Methods for Incorporating Stakeholder Engagement into Clinical Trial Design.
Methods for Incorporating Stakeholder Engagement into Clinical Trial Design.
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DOI：
10.13063/2327-9214.1274
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发表时间：
2017-05-10
期刊：
影响因子：
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通讯作者：
Lavallee, Danielle C
中科院分区：
文献类型：
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作者：
Ehlers, Anne P;Davidson, Giana H;Lavallee, Danielle C
背景：缺乏与医疗保健利益相关者的接触导致错过了理解证据转化为实践的机会。案例：利益相关者参与是药物和阑尾切除术（CODA）研究结果比较的关键组成部分，该研究是由PCORI资助的一项实用临床试验，旨在评估抗生素与急性无并发症阑尾炎紧急阑尾切除术的有效性。我们提供了一个开发利益相关者协调中心（SCC）的框架，并描述了利益相关者参与如何为研究开发提供信息的两个例子。发现：通过SCC协调参与活动，建立了与利益相关者建立重要伙伴关系的承诺。它还促进了沟通，并提供了一个中央机制，以获取对关键决策的投入，例如制定以患者为中心的同意文件和针对阑尾炎患者特定亚群的适当停止规则。主要主题：可翻译的课程包括深思熟虑的参与计划，确定对研究行为和结果有直接兴趣的利益相关者，以及将收到的输入整合到推动研究行为的决策中。结论：开展以患者为中心的研究的标准应通过展示招募研究参与者的能力，在研究期间吸引他们，并传播符合利益相关者需求的研究结果，从而解决成功吸引患者的能力。分享重要临床研究成果的过程改善了患者护理，我们相信，传播新颖的参与策略可以提高研究设计和执行的成功率。
CONTEXT: Lack of engagement with healthcare stakeholders results in missed opportunities to understand translation of evidence into practice.CASE: Stakeholder engagement is a key component of the Comparing Outcomes of Drugs and Appendectomy (CODA) Study, a pragmatic clinical trial funded by PCORI to evaluate the effectiveness of antibiotics versus urgent appendectomy for acute uncomplicated appendicitis. We provide a framework for developing a stakeholder coordinating center (SCC) and describe two examples of how stakeholder engagement can inform study development.FINDINGS: Coordinating engagement activities through the SCC established a commitment to the important partnership with stakeholders. It also facilitated communication and provided a central mechanism for obtaining input on key decisions such as development of patient-centered consent documents and appropriate stopping rules for a specific sub-population of patients with appendicitis.MAJOR THEMES: Translatable lessons include thoughtful planning for engagement, identifying stakeholders with a direct interest in the study conduct and findings, and integration of input received into the decisions that drive the conduct of the study.CONCLUSIONS: Standards for conducting patient-centered research should address the ability to successfully engage patients by demonstrating the capacity to recruit study participants, engage them over the duration of the study, and disseminate findings that are congruent with stakeholder needs. The process of sharing important clinical research findings has improved patient care, and we believe that dissemination of novel engagement strategies can lead to increased success in study design and execution.