title: A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia.
abstract: BACKGROUND
  Pre-eclampsia is a serious complication of pregnancy and contributes to maternal and offspring mortality and morbidity. Randomised controlled trials evaluating therapeutic interventions for pre-eclampsia have reported many different outcomes and outcome measures. Such variation contributes to an inability to compare, contrast, and combine individual studies, limiting the usefulness of research to inform clinical practice. The development and use of a core outcome set would help to address these issues ensuring outcomes important to all stakeholders, including patients, will be collected and reported in a standardised fashion.
  
  
  METHODS
  An international steering group including healthcare professionals, researchers, and patients, has been formed to guide the development of this core outcome set. Potential outcomes will be identified through a comprehensive literature review and semi-structured interviews with patients. Potential core outcomes will be entered into an international, multi-perspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and patients will be invited to participate. The modified Delphi method encourages whole and stakeholder group convergence towards consensus 'core' outcomes. Once core outcomes have been agreed upon it is important to determine how they should be measured. The truth, discrimination, and feasibility assessment framework will assess the quality of potential outcome measures. High quality outcome measures will be associated with core outcomes. Mechanisms exist to disseminate and implement the resulting core outcome set within an international context.
  
  
  CONCLUSIONS
  Embedding the core outcome set within future clinical trials, systematic reviews, and clinical practice guidelines could make a profound contribution to advancing the usefulness of research to inform clinical practice, enhance patient care, and improve maternal and offspring outcomes. The infrastructure created by developing a core outcome set for pre-eclampsia could be leveraged in other settings, for example selecting research priorities and clinical practice guideline development. PROSPECTIVE REGISTRATION: [1] Core Outcome Measures in Effectiveness Trials (COMET) registration number: 588. [2] International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42015015529.
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6NW, United Kingdom. Electronic address: james.duffy@balliol.ox.ac.uk.
authors.forename: James M N
authors.initials: JM
authors.lastname: Duffy
authors.affiliation: Academical Medical Centre, Amsterdam 1105 AZ, Netherlands.
authors.forename: Janneke
authors.initials: J
authors.lastname: van 't Hooft
authors.affiliation: Academic Neonatal Medicine, Imperial College London, Chelsea and Westminster Campus, 369 Fulham Road, London SW10 9NH, United Kingdom.
authors.forename: Chris
authors.initials: C
authors.lastname: Gale
authors.affiliation: Renal Unit, St George and Sutherland Hospitals, 14-18 Regent St, Kogarah, NSW 2217, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Brown
authors.affiliation: Department of Obstetrics and Gynaecology, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, United States.
authors.forename: William
authors.initials: W
authors.lastname: Grobman
authors.affiliation: Health Services Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford OX3 7LF, United Kingdom.
authors.forename: Ray
authors.initials: R
authors.lastname: Fitzpatrick
authors.affiliation: Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, United States.
authors.forename: S Ananth
authors.initials: SA
authors.lastname: Karumanchi
authors.affiliation: Obstetric Anaesthetists' Association, 21 Portland Place, London W1B 1PY, United Kingdom.
authors.forename: Nuala
authors.initials: N
authors.lastname: Lucas
authors.affiliation: St George's, University of London, Cranmer Terrace, London SW17 0RE, United Kingdom.
authors.forename: Laura
authors.initials: L
authors.lastname: Magee
authors.affiliation: Department of Obstetrics and Gynaecology, University of Adelaide, Adelaide 5005, Australia.
authors.forename: Ben
authors.initials: B
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, University of Adelaide, Adelaide 5005, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Stark
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, London E1 2AB, United Kingdom.
authors.forename: Shakila
authors.initials: S
authors.lastname: Thangaratinam
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield S10 2TN, United Kingdom.
authors.forename: Mathew
authors.initials: M
authors.lastname: Wilson
authors.affiliation: St George's, University of London, Cranmer Terrace, London SW17 0RE, United Kingdom.
authors.forename: Peter
authors.initials: P
authors.lastname: von Dadelszen
authors.affiliation: MRC North West Hub for Trials Methodology Research, Institute of Translation Medicine, University of Liverpool, Liverpool L69 3BX, United Kingdom.
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
authors.affiliation: Women's Health Research Unit, Barts and the London School of Medicine and Dentistry, London E1 2AB, United Kingdom.
authors.forename: Khalid S
authors.initials: KS
authors.lastname: Khan
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6NW, United Kingdom.
authors.forename: Sue
authors.initials: S
authors.lastname: Ziebland
authors.affiliation: Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6NW, United Kingdom.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: McManus
mesh_terms: D032921:Consensus; D003697:Delphi Technique; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D063868:Patient Outcome Assessment; D011225:Pre-Eclampsia / Q000628:therapy*; D011247:Pregnancy; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D000078202:Systematic Reviews as Topic; D016896:Treatment Outcome
keywords: Core outcome set; Modified Delphi method; Pre-eclampsia; Semi-structured interviews; Systematic review