Browsing by Author "Imperiale, Thomas F."
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Item Aberrant cholesterol metabolism in colorectal cancer represents a targetable vulnerability(Elsevier, 2023-07) Xie, Jingwu; Nguyen, Chi Mai; Turk, Anita; Nan, Hongmei; Imperiale, Thomas F.; House, Michael; Huang, Kun; Su, Jing; Biostatistics, School of Public HealthItem Adherence to Surveillance Guidelines in Nondysplastic Barrett’s Esophagus(Wolters Kluwer, 2016) Dalal, Kunal S.; Coffing, Jessica; Imperiale, Thomas F.; Department of Medicine, School of MedicineIntroduction: Surveillance patterns in Barrett's esophagus (BE) are not well characterized. Guidelines published between 2002 and 2008 recommended surveillance esophagogastroduodenoscopy (sEGD) at 3-year intervals for nondysplastic BE (NDBE). We assessed guideline adherence in incident NDBE in a Veterans Affairs (VA)-based study. Methods: At a single VA center, we identified incident cases of biopsy-confirmed NDBE between January, 2006 and December, 2008. We excluded patients aged 76 years and above and those who developed BE-associated dysplasia or cancer during follow-up. All sEGDs through October, 2014 were documented. Our primary criteria classified cases as guideline adherent if a sEGD was performed within 6 months of each expected 3-year surveillance interval; in cases with >=2 sEGDs, 1 sEGD >6 months, and <=1 year outside an interval was allowed if the average interval was between 2.5 and 3.5 years. Comorbidity, primary care encounters, presence of long-segment BE (LSBE), endoscopist recommendations, and Charlson comorbidity index (CCI) were assessed. Results: We identified 110 patients (96.4% male, 93.6% white) with mean age 58.9+/-8.5 years at index EGD. Median follow-up was 6.7 years (range, 3.7 to 8.6). Thirty-three (30.0%) cases were guideline adherent; 77 (70.0%) cases were nonadherent, including 52 (47.3%) with irregular surveillance and 25 (22.7%) with no surveillance. Forty cases (14 adherent) had 1 sEGD, 36 (18 adherent) had 2, 8 (1 adherent) had 3, and 1 nonadherent case had 4. Adherent cases were significantly older (61.5 vs. 57.9 y, P=0.04), and tended to have more LSBE (33.3% vs. 20.8%, P=0.16). There were no differences between adherent and nonadherent cases in annual primary care encounters (72.7% vs. 66.2%, P=0.66), CCI>=4 (15.2% vs. 15.6%, P=0.95), biopsy-positive sEGDs (75.8% vs. 76.6%, P=0.92), and any recommendation for subsequent surveillance (81.8% vs. 77.9%, P=0.65). A logistic regression model using age, CCI, and LSBE showed an independent association between adherence and older age (P=0.03). Conclusions: In a single-center VA cohort, sEGD of NDBE was mostly nonadherent to guidelines. Adherent cases were older at baseline with a trend toward more LSBE. A larger study is needed to identify medical and social factors associated with adherence or nonadherence to surveillance.Item AGA White Paper: Roadmap for the Future of Colorectal Cancer Screening in the United States(Elsevier, 2020) Melson, Joshua E.; Imperiale, Thomas F.; Itzkowitz, Steven H.; Llor, Xavier; Kochman, Michael L.; Grady, William M.; Schoen, Robert E.; Burke, Carol; Shaukat, Aasma; Rabeneck, Linda; Ladabaum, Uri; Bresalier, Robert; Spiegel, Brennan; Yee, Judy; Wang, Thomas; Lieberman, David; Komanduri, Srinadh; Muthusamy, V. Raman; Dey, Neelendu; Medicine, School of MedicineItem Algorithm Development and Early Performance Evaluation of a Next-Generation Multitarget Stool DNA Screening Test for Colorectal Cancer(Elsevier, 2024-05-17) Imperiale, Thomas F.; Gagrat, Zubin D.; Krockenberger, Martin; Porter, Kyle; Ziegler, Emily; Leduc, Christine M.; Matter, Michael B.; Olson, Marilyn C.; Limburg, Paul J.; Medicine, School of MedicineBackground and aims: The multitarget stool DNA (mt-sDNA) assay is a noninvasive average-risk colorectal cancer (CRC) screening test. A new biomarker panel was developed for a next-generation test to improve specificity while maintaining/increasing sensitivity. We aimed first to establish an algorithm and cutoff for the next-generation mt-sDNA test and then to validate it using archived samples from the pivotal DeeP-C study (NCT01397747) of the first-generation test. Methods: Algorithm development and cross-validation included 3011 samples from 2 specimen collection studies (NCT03821948 and NCT03789162). The algorithm and cutoff were locked before validation. Validation test set samples included 57 CRC, 583 advanced precancerous lesions (APLs), and 7022 samples negative for CRC or APLs from the DeeP-C study, which prospectively enrolled average-risk, asymptomatic adults aged 50-84 years before screening colonoscopy. Next-generation biomarkers included methylated DNA markers ceramide synthase 4 gene, leucine-rich repeat-containing protein 4 gene, serine/threonine-protein phosphatase 2A 56 kDa regulatory subunit gamma isoform gene, and zinc finger DHHC-type containing 1 gene (reference marker), and fecal hemoglobin. Primary validation end points were CRC sensitivity and specificity for the absence of advanced neoplasia. Secondary end points included APL sensitivity and specificity for non-neoplastic findings or negative colonoscopy. Results: Cross-validation and best-fit results from algorithm development closely matched, confirming algorithm reliability and reproducibility. For the test set, next-generation mt-sDNA test sensitivity was 93.0% (95% confidence interval [CI], 83.0%-98.1%) for CRC and 48.4% (95% CI, 44.2%-52.5%) for APLs. Specificity was 88.5% (95% CI, 87.7%-89.2%) for the absence of advanced neoplasia and 90.4% (95% CI, 89.5%-91.2%) for the combination of non-neoplastic findings or negative colonoscopy. Conclusion: Based on archived samples, the next-generation mt-sDNA test demonstrated promising CRC screening performance characteristics that will be further assessed in a prospective clinical validation study (BLUE-C; NCT04144738).Item Association between body-mass index and quality of split bowel preparation(Elsevier, 2013-11) Fayad, Nabil F.; Kahi, Charles J.; Abd el-jawad, Khaled H.; Shin, Andrea S.; Shah, Shenil; Lane, Kathleen A.; Imperiale, Thomas F.; Medicine, School of MedicineBACKGROUND & AIMS: Little is known about the association between obesity and bowel preparation. We investigated whether body mass index (BMI) is an independent risk factor for inadequate bowel preparation in patients who receive split preparation regimens. METHODS: We performed a retrospective study of data from 2163 consecutive patients (mean age, 60.6 ± 10.5 y; 93.8% male) who received outpatient colonoscopies in 2009 at the Veterans Affairs Medical Center in Indianapolis, Indiana. All patients received a split preparation, categorized as adequate (excellent or good, based on the Aronchick scale) or inadequate. We performed a multivariable analysis to identify factors independently associated with inadequate preparation. RESULTS: Bowel preparation quality was inadequate for 44.2% of patients; these patients had significantly higher mean BMIs than patients with adequate preparation (31.2 ± 6.5 vs 29.8 ± 5.9, respectively; P < .0001) and Charlson comorbidity scores (1.5 ± 1.6 vs 1.1 ± 1.4; P < .0001). Independent risk factors for inadequate preparation were a BMI of 30 kg/m(2) or greater (odds ratio [OR], 1.46; 95% confidence interval [CI], 1.21-1.75; P < .0001), use of tobacco (OR, 1.28; 95% CI, 1.07-1.54; P = .0084) or narcotics (OR, 1.28; 95% CI, 1.04-1.57; P = .0179), hypertension (OR, 1.30; 95% CI, 1.07-1.57; P = .0085), diabetes (OR, 1.38; 95% CI, 1.12-1.69; P = .0021), and dementia (OR, 3.02; 95% CI, 1.22-7.49; P = .0169). CONCLUSIONS: BMI is an independent factor associated with inadequate split bowel preparation for colonoscopy. Additional factors associated with quality of bowel preparation include diabetes, hypertension, dementia, and use of tobacco and narcotics. Patients with BMIs of 30 kg/m(2) or greater should be considered for more intensive preparation regimens.Item Associations of chronic diarrhoea with non-alcoholic fatty liver disease and obesity-related disorders among US adults(BMJ, 2019-08-12) Shin, Andrea; Xu, Huiping; Imperiale, Thomas F.; Medicine, School of MedicineMechanisms explaining observed associations between diarrhoea and obesity or increased body mass index (BMI) are unclear. Objective: To assess associations of bowel patterns with BMI, metabolic syndrome (MS), non-alcoholic fatty liver disease (NAFLD) and other obesity-related disorders. Design: We performed a cross-sectional analysis of data from adults who completed bowel health questions for the 2005 to 2010 cycles of the National Health and Nutrition Examination Surveys. Relationships were examined using multinomial logistic regression. Confounding effects of demographics, smoking, alcohol and BMI were examined by sequential modelling. Results: Among 13 413 adults, weighted prevalence rates of constipation and diarrhoea were 8.9% and 6.6%, respectively. Mean BMI was associated with bowel patterns (p<0.001), and was higher with diarrhoea (30.3 kg/m2) versus normal bowel patterns (28.6 kg/m2) and with diarrhoea versus constipation (27.8 kg/m2). NAFLD was more prevalent (ORs, 95% CI) in diarrhoea versus normal bowel patterns (OR=1.34, 95% CI 1.01 to 1.78) or constipation (OR=1.45, 95% CI 1.03, 2.03) in adjusted analyses. The higher prevalence of MS in diarrhoea versus constipation (OR=1.27, 95% CI 0.97 to 1.67) was not independent of BMI. Conclusions: These findings suggest an association between diarrhoea and NAFLD that is independent of BMI.Item 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(American Medical Association, 2023-07-03) Robertson, Douglas J.; Dominitz, Jason A.; Beed, Alexander; Boardman, Kathy D.; Del Curto, Barbara J.; Guarino, Peter D.; Imperiale, Thomas F.; LaCasse, Andrew; Larson, Meaghan F.; Gupta, Samir; Lieberman, David; Planeta, Beata; Shaukat, Aasma; Sultan, Shanaz; Menees, Stacy B.; Saini, Sameer D.; Schoenfeld, Philip; Goebel, Stephan; von Rosenvinge, Erik C.; Baffy, Gyorgy; Halasz, Ildiko; Pedrosa, Marcos C.; Kahng, Lyn Sue; Cassim, Riaz; Greer, Katarina B.; Kinnard, Margaret F.; Bhatt, Divya B.; Dunbar, Kerry B.; Harford, William V.; Mengshol, John A.; Olson, Jed E.; Patel, Swati G.; Antaki, Fadi; Fisher, Deborah A.; Sullivan, Brian A.; Lenza, Christopher; Prajapati, Devang N.; Wong, Helen; Beyth, Rebecca; Lieb, John G.; Manlolo, Joseph; Ona, Fernando V.; Cole, Rhonda A.; Khalaf, Natalia; Kahi, Charles J.; Kohli, Divyanshoo Rai; Rai, Tarun; Sharma, Prateek; Anastasiou, Jiannis; Hagedorn, Curt; Fernando, Ronald S.; Jackson, Christian S.; Jamal, M. Mazen; Lee, Robert H.; Merchant, Farrukh; May, Folasade P.; Pisegna, Joseph R.; Omer, Endashaw; Parajuli, Dipendra; Said, Adnan; Nguyen, Toan D.; Tombazzi, Claudio Ruben; Feldman, Paul A.; Jacob, Leslie; Koppelman, Rachel N.; Lehenbauer, Kyle P.; Desai, Deepak S.; Madhoun, Mohammad F.; Tierney, William M.; Ho, Minh Q.; Hockman, Heather J.; Lopez, Christopher; Carter Paulson, Emily; Tobi, Martin; Pinillos, Hugo L.; Young, Michele; Ho, Nancy C.; Mascarenhas, Ranjan; Promrat, Kirrichai; Mutha, Pritesh R.; Pandak, William M.; Shah, Tilak; Schubert, Mitchell; Pancotto, Frank S.; Gawron, Andrew J.; Underwood, Amelia E.; Ho, Samuel B.; Magno-Pagatzaurtundua, Priscilla; Toro, Doris H.; Beymer, Charles H.; Kaz, Andrew M.; Elwing, Jill; Gill, Jeffrey A.; Goldsmith, Susan F.; Yao, Michael D.; Protiva, Petr; Pohl, Heiko; Kyriakides, Tassos; CONFIRM Study Group; Medicine, School of MedicineImportance: 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.Item Can Streamlined Multicriteria Decision Analysis Be Used to Implement Shared Decision Making for Colorectal Cancer Screening?(Sage Publications, 2013-12-03) Dolan, James G.; Boohaker, Emily; Allison, Jeroan; Imperiale, Thomas F.; Department of Medicine, IU School of MedicineBACKGROUND: Current US colorectal cancer screening guidelines that call for shared decision making regarding the choice among several recommended screening options are difficult to implement. Multicriteria decision analysis (MCDA) is an established method well suited for supporting shared decision making. Our study goal was to determine whether a streamlined form of MCDA using rank-order-based judgments can accurately assess patients' colorectal cancer screening priorities. METHODS: We converted priorities for 4 decision criteria and 3 subcriteria regarding colorectal cancer screening obtained from 484 average-risk patients using the analytic hierarchy process (AHP) in a prior study into rank-order-based priorities using rank order centroids. We compared the 2 sets of priorities using Spearman rank correlation and nonparametric Bland-Altman limits of agreement analysis. We assessed the differential impact of using the rank-order-based versus the AHP-based priorities on the results of a full MCDA comparing 3 currently recommended colorectal cancer screening strategies. Generalizability of the results was assessed using Monte Carlo simulation. RESULTS: Correlations between the 2 sets of priorities for the 7 criteria ranged from 0.55 to 0.92. The proportions of differences between rank-order-based and AHP-based priorities that were more than ±0.15 ranged from 1% to 16%. Differences in the full MCDA results were minimal, and the relative rankings of the 3 screening options were identical more than 88% of the time. The Monte Carlo simulation results were similar. CONCLUSIONS: Rank-order-based MCDA could be a simple, practical way to guide individual decisions and assess population decision priorities regarding colorectal cancer screening strategies. Additional research is warranted to further explore the use of these methods for promoting shared decision making.Item Changes in Adult BMI and Waist Circumference Are Associated with Increased Risk of Advanced Colorectal Neoplasia(Springer, 2017-11) Gathirua-Mwangi, Wambui G.; Monahan, Patrick; Song, Yiqing; Zollinger, Terrell W.; Champion, Victoria L.; Stump, Timothy E.; Imperiale, Thomas F.; Epidemiology, School of Public HealthBACKGROUND: Waist circumference (WC) is a stronger predictor of colon cancer (CRC) risk than body mass index (BMI). However, how well change in either WC or BMI predicts risk of advanced colorectal neoplasia (AN) is unclear. AIMS: To determine the relationship between change in BMI and WC from early adulthood to later age and the risk of AN and which change measure is a stronger predictor. METHODS: In 4500 adults, ages 50-80, with no previous neoplasia and undergoing screening colonoscopy, BMI and WC at age 21 and at time of screening were reported. Changes in BMI and WC were defined using universal risk cutoffs. Known CRC risk factors were controlled in the logistic models. RESULTS: Overall, model statistics showed WC change (omnibus test χ 2 = 10.15, 2 DF, p value = 0.006) was a statistically stronger predictor of AN than BMI change (omnibus test χ 2 = 5.66, 5 DF, p value = 0.34). Independent of BMI change, participants who increased WC (OR 1.44; 95% CI 1.05-1.96) or maintained a high-risk WC (OR 2.50; 95% CI 1.38-4.53) at age 21 and at screening had an increased risk of AN compared to those with a low-risk WC. Study participants who were obese at age 21 and at screening had an increased risk of AN (OR 1.87; 95% CI 1.08-3.23) compared to those who maintained a healthy BMI. Maintaining an overweight BMI or increasing BMI was not associated with AN. CONCLUSIONS: Maintaining an unhealthy BMI and WC throughout adult life may increase risk of AN. WC change may be a better predictor of AN than BMI change.Item Colonoscopy after acute diverticulitis: from clinical epidemiology to clinical management. Are we there yet?(Elsevier, 2020-03) Krajicek, Eddie J.; Imperiale, Thomas F.; Medicine, School of Medicine