title: The ligurian human immunodeficiency virus clinical network: a web tool to manage patients with human immunodeficiency virus in primary care and multicenter clinical trials.
abstract: BACKGROUND
  In recent years, Highly-Active Anti-Retroviral Therapies (HAARTs) have modified the Human Immunodeficiency Virus (HIV) life-cycle and the disease is now considered chronic. Consequently, a longitudinal and complex follow-up is now required for HIV positive patients during their lifetime. Moreover, patients often encounter various complications due to comorbidities, related to the immunodeficiency state and HAARTs' side effects. Thus, HIV positive patients are involved in multicenter clinical trials (MCTs) to improve treatments and discover a preventive vaccine. Therefore, physicians require proper instruments to access comprehensive patient data for managing patients during follow-ups, and tools for data collection and analysis in MCTs.
  
  
  OBJECTIVE
  The Ligurian HIV Clinical Network aims to provide physicians with a Web-tool to administrate HIV positive patients' data within primary-care and to reuse the collected clinical information to perform MCTs in Northern Italy.
  
  
  METHODS
  The key aspect of the system is a relational database which allows the storage of various types of clinical information (eg, related to HIV, cardiovascular, or hepatic diseases) in multiple formats. The modular design of the database permits a rapid insertion of new parameters without requiring any changes in the database structure. Furthermore, codes from biomedical ontologies controlled vocabularies ("Logical Observation Identifier Names and Codes", and "International Classification of Diseases 9") and ontologies ("Systematized Nomenclature of Medicine Clinical Terms"), units and normality ranges used by all partners participating in the project were collected to achieve a complete semantic interoperability. Accordingly, data can be automatically normalized through the z score formula and physicians can extract and correctly compare information with external statistical tools. Moreover, to respect patients' privacy and legal issues, a local identifier, determined through an HASH cryptography algorithm, is assigned to each patient during the registration process. The database is managed by a user-friendly Web-platform which allows quick access to information during medical examinations and the reusing of the collected data for present and future MCTs. Furthermore, a bidirectional middleware was created in order to import/export information through HL7 messaging. Hence, data can be manually entered by physicians or automatically collected within HL7-compliant Hospital Information systems.
  
  
  RESULTS
  Presently, the direct storage of patients' information from the San Paolo Hospital (Savona, Italy), and San Martino and Galliera hospitals in Genoa is in a test phase. Currently, 8 centers of Infectious Diseases (located in Liguria and Piedmont) are participating in the project and almost 400 HIV positive patients have been recorded in the system. Patient data has been used for primary care and research purposes. Currently, there are 4 on-going MCTs and preliminary results have already been presented at International HIV congresses.
  
  
  CONCLUSIONS
  The Web-platform allows effective management, sharing and reuse of information within primary care and clinical research. In the future it is planned to share the clinical information from this network with other HL7-compliant workgroups and to extend the platform to other infective diseases (eg, hepatitis).
authors: Department of Informatics, Bioengineering, Robotics and System Engineering University of Genoa Genoa Italy.
authors: Paolo
authors: P
authors: Fraccaro
authors: Department of Informatics, Bioengineering, Robotics and System Engineering University of Genoa Genoa Italy.
authors: Valeria
authors: V
authors: Pupella
authors: Department of Informatics, Bioengineering, Robotics and System Engineering University of Genoa Genoa Italy.
authors: Roberta
authors: R
authors: Gazzarata
authors: Department of Infectious Diseases Sanremo Hospital Sanremo Italy ; Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Chiara
authors: C
authors: Dentone
authors: Department of Infectious Diseases Galliera Hospital Genoa Italy.
authors: Giovanni
authors: G
authors: Cenderello
authors: Department of Infectious Diseases San Paolo Hospital Savona Italy.
authors: Pasqualina
authors: P
authors: De Leo
authors: Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Federica
authors: F
authors: Bozzano
authors: Department of Infectious Diseases Pietra Ligure Hospital Pietra Ligure Italy.
authors: Giorgetta
authors: G
authors: Casalino Finocchio
authors: Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Andrea
authors: A
authors: De Maria
authors: Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Daniela
authors: D
authors: Fenoglio
authors: Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Gilberto
authors: G
authors: Filaci
authors: Department of Infectious Diseases La Spezia Hospital La Spezia Italy.
authors: Michele
authors: M
authors: Guerra
authors: Department of Infectious Diseases San Martino Hospital Genoa Italy.
authors: Antonio
authors: A
authors: Di Biagio
authors: Department of Infectious Diseases Alessandria Hospital Alessandria) Italy.
authors: Eugenio
authors: E
authors: Mantia
authors: Department of Infectious Diseases Torino Hospital Torino Italy.
authors: Giancarlo
authors: G
authors: Orofino
authors: Department of Infectious Diseases Sanremo Hospital Sanremo Italy.
authors: Giuseppe
authors: G
authors: Ferrea
authors: Department of Infectious Diseases San Martino Hospital Genoa Italy.
authors: Claudio
authors: C
authors: Viscoli
authors: Department of Informatics, Bioengineering, Robotics and System Engineering University of Genoa Genoa Italy ; Center of Excellence for Biomedical Research University of Genoa Genoa Italy.
authors: Mauro
authors: M
authors: Giacomini
keywords: biomedical ontologies; health level 7; human immunodeficiency virus; multicenter clinical trials; z score