Core outcome set for studies investigating management of selective fetal growth restriction in twins. (29th March 2020)

• Record Type: Journal Article
• Authors: Townsend, R.; Duffy, J. M. N.; Sileo, F.; Perry, H.; Ganzevoort, W.; Reed, K.; Baschat, A. A.; Deprest, J.; Gratacos, E.; Hecher, K.; Lewi, L.; Lopriore, E.; Oepkes, D.; Papageorghiou, A.; Gordijn, S. J.; Khalil, A.
• Other Names: Baschat Ahmet investigator.; Perales‐Marin Alfredo investigator.; Johnson Anthony investigator.; Silvana Arduino investigator.; Papageorghious Aris investigator.; Khurana Ashok investigator.; Khalil Asma investigator.; Trinder Bonnie investigator.; Combs C Andrew investigator.; Bailie Carolyn investigator.; Huddy Charlotte investigator.; Bolch Christie investigator.; Coutinho Conrado Milani investigator.; Skupski Daniel investigator.; Hake Danielle investigator.; Oepkes Dick investigator.; Schlembach Dietmar investigator.; Gratacos Eduardo investigator.; Lindahl Eleanor investigator.; Carreras Elena investigator.; Mantovani Elena investigator.; Giallongo Elisa investigator.; Marler Emily investigator.; Bertucci Emma investigator.; Lopriore Enrico investigator.; Prefumo Federico investigator.; Sileo Filomena G investigator.; Guy Gavin investigator.; Rizzo Giuseppe investigator.; King Hayley investigator.; Perry Helen investigator.; Valensise Herbert investigator.; Samarage Hiran investigator.; Duffy James investigator.; Deprest Jan investigator.; Denton Jane investigator.; Curado Joana investigator.; Marsden Joel investigator.; Tolosa Jorge E investigator.; Toms Joseph investigator.; Copel Joshua investigator.; Richards Justin investigator.; Ishii Keisuke investigator.; Reed Keith investigator.; Palmer Kirsten investigator.; Watkins Kirsty investigator.; Hecher Kurt investigator.; Lewi Liesbeth investigator.; McGrath Lindsay investigator.; Canolini Lisa investigator.; Dhuri Mala Vast investigator.; Kyriakidou Maria investigator.; Lanna Mariano investigator.; Treadwell Marjorie investigator.; Watson Michelle investigator.; Rankin Monica investigator.; Fenwick Natasha investigator.; Moore Pablo investigator.; O'Brien Patrick investigator.; Cincotta Robert investigator.; Townsend Rosemary investigator.; Linton Sandra investigator.; Gordijn Sanne J investigator.; Robinson Sophie investigator.; McSorley Therese investigator.; Fuchs Tomasz investigator.; Ghi Tullio investigator.; Ganzevoort Wessel investigator.; Omosebi Wunmi investigator.; Acheampong Yaa investigator.;
• Is Part Of: Ultrasound in obstetrics & gynecology. Volume 55:Number 5(2020)
• Page Start: 652
• Page End: 660
• Publication Date: 2020-03-29
• Subjects: consensus -- core outcome set -- Delphi consensus -- fetal growth restriction -- multiple pregnancy; Ultrasonics in obstetrics -- Periodicals; Generative organs, Female -- Diseases -- Diagnosis -- Periodicals; Diagnosis, Ultrasonic -- Periodicals; Genital Diseases, Female -- ultrasonography -- Periodicals; Ultrasonography, Prenatal -- Periodicals; 618.047543
• DOI: 10.1002/uog.20388
• Languages: English
• ISSNs: 0960-7692

Abstract

ABSTRACT: 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. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.