Stewart Macdonald1, Peter Jepsen2,3, Laith Alrubaiy4, Hugh Watson5, Hendrik Vilstrup2, Rajiv Jalan1. 1. Liver Failure Group, Institute for Liver and Digestive Health, University College London, London, UK. 2. Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. 3. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark. 4. St Mark's Hospital, London, UK. 5. Infectious Diseases Unit, Sanofi-Aventis R&D, Marcy l'Etoile, France.
Abstract
BACKGROUND: Severe ascites is associated with both a poor health-related quality of life (HRQL) and a mortality in excess of that captured by current prognostic clinical scores. AIM: To determine the association between HRQL and mortality in patients with severe ascites. METHODS: The HRQL data from previously published randomised controlled trials examining the efficacy of satavaptan in ascites were retrospectively evaluated. RESULTS: Of the 496 patients randomised who completed the SF-36, 405 patients had complete datasets and were included in the analysis (difficult-to-treat ascites, n = 164 or refractory ascites, n = 241). Overall, patients reported poor HRQL, in particular the physical component score (PCS) of SF-36. The physical component score (PCS) correlated with the mental component score (MCS) of SF-36 (Spearman rank correlation = 0.68) but not with markers of severity of liver disease. The PCS, but not the MCS, was significantly lower in patients who died (P = 0.01 and P = 0.84, respectively). After confounder-adjustment, the hazard ratio for a 10-point increase in the physical component score was 0.83 (95% CI; 0.72-0.97) for all-cause mortality and 0.84 (95% CI; 0.71-0.99) for cirrhosis-related deaths only, indicating that patients with better physical HRQL live longer on average. CONCLUSIONS: Poor physical component score (PCS) of SF-36 is an independent predictor of 12-month mortality in patients with severe ascites independent of current prognostic clinical scores. It holds promise not only in prognostic modelling but also as an endpoint in the evaluation of therapies targeting ascites.
BACKGROUND: Severe ascites is associated with both a poor health-related quality of life (HRQL) and a mortality in excess of that captured by current prognostic clinical scores. AIM: To determine the association between HRQL and mortality in patients with severe ascites. METHODS: The HRQL data from previously published randomised controlled trials examining the efficacy of satavaptan in ascites were retrospectively evaluated. RESULTS: Of the 496 patients randomised who completed the SF-36, 405 patients had complete datasets and were included in the analysis (difficult-to-treat ascites, n = 164 or refractory ascites, n = 241). Overall, patients reported poor HRQL, in particular the physical component score (PCS) of SF-36. The physical component score (PCS) correlated with the mental component score (MCS) of SF-36 (Spearman rank correlation = 0.68) but not with markers of severity of liver disease. The PCS, but not the MCS, was significantly lower in patients who died (P = 0.01 and P = 0.84, respectively). After confounder-adjustment, the hazard ratio for a 10-point increase in the physical component score was 0.83 (95% CI; 0.72-0.97) for all-cause mortality and 0.84 (95% CI; 0.71-0.99) for cirrhosis-related deaths only, indicating that patients with better physical HRQL live longer on average. CONCLUSIONS: Poor physical component score (PCS) of SF-36 is an independent predictor of 12-month mortality in patients with severe ascites independent of current prognostic clinical scores. It holds promise not only in prognostic modelling but also as an endpoint in the evaluation of therapies targeting ascites.
Authors: Michael Nagel; Christian Labenz; Marcus A Wörns; J U Marquardt; Peter R Galle; Jörn M Schattenberg; Marc Nguyen-Tat Journal: Health Qual Life Outcomes Date: 2020-01-13 Impact factor: 3.186
Authors: Guruprasad P Aithal; Naaventhan Palaniyappan; Louise China; Suvi Härmälä; Lucia Macken; Jennifer M Ryan; Emilie A Wilkes; Kevin Moore; Joanna A Leithead; Peter C Hayes; Alastair J O'Brien; Sumita Verma Journal: Gut Date: 2020-10-16 Impact factor: 23.059
Authors: Marcus-Alexander Wörns; Christian Labenz; Michael Nagel; Vanessa Weidner; Sina Schulz; Jens U Marquardt; Peter R Galle; Jörn M Schattenberg; Marc Nguyen-Tat Journal: Health Qual Life Outcomes Date: 2022-02-08 Impact factor: 3.186