Primary Care Support Tools for Digestive Health Care: A Mixed Method Study.

Background: To address the increasing demands for gastroenterology specialty care and increasing wait times, centralized access and triage (CAT) systems, telephone support, and clinical care pathways were implemented to streamline referrals and support management of low-risk gastrointestinal (GI) conditions in the primary care medical home. This study aimed to understand primary care providers (PCPs) and GI specialists' perceptions of these supports, factors that affect support implementation and identify barriers and facilitators for implementing supports from both PCP and GI specialists' perspectives. Methods: We conducted a mixed method study including surveys and interviews with PCPs and GI specialists. Online surveys and semistructured qualitative interviews were conducted from July 2022 to September 2022. All interviews were transcribed and coded to perform a thematic analysis. Survey data were analyzed in SPSS version 25. Descriptive statistics were employed to summarize and describe the data collected. Inferential statistics were used to identify associations and relationships within the dataset. T-test and chi-square tests were applied at 95% confidence level, with a p value <0.05 (two-sided) considered statistically significant. Results: A total of 36 PCPs responded to the survey. Most respondents were working full-time (73.5%, n = 25) and were female (73.5%, n = 25). Overall, 42% used the pathways regularly, 48% (n = 16) used them occasionally, and very few (9.1%, n = 3) said they were aware but had not used pathways. Overall, PCPs were satisfied with CAT processes and the use of primary care pathways, recognizing the importance of fair and equitable access to specialty care. Specific processes in CAT for vulnerable populations and patients using walk-in clinics were recognized as a limitation, given the lack of ease in completing the required testing and follow-up needed when utilizing the care pathway. Of the 112 GI specialists who received the survey, 28 (25%) completed it, with males (50.0%, n = 14) and females (39.2%, n = 11), remainder no response. Most participate in CAT (73.9%, n = 17) and were remunerated by an alternative relationship plan (ARP) (53.6%, n = 15). Overall, GIs were satisfied with central triaging and primary care pathways, reducing unnecessary time and resource expenditure for referrals. There were statistically significant differences in perceptions among fee for service and alternative relationship plan GI specialists regarding the effectiveness of CAT in improving access and use of health system resources. Conclusion: Overall, PCPs and GI specialists believe utilizing CAT and primary care pathways improves referral quality, reduces resource expenditure, and provides fair and equitable access to GI specialty services. Improvement in CAT processes with improved pathway awareness may reduce unnecessary referrals.

US National Estimates of Contemporary Mortality Rates in Patients with Ulcerative Colitis Undergoing Colectomy.

OBJECTIVE: Despite a growing armamentarium of medical therapies for ulcerative colitis (UC), colectomy remains an important therapeutic option. To better inform shared decision-making about surgery, we estimated the contemporary risk of mortality post-colectomy. METHODS: Mortality rates were estimated using the National Inpatient Sample (2016-2020). Factors associated with post-colectomy death were evaluated in multivariable regression. RESULTS: Post-colectomy mortality occurred in 1.2% [95% CI: 0.8%, 1.9%] of hospitalizations. Comorbidity burden, emergent laparotomy, and delays to surgery >5 days after admission were associated with mortality. CONCLUSIONS: Colectomy may be associated with mortality; however, this risk is heterogeneous based on patient- and procedural-related factors.

Classifying Inflammation on Intestinal Ultrasound Images and Cineloops - A Learning Curve Study.

BACKGROUND AND AIMS: Intestinal ultrasound has become a crucial tool for assessing inflammation in patients with inflammatory bowel disease, prompting a surge in demand for trained sonographers. While educational programs exist, the length of training needed to reach proficiency in correctly classifying inflammation remains unclear. Our study addresses this gap partly by exploring the learning curves associated with the deliberate practice of sonographic disease assessment, focusing on the key disease activity parameters of bowel wall thickness, bowel wall stratification, color Doppler signal, and inflammatory fat. METHODS: Twenty-one novices and six certified intestinal ultrasound practitioners engaged in an 80-case deliberate practice online training program. A panel of three experts independently graded ultrasound images representing various degrees of disease activity and agreed upon a consensus score. We used statistical analyses, including mixed-effects regression models, to evaluate learning trajectories. Pass/fail thresholds distinguishing novices from certified practitioners were determined through contrasting-groups analyses. RESULTS: Novices showed significant improvement in interpreting bowel wall thickness, surpassing the pass/fail threshold, and reached mastery level by case 80. For color Doppler signal and inflammatory fat, novices surpassed the pass/fail threshold but did not achieve mastery. Novices did not improve in assessing bowel wall stratification. CONCLUSIONS: We found considerable individual and group-level differences in learning curves supporting the concept of competency-based training for assessing bowel wall thickness, color Doppler signal and inflammatory fat. However, despite practice over 80 cases, novices did not improve in their interpretation of bowel wall stratification, suggesting that a different approach is needed for this parameter.

Gastroscopy for dyspeptic symptoms in patients <65 years has a low yield of clinically important findings: a retrospective study.

Background: Dyspepsia is a common, generally low-risk gastrointestinal condition. The American College of Gastroenterology and Canadian Association of Gastroenterology recommend avoiding gastroscopy in healthy patients <60 years old. Many dyspeptic patients can be effectively managed in primary care. This study aimed to determine: (1) the proportion of gastroscopies performed for dyspepsia among patients <65 years old with no alarm symptoms or clinically appropriate indications and (2) to determine the frequency of clinically actionable findings and dyspepsia-related healthcare utilization in the year following gastroscopy. Methods: Outpatient endoscopy reports were sampled and reviewed retrospectively from 2019 to -2021 in Edmonton, Alberta to identify gastroscopies performed for the indication of dyspepsia. Gastroscopies were considered low-risk for significant endoscopic findings if age <65, no alarm symptoms or other concerning indications, and insufficient evidence that first-line treatments and diagnostic approaches had been tried prior to gastroscopy. Clinically important findings were defined as those impacting management, not otherwise identifiable non-invasively. Results: Of the 358 reviewed gastroscopies for dyspepsia, 293 (81.8%) had no alarm symptoms, and 130 (36.3%) had no alarm symptoms or other appropriate indications. Clinically important findings were identified in 9 (6.9%) of the 130 low-risk cases. In the year following, one patient (1/130) visited the emergency department 3 times for their symptoms and no patients required hospital admission. No malignancies were detected. Conclusions: Many gastroscopies are performed on patients <65 years old with dyspepsia, even when they lack alarm symptoms or other clinical indications, despite recommendations against this practice and low procedure yield. Strategies to improve the uptake of current guidelines may optimize endoscopy resource utilization.

Tofacitinib as a Rescue Therapy for Ulcerative Colitis in Pregnancy.

Tofacitinib, a potentially teratogenic nonselective Janus Kinase inhibitor was used as salvage therapy for ulcerative colitis during pregnancy with corticosteroids, maintenance ustekinumab, and rectal 5-ASA therapy. Corticosteroid-free remission ensued, resulting in term delivery without congenital malformations and avoidance of colectomy.

Systematic review: Defining, diagnosing and monitoring small bowel strictures in Crohn's disease on intestinal ultrasound.

BACKGROUND: Stricturing Crohn's disease (CD) occurs most commonly in the terminal ileum and poses a clinical problem. Cross-sectional imaging modalities such as intestinal ultrasound (IUS), computed tomography enterography (CTE), and magnetic resonance enterography (MRE) allow for assessment of the entire bowel wall and associated peri-enteric findings. Radiologic definitions of strictures have been developed for CTE and MRE; their reliability and responsiveness are being evaluated in index development programs. A comprehensive assessment strategy for strictures using IUS is needed. AIMS: To provide a detailed summary of definitions, diagnosis and monitoring of strictures on IUS as well as technical aspects of image acquisition. METHODS: We searched four databases up to 6 January 2024. Two-stage screening was done in duplicate. We assessed risk of bias using QUADAS-2. RESULTS: There were 56 studies eligible for inclusion. Definitions for strictures on IUS are heterogeneous, but the overall accuracy for diagnosis of strictures is high. The capability of IUS for characterising inflammation versus fibrosis in strictures is not accurate enough to be used in clinical practice or trials. We summarise definitions for improvement of strictures on IUS, and discuss parameters for image acquisition and standardisation. CONCLUSIONS: This systematic review is the first step for a structured program to develop a stricture IUS index for CD.

Normal Infant Immunologic Assessment and Uneventful Live Rotavirus Vaccination Despite Continuous Tofacitinib Exposure In Utero and During Breastfeeding.

Background: Janus kinase (JAK) inhibitors are effective for the treatment of inflammatory bowel disease (IBD). However, this class of medications is not recommended during pregnancy or breastfeeding based on animal data suggesting teratogenesis and recent reports of transmammary transfer after maternal ingestion, raising concerns for immune system development in babies exposed to these drugs. Methods: We present the case of a patient with IBD treated with a JAK inhibitor who decided to continue the medication throughout her pregnancy and during breastfeeding. This is the first reported case of a detailed immunologic profile in a baby exposed to tofacitinib in utero and during lactation. Results: A 30-year-old female with ulcerative colitis with previous exposure to vedolizumab and infliximab achieved complete remission with tofacitinib therapy. The patient became pregnant after 5 months of JAK inhibitor therapy and decided to continue tofacitinib during pregnancy and while breastfeeding. The patient delivered a healthy offspring with no congenital malformations, a normal detailed immunologic profile, and subsequent safe provision of the live oral rotavirus vaccine. Conclusions: This case highlights the importance of individualized counseling for patients of childbearing age who are candidates for JAK inhibition. Those who are pregnant or breastfeeding with refractory disease may have limited medical therapeutic options. Ongoing effective therapy for IBD resulted in complete disease remission in the mother and favorable outcomes in the infant. Further, an in-depth infant immunological assessment can lead to specific vaccination recommendations in exposed infants.

Incidence and Prevalence of Primary Sclerosing Cholangitis: A Meta-analysis of Population-based Studies.

BACKGROUND: Primary sclerosing cholangitis is a chronic liver disease associated with significant morbidity, mortality, and healthcare utilization. We conducted a systematic review and meta-analysis of population-based studies of the incidence and prevalence of primary sclerosing cholangitis. METHODS: Medline and Embase were systematically searched to identify population-based studies of a defined geographic area and reported the incidence or prevalence of primary sclerosing cholangitis in the general population. Meta-analyses, using random-effects, were performed to calculate overall and country-specific incidence (per 100 000 persons/year) and prevalence rates (per 100 000 persons) with 95% confidence intervals. RESULTS: The 14 studies on incidence and the 12 for prevalence originated from North America, Asia, Europe, and Oceania. Incidence and prevalence rates of primary sclerosing cholangitis were 0.87 (95% confidence interval, 0.59-1.29) and 13.53 (95% confidence interval, 10.20-17.94) per 100 000 persons, respectively. CONCLUSIONS: Both the prevalence and incidence of primary sclerosing cholangitis is low in the general population. Future studies on the incidence and prevalence of primary sclerosing cholangitis in the general population should be directed at Asia, Africa, and Latin America to allow for a more robust assessment of the global epidemiology of primary sclerosing cholangitis.

Primary sclerosing cholangitis is a chronic liver disease with complications such as cirrhosis, cancer, and death. This study summarizes the incidence (0.87 per 100 000) and prevalence (13.53 per 100 000) of PSC and highlight needs in research to study the epidemiology of PSC.

Role of artificial intelligence in imaging and endoscopy for the diagnosis, monitoring and prognostication of inflammatory bowel disease: a scoping review protocol.

INTRODUCTION: Inflammatory bowel diseases (IBD) are immune-mediated conditions that are increasing in incidence and prevalence worldwide. Their assessment and monitoring are becoming increasingly important, though complex. The best disease control is achieved through tight monitoring of objective inflammatory parameters (such as serum and stool inflammatory markers), cross-sectional imaging and endoscopic assessment. Considering the complexity of the information obtained throughout a patient's journey, artificial intelligence (AI) provides an ideal adjunct to existing tools to help diagnose, monitor and predict the course of disease of patients with IBD. Therefore, we propose a scoping review assessing AI's role in diagnosis, monitoring and prognostication tools in patients with IBD. We aim to detect gaps in the literature and address them in future research endeavours. METHODS AND ANALYSIS: We will search electronic databases, including Medline, Embase, Cochrane CENTRAL, CINAHL Complete, Web of Science and IEEE Xplore. Two reviewers will independently screen the abstracts and titles first and then perform the full-text review. A third reviewer will resolve any conflict. We will include both observational studies and clinical trials. Study characteristics will be extracted using a data extraction form. The extracted data will be summarised in a tabular format, following the imaging modality theme and the study outcome assessed. The results will have an accompanying narrative review. ETHICS AND DISSEMINATION: Considering the nature of the project, ethical review by an institutional review board is not required. The data will be presented at academic conferences, and the final product will be published in a peer-reviewed journal.

Gastroscopy for dyspepsia: Understanding primary care and gastroenterologist mental models of practice: A cognitive task analysis approach.

Background: Gastroscopy to investigate dyspepsia without alarm symptoms rarely results in clinically actionable findings or sustained health-related quality-of-life improvements among patients aged 18-60 years and is, therefore, not recommended. Despite this, referrals for and performance of gastroscopy among this patient population remain high. The purpose of this study was to understand family physicians' and gastroenterologists' mental models of dyspepsia and the drivers behind referring or performing gastroscopy. Methods: Cognitive task analysis routine critical decision method interviews with family physicians (n = 8) and gastroenterologists (n = 4). Results: Family physicians and gastroenterologists hold rich mental models of dyspepsia that rely on sensemaking; however, gaps in information continuity affect their ability to plan and coordinate patient care. Drivers behind decisions to refer or perform gastroscopy were: eliminating risk for serious pathology, providing reassurance, perceived preference by patients to receive information and reassurance from gastroenterologists, maintaining relationships with patients, and saving costs to the health system. Conclusions: Family physicians refer for dyspepsia when they are seeking support from gastroenterologists, they believe that alternative factors may be impacting the patient's health or view it as a cost-saving measure. Likewise, gastroenterologists perform gastroscopy for dyspepsia when they perceive it as a cost-saving measure, they want to support their primary care colleagues and provide their colleagues and patients with reassurance. An improved degree of communication between speciality and primary care could allow for continuity in the transfer of information about patients and reduce referrals for dyspepsia.

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.

Time for a Gut Check: A Qualitative Study of Proposed Interventions to Address Gender Inequality in Gastroenterology.

Background: Gender inequalities persist in medicine, particularly in some speciality fields where fewer women are employed. Although previous research has suggested potential interventions to broadly address gender inequality in medicine, no research has focused on interventions in the field of gastroenterology. The purpose of this research was to engage women in the field of gastroenterology in Canada, to identify interventions with potential to be effective in addressing gender inequality. Methods: A World Café was hosted in 2019 to discuss gender inequality and interventions in gastroenterology. Twelve women employed in the field of gastroenterology (i.e. physicians, nurses, research staff, and trainees) were purposively recruited and participated in the event. The discussion rounds were audio-recorded, transcribed, and thematic analyses was conducted using Braun and Clarke's principles. Results: Three key themes identifying potential interventions to address gender inequality in gastroenterology were generated: (1) Education; (2) Addressing institutional structures and polices; and 3) Role modelling and mentorship. Participants indicated that interventions should target various stakeholders, including both women and men in gastroenterology, young girls, patients, and administrators. Conclusion: Many of the interventions identified by participants correspond with existing research on interventions in general medicine, suggesting that institutional changes can be made for maximum effectiveness. Some novel interventions were also identified, including publicizing instances of gender parity and supporting interventions across the educational and professional lifecourse. Moving forward, institutions must assess their readiness for change and evaluate existing policies, programs, and practices for areas of improvement.

The 2023 Impact of Inflammatory Bowel Disease in Canada: Access to and Models of Care.

Rising compounding prevalence of inflammatory bowel disease (IBD) (Kaplan GG, Windsor JW. The four epidemiological stages in the global evolution of inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2021;18:56-66.) and pandemic-exacerbated health system resource limitations have resulted in significant variability in access to high-quality, evidence-based, person-centered specialty care for Canadians living with IBD. Individuals with IBD have identified long wait times, gaps in biopsychosocial care, treatment and travel expenses, and geographic and provider variation in IBD specialty care and knowledge as some of the key barriers to access. Care delivered within integrated models of care (IMC) has shown promise related to impact on disease-related outcomes and quality of life. However, access to these models is limited within the Canadian healthcare systems and much remains to be learned about the most appropriate IMC team composition and roles. Although eHealth technologies have been leveraged to overcome some access challenges since COVID-19, more research is needed to understand how best to integrate eHealth modalities (i.e., video or telephone visits) into routine IBD care. Many individuals with IBD are satisfied with these eHealth modalities. However, not all disease assessment and monitoring can be achieved through virtual modalities. The need for access to person-centered, objective disease monitoring strategies, inclusive of point of care intestinal ultrasound, is more pressing than ever given pandemic-exacerbated restrictions in access to endoscopy and cross-sectional imaging. Supporting learning healthcare systems for IBD and research relating to the strategic use of innovative and integrative implementation strategies for evidence-based IBD care interventions are greatly needed. Data derived from this research will be essential to appropriately allocating scarce resources aimed at improving person-centred access to cost-effective IBD care.

Comment on "Ultrasonographic scores for ileal Crohn's disease assessment: better, worse or the same as contrast­enhanced ultrasound?"

We read with interest the study by Freitas et al. comparing contrast-enhanced ultrasound (CEUS) and parameters from a time-intensity curve (TIC) with the SUS-CD score and IBUS-SAS score in patients with Crohn's disease (CD) undergoing gastrointestinal ultrasound (GIUS) and ileocolonoscopy. The aim was to compare the accuracy of CEUS and aforementioned scores in predicting terminal ileal inflammatory activity in patients with CD. In this retrospective study of 50 patients, inflammatory activity was defined as a segmental score of SES-CD ≥ 7 in the terminal ileum. The study found 30 patients with active endoscopic disease demonstrating no significant difference between the "inactive" and "active" SUS CD and IBUS-SAS scores. However, the CEUS peak enhancement derived from the TIC was shown to be significantly different. The authors conclude CEUS was superior for detecting inflammation in the terminal ileum, as opposed to ultrasound scores relying on bowel wall thickness and color Doppler.

Intermittent Proton Pump Inhibitor Therapy in Low-Risk Non-Variceal Upper Gastrointestinal Bleeding May Be Significantly Cost-Saving.

BACKGROUND: High-dose proton pump inhibitor (PPI) therapy, given either intermittently or continuously for non-variceal upper gastrointestinal bleeding (NV-UGIB), is efficacious. Using intermittent PPI for low-risk patients may be cost-saving. Our objective was to estimate the annual cost savings if all low-risk NV-UGIB patients received intermittent PPI therapy. METHODS: Patients who presented to hospital in Calgary, Alberta, who received a PPI for NV-UGIB from July 2015 to March 2017 were identified using ICD-10 codes. Patients were stratified into no endoscopy, high-risk, and low-risk lesion groups and further subdivided into no PPI, oral PPI, intermittent intravenous (IV), and continuous IV subgroups. Average length of stay (LOS) in each subgroup and costs were calculated. RESULTS: We identified 4141 patients with NV-UGIBs, (median age 61, 57.4% male). One-thousand two-hundred and thirty-one low-risk patients received continuous IV PPI, with an average LOS of 6.8 days (95% CI 6.2-7.3) versus 4.9 days (95% CI 3.9-5.9) for intermittent IV patients. If continuous IV PPI patients instead received intermittent IV PPI, 3852 patient days and CAD 11,714,390 (2017 CAD)/year could be saved. CONCLUSIONS: Using real-world administrative data, we demonstrate that a sizable portion of low-risk patients with NV-UGIB who were given continuous IV PPI if switched to intermittent IV therapy could generate significant potential cost savings.

Real-world experience with subcutaneous infliximab: broadening treatment strategies for inflammatory bowel disease.

INTRODUCTION: The first subcutaneous (SC) formulation of infliximab (IFX), CT­P13 SC, has been approved in Europe and Australia, including for the treatment of inflammatory bowel disease (IBD). AREAS COVERED: We provide a comprehensive overview of available clinical trial and real-world data for IFX SC treatment of IBD, focusing on the potential benefits of switching from IFX intravenous (IV) to IFX SC. We evaluate emerging evidence for IFX SC treatment for difficult-to-treat IBD, use as monotherapy, and suitability for patients receiving escalated IFX IV doses. Therapeutic drug monitoring approaches and patient and healthcare system perspectives on IFX SC are also discussed. EXPERT OPINION: IFX SC represents a significant treatment innovation in the tumor necrosis factor inhibitor class after approximately 20 years of IFX IV availability. Evidence suggests that IFX SC is well tolerated and is associated with high patient acceptance and satisfaction. In addition, effectiveness is maintained in patients with stable disease following switch from IFX IV. Switching may be advisable, given the clinical benefits of IFX SC and its potential to improve healthcare service capacity. There are several areas requiring further research, including the role of IFX SC in difficult-to-treat and refractory disease, and the feasibility of IFX SC monotherapy.

Nutritional interventions in adult fibrostenotic Crohn's disease: A systematic review.

Background: Management of Crohn's disease (CD) using dietary interventions has become an area of increased research interest. There is a lack of specific research exploring if diet and nutrition interventions are beneficial in patients with strictures, as current dietary recommendations in fibrostenotic CD are often based on clinical judgment. The aim of this systematic review was to assess the impact of dietary interventions in fibrostenotic CD on medical and surgical outcomes. Methods: A systematic search of MEDLINE (Ovid), EMBASE (Ovid), CINAHL (EBSCO), and Cochrane Central Register of Controlled Trials (Ovid) was conducted. Studies reporting dietary interventions or nutritional factors in fibrostenotic CD were included. Outcomes for studies assessing dietary interventions such as enteral nutrition were evaluated as changes in (1) CD symptoms (CD Activity Index), (2) stricture parameters on diagnostic imaging, and (3) rates of surgical or medical intervention following dietary interventions. Results: Five studies were included in this review. Three studies assessed exclusive enteral nutrition (EEN), one evaluated total parenteral nutrition (TPN), and one studied a liquid diet. All included studies evaluated symptoms as an outcome, while diagnostic imaging parameters and surgical outcomes in the studies were either absent or too heterogeneous to appraise improvement post dietary intervention. Included EEN studies displayed similar efficacy, with approximately 60% of patients having symptom improvement. The included TPN study also reported 75% of patients with symptom improvement, while the liquid diet did not. Conclusion: Exclusive enteral nutrition and total parental nutrition may provide benefit for use as a dietary intervention for fibrostenotic CD. There remains a need for high-quality controlled trials which utilize standardized definitions of strictures.

Crohn's Disease Patient Experiences and Preferences With Disease Monitoring: An International Qualitative Study.

Background: Strategies incorporating objective disease monitoring in Crohn's disease (CD), beyond clinical symptoms are important to improve patient outcomes. Little evidence exists to explore patient understanding of CD treatment goals, nor preferences and experiences with monitoring options. This qualitative study aimed to explore patient experiences and preferences of CD monitoring to inform monitoring strategies, improve patient engagement, and optimize a patient-centered approach to care. Methods: This study used a patient-oriented, qualitative descriptive design. Convenience and snowball sampling were used to recruit adult participants diagnosed with CD who had experience with at least 2 types of disease monitoring. Online focus groups were conducted and data were analyzed using thematic analysis. Results: This international study included 37 participants from Australia, Canada, United Kingdom, and the United States. Overall, participants preferred more noninvasive types of monitoring [eg, intestinal ultrasound (IUS)] but were willing to undergo more invasive monitoring (eg, colonoscopy) if required. To improve disease monitoring, participants wanted increased access to IUS, establishment of a patient-centered interdisciplinary team and access to information and self-testing. Participants identified challenges with communication between patients and providers and stressed the importance of participating in shared decision making and being equal team members in their care. Conclusions: It is imperative to incorporate patient-driven preferences into how we can best structure monitoring strategies, to ensure equitable access to those preferred modalities and embrace a shared decision-making approach to disease management in CD.

Meta-analysis: Placebo rates in microscopic colitis randomised trials and applications for future drug development using a historical control arm.

BACKGROUND: Effective medical therapies for patients with microscopic colitis (MC) who fail budesonide are lacking. However, conducting randomised controlled trials (RCTs) in MC has been challenging due to small sample sizes. Understanding placebo responses can help inform more efficient future trials. AIMS: The aim of this study is to estimate clinical and histologic placebo response rates and to determine factors associated with placebo response in MC. METHODS: EMBASE, MEDLINE, and CENTRAL were searched until 7 January 2022, to identify placebo-controlled RCTs in adult patients with MC. Clinical and histologic response in the placebo arms were pooled using random-effects models. Stratified analyses based on disease- and trial-level characteristics, leave-one-out meta-analysis, and cumulative meta-analysis were performed. RESULTS: Twelve RCTs enrolling a total of 391 patients (placebo n = 163) with MC were included. Pooled clinical and histologic placebo response rates were 24.4% (95% CI: 12.4%-38.4%), I2  = 60.8%, p < 0.01, and 19.9% (95% CI: 5.3%-39.0%), I2  = 66.4%, p = 0.01 (tests for heterogeneity), respectively. Clinical response to placebo was numerically higher in patients with lymphocytic compared to collagenous colitis (39.9% vs. 19.8%, p = 0.08). Heterogeneity in clinical response to placebo was significantly reduced when the Miehlke 2014 RCT was excluded in the leave-one-out meta-analysis or when a more stringent secondary definition of response based on the Hjortswang criteria was applied. CONCLUSIONS: Approximately one-quarter of patients in MC trials respond to placebo, although with substantial heterogeneity, reflecting the need for standardised outcome definitions and study designs for MC. This analysis also serves to inform future MC trials that may consider incorporating an external, historical placebo control arm, rather than directly randomising patients to placebo.

Innovative Care for Inflammatory Bowel Disease Patients during the COVID-19 Pandemic: Use of Bedside Intestinal Ultrasound to Optimize Management.

Background: The COVID-19 pandemic caused by SARS-CoV-2 has reduced access to endoscopy and imaging. Safe alternatives, available at the bedside, are needed for accurate, non-invasive strategies to evaluate disease activity. The aim of this study is to establish the impact of clinic-based bedside intestinal ultrasound (IUS) on decision making, reduction in reliance on endoscopy and short-term healthcare utilization. Methods: We conducted a prospective observational evaluation during the COVID-19 pandemic, of the impact of a regional comprehensive care pathway to manage IBD patients consecutively recruited with acute symptoms, or suspected new diagnosis of IBD. Clinic-based access to sigmoidoscopy and bedside intestinal ultrasound were evaluated, used to direct clinical care and avoid hospitalization or hospital-based endoscopy. Results: A total of 72 patients were seen between March 15 and June 30, 2020. Of these, 57% (41/72) were female, 64% had Crohn's disease (46/72) with 14% (10/72) presenting with symptoms requiring investigation, of which 5 new cases of IBD were identified (50%). Immediate access to ultrasound and sigmoidoscopy led to meaningful changes in management in 80.5% (58/72) of patients. Active inflammation was detected by IUS alone (72.5%, 29/40) or in combination with in-clinic sigmoidoscopy (78%, 18/23) or sigmoidoscopy alone (78% 7/9). Six patients were referred to colorectal surgery for urgent surgical intervention including two patients admitted directly. Conclusion: Implementation of IUS as part of a clinical care pathway during the COVID-19 pandemic is a useful strategy to enhance care delivery and improve clinical decisions, while sparing other important acute care resources.