Inadequate safety reporting in pre-eclampsia trials. A systematic evaluation.
Duffy JMN., Hirsch M., Pealing L., Showell M., Khan KS., Ziebland S., McManus RJ., International Collaboration to Harmonize Outcomes in Pre-eclampsia (iHOPE). None.
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 (8%) trials 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 considering the trade-off between the benefits and harms. This article is protected by copyright. All rights reserved.