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.

Mechanical colon cleansing for screening colonoscopy: A randomized controlled trial.

OBJECTIVE: Effective screening colonoscopy depends on the quality of colon preparation. This study aimed to compare pulsed irrigation evacuation (PIE), polyethylene glycol (PEG) and sodium phosphate colon preparations. METHODS: Outpatients at a VA hospital were randomized using sealed envelopes. Preparations consisted of polyethylene glycol 4L, Fleet sodium phosphate 90 mL with four to six glasses water twice daily and 296 mL of magnesium citrate in the evening with PIE prior to colonoscopy. Colon cleansing was assessed blindly using a five-point scale: 0 (very poor) to 4 (excellent). RESULTS: Altogether 391 patients participated in the study (129 in the PEG group, 127 in the sodium phosphate and 135 in the PIE group), with a mean age of 62 years, of whom 75% were men. PIE and sodium phosphate were superior to PEG: median cleansing scored 4 (excellent) versus 3 with PEG (P < 0.01). Inadequate preparations were more common with PEG than PIE (18% vs 5%) (P < 0.01). Side-effects included vomiting: 37% in the sodium phosphate group versus 5% in the PEG and 2% in the PIE groups (P < 0.01). The three preparations were judged intolerable in ≤ 5%. CONCLUSIONS: PIE and sodium phosphate are superior to PEG for colon preparations. PIE is the preferred preparation for those at high risk of unsatisfactory preparations or with unsatisfactory traditional preparations.

Profiling lipoxygenase metabolism in specific steps of colorectal tumorigenesis.

Lipoxygenases (LOX) are key enzymes for the oxidative metabolism of polyunsaturated fatty acids into biologically active products. Clinical data on comparative levels of various LOX products in tumorigenesis are lacking. Therefore, we examined the profiles of several LOX products (5-LOX, 12-LOX, 15-LOX-1, and 15-LOX-2) by liquid chromatography/tandem mass spectrometry in the major steps of colorectal tumorigenesis (normal, polyp, and cancer) in a clinical study of 125 subjects (49 with normal colon, 36 with colorectal polyps, and 40 with colorectal cancer) who underwent prospective colorectal biopsies to control for various potential confounding factors (e.g., diet, medications). Mean 13-hydroxyoctadecadienoic acid (13-HODE) levels were significantly higher in normal colon [mean, 36.11 ng/mg protein; 95% confidence interval (95% CI), 31.56-40.67] than in paired colorectal cancer mucosa (mean, 27.01 ng/mg protein; 95% CI, 22.00-32.02; P = 0.0002), and in normal colon (mean, 37.15 ng/mg protein; 95% CI, 31.95-42.34) than in paired colorectal polyp mucosa (mean, 28.07 ng/mg protein; 95% CI, 23.66-32.48; P < 0.001). Mean 13-HODE levels, however, were similar between the left (mean, 37.15 ng/mg protein; 95% CI, 31.95-42.35) and the right normal colon (mean, 32.46 ng/mg protein; 95% CI, 27.95-36.98; P = 0.09). No significant differences with regard to 12- or 15-hydroxyeicosatetraenoic acid or leukotriene B(4) levels were detected between normal, polyp, and cancer mucosae. 15-LOX-1 inhibited interleukin-1beta expression. This study establishes that reduced 13-HODE levels are a specific alteration in the LOX product profile associated with human colorectal tumorigenesis.

Schatzki's ring: to cut or break an unresolved problem.

Symptom assessment has been proven to be less reliable than barium pill testing for success of dilation of peptic strictures. Schatzki's ring also has a high recurrence rate. Our aim here was to compare the efficacy of single dilatation with a 54-F Savary dilator and electrosurgical ring incision for symptomatic Schatzki's rings. Schatzki's ring patients who failed to pass a 12.7-mm barium pill were randomized to dilatation with a 54-F Savary dilator or four quadrant incisions with a needle knife. All received lansoprazole (30 mg) for 30 days posttreatment. Follow-up at 1, 3, 6, and 12 months used the pill test and a dysphagia score. Eleven patients (mean age, 62; median, 64) were randomized and received therapy, six with dilatation and five with incision. The ring diameter pretherapy was 9.8 +/- 1.3 mm. One patient with dilatation had a procedure-related esophageal perforation. The dysphagia score decreased (from 2.7 +/- 1.1 predilatation and 3.0 +/- 0.4 preincision) to 0 after treatment, suggesting that both therapies were equally successful. In contrast, using objective measurements with the barium pill showed that the pill failed to pass the ring in 60% at 1 month after therapy. The failure rate by 1 year was 100%. Use of an objective measure of effectiveness of treatment of symptomatic Schatzki's rings showed that neither single large-dilator dilatation nor four quadrant ring incision was a reliable and effective therapy. In the future studies, repeated dilatation may be needed to define success before long-term outcome can be accurately assessed.