Inform Health Soc Care - Multicentre clinical trials' data management: a hybrid solution to exploit the strengths of electronic data capture and electronic health records systems.

Tópicos

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{ visual(1396) interact(850) tool(830) }
{ ehr(2073) health(1662) electron(1139) }
{ patient(2837) hospit(1953) medic(668) }
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{ implement(1333) system(1263) develop(1122) }
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{ method(1969) cluster(1462) data(1082) }

Resumo

CKGROUND: Clinical Trials (CTs) are indispensable instruments for evidence-based medicine and frequently necessitate the management, sharing and analysis of large amounts of data amongst partners in different locations.METHODS: To effectively satisfy these requirements, the proposed solution combines a web platform and a Clinical Data Management System (CDMS) to exploit the strengths of Electronic Health Records (EHR) and Electronic Data Capture (EDC) systems. The core of the proposal is a relational database which has high data structuring characteristics and utilises biomedical controlled vocabularies (e.g. LOINC and ICD). In addition, units and normality ranges were collected for data comparison through the application of the Z-score transformation.RESULTS: The obtained CDMS preserves the EDC's flexibility and user autonomy and permits the creation of patient cohorts, as in the EHR. Accordingly, clinical information, after the initial recording, is available for different simultaneous multicentre CTs. Furthermore, interface runtime controls guarantee high data quality during data entering processes. Currently, the proposed system has been developed in the HIV and eye diseases fields in Italy.CONCLUSIONS: The proposed solution is flexible and suitable to perform multicentre research within a varying range of medical domains. In the future, the automatic importation of information from hospitals has been planned through an HL7 standard interface which would improve both data quantity and quality.

Resumo Limpo

ckground clinic trial cts indispens instrument evidencebas medicin frequent necessit manag share analysi larg amount data amongst partner differ locationsmethod effect satisfi requir propos solut combin web platform clinic data manag system cdms exploit strength electron health record ehr electron data captur edc system core propos relat databas high data structur characterist utilis biomed control vocabulari eg loinc icd addit unit normal rang collect data comparison applic zscore transformationresult obtain cdms preserv edc flexibl user autonomi permit creation patient cohort ehr accord clinic inform initi record avail differ simultan multicentr cts furthermor interfac runtim control guarante high data qualiti data enter process current propos system develop hiv eye diseas field italyconclus propos solut flexibl suitabl perform multicentr research within vari rang medic domain futur automat import inform hospit plan hl standard interfac improv data quantiti qualiti

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