Barriers to Engagement with Gastrointestinal Health Management.

BACKGROUND: Although behavioral interventions have been effective in gastrointestinal (GI) conditions, barriers exist in implementing these interventions into clinical practice. The majority of previously published studies have focused on workforce limitations and have not considered individual and social determinants of health (SDoH) factors that can impact engagement in GI behavioral healthcare. AIMS: To characterize barriers to engagement in appointment attendance and health management, explore individual and SDoH factors impacting GI behavioral healthcare engagement, and identify barriers that occur more often for patients with SDoH-related vulnerability (low health literacy and/or financial insecurity). METHODS: A survey was distributed to adult patients who had been seen in Gastroenterology at the Dartmouth-Hitchcock Medical Center from June 2022 to December 2022. RESULTS: One hundred participants [mean age = 58 years, 57.1% women] completed the survey. SDoH vulnerability was present in 32.3% of the population. For the entire sample, 73% reported at least one barrier to accessing care and 75% reported at least one factor which impacted health management. Those with SDoH vulnerability reported significantly more barriers to attending appointments and to managing health. In addition, they were significantly more likely to endorse physical health problems, difficulty affording medical bills, pain, mobility issues, trauma experiences, significant stress, and difficulty with concentration. CONCLUSIONS: Patients in a GI clinic reported multiple barriers to accessing care and participating in health management. Innovative, multi-level strategies are needed to address barriers to ensure that all patients are able to obtain quality GI behavioral health services.

Genetic Variations in TrkB.T1 Isoform and Their Association With Somatic and Psychological Symptoms in Individuals With IBS.

Irritable bowel syndrome (IBS), a disorder of gut-brain interaction, is often comorbid with somatic pain and psychological disorders. Dysregulated signaling of brain-derived neurotrophic factor (BDNF) and its receptor, tropomyosin-related kinase B (TrkB), has been implicated in somatic-psychological symptoms in individuals with IBS. We investigated the association of 10 single-nucleotide polymorphisms (SNPs) in the regulatory 3' untranslated region of neurotrophic receptor tyrosine kinase-2 (NTRK2) kinase domain-deficient truncated isoform (TrkB.T1) and BDNF Val66Met SNP with somatic and psychological symptoms and quality-of-life (QoL) in a cohort from the United States (IBS, n = 464; healthy controls, n = 156). We found that the homozygous recessive genotype (G/G) of rs2013566 in individuals with IBS is associated with worsened somatic symptoms, including headache, back pain, joint pain, muscle pain, and somatization as well as diminished sleep quality, energy level, and overall QoL. Validation using United Kingdom BioBank data confirmed the association of rs2013566 with an increased likelihood of headache. Several SNPs (rs1627784, rs1624327, and rs1147198) showed significant associations with muscle pain in our U.S. cohort. These 4 SNPs are predominantly located in H3K4Me1-enriched regions, suggesting their enhancer and/or transcription regulation potential. Our findings suggest that genetic variation within the 3' untranslated region region of the TrkB.T1 isoform may contribute to comorbid conditions in individuals with IBS, resulting in a spectrum of somatic and psychological symptoms impacting their QoL. These findings advance our understanding of the genetic interaction between BDNF/TrkB pathways and somatic-psychological symptoms in IBS, highlighting the importance of further exploring this interaction for potential clinical applications. PERSPECTIVE: This study aims to understand the genetic effects on IBS-related symptoms across somatic, psychological, and quality-of-life (QoL) domains, validated by United Kingdom BioBank data. The rs2013566 homozygous recessive genotype correlates with worsened somatic symptoms and reduced QoL, emphasizing its clinical significance.

Predictive Factors of Inactive Patient Participation in an Inflammatory Bowel Disease Learning Health System: A Longitudinal Cohort Study.

Patient participation is crucial to learning health systems that leverage patient data to improve care practices. Age, history of anxiety or depression, and frequency of clinic visits were associated with inactive participation in an inflammatory bowel disease learning health system.

Formative Evaluation of a Comprehensive Self-Management Intervention for Irritable Bowel Syndrome, Comorbid Anxiety, and Depression: Mixed Methods Study.

BACKGROUND: Irritable bowel syndrome (IBS) is a disorder of the gut-brain interaction that is associated with abdominal pain, altered bowel patterns, and reduced quality of life. Up to 50% of patients with IBS also report anxiety or depressive symptoms. Although effective self-management interventions exist for individuals with IBS, few have been effectively implemented, and most do not consider the unique needs of patients with comorbid IBS and anxiety or depression. OBJECTIVE: This study aimed to determine the anticipated acceptability, appropriateness, feasibility, and usability of a comprehensive self-management intervention using an implementation science and human-centered design approach among individuals with comorbid IBS and anxiety or depression and health care providers. METHODS: A convergent mixed methods design was used to elicit feedback on the comprehensive self-management intervention outline and content to identify refinement needs before testing. Patients with IBS and moderate to severe anxiety or depression and health care providers were purposefully sampled from primary care and gastroenterology settings. Participants completed semistructured interviews and surveys on anticipated acceptability, appropriateness, feasibility, and usability. RESULTS: Patient participants (n=12) were on average 36.8 (SD 12.2) years of age, and 42% (5/12) were currently receiving psychological therapy. Health care providers (n=14) were from primary care (n=7) and gastroenterology (n=7) settings. The mean usability scores (out of 100) were 52.5 (SD 14.5) for patients and 45.6 (SD 11.6) for providers. For patients and providers, qualitative data expanded the quantitative findings for acceptability and appropriateness. Acceptability findings were the comprehensive nature of the intervention and discussion of the gut-brain interaction. For appropriateness, participants reported that the intervention provided structure, accountability, and support. Feasibility was confirmed for patients, but there was a divergence of findings between quantitative and qualitative measures for providers. Patients focused on intervention feasibility, while providers focused on implementation feasibility in the clinic. Identified usability issues to address before implementation included the intervention delivery format, length, and lack of integration into health care settings that, if not addressed, may limit the reach of the intervention. CONCLUSIONS: Patients and health care providers found the intervention acceptable and appropriate. Several feasibility and usability issues were identified, including intervention delivery methods, length of intervention, and the best methods to implement in the clinic setting. The next steps are to refine the intervention to address the identified issues and test in a pilot study whether addressing usability issues leads to the anticipated improvements in implementation and uptake.

Age Differences in Upper Gastrointestinal Symptoms and Vagal Modulation in Women With Irritable Bowel Syndrome.

BACKGROUND/AIMS: Patients with irritable bowel syndrome (IBS) often report upper gastrointestinal (GI) (e.g., nausea and heartburn), somatic, and emotional symptoms. This study seeks to examine the relationships among younger and older women with IBS and indicators of autonomic nervous system (ANS) function and daily nausea and heartburn symptoms. METHODS: Women were recruited through clinics and the community. Nocturnal heart rate variability (HRV) was obtained using ambulatory electrocardiogram Holter monitors. Individual symptom severity and frequency were collected using 28-day diaries. All variables were stratified by younger (<46 years) and older (≥46 years) age groups. RESULTS: Eighty-nine women with IBS were included in this descriptive correlation study (n = 57 younger; n = 32 older). Older women had reduced indices of vagal activity when compared to younger women. In older women, there was an inverse correlation between nausea and vagal measures (Ln RMSSD, r = -.41, p = .026; Ln pNN50, r = -.39, p = .034). Heartburn in older women was associated with sleepiness (r = .59, p < .001) and anger (r = .48, p = .006). Nausea was significantly correlated with anger in the younger group (r = .41, p = .001). There were no significant relationships between HRV indicators and nausea and heartburn in younger women. CONCLUSIONS: Age-related differences in ANS function that are associated with nausea may portend unique opportunities to better understand the vagal dysregulation in women with IBS.

Genetic Variants in Carbohydrate Digestive Enzyme and Transport Genes Associated with Risk of Irritable Bowel Syndrome.

Irritable Bowel Syndrome (IBS) is characterized by abdominal pain and alterations in bowel pattern, such as constipation (IBS-C), diarrhea (IBS-D), or mixed (IBS-M). Since malabsorption of ingested carbohydrates (CHO) can cause abdominal symptoms that closely mimic those of IBS, identifying genetic mutations in CHO digestive enzymes associated with IBS symptoms is critical to ascertain IBS pathophysiology. Through candidate gene association studies, we identify several common variants in TREH, SI, SLC5A1 and SLC2A5 that are associated with IBS symptoms. By investigating rare recessive Mendelian or oligogenic inheritance patterns, we identify case-exclusive rare deleterious variation in known disease genes (SI, LCT, ALDOB, and SLC5A1) as well as candidate disease genes (MGAM and SLC5A2), providing potential evidence of monogenic or oligogenic inheritance in a subset of IBS cases. Finally, our data highlight that moderate to severe IBS-associated gastrointestinal symptoms are often observed in IBS cases carrying one or more of deleterious rare variants.

Relationship of Sleep Health and Endoscopic Disease Activity in Inflammatory Bowel Disease: Endoscopic Disease Activity and Sleep.

Among adults with inflammatory bowel disease (IBD), self-reported sleep disturbances are associated with active symptoms, but the association between sleep measures and endoscopic disease activity is unknown. This study aimed to (1) compare sleep-wake behaviors among IBD patients based on endoscopic and clinical disease activity and (2) describe associations between actigraphy, self-reported sleep measures, and symptoms of fatigue, anxiety, and depression. Participants wore a wrist actigraph for 10 consecutive days and completed self-reported sleep questionnaires (Pittsburgh Sleep Quality Index [PSQI] and Patient-Reported Outcome Measures System [PROMIS] Sleep Disturbance and Sleep Interference questionnaires). Clinical and endoscopic disease activity were assessed. Based on actigraphic recordings ( n = 26), average total nighttime sleep was 437 minutes and sleep efficiency was 84%. Objective sleep measures did not differ based on endoscopic or clinical disease activity. Individuals with active clinical disease had higher PROMIS Sleep Disturbance (57.3 vs. 49.7, d = 1.28) and PROMIS Sleep-Related Impairment (58.1 vs. 52.8, d = 0.51) compared with those with inactive clinical disease. Self-reported sleep was significantly associated with anxiety, depression, and fatigue. Further research is needed to better characterize the relationship between sleep and endoscopic disease activity, and determine underlying mechanisms related to poor sleep in the IBD population.

A Comprehensive Self-Management Intervention for Inflammatory Bowel Disease (CSM-IBD): Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Despite pharmacological treatment, individuals with inflammatory bowel disease (IBD) experience a variety of symptoms, including abdominal pain, fatigue, anxiety, and depression. Few nonmedical self-management interventions are available for people with IBD. A validated comprehensive self-management (CSM) intervention is effective for patients with irritable bowel syndrome who can have symptoms similar to those of individuals with IBD. We created a modified CSM intervention tailored to individuals with IBD (CSM-IBD). The CSM-IBD is an 8-session program delivered over 8-12 weeks with check-ins with a registered nurse. OBJECTIVE: The primary objective of this pilot study is to determine the feasibility and acceptability of study procedures and the CSM-IBD intervention and to evaluate preliminary efficacy on quality of life and daily symptoms for a future randomized controlled trial. Additionally, we will examine the association of socioecological, clinical, and biological factors with symptoms at baseline and response to intervention. METHODS: We are conducting a pilot randomized controlled trial of the CSM-IBD intervention. Participants aged 18-75 years who are experiencing at least 2 symptoms are eligible for inclusion. We plan to enroll 54 participants who will be randomized (2:1) into the CSM-IBD program or usual care. Patients in the CSM-IBD program will have 8 intervention sessions. Primary study outcomes include the feasibility of recruitment, randomization, and data or sample collection, as well as the acceptability of study procedures and interventions. Preliminary efficacy outcome variables include quality of life and symptoms. Outcomes data will be assessed at baseline, immediately post intervention, and 3 months post intervention. Participants in the usual care group will have access to the intervention after study participation. RESULTS: This project is funded by the National Institutes of Nursing Research and reviewed by the University of Washington's institutional review board. Recruitment began in February 2023. As of April 2023, we have enrolled 4 participants. We expect the study to be completed by March 2025. CONCLUSIONS: This pilot study will evaluate the feasibility and efficacy of a self-management intervention (a web-based program with weekly check-ins with a registered nurse) that aims to improve symptom management in individuals with IBD. In the long term, we aim to validate a self-management intervention to improve patient quality of life, reduce direct and indirect costs related to IBD, and be culturally appropriate and accessible, particularly in rural and underserved communities. TRIAL REGISTRATION: ClinicalTrials.gov NCT05651542; https://clinicaltrials.gov/ct2/show/NCT05651542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46307.

Age Differences in Core Symptoms and Symptom Relationships in Patients With Irritable Bowel Syndrome: A Network Analysis.

INTRODUCTION: Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction, characterized by symptoms of abdominal pain and changes in bowel habits. It often co-occurs with extraintestinal somatic and psychological symptoms. However, the nature of the interrelationships among these symptoms is unclear. Although previous studies have noted age differences in IBS prevalence and specific symptom severity, it remains unknown whether specific symptoms and symptom relationships may differ by age. METHODS: Symptom data were collected in 355 adults with IBS (mean age 41.4 years, 86.2% female). Network analysis was used to examine the interrelationships among 28 symptoms and to identify the core symptoms driving the symptom structure between young (≤45 years) vs older (>45 years) adults with IBS. We evaluated 3 network properties between the 2 age groups: network structure, edge (connection) strength, and global strength. RESULTS: In both age groups, fatigue was the top core symptom. Anxiety was a second core symptom in the younger age group, but not the older age group. Intestinal gas and/or bloating symptoms also exerted considerable influences in both age groups. The overall symptom structure and connectivity were found to be similar regardless of age. DISCUSSION: Network analysis suggests fatigue is a critical target for symptom management in adults with IBS, regardless of age. Comorbid anxiety is likely an important treatment focus for young adults with IBS. Rome V criteria update could consider the importance of intestinal gas and bloating symptoms. Additional replication with larger diverse IBS cohorts is warranted to verify our results.

Exploration of associations among dietary tryptophan, microbiome composition and function, and symptom severity in irritable bowel syndrome.

BACKGROUND: Imbalance of the tryptophan (TRP) pathway may influence symptoms among patients with irritable bowel syndrome (IBS). This study explored relationships among different components that contribute to TRP metabolism (dietary intake, stool metabolite levels, predicted microbiome metabolic capability) in females with IBS and healthy controls (HCs). Within the IBS group, we also investigated relationships between TRP metabolic determinants, Bifidobacterium abundance, and symptoms of IBS. METHODS: Participants with IBS (Rome III) and HCs completed a 28-day diary of gastrointestinal symptoms and a 3-day food record for TRP intake. They provided a stool sample for shotgun metagenomics, 16 S rRNA analyses, and quantitative measurement of TRP by mass spectrometry. RESULTS: Our cohort included 115 females, 69 with IBS and 46 HCs, with a mean age of 28.5 years (SD 7.4). TRP intake (p = 0.71) and stool TRP level (p = 0.27) did not differ between IBS and HC. Bifidobacterium abundance was lower in the IBS group than in HCs (p = 0.004). Predicted TRP metabolism gene content was higher in IBS than HCs (FDR-corrected q = 0.006), whereas predicted biosynthesis gene content was lower (q = 0.045). Within the IBS group, there was no association between symptom severity and TRP intake or stool TRP, but there was a significant interaction between Bifidobacterium abundance and TRP intake (q = 0.029) in predicting stool character. CONCLUSIONS: Dietary TRP intake, microbiome composition, and differences in TRP metabolism constitute a complex interplay of factors that could modulate IBS symptom severity.

Systematic review: Individual-level factors and social determinants of health impacting sleep health in individuals with inflammatory bowel disease.

AIM: To examine the individual-level factors and social determinants of health (SDOH) linked to sleep health among individuals with inflammatory bowel disease (IBD). DESIGN: Systematic review without meta-analysis. DATA SOURCES: Four databases (PubMed, Web of Science, CINAHL and PsycINFO) were searched in February 2022. REVIEW METHODS: Databases were searched with keywords related to IBD and sleep. The review was conducted per the PRISMA protocol. The checklist for analytical cross-sectional studies published by the Joanna Briggs Institute was used for quality appraisal. Factors were organized by individual, social and societal levels according to the social-ecological model of sleep health. RESULTS: In the review, 45 studies were identified and synthesized. All studies examined individual-level factors with sleep, with age being the most common factor studied. Only nine studies considered a social determinant of health which included marital status, number of children, education level, annual income, employment status, work tenure, type of employment, area of residence, minority status/ethnicity and COVID-19. However, the source of information for the social determinant of health was not clearly defined for more than half of these studies. CONCLUSION: Although IBD sleep research has explored individual-level factors (i.e. age) that impact sleep health, there is a lack of information on the SDOH that can contribute to sleep health. IMPACT: This review provides insight into the different factors that have been examined in IBD sleep research. By determining the SDOH that impact sleep, nursing research can inform sustainable and tailored interventions that focus on changing behaviour and improving sleep of individuals of varying backgrounds and life experiences. There is a continued need for nurses in practice and research to explore the SDOH that influence health outcomes and the daily lives of those with IBD.

Exploring the Role of Vitamin D and the Gut Microbiome: A Cross-Sectional Study of Individuals with Irritable Bowel Syndrome and Healthy Controls.

Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction with multifaceted pathophysiology. Prior studies have demonstrated higher rates of vitamin D deficiency in individuals with IBS compared to healthy controls (HC), as well as associations of vitamin D concentration with IBS symptoms. A systematic review of 10 mouse and 14 human studies reported a positive association between vitamin D (serum levels and supplementation) and beta diversity of gut microbiome in a variety of conditions. The present retrospective case-control study aimed to compare vitamin D (25(OH)D) plasma concentrations and gut microbiome composition in adult women with IBS (n=99) and HC (n=62). Plasma concentrations of 25(OH)D were assessed using the Endocrine Society Guidelines definition of vitamin D deficiency (25(OH)D <20 ng/ml) and insufficiency (25(OH)D >20-<30 ng/ml). 16S rRNA microbiome gene sequencing data was available for 39 HC and 62 participants with IBS. Genus-level Bifidobacterium and Lactobacillus and phylum-level Firmicutes and Bacteroidetes relative abundances were extracted from microbiome profiles. Results showed vitamin D deficiency in 40.3% (n=25) vs. 41.4% (n=41), and insufficiency 33.9% (n=21) vs. 34.3% (n=34) in the HCs vs. IBS groups, respectively. The odds of IBS did not differ depending on 25(OH)D status (p=0.75 for deficient, p=0.78 for insufficient), and the average plasma vitamin D concentration did not differ between IBS (mean 24.8 ng/ml) and HCs (mean 25.1 ng/ml; p=0.57). We did not find evidence of an association between plasma 25(OH)D concentration and richness, Shannon index, Simpson index or specific bacterial abundances in either HCs or the IBS group.

Symptom management needs of patients with irritable bowel syndrome and concurrent anxiety and/or depression: A qualitative study.

AIMS: To understand the experiences and needs of symptom management among individuals with irritable bowel syndrome and concurrent symptoms of anxiety and/or depression. DESIGN: This study used a qualitative descriptive research design. METHODS: Individuals with a diagnosis of irritable bowel syndrome and concurrent symptoms of anxiety and/or depression participated were recruited through an online ResearchMatch and a listserv. Semi-structured interviews focused on symptoms and experiences with symptom management interventions conducted from June to August 2020. Interviews were transcribed and data were analysed based on thematic analysis. RESULTS: Twelve individuals participated in this study; all reported current irritable bowel syndrome and anxiety/depression symptoms. The data analysis cumulated with three themes related to symptom management: (a) irritable bowel syndrome negatively impacts physical and mental well-being; (b) a trial and error approach to symptom management; and (c) challenges with healthcare professionals supporting symptom management including negative interactions with healthcare professionals and lack of nutritional expertize and support. CONCLUSION: There is a need for individualized approaches which consider patients' current symptoms of anxiety and depression, previous experiences with the trial-and-error process and consideration for intervention delivery methods. IMPACT: There is a limited qualitative research focusing on the experiences of individuals with irritable bowel syndrome and concurrent symptoms of anxiety and/or depression. This research highlights the need for individualized approaches to enhance symptom management that acknowledges patients' psychological state and past negative experiences with providers and prior dietary regimens.

Concordance and Discordance Between Patient-reported Remission, Patient-reported Outcomes, and Physician Global Assessment.

BACKGROUND: Although validated patient-reported outcome (PRO) measurements can categorize patients with inflammatory bowel disease (IBD) into clinical remission or active disease, patients may have different definitions of remission. The purpose of this study was to compare patient-defined remission to remission based on PRO measures and physician global assessment (PGA) and to understand the clinical and demographic factors associated with disagreements. METHODS: We retrospectively analyzed 3257 de-identified surveys from 2004 IBD patients who consented to participate in the Crohn's and Colitis Foundation's IBD Qorus Learning Health System between September 2019 and February 2021. We used logistic regression models with generalized estimating equations to analyze the clinical and demographic factors (eg, age, disease duration, health confidence) associated with discordance between patient-defined remission (yes/no) and PRO-defined remission for ulcerative colitis (UC; PRO2: stool frequency, rectal bleeding) and Crohn's disease (CD; PRO-3: average number of liquid stools, abdominal pain, well-being). RESULTS: Among patients with UC, overall concordance was 79% between patient self-report and PRO2-defined remission and 49% between patient self-report and PGA-defined remission. Among patients with CD, overall concordance was 69% between patient self-report and PRO3-defined remission and 54% between patient self-report and PGA-defined remission. Patients in PRO-defined remission were more likely to report active disease if they had IBD <5 years and low health confidence. Patients with PRO-defined active disease were more likely to report remission if they were not using prednisone and had high health confidence. CONCLUSION: Discordance exists between how remission is defined by patients, PRO measures, and PGA.

Discordance between patients' self-reported remission and remission defined based on patient-reported outcomes was observed in 31% of Crohn's disease visits and 21% of ulcerative colitis visits. Disease duration and health confidence were associated with discordance.

Changes in Medicare Reimbursement for Common Gastroenterology Services Over 15 Years: 2007-2022.

INTRODUCTION: We evaluated trends in Medicare reimbursement for common gastrointestinal (GI) services from 2007 to 2022. METHODS: Top GI procedures and office/inpatient visits were identified. The Physician Fee Schedule Look-Up Tool from Centers for Medicare & Medicaid Services was queried to extract reimbursement data. Reimbursement trends were analyzed, accounting for inflation. RESULTS: GI procedures exhibited an average decrease in unadjusted and adjusted reimbursement of 7.0% and 33.0%, respectively. Reimbursement for patient visits exhibited an inflation-adjusted decrease of 4.9%. DISCUSSION: The analysis revealed a steady decline in adjusted reimbursement for both GI procedures and patient visits in the past 15 years.

Delivery Methods of Cognitive Behavior Therapy for Patients With Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is the most commonly diagnosed gastrointestinal disorder and negatively impacts individuals' quality of life. Cognitive behavioral therapy appears effective for reducing symptoms in many irritable bowel syndrome patients. However, the optimal methods to deliver cognitive behavioral therapy and the effective treatment dosage for patients with IBS remain unclear. This article aims to provide an update on cognitive behavioral therapy research in IBS, particularly considering the dose of treatment, route of delivery (in-person vs. web- and telephone-based delivery), and outcome measures. A systematic literature review was conducted using databases of PubMed, CINAHL Complete, and Web of Science from 2008 through 2021. Twelve studies reporting randomized clinical trials comparing cognitive behavioral therapy delivered with in-person, telephone, and web for the management of IBS symptoms among adults with irritable bowel syndrome were found. The dose of treatment varied from 4 to 10 sessions. Six different scales measured various outcomes. No severe adverse reactions to cognitive behavioral therapy were reported. Cognitive behavioral therapy is an effective treatment for IBS symptoms regardless of the dose and the route of treatment. However, it is difficult to compare the effectiveness of these randomized clinical trials due to the various cognitive behavioral therapy protocols, combined routes of therapy delivery, and different outcome measures used.

Tofacitinib Appears Well Tolerated and Effective for the Treatment of Patients with Refractory Crohn's Disease.

BACKGROUND: Active Crohn's disease increases the risk of strictures, fistulas, and abscesses. Less than 30% of patients with Crohn's disease achieve endoscopic remission on any therapy. Tofacitinib may be a therapeutic option for patients with refractory Crohn's disease. AIMS: We aimed to evaluate the safety and effectiveness of off-label tofacitinib for refractory Crohn's disease. METHODS: We retrospectively assessed adverse events and clinical/endoscopic response after therapy. RESULTS: Forty-four patients were included in the safety analysis and 35 were included in the clinical and/or endoscopic assessments. The mean age was 41.8 years and the mean disease duration was 17.4 years. All patients had prior biologic exposure. Adverse events were reported in 52.3% of patients; 13.6% had ≥ 1 serious adverse event after a median 54.6 weeks of treatment. Seventy percent achieved clinical response after a mean 29.4 (SD 15.1) weeks, and 33.3% achieved clinical remission after a mean 33.4 (SD 17.6) weeks of therapy. Endoscopic improvement occurred in 25.0%, endoscopic remission in 12.5%, and endoscopic healing in 4.2% of patients after a mean 52.0 (SD 15.0) weeks of therapy. The mean Simple Endoscopic Score in Crohn's disease significantly improved from 23.1 ± 3.7 to 18.0 ± 13.7 after treatment (P = .02). CONCLUSIONS: In the short term, tofacitinib appears well tolerated. The most common adverse event was minor infection. One serious infection and one colorectal cancer occurred. While half of patients reported adverse events, this likely reflects the severe refractory disease in this population and no new safety events were observed. Tofacitinib achieved clinical and endoscopic improvement in some patients with refractory Crohn's disease. Further research is needed to understand the long-term safety and efficacy of tofacitinib in Crohn's disease.

Cognitive Behavioral Therapy-Based Comprehensive Self-Management Program Improves Presenteeism in Persons with Irritable Bowel Syndrome: A Secondary Data Analysis.

Individuals with irritable bowel syndrome (IBS) are more likely to miss work (absenteeism), have reduced work effectiveness (presenteeism) and experience activity impairment. This study compared the effect of a comprehensive self-management (CSM) intervention program (incorporating cognitive behavioral therapy, diet education and relaxation) versus usual care on work- and activity-impairments in adults with IBS. This secondary data analysis used daily diaries and Work Productivity and Activity Impairment in Irritable Bowel Syndrome (WPAI-IBS) questionnaire data collected at baseline, 3, 6 and 12 months post-randomization from 160 adults with IBS. Mixed-effects modeling was used to compare the effect of CSM versus usual care on work- and activity-related outcomes. The effect of CSM was shown to be superior to usual care in improving WPAI-IBS and diary-measured presenteeism, overall work productivity loss and activity impairment with sustained effects up to 12 months post-randomization (all p < 0.05). Moreover, the CSM intervention was found to be particularly beneficial for IBS patients with greater baseline work and activity impairments (all p < 0.05). The CSM intervention may bring benefits to individuals and society through improving symptoms and reducing presenteeism associated with IBS.

Relationship Between Endoscopic and Clinical Disease Activity With Fatigue in Inflammatory Bowel Disease.

Fatigue is a prevalent symptom among individuals with inflammatory bowel disease. Yet, few studies have examined the relationship between fatigue and endoscopic disease activity. A retrospective chart review was conducted to determine the prevalence of fatigue based on endoscopic inflammation and clinical disease activity and describe the factors associated with fatigue among adults with inflammatory bowel disease. One hundred sixty patients were included. The majority had Crohn disease (72.5%), with an average age of 40.5 years. Sixty-one percent reported fatigue. Both endoscopic (p = .03) and clinical disease activities (p = .001) were significantly associated with fatigue. Among participants reporting fatigue, 52% had inactive disease and 48% had active disease based on endoscopy whereas 63% reported clinically active disease and 37% reported clinically inactive disease. In the multivariate regression model, clinical disease activity (odds ratio [OR] = 8.5; 95% CI [3.9, 18.6]) and anxiety (OR = 2.8; 95% CI [1.0, 7.6]) were significantly associated with fatigue. The prevalence of fatigue is high among individuals with active and inactive disease. Clinical disease activity and anxiety, but not endoscopic disease activity, were associated with fatigue.

Prevalence of Gastrointestinal Symptoms and Irritable Bowel Syndrome Among Individuals With Symptomatic Posttraumatic Stress Disorder.

GOALS: Our aim was to describe the prevalence of irritable bowel syndrome (IBS) and other gastrointestinal symptoms in a sample of veterans with posttraumatic stress disorder (PTSD) and to examine the relationship between gastrointestinal symptoms, PTSD severity, depression severity, and number of prior traumatic events reported. BACKGROUND: IBS and PTSD can co-occur; yet, little research has focused on describing the gastrointestinal symptoms and prevalence of IBS among veterans with PTSD. MATERIALS AND METHODS: We examined baseline data from a randomized clinical trial of behavioral interventions for veterans with PTSD. Veterans completed questionnaires assessing gastrointestinal symptoms (Gastrointestinal Patient-Reported Outcome Measures Information Systems; PROMIS) and lifetime traumatic events. Multivariable regression analyses were performed to examine associations between gastrointestinal symptoms and the number of prior traumas reported PTSD severity, and depression symptom severity. RESULTS: One hundred eighty-four veterans with a diagnosis of PTSD were included. Twenty-five percent met the Rome III criteria for IBS. Veterans reported gastrointestinal symptoms including abdominal/belly pain (36%), diarrhea (21%), constipation (18%), and bloating/gas (17%). In multivariable analyses, greater PTSD severity was associated with worse constipation ( P =0.008), diarrhea ( P =0.005), and gas/bloating ( P =0.001) when controlling for age and sex. Higher levels of depressive symptoms severity were associated with greater abdominal/belly pain ( P =0.04). CONCLUSIONS: Among a sample of veterans with PTSD, rates of IBS and abdominal/belly pain are greater than general US population reference values. Although levels of constipation and bloating/gas are lower than general US population reference values, increased severity of PTSD was associated with increased gastrointestinal symptoms.