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.

Development of a Core Outcome Set for Infant Gastroesophageal Reflux Disease.

OBJECTIVE: In therapeutic trials for infant gastroesophageal reflux disease (GERD), ways to define GERD and measure and report study outcomes vary widely. The aim of this study was to develop a core outcome set (COS) for infant GERD. METHODS: The COS was developed using the Delphi technique, adhering to the Outcome Measures in Rheumatology Initiative 2.0 recommendations. Healthcare professionals (HCPs) (predominantly pediatric gastroenterologists and general pediatricians) and parents of infants (age 0-12 months) with GERD, listed up to 5 primary goals of therapy from their perspective and up to 5 persistent signs or symptoms that would signify inadequate treatment. Outcomes mentioned by >10% of participants were included in 2 shortlists. Next, HCPs and parents rated and prioritized outcomes on these shortlists. Outcomes with the highest rank formed the draft COS. The final COS was created after 2 consensus meetings between an expert panel and patient representatives. RESULTS: In total, 125 of 165 HCPs (76%) and 139 of 143 parents (97%) of infants with GERD completed the first phase. The second phase was completed by 83 of 139 HCPs (60%) and 127 of 142 different parents (89%). Outcomes of these phases were discussed during the consensus meetings and a 9-item COS was formed: "Adequate Growth," "Adequate Relief," "Adverse events,", "Crying," "Evidence of Esophagitis," "Feeding Difficulties," "Hematemesis," "No Escalation of Therapy," and "Sleep Problems." CONCLUSIONS: We developed a COS for infant GERD consisting of 9 items that should minimally be measured in future therapeutic trials to decrease study heterogeneity and ease comparability of results.

Anal Botulinum Toxin in Children with Hirschsprung Disease and Functional Constipation: A Prospective Cohort study.

INTRODUCTION: Anal sphincter botulinum toxin injections (BTIs) are used in the treatment of children with severe defecation disorders, including Hirschsprung disease (HD) and functional constipation (FC). Our objective was to evaluate the outcomes of BTI in these children. MATERIALS AND METHODS: We performed a prospective cohort study of children undergoing BTI from July 2018 to December 2018. We recorded perceived effect of the BTI, including effectiveness ranging from 0 (not at all effective) to 4 (extremely effective). In addition, we recorded symptoms and the Cleveland Clinic Constipation Score (CCCS). Data were collected at baseline and at 2 weeks, 2 months, and 4 months post-injection. RESULTS: Forty-two children (HD = 25, FC = 17) were included in the study (median age 4.3 years, IQR 2.4-7.2, 52% male). Twenty-two (88%) children with HD and eight (47%) children with FC had previously undergone a BTI. BTIs were perceived effective in 16 (76%) and 12 (71%) children with HD and eight (47%) and seven (47%) children with FC at 2-week and 2-month follow-up, respectively. Effectiveness was not rated differently between groups except at the 2-month follow-up, when patients with HD rated the BTI more effective compared to those with FC (median 2 [HD] vs. median 1 [FC], p = 0.022). Over the course of the study, 17/39 (44%) children reported self-limiting adverse effects such as fecal incontinence and pain at the injection site. CONCLUSION: Anal sphincter BTIs can be effective in the treatment of constipation in both HD and FC patients.

Epidemiology of Pediatric Foreign Body Ingestions Amidst the Coronavirus 2019 Pandemic at a Tertiary Care Children's Hospital.

OBJECTIVES: The coronavirus disease (COVID) 2019 pandemic and resultant stay-at-home orders altered caregivers' responsibilities and children's daily environments. We aimed to compare the epidemiology and morbidity of foreign body ingestions (FBIs) during the COVID pandemic and the prior year. METHODS: We performed a retrospective review of children cared for at our tertiary care children's hospital for FBI from March to July 2019 (pre-COVID) and March to July 2020 (COVID). Cases were identified via a search of all diagnoses of foreign bodies (FBs) in the alimentary tract. Charts were reviewed to determine the types of FBs ingested and the patients' clinical courses. RESULTS: A total of 71 encounters were identified. Thirty ingestions occurred in the pre-COVID cohort and 42 in the COVID cohort. One patient ingested 2 different FBs. There was a significantly higher rate of FBIs per day in May 2020 (COVID) compared with May 2019 (pre-COVID; 0.387 versus 0.161; P = 0.046). The median age at presentation was not significantly different between the two groups (pre-COVID, 63.8 months; COVID, 62.5 months; P = 0.78). FBs were located in the esophagus less frequently in the COVID cohort than in the pre-COVID cohort (P < 0.01). Endoscopies were less frequently performed in the COVID cohort (52.4% versus 70.0%; odds ratio, 0.47; 95% CI, 0.15-1.40). CONCLUSIONS: The frequency of FBIs trended higher in the COVID cohort, with significantly more FBIs in May 2020 when compared with May 2019. Patients in the COVID cohort more frequently had FBs located beyond the esophagus, indicating later presentation and a lesser need for urgent endoscopic removal.

Spirulina breath test indicates differences in gastric emptying based on age, gender, and BMI.

BACKGROUND: Measurements of gastric emptying (GE) by scintigraphy in the pediatric population are based on adult standards. Due to radiation exposure, scintigraphy cannot be performed on healthy children to establish norms of GE in the pediatric population. Stable isotope breath tests (GEBTs) pose no such health risk to children. This study sought to determine the feasibility of a GEBT in children and to investigate whether GE may differ by age, gender, or body mass index (BMI). METHODS: Fifty healthy children 6 to 18 years underwent a 13 C-Spirulina platensis GEBT. Breath samples were obtained at baseline, every 15 min for 1 h, and at 30-min intervals for 3 h thereafter. Seventeen similarly aged patients with dyspeptic symptoms concurrently underwent scintigraphy and the GEBT. KEY RESULTS: Forty-six healthy subjects were included in the final analysis. Females had an overall slower rate of GE than did males. At nearly all timepoints, children with a BMI >85th percentile had slower GE than normally weighted children. The GE rate of children aged 6-9 reached a maximum later than did the rate of older children. Thirteen patients undergoing scintigraphy were included in the comparative analysis. The agreement between scintigraphic and GEBT half-times as measured by the concordance correlation coefficient was 0.383 (95% CI: 0.02-0.65). CONCLUSIONS AND INFERENCES: GEBT was easily accomplished in healthy children. Differences of GE rates by age, gender, and BMI support the need for establishing pediatric standards of GE. One way to establish such standards may be through the use of a GEBT.

Gastric electrical stimulation improves symptoms and need for supplemental nutrition in children with severe nausea and vomiting: A ten-year experience.

BACKGROUND: Gastric electrical stimulation (GES) is a promising therapy for children with severe nausea and vomiting, but information on long-term outcomes is limited. We sought to evaluate the long-term efficacy and safety of GES and to describe patient benefit and satisfaction. METHODS: Using a prospective registry, we identified patients aged <21 years treated with GES at our institution between 2009 and 2019. Encounters were selected at baseline prior to GES and at follow-up at 1 month, 12 months, and the most recent visit. We compared symptoms, route of nutrition, and medication usage at baseline to follow-up timepoints. Factors associated with improvement were evaluated. We recorded complications and need for battery replacement. We contacted families to administer the Glasgow Children's Benefit Inventory (GCBI) and a parent satisfaction questionnaire. KEY RESULTS: Eighty-five patients (68.2% female, median age 15.8 years) completed a trial of temporary GES due to severe nausea and vomiting. Seventy-seven (90.6%) had a positive response and underwent permanent stimulator placement. Use of tube feeding or parenteral nutrition (PN) decreased from 72.7% at baseline to 29.9% at the most recent follow-up (p < 0.001). Higher baseline vomiting severity was associated with the ability to stop supplemental nutrition by 1 month (p < 0.05). Fourteen patients (18.2%) had complications, primarily due to stimulator-associated discomfort, and 29 (37.7%) required battery replacement. Median GCBI was +52.1, indicating health-related benefit. CONCLUSIONS AND INFERENCES: Children with severe nausea and vomiting treated with GES experienced significant and durable improvement in symptom severity and their ability to tolerate oral nutrition.

The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders.

OBJECTIVES: Psychotropic medications, including the atypical antipsychotics, have historically been scrutinized for cardiac effects and risk of sudden death. Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder. Adult studies have evaluated aripiprazole's effects on electrocardiograms, but no pediatric studies have been published to date. METHODS: Electrocardiographic data were collected from children and adolescents participating in a 14-week, prospective, open-label study (n=25) of aripiprazole for irritability in pervasive developmental disorder not otherwise specified and Asperger's disorder. A 12-lead electrocardiogram was obtained at the baseline and end point visits. The electrocardiograms were evaluated for abnormal findings, and the PR, QRS, QT(c), and RR intervals were recorded. The QT interval was corrected using Bazett's, United States Food and Drug Administration (FDA) Pharmacology Division, and Fridericia's formulas. RESULTS: Twenty-four subjects received both baseline and posttreatment electrocardiograms. The mean age was 8.6 years (range 5-17 years). The average final aripiprazole dose was 7.8 mg/day (range 2.5-15 mg/day). There were no significant differences noted with the PR, QRS, RR, and QT(c) intervals after aripiprazole therapy. Also, there was no significant correlation between the dose given and the percent change in the QT(c). No post-treatment QT(c) exceeded 440 ms. CONCLUSIONS: To our knowledge, this is the first systematic evaluation of the cardiac effects of aripiprazole in children and adolescents. The results are consistent with previously published literature in adults that aripiprazole has no significant cardiac effects and can be deemed a low risk for causing sudden death. It will be important to confirm these findings in a randomized controlled trial.