Progression of Pediatric Crohn's Disease Is Associated With Anti-Tumor Necrosis Factor Timing and Body Mass Index Z-Score Normalization.

BACKGROUND & AIMS: The evolution of complicated pediatric Crohn's disease (CD) in the era of anti-tumor necrosis factor (aTNF) therapy continues to be described. Because CD progresses from inflammatory to stricturing (B2) and penetrating (B3) disease behaviors in a subset of patients, we aimed to understand the risk of developing complicated disease behavior or undergoing surgery in relation to aTNF timing and body mass index z-score (BMIz) normalization. METHODS: Multicenter, 5-year longitudinal data from 1075 newly diagnosed CD patients were analyzed. Descriptive statistics, univariate and stepwise multivariate Cox proportional hazard regression (CPHR), and log-rank analyses were performed for risk of surgery and complicated disease behaviors. Differential gene expression from ileal bulk RNA sequencing was correlated with outcomes. RESULTS: Stricturing complications had the largest increase: from 2.98% to 10.60% over 5 years. Multivariate CPHR showed aTNF exposure within 3 months from diagnosis (hazard ratio [HR], 0.33; 95% CI, 0.15-0.71) and baseline L2 disease (HR, 0.29; 95% CI, 0.09-0.92) to be associated with reduced B1 to B2 progression. For children with a low BMIz at diagnosis (n = 294), multivariate CPHR showed BMIz normalization within 6 months of diagnosis (HR, 0.47; 95% CI, 0.26-0.85) and 5-aminosalicyclic acid exposure (HR, 0.32; 95% CI, 0.13-0.81) were associated with a decreased risk for surgery while B2 (HR, 4.20; 95% CI, 1.66-10.65) and B2+B3 (HR, 8.24; 95% CI, 1.08-62.83) at diagnosis increased surgery risk. Patients without BMIz normalization were enriched for genes in cytokine production and inflammation. CONCLUSIONS: aTNF exposure up to 3 months from diagnosis may reduce B2 progression. In addition, lack of BMIz normalization within 6 months of diagnosis is associated with increased surgery risk and a proinflammatory transcriptomic profile.

Travel Time to Treating Center is Associated With Diagnostic Delay in Pediatric Inflammatory Bowel Disease.

BACKGROUND & AIMS: Delayed diagnosis of inflammatory bowel disease (IBD) leads to prolonged symptoms and worse long-term outcomes. We sought to evaluate whether race, ethnicity, disease type, and social factors are associated with delayed diagnosis of pediatric IBD. METHODS: We performed a cross-sectional study of newly diagnosed pediatric patients with IBD at 22 United States sites from 2019 to 2022. Parents/guardians reported race, ethnicity, time between symptom onset and diagnosis, and other social determinants of health. Through bivariate and multivariable analyses using generalized estimating equations, we evaluated associations between these factors and diagnosis time defined as ≤60 days, 61 to 180 days, 181 to 365 days, and >365 days. RESULTS: We enrolled 869 participants (mean age at diagnosis, 13.1 years; 52% male; 57% Crohn's disease [CD]; 34% ulcerative colitis [UC]; 8% Hispanic; 30% non-White). Overall, the mean time to diagnosis was 265.9 days. After adjustment, factors associated with longer diagnosis time included CD vs UC (odds ratio [OR], 2.6; 95% confidence interval [CI], 1.9-3.5), 2 or more other health conditions (OR, 1.7; 95% CI, 1.1-2.7), and longer travel time to clinic (>1 hour [OR, 1.7; 95% CI, 1.2-2.4], >2 hours (OR, 1.8; 95% CI, 1.2-2.9] each vs <30 minutes). There was no association with race, ethnicity, birth country, sex, parent education, household income, insurance type, health literacy, and health system distrust. CONCLUSIONS: Consistent with prior literature, diagnostic delay is longer for CD than UC. Reassuringly, time to diagnosis is equitable across racioethnic groups. New models of diagnostic care are needed for communities affected by longer travel times.

Advocacy in pediatric gastroenterology: An academic clinician's impact and guide.

The current state of policy-making necessitates clinicians and their organizations to be more engaged. This article provides practical examples of how to engage in various levels of advocacy within pediatric gastroenterology.

Management and outcomes of histoplasmosis in youth with inflammatory bowel disease in an endemic area.

OBJECTIVE: Patients with inflammatory bowel disease (IBD) prescribed immunosuppressive therapies including antitumor necrosis factor (aTNF) therapies are at increased risk of histoplasmosis. We aim to evaluate the presentation, management, and outcomes of youth with IBD and concurrent histoplasmosis. METHODS: Single center, retrospective review of youth with IBD diagnosed with histoplasmosis from January 12, 2007 to January 1, 2022. Management and outcomes were followed for up to 2 years after diagnosis. RESULTS: Nineteen patients (10 male, median age 16 years, range 8-22) with IBD were diagnosed with histoplasmosis: disseminated (N = 15/19; 79%), pulmonary (N = 3/19; 16%), lymph node (N = 1/19; 5%). At the time of histoplasmosis diagnosis, patients were predominantly receiving aTNF therapy (N = 17/19; 89%, median duration 21.9 months (interquartile range 8.5-52.0). Thirteen (13/19, 68%) patients required hospitalization and 2/19 (11%) required intensive care. All achieved antigen clearance with no recurrences. At the time of histoplasmosis diagnosis, aTNF was stopped in 15/17 (88%) patients and the following IBD therapies were initiated: 5-aminosalicylates (N = 4/19; 21%), 6-mercaptopurine (N = 3/19; 16%), enteral therapy (N = 2/19; 11%), and vedolizumab (N = 2/19; 11%); 6 of 19 (32%) received no IBD therapy and 2 of 19 (11%) patients continued aTNF. During follow-up, 6 of 19 (32%) patients had an emergency department (ED) visit and/or hospitalization for symptoms attributed to active IBD, all of whom had discontinued aTNF; one patient required colectomy. CONCLUSIONS: Severe histoplasmosis infection in youth with IBD was rare. IBD treatment was modified by reducing immunosuppression. Histoplasmosis outcomes were favorable, but multiple patients required hospitalization or ED visits for IBD symptoms. The optimal approach to managing IBD during histoplasmosis treatment is challenging and requires further study.

Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease.

OBJECTIVES: The safety, efficacy, and cost savings associated with biosimilar medications are well established. However, a lack of pediatric data exists surrounding clinical outcomes when switching from an originator to a biosimilar. Our primary aim is to evaluate clinical outcomes following a nonmedical switch from the infliximab originator to a biosimilar in children and young adults with inflammatory bowel disease (IBD). Our secondary aim is to estimate cost savings associated with this switch. METHODS: A quality improvement project was implemented to establish safe switching protocols, then those patients who underwent a nonmedical switch from the infliximab originator to the biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGAs), and laboratory values were recorded 1 year pre- and post-switch. Continuation rates on the biosimilar were reported at 6 and 12 months. Cost savings were estimated using two different pricing models. RESULTS: Fifty-three patients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGA scores remained similar when assessed pre- and post-switch. No infusion reactions or antidrug antibody development occurred. Two patients reported psoriasis-like rashes. Five patients switched back to the originator during the study period. There were 379 biosimilar infusions completed with an estimated total cost savings of $11,260 (average sales price) and $566,223 (wholesale acquisition cost). CONCLUSIONS: Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after a one-time nonmedical switch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

Clinical impacts of immunomodulator withdrawal from anti-tumor necrosis factor combination therapy in pediatric inflammatory bowel disease.

OBJECTIVES: Combination therapy consists of both anti-tumor necrosis factor (anti-TNF) and an immunomodulator (IMM) and has been shown to improve outcomes in patients with inflammatory bowel disease (IBD). This study assesses the impacts of IMM withdrawal from combination therapy to anti-TNF monotherapy in children with IBD. METHODS: This single-center retrospective cohort study included children with IBD initiated on combination therapy between 2014 and 2019 who discontinued the IMM. We evaluated whether IMM withdrawal impacts laboratory values and disease activity. Linear mixed effects models with random intercepts were used to compare differences between groups. Chi-square and Kruskal-Wallis tests were used for comparisons between patients who did and did not require subsequent escalation of therapy. RESULTS: One hundred and fifty-two patients discontinued the IMM which did not significantly affect disease activity. However, 18% of patients escalated therapy after IMM withdrawal, primarily due to low anti-TNF levels. Lower anti-TNF and higher erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels before IMM withdrawal were associated with subsequent escalation of therapy. Overall, there was no statistically significant effect on anti-TNF drug levels. Patients with Crohn's disease (CD) on infliximab (IFX) and methotrexate (MTX) who discontinued the IMM had an increase in mean ESR and CRP (p < 0.05). CONCLUSIONS: IMM withdrawal from anti-TNF combination therapy may be considered safe in the setting of higher anti-TNF levels and normal serum inflammatory markers. Clinicians should consider assessing anti-TNF levels and inflammatory markers after IMM withdrawal, especially in patients with CD receiving IFX who discontinued MTX.

Proactive therapeutic drug monitoring and vedolizumab dose optimization in children with inflammatory bowel disease.

OBJECTIVES: Therapeutic drug monitoring (TDM) and dose optimization have been shown to improve clinical outcomes with antitumor necrosis factor and recent studies in adults suggest an exposure-response relationship with drug levels associated with improved clinical outcomes. However, these levels are not universally recognized as therapeutic targets for vedolizumab dosing. We aimed to assess the impact of a TDM quality improvement (QI) initiative on 52-week clinical outcomes and describe proactively obtained vedolizumab levels during the induction period in children with inflammatory bowel disease (IBD). METHODS: A QI initiative to proactively obtain TDM levels at Week 6 was implemented in 2019. A retrospective review of pediatric patients with IBD treated with vedolizumab from 2018 to 2022 was performed. Baseline demographic data, medication dosing details, disease characteristics, lab results, and 12-month clinical outcomes were recorded. For this study, we defined therapeutic target levels (>20 µg/mL at Week 6 and >12 µg/mL during maintenance) based on existing data correlating these levels with improved clinical outcomes. RESULTS: Fifty-nine patients (31 Crohn disease [CD], 28 ulcerative colitis [UC]/indeterminate colitis [IC]) were included in the study. In total, 68% (40/59) of patients had vedolizumab levels at Week 6 and 90% (53/59) had levels drawn at Week 6 or 14. Thirty-five percent of Week 6 trough levels were below our defined target of 20 µg/mL. Fifty-two of 59 patients had available data at 52 weeks. Over 80% (42/52) of patients remained on vedolizumab 52 weeks after initiation (CD 79% [23/29], UC/IC 83% [19/23]). Sixty-two percent (26/42) of patients that remained on vedolizumab at 52 weeks were treated with an intensified dosing interval of <8 weeks. Thirty-one of these 42 (74%) were in clinical remission (CR) rate at 52 weeks with 29/42 (69%) in corticosteroid-free remission. The CR rate for the entire cohort including those who discontinued therapy due to a lack of efficacy before 52 weeks was 60% (31/52). CONCLUSION: Proactive TDM and early dose optimization with vedolizumab may improve drug durability and clinical outcomes in pediatric patients with IBD.

Multidisciplinary Perspectives on Medical Decision-Making for Ostomy Surgery in Pediatric IBD: Themes from Focus Groups.

Pediatric Inflammatory Bowel Disease (IBD) is a chronic illness where patients may undergo ostomy surgery. Medical decision-making (MDM) for ostomy surgery is complex for patients/families and multidisciplinary healthcare professionals (HCPs) alike, with current uncertainty about how multidisciplinary HCPs think about ostomy care to inform future interventions to facilitate equitable multidisciplinary care for patients. This study sought to understand pediatric IBD multidisciplinary HCPs' perceptions regarding ostomy-related MDM and education. Multidisciplinary HCPs (e.g., gastroenterology medical providers, social workers, surgeons, and ostomy nurses) participated in semi-structured focus groups. Focus group data underwent qualitative analysis to identify themes. Three multidisciplinary focus groups were conducted, with n = 12 participants across all groups. Qualitative analysis identified three main themes, including (1) HCP perceptions of ostomies, (2) Patient/family-related factors, and (3) Professional roles and collaboration challenges. Ostomy surgery in pediatric IBD requires complex multidisciplinary MDM and education. Perspectives of multidisciplinary HCPs identified patient, HCP, and systems factors that may impact MDM for ostomy surgery. This work highlights nuances in MDM and education in IBD, and the critical role of ongoing research and improved standardized processes to coordinate multidisciplinary ostomy-related MDM and education in this population.

Outcomes for Standardized Home and Hospital-Based Infusions of Infliximab for Children With Inflammatory Bowel Disease.

BACKGROUND: Pediatric inflammatory bowel disease (IBD) is commonly treated with infliximab in a hospital setting. Utilization of home infusions (HI) is increasing due to insurance mandates, travel time savings, and convenience. We evaluated adverse outcomes (AOs) of infliximab infusions in children with IBD receiving HI compared to hospital-based infusions. METHODS: Children receiving HI between September 2016 and September 2018 were retrospectively matched based on age, race, ethnicity, sex, and disease type to a cohort receiving infliximab at a hospital-based center. A survival analysis evaluated the hazard ratio for AOs in HI relative to hospital-infused children over 2 years. AOs were defined as discontinuation of therapy for clinically relevant reasons, IBD-related hospitalizations, and emergency department visits. RESULTS: We included 102 children (51 pairs) (63% male, 91% White, 92% Crohn disease). Disease location, behavior, growth status, and disease severity were similar between the 2 cohorts. Quiescent disease increased from 3% to 93% after 2 years without cohort differences. At baseline, 94% of HI patients and 88% of controls were on 5 mg/kg every 8 weeks as standard maintenance therapy. Within 2 years, only 19% remained on 5 mg/kg and the remainder required increased dosing or decreased interval. The HI cohort had fewer labs obtained ( P < 0.001), though laboratory values, number of clinic visits, and frequency of AOs were similar. CONCLUSION: Drug durability, AOs, and laboratory values were similar between HI and hospital-based infusions. These findings suggest HI may be as effective as hospital-based infusions, provided a standardized care approach is utilized.

Impact of Telemedicine on Delivery of Pediatric Inflammatory Bowel Disease Care.

OBJECTIVES: Outpatient inflammatory bowel disease (IBD) care shifted from office visits (OVs) to a model with integrated telemedicine during the 2020 COVID-19 pandemic. We describe the impact of this shift on delivery of pediatric IBD care. METHODS: We collected electronic medical record data from office and telemedicine visits for pediatric patients with IBD at a single center from April 2019 to December 2020. We compared visit volume, duration, and test ordering between 2019 and 2020, and between OV and telemedicine, and assessed for differences in telemedicine adoption by sociodemographic factors. RESULTS: Visit volume was maintained between 2019 and 2020. Median overall appointment time was shorter for telemedicine versus OV [46 (interquartile range, IQR 35-72) vs 62 (IQR 51-80) minutes; P < 0.001] with no significant difference in time spent with provider [28 (IQR 21-41) vs OV 30 (IQR 24-39) minutes; P = 0.08]. Accounting for drive time, telemedicine visits were 2.6 times shorter than office visits in 2020 ( P < 0.001). In univariate analyses, there was no difference in telemedicine utilization by race or gender. Variables significantly associated with telemedicine were older age, English as primary language, being non-Hispanic, commercial insurance, living in an area of very high opportunity, and having a longer drive time to the office ( P < 0.05 for all comparisons). In multivariate analyses, visits among patients with commercial insurance were significantly more likely to be conducted via telemedicine ( P = 0.02). Among those with a telemedicine visit, multivariate analyses demonstrated multiracial patients were significantly more likely to have video visits (vs audio-only; P = 0.02), while patients with public insurance, no or missing insurance, and whose primary language was Arabic were significantly less likely to have video visits ( P < 0.05 for all comparisons). CONCLUSIONS: Integrated telemedicine allowed for continued delivery of pediatric IBD care and significantly decreased appointment time. While telemedicine may improve access for those who live further from the office, concerns remain about the introduction of disparities.

Diagnosis and Treatment of Iron Deficiency and Anemia in Youth With Inflammatory Bowel Disease.

OBJECTIVES: Iron deficiency (ID) with and without anemia is prevalent in children and adults diagnosed with inflammatory bowel disease (IBD), but often goes unrecognized. We hypothesized, quality improvement (QI) methodology could increase the screening for and treatment of ID in children newly diagnosed with IBD. METHODS: We developed and implemented an easy-to-follow algorithm to facilitate screening for and treatment of ID for patients diagnosed with IBD. Through a series of Plan-Do-Study-Act cycles, the approach was modified to increase screening and treatment of ID. Data between January 2019 and July 2021 were assessed using statistical process control. RESULTS: Among patients newly diagnosed with IBD, 298 patients were included (67% Crohn disease, 29% ulcerative colitis, 4% indeterminate colitis, and 56% males). Rates of ID screening increased significantly from a baseline of 20% to >90%. Of the 232 patients screened for ID during the improvement period, 205 (88%) met criteria for either iron deficiency anemia (IDA) or ID at diagnosis, specifically, 151 (65%) met criteria for IDA and 54 (23%) met criteria for ID. CONCLUSIONS: Use of QI methodology to standardize screening assessments for ID among children newly diagnosed with IBD improved screening rates from a baseline of 20% to >90%, with 88% of patients found to have IDA or ID.

Overweight and Obese Status Is Not Associated With Disease Activity for Children and Adolescents With Newly Diagnosed Inflammatory Bowel Disease.

INTRODUCTION: Despite the high prevalence of pediatric obesity, its impact on Crohn's disease (CD) and ulcerative colitis (UC) activity remains poorly characterized. The aim of this study was to evaluate disease-related outcomes in overweight and obese children with CD and UC. METHODS: We conducted a retrospective cohort study using the ImproveCareNow Network, a multicenter registry of children with inflammatory bowel disease. We included children with newly diagnosed CD and UC enrolled in ImproveCareNow Network from September 2006 to December 2018 who had at least 1 follow-up visit 12-18 months after diagnosis. Patients were stratified into normal weight, overweight, or obese categories. Primary outcome was remission at 1 year based on physician's global assessment (PGA); key secondary outcomes included short pediatric CD activity index and pediatric UC activity index. RESULTS: There were 4,972 children included (70% CD). Compared with normal weight, obese and overweight children with CD did not have worse disease activity at 1 year based on PGA. However, obese children did have modestly worse disease activity based on short pediatric CD activity index (inactive 43% vs 58%, mild 48% vs 36%, and moderate-severe 9% vs 7% for obese vs normal weight, P < 0.01). For children with UC, there were no differences in disease activity at 1 year based on PGA or pediatric UC activity index. Logistic regression mirrored these findings. DISCUSSION: Obese and overweight children with newly diagnosed inflammatory bowel disease do not seem to have worsened disease activity at 1 year after diagnosis compared with normal weight children.

Risk of Post-Resection Recurrence in Pediatric Crohn Disease.

BACKGROUND: Ileocecectomy related to stricturing, fistula formation, or medically refractory disease is commonly required in patients with Crohn disease (CD). Limited research exists in endoscopic recurrence (ER) in pediatric inflammatory bowel disease (IBD). In this study, we sought to determine ER rates and the impact of therapy duration before surgery in pediatric patients with CD. METHODS: This was a single-center retrospective review of patients with CD between the ages of 2 to 20 years who required ileocecectomy between January 2015 and December 2019 at Nationwide Children's Hospital. Follow-up endoscopies, laboratory values, medications, and sPCDAI scores were recorded at 6, 12, 24, and 36 months post-resection wherever available. Modified Rutgeert scores (mRS) were independently assigned to post-resection colonoscopy images by 3 trained investigators. Post-resection outcomes were compared between patients on CD therapy >30 days before resection (late surgery) to those started on CD therapy <30 days before resection (early surgery). RESULTS: A total of 48 patients underwent ileocecectomy, with a mean age at time of resection of 17 years (+/-2.3). In total, 88% of patients had a post-resection endoscopy and 57% had an endoscopy within 12 months of resection. Twenty-nine percentage had ER with a mRS ≥i2. There was no statistical difference in endoscopic and clinical outcomes after resection between the early and late surgery groups. CONCLUSIONS: Post-resection endoscopic recurrence after ileocecectomy was found in 29% of our center's pediatric CD population based on mRS. Post-resection outcomes were not affected by therapy duration before resection.

Patient and Caregivers' Perspectives on Biosimilar Use in Pediatric Inflammatory Bowel Disease.

BACKGROUND: Studies assessing adult inflammatory bowel disease (IBD) patient perspectives on biosimilar use revealed that most were unfamiliar with biosimilars and had a negative perception. The objective of this study was to evaluate the perspectives of pediatric patients with IBD and their caregivers regarding biosimilar use and non-medical switches. METHODS: A survey was given to a cross section of patients with IBD ages 11-21 years receiving the intravenous anti-tumor necrosis factor originator and caregivers of patients with IBD ages 3-21 years receiving the originator. Recruitment occurred via mail, during clinic visits, and infusions. Fisher exact tests were used to test for statistically significant differences. RESULTS: Response rate amongst caregivers was 49% (n = 98) and among patients was 35% (n = 67). Sixty-four percent of caregivers and 79% of patients had never heard of biosimilars. There was increased discomfort surrounding the use of biosimilars and switching to a biosimilar amongst caregivers who had previously heard of biosimilars compared to caregivers who had not previously heard of biosimilars ( P < 0.05). Similar concerns were not seen in patient respondents. The length of time on the originator had no effect on patient or caregiver concerns related to biosimilar efficacy, adverse effects, or switches. CONCLUSION: The majority of pediatric patients and caregivers had never heard of biosimilars. Caregivers that had heard of biosimilars before the study were more likely to have a negative perception of them. This study highlights the importance of providing thorough and accurate education to pediatric patients and families regarding the safety and efficacy of biosimilars.

6- and 12-Month Outcomes after 90:10 Enteral Nutrition Induction Therapy in Pediatric Crohn's Disease.

OBJECTIVES: Studies describing longer-term outcomes after EEN induction are limited. We describe clinical outcomes during 90:10 EN induction, and 6- and 12- month outcomes among patients that successfully completed EN induction and then continued either EN or immunomodulator (IM) maintenance therapy. METHODS: All children with CD treated with 90:10 EN induction protocol (90% formula:10% regular diet) at our IBD Center from 2013 to 2018 were retrospectively reviewed. Demographic, clinical, and laboratory data were recorded at baseline, 6, and 12 months (± 3 months at each timepoint). Therapy changes after initiation of EN induction through 12 months were recorded. Among patients that successfully completed 90:10 induction, outcomes between EN and IM maintenance groups were compared. RESULTS: In total, 44/105 (42%) patients completed 8-12 weeks of 90:10 EN induction. Sixty-one patients had incomplete EN induction, with 52% requiring corticosteroids and 25% anti-TNF therapy as alternate induction approaches. Forty-four patients completed EN induction (18 continued EN maintenance and 26 IM maintenance therapy). Twenty-seven of these 44 (61%) remained on initial maintenance therapy at 6 months (10/18 (56%) EN and 17/26 (65%) IM). In total, 16/44 (36%) remained on their initial maintenance therapy at 12 months. By 12 months, 10 patients required anti-TNF and 11 corticosteroids after successful completion of induction. CONCLUSIONS: In this retrospective study of short and longer-term outcomes after 90:10 EN induction, the need for an alternate induction therapy was common, most frequently to anti-TNF or corticosteroid therapy. Future studies are needed to evaluate for predictors of long-term success after EN induction.

Predicting Suboptimal Transitions in Adolescents With Inflammatory Bowel Disease.

OBJECTIVES: Adolescents and young adults (AYAs) are at risk for disease exacerbations and increased health care utilization around the time of transition to adult care. Our aim was to identify risk factors predictive of a suboptimal transition for AYA with inflammatory bowel disease. MATERIALS AND METHODS: We performed a retrospective chart review of patients with pediatric inflammatory bowel disease transferred to adult care from our institution in 2016 and 2017, recording demographic, psychosocial, and disease-specific data. Post-transfer data were obtained via the health care information exchange from the adult provider within our electronic medical record. We defined suboptimal transition as either a return to pediatric care or requiring care escalation within 1 year of transfer. RESULTS: Out of 104 subjects 37 (36%) were found to have had a suboptimal transition. Our models suggest that a suboptimal transition is associated with several risk factors including any mental health diagnosis (odds ratio [OR] = 4.15; 95% confidence interval [95% CI]: 1.18-14.59), history of medication nonadherence (OR = 5.15 [95% CI: 1.52-17.42]), public insurance (OR = 6.60 [95% CI: 1.25-34.96]), higher Physician Global Assessment score at time of transition (OR = 6.64 [95% CI: 1.60-27.58], and short Pediatric Crohn Disease Activity Index scores (OR = 1.17 [95% CI: 1.03-1.33]). Higher hemoglobin levels at transition were protective (OR = 0.69 [95% CI: 0.48-0.98]). Age at time of transition, disease duration, and medication type at transition were not found to be associated with transition outcomes. CONCLUSION: AYA with public insurance, a mental health history, medication nonadherence, and evidence of active disease may be at greater risk for suboptimal and poor health outcomes at transition.

Trends in Anemia, Iron, Therapy, and Transfusion in Hospitalized Pediatric Patients with Inflammatory Bowel Disease.

OBJECTIVE: To evaluate trends in diagnosis and management of iron deficiency anemia using a large national children's hospital database in pediatric patients admitted with inflammatory bowel disease (IBD). STUDY DESIGN: In this retrospective multicenter cohort study, we used the Pediatric Health Information System de-identified administrative database. Patients age <21 years with ≥2 admissions with International Classification of Disease, Ninth Revision and Tenth Revision codes for Crohn's disease or ulcerative colitis from 2012 to 2018 were included. We extracted data regarding diagnoses of anemia and/or iron deficiency, and receipt of oral iron, intravenous (IV) iron, and/or blood transfusion. Data were analyzed descriptively. RESULTS: We identified 8007 unique patients meeting study criteria for a total of 28 260 admissions. The median age at admission was 15.4 years. A diagnosis of anemia was documented in 29.8% of admissions and iron studies were performed in 12.6%. IV iron was given in 6.3% of admissions and blood transfusions in 7.4%. The prevalence of the diagnosis of anemia among IBD admissions increased from 24.6% in 2012 to 32.4% in 2018 (P < .0001). There was a steady increase in the proportion of IBD admissions that used IV iron, from 3.5% in 2012 to 10.4% in 2018 (P < .0001), and the proportion of admissions with red cell transfusions decreased over time from 9.4% to 4.4% (P < .0001). CONCLUSIONS: Iron deficiency anemia is prevalent among pediatric patients with IBD admitted to US children's hospitals. From 2012 to 2018, there was an increase in the use of inpatient IV iron for the treatment of iron deficiency anemia and a decrease in transfusions.

Improving Post-induction Antitumor Necrosis Factor Therapeutic Drug Monitoring in Pediatric Inflammatory Bowel Disease.

OBJECTIVES: Adequate serum drug levels of tumor necrosis factor-alpha inhibitors (anti-TNF) have been shown to improve outcomes in patients with inflammatory bowel disease. We aim to describe the quality improvement (QI) methods used at our institution to improve post-induction therapeutic drug monitoring (TDM) in children initiating anti-TNF therapy (infliximab and adalimumab) and describe the frequency of subtherapeutic anti-TNF levels. METHODS: Beginning in February 2016, all patients initiating anti-TNF therapy were identified and tracked. Interventions to improve TDM, including the initiation of therapy plans for infliximab, real-time reminders for practitioners, and scheduling modifications for those initiating anti-TNF therapies were implemented using the Institute for Healthcare Improvement Plan-Do-Study-Act cycle approach. Statistical process control charts were used to demonstrate improvement over time. Anti-TNF levels and presence of antidrug antibodies were also recorded. RESULTS: Using QI methodology, we improved post-induction anti-TNF TDM from a baseline of 43% in 2015 to >80% by the end of 2017, with sustained improvement. Infliximab post-induction TDM improved from a baseline of 59% to 82%, whereas adalimumab post-induction TDM improved from baseline of 14% to 79%. In total, 36% of all anti-TNF post-induction levels were <5 µg/mL, with nearly 60% of post-induction infliximab levels being <5 µg/mL. CONCLUSIONS: Through incremental QI approaches, we improved the utilization of anti-TNF post-induction TDM with sustained improvement, approaching our goal of 90%. Subtherapeutic post-induction infliximab levels were common, indicating a strong need for anti-TNF TDM and an opportunity for dose optimization.

A Quality Improvement Approach to External Infliximab Infusions in Pediatric Inflammatory Bowel Disease.

OBJECTIVES: We used a quality improvement (QI) approach to improve access and reduce barriers to care by increasing the number of external infliximab infusions at our pediatric inflammatory bowel disease center. METHODS: Using an iterative QI strategy, pediatric patients ≥12 years of age with inflammatory bowel disease were offered the opportunity to receive infliximab infusions at home/an external infusion center. They were required to first have >5 infusions at the hospital without any significant infusion reactions. Data were collected and tracked monthly using P-charts. Comparisons between control chart centerlines were analyzed using the Fisher exact test. RESULTS: Fifty-four patients received external infusions, 87% had Crohn disease, 63% boys, average age 17.6 ±â€Š2.9 years, and 89% with private insurance. From September 2016 to January 2018, the percentage of eligible patients receiving external infusions was approximately 7%, increasing to approximately 30% by January 2018. A centerline shift, representing a statistically significant change, occurred in October 2016 and June 2017 (P < 0.001). No serious safety concerns have occurred. CONCLUSIONS: Through a multidisciplinary team of stakeholders using QI strategies, we now offer external infusion service options to all appropriate patients as routine practice. Home infusions are a viable option to reduce barriers to care, and our patients did not experience any safety events.

Clinical Indices Can Standardize and Monitor Pediatric Care: A Novel Mechanism to Improve Quality and Safety.

OBJECTIVE: The Cancer Care Index (CCI), a single metric that sums the number of undesirable patient events in a given time frame (either preventable harm events or missed opportunities to provide optimal care), resulted in a 42% improvement in performance. Our objective was to test the index concept in other service lines to determine whether similar performance improvement occurred. STUDY DESIGN: Care indices were developed and introduced in 3 additional service lines: Nephrology (Chronic Kidney Disease Care Index; CKDCI), Pulmonology (Lung Transplantation Care Index; LTCI), and Otolaryngology (Tracheostomy Care Index; TCI). After reaching agreement on specific harms to be avoided and elements of optimal care that should be reliably delivered, these items were compiled into indices that were updated monthly. Reports included each element individually and the total for all elements. Baseline performance was calculated retrospectively for the previous year. RESULTS: Significant improvement in performance occurred in each program following implementation of the clinical indices. The CKDCI was decreased by 63.2% (P < .001), the LTCI was decreased by 89.5% (P < .001), and the TCI was decreased by 53.0% (P < .001). Surveyed staff indicated satisfaction with use of the metric. CONCLUSIONS: Clinical indices are useful for evaluating and managing the overall reliability of a program's ability to deliver optimal care, and are associated with improved clinical performance and satisfaction by service line staff when incorporated into a program's operation.