An Interoperability Platform Enabling Reuse of Electronic Health Records for Signal Verification Studies

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Abstract

Depending mostly on voluntarily sent spontaneous reports, pharmacovigilance studies are hampered by low quantity and quality of patient data. Our objective is to improve postmarket safety studies by enabling safety analysts to seamlessly access a wide range of EHR sources for collecting deidentified medical data sets of selected patient populations and tracing the reported incidents back to original EHRs. We have developed an ontological framework where EHR sources and target clinical research systems can continue using their own local data models, interfaces, and terminology systems, while structural interoperability and Semantic Interoperability are handled through rule-based reasoning on formal representations of different models and terminology systems maintained in the SALUS Semantic Resource Set. SALUS Common Information Model at the core of this set acts as the common mediator. We demonstrate the capabilities of our framework through one of the SALUS safety analysis tools, namely, the Case Series Characterization Tool, which have been deployed on top of regional EHR Data Warehouse of the Lombardy Region containing about 1 billion records from 16 million patients and validated by several pharmacovigilance researchers with real-life cases. The results confirm significant improvements in signal detection and evaluation compared to traditional methods with the missing background information.

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Author and article information

Journal

Journal ID (nlm-ta): Biomed Res Int

Journal ID (iso-abbrev): Biomed Res Int

Journal ID (publisher-id): BMRI

Title: BioMed Research International

Publisher: Hindawi Publishing Corporation

ISSN (Print): 2314-6133

ISSN (Electronic): 2314-6141

Publication date (Print): 2016

Publication date (Electronic): 31 March 2016

Volume: 2016

Electronic Location Identifier: 6741418

Affiliations

¹SRDC Software Research & Development and Consultancy Ltd., 06800 Ankara, Turkey

²Department of Computer Engineering, Middle East Technical University, 06800 Ankara, Turkey

³Lombardia Informatica S.p.A., Via Torquato Taramelli, 26 20124 Milano, Italy

⁴WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre (UMC), 753 20 Uppsala, Sweden

⁵Advanced Clinical Applications Research Group, Agfa HealthCare, 9000 Gent, Belgium

Author notes

*Mustafa Yuksel: mustafa@ 123456srdc.com.tr

Academic Editor: Vassilis Koutkias

Article

DOI: 10.1155/2016/6741418

PMC ID: 4830705

PubMed ID: 27123451

SO-VID: c2b6549d-9903-40dc-850a-96655254e55b

License:

This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

History

Date received : 12 June 2015

Date accepted : 4 October 2015

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