Berman, James

ABSTRACTAim:Comparison of days 1 and 2 to each other and to the total recording of 48 hours in continuous 48‐hour wireless esophageal pH monitoring in children.Methods:A retrospective study of 105 patients who underwent 48‐hour pH monitoring (Bravo) studies between January 1992 and June 2010 was performed. Reflux variables were compared between days 1 and 2.Results:A total of 58 (55.2%) patients were men. The number of reflux episodes, number of long reflux >5 minutes, duration of the longest reflux (minutes), time pH <4 (minutes), fraction time pH <4 supine (%), fraction time pH <4 upright (%), reflux index, and DeMeester score did not differ between days 1 and 2.Conclusions:No effect of anesthesia was observed on the gastroesophageal reflux parameters on children.

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.