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Major Depressive Disorder Trials Lack Complete PRO Reporting, Analysis Finds
Patient-reported outcomes (PROs) for major depressive disorder were inconsistently reported across dozens of randomized controlled trials, according to a study published in the Journal of Psychiatric Research.
“Moreover,” researchers advised, “we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with major depressive disorder and facilitate training on the application of PRO data.”
For the study, a team from the Office of Medical Student Research at Oklahoma State University Center for Health Sciences in Tulsa used the Consolidated Standards of Reporting Trials (CONSORT-PRO) tool to evaluate PRO reporting across a total 49 randomized clinical trials published between 2016 and 2020 and involving patients with major depressive disorder.
The average CONSORT-PRO completion score, the study found, was 56.7%.
Reporting was more complete in primary PRO trials compared with secondary PRO trials, in studies with follow-up periods lasting 6 months to 12 months compared with 3 months or fewer, and in trials with larger sample sizes, the study found.
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Studies of combination, “other,” and psychotherapy interventions for major depressive disorder had higher reporting completeness compared with studies of brain stimulation.
Among the 49 trials in the analysis, 46.94% involved pharmacological interventions for major depressive disorder, according to Psychiatry Advisor coverage of the study.
“Nearly half of trials (46.94%) were published in journals that recommended or required CONSORT guidelines,” Psychiatry Advisor continued, “and 12.24% endorsed CONSORT guidelines within the article.”
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