Introduction: The management of hepatocellular carcinoma (HCC) is a well-known public health problem, accounting for increasing mortality and high costs. Quality parameters able to measure clinical outcomes are still lacking. Aim of our study (Value Based Medicine in Hepatology, VBMH)was to identify and test outcome indicators (OIs) in HCC, in light of their potential use in policy decision models. Methods: A panel of experts identified a list of OIs using a modified Delphi method, according to experience and published evidence; four OIs with the highest RAND/UCLA score were tested in a prospective multicenter observational study. During 18 months, 711 HCC patients were enrolled and prospectively followed. 677 patients (95%) had at least one follow-up consultation. Median follow-up time was 14 months. Results: The first OI was 1–3–5 years survival stratified for BCLC stage or treatment (OI#1). One-year survival for BCLC stage 0/A–D was 93%, 86%, 50%, 26% respectively. One-year survival of 288 patients treated for the first time during the study was 88% for liver transplantation, 97% surgical resection, 100% ablation and 89% for TACE. The other three OIs evaluated the appropriateness of treatments: worsening of BCLC and/or CPT score after three months from a loco-regional therapy or surgical resection (OI#2), occurred in 16% of cases (76% after TACE). Recurrence of HCC within 6 months after curative treatments (OI#3) happened in 15% of patients treated, mainly after ablation (20%). Presence of severe morbidity three months after loco-regional procedure or resection, evaluated as grade≥3 according to Clavien-Dindo classification (OI#3), was found in 3% of patients treated. Conclusions: The outcome indicators identified in the VBMH study proved their feasibility in a large cohort of patients and could stand as a benchmark for healthcare providers to move towards a value-based approach in the management of HCC.
Okolicsanyi, S., Ciaccio, A., Rota, M., Gentiluomo, M., Gemma, M., Grisolia, A., et al. (2014). Value-based outcome indicators in the management of hepatocellular carcinoma: Clinical test in a large multicenter study (VBMH study). DIGESTIVE AND LIVER DISEASE, 46(Suppl 1), e63-e63 [10.1016/j.dld.2014.01.140].
Value-based outcome indicators in the management of hepatocellular carcinoma: Clinical test in a large multicenter study (VBMH study)
Okolicsanyi, S;Ciaccio, A;Rota, M;Gentiluomo, M;Gemma, M;Cortesi, P;Scalone, L;Mantovani, L;Colledan, M;Fagiuoli, S;Valsecchi, M;Cesana, G;Strazzabosco, M
2014
Abstract
Introduction: The management of hepatocellular carcinoma (HCC) is a well-known public health problem, accounting for increasing mortality and high costs. Quality parameters able to measure clinical outcomes are still lacking. Aim of our study (Value Based Medicine in Hepatology, VBMH)was to identify and test outcome indicators (OIs) in HCC, in light of their potential use in policy decision models. Methods: A panel of experts identified a list of OIs using a modified Delphi method, according to experience and published evidence; four OIs with the highest RAND/UCLA score were tested in a prospective multicenter observational study. During 18 months, 711 HCC patients were enrolled and prospectively followed. 677 patients (95%) had at least one follow-up consultation. Median follow-up time was 14 months. Results: The first OI was 1–3–5 years survival stratified for BCLC stage or treatment (OI#1). One-year survival for BCLC stage 0/A–D was 93%, 86%, 50%, 26% respectively. One-year survival of 288 patients treated for the first time during the study was 88% for liver transplantation, 97% surgical resection, 100% ablation and 89% for TACE. The other three OIs evaluated the appropriateness of treatments: worsening of BCLC and/or CPT score after three months from a loco-regional therapy or surgical resection (OI#2), occurred in 16% of cases (76% after TACE). Recurrence of HCC within 6 months after curative treatments (OI#3) happened in 15% of patients treated, mainly after ablation (20%). Presence of severe morbidity three months after loco-regional procedure or resection, evaluated as grade≥3 according to Clavien-Dindo classification (OI#3), was found in 3% of patients treated. Conclusions: The outcome indicators identified in the VBMH study proved their feasibility in a large cohort of patients and could stand as a benchmark for healthcare providers to move towards a value-based approach in the management of HCC.
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