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

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

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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
Article number	314
Pages (from-to)	1-15
Number of pages	15
Journal	BMC Medicine
Volume	21
Issue number	1
Early online date	21 Aug 2023
DOIs	https://doi.org/10.1186/s12916-023-03013-3
Publication status	Published online - 21 Aug 2023

Bibliographical note

Funding Information:
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. The views expressed are those of the author and not necessarily those of the funders, the NIHR or the UK Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.

Funding Information:
We would like to thank the following individuals, organisations and many others for helping with the recruitment of the Delphi surveys: 4M Mentor Mothers, African and Caribbean Support Northern Ireland, Alopecia UK, Ammalife, Association of South Asian Midwives, Attention Deficit Hyperactivity Disorder UK, Autism Connected, Balachandran Kumarendran, Birthrights, Black Female Doctors UK, Black Mothers Matter, Bliss, Breast Cancer Now, Bristol, North Somerset and South Gloucestershire Maternity Voices Partnership, British Adult Congenital Cardiac Nurse Association, British Association of Perinatal Medicine, British Human Immunodeficiency Virus Association, British Intrapartum Care Society, British Maternal and Fetal Medicine Society, British Thyroid Foundation, Cardiff Lupus Support Group, Cardiomyopathy UK, Chelsea and Westminster Maternity Voices Partnership, Community of Cultures Sheffield Maternity Cooperation, Core Outcome Measures in Effectiveness Trials Initiative, Crohn’s and Colitis Canada, Crohn’s and Colitis UK, Dads Matter, Diabetes UK, Disability Maternity Care (Australia), Elly Charity, E-MOTIVE Trial, Epilepsy Foundation of America, Epilepsy Society, Fair Treatment for the Women of Wales, Fibromyalgia Action UK, General Practitioners Championing Perinatal Care, Global Kidney Foundation, Graham Mcllroy, Haemophilia Foundation Australia, Hereditary Spastic Paraplegia Support Group, Institute of Health Visiting, International League Against Epilepsy (Africa), Irish Neonatal Health Alliance, Juvenile Diabetes Research Foundation, Katie’s Team, Kidney Patient Involvement Network, Kidney Wales, LGBT Mummies, MacDonald Obstetric Medicine Society, Malaysian Obstetric Medicine, Maternity and Midwifery Forum, MIDIRS Midwifery Digest, Midlands Maternal Medicine Network, Milena Forte, MQ Mental Health Research, Multiple Sclerosis Australia, Mums Like Us, Mum’s Pride, Mumsnet, Muslim Women’s Network UK, National Childbirth Trust, National Human Immunodeficiency Virus Nurses Association, National Kidney Federation, National Rheumatoid Arthritis UK, Newport Yemeni Community Association, Niina Kolehmainen, Obsessive Compulsive Disorder Action, Obstetric Anaesthetists’ Association, Organisation for Sickle Cell Anaemia Relief and Thalassaemia Support Birmingham, Parathyroid UK, Parent Voices in Wales, Parents 1st, Positive East, Positive Life Northern Ireland, Postural Tachycardia Syndrome UK, Psoriasis Association, Raham Project, Royal College of Midwives, Royal Surrey County Hospital Maternity Voices Partnership, Scottish Perinatal Network, Scottish Research Nurse, Midwife & Coordinators’ Network, Section for Women’s Mental Health Institute of Psychiatry, Psychology and Neuroscience (King’s College London), Sjogern’s India, Society of Obstetric Medicine of Australia and New Zealand, Society of Obstetric Medicine (India), Somerville Heart Foundation, Sophia Forum, South African Nephrology Society, South Asian Health Foundation, South London Applied Research Collaboration Maternal and Perinatal Mental Health Research Patient and Public Involvement, Stockport Foundation Trust, Taraki, The Black Wellbeing Collective, The International Marcé Society for Perinatal Mental Health, The Pituitary Foundation, Thyroid Patients Canada, Tommy’s, Turner Syndrome Support Society UK, UK Audit and Research Collaborative in Obstetrics and Gynaecology, UK Preconception Early-and Mid-Career Researchers Network, UK Teratology Information Service, University of Bristol Centre for Academic Primary Care and Patient and Public Involvement Panel, Vasculitis Ireland Awareness, Verity Polycystic Ovarian Syndrome UK, Wales Perinatal Mental Health Network. We would also like to thank Clare Evans for her input in reviewing this manuscript. Siang Ing Lee @IngLee17 Stephanie Hanley @shanley29 Zoe Vowles @zoe_vowles Rachel Plachcinski @Stroppybrunette Ngawai Moss @ngawai_n Megha Singh @meghasingh_16 Chris Gale @DrCGale Adeniyi Francis Fagbamigbe @franstel74 Amaya Azcoaga-Lorenzo @amaya_azcoaga Anuradhaa Subramanian @anuradhaa_s Beck Taylor @BeckTaylorPH Catherine Nelson-Piercy @nelson_piercy Christopher Yau @cwcyau Holly Hope @hfhope Kelly-Ann Eastwood @K_AEastwood Lisa Kent @LisaKent_QUB Louise Locock @LLocock Peter Brocklehurst @brocklehurst_p Sharon McCann @SharonKMcCann Sinead Brophy @SineadBr Steven Wambua @StevenWambua Shakila Thangaratinam @thangaratinam Krishnarajah Nirantharakumar @Nirantharakumar Mairead Black @maireadblack MuM-PreDiCT #mumpredict.

Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.

Keywords

multimorbidity
multiple chronic conditions
multiple long-term conditions
pregnancy
maternity
outcome
core outcome set
Maternity
Core outcome set
Multimorbidity
Multiple chronic conditions
Pregnancy
Multiple long-term conditions
Outcome

UN SDGs

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

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10.1186/s12916-023-03013-3

s12916-023-03013-3Final published version, 1.77 MBLicence: CC BY

Cite this

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., ... Black, M. (2023). The development of a core outcome set for studies of pregnant women with multimorbidity. BMC Medicine, 21(1), 1-15. Article 314. Advance online publication. https://doi.org/10.1186/s12916-023-03013-3

@article{5e1ba32bc8424c92916386497ce465ba,

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.",

keywords = "multimorbidity, multiple chronic conditions, multiple long-term conditions, pregnancy, maternity, outcome, core outcome set, Maternity, Core outcome set, Multimorbidity, Multiple chronic conditions, Pregnancy, Multiple long-term conditions, Outcome",

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",

note = "Funding Information: 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. The views expressed are those of the author and not necessarily those of the funders, the NIHR or the UK Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. Funding Information: We would like to thank the following individuals, organisations and many others for helping with the recruitment of the Delphi surveys: 4M Mentor Mothers, African and Caribbean Support Northern Ireland, Alopecia UK, Ammalife, Association of South Asian Midwives, Attention Deficit Hyperactivity Disorder UK, Autism Connected, Balachandran Kumarendran, Birthrights, Black Female Doctors UK, Black Mothers Matter, Bliss, Breast Cancer Now, Bristol, North Somerset and South Gloucestershire Maternity Voices Partnership, British Adult Congenital Cardiac Nurse Association, British Association of Perinatal Medicine, British Human Immunodeficiency Virus Association, British Intrapartum Care Society, British Maternal and Fetal Medicine Society, British Thyroid Foundation, Cardiff Lupus Support Group, Cardiomyopathy UK, Chelsea and Westminster Maternity Voices Partnership, Community of Cultures Sheffield Maternity Cooperation, Core Outcome Measures in Effectiveness Trials Initiative, Crohn{\textquoteright}s and Colitis Canada, Crohn{\textquoteright}s and Colitis UK, Dads Matter, Diabetes UK, Disability Maternity Care (Australia), Elly Charity, E-MOTIVE Trial, Epilepsy Foundation of America, Epilepsy Society, Fair Treatment for the Women of Wales, Fibromyalgia Action UK, General Practitioners Championing Perinatal Care, Global Kidney Foundation, Graham Mcllroy, Haemophilia Foundation Australia, Hereditary Spastic Paraplegia Support Group, Institute of Health Visiting, International League Against Epilepsy (Africa), Irish Neonatal Health Alliance, Juvenile Diabetes Research Foundation, Katie{\textquoteright}s Team, Kidney Patient Involvement Network, Kidney Wales, LGBT Mummies, MacDonald Obstetric Medicine Society, Malaysian Obstetric Medicine, Maternity and Midwifery Forum, MIDIRS Midwifery Digest, Midlands Maternal Medicine Network, Milena Forte, MQ Mental Health Research, Multiple Sclerosis Australia, Mums Like Us, Mum{\textquoteright}s Pride, Mumsnet, Muslim Women{\textquoteright}s Network UK, National Childbirth Trust, National Human Immunodeficiency Virus Nurses Association, National Kidney Federation, National Rheumatoid Arthritis UK, Newport Yemeni Community Association, Niina Kolehmainen, Obsessive Compulsive Disorder Action, Obstetric Anaesthetists{\textquoteright} Association, Organisation for Sickle Cell Anaemia Relief and Thalassaemia Support Birmingham, Parathyroid UK, Parent Voices in Wales, Parents 1st, Positive East, Positive Life Northern Ireland, Postural Tachycardia Syndrome UK, Psoriasis Association, Raham Project, Royal College of Midwives, Royal Surrey County Hospital Maternity Voices Partnership, Scottish Perinatal Network, Scottish Research Nurse, Midwife & Coordinators{\textquoteright} Network, Section for Women{\textquoteright}s Mental Health Institute of Psychiatry, Psychology and Neuroscience (King{\textquoteright}s College London), Sjogern{\textquoteright}s India, Society of Obstetric Medicine of Australia and New Zealand, Society of Obstetric Medicine (India), Somerville Heart Foundation, Sophia Forum, South African Nephrology Society, South Asian Health Foundation, South London Applied Research Collaboration Maternal and Perinatal Mental Health Research Patient and Public Involvement, Stockport Foundation Trust, Taraki, The Black Wellbeing Collective, The International Marc{\'e} Society for Perinatal Mental Health, The Pituitary Foundation, Thyroid Patients Canada, Tommy{\textquoteright}s, Turner Syndrome Support Society UK, UK Audit and Research Collaborative in Obstetrics and Gynaecology, UK Preconception Early-and Mid-Career Researchers Network, UK Teratology Information Service, University of Bristol Centre for Academic Primary Care and Patient and Public Involvement Panel, Vasculitis Ireland Awareness, Verity Polycystic Ovarian Syndrome UK, Wales Perinatal Mental Health Network. We would also like to thank Clare Evans for her input in reviewing this manuscript. Siang Ing Lee @IngLee17 Stephanie Hanley @shanley29 Zoe Vowles @zoe_vowles Rachel Plachcinski @Stroppybrunette Ngawai Moss @ngawai_n Megha Singh @meghasingh_16 Chris Gale @DrCGale Adeniyi Francis Fagbamigbe @franstel74 Amaya Azcoaga-Lorenzo @amaya_azcoaga Anuradhaa Subramanian @anuradhaa_s Beck Taylor @BeckTaylorPH Catherine Nelson-Piercy @nelson_piercy Christopher Yau @cwcyau Holly Hope @hfhope Kelly-Ann Eastwood @K_AEastwood Lisa Kent @LisaKent_QUB Louise Locock @LLocock Peter Brocklehurst @brocklehurst_p Sharon McCann @SharonKMcCann Sinead Brophy @SineadBr Steven Wambua @StevenWambua Shakila Thangaratinam @thangaratinam Krishnarajah Nirantharakumar @Nirantharakumar Mairead Black @maireadblack MuM-PreDiCT #mumpredict. Publisher Copyright: {\textcopyright} 2023, BioMed Central Ltd., part of Springer Nature.",

year = "2023",

month = aug,

day = "21",

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

language = "English",

volume = "21",

pages = "1--15",

journal = "BMC Medicine",

issn = "1741-7015",

publisher = "BioMed Central",

number = "1",

}

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 2023, 'The development of a core outcome set for studies of pregnant women with multimorbidity.', BMC Medicine, vol. 21, no. 1, 314, pp. 1-15. 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

N1 - Funding Information: 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. The views expressed are those of the author and not necessarily those of the funders, the NIHR or the UK Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. Funding Information: We would like to thank the following individuals, organisations and many others for helping with the recruitment of the Delphi surveys: 4M Mentor Mothers, African and Caribbean Support Northern Ireland, Alopecia UK, Ammalife, Association of South Asian Midwives, Attention Deficit Hyperactivity Disorder UK, Autism Connected, Balachandran Kumarendran, Birthrights, Black Female Doctors UK, Black Mothers Matter, Bliss, Breast Cancer Now, Bristol, North Somerset and South Gloucestershire Maternity Voices Partnership, British Adult Congenital Cardiac Nurse Association, British Association of Perinatal Medicine, British Human Immunodeficiency Virus Association, British Intrapartum Care Society, British Maternal and Fetal Medicine Society, British Thyroid Foundation, Cardiff Lupus Support Group, Cardiomyopathy UK, Chelsea and Westminster Maternity Voices Partnership, Community of Cultures Sheffield Maternity Cooperation, Core Outcome Measures in Effectiveness Trials Initiative, Crohn’s and Colitis Canada, Crohn’s and Colitis UK, Dads Matter, Diabetes UK, Disability Maternity Care (Australia), Elly Charity, E-MOTIVE Trial, Epilepsy Foundation of America, Epilepsy Society, Fair Treatment for the Women of Wales, Fibromyalgia Action UK, General Practitioners Championing Perinatal Care, Global Kidney Foundation, Graham Mcllroy, Haemophilia Foundation Australia, Hereditary Spastic Paraplegia Support Group, Institute of Health Visiting, International League Against Epilepsy (Africa), Irish Neonatal Health Alliance, Juvenile Diabetes Research Foundation, Katie’s Team, Kidney Patient Involvement Network, Kidney Wales, LGBT Mummies, MacDonald Obstetric Medicine Society, Malaysian Obstetric Medicine, Maternity and Midwifery Forum, MIDIRS Midwifery Digest, Midlands Maternal Medicine Network, Milena Forte, MQ Mental Health Research, Multiple Sclerosis Australia, Mums Like Us, Mum’s Pride, Mumsnet, Muslim Women’s Network UK, National Childbirth Trust, National Human Immunodeficiency Virus Nurses Association, National Kidney Federation, National Rheumatoid Arthritis UK, Newport Yemeni Community Association, Niina Kolehmainen, Obsessive Compulsive Disorder Action, Obstetric Anaesthetists’ Association, Organisation for Sickle Cell Anaemia Relief and Thalassaemia Support Birmingham, Parathyroid UK, Parent Voices in Wales, Parents 1st, Positive East, Positive Life Northern Ireland, Postural Tachycardia Syndrome UK, Psoriasis Association, Raham Project, Royal College of Midwives, Royal Surrey County Hospital Maternity Voices Partnership, Scottish Perinatal Network, Scottish Research Nurse, Midwife & Coordinators’ Network, Section for Women’s Mental Health Institute of Psychiatry, Psychology and Neuroscience (King’s College London), Sjogern’s India, Society of Obstetric Medicine of Australia and New Zealand, Society of Obstetric Medicine (India), Somerville Heart Foundation, Sophia Forum, South African Nephrology Society, South Asian Health Foundation, South London Applied Research Collaboration Maternal and Perinatal Mental Health Research Patient and Public Involvement, Stockport Foundation Trust, Taraki, The Black Wellbeing Collective, The International Marcé Society for Perinatal Mental Health, The Pituitary Foundation, Thyroid Patients Canada, Tommy’s, Turner Syndrome Support Society UK, UK Audit and Research Collaborative in Obstetrics and Gynaecology, UK Preconception Early-and Mid-Career Researchers Network, UK Teratology Information Service, University of Bristol Centre for Academic Primary Care and Patient and Public Involvement Panel, Vasculitis Ireland Awareness, Verity Polycystic Ovarian Syndrome UK, Wales Perinatal Mental Health Network. We would also like to thank Clare Evans for her input in reviewing this manuscript. Siang Ing Lee @IngLee17 Stephanie Hanley @shanley29 Zoe Vowles @zoe_vowles Rachel Plachcinski @Stroppybrunette Ngawai Moss @ngawai_n Megha Singh @meghasingh_16 Chris Gale @DrCGale Adeniyi Francis Fagbamigbe @franstel74 Amaya Azcoaga-Lorenzo @amaya_azcoaga Anuradhaa Subramanian @anuradhaa_s Beck Taylor @BeckTaylorPH Catherine Nelson-Piercy @nelson_piercy Christopher Yau @cwcyau Holly Hope @hfhope Kelly-Ann Eastwood @K_AEastwood Lisa Kent @LisaKent_QUB Louise Locock @LLocock Peter Brocklehurst @brocklehurst_p Sharon McCann @SharonKMcCann Sinead Brophy @SineadBr Steven Wambua @StevenWambua Shakila Thangaratinam @thangaratinam Krishnarajah Nirantharakumar @Nirantharakumar Mairead Black @maireadblack MuM-PreDiCT #mumpredict. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.

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.

KW - multimorbidity

KW - multiple chronic conditions

KW - multiple long-term conditions

KW - pregnancy

KW - maternity

KW - outcome

KW - core outcome set

KW - Maternity

KW - Core outcome set

KW - Multimorbidity

KW - Multiple chronic conditions

KW - Pregnancy

KW - Multiple long-term conditions

KW - Outcome

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U2 - 10.1186/s12916-023-03013-3

DO - 10.1186/s12916-023-03013-3

M3 - Article

C2 - 37605204

SN - 1741-7015

VL - 21

SP - 1

EP - 15

JO - BMC Medicine

JF - BMC Medicine

IS - 1

M1 - 314

ER -

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

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Keywords

UN SDGs

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