Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.

BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn's disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn's disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965.

The Combined Effects of Youth and Parent Illness Intrusiveness on Depressive Symptoms in Adolescents with Inflammatory Bowel Disease.

Inflammatory bowel disease (IBD) presents physical and emotional challenges for families and imposes significant lifestyle intrusions on both youth and parents. The present study examined the effects of IBD disease activity and youth illness intrusiveness on depressive symptoms in adolescents, and the moderating influence of parent illness intrusiveness on these associations. Adolescents and parents completed measures of illness intrusiveness; youth completed a measure of depressive symptoms. Physicians provided estimates of IBD disease activity. Mediation analysis revealed an IBD disease activity → youth intrusiveness → youth depressive symptoms indirect effect. Moderated mediation analyses revealed this indirect effect to be greater among youth whose parents endorsed more IBD-related intrusions. Youth encountering greater activity disruptions related to IBD are vulnerable to depressive symptoms. When parents also experience IBD-induced intrusions, youth are at even greater risk for depressive symptoms. Clinical implications are discussed within the context of youths' and parents' experiences of IBD.

Factor analysis of the stigma scale-child in pediatric inflammatory bowel disease.

OBJECTIVE: Illness stigma, or perceived stigma related to a chronic health condition, is pervasive among youth with inflammatory bowel disease (IBD). However, no studies exist examining the psychometric properties of illness stigma measures in this population. Using a modified version of the Child Stigma Scale originally developed for youth with epilepsy, the current study investigated the factor structure and validity of this adapted measure (i.e., Stigma Scale - Child; SS-C) in youth with IBD. METHODS: Factor analyses were conducted to determine the most parsimonious factor structure for the adapted 8-item Stigma Scale - Child in a sample of 180 youth with IBD. Correlations were conducted to assess convergent validity, and a multiple regression was conducted to further evaluate the measure's predictive validity of child depressive symptoms. RESULTS: The most parsimonious model for the SS-C is a one-factor solution with an error covariance between the two items assessing concealment/disclosure of IBD diagnosis. CONCLUSIONS: The SS-C is a psychometrically sound illness stigma measure in pediatric IBD that demonstrates strong convergent validity with psychosocial adjustment factors such as thwarted belongingness, illness uncertainty, and illness intrusiveness, as well as strong predictive validity with youth depressive symptoms. The SS-C is a viable option for use as a brief screener in youth with IBD across clinical and research settings.

Illness stigma, body image dissatisfaction, thwarted belongingness and depressive symptoms in youth with inflammatory bowel disease.

BACKGROUND: Elevated depressive symptoms are observed in a significant number of youth with inflammatory bowel disease (IBD) and have been linked to illness stigma and social isolation. Body image dissatisfaction is an understudied variable in the pediatric IBD literature that may be related to both stigma and social difficulties. It is suspected that, due to the stigmatizing nature of IBD, some youth may feel self-conscious about their body image, which contributes to decreased feelings of social belongingness and ultimately depressive symptoms. The current study tested an illness stigma→ body image dissatisfaction→ thwarted belongingness→ depressive symptoms serial mediation model, in which IBD stigma was hypothesized to indirectly influence youth depressive symptoms through the sequential effects of stigma on body image dissatisfaction and thwarted social belongingness. METHODS: Youth with IBD (N = 75) between 10 and 18 years old were recruited from a pediatric gastroenterology clinic and completed psychosocial measures. Disease severity was assessed by a physician global assessment. Current medications and BMI data were collected. RESULTS: Analyses revealed significant direct effects among the modeled variables and a significant serial indirect path for illness stigma→ body image dissatisfaction→ thwarted belongingness→ depressive symptoms, controlling for sex, BMI and prednisone medication. CONCLUSIONS: Youth who perceive greater IBD stigma are more likely to experience increased body image dissatisfaction due to their IBD, which may engender feelings of social estrangement and ultimately elevated depressive symptoms. Depressive symptoms and the psychosocial challenges faced by youth should be routinely monitored as part of comprehensive IBD management.

The impact of illness intrusiveness and overparenting on depressive symptoms in parents of youth with inflammatory bowel disease.

PURPOSE: Inflammatory bowel disease (IBD) management creates significant caregiver demands that can interfere with parents' ability to engage in a number of role functions (i.e., illness intrusiveness) well into their child's adolescence, potentially resulting in excessive or misdirected parenting (i.e., overparenting). Disruptions and limited access to routine and valued activities (e.g., family, work, and leisure) due to IBD and excessive parenting may result in parents neglecting their own personal and emotional self-care needs, increasing their risk for depressive symptoms. To explore these associations, the present study examined parents' experience of illness intrusiveness and subsequent overparenting as serial mediators in the association between disease severity and parent depressive symptoms. DESIGN AND METHODS: Participants were 146 caregivers of adolescents with IBD from an outpatient pediatric gastroenterology clinic. During a scheduled outpatient visit, parents completed measures of illness intrusiveness, overparenting, and depressive symptoms. Pediatric gastroenterologists provided ratings of disease severity. RESULTS: Several direct and indirect associations were observed among the modeled variables. Notably, mediation analysis revealed a significant disease severity → illness intrusiveness → overparenting → depressive symptoms serial indirect effect. CONCLUSIONS: Parents' experience of greater IBD-induced lifestyle disruptions is associated with increased overparenting and a heightened risk for depressive symptoms. PRACTICE IMPLICATIONS: Parents should be encouraged to establish and maintain a healthy balance between parenting and self-care/role function activities, especially during adolescence when greater youth autonomy and independence are crucial. These types of clinical efforts may reduce the likelihood of parents experiencing depressive symptoms, and have the added benefit of improving adolescent IBD self-management.

Stigma Moderates the Relation Between Peer Victimization, Thwarted Belongingness, and Depressive Symptoms in Youth with Inflammatory Bowel Disease.

PURPOSE: The stigmatizing nature of IBD symptoms may place youth at risk for being targets of peer victimization, potentially resulting in a decreased sense of social belongingness and poorer emotional adjustment. The present study tested a series of mediation and moderated mediation models examining the associations among peer victimization, thwarted social belongingness, and depressive symptoms, as well as the moderating role of IBD stigma in these associations. We hypothesized peer victimization would have an indirect effect on youth depressive symptoms through thwarted belongingness, and this effect would be amplified for youth endorsing greater IBD stigma. DESIGN AND METHODS: Seventy-five youth (10-18 yrs.) diagnosed with IBD were recruited from a pediatric gastroenterology clinic. Participants completed self-report measures of IBD stigma, peer victimization, thwarted belongingness, and depressive symptoms. RESULTS: As anticipated, mediation analyses revealed a significant peer victimization → thwarted belongingness → depressive symptoms indirect path. Moderated mediation analyses indicated that this indirect effect was moderated by IBD stigma and was significantly greater among youth reporting higher IBD stigma. CONCLUSIONS: Youth who experience higher levels of IBD-related stigma are at increased risk for depressive symptoms as a function of the socially isolating effects of peer victimization. PRACTICE IMPLICATIONS: Our findings highlight the need for routine screening and identification of the socioemotional challenges faced by youth with IBD. Clinical interventions that incorporate coping strategies aimed at minimizing youths' stigmatizing self-perceptions and improving overall social skills and social engagement may lessen the negative impact of peer victimization on youths' social and emotional adjustment.

Illness Stigma, Worry, Intrusiveness, and Depressive Symptoms in Youth With Inflammatory Bowel Disease.

BACKGROUND: Youth who experience IBD-associated stigma may manifest increased worry about aversive symptoms that can intrude on their participation in routine activities (eg, school, social events), potentially resulting in limited opportunities for reinforcement and increased depressive symptoms. The present study examined an IBD stigma → IBD worry → illness intrusiveness → depressive symptoms serial mediation model, in which stigma was hypothesized to confer an indirect effect on youth depressive symptoms through the serial effects of stigma on IBD worry and illness intrusiveness. METHODS: Youth with IBD (N = 90) between the ages of 10 and 18 years were recruited from a pediatric gastroenterology clinic and completed measures of IBD stigma, IBD worry, illness intrusiveness, and depressive symptoms. RESULTS: In addition to several independent direct effects among the modeled variables, results revealed a significant IBD stigma → IBD worry → illness intrusiveness → depressive symptoms serial mediation path (effect = 0.63, 95% CI = 0.22 to 1.20), controlling for youth sex and IBD severity. CONCLUSIONS: The experience of IBD-related stigma may prompt increased worry about IBD symptoms, independent of the influence of disease activity. Further, heightened worry appears to amplify youths' experience of IBD-imposed limitations on routine and rewarding activities, increasing their risk for experiencing depressive symptoms. Our findings highlight the importance of regular screening for depressive symptoms, as well as the identification of potential risk factors associated with emotional adjustment difficulties. Stigma-specific treatment modules could be integrated within existing cognitive-behavioral approaches for reducing worry and depressive symptoms in youth with IBD.

Stigma by Association: Parent Stigma and Youth Adjustment in Inflammatory Bowel Disease.

OBJECTIVE: Examine the indirect association between parents' experience of stigma (i.e., associative stigma) and youth depressive symptoms through the serial effects of associative stigma on parent and youth illness intrusiveness in pediatric inflammatory bowel disease (IBD). METHODS: During routine clinic visits, 150 youth with well-controlled IBD (ages 10-18 years) completed measures of perceived illness intrusiveness and depressive symptoms. Parents completed measures of associative stigma and illness intrusiveness. Pediatric gastroenterologists provided ratings of IBD disease severity. RESULTS: Structural equation modeling revealed significant direct associations for associative stigma → parent illness intrusiveness, parent illness intrusiveness → youth illness intrusiveness, and youth illness intrusiveness → youth depressive symptoms. Results also revealed a significant associative stigma → parent illness intrusiveness → youth illness intrusiveness→ youth depressive symptoms serial mediation path, indicating that parents' experience of associative stigma indirectly influenced youth depressive symptoms through its sequential effects on parent and youth perceived illness intrusiveness. CONCLUSIONS: Parents who face stigma related to their child's IBD (i.e., associative stigma) are more likely to experience IBD-induced lifestyle intrusions (i.e., illness intrusiveness), which in turn is associated with youths' illness intrusiveness and ultimately youth depressive symptoms. These findings provide further evidence for the important role of illness-related stigma in pediatric IBD, particularly the transactional relation between parents' associative stigma and youths' illness appraisals and emotional functioning. The clinical implications of our results for addressing adjustment difficulties in youth with IBD are also discussed.

Perceived stigma, illness uncertainty, and depressive symptoms in youth with inflammatory bowel disease: The moderating effect of mindfulness.

Perceived illness stigma is associated with increased depressive symptoms in youth with inflammatory bowel disease (IBD), but the mechanisms by which stigma influences emotional adjustment remain unclear. It is possible that youth with IBD who are more present-focused and better able to come to terms with aspects of their disease that are less controllable (i.e. are mindful) may develop more adaptive strategies when facing illness uncertainty, resulting in more positive emotional adjustment. The present study examined the indirect association between illness stigma, illness uncertainty, depressive symptoms, and the potential moderating effect of mindfulness on this process. One hundred and seven youth (56 female, 51 male; Mage = 14.73) with IBD completed measures of illness stigma (SS-C), illness uncertainty (CUIS), depressive symptoms (CDI-2), and trait mindfulness (MAAS-A). Analyses revealed a significant SS-C → CUIS → CDI-2 indirect path (ß = .686, 95% CI = .1346 to 1.489), which was moderated by MAAS-A (ß = -.445, 95% CI = -.972 to -.083). Results indicate that the SS-C → CUIS → CDI-2 indirect path was significant at low, but not medium or high, levels of MAAS-A. Illness uncertainty appears to be a potential route through which stigma impacts emotional adjustment in youth with IBD, particularly for youth characterized by low mindfulness. Clinical interventions that emphasize mindfulness training along with acknowledgement/acceptance of IBD illness factors may help diminish the negative effects of stigma and illness uncertainty on adjustment in this population.

The Contributions of Illness Stigma, Health Communication Difficulties, and Thwarted Belongingness to Depressive Symptoms in Youth with Inflammatory Bowel Disease.

OBJECTIVE: Youth with inflammatory bowel disease (IBD) often experience difficulties communicating about their disease. It is suspected that the stigmatizing nature of IBD symptoms contributes to youths' health communication difficulties, leaving youth feeling disconnected from their social environment and potentially resulting in decreased social belongingness and poorer emotional functioning. In this study, we tested an illness stigma → health communication difficulties → thwarted belongingness → depressive symptoms serial mediation model. It was anticipated that youth illness stigma would confer a serial indirect effect on youth depressive symptoms through the sequential effects of stigma on health communication difficulties and thwarted social belongingness. METHODS: Seventy-five youth with IBD between the ages of 10 and 18 completed measures of perceived illness stigma, health communication difficulties, thwarted belongingness, and depressive symptoms. RESULTS: Results indicated a significant illness stigma → thwarted belongingness → depressive symptoms simple mediation path. Importantly, findings also revealed a significant serial mediation path for illness stigma → health communication difficulties → thwarted belongingness → depressive symptoms. CONCLUSIONS: Youth who perceive greater IBD stigma appear to experience increased difficulty communicating about their IBD with others, which in turn is associated with feelings of thwarted social belongingness and ultimately elevated depressive symptoms. These findings suggest that difficulty communicating about IBD is one potential route by which illness stigma has a negative impact on youth adjustment outcomes. Results could also inform clinical interventions to address IBD stigma and health communication difficulties associated with the social and emotional challenges in youth with IBD.

Implementing a Novel Quality Improvement-Based Approach to Data Quality Monitoring and Enhancement in a Multipurpose Clinical Registry.

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.

Disease Severity and Depressive Symptoms in Adolescents With Inflammatory Bowel Disease: The Mediating Role of Parent and Youth Illness Uncertainty.

OBJECTIVE: The objective of this study is to examine parent and youth appraisals of illness uncertainty as potential serial mediators in the relation between disease severity and youth depressive symptoms in adolescents with inflammatory bowel disease (IBD). METHODS: Participants were 85 adolescents 13-18 years of age (Mage = 15.75, SD =1.51) with a confirmed diagnosis of IBD (Crohn's disease, 59%; ulcerative colitis, 41%) and a primary caregiver. At a scheduled outpatient visit, caregivers completed a measure of illness uncertainty, while adolescents completed measures of illness uncertainty and depressive symptoms. Pediatric gastroenterologists provided global estimates of disease severity. RESULTS: Path analysis revealed several significant direct and indirect associations among the modeled variables. Importantly, results provided support for the hypothesized disease severity→parent illness uncertainty→youth illness uncertainty→youth depressive symptoms serial mediation path (95% confidence interval = 0.04 to 1.10). CONCLUSIONS: Results indicate that increased disease activity may serve to magnify the unpredictable nature of IBD for parents, reflected in heightened perceptions of illness uncertainty. Our findings also suggest that increased parent illness uncertainty has a significant influence on youth illness uncertainty appraisals, which in turn translates into elevated depressive symptoms in adolescents with IBD. The clinical implications of our findings and suggestions for future studies are discussed.

Perceived Illness Stigma, Thwarted Belongingness, and Depressive Symptoms in Youth With Inflammatory Bowel Disease (IBD).

Background: Studies have begun to identify psychosocial factors associated with depressive symptoms in youth with IBD. However, despite considerable speculation in the literature regarding the role of perceived stigma in both social and emotional adjustment outcomes, youth appraisals of stigma have yet to receive empirical attention. The primary purpose of this study was to examine the indirect effect of perceived illness stigma on depressive symptoms through its impact on social belongingness. Methods: Eighty youth (Mage = 14.96) with IBD completed measures of illness stigma, thwarted belongingness, and depressive symptoms during a scheduled clinic visit. Pediatric gastroenterologists provided estimates of disease activity. Analyses examined the direct and indirect effects of illness stigma on perceived thwarted belongingness and depressive symptoms. Results: Bootstrapped regression results revealed significant illness stigma → depressive symptoms (ß = 0.33, 95% CI, 0.108 to 0.526), illness stigma → thwarted belongingness (ß =0.41, 95% CI, 0.061 to 0.739), and thwarted belongingness → depressive symptoms (ß =0.32, 95% CI, 0.143 to 0.474) direct paths. Mediation analyses revealed a significant illness stigma → thwarted belongingness → depressive symptoms indirect path (ß = 0.14, 95% CI, 0.034 to 0.310), suggesting increased appraisals of illness stigma impede youths' perceptions of social belongingness, which in turn, contribute to elevated depressive symptoms. Conclusions: Youth perceptions of illness stigma negatively impact social belongingness and depressive symptoms in youth with IBD. Further, decreased perceptions of social belongingness may be one potential route through which stigma influences emotional adjustment outcomes. Results support clinical observations regarding the relevance of illness stigma and social functioning as targets of intervention for improving emotional adjustment in youth with IBD. 10.1093/ibd/izy011_video1izy011.video15775252424001.

Pilot Development of an Electronic Pediatric Inflammatory Bowel Disease Quiz Game.

OBJECTIVES: Data suggest physicians poorly assess disease-specific literacy and transition readiness in pediatric patients with inflammatory bowel disease (IBD). We piloted an electronic, interactive iPad quiz game that could be used in a clinical setting, with the aims of measuring IBD-related knowledge, and concomitant mood and quality of life (QOL) in a pediatric population. METHODS: Two pediatric IBD clinics developed and tested 2 versions of "Emma." Patients between 10 and 18 years of age played Emma during an office visit. Each patient answered 12 randomly selected disease-related questions and 4 mood-related questions. RESULTS: Sites 1 and 2 tested Emma v1 between May and August 2013. Emma v2 was tested from November 2013 to January 2014 and from September 2013 to January 2014. A total of 56 patients played Emma v1, whereas 60 played Emma v2. In Emma v2, 73.1% of questions were answered correctly. Patients recognized signs of IBD (88%), causes of diarrhea in addition to IBD (79.4%), and could define lactose intolerance (95.8%), but fewer patients understood serological testing used for disease monitoring (68%) or knew that magnetic resonance enterography did not involve radiation (22.9%). Patients tended to report good functioning in the areas of energy, mood, anxiety, and school-related QOL. Patients with Crohn disease, however, reported higher stress levels compared with patients with ulcerative colitis; older patients reported lower energy levels, and postsurgical patients reported lower QOL. CONCLUSIONS: The Emma iPad game has the potential to evaluate gaps in IBD knowledge, assess emotional functioning, and increase patient engagement as a transition tool in the clinical setting.

Trends in hospitalizations of children with inflammatory bowel disease within the United States from 2000 to 2009.

BACKGROUND: The incidence and prevalence of pediatric inflammatory bowel disease (IBD) seems to be increasing in North America and Europe. Our objective was to evaluate hospitalization rates in children with IBD in the United States during the decade 2000 to 2009. METHODS: We analyzed cases with a discharge diagnosis of Crohn disease (CD) and ulcerative colitis (UC) within the Healthcare Cost and Utilization Project Kids' Inpatient Database, Agency for Healthcare Research and Quality. RESULTS: We identified 61,779 pediatric discharges with a diagnosis of IBD (CD, 39,451 cases; UC, 22,328 cases). The number of hospitalized children with IBD increased from 11,928 to 19,568 (incidence, 43.5-71.5 cases per 10,000 discharges per year; P < 0.001). For CD, the number increased from 7757 to 12,441 (incidence, 28.3-45.0; P < 0.001) and for UC, 4171 to 7127 (15.2-26.0; P < 0.001). Overall, there was a significant increasing trend for pediatric hospitalizations with IBD, CD, and UC (P < 0.001). In addition, there was an increase in IBD-related complications and comorbid disease burden (P < 0.01). CONCLUSION: There was a significant increase in the number and incidence of hospitalized children with IBD in the United States from 2000 to 2009.

Health care burden of Clostridium difficile infection in hospitalized children with inflammatory bowel disease.

BACKGROUND: Children with inflammatory bowel disease (IBD), similar to adults, are at increased risk of acquiring a Clostridium difficile infection (CDI). Our objective was to characterize the health care burden associated with CDI in hospitalized pediatric patients with IBD. METHODS: We extracted and analyzed cases with a discharge diagnosis of IBD or CDI from the U.S. Healthcare Cost and Utilization Project Kids' Inpatient Database. RESULTS: In our primary analysis, we evaluated pediatric cases with a principal diagnosis of IBD or CDI. For the year 2009, we identified 12,610 weighted cases with IBD of which 3.5% had CDI. In children with IBD, CDI was independently associated with lengthier hospital stays (8.0 versus 6.0 days; adjusted regression coefficient, 2.1 days; 95% confidence interval [CI], 1.4-2.8), higher charges ($45,126 versus $34,703; adjusted regression coefficient, $11,506; 95% CI, 6192-16,820), and greater need for parenteral nutrition (15.9% versus 12.1%; adjusted odds ratio, 1.5; 95% CI, 1.1-2.0) and blood transfusion (17.7% versus 9.8%; adjusted odds ratio, 1.8; 95% CI, 1.4-2.4). There were no deaths. We made similar observations in a subanalysis of cases with principal or secondary diagnoses of IBD or CDI. The incidence of CDI in patients with IBD increased between 2000 and 2009 from 21.7 to 28.0 cases per 1000 IBD cases per year (P < 0.001). There was a significant increase in CDI complicating ulcerative colitis (28.1 versus 42.2, P < 0.001) but not for Crohn's disease (18.3 versus 20.3). CONCLUSIONS: CDI represents a significant health care burden in hospitalized children with IBD.

Improved outcomes in a quality improvement collaborative for pediatric inflammatory bowel disease.

OBJECTIVES: Unintended variation in the care of patients with Crohn disease (CD) and ulcerative colitis (UC) may prevent achievement of optimal outcomes. We sought to improve chronic care delivery and outcomes for children with inflammatory bowel disease by using network-based quality improvement methods. METHODS: By using a modified Breakthrough Series collaborative structure, 6 ImproveCareNow Network care centers tested changes in chronic illness care and collected data monthly. We used an interrupted time series design to evaluate the impact of these changes. RESULTS: Data were available for 843 children with CD and 345 with UC. Changes in care delivery were associated with an increase in the proportion of visits with complete disease classification, measurement of thiopurine methyltransferase (TPMT) before initiation of thiopurines, and patients receiving an initial thiopurine dose appropriate to their TPMT status. These were significant in both populations for all process variables (P < .01) except for measurement of TPMT in CD patients (P = .12). There were significant increases in the proportion of CD (55%-68%) and UC (61%-72%) patients with inactive disease. There was also a significant increase in the proportion of CD patients not taking prednisone (86%-90%). Participating centers varied in the success of achieving these changes. CONCLUSIONS: Improvements in the outcomes of patients with CD and UC were associated with improvements in the process of chronic illness care. Variation in the success of implementing changes suggests the importance of overcoming organizational factors related to quality improvement success.

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

UNLABELLED: 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 patient's 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.