Abstract
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.
Original language | English |
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Pages (from-to) | 795-803 |
Number of pages | 9 |
Journal | BJOG: An International Journal of Obstetrics and Gynaecology |
Volume | 125 |
Issue number | 7 |
Early online date | 19 Dec 2017 |
DOIs | |
Publication status | Published - Jun 2018 |
Event | Royal College of Obstetricians and Gynaecologists World Congress - Cape Town, South Africa Duration: 20 Mar 2017 → 22 Mar 2017 |
Bibliographical note
This report is independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research. Prof. Richard McManus is supported by a National Institute for Health Research Professorship (NIHR-RP-R2-12-015) and the National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care, Oxford. The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.Data Availability Statement
This paper includes Author Insights, a video abstract available at https://vimeo.com/rcog/authorinsights14969Additional Supporting Information may be found in the online version of this article: Table S1.Included study characteristics. Table S2. Adverse reactions and laboratory defined toxicity reported in randomised trials evaluating magnesium sulphate. Appendix S1.EMBASE search strategy. Video S1.Author insights.
Keywords
- Adverse reactions
- core outcome sets
- outcome reporting bias
- pre-eclampsia
- systematic review