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1. Examining the association of habitual e-cigarette use with inflammation and endothelial dysfunction in young adults: The VAPORS-Endothelial function study

Author

Ellen Boakye+, S. M. Iftekhar Uddin+, Ngozi Osuji, Jill Meinert, Olufunmilayo H. Obisesan, Mohammadhassan Mirbolouk, Erfan Tasdighi, Omar El-Shahawy, John Erhabor, Albert D. Osei, Tanuja Rajan, Michael Patatanian, Janet T. Holbrook, Aruni Bhatnagar, Shyam S. Biswal, and Michael J. Blaha

Subjects
e-cigarette, endothelial dysfunction, inflammation, flow-mediated dilation, reactive hyperemia index, Diseases of the respiratory system, RC705-779, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Introduction Acute exposure to e-cigarette aerosol has been shown to have potentially deleterious effects on the cardiovascular system. However, the cardiovascular effects of habitual e-cigarette use have not been fully elucidated. Therefore, we aimed to assess the association of habitual e-cigarette use with endothelial dysfunction and inflammation – subclinical markers known to be associated with increased cardiovascular risk. Methods In this cross-sectional study, we analyzed data from 46 participants (23 exclusive e-cigarette users; 23 non-users) enrolled in the VAPORS-Endothelial function study. E-cigarette users had used e-cigarettes for ≥6 consecutive months. Non-users had used e-cigarettes

Published
2023
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2. The mediating roles of the oral microbiome in saliva and subgingival sites between e-cigarette smoking and gingival inflammation

Author

Bongsoo Park, Hyunwook Koh, Michael Patatanian, Hermes Reyes-Caballero, Ni Zhao, Jill Meinert, Janet T. Holbrook, Leah I. Leinbach, and Shyam Biswal

Subjects
Electronic cigarette, Oral microbiome, Saliva microbiome, Subgingival microbiome, Gingival inflammation, Periodontal disease, Microbiology, QR1-502
Abstract

Abstract Background Electronic cigarettes (ECs) have been widely used by young individuals in the U.S. while being considered less harmful than conventional tobacco cigarettes. However, ECs have increasingly been regarded as a health risk, producing detrimental chemicals that may cause, combined with poor oral hygiene, substantial inflammation in gingival and subgingival sites. In this paper, we first report that EC smoking significantly increases the odds of gingival inflammation. Then, through mediation analysis, we seek to identify and explain the mechanism that underlies the relationship between EC smoking and gingival inflammation via the oral microbiome. Methods We collected saliva and subgingival samples from 75 EC users and 75 non-users between 18 and 34 years in age and profiled their microbial compositions via 16S rRNA amplicon sequencing. We conducted raw sequence data processing, denoising and taxonomic annotations using QIIME2 based on the expanded human oral microbiome database (eHOMD). We then created functional annotations (i.e., KEGG pathways) using PICRUSt2. Results We found significant increases in α-diversity for EC users and disparities in β-diversity between EC users and non-users. We also found significant disparities between EC users and non-users in the relative abundance of 36 microbial taxa in the saliva site and 71 microbial taxa in the subgingival site. Finally, we found that 1 microbial taxon in the saliva site and 18 microbial taxa in the subgingival site significantly mediated the effects of EC smoking on gingival inflammation. The mediators on the genus level, for example, include Actinomyces, Rothia, Neisseria, and Enterococcus in the subgingival site. In addition, we report significant disparities between EC users and non-users in the relative abundance of 71 KEGG pathways in the subgingival site. Conclusions These findings reveal that continued EC use can further increase microbial dysbiosis that may lead to periodontal disease. Our findings also suggest that continued surveillance for the effect of ECs on the oral microbiome and its transmission to oral diseases is needed.

Published
2023
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3. 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
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4. 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

5. 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

6. Characteristics and trends of clinical trials funded by the National Institutes of Health between 2005 and 2015

Author

Gillian Gresham, Jill Meinert, Stephan Ehrhardt, Curtis L. Meinert, and Lawrence J. Appel

Subjects
medicine.medical_specialty, Biomedical Research, Databases, Factual, Alternative medicine, 030204 cardiovascular system & hematology, 03 medical and health sciences, Clinical trials, Sex Factors, 0302 clinical medicine, National Institutes of Health, National Institutes of Health Institutes and Centers, medicine, Humans, 030212 general & internal medicine, clinical trial registration, Pharmacology, Clinical Trials as Topic, Descriptive statistics, ClinicalTrials.gov, business.industry, Age Factors, Articles, General Medicine, clinical trial funding, United States, Clinical trial, National Institutes of Health (U.S.), Aggregate analysis, Research Design, Family medicine, business
Abstract

Background The National Institutes of Health is one of the largest biomedical research agencies in the world. Clinical trials are an important component of National Institutes of Health research efforts. Given the recent updates in National Institutes of Health trial reporting requirements, more information regarding the current state of National Institutes of Health-funded clinical trials is warranted. The objective of this analysis was to describe characteristics and trends of clinical trials funded by the National Institutes of Health over time and by Institutes and Centers of the National Institutes of Health. Methods Interventional studies funded by the National Institutes of Health and registered in ClinicalTrials.gov between 2005 and 2015 were included in the analysis. Trials were identified from the 27 March 2016 Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database. A descriptive analysis of trials by year and National Institutes of Health Institute/Center was performed. Results There were 12,987 National Institutes of Health-funded clinical trials registered between 2005 and 2015. There were 1,580, 1,116, and 930 trials registered in 2005, 2010, and 2015, respectively. The majority were early-development trials (phases 0, 1, or 2; 53%), randomized (61%), and single-center (63%). Trial demographics have remained unchanged over time. Median trial sample size was 64 (interquartile range 29-192) with 10% of trials enrolling ≥500 participants. Most trials were completed within 5 years of enrollment start (69%). Trial characteristics varied considerably across National Institutes of Health Institutes and Centers. Results were reported under the assumptions that most National Institutes of Health-funded trials are registered in ClinicalTrials.gov and that trials are being registered completely and accurately. Conclusion In conclusion, there has been a decline in the number of trials being funded over time, explained in part by a relatively constant budget, increases in trial costs, or other factors that cannot be quantified. National Institutes of Health-funded trials are relatively small and tend to be single-centered. There are substantial differences in the number and types of trials done by Institutes and Centers within the National Institutes of Health.

Published
2017
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7. 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
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8. Assessment of Trends in the Design, Accrual, and Completion of Trials Registered in ClinicalTrials.gov by Sponsor Type, 2000-2019

Author

Jill Meinert, Arthur G. Gresham, Curtis L. Meinert, and Gillian Gresham

Subjects
medicine.medical_specialty, Randomization, Databases, Factual, Accrual, Cross-sectional study, MEDLINE, law.invention, Randomized controlled trial, Interquartile range, law, medicine, Humans, Statistics and Research Methods, Original Investigation, Clinical Trials as Topic, Internet, business.industry, Research, General Medicine, United States, Clinical trial, Online Only, Cross-Sectional Studies, National Institutes of Health (U.S.), Research Design, Sample size determination, Family medicine, business
Abstract

Key Points Question What are the characteristics and trends of clinical trials registered in ClinicalTrials.gov over time, and how do they differ by sponsor type? Findings In this cross-sectional study of ClinicalTrials.gov registration data on 245 999 interventional studies started between 2000 and 2019 that were sponsored by the National Institutes of Health or other US government agencies, industry, or other sources (foundations, universities, hospitals, clinics, and others), most trials were small, single-site studies that did not have US Food and Drug Administration–defined phases and were sponsored by other sources. Median sample sizes and years to trial completion decreased over time. Meaning The findings suggest that the composition and design of trials changed between 2000 and 2019 and differed substantially by sponsor type; increased funding toward larger randomized clinical trials may be warranted to inform clinical decision-making and guide future research., Importance ClinicalTrials.gov is a valuable resource that can be used to trace the state and nature of trials. Since its launch in 2000, more than 345 000 trials have been registered. Little is known about the characteristics and trends in clinical trials over time and how they differ by sponsor type. Objective To assess trends in clinical trials registered in ClinicalTrials.gov over time and by sponsor type. Design, Setting, and Participants This cross-sectional study included clinical trials (interventional studies) registered in ClinicalTrials.gov from January 1, 2000, through December 31, 2019. The trials were grouped by lead sponsor: National Institutes of Health (NIH) and other US government agencies, industry, and other sources (foundations, universities, hospitals, clinics, and others). A static version of the Clinical Trials Transformation Initiative Aggregate Analysis of ClinicalTrials.gov database was downloaded on January 1, 2020, for analysis. Main Outcomes and Measures ClinicalTrials.gov registration fields, including overall status, phase, intervention, number of sites, use of masking and randomization, sample size, and time to study completion by start year and lead sponsor (organization that provided funding or support for a clinical study). Results A total of 245 999 clinical trials (interventional studies) were started between 2000 and 2019, of which 135 144 (54.9%) were completed. Among completed trials, 5113 (3.8%) were sponsored by the NIH or a US government agency, 48 668 (36.0%) by industry, and 81 363 (60.2%) by other sources. Most trials were single center (61.3%), randomized (65.6%), and phase 1 to 2 (35.5%) or did not have a US Food and Drug Administration–defined phase (38.4%), with fewer drug trials being conducted over time. Sample sizes were small (median, 60; interquartile range [IQR], 30-160) and diminished over time. Trial median completion times varied by lead sponsor: 3.4 years (IQR, 1.9-5.0 years) for NIH- and US government–sponsored trials, 1.2 years (IQR, 0.5-2.4 years) for industry trials, and 2.1 years (IQR, 1.1-3.7) for trials sponsored by other sources. Conclusions and Relevance The findings suggest that the composition and design of trials changed from 2000 to 2019 and differed substantially by sponsor type. Increased funding toward larger randomized clinical trials may be warranted to inform clinical decision-making and guide future research., This cross-sectional study assesses characteristics and trends in clinical trials registered in ClinicalTrials.gov from 2000 to 2019 and how they differed by sponsor type.

Published
2020
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9. 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

10. 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
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11. CT Metrics of Airway Disease and Emphysema in Severe COPD

Author

James Walter, David Godwin, Joyce Canterbury, Thomas E. Hartman, Yen Pin Chiang, Jeanne Smith, John J. Reilly, Hope Livingston, Abby M. Krichman, Mahasti Rittinger, Karma L. Kreizenbeck, Kymberley Anable, Ameena Al-Amin, Colleen Witt, Karen McVearry, Claude Deschamps, Selim M. Arcasoy, Liz Roessler, James K. Stoller, Yahya M. Berkmen, Paul J. Friedman, Enrique Fernandez, Laura Kotler-Klein, Chris Piker, Robert E. Hyatt, Mark J. Krasna, Priscilla McCreight, Jo Anna Baldwin, Jennifer M Lamb, Francisco Alvarez, Janet R. Maurer, Rodney Simcox, Gerald O'Brien, Iris Moskowitz, Marianne C. Fahs, Judd Gurney, A. Mark Fendrick, Mike Mantinaos, Sanjay Kalra, Robert M. Kaplan, Kevin R. Flaherty, Timothy Gilbert, James K. Garrett, Kathy Mieras, Kapreena Owens, Trina Limberg, Patricia Belt, Rolf D. Hubmayr, Roger Barnette, James Carter, Phillip M. Boiselle, Brian Woodcock, Anne Marie Kuzma, Brian F. Mullan, Dean Follmann, Mary Ellen Kleinhenz, Judith Harle, Ubaldo J. Martin, Bonnie Edwards, Fernando I. Martinez, Sandy Do, Alejandro A. Diaz, F.C. Sciurba, William Russell, David J. Sugarbaker, Theresa Alcorn, Susan Borosh, Patricia McDowell, Carolyn Wheeler, Blake Wood, Edwin K. Silverman, Alan J. Moskowitz, John F. Plankeel, William F. Bria, Susan Clark, Patricia Ward, Scott D. Ramsey, Barry J. Make, David H Kupferberg, Chinh T. Q. Nguyen, Stanley Aukberg, Elisabeth L. George, Steven Piantadosi, Geoffrey McLennan, Carl D. Mottram, Martin Zamora, Marvin Pomerantz, Ella A. Kazerooni, Jennifer Propst, Bessie Kachulis, Carol Fanning, Valentina Yegyan, Kenneth Silver, James P. Kiley, Sabine Duffy, David H. Harpole, Junfeng Guo, Donald C. Oxorn, Andrew L. Ries, Paramjit Gill, Bruce H. Culver, Todd M. Officer, Catherine Wood Larsen, John Hansen-Flaschen, Patrick Ross, Mindi Steiger, Lori Hanson, Rose Butanda, Paul F. Simonelli, Neil W. Brister, Amy Chong, Charles L. White, Eric A. Jensen, Cynthia Raymond, Mark K. Ferguson, Moulay Meziane, Mary Milburn-Barnes, James D. Luketich, Douglas E. Wood, A. John McSweeny, Woo Jin Kim, Kim Stavrolakes, John A. Waldhausen, Gregory L. Aughenbaugh, Chul Kwak, Sara L. Bartling, Joan Osterloh, Larry R. Kaiser, John S. Howe, Michael I. Lewis, Andrew Bowdle, Mark A. Gerhardt, Richard O'Connell, Brian R. Lawlor, Neil R. MacIntyre, David A. Lynch, Milton Joyner, Louie Boitano, James P. Utz, Everett Hood, Paul J. Smith, Joshua O. Benditt, John Apostolakis, Frances L. Brogan, Robert McKenna, Berend Mets, Phyllis Dibbern, Kevin Carney, Joan M. Lacomis, Kevin McCarthy, A. Laurie Shroyer, Mitchell K. O’Shea, Barry Make, Dora Greene, Janice Willey, Catherine Ramirez, Gwendolyn B. Vance, Philip R. Karsell, David DeMets, Angela DiMango, Peter Rising, Erik J. Kraenzler, Michael F. Keresztury, Laurie Ney Silfies, Michael Magliocca, Vivian Knieper, Betsy Ann Bozzarello, Marlene Edgar, Madelina Lorenzon, Deb Andrist, Sophia Chatziioannou, Darryl Atwell, Sally Frese, Ruth Etzioni, Stephen I. Marglin, Maria Shiau, Thomas Schroeder, Vincent J. Carey, Vladmir Formanek, Robert Levine, Cindy Chwalik, David Rittinger, Kenneth Martay, Brett A. Simon, Nancy Kurokawa, Anne L. Fuhlbrigge, Peter J. Julien, Michelle T. Toshima, Sean D. Sullivan, Joanne Deshler, Margaret Wu, Anthony Norris, David A. Lipson, Scott J. Swanson, Diane Lockhart, Omar A. Minai, Joseph l. Reeves-Viets, Raed A. Dweik, Keith S. Naunheim, Angela Delsing, Minnie Ellisor, Jane Whalen-Price, Victor F. Tapson, Leonard Rossoff, Susan M. Peterson, Deborah Nowakowski, David M. Shade, Susanne Snedeker, Susan Craemer, Anne Marie G. Sykes, Jennifer Norten, Manmohan S. Biring, Diane C. Strollo, Beth Elliot, Kedren Williams, Heather Sheaffer, Sheila Shearer, Robert P. Hoffman, Robert Quaife, J. Mendez, Donald A. Mahler, Janice Cook-Granroth, Scott Marlow, Zab Mosenifar, Malcolm M. DeCamp, Paul J. Christensen, Rosetta Jackson, Wissam Chatila, Robert Schilz, Glenda DeMercado, Peter B. O'Donovan, Kimberly Dubose, Robert J. Keenan, Satoshi Furukawa, Theodore Kopp, Gerald T. Ayres, Betty Collison, Stephen J. Swensen, Jennifer Stone-Wynne, Nicole Jenson, Stanley S. Siegelman, Tina Bees, Owen B. Wilson, R. Duane Davis, Pierre A. DeVilliers, Marcia Katz, Carolyn M. Clancy, Eddie L. Hoover, Bryan Benedict, Karen Kirsch, Philip M. Hartigan, Simon C. Body, Mark Stafford-Smith, David A. Zisman, Jeanne M. Hoffman, Fernando J. Martinez, Clarence Weir, Jeffrey D. Edelman, William Stanford, Zab Mohsenifar, Michael P. Donahoe, Michele Donithan, Catherine A. Meldrum, William A. Slivka, Lori Zaremba, Michael W. Smith, Martin D. Abel, Robert B Gerber, Sarah Hooper, Steven M. Scharf, Karen A. Hanson, Katherine P. Grichnik, J. Sanford Schwartz, Margaret L. Snyder, Charles J. Hearn, Joe Chin, Tammy Ojo, Gregory D.N. Pearson, Vera Edmonds, George R. Washko, Christine Young, Jennifer Minkoff-Rau, Ron Daniele, Chun Yip, Gregory L. Foster, Harold I. Palevsky, Joan E. Sexton, Dev Pathak, Pamela Fox, Paul E. Kazanjian, Karen King, Jacqueline Pfeffer, Imran Nizami, Judith Wagner, Catherine Wrona, John H. M. Austin, Karla Conejo-Gonzales, Sharon Bendel, Amir Sharafkhaneh, Carol Geaga, Denise Vilotijevic, Thomas H. Sisson, Steven H. Sheingold, Ryan Colvin, Elaine Baker, Karen Collins, Charles F. Emery, Mark Ginsburg, Abass Alavi, David D. Frankville, Joseph M. Reinhardt, Jan Drake, John M. Travaline, Rafael Espada, Kathy Lautensack, Leslie E. Quint, Jeffrey T. Chapman, Rosemary Lann, Steven M. Berkowitz, Alice L. Sternberg, Thurman Gillespy, Nadia Howlader, Frank J. Papatheofanis, Robert Frantz, Manuel L. Brown, Sarah Shirey, Yvonne Meli, Andra E. Ibrahim, Patricia A. Jellen, Rebecca Crouch, Warren B. Gefter, Michael J. Reardon, Jonathan B. Orens, Neal S. Kleiman, Marilyn L. Moy, Daniel L. Miller, Julie Fuller, Reuben M. Cherniack, Claudette Sikora, Lynn Bosco, Harry Handelsman, R. Edward Coleman, Judith M. Aronchick, James Tonascia, Delmar J. Gillespie, Patricia Berkoski, David P. Kapelanski, Cesar A. Keller, Amanda L. Blackford, Charles C. Miller, Kelly M. Campbell, Jill Meinert, Carl R. Fuhrman, Gordon R. Bernard, Connie Hudson, Roger Russell, Lewis Poole, Dale Williams, Magdy Younes, Shing Lee, Steven L. Sax, Martin Carlos, Diane C. Saunders, John Dodge, Matthew N. Bartels, Amy Jahn, Karen Taylor, Gregg L Ruppel, Wallace T. Miller, Mary Gilmartin, Tanisha Carino, Alfred P. Fishman, Gerene Bauldoff, Frank C. Sciurba, Gerard J. Criner, John Haddad, Mark D. Iannettoni, Terri Durr, Gordon F. Harms, Susan Golden, Norman E. Torres, Lisa Geyman, Alan Hibbit, Paul Rysso, Gilbert E. D'Alonzo, Henry E. Fessler, Mark L. Van Natta, Peter Wahl, James H. Harrell, Willard Chamberlain, Roger D. Yusen, Boleyn Hammel, Dawn E. Sassi-Dambron, Mark S. Allen, Jennifer Cutler, Shangqian Qi, Susan Rinaldo-Gallo, John D. Newell, June Hart, Raúl San José Estépar, Kerri McKeon, Staci Opelman, Eric S. Edell, Kathy Winner, Joe R. Rodarte, Mark A. King, Eric A. Hoffman, Laura A. Wilson, Phil Cagle, Jennifer Meyers, Kristin Berry, Mark P. Steele, Katherine Hale, Peter Barnard, Charles Soltoff, Melissa Weeks, Arfa Khan, Cary Stolar, Jeanine P. Wiener-Kronish, Jeannie Ricketts, Nancy Battaglia, Francine L. Jacobson, Satish G. Jhingran, Robert B. Teague, Mary Louise Dempsey, Leighton Chan, Philip T. Diaz, David Hicks, David E. Midthun, Charlene Levine, Andetta R. Hunsaker, Tomeka Simon, Jered Sieren, Susan Lubell, Scott A. Schartel, H P McAdams, Francis Cordova, Kris Bradt, Jeffery J. Johnson, Kenneth White, Mercedes True, Erin A. Sullivan, Byron Thomashow, Gail Weinmann, Robert A. Wise, Donna Tsang, Robert M. Kotloff, Atul C. Mehta, Gregory Tino, and Angela Wurster

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pathology, Critical Care and Intensive Care Medicine, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, Cohort Studies, Pulmonary Disease, Chronic Obstructive, Predictive Value of Tests, Forced Expiratory Volume, Internal medicine, medicine, Humans, Lung volumes, Respiratory system, Aged, Probability, Original Research, Analysis of Variance, Univariate analysis, COPD, business.industry, Total Lung Capacity, Respiratory disease, Middle Aged, respiratory system, Airway obstruction, medicine.disease, Respiratory Function Tests, respiratory tract diseases, Airway Obstruction, Dyspnea, medicine.anatomical_structure, Pulmonary Emphysema, Multivariate Analysis, Cardiology, Female, Pulmonary Ventilation, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business, Airway, Respiratory tract
Abstract

Background CT scan measures of emphysema and airway disease have been correlated with lung function in cohorts of subjects with a range of COPD severity. The contribution of CT scan-assessed airway disease to objective measures of lung function and respiratory symptoms such as dyspnea in severe emphysema is less clear. Methods Using data from 338 subjects in the National Emphysema Treatment Trial (NETT) Genetics Ancillary Study, densitometric measures of emphysema using a threshold of −950 Hounsfield units (%LAA-950) and airway wall phenotypes of the wall thickness (WT) and the square root of wall area (SRWA) of a 10-mm luminal perimeter airway were calculated for each subject. Linear regression analysis was performed for outcome variables FEV 1 and percent predicted value of FEV 1 with CT scan measures of emphysema and airway disease. Results In univariate analysis, there were significant negative correlations between %LAA-950 and both the WT ( r = −0.28, p = 0.0001) and SRWA ( r = −0.19, p = 0.0008). Airway wall thickness was weakly but significantly correlated with postbronchodilator FEV 1 % predicted (R = −0.12, p = 0.02). Multivariate analysis showed significant associations between either WT or SRWA (β = −5.2, p = 0.009; β = −2.6, p = 0.008, respectively) and %LAA-950 (β = −10.6, p = 0.03) with the postbronchodilator FEV 1 % predicted. Male subjects exhibited significantly thicker airway wall phenotypes (p = 0.007 for WT and p = 0.0006 for SRWA). Conclusions Airway disease and emphysema detected by CT scanning are inversely related in patients with severe COPD. Airway wall phenotypes were influenced by gender and associated with lung function in subjects with severe emphysema.

Published
2009
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12. 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

13. Recruitment of Participants in the Childhood Asthma Management Program (CAMP). I. Description of Methods

Author

Suzanne S. Hurd, Harold S. Nelson, Clarence E. Davis, Babi Hammond, Brian Lopez, Diane Becker, Renee Sananes, C. Warren Bierman, Virginia S. Taggart, Betsy Leritz, Bruce G. Bender, Brian Watson, Diana S. Richardson, Colleen Lum Lung, Jennifer Chay, Gail G. Shapiro, Reuben M. Cherniack, N. Franklin Adkinson, Margaret Higham, Ann Whitman, Melody Miki, Yola Benedet, Curtis L. Meinert, Henry Levison, Carolyn Wells, Rosetta Jackson, Sai R. Nimmagadda, Michael P. White, Kenneth Gore, Noah J. Friedman, Bennie McWilliams, Grace Strodtbeck, Selda Bereket, Catherine A. Nelle, Leonard C. Altman, Stephen J. Gaioni, Robert Rice, Stephanie Philips, Mary Caesar, Claire Lawhon, June Traylor, Dirk K. Greineder, Ellen Albers, F. Estelle R. Simons, Frank S. Virant, Marian Sharpe, Jessica Sheridan, Howard Eigen, Elaine M. Jenson, Sydney R. Parker, Cathy Herman, Michael S. Kennedy, Cathleen Ewing, Mary Grace, Jean McAuliffe, James G. Easton, Anne Walker, Ellen Hanson, Jeffrey Jacobs, W. Patrick Buchanan, Paola Pacella, Robert A. Wise, Marcia Hefner, Heather Eliassen, Jeryl Feeley, David Herold, Peter Barrant, Denise Rodgers, Shannon C. Bush, Rhonda Emerick, Walter Torda, Leona Cuttler, Jack Wisenauer, Martha Tata, Janice Ware, Michael W. Smith, Carl Turner, Alan J. Lincoln, Clifton T. Furukawa, Dennis Elbert, Ian MacLusky, Chris Reagan, Mildred Pessaro, Joseph Hassell, Jody Ciacco, Barbara Ortega, Margaret Moreshead, R. Menendez, Dawn Dawson, Anita Hall, Robert G. Hamilton, Kay Seligsohn, John E. Connett, Ann Mullen, Melanie Gleason, Susan Kelleher, Eva Rodriquez, Emily Glynn, Cynthia S. Rand, Mary Spicher, Nancy Boilers, Linda L. Galbreath, Robert Huffman, Michele Donithan, H. William Kelly, Karen Huss, Tina Oliver-Welker, Edwin B. Fisher, Eric Willcutt, Paul S. Albert, Alice L. Sternberg, Michael Flynn, James P. Kiley, Judith Harle, James Tonascia, Cindi Culkin, Barbara Wheeler, Jill Meinert, Dan Crawford, Avraham Moscona, David Evans, Nancy Madden, Jonathan W. Becker, Jessyca Bridges, Tom Lynch, Cynthia Moseid, Sarah Oliver, David Hunt, Gordon R. Bloomberg, Sanford Leikin, Sarma Vadlamani, Arlin Lehman, Gregg Belle, Marisa Dolinsky, Leslie P. Plotnick, Michael Schatz, Marisa Braun, Stephanie Haynes, Nevin W. Wilson, Thomas F. Smith, Michelle Collinson, Senia Pizzo, Pat Belt, D.A. Sundstrom, Christopher Dawson, Joe Reisman, Melissa Van Horn, Trella Washington, Anthony A. Horner, Margaret Wu, Sharon Sagel, Timothy G. Wighton, Carol Schatz, Agnes Martinez, Tamara Chinn, Robert S. Zeiger, Caroline Hendrickson, Paula Parks, Karen Sandoval, A.H. Liu, Margaret B. Pulsifer, Joseph D. Spahn, Ronald J. Harbeck, Meyer Kattan, Michael Mellon, Robert D. Annett, Debra Amend-Libercci, Jane Finlayson-Kulchin, Bernadette D. Heckman, Peyton A. Eggleston, James M. Corry, Vera Edmonds, Pamela Randall, Paul V. Wil-Hams, Kimberly Hyatt, Deborah Nowakowski, Michael Eltz, Daniel Hettleman, Anthony De Filippo, Betty Collison, Kristin Brelsford, John Dodge, Thomas R. DuHamel, Kung Yee Liang, Stanley J. Szefler, Bob Hughes, Kathleen Mostafa, Karen Collins, Rolland I. Poust, Elizabeth P. Ryan, Kendra Sandoval, Dominick A. Minotti, Debra Kemp, Michaela Magiari, Deborah K. White, Anne Plunkett, Dana Mandel, Al Jalowayski, Leonard B. Bacharier, Robert C. Strunk, Mark L. Van Natta, Susan C. Sylvia, Jay Koslof, Charles G. Irvin, Scott T. Weiss, Tara Junk, Kathleen Harden, Alan K. Kamada, Shirley King, Michelle M. Cloutier, and Michael H. Clayton

Subjects
Pulmonary and Respiratory Medicine, Clinical trial, Pediatrics, medicine.medical_specialty, Childhood asthma, business.industry, Pediatrics, Perinatology and Child Health, medicine, Immunology and Allergy, medicine.disease, business, Asthma
Published
1999
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14. Gender indexing in publications of clinical trials: 1991-2008

Author

Curtis L. Meinert, Jill Meinert, and Lea T. Drye

Subjects
Male, medicine.medical_specialty, Biomedical Research, Databases, Factual, Abstracting and Indexing, MEDLINE, Alternative medicine, Phases of clinical research, law.invention, Sex Factors, Randomized controlled trial, law, Social Justice, medicine, Humans, Pharmacology, Publishing, Clinical Trials as Topic, National Library of Medicine (U.S.), business.industry, General Medicine, Organizational Policy, United States, Clinical trial, Multicenter study, National Institutes of Health (U.S.), Physical therapy, Female, business, Prejudice
Abstract

Background In 1993 Congress passed the NIH Revitalization Act, which instructed the Director of the NIH to ensure that phase III clinical trials are ‘designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect females or members of minority groups, as the case may be, differently than other subjects in the trial.’ Purpose The purpose of this article is to track the PubMed indexing of gender in clinical trial publications since 1991 with a view toward assessing the impact of the legislation on the number of gender specific trials. Methods We searched PubMed for full-length publications from years 1991 to 2008 of research on humans indexed as publication type ‘clinical trial’, ‘randomized clinical trial’ and multicenter randomized trial (‘multicenter study’ AND ‘randomized clinical trial’), and counted the number of trials indexed as male-only, female-only, male and female, and gender unknown in PubMed. Results The majority of trial publications were indexed in PubMed as including both genders. The proportion of publications indexed as including both genders has increased while the number of publications not indexed with respect to gender and the number of publications indexed as male-only have decreased. In 2005, approximately 13% of NIH expenditures were for female specific or related research compared to 6% for male specific or related research. Limitations The proportion of clinical trial publications that were indexed in PubMed as including females began to increase before the legislation so it is difficult to conclude that changes in the number of female-only or male-only trials are due to the legislation. PubMed listings do not include gender enrollment, so female and male enrollment totals could not be compared. Conclusions The NIH policy should be rewritten to be made gender neutral to bring it in line with the principle of justice as embodied in the Belmont Report. Clinical Trials 2010; 7: 677—685. http://ctj.sagepub.com

Published
2010

15. Factors Predicting Visual Acuity Outcome in Intermediate, Posterior, and Panuveitis: The Multicenter Uveitis Steroid Treatment (MUST) Trial

Author

John H. Kempen, Mark L. Van Natta, Michael M. Altaweel, James P. Dunn, Douglas A. Jabs, Susan L. Lightman, Jennifer E. Thorne, Janet T. Holbrook, Glenn J. Jaffe, Brenda Branchaud, Paul Hahn, Larry Koreen, Eleonora (Nora) M. Lad, Phoebe Lin, Joseph Nissim Martel, Neha (Shah) Serrano, Cindy Skalak, Lejla Vajzovic, Claxton Baer, Joyce Bryant, Sai Chavala, Michael Cusick, Shelley Day, Pouya Dayani, Justis Ehlers, Muge Kesen, Annie Lee, Alex Melamud, Jawad A. Qureshi, Adrienne Williams Scott, Robert F. See, Robert K. Shuler, Megan Wood, Steven Yeh, Alcides Fernandes, Deborah Gibbs, Donna Leef, Daniel F. Martin, Sunil Srivastava, Hosne Begum, Jeff Boring, Kristen L. Brotherson, Bryn Burkholder, Nicholas J. Butler, Dennis Cain, Mary A. Cook, David Emmert, Janis R. Graul, Mark Herring, Ashley Laing, Theresa G. Leung, Michael C. Mahon, Ahmafreza Moradi, Antonia Nwankwo, Trucian L. Ostheimer, Terry Reed, Ellen Arnold, Patricia M. Barnabie, Marie-Lynn Belair, Stephen G. Bolton, Joseph B. Brodine, Diane M. Brown, Lisa M. Brune, Anat Galor, Theresa Gan, Adam Jacobowitz, Meera Kapoor, Sanjay Kedhar, Stephen Kim, Henry A. Leder, Alison G. Livingston, Yavette Morton, Kisten Nolan, George B. Peters, Priscilla Soto, Ricardo Stevenson, Michelle Tarver-Carr, Yue Wang, C. Stephen Foster, Stephen D. Anesi, Linda Bruner, Olga Ceron, David M. Hinkle, Nancy Persons, Bailey Wentworth, Sarah Acevedo, Fahd Anzaar, Tom Cesca, Angelica Contero, Kayleigh Fitzpatrick, Faith Goronga, Jyothir Johnson, Karina Q. Lebron, Danielle Marvell, Chandra Morgan, Nita Patel, Jennifer Pinto, Sana S. Siddique, Janet Sprague, Taygan Yilmaz, H. Nida Sen, Michael Bono, Denise Cunningham, Darryl Hayes, Dessie Koutsandreas, Robert B. Nussenblatt, Patti R. Sherry, Gregory L. Short, Wendy Smith, Alana Temple, Allison Bamji, Hanna Coleman, Geetaniali Davuluri, Lisa Faia, Chloe Gottlieb, Guy V. Jirawuthiworavong, Julie C. Lew, Richard Mercer, Dominic Obiyor, Cheryl H. Perry, Natalia Potapova, Eric Weichel, Keith J. Wroblewski, Paul A. Latkany, Corinne Coonan, Andrea Honda, Monica Lorenzo-Latkany, Robert Masini, Susan Morell, Angela Nguyen, Jason Badamo, Kenneth M. Boyd, Matthew Enos, Jenny Gallardo, Jacek Jarczynski, Ji Yun Lee, Mirjana McGrosky, Ann Nour, Meredith Sanchez, Kate Steinberg, Richard J. Stawell, Lisa Breayley, Carly D'Sylva, Elizabeth Glatz, Lauren Hodgson, Lyndell Lim, Cecilia Ling, Rachel McIntosh, Julie Morrison (Ewing), Andrew Newton, Sutha Sanmugasundram, Richard Smallwood, Ehud Zamir, Nicola Hunt, Lisa Jones, Ignatios Koukouras, Suzanne Williams, Pauline T. Merrill, Danielle Carns, Len Richine, Denise L. Voskuil-Marre, Kisung Woo, Bruce Gaynes, Christina Giannoulis, Pam Hulvey, Elaine Kernbauer, Heena S. Khan, Sarah J. Levine, Scott Toennessen, Eileen Tonner, Robert C. Wang, Hank Aguado, Sally Arceneaux, Karen Duignan, Gary E. Fish, Nick Hesse, Diana Jaramillo, Michael Mackens, Jean Arnwine, David Callanan, Kimberly Cummings, Keith Gray, Susie Howden, Karin Mutz, Brenda Sanchez, Susan Lightman, Filis Ismetova, Ashley Prytherch, Sophie Seguin-Greenstein, Oren Tomkins, Asat Bar, Kate Edwards, Lavanish Joshi, Jiten Moraji, Ahmed Samy, Timothy Stubbs, Simon Taylor, Hamish Towler, Rebecca Tronnberg, Gary N. Holland, Robert D. Almanzor, Jose Castellanos, Jean Pierre Hubschman, Ann K. Johiro, Alla Kukuyev, Ralph D. Levinson, Colin A. McCannel, Susan S. Ransome, Christine R. Gonzales, Anurag Gupta, Partho S. Kalyani, Michael A. Kapamajian, Peter J. Kappel, Cheryl Arcinue, Janne Chuang, Giulio Barteselli, Glenn Currie, Veronica Mendoza, Debbie Powell, Tom Clark, Denine E. Cochran, William R. Freeman, Joshua Hedaya, Tiara Kemper, Igor Kozak, Jacqueline M. LeMoine, Megan E. Loughran, Luzandra Magana, Francesca Mojana, Victoria Morrison, Vivian Nguyen, Stephen F. Oster, Nisha Acharya, David Clay, Salena Lee, Mary Lew, Todd P. Margolis, Jay Stewart, Ira G. Wong, Debra Brown, Claire M. Khouri, Debra A. Goldstein, Andrea Birnbaum, Andrea Degillio, Gemma De la Rosa, Carmen Ramirez, Evica Simjanowski, Mariner Skelly, Anna L. Castro-Malek, Catherine E. Crooke, Melody Huntley, Katrina Nash, Marcia Niec, Dimitry Pyatetsky, Misel Ramirez, Zuzanna Rozenbajgier, Howard H. Tessler, Janet L. Davis, Thomas A. Albini, Marie Chin, Daniela Castaño, Ariana Elizondo, Macy Ho, Jaclyn L. Kovach, Richard C-S. Lin, Efrem Mandelcorn, Jackie K-D. Nguyen, Aura Pacini, Susan Pineda, David A. Pinto, Jose Rebimbas, Kimberly E. Stepien, Claudia Teran, Susan G. Elner, Hillary Bernard, Linda Fournier, Lindsay Godsey, Linda Goings, Richard Hackel, Moella Hesselgrave, K. Thiran Jayasundera, Robert Prusak, Pamela Titus, Melissa Bergeron, Reneé Blosser, Rebecca Brown, Carrie Chrisman-McClure, Julie R. Gothrup, Stephen J. Saxe, Deanna Sizemore, James Berger, Sheri Drossner, Joan C. DuPont, Albert M. Maguire, Janice Petner, Stephanie Engelhard, Tim Hopkins, Jonathan Lo, Dawn McCall, Monique McRay, Rebecca Salvo, Daniel Will, Wei Xu, Elizabeth Windsor, Laurel Weeney, Peter R. Pavan, Ken Albritton, JoAnn Leto, Brian Madow, Lori Mayor, Scott E. Pautler, Wyatt Saxon, Judy Soto, Burton Goldstein, Amy Klukoff, Lucy Lambright, Kim McDonald, Maria Ortiz, Susan Scymanky, Dee Dee Szalay, Narsing Rao, Tamara Davis, Jackie Douglass, Judith Linton, Margaret Padilla, Sylvia Ramos, Narsing A. Rao, Alexia Aguirre, Lawrence Chong, Lupe Cisneros, Elizabeth Corona, Dean Eliott, Amani Fawzi, Jesse Garcia, Rahul Khurana, Jennifer Lim, Rachel Mead, Julie H. Tsai, Albert Vitale, Paul S. Bernstein, Bonnie Carlstrom, James Gilman, Sandra Hanseen, Paula Morris, Diana Ramirez, Kimberley Wegner, John D. Sheppard, Brianne Anthony, Amber Casper, Lisa Felix-Kent, Jeanette Fernandez, Tari Johnson, Stephen V. Scoper, R. Denise Cole, Nancy Crawford, Lisa Franklin, Krista Hamelin, Jen Martin, Rebecca Marx, Gregory Schultz, Joseph Webb, Pamela Yeager, Rosa Y. Kim, Matthew S. Benz, David M. Brown, Eric Chen, Richard H. Fish, Eric Kegley, Laura Shawver, Tien P. Wong, Rebecca De La Garza, Shayla Friday (Hay), P. Kumar Rao, Eve Adcock, Rajendra S. Apte, Amy Baladenski, Rhonda Curtis, Sarah Gould, Amanda Hebden, Jamie Kambarian, Charla Meyer, Sam Pistorius, Melanie Quinn, Greg Rathert, Kevin J. Blinder, Ashley Hartz, Pam Light, Gaurav K. Shah, Russell VanGelder, Natalie Kurinij, Diane Brown, Nancy Prusakowski, Larry Hubbard, Janet Wittes, William E. Barlow, Marc Hochberg, Alice T. Lyon, Alan G. Palestine, Lee S. Simon, James T. Rosenbaum, Harmon Smith, Janet Davis, Jennifer Thorne, Nisha R. Acharya, Albert T. Vitale, Jeffrey A. Boring, Judith Alexander, Wai Ping Ng, David S. Friedman, Anna Adler, Alyce Burke, Joanne Katz, Susan Reed, Husam Ansari, Nicholas Cohen, Sanjukta Modak, Elizabeth A. Sugar, Alyce E. Burke, Lea T. Drye, Kevin Frick, JoAnn Katz, Thomas A. Louis, David Shade, Karen Pascual, Jill S. Slutsky-Sanon, Amanda Allen, Colby Glomp, Yasmin Hilal, Melissa A. Nieves, Maria Stevens, Francis Abreu, Anne Shanklin Casper, Cathleen Ewing, Adante Hart, Andrea Lears, Shirley Li, Jill Meinert, Vinnette Morrison, Deborah Nowakowski, Girlie Reyes, Dave M. Shade, Jacqueline Smith, Karen Steuernagle, Mark Van Natta, Vidya Venugopal, Tsung Yu, Paul Chen, Karen Collins, John Dodge, Kevin D. Frick, Rosetta Jackson, Christian Jimenez, Ariel Landers, Hope Livingston, Curtis L. Meinert, Sobharani Rayapudi, Weijiang Shen, Charles Shiflett, Rochelle Smith, Ada Tieman, James A. Tonascia, Richard Zheng, James Allan, Wendy K. Benz, Amitha Domalpally, Kristine A. Johnson, Dawn J. Myers, Jeong Won Pak, James L. Reimers, Geoffrey Chambers, Debra J. Christianson, Margaret A. Fleischli, Jacquelyn Freund, Vonnie Gama, Sapna Gangaputra, Kathleen E. Glander, Anne Goulding, Dennis Hafford, Susan E. Harris, Larry D. Hubbard, Jeffrey M. Joyce, Christina N. Kruse, Lauren Nagle, Gwyn E. Padden-Lechten, Alyson Pohlman, Amy Remm, Ruth A. Shaw, Peggy Sivesind, Dennis Thayer, Erika Treichel, Kelly J. Warren, Sheila M. Watson, Mary K. Webster, James K. White, Tara Wilhelmson, and Grace Zhang

Subjects
Male, medicine.medical_specialty, Time Factors, Triamcinolone acetonide, Visual acuity, genetic structures, Visual Acuity, Article, law.invention, Fluocinolone acetonide, Randomized controlled trial, law, Ophthalmology, Panuveitis, medicine, Humans, Glucocorticoids, Macular edema, Aged, Drug Implants, business.industry, Middle Aged, medicine.disease, eye diseases, Treatment Outcome, Female, sense organs, medicine.symptom, business, Tomography, Optical Coherence, Uveitis, Follow-Up Studies, medicine.drug, Cohort study
Abstract

To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes.Cohort study using randomized controlled trial data.Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA.Baseline factors significantly associated with reduced BCVA included age ≥50 vs50 years; posterior vs intermediate uveitis; uveitis duration10 vs6 years; anterior chamber (AC) flaregrade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter (P = .52) and 10 letters (P.001), respectively. Both treatment groups and all sites of uveitis improved similarly. Factors associated with improved BCVA included resolution of active AC cells, resolution of macular thickening, and cataract surgery in an initially cataractous eye. Factors associated with worsening BCVA included longer duration of uveitis (6-10 or10 vs6 years), incident AC flare, cataract at both baseline and follow-up, pseudophakia at baseline, persistence or incidence of vitreous haze, and incidence of macular thickening.Intermediate, posterior, and panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation.

Published
2015
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16. Early Intervention in Low-Birth-Weight Premature Infants

Author

Kathy Tharp, Sam Shapiro, Anita Levine, Kathy Workman Daniels, Debra Amend Libercci, Allan Anfinson, Judy C. Bernbaum, Gerald Laveck, Moira Whitley, Ina Wallace, Patrick Casey, Rosemarie Olmedo, Charles R. Bauer, Vivian Brown, Yvonne Torna, James Tonascia, Sondra Perry, Anne Hogan, Marie C. Mccormick, Patricia Belt, Maureen Mcelhinney, Susan Paolillo, David T. Scott, Kathryn Connor, Cecelia M. Mccarton, Charlotte Gerczak, Nancy, Jeanne Brooks Gunn, Jacqueline Chalmers, Christine Kenny, Jill Meinert, Ben Silverman, Mark Swanson, Pat Lee, Marie C. McCormick, Vaughn I. Rickert, Michele Donithan, Charles Bauer, Carol Mcmullin, Damon Schweitzer, Forrest C. Bennett, Marsha Hoffman Williamson, Dawn Easton, Joann D'agostino, Jackie Hickman, Cecilia M. Mccarton, Curtis L. Meinert, Mary Triolo, Rosemary Deibler, Kathy Tekolste, Mary Ellen Lynch, Bobbie Benz, Kathleen Whitmarsh Barrett, Patrick H. Casey, Wilma Spinner, Kathleen Pearson, Janice Ware, Cecelia Mccarton, Anne Leavitt, Clifford J. Sells, Beverly Laveck, Jon E Tyson, Margaret Churchill, and Sue Paolillo

Subjects
Pediatrics, medicine.medical_specialty, Intelligence quotient, business.industry, Birth weight, Gestational age, General Medicine, medicine.disease, law.invention, Low birth weight, Randomized controlled trial, law, Premature birth, medicine, Early childhood intervention, Neonatal nursing, medicine.symptom, business, reproductive and urinary physiology
Abstract

Objective. —To evaluate the persistence of effects on health and development at age 5 years of the Infant Health and Development Program, an early childhood intervention that was provided to low-birth-weight (LBW) premature infants from neonatal discharge through age 3 years. Design. —Randomized, controlled, multicenter trial, stratified by two LBW groups: lighter (≤2000 g) and heavier (2001 to 2500 g). Setting. —Eight socioeconomically heterogeneous clinical sites. Participants. —Of 985 eligible infants weighing 2500 g or less and at 37 weeks' or less gestational age, 377 infants were randomly assigned to the intervention group and 608 to the follow-up only group. About two thirds of the infants in each group were in the lighter LBW stratum, and one third were in the heavier LBW stratum. Intervention. —The intervention group received home visits (from neonatal discharge through age 3 years) as well as center-based schooling (from 1 to 3 years of age). Children in both groups received pediatric surveillance. Main Outcome Measures. —Cognitive development, behavioral competence, and health status. Results. —At age 5 years, the intervention group had full-scale IQ scores similar to children in the follow-up only group. However, in the heavier LBW stratum, children in the intervention group had higher full-scale IQ scores (3.7 points higher;P=.03) and higher verbal IQ scores (4.2 points higher;P=.02). No significant differences between intervention and follow-up only groups in cognitive measures at age 5 years were noted in the lighter LBW infants. The intervention and follow-up groups were similar in behavior and health measures regardless of LBW stratum. Conclusion. —The early childhood intervention provided in the first 3 years of life had effects on heavier LBW premature infants' IQ and verbal performance at age 5 years that were not observed for lighter LBW premature infants. The intervention did not affect health or behavior at age 5 years in either LBW stratum. (JAMA. 1994;272:1257-1262)

Published
1994
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