higher comprehension. Despite knowing that they were participating in research, many participants still did not accept that the trial drug may have no effect. Conclusion. It is feasible to use the UBACC questionnaire for informed consent comprehension evaluation in RCTs. Repeated learning during follow-up improves comprehension over time, while a low level of education and use of interpreters reduces comprehension.