Ocean State Crohn’s & Colitis Area Registry

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The Ocean State Crohn’s & Colitis Area Registry (OSCCAR) is a CDC-sponsored research study that investigates the epidemiology of IBD and the impact of practice variation on treatment outcomes. In collaboration with the Icahn School of Medicine at Mount Sinai and investigators at Rhode Island Hospital, OSCCAR enrolled 408 newly diagnosed IBD patients in Rhode Island between 2007 and 2012, and has been tracking and analyzing their disease progression, treatment, and health outcomes. OSCCAR-derived information and data has enabled numerous studies that increase our understanding of IBD and its progression over time, and that are helping physicians to provide more effective, individualized treatment for their patients.



In October 2007, a U01 research contract from the CDC to the Crohn's & Colitis Foundation was assigned to the Ocean State Crohn’s & Colitis Area Registry (OSCCAR). The “Ocean State” of Rhode Island was chosen as an excellent location in which to conduct a population-based IBD study, because it is a small state geographically, and has a diverse and stable population as well as a relatively small number of gastroenterologists working in the state.

Enrollment in the OSCCAR cohort ended on December 31, 2012, and data collection in the follow-up of enrolled subjects is ongoing. Remarkably, 74% of OSCCAR’s cohort of 408 subjects remain in follow up, with only 2% of subjects lost to follow up (or deceased) in the last year.

OSCCAR’s goals are to :

1. Develop and implement a prototype for a national surveillance system to collect estimates of the incidence and prevalence of IBD in the US.

2. Determine the impact of IBD on affected persons.

3. Identify psychosocial, economic, demographic, clinical, and biological variables associated with disparate outcomes in IBD.

4. Develop programs to address variations in clinical practice that are associated with disparate outcomes in IBD in order to improve disease outcomes.



Principal Investigator: Bruce Sands, MD, Icahn School of Medicine at Mount Sinai (New York City)


Current Activities & Objectives

OSCCAR has enabled the following studies:

  • Serologic Markers of Inflammatory Bowel Disease
    Serologic markers associated with Crohn’s disease and ulcerative colitis may also be associated with variations in prognosis in IBD. This study assesses the accuracy of seromarkers in patients with newly diagnosed IBD, utilizing specimens obtained in the OSCCAR cohort. Its findings highlight some of the limitations of the use of seromarkers in diagnosing IBD. 
  • C. difficile in New Onset IBD
    The incidence of Clostridium difficile infection (CDI) in IBD is increasing, and CDI has a negative impact on IBD outcomes with both increased morbidity and mortality. This study sought to determine the rate of CDI testing and CDI positivity at diagnosis of IBD. It concluded that testing for CDI is significantly lower than expected at diagnosis of IBD (>5%), and that this low testing rate suggests a significant quality issue in the diagnosis of IBD, with the potential for delayed diagnosis of CDI.
  • Radiation Exposure in New Onset IBD
    Exposure to ionizing radiation in diagnostic imaging studies is a potential hazard for patients with IBD. This study assessed their exposure levels, and analyses identified risk factors associated with increased exposure to radiation in the first year of diagnosis and immediately prior. This insight could raise awareness of this risk and lead to strategies that decrease exposure to ionizing radiation among children and adults with IBD.
  • Corticosteroid Utilization in New Onset IBD
    Systemic corticosteroids (CS) are a mainstay of treatment for patients with newly diagnosed IBD. This study examined CS use during the first year of IBD diagnosis, and concluded that rates of steroid exposure are similar or slightly higher than in previous reports, suggesting that despite widespread teaching about the need to limit the use of steroids, these drugs are widely prevalent in community-based treatment of IBD.
  • Body Image in IBD
    The effect of IBD on body image is poorly understood. This study sought to determine patients’ body image dissatisfaction (BID) changes over time, and examined demographic and disease-related variables associated with greater BID. It found BID to be stable over time among men and women with IBD, despite overall improvements in disease activity; and that greater BID was associated with lower health-related quality of life.
  • Menstruation and IBD
    IBD effects on menstrual function are largely unknown. This study determined whether changes in menstrual function occur in the year before IBD diagnosis and/or in the initial years after diagnosis. It concluded that changes in menstrual function do, in fact, occur frequently in the year before IBD diagnosis, but that that cycles typically become more regular over time, suggesting that screening for menstrual irregularities should be considered in women with newly diagnosed IBD.
  • Female Sexual Function and IBD
    Low sexual function has been reported in IBD patients, impacting health-related quality of life, but little is known about the problem. This study sought to describe changes in sexual function in a prospective cohort of women. It discovered that sexual function is more compromised in women with Crohn’s disease compared to women with ulcerative colitis; and that women with newly diagnosed IBD are at high risk for sexual dysfunction. Clinicians should, therefore, consider screening newly diagnosed women for sexual dysfunction and refer appropriate patients for treatment.
  • Male Sexual Function in IBD
    Men’s sexual function was studied in a prospective cohort of adult men with IBD. It concluded that male sexual function in IBD, in contrast to women, remains stable over time in both patients with Crohn’s disease and ulcerative colitis; and, that older men, non-married men and men with higher disease activity are at risk for lower sexual function.
  • Fatigue and Health-Related Quality of Life in IBD
    While fatigue in newly diagnosed IBD patients is common, little data on this issue has been unavailable. This study described the prevalence of fatigue in patients and examined its association with health-related quality of life (HRQOL), depression and disability. It concluded that fatigue is strongly associated with these negative outcomes, even when controlling for disease activity, and suggests that monitoring fatigue could be a simple way to screen for overall disruption in patient life due to IBD.
  • Identification of Strictures through Proteomics Analysis in IBD
    Stricture formation is a complication of Crohn’s disease that commonly necessitates surgery, but we have no tests that can predict which patients may develop stricture. This study analyzed plasma from patients, and demonstrated that specific proteomic signatures were able to discriminate clusters of patients by their disease state (stricture vs. no stricture; Crohn’s disease vs. ulcerative colitis). Identification of the specific proteins discovered in this study could enable early identification of patients at risk of stricture, better monitoring, and forestalling stricture through intensified treatment.
  • Dietary Behaviors in Children with IBD
    Children with IBD may have increased nutritional needs because of active inflammation, but many suffer from poor absorption of nutrients or difficulty in eating, possibly resulting in malnutrition and impaired growth and development. This study analyzed dietary behaviors in children with IBD and found that, despite adequate energy (caloric) intake, several key nutrients were substantially less than generally recommended levels, suggesting children with IBD require consistent nutritional assessment.
  • Bone Density at Diagnosis with IBD
    Both IBD and its treatments can contribute to decreased bone density among patients. This study analyzes patients who underwent abdominal CT and applies novel software to estimate bone density, before, during and after disease onset. If coincidental bone density measurement can be validated, this may prove useful in preventing further bone loss and fractures by identifying at-risk patients from the time of diagnosis.
  • Environmental Risk Factors for IBD
    While IBD appears to be increasing in emerging nations such as India, few investigations have explored epidemiologic risks in different populations. This study explored a set of potential environmental risk factors, which may influence development of IBD, in a parallel case controlled study in India and the US. It concluded that risk factors for IBD are not uniform in different countries, and that IBD in emerging countries may result from a different set of environmental factors than those identified in western countries.
  • Incidence Rates of Inflammatory Bowel Diseases in Rhode Island
    This study sought to determine the incidence of CD and UC in the state of Rhode Island using population-based data for a two-year period. It found that overall, IBD incidence was 30.2 (95% confidence interval, 28.3–32.1) per 100,000 persons. Data also suggests incidence of IBD in Rhode Island is higher than that previously reported by other population-based cohorts in the United States.
  • Evaluation of Long-Term Outcomes in IBD, and Contribution of Treatment Approaches to Optimize Outcomes
    Statistical methodology to create prediction models that can guide choice of IBD therapy is currently limited. This study uses OSCCAR data in novel methodologies to develop high-quality estimators of individualized treatment rules from observational data. Resulting, simulated experiments demonstrate that it is possible to construct new estimators that significantly outperform existing methods.
  • Biological Associations with IBD and Disease Outcomes
    OSCCAR collection of biological specimens at diagnosis and over the course of the patient’s disease enables studies of the stool microbiome and its relationship to genetics as factors in the long-term outcomes of people with IBD. These analyses may provide a very clear biologic understanding of how the microbiome and genetics combine to shape individual prognosis.



IBD currently impacts 1.6 million Americans, and the incidence of Crohn’s disease and ulcerative colitis increases each year, but the causes of these diseases are still unknown. Treatment has improved over time, but there is relatively little scientific data to guide individual therapy.

By focusing on the State of Rhode Island, with its small size and diverse population, OSCCAR is enabling research needed to advance our understanding about the causes of IBD as well as why the course of the illness varies among individuals. OSCCAR, is the first study of its kind in the United States.

Because it includes patients drawn from a community population, rather than from tertiary care centers, the OSCCAR cohort is more representative of the general population of patients with IBD. OSCCAR is also unique in that patients are enrolled within weeks of their new diagnosis (63 days, on average), allowing collection of specimens and other data at an early time-point.

OSCCAR’s collection of blood and stool samples will permit investigators to evaluate the relationship of genetics and genomics to IBD prognosis. This also permits the OSCCAR cohort to be linked to the Crohn's & Colitis Foundation's Microbiome Initiative, which is working to gain a better understanding of the role that the millions of bacteria, viruses and fungi that inhabit the human gut play in the onset and progression of IBD.

The importance and value of the unique OSCCAR cohort will continue to grow over time as patient follow up continues. Increased amounts of data and information will enable observation of important, longer-term outcomes and allow for more robust prediction of disease outcomes.


What’s Next

As the OSCCAR cohort approaches ~4.5 years of median follow up, investigators are observing increasing occurrence of important disease outcomes (i.e., stricture or fistula occurrence, hospitalization, surgery) as well as important patient-reported outcomes (i.e., quality of life issues). Going forward, OSCCAR will focus on these outcomes to better determine IBD’s impact on patients, and identify the psychosocial, economic, demographic, clinical, and biological variables associated with disparate outcomes in IBD.

A significant, upcoming focus of OSCCAR will be anti-TNF agents (infliximab, adalimumab, certolizumab pegol and more recently, golimumab), “biologics” that revolutionized the care of patients when first introduced in 1998. As the most highly effective treatments in use, anti-TNF agents have been used increasingly to treat patients not only with disease refractory to other therapies, but also earlier in the course of disease. However, relatively little is yet known about factors associated with likelihood of anti-TNF agent utilization and patient response.

OSCCAR is studying IBD patients prescribed an anti-TNF agent in the first 18 months after diagnosis, offering an opportunity to understand factors contributing to early use and to response. Investigators will identify baseline demographic, clinical and physician factors that are associated with early use of anti-TNF agents, and explore factors associated with clinical and/or biologic response to them.

Ongoing studies (described above) will be complete and manuscripts produced for publication in scientific journals and via conferences and other meetings of IBD researchers and clinicians. OSCCAR will utilize the Foundation's communications channels to development and disseminate educational messages associated with its progress and discoveries.

Please contact Marjorie Merrick with any questions or comments regarding the Foundation's Ocean State Crohn’s & Colitis Area Registry (OSCCAR).