Correction to: Presenting symptoms in inflammatory bowel disease: descriptive analysis of a community-based inception cohort.

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Presenting symptoms in inflammatory bowel disease: descriptive analysis of a community-based inception cohort.

BACKGROUND: Few data are currently available on the initial presenting symptoms of patients with inflammatory bowel disease (IBD). METHODS: We evaluated the initial symptom presentation of patients with IBD in the Ocean State Crohn's and Colitis Area Registry (OSCCAR), a community-based inception cohort that enrolled Rhode Island IBD patients at time of diagnosis with longitudinal follow up. A 41-question symptom inventory was administered at time of enrollment to capture symptoms experienced during the 4 weeks preceding diagnosis of IBD. Frequencies of presenting symptoms were calculated. Principal component analysis (PCA) with promax rotation was used to examine possible symptom profiles among Crohn's disease (CD) and ulcerative colitis (UC) patients, respectively. Using the Scree plot, the 4-component solution was found to be optimal for both CD and UC. RESULTS: A total of 233 CD and 150 UC patients were included. The most common presenting symptoms in CD were tiredness/fatigue (80.6%) and abdominal pain (80.4%) while passage of blood with bowel movements (BM) (86.6%) and loose/watery BMs (86.5%) were most common in UC. The 5 symptoms with greatest differences between UC and CD were passage of blood with BM (UC 86.6%/CD 45.3%), urgent BM (UC 82.5%/CD 63.9%), passage of mucus with BM (UC 67.7%/CD 36.9%), passage of blood from the anus (UC 59.7%/CD 32.1%), and anxiety about distance from bathroom (UC 59%/CD 38.7%). The PCA analysis yielded a 4 symptom components solution for CD and UC. CONCLUSION: The most common presenting symptoms in CD are fatigue and abdominal pain while in UC bloody BM and diarrhea are most common. Distinct symptom phenotypes are seen with PCA analysis. Our study demonstrates symptomatic similarities and differences between CD and UC and suggests that patients may also be classified by symptom phenotype at time of diagnosis.

Corticosteroid Use in a Prospective, Community-Based Cohort of Newly Diagnosed Inflammatory Bowel Disease Patients.

BACKGROUND: Systemic corticosteroids (CS) are a mainstay of treatment for patients with newly diagnosed inflammatory bowel disease (IBD). Previous population-based studies report CS exposure rates range from 39 to 75 % within the first year of diagnosis with surgical resection rates as high as 13-18 % in the same time frame. These reports represent an older cohort of patients enrolled over prolonged periods of time and do not necessarily reflect current treatment approaches. We examine CS use during the first year of IBD diagnosis in a community-based, inception cohort. METHODS: Data were derived from the Ocean State Crohn's and Colitis Area Registry (OSCCAR), a prospective inception cohort of IBD patients who are residents of Rhode Island. RESULTS: A total of 272 patients were included in the current analyses. Overall, 60 % of Crohn's disease and 57 % of ulcerative colitis patients were exposed to at least one course of CS during year 1 of study enrollment. Most notably, only 2 % of patients (n = 5) required a surgical resection. CONCLUSIONS: In this community-based cohort, 59 % of patients were exposed to at least one course of CS during their first year of enrollment. In contrast to previous studies, OSCCAR represents a more modern cohort of patients. While steroid exposure rates were similar or slightly higher than those in previous reports, we observed a low rate of surgical resection. As our cohort ages, future analysis will focus on the role more contemporary agents may play on the low rates of surgery we observed.

Achieving Synergy: Linking an Internet-Based Inflammatory Bowel Disease Cohort to a Community-Based Inception Cohort and Multicentered Cohort in Inflammatory Bowel Disease.

BACKGROUND: Traditional cohort studies are important contributors to our understanding of inflammatory bowel diseases, but they are labor intensive and often do not focus on patient-reported outcomes. Internet-based studies provide new opportunities to study patient-reported outcomes and can be efficiently implemented and scaled. If a traditional cohort study was linked to an Internet-based study, both studies could benefit from added synergy. Existing cohort studies provide an opportunity to develop and test processes for cohort linkage. The Crohn's and Colitis Foundation of America's (CCFA) Partners study is an Internet-based cohort of more than 14,000 participants. The Ocean State Crohn's and Colitis Area Registry (OSCCAR) is an inception cohort. The Sinai-Helmsley Alliance for Research Excellence (SHARE) is a multicentered cohort of inflammatory bowel disease patients. Both the later cohorts include medical record abstraction, patient surveys, and biospecimen collection. OBJECTIVE: Given the complementary nature of these existing cohorts, we sought to corecruit and link data. METHODS: Eligible OSCCAR and SHARE participants were invited to join the CCFA Partners study and provide consent for data sharing between the 2 cohorts. After informed consent, participants were directed to the CCFA Partners website to complete enrollment and a baseline Web-based survey. Participants were linked across the 2 cohorts by the matching of an email address. We compared demographic and clinical characteristics between OSCCAR and SHARE participants who did and did not enroll in CCFA Partners and the data linkage. RESULTS: Of 408 participants in the OSCCAR cohort, 320 were eligible for participation in the CCFA Partners cohort. Of these participants, 243 consented to participation; however, only 44 enrolled in CCFA Partners and completed the linkage. OSCCAR participants who enrolled in CCFA Partners were better educated (17% with doctoral degrees) than those who did not (3% with doctoral degrees, P=.01). In the SHARE cohort, 436 participants enrolled and linked to the Partners cohort. More women (60% vs 50%) linked and those who linked were predominantly white (96%; P<.01). Crohn's disease patients who linked had lower mean scores on the Harvey-Bradshaw Index (3.6 vs 4.4, P<.01). Ulcerative colitis patients who linked had less extensive disease than those who did not link (45% vs 60%, P<.01). CONCLUSIONS: Linkage of CCFA Partners with cohorts such as OSCCAR and SHARE may be a cost-effective way to expand the infrastructure for clinical outcomes and translational research. Although linkage is feasible from a technical, legal, and regulatory perspective, participant willingness appears to be a limiting factor. Overcoming this barrier will be needed to generate meaningful sample sizes to conduct studies of biomarkers, natural history, and clinical effectiveness using linked data.

Evaluation of possible inflammatory bowel disease: a survey of Rhode Island physicians.

BACKGROUND: Patients with undiagnosed inflammatory bowel disease (IBD) are often evaluated initially by primary care physicians (PCPs). Despite the frequency with which PCPs evaluate chronic abdominal pain and chronic diarrhea, little is known about how they approach these symptoms. OBJECTIVES: To determine the diagnostic practices and referral patterns of PCPs when confronting a patient with potential IBD. METHODS: We conducted a mail survey of PCPs practicing in Rhode Island. Clinical vignettes describing patients with chronic abdominal pain and chronic diarrhea were presented. Respondents were asked to indicate how they would evaluate these scenarios and when they would refer to a specialist. RESULTS: 432 PCPs were surveyed; 35.6% responded. Wide variation in PCPs' definitions of chronic abdominal pain and chronic diarrhea was found, with only 26% and 51% of physicians, respectively, defining these symptoms to be chronic per standard definitions. Laboratory testing was found to vary significantly with practice type (p < 0.01 for 2 patient groups). Patient age influenced the ordering of diagnostic imaging (p < 0.0001), while patient gender did not. CONCLUSIONS: There is significant variability among PCPs in the threshold after which common gastrointestinal symptoms become chronic as well as in their diagnostic evaluation of these symptoms. This variability may lead to a lag in the diagnosis of IBD and influence patient outcomes.

A Longitudinal Study of Sexual Function in Women With Newly Diagnosed Inflammatory Bowel Disease.

BACKGROUND: The literature provides conflicting data on sexual function in women with inflammatory bowel disease (IBD). We aim to describe sexual function at baseline and over time in a prospective inception cohort of adult women with IBD. METHODS: Women age 18 years or older enrolled in the Ocean State Crohn's & Colitis Area Registry (OSCCAR) with 2 years of prospective follow-up were included in the study. All subjects were enrolled within 1 year of IBD diagnosis. Female sexual function was assessed using the Female Sexual Function Index (FSFI). Linear mixed effects models were used to assess changes in FSFI by various demographic and clinical factors. RESULTS: One hundred sixteen of 130 eligible women (89%) were included in the study. Ninety-seven percent of women had sexual dysfunction, defined as an FSFI score of <26.55, with a baseline mean FSFI score (SD) of 16.4 (8.4) overall (15.5 [8.6] in Crohn's disease, 17.4 [8.1] in UC, P = 0.22). Despite improvement in overall disease activity, there was no significant change in the FSFI score or individual domain scores over the entire 2-year study period. Among all women with IBD, older age, nonsingle marital status, lower Short Form Health Survey (SF-36) Physical Component Summary score, and the use of biologics were independent risk factors for sexual dysfunction. CONCLUSIONS: Almost all women experienced sexual dysfunction that did not improve over time despite improvement in overall disease activity. Future studies are warranted to identify underlying mechanisms that explain the associations between demographic and clinical factors and sexual dysfunction among newly diagnosed women.

Incidence of Crohn's Disease and Ulcerative Colitis in Rhode Island: Report from the Ocean State Crohn's and Colitis Area Registry.

BACKGROUND: Studies describing the incidence of Crohn's disease (CD) and ulcerative colitis (UC) are uncommon in the United States. We sought to determine the incidence of CD and UC in the state of Rhode Island. METHODS: The Ocean State Crohn's and Colitis Area Registry is a state-based inception cohort of patients newly diagnosed with inflammatory bowel disease (IBD) in Rhode Island. To confirm a diagnosis of CD, UC, or IBD unclassified (IBDU), the National Institute of Diabetes and Digestive and Kidney Diseases IBD Genetics Consortium criteria were applied in a review of medical records from gastroenterology practices located in the state of Rhode Island and adjacent to the Rhode Island border in Massachusetts and Connecticut. Using population-based data, we determined the statewide incidence of IBD in Rhode Island from 2008 to 2010. RESULTS: A total of 971 Rhode Island residents were diagnosed with IBD, including 444 with CD, 486 with UC, and 41 with IBD unclassified from 2008 to 2010. The overall age- and sex-adjusted IBD incidence was 30.2 (95% confidence interval, 28.3-32.1) per 100,000 persons in this time frame with 13.9, 15.1, and 1.3 per 100,000 diagnosed with CD, UC, and IBD unclassified, respectively. Of the total incident cases in Rhode Island, 30% (n = 291) were enrolled in Ocean State Crohn's and Colitis Area Registry for follow-up. CONCLUSIONS: The incidence of IBD in Rhode Island is higher than that previously reported by other population-based cohorts in the United States. Prospective follow-up of individuals enrolled in the community-based Ocean State Crohn's and Colitis Area Registry cohort is ongoing.

Risk factors for radiation exposure in newly diagnosed IBD patients.

PURPOSE: Patients with inflammatory bowel disease (IBD) may be exposed to high doses of diagnostic radiation. The purpose of this study is to identify subsets of this population at risk for significant radiation exposure. METHODS: This HIPAA compliant, IRB approved study consists of 336 patients (237 adult and 99 pediatric) within the Ocean State Crohn's & Colitis Area Registry (OSCCAR). All were newly diagnosed with IBD and prospectively enrolled between 1/2008 and 12/2012. Comprehensive chart review was performed. RESULTS: 207 (61.6%) patients were diagnosed with Crohn's disease (CD), 120 (35.7%) with ulcerative colitis (UC), and 9 (2.7%) with inflammatory bowel disease, type unspecified (IBDU). 192 (57.1%) patients were exposed to GI-specific radiation. Average GI-specific radiation dose for adult IBD patients was 14.1 mSV and was significantly greater among adult CD than adult UC patients (p = 0.01). Pediatric patients underwent fewer CT scans (p < 0.0001). Risk factors for increased radiation exposure include: GI surgery (p = 0.003), biologic therapy (p = 0.01), pain-predominant symptoms (as compared to diarrhea-predominant symptoms; p < 0.05), and isolated ileal disease (p = 0.02). Patients with stricturing or penetrating disease received higher radiation doses than patients with non-stricturing, non-penetrating disease (p < 0.0001). CONCLUSIONS: A variety of risk factors are associated with increased exposure to ionizing radiation after diagnosis of IBD. Knowledge of these risk factors can help physicians prospectively identify patients at risk for elevated radiation exposure and consider low-dose or radiation-free imaging.

Serum Proteome Profiles in Stricturing Crohn's Disease: A Pilot Study.

BACKGROUND: Crohn's disease (CD) is a form of inflammatory bowel disease with different described behaviors, including stricture. At present, there are no laboratory studies that can differentiate stricturing CD from other phenotypes of inflammatory bowel disease. We performed a pilot study to examine differences in the proteome among patients with stricturing CD, nonstricturing CD, and ulcerative colitis. METHODS: Serum samples were selected from the Ocean State Crohn's and Colitis Area Registry, an established cohort of patients with inflammatory bowel disease. Patients with CD with surgically resected stricture were matched with similar patients with CD without known stricture and with ulcerative colitis. Serum samples from each patient were digested and analyzed using liquid chromatography-mass spectrometry to characterize the proteome. Statistical analyses were performed to identify peptides and proteins that can differentiate CD with stricture. RESULTS: Samples from 9 patients in each group (27 total patients) were analyzed. Baseline demographic characteristics were similar among the 3 groups. We quantified 7668 peptides and 897 proteins for analysis. Receiver operating characteristic analysis identified a subset of peptides with an area under the curve greater than 0.9, indicating greater separation potential. Partial least squares discriminant analysis was able to distinguish among the three groups with up to 70% accuracy by peptides and up to 80% accuracy by proteins. We identified the significantly different proteins and peptides and determined their function based on previously published literature. CONCLUSIONS: The serum of patients with stricturing CD, nonstricturing CD, and ulcerative colitis is distinguishable through proteomic analysis. Some of the proteins that differentiate the stricturing phenotype have been implicated in complement activation, fibrinolytic pathways, and lymphocyte adhesion.

Body image dissatisfaction in patients with inflammatory bowel disease.

BACKGROUND: Despite the fact that the inflammatory bowel diseases (IBD) and their treatments may affect physical appearance, the effect of IBD on body image is poorly understood. The aims of this study were to determine whether body image dissatisfaction (BID) changes over time in patients with IBD and to examine the demographic and disease-related variables associated with decreased body image. METHODS: Adults aged 18 and above in the Ocean State Crohn's and Colitis Area Registry with at least 2 years of follow-up were eligible for this study. All patients were enrolled within 6 months of IBD diagnosis and followed prospectively. BID was assessed using a modified version of the Adapted Satisfaction With Appearance questionnaire. Total Adapted Satisfaction With Appearance scores and 2 subscores were calculated. To assess for changes over time, general linear models for correlated data were used for continuous outcomes, and generalized estimating equations were used for discrete outcomes. RESULTS: Two hundred seventy-four patients were studied. BID was found to be stable over time among men and women with IBD despite overall improvements in disease activity. No differences were found in BID according to IBD subtype. Female gender, greater disease activity, higher symptom burden, longer duration of steroid use, dermatologic and musculoskeletal manifestations of IBD, and ileocolonic disease location among patients with Crohn's disease were associated with greater BID. Greater BID was associated with lower health-related quality of life. CONCLUSIONS: BID remains stable in an incident cohort of IBD despite improved disease activity and is associated with lower health-related quality of life.

Testing for Clostridium difficile in patients newly diagnosed with inflammatory bowel disease in a community setting.

BACKGROUND: The incidence of Clostridium difficile infection (CDI) in inflammatory bowel disease (IBD) is increasing, and CDI has a negative impact on IBD outcomes with both increased morbidity and mortality. Data are lacking regarding the rate of appropriate testing for CDI at the time of diagnosis. METHODS: We sought to determine the rate of CDI testing and CDI positivity at diagnosis of IBD using data collected through the Ocean State Crohn's and Colitis Area Registry (OSCCAR), a prospective cohort of patients with newly diagnosed IBD. CDI testing and CDI positivity were determined by reviewing the medical records of patients enrolled into the registry and diagnosed with IBD between January 2008 and July 2011. RESULTS: Of 320 enrolled patients, 227 (70.9%) reported diarrhea, and CDI testing was performed for 113 (49.8%) of the 227 patients. CDI testing was not recorded as being performed for the remaining 114 patients who reported having diarrhea. An additional 24 patients were tested for CDI but did not report having diarrhea. Seven (5.1%) of the 137 patients tested for CDI were positive. CONCLUSIONS: Testing for CDI is significantly lower than expected at diagnosis of IBD. Although the prevalence of CDI among tested patients is approximately 5%, a low testing rate suggests a significant quality issue in the diagnosis of IBD, with the potential for delayed diagnosis of CDI.

Menstrual cycle changes in women with inflammatory bowel disease: a study from the ocean state Crohn's and colitis area registry.

BACKGROUND: The effect of the inflammatory bowel diseases (IBD) on menstrual function is largely unknown. The aims of this study were to determine whether changes in menstrual function occur in the year before IBD diagnosis or in the initial years after diagnosis. METHODS: Women aged 18 years and older in the Ocean State Crohn's and Colitis Area Registry with at least 2 years of follow-up were eligible for this study. All patients were enrolled within 6 months of IBD diagnosis and followed prospectively. Menstrual cycle characteristics were retrospectively assessed. To assess for changes over time, general linear models for correlated data were used for continuous outcomes, and generalized estimating equations were used for discrete outcomes. RESULTS: One hundred twenty-one patients were studied. Twenty-five percent of patients experienced a change in cycle interval in the year before IBD diagnosis and 21% experienced a change in the duration of flow. Among women with dysmenorrhea, 40% experienced a change in the intensity of their menstrual pain and 31% experienced a change in its duration. Overall cycle regularity increased over time. Quality of life was significantly lower in women without regular cycles across all time points. CONCLUSIONS: Changes in menstrual function occur frequently in the year before IBD diagnosis; therefore, screening for menstrual irregularities should be considered in women with newly diagnosed IBD. Patients can be reassured that cycles typically become more regular over time.

Challenges in designing a national surveillance program for inflammatory bowel disease in the United States.

This review describes the history of U.S. government funding for surveillance programs in inflammatory bowel diseases (IBD), provides current estimates of the incidence and prevalence of IBD in the United States, and enumerates a number of challenges faced by current and future IBD surveillance programs. A rationale for expanding the focus of IBD surveillance beyond counts of incidence and prevalence, to provide a greater understanding of the burden of IBD, disease etiology, and pathogenesis, is provided. Lessons learned from other countries are summarized, in addition to potential resources that may be used to optimize a new form of IBD surveillance in the United States. A consensus recommendation on the goals and available resources for a new model for disease surveillance are provided. This new model should focus on "surveillance of the burden of disease," including (1) natural history of disease and (2) outcomes and complications of the disease and/or treatments.

Validation of interactive voice response system administration of the Short Inflammatory Bowel Disease Questionnaire.

BACKGROUND: The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a written, self-administered instrument measuring quality of life in IBD. We assessed the validity of an interactive voice response system (IVRS) as a new mode of administering the SIBDQ. METHODS: An IVRS was designed using prerecorded questions to collect data via touchtone telephone. Subjects with Crohn's disease (CD) or ulcerative colitis (UC) were randomized into 2 groups with different orders of administration: written, self-administered followed by IVRS (S-I) or IVRS followed by written, self-administered (I-S). Half of the S-I group was also randomized to receive a second IVRS. Sixty-four subjects were studied: 30 in S-I, 34 in I-S. RESULTS: The mean SIBDQ scores were not different between written and IVRS modes (P = 0.26) with r = 0.93. IVRS scores were lower in active than inactive CD (36.1 +/- 9.6 versus 54.7 +/- 8.6, P < 0.001) and lower in active than inactive UC (40.8 +/- 9.6 versus 59.8 +/- 10.0, P < 0.001). Mean scores correlated highly with disease activity indices, and were not different between first and second IVRS administrations (P = 0.85) with r = 0.92. IVRS had excellent internal consistency (Cronbach alpha = 0.90). CONCLUSIONS: IVRS administration of the SIBDQ yields results similar to written self-administration, with excellent procedural validity, test-retest reliability, and internal consistency.

Exercise capacity and cardiovascular/metabolic characteristics of overweight and obese individuals with type 2 diabetes: the Look AHEAD clinical trial.

OBJECTIVE: We examined associations of cardiovascular, metabolic, and body composition measures with exercise capacity using baseline data from 5,145 overweight and/or obese (BMI > or = 25.0 kg/m2) men and women with type 2 diabetes who were randomized participants for the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS: Peak exercise capacity expressed as METs and estimated from treadmill speed and grade was measured during a graded exercise test designed to elicit a maximal effort. Other measures included waist circumference, BMI, type 2 diabetes duration, types of medication used, A1C, history of cardiovascular disease, metabolic syndrome, beta-blocker use, and race/ethnicity. RESULTS: Peak exercise capacity was higher for men (8.0 +/- 2.1 METs) than for women (6.7 +/- 1.7 METs) (P < 0.001). Exercise capacity also decreased across each decade of age (P < 0.001) and with increasing BMI and waist circumference levels in both sexes. Older age, increased waist circumference and BMI, a longer duration of diabetes, increased A1C, a history of cardiovascular disease, having metabolic syndrome, beta-blocker use, and being African American compared with being Caucasian were associated with a lower peak exercise capacity for both sexes. Hypertension and use of diabetes medications were associated with lower peak exercise capacity in women. CONCLUSIONS: Individuals with diabetes who are overweight or obese have impaired exercise capacity, which is primarily related to age, female sex, and race, as well as poor metabolic control, BMI, and central obesity.

Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the look AHEAD trial.

OBJECTIVE: The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes 1-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events. RESEARCH DESIGN AND METHODS: This study consisted of a multicentered, randomized, controlled trial of 5,145 individuals with type 2 diabetes, aged 45-74 years, with BMI >25 kg/m2 (>27 kg/m2 if taking insulin). An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. RESULTS: Participants assigned to ILI lost an average 8.6% of their initial weight vs. 0.7% in DSE group (P < 0.001). Mean fitness increased in ILI by 20.9 vs. 5.8% in DSE (P < 0.001). A greater proportion of ILI participants had reductions in diabetes, hypertension, and lipid-lowering medicines. Mean A1C dropped from 7.3 to 6.6% in ILI (P < 0.001) vs. from 7.3 to 7.2% in DSE. Systolic and diastolic pressure, triglycerides, HDL cholesterol, and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants (all P < 0.01). CONCLUSIONS: At 1 year, ILI resulted in clinically significant weight loss in people with type 2 diabetes. This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE. Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk.