Christopher B Forrest1, Wallace V Crandall2, L Charles Bailey3, Peixin Zhang4, Marshall M Joffe5, Richard B Colletti6, Jeremy Adler7, Howard I Baron8, James Berman9, Fernando del Rosario10, Andrew B Grossman11, Edward J Hoffenberg12, Esther J Israel13, Sandra C Kim2, Jenifer R Lightdale14, Peter A Margolis15, Keith Marsolo16, Devendra I Mehta17, David E Milov18, Ashish S Patel19, Jeanne Tung20, Michael D Kappelman21. 1. Department of Pediatrics, andLeonard Davis Institute of Health Economics, and forrestc@email.chop.edu. 2. Department of Pediatrics, The Ohio State University College of Medicine, Nationwide Children's Hospital, Columbus, Ohio; 3. Department of Pediatrics, andCenter for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; 4. Department of Pediatrics, and. 5. Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; 6. Department of Pediatrics, The University of Vermont College of Medicine, Burlington, Vermont; 7. Department of Pediatrics and Communicable Diseases, Division of Pediatric Gastroenterology, University of Michigan, Ann Arbor, Michigan; 8. Department of Pediatrics, University of Nevada School of Medicine, Pediatric Gastroenterology and Nutrition Associates, Las Vegas, Nevada; 9. Advocate Children's Hospital, UIC College of Medicine, Loyola University School of Medicine, Chicago, Illinois; 10. Department of Pediatrics, Division of Pediatric Gastroenterology Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware; 11. Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; 12. Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado; 13. Department of Pediatrics, Massachusetts General Hospital for Children, Harvard Medical School, Boston, Massachusetts; 14. Department of Medicine, Boston Children's Hospital, Boston, Massachusetts; 15. Department of Pediatrics, James M. Anderson Center for Health Systems Excellence, and. 16. Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio;Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; 17. Department of Pediatrics, Arnold Palmer Hospital for Children, Florida State University, Orlando, Florida; 18. Department of Pediatrics, Nemour's Children's Hospital, Orlando, Florida; 19. Department of Pediatrics, The University of Texas Southwestern Medical Center, Dallas, Texas;Department of Pediatrics, Children's Medical Center, Dallas, Texas; 20. Department of Pediatric and Adolescent Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and. 21. Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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-tumornecrosis 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.
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