University of Wisconsin School of Medicine and Public Health, Madison, WI.
Ronald O. Perelman Department of Emergency Medicine, New York University School of Medicine.
Med Care. 2021 Aug 1;59(Suppl 4):S370-S378. doi: 10.1097/MLR.0000000000001583.
Stakeholder involvement in health care research has been shown to improve research development, processes, and dissemination. The literature is developing on stakeholder engagement methods and preliminarily validated tools for evaluating stakeholder level of engagement have been proposed for specific stakeholder groups and settings.
This paper describes the methodology for engaging a Study Advisory Committee (SAC) in research and reports on the use of a stakeholder engagement survey for measuring level of engagement.
Stakeholders with previous research connections were recruited to the SAC during the planning process for a multicenter randomized control clinical trial, which is ongoing at the time of this writing. All SAC meetings undergo qualitative analysis, while the Stakeholder Engagement Survey instrument developed by the Patient-Centered Outcomes Research Institute (PCORI) is distributed annually for quantitative evaluation.
The trial's SAC is composed of 18 members from 3 stakeholder groups: patients and their caregivers; patient advocacy organizations; and health care payers. After an initial in-person meeting, the SAC meets quarterly by telephone and annually in-person. The SAC monitors research progress and provides feedback on all study processes. The stakeholder engagement survey reveals improved engagement over time as well as continued challenges.
Stakeholder engagement in the research process has meaningfully contributed to the study design, patient recruitment, and preliminary analysis of findings.
利益相关者参与医疗保健研究已被证明可以改善研究的开发、流程和传播。目前已经有关于利益相关者参与方法的文献，并针对特定利益相关者群体和环境提出了初步验证的利益相关者参与程度评估工具。
本文描述了让研究顾问委员会（SAC）参与研究的方法，并报告了使用利益相关者参与度调查来衡量参与程度的情况。
在一项多中心随机对照临床试验的规划过程中，招募了与之前的研究有联系的利益相关者加入 SAC，该试验正在进行中。所有 SAC 会议都进行定性分析，而由患者为中心的结局研究协会（PCORI）开发的利益相关者参与度调查工具则每年进行一次定量评估。
该试验的 SAC 由来自 3 个利益相关者群体的 18 名成员组成：患者及其照顾者、患者权益组织和医疗支付方。在最初的一次面对面会议后，SAC 每季度通过电话开会，每年面对面开会一次。SAC 监测研究进展并对所有研究过程提供反馈。利益相关者参与度调查显示，随着时间的推移，参与度有所提高，但仍面临挑战。
利益相关者在研究过程中的参与对研究设计、患者招募和初步分析结果有重要意义。
