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

^*Corresponding author for this work

Metabolism and Systems Research

Research output: Contribution to journal › Article › 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 <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.

Original language	English
Journal	BJOG: An International Journal of Obstetrics & Gynaecology
Early online date	11 Apr 2023
DOIs	https://doi.org/10.1111/1471-0528.17484
Publication status	E-pub ahead of print - 11 Apr 2023

Bibliographical note

Keywords

consensus development study
core outcome set
Delphi method
miscarriage management
miscarriage prevention

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/1471-0528.17484Licence: Creative Commons: Attribution (CC BY)

Dhillon‐SmithRK2023ACoreFinal published version, 910 KBLicence: Creative Commons: Attribution (CC BY)

Surgical Evacuation of Miscarriage with and without Intraoperative Ultrasound: a Programme of Research
Smith, P.
NIHR TRAINEES COORDINATING CENTRE
1/10/15 → 30/09/20
Project: Other Government Departments

Cite this

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 & Gynaecology. Advance online publication. https://doi.org/10.1111/1471-0528.17484

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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' 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.",

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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 = apr,

day = "11",

doi = "10.1111/1471-0528.17484",

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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 & Gynaecology. 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 - 2023/4/11

Y1 - 2023/4/11

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 - consensus development study

KW - core outcome set

KW - Delphi method

KW - miscarriage management

KW - miscarriage prevention

U2 - 10.1111/1471-0528.17484

DO - 10.1111/1471-0528.17484

M3 - Article

C2 - 37039256

SN - 1470-0328

JO - BJOG: An International Journal of Obstetrics & Gynaecology

JF - BJOG: An International Journal of Obstetrics & Gynaecology

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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Projects

Surgical Evacuation of Miscarriage with and without Intraoperative Ultrasound: a Programme of Research

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