Protocol for a mixed-methods study to develop a Core Outcome Set for assessing interventions and care for parents after neonatal death (iCHOOSE Neonatal study)

Abstract 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 provide a minimum set of outcomes, agreed by stakeholders to be important, that should be evaluated in all studies to support evidence syntheses and identification of the most effective interventions. Aim: We aim to develop a Core Outcome Set (COS) for assessing interventions and care after neonatal death, to support future evidence syntheses and enable identification of effective interventions and care for parents. Methods and analysis: We will develop the COS in 6 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 and professionals) to develop and refine an online survey; 4) Real-Time online international Delphi survey with bereaved parents and professionals to shortlist outcomes for consideration in the COS; 5) Adapted nominal group online consensus meetings with parents and professionals to agree final COS; 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. Registration: This COS has been registered on the COMET database.(1) The systematic review has been registered on the PROSPERO database (CRD42020151365)