Outcomes reported in randomised controlled trials of major depressive disorder in older adults: a methodological review

Major depressive disorder (MDD or depression) is prevalent among adults aged 65 years and older. The effectiveness and safety of interventions used to treat depression is often assessed through randomised controlled trials (RCTs). However, heterogeneity in the selection, measurement and reporting of outcomes in RCTs renders comparisons between trial results, interpretability and generalisability of findings challenging. There is presently no core outcome set (COS) for use in RCTs that assess interventions for older adults with MDD. We will conduct a methodological review of the literature for outcomes reported in trials for adults 65 years and older with depression to assess the heterogeneity of outcome measures.

We hope that findings from our methodological review will reduce variability in outcome selection, measurement and reporting and facilitate the development of a COS for older adults with MDD. Our review will also inform evidence synthesis efforts in identifying the best treatment practices for this clinical population.

Contributors

Study Lead - Myanca Rodrigues, McMaster University
Supervisors - Dr. Lehana Thabane, McMaster University; Dr. Zainab Samaan, McMaster University; Dr. Sameer Parpia, McMaster University
Collaborators - Dr. Nitika Sanger, McMaster University; Dr. Alexander Dufort, McMaster University; Stephanie Sanger, McMaster University; Balpreet Panesar, McMaster University; Alessia D'Elia, McMaster University

Further Study Information

Current Stage: Ongoing
Date: November 2021 - June 2022
Funding source(s): This work is not funded by a specific grant. ZS received funding from Alternate Funding Plan (No. 20-10178-480925-75153), and Canadian Institutes for Health Research (Award No. PJT-156306). MR received funding through the Ontario Graduate Scholarship


Health Area

Disease Category: Mental health

Disease Name: Depression, Major depressive disorder (MDD)

Target Population

Age Range: 65

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Epidemiologists
- Methodologists
- Statisticians

Study Type

- Systematic review of outcomes measured in trials

Method(s)

- Literature review

We will conduct a methodological review of the literature for outcomes reported in trials for adults 65 years and older with depression to assess the heterogeneity of outcome measures. RCTs evaluating pharmacotherapy, psychotherapy, or any other treatment intervention for older adults with MDD published in the last 10 years will be located using electronic database searches (MEDLINE, Embase, PsycINFO and the Cochrane Central Register of Controlled Trials). Reviewers will conduct title and abstract screening, full-text screening and data extraction of trials eligible for inclusion independently and in duplicate. Outcomes will be synthesised and mapped to core outcome-domain frameworks. We will summarise characteristics associated with trials and outcomes.

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