A Novel Decision Aid Improves Quality of Reproductive Decision-Making and Pregnancy Knowledge for Women with Inflammatory Bowel Disease.

BACKGROUND: Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowledge experience more childlessness and fear of IBD medications in pregnancy. The Pregnancy in IBD Decision Aid (PIDA), developed by an international multidisciplinary team, offers personalized online decision support regarding pregnancy in IBD. AIMS: Assess the impact of PIDA on quality of reproductive decision-making and pregnancy-related knowledge among preconception (PC) and pregnant patients with IBD, and evaluate acceptability to patients and clinicians. METHODS: PC and pregnant patients with IBD aged 18-45 completed questionnaires pre- and post-PIDA to assess quality of decision-making (Decisional Conflict Scale (DCS); Decision Self-Efficacy Scale (DSES) and IBD-in-pregnancy knowledge (Crohn's and Colitis Pregnancy Knowledge Score (CCPKnow)). Paired t test assessed for differences pre- and post-PIDA. Patients and clinicians completed acceptability surveys. RESULTS: DCS and DSES were completed by 74 patients (42 Crohn's disease, 32 ulcerative colitis); 41 PC and 33 pregnant. DCS improved significantly post-PIDA in PC patients regarding pregnancy planning (t(40) = 4.83, p < 0.0001, Cohen's dz = 0.75) and in pregnant patients regarding medication management (t(32) = 2.37, p = 0.0242, dz = 0.41). DSES for PC patients improved significantly post-PIDA (t(40) = -3.56, p = 0.001, dz = -0.56). CCPKnow improved significantly post-PIDA in PC (t(42) = 4.93, p < 0.0001, dz = -0.75) and pregnant patients (t(32) = 5.1, p < 0.0001, dz = -0.89). PIDA was deemed optimal for length, readability, and content amount and considered highly useful by patients (n = 73) and clinicians (n = 14). CONCLUSIONS: Patients using PIDA developed an improved quality of reproductive decision-making and IBD-in-pregnancy knowledge. PIDA is an accessible tool that can empower women with IBD to make values-congruent, evidence-based decisions regarding pregnancy and may reduce voluntary childlessness.

Shared decision making in pregnancy in inflammatory bowel disease: design of a patient orientated decision aid.

BACKGROUND: Research has indicated a lack of disease-specific reproductive knowledge among patients with Inflammatory Bowel Disease (IBD) and this has been associated with increased "voluntary childlessness". Furthermore, a lack of knowledge may contribute to inappropriate medication changes during or after pregnancy. Decision aids have been shown to support decision making in pregnancy as well as in multiple other chronic diseases. A published decision aid for pregnancy in IBD has not been identified, despite the benefit of pre-conception counselling and patient desire for a decision support tool. This study aimed to develop and test the feasibility of a decision aid encompassing reproductive decisions in the setting of IBD. METHODS: The International Patient Decision Aid Standards were implemented in the development of the Pregnancy in IBD Decision Aid (PIDA). A multi-disciplinary steering committee was formed. Patient and clinician focus groups were conducted to explore themes of importance in the reproductive decision-making processes in IBD. A PIDA prototype was designed; patient interviews were conducted to obtain further insight into patient perspectives and to test the prototype for feasibility. RESULTS: Issues considered of importance to patients and clinicians encountering decisions regarding pregnancy in the setting of IBD included fertility, conception timing, inheritance, medications, infant health, impact of surgery, contraception, nutrition and breastfeeding. Emphasis was placed on the provision of preconception counselling early in the disease course. Decisions relating to conception and medications were chosen as the current focus of PIDA, however content inclusion was broad to support use across preconception, pregnancy and post-partum phases. Favourable and constructive user feedback was received. CONCLUSIONS: The novel development of a decision aid for use in pregnancy and IBD was supported by initial user testing.

A Randomized Trial Comparing High Definition Colonoscopy Alone With High Definition Dye Spraying and Electronic Virtual Chromoendoscopy for Detection of Colonic Neoplastic Lesions During IBD Surveillance Colonoscopy.

OBJECTIVES: Dye spraying chromoendoscopy (DCE) is recommended for the detection of colonic neoplastic lesions in inflammatory bowel disease (IBD). The majority of neoplastic lesions are visible endoscopically and therefore targeted biopsies are appropriate for surveillance colonoscopy. To compare three different techniques for surveillance colonoscopy to detect colonic neoplastic lesions in IBD patients: high definition (HD), (DCE), or virtual chromoendoscopy (VCE) using iSCAN image enhanced colonoscopy. METHODS: A randomized non-inferiority trial was conducted to determine the detection rates of neoplastic lesions in IBD patients with longstanding colitis. Patients with inactive disease were enrolled into three arms of the study. Endoscopic neoplastic lesions were classified by the Paris classification and Kudo pit pattern, then histologically classified by the Vienna classification. RESULTS: A total of 270 patients (55% men; age range 20-77 years, median age 49 years) were assessed by HD (n=90), VCE (n=90), or DCE (n=90). Neoplastic lesion detection rates in the VCE arm was non-inferior to the DCE arm. HD was non-inferior to either DCE or VCE for detection of all neoplastic lesions. In the lesions detected, location at right colon and the Kudo pit pattern were predictive of neoplastic lesions (OR 6.52 (1.98-22.5 and OR 21.50 (8.65-60.10), respectively). CONCLUSIONS: In this randomized trial, VCE or HD-WLE is not inferior to dye spraying colonoscopy for detection of colonic neoplastic lesions during surveillance colonoscopy. In fact, in this study HD-WLE alone was sufficient for detection of dysplasia, adenocarcinoma or all neoplastic lesions.

The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy.

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.

Targeted Biopsies Identify Larger Proportions of Patients With Colonic Neoplasia Undergoing High-Definition Colonoscopy, Dye Chromoendoscopy, or Electronic Virtual Chromoendoscopy.

BACKGROUND & AIMS: It is unclear what are the best and most appropriate endoscopic procedures for detecting colonic neoplasia in patients with long-term colonic inflammatory bowel disease (IBD). Dye chromoendoscopy (DCE) is the standard used in IBD surveillance colonoscopies. However, studies are needed to determine the optimal endoscopic technique for detecting dysplastic lesions. We investigated current practices used in surveillance colonoscopies by IBD gastroenterologists at a single tertiary center. We also determined the rate of neoplasia detection among different surveillance endoscopic techniques in an analysis of random or targeted biopsies. METHODS: We collected data on 454 patients with IBD (54.5% male; mean age, 50 y; mean disease duration, 14.5 y; 55.9% with ulcerative colitis, 42.7% with Crohn's disease, and 1.3% with indeterminate colitis) who underwent surveillance colonoscopy from April 2011 through March 2014 at the University of Calgary in Canada. Subjects were examined using white-light standard-definition endoscopy (WLE), high-definition (HD) colonoscopy, virtual electronic chromoendoscopy (VCE), or DCE; random or targeted biopsy specimens were collected. Endoscopic and histologic descriptions with suspected neoplasia were recorded. Rates of neoplasia detection by the different endoscopic procedures were compared using chi-square analysis. RESULTS: Of the patients analyzed, 27.7% had WLE endoscopy with random collection of biopsy specimens, 27.3% had HD colonoscopy with random collection of biopsy specimens, 14.1% had VCE with random collection of biopsy specimens, 0.9% had DCE with random collection of biopsy specimens, 12.8% had HD colonoscopy with collection of targeted biopsy specimens, 11.9% had VCE with collection of targeted biopsy specimens, and 5.3% had DCE with collection of targeted biopsy specimens. Neoplastic lesions were detected in 8.2% of the procedures performed in the random biopsy group (95% confidence interval, 5.6-11.7) and 19.1% of procedures in the targeted biopsy group (95% confidence interval, 13.4-26.5) (P < .001). Neoplasias were detected in similar proportions of patients by HD colonoscopy, VCE, or DCE, with targeted biopsy collection. CONCLUSIONS: In a large cohort of IBD patients undergoing surveillance colonoscopy, targeted biopsies identified greater proportions of subjects with neoplasia than random biopsies. Targeted collection of biopsy specimens appears to be sufficient for detecting colonic neoplasia in patients undergoing HD colonoscopy, DCE, or VCE, but not WLE.

Postoperative Mortality Among Patients With Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis of Population-Based Studies.

BACKGROUND & AIMS: There have been varying reports of mortality after intestinal resection for the inflammatory bowel diseases (IBDs). We performed a systematic review and meta-analysis of population-based studies to determine postoperative mortality after intestinal resection in patients with IBD. METHODS: We searched Medline, EMBASE, and PubMed, from 1990 through 2015, to identify 18 articles and 3 abstracts reporting postoperative mortality among patients with IBD. The studies included 67,057 patients with ulcerative colitis (UC) and 75,971 patients with Crohn's disease (CD), from 15 countries. Mortality estimates stratified by emergent and elective surgeries were pooled separately for CD and UC using a random-effects model. To assess changes over time, the start year of the study was included as a continuous variable in a meta-regression model. RESULTS: In patients with UC, postoperative mortality was significantly lower among patients who underwent elective (0.7%; 95% confidence interval [CI], 0.6%-0.9%) vs emergent surgery (5.3%; 95% CI, 3.8%-7.4%). In patients with CD, postoperative mortality was significantly lower among patients who underwent elective (0.6%; 95% CI, 0.2%-1.7%) vs emergent surgery (3.6%; 95% CI, 1.8%-6.9%). Postoperative mortality did not differ for elective (P = .78) or emergent (P = .31) surgeries when patients with UC were compared with patients with CD. Postoperative mortality decreased significantly over time for patients with CD (P < .05) but not UC (P = .21). CONCLUSIONS: Based on a systematic review and meta-analysis, postoperative mortality was high after emergent, but not elective, intestinal resection in patients with UC or CD. Optimization of management strategies and more effective therapies are necessary to avoid emergent surgeries.

Funding a smoking cessation program for Crohn's disease: an economic evaluation.

OBJECTIVES: Patients with Crohn's disease (CD) who smoke are at a higher risk of flaring and requiring surgery. Cost-effectiveness studies of funding smoking cessation programs are lacking. Thus, we performed a cost-utility analysis of funding smoking cessation programs for CD. METHODS: A cost-utility analysis was performed comparing five smoking cessation strategies: No Program, Counseling, Nicotine Replacement Therapy (NRT), NRT+Counseling, and Varenicline. The time horizon for the Markov model was 5 years. The health states included medical remission (azathioprine or antitumor necrosis factor (anti-TNF), dose escalation of an anti-TNF, second anti-TNF, surgery, and death. Probabilities were taken from peer-reviewed literature, and costs (CAN$) for surgery, medications, and smoking cessation programs were estimated locally. The primary outcome was the cost per quality-adjusted life year (QALY) gained associated with each smoking cessation strategy. Threshold, three-way sensitivity, probabilistic sensitivity analysis (PSA), and budget impact analysis (BIA) were carried out. RESULTS: All strategies dominated No Program. Strategies from most to least cost effective were as follows: Varenicline (cost: $55,614, QALY: 3.70), NRT+Counseling (cost: $58,878, QALY: 3.69), NRT (cost: $59,540, QALY: 3.69), Counseling (cost: $61,029, QALY: 3.68), and No Program (cost: $63,601, QALY: 3.67). Three-way sensitivity analysis demonstrated that No Program was only more cost effective when every strategy's cost exceeded approximately 10 times their estimated costs. The PSA showed that No Program was the most cost-effective <1% of the time. The BIA showed that any strategy saved the health-care system money over No Program. CONCLUSIONS: Health-care systems should consider funding smoking cessation programs for CD, as they improve health outcomes and reduce costs.

The Fundamentals of Inflammatory Bowel Disease Management in Pregnancy: A Practical Review for the Gastroenterologist.

This narrative review explores the management of Inflammatory Bowel Disease (IBD) during pregnancy, emphasizing its unique challenges to maternal and fetal health, particularly within the Canadian Gastroenterology setting. Seven key principles are highlighted: 1) Preconception counselling, aiming for steroid-free remission confirmed by objective markers, should be routine for female IBD patients. 2) Medication safety, with an eye to future pregnancies, should be addressed upon initiation. Methotrexate and small molecules are contraindicated during pregnancy, while most 5-ASA therapies, biologics, and thiopurines can be continued throughout pregnancy and breastfeeding. Steroids, though not without risks, can be utilized if necessary. 3) Routine monitoring during remission should include serum biomarkers and fecal calprotectin each trimester. 4) Routine endoscopy and imaging are not required, but if indicated, lower GI endoscopy, ultrasound, and unenhanced MRI can be used. Computed tomography and gadolinium enhanced MRI should be avoided. 5) Caesarean section is advised for patients with previous ileal pouch surgeries or active perianal disease, but other patients should follow obstetric indications for delivery. 6) Postpartum period may see more active disease, requiring continued monitoring. Breastfeeding is encouraged, and routine childhood vaccinations are advised, but live vaccinations in the first 6 months warrant detailed review. 7) Complex IBD patients may benefit from a multidisciplinary approach with robust communication between gastroenterologists and obstetricians.

High-definition chromoendoscopy results in more significant dysplasia detection than white light endoscopy with random biopsies in ulcerative colitis patients: A single-center retrospective study.

The goal of this study was to determine whether high-definition white light endoscopy with random biopsies (HD-WLR) or chromoendoscopy (HDCE) yielded a higher dysplasia detection rate in ulcerative colitis patients. Ulcerative colitis (UC) patients have a 2.4-fold increased future risk of developing colorectal cancer compared to the general population and require careful dysplasia screening modalities. Both HD-WLR and HDCE are regularly used, and recent guidelines do not suggest a preference. UC patients who underwent dysplasia surveillance at our site between January 2019 and 2021 were retrospectively reviewed. We calculated the dysplasia detection rate of both techniques at the first CRC screening colonoscopy. Eighteen dysplastic lesions were detected in total, 3 by HD-WLR and fifteen by HDCE. Dysplasia was detected in 4% (3/75) and 20% (15/75) of UC patients by HD-WLR and HDCE respectively, with significantly fewer biopsies (4.44 ±â€…4.3 vs 29.1 ±â€…13.0) required using the former. HD-WLR detected 2 polypoid and one non-polypoid lesion, while HDCE detected eleven polypoid and 4 non-polypoid lesions. No invisible dysplasia or colorectal cancer was detected. Screening was performed at 10.8 ±â€…4.8 and 9.72 ±â€…3.05 years following UC diagnosis for HDCE and HD-WLR respectively. Median withdrawal time was 9.0 ±â€…2.7 minutes (HD-WLR) vs 9.6 + 3.9 minutes (HDCE). HDCE is associated with higher dysplasia detection rates compared to HD-WLR in a UC patient population. Given the former technique is less tedious and costly, our findings complement existing studies that suggest HDCE may be considered over HD-WLR for UC dysplasia surveillance.

Thiopurine Exposure During Pregnancy is Not Associated With Anemia in Infants Born to Mothers With IBD.

Background: Thiopurines are commonly used to treat inflammatory bowel disease (IBD). Thiopurines are considered safe throughout pregnancy. However, a published study suggested the risk of neonatal anemia was increased if exposed to thiopurines in utero. This prospective cohort study aimed to determine if there is an increased risk of cytopenia among infants born to pregnant people with IBD, exposed or unexposed to thiopurines, compared to infants born to those without IBD. Methods: Pregnant IBD patients, with and without thiopurine exposure, and one cohort of control individuals were recruited over a 5-year period. Consenting individuals completed a questionnaire and infants had a complete blood cell count at the newborn heel prick. Anemia was defined as hemoglobin (Hb) < 140g/L. Descriptive statistics were used to characterize the study population. Fisher exact tests were used to examine differences in outcomes between groups, a P-value of < 0.05 was deemed significant. Results: Three cohorts were recruited: 19 IBD patients on thiopurines, 50 IBD patients not on thiopurines, and 37 controls (total of 106). Neonatal median Hb was not different with 177g/L (IQR 38g/L) for the IBD thiopurine group, 180.5g/L (IQR 40g/L) for the IBD non-thiopurine group, and 181g/L (IQR 37g/L) for the controls. Nineteen infants (18%) were cytopenic with 12 (11%) anemic, 6 (5.6%) thrombocytopenic, and 1 (0.94%) lymphopenic. Thiopurine exposure was only in one, mildly anemic, infant. Conclusions: These findings further support physicians and IBD patients contemplating pregnancy that current guidelines recommending thiopurine adherence do not lead to increased perinatal risk of anemia or cytopenia.

Despite Increased Disease Activity, Women who Attended a Dedicated Inflammatory Bowel Disease and Pregnancy Clinic Had Infants With Higher Apgar Scores: A Population-Based Study.

BACKGROUND: Attendance at a subspecialty pregnancy clinic for women with inflammatory bowel disease (IBD) improves disease-specific pregnancy knowledge. We examined the impact of attendance at a dedicated IBD-pregnancy clinic on IBD and perinatal outcomes. METHODS: Using linked administrative databases in Alberta, Canada (2012-2019), we identified 1061 pregnant women with IBD who delivered singleton liveborn infants in-hospital who did (n = 314) and did not attend (n = 747) the clinic. Propensity score weighted multivariable log-binomial and multinomial logistic regression models were used to determine the risk of IBD and perinatal outcomes. RESULTS: The median number of clinic visits was 3 (Q1-Q3, 3-5), with 34.7% completing a preconception consultation. A greater proportion of women who attended lived near the clinic, were nulliparous, had a disease flare prior to pregnancy, and were on maintenance IBD medication (P < .05). Women who attended had increased risks of a disease flare during pregnancy (adjusted risk ratio [aRR], 2.02; 95% CI, 1.45-2.82), an IBD-related emergency department visit during pregnancy (aRR, 2.66; 95% CI, 1.92-3.68), and cesarean delivery (aRR, 1.78; 95% CI, 1.23-2.57). Despite this, clinic attendees had a decreased risk of delivering an infant with a low Apgar score at 1 minute (risk ratio [RR], 0.49; 95% CI, 0.32-0.76) and 5 minutes (RR, 0.32; 95% CI, 0.12-0.87). CONCLUSIONS: Women who attended a dedicated IBD-pregnancy clinic were more likely to have a disease flare prior to pregnancy, reflecting a more severe disease phenotype, but had similar perinatal outcomes and infants with better Apgar scores at birth. Our study suggests the value of these subspecialty clinics in providing enhanced IBD-specific prenatal care.

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

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

Assessment of variables associated with smoking cessation in Crohn's disease.

BACKGROUND: Patients with Crohn's disease (CD) who smoke have a more complicated disease course. AIMS: Our primary objective was to assess smoking related variables that were associated with smoking cessation versus continued smoking in patients with CD. METHODS: A multi-center study identified CD patients who were seen at the University of Chicago and University of Calgary IBD clinics. Patients were categorized into three subgroups: lifetime non-smokers, current smokers, or ex-smokers. Participants completed questionnaires assessing their cigarette smoking behavior. Current smokers were prospectively followed for 6 months to assess smoking status and attempts to quit. Logistic regression analysis was performed to identify factors associated with smoking cessation. RESULTS: Three hundred patients were enrolled with 148 identifying themselves as lifetime non-smokers, 70 as current smokers, and 82 as ex-smokers. Patients who reported their first cigarette within 5 min of waking were more likely to be current smokers (OR = 21; 95% CI 3.94-107.3) as compared to patients who waited greater than 60 min. Current smokers were more likely to have one or more household members who smoked compared to ex-smokers (P < 0.05). Nearly half (49%) of the current smokers were in the precontemplation stage of change (i.e. no intention to quit smoking). At the 6-month follow-up, only 11% reported they quit smoking. CONCLUSIONS: Patients who report a short time to first cigarette in the morning may have more difficulty in smoking cessation. Current smokers were more likely to have another smoker in the household compared to ex-smokers. Current smokers had low levels of motivation to quit smoking and consequently with no intervention, very few quit 6 months after the baseline assessment.

Review article: guide to tofacitinib dosing in patients with ulcerative colitis.

BACKGROUND: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). The induction dose is 10 mg twice daily (b.d.), whilst for maintenance therapy, the lowest effective dose should be used. AIM: To examine published evidence on the two tofacitinib dosing strategies used in UC treatment, including expert interpretation of the data and how they could inform clinical practice. METHODS: The use of tofacitinib 5 or 10 mg b.d. was assessed using data from the tofacitinib UC clinical programme in the context of different clinical scenarios. We include experts' opinions on the clinical implications of dose adjustment to inform the benefit/risk of using tofacitinib 5 or 10 mg b.d., based on clinical scenarios and real-world data. RESULTS: Factors to consider when adjusting the tofacitinib dose include disease severity, comorbidities and previous biological exposure. The endoscopic subscore can determine whether a patient is a good candidate for dose reduction. Following disease relapse, the response can be recaptured in a substantial number of patients with a dose increase. Furthermore, data are now published showing real-world use of tofacitinib and, so far, these are consistent with data from the clinical trials. CONCLUSION: Clinicians must consider the benefit/risk balance of tofacitinib 10 versus 5 mg b.d. in terms of dose-related side effects, as well as the safety implications of undertreating active disease. All patients should be closely monitored for disease relapse following dose reduction or interruption for early recapture of response.

Perceived Barriers to Professional Equality Among Women in Gastroenterology.

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.

Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program.

Objectives: The subjectivity of the Physician Global Assessment (PGA) is a limitation of the Mayo score in assessing severity of ulcerative colitis (UC). We compared treatment efficacy using endpoint definitions based on modified Mayo (mMayo) score, versus those based on Mayo score, using data from the tofacitinib OCTAVE program. Design: This post hoc analysis included data from two 8-week induction studies (OCTAVE Induction 1 and 2) and a 52-week maintenance study (OCTAVE Sustain). Methods: Remission and clinical response [with nonresponder imputation (NRI)] were assessed using mMayo (without PGA) and Mayo scores, and further stratified by prior tumor necrosis factor inhibitor (TNFi) failure status. Results: At week 8 of OCTAVE Induction 1 and 2, remission rates with placebo and tofacitinib 10 mg twice daily (BID), respectively, were 7.7% and 24.8% (mMayo) and 6.0% and 17.6% (Mayo). At week 52 of OCTAVE Sustain, remission rates with placebo, tofacitinib 5 and 10 mg BID, respectively, were 12.1%, 35.9%, and 42.1% (mMayo) and 11.1%, 34.3%, and 40.6% (Mayo). A statistically significant (p < 0.05) treatment effect of tofacitinib versus placebo was observed for remission and clinical response at all time points, regardless of scoring definition or prior TNFi failure status. Conclusions: A significant effect of tofacitinib versus placebo was demonstrated across efficacy endpoints using mMayo score, consistent with previously reported data using Mayo score. Treatment effect sizes were generally similar regardless of scoring definition. This observation may help contextualize tofacitinib therapy outcomes with those of new UC therapies and support the use of Mayo score-based endpoints in UC clinical trials. Trail registration: ClinicalTrials.gov identifiers: NCT01465763; NCT01458951; NCT01458574.

Physiological and psychological stress in pregnant women with quiescent inflammatory bowel disease: A pilot study using salivary biomarkers.

BACKGROUND: Pregnant women with inflammatory bowel disease (IBD) are more likely than the general pregnant population to experience adverse maternofetal outcomes, especially if the disease is active at the time of conception and during pregnancy. Elevated stress is often seen in patients with chronic diseases and could account for these outcomes. Salivary cortisol and alpha-amylase (sAA) are novel biomarkers of stress, reflecting the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system, respectively. Our aim in this pilot study was to assess stress differences between pregnant women with inactive IBD and matched controls using psychometric questionnaires and salivary biomarker measures. METHODS: Thirteen pregnant women with quiescent IBD (6 Crohn's disease, 7 ulcerative colitis) were matched (1:3) to 39 expectant mothers without IBD by parity and gestational age. Participants completed several psychometric questionnaires assessing stress, and salivary cortisol and sAA were collected as objective biomarkers of stress during pregnancy. RESULTS: Pregnant women with quiescent IBD did not demonstrate significant differences on any psychometric measures of stress or salivary biomarker measures when compared with controls (all P > 0.05). Pregnant women with quiescent IBD demonstrated similar cortisol and sAA awakening responses (both P > 0.05) and total levels of cortisol and sAA production (both P > 0.05) when compared with controls. CONCLUSIONS: Pregnant women with well-controlled IBD do not experience demonstrable differences in psychological stress or dysregulation of salivary stress biomarkers when compared with non-IBD controls. The effect of chronic disease may be evaluated in future studies by including a comparative group of pregnant women with active IBD.

Management of Biological Therapy Before Elective Inflammatory Bowel Disease Surgeries.

Increasing uptake of biologic therapy has contributed to declining surgical rates for inflammatory bowel disease (IBD). However, a significant number of patients on biologic therapy will go on to require surgery. The literature is conflicted with regard to the preoperative management of biologic therapy before urgent or elective IBD surgery. This article reviews the available data on postoperative complications following preoperative treatment with anti-tumor necrosis factor alpha therapy, anti-integrin therapy, and anti-interleukin therapy.

IBDoc Canadian User Performance Evaluation.

BACKGROUND: Fecal calprotectin (FC) is a stool biomarker that has been shown to be sensitive and specific for mucosal inflammation in patients with inflammatory bowel disease (IBD). The test is limited by the requirement for patients to collect and return stool samples. A home-based FC test may improve test adherence. The aim of this study is to evaluate the usability of the IBDoc, a home-based FC measuring test, and to determine the accuracy of results compared with traditional lab-based ELISA values. METHODS: Patients were prospectively enrolled from 3 tertiary sites across Canada between May and August 2017. Patients completed a questionnaire establishing ease-of-use of the IBDoc. Patients completed a FC measurement using the IBDoc, and results were compared with an ELISA-determined FC measurement on the same stool sample. RESULTS: Sixty-one participants were enrolled in the study (29 CD, 32 UC). Seventy-nine percent of patients (48 of 61) agreed that the IBDoc was easy to use, with 85% (52 of 61) of patients strongly agreeing that they were willing use the home kit in the future. The IBDoc and ELISA measurement comparison showed an 88% agreement across all values. There were no false positives or negatives using qualitative comparison. CONCLUSIONS: The home-based IBDoc FC measuring test is acceptable to patients and correlates extremely well with the standard ELISA-determined FC value. The IBDoc enables clinicians to more easily adopt a treat-to-target approach, improve long-term outcomes, and patients' quality of life with IBD. This study is registered at ClinicalTrials.gov, number NCT03408249.