Important research outcomes for treatment studies of perinatal
depression: systematic overview and development of a core outcome set
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