混合方法研究,以开发扩展到因数随机试验的SPIRIT和CONSORT陈述:报告因数试验 (RAFT) 研究
Sophie S Hall1, Edmund Juszczak2, Megan Birchenall2
1Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK sophie.hall@nottingham.ac.uk.
BMJ open
|February 17, 2025
概括
报告因数试验 (RAFT) 制定了因数试验的新指南. 这些对标准协议项目:干预试验建议 (SPIRIT) 和试验报告综合标准 (CONSORT) 的扩展将改善试验的进行和解释.
科学领域:
- 临床试验方法论 临床试验方法论
- 报告准则 报告准则
- 干预性研究是干预性的研究.
背景情况:
- 实验试验需要特定的报告标准,超出现有指导方针.
- 报告因数试验 (RAFT) 组的目标是解决这个差距.
- 现有的SPIRIT和CONSORT指导方针需要扩展到因数试验设计.
研究的目的:
- 开发针对因数试验量身定制的SPIRIT和CONSORT报告准则的扩展.
- 确保对因数试验方法和结果进行全面和透明的报告.
主要方法:
- 采用了基于共识的四阶段方法.
- 这包括一个范围审查,一个多轮的Delphi调查与104名受访者,一个共识会议与15名专家,和检查清单的完成.
- 代改进和专家审查确保了特定报告项目的开发.
主要成果:
- 范围审查确定了31项建议,导致了50个指导方针开发概念.
- 一项德尔菲调查完善了这些概念,其中49个达到了共识.
- 这一过程导致了9个SPIRIT扩展项目和17个CONSORT扩展项目.
结论:
- 采用开发的SPIRIT和CONSORT扩展程序将提高因子试验的进行,理解和解释.
- 开发过程中的透明度促进了制定未来报告准则的最佳实践.
- 这些扩展旨在提高复杂的因数试验设计报告的质量和一致性.
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