Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Balliol College, University of Oxford, Oxford, UK.
BJOG. 2018 Jun;125(7):795-803. doi: 10.1111/1471-0528.14969. Epub 2017 Dec 19.
Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions.
To assess safety reporting in pre-eclampsia trials.
Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017.
Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia.
Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting.
We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating 'safety and toleration' and 'possible side effects' would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports.
Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms.
National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK.
Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.
随机试验及其荟萃分析的综合研究为评估不良反应的频率和严重程度提供了独特的机会。
评估子痫前期试验的安全性报告。
系统检索包括 Cochrane 对照试验中央注册库、Embase 和 MEDLINE 在内的文献数据库，检索时间从建库至 2017 年 8 月。
评估抗惊厥或降压药物治疗子痫前期的随机试验。
使用描述性统计方法评估不良反应和毒性报告的充分性。
我们纳入了 60 项随机试验。其中 6 项试验（10%）在国际临床试验注册平台上注册，2 份注册记录提到了不良反应，称将收集“安全性和耐受性”和“可能的副作用”。26 项试验（43%）报告了每个研究组内的退出率，5 项试验（8%）充分报告了这些退出率。不良反应在合格试验中报告不一致：24 项（40%）试验报告无严重不良反应，36 项（60%）试验报告无轻度不良反应。不良反应的定义或测量方法在发表的试验报告中很少有报道。
子痫前期试验经常遗漏与安全性相关的关键信息。尽管报告不足，但随机试验收集了大量的安全性数据。制定和实施最小数据集可以帮助改善安全性报告，通过考虑干预措施的获益与危害之间的权衡，更平衡地评估干预措施。
英国国家卫生与保健研究院（DRF-2014-07-051）；英国产妇论坛，皇家医学会。
制定@coreoutcomes 可以帮助改善 #子痫前期试验的安全性报告。@NIHR_DC。
