title: Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large Clinical Trial.
abstract: BACKGROUND
  In the recent literature, there has been some evidence that exposure of children to anesthetic procedures during the first two 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 an 18-19 year old group; 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 an insight on 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.
authors: Mayo Clinic.
authors: Sandeep
authors: S
authors: Kadimpati
authors: Biomedical Ethics Program College of Medicine Mayo Clinic 200 1st ST SW Rochester, MN 55905.
authors: Jennifer B
authors: JB
authors: McCormick
authors: Mayo Clinic.
authors: Yichen
authors: Y
authors: Chiu
authors: Davidson College.
authors: Ashley B
authors: AB
authors: Parker
authors: University of Wisconsin Madison.
authors: Aliya Z
authors: AZ
authors: Iftikhar
authors: Mayo Clinic.
authors: Randall P
authors: RP
authors: Flick
authors: Mayo Clinic.
authors: David O
authors: DO
authors: Warner
keywords: Anesthesia; Focus groups; Learning disability; Research trial participation; Return of test results