Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis.

INTRODUCTION: This pilot, randomized controlled trial aimed to evaluate the usability, among adolescents and young adults (AYAs) with ulcerative colitis (UC), of a web-based tool ('iBDecide') designed to facilitate shared decision making (SDM). METHODS: AYAs with UC (n = 35) were randomized to intervention (iBDecide, n = 14) and control (n = 12) arms before a scheduled clinic visit. We measured the usability of iBDecide, SDM, preferred decision-making style, decision conflict and intervention use. RESULTS: Participants in the intervention group found iBDecide easy to use and agreed that it made them feel ready to participate in decision making and that they would use it to prepare for appointments. There were 130 visits to iBDecide, lasting on average 3 min, 41 s. The medication and nutrition trackers were among the most-viewed pages. Pages specifically designed to facilitate SDM were viewed only four times. Across groups, too few participants reported making decisions during clinic visits for decision-related measures to be reported. CONCLUSIONS: This pilot trial provides evidence for the usability of iBDecide and guidance for developing a larger-scale trial of a combined web-based and in-clinic SDM intervention. Overall, iBDecide shows promise in engaging AYAs with UC in SDM and condition management. PATIENT OR PUBLIC CONTRIBUTION: Patients, specifically AYAs with UC, and healthcare providers were involved in the design of this study's intervention, iBDecide. Additionally, the research team, from study conception to manuscript writing, included a young adult with inflammatory bowel disease. CLINICAL TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT04207008).

Improved Population Pharmacokinetic Model for Predicting Optimized Infliximab Exposure in Pediatric Inflammatory Bowel Disease.

BACKGROUND: Many pediatric patients with inflammatory bowel disease (IBD) lose response to infliximab (IFX) within the first year, and achieving a minimal target IFX trough concentration is associated with higher remission rates and longer durability. Population pharmacokinetic (PK) modeling can predict trough concentrations for individualized dosing. The object of this study was to refine a population PK model that accurately predicts individual IFX exposure during maintenance therapy using longitudinal real-practice data. METHODS: We exported data from the electronic health records of pediatric patients with IBD treated with originator IFX at a single center between January 2011 and March 2017. Subjects were divided into discovery and validation cohorts. A population PK model was built and then validated. RESULTS: We identified 228 pediatric patients with IBD who received IFX and had at least 1 drug concentration measured, including 135 and 93 patients in the discovery and validation cohorts, respectively. Weight, albumin, antibodies to IFX (ATI) detected by a drug-tolerant assay, and erythrocyte sedimentation rate (ESR) were identified as covariates significantly associated with IFX clearance and incorporated into the model. The model exhibited high accuracy for predicting target IFX trough concentrations with an area under the receiver operating characteristic curve (AUROC) of 0.86 (95% confidence interval [CI], 0.81-0.91) for population-based predictions without prior drug-level input. Accuracy increased further for individual-based predictions when prior drug levels were known, with an AUROC of 0.93 (95% CI, 0.90-0.97). CONCLUSIONS: A population PK model utilizing weight, albumin, ordinal drug-tolerant ATI, and ESR accurately predicts IFX trough concentrations during maintenance therapy in real-practice pediatric patients with IBD. This model, which incorporates dynamic clinical information, could be used for individualized dosing decisions to increase response durability.

Safety of percutaneous endoscopic gastrostomy in medically complicated infants.

BACKGROUND AND OBJECTIVE: Percutaneous endoscopic gastrostomy (PEG) tubes have been placed in children for more than 2 decades to provide nutrition to those unable to adequately and safely feed orally. Despite the well-documented success of PEG placement in older children, there is only 1 published article documenting the safety of PEG placement in small infants. In all children, PEG studies demonstrate the major complication rate to vary from 0.5% to 17%. The objective of this study was to evaluate the incidence of acute complications of PEG placement in medically complicated infants with a weight of less than 6 kg. PATIENTS AND METHODS: : We reviewed the charts of all infants cared for in the neonatal intensive care unit of Wheaton Franciscan Health Care-St Joseph's Regional Hospital, Milwaukee, WI, who received a PEG tube between January 2001 and June 30, 2008. RESULTS: Forty infants with a mean gestational age of 29 weeks (range 23-41 weeks) with a mean weight of 3250 g (range 2100-5600 g) at time of PEG placement were included. The primary indication for most infants was dysphagia or inability to orally feed safely. A PEG was successfully placed in 38 of 40 (95%) infants. There was 1 major complication: a 38-week infant with Prader-Willi syndrome developed a pneumomediastinum caused by a tear at the upper esophageal sphincter. In a second infant the PEG bumper could not be passed beyond the upper esophageal sphincter. Sixteen infants had other surgical procedures performed at the time of PEG placement. For those infants only having a PEG placed, the mean procedure time was 10 minutes. CONCLUSIONS: PEG placement is both feasible and safe in small, medically complicated infants.

CSF testosterone: relationship to aggression, impulsivity, and venturesomeness in adult males with personality disorder.

OBJECTIVE: Studies of various species suggest that testosterone, assayed in various compartments, is correlated with aggression and possibly related behaviors. The objective of this study was to assess the relationship between cerebrospinal fluid testosterone (CSF TEST) and measures of aggression, impulsivity, and venturesomeness in male personality disordered subjects and test the hypothesis that CSF TEST would correlate directly with each measure in this group. METHODS: Lumbar CSF for morning basal levels of testosterone were obtained from 31 male subjects with personality disorder. Aggression was assessed dimensionally through the use of the life history of aggression (LHA) assessment, and categorically by the research diagnosis of intermittent explosive disorder. Impulsiveness and venturesomeness were assessed using the Eysenck personality questionnaire - II (EPQ-II). RESULTS: CSF TEST did not correlate with measures of aggression or impulsivity but did correlate directly with venturesomeness (r = .42, p = .021). Adjusting for age and height modestly reduced the magnitude and statistical significance of this correlation. CONCLUSIONS: In contrast to some published studies, CSF TEST was not found to have a significant relationship with aggression. The presence of a modest correlation between CSF TEST and venturesomeness, but not impulsivity, in male personality-disordered subjects suggests a possible relationship between CSF TEST and a type of sensation-seeking that involves consideration of the consequences of action taken.