Hormonal Contraceptives Reduce Active Symptomatic Disease but May Increase Intestinal Inflammation in IBD.

BACKGROUND: Among women of reproductive age with inflammatory bowel disease (IBD), we aimed to assess the relationship of hormonal contraceptives (HCs) with IBD-related symptoms, and intestinal inflammation. METHODS: A nested cohort of women in the longitudinal Manitoba Living with IBD Study, ages 18 to 49, were followed for 1 year, with bi-weekly online surveys. This included a validated measure of disease activity; IBD Symptom Inventory (IBDSI), and stool samples obtained at 3 time-points for assessment of fecal calprotectin (FCAL). Use of HC included oral and vaginal intrauterine devices. Logistic regression analysis was used to assess the association between HC and IBD-related symptoms (IBDSI>14 for Crohn disease, >13 for ulcerative colitis), or inflammation (FCAL>250 ug/g) at any measurement point in the study. RESULTS: Of 71 women, 17 (24%) reported taking HC in the 1 year period. Adjusting for age, disease type, disease duration, and smoking status, the odds of having increased IBD-related symptoms (IBDSI) during the year were lower for women using HC compared with women not using HC [adjusted odds ratio 0.16, 95% CI, 0.02-0.90]. Conversely, women using HC were more likely to have inflammation during the year [adjusted odds ratio 5.7, 95% CI, 1.23-43.6]. CONCLUSIONS: HC use among women with IBD was associated with a lower likelihood of IBD-related symptoms but a higher likelihood of experiencing intestinal inflammation (FCAL>250 ug/g) over 1 year. Further work is needed to examine this dichotomous result, potentially examining aspects such as duration of HC use, and the types of HC.

Urgency for bowel movements is a highly discriminatory symptom of active disease in persons with IBD (the Manitoba Living with IBD study).

BACKGROUND: The Inflammatory Bowel Disease Symptom Inventory (IBDSI) is a validated patient self-reported measure used to assess IBD disease activity. There have yet to be more granular analyses on which symptoms are most associated with active disease. AIMS: To assess the prevalence of symptoms, and to examine which are most associated with disease activity as measured by a symptom index and objective measure of inflammation METHODS: The Manitoba Living with IBD Study is a prospective study of 156 participants with confirmed IBD who completed bi-weekly IBDSI. Relative risks (RR) and predictive values (NPV and PPV) were reported for each symptom to predict active disease defined as active IBDSI, self-reported flare and elevated faecal calprotectin (FCAL) (>250 µg/g). Analyses were undertaken following stratification based on sex, and disease type (Crohn's disease [CD] and ulcerative colitis [UC]). RESULTS: In total, 69.2% were female; 64.7% had CD. Fatigue was the most prevalent symptom in both inactive and active disease, across all three disease measures (IBDSI: 24.5% and 75.1%, self-reported flare: 42.2% and 72.2%, FCAL: 46.0% and 60.6%). The absence of fatigue had a high NPV for active IBDSI and self-reporting a flare in both CD and UC. Urgency had a consistently strong NPV and RR across all three disease measures in both IBD subtypes and sexes. The number of loose/liquid bowel movements predicted elevated FCAL in UC (RR males = 3.5, 95% CI 1.2-9.9, RR females = 1.8, 95% CI 1.2-2.7), as did blood in stool in UC females (RR = 1.8, 95% CI 1.2-2.7). In males with CD, excessive bowel gas (RR = 2.0, 95% CI 1.2-3.4) and urgency (RR = 3.9, 95% CI 1.6-9.3) best predicted an elevated FCAL. No symptom was strongly predictive of an elevated FCAL in CD females. CONCLUSIONS: Urgency was consistently associated with disease activity, irrespective of the disease measure. Fatigue was the most prevalent symptom irrespective of disease activity measure. Individual symptoms have different impacts on subjective (IBDSI) and objective (FCAL) measures in IBD.

Improving Colonoscopy Bowel Preparation and Reducing Patient Anxiety Through Recently Developed Online Information Resource: A Cross-sectional Study.

Introduction: Invasive medical procedures such as colonoscopies can cause psychological distress and anxiety. Mycolonoscopy.ca is a multilanguage website that provides online written and video information (individual items reported in prior publications to be highly rated by patients) regarding preparation and what to expect before, during, and after colonoscopy. Information about how to access the website is included with all colonoscopy appointment materials in Winnipeg, Manitoba. We evaluated the use of mycolonoscopy.ca among patients undergoing colonoscopy and examined the association between visitation to the website and patient outcomes. Methods: A paper-based survey was distributed to patients attending their colonoscopy appointments between 11/2019 and 3/2020. Logistic regression analyses were performed to determine the factors associated with website visitation, procedural worry, and bowel preparation scores. Results: Five hundred and ninety-three surveys were distributed, of which 506 were completed. 17.4% of participants had visited the website before their colonoscopy. Visitors to mycolonoscopy.ca were more likely to consume a split-dose bowel preparation (63.9%) compared with non-visitors (52.5%) (P = 0.006). 31.3% of website visitors were very/extremely worried about their colonoscopy compared with 17.9% of non-visitors. 76.6% of individuals agreed/strongly agreed that visiting the website helped them prepare for their colonoscopy and 69.7% who visited the website agreed/strongly agreed that it helped to reduce their stress/anxiety for the procedure. In multivariable analyses, visitation to website was associated with higher adequate bowel preparation (OR:10.55; 95% CI:1.35 to 82.4). Conclusion: Use of an informative online platform such as mycolonoscopy.ca can help to improve patient education before colonoscopy, reduce worry surrounding the procedure, and improve bowel preparation.

Does severity of spinal cord injury predict likelihood of suffering chronically from severe depression and anxiety?

STUDY DESIGN: Qualitative Survey study. OBJECTIVE: One might assume that those with higher and more complete spinal cord injuries are at higher risk of depression and anxiety. The objective of this study was to assess the association between level and severity of injury with the degree of anxiety and depression in chronic spinal cord injury. SETTING: Spinal Cord Injury Rehabilitation outpatient clinic. METHODS: 49 subjects were recruited from our research database. Time from injury ranged from 6 months to 20+ years. Sample included 23 motor complete and 26 motor incomplete participants; of these 24 were people with paraplegia, 25 were people with tetraplegia. They answered HADS, BDI-FS and PHQ-9 questionnaires. Participants were grouped based on time post injury and then were further divided by motor complete (AIS A/B) and incomplete (AIS C/D) and level (tetraplegia cf. paraplegia). Two-sample t-tests were conducted to evaluate the differences in depression and anxiety scores, between individuals with different completeness and injury type. RESULTS: There were no significant differences amongst the groups tested regarding severity of depression and anxiety, however, those with paraplegia or incomplete injuries had higher but not significantly higher average scores for depression and anxiety. CONCLUSION: We found there were no statistically significant differences in depression and anxiety scores among the groups. These results suggest that all people with SCI may be at similar risk of depression and anxiety, regardless of SCI severity and level.

Clinician based decision tool to guide recommended interval between colonoscopies: development and evaluation pilot study.

BACKGROUND: Optimal intervals between repeat colonoscopies could improve patient outcomes and reduce costs. We evaluated: (a) concordance between clinician and guideline recommended colonoscopy screening intervals in Winnipeg, Manitoba, (b) clinician opinions about the utility of an electronic decision-making tool to aid in recommending screening intervals, and (c) the initial use of a decision-making smartphone/web-based application. METHODS: Clinician endoscopists and primary care providers participated in four focus groups (N = 22). We asked participating clinicians to evaluate up to 12 hypothetical scenarios and compared their recommended screening interval to those of North American guidelines. Fisher's exact tests were used to assess differences in agreement with guidelines. We developed a decision-making tool and evaluated it via a pilot study with 6 endoscopists. RESULT: 53% of clinicians made recommendations that agreed with guidelines in ≤ 50% of the hypothetical scenarios. Themes from focus groups included barriers to using a decision-making tool: extra time to use it, less confidence in the results of the tool over their own judgement, and having access to the information required by the tool (e.g., family history). Most were willing to try a tool if it was quick and easy to use. Endoscopists participating in the tool pilot study recommended screening intervals discordant with guidelines 35% of the time. When their recommendation differed from that of the tool, they usually endorsed their own over the guideline. CONCLUSIONS: Endoscopists are overconfident and inconsistent with applying guidelines in their polyp surveillance interval recommendations. Use of a decision tool may improve knowledge and application of guidelines. A change in practice may require that the tool be coupled with continuing education about evidence for improved outcomes if guidelines are followed.

Self-reported flares among people living with inflammatory bowel disease are associated with stress and worry but not associated with recent diet changes: The Manitoba Living with IBD Study.

BACKGROUND: In this matched case-control longitudinal study among people living with inflammatory bowel disease (IBD), we investigated beliefs about what triggers a flare. METHODS: Adults with confirmed IBD and active disease within 2 years were enrolled in the Manitoba Living with IBD Study and followed biweekly with online surveys for 1 year. The 7-point IBD Symptom Change Indicator was used for participant identification of a flare. Flare cases were matched to non-flare controls by sex and disease type. Members of each matched pair completed supplementary information on diet changes and psychological functioning in the previous 2 weeks and provided stool samples to assess fecal calprotectin (FCAL). RESULTS: Of 128 enrolled participants, 95 matched flare/non-flare pairs were created. Those reporting a flare were more likely to have elevated FCAL (51% vs 34% among non-flares, P = 0.043). Although 61% of study participants believed at baseline that a food may trigger flares, and 25% of those in a flare believed that a food may have triggered their current flare, there was no difference in consumption of assessed foods between flares and non-flares in the previous 2 weeks. Patients with flares were more likely to be having difficulties in emotional state than controls (40% vs 18%, P = 0.001) and more likely to be stressed or worried (64% vs 33%, P = 0.001). CONCLUSION: Although a majority of individuals with IBD believe that specific foods trigger their disease flares, this was not supported by the current findings. Recent psychological functioning was associated with self-reported IBD flare.

The association of efficacy, optimism, uncertainty and health anxiety with inflammatory bowel disease activity.

OBJECTIVE: Positive and negative psychological attributes have been shown to influence disease outcomes in many chronic health conditions. We aimed to evaluate the association between self-efficacy, optimism, health anxiety and intolerance of uncertainty and disease activity in inflammatory bowel disease (IBD). METHODS: Adults with confirmed and recently active IBD enrolled in a prospective cohort study. Demographics, disease information, validated measures of psychological functioning related to general self-efficacy, optimism, health anxiety and intolerance of uncertainty were collected at baseline, week 26 and week 52. Clinical disease activity was assessed using the Inflammatory Bowel Disease Symptom Inventory (IBDSI), self-reported flares, and intestinal inflammation using fecal calprotectin (FCAL), collected at baseline, weeks 26 and 52. Generalized estimating equations were used to test the association between psychological functioning and disease activity. RESULTS: Participants' (n = 154) mean age was 43.4 years (SD 12.5), 69.5% were women and 64.1% had Crohn's disease. Adjusting for demographic variables, higher self-efficacy was associated with lower likelihood of flare by self-report (odds ratio [OR] 0.80, 95% confidence interval [CI] 0.71, 0.91) and IBDSI (OR 0.89, 95% CI 0.80, 0.99), while higher health anxiety was associated with greater likelihood of flare by self-report (OR 1.07, 95% CI 1.01, 1.18) and higher symptomatic disease activity (IBDSI; OR 1.14, 95% CI 1.05, 1.24). The psychological attributes were not significantly associated with active disease as measured by inflammation (FCAL). CONCLUSION: General self-efficacy and health anxiety are relevant in understanding patient experience with disease activity, and may be appropriate targets for psychological intervention in the care of individuals with IBD.

What Is a Flare? The Manitoba Living With IBD Study.

BACKGROUND: Flare is a poorly defined term used by patients and clinicians to indicate inflammatory bowel disease (IBD) status. This study aimed to evaluate the validity of a single-item 7-point flare indicator relative to other measures of disease flare. METHODS: The longitudinal Manitoba Living with IBD Study followed persons with IBD for 1 year; they completed biweekly online surveys and provided 3 stool samples. Disease flare on a single-item flare indicator with 7 possible responses developed for the study was defined by report of symptoms as "moderately" or "much" worse. The flare indicator was evaluated against 5 measures of disease activity: fecal calprotectin score (FCAL), a 2-point disease status indicator, a 4-point flare certainty indicator, the IBD Symptom Index short form (SIBDSI), and the short form IBD Questionnaire (SIBDQ). Participants in a flare, based on the 7-point measure, were matched to a nonflaring participant, and a stool sample was collected. RESULTS: Of the 155 IBD participants, almost half (n = 74) experienced a flare. Of those who flared, 97.0% endorsed active IBD on the 2-point indicator (controls 42.5%; P < .001); 91.9% endorsed active IBD on the 4-point certainty indicator (controls 32.9%; P < .001); 90.5% endorsed active disease on the SIBDSI (controls 34.2%; P < .001); and 48.5% had an elevated FCAL (controls 34.3%; P < .05). The mean SIBDQ was lower for the flare group compared with controls (43.9 [SD 11.1] vs 58.3 [SD 8.5]; P < .001), indicating worse disease. CONCLUSIONS: The 7-point flare indicator robustly identified symptomatic flares. This patient self-report indicator reflected meaningful changes in more complex clinical indices and had only weak concordance with the presence of inflammation.

IBD Disability Index Is Associated With Both Direct and Indirect Costs of Inflammatory Bowel Disease.

INTRODUCTION: We aimed to determine both direct (medical) and indirect (lost wages) costs of IBD and the association between the degree of IBD-related disability and extent of IBD-related costs. METHODS: Persons age 18-65 from the population-based University of Manitoba IBD Research Registry completed a survey including the IBD Disability Index (IBDDI) and questions related to employment, missed work (absenteeism), and reduced productivity at work (presenteeism). Administrative health data including surgeries, hospitalizations, physician claims, and prescriptions were linked to the survey and assessed. To calculate annual wage loss, number of days of missed work was multiplied by the average wage in Manitoba for the given occupation per Statistics Canada. Costs were adjusted to 2016-17 Canadian dollars. Using descriptive and regression analysis, we explored the association between IBDDI and annual direct and indirect costs associated with IBD. RESULTS: Average annual medical costs rose from $1918 among those with IBDDI 0-4 to $9,993 among those with IBDDI 80-86. Average annual cost of lost work rose from $0 among those with IBDDI 0-4 to $30,101 among those with IBDDI 80-86. Using linear regression, each additional unit of IBDDI was associated with an increase of $77 in annual medical cost (95% CI, $52-102; P < .001) and an increase of $341 in annual cost of lost wages (95% CI, $288-395; P < .001). CONCLUSIONS: Costs related to IBD are significantly associated with the degree of IBD-related disability. Among the approximate 30% of the IBD population with IBDDI scores ≥40, the indirect costs of absenteeism and presenteeism accounts for ~75% of the total IBD-related costs.

Costs related to IBD (both direct and indirect) are significantly associated with the degree of IBD-related disability. Among the approximately 30% of the IBD population with IBDDI scores ≥40, the indirect costs of absenteeism and presenteeism accounts for ~75% of the total IBD-related costs.

The complex relationship between diet, symptoms, and intestinal inflammation in persons with inflammatory bowel disease: The Manitoba Living With IBD Study.

BACKGROUND: We aimed to examine whether an association exists between diet quality, based on the Prospective Urban Rural Epidemiology (PURE) Healthy Diet Score (HDS), and active inflammatory bowel disease (IBD). METHODS: Participants were drawn from the Manitoba Living With IBD Study cohort. The Harvard Food Frequency Questionnaire (FFQ) was used to calculate the HDS at two time points: baseline and 1-year follow-up. Using generalized estimating equations (GEE) logistic regression, we assessed the association between the HDS and (1) the IBD Symptom Inventory (IBDSI); (2) intestinal inflammation, measured by fecal calprotectin (FCAL); and (3) self-reported IBD flares. RESULTS: There were 294 completed FFQs among 153 people. Of these, 100% had completed data about an IBD flare, 98% had FCAL measurements, and 96% had completed IBDSI scores. On a HDS scoring method of 0-8, the odds of FCAL >250 mcg/g were lower for participants with a HDS of 4 vs 0-3 (adjusted odds ratio [OR], 0.38; 95% CI, 0.19-0.77). When applying a second HDS scoring method (8-40), the odds of having an IBD flare were 3.6 times greater with a HDS between 21 and 24 compared with an HDS ≤20 (adjusted OR, 3.63; 95% CI, 1.03-12.78). CONCLUSIONS: We found that active inflammation was less likely among those with a moderate HDS , whereas symptomatic IBD flares were more likely. People may choose to consume a moderate amount of healthy foods such as fruits and vegetables, even knowing that those foods may cause a symptomatic flare.

Relaxation of social distancing restrictions: Model estimated impact on COVID-19 epidemic in Manitoba, Canada.

OBJECTIVES: The unprecedented worldwide social distancing response to COVID-19 resulted in a quick reversal of escalating case numbers. Recently, local governments globally have begun to relax social distancing regulations. Using the situation in Manitoba, Canada as an example, we estimated the impact that social distancing relaxation may have on the pandemic. METHODS: We fit a mathematical model to empirically estimated numbers of people infected, recovered, and died from COVID-19 in Manitoba. We then explored the impact of social distancing relaxation on: (a) time until near elimination of COVID-19 (< one case per million), (b) time until peak prevalence, (c) proportion of the population infected within one year, (d) peak prevalence, and (e) deaths within one year. RESULTS: Assuming a closed population, near elimination of COVID-19 in Manitoba could have been achieved in 4-6 months (by July or August) if there were no relaxation of social distancing. Relaxing to 15% of pre-COVID effective contacts may extend the local epidemic for more than two years (median 2.1). Relaxation to 50% of pre-COVID effective contacts may result in a peak prevalence of 31-38% of the population, within 3-4 months of initial relaxation. CONCLUSION: Slight relaxation of social distancing may immensely impact the pandemic duration and expected peak prevalence. Only holding the course with respect to social distancing may have resulted in near elimination before Fall of 2020; relaxing social distancing to 15% of pre-COVID-19 contacts will flatten the epidemic curve but greatly extend the duration of the pandemic.

Determining the influence of the Workers Compensation Board of Manitoba's opioid policy on prescription opioid use amongst WCB recipients.

BACKGROUND: Opioid medications are commonly used by Workers Compensation Board (WCB) claimants following workplace injuries. The purpose of this study is to describe the impact of an opioid management policy on opioid prescriptions amongst a WCB-covered population compared to changes in the use of these medications in the general population of a Canadian province. METHODS: We linked WCB claims data from 2006 to 2016 (13,155 claims, 11,905 individuals) to Manitoba provincial health records and compared opioid use amongst this group to 478,606 individuals aged 18-65. Linear regression was performed to examine the change over time in number of individuals being prescribed opioids for various durations and dosages of 50 or more, and 120 or more morphine equivalents (ME)/day for both the WCB and Manitoba population. RESULTS: WCB claimants totaled 2.5% of Manitoba residents aged 18-65 who were prescribed opioids for non-cancer pain. After the introduction of the opioid use policy for the WCB population in November 2011, the number of people prescribed opioids declined 49.4% in the WCB group, while increasing 10.8% in the province as a whole. The number of individuals using 50 ME/day or more declined 43.1% in the WCB group and increased 5.8% in the province. CONCLUSIONS: Opioid management programs organized by a compensation board can lead to a substantial reduction in the prescription of opioid medications to a WCB client population, including individuals who were prescribed higher doses of these medications when compared with general trends in the community.

Utility of the MARS-5 in Assessing Medication Adherence in IBD.

INTRODUCTION: We aimed to validate the Medication Adherence Report Scale-5 (MARS-5) as a tool for assessing medication adherence in inflammatory bowel disease (IBD) and to determine predictors of medication adherence. METHODS: One hundred twelve (N = 112) adults with confirmed IBD participating in the longitudinal Manitoba Living With IBD Study were eligible. Demographics, IBD type, surgeries, disease activity (using the Inflammatory Bowel Disease Symptom Inventory and fecal calprotectin levels), perceived stress, and medication use were collected biweekly through online surveys. The MARS-5 scores were obtained at baseline and at 1 year. Correlation between medication monitoring data and MARS-5 scores was performed and the optimal MARS-5 cutoff point for adherence assessment determined. Predictors of medication adherence were assessed at both ≥90% and ≥80%. RESULTS: Participants were predominantly female (71.4%), mean age was 42.9 (SD = 12.8), and the majority (67.9%) had Crohn disease (CD). Almost half (46.4%) were taking more than 1 IBD medication, with thiopurines (41.9%) and biologics (36.6%) the most common. Only 17.9% (n = 20) were nonadherent at a <90% level; of those, 90% (n = 18) were using oral medications. The MARS-5 was significantly associated with adherence based on medication monitoring data at baseline (r = 0.48) and week 52 (r = 0.57). Sensitivity and specificity for adherence ≥80% and ≥90% were maximized at MARS-5 scores of >22 and >23, respectively. Having CD (OR = 4.62; 95% confidence interval, 1.36-15.7) was the only significant predictor of adherence. CONCLUSION: MARS-5 is a useful measure to evaluate adherence in an IBD population. In this highly adherent sample, disease type (CD) was the only predictor of medication adherence.

Association Between Change in Inflammatory Aspects of Diet and Change in IBD-related Inflammation and Symptoms Over 1 Year: The Manitoba Living With IBD Study.

BACKGROUND: We aimed to investigate (1) the stability of inflammatory aspects of diet over 1 year among persons with inflammatory bowel disease (IBD) and (2) the impact of change in diet on changes in inflammation and IBD symptoms over 1 year. METHODS: Participants were recruited to the Manitoba Living with IBD Study and completed the Harvard Food Frequency Questionnaire (FFQ). The Dietary Inflammatory Index (DII) and the Empirical Dietary Inflammatory Index (EDII) were used to calculate the inflammatory potential of the diet. Inflammation was measured by fecal calprotectin (≥250 µg/g). Symptoms were measured by the IBD Symptom Inventory (IBDSI). All measures were obtained at baseline and 1 year. Dietary Inflammatory Index and Empirical Dietary Inflammatory Index scores >0 and <0 reflect pro- and anti-inflammatory diet, respectively. Variance components analyses were used to describe diet stability. Associations between changes in diet and changes in active inflammation and symptoms were assessed using ordinal logistic regression and multilevel linear regression modeling. RESULTS: One hundred thirty-five participants (66% CD) were included. Approximately one third of the variance in EDII (36%) and DII (33%) scores was explained by changes in diet over time. Each unit increase in the change in EDII (baseline to follow-up) was associated with a greater odds of FCAL, indicating active inflammation (>250 µg/g; odds ratio, 3.1; 95% confidence interval [CI], 1.02-9.93; P = 0.04) and with a rise in IBDSI of 6.7 (95% CI, 1.0-12.4; P = 0.022; theoretical IBDSI range, 0-81). There was no association between changes in DII and changes in FCAL or IBDSI. CONCLUSION: The EDII, but not the DII, may have utility to identify the inflammatory potential of diet. This inflammatory potential can contribute to inflammation and/or disease symptoms in persons with IBD.

An International Multicenter Comparison of IBD-Related Disability and Validation of the IBDDI.

BACKGROUND: The IBD disability index (IBDDI) has been shown to be valid and reliable. We compared the distributional and predictive properties of the IBDDI, when collected from five populations of people living with IBD- from Winnipeg, Chicago, Toronto, Hong Kong, and Jerusalem. METHODS: People with IBD from five jurisdictions were invited to complete a survey including the IBDDI, the World Health Organization Disability Assessment Scale, the Work and Social Adjustment Scale, the IBDQ, the Kessler-6 distress scale, and the Stanford presenteeism scale. Between sites, we compared the correlation between IBDDI and the other 4 measures of disability/quality of life/distress, and the association between IBDDI and presenteeism and having been hospitalized in the past year. RESULTS: There were 1121 participants from Winnipeg, 511 from Chicago, 147 from Toronto, 97 from Hong Kong, and 96 from Jerusalem. The majority had Crohn's disease. Although the mean IBDDI score varied by site, the correlation between IBDDI and each of the other 4 measures of disability/QOL/distress was nearly identical. Similarly, the regression coefficient showing the association between IBDDI and presenteeism was nearly identical in all sites, and the risk ratios showing the association between hospitalization and high IBDDI was similar in all sites. CONCLUSION: The correlation between IBDDI and different measures of disability/QOL/distress was similar across all sites. There is strong evidence of the association between IBD-related disability and presenteeism, and between hospitalization and high IBD-related disability, and that the associations are the same across different populations. The severity of disability that an individual with a given IBDDI score has is directly comparable across populations.

Ipilimumab-Induced Enterocolitis: A Systematic Review and Meta-Analysis.

INTRODUCTION: Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE: We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS: We searched MEDLINE, EMBASE, CENTRAL, the World Health Organization International Clinical Trials Registry, and conference proceedings. We included: (1) randomized controlled trials comparing ipilimumab administration with placebo/standard care/other active chemotherapy regimens and (2) prospective observational studies. Separate meta-analyses were performed for randomized controlled trials and observational studies. RESULTS: Of 4760 records, we included ten unique randomized controlled trials (n = 5814 subjects) and 34 unique prospective observational studies (n = 3699 subjects). In randomized controlled trials, the pooled relative risk of ≥ grade 3 enterocolitis or ≥ grade 3 diarrhea associated with ipilimumab was 13.31 (95% confidence interval 6.01-29.48, I2 = 0%, ten trials) and 6.72 (95% confidence interval 3.30-13.65, I2 = 63%, ten trials), respectively. In observational studies, the 3-monthly risk of developing grade 3 or higher enteritis, colitis, or enterocolitis was 4% (95% confidence interval 3-7, I2 = 77.40%, 25 studies). Randomized controlled trials and observational studies did not distinguish between acute and chronic enterocolitis. Of the included observational studies, the pooled risk of incurring small bowel involvement associated with ipilimumab was 1% (95% CI 0-4, I2 = 0%, four studies) per every 3-month time period. CONCLUSIONS: Insufficient data exist to quantify or distinguish the risk of acute vs chronic enterocolitis following ipilmumab use. Because of the serious impact of chronic enterocolitis on quality of life and further cancer treatment, future trials evaluating the safety of immunotherapy should report gastrointestinal events in greater detail.

Incidence of Adverse Psychiatric Events During Treatment of Inflammatory Bowel Disease With Biologic Therapies: A Systematic Review.

We conducted a systematic review and a fixed-effects meta-analysis to determine whether incident adverse psychiatric events (APE) including depression, anxiety, psychosis, or suicide were associated with biologic therapy in IBD. Six randomized controlled trials and a cohort study met criteria, reporting an incidence of APE in 4,882 patients. The risk difference per 100 person-months of any APE with a biologic medication was 0.01 (95% confidence interval = 0.00-0.02). There was insufficient evidence available in randomized controlled trials to conclude that biologic therapy in IBD is associated with an increased incidence of APE.

Breakthrough spikes in rapid eye movement sleep from the epilepsy monitoring unit are associated with peak seizure frequency.

STUDY OBJECTIVES: Rapid eye movement sleep (REM) usually suppresses interictal epileptiform discharges (IED) and seizures. However, breakthrough IEDs in REM sometimes continue. We aimed to determine if the amount of IED and seizures in REM, or REM duration, is associated with clinical trajectories. METHODS: Continuous electroencephalogram (EEG) recordings from the epilepsy monitoring unit (EMU) were clipped to at least 3 h of concatenated salient findings per day including all identified REM. Concatenated EEG files were analyzed for nightly REM duration and the "REM spike burden" (RSB), defined as the proportion of REM occupied by IED or seizures. Patient charts were reviewed for clinical data, including patient-reported peak seizure frequency. Logistic and linear regressions were performed, as appropriate, to explore associations between two explanatory measures (duration of REM and RSB) and six indicators of seizure activity (clinical trajectory outcomes). RESULTS: The median duration of REM sleep was 43.3 (IQR 20.9-73.2) min per patient per night. 59/63 (93.7%) patients achieved REM during EMU admission. 39/59 (66.1%) patients had breakthrough IEDs or seizures in REM with the median RSB at 0.7% (IQR 0%-8.4%). Every 1% increase in RSB was associated with 1.69 (95% CI = 0.47-2.92) more seizures per month during the peak seizure period of one's epilepsy (p = 0.007). CONCLUSIONS: Increased epileptiform activity during REM is associated with increased peak seizure frequency, suggesting an overall poorer epilepsy trajectory. Our findings suggest that RSB in the EMU is a useful biomarker to help guide about what to expect over the course of one's epilepsy.

Utility of fecal immunochemical test vs guaiac fecal occult blood test for assessment of gastrointestinal bleed in hospitalized patients.

BACKGROUND: Guaiac fecal occult blood testing (gFOBT) is often used "off-label" for gastrointestinal (GI) bleeding. Fecal Immunochemical Test (FIT) is increasingly replacing gFOBT in colorectal cancer screening and may play a role in assessment for significant bowel disease. We examined the concordance of FIT with gFOBT (Hemoccult Sensa II) among inpatients and between day 1 and day 3 gFOBT results. METHODS: FIT was performed alongside gFOBT on all inpatient stool sent for occult blood to the Winnipeg Health Sciences Centre laboratory over 1 y. gFOBT was performed on days 1 and 3 post stool collection, while FIT was performed on day 1 only. RESULTS: Positivity rates were highest for Day 1 gFOBT (27.7%), and lowest for FIT (18.3%). Concordance between FIT and Days 1 and 3 gFOBT for negative test results (96.4% and 94.1%) was significantly higher than that expected by chance alone (58.7% and 61.3%, P < .001). Similarly, concordance for positive test results (55.8% and 55.6%) was significantly higher as well as for days 1 and 3 gFOBT results. CONCLUSIONS: We found no benefit in delayed testing for 3 days post collection. FIT provides equivalent results to gFOBT in hospitalized patients.

Information experiences, needs, and preferences of colonoscopy patients: A pre-colonoscopy survey.

Better pre-colonoscopy education may lead to improved bowel preparation, decreased anxiety, and a willingness to go direct-to-colonoscopy. We assessed information experiences, needs, and preferences of patients undergoing colonoscopy.A self-administered survey was distributed between 08/2015 and 06/2016 to patients in Winnipeg, Canada when they attended an outpatient colonoscopy. The amount, type, helpfulness, and satisfaction with information provided were analyzed. Linear and logistic regression analyses were used to assess predictors of satisfaction with various aspects of the information received, as well as overall satisfaction with the provided information.Although the majority of the 1580 respondents were satisfied with the information they received, only 68% of respondents coming for a repeat colonoscopy and 59% of those coming for first colonoscopy perceived receiving just the right amount of information from their endoscopy doctor. One quarter or less of the respondents indicated they received just the right amount of information from any source other than their colonoscopy doctor. 38% coming for a first colonoscopy and 44% coming for a repeat colonoscopy indicated they received no information from their family physician. Those coming for their first colonoscopy had a lower average score (9.7 vs 11.1; P < .001) for amount of information received (scale 0-15), were less satisfied with the information they received (P = .005) and found the information to be less clear (P = .004).Many patients going for colonoscopy in a large urban practice are inadequately informed about the various aspects of the procedure and it is worse for those going for first rather than repeat colonoscopy.