Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana.
Am J Perinatol. 2020 Mar;37(4):436-452. doi: 10.1055/s-0039-1681095. Epub 2019 Feb 28.
This study aimed to develop a core outcome set of primary outcomes for studies involving cesarean deliveries with infectious morbidity outcomes.
Authors reported primary outcomes from 11 Cochrane systematic reviews (SRs), 12 other SRs, and 327 randomized controlled trials (RCTs). These outcomes were condensed into 20 primary outcome groups. Next, a modified Delphi technique was used to gain consensus on key outcomes. Authors from included SRs were sent a questionnaire consisting of a free response and multiple-choice questions. These data were used to propose a set of core outcomes.
The most frequent outcomes in RCTs were composite "infectious outcomes" (24%) with the second most common being endometritis (12%). The most common reported SR outcomes were wound infection (21%) and endometritis (16%). For the Delphi survey free response portion, wound infection (88%) and endometritis (79%) were the most commonly endorsed outcomes. Chosen list outcomes were maternal mortality (83%), wound infection (83%), wound complications (86%), and postpartum endometritis (80%). The proposed final core outcome set for cesarean trials was endometritis (primary outcome), maternal mortality, wound infection, wound complications, febrile morbidity, and neonatal morbidity.
Utilizing defined core outcomes in all studies of cesarean section can harmonize trial reports and allow data synthesis for meta-analyses.
本研究旨在为涉及感染性发病率结局的剖宫产研究制定主要结局的核心结局集。
作者从 11 项 Cochrane 系统评价（SR）、12 项其他 SR 和 327 项随机对照试验（RCT）中报告了主要结局。这些结局被浓缩为 20 个主要结局组。接下来，采用改良 Delphi 技术就关键结局达成共识。来自纳入 SR 的作者收到了一份包含自由回答和多项选择题的问卷。这些数据用于提出一套核心结局。
RCT 中最常见的结局是复合“感染性结局”（24%），其次是子宫内膜炎（12%）。报告的最常见 SR 结局是伤口感染（21%）和子宫内膜炎（16%）。在 Delphi 调查的自由回答部分，伤口感染（88%）和子宫内膜炎（79%）是最常被认可的结局。选择的清单结局是产妇死亡率（83%）、伤口感染（83%）、伤口并发症（86%）和产后子宫内膜炎（80%）。剖宫产试验的拟议最终核心结局集为子宫内膜炎（主要结局）、产妇死亡率、伤口感染、伤口并发症、发热发病率和新生儿发病率。
在所有剖宫产研究中使用定义明确的核心结局可以协调试验报告并允许进行荟萃分析的数据综合。
