Point-of-Care Fecal Calprotectin Monitoring in Preterm Infants at Risk for Necrotizing Enterocolitis.

OBJECTIVE: To establish baseline trends in fecal calprotectin, a protein excreted into the stool when there is neutrophilic inflammation in the bowel, in infants at risk for necrotizing enterocolitis (NEC). STUDY DESIGN: We performed a prospective observational cohort study in infants with a birth weight of <1500 g without existing bowel disease at a level IV neonatal intensive care unit from October 2015 to September 2016. Stools were collected once daily for 30 days or until 32 weeks postmenstrual age and processed using the Fecal Calprotectin High Range Quantitative Quantum Blue assay. RESULTS: In 64 preterm infants, during the first week after birth, 62% of infants had an initial stool sample with high baseline calprotectin levels (≥200 µg/g). In assessment of maternal and neonatal risk factors, maternal etiology for preterm birth (ie, eclamplsia or preeclampsia) was the only significant factor associated with high baseline calprotectin level. Two patients in the cohort developed NEC. Calprotectin levels for the entire cohort fluctuated during the observed period but generally increased in the third and fourth weeks after birth. CONCLUSIONS: At-risk infants had highly variable fecal calprotectin levels, with maternal causes for preterm birth associated with higher baseline levels. More longitudinal data in infants with NEC are necessary to determine whether acute rises in fecal calprotectin levels prior to clinical diagnosis can be confirmed as a diagnostic or prognostic biomarker.

A Mobile Infliximab Dosing Calculator for Therapy Optimization in Inflammatory Bowel Disease.

Background: Inadequate infliximab (IFX) drug exposure remains a clinical challenge and leads to high loss of response rates and therapy failure in inflammatory bowel disease (IBD). We aimed to determine the feasibility and pilot effectiveness of a novel, web-based, mobile IFX dosing calculator (mIDC) for therapy optimization. Methods: We developed an mIDC leveraging the known clinical variables of C-reative protein (CRP), albumin, patient's weight, disease activity indices, calprotectin, drug trough levels, and antibodies to IFX that significantly affect pharmacokinetics and/or outcomes. A prospective observational cohort study in pediatric and young adult IBD patients receiving maintenance IFX was performed. System-wide practice adoption of mIDC was achieved through a quality improvement (QI) initiative within a hospital-based infusion unit. Results: Forty-nine patients (median age: 16.0 years; 55% female; 65% Crohn's disease) were followed over 9 months. mIDC recommendations for dose optimization were followed by the treating physicians in 198 (89%) out of 222 infusions. Twenty-eight (13%) of 222 mIDC recommendations were to escalate IFX dosing; 15 (54%) of 28 escalation recommendations were declined, and these patients were more likely to already be receiving IFX dose intensification compared with those in whom escalation recommendations were followed (P < 0.05). From mIDC initiation to end of follow-up, mean albumin levels remained unchanged at 3.8 g/dL. Median CRP remained unchanged at 2 g/L. Median calprotectin levels showed a downward trend from 30 to 27 µg/g (n = 9, P < 0.05). The percentage of patients undergoing therapeutic drug monitoring in clinical care increased from 34% to 86% with the QI initiative. The target median IFX trough goal of >5 µg/mL was achieved with 81% probability throughout the QI initiative, an increase of 12% compared with pre-QI values. Conclusions: The use of a novel mIDC is feasible and potentially effective, facilitating both standardization and individualization of therapy in clinical care. mIDC appears to be a practical IFX dosing tool for point-of-care use, leveraging individual pharmacokinetic considerations.

Implementation of Depression Screening and Global Health Assessment in Pediatric Subspecialty Clinics.

PURPOSE: Adolescents with chronic illness face greater risk of psychosocial difficulties, complicating disease management. Despite increased calls to screen for patient-reported outcomes, clinical implementation has lagged. Using quality improvement methods, this study aimed to investigate the feasibility of standardized screening for depression and assessment of global health and to determine recommended behavioral health follow-up, across three pediatric subspecialty clinics. METHODS: A total of 109 patients aged 12-22 years (median = 16.6) who were attending outpatient visits for treatment of diabetes (80% type 1), inflammatory bowel disease, or cystic fibrosis completed the 9-item Patient Health Questionnaire (PHQ-9) depression and Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health measures on electronic tablets. Patients screening positive on the PHQ-9 received same-day behavioral health assessment and regular phone check-ins to facilitate necessary follow-up care. RESULTS: Overall, 89% of 122 identified patients completed screening during a 6-month window. Patients completed measures in a timely manner (within 3 minutes) without disruption to clinic flow, and they rated the process as easy, comfortable, and valuable. Depression scores varied across disease type. Patients rated lower global health relative to a previously assessed validation cohort. Depression and global health related significantly to certain medical outcomes. Fifteen percent of patients screened positive on the PHQ-9, of whom 50% confirmed attending behavioral health appointments within 6 months of screening. CONCLUSIONS: A standardized depression and global health assessment protocol implemented across pediatric subspecialties was feasible and effective. Universal behavioral health screening for adolescents and young adults living with chronic disease is necessary to meet programmatic needs in pediatric subspecialty clinics.

Correlation of rapid point-of-care vs send-out fecal calprotectin monitoring in pediatric inflammatory bowel disease.

AIM: To assess the correlation between the send-out enzyme-linked immuno sorbent assay (ELISA) and the point-of-care (POC) calprotectin test in pediatric inflammatory bowel disease (IBD) patients. METHODS: We prospectively collected stool samples in pediatric IBD patients for concomitant send-out ELISA analysis and POC calprotectin testing using the Quantum Blue® (QB) Extended immunoassay. Continuous results between 17 to 1000 µg/g were considered for comparison. Agreement between the two tests was measured by a Bland-Altman plot and statistical significance was determined using Pitman's test. RESULTS: Forty-nine stool samples were collected from 31 pediatric IBD patients. The overall means for the rapid and ELISA tests were 580.5 and 522.87 µg/g respectively. Among the 49 samples, 18 (37.5%) had POC calprotectin levels of ≤ 250 µg/g and 31 (62.5%) had levels > 250 µg/g. Calprotectin levels ≤ 250 µg/g show good correlation between the two assays. Less correlation was observed at quantitatively higher calprotectin levels. CONCLUSION: In pediatric IBD patients, there is better correlation of between ELISA and POC calprotectin measurements at clinically meaningful, low-range levels. Future adoption of POC calprotectin testing in the United States may have utility for guiding clinical decision making in real time.

Spanish and English Language Symposia to Enhance Activation in Pediatric Inflammatory Bowel Disease.

OBJECTIVES: Patient activation is an important consideration for improved health outcomes in the management of chronic diseases. Limited English proficiency among patients and primary care providers has been shown to be a predictor for worse health across disease states. We aimed to determine the baseline patient activation measure (PAM) among Spanish-speaking (SP) and English-speaking (ES) pediatric patients with IBD and parents, and to describe the feasibility and efficacy of a novel peer-group education symposium designed to enhance patient activation as measured with the PAM. METHODS: Two separate half-day educational symposia in either Spanish or English were presented and moderated by 2 native SP physicians. Content for each of the presentations were highly standardized and interactive, designed to address each of the activation domains (self-management, collaboration with a health care provider, maintenance of function and prevention of disease exacerbation, and appropriate access to high-quality care). Descriptive statistics were used to describe changes between pre- and postsymposium PAM trends. RESULTS: Eleven primarily SP and 21 ES families participated in their respective symposium. Paired pre- and post-PAM scores were available from 24 pediatric patients with IBD (8 SP, 16 ES) and 41 parents (15 SP, 26 ES). The mean age for SP and ES patients was 11.6 and 12.0 years, and female sex in 80% and 62%, respectively. Paired pre- and post-PAM scores for all participants (n = 65) were analyzed. PAM scores uniformly increased in all 4 groups after the symposia (SP patients 59.1-70.3, P = 0.05; SP parents 69.8-75.2, P = 0.2; ES patients 59.9-64.0, P = 0.08; ES parents 61.9-69.1, P = 0.002), although only the ES-parents group had sufficient sample size (n = 26) to achieve statistical significance. The overall cohort had an aggregate increase from pre-PAM of 62.9 (SD 14.5) to post-PAM of 69.4 (SD 13.9) (<0.001). CONCLUSIONS: We describe a novel peer-group educational symposium presented in Spanish and English languages to increase patient and parent activation in pediatric patients with IBD and their caregiving parents. The use of PAM to assess levels of activation appears to be feasible and effective in these groups.