Analysis of eligibility criteria complexity in clinical trials.

Abstract

Formal, computer-interpretable representations of eligibility criteria would allow computers to better support key clinical research and care use cases such as eligibility determination. To inform the development of such formal representations for eligibility criteria, we conducted this study to characterize and quantify the complexity present in 1000 eligibility criteria randomly selected from studies in ClinicalTrials.gov. We classified the criteria by their complexity, semantic patterns, clinical content, and data sources. Our analyses revealed significant semantic and clinical content variability. We found that 93% of criteria were comprehensible, with 85% of these criteria having significant semantic complexity, including 40% relying on temporal data. We also identified several domains of clinical content. Using the findings of the study as requirements for computer-interpretable representations of eligibility, we discuss the challenges for creating such representations for use in clinical research and practice.