在早产预防方面,很少有随机试验符合预定义的有用性标准
Janneke van 't Hooft1, Charlotte E van Dijk2, Cathrine Axfors3
1Meta-Research Innovation Center at Stanford (METRICS), Stanford University, Palo Alto, CA, USA; Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
Journal of clinical epidemiology
|September 1, 2023
概括
很少有用于预防早产的随机对照试验 (RCT) 符合有用性标准. 虽然最近的试验在一些领域 (如透明度) 显示了改进,但它们越来越多地使用了不太信息化的结果,并且缺乏患者参与.
科学领域:
- 产科和妇科 产科和妇科
- 临床试验方法论 临床试验方法论
- 公共卫生 公共卫生
背景情况:
- 过早分娩仍然是一个重大的全球健康挑战,需要高质量的研究来制定有效的预防策略.
- 随机对照试验 (RCT) 对于评估干预措施至关重要,但它们的有用性取决于遵守特定的方法和报告标准.
研究的目的:
- 为了使研究实用性工具用于早产预防RCT的运行.
- 评估这些RCT在多大程度上符合研究有用性的预定义标准.
- 识别随着时间的推移有用性的趋势和需要改进的领域.
主要方法:
- 通过文献搜索和共识过程,确定了一个具有八个标准和13个项目的实用性工具.
- 来自56个关于预防早产的科克莱恩综述中的347个RCT被多个评估者评估.
- 评估了符合有用性标准的情况,并对2010年以前和之后发表的试验进行了比较.
主要成果:
- 只有10%的评估RCT满足了超过一半的有用性标准.
- 最近的试验 (2010年以后) 更有可能使用信息较少的复合或替代结果 (25%对13%).
- 很少有试验 (5%) 反映了现实实践 (实用主义),没有一个试验涉及患者对优先事项或结果的意见;然而,透明度有所改善.
结论:
- 大多数早产预防RCT根据既定标准表现出有限的研究有用性.
- 2010年后,人们注意到有用性标准的改善,但信息化结果,以患者为中心,务实主义和透明度等关键领域需要专注于未来研究.
- 提高RCT的有用性对于推进有效的早产预防策略至关重要.
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