Outcomes of care in Italy: moving towards a more reliable way to assess interventions Paolo A Cortesi, PhD Research Centre on Public Health (CESP) University of Milan Bicocca In Italy the need of reliable outcomes indicators to assess the interventions and the quality of care provided by the National Health System is increasing. We conducted and we are conducting different studies to try to meet this need. Here are two examples of these studies: 1. Generation and Validation of Outcome Indicators to assess the quality of care in Hospital Setting 2. Italian population-based values of EQ-5D health states 1
Value-Based Medicine in Hepatology (VBMH) Study VBMH Study - Background The value of care for the patient and the society is the ability to achieve the best outcome for a particular condition, at the minimum cost enabling that outcome. The Value of care for any specific condition changes over time and fluctuates according to the scientific advances, but in most cases the Value is measurable and should be measured and the results should be made public and used as a model for health care governance. Even in public systems, the competition for resources could be calibrated on obtaining the best value (clinical outcomes/costs), rather than the rationing of resources. The value achieved in the best centers would create a benchmark around which other centers could re-organize their structure and clinical practice. 2
VBMH Study - Methods Phase 1. Generation of specific Outcome Indicators (OIs) for 11 Liver Diseases (hepatitis B, hepatitis C, metabolic liver disease, autoimmune liver diseases, compensated and decompensated cirrhosis, end-stage liver diseases and transplant, hepatocellular carcinoma). Phase 2. Validation of OIs in a Prospective Study (ongoing) and assessment of norm values in 3 main hospitals of Lombardy Region. Phase 3. merge study dataset with the administrative data warehouse of Lombardy Region to assess the cost per outcome achieved Phase 4. Outcomes Analysis (includes review of process), comparison between Centers. Phase 1 - Generation of VBMH OIs Step one: a Focus Group for each disease was built with the following characteristics: 5 to 10 Italian Hepatologists of well-known experience in the management of each liver disease considered 1 international expert in Hepatology The Principal Investigator 1 Assistant Hepatologist 1 Health economist 1 Epidemiologist/Biostatistician Step Two: each Focus Group was provided with up-to-date literature and best evidence on selected topics. Step Three: potential OIs were generated and analyzed in Focus Group meetings. A first set of 10 OIs were selected for further discussion and voting. 3
Phase 1 - Generation of VBMH OIs Step Four: Candidate OIs were submitted to each Panel Member and voted according to RAND/UCLA Delphi Method (1 to 9). Step Five: OIs that passed the voting session (i.e. score equal or higher than 7) were finally ranked in a last step by the expert hepatologists involved in all focus group. Phase 2. Validation of OIs Total number of patients enrolled at three tertiary Centers. Enrollment time: March 2011 November 2012 Center 1 Center 2 Center 3 Total (pts) 785 922 1506 3213 24% 29% 47% - 4
Phase 2. Validation of OIs (Enrolled patients) U.O.C. Gastroenterologia S.Gerardo Hospital MONZA U.O.C. Chirurgia 3 e Centro Trapianti, Papa Giovanni XXIII Hospital BERGAMO S.C. Epatologia e Gastroenterologia Niguarda Cà Granda Hospital MILAN DIAGNOSIS TOTAL PTS (%pts enrolled) CIRRHOSIS 1768 (55%) HEPATOCARCINOMA 738 (23%) HEPATITIS C 1545 (48%) HEPATITIS B 554 (17%) NAFLD-NASH 304 (9%) HEMOCHROMATOSIS 16 (0,5%) AUTOIMMUNE HEPATITIS 77 (2%) PRIMARY BILIARY CIRRHOSIS PRIMARY SCLEROSING CHOLANGITIS ORTHOTOPIC LIVER TRANSPLANTATION 85 (3%) 63 (2%) 315 (10%) OIs: the example of Cirrhosis N CIRRHOSIS 1 2 3 4 5 DECOMPENSATION RATE AT 1-3-5 YEARS IN COMPENSATED CIRRHOSIS 1-YEAR SURVIVAL (CPT/ MELD SCORE) IN DECOMPENSATED* CIRRHOSIS INCIDENCE OF HEPATOCELLULAR CARCINOMA IN COMPENSATED/DECOMPENSATED CIRROSIS VARICEAL BLEEDING RATE IN COMPENSATED/DECOMPENSATED CIRRHOSIS AND SURVIVAL (6 WEEKS AND OVERALL) HOSPITAL RE-ADMISSION RATE PER DECOMPENSATED PATIENT AND LENGTH OF HOSPITAL STAY *Clinically evident complications of portal hypertension (ascites, variceal hemorrhage, hepatic encephalopathy) or liver insufficiency (jaundice). Garcia-Tsao et al. Hepatology 2010 51:1445-49 5
Probability of Survival 0.0 0.2 0.4 0.6 0.8 1.0 Probability of Survival 0.0 0.2 0.4 0.6 0.8 1.0 OIs: the example of Cirrhosis Outcomes indicator 1 N OI OUTCOME INDICATOR VBMH RESULTS LITERATURE DATA Overall 6.5% 5-7% 1 1 Annual rate of decompensation (ASCITES 72%) HCV-related HBV-related 7.7% of tot cirrhotic HCV patients 1.6 % of tot cirrhotic HBV patients 2,77% - 11,7% 2 0% 3-4% 4 1 D Amico G et al. J Hepatol 2006 2 Alazawi W, et al. Aliment Pharmacol Ther 2010; 3 Lampertico P et al, EASL 2013 4 Fattovich et al, Journal of Hepatology 2008 OIs: the example of Cirrhosis - Outcomes indicator 2 Survival stratified for CPT score and MELD recorded at study entry (in decompensate cirrhosis) N QI 2 OUTCOME INDICATOR 1-year survival CHILD MELD VBMH RESULTS LITERATURE DATA A B C A B C CHILD 96% 82% 60% 95% 80% 45% <15 15 MELD Unknown 95% 56% CPT A MELD<15 CPT B MELD>=15 CPT C CPT A: 96% (95% CI 94%-98%) CPT B: 82% (95% CI 78%-86%) CPT C: 60% (95% CI 46%-74%) MELD<15: 94% (95% CI 93%-97%) MELD>=15: 56% (95% CI 43%-69%) 0 3 6 9 12 15 18 21 24 Time (months) 0 3 6 9 12 15 18 21 24 Time (months) 6
VBMH study: Next steps Phase 3. merge study dataset with the administrative data warehouse of Lombardy Region to assess the cost per outcome achieved Phase 4. Outcomes Analysis (includes review of process), comparison between Centers. Italian population-based values of EQ-5D health states 7
The importance and need of country specific utility values to perform cost-effectiveness analysis in Italy Mean Absolute Differences Italy-UK = 0.296 Italy-Spain = 0.301 Mean Absolute Differences Italy-France = 0.354 Mean Absolute Differences Italy-Germany = 0.132 Italy-Poland= 0.106 Mean Absolute Differences Italy-US = 0.103 Italy-Japan= 0.083 8
The importance and need of country specific utility values to perform cost-effectiveness analysis in Italy 12% of the 25 valued states were on average considered worse than dead in Italy, while 44% had negative values in the Spain and UK Conclusions The availability of country specific utility values is the first step to meet the need of reliable outcomes indicators. Other attempts to improve the assessment of interventions are ongoing. In Italy, we need to move towards a Health Service based on standard and more reliable methods for assensing interventions and quality of care. This approach can help to obtaining the best value (clinical outcomes/costs), rather than the rationing of resources. 9
See you in Milan next year!!!! Program Committee Co-Chairs Lorenzo Giovanni Mantovani, DSc François Meyer, MD 10