Baseline Features and Reasons for Nonparticipation in the Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) Study, a Colorectal Cancer Screening Trial.

Importance: The Colonoscopy Versus Fecal Immunochemical Test in Reducing Mortality From Colorectal Cancer (CONFIRM) randomized clinical trial sought to recruit 50 000 adults into a study comparing colorectal cancer (CRC) mortality outcomes after randomization to either an annual fecal immunochemical test (FIT) or colonoscopy. Objective: To (1) describe study participant characteristics and (2) examine who declined participation because of a preference for colonoscopy or stool testing (ie, fecal occult blood test [FOBT]/FIT) and assess that preference's association with geographic and temporal factors. Design, Setting, and Participants: This cross-sectional study within CONFIRM, which completed enrollment through 46 Department of Veterans Affairs medical centers between May 22, 2012, and December 1, 2017, with follow-up planned through 2028, comprised veterans aged 50 to 75 years with an average CRC risk and due for screening. Data were analyzed between March 7 and December 5, 2022. Exposure: Case report forms were used to capture enrolled participant data and reasons for declining participation among otherwise eligible individuals. Main Outcomes and Measures: Descriptive statistics were used to characterize the cohort overall and by intervention. Among individuals declining participation, logistic regression was used to compare preference for FOBT/FIT or colonoscopy by recruitment region and year. Results: A total of 50 126 participants were recruited (mean [SD] age, 59.1 [6.9] years; 46 618 [93.0%] male and 3508 [7.0%] female). The cohort was racially and ethnically diverse, with 748 (1.5%) identifying as Asian, 12 021 (24.0%) as Black, 415 (0.8%) as Native American or Alaska Native, 34 629 (69.1%) as White, and 1877 (3.7%) as other race, including multiracial; and 5734 (11.4%) as having Hispanic ethnicity. Of the 11 109 eligible individuals who declined participation (18.0%), 4824 (43.4%) declined due to a stated preference for a specific screening test, with FOBT/FIT being the most preferred method (2820 [58.5%]) vs colonoscopy (1958 [40.6%]; P < .001) or other screening tests (46 [1.0%] P < .001). Preference for FOBT/FIT was strongest in the West (963 of 1472 [65.4%]) and modest elsewhere, ranging from 199 of 371 (53.6%) in the Northeast to 884 of 1543 (57.3%) in the Midwest (P = .001). Adjusting for region, the preference for FOBT/FIT increased by 19% per recruitment year (odds ratio, 1.19; 95% CI, 1.14-1.25). Conclusions and Relevance: In this cross-sectional analysis of veterans choosing nonenrollment in the CONFIRM study, those who declined participation more often preferred FOBT or FIT over colonoscopy. This preference increased over time and was strongest in the western US and may provide insight into trends in CRC screening preferences.

Leflunomide treatment of Crohn's disease patients intolerant to standard immunomodulator therapy.

BACKGROUND: Immunomodulator therapy with the purine analogs azathioprine and 6-mercaptopurine (6-MP), is efficacious in the treatment of moderate to severe Crohn's disease (CD), but is not tolerated by a significant minority of patients. The pyrimidine analog, leflunomide, has demonstrated efficacy in the treatment of rheumatoid arthritis (RA) patients. Because established RA immunomodulator agents may demonstrate success in the treatment of CD, we reviewed our clinical open-label experience with leflunomide in a refractory CD population. GOALS Assess the effect of leflunomide 20 mg daily, on disease activity, steroid requirement and serologic measures of inflammatory activity in our series of CD patients intolerant to azathioprine/6-MP. STUDY: CD patients intolerant of azathioprine/6-MP were offered leflunomide treatment. The Harvey-Bradshaw (H-B) disease activity index, global assessment, serologic parameters and ability to taper corticosteroids of those who accepted were retrospectively assessed. RESULTS: Leflunomide was well tolerated and resulted in a significant reduction in the H-B score, global assessment and serologic parameters in 8/12 patients. Average follow-up was 38 weeks and a majority of steroid-dependent patients were able to successfully taper following leflunomide initiation. CONCLUSIONS: Our case series demonstrates that the pyrimidine analog leflunomide may be effective for treating moderate to severe CD patients intolerant to standard immunomodulator therapy and warrants further investigation in a randomized controlled trial.

Sphincter of Oddi dysfunction and other functional biliary disorders: evaluation and treatment.

Functional biliary disorders encompass the conditions of SOD and gallbladder dysmotility, both of which result in clinical pain syndromes. Obtaining objective diagnostic and outcomes data for both disorders has been an ongoing challenge over the last two decades. SOD, although initially believed to be strictly a biliary disorder, has now been implicated in recurrent pancreatitis. The biliary-type classification allows a clinician to stratify patients who would benefit from SOM and endoscopic sphincterotomy. Further study into the impact of endoscopic therapy for recurrent pancreatitis is needed. By the same token, the dilemma of postcholecystectomy abdominal pain, whether classified as biliary or pancreatic type III, remains challenging. The current limitations of knowledge highlight the need for prospective randomized studies to evaluate the clinical significance of SOM abnormalities to facilitate treatment of these patients.

Case report: "Popcorn" dystrophic ileal calcification in a patient with Crohn's disease.

Small bowel calcification is a rare finding, often associated with chronic infection or small intestinal neoplasms. The authors report a patient who developed dystrophic ileal calcification in the setting of medically refractory Crohn's disease. The patient had longstanding, obstructive ileal Crohn's disease, treated with corticosteroids for a 10-year period. Diffuse terminal ileal calcification was evident on radiographic studies, including plain films as well as abdominal CT scan. The patient underwent successful resection of the diseased segment of small bowel and has done well over the ensuing 3-year period. Dystrophic calcification is a rare complication of long-standing chronic inflammation in Crohn's disease that may occur in the absence of adenocarcinoma or chronic infection.

Volume and yield of screening colonoscopy at a tertiary medical center after change in medicare reimbursement.

OBJECTIVE: Starting July 1, 2001, Medicare began to reimburse for screening colonoscopy in asymptomatic adults older than 50 yr with no risk factors for colorectal cancer. We sought to determine the short-term impact of the change in Medicare reimbursement on the demand for and yield of screening colonoscopy at our tertiary institution. METHODS: Asymptomatic patients older than 50 referred for first screening colonoscopy after the change in Medicare reimbursement from July 1, 2001 to December 31, 2001 were compared with a similar cohort screened before Medicare coverage for a family history of cancer or polyps during the same months the previous year (July 1, 2000 to December 31, 2000). Patient demographics, number, size, location, and histology of polyps/cancers for these screening colonoscopies were collected. RESULTS: A total of 1282 colonoscopies were performed in our institution from July 1, 2001 to December 31, 2001, 257 (20%) for screening. During the same months in the previous year, 121 of 938 colonoscopies (12.9%) were for screening (p < 0.01). This was a 55% increase in the percentage of colonoscopies performed for screening, and a 112% increase in the number of screening colonoscopies. Patients screened after the change in Medicare reimbursement were on average 5 yr older compared with patients of the previous year (62 +/- 10 [mean +/- SD] vs 56 +/- 9 yr; p < 0.01). A total of 61 screening colonoscopies (24%) performed after the change in Medicare reimbursement had adenomatous lesions, compared with 25 (21%) screened for family history (p = ns). The number of adenomas 10 mm or larger or cancers did not differ significantly between the two groups (17 in 2001 vs 12 in 2000; p = ns). Age of 65 or older was associated with detection of adenomatous lesions (OR = 1.7; 95% CI = 1.01-2.9013). CONCLUSIONS: Since the change in Medicare reimbursement, there has been a significant increase in the number and proportion of colonoscopies performed for screening at our institution. Patients screened since this change are older, and the detection rate of neoplastic lesions is similar to those previously screened for a family history of colorectal cancer or polyps.

Successful treatment of an acute flare of steroid-resistant Crohn's colitis during pregnancy with unfractionated heparin.

Recent reports suggest that unfractionated heparin may be a useful adjunct in the treatment of inflammatory bowel disease (IBD). We report the successful use of subcutaneous unfractionated heparin to treat a moderate-to-severe flare of Crohn's disease during pregnancy, which was refractory to standard therapy. The patient received 10,000 units of unfractionated heparin subcutaneously twice a day after her Crohn's colitis failed to come under remission with intravenous corticosteroids. Heparin was continued throughout her pregnancy. Following initiation of adjunctive heparin therapy, the patient experienced a rapid clinical response, was able to discontinue intravenous steroids, discharge from the hospital, and ultimately deliver a healthy term newborn. Although there is extensive obstetric experience with heparin in the treatment of thrombosis associated with pregnancy, there is limited information regarding its use in IBD patients during pregnancy. Because heparin has an established track record in maternal-fetal medicine, this agent may be considered in women who suffer an inflammatory flare of IBD during pregnancy who have not responded to standard treatment.