To the Editors:
Thank you for your comments and your interest in our Core Outcome Set (COS).
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Our COS identified an agreed minimum set of outcomes that should be measured and reported for trials of prevention or treatment of fetal growth restriction (FGR). Note that this minimum reporting set applies to all cases of FGR, not just asymmetric FGR, which is merely one part of the spectrum of FGR. We agree that the list cannot be accepted as a complete list of outcomes to be measured. However, that was not our claim. Instead, the COS represents the minimum set to be recorded, and we highlight in the paper that researchers may wish to supplement the list with additional outcomes (eg, head circumference). One of the factors that contributes to the generalizability of research is that there is variability in the core factors reported in research studies on fetal growth restriction. The end result is a potential for bias and heterogeneity in results. A core outcome set of variables is intended to minimize these issues. This approach is not designed to be all inclusive but rather consistent. It is at the discretion of every researcher to include as many data points as they wish. Inclusion of core outcome set variables in the study of the researcher is likely to improve the quality of the research.The outcomes included in our COS were identified from the literature and consensus achieved across stakeholder groups through Delphi and face-to-face consensus processes. We note that head circumference was presented to stakeholders within that Delphi process but was not prioritized by stakeholders for inclusion as a core outcome in the final set.
We are aware of a continuing lack of consensus around the definition, diagnosis, and appropriate measurement characteristics of fetal growth restriction and hope that our COS can contribute to informing this debate. We also recommend that work is done on achieving consensus on how the individual outcomes within the COS should be measured.
Reference
- A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study.Am J Obstet Gynecol. 2019; 221: 339.e1-339.e10
Article Info
Publication History
Published online: December 06, 2019
Footnotes
The COSGROVE project was funded by the Health Research Board–Mother and Baby–Clinical Trials Network Ireland (HRB-M&B-CTNI) (grant number CTN-2014-010 ) in association with the HRB–Trials Methodology Research Network (HRB-TMRN). The Health Research Board had no role in study design, data collection and analysis, or preparation of the manuscript. A.T.P. is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC).
The COSGROVE Team: Dr Patricia Healy, Dr Sanne J Gordijn, Dr Wessel Ganzevoort, Ms Irene M Beune, Dr Ahmet Baschat, Prof Asma Khalil, Prof Louise Kenny, Prof Frank H. Bloomfield, Ms Mandy Daly, Dr Jamie Kirkham, Prof Declan Devane, Prof Aris T. Papageorghiou
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Copyright
© 2019 Elsevier Inc. All rights reserved.
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- A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE studyAmerican Journal of Obstetrics & GynecologyVol. 221Issue 4
- PreviewFetal 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.
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