Abstract
Background
Identifying disease-related costs is a crucial step to plan for proper allocation of resources and future healthcare services for persons with inflammatory bowel disease (IBD). ...Data on pediatric inflammatory bowel disease-associated costs are limited.
Aims
We aimed to estimate indirect and out of pocket (OOP) pediatric IBD-associated costs in Canada.
Methods
In a nation-wide cross-sectional analysis, caregivers of children and young adults (<17 years) with IBD were invited to complete a questionnaire on lost work hours and OOP costs related to IBD in the 4 weeks prior to the survey. Participants were re-invited to periodically answer the same questionnaire every 3–9 months for 2 years. Lost productivity was calculated using the Human Capital method. Costs were reported in 2018 inflation-adjusted Canadian dollars. Predictors of high cost users (top 25%) were examined using negative binomial regression.
Results
Consecutive 243 (82 incident cases) of 262 (92.7%) approached participants completed the first survey with a total of 450 surveys longitudinally completed over 2 years. The annual median indirect costs per patient were $5,951 (IQR $1,812- $12,278), with $5,776 (IQR $1,465-$11,733) for Crohn’s disease (CD) and $6,084 (IQR $2,470-$13,371) for ulcerative colitis (UC) (p=0.77). The annual median per patient OOP costs were $2,925 (IQR $978- $8,125) with $3,021 (IQR $978- $8,125) for CD and $2,600 (IQR $975- $8,125) for UC (p=0.55). Older age (10-17y) at diagnosis (p=0.04) and parents in part-time employment (p=0.01) were predictors of higher indirect costs, while female sex (p<0.001), parents with a lower education level (p<0.001) and lower annual family income (p<0.01) were associated with higher OOP costs.
Conclusions
Indirect and OOP IBD-associated costs are substantial and more likely to affect families with unstable employment and lower annual income. Examining different strategies and interventions to reduce these costs such as virtual platforms, telephone and outreach clinics especially in poor communities and families with low annual income is warranted.
Funding Agencies
CIHRThe Children’s Hospital Research Institute of Manitoba
Abstract
Background
In August 2016 Cortiment® was approved for use in ulcerative colitis (UC) patients in Canada, but not approved for reimbursement; the Canadian Agency for Drugs and Technology in ...Health cited no comparable benefit for its use over other approved UC medications. Real-world data comparing Cortiment® to other UC medications is limited, especially during the COVID-19 pandemic where the use of steroids is counter-indicated for COVID-19-related outcomes.
Aims
To examine the comparative risk of hospitalization, surgery, and infection after initiation of Cortiment® or oral corticosteroids among UC patients using real-world data
Methods
Using population-based data from Alberta Canada, two cohorts were compared: 1. Patients dispensed Cortiment® and an ICD diagnostic code for UC 9: 556.X; 10: K51.X (August 1, 2016 to October 31, 2019); and, 2. Validated (algorithm) UC patients dispensed a >30 day supply or >500mg in 24 hours of prednisone/prednisolone (April 1, 2016 to October 31, 2019). All hospitalizations, IBD-surgery, or infections (i.e., pneumonia, c.diff, sepsis, tuberculosis) that occurred 6 or 12 months from initial medication dispensing were identified. Cox-proportional hazard models, with Hazard Ratios (HR), assessed comparative outcomes. Kaplan-Meier survival curves were created, and Poisson regression (or negative binomial) used to assess the Average Monthly Percentage Change (AMPC) with associated 95% confidence intervals (CI).
Results
We identified 917 Cortiment® and 2,404 Prednisone patients. Over the study period, prednisone dispensing significantly decreased (AMPC:-2.53% CI:-2.85,-2.21) while Cortiment® remained stable. Dispensing of Cortiment® significantly decreased the hazard of hospitalization (all types, except surgery) at 12 months as compared to prednisone, and significantly decreased the hazard of an infection at both 6 and 12 months (Table 1, Fig 1).
Conclusions
The use of Cortiment® in a real-world setting is associated with fewer deleterious outcomes, and its use during a pandemic should be preferred, especially when it’s counterpart can exacerbate negative COVID-19-related outcomes.
Table 1
Kaplan-Meier Survival Curves of 1-year Outcomes: A) All Hospitalizations; B) IBD-Related Hospitalizations; C) IBD-Specific Hospitalizations; and, D) Any Infection.
Dashed Line
Cortiment Cohort
Solid Line
Prednisone/Prednisolone Cohort
Funding Agencies
Ferring Pharmaceuticals
Abstract
Background
The ABC risk score identifies patients at high-risk of mortality in acute lower and upper gastro-intestinal bleeding (UGIB).
Aims
We aimed to externally validate the ABC score, ...while comparing it to other prognostication scales when assessing UGIB patients at high-risk of negative outcomes prior to endoscopy.
Methods
UGIB patients from a national Canadian registry (REASON) were studied, with mortality prediction as primary outcome. Secondary endpoints included prognostication of rebleeding, intensive care unit (ICU) admission, ICU and hospitalization lengths of stay (LOS), and a previously proposed composite outcome measure. Univariable and areas under the Receiver Operating Characteristic Curve (AUROC) analyses compared discriminatory abilities of the ABC score to the AIMS65, Glasgow Blatchford (GBS) and clinical Rockall Scores.
Results
The REASON registry included 2020 patients (89.4% nonvariceal; mean age ± SD 66.3±16.4 years; 38.4% female). Overall mortality, rebleeding, ICU admission, transfusion and composite score rates were 9.9%, 11.4%, 21.1%, 69.0%, and 67.3% respectively. ICU and hospitalization LOS were 5.4 ± 9.3 days and 9.1 ± 11.5 days, respectively. The ABC score displayed superior 30-day mortality prediction (0.78 (0.73; 0.83)) compared to GBS (0.69 (0.63; 0.75) or clinical Rockall (0.64 (0.58; 0.70) but not AIMS65 (0.73 (0.67; 0.79)). Although most scales significantly prognosticated secondary outcomes in univariable analysis except for ICU LOS, discriminatory abilities on AUROC analyses were poor.
Conclusions
ABC and AIMS65 display similar good prediction of mortality. Clinical usefulness in prognosticating secondary outcomes was modest for all scales, limiting their adoptions when informing early management of high-risk UGIB patients.
Funding Agencies
International Scientific Partnership Program ISPP at King Saud University for funding this research work through ISPP-21–156
Abstract
Background
Eosinophilic esophagitis (EoE) is a chronic immune- or antigen-mediated esophageal disorder characterized by symptoms of esophageal dysfunction and eosinophil-predominant ...inflammation. With incidence rates rapidly increasing, EoE is the leading cause of food bolus impaction and the second leading cause of chronic esophagitis. The treatment of EoE includes both induction and maintenance therapy to prevent complications including esophageal fibrosis and strictures. Despite significant advances in the diagnosis and treatment of EoE, the natural history and long-term management of the disease remains poorly understood.
Aims
To describe the clinical characterization of children with EoE, and to assess remission rates after initial treatment and 1-year post-diagnosis.
Methods
In this ongoing, single-center retrospective study, the electronic medical charts of children newly diagnosed with EoE between January 2017-March 2021 participating in the EoE-AHEAD Registry study were reviewed. Children aged 6 months-18 years with a confirmed diagnosis of EoE based on consensus guidelines and receiving outpatient care at the SickKids EoE clinic were included.
Results
A total of 37 children with a median age of 11 years (IQR: 4.5, 12.5) were included, the majority of which were male (86.5%). Demographic and clinical characteristics are shown in Table 1. On initial treatment, 2.7% of children were on an elemental diet, 18.9% on a food elimination diet, 40.5% on proton-pump inhibitor (PPI) therapy, 16.2% on topical steroids, 8.1% on systemic steroids, and 13.5% on a combination therapy. Of the 30 children with a second endoscopy (mean interval since diagnosis of 6.1 months (3.9)), 30% achieved histological remission after the initial treatment (see Figure 1). Of the 14 children with a one-year follow-up endoscopy, 14.2% were in remission, 3 of which had relapsed. No significant differences in treatment modality were found between those who achieved remission and those who did not.
Conclusions
This is the first Canadian registry study to examine the longitudinal outcomes of EoE in a pediatric setting. Our preliminary results show that only 30% of children achieved histological remission following first-line treatment. The choice of initial therapy varied, although the majority of patients (62.2%) were prescribed a PPI and/or a topical steroid. Our findings highlight the importance of identifying different disease phenotypes to develop personalized therapeutic approaches for the management of EoE.
Funding Agencies
SickKids start-up funds (JM Hulst) and the Comprehensive Research Experience for Medical Students (CREMS) Program
Abstract
Background
Physicians in procedural specialties, such as gastrointestinal endoscopy, are at a high risk of musculoskeletal injuries (MSPI) which can affect physician wellness and ...productivity. Training in ergonomic principles for endoscopy may help reduce and prevent the incidence of MSPI.
Aims
The aim of this systematic review was to identify educational interventions using ergonomic strategies that target the reduction of MSPI and/or pain from GI endoscopy.
Methods
We conducted a systematic search following PRESS guidelines in MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, the Cochrane Central Register of Controlled Trials and the Cochrane Database of Systematic Reviews for articles published from inception to December 16, 2020. Studies were included if they investigated educational interventions aimed at changing knowledge and/or behaviours related to ergonomics in gastrointestinal endoscopy. After screening and full-text review, we extracted data on the study design, participants, type of training and assessment of primary outcomes. We evaluated study quality with the Medical Education Research Study Quality Instrument (MERSQI). A qualitative synthesis of the data was conducted.
Results
Of the initial 575 records identified in the search, 5 met inclusion criteria for qualitative synthesis. We found that most studies (n=4, 90%) were single armed interventional studies that were conducted in simulated and/or clinical settings. The most common types of intervention were didactic sessions and/or videos (n=4, 80%). Other interventions included individualized feedback (n=2, 40%), checklists (n=2, 40%), and simulated training (n=1, 20%). Two (40%) studies used both standardized assessment studies and formal statistical analyses to assess primary outcomes. All included studies reported a benefit of their interventions on their respective dimensions assessed for ergonomics. The mean MERSQI score was 9.7.
Conclusions
There is emerging literature demonstrating the effectiveness of interventions to improve ergonomic performance in gastrointestinal endoscopy, which is likely to reduce MSPI among endoscopists. Further higher quality research in this field is required to make robust recommendations.
Study flow diagram
Funding Agencies
None
Abstract
Background
Rectal cancer is curable by standard surgery with Total Mesorectal Excision (TME). However, there are well known associated long-term bowel and sexual dysfunctions. Non-operative ...management (NOM) is an emerging treatment for patients with operable rectal cancer. There is evidence supporting dose response for tumor control in rectal adenocarcinoma.
Aims
In the era of modern technologies, Image-guided adaptive endorectal brachytherapy is a means to deliver local radiotherapy boost treatments. We explored its role in a randomized phase II/III trial (NCT03051464) for patients aiming to achieve cure without surgery. Total Mesorectal Excision (TME) free survival at 2 years was the primary endpoint. We now present the interim analysis upon accrual of the first 40 patients.
Methods
In randomized trial, patients with operable cT2-3ab N0 M0 rectal cancer received 45 Gy in 25 fractions of pelvic external beam radiotherapy (EBRT) with concurrent 5-FU/ Capecitabine. They were randomized to receive either an EBRT boost of 9 Gy in 5 fractions (Arm A), or three weekly adaptive brachytherapy boosts for a total of 30 Gy in 3 fractions (Arm B).
Results
Forty patients were included (20 per arm). The median age was 66 years; baseline characteristics were well balanced in terms of age, tumor location, T stage and tumor size (Table 1). The acute treatment related toxicities are similar as shown in table 2 but in arm B, there were two deaths: one patient died during his chemotherapy and external beam treatment from congestive heart failure and one patient from a heart attack after treatment prior to salvage TME surgery. The proportion of complete clinical response was 50% (n=10/20) in Arm A and 90% in Arm B (n=18/20). With a median follow-up of 2.2 years, local regrowth at 2 years occurred in 4/10 patients (40%) in Arm A and 4/18 patients (22%) in Arm B. TME-free survival rate at 2 years was 45.9% in Arm A and 85.1% in Arm B (p=0.0036) (Figure 1).
Conclusions
The interim analysis of this trial suggests that these two strategies of radiation dose escalation are feasible and lead to high chances of organ preservation in patients with operable rectal cancer. The Independent Monitoring Comittee (IDMC) approved the continuation of patient recruitment in the phase III study as planned.
Funding Agencies
Elekta
Abstract
Background
Both Celiac disease (CE) and inflammatory bowel disease (IBD) are lifelong gastrointestinal tract (GIT) disorders. CE is an autoimmune disorder triggered by gluten consumption and ...can result in small intestine villus atrophy, crypt hyperplasia and epithelial permeability, while IBD is characterized by chronic, reoccurring inflammation and ulcers in the GIT. There is increasing evidence linking GIT microbes to both CE and IBD pathogenesis. Studies have also shown that CE patients are at increased risk of developing IBD, suggesting a possible link between these diseases. The duodenum can be affected in both CE and IBD, but it is understudied as compared to other GIT regions.
Aims
We thus aimed to characterize the duodenal microbiome of pediatric CE, IBD and control patients (n=76, 48 and 57 respectively) and hypothesized that the composition of microbes would vary between each diagnostic group.
Methods
We used mucosal luminal interface aspirates collected during upper endoscopy at the Children’s Hospital of Eastern Ontario. Metagenomic DNA was extracted from these samples and bacterial taxa was characterized by sequencing the V6 hypervariable region of the 16S rRNA gene.
Results
Control, CE, and IBD duodenal microbiotas showed no apparent differences in either α-diversity or β-diversity. However, we identified several significant differences between the relative abundances of specific taxa in these three patient groups. In particular, Atopobium parvulum was found to be enriched in Crohn’s disease samples when compared to non-IBD controls. There was also a trend for higher Bacteroides, Lactobacillus, Parabacteroides and Staphylococcus in CE patient MLI aspirates. These results are similar to what has been previously reported in CE patients. Finally, trends found in the duodenal MLI aspirates are more consistent with results previously found in the salivary microbiome in CD patients as opposed to studies of the large intestine.
Conclusions
This work provides unique insight into the microbial composition at the duodenum; a GIT region that has not been fully characterized in CE or IBD.
Funding Agencies
CIHRGenome Canada
Abstract
Background
Inflammatory bowel disease (IBD) which includes Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting or progressive inflammatory condition. In ...addition to physical symptoms, individuals with IBD experience uncertainty about their future, social isolation, and increased psychological stress. Conventional medical and surgical IBD treatment does not adequately address the the impact of psychological stress. Online stress reduction interventions may therefore be useful adjuncts to standard medical therapies for IBD. The Peace Power Pack (PPP) trial was a 12-week RCT testing a stress reduction intervention with two core components: (i) a yoga, breathwork and meditation video, and (ii) a behavior-change facilitation informed by cognitive behavioral therapy.
Aims
The aims of this qualitative study, which was carried out alongside the PPP trial was to: (i) explore the experience of living with IBD, (ii) understand the impacts of the PPP program, and (iii) identify potential improvements to the program.
Methods
Upon completion of the 12-week RCT, all intervention participants were invited to participate in semi-structured interviews. A qualitative descriptive approach was used. Interviews were analyzed through a theoretical thematic analysis process, whereby transcripts were coded, and codes then grouped into larger categories and themes.
Results
Of the 56 participants interviewed, 52% had CD and 48% had UC. Participants ranged in age from 23 to 73 years, were predominantly female (70%) and had been diagnosed with IBD 14.3 years ago. Three main themes (Table 1) were identified: (i) IBD as a source of stress and uncertainty, (ii) understanding the positive impacts of the stress reduction program, and (iii) suggested strategies to enhance program desirability. IBD was described as causing uncertainty, significant disruptions to daily activities, and stress. The online program was associated with a perceived reduction in IBD symptom burden, an increased ability to manage daily and disease-associated stressors, and a more positive mindset. Variation in program content and fostering connections with others in the IBD community were identified as potential strategies to enhance future programming.
Conclusions
This study highlights the power of the patient voice to deepen our understanding of the impact of IBD, and the potential benefit of an online stress reduction program including suggestions for iterative refinement.
Table 1. Themes identified with sample quotations
Funding Agencies
University of Alberta Hospital Foundation, the American College of Gastroenterology and the Inflammation, Microbiome, and Alimentation: Gastrointestinal and Neuropsychiatric Effects (IMAGINE) Network CIHR grant
Abstract
Background
The terminal ileum is the most susceptible location to develop Crohn’s disease (CD) and therefore is a valuable tissue to investigate biological mechanisms underlying chronic ...inflammation. Gene expression is highly affected by the level of inflammation, however, data on ileal transcriptomic profile in the absence of active inflammation is limited.
Aims
To investigate the ileal mucosal transcriptomic profile of CD patients in endoscopic and histologic remission compared to healthy controls (HC).
Methods
Ileal biopsies were collected during colonoscopy from patients with CD and HC. Biopsies were classified as non-inflamed based on endoscopic appearance and histologic criteria. Endo-histologic remission (EHR) was defined as simple endoscopic score < 3 and absence of active histologic inflammation. We included CD patients with EHR and HC for the analysis of this study. CD phenotype was divided into isolated colonic CD (cCD) that included Montreal L2 and ileal predominant CD (iCD) that included Montreal L1 and L3. Total RNA was extracted from samples, sequenced using a HiSeq 2500 instrument (Illumina, San Diego, CA, USA) and differential expression analysis was performed in EdgeR. Genes that were differentially expressed at the average of 2-fold-change (FC) in mean expression and False Discovery Rate (FDR) < 0.05 were considered significant.
Results
Ileal samples from 14 CD patients in EHR and 29 HC were included in the analysis. CD patients were significantly younger (median age 28.5 years, interquartile range (IQR)=24–40) compared with HC (median age 56 years, IQR=51–64). There were no differences in gender distribution (42.9% males in CD and 55.2% males in HC). We found 101 differentially expressed genes in CD patients compared to HC (99 genes were up-regulated and two were down-regulated). Dual oxidase 2 (DUOX2) and complement C6 were respectively the most significant up-regulated (logFC=4.45, FDR=1.3e-8) and down-regulated (logFC=-2.73, FDR=0.0006) genes in non-inflamed ileum CD group when compared with HC. In a subgroup analysis comparing ileal samples of CD patients with cCD (n=8) versus iCD phenotype (n=6), no differentially expressed genes were identified.
Conclusions
The mucosal transcriptomic profile of patients with inactive endoscopic and histologic ileal CD shows significant differentially expressed gene profile compared to ileal mucosa of HC. The clinical relevance of these findings should be further investigated.
Funding Agencies
IBD Genetics Consortium
Abstract
Background
SARS-CoV-2 is a novel virus currently causing a major pandemic. Recent studies have shown that SARS-CoV-2 has an affinity to ACE2 receptors which are present in the olfactory ...epithelium as well as the pulmonary and gastrointestinal (GI) systems. It is stipulated that these receptors are responsible for the entry of the virus into cells explaining the respiratory and GI symptoms of this infection. The anosmia related to COVID-19 is likely due to an aberrant immune response to the virus rather than direct damage to the olfactory epithelium. Similarly, achalasia is also believed to result from an aberrant immune response through which there is degeneration of inhibitory neurons in the myenteric plexus. In this case report, we present the first case of achalasia thought to be linked to a SARS-CoV-2 infection in contemporary literature.
Aims
We hypothesize that SARS-CoV-2 caused an aberrant immune response in our patient, leading him to develop achalasia. We hope to expose clinicians to this potential complication of COVID-19, allowing them to consider it sooner in their differential.
Methods
The patient’s file was reviewed to extract the relevant information. A second gastroenterologist’s opinion was obtained on the manometry to confirm the diagnosis of type III achalasia.
Results
A 61-year-old man with a medical history of myasthenia gravis, chronic obstructive pulmonary disease, hypothyroidism, and chronic renal failure was treated in our establishment for a SARS-CoV-2 pneumonia. He experienced new severe dysphagic symptoms, regurgitations, and lost 10 pounds during his hospitalization. He also developed anosmia and diarrhea. A CT-scan of his neck and thorax showed no extrinsic compression of his esophagus. No neoplasm was found on his gastroscopy. A barium study was then conducted showing a stagnation of contrast in the distal third of his esophagus. No relaxation of the inferior gastroesophageal sphincter was noted. A manometry was then performed and confirmed a type III achalasia. The mean lower esophageal sphincter residual pressure was elevated at 43.7 mmHg. A calculated 69% of wet swallows were premature contractions with a distal latency value less than 4.5 seconds. The mean distal contractile integral was 13613 mmHg. This corroborates the spastic nature of type III achalasia.
Conclusions
Considering that our patient developed anosmia and knowing its pathogenesis in the context of COVID-19, an inappropriate immune response to SARS-CoV-2 could have equally taken place in the esophagus. This inflammatory response might have caused the degeneration of the inhibitory neurons in the myenteric plexus responsible for the achalasia. Furthermore, given the fact that our patient had diarrhea, this suggests that the virus has a GI tropism supporting our hypothesis. We therefore believe that achalasia may be a potential complication of COVID-19.
High resolution esophageal motility study showing a type III achalasia pattern.
Funding Agencies
None
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