提高随机试验协议和报告的完整性和透明度:SPIRIT 2025和CONSORT 2025随机试验的完整性和透明度
David Moher1, Isabelle Boutron2, An-Wen Chan3
1Centre for Journalology, Methodological and Implementation Research Program, Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.
更新的SPIRIT 2025和CONSORT 2025指南提高了临床试验的透明度和可靠性. 这些修订后的报告标准通过更清晰的协议和结果提高了研究质量和患者的结果.
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
- 科学透明度 科学透明度
背景情况:
- 现有的指南SPIRIT 2013和CONSORT 2010需要更新以反映临床研究的进步.
- 确保试验协议和报告的明确性和完整性对于研究完整性和患者利益至关重要.
研究的目的:
- 更新SPIRIT (标准协议项目:干预试验建议) 和CONSORT (试验报告综合标准) 的指导方针.
- 提高临床试验协议和报告的透明度,完整性和可靠性.
主要方法:
- 对于SPIRIT 2025和CONSORT 2025都采用了包括范围审查,专家咨询和Delphi调查在内的全面审查过程.
- 方法的进步和用户的反被纳入了修订过程.
主要成果:
- SPIRIT 2025 具有 34 项检查清单,包括关于开放科学,危害评估,干预描述和患者参与的新部分.
- CONSORT 2025包括一个30项检查清单,其中包括关于危害,结果,非药物治疗和个性化治疗的新项目,以及一个开放科学部分.
- 这两份更新的指南都提供了详细的解释性检查清单,旨在改善研究报告.
结论:
- 预计更新的SPIRIT 2025和CONSORT 2025指南将提高研究的质量和可用性.
- 鼓励研究人员,资助者,伦理委员会,期刊和监管机构广泛采用,以最大限度地为患者带来好处.
- 这些修订促进了临床试验报告的更大透明度和完整性.
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