Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 73% of cases) was 96% for CPTA, 82% for CPT-B, 56% CPT-C, whereas it was 94% and 57% for MELD score respectively below or above 15. Furthermore, no significant changes in p-HRQoL between baseline and after 2 years follow-up were found in CC and CPT-A patients, while p-HRQoL progressively decreased in DC and CPT B-C patients. In conclusion, combined measurements of specific OIs and p-HRQoL scales provide the methodological bases to implement a value-based approach to the care of patients with LC. In fact, these outcomes combined with measurements of direct and indirect costs could guide future decision-making process and improve value of care in cirrhosis.
Okolicsanyi, S., Ciaccio, A., Cortesi, P., Rota, M., Gemma, M., Giani, P., et al. (2014). A value-based approach to the management of patients with liver cirrhosis through the systematic measurement of clinical outcome and quality of life indicators. HEPATOLOGY, 60(Supplement 1), 942A-943A.
A value-based approach to the management of patients with liver cirrhosis through the systematic measurement of clinical outcome and quality of life indicators
OKOLICSANYI, STEFANO;CIACCIO, ANTONIO;CORTESI, PAOLO ANGELO;ROTA, MATTEO;GEMMA, MARTA;SCALONE, LUCIANA;MANTOVANI, LORENZO GIOVANNI;Fagiuoli, S;VALSECCHI, MARIA GRAZIA;CESANA, GIANCARLO;STRAZZABOSCO, MARIO
2014
Abstract
Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 73% of cases) was 96% for CPTA, 82% for CPT-B, 56% CPT-C, whereas it was 94% and 57% for MELD score respectively below or above 15. Furthermore, no significant changes in p-HRQoL between baseline and after 2 years follow-up were found in CC and CPT-A patients, while p-HRQoL progressively decreased in DC and CPT B-C patients. In conclusion, combined measurements of specific OIs and p-HRQoL scales provide the methodological bases to implement a value-based approach to the care of patients with LC. In fact, these outcomes combined with measurements of direct and indirect costs could guide future decision-making process and improve value of care in cirrhosis.
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