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 long-list 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, birthweight, 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 that 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. Tweetable abstract: @HOPEoutcomes 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia @jamesmnduffy.
|Number of pages||11|
|Journal||BJOG: An International Journal of Obstetrics and Gynaecology|
|Early online date||21 Jun 2020|
|Publication status||Published - Nov 2020|
This study was funded by the Barts Charity, Elisabeth Garrett Anderson Hospital Charity and National Institute for Health Research. The funders have no role in the design and con-duct of the study, the collection, management, analysis or interpretation of data or the manuscript preparation.
This work reports independent research arising from a doctoral fellowship (DRF-2014-07-051) supported by the National Institute for Health Research, Barts Charity and Elisabeth Garrett Anderson Hospital Charity Travelling Fellowship in Memory of Anne Boutwood. Dr Chris Gale was supported by a Medical Research Council Clinician Scientist Fellowship. Prof. Richard McManus was 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. Prof. Richard McManus, Prof. Paula Williamson and Prof. Sue Ziebland are supported by National Institute for Health Research Senior Investigator awards. Prof. Ben Mol is supported by a National Health and Medical Research Council Investigator Grant. 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 Delphi survey and consensus development meeting participants. 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 Jacqui Belcher ,Carla Betts, Lucy Curtin, Dawn Evans, Caroline Jordan, Sarah King, Sam Monaghan, Nicola Small and Clare Wickings for administrative, technical or material support. We would like to thank Prof. Marian Knight, Nufﬁeld Department of Population Health, University of Oxford, for providing subject-speciﬁc expertise. We would like to thank colleagues at the Women’s Health Research Unit, Queen Mary, University of London, including Khalid Khan, Rehan Khan and Tracy Holtham for administrative and technical support or subject-speciﬁc expertise. We would like to thank David J. Mills for administrative and logistical support.
- Consensus development study
- core outcome set
- modified Delphi method
- modified nominal group technique
- outcome reporting bias