产科试验结果排名的可取性:说明和应用到ARRIVE试验
Grecio J Sandoval1, William A Grobman2, Scott R Evans1
1Biostatistics Center, George Washington University, Washington, DC.
American journal of obstetrics and gynecology
|September 23, 2023
概括
根据结果排名 (DOOR) 分析的可取性,39周的选择性诱导改善了孕产妇-产周结局. 这种方法同时评估母亲和婴儿的多种结果,增强临床试验决策.
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
- 围产儿医学 围产儿医学
背景情况:
- 传统的随机试验优先考虑一个单一的初级结果,可能会忽视关键的次要结果,特别是在产科中,干预措施影响到母亲和孩子.
- 结果排名的可取性 (DOOR) 提供了一个以患者为中心的方法,使得多个结果的同时评估成为可能,包括来自二元对的结果.
研究的目的:
- 适应和应用DOOR方法在产科试验中对孕产妇-孕产妇二分期结局进行调整.
- 通过DOOR框架评估39周选择性诱导对母亲和胎儿结局的影响.
主要方法:
- 使用DOOR方法的ARRIVE试验数据的二次分析.
- 从最理想到最不理想 (例如,自发性阴道分娩没有新生儿并发症到剖腹产与围产死亡).
- 对 DOOR 分布进行比较,并应用部分信贷策略来对结果进行细微评估.
主要成果:
- 在39周的选择性诱导表明,对母婴夫妇来说,更好的双向结局的概率为53%.
- 杜尔的分析表明,在不影响围产期结果的情况下,避免剖腹产的概率为52%.
- 部分信用评分分析通常有利于选择性诱导,支持其在各种结果视角上的优势.
结论:
- 门的方法是产科研究的一个有价值的工具,提供了对多个双向结果的同时视角.
- 这种方法促进了对临床决策的更好的数据翻译,并促进了产科中以人为中心的护理.
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