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 GroupTechnique.
Results
A long-list of 116 potential core outcomes was developedby combining the outcomes reported in 79 pre-eclampsia trialswith those derived from thematic analysis of 30 in-depthinterviews 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 coreoutcomes were agreed at the consensus development meeting.Maternal core outcomes: death, eclampsia, stroke, corticalblindness, retinal detachment, pulmonary oedema, acute kidney injury, liver haematoma or rupture, abruption, post partum 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.
E-mail:
james.duffy@balliol.ox.ac.uk
Jmn Duffy 1 2 , A E Cairns 2 , D Richards-Doran 2 , J van 't Hooft 3 , C Gale 4 , M Brown 5 , L C Chappell 6 , W A Grobman 7 , R Fitzpatrick 8 , S A Karumanchi 9 , A Khalil 10 , D N Lucas 11 , L A Magee 6 , B W Mol 12 , M Stark 13 , S Thangaratinam 14 , M J Wilson 15 , P von Dadelszen 6 , P R Williamson 16 , S Ziebland 2 , R J McManus 2 , International Collaboration to Harmonise Outcomes for Pre-eclampsia (iHOPE)
Affiliations
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.
Disease Category: Pregnancy & childbirth
Disease Name: Pre-eclampsia, Gestational hypertension, Hypertensive disorders in pregnancy
Age Range: Unknown
Sex: Female
Nature of Intervention: Any
- Academic research representatives
- Carer organisation/ support group representatives
- Charities
- Clinical experts
- Consumers (patients)
- Correlative science experts
- Governmental agencies
- Individuals with a known interest
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Service commissioners
- Service providers
- Study investigators
- Trialists
- COS for clinical trials or clinical research
- Delphi process
- Interview
- Systematic review
- Other
General methods: Developing a core outcome set for hypertensive disorders in pregnancy
Stage 1 Identifying Potential Outcomes
Stage 1(A): Systematic Review: Literature searches will identify randomised controlled trials evaluating interventions for hypertensive disorders in pregnancy. A systematic review of the trial reports will catalogue outcomes and outcome measures.
Stage 1(B): Qualitative Patient Interviews: Patients will be recruited through the patient representative groups including Action on Pre-eclampsia and a research network of 17 hospitals in London to take part in semi-structured interviews. Interview questions will be developed in consultation with patient representatives and guided by the literature review. Thematic content analysis will identify potential core outcomes and produce content for the Healthtalk.org website.
Stage 1(C): Outcome Inventory: A comprehensive inventory of outcomes identified by the literature review and qualitative patient interviews will be developed prior to entering into the Delphi process.
Stage 2 Determining Core Outcomes
Delphi methodology: All stakeholders will be invited to participate in a process which assesses the extent of agreement (consensus measurement) and then resolves disagreement (consensus development). Repeated reflection and scoring increases the likelihood of whole and stakeholder group convergence towards consensus “core” outcomes.
Stage 3 Determining How Core Outcomes Should be Measured
Stage 3 (A): Quality Assessment: Once core outcomes have been agreed it is important to determine how they should be measured. An assessment framework (truth, discrimination, feasibility) will assess the quality of potential outcome measures. High quality outcome measures will be incooperated into the core outcome set.
Stage 3 (B): Stakeholder Consultation: A draft document summarising the background information, methodology, and results will be circulated and presented at the International Society for the Study of Hypertension in Pregnancy (ISSHP) World Congress. Stakeholder feedback will be collated, reviewed, and incorporated into the finalised core outcome set prior to distribution.
Theme 1: International collaboration to harmonise outcomes for pre-eclampsia (iHOPE)
Stage 1: identifying potential outcomes
Literature review
Literature searches will identify randomised controlled trials evaluating interventions for pre-eclampsia. A systematic review of the trial reports will catalogue outcomes and outcome measures.
Qualitative patient interviews
Patients will be recruited through the patient representative groups including Action on Pre-eclampsia to take part in semi-structured interviews. Interview questions will be developed in consultation with patient representatives and guided by the literature review. Thematic content analysis will identify potential core outcomes and produce content for the Healthtalk.org website.
Outcome inventory
A comprehensive inventory of outcomes identified by the literature review and qualitative patient interviews will be developed prior to entering into the Delphi process.
Stage 2: determining core outcomes
Delphi methodology
All stakeholders will be invited to participate in a process which assesses the extent of agreement (consensus measurement) and then resolves disagreement (consensus development). Repeated reflection and scoring increases the likelihood of whole and stakeholder group convergence towards consensus “core” outcomes.
Stage 3: determining how core outcomes should be measured
Quality assessment
Once core outcomes have been agreed it is important to determine how they should be measured. An assessment framework (truth, discrimination, feasibility) will assess the quality of potential outcome measures. High quality outcome measures will be incooperated into the core outcome set.
Stakeholder consultation
A draft document summarising the background information, methodology, and results will be circulated and presented at various stakeholder events. Stakeholder feedback will be collated, reviewed, and incorporated into the finalised core outcome set prior to distribution.