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

R. K. Dhillon-Smith; P. Melo; A. J. Devall; P. P. Smith; M. Al-Memar; K. Barnhart; G. Condous; O. B. Christiansen; M. Goddijn; D. Jurkovic; D. Lissauer; A. Maheshwari; O. T. Oladapo; J. Preisler; L. Regan; R. Small; M. Stephenson; C. Wijeyaratne; S. Quenby; T. Bourne; A. Coomarasamy

doi:10.1111/1471-0528.17484

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

R. K. Dhillon-Smith^*, P. Melo, A. J. Devall, P. P. Smith, M. Al-Memar, K. Barnhart, G. Condous, O. B. Christiansen, M. Goddijn, D. Jurkovic, D. Lissauer, A. Maheshwari, O. T. Oladapo, J. Preisler, L. Regan, R. Small, M. Stephenson, C. Wijeyaratne, S. Quenby, T. BourneA. Coomarasamy

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Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

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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
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.

Originalsprog	Engelsk
Tidsskrift	BJOG: An International Journal of Obstetrics and Gynaecology
Vol/bind	130
Udgave nummer	11
Sider (fra-til)	1346-1354
Antal sider	9
ISSN	1470-0328
DOI	https://doi.org/10.1111/1471-0528.17484
Status	Udgivet - okt. 2023

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10.1111/1471-0528.17484Licens: CC BY 4.0

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Dhillon-Smith, R. K., Melo, P., Devall, A. J., Smith, P. P., Al-Memar, M., Barnhart, K., Condous, G., Christiansen, O. B., Goddijn, M., Jurkovic, D., Lissauer, D., Maheshwari, A., Oladapo, O. T., Preisler, J., Regan, L., Small, R., Stephenson, M., Wijeyaratne, C., Quenby, S., ... Coomarasamy, A. (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), 1346-1354. Advance online publication. https://doi.org/10.1111/1471-0528.17484

@article{2206874d16764461b9a33bb196218daf,

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

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{\textquoteright} 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.",

keywords = "Delphi method, consensus development study, core outcome set, miscarriage management, miscarriage prevention",

author = "Dhillon-Smith, {R. K.} and P. Melo and Devall, {A. J.} and Smith, {P. P.} and M. Al-Memar and K. Barnhart and G. Condous and Christiansen, {O. B.} and M. Goddijn and D. Jurkovic and D. Lissauer and A. Maheshwari and Oladapo, {O. T.} and J. Preisler and L. Regan and R. Small and M. Stephenson and C. Wijeyaratne and S. Quenby and T. Bourne and A. Coomarasamy",

note = "{\textcopyright} 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.",

year = "2023",

month = oct,

doi = "10.1111/1471-0528.17484",

language = "English",

volume = "130",

pages = "1346--1354",

journal = "BJOG: An International Journal of Obstetrics and Gynaecology",

issn = "1470-0328",

publisher = "Wiley-Blackwell",

number = "11",

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Dhillon-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 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, bind 130, nr. 11, s. 1346-1354. https://doi.org/10.1111/1471-0528.17484

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.

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

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U2 - 10.1111/1471-0528.17484

DO - 10.1111/1471-0528.17484

M3 - Journal 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 -

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

Abstract

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