Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study

Introduction Neonatal death exerts long-lasting impact on parents’ mental health, finances and relationships, and the wider family. There is national and international momentum to evaluate interventions to support parents after the death of a baby. Core Outcome Sets (COSs) provide a minimum set of o...

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Main Authors: James Webbe, Mehali Patel, Danya Bakhbakhi, Christy Burden, Mary Lynch, Laura Timlin, Lisa Hinton, Abigail Fraser, Anna Davies, Maggie Redshaw, David Odd, Charlotte Williams, Dimitris Siasakos, Abi Merriel, Sadie Mullin, Lucy Moy, Leanne Watts
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/2/e088251.full
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author James Webbe
Mehali Patel
Danya Bakhbakhi
Christy Burden
Mary Lynch
Laura Timlin
Lisa Hinton
Abigail Fraser
Anna Davies
Maggie Redshaw
David Odd
Charlotte Williams
Dimitris Siasakos
Abi Merriel
Sadie Mullin
Lucy Moy
Leanne Watts
author_facet James Webbe
Mehali Patel
Danya Bakhbakhi
Christy Burden
Mary Lynch
Laura Timlin
Lisa Hinton
Abigail Fraser
Anna Davies
Maggie Redshaw
David Odd
Charlotte Williams
Dimitris Siasakos
Abi Merriel
Sadie Mullin
Lucy Moy
Leanne Watts
author_sort James Webbe
collection DOAJ
description Introduction Neonatal death exerts long-lasting impact on parents’ mental health, finances and relationships, and the wider family. There is national and international momentum to evaluate interventions to support parents after the death of a baby. Core Outcome Sets (COSs) provide a minimum set of outcomes, agreed by stakeholders to be important, which should be evaluated in all studies to support evidence syntheses and identification of the most effective interventions. We aim to develop a COS for assessing interventions and care after neonatal death in high-income countries, to support future evidence syntheses and enable the identification of effective interventions and care for parents.Methods and analysis We will develop the COS in six phases. A parent involvement group and stakeholder steering committee have been established and have informed each planned phase: (1) systematic review of quantitative studies evaluating care and interventions provided after neonatal death, to describe interventions, outcomes and outcome measurement tools used to assess intervention effectiveness; (2) qualitative interviews with parents who have experienced neonatal death to identify outcomes important and relevant to them; (3) think-aloud interviews with stakeholders (bereaved parents, healthcare professionals and other stakeholders) to develop and refine an online survey; (4) real-time online international Delphi survey with bereaved parents, healthcare professionals and other stakeholders to shortlist outcomes for consideration in the COS; (5) adapted nominal group online consensus meetings with parents, healthcare professionals and other stakeholders to agree final COS and (6) identification of a preliminary set of measurement tools.Ethics and dissemination Ethical approval has been granted for all activities to be undertaken by the University of Bristol Health Sciences Faculty Research Ethics Committee (reference: 15121). We will disseminate the findings via peer-reviewed publications and relevant academic and professional conferences.PROSPERO registration number CRD42020151365.
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spelling doaj-art-7bafb3e7e83e4e8a9391735fa7c3ac952025-02-04T04:25:09ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-088251Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods studyJames Webbe0Mehali Patel1Danya Bakhbakhi2Christy Burden3Mary Lynch4Laura Timlin5Lisa Hinton6Abigail Fraser7Anna Davies8Maggie Redshaw9David Odd10Charlotte Williams11Dimitris Siasakos12Abi Merriel13Sadie Mullin14Lucy Moy15Leanne Watts16Section of Neonatal Medicine, Imperial College London, London, UKStillbirth and Neonatal Death Society, London, UKAcademic Women`s Health Unit, University of Bristol, Bristol, UKAcademic Women`s Health Unit, Translational Health Sciences, University of Bristol, Bristol, UKAcademic Women`s Health Unit, Translational Health Sciences, University of Bristol, Bristol, UKWomen & Children`s Health, North Bristol NHS Trust, Bristol, UKUniversity of Oxford, Oxford, UKMRC Integrative Epidemiology Unit, University of Bristol, Bristol, UKAcademic Women`s Health Unit, Translational Health Sciences, University of Bristol, Bristol, UKIndependent Research Consultant, Bristol, UKCardiff University, Cardiff, UKAcademic Women`s Health Unit, Translational Health Sciences, University of Bristol, Bristol, UKEGA Institute for Women`s Health, UCL, London, UKUniversity of Liverpool, Liverpool, UKAcademic Women`s Health Unit, Translational Health Sciences, University of Bristol, Bristol, UKUniversity of Bristol, Bristol, UKIndependent Parent Representative, London, UKIntroduction Neonatal death exerts long-lasting impact on parents’ mental health, finances and relationships, and the wider family. There is national and international momentum to evaluate interventions to support parents after the death of a baby. Core Outcome Sets (COSs) provide a minimum set of outcomes, agreed by stakeholders to be important, which should be evaluated in all studies to support evidence syntheses and identification of the most effective interventions. We aim to develop a COS for assessing interventions and care after neonatal death in high-income countries, to support future evidence syntheses and enable the identification of effective interventions and care for parents.Methods and analysis We will develop the COS in six phases. A parent involvement group and stakeholder steering committee have been established and have informed each planned phase: (1) systematic review of quantitative studies evaluating care and interventions provided after neonatal death, to describe interventions, outcomes and outcome measurement tools used to assess intervention effectiveness; (2) qualitative interviews with parents who have experienced neonatal death to identify outcomes important and relevant to them; (3) think-aloud interviews with stakeholders (bereaved parents, healthcare professionals and other stakeholders) to develop and refine an online survey; (4) real-time online international Delphi survey with bereaved parents, healthcare professionals and other stakeholders to shortlist outcomes for consideration in the COS; (5) adapted nominal group online consensus meetings with parents, healthcare professionals and other stakeholders to agree final COS and (6) identification of a preliminary set of measurement tools.Ethics and dissemination Ethical approval has been granted for all activities to be undertaken by the University of Bristol Health Sciences Faculty Research Ethics Committee (reference: 15121). We will disseminate the findings via peer-reviewed publications and relevant academic and professional conferences.PROSPERO registration number CRD42020151365.https://bmjopen.bmj.com/content/15/2/e088251.full
spellingShingle James Webbe
Mehali Patel
Danya Bakhbakhi
Christy Burden
Mary Lynch
Laura Timlin
Lisa Hinton
Abigail Fraser
Anna Davies
Maggie Redshaw
David Odd
Charlotte Williams
Dimitris Siasakos
Abi Merriel
Sadie Mullin
Lucy Moy
Leanne Watts
Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
BMJ Open
title Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
title_full Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
title_fullStr Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
title_full_unstemmed Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
title_short Developing a core outcome set for assessing interventions and care for parents after neonatal death in high-income countries (iCHOOSE Neonatal study): protocol for a mixed-methods study
title_sort developing a core outcome set for assessing interventions and care for parents after neonatal death in high income countries ichoose neonatal study protocol for a mixed methods study
url https://bmjopen.bmj.com/content/15/2/e088251.full
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