A core outcome set for pre-eclampsia research: an international consensus development study

Jmn Duffy; A E Cairns; D Richards-Doran; J van 't Hooft; C Gale; M Brown; L C Chappell; W A Grobman; R Fitzpatrick; S A Karumanchi; A Khalil; D N Lucas; L A Magee; B W Mol; M Stark; S Thangaratinam; M J Wilson; P von Dadelszen; P R Williamson; S Ziebland; R J McManus; International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE)

doi:10.1111/1471-0528.16319

A core outcome set for pre-eclampsia research: an international consensus development study

BJOG. 2020 Nov;127(12):1516-1526. doi: 10.1111/1471-0528.16319. Epub 2020 Jun 21.

Authors

Jmn Duffy^{1

2}, A E Cairns², D Richards-Doran², J van 't Hooft³, C Gale⁴, M Brown⁵, L C Chappell⁶, W A Grobman⁷, R Fitzpatrick⁸, S A Karumanchi⁹, A Khalil¹⁰, D N Lucas¹¹, L A Magee⁶, B W Mol¹², M Stark¹³, S Thangaratinam¹⁴, M J Wilson¹⁵, P von Dadelszen⁶, P R Williamson¹⁶, S Ziebland², R J McManus²; International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE)

Affiliations

¹ Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
² Institute for Women's Health, University College London, London, UK.
³ Department of Obstetrics and Gynaecology, Amsterdam UMC, Academic Medical Centre, Amsterdam, The Netherlands.
⁴ Academic Neonatal Medicine, Imperial College London, London, UK.
⁵ Department of Renal Medicine, St George Hospital and University of New South Wales, Kogarah, NSW, Australia.
⁶ Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
⁷ Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
⁸ Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁹ Cedars-Sinai Medical Center, Los Angeles, CA, USA.
¹⁰ Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK.
¹¹ London North West University Healthcare NHS Trust, Harrow, UK.
¹² Department of Obstetrics and Gynaecology, Monash University, Clayton, Vic., Australia.
¹³ Department of Obstetrics and Gynaecology, University of Adelaide, Adelaide, SA, Australia.
¹⁴ Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, London, UK.
¹⁵ School of Health and Related Research, University of Sheffield, Sheffield, UK.
¹⁶ MRC North West Hub for Trials Methodology Research, Department of Biostatistics, University of Liverpool, Liverpool, UK.

PMID: 32416644
DOI: 10.1111/1471-0528.16319

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 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: 281 healthcare professionals, 41 researchers and 110 women have developed #preeclampsia core outcomes @HOPEoutcomes @jamesmnduffy. [Correction added on 29 June 2020, after first online publication: the order has been corrected.].

Keywords: Consensus development study; core outcome set; modified Delphi method; modified nominal group technique; outcome reporting bias; pre-eclampsia.

Publication types

Consensus Development Conference
Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research*
Female
Humans
International Cooperation
Pre-Eclampsia / therapy*
Pregnancy
Pregnancy Outcome*

Abstract

Publication types

MeSH terms

Grants and funding