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Browsing by Author "Patel, Swati G."
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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 Cost Effectiveness Analysis Evaluating Real-Time Characterization of Diminutive Colorectal Polyp Histology using Narrow Band Imaging (NBI)(2020-01) Patel, Swati G.; Scott, Frank I.; Das, Ananya; Rex, Douglas K.; McGill, Sarah; Kaltenbach, Tonya; Ahnen, Dennis J.; Rastogi, Amit; Wani, Sachin; Medicine, School of MedicineBackground: Endoscopists and new computer-aided programs can achieve performance benchmarks for real-time diagnosis of colorectal polyps using Narrow-Band Imaging (NBI), though do not perform as well as endoscopists with expertise in advanced imaging. Previous cost-effectiveness studies on optical diagnosis have focused on expert performance, potentially over-estimating its benefits. Aim: Determine cost-effectiveness of an NBI ‘characterize, resect and discard (CRD)’ strategy using updated assumptions based on non-expert performance. Methods: Markov model was constructed to compare cost-effectiveness of the CRD strategy, where diminutive polyps characterized as non-adenomas with high confidence are not resected and adenomas are resected and discarded, versus standard of care (SOC) in which all polyps are resected with histologic analysis. Rates related to NBI performance, missed polyps, polyp progression, malignancy, and complications, as well as quality-adjusted life years (QALYs) were derived from the literature. Costs were age and insurer-specific. Mean QALYs and costs were calculated using first order Monte Carlo simulation. Deterministic and probabilistic sensitivity analyses were conducted. Results: The mean QALY estimates were similar for the CRD (8.563, 95% CI: 8.557-8.571) and SOC strategy (8.563, 8.557-8.571), but costs were reduced ($2,693.06 vs. $2,800.27, mean incremental cost savings: $107.21/person). Accounting for colonoscopy rates, the CRD strategy would save $708 million to $1.06 billion annually. The model was sensitive to the incidence of tubular adenomas; the results were otherwise robust in all other one-way and probabilistic analyses. Conclusions: An NBI CRD strategy is cost-effective when compared to the SOC, even when employed by non-experts. The appreciated benefit is primarily due to cost savings of the CRD strategy.Item Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines(Elsevier, 2023) Cavestro, Giulia Martina; Mannucci, Alessandro; Balaguer, Francesc; Hampel, Heather; Kupfer, Sonia S.; Repici, Alessandro; Sartore-Bianchi, Andrea; Seppälä, Toni T.; Valentini, Vincenzo; Boland, Clement Richard; Brand, Randall E.; Buffart, Tineke E.; Burke, Carol A.; Caccialanza, Riccardo; Cannizzaro, Renato; Cascinu, Stefano; Cercek, Andrea; Crosbie, Emma J.; Danese, Silvio; Dekker, Evelien; Daca-Alvarez, Maria; Deni, Francesco; Dominguez-Valentin, Mev; Eng, Cathy; Goel, Ajay; Guillem, Josè G.; Houwen, Britt B. S. L.; Kahi, Charles; Kalady, Matthew F.; Kastrinos, Fay; Kühn, Florian; Laghi, Luigi; Latchford, Andrew; Liska, David; Lynch, Patrick; Malesci, Alberto; Mauri, Gianluca; Meldolesi, Elisa; Møller, Pål; Monahan, Kevin J.; Möslein, Gabriela; Murphy, Caitlin C.; Nass, Karlijn; Ng, Kimmie; Oliani, Cristina; Papaleo, Enrico; Patel, Swati G.; Puzzono, Marta; Remo, Andrea; Ricciardiello, Luigi; Ripamonti, Carla Ida; Siena, Salvatore; Singh, Satish K.; Stadler, Zsofia K.; Stanich, Peter P.; Syngal, Sapna; Turi, Stefano; Urso, Emanuele Damiano; Valle, Laura; Vanni, Valeria Stella; Vilar, Eduardo; Vitellaro, Marco; You, Yi-Qian Nancy; Yurgelun, Matthew B.; Zuppardo, Raffaella Alessia; Stoffel, Elena M.; Associazione Italiana Familiarità Ereditarietà Tumori; Collaborative Group of the Americas on Inherited Gastrointestinal Cancer; European Hereditary Tumour Group; International Society for Gastrointestinal Hereditary Tumours; Medicine, School of MedicineBackground & aims: Patients with early-onset colorectal cancer (eoCRC) are managed according to guidelines that are not age-specific. A multidisciplinary international group (DIRECt), composed of 69 experts, was convened to develop the first evidence-based consensus recommendations for eoCRC. Methods: After reviewing the published literature, a Delphi methodology was used to draft and respond to clinically relevant questions. Each statement underwent 3 rounds of voting and reached a consensus level of agreement of ≥80%. Results: The DIRECt group produced 31 statements in 7 areas of interest: diagnosis, risk factors, genetics, pathology-oncology, endoscopy, therapy, and supportive care. There was strong consensus that all individuals younger than 50 should undergo CRC risk stratification and prompt symptom assessment. All newly diagnosed eoCRC patients should receive germline genetic testing, ideally before surgery. On the basis of current evidence, endoscopic, surgical, and oncologic treatment of eoCRC should not differ from later-onset CRC, except for individuals with pathogenic or likely pathogenic germline variants. The evidence on chemotherapy is not sufficient to recommend changes to established therapeutic protocols. Fertility preservation and sexual health are important to address in eoCRC survivors. The DIRECt group highlighted areas with knowledge gaps that should be prioritized in future research efforts, including age at first screening for the general population, use of fecal immunochemical tests, chemotherapy, endoscopic therapy, and post-treatment surveillance for eoCRC patients. Conclusions: The DIRECt group produced the first consensus recommendations on eoCRC. All statements should be considered together with the accompanying comments and literature reviews. We highlighted areas where research should be prioritized. These guidelines represent a useful tool for clinicians caring for patients with eoCRC.Item Early-Age Onset Colorectal Neoplasia in Average-Risk Individuals Undergoing Screening Colonoscopy: A Systematic Review and Meta-Analysis(Elsevier, 2021-10) Kolb, Jennifer M.; Hu, Junxiao; DeSanto, Kristen; Gao, Dexiang; Singh, Siddharth; Imperiale, Thomas; Lieberman, David A.; Boland, C. Richard; Patel, Swati G.; Medicine, School of MedicineBackground/Aims Incidence and mortality associated with early age onset colorectal cancer (EAO-CRC) is increasing, prompting professional society recommendations to lower the screening age in average risk individuals. The yield of screening individuals <50 years old is not known. Methods A systematic review of 3 databases from inception through July 2020 was performed in all languages that reported colonoscopy findings in average risk individuals<50 years old. The primary outcomes were EAO colorectal neoplasia (EAO-CRN) and advanced colorectal neoplasia (EAO-aCRN) prevalence. Subgroup analyses were performed based on sex, geographic location, time period, and age including comparison to age 50-59. Generalized linear mixed model with random intercept logistic regression and fixed subgroup effects were performed Results Of 10,123 unique articles, 17 studies published between 2002-2020, including 51,811 average-risk individuals from four continents, were included. The pooled rate of EAO-CRN was 13.7% (95%CI: 0.112-0.168) and EAO-aCRN was 2.2% (95%CI: 0.016-0.031). Prevalence of CRC was .05% (0.00029-0.0008). Rates of EAO-CRN were higher in men compared to women (RR 1.71, 1.49–1.98), and highest in the United States (15.6%:12.2-19.7) compared to Europe (14.9%:6.9-29.3), East Asia (13.4%:10.3-17.2), and the Middle East (9.8%:7.8-12.2)(p=0.04) The rate of EAO-CRN in age 45-49 and 50-59 was 17.8% (14.5-21.6) and 24.8% (19.5-30.8), respectively (p=0.04). The rate of EAO-aCRN in age 45-49 was 3.6% (1.9-6.7) and 4.2% (3.2-5.7), respectively (p=0.69) Conclusions The rate of advanced colorecta neoplasia in individuals age 45-49 was similar to the rate observed in age 50-59, suggesting that expanding screening to this population could yield similar impact on colorectal cancer risk reduction.Item Oral simethicone tablets with PEG-ELS split-prep reduces frequency of inadequate bowel cleansing and decreases bubbles(Wiley, 2021) Maratt, Jennifer K.; Freeman, Alison E.; Schoenfeld, Philip; Saini, Sameer D.; Su, Grace L.; Tai, Andrew W.; Prabhu, Anoop; Rubenstein, Joel H.; Waljee, Akbar K.; Glass, Lisa; Dang, Duyen; Parikh, Neehar D.; Govani, Shail M.; Patel, Swati G.; Menees, Stacy B.; Medicine, School of MedicineBackground: Intraluminal bubbles may prevent the visualisation of mucosa during a colonoscopy. Simethicone minimises bubbles, but its impact on incomplete bowel preparation and optimal protocols for use are unclear. Aim: To assess the impact of oral simethicone tablets when added to 2-litre, split-prep, polyethylene glycol electrolyte lavage solution + ascorbic acid on bubble score and frequency of incomplete bowel preparation. Methods: This QA/QI project assessed outpatients who underwent colonoscopy at the Veterans Affairs Ann Arbor Healthcare System. After endoscopists were trained in intraluminal bubble scoring systems, data about bubble score, frequency of inadequate bowel preparation requiring early repeat colonoscopy, quality of bowel preparation using Boston Bowel Preparation Scale (BBPS), and patient tolerance were collected before and after addition of oral simethicone 160mg to each dose of 2-litre split-prep. Results: There were no differences in patient characteristics between the baseline group (n = 348) and the simethicone group (n = 354). Simethicone improved the total mean intraluminal bubble score from 8.18 to 8.78 (P < 0.001). Early repeat colonoscopy due to inadequate bowel preparation was higher in the baseline group vs simethicone group: 8.7% vs 4.6%, P = 0.03 with an RRR = 0.5 (95% CI 0.26-0.95). Using BBPS, the frequency of having inadequate cleansing in any colon segment was higher in the baseline group vs simethicone group: 6.6% vs 3.1%; RRR = 0.55 (95% CI 0.21-0.94). Conclusions: The addition of oral simethicone to each dose of 2-litre, split-prep of polyethylene glycol + ascorbic acid decreased intraluminal bubbles and reduced the frequency of inadequate bowel preparation.Item Virtual Gastroenterology Fellowship Recruitment During COVID-19 and Its Implications for the Future(Springer, 2021) Hamade, Nour; Bhavsar-Burke, Indira; Jansson-Knodell, Claire; Wani, Sachin; Patel, Swati G.; Ehrlich, Adam C.; Paine, Elizabeth; Hosseini‑Carroll, Pegah; Menard-Katcher, Paul; Fayad, Nabil; Medicine, School of MedicineBackground and Aims Amid the COVID-19 pandemic, medical education organizations endorsed a virtual recruitment format, representing a stark change from traditional in-person interviews. We aimed to identify the attitudes and perceptions of Gastroenterology Fellowship Program Directors (PDs) and applicants regarding the virtual interview experience and the role of virtual interviews (VI) in the future. Methods We designed separate surveys targeting PDs and applicants using the Qualtrics software. At the end of the interview season, we e-mailed both survey links to all PDs and requested that they forward the applicant survey to their interviewed candidates. Surveys were voluntary and anonymous. Descriptive statistics were used to analyze the data with results presented as percentages. Results A total of 29.7% of PDs completed the survey. Compared to traditional interviews, VI were viewed by 46.5% of PDs to be very suboptimal or suboptimal. Yet, 69.1% envisioned a role for VI in the future. A total of 14.2% of applicants completed the survey. Compared to traditional interviews, VI were viewed by 42.3% of applicants to be very suboptimal or suboptimal. However, 61.8% saw a future role for VI. While both applicants and PDs reported that establishing an interpersonal connection was a disadvantage with VI, applicants placed more emphasis on this need for connection (p = 0.001). Conclusion Overall, PDs and applicants report mixed views with regard to VI but anticipate that it may continue to have a future role. VI may augment future recruitment cycles with care taken to not disadvantage applicants, who rely heavily on the interview process to create personal connections with programs.