Implementation of a clinical trial recruitment support system based on fast healthcare interoperability resources (FHIR) in a cardiology department

BACKGROUND: Clinical Trial Recruitment Support Systems can booster patient inclusion of clinical trials by automatically analyzing eligibility criteria based on electronic health records. However, missing interoperability has hindered introduction of those systems on a broader scale. PURPOSE: Our aim was to develop a recruitment support system based on FHIR R4 and evaluate its usage and features in a cardiology department. METHODS/IMPLEMENTATION: Clinical conditions, anamnesis, examinations, allergies, medication, laboratory data and echocardiography results were imported as FHIR resources. Trial study nurses and physicians were enabled to add new and edit trial information and input inclusion and exclusion criteria using a web-browser user interface in the hospital intranet. All information were recorded on the server side as the FHIR resources “ResearchStudy” and “Group”. Eligibility criteria linked by the logical operation “OR” were represented by using multiple FHIR Group resources for enrollment. On the client side, eligibility criteria were transformed to a tree-like structure (see Figure 1). Upon user demand, all hospitalized and ambulatory patients in the cardiology department were instantly screened for trial eligibility using the FHIR eligibility criteria on the existing patients' FHIR resources. Furthermore, study personal was able to manually edit trial status (i.e. ineligible, on-study, ...) of patients, which was implemented using the FHIR resource “ResearchSubject”. RESULTS: This implementation of a CTRSS based on FHIR R4 was evaluated in clinical practice: Beginning from 1st April 2021 the application was used as an additional patient screening tool for the four trials CLOSURE-AF, FAIR-HF2, SPRIRIT-HF and TORCH-PLUS of the German Centre for Cardiovascular Research. As the COVID-19 pandemic is prohibiting any proper comparison of patient inclusion rates, efficacy of the recruitment support system was tested by comparing the numbers of patients identified by the recruitment support system and enrolled in a trial to the actual number of enrolled patients irrespective of the screening method from 1st April 2021 to 23rd November 2021. The system was able to identify 52 of 55 patients included in those four clinical trials. CONCLUSION: Use of FHIR for defining eligibility criteria of clinical trials may facilitate interoperability and allow automatic screening for eligible patients at multiple sites of different healthcare providers in the future. Upcoming changes in FHIR should allow easier description of “OR”-linked eligibility criteria. FUNDING ACKNOWLEDGEMENT: Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Deutsche Forschungsgemeinschaft