Predictors of Decompensation, Acute-on-chronic Liver Failure and Mortality in Liver Cirrhosis - a Multicentre, Prospective, Observational Study From the SingHealth Chronic Liver Disease Registry (SoLiDaRity-DAM)
Conditions: Cirrhosis and Chronic Liver Disease
Sponsor: Singapore General Hospital

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Protocol version 2.1 dated 7 July 2025 
 
 
 
 
STUDY PROTOCOL 
 
PROTOCOL TITLE: 
Predictors of decompensation, acute-on-chronic liver failure and mortality in liver cirrhosis 
– a multicentre, prospective, observational study from the SingHealth Chronic Liver 
Disease Registry (SoLiDaRity-DAM) 
 
 
PROTOCOL VERSION: Version 2.1 
 
PROTOCOL DATE: 07/07/2025 
 
 
 
PRINCIPAL INVESTIGATOR:  
A/Prof Jason Chang Pik Eu, 
Senior Consultant, Department of Gastroenterology & Hepatology, Singapore General 
Hospital 
 
SITE PRINCIPAL INVESTIGATORS:  
Dr Rahul Kumar, 
Consultant, Department of Gastroenterology and Hepatology, Changi General Hospital 
 
Dr Marianne Anastasia De Roza 
Consultant, Department of Gastroenterology & Hepatology, Sengkang General Hospital 
 
 
ADVISORY BOARD: SingHealth Transplant Centre  
 

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Protocol version 2.1 dated 7 July 2025 
Table of Contents 
1. 
BACKGROUND AND RATIONALE ................................................................................... 3 
2. 
HYPOTHESIS AND OBJECTIVES .................................................................................... 5 
3. 
EXPECTED RIKS AND BENEFITS ................................................................................... 6 
4. 
STUDY POPULATION .................................................................................................... 7 
4.1. 
LIST THE NUMBER AND NATURE OF SUBJECTS TO BE ENROLLED. ............................................................... 7 
4.2. 
CRITERIA FOR RECRUITMENT AND RECRUITMENT PROCESS ..................................................................... 7 
4.3. 
INCLUSION CRITERIA ............................................................................................................................. 7 
4.4. 
EXCLUSION CRITERIA ............................................................................................................................. 7 
5. 
STUDY DESIGN AND PROCEDURES/METHODOLOGY ................................................... 8 
6. 
SAFETY MEASUREMENTS .............................................................................................. 8 
6.1. 
DEFINITIONS ......................................................................................................................................... 8 
6.2. 
COLLECTING, RECORDING AND REPORTING OF SERIOUS ADVERSE EVENTS (SAES) TO CIRB .................. 8 
6.3. 
SAFETY MONITORING PLAN .................................................................................................................... 9 
6.4. 
COMPLAINT HANDLING ........................................................................................................................... 9 
7. 
DATA ANALYSIS ............................................................................................................ 9 
7.1. 
DATA QUALITY ASSURANCE .................................................................................................................... 9 
7.2. 
DATA ENTRY AND STORAGE ................................................................................................................... 9 
8. 
SAMPLE SIZE AND STATISTICAL METHODS ................................................................. 9 
8.1. 
DETERMINATION OF SAMPLE SIZE .......................................................................................................... 9 
8.2. 
STATISTICAL AND ANALYTICAL PLANS ..................................................................................................... 9 
9. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ...................................................... 10 
10. QUALITY CONTROL AND QUALITY ASSURANCE ........................................................ 10 
11. ETHICAL CONSIDERATIONS ....................................................................................... 10 
11.1. 
INFORMED CONSENT ............................................................................................................................ 10 
11.2. 
CONFIDENTIALITY OF DATA AND PATIENT RECORDS ............................................................................. 11 
12. PUBLICATIONS ........................................................................................................... 11 
13. RETENTION OF STUDY DOCUMENTS .......................................................................... 11 
14. FUNDING AND INSURANCE ........................................................................................ 11 
LIST OF ATTACHMENTS ...................................................................................................... 12 
 
 
 
 
 
 

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Protocol version 2.1 dated 7 July 2025 
PROTOCOL SIGNATURE PAGE 
 
 
 
Protocol Title:  
Predictors of decompensation, acute-on-chronic liver failure (ACLF) and mortality in liver 
cirrhosis – a multicentre, prospective, observational study from the SingHealth Chronic Liver 
Disease Registry (SoLiDaRity-DAM) 
 
 
 
Protocol Version/ Date: Version 2.1 (7 July 2025) 
 
 
Sponsor Name: SingHealth SoLiDaRity Workgroup 
 
 
 
Declaration of Investigator 
 
I confirm that I have read the above-mentioned protocol and its attachments. I agree to conduct 
the described study in compliance with all stipulations of the protocol, regulations and ICH E6 
Guideline for Good Clinical Practice (GCP).  
 
  
 
 
Principal Investigator Name:  Jason Chang Pik Eu 
                                                            
 
Principal Investigator Signature:                                                                
 
Date:                            
 
 
 
 
 
 
 
 
 
1. 
BACKGROUND AND RATIONALE 
 
 
General Introduction:  

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Protocol version 2.1 dated 7 July 2025 
Chronic liver disease and its ensuing complications are a significant health issue in Singapore. In the 
Singapore Burden of Disease Survey, liver cirrhosis and liver cancer contributed 0.9% and 3.2% 
respectively out of 182,753 years of life lost (1). The natural history of liver cirrhosis is characterized by 
an asymptomatic “compensated” phase, followed by a rapidly progressive “decompensated” phase 
characterized by ascites, variceal bleeding, hepatic encephalopathy, and/or jaundice. Liver 
decompensation occurs at a rate of 5-7% per year and is a watershed event in the natural history of liver 
cirrhosis as the medial survival falls from more than 12 years for compensated cirrhosis to less than 2 
years in decompensated cirrhosis (2). Accurate and timely prediction of decompensation will allow pre-
emptive management strategies to prevent or delay decompensation, timely intervention to treat 
decompensation events to ensure optimal outcome and avoid early mortality, early referral to liver 
transplant, and allocation of resources to optimize value-based provision of evidenced-based care.  
Cirrhotic patients who require hospitalization for acute decompensation are at high risk of developing 
acute-on-chronic liver failure (ACLF) which is characterized by the development of organ failure and is 
associated with high rates of mortality (3). The ability to identify clinical predictors of decompensation, 
ACLF and mortality in the natural history of patients with liver cirrhosis is important as it may allow 
early intervention and potentially reduce the mortality rate. The PREDICT study identified three 
distinct clinical courses of acute decompensation – ACLF, unstable decompensated cirrhosis and stable 
decompensated cirrhosis, of which those with ACLF had a very high 3-month mortality of 53.7% (4). 
This group also identified four distinct clinical events that predicted increased 90-day mortality in 
acutely decompensated cirrhotics. However, there is a lack of data regarding predictors for 
decompensation, ACLF and mortality in patients with compensated cirrhosis. Furthermore, there is no 
local or Asian data validating the findings of PREDICT study regarding the progression and predictive 
factors for future decompensating events.  
In a recent review of the existing literature (5), the most frequent predictors of decompensation were 
liver function, portal hypertension and indicators of inflammation/fibrosis. The impact of underlying 
etiology and treatment of liver disease was also a relevant predictor. This is highly relevant in the local 
context as most of the studies conducted in the West involve alcohol as the main etiology of cirrhosis 
whereas viral and metabolic hepatitis are the main etiologies of cirrhosis in our local population (6). 
Potential areas of research interest include the role of non-invasive markers of inflammation and 
fibrosis as predictors of decompensation.  
 
In Singapore where the rates of liver transplantation remain low (7), liver cirrhosis remains an important 
cause of mortality. There is thus a pressing need to identify predictors of decompensation, ACLF and 
mortality in the natural history of liver cirrhosis in our local population. This would allow pre-emptive 
management to prevent or delay decompensation and early referral for liver transplantation to reduce 
morbidity, mortality, and healthcare burden from liver cirrhosis.  
 
The SOLIDARITY-DAM study is a prospective, multicenter, observational study of consecutive 
patients with liver cirrhosis (defined as compensated advanced chronic liver disease (cACLD), 
compensated cirrhosis and decompensated cirrhosis) to identify clinical predictors for decompensation, 
ACLF and mortality.  
 
 
1.2 
Rationale and Justification for the Study:  
There is a lack of data and understanding of the various predictive factors associated with 
decompensation, ACLF and death in patients with compensated cirrhosis, specifically in the local 
context where the primary etiology of cirrhosis is different from the West. This study aims to fill this 
knowledge gap.  
 

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Protocol version 2.1 dated 7 July 2025 
1.2.1 
Rationale for Study Population:  
As the aim of the study is to find the predictive factors associated with decompensation, ACLF and 
death in patients with cirrhosis, all patients with cirrhosis will be offered inclusion in the study.  
 
1.2.4 
Rationale for Study Design:  
This is a prospective multi-centre observational study which will involve the collection of routine 
demographic, clinical, biochemical, radiological and treatment data that are related to the routine 
management of patients with liver cirrhosis in Singapore, with a focus on identifying predictors for key 
clinical end-points of decompensation, ACLF and death.  
  
 
2. 
HYPOTHESIS AND OBJECTIVES 
 
2.1 
Hypothesis:  
As this study is designed as a prospective observational study, we do not have an a-priori mechanistic or 
pathophysiological hypothesis. We hypothesize that through this study, we will be able to identify 
clinical, biochemical and/or radiological predictors for development of decompensation, ACLF and 
mortality in patients with cirrhosis.   
 
2.2 
Primary Objectives:  
The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF 
and death in patients with cirrhosis.  
 
Specific goals of the study: 
• 
To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with 
compensated and decompensated liver cirrhosis in Singapore 
 
• 
To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation 
in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous 
bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary 
hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, 
refractory ascites, sarcopenia, and liver cancer) 
 
• 
To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF 
and death in liver cirrhosis 
 
• 
To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, 
LSPS, PREDICT, etc).  
 
• 
To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, 
and pathogenesis of AD and ACLF. These involve the following sub-goals:  
• 
To uncover mechanistic and pathophysiological processes associated with the 
development and clinical course of ACLF and to identify the precipitating events of 
ACLF. 
• 
To study the role of sarcopenia and neutrophil-lymphocyte ratio (NLR) in the 
development of acute decompensation, ACLF and death. 
• 
To predict the response to NSBB based on the blood biomarkers (ie, Neutrophil to 
lymphocyte ratio, Lymphocyte to monocyte ratio).  
• 
To develop an AI model of diagnosis of Sarcopenia and clinically significant portal 
hypertension based on Computerized Tomography (CT) imaging. 

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Protocol version 2.1 dated 7 July 2025 
• 
To develop a score predicting ACLF development and assess 28-day, 90-day, 6-
month and 1-year all-cause mortality in cirrhotic patients with acute AD, but 
without ACLF. 
Any ancillary studies which require additional collection of biosamples and/or interventions 
(e.g. CT scans) which are not part of standard-of-care management will require separate 
informed consent to be obtained from the study participants.   
 
If the initial results of our study are positive, we intend to request for an extension of the study to 10 
years to evaluate the 10-year risk of decompensation, ACLF and death as well as the effect of potential 
interventions on these risks. 
 
3. 
EXPECTED RIKS AND BENEFITS 
 
As this study is a prospective observational study, there are no distinct clinical risks to patients.  
There may be the potential risk of breach of confidentiality since patients' medical records will be 
assessed for purposes of the study. Measures to mitigate these risks include: 
(i) 
restricting RedCap access to study team members only. This will prevent other non-
authorized individuals from accessing patient data 
(ii) 
restricting RedCap access to specific institutions. This will prevent investigators from 
accessing data of patients from other hospitals. Investigators will only be able to access the 
data of participants from their own institutions. 
(iii) 
anonymizing data that will be pooled for analysis.  
The benefit to recruited patients include better understanding of the disease condition and initiation of 
treatments based on study results. 

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Protocol version 2.1 dated 7 July 2025 
4. 
STUDY POPULATION 
 
1. This multicenter study aims to recruit 2,200 (two thousand two hundred) cirrhotic patients over 
a 5 (five) year period from 3 institutions in SingHealth – Changi General Hospital (CGH), 
Sengkang General Hospital (SKH) and Singapore General Hospital (SGH).  
 
2. Patients will be recruited both from the inpatient and outpatient setting. All consecutive patients 
admitted/referred to the study center with a clinical diagnosis of liver cirrhosis (based on 
standard clinical, radiological, elastography and/or histological criteria) will be offered inclusion 
into the SoLiDaRity-DAM study.   
 
3. After the enrolment all patients will be followed up till liver transplantation or death. 
 
4. Demographic, clinical, biochemical, pharmacological and other specialized investigational data 
(done as per routine care) will be collected and stored in an electronic database in RedCap. 
 
5. Specific end-points of the study will include decompensation, ACLF and death.  
 
6. Prospective collection of biological material as part of routine standard of care and performance 
of ancillary studies investigating predictors for development and pathogenesis of ACLF may be 
carried out may be carried out with the expressed consent of study participants.  
 
4.1. 
List the number and nature of subjects to be enrolled.  
 
1. Total Number of Subjects/Patients: 2200  
2. Nature of Patients: Patients with compensated or decompensated Cirrhosis from 3 participating 
sites, namely CGH, SKGH and SGH. 
 
4.2. 
Criteria for Recruitment and Recruitment Process 
 
Patients with a clinical diagnosis of cirrhosis will be offered inclusion into the study.  
 
 
4.3. 
Inclusion Criteria 
 
1) Patients with clinical diagnosis of liver cirrhosis (radiological evidence of cirrhosis on 
ultrasound, CT and/or MRI liver, and/or liver stiffness > 10kPa or equivalent, and/or 
histology compatible with liver cirrhosis)   
2) Age 18 years and above (parental consent required if below 21 years) 
3) Willing and able to provide informed consent 
 
 
4.4. 
Exclusion Criteria 
 
1) No clinical evidence of liver cirrhosis 
2) Less than 18 years of age 
3) Declined or unable to provide informed consent to participate in study 

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Protocol version 2.1 dated 7 July 2025 
 
5. 
STUDY DESIGN AND PROCEDURES/METHODOLOGY 
 
The design of the study is a prospective observational, with the aims of understanding the factors 
associated with decompensation, ACLF and Death in patients with cirrhosis. Special focus areas are the 
critical period prior to the development of ACLF, to uncover mechanistic and pathophysiological 
processes associated with the development and clinical course of ACLF and to identify the precipitating 
events of ACLF. 
 
 
 
6. 
SAFETY MEASUREMENTS 
6.1. 
Definitions 
 
Serious adverse event (SAE) in relation to human biomedical research, means any untoward 
medical occurrence as a result of any human biomedical research which: 
• results in or contributes to death 
• is life-threatening 
• requires in-patient hospitalisation or prolongation of existing hospitalisation 
• results in or contributes to persistent or significant disability/incapacity or 
• results in or contributes to a congenital anomaly/birth defect 
• results in such other events as may be prescribed  
 
Adverse event (AE) in relation to human biomedical research means any untoward medical 
occurrence as a result of any human biomedical research which is NOT serious.  Adverse event 
can be any unfavourable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease possibly/ probably/ definitely associated with the participant in the human 
biomedical research. 
 
6.2. 
Collecting, Recording and Reporting of Serious Adverse Events (SAEs) to CIRB 
 
Only related SAEs (definitely/ probably/ possibly) will be reported to CIRB. Related means there 
is a reasonable possibility that the event may have been caused by participation in the research.  
Please refer to the CIRB website for more information on Reporting Requirement and Timeline 
for Serious Adverse Events. 
 
The investigator is responsible for informing CIRB after first knowledge that the case qualifies 
for reporting. Follow-up information will be actively sought and submitted as it becomes 
available.  
 
Related AEs will not be reported to CIRB.  However, the investigator is responsible to keep 
record of such AEs cases at the Study Site File. 
 

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Protocol version 2.1 dated 7 July 2025 
6.3. 
Safety Monitoring Plan 
 
Patients participating in the study will be offered enrolment for ancillary interventional studies as 
and when required. A separate protocol amendment for the ancillary interventional study will be 
submitted in case there are ancillary studies planned.  
 
Data collected from the study will be kept in a password-protected computer in a locked room. 
Where transfer of video clips is required, a hard drive with industry level encryption will be used. 
The Principal Investigator and co-investigators mentioned will have access to the data, which will 
not be made available to other personnel to protect the confidentiality of participants. 
 
 
6.4. 
Complaint Handling  
 
Any complaint made by participants in relation to the study will be handled as per routine clinical 
practice. We do not anticipate complaints peculiar to the study as it is non-invasive, non-
interventional. 
 
 
7. 
DATA ANALYSIS 
7.1. 
Data Quality Assurance 
 
The investigators in this study will undergo site visit initiation and be required to familiarise 
themselves with the study protocol. In addition, data collection will take place using a standard 
template to ensure accuracy and consistency of data. 
 
7.2. 
Data Entry and Storage 
 
Data will be entered and kept in RedCap.  
 
8. 
SAMPLE SIZE AND STATISTICAL METHODS 
 
8.1. 
Determination of Sample Size  
 
We aim to recruit a total of 2200 patients over 5 years for this study. 
 
8.2. 
Statistical and Analytical Plans 
a. General Considerations: Standard statistical tools will be used for data analysis.  
 
b. Safety Analyses: This is not applicable in the study as there will be no intervention arm. 
 
c. Interim Analyses; will be carried out at the completion of 1, 3 and 5 years of patient  
recruitment  
 
 
 

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Protocol version 2.1 dated 7 July 2025 
9. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
 
The investigator(s)/institution(s) will permit study-related monitoring, audits and/or IRB review 
and regulatory inspection(s), providing direct access to source data/document. 
 
 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE 
 
The Principal and Co-investigators, together with the study co-ordinator, will ensure 
completeness of data and quality assurance. In addition, as the data will be collected in RedCap, 
the use of mandatory fields will add further to the quality assurance for the study. 
 
 
11. 
ETHICAL CONSIDERATIONS 
 
This study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki and that are consistent with the Good Clinical Practice and the applicable 
regulatory requirements. 
 
This final Study Protocol, including the final version of the Participant Information and Consent 
Form, must be approved in writing by the Centralised Institutional Review Board (CIRB), prior 
to enrolment of any patient into the study. 
 
The principal investigator is responsible for informing the CIRB of any amendments to the 
protocol or other study-related documents, as per local requirement. 
 
 
11.1. Informed Consent 
 
 
Participants who present to the Department of Gastroenterology and Hepatology, Changi 
General Hospital, Sengkang General Hospital or Singapore General Hospital with clinical 
diagnosis of cirrhosis will be offered enrolment into the study. Informed consent will be obtained 
in the presence of a witness who is 18 years of age or older and has mental capacity. The witness 
will be present during the entire informed consent discussion and will not be the same person 
taking consent. The witness may be a member of the study team. Informed consent will be taken 
in the presence of impartial witness who are independent form the study if the participant is 
unable to read and/or sign and date on the consent form (i.e., using participant or legal 
representative thumbprint). If the patient is below 21 years of age, parental consent will be 
required. 
 
Participant/ legal representative who do not understand English well will have the informed 
consent form translated by the study team, a family member or clinic staff. The participant will 
be informed of the study process in a language or dialect that is understood by them, and 
translator information will be documented in the informed consent form under the section of 
"Translator information". Translation will be done in the presence of impartial witness during the 
informed consent process. 
 

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Protocol version 2.1 dated 7 July 2025 
11.2. Confidentiality of Data and Patient Records 
 
Data collected from the study will be kept on an encrypted file in a password-protected computer 
in a locked office. The Principal Investigator, co-investigator and study co-ordinator will have 
access to the data, which will not be made available to other personnel to protect the 
confidentiality of participants. 
 
RedCap access for this study will be limited to the Principal Investigator, Co-investigators, and 
the study co-ordinator. 
 
12. 
PUBLICATIONS 
 
The study findings will be published in peer-reviewed journals at the discretion of the Principal 
and co-investigator. The authorship will be based on the following 4 criteria: Substantial 
contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work in accordance to ICMJE recommendations. All contributors 
who do not meet the criteria for authorship will be listed in acknowledgement section. The 
manuscript will be reviewed and approved by all authors prior to submission. In the event of any 
publication regarding the Study, the identity of the subjects will remain confidential. 
 
13. 
RETENTION OF STUDY DOCUMENTS 
 
Records for all participants, including CRFs, all source documentation (containing evidence to 
study eligibility, history and physical findings, laboratory data, results of consultations, etc.) as 
well as IRB records and other regulatory documentation will be retained by the PI electronically 
in a secure storage facility. The records will be accessible for inspection and copying by 
authorized authorities. Research data will be retained in a secured storage facility for a minimum 
of 6 years after completion of research study or date of publication of the research using the 
research data, whichever is later.  
 
14. 
FUNDING and INSURANCE 
 
The logistics for the study is funded by the Transplant Centre, SingHealth. Other than that, there 
is no other anticipated funding needs for the study. As and when ancillary studies are planned, 
funding needs will be reassessed and the study can be funded via local or international research 
grants.  
 
 

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Protocol version 2.1 dated 7 July 2025 
List of Attachments 
 
Appendix 1 
References 
 
 
1. Muthiah M, Chong CH, Lim SG. Liver Disease in Singapore. Euroasian J Hepato-
Gastroenterol 2018;8(1):66-68 
2. D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival 
in cirrhosis: a systematic review of 118 studies. J Hepatol. 2006 Jan;44(1):217-31 
3. Moreau R, et al, CANONIC Study Investigators of the EASL–CLIF Consortium. Acute-on-
chronic liver failure is a distinct syndrome that develops in patients with acute 
decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437 
4. Trebicka J, et al; PREDICT STUDY group of the EASL-CLIF Consortium. The PREDICT 
study uncovers three clinical courses of acutely decompensated cirrhosis that have distinct 
pathophysiology. J Hepatol. 2020 Oct;73(4):842-854 
5. D’Amico G, Perricone, G. Prediction of decompensation in patients with compensated 
cirrhosis: does etiology matter? Current Hepatology Reports June 2019;18(1):1-13 
6. Chang PE, Wong GW, Li JW, Lui HF, Chow WC, Tan CK. Epidemiology and Clinical 
Evolution of Liver Cirrhosis in Singapore. Ann Acad Med Singap. 2015 Jun;44(6):218-25 
7. Tan EK, Goh BKP, Lee SY, Krishnamoorthy TL, Tan CK, Jeyaraj PR. Liver Transplant 
Waitlist Outcomes and the Allocation of Hepatocellular Carcinoma Model for End-Stage 
Liver Disease Exception Points at a Low-Volume Center. Transplant Proc. 2018 
Dec;50(10):3564-3570 
 
 

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Protocol version 2.1 dated 7 July 2025 
Appendix 2 
 
SoLiDaRity-DAM Data Collection Fields 
 
Baseline data to be collected at enrolment 
Demographics 
NRIC, Name, Ethnicity, Gender, DOB, BMI 
Co-morbids 
DM, dyslipidemia, CCF, CKD, etc 
Clinical  
Diagnosis, Etiology 
Biochemical 
LFT, PT/INR, FBC, AFP, RP 
Radiological 
US, CT, MRI 
Elastography 
LSM, SWE, MRE 
Histology 
Liver biopsy 
Physical exam 
Ascites, encephalopathy, jaundice 
Severity 
Childs score, MELD 
Medications 
NSBB, diuretics, treatment of underlying disorder 
Endoscopy 
OGD findings 
Interventions 
HVPG, RFA, TACE, Y90 
Nutrition 
 
 
Interval data to be collected during course of study (every 6 months) 
Biochemical 
LFT, PT/INR, FBC, AFP, RP 
Radiological 
US, CT, MRI 
Elastography 
LSM, SWE, MRE 
Histology 
Liver biopsy 
Physical exam 
Ascites, encephalopathy, jaundice 
Severity 
Childs score, MELD 
Medications 
NSBB, diuretics, treatment of underlying disorder 
Endoscopy 
OGD findings 
Interventions 
HVPG, RFA, TACE, Y90 
Nutrition 
BMI, HGS,  
 
 
Admissions  
 
Complications 
Ascites, variceal bleeding, encephalopathy, spontaneous bacterial 
peritonitis, portal vein thrombosis, portopulmonary hypertension, 
hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal 
syndrome, refractory ascites, sarcopenia, liver cancer, ACLF 
Death 
Cause of death (liver-related or non-liver-related) 
 
Outcome data to be collected at pre-specified analysis time-points 
Decompensation  Type, frequency and outcome of decompensation episodes 
ACLF 
Outcome of ACLF 
Death 
Cause of death (liver-related or non-liver-related)