Assessment of Real-World Patient-Reported Outcomes in Patients Initiating Biologic Agents for the Treatment of Autoimmune Diseases: An Observational Study in Four Patient-Powered Research Networks.

Background: The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement. Methods: PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant. Results: There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher. Conclusion: As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.

Computerized-adaptive testing versus short forms for pediatric inflammatory bowel disease patient-reported outcome assessment.

Introduction: Computerized-adaptive testing (CAT) may increase reliability or reduce respondent burden for assessing patient-reported outcomes compared with static short forms (SFs). We compared CAT versus SF administration of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric measures in pediatric inflammatory bowel disease (IBD). Methods: Participants completed 4-item CAT, 5- or 6-item CAT, and 4-item SF versions of the PROMIS Pediatric measures. We compared average T-scores, intra-class correlations (ICCs), floor and ceiling effects, and standard error of measurement (SEM) across forms, along with mean effect sizes between active versus quiescent IBD disease activity groups. Results: Average PROMIS T-scores across forms were <3 points (minimally important difference) of each other. All forms correlated highly with each other (ICCs ≥0.90) and had similar ceiling effects, but the CAT-5/6 had lower floor effects. The CAT-5/6 had lower SEM than the CAT-4 and SF-4, and the CAT-4 had a lower SEM than the SF-4. Mean effect sizes were similar across forms when contrasting disease activity groups. Conclusions: The CAT and SF forms produced similar score results, but the CAT had better precision and lower floor effects. Researchers should consider PROMIS pediatric CAT if they anticipate that their sample will skew toward symptom extremes.

Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned.

PURPOSE: We assessed the suitability of pooled electronic health record (EHR) data from clinical research networks (CRNs) of the patient-centered outcomes research network to conduct studies of the association between tumor necrosis factor inhibitors (TNFi) and infections. METHODS: EHR data from patients with one of seven autoimmune diseases were obtained from three CRNs and pooled. Person-level linkage of CRN data and Centers for Medicare and Medicaid Services (CMS) fee-for-service claims data was performed where possible. Using filled prescriptions from CMS claims data as the gold standard, we assessed the misclassification of EHR-based new (incident) user definitions. Among new users of TNFi, we assessed subsequent rates of hospitalized infection in EHR and CMS data. RESULTS: The study included 45 483 new users of TNFi, of whom 1416 were successfully linked to their CMS claims. Overall, 44% of new EHR TNFi prescriptions were not associated with medication claims. Our most specific new user definition had a misclassification rate of 3.5%-16.4% for prevalent use, depending on the medication. Greater than 80% of CRN prescriptions had either zero refills or missing refill data. Compared to using EHR data alone, there was a 2- to 8-fold increase in hospitalized infection rates when CMS claims data were added to the analysis. CONCLUSIONS: EHR data substantially misclassified TNFi exposure and underestimated the incidence of hospitalized infections compared to claims data. EHR-based new user definitions were reasonably accurate. Overall, using CRN data for pharmacoepidemiology studies is challenging, especially for biologics, and would benefit from supplementation by other sources.

The cost of inflammatory bowel disease in high-income settings: a Lancet Gastroenterology & Hepatology Commission.

The cost of caring for patients with inflammatory bowel disease (IBD) continues to increase worldwide. The cause is not only a steady increase in the prevalence of Crohn's disease and ulcerative colitis in both developed and newly industrialised countries, but also the chronic nature of the diseases, the need for long-term, often expensive treatments, the use of more intensive disease monitoring strategies, and the effect of the diseases on economic productivity. This Commission draws together a wide range of expertise to discuss the current costs of IBD care, the drivers of increasing costs, and how to deliver affordable care for IBD in the future. The key conclusions are that (1) increases in health-care costs must be evaluated against improved disease management and reductions in indirect costs, and (2) that overarching systems for data interoperability, registries, and big data approaches must be established for continuous assessment of effectiveness, costs, and the cost-effectiveness of care. International collaborations should be sought out to evaluate novel models of care (eg, value-based health care, including integrated health care, and participatory health-care models), as well as to improve the education and training of clinicians, patients, and policy makers.

A systematic review of epidemiology and outcomes of Crohn's disease-related enterocutaneous fistulas.

BACKGROUND: Enterocutaneous fistulas (ECF) are rare sequelae of Crohn's disease (CD) that occur either postoperatively or spontaneously. ECFs are associated with high morbidity and mortality. This systematic literature review assesses the disease burden of CD-related ECF and identifies knowledge gaps around incidence/prevalence, treatment patterns, clinical outcomes, healthcare resource utilization (HCRU), and patient-reported outcomes (PROs). METHODS: English language articles published in PubMed and Embase in the past 10 years that provided data and insight into the disease burden of CD-related ECF (PROSPERO Registration number: CRD42020177732) were identified. Prespecified search and eligibility criteria guided the identification of studies by two reviewers who also assessed risk of bias. RESULTS: In total, 582 records were identified; 316 full-text articles were assessed. Of those, eight studies met a priori eligibility criteria and underwent synthesis for this review. Limited epidemiologic data estimated a prevalence of 3265 persons with ECF in the USA in 2017. Clinical response to interventions varied, with closure of ECF achieved in 10% to 62.5% of patients and recurrence reported in 0% to 50% of patients. Very little information on HCRU is available, and no studies of PROs in this specific population were identified. CONCLUSION: The frequency, natural history, and outcomes of ECF are poorly described in the literature. The limited number of studies included in this review suggest a high treatment burden and risk of substantial complications. More robust, population-based research is needed to better understand the epidemiology, natural history, and overall disease burden of this rare and debilitating complication of CD.

A systematic review of the patient burden of Crohn's disease-related rectovaginal and anovaginal fistulas.

BACKGROUND: Crohn's disease (CD)-related rectovaginal fistulas (RVFs) and anovaginal fistulas (AVFs) are rare, debilitating conditions that present a substantial disease and treatment burden for women. This systematic literature review (SLR) assessed the burden of Crohn's-related RVF and AVF, summarizing evidence from observational studies and highlighting knowledge gaps. METHODS: This SLR identified articles in PubMed and Embase that provide data and insight into the patient experience and disease burden of Crohn's-related RVF and AVF. Two trained reviewers used pre-specified eligibility criteria to identify studies for inclusion and evaluate risk of bias using the Risk Of Bias In Non-randomized Studies of Interventions (ROBINS-I) tool for observational studies. RESULTS: Of the 582 records identified, 316 full-text articles were assessed, and 16 studies met a priori eligibility criteria and were included. Few epidemiology studies were identified, with one study estimating the prevalence of RVF to be 2.3% in females with Crohn's disease. Seven of 12 treatment pattern studies reported that patients had or required additional procedures before and/or after the intervention of interest, demonstrating a substantial treatment burden. Seven of 11 studies assessing clinical outcomes reported fistula healing rates between 50 and 75%, with varying estimates based on population and intervention. CONCLUSIONS: This SLR reports the high disease and treatment burden of Crohn's-related RVF and AVF and identifies multiple evidence gaps in this field. The literature lacks robust, generalizable data, and demonstrates a compelling need for substantial, novel research into these rare and debilitating sequelae of CD. Registration The PROSPERO registration number for the protocol for this systematic literature review is CRD42020177732.

Patients With Pouchitis Demonstrate a Significant Cost Burden in the First Two Years After Ileal Pouch-Anal Anastomosis.

Pouchitis, the most common long-term complication after colectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC), can lead to increased health care costs and diminished quality of life.1 In this study, we aimed to compare the total costs among patients diagnosed with pouchitis in the first 2 years after an IPAA with those among patients who were not diagnosed with pouchitis, using a large administrative claims database. Additionally, we aimed to investigate the specific drivers of cost among patients with an IPAA during the 2-year study period, including inpatient hospitalizations, emergency department visits, and pharmacy-related costs.

Vedolizumab Is Associated With a Lower Risk of Serious Infections Than Anti-Tumor Necrosis Factor Agents in Older Adults.

BACKGROUND & AIMS: Despite the increased numbers of older adults with inflammatory bowel diseases (IBDs), there are few studies regarding the safety and effectiveness of IBD treatments in older adults. The aim of this study was to compare the safety and effectiveness of anti-tumor necrosis factor (TNF)-α agents and vedolizumab in older adults with IBD. METHODS: We conducted a retrospective cohort study using an active comparator, new-user design for adults age 65 years and older with IBD initiating anti-TNF-α agents and vedolizumab in the Medicare claims database from 2014 to 2017. The primary safety outcome was infection-related hospitalization (excluding intra-abdominal and perianal abscesses). Co-primary outcomes to estimate effectiveness were IBD-related hospitalization, IBD-related surgery, and new corticosteroid use 60 days or more after biologic initiation. We performed propensity score weighting to control for confounding and estimated adjusted hazard ratios and 95% confidence intervals using standardized morbidity ratio-weighted variables. RESULTS: We identified 1152 anti-TNF-α new users and 480 vedolizumab new users. The median age was 71 years in both cohorts and 11% were age 80 years or older. Crohn's disease patients comprised 54% of the anti-TNF-α cohort and 57% of the vedolizumab cohort. There was no significant difference in demographics, health care utilization, or frailty in both cohorts. More than half of both cohorts had a Charlson comorbidity index of 2 or higher. Vedolizumab users had a decreased risk of infection-related hospitalization (adjusted hazard ratio, 0.47; 95% confidence interval, 0.25-0.86). There was no significant difference in the outcomes approximating effectiveness. CONCLUSIONS: Older IBD patients treated with vedolizumab had a lower risk of infection-related hospitalization compared with those initiating anti-TNFs. We observed no difference in effectiveness defined by hospitalizations, surgery, or new corticosteroid use.

Trajectories of the Transition Readiness Assessment Questionnaire Among Youth With Inflammatory Bowel Disease.

OBJECTIVE: The objective of this study was to describe in detail the trends of the Transition Readiness Assessment Questionnaire (TRAQ-20) with respect to patient age and gender among a cohort of 655 youth with inflammatory bowel disease (IBD) to enhance the tool's utility in clinical and research settings. MATERIALS AND METHODS: All participants in the Crohn's and Colitis Foundation's IBD Partners and IBD Partners Kids and Teens Cohorts ages 12 to 21 who completed the TRAQ-20 at least once were included. We computed centile scores for the TRAQ-20 and applied Kernel regression to generate curves. We computed mean scores for each TRAQ-20 domain by age for the overall cohort and stratified by gender. RESULTS: TRAQ-20 scores generally increase with age. Males have a steeper trajectory from ages 17 to 19 compared with females. By age 21, median overall TRAQ-20 scores for women and men were 4.4 and 4.7, respectively. The "Talking with Providers" domain of the TRAQ-20 had high scores throughout the age range of the cohort, while others had lower scores in younger ages and higher scores in older ages. All TRAQ-20 domains had mean scores of 4 or greater (out of a possible 5) among 21-year-olds. CONCLUSIONS: TRAQ-20 scores increase with age. The rate of increase varies by gender. Rates of increase also differ across domains. The use of transition readiness growth curves can help providers and researchers identify patients who are not achieving expected levels of transition readiness and determine the level of transition readiness that a patient much achieve before transfer to adult care.

Risks of Development of COVID-19 Among Patients With Inflammatory Bowel Disease: A Comparative Assessment of Risk Factors for Incident Infection.

Background: Patients with inflammatory bowel disease (IBD) may be at risk for development of COVID-19 infection due to innate immune dysfunction and/or immunosuppressive medication use. Methods: In a prospective cohort of adult IBD patients, we captured data on clinical risk factors and IBD medication utilization. The outcome of interest was development of patient-reported laboratory confirmed COVID-19. We calculated incidence rate and performed bivariate analyses to describe the effects of risk factors (age, immunosuppression use, obesity, and race) on development of COVID-19. We utilized logistic regression models to determine the independent risks associated with each factor. Results: A total of 3953 patients with IBD were followed for a mean duration of 212 days (SD 157). A total of 103 individuals developed COVID-19 during follow-up (2.6%, rate of 45 per 1000 person-years). Severity of infection was generally mild. Clinical characteristics were similar among those who developed COVID-19 as compared to not. African American race was associated with incident COVID-19 infection (OR 3.37, 95% CI 1.18-9.59). Immunosuppression use was not associated with development of COVID-19 (OR 1.19, 95% CI 0.72-1.75), nor was age (OR 1.00, 95% CI 0.99-1.02), nor obesity (OR 1.01, 95% CI 0.61-1.66). Conclusions: Immunosuppression use did not increase the risk of development of COVID-19. Therapeutic management of IBD should not be altered to prevent a risk of developing COVID-19.

Community engagement during COVID: A field report from seven CTSAs.

INTRODUCTION: Prior to the COVID pandemic, many CTSAs employed face-to-face interactions to conduct most of their community engagement (CE) activities. During the COVID pandemic, such engagement had to be curtailed and alternatives needed to be formulated. In addition, Community Engaged Research (CEnR) teams refocused their efforts to address this public health crisis. METHODS: To obtain a general understanding of how CTSAs have conducted CE and CEnR during the COVID pandemic, we invited seven CTSA CE leaders to provide brief field reports of their activities during the pandemic. This included how their approaches to CE and CEnR were modified during the COVID-19 pandemic and key lessons learned. RESULTS: We found that despite numerous challenges, all seven CTSAs CE cores were able to successfully carry out CE and CEnR. We also found that the fundamental principles of meaningful and authentic stakeholder engagement were of paramount importance during the pandemic. Through virtual approaches, all sites had considerable success in maintaining CE in during the COVID pandemic. They also leveraged existing bi-directional community partnerships to carry out meaningful and impactful research. This included both new COVID CEnR and also innovative approaches to sustain prior non-COVID research. CONCLUSIONS: These findings suggest that academic-community partnerships must be fostered and sustained over the many years so that when such crises emerge, all partners can build on existing trust and mutual respect. The lessons learned and the new tools and approaches developed would be key in addressing any such future public health emergencies.

Association of Care Coordination Experience and Health Services Use with Main Provider Type for Children with Inflammatory Bowel Disease.

OBJECTIVES: To describe care coordination experience for families of children with inflammatory bowel disease (IBD) and compare use of health services between families who identified a primary care physician (PCP) vs a gastroenterologist as a child's main provider. STUDY DESIGN: This is a cross-sectional survey of care coordination experiences and health services use for children 6-19 years old receiving care in the IBD program at a children's hospital during 2018. English-speaking parents completed the Family Experiences with Coordination of Care Survey about their child's main provider and reported past-year health services. Bivariate testing and multivariate logistic regression explored differences in care coordination experience and health services by main provider, adjusted for demographic and clinical variables. RESULTS: A total of 113 of 270 (42%) invited patients participated. Among 101 patients with complete data, 41% identified a PCP main provider. Performance on 5 of 16 Family Experiences with Coordination of Care indicators was higher for patients reporting a gastroenterologist vs a PCP main provider. However, having a PCP vs gastroenterologist main provider was associated with greater use of any past-year primary care services (adjusted proportion 94% vs 75%; P = .01) and of mental health services when needed (95% vs 60%; P < .01). Need for IBD-related hospitalization and emergency department visits did not differ between groups. CONCLUSIONS: Children with IBD may experience trade-offs in care coordination quality and important, non-disease-focused health services based on whom parents perceive as the main provider. Efforts to enhance cross-team coordination among families and primary and specialty care teams are needed to improve overall care quality.

Utilization patterns and characteristics of users of biologic anti-inflammatory agents in a large, US commercially insured population.

We report utilization patterns and characteristics of patients treated with biologic anti-inflammatory agents in a large commercially insured patient population in the United States. We identified adult (age ≥18 years) patients receiving biologic anti-inflammatory agents between 1 January 2012 and 31 March 2019 across the five Research Partners in the Biologic and Biosimilars Collective Intelligence Consortium's Distributed Research Network. We examined the number of incident use episodes for each biologic, as well as patient demographic and clinical characteristics. Curated data and analytic tools from the Food and Drug Administration's Sentinel System were used to perform the analyses. We identified 90,360 incident episodes of tumor necrosis factor-alpha inhibitors (TNFi) and 70,506 incident episodes of non-TNFi medications. Adalimumab was the most common TNFi drug (47% of all TNFi episodes) and showed a steady increase in utilization during the study period compared to other TNFi agents. Rituximab was the most commonly initiated non-TNFi medication (44% of non-TNFi episodes). Other non-TNFi agents, namely, ustekinumab, vedolizumab, and secukinumab, demonstrated notable increases in utilization over time. Biosimilar use was limited; we observed 653 incident episodes for infliximab-dyyb and 39 incident episodes for infliximab-abda. As more biologics enter the market, greater variation in the use of biologics with similar indications and between biologic originators and biosimilars is anticipated. Because information on efficacy and safety at the time of drug approval is limited, post-marketing surveillance and research is needed to monitor medication safety and evaluate effectiveness between biologic drugs using real-world data.

Black and White Patients With Inflammatory Bowel Disease Show Similar Biologic Use Patterns With Medicaid Insurance.

BACKGROUND: Prior studies have identified racial disparities in the treatment and outcomes of inflammatory bowel disease (IBD). These disparities could be secondary to differences in biology, care delivery, or access to appropriate therapy. The primary aim of this study was to compare medication use among Medicaid-insured black and white patients with IBD, given uniform access to gastroenterologists and therapies. METHODS: We analyzed Medicaid Analytic eXtract data from 4 states (California, Georgia, North Carolina, and Texas) between 2006 and 2011. We compared the use of IBD-specific therapies, including analyses of postoperative therapy among patients with Crohn disease (CD). We performed bivariate analyses and multivariable logistic regression, adjusting for potential confounders. RESULTS: We identified 14,735 patients with IBD (4672 black [32%], 8277 with CD [58%]). In multivariable analysis, there was no significant difference in the odds of anti-tumor necrosis factor use by race for CD (adjusted odds ratio [aOR] = 1.13; 95% confidence interval [CI], 0.99-1.28] or ulcerative colitis (aOR = 1.12; 95% CI, 0.96-1.32). Black patients with CD were more likely than white patients to receive combination therapy (aOR = 1.50; 95% CI, 1.15-1.96), and black patients were more likely than white patients to receive immunomodulator monotherapy after surgery for CD (31% vs 18%; P = 0.004). CONCLUSIONS: In patients with Medicaid insurance, where access to IBD-specific therapy should be similar for all individuals, there was no significant disparity by race in the utilization of IBD-specific therapies. Disparities in IBD treatment discussed in prior literature seem to be driven by socioeconomic or other issues affecting access to care.

Transition Readiness Not Associated With Measures of Health in Youth With IBD.

BACKGROUND: It remains unclear how transition readiness is associated with various domains of health in children and young adults. Our objective was to describe the transition readiness of children and young adults with inflammatory bowel disease (IBD) and examine its associations with demographic factors, IBD activity, and measures of physical, psychological, and social health. METHODS: We recruited children ages 12 to 17 and young adults ages 18 to 20 from 2 internet-based cohorts sponsored by the Crohn's & Colitis Foundation. Participants self-reported demographics, IBD activity, transition readiness, health-related quality of life, and Patient-Reported Outcomes Information Systems domains of physical, psychological, and social health. RESULTS: Among 361 pediatric and 119 adult participants, age and female sex were associated with transition readiness. The association was greater in the pediatric cohort. Having IBD in remission was associated with worse transition readiness in the pediatric cohort only (beta = 0.3; P = 0.003). Health-related quality of life and Patient-Reported Outcomes Information Systems measures of fatigue, pain interference, and sleep disturbance were not associated with transition readiness in either children or adults. We observed few small associations between psychological or social health and transition readiness. Better transition readiness was associated with greater anxiety in adults (beta = -0.02; P = 0.02) and greater peer relationships among children (beta = 0.01; P = 0.009). CONCLUSIONS: In children and young adults with IBD, transition readiness was associated with older age and female sex. Associations between transition readiness and physical, psychological, and social health were either small, inconsistent across age groups, or nonexistent.

Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases.

Although Crohn's disease (CD) and ulcerative colitis (UC) have been considered as disorders that affect individuals of European ancestry, the epidemiology of the inflammatory bowel diseases (IBDs) is changing. Coupled with the increasing incidence of IBD in previously low-incidence areas, the population demographics of IBD in the United States are also changing, with increases among non-White races and ethnicities. It is therefore important to fully understand the epidemiology and progression of IBD in different racial and ethnic groups, and the effects of race and ethnicity on access to care, use of resources, and disease-related outcomes. We review differences in IBD development and progression among patients of different races and ethnicities, discussing the effects of factors such as access to care, delays in diagnosis, and health and disease perception on disparities in IBD care and outcomes. We identify research priorities for improving health equity among minority patients with IBD.

Patients Who Undergo Colectomy for Pediatric Ulcerative Colitis at Low-Volume Hospitals Have More Complications.

BACKGROUND & AIMS: Adults with ulcerative colitis (UC) who undergo colectomy at high-volume centers have better outcomes and fewer complications than those at low-volume centers. We aimed to evaluate the hospital volume of total abdominal colectomy (TAC) for pediatric patients with UC and explore time trends in the proportion of colectomies performed at high-volume centers. We then evaluated the association between hospital colectomy volume and complications. METHODS: We performed a cross-sectional analysis of pediatric patients (age, ≤18 y) hospitalized for UC using the Kids' Inpatient Database, a nationally representative database of pediatric hospitalizations. We identified UC hospitalizations with a procedural code (International Classification of Diseases, 9th or 10th revision) for TAC from 1997 through 2016. We defined complications using diagnosis codes adapted from published algorithms. We defined high-volume as hospitals that performed 10 or more TACs annually. We used multivariate statistics to evaluate the association between hospital volume and in-hospital complications. RESULTS: A total of 1453 hospitalizations of children with UC included a TAC (2306 colectomies nationwide). A total of 766 hospitals performed 1 or more annual colectomies and only 36 (4.7%) were high-volume hospitals, accounting for 21% of colectomies. The proportion of colectomies at high-volume hospitals decreased over time. The absolute risk of complication was 16% at high-volume centers compared with 22% at low-volume centers (adjusted odds ratio, 0.7; 95% CI, 0.5-0.9). The effect of annual TAC volume on complication risk was not statistically significant for nonemergent admissions. CONCLUSIONS: Pediatric patients with UC who undergo colectomy at high-volume centers have fewer complications. However, only a small proportion of pediatric colectomies (<5%) are performed at high-volume centers.

Multicenter Evaluation of Emergency Department Treatment for Children and Adolescents With Crohn's Disease According to Race/Ethnicity and Insurance Payor Status.

Background: Racial and socioeconomic disparities exist in the treatment and outcomes of children and adults with Crohn's disease (CD). This study investigated the impact of race and insurance status on emergency department (ED) evaluation and treatment among children with CD in the United States. Methods: Data from the Pediatric Health Information System included ED visits between January 2007 and December 2013 for patients aged ≤21 years with a primary diagnosis of CD, or a secondary diagnosis of CD plus a primary CD-related diagnosis. Analyses were performed using mixed-effects logistic regression. Results: Subjects included 2618 unique patients (black, 612 [23%]; white, 2006 [77%]) with 3779 visits from 38 hospitals, a median age of 14.0 ± 4.0 years, and 50% male. White children had a higher median neighborhood income and were more likely to have private insurance (57% vs 30%; P < 0.001). Emergency department visits for privately insured patients had higher odds of complete blood count (odds ratio [OR], 1.43; 95% CI, 1.08-1.90) and C-reactive protein/erythrocyte sedimentation rate (OR, 1.39; 95% CI, 1.06-1.82) vs Medicaid insured. Visits for white children had higher odds of receiving antiemetics (OR, 1.52; 95% CI, 1.06-2.17) vs black children. The proportion of patients with repeat visits was greater for black children (33%) than white children (22%; P < 0.001) and greater for Medicaid-insured (27%) than privately insured patients (21%; P < 0.01). Conclusions: This cross-sectional database study demonstrated that black children and those with Medicaid insurance made more ED visits and received somewhat fewer treatments, which may be explained by greater use of the ED for routine care. An opportunity exists for better outpatient management of children with IBD so that nonemergent problems are more effectively handled.

Lack of Difference in Treatment Patterns and Clinical Outcomes Between Black and White Patients With Inflammatory Bowel Disease.

Background: Previous reports have shown differences in phenotypes among black patients with inflammatory bowel disease (IBD) compared with other racial groups, but prior studies were limited by small numbers of black patients and cross-sectional analyses. We used data from the Sinai-Helmsley Alliance for Research Excellence cohort to compare phenotypes and treatment patterns of black and white patients with IBD in a prospective study. Methods: We compared phenotypes, IBD-specific therapies, and health care utilization among black and white patients with IBD. For all analyses, we performed bivariate analyses and multivariable logistic regression to adjust for potential confounders. Results: Among 5537 patients with IBD, 314 (6%) reported black race. Black patients were more likely to report a Crohn's disease (CD)-related complication at baseline (adjusted odds ratio [aOR], 1.44; 95% confidence interval [CI], 1.06-1.95). Black patients with CD were more likely to develop a new abscess (aOR, 2.27; 95% CI, 1.31-3.93) and initiate an anti-tumor necrosis factor therapy during follow-up (aOR, 1.85; 95% CI, 1.09-3.14). Black patients with ulcerative colitis were more likely to have proctitis (24% vs 13%, P = 0.033) at baseline. There were no differences in surgery or hospitalization rates during the follow-up period. Conclusions: Black patients with CD demonstrated increased complications at baseline and during follow-up in this cohort. Despite more complicated disease, black and white patients with IBD were generally given the same medications and experienced similar rates of hospitalization and surgery during the study period. In our multicenter cohort, clinical outcomes among black and white patients with IBD were similar.

Inflammatory Bowel Diseases Can Adversely Impact Domains of Sexual Function Such as Satisfaction with Sex Life.

BACKGROUND: Aspects of sexual health, which can be adversely affected by chronic disease, have been inadequately explored in inflammatory bowel disease (IBD). AIMS: We evaluated patient-reported interest in sexual activity and satisfaction with sex life in a large cohort of IBD patients. METHODS: We conducted a cross-sectional study within the Crohn's and Colitis Foundation Partners Internet cohort. Sequential participants completed a 6-question supplemental online survey to examine sexual interest and satisfaction using the Patient-Reported Outcome Measurement Information System® (PROMIS®) Sexual Function and Satisfaction measures. One-sample t tests were used to compare interest and satisfaction scores to general population norms. RESULTS: Among 2569 individuals, 1639 had Crohn's disease (CD), 930 had ulcerative colitis (UC) or indeterminate colitis, and 71% were women. Mean PROMIS scores for sexual interest were comparable to the general US population in men (CD: 49 and UC: 50 vs. population mean 50) and women (CD: 41 and UC: 40 vs. population mean 42). However, sexual satisfaction scores were lower than the US population in men (CD: 48 and UC: 48 vs. 51) and women (CD: 47 and UC: 46 vs. 49), p < 0.01 for both. Older age, disease activity, depression, anxiety, and pain were associated with lower interest and satisfaction and lowered IBD-specific quality of life. CONCLUSIONS: IBD patients in a large online survey had similar levels of sexual interest but decreased sexual satisfaction compared to the general population. Exploring these sexual health domains during clinical encounters can aid in improving IBD quality of life.