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移植中的预后生物标志物:系统性审查和批判性评估
Marc Raynaud1, Solaf Al-Awadhi1, Kevin Louis1
1INSERM, PARCC, Paris Institute for Transplantation and Organ Regeneration, Université de Paris Cité, Paris, France.
Journal of the American Society of Nephrology : JASN
|December 6, 2023
概括
大多数移植生物标志物研究设计不佳,缺乏验证,阻碍了临床使用. 需要严格的研究来改善生物标志物在患者护理中的接受和实施.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學.
- 移植 移植 移植 移植
- 生物标志物研究 生物标志物研究
背景情况:
- 在移植中的生物标志物研究在过去二十年里显著增加.
- 然而,缺乏临床效益证明和这些生物标志物的常规实施.
- 假设低于最佳的研究设计,数据,方法和报告有助于弥补这一差距.
研究的目的:
- 批判性地评估预后性移植生物标志物研究的质量.
- 确定导致卫生当局接受的生物标志物数量有限的因素.
- 强调在移植生物标志物开发方面需要改进的研究标准.
主要方法:
- 2005年至2022年间发表的804项脏移植生物标志物研究的超流行病学研究.
- 在主要数据库 (PubMed,Embase,Scopus,Web of Science,Cochrane Library) 进行系统的文献搜索.
- 专家对评估设计,方法,结果,解释,可复制性和透明度的研究进行专家审查.
主要成果:
- 大多数研究 (81.5%) 是回顾性和单一中心 (74.0%),患者数量很少.
- 外部验证仅在4.7%的研究中进行.
- 透明度差,对预后因素的调整不足 (43.0%) 和有限的数据/代码共享 (8.8%/1.1%) 是普遍存在的.
结论:
- 移植生物标志物研究的特点是研究设计,方法和透明度低于最佳.
- 缺乏严格的验证和报告挑战了候选生物标志物的附加值.
- 实施更高的研究标准对于验证生物标志物和使其在临床上使用至关重要.
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