Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation
Ziebland S., McManus RJ., van‘t Hooft J., Gale C., Brown M., Grobman W., Fitzpatrick R., Karumanchi SA., Lucas N., Magee L., Mol B., Stark M., Thangaratinam S., Wilson M., von Dadelszen P., Williamson P.
© 2017 Royal College of Obstetricians and Gynaecologists Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. Objective: To assess safety reporting in pre-eclampsia trials. Search strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Selection criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Data collection and analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. Main results: 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. Conclusions: 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. Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.