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Objectives Endoscopic mucosal improvement is the gold standard for assessing treatment efficacy in clinical trials of Crohn’s disease. Current endoscopic indices are not routinely used in clinical practice. The lack of endoscopic information in large clinical registries limits their use for research. A quick, easy, and accurate method is needed for assessing mucosal improvement for clinicians in real-world practice. We developed and tested a novel simplified endoscopic mucosal assessment for Crohn’s disease (SEMA-CD). Methods We developed a 5-point scale for ranking endoscopic severity of ileum and colon based on Simple Endoscopic Score for Crohn’s disease (SES-CD). Central readers were trained to perform SES-CD and SEMA-CD. Pediatric patients with Crohn’s disease undergoing colonoscopy were enrolled. Video recordings of colonoscopies were de-identified and randomly assigned to blinded central readers. The SES-CD and SEMA-CD were scored for each video. The SES-CD was considered the validated standard for comparison. Correlation was assessed with Spearman rho, inter- and intrarater reliability with kappa statistics. Results Fifty-seven colonoscopies were read a total of 212 times. Correlation between SEMA-CD and SES-CD was strong (rho = 0.98, P < 0.0001). Inter-rater reliability for SEMA-CD was 0.80, and intrarater reliability was 0.83. Central readers rated SEMA-CD as easier than SES-CD. Conclusion The SEMA-CD accurately and reproducibly correlates with the standard SES-CD. Central readers viewed SEMA-CD as easier than SES-CD. Use of SEMA-CD in practice should enable collecting mucosal improvement information in large populations of patients. This will improve the quality of research that can be conducted in clinical registries. External validation is needed.

OBJECTIVES Endoscopic remission has become a standard treatment target in inflammatory bowel disease (IBD). It is unclear how widely this practice has been adopted amongst pediatric gastroenterology providers. This study determines the frequency of repeat endoscopy in pediatric IBD and evaluates for predictive baseline characteristics of providers. METHODS We developed a cross-sectional survey, which was distributed via 3 national email listservs to pediatric gastroenterology providers. We obtained baseline characteristics of respondents and assessed motivations and barriers for the practice of repeat endoscopy compared with none. RESULTS Two hundred and thirty-eight unique respondents completed the online survey. Response rate was 11% (238 of 2300 possible participants). The majority practice in an academic setting (77%) and reported participation in ImproveCareNow (63%). Overall, 65% of respondents perform repeat endoscopy to assess for endoscopic remission in pediatric IBD as part of routine clinical practice. Fifty-six percent reported repeat endoscopy as individuals in the absence of a departmental protocol. "Symptoms are not sufficient to follow IBD patients" was reported by 82% of those who repeat endoscopy; conversely, "I perform endoscopy based on clinical, biomarker, and/or imaging trends" was reported by 81% of those who do not repeat endoscopy. The establishment of a pediatric-specific guideline was most commonly reported to change current practice, based on rank-order scoring. CONCLUSIONS A majority of representative providers repeat endoscopy to assess for endoscopic remission in pediatric IBD. Fewer years in practice favored repeating endoscopy. The need for North American pediatric guidelines with pediatric-specific evidence to support the long-term benefits of endoscopic remission are highlighted in this study.

Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease in childhood. There is an increase in disease prevalence and diagnoses as it is difficult to diagnose the problem. There are currently no effective medications. Management of NAFLD is a challenge for primary care clinicians and subspecialists. This paper provides guidelines for disease screening, diagnosis, management, and algorithm for subspecialty referral.

Chronic abdominal pain is a common problem seen by pediatricians and pediatric gastroenterologist alike. There should not be evidence of underlying organic pathology, with diagnosis based upon the Rome IV criteria. Although it frequently occurs, routine diagnostic testing is not always necessary. Providing assurance and helpful coping strategies is key in the management of chronic abdominal pain. Sometimes other expertise is needed when developing these strategies.

To evaluate whether Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric patient-reported outcome (PRO) measures can serve as valid endpoints in a clinical trial of a chronic pediatric illness.We evaluated the responsiveness of PROMIS pediatric measures collected through the Clinical Outcomes of Methotrexate Binary Therapy in Practice (COMBINE) trial, a multicenter, randomized, double-blind, placebo-controlled, pragmatic clinical trial in pediatric patients with Crohn's disease (CD). We examined the relationships between changes in PROMIS pediatric measures and changes in disease activity by evaluating PRO score changes among patients who did and patients who did not experience improvement in disease activity.Participants included 266 children and adolescents with CD from a total of 35 institutions. Over the course of follow-up, participants showed improvement in most PRO domains, with the largest effect sizes observed for the clinically improved group. Patients who maintained steroid-free remission showed significantly lower PRO scores for the Pain Interference, Fatigue, and inflammatory bowel disease (IBD) Symptoms domains and higher scores for the Positive Affect domain.This study demonstrates the responsiveness of the PROMIS pediatric measures of Fatigue and Pain Interference as study endpoints in a large, multicenter pragmatic trial in pediatric CD, extending a growing body of research supporting the use of PROMIS pediatric measures as reliable PRO endpoints for clinical trials.

This article presents thoughts from a quality improvement team leader in a small institution application of methodology from the Institute for Healthcare Improvement. Successful leadership in quality improvement depends on structural supports in building learning systems as well as a supportive culture. Many resources can be used in quality improvement efforts. Serious students of quality improvement and leadership will seek out opportunities to learn and improve as they tailor their efforts to local needs and resources.

Taking the time to plan a quality improvement project before starting the project improves the likelihood of success. Understanding the tools that can be utilized for identification of a problem, the causes behind it, and the development of the theoretical framework of the planned improvement are crucial. Fishbone diagrams or cause and effect diagrams are often utilized to identify the root causes leading to an identified problem. Keydriver diagrams can provide the structure for a quality improvement project, establishing the aim and identifying the drivers and interventions that lead to change. This paper reviews these two quality improvement tools. When beginning a quality improvement project, several tools can be used to begin identifying where to target efforts. Utilizing process maps and failure modes and effects analysis (FMEA) can help define a process, identify failures, and develop interventions to be considered. Process maps identify potential gaps or excess steps and reveal sequential relationships. FMEAs aid in the development of causal relationships between a failure mode and its effects, priming the quality improver to create interventions. An additional way to model causal relationships is with fishbone diagrams and key driver diagrams. The fishbone diagram enables teams to consider why a problem has occurred and search for the root causes. The key driver diagram provides the ultimate aim of the project, identifies the drivers which will affect accomplishing the aim, and the interventions that affect the identified drivers. This paper will carefully examine both fishbone diagrams and key driver diagrams.

Background The change in subclassification of inflammatory bowel diseases (IBD) among patients with Crohn’s (CD), ulcerative colitis (UC), and IBD-unclassified (IBD-u) has previously been described in subpopulations of adult and pediatric patients. To date, no large, multinational registries have described characteristics of pediatric patients who change diagnosis. Methods We used the largest (27,628 individual patients for this study) prospective registry in the world for pediatric patients with IBD, ImproveCareNowR (ICN) to characterize those who change diagnosis. Diagnosis in the ICN registry is based on the Paris classification. Results 7.52% of pediatric patients had any change in diagnosis; 5.19% of patients experienced a change in diagnosis after the initial 3 visits (Table 1). Those who start with a diagnosis of Crohn’s are more likely to change, as compared with starting diagnoses of ulcerative colitis or IBD-u (p < 0.05). A majority of changes involve a diagnosis of IBD-u (75.8%, Figure 1). Among those who change diagnoses, those with initial diagnoses of Crohn’s or IBD-u are more likely to have a BMI Z-score of less than -2, as compared to those with initial diagnosis of UC (p < 0.05). Patients with initial diagnosis of Crohn’s who changed after 3 visits were less likely to have ileocolonic extent, penetrating or stricturing phenotype, or perianal disease documented (p < 0.05). Signs of initial miscoding occurred in less than 0.3% of patients. Discussion This is the first reported use of a large prospective pediatric registry to investigate diagnosis changes within IBD. Registration diagnosis of Crohn’s appears to have more clinically impactful findings than those with UC or IBD-u. A majority of all changes involved a diagnosis of IBD-unclassified. Further investigation of diagnosis changes across time and modeling will supplement our understanding of clinical factors predictive of change.

Worldwide incidence of inflammatory bowel disease (IBD) is stable in developed countries, but rising in developing countries. Presenting symptoms of IBD can be highly variable. New imaging modalities, a greater armamentarium of therapeutic options, and a greater understanding of complication risks have changed the diagnosis and management of pediatric inflammatory bowel diseases. Effective teamwork among those who care for pediatric patients with IBD minimizes complications and maximizes desired outcomes.

Objective: To implement a quality improvement based system to measure and improve data quality in an observational clinical registry to support a Learning Healthcare System.Data Source: ImproveCareNow Network registry, which as of September 2019 contained data from 314,250 visits of 43,305 pediatric Inflammatory Bowel Disease (IBD) patients at 109 participating care centers.Study Design: The impact of data quality improvement support to care centers was evaluated using statistical process control methodology. Data quality measures were defined, performance feedback of those measures using statistical process control charts was implemented, and reports that identified data items not following data quality checks were developed to enable centers to monitor and improve the quality of their data.Principal Findings: There was a pattern of improvement across measures of data quality. The proportion of visits with complete critical data increased from 72 percent to 82 percent. The percent of registered patients improved from 59 percent to 83 percent. Of three additional measures of data consistency and timeliness, one improved performance from 42 percent to 63 percent. Performance declined on one measure due to changes in network documentation practices and maturation. There was variation among care centers in data quality.Conclusions: A quality improvement based approach to data quality monitoring and improvement is feasible and effective.

Supplemental Digital Content is available in the text., Introduction: Children with inflammatory bowel disease (IBD) often require infliximab infusions to manage their disease. Infusions administered in the hospital setting require the patient and their families to devote many hours away from home. Changing to a rapid infusion protocol has been shown in the literature to be safe and has the potential to decrease time spent in the hospital receiving infusions. Methods: We describe stepwise changes made over a 4-month period to improve infliximab infusion efficiency and lessen the time spent in the hospital by IBD patients and their families. These changes included the implementation of a standardized order set, defaulting to rapid infusions for eligible patients, eliminating the post-infusion observation window, and improving the pharmacy's efficiency in preparing infusion medications. We utilized several established quality improvement tools, including a smart aim, key driver diagram, plan-do-study-act cycles, and statistical process control charts to measure these interventions. Results: Within three months of starting, the average door-to-door time patients spent in the hospital decreased by 128 minutes (2 hours 8 minutes). This improvement amounts to 768 minutes (12 hours 48 minutes) per year of time returned for normal childhood activities outside of the hospital. There were no infusion reactions during the period monitored. Conclusions: Implementation of a rapid infliximab infusion protocol made an impressive impact on freed family time without sacrificing patient safety. The changes we implemented could be helpful to other centers interested in decreasing in-hospital time for patients with IBD and their families.

BACKGROUND Our objective was to characterize national trends in inflammatory bowel disease (IBD)-related hospitalizations for children. We hypothesized that over time, improvements in care would be associated with a decrease in hospitalization rates, similar to what has been observed in Canadian children with IBD. METHODS Retrospective, serial, cross-sectional analysis of annual, nationally representative samples of children with IBD. RESULTS Overall, discharges for all children irrespective of diagnosis decreased from 1988 to 2011 (P for trend

OBJECTIVES Infliximab is used increasingly to treat inflammatory bowel disease (IBD). Infliximab is supplied in 100-mg vials. Doses that are typically calculated as 5 mg · kg⁻¹ · dose⁻¹ are commonly rounded up or down to the nearest 100 mg. Variation in dosing practices is unknown. Underdosing based on weight may increase the risk for disease exacerbation, whereas overimmune suppression could increase the risk of infection. Children may be at greater risk from dosage rounding. We aimed to characterize infliximab dosing practices, the use of corticosteroid premedication, and duration of infusions among pediatric practitioners participating in the ImproveCareNow Network, a national collaboration to improve IBD care and outcomes. METHODS A national survey of infliximab dosing practices was sent to 279 pediatric IBD practitioners from March to December 2011. Double data reconciliation, t test, and χ² analyses were performed. RESULTS The response rate was 74% (N = 207). Thirty-eight percent (78/207) indicated that their practice has no uniform approach to the rounding of doses. Of 114 respondents indicating a uniform approach to rounding doses, 43% always round up to the nearest 100 mg, 33% always round up or down to the nearest 100 mg, and 14% never round doses. In addition, 28% of respondents always premedicate with corticosteroids and 12% never premedicate. Of respondents indicating "it depends," 95% premedicate if there has been a previous infusion reaction, 46% if there has been a prolonged lapse between treatment doses, 40% if antibodies to infliximab are present, and 11% if giving infliximab monotherapy. The duration of infusions is most often 2 hours, but varies between 1 and 4 hours. CONCLUSIONS Wide variation exists in the practice of infliximab administration in pediatric IBD. The effect of these variations on outcomes is unknown.