TY - JOUR
T1 - A Core Outcome Set for the prevention and treatment of fetal GROwth restriction
T2 - deVeloping Endpoints: the COSGROVE study
AU - Healy, Patricia
AU - Gordijn, Sanne J.
AU - Ganzevoort, Wessel
AU - Beune, Irene M.
AU - Baschat, Ahmet
AU - Khalil, Asma
AU - Kenny, Louise
AU - Bloomfield, Frank H.
AU - Daly, Mandy
AU - Kirkham, Jamie
AU - Devane, Declan
AU - Papageorghiou, Aris T.
N1 - Funding Information:
Supported by the Health Research Board–Mother and Baby–Clinical Trials Network Ireland (grant number CTN-2014-010) in association with the Health Research Board–Trials Methodology Research Network, and by the National Institute for Health Research Oxford Biomedical Research Centre (A.T.P).
Publisher Copyright:
© 2019 The Authors
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
KW - core outcome
KW - fetal growth restriction
KW - gestational age
KW - pregnancy
KW - trial
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U2 - 10.1016/j.ajog.2019.05.039
DO - 10.1016/j.ajog.2019.05.039
M3 - Article
C2 - 31152710
AN - SCOPUS:85071115780
SN - 0002-9378
VL - 221
SP - 339.e1-339.e10
JO - American journal of obstetrics and gynecology
JF - American journal of obstetrics and gynecology
IS - 4
ER -