Explore the vast range of titles available.

Background Inflammatory bowel disease (IBD) is a heterogeneous collection of chronic inflammatory disorders of the digestive tract. Clinical, genetic, and pathological heterogeneity makes it increasingly difficult to translate efficacy studies into real-world practice. Our objective was to develop a comprehensive natural history registry derived from multi-year observational data to facilitate effectiveness and clinical phenotypic research in IBD. Methods A longitudinal, consented registry with prospectively collected data was developed at UPMC. All adult IBD patients receiving care at the tertiary care center of UPMC are eligible for enrollment. Detailed data in the electronic health record are accessible for registry research purposes. Data are exported directly from the electronic health record and temporally organized for research. Results To date, there are over 2565 patients participating in the IBD research registry. All patients have demographic data, clinical disease characteristics, and disease course data including healthcare utilization, laboratory values, health-related questionnaires quantifying disease activity and quality of life, and analytical information on treatment, temporally organized for 6 years (2009–2015). The data have resulted in a detailed definition of clinical phenotypes suitable for association studies with parameters of disease outcomes and treatment response. We have established the infrastructure required to examine the effectiveness of treatment and disease course in the real-world setting of IBD. Conclusions The IBD research registry offers a unique opportunity to investigate clinical research questions regarding the natural course of the disease, phenotype association studies, effectiveness of treatment, and quality of care research.

Background and AimsInflammatory bowel disease (IBD) patients are at increased risk of melanoma and non-melanoma skin cancers, and preventive care guidelines in IBD favor annual skin examinations. Here we estimate the cost-effectiveness of annual melanoma screening in IBD.MethodsMelanoma screening was defined as receiving annual total body skin examinations starting at age 40 from a dermatologist. Screening was compared to US background total body skin examination rates performed by primary care practitioners. A Markov model was used to estimate intervention costs and effectiveness. Future costs and effectiveness were discounted at 3% per year over a lifetime horizon. Strategies were compared using a willingness-to-pay threshold of$100,000/quality-adjusted life year (QALY) gained.ResultsAnnual melanoma screening cost an average of $ 1961 per patient, while no screening cost$81 per patient. Melanoma screening was more effective, gaining 9.2 QALYs per 1000 persons, at a cost of $ 203,400/QALY gained. Screening every other year was the preferred strategy, gaining 6.2 QALYs per 1000 persons and costing$143,959/QALY. One-way sensitivity analyses suggested the relative risk of melanoma in IBD, melanoma progression, and screening costs were most influential with clinically plausible variation, leading to scenarios costing < $ 100,000/QALY gained. Probabilistic sensitivity analyses suggested screening every other year was cost-effective in 17.4% of iterations.ConclusionsScreening for melanoma in IBD patients was effective but expensive. Screening every other year was the most cost-effective strategy. Studies to identify IBD patients at the highest risk of developing melanoma may assist in targeting a prevention program in the most cost-effective manner.

Abstract Background Lyme disease is the most common reportable zoonotic infection in the United States. Recent data suggest spread of the Ixodes tick vector and increasing incidence of Lyme disease in several states, including Pennsylvania. We sought to determine the clinical presentation and healthcare use patterns for pediatric Lyme disease in western Pennsylvania. Methods The electronic medical records of all patients with an International Classification of Disease, Ninth Revision, diagnosis of Lyme disease between 2003 and 2013 at Children's Hospital of Pittsburgh were individually reviewed to identify confirmed cases of Lyme disease. The records of 773 patients meeting these criteria were retrospectively analyzed for patient demographics, disease manifestations, and healthcare use. Results An Lyme disease increased exponentially in the pediatric population of western Pennsylvania. There was a southwestward migration of Lyme disease cases, with a shift from rural to nonrural zip codes. Healthcare provider involvement evolved from subspecialists to primary care pediatricians and emergency departments (EDs). Patients from nonrural zip codes more commonly presented to the ED, while patients from rural zip codes used primary care pediatricians and EDs equally. Conclusions The current study details the conversion of western Pennsylvania from a Lyme-naive to a Lyme-epidemic area, highlighting changes in clinical presentation and healthcare use over time. Presenting symptoms and provider type differed between those from rural and nonrural zip codes. By elucidating the temporospatial epidemiology and healthcare use for pediatric Lyme disease, the current study may inform public health measures regionally while serving as an archetype for other areas at-risk for Lyme disease epidemics. We identified 773 children with Lyme disease in western Pennsylvania, a previously Lyme-naive region. Over 10 years, the number of cases increased exponentially, with the highest burden of infection shifting from rural to nonrural areas and affecting healthcare use.

We sought to characterize the effects of diabetes mellitus on the natural history of inflammatory bowel disease. From a large cohort of inflammatory bowel disease patients, we found that although patients suffering from comorbid diabetes mellitus demonstrated evidence of increased disease severity, they may be undertreated with immunomodulator and/or biologic agents.AbstractBackgroundGiven the rising prevalence of diabetes mellitus (DM) and the limited data on its effect on the course of inflammatory bowel disease (IBD), we characterized multiyear patterns of disease severity in a cohort of IBD patients with coexistent DM.MethodsData of consented IBD patients followed prospectively in a natural history registry at a tertiary center between 2009 and 2017 were analyzed. Patients with ≥3 years of clinical follow-up were included. Patients identified with a diagnosis of DM were compared with 400 consecutive IBD controls without a diagnosis of DM, no laboratory evidence of hyperglycemia, and no history of antihyperglycemic treatment.ResultsOut of 2810 IBD patients, 141 (5%) had DM (IBD DM; 44% ulcerative colitis, 56% Crohn’s disease, 48.2% female). IBD DM had higher use of 5-aminosalicylic acid (5ASA) agents (P = 0.04), narcotics (P < 0.001), and antibiotics (P = 0.007) but not immunomodulators and/or biologics compared with IBD controls. When analyzing biomarkers of severity, IBD DM demonstrated higher frequencies of elevated C-reactive protein (CRP; P = 0.006), elevated erythrocyte sedimentation rate (ESR; P = 0.001), eosinophilia (P = 0.004), monocytosis (P = 0.02), and hypoalbuminemia (P = 0.001). IBD DM had worse quality of life (mean Short Inflammatory Bowel Disease Questionnaire; P < 0.001). IBD DM had increased health care utilization compared with controls (emergency room usage P = 0.008, hospitalizations P < 0.001, gastroenterology clinic visits P < 0.001, and median annual charges P < 0.001). Among IBD DM patients, the use of immunomodulators and/or biologics was not associated with further complications as measured by antibiotic use or hospitalizations.ConclusionsThis study of a large IBD cohort suggests that DM in IBD may be associated with increased disease severity and that there may be room for increasing use of highly effective immunomodulator and/or biologic agents in this group.Video Abstract 10.1093/ibd/izz305_video1Video Abstractizz305_video16123115852001

OBJECTIVES/SPECIFIC AIMS: Inflammatory bowel disease (IBD) patients are at an increased risk of Clostridium difficile infection (CDI) but the impact of CDI on disease severity is unclear. The aim of this study was to determine the effect of CDI on long-term disease outcome in a cohort of IBD patients. METHODS/STUDY POPULATION: We analyzed patients enrolled in a prospective IBD natural history registry. Patients who tested positive at least once formed the CDI positive group. We generated a 2:1 propensity matched control cohort based on risk factors of CDI in the year before infection. Healthcare utilization data (emergency department use, subsequent hospitalizations, telephone encounters), medications, labs, disease activity, and quality of life metrics were temporally organized. RESULTS/ANTICIPATED RESULTS: A total of 198 patients (66 CDI, 132 matched controls) were included [56.6% female; 60.1% Crohn’s disease (CD), 39.9% ulcerative colitis (UC)]. Groups were not significantly different in the year before infection in all metrics but in the year of infection, having CDI was significantly associated with more steroid and antibiotic exposure, elevated C-reactive protein or erythrocyte sedimentation rate, and low vitamin D (all p <0.01). Infection was associated with increased disease activity metrics (UC: p =0.036, CD: p =0.003), worse disease-related quality of life ( p =0.003), and increased healthcare utilization ( p <0.001). In the next year after infection those with prior CDI continued to have increased exposure to vancomycin or fidaxomicin ( p <0.001) and all other antibiotics ( p =0.01). They also continued to have more clinic visits ( p =0.006), telephone encounters ( p =0.001), and worse disease-related quality of life ( p =0.03), but disease activity and biomarkers of severity were not significantly different between groups. DISCUSSION/SIGNIFICANCE OF IMPACT: CDI infection in IBD is significantly associated with various surrogate markers of disease severity, increased healthcare utilization and poor quality of life during the year of infection. CDI patients continue to experience poor quality of life after infection with increased clinic visits and antibiotic exposure while disease activity is no longer significantly increased. These findings suggest that CDI infection may have a lasting effect on healthcare utilization beyond the acute treatment period.

OBJECTIVES/SPECIFIC AIMS: Inflammatory bowel disease (IBD) patients are at an increased risk of Clostridium difficile infection (CDI) but the impact of CDI on disease severity is unclear. The aim of this study was to determine the effect of CDI on long-term disease outcome in a cohort of IBD patients. METHODS/STUDY POPULATION: We analyzed patients enrolled in a prospective IBD natural history registry. Patients who tested positive at least once formed the CDI positive group. We generated a 2:1 propensity matched control cohort based on risk factors of CDI in the year before infection. Healthcare utilization data (emergency department use, subsequent hospitalizations, telephone encounters), medications, labs, disease activity, and quality of life metrics were temporally organized. RESULTS/ANTICIPATED RESULTS: A total of 198 patients (66 CDI, 132 matched controls) were included [56.6% female; 60.1% Crohn’s disease (CD), 39.9% ulcerative colitis (UC)]. Groups were not significantly different in the year before infection in all metrics but in the year of infection, having CDI was significantly associated with more steroid and antibiotic exposure, elevated C-reactive protein or erythrocyte sedimentation rate, and low vitamin D (all p<0.01). Infection was associated with increased disease activity metrics (UC: p=0.036, CD: p=0.003), worse disease-related quality of life (p=0.003), and increased healthcare utilization (p<0.001). In the next year after infection those with prior CDI continued to have increased exposure to vancomycin or fidaxomicin (p<0.001) and all other antibiotics (p=0.01). They also continued to have more clinic visits (p=0.006), telephone encounters (p=0.001), and worse disease-related quality of life (p=0.03), but disease activity and biomarkers of severity were not significantly different between groups. DISCUSSION/SIGNIFICANCE OF IMPACT: CDI infection in IBD is significantly associated with various surrogate markers of disease severity, increased healthcare utilization and poor quality of life during the year of infection. CDI patients continue to experience poor quality of life after infection with increased clinic visits and antibiotic exposure while disease activity is no longer significantly increased. These findings suggest that CDI infection may have a lasting effect on healthcare utilization beyond the acute treatment period.

Objectives:Anastomotic reconstruction following intestinal resection in Crohn's disease (CD) may employ side-to-side anastomosis (STSA; anti-peristaltic orientation) or end-to-end anastomosis (ETEA). Our aim was to determine the impact of these two anastomotic techniques on long-term clinical status in postoperative CD patients.Methods:We performed a comparative effectiveness study of prospectively collected observational data from consented CD patients undergoing their first or second ileocolonic bowel resection and re-anastomosis between 2008 and 2012, in order to assess the association between anastomosis type and 2-year postoperative quality of life (QoL), healthcare utilization, disease clinical or endoscopic recurrence, use of medications, and need for repeat resection.Results:One hundred and twenty eight postoperative CD patients (60 STSA and 68 ETEA) were evaluated. At 2 years postoperatively, STSA patients had higher rates of emergency department visits (33.3% vs. 14.7%; P=0.01), hospitalizations (30% vs. 11.8%; P=0.01), and abdominal computed tomography scans (50% vs. 13.2%; P<0.001) with lower QoL (mean short inflammatory bowel disease questionnaire 47.9 vs. 53.4; P=0.007). There was no difference among the two groups in the 30 day surgical complications and 2-year patterns of disease activity, CD medication requirement, endoscopic recurrence, and need for new surgical management (all P > 0.05).Conclusions:At 2 years postoperatively, CD patients with ETEA demonstrated better QoL and less healthcare utilization compared with STSA, despite having similar patterns of disease recurrence and CD treatment. These findings suggest that surgical reconstruction of the bowel as an intact tube (ETEA) contribute to improved functional and clinical status in patients with CD.

Peripheral blood eosinophilia (PBE) in inflammatory bowel disease (IBD) is associated with ulcerative colitis (UC) and active disease. Little data exist on the long-term impact of PBE on disease course. We aimed to investigate the multi-year patterns of PBE and its impact on disease severity in a large IBD cohort. We performed a registry analysis of a consented, prospective, natural history IBD cohort at a tertiary center from 2009 to 2014. Demographics, comorbidities, disease activity, healthcare utilization, and time to hospitalization or surgical resection of patients who displayed PBE were compared to patients without PBE. Of the 2,066 IBD patients, 19.2% developed PBE. PBE was significantly associated with UC (P<0.001), extensive colitis (P<0.001), and shorter disease duration (P=0.03). Over six years, PBE patients had more active disease (Harvey-Bradshaw Index P=0.001; ulcerative colitis activity index P<0.001), concurrent C-reactive protein elevation (P<0.001), healthcare utilization (hospitalization P<0.001, IBD surgery P<0.001), and more aggressive medical therapy (prednisone P<0.001, anti-TNF P<0.001). Patients with PBE had a significantly reduced time to hospitalization in both UC (P<0.001) and Crohn's disease (CD) (P<0.001) and reduced time to colectomy in UC (P=0.003). On multivariable modeling, PBE remained significantly associated with hospitalization and surgery in both CD and UC. New diagnosis of UC with PBE was associated with increased steroid (P=0.007) and anti-TNF (P=0.001) requirement. This multi-year study of a large IBD cohort suggests that peripheral blood eosinophilia represents a biomarker of a distinct IBD subgroup, with a unique inflammatory signature, and at risk for worse clinical outcomes.

The Advanced Placement (AP) program is an educational program that permits high school students to take introductory college-level courses and receive college credit by passing a standardized end-of-course exam. Data were obtained from a statewide database of 2 high school graduating cohorts (N = 90,044). We used a series of propensity score analyses and marginal mean weighting through stratification to examine the impact of the AP program on students' academic achievement as measured by ACT scores. Results indicate that merely enrolling in an AP course produces very little benefit for students. Students who take and pass the AP exam, however, obtain higher ACT scores, even after controlling for a wide variety of academic, socioeconomic, and demographic variables. The authors conclude the article by discussing aspects of the AP program that remain unanswered.

Patient-reported Crohn's disease (CD) symptoms and endoscopic evaluation have historically guided routine care, but the risk of complications in asymptomatic patients with elevated C-reactive protein (CRP) is unknown. We conducted a prospective observational cohort study of patients with CD from a tertiary care center. Subjects with short inflammatory bowel disease questionnaire scores ≥ 50, Harvey-Bradshaw CD scores ≤ 4, and same-day CRP measurement were eligible for inclusion. The primary outcome was disease-related hospitalization up to 24 months after the qualifying clinic visit. We assessed the relationship between CRP elevation and subsequent hospitalization. There were 351 asymptomatic patients with CD (median age 40 yr; 50.4% female) who met inclusion criteria, and CRP was elevated in 19.7% of these individuals (n = 69). At 24 months, 16.8% (n = 59) of the study population had been hospitalized for CD-related complications. Significantly, more patients with an elevated CRP were hospitalized (33.3% versus 12.8%, P < 0.0001) compared with those with a normal CRP and were hospitalized at increased rate (P < 0.001) on Kaplan-Meier analysis. CRP elevation was significantly and independently associated with increased risk of hospitalization (adjusted hazard ratio 2.12; 95% confidence interval, 1.13-3.98; P = 0.02) in multivariable survival analysis. Asymptomatic patients with CD with elevated CRP are at a nearly 2-fold higher risk for hospitalization over the subsequent 2 years compared with asymptomatic patients with CD without CRP elevation.