https://orcid.org/0000-0002-3906-6811
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Abstract
Background
Biopsy remains the gold standard for determining fibrosis stage in patients with primary biliary cholangitis (PBC), but it is unavailable for most patients. We used data from the 11 US health systems in the FibrOtic Liver Disease Consortium to explore a combination of biochemical markers and electronic health record (EHR)-based diagnosis/procedure codes (DPCs) to identify the presence of cirrhosis in PBC patients.
Methods
Histological fibrosis staging data were obtained from liver biopsies. Variables considered for the model included demographics (age, gender, race, ethnicity), total bilirubin, alkaline phosphatase, albumin, aspartate aminotransferase (AST) to platelet ratio index (APRI), Fibrosis 4 (FIB4) index, AST to alanine aminotransferase (ALT) ratio, and >100 DPCs associated with cirrhosis/decompensated cirrhosis, categorized into ten clusters. Using least absolute shrinkage and selection operator regression (LASSO), we derived and validated cutoffs for identifying cirrhosis.
Results
Among 4328 PBC patients, 1350 (32%) had biopsy data; 121 (9%) were staged F4 (cirrhosis). DPC clusters (including codes related to cirrhosis and hepatocellular carcinoma diagnoses/procedures), Hispanic ethnicity, ALP, AST/ALT ratio, and total bilirubin were retained in the final model (AUROC=0.86 and 0.83 on learning and testing data, respectively); this model with two cutoffs divided patients into three categories (no cirrhosis, indeterminate, and cirrhosis) with specificities of 81.8% (for no cirrhosis) and 80.3% (for cirrhosis). A model excluding DPCs retained ALP, AST/ALT ratio, total bilirubin, Hispanic ethnicity, and gender (AUROC=0.81 and 0.78 on learning and testing data, respectively).
Conclusion
An algorithm using laboratory results and DPCs can categorize a majority of PBC patients as cirrhotic or noncirrhotic with high accuracy (with a small remaining group of patients’ cirrhosis status indeterminate). In the absence of biopsy data, this EHR-based model can be used to identify cirrhosis in cohorts of PBC patients for research and/or clinical follow-up.
Author Contributions
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.
Disclosure
Stuart C. Gordon receives grant/research support from AbbVie Pharmaceuticals, Conatus, CymaBay, Eiger Pharmaceuticals, Eli Lilly, Genfit, Gilead Sciences, GlaxoSmithKline, Intercept Pharmaceuticals, Merck, and Viking Therapeutics. Mei Lu, Joseph A. Boscarino, Mark A. Schmidt, Yihe G. Daida, Jia Li, Loralee B. Rupp, and Sheri Trudeau receive research grant support from Gilead Sciences and Intercept Pharmaceuticals. Carla V. Rodriguez-Watson owns stock in Gilead (<$5000). Heather Anderson receives grant/research support from Intercept Pharmaceuticals. Jeffrey J. VanWormer receives grant/research support from Retrophin. Christopher L. Bowlus receives grant/research support from AbbVie Pharmaceuticals, Bristol-Myers-Squibb, CymaBay, Gilead Biosciences, GlaxoSmithKline, Intercept Pharmaceuticals, Merck, Mirum, Shire Pharmaceuticals, Takeda Pharmaceuticals, TARGET Pharmasolutions, and has served as an advisor for Bristol-Myers-Squibb, Gilead Biosciences, Intercept Pharmaceuticals, and Takeda. Keith Lindor is a consultant/advisor for Biopharma and has served as an ad hoc advisor for HighTide, Takeda, Shire, and Intercept Pharmaceuticals. He sits on a Data Safety Monitoring Board for Takeda. Robert J. Romanelli receives received grant/research support from Pfizer Inc. and Janssen Scientific Affairs. The authors report no other conflicts of interest in this work.