TrialCompass: Visual Analytics for Enhancing the Eligibility Criteria Design of Clinical Trials

TL;DR

TrialCompass is a visual analytics system that helps clinicians iteratively explore and refine clinical trial eligibility criteria by integrating outcome and knowledge-driven approaches, utilizing detailed EHR data for better decision-making.

Contribution

It introduces a novel interactive workflow and history-tracking feature that enhances exploration and understanding of eligibility criteria impacts in clinical trial design.

Findings

Effective in exploring eligibility criteria for septic shock and AKI

Supports systematic refinement of criteria based on outcome and patient data

Facilitates understanding of criteria impact on patient outcomes

Abstract

Eligibility criteria play a critical role in clinical trials by determining the target patient population, which significantly influences the outcomes of medical interventions. However, current approaches for designing eligibility criteria have limitations to support interactive exploration of the large space of eligibility criteria. They also ignore incorporating detailed characteristics from the original electronic health record (EHR) data for criteria refinement. To address these limitations, we proposed TrialCompass, a visual analytics system integrating a novel workflow, which can empower clinicians to iteratively explore the vast space of eligibility criteria through knowledge-driven and outcome-driven approaches. TrialCompass supports history-tracking to help clinicians trace the evolution of their adjustments and decisions when exploring various forms of data (i.e., eligibility criteria, outcome metrics, and detailed characteristics of original EHR data) through these two approaches. This feature can help clinicians comprehend the impact of eligibility criteria on outcome metrics and patient characteristics, which facilitates systematic refinement of eligibility criteria. Using a real-world dataset, we demonstrated the effectiveness of TrialCompass in providing insights into designing eligibility criteria for septic shock and sepsis-associated acute kidney injury. We also discussed the research prospects of applying visual analytics to clinical trials.