An automated platform trial framework for A/B testing.

This paper proposes a platform trial for conducting A/B tests with multiple arms and interim monitoring to investigate the impact of several factors on the expected sample size and probability of early stopping. We examined the performance of three stopping boundaries: O'Brien Fleming (OBF) stopping for either futility or difference (both), Pocock stopping for futility only, and fixed sample size design. We simulated twelve scenarios of different orders of arms based on various effect sizes, as well as considered 1 or 3 interim looks.

Renal Response Outcomes of the EuroLupus and National Institutes of Health Cyclophosphamide Dosing Regimens in Childhood-Onset Proliferative Lupus Nephritis.

Objective: We compared clinical characteristics and renal response in patients with childhood-onset proliferative lupus nephritis (LN) treated with the EuroLupus versus National Institutes of Health (NIH) cyclophosphamide (CYC) regimen.

Methods: A retrospective cohort study was conducted at 11 pediatric centers in North America that reported using both CYC regimens. Data were extracted from the electronic medical record at baseline and 3, 6, and 12 months after treatment initiation with CYC.

Medication Adherence Rates in Adolescents With Eosinophilic Esophagitis Are Low and Are Associated With Health Habits.

Although swallowed topical steroids are effective in inducing histological remission in eosinophilic esophagitis (EoE), their efficacy is limited by treatment nonadherence. In this study, we objectively measured adherence rates to swallowed topical steroids in adolescents with EoE over the course of 8 weeks and analyzed the association between adherence rate, disease and demographic features, symptom severity, and medication-taking habit strength. We found that approximately 20% of adolescents with EoE were over-dosing on their medications.

Examining Disparities in Pediatric Eosinophilic Esophagitis.

Background: Little is known regarding the impact of race, ethnicity, and socioeconomic status on the health outcomes of children with eosinophilic esophagitis (EoE).

Objective: To (1) identify demographic characteristics of children diagnosed with EoE in a large tertiary care center, and (2) determine associations between a patient's demographics and depth of evaluation or treatment choices.

Methods: This retrospective cohort study included children 0 to 18 years old seen in Children's Hospital Colorado between January 1, 2009, and December 31, 2020.

The spectrum of eating environments encountered in free living adults documented using a passive capture food intake wearable device.

Introduction: The aim of this feasibility and proof-of-concept study was to examine the use of a novel wearable device for automatic food intake detection to capture the full range of free-living eating environments of adults with overweight and obesity. In this paper, we document eating environments of individuals that have not been thoroughly described previously in nutrition software as current practices rely on participant self-report and methods with limited eating environment options.

Methods: Data from 25 participants and 116 total days (7 men, 18 women, M = 44 ± 12 years, BMI 34.

Approaches to analyzing binary data for large-scale A/B testing.

An industry-academic collaboration was established to evaluate the choice of statistical test and study design for A/B testing in larger-scale industry experiments. Specifically, the standard approach at the industry partner was to apply a -test for all outcomes, both continuous and binary, and to apply naïve interim monitoring strategies that had not evaluated the potential implications on operating characteristics such as power and type I error rates. Although many papers have summarized the robustness of the -test, its performance for the A/B testing context of large-scale proportion data, with or without interim analyses, is needed.

Creative Arts Therapy Among Children With Cancer: Symptom Assessment Reveals Reduced Anxiety.

Background: Symptom distress is related to decreased quality of life (QOL) among children with cancer, with high levels of pain, nausea, and anxiety reported. Creative arts therapy (CAT) has been related to improved QOL and symptoms in pediatric oncology, but the quality of evidence is mixed.

Objective: This article aims to examine the QOL symptom subscales in relation to CAT over time in children during the first year of cancer treatment.

Body mass index and variability in meal duration and association with rate of eating.

Background: A fast rate of eating is associated with a higher risk for obesity but existing studies are limited by reliance on self-report and the consistency of eating rate has not been examined across all meals in a day. The goal of the current analysis was to examine associations between meal duration, rate of eating, and body mass index (BMI) and to assess the variance of meal duration and eating rate across different meals during the day.

Methods: Using an observational cross-sectional study design, non-smoking participants aged 18-45 years ( = 29) consumed all meals (breakfast, lunch, and dinner) on a single day in a pseudo free-living environment.

Macronutrient and Micronutrient Intake in Adolescents With Non-alcoholic Fatty Liver Disease: The Association With Disease Severity.

Objectives: While dietary changes are recommended to treat pediatric non-alcoholic fatty liver disease (NAFLD), the role of specific nutrients in disease progression is unclear. The objective of this study is to (1) assess the macronutrient and micronutrient intake in adolescents with liver biopsy proven NAFLD [with and without non-alcoholic steatohepatitis (NASH)] and lean controls; (2) determine nutritional predictors of disease severity amongst these groups.

Methods: Adolescents with biopsy-proven NAFLD and lean controls completed the Harvard Food Frequency Questionnaire.

Quality of Life Outcomes With Creative Arts Therapy in Children With Cancer.

: Children with cancer experience distress and decreased quality of life (QOL). Creative arts therapy (CAT) is a therapeutic modality which may improve QOL. This study examined the relationship between CAT and QOL in children and adolescents with cancer.

Quality Improvement Initiative to Improve Endoscopic Reassessment of Eosinophilic Esophagitis.

Unlabelled: The eosinophilic esophagitis (EoE) endoscopic reference score (EREFS) is a validated system for description, recognition, and reporting of EoE findings during esophagogastroduodenoscopy (EGD). This scoring system correlates with esophageal eosinophilia and therapeutic responses and has validated diagnostic accuracy with good inter- and intraobserver reliability in pediatric and adult patients. In this study, we aimed to improve physician education on and documentation of EREFS and correlate EREFS scoring with eosinophil density on histology.

Higher Mortality in Pediatric Liver Transplant Candidates With Sarcopenia.

Little is known about the impact of sarcopenia (reduced muscle mass and function) in pediatric chronic liver disease. We compared psoas muscle surface area (PMSA), measured at the 4th lumbar vertebrae, in children listed for liver transplantation (LT) to that of healthy controls and studied the impact of sarcopenia on transplant-associated outcomes. The effect of PMSA (raw value and z score) on survival was studied using multivariable proportional hazards, whereas the impact of PMSA on other transplant-associated outcomes was assessed by multivariable linear or logistic regression.

Circulating cyclic adenosine monophosphate concentrations in milrinone treated paediatric patients after congenital heart surgery.

Background: Milrinone is a phosphodiesterase type 3 inhibitor that results in a positive inotropic effect in the heart through an increase in cyclic adenosine monophosphate. The purpose of this study was to evaluate circulating cyclic adenosine monophosphate and milrinone concentrations in milrinone treated paediatric patients undergoing congenital heart surgery.

Methods: Single-centre prospective observational pilot study from January 2015 to December 2017 including children aged birth to 18 years.