title: Effectiveness of anti-TNFα for Crohn disease: research in a pediatric learning health system.
abstract: OBJECTIVE
  ImproveCareNow (ICN) is the largest pediatric learning health system in the nation and started as a quality improvement collaborative. To test the feasibility and validity of using ICN data for clinical research, we evaluated the effectiveness of anti-tumor necrosis factor-α (anti-TNFα) agents in the management of pediatric Crohn disease (CD).
  
  
  METHODS
  Data were collected in 35 pediatric gastroenterology practices (April 2007 to March 2012) and analyzed as a sequence of nonrandomized trials. Patients who had moderate to severe CD were classified as initiators or non-initiators of anti-TNFα therapy. Among 4130 patients who had pediatric CD, 603 were new users and 1211 were receiving anti-TNFα therapy on entry into ICN.
  
  
  RESULTS
  During a 26-week follow-up period, rate ratios obtained from Cox proportional hazards models, adjusting for patient and disease characteristics and concurrent medications, were 1.53 (95% confidence interval [CI], 1.20-1.96) for clinical remission and 1.74 (95% CI, 1.33-2.29) for corticosteroid-free remission. The rate ratio for corticosteroid-free remission was comparable to the estimate produced by the adult SONIC study, which was a randomized controlled trial on the efficacy of anti-TNFα therapy. The number needed to treat was 5.2 (95% CI, 3.4-11.1) for clinical remission and 5.0 (95% CI, 3.4-10.0) for corticosteroid-free remission.
  
  
  CONCLUSIONS
  In routine pediatric gastroenterology practice settings, anti-TNFα therapy was effective at achieving clinical and corticosteroid-free remission for patients who had Crohn disease. Using data from the ICN learning health system for the purpose of observational research is feasible and produces valuable new knowledge.
authors.affiliation: Department of Pediatrics, andLeonard Davis Institute of Health Economics, and forrestc@email.chop.edu.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Forrest
authors.affiliation: Department of Pediatrics, The Ohio State University College of Medicine, Nationwide Children's Hospital, Columbus, Ohio;
authors.forename: Wallace V
authors.initials: WV
authors.lastname: Crandall
authors.affiliation: Department of Pediatrics, andCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
authors.forename: L Charles
authors.initials: LC
authors.lastname: Bailey
authors.affiliation: Department of Pediatrics, and.
authors.forename: Peixin
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania;
authors.forename: Marshall M
authors.initials: MM
authors.lastname: Joffe
authors.affiliation: Department of Pediatrics, The University of Vermont College of Medicine, Burlington, Vermont;
authors.forename: Richard B
authors.initials: RB
authors.lastname: Colletti
authors.affiliation: Department of Pediatrics and Communicable Diseases, Division of Pediatric Gastroenterology, University of Michigan, Ann Arbor, Michigan;
authors.forename: Jeremy
authors.initials: J
authors.lastname: Adler
authors.affiliation: Department of Pediatrics, University of Nevada School of Medicine, Pediatric Gastroenterology and Nutrition Associates, Las Vegas, Nevada;
authors.forename: Howard I
authors.initials: HI
authors.lastname: Baron
authors.affiliation: Advocate Children's Hospital, UIC College of Medicine, Loyola University School of Medicine, Chicago, Illinois;
authors.forename: James
authors.initials: J
authors.lastname: Berman
authors.affiliation: Department of Pediatrics, Division of Pediatric Gastroenterology Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware;
authors.forename: Fernando
authors.initials: F
authors.lastname: del Rosario
authors.affiliation: Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania;
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Grossman
authors.affiliation: Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado;
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Hoffenberg
authors.affiliation: Department of Pediatrics, Massachusetts General Hospital for Children, Harvard Medical School, Boston, Massachusetts;
authors.forename: Esther J
authors.initials: EJ
authors.lastname: Israel
authors.affiliation: Department of Pediatrics, The Ohio State University College of Medicine, Nationwide Children's Hospital, Columbus, Ohio;
authors.forename: Sandra C
authors.initials: SC
authors.lastname: Kim
authors.affiliation: Department of Medicine, Boston Children's Hospital, Boston, Massachusetts;
authors.forename: Jenifer R
authors.initials: JR
authors.lastname: Lightdale
authors.affiliation: Department of Pediatrics, James M. Anderson Center for Health Systems Excellence, and.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Margolis
authors.affiliation: Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio;
authors.forename: Keith
authors.initials: K
authors.lastname: Marsolo
authors.affiliation: Department of Pediatrics, Arnold Palmer Hospital for Children, Florida State University, Orlando, Florida;
authors.forename: Devendra I
authors.initials: DI
authors.lastname: Mehta
authors.affiliation: Department of Pediatrics, Nemour's Children's Hospital, Orlando, Florida;
authors.forename: David E
authors.initials: DE
authors.lastname: Milov
authors.affiliation: Department of Pediatrics, The University of Texas Southwestern Medical Center, Dallas, Texas;Department of Pediatrics, Children's Medical Center, Dallas, Texas;
authors.forename: Ashish S
authors.initials: AS
authors.lastname: Patel
authors.affiliation: Department of Pediatric and Adolescent Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Tung
authors.affiliation: Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Kappelman
mesh_terms: D000293:Adolescent; D035843:Biomedical Research; D018849:Controlled Clinical Trials as Topic; D003424:Crohn Disease / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D014409:Tumor Necrosis Factor-alpha
keywords: Crohn disease; anti-tumor necrosis factor-α; child; comparative effectiveness research