Providing the results of research to participants: a mixed-method study of the benefits and challenges of a consultative approach
Providing the results of research to participants: a mixed-method study of the benefits and challenges of a consultative approach
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DOI：
10.1177/1740774511403514
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发表时间：
2011-06-01
期刊：
影响因子：
2.7
通讯作者：
Kenyon, Sara
中科院分区：
文献类型：
--
作者：
Dixon-Woods, Mary;Tarrant, Carolyn;Kenyon, Sara
背景如何最好地提供研究的结果，研究participations.Purpose仍然知之甚少，我们的目的是开发，提供和评估咨询的方法，告知提供有关研究结果的反馈，参与者在甲骨文儿童研究（OCS）。OCS已经确定了一些儿童的母亲被规定抗生素作为试验的一部分，在pregnancy.Methods一个迭代的过程中，包括焦点小组与OCS参与者和其他OCS利益相关者的咨询，不良后果被用来通知开发的反馈包，包括结果传单，为OCS参与者。对参与者收到结果传单的反应进行了问卷调查。Kolmogorov-Smirnov双样本检验用于比较不同受访者群体之间的反应。开放式的意见问卷分析的基础上不断比较method.Results三个焦点小组与研究参与者提供了深入了解潜在的情感影响，收到的结果，并进入如何的结果可能是最清楚的解释。与其他利益攸关方的谈判确定了其他优先事项，包括科学可信性的必要性。必须平衡这些多重需求。结果传单张贴到所有4676英国OCS参与者。从1124（25%）的参与者收到了调查答复。他们表示，参与者大多对反馈意见反应良好。那些孩子受到影响的条件与风险增加的试验参与更有可能遇到情绪困扰的接收试验结果，但也有证据表明，其他一些意想不到的impactions.Limitations本研究是有限的低响应率调查。结论重要的经验教训，可以从使用协商的方法来发展研究结果的反馈研究参与者。特别是在调查结果不受欢迎的情况下，反馈开发可能涉及方法，道德，情感和实际挑战，需要资源密集型，需要早期规划。临床试验2011; 8：330-341。http://ctj.sagepub.com
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. Clinical Trials 2011; 8: 330-341. http://ctj.sagepub.com