TY - JOUR
T1 - A core outcome set for trials in miscarriage management and prevention
T2 - An international consensus development study
AU - Dhillon-Smith, R. K.
AU - Melo, P.
AU - Devall, A. J.
AU - Smith, P. P.
AU - Al-Memar, M.
AU - Barnhart, K.
AU - Condous, G.
AU - Christiansen, O. B.
AU - Goddijn, M.
AU - Jurkovic, D.
AU - Lissauer, D.
AU - Maheshwari, A.
AU - Oladapo, O. T.
AU - Preisler, J.
AU - Regan, L.
AU - Small, R.
AU - Stephenson, M.
AU - Wijeyaratne, C.
AU - Quenby, S.
AU - Bourne, T.
AU - Coomarasamy, A.
N1 - Funding Information: This study was funded as part of a postdoctoral fellowship award from the National Institute for Health Research (NIHR), reference: PDF-2015-08-099. Miscarriage is defined as the spontaneous loss of a pregnancy before viability; specifically a pregnancy loss is the spontaneous demise of a pregnancy, which has been confirmed by at least two positive β-human chorionic gonadotropins (hCGs) in the serum or urine.1 Clinical miscarriage affects around 15% of pregnancies, which translates to approximately 23 million miscarriages a year worldwide.2 There is a great deal of research focused on trying to reduce miscarriage rates and improve the care for couples who suffer pregnancy loss. However, studies on miscarriage often do not address the same outcomes, making it difficult to draw conclusions and make recommendations when the evidence is synthesised. A systematic review of published trials on miscarriage management and prevention found 112 different outcomes used in miscarriage management trials and 61 outcomes for miscarriage prevention trials.3 Core outcome sets (COS) are an agreed, standardised set of outcomes based on what key stakeholders (e.g. healthcare providers, patients, researchers, guideline developers and funding organisations) consider the essential and guideline decision making outcomes in the management or prevention of a condition.4 The use of core outcome sets reduces inconsistencies in trial reporting, allowing results from different studies to be accurately compared and combined, and thus can reduce research waste. Core outcome sets are now being widely used across all specialties for several health conditions. The Cochrane collaboration and the National Institute for Health Research Health Technology Assessment (UK) advocate their use. Examples of COS specific to women's health include those published on endometriosis,5 postpartum haemorrhage,6 pre-eclampsia7 and subfertility.8 Developing a COS involves three stages. First, investigators systematically review published trials and conduct qualitative interviews with patients to collate all potential core outcomes. The systematic review relevant to our miscarriage COS was published in 2019.3 Secondly, COS developers refine the list of core outcomes using formal consensus methods. The third stage is to determine the final list of core outcomes and outline how each outcome should be defined and measured. The work of this paper describes the process of stages 2 and 3 and the resulting final COS for both miscarriage management and prevention trials. This study has focused on the production of the core outcomes themselves; the standardisation of definitions and measures will be reported in a separate paper. The aim of this COS is to form a foundation on which to support clinical guideline decision-making and improve the quality of future research for couples suffering a miscarriage. In addition, this work will help to improve the care and understanding of the efficacy interventions for miscarriage treatment and prevention. Funding Information: This study was funded as part of a postdoctoral fellowship award from the National Institute for Health Research (NIHR), reference: PDF‐2015‐08‐099. Publisher Copyright: © 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
KW - Delphi method
KW - consensus development study
KW - core outcome set
KW - miscarriage management
KW - miscarriage prevention
UR - http://www.scopus.com/inward/record.url?scp=85152774930&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/1471-0528.17484
DO - https://doi.org/10.1111/1471-0528.17484
M3 - Article
C2 - 37039256
SN - 1470-0328
VL - 130
SP - 1346
EP - 1354
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 11
ER -