Core outcome set for studies investigating management of selective fetal growth restriction in twins.
Birth Weight
Consensus
Delphi Technique
Endpoint Determination
Female
Fetal Growth Retardation
/ therapy
Gestational Age
Humans
Infant, Newborn
Live Birth
Obstetric Surgical Procedures
/ methods
Outcome Assessment, Health Care
/ methods
Pregnancy
Pregnancy, Twin
Treatment Outcome
Twins, Monozygotic
/ statistics & numerical data
Delphi consensus
consensus
core outcome set
fetal growth restriction
multiple pregnancy
Journal
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology
ISSN: 1469-0705
Titre abrégé: Ultrasound Obstet Gynecol
Pays: England
ID NLM: 9108340
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
28
03
2019
revised:
07
06
2019
accepted:
21
06
2019
pubmed:
6
7
2019
medline:
27
11
2021
entrez:
6
7
2019
Statut:
ppublish
Résumé
Selective fetal growth restriction (sFGR) occurs in monochorionic twin pregnancies when unequal placental sharing leads to restriction in the growth of just one twin. Management options include laser separation of the fetal circulations, selective reduction or expectant management, but what constitutes the best treatment is not yet known. New trials in this area are urgently needed but, in this rare and complex group, maximizing the relevance and utility of clinical research design and outputs is paramount. A core outcome set ensures standardized outcome collection and reporting in future research. The objective of this study was to develop a core outcome set for studies evaluating treatments for sFGR in monochorionic twins. An international steering group of clinicians, researchers and patients with experience of sFGR was established to oversee the process of development of a core outcome set for studies investigating the management of sFGR. Outcomes reported in the literature were identified through a systematic review and informed the design of a three-round Delphi survey. Clinicians, researchers, and patients and family representatives participated in the survey. Outcomes were scored on a Likert scale from 1 (limited importance for making a decision) to 9 (critical for making a decision). Consensus was defined a priori as a Likert score of ≥ 8 in the third round of the Delphi survey. Participants were then invited to take part in an international meeting of stakeholders in which the modified nominal group technique was used to consider the consensus outcomes and agree on a final core outcome set. Ninety-six outcomes were identified from 39 studies in the systematic review. One hundred and three participants from 23 countries completed the first round of the Delphi survey, of whom 88 completed all three rounds. Twenty-nine outcomes met the a priori criteria for consensus and, along with six additional outcomes, were prioritized in a consensus development meeting, using the modified nominal group technique. Twenty-five stakeholders participated in this meeting, including researchers (n = 3), fetal medicine specialists (n = 3), obstetricians (n = 2), neonatologists (n = 3), midwives (n = 4), parents and family members (n = 6), patient group representatives (n = 3), and a sonographer. Eleven core outcomes were agreed upon. These were live birth, gestational age at birth, birth weight, intertwin birth-weight discordance, death of surviving twin after death of cotwin, loss during pregnancy or before final hospital discharge, parental stress, procedure-related adverse maternal outcome, length of neonatal stay in hospital, neurological abnormality on postnatal imaging and childhood disability. This core outcome set for studies investigating the management of sFGR represents the consensus of a large and diverse group of international collaborators. Use of these outcomes in future trials should help to increase the clinical relevance of research on this condition. Consensus agreement on core outcome definitions and measures is now required. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Types de publication
Journal Article
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
652-660Investigateurs
Ahmet Baschat
(A)
Alfredo Perales-Marin
(A)
Anthony Johnson
(A)
Arduino Silvana
(A)
Aris Papageorghious
(A)
Ashok Khurana
(A)
Asma Khalil
(A)
Bonnie Trinder
(B)
C Andrew Combs
(CA)
Carolyn Bailie
(C)
Charlotte Huddy
(C)
Christie Bolch
(C)
Conrado Milani Coutinho
(CM)
Daniel Skupski
(D)
Danielle Hake
(D)
Dick Oepkes
(D)
Dietmar Schlembach
(D)
Eduardo Gratacos
(E)
Eleanor Lindahl
(E)
Elena Carreras
(E)
Elena Mantovani
(E)
Elisa Giallongo
(E)
Emily Marler
(E)
Emma Bertucci
(E)
Enrico Lopriore
(E)
Federico Prefumo
(F)
Filomena G Sileo
(FG)
Gavin Guy
(G)
Giuseppe Rizzo
(G)
Hayley King
(H)
Helen Perry
(H)
Herbert Valensise
(H)
Hiran Samarage
(H)
James Duffy
(J)
Jan Deprest
(J)
Jane Denton
(J)
Joana Curado
(J)
Joel Marsden
(J)
Jorge E Tolosa
(JE)
Joseph Toms
(J)
Joshua Copel
(J)
Justin Richards
(J)
Keisuke Ishii
(K)
Keith Reed
(K)
Kirsten Palmer
(K)
Kirsty Watkins
(K)
Kurt Hecher
(K)
Liesbeth Lewi
(L)
Lindsay McGrath
(L)
Lisa Canolini
(L)
Mala Vast Dhuri
(MV)
Maria Kyriakidou
(M)
Mariano Lanna
(M)
Marjorie Treadwell
(M)
Michelle Watson
(M)
Monica Rankin
(M)
Natasha Fenwick
(N)
Pablo Moore
(P)
Patrick O'Brien
(P)
Robert Cincotta
(R)
Rosemary Townsend
(R)
Sandra Linton
(S)
Sanne J Gordijn
(SJ)
Sophie Robinson
(S)
Therese McSorley
(T)
Tomasz Fuchs
(T)
Tullio Ghi
(T)
Wessel Ganzevoort
(W)
Wunmi Omosebi
(W)
Yaa Acheampong
(Y)
Informations de copyright
Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
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