A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study.

Background
Fetal growth restriction refers to a fetus that does not reach its genetically predetermined growth potential. It is well-recognized that growth-restricted fetuses are at increased risk of both short- and long-term adverse outcomes. Systematic evaluation of the evidence from clinical trials of fetal growth restriction is often difficult because of variation in the outcomes that are measured and reported. The development of core outcome sets for fetal growth restriction studies would enable future trials to measure similar meaningful outcomes.

Objective
The purpose of this study was to develop core outcome sets for trials of prevention or treatment of fetal growth restriction.

Study Design
This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for inclusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users.

Results
In total, 22 outcomes were included in the final core outcome set. These outcomes were grouped under 4 domains: maternal (n=4), fetal (n=1), neonatal (n=12), and childhood (n=5).

Conclusion
The Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints study identified a large number of potentially relevant outcomes and then reached consensus on those factors that, as a minimum, should be measured and reported in all future trials of prevention or treatment of fetal growth restriction. This will enable future trials to measure similar meaningful outcomes and to ensure that findings from different studies can be compared and combined.

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

Contributors

Healy, P., S. J. Gordijn, W. Ganzevoort, I. M. Beune, A. Baschat, A. Khalil, L. Kenny, F. H. Bloomfield, M. Daly, J. Kirkham, D. Devane and A. T. Papageorghiou

Publication

Journal: American Journal of Obstetrics and Gynecology
Volume: 221
Issue: 4
Pages: 339 -
Year: 2019
DOI: 10.1016/j.ajog.2019.05.039

Further Study Information

Current Stage: Completed
Date: March 2017 - March 2019
Funding source(s): Supported by the Health Research BoardeMother and BabyeClinical Trials Network Ireland (grant number CTN- 2014-010) in association with the Health Research BoardeTrials Methodology Research Network, and by the National Institute for Health Research Oxford Biomedical Research Centre (A.T.P).

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Intrauterine growth restriction

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers
- Service users
- Policy makers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Literature review

This was a Delphi consensus study. A comprehensive literature review was conducted to identify outcomes that were reported in studies of prevention or treatment of fetal growth restriction. All outcomes were presented for prioritization to key stakeholders (135 healthcare providers, 68 researchers/academics, and 35 members of the public) in 3 rounds of online Delphi surveys. A priori consensus criteria were used to reach agreement on the final outcomes for inclusion in the core outcome set at a face-to-face meeting with 5 healthcare providers, 5 researchers/academics, and 6 maternity service users.

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