Core Outcome Measures in Effectiveness Trials

Treatment of perinatal depression: protocol for a systematic review of outcomes in the literature and identification of a core outcome set using a Delphi survey

General Information

Summary:
Background: Perinatal depression is depression experienced during pregnancy (known as ante or prenatal depression) or after childbirth (known as postnatal depression). To date there is no core outcome set available for this condition.

Methods/Design: 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.

Discussion: A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. This study will aim to identify a core outcome set that can be used in future trials of the treatment of perinatal depression, improving the consistency of research in this clinical area.

Contributors:
Christel Hellberg, SBU, principal investigator
Marie Ă–sterberg, SBU, investigator
Sara Fundell,SBU, Project assistant
Ann Kristine Jonsson, SBU, Information specialist
Maria Jonsson, Associated professor of Obstetrics and Gynecology in Uppsala University
Alkistis Skalkidou, Professor of Obstetrics and Gynecology in Uppsala University
Frida Trönnberg, Patient representative

Further Study Information

Current Stage:
Ongoing
Date:
September 2019 - August 2020
Funding source(s):
None

Health Area

Disease Category
Pregnancy & childbirth

Disease Name
Antenatal depression
Depression
Perinatal depression
Postnatal depression
Postpartum depression
Prenatal depression

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Any
Prenatal depression

Method(s)

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.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Methodologists
Patient/ support group representatives
Policy makers
Regulatory agency representatives
Researchers
Service providers

Study Type

COS for clinical trials or clinical research

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