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)

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) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Method Article 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Neonatal study) Anna Davies, Charlotte Williams, Christy Burden, Sadie Mullin, and 13 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4353851/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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) Pediatrics Neonatal death core outcome sets bereavement care Figures Figure 1 Full Text Additional Declarations The authors declare no competing interests. Supplementary Files Supplementaryfile1COSSTAPReportingChecklistiCHOOSENeonatal.docx COS-STAP Reporting Checklist Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4353851","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Method Article","associatedPublications":[],"authors":[{"id":297578236,"identity":"77a28253-4034-46b6-bed6-80263f75a005","order_by":0,"name":"Anna 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