Implementation of inclusion and exclusion criteria of clinical studies in the software OHDSI ATLAS

Abstract

Abstract Background Clinical trials are an essential part of the medical research process, but trials are often canceled due to lack of enrollment. Clinical trial recruitment support systems can help increase the number of participants by finding more suitable subjects. The ATLAS software (developed by OHDSI) can support the initiation of a clinical trial by building cohorts of patients who meet certain eligibility criteria. The correct use of medical classification systems for clearly defined inclusion and exclusion criteria in studies is an important pillar of this software.Objectives The purpose of this study is to determine whether ATLAS can be used in a Clinical Trial Recruitment Support System to represent the eligibility criteria of clinical trials. Therefore, we have considered the set of criteria implemented in ATLAS and realistically identified the strengths and problems of the software.Methods We analyzed ATLAS using 223 eligibility criteria from 30 randomly selected studies from the past 10 years. Therefore, appropriate ICD, OPS, LOINC, or ATC codes were selected during the data collection process to feed the software. Each criterion and study was ranked for feasibility of implementation in the software.Results According to the observations, 49.33% of the analyzed inclusion criteria are fully implemented in ATLAS. In our selected sample set, 10% of the studies are classified as fully portrayable and 73.33% as portrayable. In addition, the software is evaluated with respect to its usability and its interaction with medical classification systems.Conclusions To improve and extend the coverage of criteria in cohort definition in a real-world setting, we recommend working closely with the individuals involved in the study to precisely define the criteria and carefully select terminology systems. The selected criteria will be combined according to the individual setting. Further work is needed to specify the relevance and quantity of the extracted criteria.