The Effect of an Electronic Medical Record-Based Clinical Decision Support System on Adherence to Clinical Protocols in Inflammatory Bowel Disease Care: Interrupted Time Series Study.

Background: Clinical decision support systems (CDSSs) embedded in electronic medical records (EMRs), also called electronic health records, have the potential to improve the adoption of clinical guidelines. The University of Alberta Inflammatory Bowel Disease (IBD) Group developed a CDSS for patients with IBD who might be experiencing disease flare and deployed it within a clinical information system in 2 continuous time periods. Objective: This study aims to evaluate the impact of the IBD CDSS on the adherence of health care providers (ie, physicians and nurses) to institutionally agreed clinical management protocols. Methods: A 2-period interrupted time series (ITS) design, comparing adherence to a clinical flare management protocol during outpatient visits before and after the CDSS implementation, was used. Each interruption was initiated with user training and a memo with instructions for use. A group of 7 physicians, 1 nurse practitioner, and 4 nurses were invited to use the CDSS. In total, 31,726 flare encounters were extracted from the clinical information system database, and 9217 of them were manually screened for inclusion. Each data point in the ITS analysis corresponded to 1 month of individual patient encounters, with a total of 18 months of data (9 before and 9 after interruption) for each period. The study was designed in accordance with the Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI) guidelines for health informatics evaluations. Results: Following manual screening, 623 flare encounters were confirmed and designated for ITS analysis. The CDSS was activated in 198 of 623 encounters, most commonly in cases where the primary visit reason was a suspected IBD flare. In Implementation Period 1, before-and-after analysis demonstrates an increase in documentation of clinical scores from 3.5% to 24.1% (P<.001), with a statistically significant level change in ITS analysis (P=.03). In Implementation Period 2, the before-and-after analysis showed further increases in the ordering of acute disease flare lab tests (47.6% to 65.8%; P<.001), including the biomarker fecal calprotectin (27.9% to 37.3%; P=.03) and stool culture testing (54.6% to 66.9%; P=.005); the latter is a test used to distinguish a flare from an infectious disease. There were no significant slope or level changes in ITS analyses in Implementation Period 2. The overall provider adoption rate was moderate at approximately 25%, with greater adoption by nurse providers (used in 30.5% of flare encounters) compared to physicians (used in 6.7% of flare encounters). Conclusions: This is one of the first studies to investigate the implementation of a CDSS for IBD, designed with a leading EMR software (Epic Systems), providing initial evidence of an improvement over routine care. Several areas for future research were identified, notably the effect of CDSSs on outcomes and how to design a CDSS with greater utility for physicians. CDSSs for IBD should also be evaluated on a larger scale; this can be facilitated by regional and national centralized EMR systems.

System Configuration Evaluation for a Province-Wide Clinical Information System Using the eSafety Checklist.

BACKGROUND: According to Digital Health Canada 2013 eSafety Guidelines, an estimated one-third of patient safety incidents following implementation of clinical information systems (CISs) are technology-related. An eSafety checklist was previously developed to improve CIS safety by providing a comprehensive listing of system-agnostic, evidence-based configuration recommendations. OBJECTIVES: We sought to use the checklist to support safe initial configuration of a provincial system-wide CIS (Alberta, Canada), referred to as Connect Care. METHODS: The checklist was applied to 13 Connect Care modules in three successive phases. First, the checklist was adapted to an abbreviated high-priority version. Second, demonstrations of each module were recorded. Finally, independent evaluation of each recording was conducted by two eSafety evaluators using the abbreviated eSafety checklist. RESULTS: All modules achieved greater than 72% compliance, with an average of 84%. Overall, 273 opportunities for improvement were identified, with four major areas or themes emerging: (1) inconsistent date and time, (2) unclear patient identification, (3) ineffective alert system, and (4) insufficient decision support. These opportunities were forwarded to the appropriate build teams for review and implementation. CONCLUSION: This work is the first to utilize the eSafety checklist in a real-world CIS, which will become one of the largest in Canada. The checklist has shown clinical applicability in identifying gaps in CIS configuration and should be considered for use in future and pre-existing CISs.

Impact of Disease Activity and Inflammatory Bowel Disease Subtype on Quality of Life in Preconception and Pregnant Patients.

BACKGROUND: Inflammatory bowel disease (IBD) and pregnancy both impact health-related quality of life (HRQoL). However, little is known about IBD-related HRQoL around pregnancy. AIMS: To assess the trajectory and predictors of HRQoL in preconception and pregnant patients with Crohn's disease (CD) and ulcerative colitis (UC). METHODS: Preconception and pregnant patients with IBD were followed prospectively from preconception to twelve months postpartum at a tertiary referral centre. Participants completed the Short IBD Questionnaire (SIBDQ) and were assessed for clinical disease activity (modified Harvey Bradshaw Index or partial Mayo score) and objective disease activity (C-reactive protein [CRP], fecal calprotectin [FCP]). RESULTS: A total of 61 patients with IBD (25 CD, 36 UC) were included. During preconception, patients with UC had higher SIBDQ bowel and social sub-scores than those with CD, but this reversed during postpartum. Patients with CD but not UC developed a significant, sustained improvement in SIBDQ upon becoming pregnant, which persisted into 12 months postpartum. In a multivariable linear regression model, clinical disease activity negatively predicted SIBDQ at every pregnancy timepoint and up to 12 months postpartum. SIBDQ was significantly lower in patients with CRP ≥ 8.0 mg/L during trimester 1 (T1), but not later in pregnancy. SIBDQ bowel sub-scores were significantly lower in patients with FCP ≥ 250 mg/kg at T2, T3, and 6 months postpartum. CONCLUSIONS: Clinical disease activity is a consistent negative predictor of HRQoL from conception to 12 months postpartum. Patients with UC experience better preconception HRQoL but suffer worse postpartum HRQoL than those with CD.

Artificial intelligence enabled automated diagnosis and grading of ulcerative colitis endoscopy images.

Endoscopic evaluation to reliably grade disease activity, detect complications including cancer and verification of mucosal healing are paramount in the care of patients with ulcerative colitis (UC); but this evaluation is hampered by substantial intra- and interobserver variability. Recently, artificial intelligence methodologies have been proposed to facilitate more objective, reproducible endoscopic assessment. In a first step, we compared how well several deep learning convolutional neural network architectures (CNNs) applied to a diverse subset of 8000 labeled endoscopic still images derived from HyperKvasir, the largest multi-class image and video dataset from the gastrointestinal tract available today. The HyperKvasir dataset includes 110,079 images and 374 videos and could (1) accurately distinguish UC from non-UC pathologies, and (2) inform the Mayo score of endoscopic disease severity. We grouped 851 UC images labeled with a Mayo score of 0-3, into an inactive/mild (236) and moderate/severe (604) dichotomy. Weights were initialized with ImageNet, and Grid Search was used to identify the best hyperparameters using fivefold cross-validation. The best accuracy (87.50%) and Area Under the Curve (AUC) (0.90) was achieved using the DenseNet121 architecture, compared to 72.02% and 0.50 by predicting the majority class ('no skill' model). Finally, we used Gradient-weighted Class Activation Maps (Grad-CAM) to improve visual interpretation of the model and take an explainable artificial intelligence approach (XAI).

Pregnancy-Related Beliefs and Concerns of Inflammatory Bowel Disease Patients Modified After Accessing e-Health Portal.

OBJECTIVE: Poor inflammatory bowel disease (IBD)-specific reproductive knowledge is associated with concerns and medication noncompliance. Having shown an educational portal can improve knowledge, we evaluated its effectiveness for addressing IBD patients' reproductive and medication concerns. METHODS: Adult IBD participants (aged 18 to 45 years) were invited to access an e-health portal providing information on heritability, fertility, surgery, pregnancy outcomes, delivery, postpartum, and breastfeeding in the context of IBD and IBD medications. At pre-, post-, and 6+-month postintervention, participants completed a questionnaire on IBD-specific pregnancy concerns, medication concerns from the Beliefs About Medicines Questionnaire (BMQ), and medication adherence via the Medication Adherence Rating Scale (MARS). The Wilcoxon signed-rank test was used to compare median differences between scores (95% confidence). RESULTS: Demographics for 78 (70.3%) participants completing postintervention questionnaires: median age 29.3 (interquartile range: 25.6 to 32.9) years; 54 (69.2%) Crohn's disease; 21 (26.9%) ulcerative colitis; 63 (80.3%) females, 5 (7.9%) pregnant; and 19 (30.2%) previously pregnant. Postintervention, the median number of reproductive concerns decreased from 3 to 1, and remained stable 6+ months later (P < 0.001*). The median BMQ score decreased from 28 to 25, and remained stable 6+ months later (P = 0.032*). Participants adherent to medications increased from 82.4% to 87.8% postintervention (P = 0.099). CONCLUSION: Using an e-health portal may potentially reduce IBD-specific reproductive and medications concerns. An e-health portal is feasible as one component of managing IBD patient's reproductive and medication concerns during preconception and pregnancy.

An overview of clinical decision support systems: benefits, risks, and strategies for success.

Computerized clinical decision support systems, or CDSS, represent a paradigm shift in healthcare today. CDSS are used to augment clinicians in their complex decision-making processes. Since their first use in the 1980s, CDSS have seen a rapid evolution. They are now commonly administered through electronic medical records and other computerized clinical workflows, which has been facilitated by increasing global adoption of electronic medical records with advanced capabilities. Despite these advances, there remain unknowns regarding the effect CDSS have on the providers who use them, patient outcomes, and costs. There have been numerous published examples in the past decade(s) of CDSS success stories, but notable setbacks have also shown us that CDSS are not without risks. In this paper, we provide a state-of-the-art overview on the use of clinical decision support systems in medicine, including the different types, current use cases with proven efficacy, common pitfalls, and potential harms. We conclude with evidence-based recommendations for minimizing risk in CDSS design, implementation, evaluation, and maintenance.

Incidence Rates for Surgery in Crohn's Disease Have Decreased: A Population-based Time-trend Analysis.

BACKGROUND: Many Crohn's disease (CD) patients will undergo surgery over the course of their life. It is thought that with the introduction of disease-modifying agents like anti-TNF therapy, there would be a population-level decrease in the need for surgery. This time-trend study aimed to assess the changes in surgical rates following the induction of anti-TNF therapy. METHODS: Adult CD patients who underwent abdominal surgery (identified by administrative coding) between January of 1996 and December of 2013 at 1 of the 4 Edmonton-area hospitals were included. Patient charts were manually reviewed to confirm diagnosis and gather demographic and disease-related data. Population-adjusted annual incidence rates for IBD surgery were calculated by dividing the number of surgeries by estimates for total population of CD patients in Edmonton. Time-trend analysis was conducted to identify change points, calculate annual percent change (APC), and associated 95% confidence intervals (CIs). RESULTS: A total of 1410 patients with Crohn's disease underwent surgery for their disease. The surgical rate decreased by 8.4% each year (95% CI, -9.6% to -7.3%). There was a 36.2% increase in the use of anti-TNF therapy per year (95% CI, 31.3% to 41.5%). Changes in modifiable risk factors for surgery were also seen, including the proportion of active smokers decreasing by 2.2% per year (95% CI, -3.7% to -0.6%). CONCLUSIONS: Although anti-TNF therapy seems to play a role, the decrease in surgical trends is likely multifactorial, owing to a decline in smoking trends, earlier diagnosis, earlier treatment, improved patient education, and changes in clinical practice.

Management of Inflammatory Bowel Disease Patients With Clinical Care Pathways Reduces Emergency Department Utilization.

Background: Standardizing care through pathways has the potential to reduce emergency department (ED) utilization. We developed and evaluated inflammatory bowel disease (IBD) care pathways for that purpose. Methods: Over 2014-2016, IBD patients were retrospectively stratified into those managed and not managed by pathways. Patient data were extracted, and negative binomial regression used to predict the annual number of ED visits. Results: There was a difference of 30.7 ED visits/100 patients between managed and nonmanaged at 12 months (P < 0.001). The incidence rate ratio of total ED visits occurring annually was 0.750 (P = 0.008). Conclusions: Management with IBD care pathways reduces ED utilization.

Knowledge translation dataset: An e-health intervention for pregnancy in inflammatory bowel disease.

This article presents data collected from a cohort of patients with inflammatory bowel disease, who expressed interest in family planning and reproductive health in their clinical context. They were randomized (1:1, text-only vs. multimedia content) to access an online e-health portal containing educational information on the topic. The data collected includes baseline demographics, medication history, reproductive history, as well as standardized, validated questionnaires on knowledge ('CCPKnow'), reproductive concerns, beliefs about medications ('BMQ'), and medication adherence ('MARS-5'). These questionnaires were administered prior to the intervention, immediately after accessing the materials, and a minimum of 6 months later (without re-accessing the online material). Two publications have been generated from analysis and aggregation of the CCPKnow data ("Pregnancy-related Beliefs and Concerns of Inflammatory Bowel Disease Patients are Modified After Accessing e-Health Portal" (Sutton et al., in press), "Innovative Online Educational Portal Improves Disease-Specific Reproductive Knowledge Among Patients With Inflammatory Bowel Disease" (Sutton et al., 2018) however this is an extensive dataset that could be analyzed or combined with others' datasets for further insights.

Lower Abundance and Impaired Function of CD71+ Erythroid Cells in Inflammatory Bowel Disease Patients During Pregnancy.

BACKGROUND AND AIMS: CD71+ erythroid cells are enriched during pregnancy with immuno suppressive properties. We investigated the frequency and functionality of CD71+ erythroid cells in peripheral blood, cord blood, and placenta of inflammatory bowel disease [IBD] patients versus healthy controls [HCs]. We aimed to determine their role in IBD pathogenesis during pregnancy. METHODS: Peripheral blood was collected at preconception, the first, second and third trimesters, and postpartum. Cord blood and placental tissues were collected at the time of birth. Cells from different specimens were subjected to immune-phenotyping and functional assays. CD71+ erythroid cells were purified for quantitative polymerase chain reaction [qPCR] analysis. Using an allogeneic mouse model of pregnancy, the effects of CD71+ erythroid cells depletion on intestinal homeostasis and dysbiosis was studied. RESULTS: IBD patients had lower CD71+ erythroid cells during pregnancy compared with HCs. Placenta and cord blood CD71+ erythroid cells from IBD patients exhibited impaired functionality and expressed lower inhibitory molecules including VISTA, TGF-ß, and reactive oxygen species [ROS]. Lower CD71+ erythroid cells were correlated with reduced regulatory T cells and increased immune-activation in IBD patients. Depletion of CD71+ erythroid cells in an allogeneic pregnancy model resulted in upregulation of TLRs, IL-6, and CXCL-1, and enhanced production of TNF-α, in intestinal tissues. In contrast, TGF-ß gene expression was reduced. Excessive inflammatory response in the gut [e.g. TNF-α] affects intestinal integrity and CD71+ erythroid cells impact on the gut's bacterial composition. CONCLUSIONS: Reduced frequency and/or impaired functionality of CD71+ erythroid cells during pregnancy may predispose IBD patients to a more pro-inflammatory milieu in their gastrointestinal tract, characterised by lower Tregs, higher IL-6, and TNF-α, and dysbiosis.

The Profile of Human Milk Metabolome, Cytokines, and Antibodies in Inflammatory Bowel Diseases Versus Healthy Mothers, and Potential Impact on the Newborn.

BACKGROUND AND AIMS: For women with inflammatory bowel disease [IBD], it is not very well known how IBD or IBD treatment affects their breast milk components. We aimed to investigate whether breast milk composition differs in healthy control [HC] versus IBD mothers in terms of antibodies, cytokines, and metabolite,s to identify potential impact of IBD breast milk on neonatal immune system. METHODS: Breast milk specimens from HC [n = 17] and IBD [n = 31 for Crohn's disease [CD]; and n = 41 for ulcerative colitis [UC]; were collected at 3 and 6 months postpartum [PP3] and [PP6], respectively. Faecal samples were also collected. Cytokines and immunoglobulins [IgA/IgG/IgE] were analysed by multiplex Meso Scale Discovery [MSD] and commercial kits. Moreover, breast milk metabolites were analysed by 1H nuclear magnetic resonance [NMR]. RESULTS: We found that breast milk from IBD mothers showed significantly lower levels of IgA, sugar metabolite [lactose], and 2-aminobutyrate. In contrast, we observed that breast milk from mothers with IBD had increased levels of pro-inflammatory cytokines and higher energy metabolites [lactate and succinate] than milk from healthy mothers. In addition, we noticed that the type of treatment [5-aminosalicylic acid versus biologics] influenced the milk cytokines and metabolites profile. CONCLUSIONS: The reduction in immunoprotective components of IBD breast milk such as sIgA and lactose theoretically may modulate the potential protective effects of breastfeeding. On the other hand, presence of higher levels of pro-inflammatory cytokines, lactate, and succinate may predispose the offspring to an inflammatory condition or impact on the gut microbiome. Better understanding of the role of succinate in infants and its potential effects on microbiome or mucosal immunity merits further investigations.

Mode of delivery by an ulcerative colitis mother in a case of twins: Immunological differences in cord blood and placenta.

AIM: To understand the effects of delivery mode on the immune cells frequency and function in cord blood and placenta. METHODS: We evaluated immunological differences in cord blood and placental tissues for a case of twins one of which delivered vaginally while the other delivered by caesarian section (C-section). Cord blood mononuclear cells were isolated and placenta tissues were processed for cell isolation. Immune phenotyping was performed by flow cytometry methods following staining for T cells, natural killer (NK) cells, monocytes, neutrophils and CD71+ erythroid cells in both cord blood and placenta tissues. In addition, fetal calprotectin of twins was measured 12 wk after birth. RESULTS: We found lower percentages of immune cells (e.g. T cells, monocytes and neutrophils) in the cord blood of C-section delivered compared to vaginally delivered newborn. In contrast, percentages of monocytes and neutrophils were > 2 folds higher in the placental tissues of C-section delivered newborn. More importantly, we observed lower percentages of CD71+ erythroid cells in both cord blood and placental tissues of C-section delivered case. Lower CD71+ erythroid cells were associated with a more pro-inflammatory milieu at the fetomaternal interface reflected by higher expression of inhibitory receptors on CD4+ T cells, higher frequency of monocytes and neutrophils. Furthermore, type of delivery impacted the gene expression profile in CD71+ erythroid cells. Finally, we found that C-section delivered child had > 20-fold higher FCP in his fecal sample at 12 wk of age. CONCLUSION: Mode of delivery impacted immune cells profile in cord blood/placenta. In particular frequency of immunosuppressive CD71+ erythroid cells was reduced in C-section delivered newborn.

Innovative Online Educational Portal Improves Disease-Specific Reproductive Knowledge Among Patients With Inflammatory Bowel Disease.

Background: Inflammatory bowel disease (IBD) is often diagnosed in early adulthood, affecting patients through their reproductive years. Many patients, lacking knowledge about IBD and reproduction, make uninformed decisions. Although patients have turned to the Internet for information, it remains unclear if online resources are effective for improving and retaining IBD-specific reproductive knowledge. We aimed to elucidate if a multimedia vs text-only online educational intervention could improve IBD-specific reproductive knowledge for more than 6 months. Methods: We developed a website covering genetics, fertility, surgery, pregnancy, medications, delivery, and postpartum in the context of IBD. Adult IBD patients were randomized into study groups (multimedia or text-only) and provided 60-day access. Participants completed pre-, post-, and 6+ month-postintervention pregnancy knowledge (CCPKnow) questionnaires. Results were compared using nonparametric tests. Results: Of 111 registered participants, 78 (70.3%) completed pre- and postintervention questionnaires, and 37 (47.4%) subsequently completed the 6+ month questionnaire. Demographics were as follows: median age (interquartile range [IQR]) 29.3 (25.6-32.9) years, Crohn's disease n = 54 (69.2%), females n = 63 (80.3%), of which n = 5 (7.9%) were pregnant and n = 19 (30.2%) had previously been pregnant. The median CCPKnow scores (/17) (IQR) were 8.0 (3.0-10.0) pre-intervention, 16.0 (13.00-17.00) postintervention, and 14.0 (12.0-15.0) 6+ months postintervention. The median within-subject increase in score was 6.5 pre- to postintervention, and 4.0 pre- to 6+ months postintervention (both P < 0.001). The median increase in score (pre- to post-) was 8.0 for the multimedia group and 6.0 for the text-only group (P = 0.216). Conclusions: An evidence-based, online educational portal can significantly improve and maintain IBD-specific reproductive patient knowledge for more than 6 months.