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Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Siang Ing Lee, Kelly-Ann Eastwood, Ngawai Moss, Amaya Azcoaga-Lorenzo, Anuradhaa Subramanian, Astha Anand, Beck Taylor, Catherine Nelson-Piercy, Christopher Yau, Colin McCowan, Dermot O'Reilly, Holly Hope, Jonathan Kennedy, Kathryn Mary Abel, Louise Locock, Peter Brocklehurst, Rachel Plachcinski, Sinead Brophy Orcid Logo, Utkarsh Agrawal, Shakila Thangaratinam, Krishnarajah Nirantharakumar, Mairead Black

BMJ Open, Volume: 11, Issue: 10, Start page: e044919

Swansea University Authors: Jonathan Kennedy, Sinead Brophy Orcid Logo

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DOI (Published version): 10.1136/bmjopen-2020-044919

Abstract

Increasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women wit...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2021
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This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings. We propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field. This study has been approved by the University of Birmingham's ethical review committee. 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spelling 2021-12-07T15:22:15.5312841 v2 58679 2021-11-15 Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity 08163d1f58d7fefcb1c695bcc2e0ef68 Jonathan Kennedy Jonathan Kennedy true false 84f5661b35a729f55047f9e793d8798b 0000-0001-7417-2858 Sinead Brophy Sinead Brophy true false 2021-11-15 HDAT Increasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings. We propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field. This study has been approved by the University of Birmingham's ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders. [Abstract copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.] Journal Article BMJ Open 11 10 e044919 BMJ 2044-6055 2044-6055 Outcome Assessment, Health Care, public health, Pregnant Women, Female, Pregnancy, Multimorbidity, Parturition, maternal medicine, Research Design, Delphi Technique, Humans, preventive medicine 29 10 2021 2021-10-29 10.1136/bmjopen-2020-044919 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University Medical Research Council Grant: MR/V005243/1 2021-12-07T15:22:15.5312841 2021-11-15T15:24:20.3268585 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Siang Ing Lee 1 Kelly-Ann Eastwood 2 Ngawai Moss 3 Amaya Azcoaga-Lorenzo 4 Anuradhaa Subramanian 5 Astha Anand 6 Beck Taylor 7 Catherine Nelson-Piercy 8 Christopher Yau 9 Colin McCowan 10 Dermot O'Reilly 11 Holly Hope 12 Jonathan Kennedy 13 Kathryn Mary Abel 14 Louise Locock 15 Peter Brocklehurst 16 Rachel Plachcinski 17 Sinead Brophy 0000-0001-7417-2858 18 Utkarsh Agrawal 19 Shakila Thangaratinam 20 Krishnarajah Nirantharakumar 21 Mairead Black 22 58679__21544__14483c39a70c4ef9b8fa4be78ea639fe.pdf 58679.pdf 2021-11-15T15:26:19.2419280 Output 1104448 application/pdf Version of Record true © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. true eng https://creativecommons.org/licenses/by/4.0/
title Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
spellingShingle Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
Jonathan Kennedy
Sinead Brophy
title_short Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
title_full Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
title_fullStr Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
title_full_unstemmed Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
title_sort Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity
author_id_str_mv 08163d1f58d7fefcb1c695bcc2e0ef68
84f5661b35a729f55047f9e793d8798b
author_id_fullname_str_mv 08163d1f58d7fefcb1c695bcc2e0ef68_***_Jonathan Kennedy
84f5661b35a729f55047f9e793d8798b_***_Sinead Brophy
author Jonathan Kennedy
Sinead Brophy
author2 Siang Ing Lee
Kelly-Ann Eastwood
Ngawai Moss
Amaya Azcoaga-Lorenzo
Anuradhaa Subramanian
Astha Anand
Beck Taylor
Catherine Nelson-Piercy
Christopher Yau
Colin McCowan
Dermot O'Reilly
Holly Hope
Jonathan Kennedy
Kathryn Mary Abel
Louise Locock
Peter Brocklehurst
Rachel Plachcinski
Sinead Brophy
Utkarsh Agrawal
Shakila Thangaratinam
Krishnarajah Nirantharakumar
Mairead Black
format Journal article
container_title BMJ Open
container_volume 11
container_issue 10
container_start_page e044919
publishDate 2021
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2020-044919
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
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description Increasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings. We propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field. This study has been approved by the University of Birmingham's ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders. [Abstract copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.]
published_date 2021-10-29T04:15:23Z
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score 11.012678

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