David E. Milov

ImproveCareNow: The development of a pediatric inflammatory bowel disease improvement network

&NA; There is significant variation in diagnostic testing and treatment for inflammatory bowel disease. Quality improvement science methods can help address unwarranted variations in care and outcomes. Methods: The ImproveCareNow Network was established under the sponsorship of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the American Board of Pediatrics as a prototype for a model of improving subspecialty care that included three components: 1) creating enduring multicenter collaborative networks of pediatric subspecialists, 2) sharing of performance data collected in patient registries, and 3) training in quality improvement. The network began with a focus on improving initial diagnostic testing and evaluation, the classification of the severity and extent of disease, the detection and treatment of inadequate nutrition and growth, and the appropriate dosing of immunomodulator medications. Changes are based on an evidence‐based model of chronic illness care involving the use of patient registries for population management, previsit planning, decision support, promoting self‐management, and auditing of care processes. Results: Currently, patients are being enrolled at 23 sites. Through 2009, data have been analyzed on over 2500 patients from over 7500 visits. Initial results suggest improvements in both care processes (e.g., appropriate medication dosing and completion of a classification bundle that includes the patients diagnosis, disease activity, distribution and phenotype, growth status, and nutrition status) and outcomes (e.g., the percentage of patients in remission). Conclusions: These improvements suggest that practice sites are learning how to apply quality improvement methods to improve the care of patients. (Inflamm Bowel Dis 2011;)

Short pediatric Crohn's disease activity index for quality improvement and observational research†

Background: Practical and objective instruments to assess pediatric Crohns disease (CD) activity are required for observational research and quality improvement. The objectives were: 1) to determine the feasibility of completing the Pediatric Crohns Disease Activity Index (PCDAI) and the Abbreviated PCDAI (APCDAI); and 2) to create a Short PCDAI by retaining and reweighting the most practical and informative components. Methods: Physicians in the ImproveCareNow Collaborative for pediatric inflammatory bowel disease (IBD) were asked to record components of the PCDAI and assign a Physician Global Assessment (PGA) of disease severity at each patient encounter. We assessed the feasibility of the PCDAI, the APCDAI, and the individual index components by determining the proportion of visits in which data were recorded. We created a short index by retaining and reweighting components of the PCDAI completed in ≥80% of visits. The feasibility of the Short PCDAI and its ability to discriminate between PGA categories were evaluated using descriptive statistics. Results: This study population included 1355 subjects with CD (6373 visits). The PCDAI and APCDAI were complete in 16.7% and 44.1% of visits, respectively. A Short PCDAI, including general well‐being, abdominal pain, stools, weight, abdominal exam, and extraintestinal manifestations were completed in 66.5% of visits. The correlation between the Short PCDAI and PGA was similar to that of the PCDAI (r = 0.60, P < 0.001 versus 0.61, P < 0.001). Conclusions: The Short PCDAI is a practical and valid tool to measure pediatric CD activity. Its use should facilitate quality improvement and observational research. (Inflamm Bowel Dis 2011;)

Variation in care in pediatric Crohn disease.

Objectives:Variation in medical care can be a barrier to improving clinical outcomes. We aim to describe the variation in care of Crohn disease as provided by a broad sample of pediatric gastroenterologists. Methods:Two hundred forty-six Crohn disease patients of 93 pediatric gastroenterologists from 48 practice sites starting treatment with either thiopurine or infliximab were studied. We assessed variation in diagnostic testing that had been performed to establish the diagnosis of Crohn disease and to assess the phenotype, extent, and severity of disease. We also assessed variation in initial thiopurine and infliximab dosage and in nutritional therapy. Results:Diagnostic studies in which care was uniform included complete blood count, performed in 100% of patients, erythrocyte sedimentation rate and colonoscopy in 96%, and upper endoscopy in 89%. However, imaging of the small bowel had not been performed in 19%, and a stool test for pathogens had not been performed in 29%. Thiopurine methyltransferase (TPMT) had been measured in 61% of patients before treatment with a thiopurine; in 85%, TPMT was normal. Nonetheless, even when TPMT was normal, 40% of patients received an initial dose of thiopurine that was lower than recommended. Testing for tuberculosis before initiating treatment with infliximab was not performed in 30%. In addition, 36% of severely underweight patients were not receiving a multivitamin supplement, supplemental formula, or tube feeding. Conclusions:There is variation in diagnostic and therapeutic interventions in the management of pediatric Crohn disease, and gaps exist between recommended and actual care.

PEDSnet: a National Pediatric Learning Health System

A learning health system (LHS) integrates research done in routine care settings, structured data capture during every encounter, and quality improvement processes to rapidly implement advances in new knowledge, all with active and meaningful patient participation. While disease-specific pediatric LHSs have shown tremendous impact on improved clinical outcomes, a national digital architecture to rapidly implement LHSs across multiple pediatric conditions does not exist. PEDSnet is a clinical data research network that provides the infrastructure to support a national pediatric LHS. A consortium consisting of PEDSnet, which includes eight academic medical centers, two existing disease-specific pediatric networks, and two national data partners form the initial partners in the National Pediatric Learning Health System (NPLHS). PEDSnet is implementing a flexible dual data architecture that incorporates two widely used data models and national terminology standards to support multi-institutional data integration, cohort discovery, and advanced analytics that enable rapid learning.

Multi-Institutional Sharing of Electronic Health Record Data to Assess Childhood Obesity

Objective To evaluate the validity of multi-institutional electronic health record (EHR) data sharing for surveillance and study of childhood obesity. Methods We conducted a non-concurrent cohort study of 528,340 children with outpatient visits to six pediatric academic medical centers during 2007–08, with sufficient data in the EHR for body mass index (BMI) assessment. EHR data were compared with data from the 2007–08 National Health and Nutrition Examination Survey (NHANES). Results Among children 2–17 years, BMI was evaluable for 1,398,655 visits (56%). The EHR dataset contained over 6,000 BMI measurements per month of age up to 16 years, yielding precise estimates of BMI. In the EHR dataset, 18% of children were obese versus 18% in NHANES, while 35% were obese or overweight versus 34% in NHANES. BMI for an individual was highly reliable over time (intraclass correlation coefficient 0.90 for obese children and 0.97 for all children). Only 14% of visits with measured obesity (BMI ≥95%) had a diagnosis of obesity recorded, and only 20% of children with measured obesity had the diagnosis documented during the study period. Obese children had higher primary care (4.8 versus 4.0 visits, p<0.001) and specialty care (3.7 versus 2.7 visits, p<0.001) utilization than non-obese counterparts, and higher prevalence of diverse co-morbidities. The cohort size in the EHR dataset permitted detection of associations with rare diagnoses. Data sharing did not require investment of extensive institutional resources, yet yielded high data quality. Conclusions Multi-institutional EHR data sharing is a promising, feasible, and valid approach for population health surveillance. It provides a valuable complement to more resource-intensive national surveys, particularly for iterative surveillance and quality improvement. Low rates of obesity diagnosis present a significant obstacle to surveillance and quality improvement for care of children with obesity.

Effectiveness of Anti-TNFα for Crohn Disease: 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-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.

Chewing Gum Bezoars of the Gastrointestinal Tract

Children have chewed gum since the Stone Age. Black lumps of prehistoric tar with human tooth impressions have been found in Northern Europe dating from ∼7000 BC (Middle Stone Age) to 2000 BC (Bronze Age). 1 The bite impressions suggest that most chewers were between 6 and 15 years of age. The Greeks chewed resin from the mastic tree (mastic gum). North American Indians chewed spruce gum. The first manufacturing patent for chewing gum was issued in 1869 for a natural gum, chicle, derived from the Sopadilla tree, indigenous to Central America. Chewing gum sold today is a mixture of natural and synthetic gums and resins, with added color and flavor sweetened with corn syrup and sugar. Chewing gum is big business. A significant amount of the

151 Improved Outcomes in a Quality Improvement Collaborative for Pediatric Ulcerative Colitis

21 billion US candy industry sales is from chewing gums, many of which appeal almost exclusively to children. Despite the history and prevalence of gum chewing, the medical literature contains very little information about the adverse effects of chewing gum. In the present report, we briefly review gum-chewing complications and describe three children who developed intestinal tract and esophageal obstruction as a consequence of swallowing gum.

3563 Enodoscopic reduction of colonic volvulus in pediatric patients.

Aim: 30% of patients hospitalized with severe UC prove steroid-refractory. We aimed to evaluate outcomes and predictors of response to infliximab as rescue therapy in severe pediatric UC. Methods: As part of a prospective multicenter study, we evaluated factors associated with immediate and 1-year response to infliximab in steroid-refractory severe pediatric UC. Data were recorded at admission, days 3 and 5, at introduction of infliximab, at discharge and 1-year thereafter, using standardized data collection forms. Disease activity was determined using the validated Pediatric UC Activity Index (PUCAI). Serum TNF alpha level was determined before infliximab treatment using a cytokine antibody panel (TransSignal, CA). Concurrently, fecal calprotectin and lactoferrin levels were ascertained using standard assays in a central laboratory. Results: Of 128 children admitted, 33 failed steroids and treated with infliximab within 10.5±6 days. Mean PUCAI score at introduction of infliximab was 66±13 points, indicating persistence of severe colitis. 25/33 children (76%) responded and were discharged within 5±4 days of infliximab therapy; 7 in complete clinical remission (PUCAI 0.2). CRP, ESR, albumin and hemoglobin were not predictive of response to infliximab. Neither fecal calprotectin nor lactoferrin values were predictive of response (area under ROC curve 0.61 and 0.63, respectively; P>0.2). Serum TNF-alpha level was similar between responders and non-responders (10.6pg/ml (IQR 4-30) vs. 8.3pg/ml (5.7-11); P=0.4). 8 of the 25 responders received only 3-dose induction, and the others continued maintenance therapy without concomitant immunomodulation. Cumulative 1-year sustained response rate was 55% (18/33). There were no deaths and only 1 patient stopped treatment due to infusion reaction. Conclusion: Infliximab is safe and effective in inducing and maintaining clinical remission in steroid-refractory pediatric UC. Serum TNF-alpha level and fecal biomarkers are not useful in predicting outcome, but higher disease severity, judged clinically, and new onset disease are associated with reduced response.

Growth hormone has anabolic effects in glucocorticosteroid-dependent children with inflammatory bowel disease: A pilot study

Colonic volvulus (CV) typically involves the cecum or sigmoid colon and is most likely to occur in the geriatric population. Risk factors include chronic constipation, megacolon and inactivity. Endoscopic reduction of CV is a well-accepted treatment in such patients.We report two adolescents (both age 13 years) with CV. Each had a history of megacolon and presented with abdominal distention and pain. In both cases the CV was reduced by colonoscopy during conscious sedation. One case involved the cecum; the other involved sigmoid colon. Case 1: A boy with a history of extensive cervical spinal fusion developed severe abdominal pain and distention with obstructive pattern by plain film radiograph. Emergent laparotomy was aborted due to an inability to intubate the airway secondary to his to a fixed cervical spine. Gastrograffin enema proved, but failed to reduce, a CV involving the cecum. Colonoscopy to the right colon ended in an abruptly narrowed twisted colonic lumen. A counterclockwise torque, air and gentle pressure were applied to the leading edge of the twisted lumen. The sudden appearance of cecal landmarks indicated reduction of the CV. He has had no recurrence in the 4 years since. Case 2. A young lady with advanced constipation and spinal dysraphism underwent Malone procedure (appendico-cutaneous fistula) to manage constipation by proximal colonic lavage. Her recovery from the procedure was unremarkable until postoperative day 9 when she developed exquisite and unremitting left lower quadrant pain, abdominal distention and radiographic evidence for distal colonic obstruction. Emergent colonoscopy revealed the odd and twisted-lumen appearance of CV at the sigmoid turn. The above endoscopic technique (torque, air, and gentle pressure) was applied. Reduction was associated with immediate relief of pain and distention and was also productive of a massive volume of watery stool. Previously unreported in the pediatric population, these cases illustrate the need to consider CV in the differential diagnosis of acute abdominal pain and distention in the child whose history includes chronic constipation, spinal anomaly and megacolon.