Dhillon-Smith, RK;
Melo, P;
Devall, AJ;
Smith, PP;
Al-Memar, M;
Barnhart, K;
Condous, G;
... Coomarasamy, A; + view all
(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.
10.1111/1471-0528.17484.
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Abstract
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.
| Type: | Article |
|---|---|
| Title: | A core outcome set for trials in miscarriage management and prevention: An international consensus development study |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1111/1471-0528.17484 |
| Publisher version: | http://dx.doi.org/10.1111/1471-0528.17484 |
| Language: | English |
| Additional information: | © 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
| Keywords: | Delphi method, consensus development study, core outcome set, miscarriage management, miscarriage prevention, Infant, Newborn, Pregnancy, Humans, Female, Abortion, Spontaneous, Consensus, Fetal Growth Retardation, Maternal Death, Research Design, Delphi Technique, Outcome Assessment, Health Care, Treatment Outcome |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Reproductive Health |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10189274 |
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