Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set and identification of outcome measurement tools for interventions for prevention of stillbirth and care after stillbirth (International Collaboration for Harmonising Outcomes fOr Stillbirth resEarch: ICHOOSE)

General Information

Summary:
We aim to define a core outcome set for bereavement care interventions following intrauterine death, stillbirth and neonatal loss, that is evidence-based, relevant and appropriate for patients and researchers alike.
Objectives
1) To identify a list of outcome domains through systematic review of published studies reporting on outcomes following stillbirth, intrauterine death and early neonatal loss
2) To identify a list of potentially important outcome domains reported by women and their partners who have experienced stillbirth, intrauterine death and early neonatal loss to augment the list generated from (1)
3) To prioritise and reach a consensus regarding the most important outcome domains in order to create a Core Outcome Set (COS) in compliance with COMET (Core Outcome Measures in Effectiveness Trials) and CROWN (Core Outcomes in Women’s Health) principles

Contributors:
Principal Investigator: Dr Danya Bakhbakhi
Educational Supervisor: Mr Dimitrios Siassakos, Senior Clinical Lecturer & Honorary Consultant in Obstetrics
CROWN initiative
EMBRACING CHANGE co-applicants
Dr Sara Brookes, Senior Lecturer in Medical Statistics, University of Bristol
Prof Khalid Khan, Professor of Women’s Health and Clinical Epidemiology, Barts and the London School of Medicine, Queen Mary University of London
Dr Lisa Hinton, Senior Qualitative Researcher, University of Oxford
Dr Abi Fraser, Senior Research Fellow, University of Bristol
Dr Christy Burden, Academic Clinical Lecturer, University of Bristol
Dr Maggie Redshaw, University of Oxford
Dr James Duffy, NIHR Doctoral Research Fellow, University of Oxford
Prof Vicki Flenady, Director of the Stillbirth Centre for Research Excellence, University of Queensland
Prof Soo Downe, Professor of Midwifery Studies, University of Central Lancashire
Prof Pauline Slade, Professor of Clinical Psychology and Mental Health
Prof Ben Mol, Professor of Obstetrics and Gynaecology, University of Adelaide


Further Study Information

Current Stage:
Ongoing
Date:
January 2016 - 2018
Funding source(s):

Health Area

Disease Category
Neonatal care
Pregnancy & childbirth

Disease Name
Intrauterine death
Neonatal loss
Stillbirth

Target Population

Age Range
0 - 100

Sex
Either


Nature / type of Intervention
Nonpharmacological
Psychological & behavioural

Method(s)

Consensus meeting
Delphi process
Interview
Systematic review

We will use a mixed methods design consisting of systematic reviews, qualitative research and consensus voting. There will be five distinct phases to this study: 1) Generating a list of all possible outcomes domains following perinatal death using a systematic review of the literature; 2) Identifying additional patient reported outcomes to the list of outcome domains using semi-structured interviews; 3) Prioritisation of outcome domains by key stakeholder groups using a Delphi consensus; 4) A consensus meeting to agree on the final COS and 5) Dissemination of COS results.


Stakeholders Involved

Unknown

Study Type

COS for clinical trials or clinical research

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