Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol
Introduction Myosteatosis, characterised by altered muscle composition detectable by muscle radiodensity attenuation on CT scans, has been associated with increased mortality in patients with cirrhosis. However, standard attenuation cut-offs, derived primarily from oncology populations, may not be a...
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BMJ Publishing Group
2025-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/3/e094252.full |
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| author | Gennaro D'Amico Manuela Merli Aldo Montano-Loza Simone Di Cola Maryam Motamedrad |
| author_facet | Gennaro D'Amico Manuela Merli Aldo Montano-Loza Simone Di Cola Maryam Motamedrad |
| author_sort | Gennaro D'Amico |
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| description | Introduction Myosteatosis, characterised by altered muscle composition detectable by muscle radiodensity attenuation on CT scans, has been associated with increased mortality in patients with cirrhosis. However, standard attenuation cut-offs, derived primarily from oncology populations, may not be appropriate for patients with cirrhosis. This study protocol aims to address this diagnostic gap by validating the Ebadi cut-offs, which are based on a retrospective cohort and have not been extensively validated in a cirrhotic population. The aim of the study is to refine these cut-offs for more accurate prediction of mortality in patients with cirrhosis using two independent patient cohorts (retrospective and prospective).Methods and analysis This post hoc validation study analyses muscle weakness cut-offs in patients with cirrhosis using data from two independent cohorts. A total of 1537 patients will be analysed. The study will assess interobserver variability to ensure robust results by analysing random samples of 60 patients from the two cohorts. Statistical methods will be used to determine the accuracy and relevance of current cut-offs in predicting patient mortality. The analysis will also examine the relationship between muscle wasting and clinical outcomes in cirrhosis and the relationship with muscle mass loss.Ethics and dissemination Ethical approval for this study has been obtained from the relevant institutional review boards. The results will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. The results of the study are expected to contribute to improved diagnostic criteria for myosteatosis in cirrhosis, providing clinicians with more tailored and accurate tools for cirrhosis prognosis.Trial registration number NCT06593015. |
| format | Article |
| id | doaj-art-2009647dc20c46c48264d3e53fcac9a5 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
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| spelling | doaj-art-2009647dc20c46c48264d3e53fcac9a52025-08-20T03:42:22ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-094252Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocolGennaro D'Amico0Manuela Merli1Aldo Montano-Loza2Simone Di Cola3Maryam Motamedrad42 Gastroenterology, Ospedale V Cervello, Palermo, Italy1 Department of Translational and Precision Medicine, University of Rome La Sapienza, Rome, Lazio, Italy3 Gastroenterology Division and Liver Unit, University of Alberta, Edmonton, Alberta, Canada1 Department of Translational and Precision Medicine, University of Rome La Sapienza, Rome, Lazio, Italy3 Gastroenterology Division and Liver Unit, University of Alberta, Edmonton, Alberta, CanadaIntroduction Myosteatosis, characterised by altered muscle composition detectable by muscle radiodensity attenuation on CT scans, has been associated with increased mortality in patients with cirrhosis. However, standard attenuation cut-offs, derived primarily from oncology populations, may not be appropriate for patients with cirrhosis. This study protocol aims to address this diagnostic gap by validating the Ebadi cut-offs, which are based on a retrospective cohort and have not been extensively validated in a cirrhotic population. The aim of the study is to refine these cut-offs for more accurate prediction of mortality in patients with cirrhosis using two independent patient cohorts (retrospective and prospective).Methods and analysis This post hoc validation study analyses muscle weakness cut-offs in patients with cirrhosis using data from two independent cohorts. A total of 1537 patients will be analysed. The study will assess interobserver variability to ensure robust results by analysing random samples of 60 patients from the two cohorts. Statistical methods will be used to determine the accuracy and relevance of current cut-offs in predicting patient mortality. The analysis will also examine the relationship between muscle wasting and clinical outcomes in cirrhosis and the relationship with muscle mass loss.Ethics and dissemination Ethical approval for this study has been obtained from the relevant institutional review boards. The results will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. The results of the study are expected to contribute to improved diagnostic criteria for myosteatosis in cirrhosis, providing clinicians with more tailored and accurate tools for cirrhosis prognosis.Trial registration number NCT06593015.https://bmjopen.bmj.com/content/15/3/e094252.full |
| spellingShingle | Gennaro D'Amico Manuela Merli Aldo Montano-Loza Simone Di Cola Maryam Motamedrad Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol BMJ Open |
| title | Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol |
| title_full | Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol |
| title_fullStr | Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol |
| title_full_unstemmed | Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol |
| title_short | Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study – a study protocol |
| title_sort | study protocol to redefine muscle attenuation cut offs for better prediction of mortality in patients with cirrhosis a comprehensive post hoc validation study a study protocol |
| url | https://bmjopen.bmj.com/content/15/3/e094252.full |
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