Ten Years of Medical Informatics and Standards Support for Clinical Research in an Infectious Diseases Network

Author:

Mora Sara1,Giannini Barbara1,Di Biagio Antonio23,Cenderello Giovanni4,Nicolini Laura Ambra2,Taramasso Lucia2,Dentone Chiara2,Bassetti Matteo23,Giacomini Mauro1

Affiliation:

1. Department of Informatics, Bioengineering, Robotics and System Engineering (DIBRIS), University of Genoa, Genoa, Italy

2. Infectious Diseases Unit, Policlinico San Martino Hospital, IRCCS for Oncology and Neuroscience, Genoa, Italy

3. Department of Infectious Disease, IRCCS AOU San Martino IST, (DISSAL), University of Genoa, Italy

4. Infectious Diseases Unit, ASL-1 Imperiese, Sanremo, Imperia, Italy

Abstract

Abstract Background It is 30 years since evidence-based medicine became a great support for individual clinical expertise in daily practice and scientific research. Electronic systems can be used to achieve the goal of collecting data from heterogeneous datasets and to support multicenter clinical trials. The Ligurian Infectious Diseases Network (LIDN) is a web-based platform for data collection and reuse originating from a regional effort and involving many professionals from different fields. Objectives The objective of this work is to present an integrated system of ad hoc interfaces and tools that we use to perform pseudonymous clinical data collection, both manually and automatically, to support clinical trials. Methods The project comprehends different scenarios of data collection systems, according to the degree of information technology of the involved centers. To be compliant with national regulations, the last developed connection is based on the standard Clinical Document Architecture Release 2 by Health Level 7 guidelines, interoperability is supported by the involvement of a terminology service. Results Since 2011, the LIDN platform has involved more than 8,000 patients from eight different hospitals, treated or under treatment for at least one infectious disease among human immunodeficiency virus (HIV), hepatitis C virus, severe acute respiratory syndrome coronavirus 2, and tuberculosis. Since 2013, systems for the automatic transfer of laboratory data have been updating patients' information for three centers, daily. Direct communication was set up between the LIDN architecture and three of the main national cohorts of HIV-infected patients. Conclusion The LIDN was originally developed to support clinicians involved in the project in the management of data from HIV-infected patients through a web-based tool that could be easily used in primary-care units. Then, the developed system grew modularly to respond to the specific needs that arose over a time span of more than 10 years.

Publisher

Georg Thieme Verlag KG

Subject

Health Information Management,Computer Science Applications,Health Informatics

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