Jennifer L. Vincent D.O.

Lu, M., Bowlus, C.L., Lindor, K., Rodriguez-Watson, C.V., Romanelli, R.J., Haller, I.V., Anderson, H., VanWormer, J.J., Boscarino, J.A., Schmidt, M.A., Daida, Y.G., Sahota, A., Vincent, J., Li, J., Trudeau, S., Rupp, L.B. and Gordon, S.C. (2020). “Validity of an Automated Algorithm to Identify Cirrhosis Using Electronic Health Records in Patients with Primary Biliary Cholangitis.” Clin Epidemiol 12: 1261-1267.

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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.

Kelly, C.R., Yen, E.F., Grinspan, A.M., Kahn, S.A., Atreja, A., Lewis, J.D., Moore, T.A., Rubin, D.T., Kim, A.M., Serra, S., Nersesova, Y., Fredell, L., Hunsicker, D., McDonald, D., Knight, R., Allegretti, J.R., Pekow, J., Absah, I., Hsu, R., Vincent, J., Khanna, S., Tangen, L., Crawford, C.V., Mattar, M.C., Chen, L.A., Fischer, M., Arsenescu, R.I., Feuerstadt, P., Goldstein, J., Kerman, D., Ehrlich, A.C., Wu, G.D. and Laine, L. (2020). “Fecal Microbiota Transplant is Highly Effective in Real-World Practice: Initial Results from the FMT National Registry.” Gastroenterology Sep 30;S0016-5085(20)35221-5. [Epub ahead of print.].

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INTRODUCTION: Fecal microbiota transplantation (FMT) is commonly used for treatment of C. difficile infections (CDI), although prospective safety data are limited and real-world FMT practice and outcomes are not well described. The FMT National Registry was designed to assess FMT methods and both safety and effectiveness outcomes from North American FMT providers. METHODS: Patients undergoing FMT in clinical practices across North America are eligible. Participating investigators enter de-identified data into an online platform including FMT protocol, baseline patient characteristics, CDI cure and recurrence, and short and long-term safety outcomes. RESULTS: Of the first 259 participants enrolled at 20 sites, 222 have completed short-term follow-up at 1 month, and 123 have follow-up to 6 months; 171 (66%) are female. All FMTs were done for CDI, and 249 (96%) used an unknown donor (e.g., stool bank). One-month cure occurred in 200 (90%); of these, 197 (98%) received only a single FMT. Among 112 with initial cure who were followed to 6 months, 4 (4%) had CDI recurrence. Severe symptoms reported within 1-month of FMT included diarrhea (5 (2%)) and abdominal pain (4 (2%)); 3 (1%) had hospitalizations possibly related to FMT. At 6 months, new diagnoses of irritable bowel syndrome were made in 2 (1%) and inflammatory bowel disease in 2 (1%). CONCLUSIONS: This prospective real-world study demonstrated high effectiveness of FMT for CDI with a good safety profile. Assessment of new conditions at long-term follow-up is planned as this registry grows and will be important for determining the full safety profile of FMT.