Consensus Statement on Managing Anxiety and Depression in Individuals with Inflammatory Bowel Disease.

BACKGROUND: Studies have found a higher risk of comorbid anxiety and depression among patients with inflammatory bowel disease (IBD) compared with healthy individuals. If left untreated, comorbid depression and anxiety in patients with IBD can lead to poorer health outcomes and an increased healthcare utilization. The goal of this work was to develop a consensus statement to begin to address patient and provider needs and responsibilities related to screening and treatment of depression and anxiety symptoms among patients with IBD. METHODS: A literature scan was conducted to gather evidence-based background information and recommendations on the screening, diagnosis, and treatment of anxiety and depression in patients with IBD. This was followed by the engagement of a panel of IBD and mental health experts and patient advocates using a modified Delphi process to synthesize the literature and distill the information into a core set of statements to support provider actions and care delivery. RESULTS: Six statements were distilled from the literature and consensus process that link to the general management, screening, and treatment of anxiety and depression in patients with IBD. CONCLUSIONS: Mental healthcare and support for IBD patients is critical; the statements included in this article represent practical considerations for IBD healthcare professionals in addressing key issues on provider awareness, knowledge and behaviors, screening and treatment resources, and patient education.

This work aimed to develop a consensus statement on screening and treatment of anxiety and depression in individuals with inflammatory bowel disease. A literature scan was conducted, and an expert panel developed practical statements to guide inflammatory bowel disease healthcare professionals.

Communicating Information Regarding IBD Remission to Patients: Evidence From a Survey of Adult Patients in the United States.

BACKGROUND: Previous research suggests patients living with inflammatory bowel disease (IBD) understand IBD remission differently than healthcare professionals, which could influence patient expectations and clinical outcomes. We investigated 3 questions to better understand this: (1) How do patients currently understand remission; (2) Do patients currently face any barriers to communicating with their healthcare professional about remission; and (3) Can existing educational material be improved to help patients feel more prepared to discuss remission and treatment goals with their healthcare professional? METHODS: We sent a web-based survey to adult patients with IBD in the United States. This survey included an educational experiment where patients were randomly assigned to 1 of 3 improved versions of existing educational material. RESULTS: In total, 1495 patients with IBD completed the survey. The majority of patients (67%) agreed that remission is possible in IBD, but there was significant diversity in how they defined it with the most common being "my symptoms are reduced" (22%) and "I am no longer experiencing any symptoms" (14%). Patients reported being able to communicate openly with their healthcare professionals. Exposure to improved educational material did not have a statistically significant effect on patients' feelings of preparedness for discussing different aspects of their care with their healthcare professionals. CONCLUSIONS: Our study confirms that patients tend to define remission in terms of resolving symptoms. We found little evidence of barriers preventing patients from discussing remission with their healthcare professionals. This suggests that educational material could be used to resolve this discrepancy in understanding.

We surveyed 1495 patients with inflammatory bowel disease (IBD). We found that patients tend to define IBD remission in terms of resolving symptoms and that there is little evidence of barriers preventing patients from discussing remission with their healthcare professionals.

Opioid Use Associated With Higher Costs Among Patients With Inflammatory Bowel Disease.

Background: Opioid use by patients with inflammatory bowel disease (IBD) has been associated with poorer health outcomes. This study describes socioeconomic characteristics; health utilization trends; and costs of patients with IBD and either no opioid prescriptions, or in 1 of 3 opioid duration categories based on Center for Disease Control guidelines: acute (0-30 days), moderate (31-90 days), or chronic (>90 days). We utilized the Cost of IBD Care Optum research database results for this study. Methods: The Optum Research Database from years 2007 to 2016 including IBD patients with commercial or Medicare Advantage insurance in the United States was used. Additional inclusion criteria included continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before and 12 months after the index date of IBD diagnosis). The association between costs and patient characteristics were assessed across a no opioid use group during this period and the 3 opioid duration groups. Results: Among 51,178 IBD patients, 33,229 (64.93%) were part of the no opioid use group, while 13,635 (26.64%) were in acute, 1698 (3.32%) were in moderate, and 2616 (5.11%) were in chronic use groups, as determined by pharmacy claims data. Patients in the chronic group were more likely to be white (75.38%) compared to all the other groups (no opioid use, acute, and moderate), have attained less education (only high school diploma), have had lower incomes, and have had Medicare instead of commercial insurance. Patients across all opioid prescription groups were more likely to have had diagnoses associated with pain in the prior year, with rates increasing by the length of opioid prescription (63.68%, 80.17%, and 86.11% for acute, moderate, and chronic groups). Compared to the no-use group, the acute group had more ambulatory (outpatient) visits, while the chronic group had fewer. Emergency department visits and inpatient hospitalizations were higher in all 3 opioid groups compared to the no opioid use group. Ambulatory, emergency department, inpatient, and total (medical + pharmacy) costs were higher in all 3 opioid groups, compared to the no opioid use group, even after adjusting for demographic and clinical patient characteristics. Conclusions: Among patients with IBD, increasing opioid use was associated with higher healthcare resource utilization and, concomitantly, higher healthcare costs during this period.

Mental Health Costs of Inflammatory Bowel Diseases.

BACKGROUND: Mental health diagnoses (MHDs) were identified as significant drivers of inflammatory bowel disease (IBD)-related costs in an analysis titled "Cost of Care Initiative" supported by the Crohn's & Colitis Foundation. In this subanalysis, we sought to characterize and compare IBD patients with and without MHDs based on insurance claims data in terms of demographic traits, medical utilization, and annualized costs of care. METHODS: We analyzed the Optum Research Database of administrative claims from years 2007 to 2016 representing commercially insured and Medicare Advantage insured IBD patients in the United States. Inflammatory bowel disease patients with and without an MHD were compared in terms of demographics (age, gender, race), insurance type, IBD-related medical utilization (ambulatory visits, emergency department [ED] visits, and inpatient hospitalizations), and total IBD-related costs. Only patients with costs >$0 in each of the utilization categories were included in the cost estimates. RESULTS: Of the total IBD study cohort of 52,782 patients representing 179,314 person-years of data, 22,483 (42.6%) patients had at least 1 MHD coded in their claims data with a total of 46,510 person-years in which a patient had a coded MHD. The most commonly coded diagnostic categories were depressive disorders, anxiety disorders, adjustment disorders, substance use disorders, and bipolar and related disorders. Compared with patients without an MHD, a significantly greater percentage of IBD patients with MHDs were female (61.59% vs 48.63%), older than 75 years of age (9.59% vs 6.32%), white (73.80% vs 70.17%), and significantly less likely to be younger than 25 years of age (9.18% vs 11.39%) compared with those without mental illness (P < 0.001). Patients with MHDs had significantly more ED visits (14.34% vs 7.62%, P < 0.001) and inpatient stays (19.65% vs 8.63%, P < 0.001) compared with those without an MHD. Concomitantly, patients with MHDs had significantly higher ED costs ($970 vs $754, P < 0.001) and inpatient costs ($39,205 vs $29,550, P < 0.001) compared with IBD patients without MHDs. Patients with MHDs also had significantly higher total annual IBD-related surgical costs ($55,693 vs $40,486, P < 0.001) and nonsurgical costs (medical and pharmacy) ($17,220 vs $11,073, P < 0.001), and paid a larger portion of the total out-of-pocket cost for IBD services ($1017 vs $905, P < 0.001). CONCLUSION: Patients whose claims data contained both IBD-related and MHD-related diagnoses generated significantly higher costs compared with IBD patients without an MHD diagnosis. Based on these data, we speculate that health care costs might be reduced and the course of patients IBD might be improved if the IBD-treating provider recognized this link and implemented effective behavioral health screening and intervention as soon as an MHD was suspected during management of IBD patients. Studies investigating best screening and intervention strategies for MHDs are needed.

Development of Entrustable Professional Activities for Advanced Inflammatory Bowel Disease Fellowship Training in the United States.

BACKGROUND: The level of inflammatory bowel disease (IBD) training in general gastroenterology fellowship is often insufficient to prepare trainees to deliver advanced IBD care in practice. Advanced IBD fellowships have been developed to fill this training gap, but there is no established curriculum, and significant variability exists across programs. Entrustable professional activities (EPAs) are practical and realistic objectives that define essential tasks of a specialty that physicians should master to be competent during independent practice. The American College of Gastroenterology (ACG) and Crohn's & Colitis Foundation (Foundation) established a task force to develop and appraise EPAs for advanced IBD fellowship. METHODS: Entrustable professional activities were developed using a multistep approach in a similar manner to other specialties. Initial EPAs identified via focus groups were evaluated, critiqued, and changed using an iterative model of feedback. The final EPAs were selected after the task force conducted a 3-phase modified Delphi method consisting of 2 sequential rounds of web-based voting and an in-person consensus meeting. RESULTS: Ten EPAs for advanced IBD fellowship were established including detailed descriptions with the associated knowledge, skills, and attitudes for each that can serve as curricular milestones. CONCLUSION: Ten EPAs describing the core work of an advanced IBD fellowship-trained physician have been established by a multisociety task force. Creating EPAs for an advanced curriculum comes with unique challenges, particularly the need to prevent duplication of prior training competencies while demonstrating the potential for unique milestones.

The Cost of Inflammatory Bowel Disease: An Initiative From the Crohn's & Colitis Foundation.

BACKGROUND: The Crohn's & Colitis Foundation's Cost of Inflammatory Bowel Disease (IBD) Care Initiative seeks to quantify the wide-ranging health care costs affecting patients living with IBD. We aimed to (1) describe the annualized direct and indirect costs of care for patients with Crohn's disease (CD) or ulcerative colitis (UC), (2) determine the longitudinal drivers of these costs, and (3) characterize the cost of care for newly diagnosed patients. METHODS: We analyzed the Optum Research Database from the years 2007 to 2016, representing commercially insured and Medicare Advantage-insured patients in the United States. Inclusion for the study was limited to those who had continuous enrollment with medical and pharmacy benefit coverage for at least 24 months (12 months before through 12 months after the index date of diagnosis). The value of patient time spent on health care was calculated as number of workplace hours lost due to health care encounters multiplied by the patients' estimated average wage derived from the Bureau of Labor Statistics. Comparisons between IBD patients and non-IBD patients were analyzed based on demographics, health plan type, and length of follow-up. We used generalized linear models to estimate the association between total annual costs and various patient variables. RESULTS: There were 52,782 IBD patients (29,062 UC; 23,720 CD) included in the analysis (54.1% females). On a per-annual basis, patients with IBD incurred a greater than 3-fold higher direct cost of care compared with non-IBD controls ($22,987 vs $6956 per-member per-year paid claims) and more than twice the out-of-pocket costs ($2213 vs $979 per-year reported costs), with all-cause IBD costs rising after 2013. Patients with IBD also experienced significantly higher costs associated with time spent on health care as compared with controls. The burden of costs was most notable in the first year after initial IBD diagnosis (mean = $26,555). The study identified several key drivers of cost for IBD patients: treatment with specific therapeutics (biologics, opioids, or steroids); ED use; and health care services associated with relapsing disease, anemia, or mental health comorbidity. CONCLUSION: The costs of care for IBD have increased in the last 5 years and are driven by specific therapeutics and disease features. In addition, compared with non-IBD controls, IBD patients are increasingly incurring higher costs associated with health care utilization, out-of-pocket expenditures, and workplace productivity losses. There is a pressing need for cost-effective strategies to address these burdens on patients and families affected by IBD.

Preferences of Adult Patients With Inflammatory Bowel Disease for Attributes of Clinical Trials: Evidence From a Choice-Based Conjoint Analysis.

Background: Clinical trial recruitment is the rate-limiting step in developing new treatments. To understand inflammatory bowel disease (IBD) patient recruitment, we investigated two questions: Do changes in clinical trial attributes, like monetary compensation, influence recruitment rates, and does this influence differ across subgroups? Methods: We answered these questions through a conjoint survey of 949 adult IBD patients. Results: Recruitment rates are influenced by trial attributes: small but significant increases are predicted with lower placebo rates, reduced number of endoscopies, less time commitment, open label extension, and increased involvement of participant's primary GI physician. A much stronger effect was found with increased monetary compensation. Latent class analysis indicated three patient subgroups: some patients quite willing to participate in IBD trials, some quite reluctant, and others who can be persuaded. The persuadable group is quite sensitive to monetary compensation, and payments up to US$2,000 for a 1-year study could significantly increase recruitment rates for IBD clinical trials. Conclusions: This innovative study provides researchers with a framework for predicting recruitment rates for different IBD clinical trials.

Assessment of Gaps in Care and the Development of a Care Pathway for Anemia in Patients with Inflammatory Bowel Diseases.

BACKGROUND: Anemia is a common complication among patients with inflammatory bowel diseases (IBD) and is associated with high rates of IBD-related complications, resource utilization, and impaired quality of life. Despite practice guidelines for anemia in patients with IBD, gaps remain in the perceptions of anemia among health care providers. The aims of this study were to identify gaps in care and to develop a care pathway for anemia in patients with IBD. METHODS: The Crohn's & Colitis Foundation of America anemia care pathway was developed by a committee using principles of cognitive task analysis. Focus groups of providers of patients with IBD were performed to identify domains of perceptions and management decisions for anemia and IBD. Knowledge elicitation from subject experts in anemia was conducted using case-based scenarios of patients with IBD and anemia to determine decision-making branch points. The care pathway was modified in an iterative fashion to encompass clinical presentations of anemia in IBD and potential barriers to the recognition, management, and follow-up of anemia. RESULTS: Variations were observed in how providers define iron deficiency, thresholds for treatment of anemia, and route of iron therapy. A care pathway for anemia incorporating the World Health Organization definition of anemia, universal hemoglobin and ferritin screening, evaluation of iron stores using ferritin and transferrin saturation, management of anemia based on adequacy of iron stores, and follow-up was developed. CONCLUSIONS: The authors identified domains of how providers perceive and manage patients with IBD and anemia, and developed a care pathway to align clinical practices with guideline recommendations.

Knowledge, Attitudes, and Beliefs Regarding the Role of Nutrition in IBD Among Patients and Providers.

BACKGROUND: Malnutrition is common in inflammatory bowel disease (IBD). Identifying patients who are malnourished or at risk for malnutrition may lead to early intervention and improve patient outcomes. To date, little is known about the role of nutritional assessment and management in IBD care. We aimed to evaluate knowledge, attitudes, and beliefs regarding nutrition in IBD among patients and providers. METHODS: Surveys were mailed electronically to patients and providers identified through their membership in the Crohn's & Colitis Foundation of America. In addition, patient and provider focus groups were conducted to explore nutrition-related themes. These surveys and focus groups were designed to evaluate knowledge and perceived importance of nutrition, patient-provider interactions regarding nutrition and use of nutritional resources. RESULTS: There were 223 provider respondents (65.5% gastroenterologists, 15.2% nurses, and 6.7% dietitians). Forty-one percent of the gastroenterologists rated their knowledge of nutrition in IBD as "very good" compared with 87% of dietitians and 16% of nurses (P < 0.001). Thirty-three percent of the gastroenterologists reported not routinely screening their IBD patients for malnutrition. The patient survey had 567 respondents with 27% rating their knowledge of nutrition in IBD as "very good." In the focus groups, a lack of adequate IBD nutritional resources was evident along with a desire for improved access to nutrition specialists. CONCLUSIONS: Significant gaps in knowledge relating to nutrition in IBD seem to exist. Targeted educational initiatives and improved access to nutritional experts are warranted. In addition, a standardized process for the assessment of malnutrition among patients with IBD should be developed.