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 ≥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

Rabies-Related Knowledge and Practices Among Persons At Risk of Bat Exposures in Thailand

Rabies is a fatal encephalitis caused by lyssaviruses. Evidence of lyssavirus circulation has recently emerged in Southeast Asian bats. We surveyed persons regularly exposed to bats and bat habitats in Thailand to assess rabies‐related knowledge and practices. Targeted groups included guano miners, bat hunters, game wardens, and residents/personnel at Buddhist temples where mass bat roosting occurs. Of the 106 people interviewed, 11 (10%) identified bats as a source of rabies. History of a bat bite/scratch was reported by 29 (27%), and 38 (36%) expressed either that they would do nothing or that they did not know what they would do in response to a bat bite. Guano miners were less likely than other groups to indicate animal bites as a mechanism of transmission (68% vs. 90%, p=0.03) and were less likely to say they would respond appropriately to a bat bite or scratch (61% vs. 27%, p=0.003). These findings indicate a need for educational outreach in Thailand to raise awareness of bat rabies, promote exposure prevention, and ensure health‐seeking behaviors for bat‐inflicted wounds, particularly among at‐risk groups

Post-mastectomy breast reconstruction: reducing the disparity through educational outreach to the underserved.

PURPOSE: Poor health literacy and awareness are thought to be some of the major contributors to existing racial/ethnic disparities in access to breast reconstruction after mastectomy. This study aimed to determine whether physician led, community-based educational symposium improves understanding of breast cancer care and breast reconstruction in underserved populations. METHODS: Annual educational symposiums were held between 2017 and 2019 in underserved communities in the greater Philadelphia area. The symposium consisted of a series of short lectures on breast health, cancer screening, surgical management and reconstruction, patient testimonials, a Q&A panel, and an exhibitor fair. Attendees were given pre- and post-symposium surveys that evaluated knowledge of breast cancer care and reconstruction on a 0-100 scale based on percentage of correct answers. RESULTS: Of 169 individuals, 92%, 91%, and 83% completed pre-symposium, post-symposium, and both surveys, respectively. Median age was 60 years, and 92% were Black. Knowledge/understanding survey scores significantly improved after the symposium (50 vs. 87, p \u3c 0.01). Of all respondents, 92% found the symposium to be useful, 89% were introduced to resources that they were not previously aware of, 90% would recommend the symposium to others, and 91% would pass along the information they learned. CONCLUSION: This study presents an effective and reproducible strategy to increase community awareness and understanding of general breast cancer concepts and breast reconstruction options. Through community outreach and education, physicians can help underserved populations have a better understanding of their potential options for breast reconstruction and ultimately reduce this well documented but inadequately addressed disparity in cancer care