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

Autor: Dhillon-Smith RK; Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.; Birmingham Women's and Children's NHS Healthcare Trust, Birmingham, UK., Melo P; Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK., Devall AJ; Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK., Smith PP; Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.; Birmingham Women's and Children's NHS Healthcare Trust, Birmingham, UK., Al-Memar M; Tommy's National Centre for Miscarriage Research, Institute of Reproductive Developmental Biology, Imperial College London, London, UK.; Queen Charlotte's & Chelsea Hospital, Imperial College NHS Healthcare Trust, London, UK., Barnhart K; Department of Obstetrics and Gynecology, The Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Condous G; Deparment of Obstetrics and Gynaecology at Sydney Medical School Nepean, University of Sydney, Kingswood, New South Wales, Australia., Christiansen OB; Centre for Recurrent Pregnancy Loss of Western Denmark, Department of Obstetrics and Gynaecology, Aalborg University Hospital, Aalborg, Denmark., Goddijn M; Centre for Reproductive Medicine, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development Research Institute, Amsterdam University Medical Center, Amsterdam, The Netherlands., Jurkovic D; Institute for Women's Health, University College Hospital, London, UK., Lissauer D; Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK., Maheshwari A; Aberdeen Fertility Centre, NHS Grampian Scotland, Aberdeen, UK., Oladapo OT; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland., Preisler J; Departamento de Ginecología y Obstetricia, Facultad de Medicina, Clínica Alemana-Universidad del Desarrollo, Santiago, Chile.; Departamento de Ginecología y Obstetricia, Hospital Clínico Universidad de Chile, Santiago, Chile., Regan L; St Mary's Hospital, Imperial College NHS Healthcare Trust, London, UK., Small R; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Stephenson M; Department of Obstetrics and Gynecology, University of Illinois, Chicago, Illinois, USA., Wijeyaratne C; Department of Obstetrics & Gynaecology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka., Quenby S; University Hospitals Coventry and Warwickshire, Clifford Bridge Road, Coventry, UK., Bourne T; Tommy's National Centre for Miscarriage Research, Institute of Reproductive Developmental Biology, Imperial College London, London, UK.; Department of Development & Regeneration, KU Leuven, Leuven, Belgium., Coomarasamy A; Tommy's National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.; Birmingham Women's and Children's NHS Healthcare Trust, Birmingham, UK.
Jazyk: angličtina
Zdroj: BJOG : an international journal of obstetrics and gynaecology [BJOG] 2023 Oct; Vol. 130 (11), pp. 1346-1354. Date of Electronic Publication: 2023 Apr 11.
DOI: 10.1111/1471-0528.17484
Abstrakt: Objective: 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.
(© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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