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Trials. 2019 Jan 9;20(1):35. doi: 10.1186/s13063-018-3153-y.

Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies.

Author information

1
Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK. akhalil@sgul.ac.uk.
2
Fetal Medicine Unit, Department of Obstetrics and Gynaecology, St. George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK. akhalil@sgul.ac.uk.
3
Balliol College, University of Oxford, Broad Street, Oxford, OX1 3BJ, UK.
4
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.
5
Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, London, SW17 0RE, UK.
6
Fetal Medicine Unit, Department of Obstetrics and Gynaecology, St. George's University Hospitals NHS Foundation Trust, Blackshaw Road, London, SW17 0QT, UK.
7
Department of Obstetrics and Gynecology, Academic Medical Center Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.
8
Twin and Multiple Births Association (TAMBA), The Manor House Manor Park, Church Hill, Aldershot, GU12 4JU, UK.
9
The Johns Hopkins Center for Fetal Therapy, 600 North Wolfe, Nelson 228, Baltimore, MD, 21287, USA.
10
Department of Obstetrics and Gynecology, University Hospitals of KU Leuven, Herestraat, 49 3000, Leuven, Belgium.
11
Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Clínic and Hospital Sant Joan de Deu, Universitat de Barcelona; Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), and Centre for Biomedical Research on Rare Diseases (CIBER-ER), Barcelona, Spain.
12
Department of Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf, Neues Klinikum, Gebäude O10 Martinistr. 52, 20246, Hamburg, Germany.
13
Division of Fetal Medicine, Department of Obstetrics, Leiden University Medical Center, K-06-35, P.O. Box 9600, 2300RC, Leiden, The Netherlands.
14
Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Abstract

BACKGROUND:

Selective fetal growth restriction in monochorionic twin pregnancies is associated with an increased risk of perinatal mortality and morbidity and represents a clinical dilemma. Interventions include expectant management with early preterm delivery if there are signs of fetal compromise, selective termination of the compromised twin, fetoscopic laser coagulation of the communicating placental vessels or termination of the whole pregnancy. Previous studies evaluating interventions have reported many different outcomes and outcome measures. Such variation makes comparing, contrasting, and combining results challenging, limiting ongoing research on this uncommon condition to inform clinical practice. We aim to produce, disseminate, and implement a core outcome set for selective fetal growth restriction research in monochorionic twin pregnancies.

METHODS:

An international steering group, including professionals, researchers, and lay experts, has been established to oversee the development of this core outcome set. The methods have been guided by the Core Outcome Measures in Effectiveness Trials Initiative Handbook. Potential core outcomes will be developed by undertaking a systematic review of studies evaluating interventions for selective fetal growth restriction in monochorionic twin pregnancies. Potential core outcomes will be entered into a three-round Delphi survey and key stakeholders including clinical professionals, researchers, and lay experts will be invited to participate. Repeated reflection and rescoring of individual outcomes should encourage group and individual stakeholder convergence towards consensus outcomes which will be entered into a modified Nominal Group Technique to finalize the core outcome set. Once core outcomes have been agreed, we will establish standardized definitions and recommend high-quality measurement instruments for each outcome.

DISCUSSION:

The development, dissemination, and implementation of a core outcome set for selective fetal growth restriction should ensure that future research protocols select, collect, and report outcomes and outcome measures in a standardized manner. Data synthesis will be possible on a broad level and rigorous implementation should advance the quality of research studies and their effective use in order to guide clinical practice, improve patient care, maternal, short-term perinatal outcomes, and long-term neurodevelopmental outcomes.

TRIAL REGISTRATION:

Core Outcome Measures in Effectiveness Trials (COMET) registration number: 998. International Prospective Register of Systematic Reviews (PROSPERO) registration number: CRD42018092697 . 18th April 2018.

KEYWORDS:

Consensus development study; Core outcome set; Modified Delphi method; Modified Nominal Group Technique; Selective fetal growth restriction; Selective intrauterine growth restriction

PMID:
30626413
PMCID:
PMC6327411
DOI:
10.1186/s13063-018-3153-y
[Indexed for MEDLINE]
Free PMC Article

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