Core Outcome Measures in Effectiveness Trials

Developing a core outcome set for hypertensive disorders in pregnancy

General Information

Summary:
Summary: Hypertensive disorders affect 1 in 10 pregnancies and cause significant maternal and offspring morbidity and mortality. Trials evaluating therapeutic interventions have reported many different outcomes resulting in significant outcome reporting bias and an inability to synthesise results across studies. The development and use of core outcome sets would help to address these issues.

Objective
Produce, disseminate, and implement core outcome sets for hypertensive disorders in pregnancy.

Theme 1
International collaboration to harmonise outcomes for pre-eclampsia (iHOPE)
1. Produce, disseminate, and implement a core outcome set for pre-eclampsia.
2. Develop a healthtalk.org section to improve patient, public, and professional understanding of pre-eclampsia.

Protocol: http://www.sciencedirect.com/science/article/pii/S2210778916300149

Website:
http://eepurl.com/bcW5GH

Protocol:
http://www.sciencedirect.com/science/article/pii/S2210778916300149

E-mail:
james.duffy@balliol.ox.ac.uk

Contributors:
Principal investigator:
Dr James M. N. Duffy
NIHR Doctoral Fellow, University of Oxford

Educational supervision:
Prof Richard McManus
NIHR Professor of Primary Care, University of Oxford
Prof Sue Ziebland
Director, Health Experiences Research Group, University of Oxford
Prof Khalid Khan
Professor of Women's Health and Clinical Epidemiology, University of London

Study committee:
Prof Doug Altman
Director, Centre for Statistics in Medicine, University of Oxford
Prof Ray Fitzpatrick
Professor of Public Health and Primary Care, University of Oxford
Prof Ananth Karumanchi
Centre for Vascular Biology Research, Harvard University
Prof Paula Williamson
Professor of Biostatics, University of Liverpool
Action on Pre-eclampsia

Further Study Information

Current Stage:
Ongoing
Date:
January 2014 - October 2016
Funding source(s):
NIHR Doctoral Fellowship (DRF-2014-07-051)

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Gestational hypertension
Hypertensive disorders in pregnancy
Pre-eclampsia

Target Population

Age Range
-

Sex
Female


Nature / type of Intervention
Any

Method(s)

Delphi process
Interview
Other
Systematic review

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.


Stakeholders Involved

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

Study Type

COS for clinical trials or clinical research

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