HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy
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 Pathw...
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| creator | Croce, Davide Lazzarin, Adriano Rizzardini, Giuliano Gianotti, Nicola Scolari, Francesca Foglia, Emanuela Garagiola, Elisabetta Ricci, Elena Bini, Teresa Quirino, Tiziana Viganò, Paolo Re, Tiziana D'Arminio Monforte, Antonella Bonfanti, Paolo |
| description | 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 |
| doi_str_mv | 10.1371/journal.pone.0168399 |
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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.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0168399</identifier><identifier>PMID: 28030621</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Adult ; Adults ; AIDS ; Anti-HIV Agents - economics ; Anti-HIV Agents - therapeutic use ; Antiretroviral drugs ; Biology and Life Sciences ; Care and treatment ; CD4 antigen ; Collaboration ; Cost control ; Critical Pathways ; Disease control ; Drug therapy ; Economic forecasts ; Female ; Guidelines as Topic ; Health care ; Health care expenditures ; Health economics ; Health Plan Implementation ; Highly active antiretroviral therapy ; HIV ; HIV Infections - drug therapy ; HIV Infections - economics ; HIV Infections - virology ; HIV-1 - genetics ; HIV-1 - isolation & purification ; Hospitals ; Human immunodeficiency virus ; Humans ; Immunology ; Infections ; Infectious diseases ; Italy ; Laboratory tests ; Lentivirus ; Life expectancy ; Male ; Management ; Medical care ; Medical diagnosis ; Medicine and Health Sciences ; Middle Aged ; Patient Compliance ; Patients ; People and Places ; Pharmaceuticals ; Population studies ; Prospective Studies ; Retroviridae ; Ribonucleic acid ; RNA ; RNA, Viral - genetics ; Social Sciences ; Sustainability ; Toxicity ; Viral Load</subject><ispartof>PloS one, 2016-12, Vol.11 (12), p.e0168399</ispartof><rights>COPYRIGHT 2016 Public Library of Science</rights><rights>2016 Croce et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2016 Croce et al 2016 Croce et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c725t-1fe50664128fafc49afa94a0bd063deab9811a117968bc872f7513b07e9653de3</citedby><cites>FETCH-LOGICAL-c725t-1fe50664128fafc49afa94a0bd063deab9811a117968bc872f7513b07e9653de3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193418/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5193418/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28030621$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Croce, Davide</creatorcontrib><creatorcontrib>Lazzarin, Adriano</creatorcontrib><creatorcontrib>Rizzardini, Giuliano</creatorcontrib><creatorcontrib>Gianotti, Nicola</creatorcontrib><creatorcontrib>Scolari, Francesca</creatorcontrib><creatorcontrib>Foglia, Emanuela</creatorcontrib><creatorcontrib>Garagiola, Elisabetta</creatorcontrib><creatorcontrib>Ricci, Elena</creatorcontrib><creatorcontrib>Bini, Teresa</creatorcontrib><creatorcontrib>Quirino, Tiziana</creatorcontrib><creatorcontrib>Viganò, Paolo</creatorcontrib><creatorcontrib>Re, Tiziana</creatorcontrib><creatorcontrib>D'Arminio Monforte, Antonella</creatorcontrib><creatorcontrib>Bonfanti, Paolo</creatorcontrib><title>HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>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.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adult</subject><subject>Adults</subject><subject>AIDS</subject><subject>Anti-HIV Agents - economics</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral drugs</subject><subject>Biology and Life Sciences</subject><subject>Care and treatment</subject><subject>CD4 antigen</subject><subject>Collaboration</subject><subject>Cost control</subject><subject>Critical Pathways</subject><subject>Disease control</subject><subject>Drug therapy</subject><subject>Economic forecasts</subject><subject>Female</subject><subject>Guidelines as Topic</subject><subject>Health care</subject><subject>Health care expenditures</subject><subject>Health economics</subject><subject>Health Plan Implementation</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - economics</subject><subject>HIV Infections - virology</subject><subject>HIV-1 - genetics</subject><subject>HIV-1 - isolation & purification</subject><subject>Hospitals</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Immunology</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Italy</subject><subject>Laboratory tests</subject><subject>Lentivirus</subject><subject>Life expectancy</subject><subject>Male</subject><subject>Management</subject><subject>Medical care</subject><subject>Medical diagnosis</subject><subject>Medicine and Health Sciences</subject><subject>Middle Aged</subject><subject>Patient Compliance</subject><subject>Patients</subject><subject>People and Places</subject><subject>Pharmaceuticals</subject><subject>Population studies</subject><subject>Prospective Studies</subject><subject>Retroviridae</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - genetics</subject><subject>Social Sciences</subject><subject>Sustainability</subject><subject>Toxicity</subject><subject>Viral Load</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNqNk1tv0zAUxyMEYmPwDRBYQkLw0OJLnAsPSFUFW6WJoW3s1Tpx7NZTYnexs9Fvj7tmU4P2gPxg6_h3_udinyR5S_CUsJx8uXZ9Z6GZrp1VU0yygpXls-SQlIxOMorZ873zQfLK-2uMOSuy7GVyQAvMcEbJYeJPFldo3hhrJDToF4TVHWy-ohn6qe7QbL3uHMgVCg7NXVsZq9Bxb2oVeeUR2Bpd9D6AsVCZxoQNchrNbDCTcxU6d2u6qHnZKQitsgEZixYBms3r5IWGxqs3w36U_P7x_XJ-Mjk9O17MZ6cTmVMeJkQrjrMsJbTQoGVagoYyBVzVOGO1gqosCAFC8jIrKlnkVOecsArnqsx4BNhR8n6nu26cF0O_vCAFZzmjKU0jsdgRtYNrse5MC91GODDi3uC6pYAuGNkoUUmacsbyCusqplJCISmvdS6ZIrTSLGp9G6L1VatqGSuO5Y9ExzfWrMTS3QoenyklRRT4NAh07qZXPojWeKmaBqxy_X3eZZrnjPCIfvgHfbq6gVpCLMBY7WJcuRUVszTntCg4x5GaPkHFVavWyPi5tIn2kcPnkUNkgvoTltB7LxYX5__Pnl2N2Y977EpBE1beNX0wzvoxmO5A2TnvO6Ufm0yw2M7GQzfEdjbEMBvR7d3-Az06PQwD-wtCGwkj</recordid><startdate>20161228</startdate><enddate>20161228</enddate><creator>Croce, Davide</creator><creator>Lazzarin, Adriano</creator><creator>Rizzardini, Giuliano</creator><creator>Gianotti, Nicola</creator><creator>Scolari, Francesca</creator><creator>Foglia, Emanuela</creator><creator>Garagiola, Elisabetta</creator><creator>Ricci, Elena</creator><creator>Bini, Teresa</creator><creator>Quirino, Tiziana</creator><creator>Viganò, Paolo</creator><creator>Re, Tiziana</creator><creator>D'Arminio Monforte, Antonella</creator><creator>Bonfanti, Paolo</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AEUYN</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20161228</creationdate><title>HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy</title><author>Croce, Davide ; Lazzarin, Adriano ; Rizzardini, Giuliano ; Gianotti, Nicola ; Scolari, Francesca ; Foglia, Emanuela ; Garagiola, Elisabetta ; Ricci, Elena ; Bini, Teresa ; Quirino, Tiziana ; Viganò, Paolo ; Re, Tiziana ; D'Arminio Monforte, Antonella ; Bonfanti, Paolo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c725t-1fe50664128fafc49afa94a0bd063deab9811a117968bc872f7513b07e9653de3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adult</topic><topic>Adults</topic><topic>AIDS</topic><topic>Anti-HIV Agents - 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Croce, Davide</au><au>Lazzarin, Adriano</au><au>Rizzardini, Giuliano</au><au>Gianotti, Nicola</au><au>Scolari, Francesca</au><au>Foglia, Emanuela</au><au>Garagiola, Elisabetta</au><au>Ricci, Elena</au><au>Bini, Teresa</au><au>Quirino, Tiziana</au><au>Viganò, Paolo</au><au>Re, Tiziana</au><au>D'Arminio Monforte, Antonella</au><au>Bonfanti, Paolo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2016-12-28</date><risdate>2016</risdate><volume>11</volume><issue>12</issue><spage>e0168399</spage><pages>e0168399-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><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.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28030621</pmid><doi>10.1371/journal.pone.0168399</doi><tpages>e0168399</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2016-12, Vol.11 (12), p.e0168399 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1853732424 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry; Public Library of Science (PLoS) |
| subjects | Acquired immune deficiency syndrome Adult Adults AIDS Anti-HIV Agents - economics Anti-HIV Agents - therapeutic use Antiretroviral drugs Biology and Life Sciences Care and treatment CD4 antigen Collaboration Cost control Critical Pathways Disease control Drug therapy Economic forecasts Female Guidelines as Topic Health care Health care expenditures Health economics Health Plan Implementation Highly active antiretroviral therapy HIV HIV Infections - drug therapy HIV Infections - economics HIV Infections - virology HIV-1 - genetics HIV-1 - isolation & purification Hospitals Human immunodeficiency virus Humans Immunology Infections Infectious diseases Italy Laboratory tests Lentivirus Life expectancy Male Management Medical care Medical diagnosis Medicine and Health Sciences Middle Aged Patient Compliance Patients People and Places Pharmaceuticals Population studies Prospective Studies Retroviridae Ribonucleic acid RNA RNA, Viral - genetics Social Sciences Sustainability Toxicity Viral Load |
| title | HIV Clinical Pathway: A New Approach to Combine Guidelines and Sustainability of Anti-Retroviral Treatment in Italy |
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