Feasibility of structuring electronic health record data to facilitate real‐world data research: ICAREdata methods applied to multicenter cancer clinical trials

Author:

George Suzanne1,Campbell Nancy2,Hillman Shauna L.3,Harlos Elizabeth S.3,Stein David W. J.4,Chan Miranda Y.4,Chow Selina L.5,Elrahi Cassandra L.2,Quina Andre C.4,Kokolus Maeve C.4,Casagni Michelle D.6,Weiss Matthias7,Anderson Daniel M.8,Stadler Walter M.9ORCID,Hoff Olivia C.8,Rivera Donna R.10,Kluetz Paul G.10,Mandrekar Sumithra J.3,Piantadosi Steven11ORCID

Affiliation:

1. Dana‐Farber/Harvard Cancer Center Boston Massachusetts USA

2. Data Innovation Lab LLC, Alliance for Clinical Trials in Oncology Boston Massachusetts USA

3. Alliance Statistics and Data Management Center Mayo Clinic Rochester Minnesota USA

4. The MITRE Corporation Bedford Massachusetts USA

5. Alliance for Clinical Trials in Oncology Chicago Illinois USA

6. The MITRE Corporation Tampa Florida USA

7. ThedaCare Regional Cancer Center Appleton Wisconsin USA

8. Metro‐Minnesota Community Oncology Research Consortium St Louis Park Minnesota USA

9. University of Chicago Comprehensive Cancer Center Chicago Illinois USA

10. Oncology Center of Excellence US Food and Drug Administration Silver Spring Maryland USA

11. Brigham and Women's Hospital Boston Massachusetts USA

Abstract

AbstractBackgroundThe use of electronic health record (EHR) data for research is limited by a lack of structure and a standard data model. The objective of the ICAREdata (Integrating Clinical Trials and Real‐World Endpoints Data) project was to structure key research data elements in EHRs using a minimal Common Oncology Data Elements (mCODE) data model to extract and transmit data.MethodsThe ICAREdata project captured two EHR data elements essential to clinical trials: cancer disease status and treatment plan change. The project was implemented in clinical sites participating in Alliance for Clinical Trials in Oncology trials. Data were extracted from EHRs and sent by secure Fast Healthcare Interoperability Resource messaging (a standard for exchanging EHRs) to a database. Selected elements were compared with corresponding data from the trial's electronic data capture (EDC) system, Medidata Rave.ResultsBy December 2023, data were extracted and transmitted from 10 sites for 35 patients, involving 367 clinical encounters across 15 clinical trials. Data through March 2023 demonstrated that concordance for the elements treatment plan change and cancer disease status was 79% and 34%, respectively. When disease evaluation was reported by both EHR and EDC (n = 15), there was 87% agreement on cancer disease status.ConclusionsDocumentation, extraction, and aggregation of structured data elements in EHRs using mCODE and ICAREdata methods is feasible in multi‐institutional cancer clinical trials. EDC as a reference data set allowed assessment of the completeness of EHR data capture. Future initiatives will focus on elements with shared definitions in clinical and research environments and efficient workflows.Plain Language Summary Clinical trials use electronic case report forms to report data, and data must be manually entered on these forms, which is costly and time consuming. ICAREdata methods use structured, organized data from clinical trials that can be more easily shared instead having to enter free text into electronic health records.

Publisher

Wiley

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