Diagnostic Accuracy of Non-Invasive Imaging for Detection of Colonic Inflammation in Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.

Endoscopy is the gold standard for objective assessment of colonic disease activity in inflammatory bowel disease (IBD). Non-invasive colonic imaging using bowel ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI) may have a role in quantifying colonic disease activity. We reviewed the diagnostic accuracy of these modalities for assessment of endoscopically or histopathologically defined colonic disease activity in IBD.

A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT.

Background: Tranexamic acid reduces blood loss in surgery and the risk of death in trauma patients. Meta-analyses of small trials suggest that tranexamic acid decreases the number of deaths from gastrointestinal bleeding, but these meta-analyses are prone to selection bias.

Objective: The trial provides reliable evidence of the effect of tranexamic acid on mortality, rebleeding and complications in significant acute gastrointestinal bleeding.

Effectiveness of Reinduction and/or Dose Escalation of Ustekinumab in Crohn's Disease: A Systematic Review and Meta-analysis.

Background & Aims: Patients with Crohn's disease (CD) treated with ustekinumab who experience inadequate response, or loss of response after standard induction and/or maintenance dosing may benefit from dose escalation. We conducted a systematic review and meta-analysis examining the effectiveness of reinduction and/or dose interval shortening of ustekinumab in patients with active CD despite standard induction and maintenance.

Methods: Through a systematic literature search through March 31, 2021, we identified 15 cohort studies in 925 adults with CD with inadequate response or loss of response to standard dose ustekinumab, underwent dose escalation (reinduction and/or dose interval shortening to <8 weeks), and reported rates of achieving clinical response, corticosteroid-free clinical remission, endoscopic response, and/or remission.

A Microsimulation Model to Determine the Cost-Effectiveness of Treat-to-Target Strategies for Crohn's Disease.

Introduction: Cost-effectiveness of biomarker- vs endoscopy-based treat-to-target monitoring in Crohn's disease (CD) is unknown.

Methods: A microsimulation model for CD was built to simulate biomarker (fecal calprotectin) vs endoscopy-based monitoring in a treat-to-target fashion. Published literature in combination with patient-level data from phase 3 clinical trials and population estimates for therapeutic drug monitoring were used to generate transition probabilities, costs, and utilities.

Development of antifibrotic therapy for stricturing Crohn's disease: lessons from randomized trials in other fibrotic diseases.

Intestinal fibrosis is considered an inevitable complication of Crohn's disease (CD) that results in symptoms of obstruction and stricture formation. Endoscopic or surgical treatment is required to treat the majority of patients. Progress in the management of stricturing CD is hampered by the lack of effective antifibrotic therapy; however, this situation is likely to change because of recent advances in other fibrotic diseases of the lung, liver, and skin.

Systematic Review of Outcome Measures Used in Observational Studies of Adults with Eosinophilic Esophagitis.

Background: Over the last 20 years, diverse outcome measures have been used to evaluate the effectiveness of therapies for eosinophilic esophagitis (EoE). This systematic review aims to identify the readouts used in observational studies of topical corticosteroids, diet, and dilation in adult EoE patients.

Methods: We searched MEDLINE and Embase for prospective and retrospective studies (cohorts/case series, randomized open-label, and case-control) evaluating the use of diets, dilation, and topical corticosteroids in adults with EoE.

Meta-analysis of gene expression disease signatures in colonic biopsy tissue from patients with ulcerative colitis.

Publicly available ulcerative colitis (UC) gene expression datasets from observational studies and clinical trials include inherently heterogeneous disease characteristics and methodology. We used meta-analysis to identify a robust UC gene signature from inflamed biopsies. Eight gene expression datasets derived from biopsy tissue samples from noninflammatory bowel disease (IBD) controls and areas of active inflammation from patients with UC were publicly available.

The Relationship Between Endoscopic and Clinical Recurrence in Postoperative Crohn's Disease: A Systematic Review and Meta-analysis.

Background And Aims: We aimed to quantify the magnitude of the association between endoscopic recurrence and clinical recurrence [symptom relapse] in patients with postoperative Crohn's disease.

Methods: Databases were searched to October 2, 2020, for randomised controlled trials [RCTs] and cohort studies of adult patients with Crohn's disease with ileocolonic resection and anastomosis. Summary effect estimates for the association between clinical recurrence and endoscopic recurrence were quantified by risk ratios [RR] and 95% confidence intervals [95% CI].

Machine Learning-based Prediction Models for Diagnosis and Prognosis in Inflammatory Bowel Diseases: A Systematic Review.

Background And Aims: There is increasing interest in machine learning-based prediction models in inflammatory bowel diseases [IBD]. We synthesised and critically appraised studies comparing machine learning vs traditional statistical models, using routinely available clinical data for risk prediction in IBD.

Methods: Through a systematic review till January 1, 2021, we identified cohort studies that derived and/or validated machine learning models, based on routinely collected clinical data in patients with IBD, to predict the risk of harbouring or developing adverse clinical outcomes, and reported its predictive performance against a traditional statistical model for the same outcome.

Impact of Drug Approval Pathways for Paediatric Inflammatory Bowel Disease.

Background And Aims: Timely access to approved medications is a priority in paediatric inflammatory bowel disease [IBD]. To date, the timing of drug studies in paediatric IBD has been suboptimal, with most studies conducted long after approval has been granted for adult IBD. This delay in approval leads to extensive off-label prescribing of medications in children, often without clear guidance on optimal dosing.

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).

Systematic Review and Meta-Analysis: Clinical, Endoscopic, Histological and Safety Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.

Background And Aims: Quantifying placebo rates and the factors influencing them are essential to inform trial design. We provide a contemporary summary of clinical, endoscopic, histological and safety placebo rates in induction and maintenance clinical trials of ulcerative colitis, and identify factors influencing them.

Methods: MEDLINE, EMBASE and the Cochrane library were searched from April 2014 to April 2020, updating a prior meta-analysis that searched from inception to April 2014.

Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

Background: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments.

Objective: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE.

Disease Activity Indices for Pouchitis: A Systematic Review.

Background: Several indices exist to measure pouchitis disease activity; however, none are fully validated. As an initial step toward creating a validated instrument, we identified pouchitis disease activity indices, examined their operating properties, and assessed their value as outcome measures in clinical trials.

Methods: Electronic databases were searched to identify randomized controlled trials including indices that evaluated clinical, endoscopic, or histologic pouchitis disease activity.

Biomarkers for the Prediction and Diagnosis of Fibrostenosing Crohn's Disease: A Systematic Review.

Background And Aims: Intestinal strictures are a common complication of Crohn's disease (CD). Biomarkers of intestinal strictures would assist in their prediction, diagnosis, and monitoring. Herein we provide a comprehensive systematic review of studies assessing biomarkers that may predict or diagnose CD-associated strictures.

Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016.

Background: Inflammatory bowel diseases (IBD) are rising in prevalence and are associated with high health care costs. We estimated trends in U.S.

International consensus to standardise histopathological scoring for small bowel strictures in Crohn's disease.

Objective: Effective medical therapy and validated trial outcomes are lacking for small bowel Crohn's disease (CD) strictures. Histopathology of surgically resected specimens is the gold standard for correlation with imaging techniques. However, no validated histopathological scoring systems are currently available for small bowel stricturing disease.

Higher Postinduction Infliximab Concentrations Are Associated With Improved Clinical Outcomes in Fistulizing Crohn's Disease: An ACCENT-II Post Hoc Analysis.

Introduction: There are only limited data regarding the role of therapeutic drug monitoring in fistulizing Crohn's disease (CD). We investigated the association between both induction and maintenance serum infliximab concentrations and favorable therapeutic outcomes in patients with fistulizing CD.

Methods: This was a post hoc analysis of the ACCENT-II trial evaluating patients with fistulizing CD receiving induction (n = 282) and maintenance infliximab therapy (n = 139).

A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy.

Background: The optimal dose of simethicone before capsule endoscopy is unknown. Prior studies have reported inconsistent cleansing, with some showing improved visualization only in the proximal small intestine. We hypothesized a higher volume of simethicone may improve cleansing and diagnostic yield, especially in the distal small bowel.