Core Outcome Measures in Effectiveness Trials

Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE)

General Information

Summary:
Developing a COS for use in all studies of the prevention and treatment of fetal growth restriction (FGR) is timely and important. Interventions for preventing and treating FGR have been studied in many trials, but evidence is often difficult to synthesise and compare because of differences in the selection and definition of outcomes. To enable future trials to measure similar, meaningful outcomes, we are developing two core outcome sets (COS); one for prevention and the other for treatment of FGR.

Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2819-9

Contributors:
Professor Declan Devane (PI)
Professor of Midwifery, NUI Galway
Professor of Midwifery, Saolta University Health Care Group
Director, Health Research Board – Trials Methodology Research Network (HRB-TMRN), Ireland

Dr Patricia Healy1,2, , Dr Sanne Gordijn3, Dr Wessel Ganzevoort4, Ms Irene Beune3, Dr Ahmet Baschat5, Dr Asma Khalil6, Prof Louise Kenny7, Prof Frank Bloomfield8, Ms Mandy Daly9, Dr Aris Papageorghiou6,10*,

1Health Research Board – Trials Methodology Research Network, Ireland
2School of Nursing and Midwifery, NUI Galway, Galway, Ireland
3Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
4Department of Obstetrics and Gynecology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
5Johns Hopkins Center for Fetal Therapy, Baltimore, USA
6Fetal Medicine Unit, St George's University and St George's University Hospitals NHS Foundation Trust, London, UK.
7 The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Ireland.
8Liggins Institute, University of Auckland, Auckland, New Zealand
9 Advocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland
10University of Oxford Nuffield Department of Obstetrics and Gynaecology, Level 3, Women’s Centre, John Radcliffe Hospital, Headington, Oxford OX3 9DU

Further Study Information

Current Stage:
Ongoing
Date:
March 2017 - March 2019
Funding source(s):
Health Research Board (Ireland)

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Intrauterine growth restriction

Target Population

Age Range
16 - 100

Sex
Female


Nature / type of Intervention
N/A

Method(s)

Consensus meeting
Delphi process
Systematic review

• A review of the literature to identify reported outcome measures in clinical trials on fetal growth restriction;
• Development of a preliminary COS for use in fetal growth restriction studies to include in an e-Delphi;
• Consensus meeting to discuss and agree on the final fetal growth restriction -COS.


Stakeholders Involved

Clinical experts
Consumers (patients)
Policy makers
Researchers
Service users

Study Type

COS for clinical trials or clinical research

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