Lyden Angela K, Kalpakjian Claire Z, Spino Cathie, Murphy Susan L, Lumeng Julie C, Lok Anna S
Michigan Institute for Clinical and Health Research, University of Michigan, Ann Arbor, Michigan, USA.
Clinical Trials Support Office, University of Michigan, Ann Arbor, Michigan, USA.
Clin Transl Sci. 2025 May;18(5):e70240. doi: 10.1111/cts.70240.
A high-quality protocol document is essential for the successful and efficient implementation of clinical trials, but there is no consensus on how clinical trial protocol document quality should be evaluated. We used a modified Delphi approach and cognitive interviews to develop a new protocol document quality assessment tool, the Protocol Quality Rating Tool (PQRT). We compiled a checklist of elements that should be included in a high-quality trial protocol document and asked experts to rate the importance of each element. We developed the PQRT by describing the expected content of each element and identified essential vs. additional (bonus) content to differentiate high- versus low-quality protocol documents and then organized the elements into 18 sections. We revised the PQRT based on feedback from and cognitive interviews with our protocol quality rating team. We then tested the PQRT using ten protocol documents previously approved by the Institutional Review Board. All the protocol quality raters found the tool easy to use and their scores were highly concordant for eight of ten protocol documents. We have developed and tested a simple tool to measure clinical trial protocol document quality and encourage other researchers to evaluate and validate it.
一份高质量的方案文件对于临床试验的成功和高效实施至关重要，但对于如何评估临床试验方案文件的质量尚无共识。我们采用改良的德尔菲法和认知访谈来开发一种新的方案文件质量评估工具，即方案质量评级工具（PQRT）。我们编制了一份高质量试验方案文件应包含的要素清单，并请专家对每个要素的重要性进行评级。我们通过描述每个要素的预期内容来开发PQRT，并确定了区分高质量与低质量方案文件的基本内容与附加（加分）内容，然后将这些要素组织成18个部分。我们根据方案质量评级团队的反馈和认知访谈对PQRT进行了修订。然后，我们使用十份先前经机构审查委员会批准的方案文件对PQRT进行了测试。所有方案质量评估者都认为该工具易于使用，并且对于十份方案文件中的八份，他们的评分高度一致。我们已经开发并测试了一种用于衡量临床试验方案文件质量的简单工具，并鼓励其他研究人员对其进行评估和验证。
