Reliability of Intestinal Ultrasound for Evaluating Crohn's Disease Activity Using Point-of-care and Central Reading.

BACKGROUND & AIMS: Intestinal ultrasound (IUS) is increasingly used to assess Crohn's disease (CD) activity in clinical practice. However, application in clinical trials has been limited by heterogeneous scoring methods and concerns about reliability. We aimed to determine the inter- and intra-rater reliability of locally and centrally read IUS parameters for evaluating CD using prospectively performed scans. METHODS: Twenty-four participants with CD and 6 gastroenterologists participated in a 2-day workshop where each participant underwent 6 IUS scans in total. Eight IUS parameters (bowel wall thickness [BWT], bowel wall stratification [BWS], color Doppler signal [CDS], inflammatory mesenteric fat [i-fat], submucosal prominence, submucosal layer thickness, haustra coli/peristalsis, and affected segment length) and an overall measure of sonographic disease activity were blindly assessed by the 6 local readers and 4 central gastroenterologist-sonographers. Reliability was quantified using intraclass correlation coefficients (ICCs). Institutional review board approval was granted for this study (12938). RESULTS: Five IUS parameters demonstrated at least moderate (ICC ≥0.41) inter- and intra-rater reliability when local and central reading was performed (BWT, CDS, i-fat, submucosal prominence, and affected segment length). Reliability was generally better with central, in distinction to local, reading. ICCs for BWS and i-fat were highest when evaluated as binary outcomes. Sensitivity analyses demonstrated that IUS parameters are most reliable when evaluated in the worst affected segment. Fair reliability was observed when local readers identified the worst affected segment. CONCLUSIONS: Local and central reading of IUS demonstrated at least moderate inter- and intra-rater reliability for several parameters. This study supports refining existing activity indices and incorporating IUS central reading into clinical trials.

Effect of Wearing a Face Mask on Hand-to-Face Contact by Children in a Simulated School Environment: The Back-to-School COVID-19 Simulation Randomized Clinical Trial.

Importance: Wearing a face mask in school can reduce SARS-CoV-2 transmission but it may also lead to increased hand-to-face contact, which in turn could increase infection risk through self-inoculation. Objective: To evaluate the effect of wearing a face mask on hand-to-face contact by children while at school. Design, Setting, and Participants: This prospective randomized clinical trial randomized students from junior kindergarten to grade 12 at 2 schools in Toronto, Ontario, Canada, during August 2020 in a 1:1 ratio to either a mask or control class during a 2-day school simulation. Classes were video recorded from 4 angles to accurately capture outcomes. Interventions: Participants in the mask arm were instructed to bring their own mask and wear it at all times. Students assigned to control classes were not required to mask at any time (grade 4 and lower) or in the classroom where physical distancing could be maintained (grade 5 and up). Main Outcomes and Measures: The primary outcome was the number of hand-to-face contacts per student per hour on day 2 of the simulation. Secondary outcomes included hand-to-mucosa contacts and hand-to-nonmucosa contacts. A mixed Poisson regression model was used to derive rate ratios (RRs), adjusted for age and sex with a random intercept for class with bootstrapped 95% CIs. Results: A total of 174 students underwent randomization and 171 students (mask group, 50.6% male; control group, 52.4% male) attended school on day 2. The rate of hand-to-face contacts did not differ significantly between the mask and the control groups (88.2 vs 88.7 events per student per hour; RR, 1.00; 95% CI, 0.78-1.28; P = >.99). When compared with the control group, the rate of hand-to-mucosa contacts was significantly lower in the mask group (RR, 0.12; 95% CI, 0.07-0.21), while the rate of hand-to-nonmucosa contacts was higher (RR, 1.40; 95% CI, 1.08-1.82). Conclusions and Relevance: In this clinical trial of simulated school attendance, hand-to-face contacts did not differ among students required to wear face masks vs students not required to wear face masks; however, hand-to-mucosa contracts were lower in the face mask group. This suggests that mask wearing is unlikely to increase infection risk through self-inoculation. Trial Registration: ClinicalTrials.gov Identifier: NCT04531254.

Carbohydrate Counting App Using Image Recognition for Youth With Type 1 Diabetes: Pilot Randomized Control Trial.

BACKGROUND: Carbohydrate counting is an important component of diabetes management, but it is challenging, often performed inaccurately, and can be a barrier to optimal diabetes management. iSpy is a novel mobile app that leverages machine learning to allow food identification through images and that was designed to assist youth with type 1 diabetes in counting carbohydrates. OBJECTIVE: Our objective was to test the app's usability and potential impact on carbohydrate counting accuracy. METHODS: Iterative usability testing (3 cycles) was conducted involving a total of 16 individuals aged 8.5-17.0 years with type 1 diabetes. Participants were provided a mobile device and asked to complete tasks using iSpy app features while thinking aloud. Errors were noted, acceptability was assessed, and refinement and retesting were performed across cycles. Subsequently, iSpy was evaluated in a pilot randomized controlled trial with 22 iSpy users and 22 usual care controls aged 10-17 years. Primary outcome was change in carbohydrate counting ability over 3 months. Secondary outcomes included levels of engagement and acceptability. Change in HbA1c level was also assessed. RESULTS: Use of iSpy was associated with improved carbohydrate counting accuracy (total grams per meal, P=.008), reduced frequency of individual counting errors greater than 10 g (P=.047), and lower HbA1c levels (P=.03). Qualitative interviews and acceptability scale scores were positive. No major technical challenges were identified. Moreover, 43% (9/21) of iSpy participants were still engaged, with usage at least once every 2 weeks, at the end of the study. CONCLUSIONS: Our results provide evidence of efficacy and high acceptability of a novel carbohydrate counting app, supporting the advancement of digital health apps for diabetes care among youth with type 1 diabetes. Further testing is needed, but iSpy may be a useful adjunct to traditional diabetes management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04354142; https://clinicaltrials.gov/ct2/show/NCT04354142.