A feasibility study using quantitative and interpretable histological analyses of celiac disease for automated cell type and tissue area classification.

Histological assessment is essential for the diagnosis and management of celiac disease. Current scoring systems, including modified Marsh (Marsh-Oberhuber) score, lack inter-pathologist agreement. To address this unmet need, we aimed to develop a fully automated, quantitative approach for histology characterisation of celiac disease.

Can artificial intelligence replace endoscopists when assessing mucosal healing in ulcerative colitis? A systematic review and diagnostic test accuracy meta-analysis.

Backgrounds And Aims: Mucosal healing (MH) in inflammatory bowel diseases (IBD) is an important landmark for clinical decision making. Artificial intelligence systems (AI) that automatically deliver the grade of endoscopic inflammation may solve moderate interobserver agreement and the need of central reading in clinical trials.

Methods: We performed a systematic review of EMBASE and MEDLINE databases up to 01/12/2022 following PRISMA and the Joanna Briggs Institute methodologies to answer the following question: "Can AI replace endoscopists when assessing MH in IBD?".

Pathologist-trained machine learning classifiers developed to quantitate celiac disease features differentiate endoscopic biopsies according to modified marsh score and dietary intervention response.

Background: Histologic evaluation of the mucosal changes associated with celiac disease is important for establishing an accurate diagnosis and monitoring the impact of investigational therapies. While the Marsh-Oberhuber classification has been used to categorize the histologic findings into discrete stages (i.e.

Identifying Measures of Suboptimal Healthcare Interaction (SOHI) to Develop a Claims-Based Model for Predicting Patients with Inflammatory Bowel Disease at Risk for SOHI.

Background: Understanding the demographic and clinical characteristics of patients with Inflammatory Bowel Disease (IBD) who are likely to experience poor disease outcomes may allow early interventions that can improve health outcomes.

Objectives: To describe demographic and clinical characteristics of patients with ulcerative colitis (UC) and Crohn's disease (CD) with the presence of at least one Suboptimal Healthcare Interaction (SOHI) event, which can inform the development of a model to predict SOHI in members with IBD based on insurance claims, with the goal of offering these patients some additional intervention.

Methods: We identified commercially insured individuals with IBD between 01 January 2019 and 31 December 2019 using Optum Labs' administrative claims database.

Medication use among patients with Crohn's disease or ulcerative colitis before and after the initiation of advanced therapy.

Background: Although various treatments help reduce abdominal pain, real-world pain medication utilization among patients with Crohn's disease (CD) or ulcerative colitis (UC) receiving advanced therapies is poorly understood. The aim is to understand the utilization of pain medication 12 months before and after the initiation of advanced therapies among patients with newly diagnosed CD or UC.

Methods: This retrospective, observational cohort study used administrative medical and pharmacy claims data of patients with CD or UC from HealthCore Integrated Research Database (HIRD).

LGBTQ+ Perspectives on Conducting Genomic Research on Sexual Orientation and Gender Identity.

We conducted in-depth, semi-structured interviews with LGBTQ+-identified individuals (n = 31) to explore the range of LGBTQ+ perspectives on genomic research using either sexual orientation or gender identity (SOGI) data. Most interviewees presumed that research would confirm genetic contributions to sexual orientation and gender identity. Primary hopes for such confirmation included validating LGBTQ+ identities, improved access to and quality of healthcare and other resources, and increased acceptance in familial, socio-cultural, and political environments.

Reflections on Dr. Donald A.B. Lindberg and Native Voices.

Personal reflections on Donald A.B. Lindberg M.

Reflections on Dr. Donald A.B. Lindberg and Native Voices.

Personal reflections on Donald A.B. Lindberg M.

Automatic treatment planning of VMAT for left-sided breast cancer with lymph nodes.

Background: The standard in Denmark for treating breast cancer patients receiving loco-regional irradiation is tangential 3D Conformal RadioTherapy (3DCRT), treated in deep inspiration breath-hold (DIBH). Treating with Volumetric Modulated Arc Therapy (VMAT) may reduce the treatment time, which is particularly important for DIBH treatments. The VMAT should be performed without increased dose to the heart, lung, and contralateral breast.

Baricitinib and primary biliary cholangitis.

Background And Aims: There is an unmet need for alternative treatments for patients with primary biliary cholangitis (PBC) who do not respond to treatment with ursodeoxycholic acid (UDCA). A proof-of-concept study of baricitinib, an orally administered Janus kinase 1 and 2 inhibitor, was initiated to evaluate its use in PBC patients.

Approach And Results: Patients with PBC showing inadequate response or intolerance to UDCA were eligible.

Sequentially Determined Measures of Interobserver Agreement (Kappa) in Clinical Trials May Vary Independent of Changes in Observer Performance.

Background: Cohen's kappa is a statistic that estimates interobserver agreement. It was originally introduced to help develop diagnostic tests. Interpretative readings of 2 observers, for example, of a mammogram or other imaging, were compared at a single point in time.

Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments.

Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument).

Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study.

Background: Influenza is an important public health problem and existing vaccines are not completely protective. New vaccines that protect by alternative mechanisms are needed to improve efficacy of influenza vaccines. In 2015, we did a phase 1 trial of an oral influenza vaccine, VXA-A1.

Health care utilisation changes among Alaska Native adults after participation in an indigenous community programme to address adverse life experiences: a propensity score-matched analysis.

The aim of this study was to investigate whether participation in Family Wellness Warriors Initiative (FWWI), an Alaska Native program that addresses adverse life experiences, is associated with changes in health care utilisation. The study method was a propensity score-matched cohort analysis using retrospective electronic health record data from Southcentral Foundation, a tribal health care system, from 2012 to 2017. Ninety p\articipants in FWWI trainings were identified as the intervention cohort and were propensity matched with 90 people who participated in other emotional wellness-related interventions.

Production and Clinical Evaluation of Norwalk GI.1 Virus Lot 001-09NV in Norovirus Vaccine Development.

Background: Human noroviruses (HuNoV) are the leading cause of gastroenteritis. No vaccine is currently available to prevent norovirus illness or infection. Safe, infectious challenge strains are needed to assess vaccine efficacy in the controlled human infection model (CHIM).

Sequentially Determined Measures of Interobserver Agreement (Kappa) in Clinical Trials May Vary Independent of Changes in Observer Performance.

Background: Cohen's kappa is a statistic that estimates interobserver agreement. It was originally introduced to help develop diagnostic tests. Interpretative readings of 2 observers, for example, of a mammogram or other imaging, were compared at a single point in time.

Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.

Background & Aims: In 2016, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released revised EMA and new FDA draft guidelines related to the development of drugs intended for the treatment of ulcerative colitis. We sought to compare and contrast the EMA draft guideline with the FDA draft guidance to facilitate further discussion and perhaps harmonization between the 2 guidelines when they are finalized.

Methods: A concordance document was created by arranging like or similar topics addressed by the guidelines side by side in a tabular format.

Development of a Natural Language Processing Algorithm to Identify and Evaluate Transgender Patients in Electronic Health Record Systems.

Objective: To create a natural language processing (NLP) algorithm to identify transgender patients in electronic health records.

Design: We developed an NLP algorithm to identify patients (keyword + billing codes). Patients were manually reviewed, and their health care services categorized by billing code.

First clinical experiences with a high field 1.5 T MR linac.

A 1.5 T MR Linac (MRL) has recently become available. MRL treatment workflows (WF) include online plan adaptation based on daily MR images (MRI).

Erratum: Selection of a cut-off for high- and low-methane producers using a spot-methane breath test: results from a large north American dataset of hydrogen, methane and carbon dioxide measurements in breath.

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Safety and immunogenicity of an oral tablet norovirus vaccine, a phase I randomized, placebo-controlled trial.

Background: Noroviruses are the leading cause of epidemic acute gastroenteritis and foodborne diarrheal disease in humans. However, there are no approved vaccines for noroviruses. Potential correlates of protection identified through human challenge studies include mucosal IgA, memory B cells, and serum-blocking antibody titers (BT50).