title: HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy.
abstract: The present article describes the case study of a "real world" HIV practice within the debate concerning the strategic role of Clinical Governance (CG) tools in the management of a National Healthcare System's sustainability. The study aimed at assessing the impact of a Clinical Pathway (CP) implementation, required by the Regional Healthcare Service, in terms of effectiveness (virological and immunological conditions) and efficiency (economic resources absorption), from the budget holder perspective. Data derived from a multi-centre cohort of patients treated in 6 Hospitals that provided care to approximately 42% of the total HIV+ patients, in Lombardy Region, Italy. Two phases were compared: Pre-CP (2009-2010) vs. Post-CP implementation (2011-2012). All HIV infected adults, observed in the participating hospitals during the study periods, were enrolled and stratified into the 3 categories defined by the Regional CP: first-line, switch for toxicity/other, and switch for failure. The study population was composed of 1,284 patients (Pre-CP phase) and 1,135 patients (Post-CP phase). The results showed that the same level of virological and immunological effectiveness was guaranteed to HIV+ patients: 81.2% of Pre-CP phase population and 83.2% of Post-CP phase population had undetectable HIV-RNA (defined as <50 copies/mL) at 12-month follow up. CD4+ cell counts increased by 28 ± 4 cells/mm3 in Pre-CP Phase and 39 ± 5 cells/mm3 in Post-CP Phase. From an economic point of view, the CP implementation led to a substantial advantage: the mean total costs related to the management of the HIV disease (ART, hospital admission and laboratory tests) decreased (-8.60%) in the Post-CP phase (p-value < 0.0001). Results confirmed that the CP provided appropriateness and quality of care, with a cost reduction for the budget holder.
authors.affiliation: Centre for Research in Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, Varese, Italy.|School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Davide
authors.initials: D
authors.lastname: Croce
authors.affiliation: Clinic of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Lazzarin
authors.affiliation: Department of Infectious Diseases, Fatebebefratelli Sacco Hospital, Milan, Italy.|School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Rizzardini
authors.affiliation: Clinic of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Gianotti
authors.affiliation: Centre for Research in Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, Varese, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Scolari
authors.affiliation: Centre for Research in Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, Varese, Italy.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Foglia
authors.affiliation: Centre for Research in Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, Varese, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Garagiola
authors.affiliation: Department of Infectious Diseases, Fatebebefratelli Sacco Hospital, Milan, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Ricci
authors.affiliation: Unit of Infectious Diseases, Santi Paolo e Carlo Hospital, Milan, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Bini
authors.affiliation: Department of Infectious Diseases, Valle Olona Hospital, Busto Arsizio, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Quirino
authors.affiliation: Department of Infectious Diseases, Ovest Milanese Hospital, Legnano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Viganò
authors.affiliation: Department of Infectious Diseases, Ovest Milanese Hospital, Legnano, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Re
authors.affiliation: Unit of Infectious Diseases, Santi Paolo e Carlo Hospital, Milan, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: D'Arminio Monforte
authors.affiliation: Department of Infectious Diseases, Lecco Hospital, Lecco, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bonfanti
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000191:economics / Q000627:therapeutic use*; D019091:Critical Pathways; D005260:Female; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D006284:Health Plan Implementation; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D012367:RNA, Viral / Q000235:genetics; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D012367:RNA, Viral