recruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)

• Published in: Computers in biology and medicine Vol. 174; p. 108411
• Main Authors: Gulden, Christian, Macho, Philipp, Reinecke, Ines, Strantz, Cosima, Prokosch, Hans-Ulrich, Blasini, Romina
• Format: Journal Article
• Language: English
• Published: United States Elsevier Ltd 01.05.2024; Elsevier Limited
• Subjects: Clinical trials; Clinical Trials as Topic; Cloud Computing; Data models; Electronic health records; Health care; Health informatics; Health Information Interoperability; Health Level Seven; Humans; Information sharing; Interoperability; Metadata; Open source software; Partnerships; Patient Selection; Patients; Queries; Questionnaires; Recruitment; Software; Support systems; Usability
• ISSN: 0010-4825; 1879-0534
• DOI: 10.1016/j.compbiomed.2024.108411

Clinical trials (CTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment remains the most frequent reason for premature discontinuation or costly extension of clinical trials. We designed and implemented a novel, open-source software system to support the recruitment process in clinical trials by generating automatic recruitment recommendations. The development is guided by modern, cloud-native design principles and based on Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) as an interoperability standard with the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) being used as a source of patient data. We evaluated the usability using the system usability scale (SUS) after deploying the application for use by study personnel. The implementation is based on the OMOP CDM as a repository of patient data that is continuously queried for possible trial candidates based on given clinical trial eligibility criteria. A web-based screening list can be used to display the candidates and email notifications about possible new trial participants can be sent automatically. All interactions between services use HL7 FHIR as the communication standard. The system can be installed using standard container technology and supports more sophisticated deployments on Kubernetes clusters. End-users (n = 19) rated the system with a SUS score of 79.9/100. We contribute a novel, open-source implementation to support the patient recruitment process in clinical trials that can be deployed using state-of-the art technologies. According to the SUS score, the system provides good usability. •recruIT is an Open Source trial recruitment support tool based on FHIR and OMOP.•Uses modern development and deployment practices based on containers and Kubernetes.•Usability evaluation shows good usability with a SUS score of 79.9/100.