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

Patricia Healy,Wessel Ganzevoort,Sanne Gordijn,Louise Kenny,Irene Beune,Declan Devane,Mandy Daly,Frank Bloomfield,Ahmet Baschat,Aris Papageorghiou,Asma Khalil

doi:10.1186/s13063-018-2819-9

Abstract

BackgroundFoetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential. It is well recognised that growth-restricted foetuses are at increased risk of stillbirth, foetal compromise, early neonatal death and neonatal morbidity. Later in life, they are prone to health problems, including increased risk of cardiovascular diseases and neurodevelopmental disorders. 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.MethodsWe will review the literature to identify previously reported outcomes. An international panel of relevant stakeholders who have experience of FGR (parent or carer of a baby that was growth restricted, health professional involved in the care of mothers and babies affected by FGR, a person with expertise in FGR research) will rate the importance of each of those outcomes in a series of three sequential online rounds of a Delphi study. Participants will be able to add items to the proposed list in round 1. A final face-to-face consensus meeting will be held with representatives of each stakeholder group at which a final list of outcomes for inclusion in the COS will be agreed.DiscussionThe development of COSs in FGR will ensure the collection and reporting of a minimum dataset agreed by stakeholder consensus and will reduce inconsistencies in the reporting of outcomes across relevant trials. Such standardisation in the reporting of outcomes will improve synthesis of evidence and generalisability of knowledge in the future by reducing heterogeneity in outcomes between trials and thus improve the results of systematic reviews and meta-analyses. Ultimately, we hope that the COSs will lead to an improvement in the quality of evidence-based clinical practice, enhance patient care, and improve the quality and consistency of research.Trial registrationNot applicable. This study is registered in the Core Outcome Measures for Effectiveness (COMET) database.

Highlights

Foetal growth restriction (FGR) refers to a foetus that does not reach its genetically predetermined growth potential
Description Consensus that outcome should be included in the core outcome set Consensus that outcome should not be included in the core outcome set Uncertainty about importance of outcome so retain for round
We acknowledge the potential for overlap between some outcomes in this core outcome sets (COS) and other COSs such as preterm birth, stillbirth and pre-eclampsia, but believe that a separate COS for FGR, and for other conditions, is valuable and necessary

Summary

Methods

The design of this COS project will be guided by The Core Outcome Set-STAndards for Development (COS-STAD). Data analysis Once data from all included studies have been extracted, a list of unique outcomes of FGR will be developed. To ensure completeness of outcomes, participants in this round will be invited to add up to two further ‘new’ outcomes that they would consider important or relevant for inclusion in either the prevention or treatment of FGR COSs. The panel will be asked to rate the outcomes for FGR prevention and treatment on a 9-point Likert-scale. For each outcome from round 1, the rating results (i.e. the proportion of participants rating each point on the 9-point rating scale) from each stakeholder group (maternity service users, midwives, obstetricians, paediatricians/neonatologists, and groups with expertise in FGR and research) will be presented numerically in the form of proportions within DelphiManager. This sWP will develop a detailed dissemination and implementation strategy to ensure effective dissemination of the final FGR COSs, to raise awareness of the developed COSs and to encourage their use in future studies in FGR

Discussion

Background

Findings