BJOG : an international journal of obstetrics and gynaecology | 2021
Important research outcomes for treatment studies of perinatal depression: systematic overview and development of a core outcome set.
Abstract
OBJECTIVE\nTo develop a Core Outcome Set (COS) for treatment of perinatal depression DESIGN: Systematic overview of outcomes reported in the literature and consensus development study SETTING: International.\n\n\nPOPULATION\nTwo hundred and twenty-two participants, mainly patients, healthcare professionals and researchers, representing thirteen countries.\n\n\nMETHODS\nA systematic overview of outcomes reported in recently published research, a two-round Delphi survey, a consensus meeting at which the final COS was decided using modified nominal group technique.\n\n\nMAIN RESULTS\nIn the literature search, 1772 abstracts were identified and evaluated, 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. 13 participants attended the consensus meeting, where 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.\n\n\nCONCLUSIONS\nThe relevant stakeholders prioritised outcomes and reached consensus on a COS comprising nine outcomes. We expect that this COS will contribute to consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression.