Abstract

BackgroundClinical data registry is designed to collect and manage information about the practices and outcomes of a patient population for improving the quality and safety of care and facilitating novel researches. Semantic interoperability is a challenge when integrating the data from more than one clinical data registry. The openEHR approach can represent the information and knowledge semantics by multi-level modeling, and it advocates the use of collaborative modeling to facilitate reusing existing archetypes with consistent semantics so as to be a potential solution to improve the semantic interoperability.MethodsThis paper proposed an openEHR based approach to improve the semantic interoperability of clinical data registry. The approach consists of five steps: clinical data registry meta-information collection, data element definition, archetype modeling, template editing, and implementation. Through collaborative modeling and maximum reusing of existing archetype at the archetype modeling step, the approach can improve semantic interoperability. To verify the feasibility of the approach, this paper conducted a case study of building a Coronary Computed Tomography Angiography (CCTA) registry that can interoperate with an existing Electronic Health Record (EHR) system.ResultsThe CCTA registry includes 183 data elements, which involves 20 archetypes. A total number of 45 CCTA data elements and EHR data elements have semantic overlap. Among them, 38 (84%) CCTA data elements can be found in the 10 reused EHR archetypes. These corresponding clinical data can be collected from the EHR system directly without transformation. The other 7 (16%) CCTA data elements correspond to one coarse-grained EHR data elements, and these clinical data can be collected with mapping rules. The results show that the approach can improve semantic interoperability of clinical data registry.ConclusionsUsing an openEHR based approach to develop clinical data registry can improve the semantic interoperability. Meanwhile, some challenges for broader semantic interoperability are identified, including domain experts’ involvement, archetype sharing and reusing, and archetype semantic mapping. Collaborative modeling, easy-to-use tools, and semantic relationship establishment are potential solutions for these challenges. This study provides some experience and insight about clinical modeling and clinical data registry development.

Highlights

  • Clinical data registry is designed to collect and manage information about the practices and outcomes of a patient population for improving the quality and safety of care and facilitating novel researches

  • Given that the Coronary Computed Tomography Angiography (CCTA) registry needed to extract specific clinical data from an Electronic Health Record (EHR) system, we developed archetypes based on the aforementioned approach through reusing existing archetypes implemented within the EHR system and Clinical knowledge manager (CKM)

  • Among them 10 archetypes were from EHR archetype repository, 7 archetypes were from CKM

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Summary

Introduction

Clinical data registry is designed to collect and manage information about the practices and outcomes of a patient population for improving the quality and safety of care and facilitating novel researches. Gliklich RE et al [3] define clinical registry as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical, or policy purpose(s).”. All of these definitions of clinical registry have one or more of the following features: (1) aiming at one or more objectives or purposes; (2) having a specific criteria to certify the eligibility of patient data; (3) providing a real-world health care view; (4) having a broader patient population. Clinical experts defined data elements with DiAE, including name, description, terminology or constraints, data type, and reference source

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