用于开发SPIRIT 2024和CONSORT 2024声明的方法
Ruth Tunn1, Isabelle Boutron2, An-Wen Chan3
1Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK; Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Journal of clinical epidemiology
|March 1, 2024
概括
临床试验的最新报告准则,SPIRIT 2024和CONSORT 2024,是通过利益相关者的共识制定的. 这些指导方针协调了试验方案和结果的报告,以提高研究透明度.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究报告标准 研究报告标准
- 基于证据的医学基于证据的医学.
背景情况:
- SPIRIT (标准协议项目:干预试验建议) 和CONSORT (临床试验报告综合标准) 的指导方针对于对临床试验协议和结果的透明报告至关重要.
- 之前的版本 (SPIRIT 2013,CONSORT 2010) 需要更新以纳入新的证据和扩展.
- 协议与结果报告指南之间的协调对于一致性至关重要.
研究的目的:
- 描述开发更新的SPIRIT 2024和CONSORT 2024报告准则的方法和理由.
- 协调SPIRIT和CONSORT指导方针,以便对试验方案和结果进行一致的报告.
- 将关键扩展内容和利益相关者的反纳入更新的指南中.
主要方法:
- 同时开发SPIRIT 2024和CONSORT 2024以确保协调.
- 对以前版本和相关扩展的评论进行范围审查.
- 国际在线Delphi调查与利益相关者进行反关于拟议的变化.
- 在线专家共识会议讨论Delphi结果并最终确定建议.
- 根据反,起草和修订更新的SPIRIT和CONSORT检查清单.
主要成果:
- 对于SPIRIT和CONSORT,总共产生了33个潜在的变化.
- 317名参与者回应了德尔菲调查 (68%第1轮).
- 在35个提议的变更中,有14个在德尔菲调查中达到共识值.
- 共识会议参与者同意实施11/14德尔菲共识变化和4/21非共识变化.
- 还提出了进一步的建议,以改进关键概念并提高清晰度.
结论:
- 即将发布的SPIRIT 2024和CONSORT 2024声明为报告临床试验协议和结果提供了更新的,协调的指导.
- 开发过程整合了当前的经验证据和广泛的利益相关者的投入.
- 该方法报告旨在协助未来的报告准则开发团队.
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