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1. Incidence of Type 2 Diabetes in Children With Nonalcoholic Fatty Liver Disease

Author

Kimberly P. Newton, Laura A. Wilson, Nancy A. Crimmins, Mark H. Fishbein, Jean P. Molleston, Stavra A. Xanthakos, Cynthia Behling, Jeffrey B. Schwimmer, Donna Garner, Paula Hertel, Alicia Lawson, Yen Pham, Nicole Triggs, Kristin Bramlage, April Carr, Meghan McNeill, Marialena Mouzaki, Stavra Xanthakos, Adina Alazraki, Rebecca Cleeton, Maria Cordero, Saul Karpen, Miriam Vos, Laura Carr, Oscar W. Cummings, Kathryn Harlow, Ann Klipsch, Wendy Morlan, Emily Ragozzino, Cindy Sawyers, Angela Anthony, Theresa Cattoor, Janet Freebersyser, Ajay K. Jain, Susan Torretta, Janis Durelle, Nidhi P. Goyal, Patricia Ugalde-Nicalo, Andrew Wang, Niviann Blondet, Kara Cooper, Randolph Otto, Matthew Yeh, Melissa Young, David E. Kleiner, Edward C. Doo, Sherry Hall, Jay H. Hoofnagle, Averell H. Sherker, Rebecca Torrance, Patricia R. Robuck, Peggy Adamo, Patricia Belt, Jeanne M. Clark, Jill Meinert, Laura Miriel, Carrie Shade, Emily P. Sharkey, Jacqueline Smith, Michael Smith, Alice Sternberg, ScM, James Tonascia, Mark L. Van Natta, Annette Wagoner, Tinsay Woreta, Katherine P. Yates, John Dodge, Michele Donithan, and Milana Isaacson

Subjects
Hepatology, Gastroenterology
Abstract

Type 2 diabetes (T2D) is a growing problem in children. Children with NAFLD are at potentially high risk for developing T2D; however, the incidence of T2D in this population is unknown. This study aimed to determine the incidence of T2D in children with NAFLD and identify associated risk factors.Children with NAFLD enrolled in the Nonalcoholic Steatohepatitis Clinical Research Network were followed longitudinally. Incidence of T2D was determined by using clinical history and fasting laboratory values. Cumulative incidence curves were developed for time to T2D. A Cox regression multivariable model was constructed using best subsets Akaike's Information Criteria selection.This study included 892 children with NAFLD and with a mean age of 12.8 years (2.7) followed for 3.8 years (2.3) with a total 3234 person-years at risk. The incidence rate of T2D was 3000 new cases per 100,000 person-years at risk. At baseline, 63 children had T2D, and during follow-up, an additional 97 children developed incident T2D, resulting in a period prevalence of 16.8%. Incident T2D was significantly higher in females versus males (hazard ratio [HR], 1.8 [1.0-2.8]), associated with BMI z-score (HR, 1.8 [1.0-3.0]), and more severe liver histology including steatosis grade (HR, 1.3 [1.0-1.7]), and fibrosis stage (HR, 1.3 [1.0-1.5]).Children with NAFLD are at high risk for existing and incident T2D. In addition to known risk factors for T2D (female and BMI z-score), severity of liver histology at the time of NAFLD diagnosis was independently associated with T2D development. Targeted strategies to prevent T2D in children with NAFLD are needed.

Published
2023

2. Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study

Author

Timothy B Plante, Kelly T Gleason, Hailey N Miller, Jeanne Charleston, Kristen McArthur, Cheryl Dennison Himmelfarb, Mariana Lazo, Daniel E Ford, Edgar R Miller, Lawrence J Appel, Stephen P Juraschek, Nicole Cronin, Scott McClure, Jennifer Miskimon, Christine M. Mitchell, Rita R. Kalyani, David L. Roth, Jennifer A. Schrack, Sarah L. Szanton, Jacek Urbanek, Jeremy Walston, Amal Wanigatunga, Sheriza N. Baksh, Amanda L. Blackford, Shumon Chattopadhyay, Lea T. Drye, John Dodge, Cathleen Ewing, Sana Haider, Stephanie C. Holland, Rosetta Jackson, Andrea Lears, Curtis Meinert, David Shade, Michael Smith, Alice L. Sternberg, James Tonascia, Mark L. Van Natta, Annette Wagoner, George W. Comstock, Erin D. Michos, J. Denise Bennett, Pamela Bowers, Josef Coresh, Patricia Crowley, Tammy Crunkleton, Briana Dick, Rebecca Evans, Mary Godwin, Lynne Hammann, Deborah Hawks, Karen Horning, Erika Hull, Brandi Mills, Melissa Minotti, Leann Raley, Amanda Reed, Rhonda Reeder, Cassie Reid, Melissa Shuda, Adria Spikes, Rhonda Stouffer, Kelly Weicht, Caroline Abbas, Bernellyn Carey, Syree Davis, Naomi DeRoche-Brown, Debra Gayles, Sherlina Holland, Ina Glenn-Smith, Duane Johnson, Mia Johnson, Eva Keyes, Danielle Santiago, Chanchai Sapun, Valerie Sneed, Lee Swartz, Letitia Thomas, Robert H. Christenson, Show-Hong Duh, Heather Rebuck, Clifford Rosen, Tom Cook, Pamela Duncan, Karen Hansen, Anne Kenny, Sue Shapses, Judy Hannah, Sergei Romashkan, Cindy D. Davis, Christopher T. Sempos, Jack M. Guralnik, and J.C. Gallagher

Subjects
Male, medicine.medical_specialty, 020205 medical informatics, Pilot Projects, 02 engineering and technology, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Patient Portals, Randomized controlled trial, law, 0202 electrical engineering, electronic engineering, information engineering, Electronic Health Records, Humans, Medicine, 030212 general & internal medicine, Vitamin D, Recruitment methods, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Pharmacology, Text Messaging, Electronic Mail, business.industry, Patient Selection, Electronic medical record, Patient portal, Vitamins, General Medicine, Clinical trial, Research Design, Physical therapy, Accidental Falls, Female, business
Abstract

Background/aim:Cost-efficient methods are essential for successful participant recruitment in clinical trials. Patient portal messages are an emerging means of recruiting potentially eligible patients into trials. We assessed the response rate and complaint rate from direct-to-patient, targeted recruitment through patient portals of an electronic medical record for a clinical trial, and compared response rates by differences in message content.Methods:The Study to Understand Fall Reduction and Vitamin D in You (STURDY) trial is a National Institutes of Health–sponsored, community-based study of vitamin D supplementation for fall prevention in older adults conducted at Johns Hopkins. Potential participants were identified using the Epic electronic medical record at the Johns Hopkins Health System based on age (≥70 years), ZIP code (30-mile radius of study site), and prior activation of a patient portal account. We prepared a shorter message and a longer message. Both had basic information about study participation, but the longer message also contained information about the significance of the study and a personal invitation from the STURDY principal investigator. The Hopkins Institutional Review Board did not require prior consent from the patient or their providers. We calculated the response rate and tracked the number of complaints and requests for removal from future messages. We also determined response rate according to message content.Results:Of the 5.5 million individuals receiving care at the Johns Hopkins Health System, a sample of 6896 met our inclusion criteria and were sent one patient portal recruitment message between 6 April 2017 and 3 August 2017. Assessment of enrollment by this method ended on 1 December 2017. There were 116 patients who expressed interest in the study (response rate: 1.7%). Twelve (0.2%) recipients were randomized. There were two complaints (0.03%) and one request to unsubscribe from future recruitment messages (0.01%). Response rate was higher with the longer message than the shorter message (2.1% vs 1.2%; p = 0.005).Conclusion:Patient portal messages inviting seniors to participate in a randomized controlled trial resulted in a response rate similar to commercial email marketing and resulted in very few complaints or opt-out requests. Furthermore, a longer message with more content enhanced response rate. Recruitment through patient portals might be an effective strategy to enroll trial participants.

Published
2019

3. Factors Associated with Persistence of Severe Asthma from Late Adolescence to Early Adulthood

Author

Neema Izadi, David Baraghoshi, Douglas Curran-Everett, Robert S. Zeiger, Stanley J. Szefler, Ronina A. Covar, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Fuhlbrigge, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Robert C. Strunk, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger

Subjects
Pulmonary and Respiratory Medicine, Persistence (psychology), Pediatrics, medicine.medical_specialty, Severe asthma, Friends, macromolecular substances, Critical Care and Intensive Care Medicine, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Early adulthood, medicine, Humans, 030212 general & internal medicine, Lung function, Asthma, business.industry, musculoskeletal, neural, and ocular physiology, Original Articles, Late adolescence, medicine.disease, nervous system, 030228 respiratory system, business
Abstract

Rationale: Asthma in children generally starts as being mild but may progress to being severe and may stay severe for unknown reasons. Objectives: To identify factors in childhood that predict the persistence of severe asthma in late adolescence and early adulthood. Methods: The CAMP (Childhood Asthma Management Program) is, to our knowledge, the largest and longest asthma trial to date; it includes 1,041 children aged 5–12 years with mild to moderate asthma. We evaluated 682 program participants with analyzable data in late adolescence (age, 17–19 yr) and early adulthood (age, 21–23 yr). Measurements and Main Results: To best capture the cases of severe asthma, a status of severe asthma was defined by using criteria from the American Thoracic Society and the National Asthma Education and Prevention Program. Logistic regression with stepwise elimination was used to analyze the clinical features, biomarkers, and lung function that are predictive of the persistence of severe asthma. In late adolescence and early adulthood, 12% and 19% of the participants had severe asthma, respectively; only 6% at both time points had severe cases. For every 5% decrease in the postbronchodilator FEV(1)/FVC ratio in childhood, the odds of the persistence of severe asthma increased by 2.36-fold (95% confidence interval [CI], 1.70–3.28; P

Published
2021

4. Functional Dyspepsia and Gastroparesis in Tertiary Care are Interchangeable Syndromes With Common Clinical and Pathologic Features

Author

Pankaj J. Pasricha, Madhusudan Grover, Katherine P. Yates, Thomas L. Abell, Cheryl E. Bernard, Kenneth L. Koch, Richard W. McCallum, Irene Sarosiek, Braden Kuo, Robert Bulat, Jiande Chen, Robert J. Shulman, Linda Lee, James Tonascia, Laura A. Miriel, Frank Hamilton, Gianrico Farrugia, Henry P. Parkman, Pankaj Jay Pasricha, Robert Burns, Guillermo Barahona Hernandez, Megan McKnight, April Mendez, Kyle Staller, Andrea Thurler, Christopher Velez, Casey Silvernale, Zubair Malik, Alan Maurer, Amiya Palit, Natalia Vega, Denise Vasquez, Sean Connery, Karina Espino, Marvin Friedman, Thomas Abell, Abigail Stocker, Bridget Cannon, Lindsay McElmurray, Kelly Cooper, Catherine McBride, Kenneth Koch, Lynn Baxter, Anya Brown, Paula Stuart, Amirah Abdullah, William Snape, Nata DeVole, Karen Earle, Kjersti Kirkeby, Candice Lee, Mimi Lin, Doug Troyer, Anna von Bakonyi, Robert Shulman, Bruno Chumpitazi, Liz Febo-Rodriguez, John Hollier, Cynthia Bouette, Heather Charron, Samuel Nurko, Stephanie Wall, Madeline Kane, Kent Williams, Lina Yossef-Salameh, Frederick Woodley, Cheryl Bernard, Jose Serrano, Sherry Hall, Stephen James, Rebecca Torrance, Margaret Adamo, Patricia Belt, John Dodge, Michele Donithan, Milana Isaacson, Jill Meinert, Laura Miriel, Emily Sharkey, Jacqueline Smith, Michael Smith, Alice Sternberg, Mark Van Natta, Annette Wagoner, Laura Wilson, Goro Yamada, and Katherine Yates

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Gastroparesis, Vomiting, Gastroenterology, Tertiary care, Severity of Illness Index, Tertiary Care Centers, 03 medical and health sciences, symbols.namesake, 0302 clinical medicine, Internal medicine, medicine, Upper gastrointestinal, Humans, Registries, Dyspepsia, Hepatology, Gastric emptying, Adult patients, business.industry, Stomach, Nausea, Middle Aged, medicine.disease, Interstitial Cells of Cajal, Pathophysiology, Interstitial cell of Cajal, Abdominal Pain, 030104 developmental biology, medicine.anatomical_structure, Gastric Emptying, Case-Control Studies, symbols, 030211 gastroenterology & hepatology, Female, Symptom Assessment, business
Abstract

Background The aim of this study was to clarify the pathophysiology of functional dyspepsia (FD), a highly prevalent gastrointestinal syndrome, and its relationship with the better-understood syndrome of gastroparesis. Methods Adult patients with chronic upper gastrointestinal symptoms were followed up prospectively for 48 weeks in multi-center registry studies. Patients were classified as having gastroparesis if gastric emptying was delayed; if not, they were labeled as having FD if they met Rome III criteria. Study analysis was conducted using analysis of covariance and regression models. Results Of 944 patients enrolled during a 12-year period, 720 (76%) were in the gastroparesis group and 224 (24%) in the FD group. Baseline clinical characteristics and severity of upper gastrointestinal symptoms were highly similar. The 48-week clinical outcome was also similar but at this time 42% of patients with an initial diagnosis of gastroparesis were reclassified as FD based on gastric-emptying results at this time point; conversely, 37% of patients with FD were reclassified as having gastroparesis. Change in either direction was not associated with any difference in symptom severity changes. Full-thickness biopsies of the stomach showed loss of interstitial cells of Cajal and CD206+ macrophages in both groups compared with obese controls. Conclusions A year after initial classification, patients with FD and gastroparesis, as seen in tertiary referral centers at least, are not distinguishable based on clinical and pathologic features or based on assessment of gastric emptying. Gastric-emptying results are labile and do not reliably capture the pathophysiology of clinical symptoms in either condition. FD and gastroparesis are unified by characteristic pathologic features and should be considered as part of the same spectrum of truly "organic" gastric neuromuscular disorders. ClinicalTrials.gov Identifier NCT00398801, NCT01696747

Published
2020

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

Author

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

Subjects
Blood Glucose, Male, 0301 basic medicine, Pediatric Obesity, Time Factors, Cirrhosis, Biopsy, Type 2 diabetes, Chronic liver disease, Severity of Illness Index, Gastroenterology, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Risk Factors, Nonalcoholic fatty liver disease, Medicine, Glucose homeostasis, Prospective Studies, Child, Randomized Controlled Trials as Topic, Fatty liver, Age Factors, Alanine Transaminase, Treatment Outcome, Disease Progression, Female, 030211 gastroenterology & hepatology, medicine.medical_specialty, Adolescent, Risk Assessment, digestive system, Article, 03 medical and health sciences, Internal medicine, Humans, Aspartate Aminotransferases, Healthy Lifestyle, Hepatology, business.industry, nutritional and metabolic diseases, Odds ratio, medicine.disease, digestive system diseases, 030104 developmental biology, Diabetes Mellitus, Type 2, business, Risk Reduction Behavior, Body mass index, Biomarkers
Abstract

BACKGROUND & AIMS: Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth. METHODS: We 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. RESULTS: At 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 or in fibrosis occurred in 36% of the children, and both occurred in 11% of the children. Any improvement in NASH or fibrosis occurred in 52%, and both occurred in 20% of children. Type 2 diabetes developed in 5% of the cohort. Any progression to NASH and/or fibrosis was associated with adolescent age, higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein-cholesterol at baseline, increasing level of alanine aminotransferase, and hemoglobin A1C (P < .05). Progression to NASH and/or fibrosis were also associated with increasing level of gamma-glutamyl transferase and development of type 2 diabetes (P < .01). Increasing level of gamma-glutamyl transferase also associated with reduced odds of any improvement (P = .003). CONCLUSIONS: One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.

Published
2020

6. The Long-Term Oxygen Treatment Trial for Chronic Obstructive Pulmonary Disease: Rationale, Design, and Lessons Learned

Author

Roger D. Yusen, Gerard J. Criner, Alice L. Sternberg, David H. Au, Anne L. Fuhlbrigge, Richard K. Albert, Richard Casaburi, James K. Stoller, Kathleen F. Harrington, J. Allen D. Cooper, Philip Diaz, Steven Gay, Richard Kanner, Neil MacIntyre, Fernando J. Martinez, Steven Piantadosi, Frank Sciurba, David Shade, Thomas Stibolt, James Tonascia, Robert Wise, William C. Bailey, Ernestina Sampong, Karin Sloan, Ashley Wagner, Susan Anderson, Marilyn Moy, Osarenoma Okunbor, Scott Marlow, Yvonne Meli, Richard Rice, Loutfi S. Aboussouan, Robert Castele, Joseph Parambil, Sumita Khatri, Aman Pande, Joe Zein, Thomas Olbrych, Stephan Alkins, Christine Jocko, Franck Rahaghi, Jean Barton, Jennifer Underwood, Barry Make, John Davies, Richard Mularski, Allison Naleway, Sarah Vertrees, Janos Porszasz, Peggy Walker, Renee Indelicato, Lennard Specht, Kathleen Ellstrom, Jamie Portillo, David Horak, Brian Tiep, Mary Barnett, Janice Drake, Mahasti Rittinger, Rachael Compton, Scott Miller, Ralph J. Panos, Laura A. Lach, Gerard Criner, Carla Grabianowski, Francis Cordova, Parag Desai, Samuel Krachman, James Mamary, Nathaniel Marchetti, Aditi Satti, Eileen Mumm, Michelle Vega-Olivo, Jenny Hua, Vanna Tauch, Lii-Yoong Criner, Michael Jacobs, Peter Rising, Paul Simonelli, Michele Mitchell, Matthew Lammi, Connie Romaine, Howard Lee, Mary Ianacone, Steven Scharf, Wanda Bell-Farrell, M. Jeffery Mador, Ayesha Rahman, Mumtaz Zaman, Lisa Hill, Alec Platt, J. Allen Cooper, Kathleen Harrington, Mark Dransfield, Patti Smith, Donald Davis, Peruvemba Sriram, Katherine Herring, Fernando Martinez, Meilan Han, Kelly Rysso, Catherine Meldrum, K. P. Ravikrishnan, Daniel Keena, Jennifer DeRidder, Beth Kring, Antonio Anzueto, Alex Aguilera, Timothy Houlihan, Reda Girgis, Jennifer Cannestra, Benjamin Kelly, Mary Beth Scholand, G. Martin Villegas, Judy Carle, Edmunds Udris, Randall Curtis, David Au, Laura C. Feemster, Richard Goodman, Brianna Moss, Lynn Reinke, Moira Aitken, Bruce Culver, Mario Castro, Brigitte Mittler, Jeanne Heaghney, Myron Jacobs, Min Joo, Nina Bracken, Edward Diamond, Mary K. Joseph, Xavier Soler, Arianna Villa, Daniel Layish, Edwin Silverman, Roxanne Kelly, Daniel Cossette, Patricia Belt, Amanda Blackford, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, K Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Mark Van Natta, Laura Wilson, Annette Wagoner, Katherine P. Yates, Rosemarie Hakim, Antonello Punturieri, Julie Bamdad, Thomas Croxton, Joanne Deshler, Pamela McCord-Reynolds, Mario Stylianou, Gail Weinmann, Gordon Bernard, James Anderson, Bernard Lo, Andrew Ries, Stuart Stoloff, Byron Thomashow, Barbara Tilley, and Kevin Weiss

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Randomization, Time Factors, medicine.medical_treatment, Population, law.invention, Hypoxemia, Treatment and control groups, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Patient Admission, Randomized controlled trial, law, Oxygen therapy, Medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, education, Aged, Randomized Controlled Trials as Topic, Clinical Study Design, Aged, 80 and over, education.field_of_study, Geography, business.industry, Oxygen Inhalation Therapy, Middle Aged, Long-Term Care, United States, Clinical trial, Oxygen, 030228 respiratory system, Sample size determination, Emergency medicine, Physical therapy, Quality of Life, Female, medicine.symptom, business
Abstract

The Long-Term Oxygen Treatment Trial demonstrated that long-term supplemental oxygen did not reduce time to hospital admission or death for patients who have stable chronic obstructive pulmonary disease and resting and/or exercise-induced moderate oxyhemoglobin desaturation, nor did it provide benefit for any other outcome measured in the trial. Nine months after initiation of patient screening, after randomization of 34 patients to treatment, a trial design amendment broadened the eligible population, expanded the primary outcome, and reduced the goal sample size. Within a few years, the protocol underwent minor modifications, and a second trial design amendment lowered the required sample size because of lower than expected treatment group crossover rates. After 5.5 years of recruitment, the trial met its amended sample size goal, and 1 year later, it achieved its follow-up goal. The process of publishing the trial results brought renewed scrutiny of the study design and the amendments. This article expands on the previously published design and methods information, provides the rationale for the amendments, and gives insight into the investigators' decisions about trial conduct. The story of the Long-Term Oxygen Treatment Trial may assist investigators in future trials, especially those that seek to assess the efficacy and safety of long-term oxygen therapy. Clinical trial registered with clinicaltrials.gov (NCT00692198).

Published
2018

7. Aprepitant has Mixed Effects on Nausea and Reduces Other Symptoms in Patients With Gastroparesis and Related Disorders

Author

Pankaj J. Pasricha, Katherine P. Yates, Irene Sarosiek, Richard W. McCallum, Thomas L. Abell, Kenneth L. Koch, Linda Anh B. Nguyen, William J. Snape, William L. Hasler, John O. Clarke, Sameer Dhalla, Ellen M. Stein, Linda A. Lee, Laura A. Miriel, Mark L. Van Natta, Madhusudan Grover, Gianrico Farrugia, James Tonascia, Frank A. Hamilton, Henry P. Parkman, Nata DeVole, Karen Earle, Kjersti Kirkeby, Candice Lee, Mimi Lin, Katie Ponting, Gloria Yee, Pankaj Jay Pasricha, Ellen Stein, Yale Kim, Gotzone Garay, Chiara Orlando, Alan Mauer, Perry Orthey, Amiya Palit, Sean Connery, Yvette Gomez, Roberta Romero, Natalia Vega, Ben Alvarado, Lisa Hatter, Ronna Howard, Lindsay Nowotny, William Herman, Andrew Kraftson, Amy E. Rothberg, Sophanara Wootten, Lynn Baxter, Anya Brown, Paula Stuart, Samantha Culler, Cheryl Bernard, Frank Hamilton, Jose Serrano, Stephen James, Rebecca Torrance, Sherry Hall, Patricia Belt, John Dodge, Michele Donithan, Erin Hallinan, Milana Isaacson, Patrick K. May, Laura Miriel, Alice Sternberg, Mark Van Natta, Annette Wagoner, and Laura Wilson

Subjects
Adult, Male, medicine.medical_specialty, Gastroparesis, Nausea, Visual analogue scale, Vomiting, Morpholines, Placebo, Gastroenterology, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Medicine, Humans, Adverse effect, Aprepitant, Hepatology, business.industry, Middle Aged, medicine.disease, Treatment Outcome, 030220 oncology & carcinogenesis, Anesthesia, Chronic Disease, Antiemetics, 030211 gastroenterology & hepatology, Female, medicine.symptom, business, medicine.drug
Abstract

Background & Aims There are few effective treatments for nausea and other symptoms in patients with gastroparesis and related syndromes. We performed a randomized trial of the ability of the neurokinin-1 receptor antagonist aprepitant to reduce symptoms in patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome. Methods We conducted a 4-week multicenter, double-masked trial of 126 patients with at least moderate symptoms of chronic nausea and vomiting of presumed gastric origin for a minimum of 6 months. Patients were randomly assigned to groups given oral aprepitant (125 mg/day, n = 63) or placebo (n = 63). The primary outcome from the intention-to-treat analysis was reduction in nausea, defined as a decrease of 25 mm or more, or absolute level below 25 mm, on a daily patient-reported 0-to-100 visual analog scale (VAS) of nausea severity. We calculated relative risks of nausea improvement using stratified Cochran-Mental-Haenszel analysis. Results Aprepitant did not reduce symptoms of nausea, based on the primary outcome measure (46% reduction in the VAS score in the aprepitant group vs 40% reduction in the placebo group; relative risk, 1.2; 95% CI, 0.8–1.7) ( P = .43). However, patients in the aprepitant group had significant changes in secondary outcomes such as reduction in symptom severity (measured by the 0–5 Gastroparesis Clinical Symptom Index) for nausea (1.8 vs 1.0; P = .005), vomiting (1.6 vs 0.5; P = .001), and overall symptoms (1.3 vs 0.7; P = .001). Adverse events, predominantly mild or moderate in severity grade, were more common in aprepitant (22 of 63 patients, 35% vs 11 of 63, 17% in the placebo group) ( P = .04). Conclusions In a randomized trial of patients with chronic nausea and vomiting caused by gastroparesis or gastroparesis-like syndrome, aprepitant did not reduce the severity of nausea when reduction in VAS score was used as the primary outcome. However, aprepitant had varying effects on secondary outcomes of symptom improvement. These findings support the need to identify appropriate patient outcomes for trials of therapies for gastroparesis, including potential additional trials for aprepitant. ClinicalTrials.gov no: NCT01149369.

Published
2017

8. Diagnostic Accuracy of Noninvasive Fibrosis Models to Detect Change in Fibrosis Stage

Author

Mohammad Shadab Siddiqui, Goro Yamada, Raj Vuppalanchi, Mark Van Natta, Rohit Loomba, Cynthia Guy, Danielle Brandman, James Tonascia, Naga Chalasani, Brent Neuschwander-Tetri, Arun J. Sanyal, Daniela Allende, Srinivasan Dasarathy, Arthur J. McCullough, Revathi Penumatsa, Jaividhya Dasarathy, Joel E. Lavine, Manal F. Abdelmalek, Mustafa Bashir, Stephanie Buie, Anna Mae Diehl, Christopher Kigongo, Mariko Kopping, David Malik, Dawn Piercy, Oscar W. Cummings, Samer Gawrieh, Linda Ragozzino, Kumar Sandrasegaran, Elizabeth M. Brunt, Theresa Cattoor, Danielle Carpenter, Janet Freebersyser, Debra King, Jinping Lai, Brent A. Neuschwander-Tetri, Joan Siegner, Susan Stewart, Susan Torretta, Kristina Wriston, Maria Cardona Gonzalez, Jodie Davila, Manan Jhaveri, Kris V. Kowdley, Nizar Mukhtar, Erik Ness, Michelle Poitevin, Brook Quist, Sherilynn Soo, Brandon Ang, Cynthia Behling, Archana Bhatt, Michael S. Middleton, Claude Sirlin, Maheen F. Akhter, Nathan M. Bass, Ryan Gill, Bilal Hameed, Jacqueline Maher, Norah Terrault, Ashley Ungermann, Matthew Yeh, Sherry Boyett, Melissa J. Contos, Sherri Kirwin, Velimir A.C. Luketic, Puneet Puri, Jolene Schlosser, Mohammad S. Siddiqui, Leslie Yost-Schomer, Kathryn Fowler, David E. Kleiner, Edward C. Doo, Sherry Hall, Jay H. Hoofnagle, Jessica J. Lee, Patricia R. Robuck, Averell H. Sherker, Rebecca Torrance, Patricia Belt, Jeanne M. Clark, John Dodge, Michele Donithan, Erin Hallinan, Milana Isaacson, Mariana Lazo, Jill Meinert, Laura Miriel, Jacqueline Smith, Michael Smith, Alice Sternberg, Mark L. Van Natta, Annette Wagoner, Laura A. Wilson, and Katherine Yates

Subjects
Adult, Liver Cirrhosis, Male, Longitudinal study, medicine.medical_specialty, Biopsy, Sensitivity and Specificity, Severity of Illness Index, Gastroenterology, Article, Non-alcoholic Fatty Liver Disease, Predictive Value of Tests, Median follow-up, Fibrosis, Internal medicine, Nonalcoholic fatty liver disease, medicine, Humans, Aspartate Aminotransferases, Stage (cooking), Retrospective Studies, Hepatology, medicine.diagnostic_test, Platelet Count, business.industry, Alanine Transaminase, Middle Aged, medicine.disease, Clinical research, Liver, Disease Progression, Female, Hepatic fibrosis, business
Abstract

BACKGROUND & AIMS: Noninvasive methods are needed to determine disease stage in patients with nonalcoholic fatty liver disease (NAFLD). We evaluated the diagnostic performance of several widely available fibrosis models for the assessment of hepatic fibrosis in patients with NAFLD. METHODS: We performed a retrospective analysis of data from individuals enrolled in the NIDDK NASH Clinical Research Network, from 2004 through 2018. Using biopsy as the reference standard, we determined the diagnostic performance of the aspartate aminotransferase (AST):platelet ratio (APRI), FIB-4, ratio of AST:alanine aminotransferase (ALT) and the NAFLD fibrosis score (NFS) in a cross-sectional study of 1904 subjects. The ability of these models to detect changes in fibrosis stage was assessed in a longitudinal data set of 292 subjects with 2 biopsies and accompanying laboratory data. Outcomes were detection of fibrosis of any stage (stages 0 to 4), detection of moderate fibrosis (stages 0–1 vs 2–4), and detection of advanced fibrosis (stages 0–2 vs 3–4). Diagnostic performance was evaluated using the C-statistic, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) analyses. RESULTS: In the cross-sectional study, FIB-4 and NFS outperformed other non-invasive models for detecting advanced fibrosis; the C-statistics were 0.80 for FIB-4 and 0.78 for NFS. In the longitudinal study, 216 patients had non-advanced fibrosis at baseline and 35 patients progressed to advanced fibrosis after median follow up of 2.6 years. After we adjusted for fibrosis stage and model score at initial biopsy, change in APRI, FIB-4, and NFS were significantly associated with change in fibrosis. A unit change in APRI, FIB-4, or NFS was associated with changes in fibrosis stage of 0.33 (95% CI, 0.20-0.45; P

Published
2019

9. Airway obstruction worsens in young adults with asthma who become obese

Author

Robert C. Strunk, Ryan Colvin, Leonard B. Bacharier, Anne Fuhlbrigge, Erick Forno, Ana Maria Arbelaez, Kelan G. Tantisira, Paul Williams, Mary V. Lasley, Tamara Chinn, Michele Hinatsu, Clifton T. Furukawa, Leonard C. Altman, Frank S. Virant, Michael S. Kennedy, Stephen Tilles, Jonathan W. Becker, C. Warren Bierman, Dan Crawford, Thomas DuHamel, Heather Eliassen, Babi Hammond, Miranda MacLaren, Dominick A. Minotti, Chris Reagan, Gail Shapiro, Marian Sharpe, Ashley Tatum, Grace White, Timothy G. Wighton, Anne Plunkett, Nancy Madden, Susan Anderson, Mark Boehnert, Anita Feins, Amanda Gentile, Natalia Kandror, Kelly MacAulay, Ernestina Sampong, Scott Weiss, Walter Torda, Martha Tata, Sally Babigian, Peter Barrant, Linda Benson, Jose Caicedo, Tatum Calder, Christine Darcy, Anthony DeFilippo, Cindy Dorsainvil, Julie Erickson, Phoebe Fulton, Mary Grace, Jennifer Gilbert, Dirk Greineder, Stephanie Haynes, Margaret Higham, Deborah Jakubowski, Susan Kelleher, Jay Koslof, Dana Mandel, Patricia Martin, Agnes Martinez, Jean McAuliffe, Erika Nakamoto, Paola Pacella, Paula Parks, Johanna Sagarin, Kay Seligsohn, Susan Swords, Meghan Syring, June Traylor, Melissa Van Horn, Carolyn Wells, Ann Whitman, Hartmut Grasemann, Melody Miki, Melinda Solomon, Padmaja Subbarao, Ian MacLusky, Joe Reisman, Henry Levison, Anita Hall, Yola Benedet, Susan Carpenter, Jennifer Chay, Michelle Collinson, Jane Finlayson-Kulchin, Kenneth Gore, Nina Hipolito, Noreen Holmes, Erica Hoorntje, Sharon Klassen, Joseé Quenneville, Renée Sananes, Christine Wasson, Margaret Wilson, N. Franklin Adkinson, Deborah Bull, Stephanie Philips, Peyton Eggleston, Karen Huss, Leslie Plotnick, Margaret Pulsifer, Cynthia Rand, Elizabeth Aylward, Nancy Bollers, Kathy Pessaro, Barbara Wheeler, Stanley Szefler, Ronina Covar, Harold S. Nelson, Bruce Bender, Andrew Liu, D. Sundström, Melanie Phillips, Michael P. White, Melanie Gleason, Kristin Brelsford, Jessyca Bridges, Jody Ciacco, Michael Eltz, Jeryl Feeley, Michael Flynn, Tara Junk-Blanchard, Joseph Hassell, Marcia Hefner, Caroline Hendrickson, Daniel Hettleman, Charles G. Irvin, Alan Kamada, Marzena Krawiec, Gary Larsen, Sai Nimmagadda, Kendra Sandoval, Jessica Sheridan, Joseph Spahn, Gayle Spears, Trella Washington, Eric Willcutt, Ivan Cardona, Kirstin Carel, Jayna Doshi, Rich Hendershot, Jeffrey Jacobs, Neal Jain, June-ku Brian Kang, Tracy Kruzick, Harvey Leo, Beth Macomber, Jonathan Malka, Chris Mjaanes, John Prpich, Lora Stewart, Ben Song, Grace Tamesis, Robert S. Zeiger, Noah Friedman, Michael H. Mellon, Michael Schatz, Terrie Long, Travis Macaraeg, Sandra Christensen, James G. Easton, M. Feinberg, Linda L. Galbreath, Jennifer Gulczynski, Kathleen Harden, Ellen Hansen, Al Jalowayski, Elaine Jenson, Alan Lincoln, Jennie Kaufman, Shirley King, Brian Lopez, Michaela Magiari-Ene, Kathleen Mostafa, Avraham Moscona, Catherine A. Nelle, Jennifer Powers, Elsa Rodriguez, Eva Rodriguez, Karen Sandoval, Nevin W. Wilson, Hengameh H. Raissy, Aaron Jacobs, H. William Kelly, Mary Spicher, Christina Batson, Michelle Harkings, Katie McCallum, Robert Annett, Teresa Archibeque, Naim Bashir, H. Selda Bereket, Marisa Braun, Carrie Bush, Shannon C. Bush, Michael Clayton, Angel Colon-Semidey, Sara Devault, Anna Esparham, Roni Grad, David Hunt, Jeanne Larsson, Sandra McClelland, Bennie McWilliams, Elisha Montoya, Margaret Moreshead, Shirley Murphy, Barbara Ortega, David Weers, Jose Zayas, Leonard Bacharier, Denise Rodgers, Ellen Albers, Gregg Belle, Gordon R. Bloomberg, W. Patrick Buchanan, Mary Caesar, James M. Corry, Karen DeMuth, Marisa Dolinsky, Edwin B. Fisher, Stephen J. Gaioni, Emily Glynn, Bernadette D. Heckman, Debra Kemp, Lila Kertz, Claire Lawhon, Valerie Morgan, Cynthia Moseid, Tina Oliver-Welker, Diana Richardson, Elizabeth Ryan, Sharon Sagal, Thomas F. Smith, Susan Sylvia, Carl Turner, Deborah K. White, James Tonascia, Patricia Belt, Karen Collins, Betty Collison, John Dodge, Michele Donithan, Cathleen Ewing, Rosetta Jackson, Patrick May, Jill Meinert, Girlie Reyes, Michael Smith, Alice L. Sternberg, Mark L. Van Natta, Annette Wagoner, Laura Wilson, Robert Wise, Katherine Yates, Virginia Taggart, Lois Eggers, James Kiley, Howard Moore, Gang Zheng, Paul Albert, Suzanne Hurd, Sydney Parker, Pamela Randall, Margaret Wu, Michelle Cloutier, John Connett, Leona Cuttler, Frank Gilliland, Clarence E. Davis, Howard Eigen, David Evans, Meyer Kattan, Rogelio Menendez, F. Estelle R. Simons, Sanford Leikin, Robert Strunk, Reuben Cherniack, Thomas R. DuHamel, Curtis L. Meinert, Gail G. Shapiro, and Robert Zeiger

Subjects
Adult, Male, Risk, Vital capacity, Pediatrics, medicine.medical_specialty, Adolescent, Childhood obesity, Article, Pulmonary function testing, Body Mass Index, FEV1/FVC ratio, Young Adult, Nedocromil, medicine, Immunology and Allergy, Humans, Obesity, Young adult, Budesonide, Child, Asthma, business.industry, Airway obstruction, medicine.disease, respiratory tract diseases, Respiratory Function Tests, Airway Obstruction, Child, Preschool, Physical therapy, Disease Progression, Female, business, Body mass index, Follow-Up Studies
Abstract

Few studies have examined how developing obesity in early adulthood affects the course of asthma.We analyzed lung function and asthma impairment and risk among nonobese children with asthma, comparing those who were obese in young adulthood with those who remained nonobese.We carried out the post hoc analysis of 771 subjects with mild to moderate asthma who were not obese (pediatric definition, body mass index [BMI]95th percentile) when enrolled in the Childhood Asthma Management Program at ages 5-12 years. The subjects were then followed to age 20 years or more. For visits at ages 20 years or more, spirometry values as percent predicted and recent asthma symptom scores and prednisone exposure were compared between 579 subjects who were nonobese at all visits and 151 who were obese (adult definition of BMI ≥ 30 kg/m(2)) on at least 1 visit (median number of visits when obese = 4, IQR 2-7).Compared with participants who were nonobese (BMI 23.4 ± 2.6 kg/m(2)), those who became obese (BMI 31.5 ± 3.8 kg/m(2)) had significant decreases in forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) (P.0003) and FEV1 (P = .001), without differences in FVC (P = .15) during visits at ages 20 years or more. For each unit increase of BMI, FEV1 percent predicted decreased by 0.29 (P = .0009). The relationship between BMI and lung function was not confounded by sex or BMI at baseline. Asthma impairment (symptom scores) and risk (prednisone use) did not differ between the 2 groups.Becoming obese in early adulthood was associated with increased airway obstruction, without impact on asthma impairment or risk.

Published
2015

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