The 2023 Impact of Inflammatory Bowel Disease in Canada: Direct Health System and Medication Costs.

Healthcare utilization among people living with inflammatory bowel disease (IBD) in Canada has shifted from inpatient management to outpatient management; fewer people with IBD are admitted to hospitals or undergo surgery, but outpatient visits have become more frequent. Although the frequency of emergency department (ED) visits among adults and seniors with IBD decreased, the frequency of ED visits among children with IBD increased. Additionally, there is variation in the utilization of IBD health services within and between provinces and across ethnocultural and sociodemographic groups. For example, First Nations individuals with IBD are more likely to be hospitalized than the general IBD population. South Asian children with Crohn's disease are hospitalized more often than their Caucasian peers at diagnosis, but not during follow-up. Immigrants to Canada who develop IBD have higher health services utilization, but a lower risk of surgery compared to individuals born in Canada. The total direct healthcare costs of IBD, including the cost of hospitalizations, ED visits, outpatient visits, endoscopy, cross-sectional imaging, and medications are rising rapidly. The direct health system and medication costs of IBD in Canada are estimated to be $3.33 billion in 2023, potentially ranging from $2.19 billion to $4.47 billion. This is an increase from an estimated $1.28 billion in 2018, likely due to sharp increases in the use of biologic therapy over the past two decades. In 2017, 50% of total direct healthcare costs can be attributed to biologic therapies; the proportion of total direct healthcare costs attributed to biologic therapies today is likely even greater.

The 2023 Impact of Inflammatory Bowel Disease in Canada: Indirect (Individual and Societal) and Direct Out-of-Pocket Costs.

People living with inflammatory bowel disease (IBD) and their caregivers are faced with indirect and out-of-pocket costs that they would not otherwise experience. These costs impact one's ability to contribute to the economy to their fullest potential. The indirect costs of IBD in Canada are estimated to be at least $1.51 billion in 2023 and include costs associated with lost productivity resulting from a combination of missed work (absenteeism), decreased workplace productivity (presenteeism), unemployment, premature mortality, and caregiving costs. Unemployment is the largest contributor to indirect costs ($1.14 billion), followed by costs of absenteeism and presenteeism ($285 million). Caregiving costs for children with IBD are estimated to be nearly $58 million. Canadians with IBD also pay $536 million every year for care that is not covered by universal or supplemental private health insurance; this includes allied healthcare (e.g., care provided by psychologists), medication, and other supportive therapy. Combined, the indirect and out-of-pocket costs of IBD in Canada are estimated at more than $2 billion CAD in 2023. This is substantially higher than the estimate of $1.29 billion in Crohn's and Colitis Canada's 2018 Impact of IBD report with differences attributable to a combination of rising prevalence, inflation, and the addition of presenteeism and caregiving costs to the total indirect costs.

Do You See What I See? An Assessment of Endoscopic Lesions Recognition and Description by Gastroenterology Trainees and Staff Physicians.

BACKGROUND: Gastroenterologists should accurately describe endoscopic findings and integrate them into management plans. We aimed to determine if trainees and staff are describing inflammatory bowel disease (IBD) lesions in a similar manner. METHODS: Using 20 ileocolonoscopy images, participants described IBD inflammatory burden based on physician severity rating, and Mayo endoscopic score (MES) (ulcerative colitis [UC]) or simple endoscopic score (SES-CD) (Crohn's disease [CD]). Images were selected based on agreement by three IBD experts. Findings of varying severity were presented; 10 images included a question about management. We examined inter-observer agreement among trainees and staff, compared trainees to staff, and determined accuracy of response comparing both groups to IBD experts. RESULTS: One hundred and twenty-nine staff and 47 trainees participated from across Canada. There was moderate inter-rater agreement using physician severity rating (κ = 0.53 UC and 0.52 CD for staff, κ = 0.51 UC and 0.43 CD for trainees). There was moderate inter-rater agreement for MES for staff and trainees (κ = 0.49 and 0.48, respectively), but fair agreement for SES-CD (κ = 0.37 and 0.32, respectively). For accuracy of response, the mean score was 68.7% for staff and 63.7% for trainees (P = 0.028). Both groups identified healed bowel or severe disease better than mild/moderate (P < 0.05). There was high accuracy for management, but staff scored higher than trainees for UC (P < 0.01). CONCLUSION: Inter-rater agreement on description of IBD lesions was moderate at best. Staff and trainees more accurately describe healed and severe disease, and better describe lesions in UC than CD.

The Impact of Inflammatory Bowel Disease in Canada 2018: Indirect Costs of IBD Care.

The indirect cost of illness represents the portion of human capital that is foregone due to lost productivity of patients and their caregivers and out-of-pocket healthcare expenses borne directly by patients. Indirect costs among persons with inflammatory bowel diseases (IBD) may be substantial because disease onset occurs during the teens and 20s for most persons and is lifelong. Thus, most persons with IBD are affected during periods of study or employment. The literature on indirect health-related costs among persons with IBD is limited, particularly with regard to Canadian studies. The greatest burden of indirect costs in this population relates to absenteeism and presenteeism among working individuals and premature retirement. However, costs related to reduced professional development and personal achievement due to illness-as well as caregiver costs-are largely unknown. After being extrapolated from multiple sources, the total indirect health-related cost of IBD in Canada in 2018 is estimated to be $1.29 billion Canadian dollars. Notably, this may be a significant underestimate because costs relating to presenteeism, reduced achievement and caregiver burden could not be estimated and are excluded from this calculation. HIGHLIGHTS: Indirect costs account for a major portion of total healthcare costs among persons with inflammatory bowel disease (IBD) and are higher than indirect costs among persons without IBD.Persons with IBD are more likely to require time off work (absenteeism) and have reduced productivity at work (presenteeism) due to illness as compared with persons without IBD.Premature retirement and long-term disability are major factors contributing to indirect costs among IBD patients.A substantial proportion of individuals with IBD pay out-of-pocket for complementary and alternative medicines.After being extrapolated from multiple sources, the total annual indirect cost of IBD in Canada is estimated to be $1.29 billion CAD in 2018, or $4781 CAD per person with IBD. KEY SUMMARY POINTS: The total indirect economic burden of IBD in Canada is estimated to be $1.29 billion CAD in 2018, or roughly $4781 CAD per person with IBD. This estimate comprises lost wages related to sick days and disability, premature retirement and premature death, and out-of-pocket costs. Losses from presenteeism, reduced professional development and caregiver burden are not included due to insufficient data on the cost impact of these factors.In a meta-analysis of studies between 1994 and 2014, the annual indirect cost of absenteeism for IBD patients ranged from $515.67 USD (USA) to $14,727 USD (Germany) per patient per annum (pooled estimate $7189 USD), after adjusting for purchasing power disparity.A large US survey found that, on average, IBD patients incurred an extra 4.8 days off of work and $783 USD in excess lost wages annually compared with persons without IBD.A study based on US private insurance claims found that ulcerative colitis patients cost an additional $2164 per person per annum relating to disability days and medically related absenteeism.A prospective study from an IBD centre reported weekly indirect health-related costs of $1133 for IBD patients with active disease, $370.13 for IBD patients in remission, and $191.23 for persons without IBD relating to both presenteeism and absenteeism.In a survey of 744 IBD patients from Manitoba, reduced workplace productivity during the previous 14 days was reported in 37% of individuals, including a reduction of one to two days by 18% of patients, thre to nine days by 16% of patients, and on most days by 3% of patients.The estimated average lifetime lost wages due to premature retirement is $1,044,498 CAD per person with Crohn's disease and $994,760 CAD per person with ulcerative colitis. Aggregated over all IBD retirees, this equates to roughly $629 million CAD in permanent lost wages annually due to premature retirement.The lifetime indirect cost associated with premature death among IBD patients is estimated to be $746,070 CAD per decedent, or roughly $33.6 million aggregated across all IBD decedents of working age.In a US study of caregivers of children, the average unadjusted annual work loss was 214 hours for caregivers of Crohn's disease patients and 170 hours for caregivers of children without IBD, translating to an additional $1122 in lost productivity for caregivers of persons with Crohn's disease.Canadian studies have reported complementary and alternative medicines (CAMs) use in 56% to 74% of people with IBD. A US national survey study estimated annual per-person out of pocket costs of $1603 USD for Crohn's disease patients and $1263 USD for ulcerative colitis patients, which were substantially higher than in persons without IBD. GAPS IN KNOWLEDGE AND FUTURE DIRECTIONS: Canadian-specific data on indirect health-related costs of IBD is sparse across all domains of indirect costs.In particular, the rates of absenteeism, presenteeism and premature retirement among IBD patients living in Canada require further study to gauge more accurately the indirect health-related costs of IBD in Canada.Indirect costs relating to decreased professional development, caregiver burden and out-of-pocket purchases among IBD patients are largely unknown and require further study.Indirect costs incurred by Canadian children with IBD and their families or caregivers are largely unknown.

The Impact of Inflammatory Bowel Disease in Canada 2018: Direct Costs and Health Services Utilization.

Direct health care costs of illness reflect the costs of medically necessary services and treatments paid for by public and private payers, including hospital-based care, outpatient physician consultations, prescription medications, diagnostic testing, complex continuing care, and home care. The costs of caring for persons with inflammatory bowel disease (IBD) have been rising well above inflation over the past fifteen years in Canada, largely due to the introduction and penetration of expensive biologic therapies. Changing paradigms of care toward frequent patient monitoring and achievement of stricter endpoints for disease control have also increased health services utilization and costs among IBD patients. While the frequency and costs of surgeries and hospitalizations have declined slightly in parallel with increased biologic use (due to better overall disease control), the direct medical costs of care for IBD patients are largely dominated by prescription drug costs. Introduction and penetration of biosimilar agents (at a markedly lower price point than the originator drugs) and increasing gastroenterologist involvement in the care of IBD patients may help to balance rising health care costs while improving health outcomes and quality of life for IBD patients. Ultimately, however, the predicted rise in the prevalence of IBD over the next decade, combined with increasing use of expensive biologic therapies, will likely dictate a continued rise in the direct costs of IBD patient care in Canada for years to come. In 2018, direct health care costs of IBD are estimated to be at least $1 billion Canadian dollars (CAD) and possibly higher than $2 billion CAD. HIGHLIGHTS: 1. In Canada, the direct cost of caring for people living with IBD is estimated in 2018 to be close to $1.28 billion (roughly $4731 per person with IBD).2. The costs of caring for people living with IBD are dominated by prescription drugs, followed by hospitalization costs. There has been a shift away from hospitalizations and toward pharmaceuticals as the predominant driver of direct health care costs in IBD patients, due to the introduction and widespread use of expensive biologic therapies.3. The rates of hospitalizations and major abdominal surgeries have been declining in IBD patients in Canada over the past two decades, possibly due to penetration of biologic therapies and advances in patient management paradigms.4. Inflammatory bowel disease patients cared for by gastroenterologists have better outcomes, including lower risks of surgery and hospitalization. Canadians who live in rural and underserviced areas are less likely to receive gastroenterologist care, potentially due to care preferences or poorer access, which may result in poorer long-term outcomes.5. Introduction of biosimilar agents at a lower price point than originator biologic therapies, increased gastroenterologist care of IBD patients, and improvements in IBD care paradigms may balance overall treatment costs while improving health outcomes and quality of life for IBD patients. However, in the long-term, direct costs of care may continue to increase, dictated by a rising IBD prevalence and increasing use of biologic therapies. KEY SUMMARY POINTS: 1. The costs of health care for patients with IBD are more than double those without IBD.2. Prescription drug use accounts for 42% of total direct costs in IBD patients, and costs to treat IBD continue to rise due to increased use of existing biologic therapies and the introduction of several new biologic therapies in recent years.3. In Manitoba, the mean health care utilization and medication costs for persons with IBD in the year before beginning anti-TNF therapy was $10,206 and increased to $44,786 in the first year of therapy.4. Biosimilar agents to anti-TNF drugs are now entering the Canadian marketplace and may result in cost savings in patients using biologic agents to treat their IBD.5. Timely gastroenterologist care has been associated with reduced risks of requiring surgery and emergency care among ambulatory IBD patients and a reduced risk of death among hospitalized patients with ulcerative colitis.6. Inflammatory bowel disease care provided by gastroenterologists has increased over the past two decades. Even then, the average time from symptom onset to IBD diagnosis exceeds six months, and only one-third of IBD patients receive continuing care with a gastroenterologist during the first five years following diagnosis.7. Senior (age ≥65), rural-dwelling, and non-immigrant IBD patients have less frequent gastroenterologist care than other groups.8. About one in five adults with Crohn's disease and one in eight adults with ulcerative colitis are hospitalized in Ontario every year. Hospitalizations are most common during the first year following IBD diagnosis. Children with IBD (age <18) have the highest rates of hospitalizations and hospital re-admissions.9. In Canada, 16% of patients hospitalized for Crohn's disease undergo an intestinal resection, and 11% of patients hospitalized for ulcerative colitis undergo a colectomy during their initial hospitalization. Rates of intestinal resection and colectomy are declining in Canada in persons with Crohn's disease and ulcerative colitis, respectively.10. In Ontario, one-third of adult-onset Crohn's disease patients undergo intestinal resection within ten years of diagnosis. Among Canadian children with Crohn's disease, approximately one in fifteen children will require intestinal surgery within the first year of diagnosis, and up to one-third will require surgery within ten years of diagnosis.11. In Ontario, the ten-year colectomy risk following ulcerative colitis diagnosis is 13.3% among young persons and adults and 18.5% among individuals with senior-onset ulcerative colitis. In children with ulcerative colitis, the risk of colectomy is 4.8% to 6% in the first year following diagnosis and increases to 15% to 17% by ten years. GAPS IN KNOWLEDGE AND FUTURE DIRECTIONS: 1. Forecasting models are necessary to predict the rising costs attributable to biologics associated with increasing prevalence of IBD, more frequent use of these medications, and the introduction of newer agents.2. Research into ways to minimize the escalating costs associated with increasing use of biologic therapies to treat IBD (and other chronic diseases) is necessary to ensure sustainability of our publicly funded health care system. Biosimilars offer an opportunity to drive down the cost of biologic therapies, and future research should assess the uptake of biosimilars as new biosimilars are introduced into the marketplace.3. Cost-utility models and budget impact analyses that integrate changes in direct costs (i.e., reduced hospitalizations and increased pharmaceutical costs) with indirect cost savings from improved quality of life are necessary to inform policy decisions.4. Research into ways to reduce IBD hospitalizations further through targeted outpatient interventions is equally important for health system sustainability and to improve patient quality of life.5. Research into reasons for reduced gastroenterologist care among rural and underserviced IBD residents would allow targeted interventions to improve specialist care and thereby improve patient health outcomes and quality of life.

Quality of care indicators in inflammatory bowel disease in a tertiary referral center with open access and objective assessment policies.

BACKGROUND: In the management of inflammatory bowel diseases, there is considerable variation in quality of care. AIMS: The aim of this study was to evaluate structural, access/process components and outcome quality indicators in our tertiary referral IBD center. METHODS: In the first phase, structural/process components were assessed, followed by the second phase of formal evaluation of access and management on a set of consecutive IBD patients with and without active disease (248CD/125UC patients, median age 35/39 years). RESULTS: Structural/process components of our IBD center met the international recommendations. At or around the time of diagnosis usual procedures were full colonoscopy in all patients, with ileocolonoscopy/gastroscopy/CT/MRI in 81.8/45.5/66.1/49.6% of CD patients. A total of 86.7% of CD patients had any follow-up imaging evaluation or endoscopy. The median waiting time for non-emergency endoscopy/CT/MRI was 16/14/22 days. During the observational period patients with flares (CD/UC:50.6/54.6%) were seen by specialist at the IBD clinic within a median of 1day with same day laboratory assessment, abdominal US, CT scan/surgical consult and change in therapy if needed. Surgery and hospitalization rates were 20.1/1.4% and 17.3/3.2% of CD/UC patients. CONCLUSION: Our results highlight that structural components and processes applied in our center are in line with international recommendations, including an open clinic concept and fast track access to specialist consultation, endoscopy and imaging.

Treatment Algorithm for Chronic Idiopathic Constipation and Constipation-Predominant Irritable Bowel Syndrome Derived from a Canadian National Survey and Needs Assessment on Choices of Therapeutic Agents.

Background. Chronic idiopathic constipation (CIC) and constipation-predominant irritable bowel syndrome (IBS-C) are common functional lower gastrointestinal disorders that impair patients' quality of life. In a national survey, we aimed to evaluate (1) Canadian physician practice patterns in the utilization of therapeutic agents listed in the new ACG and AGA guidelines; (2) physicians satisfaction with these agents for their CIC and IBS-C patients; and (3) the usefulness of these new guidelines in their clinical practice. Methods. A 9-item questionnaire was sent to 350 Canadian specialists to evaluate their clinical practice for the management of CIC and IBS-C. Results. The response rate to the survey was 16% (n = 55). Almost all (96%) respondents followed a standard, stepwise approach for management while they believed that only 24% of referring physicians followed the same approach. Respondents found guanylyl cyclase C (GCC) agonist most satisfying when treating their patients. Among the 69% of respondents who were aware of published guidelines, only 50% found them helpful in prioritizing treatment choices and 69% of respondents indicated that a treatment algorithm, applicable to Canadian practice, would be valuable. Conclusion. Based on this needs assessment, a treatment algorithm was developed to provide clinical guidance in the management of IBS-C and CIC in Canada.

The Modified Mayo Endoscopic Score (MMES): A New Index for the Assessment of Extension and Severity of Endoscopic Activity in Ulcerative Colitis Patients.

BACKGROUND AND AIMS: Current endoscopic activity scores for ulcerative colitis (UC) do not take into account the extent of mucosal inflammation. We have developed a simple endoscopic index for UC that takes into account the severity and distribution of mucosal inflammation. METHODS: In this multicentre trial, UC patients undergoing colonoscopy were prospectively enrolled. For the Modified Score (MS), the sum of Mayo Endoscopic Subscores (MESs) for five colon segments (ascending, transverse, descending, sigmoid and rectum) was calculated. The Extended Modified Score (EMS) was obtained by multiplying the MS by the maximal extent of inflammation. The Modified Mayo Endoscopic Score (MMES) was obtained by dividing the EMS by the number of segments with active inflammation. Colon biopsies were obtained from the rectum and sigmoid, as well as from all inflamed segments, by standard methods. Clinical activity was scored according to the Partial Mayo Score (PMS). Biological activity was scored according to C-reactive protein (CRP) and faecal calprotectin (FC) levels. Histological activity was scored according to the Geboes Score (GS). RESULTS: One hundred and seventy-one UC patients (38% female, median age 47 years, median disease duration 13 years) were included. The MMES correlated significantly with the PMS (r = 0.535), CRP (r = 0.238), FC (r = 0.730) and GS (r = 0.615) (all p < 0.001). Median MMES scores were significantly higher in patients with clinical, biological or histological activity (all p ≤ 0.001) CONCLUSIONS: The MMES is an easy to use endoscopic index for UC that combines the severity analysis of the MES with disease extent, and correlates very well with clinical, biological and histological disease activity.

Risk of Lymphoma, Colorectal and Skin Cancer in Patients with IBD Treated with Immunomodulators and Biologics: A Quebec Claims Database Study.

BACKGROUND: Immunomodulatory medications in patients with inflammatory bowel disease (IBD) have been associated with an increased risk of developing certain malignancies. The aim of this study was to evaluate the risk of melanoma, nonmelanoma skin cancer, colorectal cancer and lymphoma associated with immunomodulators and biologics in patients with IBD. METHODS: A nested case-control study was carried out using the provincial health insurance database of Québec, Canada (RAMQ/MedECHO). RESULTS: A total of 41,176 patients with IBD were identified of whom 19,582 patients were eligible for inclusion in the study. Treatment with thiopurine for more than 5 years was associated with a significantly increased risk of nonmelanoma skin cancer (odds ratio: 1.78; 95% confidence interval, 1.25-2.54). Immunomodulator treatment was not associated with an increased risk of non-Hodgkin's lymphoma (odds ratio: 0.87; 95% confidence interval, 0.53-1.41). Neither immunomodulators nor anti-TNF-α agents were associated with an increased risk of melanoma or colorectal cancer. CONCLUSIONS: In a large provincial IBD cohort, treatment with immunomodulators for more than 5 years was associated with an increased risk of non-melanoma skin cancer, whereas the risk of lymphoma, melanoma, and colorectal cancer was not increased. No association was found between the risk of the evaluated malignancies and anti-TNF-α medications.

Vitamin B12 deficiency in inflammatory bowel disease: prevalence, risk factors, evaluation, and management.

BACKGROUND: Management of vitamin B(12) (cobalamin, Cbl) deficiency in inflammatory bowel disease (IBD) is often not evidenced-based because of uncertainty on whether it causes enough malabsorption to result in clinical disease. This systematic review examines whether IBD predisposes to Cbl deficiency. We provide an approach to the management of abnormal Cbl values in IBD based on current literature and consensus-based guidelines. METHODS: An extensive search of the Ovid MEDLINE and EMBASE databases by independent reviewers identified 42 articles with a total of 3732 patients evaluating Cbl deficiency in IBD. RESULTS: Crohn's disease without ileal resection, regardless of disease location in the ileum, did not increase the risk for Cbl deficiency. Ileal resections greater than 30 cm were associated with Cbl deficiency in Crohn's disease, whereas those less than 20 cm were not. The effects of 20 to 30 cm resections were inconsistent. Ulcerative colitis did not predispose to deficiency. All studies failed to use confirmatory biomarker testing as stipulated by diagnostic guidelines for Cbl deficiency. CONCLUSIONS: This literature does not support an association of Crohn's disease in general, regardless of ileal involvement, with Cbl deficiency. Only ileal resections greater than 20 cm in Crohn's disease predispose to deficiency and warrant treatment. Based on these findings, we suggest a diagnostic and therapeutic algorithm. All findings and recommendations require verification in further studies using confirmatory biomarkers as per diagnostic guidelines for Cbl deficiency. Serum Cbl levels alone are likely insufficient to diagnose deficiency in asymptomatic patients.

Inflammatory bowel disease: a Canadian burden of illness review.

BACKGROUND: Inflammatory bowel diseases (IBD) - Crohn's disease (CD) and ulcerative colitis (UC) - significantly impact quality of life and account for substantial costs to the health care system and society. OBJECTIVE: To conduct a comprehensive review and summary of the burden of IBD that encompasses the epidemiology, direct medical costs, indirect costs and humanistic impact of these diseases in Canada. METHODS: A literature search focused on Canadian data sources. Analyses were applied to the current 2012 Canadian population. RESULTS: There are approximately 233,000 Canadians living with IBD in 2012 (129,000 individuals with CD and 104,000 with UC), corresponding to a prevalence of 0.67%. Approximately 10,200 incident cases occur annually. IBD can be diagnosed at any age, with typical onset occurring in the second or third decade of life. There are approximately 5900 Canadian children <18 years of age with IBD. The economic costs of IBD are estimated to be $2.8 billion in 2012 (almost $12,000 per IBD patient). Direct medical costs exceed $1.2 billion per annum and are driven by cost of medications ($521 million), hospitalizations ($395 million) and physician visits ($132 million). Indirect costs (society and patient costs) total $1.6 billion and are dominated by long-term work losses of $979 million. Compared with the general population, the quality of life patients experience is low across all dimensions of health. CONCLUSIONS: The present review documents a high burden of illness from IBD due to its high prevalence in Canada combined with high per-patient costs. Canada has among the highest prevalence and incidence rates of IBD in the world. Individuals with IBD face challenges in the current environment including lack of awareness of IBD as a chronic disease, late or inappropriate diagnosis, inequitable access to health care services and expensive medications, diminished employment prospects and limited community-based support.

Assessment of reliability and validity of IBD phenotyping within the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) IBD Genetics Consortium (IBDGC).

BACKGROUND: The NIDDK IBD Genetics Consortium (IBDGC) collects DNA and phenotypic data from inflammatory bowel disease (IBD) subjects to provide a resource for genetic studies. No previous studies have been performed on the reliability and validity of phenotypic determinations in either Crohn's disease (CD) or ulcerative colitis (UC) using primary records. Our aim was to determine the reliability and validity of these phenotypic assessments. METHODS: The de-identified records of 30 IBD patients were reviewed by 2 phenotypers per center using a standard protocol for phenotypic assessment. Each phenotyper evaluated 10 charts on 2 occasions 5 months apart. Reliability was expressed as the kappa (kappa) statistic. Performance characteristics were determined by comparison to a consensus-derived "gold standard" and by generation of receiver operating characteristic (ROC) curves. RESULTS: Agreement for diagnosis was excellent (kappa = 0.82; 95% confidence interval [CI]: 0.71-0.92). Agreement for CD location was good for jejunal, ileal, colorectal, and perianal disease with kappa between 0.60 and 0.74 but was fair for esophagogastroduodenal (kappa = 0.36). Agreement for UC extent (kappa = 0.67; 95% CI: 0.48-0.85), and CD behavior (kappa = 0.67; 95% CI: 0.49-0.83) were very good. Area under the ROC curves was greater than 0.84 for diagnosis, CD behavior, UC extent, and ileal and colonic CD location. CONCLUSIONS: IBD phenotype classification using a standard protocol exhibited very good to excellent inter- and intrarater agreement and validity. This study highlights the importance of standard protocols in generating reliable and valid phenotypic assessments. The data will facilitate estimates of phenotyping misclassification rates that should be considered when making inferences from IBD genotype-phenotype studies.