West Page 1 Risk of Hepatocellular Carcinoma Among Individuals with Different Aetiologies of Cirrhosis: a Population-Based Cohort Study Professor Joe West 1*, Dr Timothy R Card 1,2 , Professor Guruprasad P Aithal 2 , Dr Kate M Fleming 13 Professor Joe West was supported by a University of Nottingham/Nottingham University Hospitals NHS Trust Senior Clinical Research Fellowship that funded this work (1) Division of Epidemiology and Public Health, Clinical Sciences Building 2, City Hospital Campus, The University of Nottingham, Nottingham, NG5 1PB, United Kingdom. (2) NIHR Nottingham Digestive Diseases Biomedical Research Unit at Nottingham University Hospitals NHS Trust and University of Nottingham, Nottingham, UK (3) Public Health Institute, Liverpool John Moores University, Liverpool L3 2ET, UK *Corresponding author Joe West Risk of HCC in cirrhosis 1 2 3 4 5 6 7 8 1 2
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West Page 1
Risk of Hepatocellular Carcinoma Among Individuals with
Different Aetiologies of Cirrhosis: a Population-Based Cohort
Study
Professor Joe West1*, Dr Timothy R Card1,2, Professor Guruprasad P Aithal2, Dr Kate M
Fleming13
Professor Joe West was supported by a University of Nottingham/Nottingham University
Hospitals NHS Trust Senior Clinical Research Fellowship that funded this work
(1) Division of Epidemiology and Public Health, Clinical Sciences Building 2, City Hospital
Campus, The University of Nottingham, Nottingham, NG5 1PB, United Kingdom.
(2) NIHR Nottingham Digestive Diseases Biomedical Research Unit at Nottingham
University Hospitals NHS Trust and University of Nottingham, Nottingham, UK
(3) Public Health Institute, Liverpool John Moores University, Liverpool L3 2ET, UK
Author contribution area JW TC GA KFstudy concept and design √ √ √ √ acquisition of data √ analysis and interpretation of data √ √ √ √ drafting of the manuscript √ √ √ √ critical revision of the manuscript for important intellectual content √ √ √ √ statistical analysis √ √ obtained funding √ technical, or material support √ study supervision √
No conflict of interest
I, the designated Corresponding Author, on behalf of myself and my co-authors declare that no
relevant conflicts of interest exist.
Financial support: JW was supported by a University of Nottingham/Nottingham University
Hospital’s NHS Trust Senior Clinical Research Fellowship
Table 2. Absolute incidence rates of HCC for all follow up time and Hazard Ratios (for HCC incidence) and their 95% confidence intervals for the cirrhosis cohort by age, sex and aetiology
* adjusted for sex, age groups, smoking status, BMI, diabetes mellitus and aetiology
Risk of HCC in cirrhosis
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3
4
5
1
2
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Table 3. Estimated cumulative incidence (%) of HCC accounting for competing risks of death and liver transplant by aetiology at 1, 5 and 10-years of follow up
Footnote: Viral hepatitis = hepatitis B or C; Auto/Meta = Autoimmune or metabolic liver disease; Alcohol = alcoholic; Cryptogenic = no other distinct aetiology identified. Values on the y axis represent proportions i.e. the risk of HCC at 10 years of follow up among those people with cirrhosis with chronic viral hepatitis (B or C) is 4%
Risk of HCC in cirrhosis
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234567
1
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STROBE Statement—Checklist of items that should be included in reports of cohort studies Item No Recommendation
Done
Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title
or the abstract
Yes
(b) Provide in the abstract an informative and balanced summary of
what was done and what was found
Yes
IntroductionBackground/rationale 2 Explain the scientific background and rationale for the investigation
being reported
Yes
Objectives 3 State specific objectives, including any prespecified hypotheses Yes
MethodsStudy design 4 Present key elements of study design early in the paper Yes
Setting 5 Describe the setting, locations, and relevant dates, including periods of
recruitment, exposure, follow-up, and data collection
Yes
Participants 6 (a) Give the eligibility criteria, and the sources and methods of
selection of participants. Describe methods of follow-up
Yes
(b) For matched studies, give matching criteria and number of exposed
and unexposed
Yes
Variables 7 Clearly define all outcomes, exposures, predictors, potential
confounders, and effect modifiers. Give diagnostic criteria, if
applicable
Yes
Data sources/
measurement
8* For each variable of interest, give sources of data and details of
methods of assessment (measurement). Describe comparability of
assessment methods if there is more than one group
Yes
Bias 9 Describe any efforts to address potential sources of bias Yes
Study size 10 Explain how the study size was arrived at Yes
Risk of HCC in cirrhosis
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Quantitative variables 11 Explain how quantitative variables were handled in the analyses. If
applicable, describe which groupings were chosen and why
Yes
Statistical methods 12 (a) Describe all statistical methods, including those used to control for
confounding
Yes
(b) Describe any methods used to examine subgroups and interactions Yes
(c) Explain how missing data were addressed Yes
(d) If applicable, explain how loss to follow-up was addressed Yes
(e) Describe any sensitivity analyses Yes
ResultsParticipants 13* (a) Report numbers of individuals at each stage of study—eg numbers
potentially eligible, examined for eligibility, confirmed eligible,
included in the study, completing follow-up, and analysed
Yes
(b) Give reasons for non-participation at each stage Yes
(c) Consider use of a flow diagram
Descriptive data 14* (a) Give characteristics of study participants (eg demographic, clinical,
social) and information on exposures and potential confounders
Yes
(b) Indicate number of participants with missing data for each variable
of interest
Yes
(c) Summarise follow-up time (eg, average and total amount) Yes
Outcome data 15* Report numbers of outcome events or summary measures over time Yes
Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted
estimates and their precision (eg, 95% confidence interval). Make clear
which confounders were adjusted for and why they were included
Yes
(b) Report category boundaries when continuous variables were
categorized
Yes
(c) If relevant, consider translating estimates of relative risk into Yes
Risk of HCC in cirrhosis1
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absolute risk for a meaningful time period
Other analyses 17 Report other analyses done—eg analyses of subgroups and
interactions, and sensitivity analyses
Yes
DiscussionKey results 18 Summarise key results with reference to study objectives Yes
Limitations 19 Discuss limitations of the study, taking into account sources of
potential bias or imprecision. Discuss both direction and magnitude of
any potential bias
Yes
Interpretation 20 Give a cautious overall interpretation of results considering objectives,
limitations, multiplicity of analyses, results from similar studies, and
other relevant evidence
Yes
Generalisability 21 Discuss the generalisability (external validity) of the study results Yes
Other informationFunding 22 Give the source of funding and the role of the funders for the present
study and, if applicable, for the original study on which the present
article is based
Yes
*Give information separately for exposed and unexposed groups.
Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is available at http://www.strobe-statement.org.