Development of a core outcome set for stillbirth and neonatal death care research (iCHOOSE Study)

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-, middle- and low- income countries. 4) Deciding the core outcome set by consensus meetings with key stakeholders and 4) Dissemination and promotion of the core outcome set. A parent and public involvement panel and international steering committee has been convened to co-produce 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 Ref 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 speciality journals, shared at national and international conferences and promoted through parent organisations and charities.


Danya Bakhbakhi, University of Bristol,
Abigail Fraser, University of Bristol
Dimitrios Siassakos
Lisa Hinton, THIS, University of Cambridge
Anna Davies, University of Bristol
James M N Duffy
Maggie Redshaw, University of Oxford
Mary Lynch, University of Bristol
Abi Merriel, University of Bristol
Laura Timlin, North Bristol NHS Trust
Vicki Flenady, The University of Queensland
Alexander Heazell, University of Manchester
Soo Downe, University of Central Lancashire
Pauline Slade, University of Liverpool
Sara Brookes, University of Birmingham
Aleena Wojcieszek, The University of Queensland
Margaret Murphy, University College Cork
Heloisa de O. Salgado, University of Sao Paulo
Danielle Pollock, JBI, University of Adelaide
Neelam Aggarawal, Post Graduate Institute of Medical Education and Research, Chandigarh, India
Irene Attachie, University of Health and Allied Sciences, Ghana,
Susannah Hopkins Leisher, International Stillbirth Alliance,
Wanjiru Kihusa, Still a Mum, Kenya
Kate Mulley, Sands Charity, United Kingdom,
Lindsey Wimmer, Star Legacy Foundation,
UK iCHOOSE parent involvement group

Further Study Information

Current Stage: Ongoing
Date: January 2016 - June 2022
Funding source(s): NIHR Doctoral Research Training Fellowship

Health Area

Disease Category: Neonatal care, Pregnancy & childbirth

Disease Name: Intrauterine death, Stillbirth , Neonatal loss

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Nonpharmacological , Psychological & behavioural

Stakeholders Involved

Study Type

- COS for clinical trials or clinical research


- Consensus meeting
- Delphi process
- Interview
- Systematic review