Sgro Gina M, Maurer Maureen, Nguyen Beth, Siegel Joanna E
American Institutes for Research, Atlanta, GA, USA.
American Institutes for Research, Chapel Hill, NC, USA.
Contemp Clin Trials Commun. 2023 Apr 14;33:101136. doi: 10.1016/j.conctc.2023.101136. eCollection 2023 Jun.
Most researchers and study participants believe that the summary, or aggregate, results of health research should be returned to study participants. However, researchers often do not return aggregate results. A better understanding of the impediments to results return could support improvements in this practice.
This qualitative study convened eight virtual focus groups, four with investigators and four with patient partners from research studies funded by the Patient-Centered Outcomes Research Institute (PCORI). In total, 23 investigators and 20 partners participated. We explored perspectives, experiences, influences, and recommendations related to aggregate results return.
Focus group participants described the ethical importance of returning aggregate results, as well as the benefits to study participants. They also noted important impediments to results return, emphasizing IRB and logistical challenges and describing a lack of support for the practice both on the part of institutions and the field at large. Participants highlighted the value of patients and caregivers' perspectives and contributions to results return, which focused on returning the most relevant findings through effective channels and formats. They further emphasized the importance of planning and identified resources that could support results return.
Researchers, funders, and the field can better facilitate results return by promoting standardized processes in research, such as the earmarking of funds for results return and inclusion of results returns milestones in research plans. More intentional policies, infrastructures, and resources that support results return may lead to more widespread return of study results to those who make these studies possible.
大多数研究人员和研究参与者认为，健康研究的总结性或汇总性结果应反馈给研究参与者。然而，研究人员往往不反馈汇总结果。更好地了解结果反馈的障碍有助于改进这一做法。
这项定性研究召集了8个虚拟焦点小组，其中4个由研究人员组成，4个由患者合作伙伴组成，这些研究人员和患者合作伙伴来自以患者为中心的结果研究所（PCORI）资助的研究项目。共有23名研究人员和20名合作伙伴参与。我们探讨了与汇总结果反馈相关的观点、经验、影响因素和建议。
焦点小组参与者描述了反馈汇总结果的伦理重要性以及对研究参与者的益处。他们还指出了结果反馈的重要障碍，强调了机构审查委员会（IRB）和后勤方面的挑战，并描述了机构和整个领域对这一做法缺乏支持。参与者强调了患者及其护理人员的观点和对结果反馈的贡献的价值，这集中在通过有效的渠道和形式反馈最相关的研究结果。他们进一步强调了规划的重要性，并确定了可以支持结果反馈的资源。
研究人员、资助者和整个领域可以通过推动研究中的标准化流程，如为结果反馈指定资金以及在研究计划中纳入结果反馈的里程碑，来更好地促进结果反馈。更多支持结果反馈的有意政策、基础设施和资源可能会导致研究结果更广泛地反馈给那些使这些研究成为可能的人。
