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1. Costs of pediatric liver transplantation among commercially insured and Medicaid-insured patients with cholestasis in the US.

Author

Miloh, Tamir, Goldstein, Andrea, Howard, Robin, Mogul, Douglas, Marden, Jessica, Anderson, Annika, Gaburo, Katherine, Kirson, Noam, and Rosenthal, Philip

Subjects
United States, Humans, Child, Adolescent, Medicaid, Insurance, Health, Retrospective Studies, Health Care Costs, Liver Transplantation, Cholestasis
Abstract

Children with rare cholestatic liver diseases, such as Alagille syndrome, progressive familial intrahepatic cholestasis, and biliary atresia typically require liver transplantation (LT). The objective of this analysis was to assess the economic burden of LT on these patients. Health care resource utilization and costs associated with pediatric LT were retrospectively assessed using insurance claims data from the US IBM MarketScan Commercial and Medicaid databases collected between October 2015 and December 2019. Inclusion criteria were as follows: ≥1 procedure code for LT,

Published
2023

2. Alanine Aminotransferase and Gamma‐Glutamyl Transpeptidase Predict Histologic Improvement in Pediatric Nonalcoholic Steatohepatitis

Author

Newton, Kimberly P, Lavine, Joel E, Wilson, Laura, Behling, Cynthia, Vos, Miriam B, Molleston, Jean P, Rosenthal, Philip, Miloh, Tamir, Fishbein, Mark H, Jain, Ajay K, Murray, Karen F, Schwimmer, Jeffrey B, and Network, for the Nonalcoholic Steatohepatitis Clinical Research

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Chronic Liver Disease and Cirrhosis, Pediatric, Digestive Diseases, Hepatitis, Oral and gastrointestinal, Good Health and Well Being, Adolescent, Alanine Transaminase, Aspartate Aminotransferases, Child, Cysteamine, Delayed-Action Preparations, Female, Humans, Liver, Male, Non-alcoholic Fatty Liver Disease, Predictive Value of Tests, Prognosis, Remission Induction, Treatment Outcome, gamma-Glutamyltransferase, Nonalcoholic Steatohepatitis Clinical Research Network, Medical Biochemistry and Metabolomics, Immunology, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background and aimsPredictive, noninvasive tools are needed to monitor key features of nonalcoholic fatty liver disease (NAFLD) in children that relate to improvement in liver histology. The purpose of this study was to evaluate the relationship between liver chemistries and liver histology using data from the CyNCh (Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children) clinical trial.Approach and resultsThis study included 146 children. Improvement in liver histology, defined as decrease in nonalcoholic fatty liver disease (NAFLD) Activity Score ≥2 points without worsening of fibrosis, occurred in 43 participants (30%). There were 46 participants with borderline zone 1 nonalcoholic steatohepatitis (NASH) at baseline, with resolution in 28% (12 of 46). Multivariate models were constructed using baseline and change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) at 52 weeks, for improvement in (1) liver histology primary outcome, (2) borderline zone 1 NASH, and (3) fibrosis. For improvement in histology, the model (P

Published
2021

3. Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice

Author

Xanthakos, Stavra A, Lavine, Joel E, Yates, Katherine P, Schwimmer, Jeffrey B, Molleston, Jean P, Rosenthal, Philip, Murray, Karen F, Vos, Miriam B, Jain, Ajay K, Scheimann, Ann O, Miloh, Tamir, Fishbein, Mark, Behling, Cynthia A, Brunt, Elizabeth M, Sanyal, Arun J, Tonascia, James, Abrams, Stephanie, Garner, Donna, Hertel, Paula, Himes, Ryan, Lawson, Alicia, Triggs, Nicole, Bramlage, Kristin, Carr, April, Cecil, Kim, McNeill, Meghan, Mouzaki, Marialena, Trout, Andrew, Xanthakos, Stavra, Bernstein, Kimberlee, DeVore, Stephanie, Kohli, Rohit, Lake, Kathleen, Podberesky, Daniel, Towbin, Alex, Mencin, Ali, Reynoso, Elena, Alazraki, Adina, Cleeton, Rebecca, Cordero, Maria, Hernandez, Albert, Karpen, Saul, Munos, Jessica Cruz, Raviele, Nicholas, Vos, Miriam, Bozic, Molly, Carr, Laura, Cummings, Oscar W, Harlow, Kathryn, Klipsch, Ann, Ragozzino, Emily, Rao, Girish, Kafka, Kimberly, Scheimann, Ann, Fishbein, Mark H, Ito, Joy, Mohammad, Saeed, Whitington, Peter F, Barlow, Sarah, Carpenter, Danielle, Cattoor, Theresa, Derdoy, Jose, Freebersyser, Janet, Jain, Ajay, King, Debra, Lai, Jinping, Siegner, Joan, Stewart, Susan, Torretta, Susan, Wriston, Kristina, Angeles, Jorge, Arin, Jennifer, Behling, Cynthia, Bross, Craig, Carrier, Carissa, Collins, Jennifer, De La Pena, Diana, Durelle, Janis, Huckaby, Mary Catherine, Middleton, Michael S, Newton, Kimberly, Sirlin, Claude, Ugalde-Nicalo, Patricia, Courtier, Jesse, Gill, Ryan, Langlois, Camille, Perito, Emily Rothbaum, Tsai, Patrika, Blondet, Niviann, Cooper, Kara, Murray, Karen, Otto, Randolph, and Yeh, Matthew

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Obesity, Clinical Trials and Supportive Activities, Clinical Research, Digestive Diseases, Liver Disease, Chronic Liver Disease and Cirrhosis, Pediatric, Diabetes, Hepatitis, Oral and gastrointestinal, Adolescent, Age Factors, Alanine Transaminase, Aspartate Aminotransferases, Biomarkers, Biopsy, Blood Glucose, Child, Diabetes Mellitus, Type 2, Disease Progression, Female, Healthy Lifestyle, Humans, Male, Non-alcoholic Fatty Liver Disease, Pediatric Obesity, Prospective Studies, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Risk Reduction Behavior, Severity of Illness Index, Time Factors, Treatment Outcome, ALT, Cirrhosis, Histology, Natural History, NASH Clinical Research Network, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology, Clinical sciences, Nutrition and dietetics
Abstract

Background & aimsNonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth.MethodsWe compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13 ± 3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis.ResultsAt enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean period of 1.6 ± 0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH and/or in fibrosis was associated with adolescent age, and higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein cholesterol at baseline (

Published
2020

4. Measles, mumps, rubella (vaccine) and varicella vaccines in pediatric liver transplant: An initial analysis of post‐transplant immunity.

Author

Yoeli, Jordan K., Yoeli, Dor, Miloh, Tamir A., Rana, Abbas, Goss, John A., and Munoz‐Rivas, Flor

Subjects
RUBELLA, CHICKENPOX, MEASLES, LIVER transplantation, MUMPS, VACCINES, IMMUNITY
Abstract

Varicella and measles infection represents a significant source of morbidity and mortality for pediatric LT recipients. We evaluated the prevalence and correlates of post‐transplant immunity in pediatric LT recipients previously immunized against measles (n = 72) and varicella (n = 67). Sixteen of seventy‐two (22%) patients were measles non‐immune, and 42/67 (63%) were varicella non‐immune after LT. Median time from LT to titers for measles and varicella was 4.0 and 3.3 years, respectively. In the measles cohort, non‐immune patients received fewer pretransplant vaccine doses (P = 0.026) and were younger at both time of vaccination (P = 0.006) and LT (P = 0.004) compared with immune patients. Upon multivariable analysis, weight > 10 kg at LT (OR 5.91, 95% CI 1.27‐27.41) and technical variant graft (OR 0.07, 95% CI 0.01‐0.37) were independently, significantly associated with measles immunity. In the varicella cohort, non‐immune patients received fewer pretransplant vaccine doses (P = 0.028), were younger at transplant (P = 0.022), and had less time lapse between their last vaccine and transplant (P = 0.012) compared with immune patients. Upon multivariate analysis, time > 1 year from last vaccine to LT was independently, significantly associated with varicella immunity (OR 3.78, CI 1.30‐11.01). This study demonstrates that non‐immunity to measles and varicella is a prevalent problem after liver transplantation in children and identifies 3 unique risk factors for non‐immunity in this high‐risk population. [ABSTRACT FROM AUTHOR]

Published
2019
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5. The Sclerosing Cholangitis Outcomes in Pediatrics (SCOPE) Index: A Prognostic Tool for Children

Author

Matjaz Homan, Binita M. Kamath, Bart G. P. Koot, Mansi Amin, Parvathi Mohan, Amanda Ricciuto, Melissa Zerofsky, Madeleine Aumar, Kathleen B. Schwarz, Laura G. Draijer, Annemarie Broderick, Kaija-Leena Kolho, Stephen L. Guthery, Nanda Kerkar, Saeed Mohammad, Nisreen Soufi, Alexandra Papadopoulou, Eyal Shteyer, Raffaele Iorio, Nadia Ovchinsky, M. Kyle Jensen, Simon Horslen, Ruchi Singh, Maureen M. Jonas, Kyung Mo Kim, Alexander Miethke, Girish S. Rao, Federica Ferrari, Achiya Z. Amir, Cara L. Mack, Douglas Mogul, Matthew DiGuglielmo, Vratislav Smolka, Christine K. Lee, Pushpa Sathya, Katryn N. Furuya, Nitika A. Gupta, Mercedes Martinez, Atsushi Tanaka, Tamir Miloh, Kathleen M. Loomes, Bernadette Vitola, Uzma Shah, Pamela L. Valentino, Andréanne Zizzo, Mark Deneau, Jessica T. Hochberg, Wael El-Matary, Stacy Moroz, Marcus Auth, Emily R. Perito, Trevor J. Laborda, Marek Woynarowski, Eleonora Druve Tavares Fagundes, Alexandre Rodrigues Ferreira, Raghu Varier, Sirish Palle, Graduate School, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ARD - Amsterdam Reproduction and Development, Paediatric Gastroenterology, R Deneau, Mark, Mack, Cara, R Perito, Emily, Ricciuto, Amanda, L Valentino, Pamela, Amin, Mansi, Z Amir, Achiya, Aumar, Madeleine, Auth, Marcu, Broderick, Annemarie, Diguglielmo, Matthew, G Draijer, Laura, Druve Tavares Fagundes, Eleonora, El-Matary, Wael, Ferrari, Federica, N Furuya, Katryn, Gupta, Nitika, T Hochberg, Jessica, Homan, Matjaz, Horslen, Simon, Iorio, Raffaele, Kyle Jensen, M, M Jonas, Maureen, M Kamath, Binita, Kerkar, Nanda, Mo Kim, Kyung, Kolho, Kaija-Leena, P Koot, Bart G, J Laborda, Trevor, K Lee, Christine, M Loomes, Kathleen, Martinez, Mercede, Miethke, Alexander, Miloh, Tamir, Mogul, Dougla, Mohammad, Saeed, Mohan, Parvathi, Moroz, Stacy, Ovchinsky, Nadia, Palle, Sirish, Papadopoulou, Alexandra, Rao, Girish, Rodrigues Ferreira, Alexandre, Sathya, Pushpa, B Schwarz, Kathleen, Shah, Uzma, Shteyer, Eyal, Singh, Ruchi, Smolka, Vratislav, Soufi, Nisreen, Tanaka, Atsushi, Varier, Raghu, Vitola, Bernadette, Woynarowski, Marek, Zerofsky, Melissa, Zizzo, Andréanne, L Guthery, Stephen, Children's Hospital, and HUS Children and Adolescents

Subjects
0301 basic medicine, Male, Pediatrics, medicine.medical_treatment, Biopsy, Autoimmune hepatitis, Liver transplantation, 0302 clinical medicine, Cholangiography, Risk Factors, Retrospective Studie, Stage (cooking), Child, RISK, medicine.diagnostic_test, gamma-Glutamyltransferase, Prognosis, 3. Good health, SURVIVAL, Disease Progression, 030211 gastroenterology & hepatology, Female, Human, medicine.medical_specialty, Cancer complication, Adolescent, Prognosi, Cholangitis, Sclerosing, VALIDATION, Primary sclerosing cholangitis, CHOLANGIOCARCINOMA, 03 medical and health sciences, medicine, Humans, Serum Albumin, Retrospective Studies, Hepatology, business.industry, Platelet Count, Risk Factor, Retrospective cohort study, Bilirubin, NATURAL-HISTORY, medicine.disease, Liver Transplantation, Clinical trial, MODEL, 030104 developmental biology, 3121 General medicine, internal medicine and other clinical medicine, AUTOIMMUNE HEPATITIS, business
Abstract

Background and Aims: Disease progression in children with primary sclerosing cholangitis (PSC) is variable. Prognostic and risk-stratification tools exist for adult-onset PSC, but not for children. We aimed to create a tool that accounts for the biochemical and phenotypic features and early disease stage of pediatric PSC. Approach and Results: We used retrospective data from the Pediatric PSC Consortium. The training cohort contained 1,012 patients from 40 centers. We generated a multivariate risk index (Sclerosing Cholangitis Outcomes in Pediatrics [SCOPE] index) that contained total bilirubin, albumin, platelet count, gamma glutamyltransferase, and cholangiography to predict a primary outcome of liver transplantation or death (TD) and a broader secondary outcome that included portal hypertensive, biliary, and cancer complications termed hepatobiliary complications (HBCs). The model stratified patients as low, medium, or high risk based on progression to TD at rates of

Published
2021

6. The natural history of primary sclerosing cholangitis in 781 children: A multicenter, international collaboration

Author

Jason Yap, Madeleine Gottrand, Amanda Ricciuto, Raghu Varier, Niamh O'Cathain, Raffaele Iorio, Mounif El-Youssef, Annemarie Broderick, Wael El-Matary, Atushi Tanaka, Alexandra Papadopoulou, Marcus Auth, Achiya Z. Amir, Lawrence J. Saubermann, Pamela L. Valentino, Bernadette Vitola, Reham Abdou, Sylvia Doan, Mark Deneau, M. Kyle Jensen, Kaija-Leena Kolho, Mansi Amin, Fateh Bazerbachi, Oren Ledder, Parvathi Mohan, Veena Venkat, Kyung Mo Kim, Jillian M. Cotter, Nitika A. Gupta, Anastasia Konidari, Cara L. Mack, Miriam B. Vos, Federica Ferrari, Pushpa Sathya, Marek Woynarowski, Katryn N. Furuya, Vratislav Smolka, Eyal Shteyer, Frédéric Gottrand, Matjaz Homan, Binita M. Kamath, Bart G. P. Koot, Khaled Alqoaer, Albert Chan, Mercedes Martinez, Tamir Miloh, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, ARD - Amsterdam Reproduction and Development, Paediatric Gastroenterology, Deneau, Mark R., El-Matary, Wael, Valentino, Pamela L., Abdou, Reham, Alqoaer, Khaled, Amin, Mansi, Amir, Achiya Z., Auth, Marcu, Bazerbachi, Fateh, Broderick, Annemarie, Chan, Albert, Cotter, Jillian, Doan, Sylvia, El-Youssef, Mounif, Ferrari, Federica, Furuya, Katryn N., Gottrand, Madeleine, Gottrand, Frederic, Gupta, Nitika, Homan, Matjaz, Kamath, Binita M., Kim, Kyung Mo, Kolho, Kaija-Leena, Konidari, Anastasia, Koot, Bart, Iorio, Raffaele, Ledder, Oren, Mack, Cara, Martinez, Mercede, Miloh, Tamir, Mohan, Parvathi, O'Cathain, Niamh, Papadopoulou, Alexandra, Ricciuto, Amanda, Saubermann, Lawrence, Sathya, Pushpa, Shteyer, Eyal, Smolka, Vratislav, Tanaka, Atushi, Varier, Raghu, Venkat, Veena, Vitola, Bernadette, Vos, Miriam B., Woynarowski, Marek, Yap, Jason, and Jensen, M. Kyle

Subjects
Male, Internationality, medicine.medical_treatment, Predictive Value of Test, Autoimmune hepatitis, Liver transplantation, Gastroenterology, Inflammatory bowel disease, Severity of Illness Index, Cohort Studies, 0302 clinical medicine, Liver Function Tests, Japan, Retrospective Studie, Child, Multivariate Analysi, medicine.diagnostic_test, Liver Function Test, Hazard ratio, Biopsy, Needle, Immunohistochemistry, 3. Good health, 030220 oncology & carcinogenesis, Disease Progression, 030211 gastroenterology & hepatology, Female, Survival Analysi, Human, medicine.medical_specialty, Cholangitis, Sclerosing, Risk Assessment, Disease-Free Survival, Primary sclerosing cholangitis, Follow-Up Studie, 03 medical and health sciences, Predictive Value of Tests, Internal medicine, medicine, Humans, Survival analysis, Proportional Hazards Models, Retrospective Studies, Analysis of Variance, Hepatology, business.industry, sclerosing cholangitis, pediatric, liver complications, chronic hepatitis-c, term-follow-up, autoimmune hepatitis, prognostic-factors, transient elastography, consensus guidelines, significant fibrosis, management, cholangiocarcinoma, predictors, medicine.disease, Survival Analysis, digestive system diseases, Liver Transplantation, Multivariate Analysis, Proportional Hazards Model, Cohort Studie, Liver function tests, business, Follow-Up Studies
Abstract

There are limited data on the natural history of primary sclerosing cholangitis (PSC) in children. We aimed to describe the disease characteristics and long-term outcomes of pediatric PSC. We retrospectively collected all pediatric PSC cases from 36 participating institutions and conducted a survival analysis from the date of PSC diagnosis to dates of diagnosis of portal hypertensive or biliary complications, cholangiocarcinoma, liver transplantation, or death. We analyzed patients grouped by disease phenotype and laboratory studies at diagnosis to identify objective predictors of long-term outcome. We identified 781 patients, median age 12 years, with 4,277 person-years of follow-up; 33% with autoimmune hepatitis, 76% with inflammatory bowel disease, and 13% with small duct PSC. Portal hypertensive and biliary complications developed in 38% and 25%, respectively, after 10 years of disease. Once these complications developed, median survival with native liver was 2.8 and 3.5 years, respectively. Cholangiocarcinoma occurred in 1%. Overall event-free survival was 70% at 5 years and 53% at 10 years. Patient groups with the most elevated total bilirubin, gamma-glutamyltransferase, and aspartate aminotransferase-to-platelet ratio index at diagnosis had the worst outcomes. In multivariate analysis PSC–inflammatory bowel disease and small duct phenotypes were associated with favorable prognosis (hazard ratios 0.6, 95% confidence interval 0.5-0.9, and 0.7, 95% confidence interval 0.5-0.96, respectively). Age, gender, and autoimmune hepatitis overlap did not impact long-term outcome. Conclusion: PSC has a chronic, progressive course in children, and nearly half of patients develop an adverse liver outcome after 10 years of disease; elevations in bilirubin, gamma-glutamyltransferase, and aspartate aminotransferase-to-platelet ratio index at diagnosis can identify patients at highest risk; small duct PSC and PSC–inflammatory bowel disease are more favorable disease phenotypes. (Hepatology 2017;66:518–527).

Published
2017

7. Recommendations for Probiotic Use-2015 Update: Proceedings and Consensus Opinion

Author

W. Allan Walker, Mario Guslandi, David A. Brenner, Alfredo Guarino, Tamir A. Miloh, Max Nieuwdorp, Amir A. Qamar, Eamonn Martin Quigley, Levinus A. Dieleman, Yehuda Ringel, Mary Ellen Sanders, Lawrence J. Brandt, Adam Kim, Martin H. Floch, ACS - Amsterdam Cardiovascular Sciences, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Vascular Medicine, Experimental Vascular Medicine, Floch, Martin H, Walker, W. Allan, Sanders, Mary Ellen, Nieuwdorp, Max, Kim, Adam S, Brenner, David A, Qamar, Amir A, Miloh, Tamir A, Guarino, Alfredo, Guslandi, Mario, Dieleman, Levinus A, Ringel, Yehuda, Quigley, Eamonn M. M, Brandt, Lawrence J., Internal medicine, and ICaR - Circulation and metabolism

Subjects
Adult, Diarrhea, medicine.medical_specialty, education, MEDLINE, Gastroenterology, Inflammatory bowel disease, law.invention, Irritable Bowel Syndrome, Probiotic, law, Enterocolitis, Necrotizing, Internal medicine, medicine, Humans, Child, Irritable bowel syndrome, Enterocolitis, Pseudomembranous, Enterocolitis, Childhood diarrhea, business.industry, Clostridioides difficile, Liver Diseases, Probiotics, Clostridium difficile diarrhea, medicine.disease, Family medicine, Necrotizing enterocolitis, medicine.symptom, business
Abstract

This paper describes the consensus opinion of the participants in the 4th Triennial Yale/Harvard Workshop on Probiotic Recommendations. The recommendations update those of the first 3 meetings that were published in 2006, 2008, and 2011. Recommendations for the use of probiotics in necrotizing enterocolitis, childhood diarrhea, inflammatory bowel disease, irritable bowel syndrome and Clostridium difficile diarrhea are reviewed. In addition, we have added recommendations for liver disease for the first time. As in previous publications, the recommendations are given as A, B, or C ratings.

Published
2015

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