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

Patricia Healy; Sanne J. Gordijn; Wessel Ganzevoort; Irene M. Beune; Ahmet Baschat; Asma Khalil; Louise Kenny; Frank H. Bloomfield; Mandy Daly; Jamie Kirkham; Declan Devane; Aris T. Papageorghiou

doi:10.1016/j.ajog.2019.05.039

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

Patricia Healy^*, Sanne J. Gordijn, Wessel Ganzevoort, Irene M. Beune, Ahmet Baschat, Asma Khalil, Louise Kenny, Frank H. Bloomfield, Mandy Daly, Jamie Kirkham, Declan Devane, Aris T. Papageorghiou

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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 in-clusion 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.

Original language	English
Pages (from-to)	339.e1-339.e10
Number of pages	10
Journal	American Journal of Obstetrics and Gynecology
Volume	221
Issue number	4
DOIs	https://doi.org/10.1016/j.ajog.2019.05.039
Publication status	Published - Oct-2019

Keywords

Birth Weight
Bronchopulmonary Dysplasia
Cerebral Palsy
Cognitive Dysfunction
Consensus
Delphi Technique
Eclampsia
Enterocolitis, Necrotizing
Female
Fetal Growth Retardation/prevention & control
Gestational Age
Hearing Loss
Humans
Hypoxia-Ischemia, Brain
Infant, Low Birth Weight
Infant, Newborn
Maternal Death
Outcome Assessment, Health Care
Perinatal Death
Pre-Eclampsia
Pregnancy
Premature Birth
Respiration, Artificial
Stillbirth
Vision Disorders

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A Core Outcome Set for the prevention and treatment of fetal GROwth restrictionFinal publisher's version, 271 KBLicence: CC BY-NC-ND

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Healy, P., Gordijn, S. J., Ganzevoort, W., Beune, I. M., Baschat, A., Khalil, A., Kenny, L., Bloomfield, F. H., Daly, M., Kirkham, J., Devane, D., & Papageorghiou, A. T. (2019). A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study. American Journal of Obstetrics and Gynecology, 221(4), 339.e1-339.e10. https://doi.org/10.1016/j.ajog.2019.05.039

@article{642b1e88488748d39699362aa97493ef,

title = "A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study",

abstract = "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 in-clusion 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.",

keywords = "Birth Weight, Bronchopulmonary Dysplasia, Cerebral Palsy, Cognitive Dysfunction, Consensus, Delphi Technique, Eclampsia, Enterocolitis, Necrotizing, Female, Fetal Growth Retardation/prevention & control, Gestational Age, Hearing Loss, Humans, Hypoxia-Ischemia, Brain, Infant, Low Birth Weight, Infant, Newborn, Maternal Death, Outcome Assessment, Health Care, Perinatal Death, Pre-Eclampsia, Pregnancy, Premature Birth, Respiration, Artificial, Stillbirth, Vision Disorders",

author = "Patricia Healy and Gordijn, {Sanne J.} and Wessel Ganzevoort and Beune, {Irene M.} and Ahmet Baschat and Asma Khalil and Louise Kenny and Bloomfield, {Frank H.} and Mandy Daly and Jamie Kirkham and Declan Devane and Papageorghiou, {Aris T.}",

year = "2019",

month = oct,

doi = "10.1016/j.ajog.2019.05.039",

language = "English",

volume = "221",

pages = "339.e1--339.e10",

journal = "American Journal of Obstetrics and Gynecology",

issn = "0002-9378",

publisher = "MOSBY-ELSEVIER",

number = "4",

}

Healy, P, Gordijn, SJ, Ganzevoort, W, Beune, IM, Baschat, A, Khalil, A, Kenny, L, Bloomfield, FH, Daly, M, Kirkham, J, Devane, D & Papageorghiou, AT 2019, 'A Core Outcome Set for the prevention and treatment of fetal GROwth restriction: deVeloping Endpoints: the COSGROVE study', American Journal of Obstetrics and Gynecology, vol. 221, no. 4, pp. 339.e1-339.e10. https://doi.org/10.1016/j.ajog.2019.05.039

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.

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 in-clusion 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 in-clusion 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 - Birth Weight

KW - Bronchopulmonary Dysplasia

KW - Cerebral Palsy

KW - Cognitive Dysfunction

KW - Consensus

KW - Delphi Technique

KW - Eclampsia

KW - Enterocolitis, Necrotizing

KW - Female

KW - Fetal Growth Retardation/prevention & control

KW - Gestational Age

KW - Hearing Loss

KW - Humans

KW - Hypoxia-Ischemia, Brain

KW - Infant, Low Birth Weight

KW - Infant, Newborn

KW - Maternal Death

KW - Outcome Assessment, Health Care

KW - Perinatal Death

KW - Pre-Eclampsia

KW - Pregnancy

KW - Premature Birth

KW - Respiration, Artificial

KW - Stillbirth

KW - Vision Disorders

U2 - 10.1016/j.ajog.2019.05.039

DO - 10.1016/j.ajog.2019.05.039

M3 - Article

C2 - 31152710

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 -

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

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