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

Abstract

IntroductionStillbirth 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 analysisThe 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 disseminationEthical 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 numberCRD42018087748.

Protocol for the development of a meta-core outcome set for stillbirth prevention and bereavement care following stillbirth

“…The 56 outcomes entered into the Delphi study from the COSTIL study [3] and the 108 outcomes entered into the Delphi for the iCHOOSE study [4]…”

“…Plain language summaries of each outcome and a summary of Delphi scores (if available) obtained for each outcome from the COSTIL and iCHOOSE COS studies will be also presented. Each CL will then have an opportunity to comment on these descriptions and results through think-aloud interviews [12], a technique also used in the iCHOOSE COS to improve questionnaire development and to refine the list of outcomes [4]. The recorded interviews conducted over ‘Zoom’ will be used to examine how CLs interpret outcome descriptions and to review the relevance (scope) of each outcome with respect to a LMiC setting, and with some knowledge on how outcomes were rated in the two previous related COS studies.…”

“…1) The 56 outcomes entered into the Delphi study from the COSTIL study [3] and the 108 outcomes entered into the Delphi for the iCHOOSE study [4] 2) Outcomes will also be extracted from a narrative synthesis of the qualitative literature using methods described in a similar review for type 2 diabetes [8]. In brief the review will aim to capture the outcome suggestions from the several hundred qualitative interviews already conducted in an LMiC setting with both parents and health care professionals on the topic of stillbirth [9][10][11].…”

“…To increase the relevance and comparability of results from stillbirth studies, a core outcome set (COS) for stillbirth prevention (COSTIL COS) has been developed to improve the usefulness of research to guide clinical practice in this field [3]. In addition, a COS has been agreed (iCHOOSE COS) for care after stillbirth [4] but is not yet published. Despite the robust methodology used to develop these COS and the inclusion of the three main stakeholder groups (clinicians, researchers and parents) identified by the Core Outcome Set-STAndards for Development (COS-STAD) [5] within the consensus process, the involvement of stakeholders, particularly parents from an LMiC settings has been limited.…”

Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set

“…12 The iCHOOSE study is addressing and expanding these priorities by developing a core outcome set for stillbirth care research. 13 Here we report on a systematic review that aims to identify what interventions and outcomes have been reported as an initial step in core outcome set development.…”