Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

doi:10.1136/bmjopen-2021-056629

. 2022 Feb 9;12(2):e056629.

doi: 10.1136/bmjopen-2021-056629.

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

Danya Bakhbakhi¹, Abigail Fraser², Dimitris Siasakos³, Lisa Hinton⁴, Anna Davies⁵, Abi Merriel², James M N Duffy⁶, Maggie Redshaw⁷, Mary Lynch⁸, Laura Timlin⁹, Vicki Flenady¹⁰, Alexander Edward Heazell¹¹, Soo Downe¹², Pauline Slade¹³, Sara Brookes¹⁴, Aleena Wojcieszek¹⁰, Margaret Murphy¹⁵, Heloisa de Oliveira Salgado¹⁶, Danielle Pollock¹⁷, Neelam Aggarwal¹⁸, Irene Attachie¹⁹, Susannah Leisher²⁰, Wanijiru Kihusa²¹, Kate Mulley²², Lindsey Wimmer²³; UK iCHOOSE parent involvement group; Christy Burden²⁴

Collaborators, Affiliations

Collaborators

UK iCHOOSE parent involvement group:
Lisa Thorne, Will Hatton, Carla Mereu Keating, Heather Jane Coombs, Dave Coombs, Michelle Fischer, Ali Fischer, Fraser Morton, Naomi Hepworth

Affiliations

¹ Translational Health Sciences, University of Bristol Medical School, Bristol, UK danya.bakhbakhi@bristol.ac.uk.
² Population Health Sciences, University of Bristol Medical School, Bristol, UK.
³ UCL EGA Institute for Women's Health, UCL, London, UK.
⁴ The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, UK.
⁵ Centre for Academic Child Health, University of Bristol, Bristol, UK.
⁶ Obstetrics and Gynaecology Department, North Middlesex University Hospital NHS Trust, London, UK.
⁷ Department of Population Health, NPEU, Oxford, UK.
⁸ Faculty of Health Sciences, University of Bristol, Bristol, UK.
⁹ Women & Children's Health Department, North Bristol NHS Trust, Bristol, UK.
¹⁰ Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Brisbane, Queensland, Australia.
¹¹ Maternal and Fetal Health Research Centre, University of Manchester, Manchester, UK.
¹² Research in Childbirth and Health, University of Central Lancashire, Preston, UK.
¹³ Psychological Sciences, University of Liverpool, Liverpool, UK.
¹⁴ Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
¹⁵ Nursing and Midwifery, University College Cork National University of Ireland, Cork, Ireland.
¹⁶ Department of Social Medicine, University of São Paulo, Sao Paulo, Brazil.
¹⁷ Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
¹⁸ Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
¹⁹ Department of Nursing and Midwifery, University of Health and Allied Sciences School of Public Health, Hohoe, Ghana.
²⁰ International Stillbirth Alliance, Millburn, New Jersey, USA.
²¹ Still a mum, Nairobi, Kenya.
²² Research department, Sands, London, UK.
²³ Star Legacy Foundation, Minneapolis, Minnesota, USA.
²⁴ Translational Health Sciences, University of Bristol Medical School, Bristol, UK.

PMID: 35140161
PMCID: PMC8830254
DOI: 10.1136/bmjopen-2021-056629

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

Danya Bakhbakhi et al. BMJ Open. 2022.

. 2022 Feb 9;12(2):e056629.

doi: 10.1136/bmjopen-2021-056629.

Authors

Collaborators

UK iCHOOSE parent involvement group:
Lisa Thorne, Will Hatton, Carla Mereu Keating, Heather Jane Coombs, Dave Coombs, Michelle Fischer, Ali Fischer, Fraser Morton, Naomi Hepworth

Affiliations

¹ Translational Health Sciences, University of Bristol Medical School, Bristol, UK danya.bakhbakhi@bristol.ac.uk.
² Population Health Sciences, University of Bristol Medical School, Bristol, UK.
³ UCL EGA Institute for Women's Health, UCL, London, UK.
⁴ The Healthcare Improvement Studies Institute, University of Cambridge, Cambridge, UK.
⁵ Centre for Academic Child Health, University of Bristol, Bristol, UK.
⁶ Obstetrics and Gynaecology Department, North Middlesex University Hospital NHS Trust, London, UK.
⁷ Department of Population Health, NPEU, Oxford, UK.
⁸ Faculty of Health Sciences, University of Bristol, Bristol, UK.
⁹ Women & Children's Health Department, North Bristol NHS Trust, Bristol, UK.
¹⁰ Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Brisbane, Queensland, Australia.
¹¹ Maternal and Fetal Health Research Centre, University of Manchester, Manchester, UK.
¹² Research in Childbirth and Health, University of Central Lancashire, Preston, UK.
¹³ Psychological Sciences, University of Liverpool, Liverpool, UK.
¹⁴ Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
¹⁵ Nursing and Midwifery, University College Cork National University of Ireland, Cork, Ireland.
¹⁶ Department of Social Medicine, University of São Paulo, Sao Paulo, Brazil.
¹⁷ Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
¹⁸ Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
¹⁹ Department of Nursing and Midwifery, University of Health and Allied Sciences School of Public Health, Hohoe, Ghana.
²⁰ International Stillbirth Alliance, Millburn, New Jersey, USA.
²¹ Still a mum, Nairobi, Kenya.
²² Research department, Sands, London, UK.
²³ Star Legacy Foundation, Minneapolis, Minnesota, USA.
²⁴ Translational Health Sciences, University of Bristol Medical School, Bristol, UK.

PMID: 35140161
PMCID: PMC8830254
DOI: 10.1136/bmjopen-2021-056629

Abstract

Introduction: Stillbirth is associated with significant physical, psychosocial and economic consequences for parents, families, wider society and the healthcare system. There is emerging momentum to design and evaluate interventions for care after stillbirth and in subsequent pregnancies. However, there is insufficient evidence to inform clinical practice compounded by inconsistent outcome reporting in research studies. To address this paucity of evidence, we plan to develop a core outcome set for stillbirth care research, through an international consensus process with key stakeholders including parents, healthcare professionals and researchers.

Methods and analysis: The development of this core outcome set will be divided into five distinct phases: (1) Identifying potential outcomes from a mixed-methods systematic review and analysis of interviews with parents who have experienced stillbirth; (2) Creating a comprehensive outcome long-list and piloting of a Delphi questionnaire using think-aloud interviews; (3) Choosing the most important outcomes by conducting an international two-round Delphi survey including high-income, middle-income and low-income countries; (4) Deciding the core outcome set by consensus meetings with key stakeholders and (5) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to coproduce every stage of the development of this core outcome set.

Ethics and dissemination: Ethical approval for the qualitative interviews has been approved by Berkshire Ethics Committee REC Reference 12/SC/0495. Ethical approval for the think-aloud interviews, Delphi survey and consensus meetings has been awarded from the University of Bristol Faculty of Health Sciences Research Ethics Committee (Reference number: 116535). The dissemination strategy is being developed with the parent and public involvement panel and steering committee. Results will be published in peer-reviewed specialty journals, shared at national and international conferences and promoted through parent organisations and charities.

Prospero registration number: CRD42018087748.

Keywords: fetal medicine; maternal medicine; obstetrics; protocols & guidelines; qualitative research; quality in health care.

PubMed Disclaimer

Conflict of interest statement

Competing interests: AW has received consulting fees from the Sillbirth CRE.

Figures

**Figure 1**
Types of interventions after stillbirth that should be evaluated using outcomes identified in the core outcome set.

**Figure 2**
iCHOOSE study overview. iCHOOSE, International Collaboration for Harmonising Outcomes fOr Stillbirth research and carE.

See this image and copyright information in PMC

Cited by

Vaginal birth core information set: study protocol for a Delphi study to achieve a consensus on a 'core information set' for vaginal birth.
Demetri A, Davies A, Bakhbakhi D, Ijaz S, Dawson S, McGuinness S, Beasor G, Clayton G, Johnson A, de Souza C, Dempsey A, Snook G, Sharp A, Lissauer D, McGoldrick E, Burden C, Merriel A. Demetri A, et al. BMJ Open. 2023 Aug 7;13(8):e070215. doi: 10.1136/bmjopen-2022-070215. BMJ Open. 2023. PMID: 37550021 Free PMC article.
A meta-core outcome set for stillbirth prevention and bereavement care following stillbirth in LMIC.
Dube K, Marenga F, Ayebare EO, Bedwell C, Chaudhry N, Chilinda I, Chimwaza A, Devane D, Fattepur S, Goshomi U, Kiran T, Laisser R, Lavender T, Mills TA, Nabisere A, Un Nisa Z, Vwalika B, Wakasiaka S, Kirkham JJ. Dube K, et al. BMJ Glob Health. 2025 Jan 28;10(1):e017688. doi: 10.1136/bmjgh-2024-017688. BMJ Glob Health. 2025. PMID: 39875140 Free PMC article.
Support for parents and families after stillbirth and neonatal death.
Loughnan S, Bakhbakhi D, Ellwood DA, Boyle F, Middleton P, Burden C, Ludski K, Saunders R, Flenady V. Loughnan S, et al. Cochrane Database Syst Rev. 2024 Nov 13;11(11):CD015798. doi: 10.1002/14651858.CD015798. Cochrane Database Syst Rev. 2024. PMID: 39535308 Free PMC article.
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.
Davies A, Williams C, Burden C, Mullin S, Moy L, Redshaw M, Patel M, Fraser A, Hinton L, Lynch M, Merriel A, Siasakos D, Webbe J, Odd D, Timlin L, Watts L, Bakhbakhi D. Davies A, et al. BMJ Open. 2025 Feb 3;15(2):e088251. doi: 10.1136/bmjopen-2024-088251. BMJ Open. 2025. PMID: 39900413 Free PMC article.
Swedish massage as an adjunct approach to Help suppOrt individuals Pregnant after Experiencing a prior Stillbirth (HOPES): a convergent parallel mixed-methods single-arm feasibility trial protocol.
Fogarty S, Heazell AEP, Munk N, Hay P. Fogarty S, et al. Pilot Feasibility Stud. 2024 Apr 30;10(1):67. doi: 10.1186/s40814-024-01499-z. Pilot Feasibility Stud. 2024. PMID: 38689324 Free PMC article.

References

1. Unicef . Unicef stillbirth data, 2020.
1. Heazell AEP, Siassakos D, Blencowe H, et al. . Stillbirths: economic and psychosocial consequences. The Lancet 2016;387:604–16. 10.1016/S0140-6736(15)00836-3 - DOI - PubMed
1. Burden C, Bradley S, Storey C, et al. . From grief, guilt pain and stigma to hope and pride - a systematic review and meta-analysis of mixed-method research of the psychosocial impact of stillbirth. BMC Pregnancy Childbirth 2016;16:9. 10.1186/s12884-016-0800-8 - DOI - PMC - PubMed
1. Sarkar A, Siwatch S, Aggarwal N, et al. . The unheard parental Cry of a stillbirth: fathers and mothers. Arch Gynecol Obstet 2021. 10.1007/s00404-021-06120-9. [Epub ahead of print: 12 Jun 2021]. - DOI - PubMed
1. Black M, Shetty A, Bhattacharya S. Obstetric outcomes subsequent to intrauterine death in the first pregnancy. BJOG 2008;115:269-74. 10.1111/j.1471-0528.2007.01562.x - DOI - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Medical
- MedlinePlus Health Information

[1] Unicef . Unicef stillbirth data, 2020.

[2] Unicef . Unicef stillbirth data, 2020.

[3] Heazell AEP, Siassakos D, Blencowe H, et al. . Stillbirths: economic and psychosocial consequences. The Lancet 2016;387:604–16. 10.1016/S0140-6736(15)00836-3 - DOI - PubMed

[4] Heazell AEP, Siassakos D, Blencowe H, et al. . Stillbirths: economic and psychosocial consequences. The Lancet 2016;387:604–16. 10.1016/S0140-6736(15)00836-3 - DOI - PubMed

[5] Burden C, Bradley S, Storey C, et al. . From grief, guilt pain and stigma to hope and pride - a systematic review and meta-analysis of mixed-method research of the psychosocial impact of stillbirth. BMC Pregnancy Childbirth 2016;16:9. 10.1186/s12884-016-0800-8 - DOI - PMC - PubMed

[6] Burden C, Bradley S, Storey C, et al. . From grief, guilt pain and stigma to hope and pride - a systematic review and meta-analysis of mixed-method research of the psychosocial impact of stillbirth. BMC Pregnancy Childbirth 2016;16:9. 10.1186/s12884-016-0800-8 - DOI - PMC - PubMed

[7] Sarkar A, Siwatch S, Aggarwal N, et al. . The unheard parental Cry of a stillbirth: fathers and mothers. Arch Gynecol Obstet 2021. 10.1007/s00404-021-06120-9. [Epub ahead of print: 12 Jun 2021]. - DOI - PubMed

[8] Sarkar A, Siwatch S, Aggarwal N, et al. . The unheard parental Cry of a stillbirth: fathers and mothers. Arch Gynecol Obstet 2021. 10.1007/s00404-021-06120-9. [Epub ahead of print: 12 Jun 2021]. - DOI - PubMed

[9] Black M, Shetty A, Bhattacharya S. Obstetric outcomes subsequent to intrauterine death in the first pregnancy. BJOG 2008;115:269-74. 10.1111/j.1471-0528.2007.01562.x - DOI - PubMed

[10] Black M, Shetty A, Bhattacharya S. Obstetric outcomes subsequent to intrauterine death in the first pregnancy. BJOG 2008;115:269-74. 10.1111/j.1471-0528.2007.01562.x - DOI - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

Collaborators

Affiliations

Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical

Abstract

Conflict of interest statement

Figures

Similar articles

Cited by

References

Publication types

MeSH terms

Related information

LinkOut - more resources

Full Text Sources

Medical