Composite Assessment Using Intestinal Ultrasound and Calprotectin Is Accurate in Predicting Histological Activity in Ulcerative Colitis: A Cohort Study.

BACKGROUND: Beyond endoscopic remission, histological remission in ulcerative colitis (UC) is predictive of clinical outcomes. Intestinal ultrasound (IUS) may offer a noninvasive surrogate marker for histological activity; however, there are limited data correlating validated ultrasound and histological indices. AIM: Our aim was to determine the correlation of IUS activity in UC with a validated histological activity index. METHODS: Twenty-nine prospective, paired, same-day IUS/endoscopy/histology/fecal calprotectin (FC) cases were included. Intestinal ultrasound activity was determined using the Milan Ultrasound Criteria, histological activity using the Nancy Histological Index, endoscopic activity using Mayo endoscopic subscore and Ulcerative Colitis Endoscopic Index of Severity, and clinical activity using the Simple Clinical Colitis Activity Score. RESULTS: Histological activity demonstrated a significant linear association with overall IUS activity (coefficient 0.14; 95% CI, 0.03-0.25; P = .011). Intestinal ultrasound activity was also significantly associated with endoscopic activity (0.32; 95% CI, 0.14-0.49; P < 0.001), total Mayo score (0.31; 95% CI, 0.02-0.60; P = .036) but not FC (0.10; 95% CI, -0.01 to 0.21; P = .064) or clinical disease activity (0.04; 95% CI, -0.21 to 0.28; P = .768). A composite of IUS and FC showed the greatest association (1.31; 95% CI, 0.43-2.18; P = .003) and accurately predicted histological activity in 88% of cases (P = .007), with sensitivity of 88%, specificity 80%, positive predictive value 95%, and negative predictive value 57%. CONCLUSIONS: Intestinal ultrasound is an accurate noninvasive marker of histological disease activity in UC, the accuracy of which is further enhanced when used in composite with FC. This can reduce the need for colonoscopy in routine care by supporting accurate point-of-care decision-making in patients with UC.

Bedside Intestinal Ultrasound Performed in an Inflammatory Bowel Disease Urgent Assessment Clinic Improves Clinical Decision-Making and Resource Utilization.

Background: Patients with inflammatory bowel disease (IBD) require accessible, timely, and noninvasive strategies to monitor disease. The aim was to assess the integration of intestinal ultrasound (IUS) on decision-making and endoscopy utilization in a standardized care pathway. Methods: This prospective, multicenter, international, observational cohort study included patients seen within a centralized model for IBD care was conducted during the COVID pandemic. Patients were evaluated with IUS alone or in combination with an in-clinic, unsedated sigmoidoscopy. Demographic, clinical, laboratory, and imaging data, clinical decisions, and need for urgent endoscopy, hospitalization, and surgeries were recorded. Results: Of the 158 patients included, the majority had an established diagnosis of Crohn's disease (n = 123, 78%), and 47% (n = 75) of patients were on biologic therapy. IUS identified active inflammation in 65% (n = 102) of patients, and strictures in 14% (n = 22). Fecal calprotectin levels correlated with inflammation detected on IUS (median of 50 µg/g [Q1-Q3: 26-107 µg/g] without inflammation and 270 µg/g [Q1-Q3: 61-556 µg/g] with inflammation; p = 0.0271). In the majority of patients, clinical assessment with IUS led to an acute change in IBD-specific medications (57%, n = 90) and avoided or delayed the need for urgent endoscopy (85%, n = 134). Four patients were referred for urgent surgical consultation. Conclusions: Point-of-care IUS used in a flare clinic pathway is a useful strategy to improve effective IBD care delivery and to assist in therapeutic management decisions, in many cases avoiding the acute need for endoscopy.

Defining Transabdominal Intestinal Ultrasound Treatment Response and Remission in Inflammatory Bowel Disease: Systematic Review and Expert Consensus Statement.

BACKGROUND AND AIMS: No consensus exists on defining intestinal ultrasound response, transmural healing, or transmural remission in inflammatory bowel disease, nor clear guidance for optimal timing of assessment during treatment. This systematic review and expert consensus study aimed to define such recommendations, along with key parameters included in response reporting. METHODS: Electronic databases were searched from inception to July 26, 2021, using pre-defined terms. Studies were eligible if at least two intestinal ultrasound [IUS] assessments at different time points during treatment were reported, along with an appropriate reference standard. The QUADAS-2 tool was used to examine study-level risk of bias. An international panel of experts [n = 18] rated an initial 196 statements [RAND/UCLA process, scale 1-9]. Two videoconferences were conducted, resulting in additional ratings of 149 and 13 statements, respectively. RESULTS: Out of 5826 records, 31 full-text articles, 16 abstracts, and one research letter were included; 83% [40/48] of included studies showed a low concern of applicability, and 96% [46/48] had a high risk of bias. A consensus was reached on 41 statements, with clear definitions of IUS treatment response, transmural healing, transmural remission, timing of assessment, and general considerations when using intestinal ultrasound in inflammatory bowel disease. CONCLUSIONS: Response criteria and time points of response assessment varied between studies, complicating direct comparison of parameter changes and their relation to treatment outcomes. To ensure a unified approach in routine care and clinical trials, we provide recommendations and definitions for key parameters for intestinal ultrasound response, to incorporate into future prospective studies.

Systematic Review: Patient Perceptions of Monitoring Tools in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) is a lifelong disease requiring frequent assessment to guide treatment and prevent flares or progression. Multiple tools are available for clinicians to monitor disease activity; however, there are a paucity of data to inform which monitoring tools are most acceptable to patients. The review aims to describe the available evidence for patient preference, satisfaction, tolerance and/or acceptability of the available monitoring tools in adults with IBD. METHODS: Embase, Medline, Cochrane Central and Clinical Trials.gov were searched from January 1980 to April 2019 for all study types reporting on the perspectives of adults with confirmed IBD on monitoring tools, where two or more tools were compared. Outcome measures with summary and descriptive data were presented. RESULTS: In 10 studies evaluating 1846 participants, monitoring tools included venipuncture, stool collection, gastrointestinal ultrasound, computed tomography, magnetic resonance imaging, wireless capsule endoscopy, barium follow-through and endoscopy. Outcome domains were patient satisfaction, acceptability of monitoring tool and patient preference. Noninvasive investigations were preferable to endoscopy in nine studies. When assessed, gastrointestinal ultrasound was consistently associated with greater acceptability and satisfaction compared with endoscopy or other imaging modalities. CONCLUSIONS: Adults with IBD preferred noninvasive investigations, in particular gastrointestinal ultrasound, as compared to endoscopy for monitoring disease activity. When assessing disease activity, patient perceptions should be considered in the selection of monitoring tools. Further research should address whether adpoting monitoring approaches considered more acceptable to patients results in greater satisfaction, adherence and ultimately more beneficial clinical outcomes.

Standardisation of intestinal ultrasound scoring in clinical trials for luminal Crohn's disease.

BACKGROUND: Intestinal ultrasound (IUS) is a valuable tool for assessment of Crohn's disease (CD). However, there is no widely accepted luminal disease activity index. AIMS: To identify appropriate IUS protocols, indices, items, and scoring methods for measurement of luminal CD activity and integration of IUS in CD clinical trials. METHODS: An expert international panel of adult and paediatric gastroenterologists (n = 15) and radiologists (n = 3) rated the appropriateness of 120 statements derived from literature review and expert opinion (scale of 1-9) using modified RAND/UCLA methodology. Median panel scores of 1 to ≤3.5, >3.5 to <6.5 and ≥6.5 to 9 were considered inappropriate, uncertain and appropriate ratings respectively. The statement list and survey results were discussed prior to voting. RESULTS: A total of 91 statements were rated appropriate with agreement after two rounds of voting. Items considered appropriate measures of disease activity were bowel wall thickness (BWT), vascularity, stratification and mesenteric inflammatory fat. There was uncertainty if any of the existing IUS disease activity indices were appropriate for use in CD clinical trials. Appropriate trial applications for IUS included patient recruitment qualification when diseased segments cannot be adequately assessed by ileocolonoscopy and screening for exclusionary complications. At outcome assessment, remission endpoints including BWT and vascularity, with or without mesenteric inflammatory fat, were considered appropriate. Components of an ideal IUS disease activity index were identified based upon panel discussions. CONCLUSIONS: The panel identified appropriate component items and applications of IUS for CD clinical trials. Empiric evidence, and development and validation of an IUS disease activity index are needed.

Systematic Review: Gastrointestinal Ultrasound Scoring Indices for Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Serial measurements of luminal disease activity may facilitate inflammatory bowel disease management. Gastrointestinal ultrasound is an easily performed, non-invasive alternative to other assessment modes. However, its widespread use is limited by concerns regarding validity, reliability, and responsiveness. We systematically identified ultrasound scoring indices used to evaluate inflammatory bowel disease activity and examine their operating characteristics. METHODS: Electronic databases were searched from inception to June 14, 2019 using pre-defined terms. Studies that reported on gastrointestinal ultrasound index operating properties in an inflammatory bowel disease population were eligible for inclusion. Study characteristics, index components, and operating property data [ie, validity, reliability, responsiveness, sensitivity, specificity, accuracy, positive predictive value, and negative predictive value] were extracted. The QUADAS-2 tool was used to examine study-level risk of bias. RESULTS: Of the 2610 studies identified, 26 studies reporting on 21 ultrasound indices were included. The most common index components included bowel wall thickness, colour Doppler imaging, and bowel wall stratification. The correlation between ultrasound indices and references standards ranged r = 0.62-0.95 and k = 0.40-0.96. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive values ranged 39-100%, 63-100%, 73-100%, 57-100%, and 40-100%, respectively. Reliability and responsiveness data were limited. Most [92%, 24/26] studies received at least one unclear or high risk of bias rating. CONCLUSIONS: Several gastrointestinal ultrasound indices for use in inflammatory bowel disease have been developed. Future research should focus on fully validating existing or novel gastrointestinal ultrasound scoring instruments for assessment of Crohn's disease and ulcerative colitis.

Understanding attitudes, concerns, and health behaviors of patients with inflammatory bowel disease during the coronavirus disease 2019 pandemic.

BACKGROUND AND AIM: The coronavirus disease 2019 (COVID-19) pandemic has led to a rapid shift in care delivery models for patients with inflammatory bowel disease (IBD); however, little is known about patient perceptions during this period. We aimed to prospectively evaluate the attitudes, concerns, and health behavior of IBD patients during COVID-19. METHODS: An online survey was sent to patients from a tertiary IBD Service. The survey included demographic information and questions about the impact of COVID-19, levels of concern caused by COVID-19, perceived risk of IBD medications, medication cessation, and care delivery preferences. RESULTS: Of 97 respondents (39%), 95 (98%) reported concern about the impact of COVID-19 on their health, and 43% felt their risk of contracting COVID-19 was above average; 62% reported concern about medication-induced COVID-19 risk, and 11% stopped medications because of COVID-19. Patients considered all medications to increase the risk of COVID-19 susceptibility and severity; 45% preferred telehealth while 16% preferred face-to-face clinic reviews. Preference for IBD monitoring tools in decreasing order was blood testing, stool collection, gastrointestinal ultrasound, magnetic resonance enterography, and then colonoscopy. CONCLUSIONS: Patients with IBD are demonstrated to experience concern related to their diagnosis and medications. The insights provided by the survey are informative for a possible "second-wave" of COVID-19 and routine care, including acceptance of telemedicine, preference for non-invasive investigations, and a need for dissemination of information and education.