在试验报告中报告结果的指导方针:CONSORT结果2022扩展
Nancy J Butcher1,2, Andrea Monsour1, Emma J Mew1,3
1Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
新的CONSORT-Outcomes 2022指南提供了临床试验报告的17个基本项目. 这些标准提高了透明度,并减少了对结果的选择性报告,以更好地基于证据的决策.
科学领域:
- 临床试验方法
- 卫生研究报告标准
背景情况:
- 临床医生,患者和决策者依靠临床试验结果做出基于证据的决定.
- 关于试验计划,方法和结果的完整和透明报告对于批判性评估至关重要.
- 缺乏报告实践使结果选择,评估和分析问题变得模糊,需要改进指导.
研究的目的:
- 在临床试验报告中制定基于证据和共识的协调标准.
- 将这些标准与2010年"报告试验综合标准" (CONSORT) 声明相结合.
主要方法:
- 使用"提高健康研究质量和透明度" (EQUATOR) 方法框架.
- 进行现有成果报告指南和专家商的范围审查.
- 采用了3轮国际Delphi投票过程,有124名小组成员参加,并与25名小组成员进行了面对面的共识会议.
主要成果:
- 确定了128条建议,其中83%没有纳入CONSORT 2010声明.
- 整合了64项建议进行德尔菲投票,其中30项提前到达共识会议.
- 在CONSORT-Outcomes 2022扩展中获得了17个关键的具体结果项目.
结论:
- 对于临床试验出版物,CONSORT-结果2022扩展提供了17个结果特定的报告项目.
- 这些项目旨在提高试验的实用性,可复制性和透明度.
- 实施可能会最大限度地降低临床试验结果的选择性不报告的风险.
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