档次注意事项4:在没有"证据"时如何使用档次? 使用未公布的注册表数据的案例研究
Ibrahim K El Mikati1, Brandy Begin2, Dagmara Borzych-Duzalka3
1Department of Internal Medicine, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA.
Journal of clinical epidemiology
|October 23, 2024
概括
当缺乏临床指导方针的公布证据时,使用未公布的注册表数据可以生成初级数据来回答重要问题,特别是在罕见或脆弱人群中. 报告的透明度至关重要.
科学领域:
- 医学研究方法学 医学研究方法学
- 基于证据的医学基于证据的医学.
- 数据科学数据科学数据科学
背景情况:
- 值得信赖的临床指南取决于对已发表证据的系统审查.
- 在没有直接证据的情况下,GRADE工作组为制定建议提供指导.
- 从注册表生成初级数据提供了一个替代方案,当出版文献不足时.
研究的目的:
- 举一个用注册表来生成初级数据的案例.
- 为解决缺乏公布证据的指导方针开发问题.
- 探索传统系统审查的替代方案.
主要方法:
- 利用临床和统计专业知识来利用可用的注册表来生成初级数据.
- 专注于没有直接出版的文献的指导性问题.
- 应用注册表数据来回答具有临床意义的问题.
主要成果:
- 在儿科腹膜透析感染的54个指南问题中,25个缺乏证据.
- 未公布的注册表数据为这些25个问题中的12个提供了主要信息.
- 登记数据补充了其他9个问题的现有证据.
结论:
- 从未公布的注册表数据生成初级证据在直接证据稀缺时是有价值的.
- 这种方法对罕见疾病或脆弱人群特别有益.
- 在使用未公布数据时,数据报告和分析计划的透明度至关重要.
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