The development of a core outcome set for studies of pregnant women with multimorbidity

Siang Ing Lee; Stephanie Hanley; Zoe Vowles; Rachel Plachcinski; Ngawai Moss; Megha Singh; Chris Gale; Adeniyi Francis Fagbamigbe; Amaya Azcoaga-Lorenzo; Anuradhaa Subramanian; Beck Taylor; Catherine Nelson-Piercy; Christine Damase-Michel; Christopher Yau; Colin McCowan; Dermot O’Reilly; Gillian Santorelli; Helen Dolk; Holly Hope; Katherine Phillips; Kathryn M. Abel; Kelly-Ann Eastwood; Lisa Kent; Louise Locock; Maria Loane; Mohamed Mhereeg; Peter Brocklehurst; Sharon McCann; Sinead Brophy; Steven Wambua; Sudasing Pathirannehelage Buddhika Hemali Sudasinghe; Shakila Thangaratinam; Krishnarajah Nirantharakumar; Mairead Black; on behalf of the MuM-PreDiCT Group

doi:10.1186/s12916-023-03013-3

The development of a core outcome set for studies of pregnant women with multimorbidity

Siang Ing Lee, Stephanie Hanley, Zoe Vowles, Rachel Plachcinski, Ngawai Moss, Megha Singh, Chris Gale, Adeniyi Francis Fagbamigbe, Amaya Azcoaga-Lorenzo, Anuradhaa Subramanian, Beck Taylor, Catherine Nelson-Piercy, Christine Damase-Michel, Christopher Yau, Colin McCowan, Dermot O’Reilly, Gillian Santorelli, Helen Dolk, Holly Hope, Katherine PhillipsKathryn M. Abel, Kelly-Ann Eastwood, Lisa Kent, Louise Locock, Maria Loane, Mohamed Mhereeg, Peter Brocklehurst, Sharon McCann, Sinead Brophy, Steven Wambua, Sudasing Pathirannehelage Buddhika Hemali Sudasinghe, Shakila Thangaratinam, Krishnarajah Nirantharakumar, Mairead Black, on behalf of the MuM-PreDiCT Group

Research output: Contribution to journal › Article › peer-review

Abstract

Background
Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity.

Methods
We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations.

Results
Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs.

Conclusions
Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group.

Original language	English
Journal	BMC Medicine
Volume	21
DOIs	https://doi.org/10.1186/s12916-023-03013-3
Publication status	Published - 21 Aug 2023

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Copyright © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
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Lee, S. I., Hanley, S., Vowles, Z., Plachcinski, R., Moss, N., Singh, M., Gale, C., Fagbamigbe, A. F., Azcoaga-Lorenzo, A., Subramanian, A., Taylor, B., Nelson-Piercy, C., Damase-Michel, C., Yau, C., McCowan, C., O’Reilly, D., Santorelli, G., Dolk, H., Hope, H., ... Group, O. B. O. T. M.-PT. (2023). The development of a core outcome set for studies of pregnant women with multimorbidity. BMC Medicine, 21. https://doi.org/10.1186/s12916-023-03013-3

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title = "The development of a core outcome set for studies of pregnant women with multimorbidity",

abstract = "Background Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity. Methods We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations. Results Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70\% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80\% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs. Conclusions Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group.",

author = "Lee, \{Siang Ing\} and Stephanie Hanley and Zoe Vowles and Rachel Plachcinski and Ngawai Moss and Megha Singh and Chris Gale and Fagbamigbe, \{Adeniyi Francis\} and Amaya Azcoaga-Lorenzo and Anuradhaa Subramanian and Beck Taylor and Catherine Nelson-Piercy and Christine Damase-Michel and Christopher Yau and Colin McCowan and Dermot O{\textquoteright}Reilly and Gillian Santorelli and Helen Dolk and Holly Hope and Katherine Phillips and Abel, \{Kathryn M.\} and Kelly-Ann Eastwood and Lisa Kent and Louise Locock and Maria Loane and Mohamed Mhereeg and Peter Brocklehurst and Sharon McCann and Sinead Brophy and Steven Wambua and \{Hemali Sudasinghe\}, \{Sudasing Pathirannehelage Buddhika\} and Shakila Thangaratinam and Krishnarajah Nirantharakumar and Mairead Black and Group, \{on behalf of the MuM-PreDiCT\}",

note = "This work was funded by the Strategic Priority Fund “Tackling multimorbidity at scale” programme (grant number MR/W014432/1) delivered by the Medical Research Council and the National Institute for Health Research in partnership with the Economic and Social Research Council and in collaboration with the Engineering and Physical Sciences Research Council. BT was funded by the National Institute for Health Research (NIHR) West Midlands Applied Research Collaboration.",

year = "2023",

month = aug,

day = "21",

doi = "10.1186/s12916-023-03013-3",

language = "English",

volume = "21",

journal = "BMC Medicine",

issn = "1741-7015",

publisher = "BioMed Central",

}

Lee, SI, Hanley, S, Vowles, Z, Plachcinski, R, Moss, N, Singh, M, Gale, C, Fagbamigbe, AF, Azcoaga-Lorenzo, A, Subramanian, A, Taylor, B, Nelson-Piercy, C, Damase-Michel, C, Yau, C, McCowan, C, O’Reilly, D, Santorelli, G, Dolk, H, Hope, H, Phillips, K, Abel, KM, Eastwood, K-A, Kent, L, Locock, L, Loane, M, Mhereeg, M, Brocklehurst, P, McCann, S, Brophy, S, Wambua, S, Hemali Sudasinghe, SPB, Thangaratinam, S, Nirantharakumar, K, Black, M & Group, OBOTM-PT 2023, 'The development of a core outcome set for studies of pregnant women with multimorbidity', BMC Medicine, vol. 21. https://doi.org/10.1186/s12916-023-03013-3

TY - JOUR

T1 - The development of a core outcome set for studies of pregnant women with multimorbidity

AU - Lee, Siang Ing

AU - Hanley, Stephanie

AU - Vowles, Zoe

AU - Plachcinski, Rachel

AU - Moss, Ngawai

AU - Singh, Megha

AU - Gale, Chris

AU - Fagbamigbe, Adeniyi Francis

AU - Azcoaga-Lorenzo, Amaya

AU - Subramanian, Anuradhaa

AU - Taylor, Beck

AU - Nelson-Piercy, Catherine

AU - Damase-Michel, Christine

AU - Yau, Christopher

AU - McCowan, Colin

AU - O’Reilly, Dermot

AU - Santorelli, Gillian

AU - Dolk, Helen

AU - Hope, Holly

AU - Phillips, Katherine

AU - Abel, Kathryn M.

AU - Eastwood, Kelly-Ann

AU - Kent, Lisa

AU - Locock, Louise

AU - Loane, Maria

AU - Mhereeg, Mohamed

AU - Brocklehurst, Peter

AU - McCann, Sharon

AU - Brophy, Sinead

AU - Wambua, Steven

AU - Hemali Sudasinghe, Sudasing Pathirannehelage Buddhika

AU - Thangaratinam, Shakila

AU - Nirantharakumar, Krishnarajah

AU - Black, Mairead

AU - Group, on behalf of the MuM-PreDiCT

N1 - This work was funded by the Strategic Priority Fund “Tackling multimorbidity at scale” programme (grant number MR/W014432/1) delivered by the Medical Research Council and the National Institute for Health Research in partnership with the Economic and Social Research Council and in collaboration with the Engineering and Physical Sciences Research Council. BT was funded by the National Institute for Health Research (NIHR) West Midlands Applied Research Collaboration.

PY - 2023/8/21

Y1 - 2023/8/21

N2 - Background Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity. Methods We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations. Results Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs. Conclusions Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group.

AB - Background Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity. Methods We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations. Results Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs. Conclusions Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group.

UR - https://www.scopus.com/pages/publications/85168521757

U2 - 10.1186/s12916-023-03013-3

DO - 10.1186/s12916-023-03013-3

M3 - Article

SN - 1741-7015

VL - 21

JO - BMC Medicine

JF - BMC Medicine

ER -

The development of a core outcome set for studies of pregnant women with multimorbidity

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