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Indigenous people in Canada often face barriers to access specialized care, with limited data in evaluating health care utilization among Indigenous people with inflammatory bowel disease (IBD). We aimed to compare health care utilization between First Nations patients and those in the general population diagnosed with IBD in Saskatchewan.We conducted a patient-oriented, population-based, retrospective cohort study by linking administrative health databases of Saskatchewan between fiscal years 1998/99 and 2017/18. We designed and completed this study in partnership with Indigenous patients and family advocates. We applied a validated algorithm to identify IBD incident cases and then used the self-declared First Nations status variable to divide those cases. We applied a 1:5 ratio for age and sex matching and used Cox proportional models to assess associations. Hazard ratios (HRs) and 95% confidence intervals (CIs) were reported.We created a matched cohort with 696 IBD incident cases: 116 First Nations patients and 580 patients in the general population. We observed differences between the groups for IBD-specific hospital admissions (HR 1.33, 95% CI 1.01-1.75), IBD-related hospital admissions (HR 1.55, 95% CI 1.20-2.01), medication claims for IBD (HR 0.52, 95% CI 0.41-0.65) and 5-aminosalicylic acid claims (HR 0.56, 95% CI 0.45-0.71) adjusting by rural or urban residence and diagnosis type. There were no significant differences in the hazard rate of outpatient gastroenterology visits (HR 1.13, 95% CI 0.90-1.41), colonoscopies (HR 1.14, 95% CI 0.92-1.41) and surgeries for IBD (HR 1.14, 95% CI 0.80-1.64).We identified that First Nations patients diagnosed with IBD had a higher rate of hospital admissions owing to IBD than patients in the general population diagnosed with IBD. We also found an inverse association between First Nations status and having prescription medication claims for IBD.

Item does not contain fulltext BACKGROUND: Etrolizumab is a gut-targeted anti-β7 integrin monoclonal antibody. In a previous phase 2 induction study, etrolizumab significantly improved clinical remission versus placebo in patients with moderately to severely active ulcerative colitis. We aimed to compare the safety and efficacy of etrolizumab with infliximab in patients with moderately to severely active ulcerative colitis. METHODS: We conducted a randomised, double-blind, double-dummy, parallel-group, phase 3 study (GARDENIA) across 114 treatment centres worldwide. We included adults (age 18-80 years) with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6-12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) who were naive to tumour necrosis factor inhibitors. Patients were required to have had an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. Participants were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg once every 4 weeks or intravenous infliximab 5 mg/kg at 0, 2, and 6 weeks and every 8 weeks thereafter for 52 weeks. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants, and baseline disease activity. All participants and study site personnel were masked to treatment assignment. The primary endpoint was the proportion of patients who had both clinical response at week 10 (MCS ≥3-point decrease and ≥30% reduction from baseline, plus ≥1-point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) and clinical remission at week 54 (MCS ≤2, with individual subscores ≤1); efficacy was analysed using a modified intention-to-treat population (all randomised patients who received at least one dose of study drug). GARDENIA was designed to show superiority of etrolizumab over infliximab for the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT02136069, and is now closed to recruitment. FINDINGS: Between Dec 24, 2014, and June 23, 2020, 730 patients were screened for eligibility and 397 were enrolled and randomly assigned to etrolizumab (n=199) or infliximab (n=198). 95 (48%) patients in the etrolizumab group and 103 (52%) in the infliximab group completed the study through week 54. At week 54, 37 (18·6%) of 199 patients in the etrolizumab group and 39 (19·7%) of 198 in the infliximab group met the primary endpoint (adjusted treatment difference -0·9% [95% CI -8·7 to 6·8]; p=0·81). The number of patients reporting one or more adverse events was similar between treatment groups (154 [77%] of 199 in the etrolizumab group and 151 [76%] of 198 in the infliximab group); the most common adverse event in both groups was ulcerative colitis (55 [28%] patients in the etrolizumab group and 43 [22%] in the infliximab group). More patients in the etrolizumab group reported serious adverse events (including serious infections) than did those in the infliximab group (32 [16%] vs 20 [10%]); the most common serious adverse event was ulcerative colitis (12 [6%] and 11 [6%]). There was one death during follow-up, in the infliximab group due to a pulmonary embolism, which was not considered to be related to study treatment. INTERPRETATION: To our knowledge, this trial is the first phase 3 maintenance study in moderately to severely active ulcerative colitis to use infliximab as an active comparator. Although the study did not show statistical superiority for the primary endpoint, etrolizumab performed similarly to infliximab from a clinical viewpoint. FUNDING: F Hoffmann-La Roche.

Canada has one of the highest rates of inflammatory bowel disease (IBD), with older adults as the fastest-growing group of individuals affected. This exploratory mixed methods study aimed to understand perceived health-related quality of life and care experiences in older adults with IBD. Participants greater than 60 years of age, who were diagnosed with IBD, and who lived in Saskatchewan, Canada were invited to participate in both an online survey and telephone interview. Seventy-three respondents completed the survey, and 18 participants were interviewed. Most individuals were diagnosed before age 60, believed their IBD was well controlled, believed their current treatment was useful, and were satisfied with their care. Individuals also reported a moderate health-related quality of life. However, collaborative management of IBD care between providers and older adults with IBD was identified as an area with room for improvement. Strategies to enhance disease self-management and engaged chronic illness care are critical.

Background Inflammatory bowel disease (IBD) is common in women of childbearing years, and active IBD during pregnancy is associated with increased rates of preterm delivery and low-birth-weight newborns. Changes in the vaginal microbiome have been associated with preterm delivery. We aimed to determine the taxonomic composition of the vaginal microbiota at 3 time points during pregnancy in a population of women with IBD. Methods Participants were recruited from the patient registry of the Preconception and Pregnancy IBD Clinic at Royal University Hospital in Saskatoon, Canada. Self-collected vaginal swabs were obtained from patients at each trimester. Microbiota profiles were created by cpn60 amplicon sequencing. Results We characterized the vaginal microbiota of 32 pregnant participants with IBD (33 pregnancies) during each trimester. A total of 32 of 33 pregnancies resulted in a live birth with 43.8% (n = 14 of 32, 2 missing) by caesarean section; 2 of 32 were preterm. Microbiota compositions corresponded to previously described community state types, with most participants having microbiota dominated by Lactobacillus crispatus. In 25 of 29 participants in which samples were available for more than 1 time point, there was no change in the community state type over time. Prevalence of Mollicutes (Mycoplasma and/or Ureaplasma) was significantly higher in pregnant participants with IBD than in a previously profiled cohort of 172 pregnant women without IBD who delivered at term. Conclusions The vaginal microbiome of participants with IBD was stable throughout pregnancy. Prevalence of Mollicutes, which has been associated with preterm delivery, warrants further study in this patient group.

There has been a dramatic rise in mental health difficulties during the coronavirus disease 2019 (COVID-19) pandemic. While young adults have the lowest risk of hospitalization and mortality due to COVID-19, they have been identified as being at highest risk of detrimental mental health outcomes during the pandemic, along with women, those with lower socioeconomic status and those with pre-existing mental health conditions. Somewhat of a crisis in mental health has emerged across the general population through the evolution of the pandemic. A national Canadian survey identified a quadrupling of those experiencing pervasive elevated anxiety symptoms early in the pandemic compared to pre-pandemic levels, and a doubling of those with pervasive elevated depressive symptoms. Independent of the pandemic, persons with inflammatory bowel disease (IBD) can face multiple challenges related to their disease, which can result in a significant psychosocial burden and psychologic distress. Anxiety and depression have been found to be more prevalent in persons with IBD. Many potential factors contribute to the increased psychologic distress and negative impacts on mental health of the COVID-19 pandemic on persons with IBD. These include the fears of contracting COVID-19 or infecting other people. Many believe that IBD or its treatments predispose them to an increased risk of COVID-19 or a worse outcome if acquired. Concerns about access to health care add to mental distress. People with IBD generally report lower quality of life (QOL) compared to community controls. Psychologic interventions, in addition to adequate disease control, have been shown to improve health-related QOL. Uncertainty is another factor associated with reduced health-related QOL. Most studies suggest that persons with IBD have suffered QOL impairment during the pandemic in comparison to the pre-pandemic period. Uncertainties brought on by the pandemic are important contributors for some of the reduction in QOL.

The prevalence of inflammatory bowel diseases (IBD), Crohn’s disease and ulcerative colitis, in Canada, is over 0.75% in 2021. Many individuals with IBD are immunocompromised. Consequently, the World Health Organization’s declaration of a global pandemic uniquely impacted those with IBD. Crohn’s and Colitis Canada (CCC) formed the COVID-19 and IBD Taskforce to provide evidence-based guidance during the pandemic to individuals with IBD and their families. The Taskforce met regularly through the course of the pandemic, synthesizing available information on the impact of COVID-19 on IBD. At first, the information was extrapolated from expert consensus guidelines, but eventually, recommendations were adapted for an international registry of worldwide cases of COVID-19 in people with IBD. The task force launched a knowledge translation initiative consisting of a webinar series and online resources to communicate information directly to the IBD community. Taskforce recommendations were posted to CCC’s website and included guidance such as risk stratification, management of immunosuppressant medications, physical distancing, and mental health. A weekly webinar series communicated critical information directly to the IBD community. During the pandemic, traffic to CCC’s website increased with 484,755 unique views of the COVID-19 webpages and 126,187 views of the 23 webinars, including their video clips. CCC’s COVID-19 and IBD Taskforce provided critical guidance to the IBD community as the pandemic emerged, the nation underwent a lockdown, the economy reopened, and the second wave ensued. By integrating public health guidance through the unique prism of a vulnerable population, CCC’s knowledge translation platform informed and protected the IBD community.

Background Canada has the highest global age-adjusted incidence and prevalence rates of inflammatory bowel disease (IBD). Due to IBD patient volumes and limited resources, challenges to timely access to specialty care have emerged. To address this gap, the aim of this paper was to understand the experiences and perspectives of persons living with IBD with a focus on accessing health care. Methods Using a qualitative descriptive approach, patients diagnosed with IBD (≥18 years of age) were purposively sampled from rural and urban gastroenterology clinics and communities across Canada. Co-facilitated by a researcher and patient research partner, 14 focus groups were recorded, transcribed, and coded for themes. Thematic analysis was used to ascertain the congruence or discordance of IBD specialty care access experiences. Results A total of 63 individuals participated in the study. The majority of participants were female (41/63, 65%) and from urban/suburban regions (33/63, 52%), with a mean age of 48.39 (range 16–77 years). The analysis generated three main themes: (1) need for patient to be partner, (2) adapting IBD care access to individual context, and (3) patient-defined care priorities should guide access to IBD care. Conclusions The complexity of specialty care access for IBD patients cannot be underestimated. It is vital to possess a robust understanding of healthcare system structures, processes, and the impact of these factors on accessing care. Using a patient-centered exploration of barriers and facilitators, IBD specialty care access in Canada can be better understood and improved on provincial and national levels.

Although significant progress relating to professional equality among men and women in medicine has been made over the past few decades, evidence derived from the medical literature suggests that inequity persists with respect to income, attainment of leadership positions, and professional advancement. These inequities have been observed to be more pronounced in gastroenterology. Literature relating to gender-specific barriers to professional equity in gastroenterology is limited. This qualitative study explored perceived barriers to professional equality among women in gastroenterology in Canada through focus groups using a World Café Approach. Several perceived barriers to professional equality were identified. Identification of barriers to professional equality is an important first step to creating meaningful interventions that address the root causes of gender-related inequity in gastroenterology.

Objectives Our study aimed to calculate the prevalence and estimate the direct health care costs of inflammatory bowel disease (IBD), and test if trends in the prevalence and direct health care costs of IBD increased over two decades in the province of Saskatchewan, Canada. Methods We conducted a retrospective population-based cohort study using administrative health data of Saskatchewan between 1999/2000 and 2016/2017 fiscal years. A validated case definition was used to identify prevalent IBD cases. Direct health care costs were estimated in 2013/2014 Canadian dollars. Generalized linear models with generalized estimating equations tested the trend. Annual prevalence rates and direct health care costs were estimated along with their 95% confidence intervals (95%CI). Results In 2016/2017, 6468 IBD cases were observed in our cohort; Crohn’s disease: 3663 (56.6%), ulcerative colitis: 2805 (43.4%). The prevalence of IBD increased from 341/100,000 (95%CI 340 to 341) in 1999/2000 to 664/100,000 (95%CI 663 to 665) population in 2016/2017, resulting in a 3.3% (95%CI 2.4 to 4.3) average annual increase. The estimated average health care cost for each IBD patient increased from $1879 (95%CI 1686 to 2093) in 1999/2000 to $7185 (95%CI 6733 to 7668) in 2016/2017, corresponding to an average annual increase of 9.5% (95%CI 8.9 to 10.1). Conclusions Our results provide relevant information and analysis on the burden of IBD in Saskatchewan. The evidence of the constant increasing prevalence and health care cost trends of IBD needs to be recognized by health care decision-makers to promote cost-effective health care policies at provincial and national levels and respond to the needs of patients living with IBD.

Background and Aims Canada has one of the highest inflammatory bowel disease (IBD) incidence rates worldwide. Higher IBD incidence rates have been identified among urban regions compared to rural regions. The study objectives were to (i) estimate IBD incidence rates in Saskatchewan from 1999 to 2016 and (ii) test for differences in IBD incidence rates for rural and urban regions of Saskatchewan. Methods A population-based study was conducted using provincial administrative health databases. Individuals aged 18+ years with newly diagnosed Crohn’s disease or ulcerative colitis were identified using a validated case definition. Generalized linear models with a negative binomial distribution were used to estimate incidence rates and incidence rate ratios (IRRs) adjusted for age group, sex and rurality with 95% confidence intervals (CIs). Results The average annual incidence rate of IBD among adults in Saskatchewan decreased from 75/100,000 (95% CI 67 to 84) in 1999 to 15/100,000 (95% CI 12 to 18) population in 2016. The average annual incidence of IBD declined significantly by 6.9% (95% CI −7.6 to −6.2) per year. Urban residents had a greater overall risk of IBD (IRR = 1.19, 95% CI 1.11 to 1.27) than rural residents. This risk difference was statistically significant for Crohn’s disease (IRR = 1.25, 95% CI 1.14 to 1.36), but not for ulcerative colitis (IRR = 1.08, 95% CI 0.97 to 1.19). Conclusions The incidence of IBD in Saskatchewan dropped significantly from 1999 to 2016 with urban dwellers having a 19% higher risk of IBD onset compared to their rural counterparts. Health care providers and decision-makers should plan IBD-specific health care programs considering these specific IBD rates.

Summary Background Etrolizumab is a gut-targeted, anti-β7 integrin, monoclonal antibody. In an earlier phase 2 induction study, etrolizumab significantly improved clinical remission compared with placebo in patients with moderately to severely active ulcerative colitis. We aimed to evaluate the efficacy and safety of etrolizumab in patients with moderately to severely active ulcerative colitis who had been previously treated with anti-tumour necrosis factor (TNF) agents. Methods HICKORY was a multicentre, phase 3, double-blind, placebo-controlled study in adult (18–80 years) patients with moderately to severely active ulcerative colitis (Mayo Clinic total score [MCS] of 6–12 with an endoscopic subscore of ≥2, a rectal bleeding subscore of ≥1, and a stool frequency subscore of ≥1) previously treated with TNF inhibitors. Patients were recruited from 184 treatment centres across 24 countries in North America, South America, Europe, Asia, Oceania, and the Middle East. Patients needed to have an established diagnosis of ulcerative colitis for at least 3 months, corroborated by both clinical and endoscopic evidence, and evidence of disease extending at least 20 cm from the anal verge. In cohort 1, patients received open-label etrolizumab 105 mg every 4 weeks for a 14-week induction period. In cohort 2, patients were randomly assigned (4:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks for the 14-week induction phase. Patients in either cohort achieving clinical response to etrolizumab induction were eligible for the maintenance phase, in which they were randomly assigned (1:1) to receive subcutaneous etrolizumab 105 mg or placebo every 4 weeks through to week 66. Randomisation was stratified by baseline concomitant treatment with corticosteroids, concomitant treatment with immunosuppressants (induction randomisation only), baseline disease activity, week 14 MCS remission status (maintenance randomisation only), and induction cohort (maintenance randomisation only). All patients and study site personnel were masked to treatment assignment. Primary endpoints were remission (Mayo Clinic total score [MCS] ≤2, with individual subscores of ≤1 and a rectal bleeding subscore of 0) at week 14, and remission at week 66 among patients with a clinical response (MCS with ≥3-point decrease and ≥30% reduction from baseline, plus ≥1 point decrease in rectal bleeding subscore or absolute rectal bleeding score of 0 or 1) at week 14. Efficacy was analysed using a modified intent-to-treat population. Safety analyses included all patients who received at least one dose of study drug during the induction phase. This study is registered at ClinicalTrials.gov , NCT02100696 . Findings HICKORY was conducted from May 21, 2014, to April 16, 2020, during which time 1081 patients were screened, and 609 deemed eligible for inclusion. 130 patients were included in cohort 1. In cohort 2,479 patients were randomly assigned to the induction phase (etrolizumab n=384, placebo n=95). 232 patients were randomly assigned to the maintenance phase (etrolizumab to etrolizumab n=117, etrolizumab to placebo n=115). At week 14, 71 (18·5%) of 384 patients in the etrolizumab group and six (6·3%) of 95 patients in the placebo group achieved the primary induction endpoint of remission (p=0·0033). No significant difference between etrolizumab and placebo was observed for the primary maintenance endpoint of remission at week 66 among patients with a clinical response at week 14 (27 [24·1%] of 112 vs 23 [20·2%] of 114; p=0·50). Four patients in the etrolizumab group reported treatment-related adverse events leading to treatment discontinuation. The proportion of patients reporting at least adverse event was similar between treatment groups for induction (etrolizumab 253 [66%] of 384; placebo 63 [66%] of 95) and maintenance (etrolizumab to etrolizumab 98 [88%] of 112; etrolizumab to placebo 97 [85%] of 114). The most common adverse event in both groups was ulcerative colitis flare. Most adverse events were mild or moderate. During induction, the most common serious adverse event was ulcerative colitis flare (etrolizumab ten [3%] of 384; placebo: two [2%] of 95). During maintenance, the most common serious adverse event in the etrolizumab to etrolizumab group was appendicitis (two [2%] of 112) and the most common serious adverse events in the etrolizumab to placebo group were ulcerative colitis flare (two [2%] of 114) and anaemia (two [2%] of 114). Interpretation HICKORY demonstrated that a significantly higher proportion of patients with moderately to severely active ulcerative colitis who had been previously treated with anti-TNF agent were able to achieve remission at week 14 when treated with etrolizumab compared with placebo; however, there was no significant difference between groups in remission at week 66 among patients with a clinical response at week 14. Funding F Hoffmann-La Roche.

Experiential education is a critical component of any pharmacy undergraduate curriculum. Establishing new, high-quality practice sites can be challenging. We designed a new advanced pharmacy practice experiential rotation suitable for implementation in most community pharmacy settings. The aim of this article is to describe the design of this rotation entitled the Targeted Pharmacy Intervention in Inflammatory Bowel Disease (TPI-IBD) and to determine its impact on student knowledge and confidence using a before-after survey design. The TPI-IBD utilizes a student-delivered intervention as a platform for experiential learning in community pharmacy practice. The TPI was focused on patients with IBD, and implementation was guided by a co-preceptor from the university in collaboration with onsite-preceptors at each pharmacy. The TPI-IBD rotation was delivered from 6 community pharmacies during 5 weeks in 2018. Students conducted standardized monitoring on patients with IBD and met weekly with the university preceptor for case presentations and therapeutic discussions. Electronic charts were maintained by students who were responsible for ensuring detailed documentation on each patient. Knowledge, confidence, and overall satisfaction were assessed by a survey given to students before and after the rotation. Students were highly satisfied with the learning experience and improvements in knowledge and confidence were clearly demonstrated. The TPI strategy was an effective way to expand rotation options in community pharmacy sites with minimal burden on local preceptors.

Persons with inflammatory bowel disease (IBD) make up more than 0.75% of the Canadian population in 2021. Early in the COVID-19 pandemic, individuals with IBD, particularly those on immunosuppressive therapies, were concerned that their health status may place them at higher risk of contracting COVID-19 or experiencing more severe disease course if infected with SARS-CoV-2. In response, Crohn’s and Colitis Canada developed the COVID-19 and IBD Taskforce in March 2020 to rapidly synthesize the evolving knowledge of COVID-19 as relevant to Canadians with IBD. The Taskforce communicated expert information directly to the Canadian IBD community through online tools and a webinar series. In order to understand the full impact of COVID-19 on the IBD community, Crohn’s and Colitis Canada commissioned a policy report that was informed through a systematic literature review and synthesized across working groups along the following domains: Epidemiology, Children and Expectant Mothers with IBD, Seniors with IBD, Mental Health, Risk Factors and Medications, Vaccines, and Healthcare Delivery during the Pandemic and the Future Model of IBD Care. This report from Canadian physicians, researchers, and IBD community representatives highlights the physical, mental, and health systems impact of COVID-19 on the entire spectrum of the IBD community, including children, adolescents, adults, seniors, and pregnant people with IBD. This executive summary provides an overview of the crucial information from each of the chapters of the policy report, supplemented with additional information made available through Crohn’s and Colitis Canada’s webinar-based knowledge translation platform.

Introduction: Inflammatory bowel disease (IBD) is a chronic inflammatory condition of the gastrointestinal tract with no known cure. Management of IBD is complex and requires those with IBD to have lifelong interactions with the healthcare system. Individuals with IBD who live in rural areas are at risk of poorer health outcomes due to their limited access to care. This study examined healthcare utilization and access to care for rural adults with IBD. The research questions explored in this study were: What are the care experiences of healthcare providers (HCPs) and persons living with IBD in rural areas? What are the enablers and barriers to optimal IBD care in rural environments? What strategies are necessary to enhance care delivery for these individuals with IBD? Methods: This patient-oriented research initiative involved patient and family advisors as active and equal team members in decision-making throughout the project. This article reports on the qualitative findings of a larger mixed-methods study. The setting was one western Canadian province. Fourteen individuals with IBD living in rural areas and three HCPs working in rural areas participated. Interview data were analyzed using thematic analysis. Results: Three themes were identified: communication, stressors and support systems, and coordination of care. Communication with and between HCPs was challenging due to the distance to access care. Participants described challenges related to rural HCPs' lack of IBD-related knowledge. Virtual communication, such as telehealth and phone clinics, was infrequently used yet highly recommended by participants. Individuals with IBD described various stressors and feelings of isolation while living in rural environments, and both participant groups described the need for additional formal and informal support systems to ease these stressors. Coordination of care was considered essential to optimal health outcomes, but individuals frequently experienced gaps in care. Lack of local services such as outpatient clinics, hospitals, laboratory testing, infusion clinics, and pharmacies meant individuals with IBD frequently had to travel to access care. Some participants reported bypassing existing local services, instead preferring the expedited, specialist care within larger centers. Conclusion: Most participants described challenges associated with living in rural areas and suggested health system improvements. Access to multidisciplinary care teams, including IBD physicians and nurses, psychologists, and dieticians, for individuals in rural areas is encouraged, as is the use of virtual care delivery options such as telehealth, online clinics, telephone clinics or advice lines, web-based video-conferencing, and email communication to increase access to care. Continued efforts to recruit and retain rural HCPs with knowledge of IBD are deemed necessary to provide continuity of care within rural environments. Strengthening formal and informal support systems and enhancing psychosocial supports in rural communities are warranted to ensure optimal wellbeing. Online strategies to provide individual and group education related to IBD are strongly recommended. Facilitating access to care in rural areas can increase disease remission, decrease direct and indirect care costs, and promote quality of life in individuals with IBD.

Background There is limited to no evidence of the prevalence and incidence rates of inflammatory bowel disease (IBD) among Indigenous peoples. In partnership with Indigenous patients and family advocates, we aimed to estimate the prevalence, incidence, and trends over time of IBD among First Nations (FNs) since 1999 in the Western Canadian province of Saskatchewan. Methods We conducted a retrospective population-based study linking provincial administrative health data from the 1999-2000 to 2016-2017 fiscal years. An IBD case definition requiring multiple health care contacts was used. The prevalence and incidence data were modeled using generalized linear models and a negative binomial distribution. Models considered the effect of age groups, sex, diagnosis type (ulcerative colitis [UC], Crohn disease [CD]), and fiscal years to estimate prevalence and incidence rates and trends over time. Results The prevalence of IBD among FNs increased from 64/100,000 (95% confidence interval [CI], 62-66) in 1999-2000 to 142/100,000 (95% CI, 140-144) people in 2016-2017, with an annual average increase of 4.2% (95% CI, 3.2%-5.2%). Similarly, the prevalence of UC and CD, respectively, increased by 3.4% (95% CI, 2.3%-4.6%) and 4.1% (95% CI, 3.3%-4.9%) per year. In contrast, the incidence rates of IBD, UC, and CD among FNs depicted stable trends over time; no statistically significant changes were observed in the annual change trend tests. The ratio of UC to CD was 1.71. Conclusions We provided population-based evidence of the increasing prevalence and stable incidence rates of IBD among FNs. Further studies are needed in other regions to continue understanding the patterns of IBD among Indigenous peoples.

Inflammatory bowel disease (IBD) is a lifelong chronic disease that frequently requires long-term medical treatment to maintain remission. Patient perspectives on IBD medication are important to understand as nonadherence to IBD medication is common. We aim to synthesize the evidence about patients' perspectives on medication for IBD. A mixed-method systematic review was conducted on Scopus, EMBASE, Web of Science, and CINAHL. The convergent integrated approach to synthesis and integration of qualitative and quantitative findings was used for data analysis. Twenty-five articles from 20 countries were included in this review (20 quantitative, 3 qualitative, and 2 mixed-method studies). Patients have identified a lack of knowledge in the areas of efficacy, side effects, and characteristics of medications as key elements. Some negative views on IBD medication may also be present (e.g. the high number of pills and potential side effects). Lack of knowledge about medication for IBD was identified as a common issue for patients. Health services delivery for IBD should take into consideration these patients' perspectives. A focus on improving patient education in these areas could help empower patients and alleviate doubts resulting in better disease management and improved healthcare outcomes.

Background Inflammatory bowel disease (IBD) is a chronic digestive condition with significant complications if left untreated. Rural dwellers face barriers to access specialised health care, which is located in larger urban centres. We aimed to contrast health care utilization (outpatient gastroenterology visits, colonoscopies, claims for IBD medications, IBD-specific and IBD-related hospitalizations, and surgeries for IBD) between rural and urban residents diagnosed with IBD in the Canadian province of Saskatchewan (SK). Methods We completed a population-based retrospective study using SK administrative health databases (hospital discharge abstracts, medication claims, and physician billings) between the 1999 to 2016 fiscal years. A validated IBD algorithm requiring multiple health care contacts was used for case ascertainment. IBD incidence cases were identified by requiring eight years of continuous health care coverage without IBD health care contacts before the date of diagnosis. Cases were assigned to a rural or urban location based on their residential postal codes at the date of IBD diagnosis. Study outcomes were measured from IBD diagnosis to the end of the study period or end of health care coverage. Cox proportional regression models were used to evaluate the associations between rural-urban residence and each study outcome. Models were adjusted by sex, age, neighbourhood income quintile at IBD diagnosis, and disease type (Crohn’s disease and ulcerative colitis). Adjusted hazard ratios (HR) and 95% confidence intervals (95%CI) were reported. Results We identified 5,173 IBD incident cases in SK between 1999 and 2016; 1,544 (29.8%) individuals were living in rural locations at the date of diagnosis. Compared to urban dwellers, rural residents had lower gastroenterology visits (HR=0.82, 95%CI 0.77–0.88) and higher 5-aminosalicylic acid (5-ASA) claims (HR=1.10, 95%CI 1.02–1.18). Furthermore, rural residents had a higher risk of IBD-specific (HR=1.23, 95%CI 1.13–1.34) and IBD-related (HR=1.20, 95%CI 1.11–1.31) hospitalizations than their urban counterparts. We did not observe significant rural-urban differences in the access to colonoscopies, biologic and immune modulator therapies, and surgeries for IBD. Conclusion We identified rural-urban disparities in IBD health care access, specifically, lower outpatient gastroenterology visits, higher 5-ASA claims, and a higher risk of hospitalizations for individuals living in rural locations at IBD diagnosis. Our findings reflect rural-urban inequities in the access to IBD care that require the attention of health care providers and decision-makers to promote health care innovation and equitable management of patients with IBD living in rural areas.

Objectives Endoscopy remains the gold standard to diagnose and evaluate inflammatory bowel disease (IBD) activity. Current biomarkers or their combinations cannot adequately predict IBD risk, diagnosis, progression or relapse, and response to therapy. Pyruvate kinase M2 (PKM2) is emerging as a significant mediator of the inflammatory process. We aimed to assess levels of serum PKM2 in healthy and newly diagnosed IBD patients and its relationship with IBD indices and microbiota changes. Design and methods IBD serum samples from newly diagnosed patients were collected and analyzed using a PKM2-ELISA and correlated with disease activity scores , IBD disease type, and intestinal microbiota . Furthermore, we tested the genetic and protein expression of PKM2 in an in vitro intestinal cell model of inflammation. Results Serum PKM2 levels were 6-fold higher in IBD patients compared to healthy controls, with no sensitivity to disease phenotype (Crohn's Disease or Ulcerative Colitis) or localization of inflammation. Serum PKM2 had considerably less interindividual variability than established IBD fecal biomarkers. A positive Pearson correlation (r = 0.6121) existed between serum PKM2 and Bacteroidetes fecal levels in Crohn's disease (CD), while a negative (r = − 0.6128) correlation was observed with Actinobacteria fecal levels. Furthermore, LPS (500 ng/mL) significantly increased PKM2 expression in vitro , which was significantly suppressed by an anti-inflammatory flaxseed bioactive agent. Conclusion Our data suggests PKM2 as a putative biomarker for IBD and the dysbiosis of microflora in CD. Investigations involving larger number of clinical patients are necessary to validate its use as a serum biomarker of IBD.

Background Indigenous patients with inflammatory bowel disease (IBD) have expressed concerns about barriers to access IBD care. The limited evidence of IBD among Indigenous people highlights the need for studies evaluating access to IBD care in this population. Aims We aimed to compare health care utilization between First Nations (FNs) and individuals from the general population (GP) diagnosed with IBD in Saskatchewan (SK). Methods A population-based retrospective cohort study was conducted using administrative health databases of SK from 1998 to 2017 fiscal years. As a patient-oriented research initiative, outcomes of interest were chosen in collaboration with Indigenous patients and family advocates. A validated algorithm requiring multiple health care contacts was applied to identify incident IBD cases. The self-declared FN status variable was used to divide IBD cases between FNs and the general population (GP). To balance the groups, 1:5 age and sex matching was applied. Cox-proportional models were used to estimate hazard ratios (HRs) and 95% confidence intervals (95%CI). Stratified analysis was completed for those diagnosed before and after 2008 (pre- and post-biologic eras). Results A matched cohort with 696 IBD incident cases was created (FN=116, GP=580). Comparing health care utilization of FNs and individuals from the GP with IBD, there were no statistically significant differences in outpatient gastroenterology visits (FNs=81.0%, GP=83.6%), colonoscopies (FNs=91.4%, GP=86.9%), and surgeries for IBD (FNs=31.0%, GP=33.5%). We observed differences in prescription claims for any medication for IBD (FNs=79.3%, GP=89.3%) and 5-aminosalicylic acid (5-ASA) claims (FNs=75.9%, GP=81.4%). The HRs adjusted by rural/urban residence and diagnostic type showed differences in prescription claims for any IBD medication (HR=0.52, 95%CI 0.41–0.65) and 5-ASA (HR=0.57, 95%CI 0.45–0.72). In the pre-biologic era, FNs had a lower risk of having a prescription claim for any IBD medication (HR=0.32, 95%CI 0.23–0.45) and 5-ASA (HR=0.33, 95%CI 0.24–0.47), respectively. These differences were not significant in the post-biologic era. Conclusions Our study identified an inverse association between FN status and having prescription medication claims for IBD in SK. We considered multiple confounding variables when evaluating this association but could not control by disease severity. Thus, this association might reflect a barrier to access IBD medications or that FNs with IBD might present a milder disease. Further studies should continue evaluating access to IBD care, medication use, and disease severity among FNs living with IBD. Funding Agencies Saskatchewan Centre for Patient-Oriented Research (SCPOR), Saskatchewan Health Research Foundation (SHRF), and College of Medicine, University of Saskatchewan.

Evidence from the literature suggests that dietary flaxseed lignans have the ability to modulate inflammation, which is recognized as the underlying basis of multiple chronic human diseases in older adults. Our objective was to determine the effects of oral lignan supplementation on biochemical and functional indicators of inflammation as well as safety and tolerability in older healthy adults. We designed a randomized, double-blind, placebo-controlled clinical trial in older healthy adults (60-80 years) to assess flaxseed lignan-enriched complex (∼38% secoisolariciresinol diglucoside [SDG]; 600 mg SDG dose) oral supplementation effects on biochemical and functional indicators of inflammation and safety and tolerability in older healthy adults after 6 months of once-daily oral administration. The clinical trial confirmed that plasma concentration of total flaxseed lignans (free and conjugated forms) secoisolariciresinol (SECO), enterodiol (ED), and enterolactone (ENL) were significantly associated with daily oral supplementation of flaxseed lignan-enriched complex (p0.05). A significant decrease in systolic blood pressure (SBP; from a mean of 155 ± 13 mm Hg at baseline to 140 ± 11 mm Hg at 24 weeks) was observed in lignan-supplemented participants stratified into an SBP ≥140 mm Hg subcategory (p = 0.04). No differences were found between treatment or placebo groups in terms of cognition, pain, activity, physical measurements (calf, waist, and upper arm circumstances), and grip strength. With respect to blood inflammatory markers, lipid profiles, and biochemical parameters, no significant differences were found between treatment and placebo groups at the end of the 6-month supplementation. No adverse effects were reported during supplementation. These data further support the safety and tolerability of long-term flaxseed lignan-enriched complex supplementation in older adults and identify an ability to favorably modulate SBP, an important risk factor in cardiovascular disease.

Background and Aims Studies evaluating the impact of integrated models of care [IMC] for inflammatory bowel disease [IBD] on disease-related outcomes are needed. We compared the risk of IBD-related outcomes and prescription medication claims between patients exposed and non-exposed to an IMC. Methods A retrospective population-based matched cohort study was conducted between 2009 and 2015, using administrative health data of Saskatchewan, Canada. Patients aged 18+ years with a diagnosis of IBD were identified with a validated administrative definition. Cases were classified as exposed and non-exposed to the IMC for IBD and matched based on propensity scores and disease duration. IBD-related hospitalisations, surgeries, prescription medication claims, and corticosteroid dependency [CsDep] were measured. Cox and logistic regression models evaluated differences between the groups, estimating hazard [HRs] and odds [ORs] ratios with corresponding confidence intervals [CIs]. Results In total, 2312 matched patients were included; 24.3% were exposed individuals. Compared with non-exposed, exposed patients had a lower risk of IBD-related surgeries [HR = 0.78, 95% CI 0.61-0.99], higher risk of prescriptions of immune modulators [HR = 1.68, 95% CI 1.42-1.99], and biologics [HR = 1.85, 95% CI 1.52-2.27], and a lower risk of 5-aminosalicylic acid prescriptions [HR = 0.81, 95% CI 0.69-0.95]. A lower risk of IBD-related hospitalisations among exposed ulcerative colitis [UC] patients [HR = 0.66, 95% CI 0.49-0.89] was identified in stratified analyses. The odds of CsDep among exposed UC patients was 0.39 [95% CI 0.15-0.98]. Conclusions The observed differences in disease-related outcomes and use of steroid-sparing maintenance therapies between exposed and non-exposed individuals support the concept that enhanced quality of care can be achieved within IMC for IBD.

Background and aims The prevalence and incidence of inflammatory bowel disease (IBD) in North America is among the highest in the world and imparts substantial direct and indirect medical costs. The Choosing Wisely Campaign was launched in wide variety of medical specialties and disciplines to reduce unnecessary or harmful tests or treatment interventions. Methods The Choosing Wisely list for IBD was developed by the Canadian IBD Network for Research and Growth in Quality Improvement (CINERGI) in collaboration with Crohn's and Colitis Canada (CCC) and the Canadian Association of Gastroenterology (CAG). Using a modified Delphi process, 5 recommendations were selected from an initial list of 30 statements at a face-to-face consensus meeting. Results The 5 things physicians and patients should question: (1) Don't use steroids (e.g., prednisone) for maintenance therapy in IBD; (2) Don't use opioids long-term to manage abdominal pain in inflammatory bowel disease (IBD); (3) Don't unnecessarily prolong the course of intravenous corticosteroids in patients with acute severe ulcerative colitis (UC) in the absence of clinical response; (4) Don't initiate or escalate long-term medical therapies for the treatment of IBD based only on symptoms; and (5) Don't use abdominal computed tomography (CT) scan to assess IBD in the acute setting unless there is suspicion of a complication (obstruction, perforation, abscess) or a non-IBD etiology for abdominal symptoms. Conclusions The Choosing Wisely recommendations will foster patient-physician discussions to optimize IBD therapy, reduce adverse effects from testing and treatment, and reduce medical expenditure.

Background Inflammatory Bowel Disease (IBD) is a chronic condition with significant life-threatening disease-related complications and reductions in quality of life if left untreated. Despite available research about IBD in the general population, there is limited-to-no evidence about IBD among Indigenous peoples in Canada and around the world. Aims We aimed to define a collaborative framework, estimate the prevalence and incidence rates of IBD among First Nations in Saskatchewan, Canada, and explore perceptions of IBD among Indigenous peoples in the province. Methods This study began when Indigenous patients shared their health experiences with IBD with research team members. An interdisciplinary research team was formed including Indigenous patient and family advocates (IPFAs, Indigenous patients living with IBD and parents of an Indigenous person with IBD), an IBD gastroenterologist, knowledge users, and Indigenous and non-Indigenous researchers. Our research team committed to raise awareness of IBD among Indigenous peoples within Indigenous communities and among health care providers and to advocate for better healthcare and well-being by providing evidence of IBD among Indigenous peoples living with IBD in Saskatchewan. We defined a mixed methodology. The first phase of the study used Saskatchewan administrative health data to estimate the prevalence and incidence rates with 95% confidence intervals (95%CI) of IBD among First Nations. The second phase of the study will use a photovoice methodology to gather “the voices” of Indigenous peoples with IBD, encouraging self-interpretation of pictures, engaging their communities, and empowering them with the study findings. Results The IPFAs play a critical role in the project by sharing their experiences and defining the directions of the project, as well as defining our research framework (Figure 1). Preliminary results show that the prevalence of IBD among First Nations in Saskatchewan increased from 66 (95%CI 65–68) per 100,000 population in 1999 to 148 (95%CI 145–151) per 100,000 people in 2015. In contrast, the incidence rates appear to be stable over time, 11/100,000 (95%CI 4–24) in 1999 and 11/100,000 (95%CI 5–20) in 2015. We started recruiting participants for the photovoice study in September 2019. Conclusions This ground-breaking patient-driven study is the first stage to improve health among Indigenous peoples living with IBD in Saskatchewan. This project will generate community-engaged knowledge and expertise to inform the development of an Indigenous IBD framework that could promote better and knowledge-based healthcare for Indigenous peoples with IBD in Canada and worldwide. Funding Agencies CIHRSaskatchewan Health Research Foundation (SHRF) and Saskatchewan Centre for Patient-Oriented Research (SCPOR)

Background Living with Inflammatory Bowel Disease (IBD) requires lifelong, repeated interactions with the healthcare system. Individuals with IBD living in rural areas are often disadvantaged with limited access to IBD-related healthcare services in their local communities which can result in poor health outcomes. Furthermore, these individuals encounter additional out of pocket expenses to travel to urban centres for care. There is limited information about the experiences of access to IBD-related care from the perspectives of patients and providers living in rural communities. The purpose of this study was to examine healthcare utilization and access to care in individuals with IBD who reside in rural areas within one Canadian province. Methods The qualitative results from a larger patient-oriented, mixed methods study will be reported. Seventeen individuals residing in rural communities from one Canadian province were recruited to participate. Fourteen individuals living with IBD and three healthcare providers were interviewed and shared their experiences on IBD-related access to care and healthcare use. Data was collected prior to the pandemic. Interview data was analyzed using thematic analysis to identify common themes. Results Many participants identified access to care challenges associated with living in rural communities. Communication, stressors and support systems, and coordination of care were identified as themes. Participants described disconnects in communication with and between healthcare providers. They suggested virtual technology was underutilized and was a cost-effective means to enhance communication. Participants experienced feelings of isolation and identified stressors while living in rural areas. They recommended the integration of formal and informal supports to ease stressors and promote mental well-being. Participants reported gaps in care and described a lack of accessible, multidisciplinary rural healthcare providers to optimize their IBD-related care and health outcomes. This lack of access to rural care resulted in frequent travel to access a variety of services. Recruitment and retention of rural care providers was identified as a strategy to enhance access to care. Conclusion Participants offered many suggestions to improve rural IBD-related care access within the healthcare system. These initiatives have great potential to increase quality of care, enhance quality of life, and reduce health system costs.

Supplemental Material, Appendices_-_A-B-C for An Advanced Pharmacy Practice Experience for Community Pharmacies Based on a Clinical Intervention Targeting Patients With Inflammatory Bowel Disease by David F. Blackburn, Sharyle Fowler, Alex Crawley, Shauna Gerwing, Jane Alcorn, Holly Mansell, Charity Evans, Kerry Mansell, Jeff Taylor, Derek Jorgenson, Danielle Larocque, Thomas Rotter and Yvonne Shevchuk in Journal of Pharmacy Practice

Background More than 0.3% of the populations in Europe, North America, and Oceania live with inflammatory bowel disease (IBD). Canada has increasing prevalence trends of IBD with 1% of Canadians estimated to have IBD by 2030. Evidence about IBD prevalence and health care costs over time can contribute to health resources allocation and health care planning. Our study aimed to 1) estimate the prevalence and direct health care costs of IBD in the province of Saskatchewan (SK), Canada, and 2) test if trends in the prevalence and direct health care costs of IBD increased over two decades. Methods We conducted a retrospective population-based cohort study using administrative health data of SK between 1999/00 and 2016/17 fiscal years. A validated case definition was used to identify prevalent IBD cases. The costing method adopted by the Canadian Institute for Health Information was used to estimate direct health care costs in 2013/14 Canadian dollars among IBD cases. Generalised linear models (GLMs) with generalised estimating equations were used to test the trends. Negative binomial and gamma distributions were used to, respectively, model prevalence and health care cost trends. Sex and age group were covariates in all models; the Charlson comorbidity index was also included in the cost model. Annual prevalence rates and direct health care cost estimates with their 95% confidence intervals (95%CI) were reported. Results In 2016, there were 6468 (Crohn’s disease: 3663 [56.63%], ulcerative colitis: 2805 [43.37%]) IBD cases ascertained in SK. The number of prevalent cases increased over the analysis period by 56%. The total direct health care costs increased from $7.8 million in 1999 to $50.8 million in 2016. The average annual IBD prevalence increased from 341/100,000 (95%CI 340–341) in 1999 to 664/100,000 (95%CI 663–665) in 2016, a 3.3% (95%CI 2.4–4.3) average annual increase. The total average annual direct health care costs of IBD increased from $1.8 (95%CI $1.6–2.0) thousand per patient in 1999 to $7.1 (95%CI $6.7–7.5) thousand per patient in 2016, an average annual increase of 9.2% (95% CI 8.5–9.8), Figure 1. Conclusion In the Canadian province of SK, prevalence and direct health care costs, respectively, tripled and quadrupled over two decades. Our results provide relevant information and analysis on the burden of IBD in SK. These findings are in agreement with previous studies from other provinces. The evidence of constant increasing prevalence and health care cost trends of IBD needs to be recognised by health care decision-makers to promote cost-effective health care policies at provincial and national levels and respond to the needs of patients living with IBD.

We performed a scoping review on sought-after complementary therapies for patients with inflammatory bowel disease (IBD), specifically diet, physical activity and exercise (PA/E), and psychotherapy. We aim to update patients with IBD on therapies for self-care and provide physicians with guidance on how to direct their patients for the management of IBD. A search of MEDLINE, EMBASE, and PUBMED was completed in Sept 2016. Studies on diet, PA/E, or psychotherapy in patients with IBD were included. Medical Subject Heading terms and Boolean operators were used. The search was limited to full-text English articles describing an adult population. This review included 67 studies: Diet (n = 19); PA/E (n = 19); and psychotherapy (n = 29). We have made the following recommendations: (1) Diet: Consumption of diets rich in vegetables, fruit and soluble fiber may be beneficial in IBD. A trial of a low FODMAP diet can be considered in those patients with functional gastrointestinal symptoms. Restrictive diets are lacking in evidence and should be avoided; (2) PA/E: Regular low-moderate intensity activity, including cardiovascular and resistance exercise, has been shown to improve quality of life (QOL) and may improve inflammation; and (3) psychotherapy: Therapies such as cognitive-behavioural interventions, mindfulness, hypnosis, and stress management have been shown to improve QOL, but evidence is limited on their impact on anxiety, depression, and disease activity. Overall, these complementary therapies are promising and should be used to treat patients with IBD from a more holistic perspective.

Background 3 classes of biologics are now available for the treatment of Crohn's disease. The availability of multiple treatment options has led to questions regarding the appropriateness of each agent for a given patient. We aimed to evaluate physician preferences for the use of specific biologic agents in a variety of Crohn's disease management scenarios using the RAND/UCLA Appropriateness Methodology. Methods A panel consisting of members of the CINERGI group (Canadian IBD Network for Research and Growth in Quality Improvement) was assembled. A literature review was performed on factors identified as influential upon choice of biologic therapy. Clinical scenarios were developed, and panelists rated the appropriateness of biologic therapy classes in each scenario individually and again during a face-to-face meeting after moderated discussion. Results Two hundred eighty-eight modifications of 3 clinical scenarios were rated. Factors that influenced biologic choice included perianal disease, antidrug antibody status, extraintestinal manifestations, consideration of potential pregnancy, and history of serious infection or malignancy. Anti-TNF therapy was considered appropriate in the postoperative patient. Ustekinumab and vedolizumab were considered appropriate in patients without perianal disease over the age of 65 with a history of malignancy or serious infection. The use of anti-TNF therapy was considered inappropriate in some scenarios whereby drug level was adequate and no antidrug antibody (ADA) was detectable. Conclusions We evaluated the appropriateness of the 3 available classes of biologics in a number of scenarios for the treatment of Crohn's disease. History of serious infection and malignancy, particularly in individuals over 65 years, and consideration of future pregnancy were patient-specific variables that impacted treatment decisions. These findings can serve as a guide for providers considering biologic therapy in patients with Crohn's disease. 10.1093/ibd/izy333_video1izy333.video15850922807001.

Small, open-label studies show promising results for ECP in the treatment of steroid-dependent and medically-refractory Crohn's disease. However, proper randomized, sham-controlled trials have not yet been performed. Based on the proposed mechanism of action of ECP, induction of a tolerogenic T cell response, ECP should be assessed in patients with early inflammatory disease rather than those who have progressed to fibrotic or stricturing disease. Randomized, sham-controlled trials need to be performed before ECP can be incorporated into standard clinical practice for the treatment of Crohn's disease.

Background Inflammatory Bowel Disease (IBD) is a chronic immune-mediated disease which affects nearly two million North Americans, with Canada demonstrating the highest age-adjusted incidence and prevalence rates globally. Resulting from compounding prevalence rates, the IBD clinical burden continues to grow. With high demand and limited resources, timely access to specialty healthcare services continues to be a difficulty faced by both patients and healthcare providers. Despite this pervasive issue, there has been no published research to date elucidating the patient perspective using qualitative approaches to compare and contrast the patient experience across Canada. Aims The aim of the study was to elicit a qualitative stream of data to better understand phenomena related to access to healthcare for individuals living with IBD from a patient-centered perspective. Methods Patients diagnosed with IBD (≥18 years of age) were recruited from gastroenterology clinics and communities through IBD specialists and Crohn’s & Colitis Canada. To ensure geographic diversity and representation, patients were recruited from both urban and rural regions. In order to acquire multiple access perspectives, patients were invited to bring a family member who was involved in their care to the focus groups. Co-facilitated by a researcher and a patient research partner, the focus groups were held in seven provinces across Canada. All focus groups were audio recorded, transcribed verbatim, and coded for themes. Themes were distilled through qualitative thematic analysis using Atlas.ti software to ascertain congruence or discordance of patient experiences in relation to IBD care access. Results A total of 63 participants were recruited in fourteen focus groups across seven provinces. The majority of participants were female (41/63, 65%) and from urban/suburban regions (34/63, 54%). The mean age of participants was 48 years (SD=16 years, range=16 to 77 years). Preliminary analyses illustrated three patient-identified access barrier themes: 1) Lack of multidisciplinary care (psycho-social and nutrition support), 2) Diagnostic delay, and 3) Inability to effectively receive and provide communication with healthcare providers. In response, four solutions were proposed: 1) Integration of holistic care into the clinical practice, 2) Readily accessible psycho-social and nutritional support, 3) Increased patient advocacy, and 4) Continuity and liaison through provision of a healthcare navigator resource. Conclusions The complexity of specialty care access for IBD patients cannot be underestimated. It is vital to possess a robust understanding of healthcare system structures, processes, and the significant impact these factors have on patients and the care received. Through the use of patient-centered exploration of barriers and facilitators, access to IBD specialty care in can be better understood and improved on both a provincial and national scale.

Background and aims More than 80% of Crohn's disease (CD) patients will require surgery. Surgery is not curative and rates of re-operation are high. Identification of genetic variants associated with repeat surgery would allow risk stratification of patients who may benefit from early aggressive therapy and/or post-operative prophylactic treatment. Methods CD patients who had at least one CD-related bowel resection were identified from the Prospective Registry in IBD Study at Massachusetts General Hospital (PRISM). The primary outcome was surgical recurrence. Covariates and potential interactions were assessed using the Cox proportional hazard model. Kaplan–Meier curves for time to surgical recurrence were developed for each genetic variant and analyzed with the log-rank test. Results 194 patients were identified who had at least 1 resection. Of these, 69 had two or more resections. Clinical predictors for repeat surgery were stricturing (HR 4.18, p = 0.022) and penetrating behavior (HR 3.97, p = 0.024). Smoking cessation was protective for repeat surgery (HR 0.45, p = 0.018). SMAD3 homozygosity for the risk allele was also independently associated with increased risk of repeat surgery (HR 4.04, p = 0.001). NOD2 was not associated with increased risk of surgical recurrence. Conclusion Stricturing and penetrating behavior were associated with increased risk of surgical recurrence, while smoking cessation was associated with a decreased risk. A novel association between SMAD3 and increased risk of repeat operation and shorter time to repeat surgery was observed. This finding is of particular interest as SMAD3 may represent a new therapeutic target specifically for prevention of post-surgical disease recurrence.

BACKGROUND: Despite trials demonstrating its efficacy, many physicians harbor concerns regarding the use of natalizumab in the treatment of patients with refractory Crohn's disease (CD). The purpose of this study was to perform a descriptive analysis of a series of CD patients not currently enrolled in a clinical trial. METHODS: A retrospective case review of patients treated with natalizumab at 6 sites in Massachusetts: Boston Medical Center, Beth Israel Deaconess Medical Center, Brigham & Women's Hospital, Lahey Clinic, Massachusetts General Hospital, and UMass Medical Center. RESULTS: Data on 69 CD patients on natalizumab were collected. At the start of treatment, patients' disease duration was 12 years. A high proportion of patients were women (68%), presented with perianal disease (65%) and upper gastrointestinal tract involvement (14%). Prior nonbiologic therapies were steroids (96%), thiopurines (94%), antibiotics (74%), methotrexate (58%), and at least two anti-tumor necrosis factor agent failures (81%). Sixty-nine percent (44 of 64 patients) with available medical evaluation had a partial or complete clinical response. Loss of response was 13% after an average of 1 year of treatment. Adverse events were infusion reactions, headaches, fever, and infections. No case of progressive multifocal leukoencephalopathy was observed. CONCLUSIONS: In our clinical experience outside the context of a clinical trial, natalizumab is largely reserved for CD patients with extensive ileocolonic disease who have failed conventional immunosuppressants and of at least 2 anti-tumor necrosis factor agents. This drug is, however, well tolerated and offers significant clinical improvement for more than a year in one-third of these difficult-to-treat CD patients.

Background The Crohn's Disease Activity Index (CDAI), a scoring index including patient-reported outcomes (PROs), has known limitations for measuring intestinal inflammatory disease burden. Noninvasive markers of inflammation could prove more accurate than PROs; thus, regulatory authorities are exploring the use of PROs and endoscopic data as coprimary end points in clinical trials. The aim of this study was to assess the predictive ability of individual components of the CDAI, along with biomarker concentrations, to create models for predicting endoscopic disease activity. Methods Between 2004 and 2006, 164 patients with established Crohn's disease (CD) undergoing clinically indicated ileocolonoscopy were recruited. Individual CDAI variables and fecal calprotectin (FC) were selected to explore their predictive accuracy for endoscopic disease activity, with the Simple Endoscopic Score-Crohn's Disease (SES-CD) as the outcome variable. Simple Poisson regression was performed on each variable, and 2 multivariate models were created (PRO-exclusive and PRO+FC [PRO+]). Additional analyses explored the patient-level agreement between models. Results Number of liquid stools, abdominal pain, hematocrit (Hct), FC, and high-sensitivity C-reactive protein (hsCRP) correlated significantly with the SES-CD. For the prediction of SES-CD (>7 vs ≤6), the area under the curve (AUC) was 0.81, with 63% and 88% sensitivity and specificity, for the PRO+ model, compared with a 0.56 AUC, with 61% and 55%, respectively, for the PRO model. Intra-individual comparison revealed the PRO+ model to be superior in the prediction of endoscopically active disease. Conclusions The inclusion of biomarkers significantly improved predictive accuracy for endoscopic disease activity compared with PRO-exclusive models.

Background Few details are available about the factors driving cost increases of biologic medications. Objectives To describe trends in utilization and cost of biologic agents using administrative databases in Saskatchewan, Canada. Methods Two analyses were conducted. First, aggregate utilization of biologics based on prescriptions dispensed was measured in each calendar year between 2001 and 2013. Second, a retrospective cohort of new biologic users was created to examine trends in spending between 2001 and 2013. During the first year of biologic therapy, biologic cost was quantified for each specific biologic agent as: (a) total spending; (b) total mil - ligrams dispensed; and (c) estimated unit cost (i.e., total cost in 2013 $CAD divided by total milligrams dispensed during the year). Data analyses were descriptive and all biologic costs were adjusted to 2013 dollars (CAD). Results In the first year of biologic availability in Saskatchewan (2001), 133 patients were dispensed at least one biologic agent for a total cost of $0.5 million. In 2013, 2,402 biologic recipients were identified for a total cost of $51.8 million. Almost all of these biologic costs (88.9%) were paid by the provincial government. In 2013, infliximab was the most frequently used agent, accounting for 46.5% of all spending on biolog - ics. Infliximab was also the most expensive agent in 2013 (mean cost $31,340 ± 15,307) and showed the highest increase in the mean yearly cost over time due to greater quantities dispensed. Conclusion Biologic utilization will require ongoing monitoring to optimize patient-level and societal-level benefits.

One of the challenges in natural orifice transluminal endoscopic surgery (NOTES) is spatial orientation. The Queen's NOTES group has devised a novel method of orientation by using a magnetic device that passes within an endoscope channel allowing for 3-dimensional imaging of the shape and orientation of the endoscope.To assess the feasibility and utility of a novel orientation device.Randomized, controlled trial.Animal research laboratory study on four 25-kg pigs.The device was tested by 6 endoscopists and 6 laparoscopic surgeons. Starting at the gastrotomy, the time to identify 4 targets was recorded. Participants were required to identify and touch the gallbladder, the fallopian tube, a clip on the abdominal wall, and the liver edge. Use of the orientation device was randomized for each session.Time to identify targets with and without the device. Secondary analysis assessed differences between medical specialties and level of training.The mean time to identify all 4 targets with the device was 75.08 ± 42.68 seconds versus 100.20 ± 60.70 seconds without the device (P.001). The mean time to identify all 4 targets on the first attempt was 102.29 ± 61.36 seconds versus 72.99 ± 40.19 seconds on the second attempt (P.001). No differences based on specialty or level of training were identified.Small sample size and simplicity of tasks.Regardless of randomization order, both groups were faster with the device. These encouraging results warrant further study using more complex scenarios.

BACKGROUND: Propofol is an anesthetic agent that is commonly used for conscious sedation. Propofol has advantages as a sedative agent for endoscopic procedures including rapid onset, short half-life and rapid recovery time. However, concerns exist regarding the potential for respiratory depression, hypotension, perforation due to deep sedation and the need for monitoring by an anesthetist. Propofol has been used under endoscopist supervision at the Stanton Territorial Hospital in Yellowknife, Northwest Territories since 1996 (approximately 7000 cases).METHODS: A retrospective chart review of endoscopic procedures conducted at the Stanton Territorial Hospital between January 1996 and May 2007 was performed. A random sample of 680 procedures was reviewed from a total of 6396 procedures.RESULTS: The mean (± SD) baseline systolic blood pressure (SBP) was 122.8±17.0 mmHg. The mean lowest SBP was 101.7±14.5 mmHg. The mean absolute drop in SBP was 21.1±16.7 mmHg, with a mean per cent drop of 16.3%±11.7%. Eighty-eight patients (12.9%) developed transient hypotension (SBP lower than 90 mmHg). All patients regained normal blood pressure spontaneously on repeated measurement. No patients required intravenous fluid resuscitation. The mean O2saturation was 96.4%±2.1%. One patient (0.1%) transiently desaturated (O2saturation 89%), but recovered spontaneously on repeat measurement with no intervention. No procedures were aborted for patient safety. There were no major complications, including perforation or death. There was one mucosal tear during nontherapeutic colonoscopy (0.1%).CONCLUSIONS: Propofol can be safely administered in a community hospital setting under endoscopist supervision, with no additional support or monitoring.

BACKGROUND & AIMS: The management of inflammatory bowel disease (IBD) poses a particular challenge during pregnancy because the health of both the mother and the fetus must be considered. METHODS: A systematic literature search identified studies on the management of IBD during pregnancy. The quality of evidence and strength of recommendations were rated using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. RESULTS: Consensus was reached on 29 of the 30 recommendations considered. Preconception counseling and access to specialist care are paramount in optimizing disease management. In general, women on 5-ASA, thiopurine, or anti-tumor necrosis factor (TNF) monotherapy for maintenance should continue therapy throughout pregnancy. Discontinuation of anti-TNF therapy or switching from combination therapy to monotherapy may be considered in very select low-risk patients. Women who have a mild to moderate disease flare while on optimized 5-ASA or thiopurine therapy should be managed with systemic corticosteroid or anti-TNF therapy, and those with a corticosteroid-resistant flare should start anti-TNF therapy. Endoscopy or urgent surgery should not be delayed during pregnancy if indicated. Decisions regarding cesarean delivery should be based on obstetric considerations and not the diagnosis of IBD alone, with the exception of women with active perianal Crohn's disease. With the exception of methotrexate, the use of medications for IBD should not influence the decision to breast-feed and vice versa. Live vaccinations are not recommended within the first 6 months of life in the offspring of women who were on anti-TNF therapy during pregnancy. CONCLUSIONS: Optimal management of IBD before and during pregnancy is essential to achieving favorable maternal and neonatal outcomes.

Background: Increased oxidative stress and inflammation are associated with aging, and contribute to an increased risk of chronic disease in older adults. Flaxseed lignans demonstrate antioxidant and anti-inflammatory activity, but their ability to reduce oxidative stress and inflammation markers in older adult populations has received limited investigation. Objective: This is a chronic intervention trial of community-dwelling healthy older adults to examine the effects of a flaxseed lignan (secoisolariciresinol diglucoside; SDG) enriched supplement (BeneFlax) compared to a placebo. The primary aim was to demonstrate the safety of BeneFlax and confirm its anti-inflammatory efficacy on markers of oxidative stress and inflammation, and subsequent functional outcomes, including those associated with its anti-inflammatory efficacy. A secondary aim was to determine flaxseed lignan metabolite concentrations in blood. Methods: A double-blind randomized clinical trial was conducted. Subjects were healthy community-dwelling adults aged 60-80 years. Testing was performed at baseline, 8, 16, and 24 weeks. The 24-week intervention consisted of 600 milligrams (mg) of SDG daily or an equivalent amount (volume) of placebo. All participants received 1000 international units of vitamin D to ensure adequate vitamin D status. Measurements consisted of blood pressure, hematology, and tolerability for safety assessments; blood oxidative stress and inflammatory biomarkers for efficacy; and cognition, muscle strength, and pain as functional outcomes. Secondary endpoints of plasma levels of lignan metabolites were analyzed by mass spectrometry. Other tests, such as bone turnover markers and fecal levels of flax cyclolinopeptides, will be performed at a later date. Results: Thirty-two participants were recruited (19 intervention and 13 control) and all completed the trial. Numerous Health Canada-imposed exclusion criteria limited recruitment success. Analyses are ongoing, but the baseline data available for a number of parameters indicate no differences between treatment groups. Safety measures (vital signs) did not change from baseline and were not significantly different between treatment and placebo groups at 24 weeks. Conclusions: Preliminary results indicate that no safety concerns are associated with administering 600 mg SDG for 24 weeks to adults between the ages of 60 and 80 years. Trial Registration: Clinicaltrials.gov NCT01846117; https://clinicaltrials.gov/ct2/show/NCT01846117 (Archived by WebCite at http://www.webcitation.org/6nlDZNjmA) [JMIR Res Protoc 2017;6(2):e14]

Background & Aims Little is known about the effects of cancer therapy for extraintestinal malignancy in patients with inflammatory bowel diseases (IBDs). Methods We analyzed data from the Massachusetts General Hospital and the Brigham and Women's Hospital on 84 patients diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis found to have a solid malignant extraintestinal neoplasm between January 15, 1993, and December 15, 2011. We investigated the incidence of remission with cancer treatment (cytotoxic chemotherapy, hormone therapy, or both) among patients with active IBD (n = 15) and time to disease activation after cancer treatment of those with inactive disease (n = 69). Cox proportional hazards models and survival curves were constructed to identify independent predictors of these outcomes. Results Among patients with active IBD at cancer diagnosis, 66.7% (n = 10/15) achieved remission during cancer treatment; the median duration of remission was 27 months. Ninety percent of these patients had received cytotoxic chemotherapy. For patients with IBD in remission at cancer diagnosis, 17.4% (n = 12/69) developed active IBD; the type of treatment was the strongest predictor of IBD reactivation. The risk of IBD reactivation was greatest among patients who received a combination of cytotoxic chemotherapy and adjuvant hormone therapy (hazard ratio, 12.25; 95% confidence interval, 1.51–99.06) or only hormone therapy (hazard ratio, 11.56; 95% confidence interval, 1.39–96.43). Ninety percent of patients who received cytotoxic chemotherapy remained in remission at 5 years compared with 64% of those who received only hormone therapy or the combination of cytotoxic chemotherapy and adjuvant hormone therapy (log rank, P = .02). Conclusions IBD is more likely to remit among patients who receive cytotoxic chemotherapy for solid malignancies than those who receive only hormone therapy or the combination of cytotoxic chemotherapy and adjuvant hormone therapy. Among patients with inactive IBD at the time of cancer diagnosis, hormonal therapy, alone or in combination with cytotoxic chemotherapy, increases the risk of IBD reactivation.