BACKGROUND: How best to provide the findings of research to study participants remains poorly understood. PURPOSE: We aimed to develop, deliver, and evaluate a consultative approach to inform provision of feedback about research findings to participants in the Oracle Children Study (OCS). The OCS had identified adverse outcomes for some children whose mothers had been prescribed antibiotics as part of a trial in pregnancy. METHODS: An iterative process, including focus groups with OCS participants and consultation with other OCS stakeholders, was used to inform the development of a feedback package, including a results leaflet, for OCS participants. A questionnaire survey of participants' reactions to receiving the results leaflet was conducted. The Kolmogorov-Smirnov two-sample test was used to compare responses between different groups of respondents. Analysis of open-ended comments on the questionnaire was based on the constant comparative method. RESULTS: Three focus groups with study participants provided insight into the potential emotional impact of receiving the results and into how the results might most clearly be explained. Negotiations with other stakeholders identified other priorities, including the need for scientific credibility. These multiple needs had to be balanced. The results leaflet was posted to all 4676 UK OCS participants. Survey responses were received from 1124 (25%) of participants. They indicated that the feedback was mostly well received by participants. Those whose children were affected by conditions associated with increased risk from trial participation were more likely to experience emotional distress on receiving the trial results, but there was also evidence of some other unanticipated impacts. LIMITATIONS: This study is limited by the low response rate to the survey. CONCLUSIONS: Important lessons can be learned from using a consultative approach to developing feedback about research results for study participants. Especially where the findings are unwelcome, feedback development may involve methodological, ethical, emotional, and practical challenges, be resource-intensive, and need early planning.
BACKGROUND: How best to provide the findings of research to study participants remains poorly understood. PURPOSE: We aimed to develop, deliver, and evaluate a consultative approach to inform provision of feedback about research findings to participants in the Oracle Children Study (OCS). The OCS had identified adverse outcomes for some children whose mothers had been prescribed antibiotics as part of a trial in pregnancy. METHODS: An iterative process, including focus groups with OCS participants and consultation with other OCS stakeholders, was used to inform the development of a feedback package, including a results leaflet, for OCS participants. A questionnaire survey of participants' reactions to receiving the results leaflet was conducted. The Kolmogorov-Smirnov two-sample test was used to compare responses between different groups of respondents. Analysis of open-ended comments on the questionnaire was based on the constant comparative method. RESULTS: Three focus groups with study participants provided insight into the potential emotional impact of receiving the results and into how the results might most clearly be explained. Negotiations with other stakeholders identified other priorities, including the need for scientific credibility. These multiple needs had to be balanced. The results leaflet was posted to all 4676 UK OCS participants. Survey responses were received from 1124 (25%) of participants. They indicated that the feedback was mostly well received by participants. Those whose children were affected by conditions associated with increased risk from trial participation were more likely to experience emotional distress on receiving the trial results, but there was also evidence of some other unanticipated impacts. LIMITATIONS: This study is limited by the low response rate to the survey. CONCLUSIONS: Important lessons can be learned from using a consultative approach to developing feedback about research results for study participants. Especially where the findings are unwelcome, feedback development may involve methodological, ethical, emotional, and practical challenges, be resource-intensive, and need early planning.
Authors: Erin Lebow-Skelley; Sarah Yelton; Brandi Janssen; Esther Erdei; Melanie A Pearson Journal: Int J Environ Res Public Health Date: 2020-09-16 Impact factor: 3.390