SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
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DOI：
10.7326/0003-4819-158-3-201302050-00583
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发表时间：
2013-02-05
影响因子：
39.2
通讯作者：
Moher, David
中科院分区：
文献类型：
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作者：
Chan, An-Wen;Tetzlaff, Jennifer M.;Moher, David
临床试验方案是研究计划、实施、报告和评估的基础。然而，试验方案和现有的方案指南在内容和质量上差异很大。本文介绍了SPIRIT（Standard Protocol Items：Recommendations for Interventional Trials）2013的系统发展和范围。SPIRIT是临床试验方案的最低内容指南。33项SPIRIT检查表适用于所有临床试验的方案，侧重于内容而不是格式。检查表建议对计划内容进行完整描述，但没有规定如何设计或进行试验。通过为关键内容提供指导，SPIRIT建议旨在促进起草高质量的协议。遵守SPIRIT还将提高试验方案的透明度和完整性，使研究者、试验参与者、患者、申办者、资助者、研究伦理委员会或机构审查委员会、同行评审员、期刊、试验登记处、政策制定者、监管机构和其他关键利益相关者受益。
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.