A Survey of the Perceptions, Knowledge, and Utilization of Core Outcome Sets in Depression

Background: Depression significantly burdens the U.S population. Efforts to find the best treatment and intervention through the use of Core Outcome Sets (COS) among clinical trials is essential for mitigating the negative effects of depression on the U.S. population. COS in research refers to predefined, standardized sets of outcomes that should be measured and reported in all studies on a particular topic or condition. These outcomes help evaluate the effectiveness of interventions for depression. This study aims to explore the awareness of COS among clinical trialists engaged in depression research.

Methods: Authors of depression trials were recruited through the ClinicalTrials.gov registry. Information, including names, emails, and affiliated articles were extracted. Surveys were administered through REDCap (Research Electronic Data Capture), a secure web-based data collection tool, to collect demographics, COS familiarity, and authors’ perceptions on its usefulness. Data analysis will focus on both qualitative and quantitative approaches. Quantitative data will be measured via chi-squared tests and t-tests to identify variables between demographic groups and survey responses Qualitative data will be measured through open-ended survey responses. Open-ended question responses will be independently reviewed by multiple coders to prevent bias. Both quantitative and qualitative data analysis is integral to provide a comprehensive understanding of the participants’ perceptions and experiences using COS for depression trials. Ethical principles were respected due to the informed consent, anonymity, and protection of human subjects. This study has received Institutional Review Board (IRB) approval, and any modification to the protocol post-approval will be communicated to and approved by the IRB.

Results: Data collection is ongoing, with analysis yet to commence. The anticipated analysis will include: (i) descriptive statistics to summarize patient demographics and responses to close-ended questions, (ii) inferential statistics, such as chi-square tests and t-tests, to identify relationships between variables or differences among subgroups, and (iii) qualitative data, which will undergo thematic analysis to discern recurring themes and patterns.

Conclusion: The completion of our study aims to provide new insights into clinical trialists’ use and comprehension of COS in depression research. Further understanding of the COS may provide a foundation for future initiatives aimed at encouraging clinical trialists to implement COS in their research. Proper COS reporting may promote outcome standardization, potentially improving care for patients with depression.