Posted by ImproveCareNow on June 27, 2014
Dr. Richard Colletti, Executive Network Director for ImproveCareNow, announced earlier this month that an innovative study by ImproveCareNow, using the ImproveCareNow registry database ("ICN2"), has been published in Pediatrics. In addition, the article is being highlighted by the American Gastroenterological Society (AGA). Below are the abstract and the AGA highlights. Congratulations to all of the ImproveCareNow community members, including patients, parents, clinicians, researchers and all committed improvers, who made this possible.
Research in a Pediatric Learning Health System
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-a (anti-TNFa) 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-TNFa therapy. Among 4130 patients who had pediatric CD, 603 were new users and 1211 were receiving anti-TNFa 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-TNFa 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-TNFa 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: Christopher B. Forrest, MD, PhD,a,b Wallace V. Crandall, MD,c L. Charles Bailey, MD, PhD,a,d Peixin Zhang, PhD,a Marshall M. Joffe, MD, MPH, PhD,d Richard B. Colletti, MD,e Jeremy Adler, MD,f Howard I. Baron, MD,g James Berman, MD,h Fernando del Rosario, MD,i Andrew B. Grossman, MD,j Edward J. Hoffenberg, MD,k Esther J. Israel, MD,l Sandra C. Kim, MD,c Jenifer R. Lightdale, MD, MPH,m Peter A. Margolis, MD, PhD,n Keith Marsolo, PhD,o,p Devendra I. Mehta, MD, MS, MRCP,q David E. Milov, MD,r Ashish S. Patel, MD,s,t Jeanne Tung, MD,u and Michael D. Kappelman, MD, MPH,v