A core outcome set for pre-eclampsia research: An international consensus development study
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Published version
Author(s)
Type
Journal Article
Abstract
OBJECTIVE: To develop a core outcome set for pre-eclampsia. DESIGN: Consensus development study. SETTING: International. POPULATION: Two hundred and eight one healthcare professionals, 41 researchers, and 110 patients, representing 56 countries, participated METHODS: Modified Delphi method and Modified Nominal Group Technique. RESULTS: A longlist of 116 potential core outcomes was developed, by combining the outcomes reported in 79 pre-eclampsia trials with those derived from thematic analysis of 30 in-depth interviews of women with lived experience of pre-eclampsia. Forty-seven consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birth weight, small-for-gestational-age, neonatal mortality, seizures, admission to neonatal unit required, and respiratory support. CONCLUSIONS: The core outcome set for pre-eclampsia should underpin future randomised trials and systematic reviews. Such implementation should ensure future research holds the necessary reach and relevance to inform clinical practice, enhance women's care, and improve the outcomes of pregnant women and their babies.
Date Issued
2020-06-21
Date Acceptance
2020-05-11
Citation
BJOG: an International Journal of Obstetrics and Gynaecology, 2020, 127 (12), pp.1516-1526
ISSN
1470-0328
Publisher
Wiley
Start Page
1516
End Page
1526
Journal / Book Title
BJOG: an International Journal of Obstetrics and Gynaecology
Volume
127
Issue
12
Copyright Statement
© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists. This is an open access article under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits use,distribution and reproduction in any medium, provided the original work is properly cited.
License URL
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/32416644
Subjects
Consensus development study
core outcome set
modified Delphi method
modified nominal group technique
outcome reporting bias
pre-eclampsia
Publication Status
Published
Coverage Spatial
England
Date Publish Online
2020-05-16