Effectiveness of Ustekinumab for Patients With Moderate-to-Severe Ulcerative Colitis: A Multicenter Real-World Canadian Study.

Introduction: We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naive and bio-exposed ulcerative colitis patients in a real-world setting.

Methods: Retrospective, Canadian multicenter cohort study. Primary outcomes were clinical remission and endoscopic remission.

Reliability of CT Enterography for Describing Fibrostenosing Crohn Disease.

Background Standardized methods to measure and describe Crohn disease strictures at CT enterography are needed to guide clinical decision making and for use in therapeutic studies. Purpose To assess the reliability of CT enterography features to describe Crohn disease strictures and their correlation with stricture severity. Materials and Methods A retrospective study was conducted in 43 adult patients with symptomatic terminal ileal Crohn disease strictures who underwent standard-of-care CT enterography at a tertiary care center at the Cleveland Clinic between January 2008 and August 2016.

Extending the DeLong algorithm for comparing areas under correlated receiver operating characteristic curves with missing data.

A nonparametric method proposed by DeLong et al in 1988 for comparing areas under correlated receiver operating characteristic curves is used widely in practice. However, the DeLong method as implemented in popular software quietly deletes individuals with any missing values, yielding potentially invalid and/or inefficient results. We simplify the DeLong algorithm using ranks and extend it to accommodate missing data by using a mixed model approach for multivariate data.

Toward Patient Centricity: Why Do Patients With Inflammatory Bowel Disease Participate in Pharmaceutical Clinical Trials? A Mixed-Methods Exploration of Study Participants.

Background: A better understanding of motivations to participate as well as recommendations to reduce barriers to enrollment may assist in design of future clinical trials.

Methods: We developed a 32-item electronic questionnaire to explore motivations, experiences, and recommendations of inflammatory bowel disease patients, who had participated in pharmaceutical clinical trials in a tertiary center in Canada over the last decade. We employed a mixed-methods approach that integrates both quantitative and qualitative research methods.

Propofol sedation does not improve measures of colonoscopy quality but increase cost - findings from a large population-based cohort study.

Background: Propofol is often used for sedation during colonoscopy. We assessed the impact of propofol sedation on colonoscopy related quality metrics and cost in a population-based cohort study.

Methods: All colonoscopies performed at 21 hospitals in the province of Ontario, Canada, during an 18-month period, from April 1, 2017 to October 31, 2018, using either propofol or conscious sedation were evaluated.

Temporal trends of splenectomy in pediatric hospitalizations with hereditary spherocytosis from 2000 to 2019: A national survey.

Background: Total and partial splenectomy are used in pediatric patients with hereditary spherocytosis to resolve anemia and hemolytic complications.

Procedure: Data from the Healthcare Cost and Utilization Project's Kid's Inpatient Database was used to profile and describe temporal trends in pediatric (≤18 years) hospital admissions in the United States from 2000 to 2019 data release years. Survey sampling methods were used to produce national estimates.

Recommendations for Standardizing MRI-based Evaluation of Perianal Fistulizing Disease Activity in Pediatric Crohn's Disease Clinical Trials.

Background: Perianal fistulas and abscesses occur commonly as complications of pediatric Crohn's disease (CD). A validated imaging assessment tool for quantification of perianal disease severity and activity is needed to evaluate treatment response. We aimed to identify magnetic resonance imaging (MRI)-based measures of perianal fistulizing disease activity and study design features appropriate for pediatric patients.

Epidemiology and outcomes of choledocholithiasis and cholangitis in the United States: trends and urban-rural variations.

Background: Gallstone disease poses a significant health burden in the United States. Choledocholithiasis and cholangitis are common complications of gallstone disease for which data on current epidemiological trends are lacking. We aimed to evaluate temporal changes in hospitalization, management, and outcomes for patients with choledocholithiasis and cholangitis.

Endoscopy Unit Level Interventions to Improve Adenoma Detection Rate: A Systematic Review and Meta-Analysis.

Background & Aims: Adenoma detection rate (ADR) is inversely correlated with the risk of interval colon cancer and is a key target for quality improvement in endoscopy units. We conducted a systematic review and meta-analysis to identify and evaluate the effectiveness of interventions that can be implemented at the endoscopy unit level to improve ADRs.

Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic search was conducted in MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases between January 1990 and December 2022 to identify relevant studies.

Epidemiology and Outcomes of Symptomatic Cholelithiasis and Cholecystitis in the USA: Trends and Urban-Rural Variations.

Background: Gallstone disease remains a major health issue. There have been significant changes in the management and demographics of patients with these conditions. We aimed to evaluate trends in hospitalization, management, and post-procedural adverse events for patients with gallstone disease.

Association of Trainee Participation in Colonoscopy Procedures With Quality Metrics.

Importance: Trainees routinely participate in colonoscopy procedures, yet whether their involvement is positively or negatively associated with procedural quality is unknown because prior studies involved small number of trainees and/or supervisors, lacked generalizability, and/or failed to adjust for potential confounders.

Objective: To assess the association between trainee participation and colonoscopy quality metrics.

Design, Setting, And Participants: This multicenter population-based cohort study was conducted at 21 academic and community hospitals between April 1, 2017, and October 31, 2018, among consecutive adult patients undergoing colonoscopy.

Clinical, Endoscopic, and Radiological Effectiveness of Ustekinumab in Bio-naïve Versus Bio-experienced Patients With Crohn's Disease: Real-world Experience From a Large Canadian Center.

Introduction: With the expanding therapeutic armamentarium for inflammatory bowel disease (IBD), real-world data may help inform drug positioning. We assessed clinical, endoscopic, imaging, and biochemical response/remission outcomes in patients with Crohn's disease (CD) treated with ustekinumab in a large Canadian IBD center.

Methods: A retrospective cohort study of CD patients was treated with ustekinumab.

CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.

Background & Aims: End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease.

Methods: Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews.

Comparison of Risk Scores for Lower Gastrointestinal Bleeding: A Systematic Review and Meta-analysis.

Importance: Clinical prediction models, or risk scores, can be used to risk stratify patients with lower gastrointestinal bleeding (LGIB), although the most discriminative score is unknown.

Objective: To identify all LGIB risk scores available and compare their prognostic performance.

Data Sources: A systematic search of Ovid MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from January 1, 1990, through August 31, 2021, was conducted.

Development and Validation of a Digital Analysis Method to Quantify CD3-immunostained T Lymphocytes in Whole Slide Images of Crohn's Disease Biopsies.

The T-lymphocyte-mediated inflammation in Crohn's disease can be assessed by quantifying CD3-positive T-lymphocyte counts in colonic sections. We developed and validated a process to reliably quantify immunohistochemical marker-positive cells in a high-throughput setting using whole slide images (WSIs) of CD3-immunostained colonic and ileal tissue sections. In regions of interest (ROIs) and/or whole tissue sections of 40 WSIs from 36 patients with Crohn's disease, CD3-positive cells were quantified by an expert gastrointestinal pathologist (gold standard) and by image analysis algorithms developed with software from 3 independent vendors.

Recommendations for standardizing biopsy acquisition and histological assessment of immune checkpoint inhibitor-associated colitis.

Immune checkpoint inhibitor-associated colitis (ICIC) affects approximately 15% of cancer patients treated with immunotherapy. Although histological evaluation is potentially valuable for both the diagnosis of ICIC and evaluation of disease activity, use in clinical practice is heterogeneous. We aimed to develop expert recommendations to standardize histological assessment of disease activity in patients with ICIC.

Responsiveness of Magnetic Resonance Enterography Indices for Evaluation of Luminal Disease Activity in Crohn's Disease.

Background & Aims: Magnetic resonance enterography (MRE) is having an increasing role in Crohn's disease; however, fully validated indices are needed. We evaluated the responsiveness of 4 MRE indices in luminal Crohn's disease.

Methods: Paired MRE images (pretreatment and post-treatment at weeks 12 or 14) from 41 patients were scored by 3 blinded radiologists.

Reliability and responsiveness of endoscopic disease activity assessment in eosinophilic esophagitis.

Background And Aims: Endoscopic outcomes have become important measures of eosinophilic esophagitis (EoE) disease activity, including as an endpoint in randomized controlled trials (RCTs). We evaluated the operating properties of endoscopic measures for use in EoE RCTs.

Methods: Modified Research and Development/University of California Los Angeles appropriateness methods and a panel of 15 international EoE experts identified endoscopic items and definitions with face validity that were used in a 2-round voting process to define simplified (all items graded as absent or present) and expanded versions (additional grades for edema, furrows, and/or exudates) of the EoE Endoscopic Reference Score (EREFS).

A Clinical Prediction Model to Determine Probability of Response to Certolizumab Pegol for Crohn's Disease.

Background: Certolizumab pegol (CZP) is effective for moderately to severely active Crohn's disease (CD). Higher plasma concentrations are associated with better outcomes and increased drug clearance is the driver of subtherapeutic CZP concentrations.

Objective: We aimed to develop a prediction model incorporating predicted CZP clearance and patient variables to allow estimation of the probability for remission prior to initiating therapy.

Responsiveness of a Histologic Scoring System Compared With Peak Eosinophil Count in Eosinophilic Esophagitis.

Introduction: The optimal instrument for assessing histologic disease activity in patients with eosinophilic esophagitis (EoE) is unclear. We assessed the responsiveness of the EoE Histologic Scoring System (EoE-HSS) when compared with that of the peak eosinophil count (PEC).

Methods: Histopathology slides were obtained from patients with EoE at baseline and after 8 weeks of treatment with swallowed topical budesonide or elimination diet.

Recommendations for Standardizing Clinical Trial Design and Endoscopic Assessment in Postoperative Crohn's Disease.

Background: The lack of standardized methods for clinical trial design and disease activity assessment has contributed to an absence of approved medical therapies for the prevention of postoperative Crohn's disease (CD). We developed recommendations for regulatory trial design for this indication and for endoscopic assessment of postoperative CD activity.

Methods: An international panel of 19 gastroenterologists was assembled.

Reliability of the Endoscopic Ultrasound Ulcerative Colitis (EUS-UC) score for assessment of inflammation in patients with ulcerative colitis.

Endoscopic ultrasound (EUS) may be a useful modality for disease assessment and risk stratification in ulcerative colitis. We assessed the reliability of a newly developed EUS index of inflammation called the EUS-Ulcerative Colitis (EUS-UC) score. The EUS-UC score components include total wall thickness, hyperemia, and depth of inflammation (DOI).