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      Comparison of the Prognosis of Decompensated Cirrhosis in Patients with and Without Eradication of Hepatitis C Virus

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          Abstract

          Introduction

          In patients with hepatitis C virus (HCV) infection and decompensated cirrhosis (DC), it is uncertain whether viral clearance is clinically meaningful and whether it decreases liver-related and non-liver-related mortality. The aim of this study was to assess whether viral eradication reduced liver-related and non-liver-related mortality in patients with HCV infection and DC.

          Methods

          To clarify the impact of viral eradication on liver-related and non-liver-related mortality, 364 patients with DC who received direct-acting antivirals (DAAs) and achieved sustained virological response (SVR) in the UK (DAA group) were compared with 249 patients with DC who did not receive DAAs and who underwent symptomatic treatment in Japan (non-DAA group). Propensity score matching and inverse probability weighting (IPW) were performed to adjust the baseline characteristics in the DAA and non-DAA groups. Liver-related and non-liver-related mortality were analyzed using the competing risks IPW cumulative incidence functions estimator.

          Results

          The cumulative all-cause mortality rate in the DAA group was significantly lower than that in the non-DAA group ( p < 0.0001, IPW-adjusted log-rank test). The cumulative incidence rates of both liver-related and non-liver-related mortality were significantly lower in the DAA group than those in the non-DAA group ( p < 0.0001 for both).

          Conclusion

          DAA-mediated viral eradication reduced not only liver-related mortality but also non-liver-related mortality in patients with HCV infection and DC.

          Supplementary Information

          The online version contains supplementary material available at 10.1007/s40121-021-00441-7.

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          Most cited references30

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          Investigation of the freely available easy-to-use software ‘EZR' for medical statistics

          Y Kanda (2012)
          Although there are many commercially available statistical software packages, only a few implement a competing risk analysis or a proportional hazards regression model with time-dependent covariates, which are necessary in studies on hematopoietic SCT. In addition, most packages are not clinician friendly, as they require that commands be written based on statistical languages. This report describes the statistical software ‘EZR' (Easy R), which is based on R and R commander. EZR enables the application of statistical functions that are frequently used in clinical studies, such as survival analyses, including competing risk analyses and the use of time-dependent covariates, receiver operating characteristics analyses, meta-analyses, sample size calculation and so on, by point-and-click access. EZR is freely available on our website (http://www.jichi.ac.jp/saitama-sct/SaitamaHP.files/statmed.html) and runs on both Windows (Microsoft Corporation, USA) and Mac OS X (Apple, USA). This report provides instructions for the installation and operation of EZR.
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            A Proportional Hazards Model for the Subdistribution of a Competing Risk

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              Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies

              The propensity score is defined as a subject's probability of treatment selection, conditional on observed baseline covariates. Weighting subjects by the inverse probability of treatment received creates a synthetic sample in which treatment assignment is independent of measured baseline covariates. Inverse probability of treatment weighting (IPTW) using the propensity score allows one to obtain unbiased estimates of average treatment effects. However, these estimates are only valid if there are no residual systematic differences in observed baseline characteristics between treated and control subjects in the sample weighted by the estimated inverse probability of treatment. We report on a systematic literature review, in which we found that the use of IPTW has increased rapidly in recent years, but that in the most recent year, a majority of studies did not formally examine whether weighting balanced measured covariates between treatment groups. We then proceed to describe a suite of quantitative and qualitative methods that allow one to assess whether measured baseline covariates are balanced between treatment groups in the weighted sample. The quantitative methods use the weighted standardized difference to compare means, prevalences, higher‐order moments, and interactions. The qualitative methods employ graphical methods to compare the distribution of continuous baseline covariates between treated and control subjects in the weighted sample. Finally, we illustrate the application of these methods in an empirical case study. We propose a formal set of balance diagnostics that contribute towards an evolving concept of ‘best practice’ when using IPTW to estimate causal treatment effects using observational data. © 2015 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.
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                Author and article information

                Contributors
                takashi.kumada@gmail.com
                tkumada@he.mirai.ne.jp
                satoshi.yasuda.1982@gmail.com
                tadat0627@gmail.com
                jun-tanaka@hiroshima-u.ac.jp
                chayama@mba.ocn.ne.jp
                Philip.Johnson@liverpool.ac.uk
                Will.Irving@nottingham.ac.uk
                Journal
                Infect Dis Ther
                Infect Dis Ther
                Infectious Diseases and Therapy
                Springer Healthcare (Cheshire )
                2193-8229
                2193-6382
                21 April 2021
                21 April 2021
                June 2021
                : 10
                : 2
                : 1001-1013
                Affiliations
                [1 ]GRID grid.440873.c, ISNI 0000 0001 0728 9757, Department of Nursing, Faculty of Nursing, , Gifu Kyoritsu University, ; 5-50, Kitagata-cho, Ogaki-shi, Gifu-ken, Ogaki, Gifu 503-8550 Japan
                [2 ]GRID grid.416762.0, ISNI 0000 0004 1772 7492, Department of Gastroenterology and Hepatology, , Ogaki Municipal Hospital, ; Ogaki, Gifu Japan
                [3 ]GRID grid.257022.0, ISNI 0000 0000 8711 3200, Department of Epidemiology, Infectious Disease Control, and Prevention, , Hiroshima University Institute of Biomedical and Health Sciences, ; Hiroshima, Japan
                [4 ]GRID grid.470097.d, ISNI 0000 0004 0618 7953, Department of Gastroenterology and Metabolism, Institute of Biomedical and Health Sciences, , Hiroshima University Hospital, ; Hiroshima, Japan
                [5 ]GRID grid.10025.36, ISNI 0000 0004 1936 8470, Department of Molecular and Clinical Cancer Medicine, , University of Liverpool, ; Liverpool, UK
                [6 ]GRID grid.4563.4, ISNI 0000 0004 1936 8868, NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust, , The University of Nottingham, ; Nottingham, UK
                Author information
                http://orcid.org/0000-0003-2211-495X
                Article
                441
                10.1007/s40121-021-00441-7
                8116463
                33881712
                0b8aeaa3-b1df-4db3-be45-ea97d28b657f
                © The Author(s) 2021

                Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 29 January 2021
                : 24 March 2021
                Funding
                Funded by: The Medical Research Foundation
                Award ID: C0365
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/501100003478, Ministry of Health, Labour and Welfare;
                Categories
                Original Research
                Custom metadata
                © The Author(s) 2021

                hepatitis c virus (hcv),decompensated cirrhosis,direct-acting antiviral (daa),sustained virological response (svr),hepatocarcinogenesis,liver-related mortality,non-liver-related mortality

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