© 2010 Brighton Collaboration
The Italian arm of the study will use two databases one is the Health Search Database (HSD), a longitudinal observational database that is representative of the general Italian population. It was established in 1998 by the Italian College of General Practitioners 7. The HSD contains data from computer-based patient records from a select group of GPs (covering a total of 1.5 million patients) located throughout Italy who voluntarily agreed to collect data for the database and attend specified training courses 7. The database includes information on the age, gender, and identification of the patient, and GP registration information, which is linked to prescription information, clinical events and diagnoses, hospital admission, and causes of death.
All diagnoses are coded according to the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM). Drug names are coded according to the ATC classification system. To be included in the study, GPs must have provided data for at least 1 year and meet standard quality criteria pertaining to: levels of coding, prevalence of well-known diseases, and mortality rates 8. At the time in which this study will initiate, 500 GPs homogenously distributed across all Italian areas, covering a patient population of around 800,000 patients, reached the standard quality criteria.
The HSD complies with European Union, guidelines on the use of medical data for research. The HSD has been the data source for a number of peer-reviewed publications on the prevalence of disease conditions 8, drug safety and prescription patterns 9 in Italian primary care. Approval for use of data is obtained from the Italian College of Primary Care Physicians.
Data are in house, no ethical approval needed.