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Interventions, outcomes and outcome measurement instruments in stillbirth care research: A systematic review to inform the development of a core outcome set
  • +29
  • Danya Bakhbakhi,
  • Dimitrios Siassakos,
  • Anna Davies,
  • Abi Merriel,
  • Katie Barnard,
  • Emma Stead,
  • Clare Shakespeare,
  • James Duffy,
  • Lisa Hinton,
  • Karolina McDowell,
  • Anna Lyons,
  • Margaret Redshaw,
  • Vicki Flenady,
  • Alexander Heazell,
  • Laura Timlin,
  • Mary Lynch,
  • Soo Downe,
  • Pauline Slade,
  • Lisa Thorne,
  • Heatherjane Coombs,
  • Aleena Wojcieszek,
  • Margaret Murphy,
  • Heloisa Salgado,
  • Lindsey Wimmer,
  • Danielle Pollock,
  • Neelam Aggarwal,
  • Susannah Leisher,
  • Kate Mulley ,
  • Irene Attachie,
  • Bethany Atkins,
  • Christy Burden,
  • Abigail Fraser
Danya Bakhbakhi
University of Bristol Faculty of Health Sciences

Corresponding Author:[email protected]

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Dimitrios Siassakos
Institute for Women's Health, University College London
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Anna Davies
North Bristol NHS Trust
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Abi Merriel
University of Bristol
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Katie Barnard
Southmead Hospital, North Bristol NHS Trust
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Emma Stead
Liverpool University Hospitals NHS Foundation Trust
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Clare Shakespeare
University of Bristol
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James Duffy
North Middlesex University Hospital NHS Trust
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Lisa Hinton
University of Cambridge
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Karolina McDowell
North Bristol NHS Trust
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Anna Lyons
Northern General Hospital
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Margaret Redshaw
Oxford University
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Vicki Flenady
Mater Research Institute, University of Queensland
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Alexander Heazell
The University of Manchester
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Laura Timlin
North Bristol NHS Trust
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Mary Lynch
University of Bristol Faculty of Health Sciences
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Soo Downe
University of Central Lancashire
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Pauline Slade
University of Liverpool Institute of Psychology, Health and Society
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Lisa Thorne
NHS Devon Cornwall and Isles of Scilly Local Area Team
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Heatherjane Coombs
SANDS
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Aleena Wojcieszek
University of Queensland
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Margaret Murphy
University College Cork
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Heloisa Salgado
School of Public Health of University of Sao Paulo
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Lindsey Wimmer
Star Legacy Foundation
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Danielle Pollock
The University of Adelaide
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Neelam Aggarwal
Post Graduate Institute of Medical Education and Research
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Susannah Leisher
International Stillbirth Alliance
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Kate Mulley
SANDS
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Irene Attachie
University of Ghana
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Bethany Atkins
University College London
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Christy Burden
University of Bristol
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Abigail Fraser
University of Bristol
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Abstract

Background A core outcome set could address inconsistent outcome reporting and improve evidence for stillbirth care research, which has been identified as an important research priority. Objectives To identify outcomes and outcome measurement instruments reported by studies evaluating interventions after the diagnosis of a stillbirth. Search strategy Amed, BNI, CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase, MEDLINE, PsycINFO, and WHO ICTRP from 1998 to August 2021. Selection criteria Randomised and non-randomised comparative or non-comparative studies reporting a stillbirth care intervention. Data collection and analysis Interventions, outcomes reported, definitions and outcome measurement tools were extracted. Main results 40 randomised and 200 non-randomised studies were included. 58 different interventions were reported, labour and birth care (52 studies), hospital bereavement care (28 studies), clinical investigations (116 studies), care in a multiple pregnancy (2 studies), psychosocial support (28 studies) and care in a subsequent pregnancy (14 studies). 391 unique outcomes were reported and organised into 14 outcome domains: labour and birth; postpartum; delivery of care; investigations; multiple pregnancy; mental health; emotional functioning; grief and bereavement; social functioning; relationship; whole person; subsequent pregnancy; subsequent children and siblings and economic. 242 outcome measurement instruments were used, with 0-22 tools per outcome. Conclusions Heterogeneity in outcome reporting, outcome definition and measurement tools in care after stillbirth exists. Considerable research gaps on specific intervention types in stillbirth care were identified. A core outcome set is needed to standardise outcome collection and reporting for stillbirth care research.
08 Jun 2022Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
14 Jun 2022Submission Checks Completed
14 Jun 2022Assigned to Editor
15 Jun 2022Reviewer(s) Assigned
09 Jul 2022Review(s) Completed, Editorial Evaluation Pending
05 Aug 2022Editorial Decision: Revise Major
08 Oct 20221st Revision Received
11 Oct 2022Submission Checks Completed
11 Oct 2022Assigned to Editor
11 Oct 2022Review(s) Completed, Editorial Evaluation Pending
26 Oct 2022Editorial Decision: Accept