Methods Inf Med - Bridging data models and terminologies to support adverse drug event reporting using EHR data.

Tópicos

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Resumo

TRODUCTION: This article is part of the Focus Theme of METHODs of Information in Medicine on "Managing Interoperability and Complexity in Health Systems".BACKGROUND: SALUS project aims at building an interoperability platform and a dedicated toolkit to enable secondary use of electronic health records (EHR) data for post marketing drug surveillance. An important component of this toolkit is a drug-related adverse events (AE) reporting system designed to facilitate and accelerate the reporting process using automatic prepopulation mechanisms.OBJECTIVE: To demonstrate SALUS approach for establishing syntactic and semantic interoperability for AE reporting.METHOD: Standard (e.g. HL7 CDA-CCD) and proprietary EHR data models are mapped to the E2B(R2) data model via SALUS Common Information Model. Terminology mapping and terminology reasoning services are designed to ensure the automatic conversion of source EHR terminologies (e.g. ICD-9-CM, ICD-10, LOINC or SNOMED-CT) to the target terminology MedDRA which is expected in AE reporting forms. A validated set of terminology mappings is used to ensure the reliability of the reasoning mechanisms.RESULTS: The percentage of data elements of a standard E2B report that can be completed automatically has been estimated for two pilot sites. In the best scenario (i.e. the available fields in the EHR have actually been filled), only 36% (pilot site 1) and 38% (pilot site 2) of E2B data elements remain to be filled manually. In addition, most of these data elements shall not be filled in each report.CONCLUSION: SALUS platform's interoperability solutions enable partial automation of the AE reporting process, which could contribute to improve current spontaneous reporting practices and reduce under-reporting, which is currently one major obstacle in the process of acquisition of pharmacovigilance data.

Resumo Limpo

troduct articl part focus theme method inform medicin manag interoper complex health systemsbackground salus project aim build interoper platform dedic toolkit enabl secondari use electron health record ehr data post market drug surveil import compon toolkit drugrel advers event ae report system design facilit acceler report process use automat prepopul mechanismsobject demonstr salus approach establish syntact semant interoper ae reportingmethod standard eg hl cdaccd proprietari ehr data model map ebr data model via salus common inform model terminolog map terminolog reason servic design ensur automat convers sourc ehr terminolog eg icdcm icd loinc snomedct target terminolog meddra expect ae report form valid set terminolog map use ensur reliabl reason mechanismsresult percentag data element standard eb report can complet automat estim two pilot site best scenario ie avail field ehr actual fill pilot site pilot site eb data element remain fill manual addit data element shall fill reportconclus salus platform interoper solut enabl partial autom ae report process contribut improv current spontan report practic reduc underreport current one major obstacl process acquisit pharmacovigil data

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