A core outcome set for trials in miscarriage management and prevention: An international consensus development study

Dhillon-Smith, RK, Melo, P, Devall, AJ, Smith, PP, Al-Memar, M, Barnhart, K, Condous, G, Christiansen, OB, Goddijn, M, Jurkovic, D
et al (show 11 more authors) (2023) A core outcome set for trials in miscarriage management and prevention: An international consensus development study. BJOG-AN INTERNATIONAL JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 130 (11). pp. 1346-1354.

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<h4>Objective</h4>To develop core outcome sets (COS) for miscarriage management and prevention.<h4>Design</h4>Modified Delphi survey combined with a consensus development meeting.<h4>Setting</h4>International.<h4>Population</h4>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.<h4>Methods</h4>Modified Delphi method and modified nominal group technique.<h4>Results</h4>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.<h4>Conclusions</h4>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.

Item Type: Article
Uncontrolled Keywords: consensus development study, core outcome set, Delphi method, miscarriage management, miscarriage prevention
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 05 Oct 2023 15:38
Last Modified: 05 Oct 2023 15:38
DOI: 10.1111/1471-0528.17484
Open Access URL: https://doi.org/10.1111/1471-0528.17484
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3173480