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Important research outcomes for treatment studies of perinatal depression: systematic overview and development of a core outcome set
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  • Christel Hellberg,
  • Marie Österberg,
  • AnnKristine Jonsson,
  • Sara Fundell,
  • Frida Trönnberg,
  • Maria Jonsson,
  • Alkistis Skalkidou
Christel Hellberg
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
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Marie Österberg
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
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AnnKristine Jonsson
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
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Sara Fundell
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Stockholm, Sweden
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Frida Trönnberg
Patient representative
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Maria Jonsson
Department of Women's and Children's Health, Uppsala University
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Alkistis Skalkidou
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Abstract

Objective To develop a Core Outcome Set (COS) for treatment of perinatal depression Design Systematic overview of outcomes reported in the literature and consensus development study using a Delphi survey and modified nominal group technique. Setting International. Population Two hundred and twenty-two participants, representing thirteen countries. Methods A systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided. Main results In the literature search, 1772 abstracts were identified and evaluated, 284 papers/protocols were assessed in full and 165 studies were finally included in the review. In all, 106 outcomes were identified and thus included in the Delphi survey. 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. The following 9 outcomes were agreed upon for inclusion in the final COS: self-assessed symptoms of depression, diagnosis of depression by a clinician, parent to infant bonding, self-assessed symptoms of anxiety, quality of life, satisfaction with intervention, suicidal thoughts, attempted or committed suicide, thoughts of harming the baby, and adverse events. Conclusions The relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We hope that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression Funding This article is adapted from a report by SBU, which provided funding for the study. Keywords: perinatal depression, postpartum depression, antenatal depression, COS

Peer review status:ACCEPTED

10 Dec 2020Submitted to BJOG: An International Journal of Obstetrics and Gynaecology
11 Dec 2020Submission Checks Completed
11 Dec 2020Assigned to Editor
15 Dec 2020Reviewer(s) Assigned
13 Jan 2021Review(s) Completed, Editorial Evaluation Pending
19 Mar 2021Editorial Decision: Revise Major
22 Apr 20211st Revision Received
23 Apr 2021Submission Checks Completed
23 Apr 2021Assigned to Editor
23 Apr 2021Review(s) Completed, Editorial Evaluation Pending
03 May 2021Editorial Decision: Accept