Exploring Clinical Trialists Perspectives on Core Outcome Sets in Anxiety Trials: A Web-Based Survey Study

Importance: Without a consistent set of outcome measures in clinical trials, it is challenging to draw meaningful comparisons and make informed decisions regarding the most effective interventions for anxiety disorders. In an attempt to enhance research quality, a core outcome set (COS) for anxiety disorder was established in 2017 with the goal of improving the quality and comparability of clinical trials focused on anxiety disorders. The COS established a standard set of outcomes expected to be measured by trialists specifically when studying interventions related to anxiety disorders. Our study aimed to investigate the perception, knowledge and utilization of the core outcome sets by lead investigators in clinical trials of anxiety disorders.

Design: In this cross-sectional analysis, participants consisted of clinical trialists involved in the design, administration, or analysis of clinical trials studying anxiety disorders. Using the secure web-based data collection tool REDCap, we formulated a comprehensive survey consisting of 20 questions aimed to gather demographic information of participants as well as trialists familiarity with the anxiety COS. Responses will be collected for a total of eight weeks with bi-weekly reminders for surveys not already responded to. For quantitative data we will use both descriptive and inferential statistics to identify relationships between variables and a thematic analysis will be used to identify recurring patterns of open-ended responses.

Results: Data is currently being collected and what is currently available is only preliminary data.

Conclusion: The variation in outcomes reported across clinical trials poses challenges in synthesizing primary reports by systematic reviews. Implementing core outcome sets in clinical research has the potential to enhance the reliability and comparability of trial outcomes, benefiting evidence-based care for patients with anxiety disorders. However, understanding why trialists are or are not utilizing the core outcome sets is a pivotal first step in standardizing clinical trial outcome reporting.