Background: In the recent literature, there has been some evidence that exposure of children to anesthetic procedures during the first 2 years of life may impair cognitive function and learning in later life. We planned a clinical study to quantify this risk, a study involving testing 1,000 children for neurodevelopmental deficits. As a part of this planning, we conducted focus groups involving potential participants and their parents to elicit information regarding three issues: communications with the community and potential participants, recruitment and consent processes, and the return of neurodevelopmental testing results. Methods: Three focus groups were conducted with the parents of potential participants and one focus group was conducted with a group 18 years old; each group consisted of 6-10 participants. The moderated discussions had questions about recruitment, consenting issues, and expectations from the study about return of both overall trial findings and individual research test results. Results: The focus group data gave us insight into potential participants' views on recruitment, consenting, communications about the study, and expectations about return of both overall trial findings and individual research test results. The concerns expressed were largely addressable. In addition, the concern we had about some parents enrolling their children in the study solely for the sake of getting their child's cognitive function results was dispelled. Conclusions: We found that the individuals participating in our focus groups were generally enthusiastic about the large clinical study and could see the value in answering the study question. The data from the focus groups were used to inform changes to the recruitment and consent process. Focus group input was also instrumental in affirming the study design regarding return of results. Our experience suggests that the approach we used may serve as a model for other investigators to help inform the various elements of clinical study design, in particular the recruitment and consenting processes and expectations of potential participants regarding the return of individual research findings.
All Science Journal Classification (ASJC) codes
- Health(social science)
- Health Policy