OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.
Summary Background: By the end of the first quarter of 2017, 1212 standard Clinical Pathways (CPs) had been developed and implemented in China since 2009, however, Chinese standard CPs are still paper-based CPs. Objectives: To optimize the data structure and content of Chinese standard CPs based on Chinese health standards by two-level modeling approach and archetype method, and develop an Open Metadata Schema for Clinical Pathway (openCP) in China. Methods: We chose 43 diseases covering 7 departments of internal medicine as samples and source materials including Respiratory, Gastroenterology, Neurology, Cardiology, Nephrology, Endocrinology, and Hematology, and we followed 4 steps to develop openCP: identify reference model of openCP; develop archetype models; standardize archetype terms and metadata; and evaluate its functionality. Results: We have built hierarchical reference model and archetypes of openCP, created and standardized archetype terms and metadata, and evaluate the functionality of openCP. The qualitative comments from 5 doctors were inspiring. Discussion and Conclusions: Medical staff may easily build localized CPs in openCP which can be integrated into EHR systems and shared among different hospitals and clinics.
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