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

Made available in DSpace on 2022-04-28T19:28:54Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-11-01 National Institute for Health Research Barts Charity 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.]. Nuffield Department of Primary Care Health Sciences University of Oxford Institute for Women's Health University College London Department of Obstetrics and Gynaecology Amsterdam UMC Academic Medical Centre Academic Neonatal Medicine Imperial College London Department of Renal Medicine St George Hospital and University of New South Wales Department of Women and Children's Health School of Life Course Sciences King's College London Department of Obstetrics and Gynecology Feinberg School of Medicine Northwestern University Health Services Research Unit Nuffield Department of Population Health University of Oxford Cedars-Sinai Medical Center Vascular Biology Research Centre Molecular and Clinical Sciences Research Institute St George's University of London London North West University Healthcare NHS Trust Department of Obstetrics and Gynaecology Monash University Department of Obstetrics and Gynaecology University of Adelaide Women's Health Research Unit Barts and the London School of Medicine and Dentistry School of Health and Related Research University of Sheffield MRC North West Hub for Trials Methodology Research Department of Biostatistics University of Liverpool Centro Rosarino de Estudios Perinatales Chelsea and Westminster Hospital NHS Foundation Trust Babcock University Ailem Academic Counselling KU Leuven Universidad Nacional de Colombia Northwell Health University of Oxford Université de Montréal University of Montreal Hospital Centre Ondokuz Mayis University Prince Sultan Military Medical City Postgraduate Institute of Medical Education and Research Chandigarh University Hospital Limerick Drexel University University of Aberdeen University of Groningen University of Auckland Haaglanden Medisch Centrum Nottingham University Medical School Utrecht University King Edward Memorial Hospital for Women Imperial College Healthcare NHS Trust Jean-Verdier Hospital Downland Practice University of Campinas Université Lyon University of North Carolina School of Medicine South Ural State Medical University Stellenbosch University Irish Neonatal Health Alliance University of Rzeszow Royal Brisbane and Women's Hospital Nottingham University Hospitals NHS Trust University Hospitals of Leicester North Bristol NHS Trust University of Nottingham Soroka University Medical Centre Ben Gurion University of the Negev St George's University Hospitals NHS Foundation Trust Hospitalsenhed Midt University of Glasgow Postgraduate Institute of Medical Education and Research Amsterdam Universitair Medische Centra All India Institute of Medical Sciences Patna Luton and Dunstable University Hospital Khyber Medical University Institution of Medical Sciences Midwife Mid Essex Hospitals NHS Trust University of Oulu University of Michigan Bastyr University Irish Nurses and Midwives Organisation University of Toronto Barts Health NHS Trust University Hospitals Plymouth NHS Trust Burnet Institute Aga Khan University Medical University of Graz Homerton University Hospital NHS Foundation Trust Mount Royal University Université de Paris Royal Surrey County Hospital University Hospital Southampton NHS Foundation Trust University of Washington School of Nursing Evelina London Children's Hospital Neonatal Unit University of Sydney University of Leicester Academic Hospital of Udine NHS Borders Weill Cornell Medical College University of Dundee University of Edinburgh South Australian Health and Medical Research Institute University of Sheffield Monash University and Monash Health United Lincolnshire Hospitals NHS Trust University of Kwa Zulu-Natal Beatrix Hospital Keele University Government Medical College Nagpur Institut Catala de la Salut. IdiapJgol University College London National Centre for Child Health and Development Basavatarakam Indo-American Cancer Hospital and Research Institute Axon Anaesthesia Associates Pennine Acute Hospitals NHS Trust St George's University of London Norfolk and Norwich University Hospital Jichi Medical University School of Medicine São Paulo State University National Institute of Public Health University of Kyrenia King Edward Memorial Hospital Amsterdam University Centres University of British Columbia Chulalongkorn University University of Brescia University of Montreal Women's Clinic of Tartu University Hospital Universidade Federal de São Paulo Université de Sherbrooke University Hospital of Wales University of Iowa King's College London Westmead Hospital Princess Royal Maternity Leipzig University Centre Hospitalier Public du Cotentin Lewisham and Greenwich NHS Trust Juntendo University Faculty of Medicine Western Sydney University National Institute of Health Research University of Washington Baylor College of Medicine Capelle aan den Ijssel Sanatorio Anchorena Oxford University Hospitals NHS Foundation Trust University of Leeds Institute of Medical Sciences Lahore UPMC Magee Womens Hospital Penn Medicine Princeton Health University of North Carolina at Chapel Hill USA and Dr Arnold G. Zermansky University of Leeds São Paulo State University