Transition Readiness Not Associated With Measures of Health in Youth With IBD.

BACKGROUND: It remains unclear how transition readiness is associated with various domains of health in children and young adults. Our objective was to describe the transition readiness of children and young adults with inflammatory bowel disease (IBD) and examine its associations with demographic factors, IBD activity, and measures of physical, psychological, and social health. METHODS: We recruited children ages 12 to 17 and young adults ages 18 to 20 from 2 internet-based cohorts sponsored by the Crohn's & Colitis Foundation. Participants self-reported demographics, IBD activity, transition readiness, health-related quality of life, and Patient-Reported Outcomes Information Systems domains of physical, psychological, and social health. RESULTS: Among 361 pediatric and 119 adult participants, age and female sex were associated with transition readiness. The association was greater in the pediatric cohort. Having IBD in remission was associated with worse transition readiness in the pediatric cohort only (beta = 0.3; P = 0.003). Health-related quality of life and Patient-Reported Outcomes Information Systems measures of fatigue, pain interference, and sleep disturbance were not associated with transition readiness in either children or adults. We observed few small associations between psychological or social health and transition readiness. Better transition readiness was associated with greater anxiety in adults (beta = -0.02; P = 0.02) and greater peer relationships among children (beta = 0.01; P = 0.009). CONCLUSIONS: In children and young adults with IBD, transition readiness was associated with older age and female sex. Associations between transition readiness and physical, psychological, and social health were either small, inconsistent across age groups, or nonexistent.

The Burden of Hospital Readmissions among Pediatric Patients with Inflammatory Bowel Disease.

OBJECTIVE: To evaluate the burden and predictors of hospital readmissions among pediatric patients with inflammatory bowel disease using the Nationwide Readmissions Database. STUDY DESIGN: We performed a retrospective cohort study using 2013 Nationwide Readmissions Database. International Classification of Diseases, Ninth Revision, Clinical Modification codes were used to identify patients <18 years with diagnoses of ulcerative colitis (UC) or Crohn's disease (CD). Demographic factors and details of hospitalizations were evaluated using survey procedures in SAS v 9.4 (SAS Institute, Cary, North Carolina). Multivariable logistic regression was used to estimate ORs and 95% CIs of readmission. RESULTS: Among 2733 hospitalizations (63% CD, 37% UC), 611 (22%) patients were readmitted within 90 days of the index hospitalization. Readmission resulted in weighted estimates of 11 440 excess days of hospitalization and total charges of over $107 million. For CD, male sex (aOR 1.36, 95% CI 1.03-1.81) and co-existing anxiety or depression (aOR 1.89, 95% CI 1.06-3.40) were associated with increased readmissions, while patients who underwent surgery had decreased readmissions (aOR 0.40, 95% CI 0.24-0.65). In patients with UC, an index admission of >7 days was associated with increased readmissions (aOR 1.69, 95% CI 1.09-2.62). CONCLUSIONS: Readmission occurs frequently in children with inflammatory bowel disease and is associated with significant cost and resource burdens. Among patients with CD, psychiatric comorbidities such as anxiety and depression are apparent drivers of readmission.

Racial differences in obesity measures and risk of colorectal adenomas in a large screening population.

Obesity is an important risk factor for colorectal neoplasia; however, little research exists on racial differences in obesity measures [body mass index (BMI), waist circumference (WC), and waist-hip-ratio (WHR)] associated with adenoma. We used data from the Diet and Health Studies, Phases III-V to examine differences in the contribution of obesity measures to adenoma risk by race. The sample consisted of 2184 patients (1806 white, 378 African American) undergoing outpatient colonoscopy for average risk screening. Covariates included demographics, health history, and validated measures of diet and physical activity. Among whites, BMI [overweight: odds ratio (OR) = 1.31, 95% confidence interval (CI), 1.00-1.71; obese: OR = 1.89, 95% CI, 1.41-2.56), WC (OR = 1.47, 95% CI, 1.09-1.99), and WHR (OR = 1.60, 95% CI, 1.24-2.06) were associated with adenomas. BMI was not associated with adenomas in African Americans. Although the CIs were wide, the point estimates for WHR (OR = 1.07, 95% CI, 0.51-2.22) and WC (OR = 1.04, 95% CI, 0.56-1.92) were slightly elevated above the null. BMI was associated with adenomas only among whites, whereas WHR and WC appeared to be important risk factors among both races. Racial differences in adenoma risk may be due to differences in body shape and weight and/or fat distribution.

Health-care utilization, costs, and the burden of disease related to eosinophilic esophagitis in the United States.

OBJECTIVES: Eosinophilic esophagitis (EoE) has rapidly become a major cause of upper GI morbidity, but health-care costs related to EoE have not been described. This study aimed to estimate EoE-related health-care costs and utilization in the United States. METHODS: We performed a study on health-care utilization of EoE cases compared with age- and sex-matched controls using administrative claims data, representative of the commercially insured population in the United States. Cases of EoE were identified using a previously validated definition. We assessed inpatient, outpatient, emergency department, outpatient prescription, and endoscopy-related costs for patients with EoE, and estimated total costs related to EoE extrapolated to the US population. RESULTS: We identified 8,135 cases of EoE and 32,540 controls. The median total annual cost per EoE case was $3,304 compared with $1,001 for controls (P<0.001). For EoE, the median costs included $2,508/year for outpatient visits, $157 for endoscopies, and $325 for pharmacy claims, compared with $699, $0, and $76 for controls (P<0.001 for all). The overall median cost associated with EoE was $2,302/year/patient. Total costs in the United States ranged from $503 million to $1.36 billion/year, depending on the prevalence estimate, with costs attributable to EoE ranging from $350 to $947 million/year. CONCLUSIONS: Patients with EoE have an estimated annual health-care cost of as much as $1.4 billion in the United States. This represents a remarkable burden of disease for an entity that was essentially unknown two decades ago. These cost data can be used by policy makers to guide resource allocation.

Effect of adjuvant chemotherapy on survival of patients with stage III colon cancer diagnosed after age 75 years.

PURPOSE: Few patients 75 years of age and older participate in clinical trials, thus whether adjuvant chemotherapy for stage III colon cancer (CC) benefits this group is unknown. METHODS: A total of 5,489 patients ≥ 75 years of age with resected stage III CC, diagnosed between 2004 and 2007, were selected from four data sets containing demographic, stage, treatment, and survival information. These data sets included SEER-Medicare, a linkage between the New York State Cancer Registry (NYSCR) and its Medicare programs, and prospective cohort studies Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) and the National Comprehensive Cancer Network. Data sets were analyzed in parallel using covariate adjusted and propensity score (PS) matched proportional hazards models to evaluate the effect of treatment on survival. PS trimming was used to mitigate the effects of selection bias. RESULTS: Use of adjuvant therapy declined with age and comorbidity. Chemotherapy receipt was associated with a survival benefit of comparable magnitude to clinical trials results (SEER-Medicare PS-matched mortality, hazard ratio [HR], 0.60; 95% CI, 0.53 to 0.68). The incremental benefit of oxaliplatin over non-oxaliplatin-containing regimens was also of similar magnitude to clinical trial results (SEER-Medicare, HR, 0.84; 95% CI, 0.69 to 1.04; NYSCR-Medicare, HR, 0.82, 95% CI, 0.51 to 1.33) in two of three examined data sources. However, statistical significance was inconsistent. The beneficial effect of chemotherapy and oxaliplatin did not seem solely attributable to confounding. CONCLUSION: The noninvestigational experience suggests patients with stage III CC ≥ 75 years of age may anticipate a survival benefit from adjuvant chemotherapy. Oxaliplatin offers no more than a small incremental benefit. Use of adjuvant chemotherapy after the age of 75 years merits consideration in discussions that weigh individual risks and preferences.

Development of an internet-based cohort of patients with inflammatory bowel diseases (CCFA Partners): methodology and initial results.

BACKGROUND: The widespread use of the Internet allows for unique research opportunities. We aimed to develop and follow an Internet-based cohort (e-cohort) of patients with self-reported inflammatory bowel diseases (IBD) over time. METHODS: We established an e-cohort of adults with IBD (CCFA Partners) by recruiting through Crohn's and Colitis Foundation of America (CCFA) email rosters, CCFA Website promotion, social media, and other publicity mechanisms. The baseline survey included modules on disease course and activity, diet and exercise, and patient-reported outcomes (PROs). Baseline characteristics of the cohort are summarized using descriptive statistics. RESULTS: A total of 7819 adults with IBD joined CCFA Partners through August, 2011. The median age was 42 years (interquartile range [IQR] 30-54), 5074 (72.3%) were female. A total of 4933 (63.1%) had Crohn's disease (CD), 2675 (34.2%) had ulcerative colitis (UC), and 211 (2.7%) had IBD unspecified. For CD, the mean short CD Activity Index (CDAI) was 151.9 (standard deviation [SD] 106.4), with 2274 (59.4%) in remission. For UC, the mean simple clinical colitis activity index (SCCAI) was 3.6 (SD 2.8), with 937 (42.9%) in remission. The mean short IBD questionnaire (SIBDQ) score was 48.7 (SD 11.8). SIBDQ was inversely correlated with disease activity (P < 0.01). The mean Morisky medication adherence score (MMAS) was 5.7 (SD 2.0). MMAS scores were inversely correlated with disease activity (P < 0.01). CONCLUSIONS: CCFA Partners is a novel e-cohort. Enrollment is ongoing, with surveys twice yearly. CCFA Partners represents a unique resource to study PROs and changes in disease management over time.

Comparative effectiveness of oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy for stage III colon cancer.

BACKGROUND: The addition of oxaliplatin to adjuvant 5-fluorouracil (5-FU) improves survival of patients with stage III colon cancer in randomized clinical trials (RCTs). However, RCT participants are younger, healthier, and less racially diverse than the general cancer population. Thus, the benefit of oxaliplatin outside RCTs is uncertain. SUBJECTS AND METHODS: Patients younger than 75 years with stage III colon cancer who received chemotherapy within 120 days of surgical resection were identified from five observational data sources-the Surveillance, Epidemiology, and End Results registry linked to Medicare claims (SEER-Medicare), the New York State Cancer Registry (NYSCR) linked to Medicaid and Medicare claims, the National Comprehensive Cancer Network (NCCN) Outcomes Database, and the Cancer Care Outcomes Research & Surveillance Consortium (CanCORS). Overall survival (OS) was compared among patients treated with oxaliplatin vs non-oxaliplatin-containing adjuvant chemotherapy. Overall survival for 4060 patients diagnosed during 2004-2009 was compared with pooled data from five RCTs (the Adjuvant Colon Cancer ENdpoinTs [ACCENT] group, n = 8292). Datasets were juxtaposed but not combined using Kaplan-Meier curves. Covariate and propensity score adjusted proportional hazards models were used to calculate adjusted survival hazard ratios (HR). Stratified analyses examined effect modifiers. All statistical tests were two-sided. RESULTS: The survival advantage associated with the addition of oxaliplatin to adjuvant 5-FU was evident across diverse practice settings (3-year OS: RCTs, 86% [n = 1273]; SEER-Medicare, 80% [n = 1152]; CanCORS, 88% [n = 129]; NYSCR-Medicaid, 82% [n = 54]; NYSCR-Medicare, 79% [n = 180]; and NCCN, 86% [n = 438]). A statistically significant improvement in 3-year overall survival was seen in the largest cohort, SEER-Medicare, and in the NYSCR-Medicare cohort (non-oxaliplatin-containing vs oxaliplatin-containing adjuvant therapy, adjusted HR of death: pooled RCTs: HR = 0.80, 95% CI = 0.70 to 0.92, P = .002; SEER-Medicare: HR = 0.70, 95% CI = 0.60 to 0.82, P < .001; NYSCR-Medicare patients aged ≥65 years: HR = 0.58, 95% CI = 0.38 to 0.90, P = .02). The association between oxaliplatin treatment and better survival was maintained in older and minority group patients, as well as those with higher comorbidity. CONCLUSION: The addition of oxaliplatin to 5-FU appears to be associated with better survival among patients receiving adjuvant colon cancer treatment in the community.

Associations between trans fatty acid consumption and colon cancer among Whites and African Americans in the North Carolina colon cancer study I.

Disparities in incidence and mortality rates of colon cancer exist between Whites and African Americans. Prior studies examined the association between trans fatty acid consumption and colorectal cancer, but none assessed this possible relationship within a large study population of African Americans and Whites. Using data from a population-based, case-control study in North Carolina, we investigated this association with attention to possible racial differences. Cases and matched controls were queried on demographic characteristics, lifestyle factors, medical history, and diet. Cases reported higher daily consumption (g/day) of trans fatty acids (mean = 5.9, SD = 2.9, median = 5.5, IQR = 3.8-7.5) compared to controls (mean = 5.2, SD = 2.4, median = 4.7, IQR = 3.5-6.4). Energy-adjusted trans fatty acid consumption was not associated with colon cancer. Compared to participants in the lowest quartile of consumption, those in the highest quartile had an adjusted odds ratio of 1.01 (95% confidence interval 0.69, 1.49) for Whites and 0.99 (95% confidence interval 0.61, 1.62) for African Americans. No association was found between increased consumption of trans fatty acid and specific tumor location (proximal or distal colon). In conclusion, trans fatty acid consumption is not associated with colon cancer and does not contribute to disparities in colon cancer rates.

Insurance, employment, and psychosocial consequences of a diagnosis of hereditary hemochromatosis in subjects without end organ damage.

OBJECTIVES: Asymptomatic individuals with hereditary hemochromatosis (HH) may experience difficulties in obtaining employment or insurance, despite their good health. The extent to which these difficulties occur is unclear. The aim of this study was to assess the insurance, employment, and psychosocial consequences of a diagnosis of HH in subjects with no end organ damage. METHODS: In three outpatient clinics specializing in the treatment of HH, we performed a survey of individuals diagnosed with HH who were without end organ damage secondary to iron overload, along with their unaffected siblings. A review of the medical records of subjects with HH was performed. Main outcomes were attaining and keeping employment; health, disability and life insurance; and scores on the SF-36, a quality of life measure, and the SCL-90-R, a measure of psychological well-being. RESULTS: Of 130 eligible subjects with HH, 126 (97%) responded. Of the 55 eligible controls, 46 (84%) responded. Of the 126 subjects with HH, 25 (20%) described 28 incidents of insurance denial or increased premium rates, which they attributed to their diagnosis HH. Of the 28 incidents, 16 (57%) involved life insurance, eight (29%) involved health insurance, and four (14%) involved disability insurance. One subject reported an employment refusal. Five of the 25 subjects (20%) reporting insurance denial or increased premiums had significant comorbid conditions. One of 46 sibling controls (2%) reported an increased rate for life insurance (p = 0.003). No differences were noted in either the SF-36 or the SCL-90-R scores between subjects with HH and unaffected siblings. Overall rates of active health, disability, and life insurance were similar between the groups. CONCLUSIONS: Insurance denial and increased premium rates are reported commonly among individuals with HH without end organ damage. However, the overall proportion of those with active insurance, the quality of life, and the psychological well-being of these subjects were similar to those of unaffected siblings.