TY - JOUR
T1 - Core outcome set for studies investigating management of selective fetal growth restriction in twins
AU - Townsend, R.
AU - Duffy, J. M. N.
AU - Sileo, F.
AU - Perry, H.
AU - Ganzevoort, W.
AU - Reed, K.
AU - Baschat, A. A.
AU - Deprest, J.
AU - Gratacos, E.
AU - Hecher, K.
AU - Lewi, L.
AU - Lopriore, E.
AU - Oepkes, D.
AU - Papageorghiou, A.
AU - Gordijn, S. J.
AU - Khalil, A.
AU - the International Collaboration to Harmonise Outcomes for Selective Fetal Growth Restriction (CHOOSE-FGR)
AU - Baschat, Ahmet
AU - Perales-Marin, Alfredo
AU - Johnson, Anthony
AU - Silvana, Arduino
AU - Papageorghious, Aris
AU - Khurana, Ashok
AU - Khalil, Asma
AU - Trinder, Bonnie
AU - Combs, C. Andrew
AU - Bailie, Carolyn
AU - Huddy, Charlotte
AU - Bolch, Christie
AU - Coutinho, Conrado Milani
AU - Skupski, Daniel
AU - Hake, Danielle
AU - Oepkes, Dick
AU - Schlembach, Dietmar
AU - Gratacos, Eduardo
AU - Lindahl, Eleanor
AU - Carreras, Elena
AU - Mantovani, Elena
AU - Giallongo, Elisa
AU - Marler, Emily
AU - Bertucci, Emma
AU - Lopriore, Enrico
AU - Prefumo, Federico
AU - Sileo, Filomena G.
AU - Guy, Gavin
AU - Rizzo, Giuseppe
AU - King, Hayley
AU - Perry, Helen
AU - Valensise, Herbert
AU - Samarage, Hiran
AU - Ganzevoort, Wessel
N1 - Publisher Copyright: Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Objective: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Delphi consensus
KW - consensus
KW - core outcome set
KW - fetal growth restriction
KW - multiple pregnancy
UR - http://www.scopus.com/inward/record.url?scp=85082498054&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/uog.20388
DO - https://doi.org/10.1002/uog.20388
M3 - Article
C2 - 31273879
SN - 0960-7692
VL - 55
SP - 652
EP - 660
JO - Ultrasound in Obstetrics & Gynecology
JF - Ultrasound in Obstetrics & Gynecology
IS - 5
ER -