Abstract
Objective: To investigate the adherence of randomized controlled trials to the proposed Core Outcome Set among patients diagnosed with depression.
Background: Given the medical and financial ramifications of depression, establishing evidenced based treatment options is paramount. However, the lack of standardization between trials complicates comparability. A potential solution is for trialists to follow the depression Core Outcome Set (COS). This COS determined symptom burden, medication side effects, functioning impairments, and absenteeism as the minimum set of outcomes to be measured in RCTs.
Methods: An electronic clinical trial registry (ClinicalTrials.gov database) was used to identify phase III/IV RCTs focused on depression. Authors screened clinical trial registries of all search results to assess study inclusion. Following data screening, data was extracted in a masked, duplicate fashion. We determined whether the full depression core outcome set was followed in the trial registry entries.
Results: Although 221 trials (98.7%) measured symptom burden, 32 trials (14.29%) used the COS recommended questionnaire, PHQ-9. Sixty-two trials (27.7%) measured medication side effects. Only 4 trials (1.8%) used the WHODAS 2.0 questionnaire, however 213 (95.1%) trials used different questionnaires that measured functioning.
Conclusion: Our study found that there was not a notable uptake in COS adoption after it was published in 2017. Side effects and absenteeism were mentioned less frequently as outcomes by trialists. Conversely, symptom burden and functioning were listed as outcomes in over 90% of trials analyzed. However, various scales were used for both symptom burden and functioning, complicating comparability. Overall, the lack of COS uptake may be of concern given its ability to assist in standardizing clinical trials and ensuring complete reporting of results. Future research should actively engage stakeholders to identify any modifications to the present COS to ensure its relevance, comprehensiveness, and alignment with the evolving needs of the field.
Background: Given the medical and financial ramifications of depression, establishing evidenced based treatment options is paramount. However, the lack of standardization between trials complicates comparability. A potential solution is for trialists to follow the depression Core Outcome Set (COS). This COS determined symptom burden, medication side effects, functioning impairments, and absenteeism as the minimum set of outcomes to be measured in RCTs.
Methods: An electronic clinical trial registry (ClinicalTrials.gov database) was used to identify phase III/IV RCTs focused on depression. Authors screened clinical trial registries of all search results to assess study inclusion. Following data screening, data was extracted in a masked, duplicate fashion. We determined whether the full depression core outcome set was followed in the trial registry entries.
Results: Although 221 trials (98.7%) measured symptom burden, 32 trials (14.29%) used the COS recommended questionnaire, PHQ-9. Sixty-two trials (27.7%) measured medication side effects. Only 4 trials (1.8%) used the WHODAS 2.0 questionnaire, however 213 (95.1%) trials used different questionnaires that measured functioning.
Conclusion: Our study found that there was not a notable uptake in COS adoption after it was published in 2017. Side effects and absenteeism were mentioned less frequently as outcomes by trialists. Conversely, symptom burden and functioning were listed as outcomes in over 90% of trials analyzed. However, various scales were used for both symptom burden and functioning, complicating comparability. Overall, the lack of COS uptake may be of concern given its ability to assist in standardizing clinical trials and ensuring complete reporting of results. Future research should actively engage stakeholders to identify any modifications to the present COS to ensure its relevance, comprehensiveness, and alignment with the evolving needs of the field.
| Original language | American English |
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| State | Published - 21 Jul 2023 |
| Event | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States Duration: 21 Jul 2023 → 21 Jul 2023 |
Conference
| Conference | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics |
|---|---|
| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |