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.
Setting: International.
Population: Two hundred and twenty-two participants, mainly patients, healthcare professionals and researchers, representing 13 countries.
Methods: A systematic overview of outcomes reported in recently published research, a two-round Delphi survey and a consensus meeting at which the final COS was decided using modified nominal group technique.
Main results: In 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 included in the Delphi survey. In all, 222 participants registered for the first round of the Delphi survey and 151 (68%) responded. In the second round, 123 (55%) participants responded. Thirteen participants attended the consensus meeting, where the following nine 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 expect that this COS will contribute to the consistency and uniformity of outcome selection and reporting in future clinical trials involving treatment of perinatal depression.
Christel Hellberg, SBU, principal investigator
Marie Ă–sterberg, SBU, investigator
Ann Kristine Jonsson, SBU, Information specialist
Sara Fundell,SBU, Project assistant
Frida Trönnberg, Patient representative
Maria Jonsson, Associated professor of Obstetrics and Gynecology in Uppsala University
Alkistis Skalkidou, Professor of Obstetrics and Gynecology in Uppsala University
Disease Category: Pregnancy & childbirth, Mental health
Disease Name: Perinatal depression, Depression, Prenatal depression, Antenatal depression, Postnatal depression, Postpartum depression
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Governmental agencies
- Methodologists
- Patient/ support group representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service providers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
This study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi survey with different stakeholder, eg patients, relatives, clinicians and researcher within the field. The Delphi survey will consist of two rounds. In the first round we will ask panel members to score the outcome list using a 9 point Likert scale. They will also be given the opportunity to add any outcomes they think are missing from the list. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. A final consensus meeting will be held with some representatives from all stakeholder groups, to agree on a final set of core outcomes.