A meta-epidemiological study found a lack of complete patient-reported outcomes (PROs) in clinical trials of major depressive disorder (MDD). These findings were published in the Journal of Psychiatric Research.
Investigators from Oklahoma State University Center for Health Sciences evaluated randomized controlled trials of MDD published between 2016 and 2020 for the quality of their PRO reporting. The quality of reporting was evaluating using the Consolidated Standards of Reporting Trials (CONSORT-PRO) adaptation.
A total of 49 published trials were included in this study, nearly half of which (46.94%) evaluated pharmacological interventions for MDD.
Nearly half of trials (46.94%) were published in journals that recommended or required CONSORT guidelines and 12.24% endorsed CONSORT guidelines within the article.
PROs were among the primary outcomes in 16 trials and secondary outcomes in 33. In total, there were 88 unique PRO measurement tools used. The most common tools were the Patient Health Questionnaire (18.37%), the Beck Depression Inventory (16.32%), Beck Depression Inventory-II (14.29%), the Inventory of Depressive Symptomatology-Self Report (12.24%), and the 36-item Short-Form (10.20%).
The mean completion rate for the CONSORT-PRO checklist was 56.74%. The completion rate was higher for studies that included PROs as a primary endpoint (67.08% vs 51.73%).
Overall, trials which included PROs as a secondary endpoint were 15.35% less complete than those which used PROs as a primary endpoint. Studies which had a follow-up between 6 and 12 months were 16.11% more complete than those with a 3-month or less follow-up time.
No relationship between completeness and risk for bias were observed.
The study authors acknowledge that some important trials may have been overlooked and any study published in a language other than English were excluded from this review.
The study authors concluded, “Our study found the completeness of PRO reporting to be inconsistent in MDD trials. To improve translation of PRO evidence into clinical decision-making, we urge journals to require the CONSORT-PRO checklist for RCTs containing a PRO measure. Moreover, we advocate for the need to establish a core outcome set relevant to the management of adults diagnosed with MDD and ongoing clinician training on the interpretation and application of PRO data. A critical appraisal of PRO completeness of reporting may improve patient quality of life, improve shared decision making, and improve the patient-centered approach to disease management.”
Minley K, Smith CA, Batioja K, et al. The evaluation of reporting of patient-reported outcomes in MDD: A meta-epidemiological study of clinical trials. J Psychiatr Res. 2022;150:79-86. doi:10.1016/j.jpsychires.2022.03.028