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

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dc.contributor.authorBakhbakhi, Danya
dc.contributor.authorFraser, Abigail
dc.contributor.authorSiasakos, Dimitris
dc.contributor.authorHinton, Lisa
dc.contributor.authorDavies, Anna
dc.contributor.authorMerriel, Abi
dc.contributor.authorDuffy, James M. N.
dc.contributor.authorRedshaw, Maggie
dc.contributor.authorLynch, Mary
dc.contributor.authorTimlin, Laura
dc.contributor.authorFlenady, Vicki
dc.contributor.authorHeazell, Alexander Edward P.
dc.contributor.authorDowne, Soo
dc.contributor.authorSlade, Pauline
dc.contributor.authorBrookes, Sara
dc.contributor.authorWojcieszek, Aleena M.
dc.contributor.authorMurphy, Margaret
dc.contributor.authorSalgado, Heloisa de Oliveira
dc.contributor.authorPollock, Danielle
dc.contributor.authorAggarwal, Neelam
dc.contributor.authorAttachie, Irene
dc.contributor.authorLeisher, Susannah H.
dc.contributor.authorKihusa, Wanijiru
dc.contributor.authorMulley, Kate
dc.contributor.authorWimmer, Lindsey
dc.contributor.authorBurden, Christy
dc.contributor.funderNational Institute for Health Researchen
dc.date.accessioned2023-01-18T17:16:44Z
dc.date.available2023-01-18T17:16:44Z
dc.date.issued2022-02-09
dc.date.updated2023-01-15T13:11:35Z
dc.description.abstractIntroduction: 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.en
dc.description.sponsorshipNational Institute for Health Research (NIHR DRF-2017-10-130)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleide056629en
dc.identifier.citationBakhbakhi, D., Fraser, A., Siasakos, D., Hinton, L., Davies, A., Merriel, A., Duffy, J. M. N., Redshaw, M., Lynch, M., Timlin, L., Flenady, V., Heazell, A. E., Downe, S., Slade, P., Brookes, S., Wojcieszek, A., Murphy, M., Salgado, H. D., Pollock, D., Aggarwal, N., Attachie, I., Leisher, S., Kihusa, W., Mulley, K., Wimmer, L. and Burden, C. (2022) 'Protocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)', BMJ Open 2022, 12, e056629 (10pp). doi: 10.1136/bmjopen-2021-056629en
dc.identifier.doi10.1136/bmjopen-2021-056629en
dc.identifier.eissn2044-6055
dc.identifier.endpage10en
dc.identifier.journaltitleBMJ Openen
dc.identifier.startpage1en
dc.identifier.urihttps://hdl.handle.net/10468/14103
dc.identifier.volume12en
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.rights© 2022, the Authors (or their employers). Re-use permitted under CC BY. Published by BMJ.en
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en
dc.subjectSubsequenten
dc.subjectExperiencesen
dc.subjectPregnancyen
dc.subjectBehavioren
dc.subjectParentsen
dc.subjectDeathen
dc.subjectThinken
dc.titleProtocol for the development of a core outcome set for stillbirth care research (iCHOOSE Study)en
dc.typeArticle (peer-reviewed)en
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