How to Improve Cancer Patients ENrollment in Clinical Trials From rEal-Life Databases Using the Observational Medical Outcomes Partnership Oncology Extension: Results of the PENELOPE Initiative in Urologic Cancers.

PURPOSE: To compare the computability of Observational Medical Outcomes Partnership (OMOP)-based queries related to prescreening of patients using two versions of the OMOP common data model (CDM; v5.3 and v5.4) and to assess the performance of the Greater Paris University Hospital (APHP) prescreening tool. MATERIALS AND METHODS: We identified the prescreening information items being relevant for prescreening of patients with cancer. We randomly selected 15 academic and industry-sponsored urology phase I-IV clinical trials (CTs) launched at APHP between 2016 and 2021. The computability of the related prescreening criteria (PC) was defined by their translation rate in OMOP-compliant queries and by their execution rate on the APHP clinical data warehouse (CDW) containing data of 205,977 patients with cancer. The overall performance of the prescreening tool was assessed by the rate of true- and false-positive cases of three randomly selected CTs. RESULTS: We defined a list of 15 minimal information items being relevant for patients' prescreening. We identified 83 PC of the 534 eligibility criteria from the 15 CTs. We translated 33 and 62 PC in queries on the basis of OMOP CDM v5.3 and v5.4, respectively (translation rates of 40% and 75%, respectively). Of the 33 PC translated in the v5.3 of the OMOP CDM, 19 could be executed on the APHP CDW (execution rate of 58%). Of 83 PC, the computability rate on the APHP CDW reached 23%. On the basis of three CTs, we identified 17, 32, and 63 patients as being potentially eligible for inclusion in those CTs, resulting in positive predictive values of 53%, 41%, and 21%, respectively. CONCLUSION: We showed that PC could be formalized according to the OMOP CDM and that the oncology extension increased their translation rate through better representation of cancer natural history.

AP-HP Health Data Space (AHDS) to the Test of the Covid-19 Pandemic.

Sharing observational and interventional health data within a common data space enables university hospitals to leverage such data for biomedical discovery and moving towards a learning health system. OBJECTIVE: To describe the AP-HP Health Data Space (AHDS) and the IT services supporting piloting, research, innovation and patient care. METHODS: Built on three pillars - governance and ethics, technology and valorization - the AHDS and its major component, the Clinical Data Warehouse (CDW) have been developed since 2015. RESULTS: The AP-HP CDW has been made available at scale to AP-HP both healthcare professionals and public or private partners in January 2017. Supported by an institutional secured and high-performance cloud and an ecosystem of tools, mostly open source, the AHDS integrates a large amount of massive healthcare data collected during care and research activities. As of December 2021, the AHDS operates the electronic data capture for almost +840 clinical trials sponsored by AP-HP, the CDW is enabling the processing of health data from more than 11 million patients and generated +200 secondary data marts from IRB authorized research projects. During the Covid-19 pandemic, AHDS has had to evolve quickly to support administrative professionals and caregivers heavily involved in the reorganization of both patient care and biomedical research. CONCLUSION: The AP-HP Data Space is a key facilitator for data-driven evidence generation and making the health system more efficient and personalized.

Initializing a hospital-wide data quality program. The AP-HP experience.

BACKGROUND AND OBJECTIVES: Data Quality (DQ) programs are recognized as a critical aspect of new-generation research platforms using electronic health record (EHR) data for building Learning Healthcare Systems. The AP-HP Clinical Data Repository aggregates EHR data from 37 hospitals to enable large-scale research and secondary data analysis. This paper describes the DQ program currently in place at AP-HP and the lessons learned from two DQ campaigns initiated in 2017. MATERIALS AND METHODS: As part of the AP-HP DQ program, two domains - patient identification (PI) and healthcare services (HS) - were selected for conducting DQ campaigns consisting of 5 phases: defining the scope, measuring, analyzing, improving and controlling DQ. Semi-automated DQ profiling was conducted in two data sets - the PI data set containing 8.8 M patients and the HS data set containing 13,099 consultation agendas and 2122 care units. Seventeen DQ measures were defined and DQ issues were classified using a unified DQ reporting framework. For each domain, actions plans were defined for improving and monitoring prioritized DQ issues. RESULTS: Eleven identified DQ issues (8 for the PI data set and 3 for the HS data set) were categorized into completeness (n = 6), conformance (n = 3) and plausibility (n = 2) DQ issues. DQ issues were caused by errors from data originators, ETL issues or limitations of the EHR data entry tool. The action plans included sixteen actions (9 for the PI domain and 7 for the HS domain). Though only partial implementation, the DQ campaigns already resulted in significant improvement of DQ measures. CONCLUSION: DQ assessments of hospital information systems are largely unpublished. The preliminary results of two DQ campaigns conducted at AP-HP illustrate the benefit of the engagement into a DQ program. The adoption of a unified DQ reporting framework enables the communication of DQ findings in a well-defined manner with a shared vocabulary. Dedicated tooling is needed to automate and extend the scope of the generic DQ program. Specific DQ checks will be additionally defined on a per-study basis to evaluate whether EHR data fits for specific uses.