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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
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
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.
PMCID:10336619
PMID: 37432690
ISSN: 2574-3805
CID: 5537022
Colorectal Cancer Screening and Surveillance in the Geriatric Population
Cheong, Janice; Faye, Adam; Shaukat, Aasma
PURPOSE OF THE REVIEW/OBJECTIVE:Our national guidelines regarding screening and surveillance for colorectal cancer recommend individualized discussions with patients 75-85 years of age. This review explores the complex decision-making that surrounds these discussions. RECENT FINDINGS/RESULTS:Despite updated guidelines for colorectal cancer screening and surveillance, the guidance for patients 75 years of age or older remains unchanged. Studies exploring the risks to colonoscopy in this population, patient preferences, life expectancy calculators and additional studies in the subpopulation of inflammatory bowel disease patients provide points of consideration to aid in individualized discussions. The benefit-risk discussion for colorectal cancer screening in patients over 75 years old warrants further guidance to develop best practice. To craft more comprehensive recommendations, additional research with inclusion of such patients is needed.
PMCID:10330554
PMID: 37219764
ISSN: 1534-312x
CID: 5536572
Randomized Trial of Facilitated Adherence to Screening Colonoscopy vs Sequential Fecal-Based Blood Test
Zauber, Ann G; Winawer, Sidney J; O'Brien, Michael J; Mills, Glenn M; Allen, John I; Feld, Andrew D; Jordan, Paul A; Fleisher, Martin; Orlow, Irene; Meester, Reinier G S; Lansdorp-Vogelaar, Iris; Rutter, Carolyn M; Knudsen, Amy B; Mandelson, Margaret; Shaukat, Aasma; Mendelsohn, Robin B; Hahn, Anne I; Lobaugh, Stephanie M; Soto Palmer, Brittany; Serrano, Victoria; Kumar, Julie R; Fischer, Sara E; Chen, Jennifer C; Bayuga-Miller, Sharon; Kuk, Deborah; O'Connell, Kelli; Church, Timothy R
BACKGROUND & AIMS/OBJECTIVE:Colorectal cancer (CRC) screening guidelines include screening colonoscopy and sequential high-sensitivity fecal occult blood testing (HSgFOBT), with expectation of similar effectiveness based on the assumption of similar high adherence. However, adherence to screening colonoscopy compared with sequential HSgFOBT has not been reported. In this randomized clinical trial, we assessed adherence and pathology findings for a single screening colonoscopy vs sequential and nonsequential HSgFOBTs. METHODS:Participants aged 40-69 years were enrolled at 3 centers representing different clinical settings. Participants were randomized into a single screening colonoscopy arm vs sequential HSgFOBT arm composed of 4-7 rounds. Initial adherence to screening colonoscopy and sequential adherence to HSgFOBT, follow-up colonoscopy for positive HSgFOBT tests, crossover to colonoscopy, and detection of advanced neoplasia or large serrated lesions (ADN-SERs) were measured. RESULTS:There were 3523 participants included in the trial; 1761 and 1762 participants were randomized to the screening colonoscopy and HSgFOBT arms, respectively. Adherence was 1473 (83.6%) for the screening colonoscopy arm vs 1288 (73.1%) for the HSgFOBT arm after 1 round (relative risk [RR], 1.14; 95% CI, 1.10-1.19; P ≤ .001), but only 674 (38.3%) over 4 sequential HSgFOBT rounds (RR, 2.19; 95% CI, 2.05-2.33). Overall adherence to any screening increased to 1558 (88.5%) in the screening colonoscopy arm during the entire study period and 1493 (84.7%) in the HSgFOBT arm (RR, 1.04; 95% CI, 1.02-1.07). Four hundred thirty-six participants (24.7%) crossed over to screening colonoscopy during the first 4 rounds. ADN-SERs were detected in 121 of the 1473 participants (8.2%) in the colonoscopy arm who were adherent to protocol in the first 12 months of the study, whereas detection of ADN-SERs among those who were not sequentially adherent (n = 709) to HSgFOBT was subpar (0.6%) (RR, 14.72; 95% CI, 5.46-39.67) compared with those who were sequentially adherent (3.3%) (n = 647) (RR, 2.52; 95% CI, 1.61-3.98) to HSgFOBT in the first 4 rounds. When including colonoscopies from HSgFOBT patients who were never positive yet crossed over (n = 1483), 5.5% of ADN-SERs were detected (RR, 1.50; 95% CI, 1.15-1.96) in the first 4 rounds. CONCLUSIONS:Observed adherence to sequential rounds of HSgFOBT was suboptimal compared with a single screening colonoscopy. Detection of ADN-SERs was inferior when nonsequential HSgFOBT adherence was compared with sequential adherence. However, the greatest number of ADN-SERs was detected among those who crossed over to colonoscopy and opted to receive a colonoscopy. The effectiveness of an HSgFOBT screening program may be enhanced if crossover to screening colonoscopy is permitted. CLINICALTRIALS/RESULTS:gov, Number: NCT00102011.
PMID: 36948424
ISSN: 1528-0012
CID: 5507832
The Prognostic Significance of Laterality in Endoscopically Resected Colonic Polyps with High Grade Dysplasia [Meeting Abstract]
Boatman, S; Kohn, J; Troester, A M; Mott, S; Marmor, S; Madoff, R D; Shaukat, A; Melton-Meaux, G B; Hassan, I; Goffredo, P
Introduction: Colonic polyps with carcinoma in situ (Tis) are considered advanced adenomas, appropriately treated by endoscopic resection. However, they represent a risk factor for metachronous neoplasia for which current guidelines recommend shorter interval surveillance as compared with low-risk adenomas. While the worse survival of proximal colon cancers has been established, the prognostic impact of laterality for Tis remains unknown. Additionally, proximal adenomas are more challenging to identify and resect, and possibly associated with higher rates of subsequent pathology; therefore, we hypothesized that Tis polyps in this location would have worse prognosis.
Method(s): Adult patients with TisNxMx tumors managed with endoscopic polypectomy alone were identified in the National Cancer Database, 2004-2017.
Result(s): A total of 3,980 patients were included; 29% had proximal lesions. Endoscopically excised proximal Tis polyps were more common in elderly, Black patients, and those with public insurance and more comorbidities (all p<0.01). There was no difference in median size (10mm) between sides. Unadjusted 5-year overall survival (OS) was 81% vs 89% for proximal and distal polyps, while 10-year OS was 67% vs 78% (p<0.01). In multivariable analysis, proximal location did not demonstrate significant worse prognosis (HR=1.11, 95%CI 0.94-1.31).
Conclusion(s): After adjusting for patient factors, proximal Tis polyps did not have significantly lower OS. However, survival may not be the optimal outcome for high-risk adenomas, particularly when considering the relatively low cancer incidence and effective treatment for early-stage malignancy. Future research should focus on risk of metachronous neoplasia, excluded from most national databases, to determine optimal surveillance protocols
EMBASE:641389575
ISSN: 1879-1190
CID: 5514352
Interventions to improve the performance of ERCP and EUS quality indicators
Keswani, Rajesh N; Duloy, Anna; Nieto, Jose M; Panganamamula, Kashyap; Murad, M Hassan; Bazerbachi, Fateh; Shaukat, Aasma; Elmunzer, B Joseph; Day, Lukejohn W
PMID: 36967249
ISSN: 1097-6779
CID: 5463062
Colon Cancer Screening and the End of Life: Is Age Just a Number?
Reinink, Andrew R; Malhotra, Ashish; Shaukat, Aasma
Age is the strongest risk factor for colorectal cancer. Although there is updated guidance for the age at which to start screening, there is little guidance for individuals or their medical teams on how to decide when to stop. Current recommendations from the US Preventive Services Task Force and other societies focus primarily on age. For patients older than 85 years, guidelines discourage screening because the harms largely outweigh benefits. Although at a population level, the overall benefit of screening in older individuals decreases, one must individualize the recommendation based on comorbidities, functional status, screening history, and gender-not solely base it on age. Patient and caregiver preferences must also be thoroughly explored. Current models struggle with incorporating other colorectal cancer risk factors such as family history, previous adenomas, and modality of previous screening into recommendations and simulations, but are likely to improve with machine learning and whole electronic health record prediction-based approaches.
PMID: 36695761
ISSN: 1572-0241
CID: 5447872
Endoscopic polypectomy for malignant polyps: Should tumor location (right versus left side) guide clinical decisions?
Boatman, Sonja; Mott, Sarah L; Shaukat, Aasma; Melton, Genevieve B; Gaertner, Wolfgang B; Weiser, Martin; Ikramuddin, Sayeed; Madoff, Robert; Hassan, Imran; Goffredo, Paolo
BACKGROUND:Current guidelines consider endoscopic resection appropriate treatment for malignant colon polyps with negative margins, low-grade histology, and no lymphovascular invasion. While increasing literature demonstrates a worse prognosis for advanced stage right- versus left-sided colon cancers after curative treatment, there is paucity of data regarding prognostic effect of location in patients undergoing endoscopic resection of T1 polyps. We hypothesized the more aggressive biologic behavior observed in advanced right-sided cancers would be similarly represented in malignant polyps, and this location would be associated with lower overall survival. METHODS:The National Cancer Database was queried for adults with T1NxMx tumors who underwent endoscopic polypectomy (2004-2017). Patients with positive margins or without follow-up information were excluded. RESULTS:A total of 2,337 patients met inclusion criteria; 22% had right-sided polyps. Endoscopically excised proximal tumors were more common in elderly, and those with public insurance and more comorbidities (all P < .01). Among patients with complete pathologic data, there were no statistical differences between right- and left-sided polyps with 1 cm median size, >92% without lymphovascular invasion, and 100% without tumor deposits. Univariate analysis showed 73% vs 86% 5-year overall survival for right versus left polyps (P < .01). After adjustment for available confounders, right-sided location remained significantly associated with worse overall survival (hazard ratio 1.49, 95% confidence interval 1.21-1.83). CONCLUSION/CONCLUSIONS:In this national cohort of patients with endoscopically excised malignant polyps, we identified right colon location as an independent prognostic factor associated with increased risk of mortality. Our data suggest polyp location should be taken into consideration when making clinical decisions regarding treatment and/or surveillance.
PMID: 36266122
ISSN: 1532-7361
CID: 5360532
Faecal haemoglobin concentrations are associated with all-cause mortality and cause of death in colorectal cancer screening
Kaalby, Lasse; Deding, Ulrik; Al-Najami, Issam; Berg-Beckhoff, Gabriele; Bjørsum-Meyer, Thomas; Laurberg, Tinne; Shaukat, Aasma; Steele, Robert J C; Koulaouzidis, Anastasios; Rasmussen, Morten; Kobaek-Larsen, Morten; Baatrup, Gunnar
BACKGROUND:Colorectal cancer (CRC) screening reduces all-cause and CRC-related mortality. New research demonstrates that the faecal haemoglobin concentration (f-Hb) may indicate the presence of other serious diseases not related to CRC. We investigated the association between f-Hb, measured by a faecal immunochemical test (FIT), and both all-cause mortality and cause of death in a population-wide cohort of screening participants. METHODS:Between 2014 and 2018, 1,262,165 participants submitted a FIT for the Danish CRC screening programme. We followed these participants, using the Danish CRC Screening Database and several other national registers on health and population, until December 31, 2018. We stratified participants by f-Hb and compared them using a Cox proportional hazards regression on all-cause mortality and cause of death reported as adjusted hazard ratios (aHRs). We adjusted for several covariates, including comorbidity, socioeconomic factors, demography and prescription medication. RESULTS:We observed 21,847 deaths in the study period. Our multivariate analyses indicated an association relationship between increasing f-Hb and the risk of dying in the study period. This risk increased steadily from aHR 1.38 (95% CI: 1.32, 1.44) in those with a f-Hb of 7.1-11.9 μg Hb/g faeces to 2.20 (95% CI: 2.10, 2.30) in those with a f-Hb ≥60.0 μg Hb/g faeces, when compared to those with a f-Hb ≤7.0 μg Hb/g faeces. The pattern remained when excluding CRC from the analysis. Similar patterns were observed between incrementally increasing f-Hb and the risk of dying from respiratory disease, cardiovascular disease and cancers other than CRC. Furthermore, we observed an increased risk of dying from CRC with increasing f-Hb. CONCLUSIONS:Our findings support the hypothesis that f-Hb may indicate an elevated risk of having chronic conditions if causes for the bleeding have not been identified. The mechanisms still need to be established, but f-Hb may be a potential biomarker for several non-CRC diseases.
PMCID:9872406
PMID: 36691009
ISSN: 1741-7015
CID: 5415102
Colorectal cancer screening-what does the recent NordICC trial mean for the U.S. population?
Das, Taranika Sarkar; Rauch, Jessica; Shaukat, Aasma
The incidence of colorectal cancer (CRC) has declined over time, though it remains a significant cause of morbidity and mortality in the U.S. It has the third highest incidence in incidence among all cancers and is the second leading cause of cancer death in both men and women. Screening reduces the incidence and mortality from CRC. There are several modalities for CRC screening, but the most common ones are a choice between a non-invasive stool-based test, such as fecal immunochemical testing (FIT) or an invasive endoscopic modality, such as colonoscopy. In the U.S. colonoscopy is the predominant CRC screening modality, with observational studies reporting large reductions in CRC incidence and mortality. Recently, a large randomized controlled trial (RCT) on effectiveness of colonoscopy reported smaller than expected reduction in CRC incidence and no reduction in CRC mortality with colonoscopy screening. Explanations of the lower than expected benefit include low uptake of colonoscopy, short follow-up for mortality endpoints and quality indicators (QIs) for some of the endoscopists participating in the screening colonoscopies. The findings of the study need to be taken in context with other literature on effectiveness of colonoscopy, with the overall message of reassuring patients of the benefits of screening, and colonoscopy. Here, we discuss the latest evidence on colonoscopy screening and it in the context of other screening modalities and the landscape.
PMCID:10643301
PMID: 38021363
ISSN: 2415-1289
CID: 5617162
Risk factors for incomplete telehealth appointments among patients with inflammatory bowel disease
Stone, Katherine L; Kulekofsky, Emma; Hudesman, David; Kozloff, Samuel; Remzi, Feza; Axelrad, Jordan E; Katz, Seymour; Hong, Simon J; Holmer, Ariela; McAdams-DeMarco, Mara A; Segev, Dorry L; Dodson, John; Shaukat, Aasma; Faye, Adam S
BACKGROUND/UNASSIGNED:The COVID-19 pandemic led to the urgent implementation of telehealth visits in inflammatory bowel disease (IBD) care; however, data assessing feasibility remain limited. OBJECTIVES/UNASSIGNED:We looked to determine the completion rate of telehealth appointments for adults with IBD, as well as to evaluate demographic, clinical, and social predictors of incomplete appointments. DESIGN/UNASSIGNED:We conducted a retrospective analysis of all patients with IBD who had at least one scheduled telehealth visit at the NYU IBD Center between 1 March 2020 and 31 August 2021, with only the first scheduled telehealth appointment considered. METHODS/UNASSIGNED:Medical records were parsed for relevant covariables, and multivariable logistic regression was used to estimate the adjusted association between demographic factors and an incomplete telehealth appointment. RESULTS/UNASSIGNED: = 0.22). After adjustment, patients with CD had higher odds of an incomplete appointment as compared to patients with UC [adjusted odds ratio (adjOR): 1.37, 95% confidence interval (CI): 1.10-1.69], as did females (adjOR: 1.26, 95% CI: 1.04-1.54), and patients who had a non-first-degree relative listed as an emergency contact (adjOR: 1.69, 95% CI: 1.16-2.44). While age ⩾60 years was not associated with appointment completion status, we did find that age >80 years was an independent predictor of missed telehealth appointments (adjOR: 2.92, 95% CI: 1.12-7.63) when compared to individuals aged 60-70 years. CONCLUSION/UNASSIGNED:telehealth, particularly those aged 60-80 years, may therefore provide an additional venue to complement in-person care.
PMCID:10134163
PMID: 37124374
ISSN: 1756-283x
CID: 5544752