A core outcome set for trials in miscarriage management and prevention: An international consensus development study.
Delphi method
consensus development study
core outcome set
miscarriage management
miscarriage prevention
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
revised:
12
02
2023
received:
04
11
2022
accepted:
20
03
2023
medline:
4
9
2023
pubmed:
12
4
2023
entrez:
11
4
2023
Statut:
ppublish
Résumé
To develop core outcome sets (COS) for miscarriage management and prevention. Modified Delphi survey combined with a consensus development meeting. International. Stakeholder groups included healthcare providers, international experts, researchers, charities and couples with lived experience of miscarriage from 15 countries: 129 stakeholders for miscarriage management and 437 for miscarriage prevention. Modified Delphi method and modified nominal group technique. The final COS for miscarriage management comprises six outcomes: efficacy of treatment, heavy vaginal bleeding, pelvic infection, maternal death, treatment or procedure-related complications, and patient satisfaction. The final COS for miscarriage prevention comprises 12 outcomes: pregnancy loss <24 weeks' gestation, live birth, gestation at birth, pre-term birth, congenital abnormalities, fetal growth restriction, maternal (antenatal) complications, compliance with intervention, patient satisfaction, maternal hospitalisation, neonatal or infant hospitalisation, and neonatal or infant death. Other outcomes identified as important were mental health-related outcomes, future fertility and health economic outcomes. This study has developed two core outcome sets, through robust methodology, that should be implemented across future randomised trials and systematic reviews in miscarriage management and prevention. This work will help to standardise outcome selection, collection and reporting, and improve the quality and safety of future studies in miscarriage.
Identifiants
pubmed: 37039256
doi: 10.1111/1471-0528.17484
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1346-1354Subventions
Organisme : World Health Organization
ID : 001
Pays : International
Informations de copyright
© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
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