TY - JOUR
T1 - Inadequate safety reporting in pre-eclampsia trials
T2 - a systematic evaluation
AU - the International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)
AU - Duffy, J. M.N.
AU - Hirsch, M.
AU - Pealing, L.
AU - Showell, M.
AU - Khan, K. S.
AU - Ziebland, S.
AU - McManus, R. J.
AU - van‘t Hooft, Janneke
AU - Gale, Chris
AU - Brown, Mark
AU - Grobman, William
AU - Fitzpatrick, Ray
AU - Karumanchi, S. Ananth
AU - Lucas, Nuala
AU - Magee, Laura
AU - Mol, Ben
AU - Stark, Michael
AU - Thangaratinam, Shakila
AU - Wilson, Mathew
AU - von Dadelszen, Peter
AU - Williamson, Paula
N1 - Funding Information:
National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK. 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. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health. We would like to thank the Radcliffe Women's Health Patient Participation group, Action on Pre-eclampsia, and our patient and public representatives who assisted with study design, data interpretation, and planned dissemination. We would like to thank colleagues at the Nuffield Department of Primary Care Health Sciences, University of Oxford, including Carla Betts, Dawn Evans, Caroline Jordan, Sam Monaghan, Dan Richards-Doran, Nicola Small, and Clare Wickings for administrative, technical, and material support. We would like to thank colleagues at the Women's Health Research Unit, Queen Mary University of London, including Tracy Holtham and Rehan Khan for administrative and technical support, and subject-specific expertise. We would like to thank David J. Mills for administrative and material support.
Funding Information:
Conference presentation: Presented at the Royal College of Obstetricians and Gynaecologists World Congress, 20–22 March 2017, Cape Town, South Africa. Generously supported by the Maternity Forum, Royal Society of Medicine, UK. *Steering group listed in Appendix.
Funding Information:
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.
Publisher Copyright:
© 2017 Royal College of Obstetricians and Gynaecologists
PY - 2018/6
Y1 - 2018/6
N2 - 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.
AB - 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.
KW - Adverse reactions
KW - core outcome sets
KW - outcome reporting bias
KW - pre-eclampsia
KW - systematic review
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U2 - 10.1111/1471-0528.14969
DO - 10.1111/1471-0528.14969
M3 - Review article
C2 - 29030992
AN - SCOPUS:85038433888
SN - 1470-0328
VL - 125
SP - 795
EP - 803
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 7
ER -