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Utilizing Focus Groups with Potential Participants and Their Parents: An Approach to Inform Study Design in a Large
Sandeep Kadimpati1, Jennifer B McCormick2, Yichen Chiu1
1Mayo Clinic.
Insights
Focus groups involving parents and children informed the design of a clinical study on early-life anesthesia and cognitive function. This approach helps refine recruitment, consent, and results return for pediatric research.
Area of Science:
- Pediatric Anesthesia
- Neurodevelopmental Research
- Clinical Study Design
Background:
- Emerging evidence suggests early-life anesthesia may impact later cognitive function.
- A clinical study is planned to assess neurodevelopmental deficits in 1,000 children.
- Focus groups were conducted to inform study planning.
Purpose of the Study:
- To gather community and participant input on study design elements.
- To address communication, recruitment, consent, and results return.
- To inform the planning of a large-scale clinical trial.
Main Methods:
- Conducted three focus groups with parents of potential participants.
- Conducted one focus group with 18-19 year old individuals.
- Utilized moderated discussions to explore recruitment, consent, and data return expectations.
Main Results:
- Gained insights into participant views on study logistics and data sharing.
- Identified and addressed concerns regarding recruitment and consent processes.
- Dispelled concerns about parents enrolling children solely for cognitive testing results.
Conclusions:
- Participants were enthusiastic about the study and its objectives.
- Focus group data informed modifications to recruitment and consent procedures.
- The methodology provides a model for designing future clinical studies, particularly regarding participant engagement and results dissemination.
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.
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