Impact of adalimumab on disease burden in moderate-to-severe ulcerative colitis patients: The one-year, real-world UCanADA study.

BACKGROUND: A gap remains in documenting the impact of anti-tumor necrosis factor therapy on disease burden in ulcerative colitis (UC) patients treated in a real-world setting. The use of patient-reported outcomes (PROs) has been discussed as a primary endpoint in the context of the FDA PRO Guidance, for labelling purposes. Specifically, the efficacy and safety of adalimumab have been demonstrated in pivotal trials; however, data are needed to understand how clinical results translate into improvements in key aspects of the daily lives of UC patients, such as symptoms, health-related quality of life (HRQoL), and disability. AIM: To assess real-world effectiveness of adalimumab on PRO measures in patients with moderate-to-severe UC. METHODS: UCanADA was a single arm, prospective, 1-year multicenter Canadian post-marketing observational study in which multiple PRO questionnaires were completed-with psychologic distress/depression symptoms as the primary endpoint-by patients with moderate-to-severe UC. Assessments were performed during patients' routine care visit schedule, which was at the initiation of adalimumab (baseline), after induction (approximately 8 wk), and 52 wk after baseline. Additional optional assessments between weeks 8 and 52 were collected at least once but no more than two times during this period. Serious safety events and per-protocol adverse events were collected. RESULTS: From 23 Canadian centres, 100 patients were enrolled and 48 completed the study. Measured with the Patient Health Questionnaire-9 items at week 52, 61.5% (40/65) [95% confidence interval (CI): 49.7%-73.4%] of the patients improved in psychologic distress/depression symptoms, which was slightly higher in completers [65.9% (29/44); 95%CI: 51.9%-79.9%)]. At week 52, clinical response and clinical remission were achieved respectively by 65.7% (44/73) and 47.8% (32/73) of the patients. The odds of improving depressive symptoms for those achieving a clinical remission at week 52 was 7.94 higher compared with those not achieving a clinical remission (CI: 1.42, 44.41; P = 0.018). Significant changes from baseline to weeks 8 and 52 were observed in disability, HRQoL, and fatigue. Meaningful improvement was reported in work impairment. CONCLUSION: At week 52, over 60% of the UCanADA patients had depressive symptoms significantly reduced, as well as HRQoL, fatigue symptoms, and work impairment improved. No new safety signals were detected.

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease.

Technological advances now permit self-management strategies using mobile applications which could greatly benefit patient care. The purpose of this study was to investigate whether the use of the inflammatory bowel disease (IBD) digital health monitoring platform, HealthPROMISE, leads to better quality of care and improved health outcomes in IBD patients. IBD patients were recruited in gastroenterology clinics and asked to install the HealthPROMISE application onto their smartphones. Patient satisfaction, quality of care, quality of life, patient symptoms, and resource utilization metrics were collected throughout the study and sent directly to their healthcare teams. Patients with abnormal symptom/SIBDQ scores were flagged for their physicians to follow up. After one-year, patient outcome metrics were compared to baseline values. Overall, out of 59 patients enrolled in the study, 32 patients (54%) logged into the application at least once during the study period. The number of IBD-related ER visits/hospitalizations in the year of use compared to the prior year demonstrated a significant decrease from 25% of patients (8/32) to 3% (1/32) (p = 0.03). Patients also reported an increase in their understanding of the nature/causes of their condition after using the application (p = 0.026). No significant changes were observed in the number of quality indicators met (p = 0.67) or in SIBDQ scores (p = 0.48). Given the significant burden of IBD, there is a need to develop effective management strategies. This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.

Longitudinal Trends in the Direct Costs and Health Care Utilization Ascribable to Inflammatory Bowel Disease in the Biologic Era: Results From a Canadian Population-Based Analysis.

OBJECTIVES: The prevalence of inflammatory bowel disease (IBD) is increasing. The total direct costs of IBD have not been assessed on a population-wide level in the era of biologic therapy. DESIGN: We identified all persons with IBD in Manitoba between 2005 and 2015, with each matched to 10 controls on age, sex, and area of residence. We enumerated all hospitalizations, outpatient visits and prescription medications including biologics, and their associated direct costs. Total and per capita annual IBD-attributable costs and health care utilization (HCU) were determined by taking the difference between the costs/HCU accrued by an IBD case and their controls. Generalized linear modeling was used to evaluate trends in direct costs and Poisson regression for trends in HCU. RESULTS: The number of people with IBD in Manitoba increased from 6,323 to 7,603 between 2005 and 2015. The total per capita annual costs attributable to IBD rose from $3,354 in 2005 to $7,801 in 2015, primarily driven by an increase in per capita annual anti-tumor necrosis factor costs, which rose from $181 in 2005 to $5,270 in 2015. There was a significant decline in inpatient costs for CD ($99 ± 25/yr. P < 0.0001), but not for ulcerative colitis ($8 increase ±$18/yr, P = 0.63). DISCUSSION: The direct health care costs attributable to IBD have more than doubled over the 10 years between 2005 and 2015, driven mostly by increasing expenditures on biological medications. IBD-attributable hospitalization costs have declined modestly over time for persons with CD, although no change was seen for patients with ulcerative colitis.

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.

The Effect of Initiation of Anti-TNF Therapy on the Subsequent Direct Health Care Costs of Inflammatory Bowel Disease.

BACKGROUND: Anti-tumor necrosis factor (anti-TNF) drugs are highly effective in the treatment of moderate-to-severe Crohn's disease (CD) and ulcerative colitis (UC), but they are very costly. Due to their effectiveness, they could potentially reduce future health care spending on other medical therapies, hospitalization, and surgery. The impact of downstream costs has not previously been quantified in a real-world population-based setting. METHODS: We used the University of Manitoba IBD Database to identify all persons in a Canadian province with CD or UC who received anti-TNF therapy between 2004 and 2016. All inpatient, outpatient, and drug costs were enumerated both in the year before anti-TNF initiation and for up to 5 years after anti-TNF initiation. Costs before and after anti-TNF initiation were compared, and multivariate linear regression analyses were performed to look for predictors of higher costs after anti-TNF initiation. RESULTS: A total of 928 people with IBD (676 CD, 252 UC) were included for analyses. The median cost of health care in the year before anti-TNF therapy was $4698 for CD vs $6364 for UC. The median cost rose to $39,749 and $49,327, respectively, in the year after anti-TNF initiation, and to $210,956 and $245,260 in the 5 years after initiation for continuous anti-TNF users. Inpatient and outpatient costs decreased in the year after anti-TNF initiation by 12% and 7%, respectively, when excluding the cost of anti-TNFs. CONCLUSIONS: Direct health care expenditures markedly increase after anti-TNF initiation and continue to stay elevated over pre-initiation costs for up to 5 years, with only small reductions in the direct costs of non-drug-related health care.

Predictive models of disease burden at diagnosis in persons with adult-onset ulcerative colitis using health administrative data.

BACKGROUND: Health administrative data is increasingly used to conduct population-based health services research. A major limitation of these data for the study of inflammatory bowel diseases is the absence of detailed clinical information relating to disease burden. We used Ontario health administrative data to develop predictive models of disease burden at diagnosis in ulcerative colitis (UC) patients for future use in population-based studies of incident UC cohorts. METHODS: Through chart review, we characterized macroscopic colitis activity and extent at diagnosis in consecutive adult-onset UC patients diagnosed at The Ottawa Hospital between 2001 and 2012. We linked this cohort to Ontario health administrative data to test the capacity of administrative variables to discriminate different levels of disease activity, disease extent and the disease burden (a composite of disease extent and activity). We modelled outcomes as binary (using logistic regression) and ordinal (using proportional odds regression) variables and performed bootstrap validation of our final models. RESULTS: We tested 20 administrative variables in 587 eligible patients. The logistic model of total disease burden (severe and extensive colitis vs. all other phenotypes) showed moderate discriminatory capacity (optimism-corrected c-statistic value 0.729). Individual models of disease extent and disease activity showed poorer discriminatory capacity (c-statistic value < 0.7 for 3 of 4 models). CONCLUSIONS: Ontario health administrative data may reasonably discriminate levels of total disease burden at diagnosis in adult-onset UC patients. Our models should be externally validated before their widespread application in future population-based studies of incident UC cohorts to adjust for the confounding effects of differences in disease burden.

Impact of experience on self-assessment accuracy of clinical colonoscopy competence.

BACKGROUND AND AIMS: Self-assessment is important for life-long learning and a recommended assessment method for endoscopy skills. Prior literature has not investigated self-assessment accuracy of colonoscopic competence in the clinical setting. This study aimed to determine the self-assessment accuracy of novice, intermediate, and experienced endoscopists. METHODS: Novice (performed <50 previous colonoscopies), intermediate (50-500), and experienced (>1000) endoscopists from 5 hospitals each performed a clinical colonoscopy. Video recordings of procedures were independently assessed by 2 blinded expert endoscopists by using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT). Externally assessed and self-assessed GiECAT scores were defined as the mean of the 2 video-based ratings and as participants' own assigned ratings, respectively. Self-assessment accuracy between the externally assessed and self-assessed scores was evaluated by using absolute difference scores, intraclass correlation coefficients, and the Bland-Altman analysis. RESULTS: Twenty novice, 10 intermediate, and 10 experienced endoscopists participated. There was moderate agreement of externally assessed and self-assessed GiECAT scores, with an intraclass correlation coefficient of 0.65 (95% confidence interval, 0.44-0.80). The absolute difference scores among the 3 groups were significantly different (P = .002), with experienced endoscopists demonstrating a more accurate self-assessment ability compared with novices (P = .002). Bland-Altman plots suggest that novice and experienced endoscopists tend to overrate and underrate their clinical competence, respectively; no specific trends were associated with intermediates. CONCLUSION: Participants demonstrated moderate self-assessment accuracy of clinical competence. Endoscopist experience was positively associated with self-assessment accuracy; novices demonstrated lower self-assessment accuracy compared with experienced endoscopists. Moreover, novices tended to overestimate their performances. Novice endoscopists may benefit from targeted interventions to improve self-assessment accuracy.

Cost-utility Analysis: Thiopurines Plus Endoscopy-guided Biological Step-up Therapy is the Optimal Management of Postoperative Crohn's Disease.

BACKGROUND: Postoperative recurrence of Crohn's disease is common. This study sought to assess whether the postoperative management should be based on biological therapy alone or combined with thiopurines and whether the therapy should be started immediately after surgery or guided by either endoscopic or clinical recurrence. METHODS: A Markov model was developed to estimate expected health outcomes in quality-adjusted life years (QALYs) and costs in Canadian dollars (CAD$) accrued by hypothetical patients with high recurrence risk after ileocolic resection. Eight strategies of postoperative management were evaluated. A lifetime time horizon, an annual discount rate of 5%, a societal perspective, and a cost-effectiveness threshold of 50,000 CAD$/QALY were assumed. Deterministic and probabilistic sensitivity analyses were conducted. The model was validated against randomized trials and historical cohorts. RESULTS: Three strategies dominated the others: endoscopy-guided full step-up therapy (14.80 QALYs, CAD$ 462,180), thiopurines immediately post-surgery plus endoscopy-guided biological step-up therapy (14.89 QALYs, CAD$ 464,099) and combination therapy immediately post-surgery (14.94 QALYs, CAD$ 483,685). The second strategy was the most cost-effective, assuming a cost-effectiveness threshold of 50,000 CAD$/QALY. Probabilistic sensitivity analysis showed that the second strategy has the highest probability of being the optimal alternative in all comparisons at cost-effectiveness thresholds from 30,000 to 100,000 CAD$/QALY. The strategies guided only by clinical recurrence and those using biologics alone were dominated. CONCLUSIONS: According to this decision analysis, thiopurines immediately after surgery and addition of biologics guided by endoscopic recurrence is the optimal strategy of postoperative management in patients with Crohn's disease with high risk of recurrence (see Video Abstract, Supplemental Digital Content 1, http://links.lww.com/IBD/B654).

Public versus Private Drug Insurance and Outcomes of Patients Requiring Biologic Therapies for Inflammatory Bowel Disease.

Background. Antitumor necrosis factor (anti-TNF) therapy is a highly effective but costly treatment for inflammatory bowel disease (IBD). Methods. We conducted a retrospective cohort study of IBD patients who were prescribed anti-TNF therapy (2007-2014) in Ontario. We assessed if the insurance type was a predictor of timely access to anti-TNF therapy and nonroutine health utilization (emergency department visits and hospitalizations). Results. There were 268 patients with IBD who were prescribed anti-TNF therapy. Public drug coverage was associated with longer median wait times to first dose than private one (56 versus 35 days, P = 0.002). After adjusting for confounders, publicly insured patients were less likely to receive timely access to anti-TNF therapy compared with those privately insured (adjusted hazard ratio, 0.66; 95% CI: 0.45-0.95). After adjustment for demographic and clinical characteristics, publicly funded subjects were more than 2-fold more likely to require hospitalization (incidence rate ratio [IRR], 2.30; 95% CI: 1.19-4.43) and ED visits (IRR 2.42; 95% CI: 1.44-4.08) related to IBD. Conclusions. IBD patients in Ontario with public drug coverage experienced greater delays in access to anti-TNF therapy than privately insured patients and have a higher rate of hospitalizations and ED visits related to IBD.

The Challenges of Living with Inflammatory Bowel Disease: Summary of a Summit on Patient and Healthcare Provider Perspectives.

Canada has one of the highest rates of inflammatory bowel disease (IBD) and the disease represents a significant health, social, and economic burden. There is currently no cure for IBD, although earlier diagnosis and new therapies have improved the overall health outcomes and quality of life for patients. Crohn's and Colitis Canada is Canada's only national, volunteer-based charity dedicated to finding cures for IBD and improving the lives of those affected, through research, education, patient programs, advocacy, and increased awareness. On April 30, 2015, Crohn's and Colitis Canada hosted the "Patient and Healthcare Professional Summit on the Burden of Disease in IBD" to obtain a deeper understanding of the unmet needs of IBD patients and their caregivers. Through personal vignettes, patients articulated a pressing need to increase understanding of the challenges faced by people suffering from IBD among both health care professionals and the general public, develop best practices for navigating life transitions and addressing the unique challenges faced by children with IBD, and provide equitable access to appropriate, effective, and affordable treatments. The recommendations that emerged from the summit will inform about efforts to increase public awareness, inform about advocacy strategies, and contribute to the development of research priorities.

Diverticular disease: changing epidemiology and management.

Diverticulosis is the most common pathological finding in routine colonoscopy. Diverticular disease comprises both diverticulitis and diverticular hemorrhage. This review examines the pathophysiological basis for disease including the importance of the elastin/collagen profile in diverticula formation. It summarizes the latest epidemiological findings with an emphasis on age- and sex-related differences. Risk factors including obesity, medications, hereditary factors, and diet are critically reviewed with the most up-to-date evidence. A detailed appraisal of therapeutic options is provided with special emphasis on 5-aminosalicylate, probiotics, mesalamine, percutaneous abscess drainage, and image-guided embolization. The role of antibiotics and surgery is discussed and compared with guideline recommendations. A more conservative approach, averting admission and even antibiotics, is explored. Finally, a careful review of the data surrounding the utility of colonoscopy in diagnosis and management is provided given the increasing number of reports citing the low incidence of colorectal neoplasia after an episode of diverticulitis. Throughout the review we focus on the older patient with diverticular disease.

Gastrointestinal Endoscopy Competency Assessment Tool: reliability and validity evidence.

BACKGROUND: Rigorously developed and validated direct observational assessment tools are required to support competency-based colonoscopy training to facilitate skill acquisition, optimize learning, and ensure readiness for unsupervised practice. OBJECTIVE: To examine reliability and validity evidence of the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) for colonoscopy for use within the clinical setting. DESIGN: Prospective, observational, multicenter validation study. Sixty-one endoscopists performing 116 colonoscopies were assessed using the GiECAT, which consists of a 7-item global rating scale (GRS) and 19-item checklist (CL). A second rater assessed procedures to determine interrater reliability by using intraclass correlation coefficients (ICCs). Endoscopists' first and second procedure scores were compared to determine test-retest reliability by using ICCs. Discriminative validity was examined by comparing novice, intermediate, and experienced endoscopists' scores. Concurrent validity was measured by correlating scores with colonoscopy experience, cecal and terminal ileal intubation rates, and physician global assessment. SETTING: A total of 116 colonoscopies performed by 33 novice (<50 previous procedures), 18 intermediate (50-500 previous procedures), and 10 experienced (>1000 previous procedures) endoscopists from 6 Canadian hospitals. MAIN OUTCOME MEASUREMENTS: Interrater and test-retest reliability, discriminative, and concurrent validity. RESULTS: Interrater reliability was high (total: ICC=0.85; GRS: ICC=0.85; CL: ICC=0.81). Test-retest reliability was excellent (total: ICC=0.91; GRS: ICC=0.93; CL: ICC=0.80). Significant differences in GiECAT scores among novice, intermediate, and experienced endoscopists were noted (P<.001). There was a significant positive correlation (P<.001) between scores and number of previous colonoscopies (total: ρ=0.78, GRS: ρ=0.80, CL: Spearman's ρ=0.71); cecal intubation rate (total: ρ=0.81, GRS: Spearman's ρ=0.82, CL: Spearman's ρ=0.75); ileal intubation rate (total: Spearman's ρ=0.82, GRS: Spearman's ρ=0.82, CL: Spearman's ρ=0.77); and physician global assessment (total: Spearman's ρ=0.90, GRS: Spearman's ρ=0.94, CL: Spearman's ρ=0.77). LIMITATIONS: Nonblinded assessments. CONCLUSION: This study provides evidence supporting the reliability and validity of the GiECAT for use in assessing the performance of live colonoscopies in the clinical setting.

National estimates of the burden of inflammatory bowel disease among racial and ethnic groups in the United States.

BACKGROUND: The epidemiology of inflammatory bowel disease (IBD) is poorly characterized in minorities in the U.S. We sought to enumerate the burden of IBD among racial and ethnic groups using national-level data. METHODS: Data from the National Health Interview Survey was used to calculate prevalence and incidence of IBD among adults (≥ 18 years) in 1999. The Nationwide Inpatient Sample was queried to ascertain rates of IBD-related hospitalizations and the Underlying Cause of Death Database was accessed to quantify IBD-related mortality. RESULTS: An estimated 1,810,773 adult Americans were affected by IBD yielding a prevalence of 908/100,000, which was higher in Non-Hispanic Whites (1099/100,000) compared with Non-Hispanic Blacks (324/100,000), Hispanics (383/100,000), and non-Hispanic Other (314/100,000). Relative to Non-Hispanic Whites, the odds ratios for having a diagnosis of IBD associated with being Non-Hispanic Black, Hispanic, and Other Non-Hispanic race after adjusting for age, sex, and geographic region were 0.33 (95% CI: 0.19 - 0.57), 0.45 (95% CI: 0.26 - 0.77), and 0.34 (95% CI: 0.12 - 0.93), respectively. IBD incidence was similarly lower in Non-Hispanic Blacks (24.9/100,000) and Hispanics (9.9/100,000) compared to Non-Hispanic Whites (70.2/100,000). The ratio of IBD hospitalizations to prevalence was disproportionately higher among Non-Hispanic Blacks (7.3%) compared with Non-Hispanic Whites (3.0%) and Hispanics (2.7%). Similarly, the ratio of IBD-related mortality was greater in Non-Hispanic Blacks (0.061%) compared to Non-Hispanic Whites (0.036%) and Hispanics (0.026%). CONCLUSIONS: IBD disease burden is lower in ethnic minorities compared to Non-Hispanic Whites. However, IBD-related hospitalizations and deaths seem disproportionately high in Non-Hispanic Blacks.

Hepatitis C as a prognostic indicator among noncirrhotic patients hospitalized with alcoholic hepatitis.

OBJECTIVE: A nationwide analysis of alcoholic hepatitis (AH) admissions was conducted to determine the impact of hepatitis C virus (HCV) infection on short-term survival and hospital resource utilization. METHODS: Using the Nationwide Inpatient Sample, noncirrhotic patients admitted with AH throughout the United States between 1998 and 2006 were identified with diagnostic codes from the International Classification of Diseases, Ninth Revision. The in-hospital mortality rate (primary end point) of AH patients with and without co-existent HCV infection was determined. Hospital resource utilization was assessed as a secondary end point through linear regression analysis. RESULTS: From 1998 to 2006, there were 112,351 admissions for AH. In-hospital mortality was higher among patients with coexistent HCV infection (41.1% versus 3.2%; P=0.07). The adjusted odds of in-hospital mortality in the presence of HCV was 1.48 (95% CI 1.10 to 1.98). Noncirrhotic patients with AH and HCV also had longer length of stay (5.8 days versus 5.3 days; P<0.007) as well as greater hospital charges (US$25,990 versus US$21,030; P=0.0002). CONCLUSIONS: Among noncirrhotic patients admitted with AH, HCV infection was associated with higher in-hospital mortality and resource utilization.

Duration of anticoagulation for the management of venous thromboembolism in inflammatory bowel disease: a decision analysis.

OBJECTIVES: There is practice variation in the duration of anticoagulation for venous thromboembolism (VTE) in inflammatory bowel disease (IBD) patients. Clinicians must weigh the high risk of recurrent VTE with the risk of gastrointestinal bleeding. METHODS: We implemented Markov decision analysis to compare the costs and effectiveness of extended anticoagulation vs. time-limited anticoagulation (6 months) among IBD patients with first unprovoked VTE over a 5-year time horizon. In a secondary analysis, we added two strategies in which therapeutic-dose or prophylactic-dose anticoagulation was administered during IBD flares. RESULTS: Compared with time-limited anticoagulation, extended anticoagulation yielded slightly higher quality-adjusted life years (QALYs) (4.40 vs. 4.38) and costs ($21,158 vs. $20,825), and an incremental cost-effectiveness ratio (ICER) of $15,254/QALY over 5 years. In secondary analysis, pharmacological prophylaxis during IBD flares was associated with the highest QALYs (4.41) and costs ($28,177), but was not cost-effective when compared with extended anticoagulation (ICER=$1,158,717/QALY). Anticoagulation during flares yielded the lowest cost ($19,681) and same QALYs as extended anticoagulation. In probabilistic sensitivity analysis, extended anticoagulation yielded higher QALYs than time-limited anticoagulation in 91% of trials and was dominant or cost-effective (<$50,000/QALY) in 72% of trials. When analyzed over a lifetime, extended anticoagulation dominated time-limited anticoagulation with higher effectiveness (18.44 vs. 17.95 QALYs) and lower costs ($94,738 vs. $102,874) and was highly robust in sensitivity analyses. CONCLUSIONS: Our analyses suggest that extended anticoagulation may provide marginal benefit over time-limited anticoagulation and should be considered in the management of first unprovoked VTE in IBD. Anticoagulation and prophylaxis during IBD flares are alternative viable strategies.

Feasibility of venous thromboembolism prophylaxis during inflammatory bowel disease flares in the outpatient setting: a decision analysis.

BACKGROUND: Inflammatory bowel disease (IBD) patients are at increased risk of venous thromboembolism (VTE), which is most pronounced during a disease flare. We explored the cost-effectiveness of pharmacological VTE prophylaxis in an outpatient setting. METHODS: Markov decision analysis was conducted from a societal perspective to compare the relative costs and effectiveness of pharmacological VTE prophylaxis versus no anticoagulation during ambulatory IBD flares among a hypothetical cohort of 10,000 IBD patients. The time horizon was from time of IBD diagnosis until death. Univariate and probabilistic sensitivity analyses were performed. RESULTS: In base case analysis, VTE prophylaxis was, compared with no anticoagulation, associated with higher average costs (U.S. $141,036 versus $90,338) and quality-adjusted life-years (QALYs) (22.29 versus 22.25), yielding an incremental cost-effectiveness ratio of $1,267,450/QALY. Venous thromboembolism prophylaxis resulted in higher unadjusted life-years (47.76 life-years versus 46.67 life-years) and lower lifetime risk of VTE (6.2% versus 9.3%). The number needed to treat to prevent one VTE event over a lifetime was 32.3. Univariate sensitivity analysis showed that the incremental cost-effectiveness ratio was most sensitive to variations in the efficacy of VTE prophylaxis. In probabilistic sensitivity analysis, only 20% of 1000 simulated trials showed that VTE prophylaxis increased QALYs. In the remaining 80%, it was associated with both higher costs and fewer QALYs. CONCLUSIONS: Although the administration of pharmacological VTE prophylaxis during IBD flares in the outpatient setting was associated with increased life-years and reduced VTE events, it was not cost effective. Moreover, the benefits of VTE prophylaxis were not robust to probabilistic sensitivity analysis.

Racial disparities in mortality in patients undergoing bariatric surgery in the U.S.A.

BACKGROUND: Non-Hispanic blacks bear a disproportionate burden of the growing obesity epidemic. Bariatric surgery is an effective treatment for morbid obesity. We sought to assess for racial disparities in short-term outcomes following bariatric surgery. METHODS: Patients undergoing bariatric surgery were extracted from the Nationwide Inpatient Sample between 1999 and 2007. In-hospital mortality and length of stay were compared between different racial groups undergoing bariatric surgery after stratification by gender, and multivariate analysis was conducted to adjust for demographic, surgery year, and clinical and hospital characteristics. RESULTS: There were 115,507 bariatric surgeries. Overall mortality rate was 2.5 deaths per 1,000 and was higher among non-Hispanic blacks compared to non-Hispanic whites (3.7 vs. 2.3 per 1,000; P = 0.007). Racial mortality disparities were most pronounced among males and at hospitals with lowest surgical volumes. In multivariate analysis, predictors of mortality were non-Hispanic black race (odds ratio [OR], 1.73; 95% confidence interval [CI], 1.22-2.45), increasing age, increasing Charlson index (OR, 1.26; 95% CI, 1.16-1.37), Medicare (OR, 2.13; 95% CI, 1.57-2.91), and Medicaid (OR, 3.35; 95% CI, 2.29-4.91) insurance. Incremental calendar year had reduced odds of mortality (OR, 0.80; 95% CI, 0.76-0.83). Above national median neighborhood income (OR, 0.59; 95% CI, 0.42-0.83) was protective in males, while teaching hospital status conveyed greater mortality (OR, 2.12; 95% CI, 1.40-3.22). CONCLUSIONS: Non-Hispanic blacks undergoing bariatric surgery demonstrate higher in-hospital mortality than their racial counterparts. It is unclear if this disparity is due to susceptibility to obesity-related mortality or suboptimal delivery of healthcare in the perioperative setting.

Postoperative health-care utilization in Crohn's disease: the impact of specialist care.

OBJECTIVES: Crohn's disease (CD) patients frequently require surgery. We sought to characterize postoperative health-care utilization and its impact on outcomes. METHODS: We assembled a population-based cohort of CD patients who underwent first surgery in Ontario, Canada, between 1996 and 2009. We compared intra-individual preoperative and postoperative health-care utilization and characterized utilization of early postoperative gastrointestinal care (EPGIC) and its impact on health outcomes. RESULTS: For the 2,943 CD patients who underwent surgery, the 5-year risk of recurrent surgery was 26%. In the 5th postoperative year, the average annual number of inflammatory bowel disease (IBD)-related clinic visits, emergency department visits, endoscopy procedures, radiological procedures, and hospitalizations decreased by 62, 62, 82, 78, and 89% compared with prior to surgery. Regional utilization of EPGIC varied between 18 and 62% and correlated with the number of gastroenterologists within a regional local health integration network (ρ=0.71; P=0.006). EPGIC was associated with reduced risk of late postoperative CD-related hospitalizations (at least 1 year after surgery; adjusted incidence ratio (IRR), 0.82; 95% confidence interval (CI): 0.72-0.94). Other predictors of late hospitalizations included having an emergency department visit within 6 months (adjusted IRR, 2.60; 95% CI: 2.21-3.05), lower income, and higher comorbidity. Individuals residing in regions with high aggregate EPGIC utilization experienced lower rates of hospitalization compared with those in regions with low utilization (adjusted IRR, 0.83; 95% CI: 0.70-0.95). CONCLUSIONS: IBD-related health-care utilization decreased significantly up to 5 years following surgery. EPGIC may reduce late CD-related hospitalizations following surgery.

Increased risk of vancomycin-resistant enterococcus (VRE) infection among patients hospitalized for inflammatory bowel disease in the United States.

BACKGROUND: Vancomycin-resistant Enterococcus (VRE) infection has become an increasingly common hospital-acquired infection in U.S. hospitals. Patients with inflammatory bowel disease (IBD) frequently require hospitalization and therefore may be at increased risk of nosocomial infections. METHODS: We used the Nationwide Inpatient Sample (NIS) to identify admissions for IBD (n = 116,842) between 1998 and 2004. We compared the prevalence of VRE in this group to that of non-IBD gastrointestinal (GI) inpatients and general inpatients and assessed for associations between VRE and hospital mortality, length of stay, and total charges. RESULTS: The crude VRE prevalence was 2.1/10,000 in hospitalized IBD patients, 1.3/10,000 in non-IBD GI patients, and 0.9/10,000 in general inpatients. After adjustment for confounders, IBD inpatients were at increased risk of VRE compared to the non-IBD GI (adjusted odds ratio [aOR] 1.65; 95% confidence interval [CI]: 1.03-2.64) and general inpatient (aOR 2.37; 95% CI: 1.31-4.27) groups. Among IBD patients, there was a higher prevalence of VRE infection in those who had surgery (4.4/10,000 versus 1.7/10,000; P < 0.04) and total parenteral nutrition (6.9/10,000 versus 1.8/10,000; P < 0.003). VRE infection was not associated with an increase in mortality (0% versus 0.7%, P = 0.8); however, it was associated with 3-fold higher total hospital charges ($63,517 versus $21,918 USD; P < 0.0001) and increased average length of stay in hospital (16.1 versus 6.1 days; P < 0.0001). CONCLUSIONS: Hospitalized IBD patients have increased susceptibility to VRE that is associated with increased economic burden. This study reinforces the importance of measures to prevent nosocomial infection, particularly in the vulnerable IBD population.