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Clinical outcome indicators in chronic hepatitis B and C: A primer for value‐based medicine in hepatology
Author(s) -
Strazzabosco Mario,
Cortesi Paolo A.,
Conti Sara,
Okolicsanyi Stefano,
Rota Matteo,
Ciaccio Antonio,
Cozzolino Paolo,
Fornari Carla,
Gemma Marta,
Scalone Luciana,
Cesana Giancarlo,
Fabris Luca,
Colledan Michele,
Fagiuoli Stefano,
Ideo Gaetano,
Zavaglia Claudio,
Perricone Giovanni,
Munari Luca M.,
Mantovani Lorenzo G.,
Belli Luca S.
Publication year - 2020
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/liv.14285
Subject(s) - hepatology , medicine , clinical practice , delphi method , observational study , family medicine , health care , hepatitis c , liver disease , chronic hepatitis , immunology , statistics , mathematics , economics , economic growth , virus
Abstract Background & Aims Chronic liver diseases (CLDs) are major health problems that require complex and costly treatments. Liver‐specific clinical outcome indicators (COIs) able to assist both clinicians and administrators in improving the value of care are presently lacking. The Value‐Based Medicine in Hepatology (VBMH) study aims to fill this gap, devising and testing a set of COIs for CLD, that could be easily collected during clinical practice. Here we report the COIs generated and recorded for patients with HBV or HCV infection at different stages of the disease. Methods / Results In the first phase of VBMH study, COIs were identified, based on current international guidelines and literature, using a modified Delphi method and a RAND 9‐point appropriateness scale. In the second phase, COIs were tested in an observational, longitudinal, prospective, multicentre study based in Lombardy, Italy. Eighteen COIs were identified for HBV and HCV patients. Patients with CLD secondary to HBV (547) or HCV (1391) were enrolled over an 18‐month period and followed for a median of 4 years. The estimation of the proposed COIs was feasible in the real‐word clinical practice and COI values compared well with literature data. Further, the COIs were able to capture the impact of new effective treatments like direct‐acting antivirals (DAAs) in the clinical practice. Conclusions The COIs efficiently measured clinical outcomes at different stages of CLDs. While specific clinical practice settings and related healthcare systems may modify their implementation, these indicators will represent an important component of the tools for a value‐based approach in hepatology and will positively affect care delivery.