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

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dc.contributor.authorDhillon-Smith, Rima K.
dc.contributor.authorMelo, Pedro
dc.contributor.authorDevall, Adam James
dc.contributor.authorSmith, Paul Philip
dc.contributor.authorAl-Memar, Maya
dc.contributor.authorBarnhart, Kurt
dc.contributor.authorCondous, George
dc.contributor.authorChristiansen, Ole Bjarne
dc.contributor.authorGoddijn, Mariƫtte
dc.contributor.authorJurkovic, Davor
dc.contributor.authorLissauer, David
dc.contributor.authorMaheshwari, Abha
dc.contributor.authorOladapo, Olufemi
dc.date.accessioned2024-05-30T21:59:21Z
dc.date.available2024-05-30T21:59:21Z
dc.date.issued2023
dc.description.abstractObjective: To develop core outcome sets (COS) for miscarriage management and prevention. Design: Modified Delphi survey combined with a consensus development meeting. Setting: International. Population: 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. Methods: Modified Delphi method and modified nominal group technique. Results: 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. Conclusions: 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.
dc.description.versionVersiĆ³n publicada
dc.format.extent9 p.
dc.identifier.citationDhillon-Smith RK, Melo P, Devall AJ, Smith PP, Al-Memar M, Barnhart K, Condous G, Christiansen OB, Goddijn M, Jurkovic D, Lissauer D, Maheshwari A, Oladapo OT, Preisler J, Regan L, Small R, Stephenson M, Wijeyaratne C, Quenby S, Bourne T, Coomarasamy A. A core outcome set for trials in miscarriage management and prevention: An international consensus development study. BJOG. 2023 Oct;130(11):1346-1354. doi: 10.1111/1471-0528.17484.
dc.identifier.doihttps://doi.org/0.1111/1471-0528.17484
dc.identifier.urihttps://hdl.handle.net/11447/8978
dc.language.isoen
dc.rightsAtribuciĆ³n-NoComercial-CompartirIgual 3.0 Chile (CC BY-NC-SA 3.0 CL)
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/3.0/cl/
dc.subjectDelphi method
dc.subjectConsensus development study
dc.subjectCore outcome set
dc.subjectMiscarriage management
dc.subjectMiscarriage prevention
dc.titleA core outcome set for trials in miscarriage management and prevention: An international consensus development study
dc.typeArticle
dcterms.accessRightsAcceso abierto
dcterms.sourceBJOG
dspace.entity.typePublication

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