Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation

Jmn Duffy; M Hirsch; L Pealing; M Showell; K S Khan; S Ziebland; R J McManus; International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)

doi:10.1111/1471-0528.14969

Inadequate safety reporting in pre-eclampsia trials: a systematic evaluation

BJOG. 2018 Jun;125(7):795-803. doi: 10.1111/1471-0528.14969. Epub 2017 Dec 19.

Authors

Jmn Duffy^{1

2}, M Hirsch^{3

4}, L Pealing¹, M Showell⁵, K S Khan³, S Ziebland¹, R J McManus¹; International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE)

Collaborators

International Collaboration to Harmonise Outcomes in Pre-eclampsia (iHOPE):
Janneke Van't Hooft, Chris Gale, Mark Brown, William Grobman, Ray Fitzpatrick, S Ananth Karumanchi, Nuala Lucas, Laura Magee, Ben Mol, Michael Stark, Shakila Thangaratinam, Mathew Wilson, Peter von Dadelszen, Paula Williamson

Affiliations

¹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
² Balliol College, University of Oxford, Oxford, UK.
³ Women's Health Research Unit, The Blizard Institute, Barts and the London School of Medicine and Dentistry, London, UK.
⁴ Royal Free London NHS Trust, London, UK.
⁵ Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand.

PMID: 29030992
DOI: 10.1111/1471-0528.14969

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.

Funding: National Institute for Health Research (DRF-2014-07-051), UK; Maternity Forum, Royal Society of Medicine, UK.

Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.

Keywords: Adverse reactions; core outcome sets; outcome reporting bias; pre-eclampsia; systematic review.

Publication types

Systematic Review

MeSH terms

Anticonvulsants / adverse effects*
Antihypertensive Agents / adverse effects*
Drug-Related Side Effects and Adverse Reactions / epidemiology
Drug-Related Side Effects and Adverse Reactions / etiology*
Female
Humans
Patient Safety / statistics & numerical data*
Pre-Eclampsia / drug therapy*
Pregnancy
Randomized Controlled Trials as Topic
Research Design / standards*

Substances

Anticonvulsants
Antihypertensive Agents

Abstract

Publication types

MeSH terms

Substances

Grants and funding