Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Balliol College, University of Oxford, Oxford, UK.
Int J Gynaecol Obstet. 2017 Dec;139(3):262-267. doi: 10.1002/ijgo.12298. Epub 2017 Sep 7.
An evaluation of outcome reporting is required to develop a core outcome set.
To assess primary outcomes and outcome measure reporting in pre-eclampsia trials.
Five online databases were searched from inception to January 2016 using terms including "preeclampsia" and "randomized controlled trial".
Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included.
Primary outcomes and data on outcome measure reporting were systematically extracted and categorized.
Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described.
In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.
为了制定核心结局集，需要对结局报告进行评估。
评估子痫前期试验中的主要结局和结局测量报告。
使用包括“子痫前期”和“随机对照试验”在内的术语，从建库至 2016 年 1 月，在 5 个在线数据库中进行检索。
评估子痫前期治疗的随机对照试验，不论语言均纳入研究。
系统地提取和分类主要结局以及结局测量报告的数据。
共纳入 79 项随机试验，包括 31615 名女性的数据。其中，38 项（48%）报告了 35 种不同的主要结局；28 项为母亲结局，7 项为胎儿/新生儿结局。3 项随机试验报告了包含 6 至 9 个结局成分的复合结局。定义或测量方法很少或很差。即使结局在试验中一致，也经常描述不同的定义或测量方法。
在评估子痫前期干预措施的随机试验中，与主要结局相关的关键信息，包括定义和测量，经常被遗漏。为子痫前期试验制定核心结局集将有助于告知主要结局选择和结局测量报告。
