AGA Clinical Practice Update on Pain Management in Inflammatory Bowel Disease: Commentary.

DESCRIPTION: Pain is a common symptom among patients with inflammatory bowel disease (IBD). Although pain typically occurs during episodes of inflammation, it is also commonly experienced when intestinal inflammation is quiescent. Many gastroenterologists are at a loss how to approach pain symptoms when they occur in the absence of gut inflammation. We provide guidance in this area as to the evaluation, diagnosis, and treatment of pain among patients with IBD. METHODS: This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important as well as recently published studies in this field, and it reflects the experiences of the authors. Formal ratings regarding the quality of evidence or strength of the presented considerations were not included because systematic reviews were not performed.

Mental Health Experiences of Adolescents and Young Adults with Inflammatory Bowel Disease During Transition to Adult Care: A Qualitative Descriptive Study.

OBJECTIVE: To explore the mental health experiences of adolescents and young adults (AYA) with inflammatory bowel disease (IBD) enrolled in a randomized controlled trial evaluating the impact of a multimodal transition intervention. STUDY DESIGN: Virtual semistructured interviews were held with 21 AYA aged 16 through 18 years with IBD. Guided by qualitative description, interviews were digitally recorded, transcribed verbatim, and analyzed using an inductive approach to reflexive thematic analysis. RESULTS: Three themes were generated from the data: (1) a continuum of integration between IBD and personal identity in adolescence and young adulthood; (2) manifestations of the mind-gut connection among AYA with IBD; and (3) hopes and priorities for addressing mental health in IBD care. CONCLUSIONS: AYA with IBD endorsed the criticality of incorporating mental health discussions into routine care during the transition to adult care, given the co-occurrence of psychosocial stressors throughout this period. A series of factors promoting and hindering the integration of IBD into one's identity were identified and could be explored in clinical encounters.

Development and validation of a 13-item short version of the inflammatory bowel disease self-efficacy scale.

BACKGROUND: The inflammatory bowel disease self-efficacy scale (IBD-SES) is an instrument used across many countries to measure important health outcomes of patients with inflammatory bowel disease (IBD). We aimed to develop and validate a substantially shorter version of this scale to reduce patients' response burden. METHODS: A total of 919 patients with IBD, 482 recruited from an IBD clinic and 437 recruited online, completed the Japanese version of the original, 29-item IBD-SES. These data were then used to develop a shorter version of the scale. The original 29 items of the IBD-SES were reduced with three analytic steps: assessing ceiling and floor effect, testing correlation between items, and assessing test-retest reliability. The resulting 13-item IBD-SES was evaluated for construct validity by confirmatory factor analysis, criterion validity by Pearson correlation coefficients with original version, and internal consistency by item-total correlations and the Cronbach's α coefficient. RESULTS: The short version consisted of the same four subscales "managing stress and emotions," "managing medical care," "managing symptoms and disease," and "maintaining remission" as the original scale. The fit indices of the final model were as follows: normed chi-square, 7.18 (p < 0.001); comparative fit index, 0.94; goodness-of-fit index, 0.93; adjusted goodness-of-fit index, 0.89; parsimony goodness-of-fit index, 0.60; and root mean square error of approximation, 0.084. Correlation of each subscale with the original scale was high (0.97-0.98). Cronbach's α for each subscale ranged from 0.68 to 0.86. CONCLUSIONS: A short version of the IBD-SES was developed. The results confirmed the improved validity, reliability, and psychometric properties of the IBD-SES. TRIAL REGISTRATION: Not applicable.

How Should Pain, Fatigue, and Emotional Wellness Be Incorporated Into Treatment Goals for Optimal Management of Inflammatory Bowel Disease?

Early diagnosis and the optimal control of inflammation, with a continuous cycle of assessment, treatment, monitoring, and adjustment of therapy, is best practice for the management of inflammatory bowel disease. However, patients express frustration with ongoing challenging symptoms, often discordant with inflammation, including abdominal pain, fatigue, depression, anxiety, and emotional wellness; these are often not optimally addressed by inflammatory bowel disease clinicians due to lack of time or resources. This review will highlight the burden of these symptoms and issues, suggest ways of assessing these in clinical practice, highlight the importance of acknowledging and validating the symptoms and issues with patients, reassuring them that they are being heard, and discuss different possible models of service delivery for psychosocial support, from fully integrated gastropsychology models to referral pathways that optimize community support. We suggest the importance of the treat-to-target concept, where the target is not only control of inflammation but also emotional wellness.

A Rome Working Team Report on Brain-Gut Behavior Therapies for Disorders of Gut-Brain Interaction.

BACKGROUND AND AIMS: This Rome Foundation Working Team Report reflects the consensus of an international interdisciplinary team of experts regarding the use of behavioral interventions, specifically brain-gut behavior therapies (BGBTs), in patients with disorders of gut-brain interaction (DGBIs). METHODS: The committee members reviewed the extant scientific literature and, when possible, addressed gaps in this literature through the lens of their clinical and scientific expertise. The Delphi method was used to create consensus on the goals, structure, and framework before writing the report. The report is broken into 5 parts: 1) definition and evidence for BGBT, 2) the gut-brain axis as the mechanistic basis for BGBT, 3) targets of BGBTs, 4) common and unique therapeutic techniques seen in BGBT, and 5) who and how to refer for BGBT. RESULTS: We chose to not only review for the reader the 5 existing classes of BGBT and their evidence, but to connect DGBI-specific behavioral targets and techniques as they relate directly, or in some cases indirectly, to the gut-brain axis. In doing so, we expect to increase gastrointestinal providers' confidence in identifying and referring appropriate candidates for BGBT and to support clinical decision making for mental health professionals providing BGBT. CONCLUSIONS: Both gastrointestinal medical providers and behavioral health providers have an opportunity to optimize care for DGBIs through a collaborative integrated approach that begins with an effective patient-provider relationship, thoughtful communication about the brain-gut axis and, when appropriate, a well communicated referral to BGBT.

Risk Factors for Abdominal Pain-Related Disorders of Gut-Brain Interaction in Adults and Children: A Systematic Review.

BACKGROUND & AIMS: Many studies have assessed risk factors of irritable bowel syndrome (IBS) and other abdominal pain-related disorders of gut-brain interaction (AP-DGBI); however, the role of these factors is unclear due to heterogeneous study designs. The aim of this systematic review was to extensively evaluate the literature and determine clinical risk and protective factors for the presence and persistence of AP-DGBI in children and adults. METHODS: A PubMed search identified studies investigating potential risk and protective factors for AP-DGBI in adults and children. Inclusion criteria included fully published studies with a control group; exclusion criteria included poor-quality studies (using a validated scale). For each factor, the proportion of studies that found the factor to be a risk factor, protective factor, or neither was summarized. The number of studies, diagnostic criteria, number of subjects, and average study quality rating provided further context. Whenever possible, a meta-analysis generated pooled odds ratios or mean difference. RESULTS: The systematic review included 348 studies. Female sex, gastroenteritis, abuse, stress, psychological disorders, somatic symptoms, and poor sleep were consistent risk factors for developing AP-DGBI in adults and children. In adults, additional risk factors included obesity, smoking, and increased use of medical resources. Protective AP-DGBI factors in adults included social support and optimism; no studies for protective factors were found for children. CONCLUSIONS: There are multiple risk factors for AP-DGBI in adults and children. These include female sex, gastroenteritis, abuse, stress, poor sleep, obesity, psychological disorders, and somatic symptoms. Additional studies are needed in children, on protective factors, and on factors associated with persistence of AP-DGBI.

Approach to patient reported outcome measures selection and implementation in a chronic norovirus clinical efficacy trial for patients after solid organ transplant.

Norovirus is the second most common cause of diarrhea among solid organ transplant recipients. There are currently no approved therapies for Norovirus, which can substantially impact quality of life, particularly in an immunocompromised patient population. In order to establish clinical efficacy and support any medication claims related to a patient's symptoms or function, the Food and Drug Administration requires that a trial's primary endpoints be derived from patient reported outcome measures- an outcome that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else. In this paper, we describe our study team's approach to the definition, selection, measurement and evaluation of patient reported outcome measures as part of establishing clinical efficacy of Nitazoxanide for acute and chronic Norovirus in solid organ transplant recipients. We specifically describe our approach to measuring the primary efficacy endpoint- days to cessation of vomiting and diarrhea after randomization through 160 days, measured through daily symptom diaries as well as the impact of treatment on exploratory efficacy endpoints, particularly change in the impact of norovirus on psychological function and quality of life.

Perceptions of and Experiences with the COVID-19 Pandemic Among Individuals with Inflammatory Bowel Disease.

The COVID-19 pandemic resulted in increased feelings of emotional distress and disruptions in care across diverse patients subgroups, including those with chronic medical conditions such as inflammatory bowel diseases (IBD). We sought to understand the impact of the pandemic on the physical and emotional well-being of individuals with IBD and concurrent depression and/or anxiety symptoms. We conducted qualitative interviews after the beginning of the pandemic with 46 adults with IBD. Participants reported increased levels of emotional distress, feelings of social isolation, and uncertainty over whether IBD medications put them at increased risk. Young adults discussed feeling as if their lives had been disrupted. In addition, several individuals demonstrated resiliency and emphasized positives about the pandemic, including increased connectivity with family and friends, the convenience of being able to work from home despite their IBD symptoms, and lessened feelings of "missing out." Our findings highlight several opportunities to improve the health and well-being of individuals with IBD and beyond including increased support for combatting social isolation, enhanced counseling about medication risks and benefits, and the incorporation of resiliency skills building.

Behavioral and Diet Therapies in Integrated Care for Patients With Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is a common, symptom-based condition that has negative effects on quality of life and costs health care systems billions of dollars each year. Until recently, management of IBS has focused on over-the-counter and prescription medications that reduce symptoms in fewer than one-half of patients. Patients have increasingly sought natural solutions for their IBS symptoms. However, behavioral techniques and dietary modifications can be effective in treatment of IBS. Behavioral interventions include gastrointestinal-focused cognitive behavioral therapy and gut-directed hypnotherapy to modify interactions between the gut and the brain. In this pathway, benign sensations from the gut induce maladaptive cognitive or affective processes that amplify symptom perception. Symptoms occur in response to cognitive and affective factors that trigger fear of symptoms or lack of acceptance of disease, or from stressors in the external environment. Among the many dietary interventions used to treat patients with IBS, a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols is the most commonly recommended by health care providers and has the most evidence for efficacy. Patient with IBS who choose to follow a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols should be aware of its 3 phases: restriction, reintroduction, and personalization. Management of IBS should include an integrated care model in which behavioral interventions, dietary modification, and medications are considered as equal partners. This approach offers the greatest likelihood for success in management of patients with IBS.

Validation of the Short-Form Esophageal Hypervigilance and Anxiety Scale.

BACKGROUND & AIMS: Esophageal hypervigilance and anxiety are emerging as important drivers of dysphagia symptoms and reduced quality of life across esophageal diagnoses. The esophageal hypervigilance and anxiety scale (EHAS) is a validated measure of these cognitive-affective processes. However, its length may preclude it from use in clinical practice. We aimed to create a short form version of the EHAS using established psychometric practices. METHODS: A retrospective review of a registry of patients who visited a university-based esophageal motility clinic for diagnostic testing was conducted. Patients were included if they completed the 15-item EHAS and questionnaires assessing dysphagia severity and health-related quality of life (HRQOL) at the time of motility testing. Principle components factor analysis identified items for possible removal. Tests for reliability and concurrent validity were performed on the full EHAS and short-form version (EHAS-7). RESULTS: 3,976 adult patients with confirmed esophageal disease were included: 30% with achalasia or EGJOO, 13% with EoE, 13% with GERD, 39% normal motility. Eight items were removed from the scale based on a factor loading of > 0.70, resulting in a single scale 7-item EHAS-7 scored from 0 to 28. The EHAS-7 demonstrated excellent internal consistency (α = 0.91) and split-half reliability (0.88) as was found in the full EHAS in the current study and prior validation. Concurrent validity existed between the EHAS-7 and measures of dysphagia (r = 0.33) and HRQOL (r = -0.73, both P < .001). CONCLUSIONS: The EHAS-7 is a 7-item scale to assess esophageal hypervigilance and symptom-specific anxiety that performs as well as the original 15-item version. Shorter questionnaires allow for implementation in clinical practice. The EHAS-7 is a useful tool for clinicians to quickly assess how hypervigilance and anxiety may be contributing to their patients' clinical presentations.

Resilience-based Integrated IBD Care Is Associated With Reductions in Health Care Use and Opioids.

BACKGROUND & AIMS: Integrated inflammatory bowel disease (IBD) care is effective but not routinely implemented. Validated methods that simultaneously address mind and body targets such as resilience may improve access and outcomes. We describe the development and implementation of the GRITT method and its impact on resilience, health care utilization (HCU), and opioid use in IBD. METHODS: Consecutive patients from an academic IBD center were evaluated for low resilience on the basis of provider referral. Low resilience patients were invited to participate in the GRITT program. Primary outcome was % reduction in HCU. Secondary outcomes were change in resilience and corticosteroid and opioid use. Patients were allocated into 2 groups for analysis: GRITT participants (GP) and non-participants (NP). Clinical data and HCU in the year before enrollment were collected at baseline and 12 months. One-way repeated measures multivariate analysis of covariance evaluated group × time interactions for the primary outcome. Effect size was calculated for changes in resilience over time. RESULTS: Of 456 screened IBD patients 394 were eligible, 184 GP and 210 NP. GP had greater reduction in HCU than NP: 71% reduction in emergency department visits, 94% reduction in unplanned hospitalizations. There was 49% reduction in opioid use and 73% reduction in corticosteroid use in GP. Resilience increased by 27.3 points (59%), yielding a large effect size (d = 2.4). CONCLUSIONS: Mind-body care that focuses on building resilience in the context of IBD care may be a novel approach to reduce unplanned HCU and opioid use, but large, multicenter, randomized controlled trials are needed.

Psychological Considerations in the Dietary Management of Patients With DGBI.

In this article, an expert team of 2 gastro-psychologists, a dietician, and an academic gastroenterologist provides insights into the psychological and social implications of evidence-based and "popular" dietary interventions in disorders of gut-brain interaction (DGBI). We focus on practical approaches for evaluating a patient's appropriateness for a dietary intervention, considering the nutritional, psychological, behavioral, and social context in which a patient may find themselves managing their DGBI with dietary intervention. We also discuss how to identify risk factors for and symptoms of avoidant/restrictive food intake disorder, a growing concern in the DGBI population.

Burnout Among Transplant Hepatologists in the United States.

Burnout among transplant hepatologists has not been well characterized. The goal of this study was to describe the prevalence and predictors of burnout among practicing transplant hepatologists in the United States. We designed a 69-item survey, including the Maslach Burnout Inventory (MBI)-Human Services Survey and questions on provider demographics, practice characteristics, and psychological factors. The survey was administered to practicing US transplant hepatologists between October and December 2019. We described burnout using MBI subscales (emotional exhaustion [EE], depersonalization [DP], and personal accomplishment [PA]) and determined significant predictors of burnout, which we defined as high EE, using univariate and multivariate analyses. A total of 185 transplant hepatologists completed the survey (response rate = 25% of 738 practicing transplant hepatologists in the United States). A total of 40% reported high EE, whereas 17% and 16% reported high DP and low PA, respectively. On multivariate analysis, respondents with more than 5 colleagues (odds ratio [OR], 0.44; 95% confidence interval [CI], 0.23-0.84) reporting adequate time for outpatient visits (OR, 0.42; 95% CI, 0.22-0.80), reporting greater comfort with their clinical caseload (OR, 0.61; 95% CI, 0.39-0.96), and reporting higher confidence in their prior training (OR, 0.49; 95% CI, 0.28-0.87) had a lower likelihood of high EE. Working 6 or more hours from home outside of work per week (OR, 2.04; 95% CI, 1.07-3.89) predicted a higher likelihood of burnout. Compensation, age, gender, career phase, caregiver status, and transplant center volume did not predict burnout. Of the surveyed transplant hepatologists, 40% experienced burnout, predicted mostly by factors related to work-time distribution, peer support, and affect. These findings should prompt development of system-level initiatives.

Multimodal intervention to improve the transition of patients with inflammatory bowel disease from pediatric to adult care: protocol for a randomized controlled trial.

BACKGROUND: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there are no Level 1 evidence-based interventions to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the clinical and implementation effectiveness of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. METHODS: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0-17.5 years. The intervention program consists of 4 core components: (1) individualized assessment, (2) transition navigator, (3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and (4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness and success, anxiety and depression scales, and health service utilization rates. Additionally, we will measure implementation outcomes and related barriers and facilitators for the intervention program. DISCUSSION: The type 1 hybrid effectiveness-implementation design will allow for the development of a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will allow centralization of interventions and funding in order to minimize the impact on local clinical practice or hospital resources. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach. TRIAL REGISTRATION: NCT05221281. Registry: ClinicalTrials.gov. Date of registration: February 2, 2022. https://clinicaltrials.gov/ct2/show/NCT05221281 .

Development and Validation of the Gastrointestinal Unhelpful Thinking Scale (GUTs): A Brief Self-Report Measure for Clinical and Research Settings.

This article describes the development and validation of the Gastrointestinal Unhelpful Thinking scale. The purpose of the research was to develop the Gastrointestinal Unhelpful Thinking scale to assess in tandem the primary cognitive-affective drivers of brain-gut dysregulation, gastrointestinal-specific visceral anxiety, and pain catastrophizing. The research involved 3 phases which included undergraduate and community samples. In the first phase, an exploratory factor analysis revealed a 15-item 2-factor (visceral sensitivity and pain catastrophizing) scale (N= 323), which then was confirmed in the second phase: N = 399, χ2(26) = 2.08, p = .001, Tucker-Lewis Index = 0.94, comparative fit index = 0.96, standardized root mean square residual = 0.05, and root mean square error of approximation = 0.07. Demonstrating convergent validity, Gastrointestinal Unhelpful Thinking scale total and subscales were strongly correlated with the modified Manitoba Index, Irritable Bowel Syndrome Symptom Severity Scale scores, Visceral Sensitivity Index, and the Pain Catastrophizing Scale. A third phase (N = 16) established test-retest reliability for the Gastrointestinal Unhelpful Thinking scale (total and subscales). The test-retest reliability correlation coefficient for the Gastrointestinal Unhelpful Thinking scale total score was .93 (p < .001) and for the subscales was .86 (p < .001) and .94 (p < .001), respectively. The Gastrointestinal Unhelpful Thinking scale is a brief psychometrically valid measure of visceral anxiety and pain catastrophizing that can be useful for both clinicians and researchers who wish to measure these thinking patterns and relate them to changes in gastrointestinal and psychological symptoms.

AGA Clinical Practice Update on Management of Chronic Gastrointestinal Pain in Disorders of Gut-Brain Interaction: Expert Review.

DESCRIPTION: This expert review summarizes approaches to management of pain in disorders of gut-brain interaction. This review focuses specifically on approaches to pain that persist if first-line therapies aimed at addressing visceral causes of pain are unsuccessful. The roles of a therapeutic patient-provider relationship, nonpharmacologic and pharmacologic therapies, and avoidance of opioids are discussed. METHODS: This was not a formal systematic review but was based on a review of the literature to provide best practice advice statements. No formal rating of the quality of evidence or strength of recommendation was performed. BEST PRACTICE ADVICE 1: Effective management of persistent pain in disorders of gut-brain interaction requires a collaborative, empathic, culturally sensitive, patient-provider relationship. BEST PRACTICE ADVICE 2: Providers should master patient-friendly language about the pathogenesis of pain, leveraging advances in neuroscience and behavioral science. Providers also must understand the psychological contexts in which pain is perpetuated. BEST PRACTICE ADVICE 3: Opioids should not be prescribed for chronic gastrointestinal pain because of a disorder of gut-brain interaction. If patients are referred on opioids, these medications should be prescribed responsibly, via multidisciplinary collaboration, until they can be discontinued. BEST PRACTICE ADVICE 4: Nonpharmacologic therapies should be considered routinely as part of comprehensive pain management, and ideally brought up early on in care. BEST PRACTICE ADVICE 5: Providers should optimize medical therapies that are known to modulate pain and be able to differentiate when gastrointestinal pain is triggered by visceral factors vs centrally mediated factors. BEST PRACTICE ADVICE 6: Providers should familiarize themselves with a few effective neuromodulators, knowing the dosing, side effects, and targets of each and be able to explain to the patient why these drugs are used for the management of persistent pain.

The Role of Resilience in Irritable Bowel Syndrome, Other Chronic Gastrointestinal Conditions, and the General Population.

BACKGROUND & AIMS: Resilience is the ability to adapt positively to stress and adversity. It is a potential therapeutic target as it is reduced in irritable bowel syndrome (IBS) compared to healthy controls and associated with worse symptom severity and poorer quality of life. The aim of this study was to examine if these findings are generalizable by comparing resilience between IBS versus the general population and other chronic gastrointestinal (GI) conditions. METHODS: Participants in the general population completed an online survey containing questionnaires measuring demographics, diagnosis of IBS and other GI conditions, symptom severity, psychological symptoms, resilience, and early adverse life events (EALs). IBS was defined as having a physician diagnosis of IBS and/or meeting Rome criteria without co-morbid GI disease. All others were included in the general population group. The chronic GI conditions group included those with inflammatory bowel disease, celiac disease and/or microscopic colitis. RESULTS: Resilience was lower in IBS (n = 820) than the general population (n = 1026; p < 0.001) and associated with worse IBS symptom severity (p < 0.05). Global mental health affected resilience differently in IBS compared to the general population (all p's < 0.05). EALs were associated with decreased ability to bounce back from adversity in both IBS and the general population (p < 0.001). Resilience scores were similar in IBS and other chronic GI conditions that present with similar symptoms. CONCLUSIONS: Resilience is lower compared to the general U.S. population but does not appear to be specific to IBS as it is comparable to other chronic GI conditions. Low resilience negatively affects symptom severity and mental health and thus, may serve as a novel therapeutic target.

ACG Clinical Guideline: Management of Irritable Bowel Syndrome.

Irritable bowel syndrome (IBS) is a highly prevalent, chronic disorder that significantly reduces patients' quality of life. Advances in diagnostic testing and in therapeutic options for patients with IBS led to the development of this first-ever American College of Gastroenterology clinical guideline for the management of IBS using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Twenty-five clinically important questions were assessed after a comprehensive literature search; 9 questions focused on diagnostic testing; 16 questions focused on therapeutic options. Consensus was obtained using a modified Delphi approach, and based on GRADE methodology, we endorse the following: We suggest that a positive diagnostic strategy as compared to a diagnostic strategy of exclusion be used to improve time to initiating appropriate therapy. We suggest that serologic testing be performed to rule out celiac disease in patients with IBS and diarrhea symptoms. We suggest that fecal calprotectin be checked in patients with suspected IBS and diarrhea symptoms to rule out inflammatory bowel disease. We recommend a limited trial of a low fermentable oligosaccharides, disacchardies, monosaccharides, polyols (FODMAP) diet in patients with IBS to improve global symptoms. We recommend the use of chloride channel activators and guanylate cyclase activators to treat global IBS with constipation symptoms. We recommend the use of rifaximin to treat global IBS with diarrhea symptoms. We suggest that gut-directed psychotherapy be used to treat global IBS symptoms. Additional statements and information regarding diagnostic strategies, specific drugs, doses, and duration of therapy can be found in the guideline.

Contrasting Clinician and Insurer Perspectives to Managing Irritable Bowel Syndrome: Multilevel Modeling Analysis.

INTRODUCTION: Insurance coverage is an important determinant of treatment choice in irritable bowel syndrome (IBS), often taking precedence over desired mechanisms of action or patient goals/values. We aimed to determine whether routine and algorithmic coverage restrictions are cost-effective from a commercial insurer perspective. METHODS: A multilevel microsimulation tracking costs and outcomes among 10 million hypothetical moderate-to-severe patients with IBS was developed to model all possible algorithms including common global IBS treatments (neuromodulators; low fermentable oligo-, di-, and mono-saccharides, and polyols; and cognitive behavioral therapy) and prescription drugs treating diarrhea-predominant IBS (IBS-D) or constipation-predominant IBS (IBS-C) over 1 year. RESULTS: Routinely using global IBS treatments (central neuromodulator; low fermentable oligo-, di-, and mono-saccharides, and polyols; and cognitive behavioral therapy) before US Food and Drug Administration-approved drug therapies resulted in per-patient cost savings of $9,034.59 for IBS-D and $2,972.83 for IBS-C over 1 year to insurers, compared with patients starting with on-label drug therapy. Health outcomes were similar, regardless of treatment sequence. Costs varied less than $200 per year, regardless of the global IBS treatment order. The most cost-saving and cost-effective IBS-D algorithm was rifaximin, then eluxadoline, followed by alosetron. The most cost-saving and cost-effective IBS-C algorithm was linaclotide, followed by either plecanatide or lubiprostone. In no scenario were prescription drugs routinely more cost-effective than global IBS treatments, despite a stronger level of evidence with prescription drugs. These findings were driven by higher prescription drug prices as compared to lower costs with global IBS treatments. DISCUSSION: From an insurer perspective, routine and algorithmic prescription drug coverage restrictions requiring failure of low-cost behavioral, dietary, and off-label treatments appear cost-effective. Efforts to address insurance coverage and drug pricing are needed so that healthcare providers can optimally care for patients with this common, heterogenous disorder.

High-Dose Opioid Use Among Veterans with Unexplained Gastrointestinal Symptoms Versus Structural Gastrointestinal Diagnoses.

BACKGROUND: In a cohort of Veterans dually enrolled in the Department of Veterans Affairs (VA) and Medicare Part D, we sought to describe high-dose daily opioid use among Veterans with unexplained gastrointestinal (GI) symptoms and structural GI diagnoses and examine factors associated with high-dose use. METHODS: We used linked national patient-level data from the VA and Centers for Medicare and Medicaid Services (CMS). We grouped patients into 3 subsets: those with unexplained GI symptoms (e.g., chronic abdominal pain); structural GI diagnoses (e.g., chronic pancreatitis); and those with a concurrent unexplained GI symptom and structural GI diagnosis. High-dose daily opioid use levels were examined as a binary variable [≥ 100 morphine milligram equivalents (MME)/day] and as an ordinal variable (50-99 MME/day, 100-119 MME/day, or ≥ 120 MME/day). RESULTS: We identified 141,805 chronic GI patients dually enrolled in VA and Part D. High-dose opioid use was present in 11% of Veterans with unexplained GI symptoms, 10% of Veterans with structural GI diagnoses, and 15% of Veterans in the concurrent GI group. Compared to Veterans with only an unexplained GI symptom or structural diagnosis, concurrent GI patients were more likely to have higher daily opioid doses, more opioid days ≥ 100 MME, and higher risk of chronic use. Factors associated with high-dose use included opioid receipt from both VA and Part D, younger age, and benzodiazepine use. CONCLUSIONS: A significant subset of chronic GI patients in the VA are high-dose opioid users. Efforts are needed to reduce high-dose use among Veterans with concurrent GI symptoms and diagnoses.