Roberta Gazzarata

The ligurian human immunodeficiency virus clinical network: a web tool to manage patients with human immunodeficiency virus in primary care and multicenter clinical trials.

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).

The integration of e-health into the clinical workflow --- electronic health record and standardization efforts

The continuous increase in the number of different devices within medical information systems produces a large amount of heterogenic clinical information which must be integrated and correctly stored in order to improve patients health and decrease healthcare costs. The use of the universally recognized standards of information and knowledge transmission and storage can be an excellent instrument to develop innovative eHealth solution. A EN13606 compliant telemonitoring solution is described in this paper; it is based on a collection and a semantic organization of sensor data, a standardized information transmission and storage within an internal repository during the monitoring period. This solution represents an example of care continuum concretization completely integrated with the European Health System directives.

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patients own center, in which personal details are shown and the other for statistical purposes, where all centers anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies.

A Semantically Enriched Architecture for an Italian Laboratory Terminology System

This paper presents the architectural solutions and the first implementation results of a terminology service that aims to support Italian health institutions in the deployment of their clinical data in a semantically standardized format while maintaining their internal coding habits unchanged. As a first example of this general idea, an implementation structure of a translation system in LOINC for laboratory tests is presented. The first prototype of this system is at a testing stage within some clinical institutions of the Ligurian region. In this paper, the workflow of collaboration between the staff of a medical informatics academic laboratory and some hospital analysis laboratories is presented. With this system more than 400 records relative to clinical tests were coded with the appropriate LOINC code and these translations were inserted into a Common Terminology Services 2 (CTS2) based tool to support future cooperative maintenance of the coding system. A comparison with similar implementations in other English and non-English speaking countries is present. The authors thinks that the present example could be easily adopted both at a regional and at a national level in order to form an interconnected laboratory network towards real semantic interoperability.

Cancer precision medicine today: Towards omic information in healthcare systems

Introduction: This article focuses on the integration of omics data in electronic health records and on interoperability aspects relating to big data analysis for precision medicine. Methods: Omics data integration methods for electronic health record and for systems interoperability are considered, with special reference to the high number of specific software tools used to manage different aspects of patient treatment. This is an important barrier against the use of this integrated approach in daily clinical routine. Results: The correct use of all three levels of interoperability (technical, semantic, and process interoperability) plays a key role in order to achieve an easy access to a significant amount of data, all with correct contextualization, which is the only way to obtain a real value from data for precision medicine. Conclusions: The proposed architecture could improve the potentialities of data routinely collected in many health information systems to form a real patient center information environment.

A SOA-Based Solution to Monitor Vaccination Coverage Among HIV-Infected Patients in Liguria.

Vaccination in HIV-infected patients constitutes an essential tool in the prevention of the most common infectious diseases. The Ligurian Vaccination in HIV Program is a proposed vaccination schedule specifically dedicated to this risk group. Selective strategies are proposed within this program, employing ICT (Information and Communication) tools to identify this susceptible target group, to monitor immunization coverage over time and to manage failures and defaulting. The proposal is to connect an immunization registry system to an existing regional platform that allows clinical data re-use among several medical structures, to completely manage the vaccination process. This architecture will adopt a Service Oriented Architecture (SOA) approach and standard HSSP (Health Services Specification Program) interfaces to support interoperability. According to the presented solution, vaccination administration information retrieved from the immunization registry will be structured according to the specifications within the immunization section of the HL7 (Health Level 7) CCD (Continuity of Care Document) document. Immunization coverage will be evaluated through the continuous monitoring of serology and antibody titers gathered from the hospital LIS (Laboratory Information System) structured into a HL7 Version 3 (v3) Clinical Document Architecture Release 2 (CDA R2).

Reuse of Clinical Information: Integrating Primary Care and Clinical Research through a Bidirectional Standard Interface

Nowadays, most healthcare providers archive and manage patients’ information in electronic format. The reuse of such Clinical Information is essential from both a scientific and financial perspective, and for the integration of Primary Care and Clinical Research; which has become a principal goal. The solution proposed aims at integrating data between a web platform, developed for research purposes, and Hospital Information Systems. Information is shared through a Bidirectional Standard Interface, which adopts biomedical controlled vocabularies and ontologies (LOINC, ICD and SNOMED), and HL7 messaging (CDA V3 R2) for data exchanging. Such an interface allows the importation of data from Hospital Information Systems to a web platform, and the exportation of information from the platform to Hospital Information Systems. Currently, this project has been implemented in the Infectious Diseases context, and complete data integration and semantic interoperability has been obtained between the “Ligurian HIV Clinical Network” and the Infectious Diseases Department of the San Paolo Hospital (Savona, Italy).

SILAM: Integrating Laboratory Information System within the Liguria Region Electronic Health Record

In the last few years a significant challenge has been faced in the healthcare world, after the development of the LOINC (Logical Observation Identifiers Names And Codes) and the HL7 (Health level 7) standards; in order to provide systems of interoperable platforms, interconnected and utilizing standard language for the processing, communication and treatment of data. The aim of this paper is to demonstrate how a small local laboratory can easily communicate with a central data repository using these standards. This was realized by creating: a database with laboratory observations codified in LOINC, a web server that represents the general repository of data and by using two clients that directly link to the Web Service (WS) and which also allows clinicians and laboratory biologists to communicate with each other. The results clearly demonstrate that these standards are able to realize interoperability among heterogeneous systems. A future development should consist in testing this reality at a national level, with a national data repository.