Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening.

BACKGROUND: A next-generation multitarget stool DNA test, including assessments of DNA molecular markers and hemoglobin level, was developed to improve the performance of colorectal cancer screening, primarily with regard to specificity. METHODS: In a prospective study, we evaluated a next-generation multitarget stool DNA test in asymptomatic adults 40 years of age or older who were undergoing screening colonoscopy. The primary outcomes were sensitivity of the test for colorectal cancer and specificity for advanced neoplasia (colorectal cancer or advanced precancerous lesions). Advanced precancerous lesions included one or more adenomas or sessile serrated lesions measuring at least 1 cm in the longest dimension, lesions with villous histologic features, and high-grade dysplasia. Secondary objectives included the quantification of sensitivity for advanced precancerous lesions and specificity for nonneoplastic findings or negative colonoscopy and comparison of sensitivities for colorectal cancer and advanced precancerous lesions between the multitarget stool DNA test and a commercially available fecal immunochemical test (FIT). RESULTS: Of 20,176 participants, 98 had colorectal cancer, 2144 had advanced precancerous lesions, 6973 had nonadvanced adenomas, and 10,961 had nonneoplastic findings or negative colonoscopy. With the next-generation test, sensitivity for colorectal cancer was 93.9% (95% confidence interval [CI], 87.1 to 97.7), and specificity for advanced neoplasia was 90.6% (95% CI, 90.1 to 91.0). Sensitivity for advanced precancerous lesions was 43.4% (95% CI, 41.3 to 45.6), and specificity for nonneoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2 to 93.1). With the FIT, sensitivity was 67.3% (95% CI, 57.1 to 76.5) for colorectal cancer and 23.3% (95% CI, 21.5 to 25.2) for advanced precancerous lesions; specificity was 94.8% (95% CI, 94.4 to 95.1) for advanced neoplasia and 95.7% (95% CI, 95.3 to 96.1) for nonneoplastic findings or negative colonoscopy. As compared with FIT, the next-generation test had superior sensitivity for colorectal cancer (P<0.001) and for advanced precancerous lesions (P<0.001) but had lower specificity for advanced neoplasia (P<0.001). No adverse events occurred. CONCLUSIONS: The next-generation multitarget stool DNA test showed higher sensitivity for colorectal cancer and advanced precancerous lesions than FIT but also showed lower specificity. (Funded by Exact Sciences; BLUE-C ClinicalTrials.gov number, NCT04144738.).

CRC screening with sigmoidoscopy extends life by 110 d; other cancer screening tests do not extend life.

SOURCE CITATION: Bretthauer M, Wieszczy P, Løberg M, et al. Estimated lifetime gained with cancer screening tests: a meta-analysis of randomized clinical trials. JAMA Intern Med. 2023;183:1196-1203. 37639247.

Patient Navigation Plus Tailored Digital Video Disc Increases Colorectal Cancer Screening Among Low-Income and Minority Patients Who Did Not Attend a Scheduled Screening Colonoscopy: A Randomized Trial.

BACKGROUND: Up to 50% of people scheduled for screening colonoscopy do not complete this test and no studies have focused on minority and low-income populations. Interventions are needed to improve colorectal cancer (CRC) screening knowledge, reduce barriers, and provide alternative screening options. Patient navigation (PN) and tailored interventions increase CRC screening uptake, however there is limited information comparing their effectiveness or the effect of combining them. PURPOSE: Compare the effectiveness of two interventions to increase CRC screening among minority and low-income individuals who did not attend their screening colonoscopy appointment-a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based PN compared to usual care. METHODS: Patients (n = 371) aged 45-75 years at average risk for CRC who did not attend a screening colonoscopy appointment were enrolled and were randomized to: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. CRC screening outcomes were from electronic medical records at 12 months. Multivariable logistic regression analyses were used to study intervention effects. RESULTS: Participants randomized to tailored DVD plus PN were four times more likely to complete CRC screening compared to usual care and almost two and a half times more likely than those who were sent the DVD alone. CONCLUSIONS: Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend their screening colonoscopy appointments and has potential for wide dissemination.

Up to half of people scheduled for a screening colonoscopy do not complete this test. There is a need for interventions to improve knowledge about colorectal cancer (CRC) screening, enhance access to screening by offering alternative test options, foster skills for completing screening, and mitigate barriers. The purpose of this study was to compare the effects of two interventions aimed at increasing CRC screening­a mailed tailored digital video disc (DVD) alone versus the mailed DVD plus telephone-based patient navigation (PN)­for patients who had not completed a scheduled screening colonoscopy. We enrolled 371 patients aged 45­75 years who had no CRC risk factors other than age, who were scheduled for a screening colonoscopy but did not attend their appointment. Participants were randomized to receive either: (i) a mailed tailored DVD; (ii) the mailed DVD plus phone-based PN; or (iii) usual care. Those who received the tailored DVD plus PN were four times more likely to complete CRC screening with stool test or colonoscopy compared to usual care. Combining telephone-based PN with a mailed, tailored DVD increased CRC screening among low-income and minority patients who did not attend a scheduled screening colonoscopy appointment.

In adults, sigmoidoscopy screening invitation reduced CRC incidence and related mortality at 15 y.

SOURCE CITATION: Juul FE, Cross AJ, Schoen RE, et al. 15-year benefits of sigmoidoscopy screening on colorectal cancer incidence and mortality: a pooled analysis of randomized trials. Ann Intern Med. 2022;175:1525-33. 36215714.

In adults, a single colonoscopy screening invitation vs. no invitation reduced CRC incidence at 10 y.

SOURCE CITATION: Bretthauer M, Løberg M, Wieszczy P, et al. Effect of colonoscopy screening on risks of colorectal cancer and related death. N Engl J Med. 2022;387:1547-56. 36214590.

The Prevalence, Humanistic Burden, and Health Care Impact of Irritable Bowel Syndrome Among United States Veterans.

BACKGROUND & AIMS: Irritable bowel syndrome (IBS) in veterans is understudied. This study sought to investigate (1) prevalence of IBS; (2) phenotypic, environmental, and psychosocial factors associated with IBS; and (3) associations of IBS with health-related quality of life and health care use. METHODS: From June 2018 to April 2020, we invited veterans to complete the Rome IV IBS questionnaire; Short Form-12; posttraumatic stress disorder (PTSD) checklist; Hospital Anxiety and Depression Scale; and questionnaires on general health, antibiotic use, infectious enteritis (IE), and health care use. RESULTS: Among 858 veteran respondents, 244 (28.4%) met Rome IV IBS criteria (47.5% IBS with diarrhea, 16.8% IBS with constipation, 33.6% mixed IBS). IBS was associated with greater anxiety and depression and lower quality of life (all P < .001). Provisional PTSD, IE, and bowel problems after antibiotics were more common in IBS (all P < .001) as were multiple doctor visits (P < .01) and hospitalizations (P = .04). Comparisons across non-IBS and IBS subgroups revealed overall associations of psychological comorbidities (P < .01), multiple doctor visits (P < .01), hospitalizations (P = .03), IE (P < .01), and bowel problems after IE (P = .03) or antibiotics (P < .01) with subgroup. Highest anxiety and depression scores, PTSD, multiple doctor visits, hospitalizations, and bowel problems after IE were observed in IBS with constipation. In adjusted analyses, IBS was associated (all P < .001) with anxiety (odds ratio [OR], 3.47), depression (OR, 2.88), lower quality of life, PTSD (OR, 3.09), IE (OR, 4.44), bowel problems after antibiotics (OR, 1.84), multiple doctor visits (OR, 2.08), and hospitalizations (OR, 1.78). CONCLUSIONS: IBS is prevalent among veterans and has a measurable impact on individuals and health care resources. Veterans with IBS may experience significant psychological impairment.

Tailoring Surveillance Colonoscopy in Patients With Advanced Adenomas.

BACKGROUND & AIMS: Patients with advanced colorectal adenomas (AAs) are directed to undergo intensive surveillance. However, the benefit derived from surveillance may be outweighed by the risk of death from non-colorectal cancer (CRC) causes, leading to uncertainty on how best to individualize follow-up. The aim of this study was to derive a risk prediction model and risk index that estimate and stratify the risk for non-CRC cancer mortality (NCM) subsequent to diagnosis and removal of AA. METHODS: We conducted a retrospective cohort study of veterans ≥40 years old who had colonoscopy for diagnostic or screening indications at 13 Veterans Affairs Medical Centers between 2002 and 2009 and had 1 or more AAs. The primary outcome was NCM using a fixed follow-up time period of 5 years. Logistic regression using the lasso technique was used to identify factors independently associated with NCM, and an index based on points from regression coefficients was constructed to estimate risk of 5-year NCM. RESULTS: We identified 2943 veterans with AA (mean age [standard deviation] 63 [8.6] years, 98% male, 74% white), with an overall 5-year mortality of 16.7%, which was nearly all due to NCM (16.6%). Age, comorbidity burden, specific comorbid conditions, and hospitalization within the preceding year were independently associated with NCM. The risk prediction model had a goodness of fit (calibration) P value of .41 and c-statistic (discrimination) of 0.74 (95% confidence interval, 0.71-0.76). On the basis of comparable 5-year risks of NCM, the scores comprised 3 risk categories: low (score of 0-1), intermediate (score of 2-4), and high (score of ≥5), in which NCM occurred in 6.5%, 14.1%, and 33.2%, respectively. CONCLUSIONS: We derived a risk prediction model that identifies veterans with advanced adenomas who are at high risk of NCM within 5 years, and who are thus unlikely to benefit from further surveillance.

AGA White Paper: Challenges and Gaps in Innovation for the Performance of Colonoscopy for Screening and Surveillance of Colorectal Cancer.

In 2018, the American Gastroenterological Association's Center for GI Innovation and Technology convened a consensus conference, entitled "Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes." The conference participants, which included more than 60 experts in colorectal cancer, considered recent improvements in colorectal cancer screening rates and polyp detection, persistent barriers to colonoscopy uptake, and opportunities for performance improvement and innovation. This white paper originates from that conference. It aims to summarize current patient- and physician-centered gaps and challenges in colonoscopy, diagnostic and therapeutic challenges affecting colonoscopy uptake, and the potential use of emerging technologies and quality metrics to improve patient outcomes.

Yield and Risk Factors for Advanced Colorectal Neoplasia and Long-term Outcomes in Veterans With 3 or More Nonadvanced Adenomas.

BACKGROUND AND AIMS: Until recently, guidelines recommended a 3-year surveillance colonoscopy for persons with 3 to 10 nonadvanced adenomas (NAA). In this study, we quantify yield for metachronous advanced neoplasia (AN); attempt to identify risk factors for AN; and measure colorectal cancer (CRC) incidence and mortality. METHODS: We used natural language processing to screen an existing data set for Veterans with 3 to 10 NAA. We manually reviewed colonoscopy and pathology reports to verify baseline findings and determine results of subsequent colonoscopy (sCY). Baseline features were extracted from the electronic medical record (EMR) and a national data set, CRC incidence was obtained from the Veterans Affairs cancer registry, and CRC mortality from the National Death Index through September 30, 2017. CRC incidence and mortality were compared between Veterans who did versus did not have sCY. RESULTS: Natural language processing identified 3673 Veterans who potentially had 3 to 10 NAA, of which 1672 were excluded after EMR review. In the analytical cohort of 2001 subjects, 1178 (59%) had sCY at a mean (SD) follow-up of 4.3 (2.2) years. The sCY group was younger (mean age: 61 vs. 67 y; P<0.01) and were less likely to have diabetes (27% vs. 31%; P=0.02) and congestive heart failure (4% vs. 9%; P<0.01). sCY showed AN in 182 subjects (15.5%). Baseline features were no different between those with versus without metachronous AN. Subjects with sCY had a greater CRC incidence (n=7 vs. n=0; P=0.046), but there was no difference in CRC mortality (0 for both subgroups). CONCLUSIONS: Among patients with 3 to 10 NAA on index colonoscopy who underwent sCY, AN was present in 15.5% at mean follow-up of 4.3 years. No risk factors for AN were identified. CRC incidence, but not CRC mortality, was higher among those with sCY.

Colorectal cancer screening offering colonoscopy and FIT vs. colonoscopy alone improved participation.

SOURCE CITATION: Pilonis ND, Bugajski M, Wieszczy P, et al. Participation in competing strategies for colorectal cancer screening: a randomized health services study (PICCOLINO study). Gastroenterology. 2021;160:1097-105. 33307024.

A two-phase approach to re-calibrating expensive computer simulation for sex-specific colorectal neoplasia development modeling.

BACKGROUND: Medical evidence from more recent observational studies may significantly alter our understanding of disease incidence and progression, and would require recalibration of existing computational and predictive disease models. However, it is often challenging to perform recalibration when there are a large number of model parameters to be estimated. Moreover, comparing the fitting performances of candidate parameter designs can be difficult due to significant variation in simulated outcomes under limited computational budget and long runtime, even for one simulation replication. METHODS: We developed a two-phase recalibration procedure. As a proof-of-the-concept study, we verified the procedure in the context of sex-specific colorectal neoplasia development. We considered two individual-based state-transition stochastic simulation models, estimating model parameters that govern colorectal adenoma occurrence and its growth through three preclinical states: non-advanced precancerous polyp, advanced precancerous polyp, and cancerous polyp. For the calibration, we used a weighted-sum-squared error between three prevalence values reported in the literature and the corresponding simulation outcomes. In phase 1 of the calibration procedure, we first extracted the baseline parameter design from relevant studies on the same model. We then performed sampling-based searches within a proper range around the baseline design to identify the initial set of good candidate designs. In phase 2, we performed local search (e.g., the Nelder-Mead algorithm), starting from the candidate designs identified at the end of phase 1. Further, we investigated the efficiency of exploring dimensions of the parameter space sequentially based on our prior knowledge of the system dynamics. RESULTS: The efficiency of our two-phase re-calibration procedure was first investigated with CMOST, a relatively inexpensive computational model. It was then further verified with the V/NCS model, which is much more expensive. Overall, our two-phase procedure showed a better goodness-of-fit than the straightforward employment of the Nelder-Mead algorithm, when only a limited number of simulation replications were allowed. In addition, in phase 2, performing local search along parameter space dimensions sequentially was more efficient than performing the search over all dimensions concurrently. CONCLUSION: The proposed two-phase re-calibration procedure is efficient at estimating parameters of computationally expensive stochastic dynamic disease models.

Process Evaluation of a Mailed Interactive Educational DVD in a Comparative Effectiveness Trial to Promote Colorectal Cancer Screening.

A process evaluation was conducted as part of a comparative effectiveness trial of a mailed interactive educational DVD intervention to promote colorectal cancer screening among average-risk patients who did not attend a scheduled colonoscopy. Participants (n = 371) for the trial were randomized to (1) mailed DVD, (2) mailed DVD plus patient navigation, or (3) usual care. Participants (n = 243) randomized to the two DVD intervention arms were called 2 weeks after mailing materials to complete a process evaluation interview about the DVD (September 2017-February 2020). Forty-nine (20%) participants were not reached, and 194 (80%) participants watched the DVD and completed the interview. The process evaluation assessed whether (1) the DVD content was helpful, (2) any new information was learned by participants, (3) the appropriate amount of information was included in the DVD, (4) participants were engaged when watching the DVD, (5) the DVD content was relevant, (6) participants were satisfied with the DVD (7) participants would recommend the DVD to others, and (8) their opinion about colorectal cancer screening was changed by watching the DVD. Among participants who watched the DVD, 99% reported the screening information was very or somewhat helpful, 47% learned new information, 75% said the DVD included the right amount of information, they were engaged (M = 3.35 out of 4, SD = 0.49), 87% reported all or most information applied to them, they were satisfied (M = 3.42 out of 4, SD = 0.39) with DVD content, 99% would recommend the DVD to others, and 45% reported changing their opinion about screening. To understand the effects of interventions being tested in trials and to plan the dissemination of evidence-based interventions, process evaluation is critical to assess the dose received and acceptability of behavioral interventions.

Derivation and validation of a predictive model for advanced colorectal neoplasia in asymptomatic adults.

OBJECTIVE: Knowing risk for advanced colorectal neoplasia (AN) could help patients and providers choose among screening tests, improving screening efficiency and uptake. We created a risk prediction model for AN to help decide which test might be preferred, a use not considered for existing models. DESIGN: Average-risk 50-to-80-year olds undergoing first-time screening colonoscopy were recruited from endoscopy units in Indiana. We measured sociodemographic and physical features, medical and family history and lifestyle factors and linked these to the most advanced finding. We derived a risk equation on two-thirds of the sample and assigned points to each variable to create a risk score. Scores with comparable risks were collapsed into risk categories. The model and score were tested on the remaining sample. RESULTS: Among 3025 subjects in the derivation set (mean age 57.3 (6.5) years; 52% women), AN prevalence was 9.4%. The 13-variable model (c-statistic=0.77) produced three risk groups with AN risks of 1.5% (95% CI 0.72% to 2.74%), 7.06% (CI 5.89% to 8.38%) and 27.26% (CI 23.47% to 31.30%) in low-risk, intermediate-risk and high-risk groups (p value <0.001), containing 23%, 59% and 18% of subjects, respectively. In the validation set of 1475 subjects (AN prevalence of 8.4%), model performance was comparable (c-statistic=0.78), with AN risks of 2.73% (CI 1.25% to 5.11%), 5.57% (CI 4.12% to 7.34%) and 25.79% (CI 20.51% to 31.66%) in low-risk, intermediate-risk and high-risk subgroups, respectively (p<0.001), containing proportions of 23%, 59% and 18%. CONCLUSION: Among average-risk persons, this model estimates AN risk with high discrimination, identifying a lower risk subgroup that may be screened non-invasively and a higher risk subgroup for which colonoscopy may be preferred. The model could help guide patient-provider discussions of screening options, may increase screening adherence and conserve colonoscopy resources.

Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial.

INTRODUCTION: Although African Americans have the highest colorectal cancer (CRC) incidence and mortality rates of any racial group, their screening rates remain low. STUDY DESIGN/PURPOSE: This randomized controlled trial compared efficacy of two clinic-based interventions for increasing CRC screening among African American primary care patients. METHODS: African American patients from 11 clinics who were not current with CRC screening were randomized to receive a computer-tailored intervention (n = 335) or a non-tailored brochure (n = 358) designed to promote adherence to CRC screening. Interventions were delivered in clinic immediately prior to a provider visit. Univariate and multivariable logistic regression models analyzed predictors of screening test completion. Moderators and mediators were determined using multivariable linear and logistic regression analyses. RESULTS: Significant effects of the computer-tailored intervention were observed for completion of a stool blood test (SBT) and completion of any CRC screening test (SBT or colonoscopy). The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant. Predictors of SBT completion were: receipt of the computer-tailored intervention; being seen at a Veterans Affairs Medical Center clinic; baseline stage of adoption; and reason for visit. Mediators of intervention effects were changes in perceived SBT barriers, changes in perceived colonoscopy benefits, changes in CRC knowledge, and patient-provider discussion. Moderators of intervention effects were age, employment, and family/friend recommendation of screening. CONCLUSION: This one-time computer-tailored intervention significantly improved CRC screening rates among low-income African American patients. This finding was largely driven by increasing SBT but the impact of the intervention on colonoscopy screening was strong. Implementation of a CRC screening quality improvement program in the VA site that included provision of stool blood test kits and follow-up likely contributed to the strong intervention effect observed at that site. The trial is registered at ClinicalTrials.gov as NCT00672828.

Prevalence of Advanced Colorectal Neoplasia in Veterans: Effects of Age, Sex, and Race/Ethnicity.

GOAL: We sought to quantify the independent effects of age, sex, and race/ethnicity on risk of colorectal cancer (CRC) and advanced neoplasia (AN) in Veterans. STUDY: We conducted a retrospective, cross-sectional study of Veterans aged 40 to 80 years who had diagnostic or screening colonoscopy between 2002 and 2009 from 1 of 14 Veterans Affairs Medical Centers. Natural language processing identified the most advanced finding and location (proximal, distal). Logistic regression was used to examine the adjusted, independent effects of age, sex, and race, both overall and in screening and diagnostic subgroups. RESULTS: Among 90,598 Veterans [mean (SD) age 61.7 (9.4) y, 5.2% (n=4673) were women], CRC and AN prevalence was 1.3% (n=1171) and 8.9% (n=8081), respectively. Adjusted CRC risk was higher for diagnostic versus screening colonoscopy [odds ratio (OR)=3.79; 95% confidence interval (CI), 3.19-4.50], increased with age, was numerically (but not statistically) higher for men overall (OR=1.53; 95% CI, 0.97-2.39) and in the screening subgroup (OR=2.24; 95% CI, 0.71-7.05), and was higher overall for Blacks and Hispanics, but not in screening. AN prevalence increased with age, and was present in 9.2% of men and 3.9% of women [adjusted OR=1.90; 95% CI, 1.60-2.25]. AN risk was 11% higher in Blacks than in Whites overall (OR=1.11; 95% CI, 1.04-1.20), was no different in screening, and was lower in Hispanics (OR=0.74; 95% CI, 0.55-0.98). Women had more proximal CRC (63% vs. 39% for men; P=0.03), but there was no difference in proximal AN (38.3% for both genders). CONCLUSIONS: Age and race were associated with AN and CRC prevalence. Blacks had a higher overall prevalence of both CRC and AN, but not among screenings. Men had increased risk for AN, while women had a higher proportion of proximal CRC. These findings may be used to tailor when and how Veterans are screened for CRC.

Cost Effectiveness of Different Strategies for Detecting Cirrhosis in Patients With Nonalcoholic Fatty Liver Disease Based on United States Health Care System.

BACKGROUND & AIMS: Several strategies are available for detecting cirrhosis in patients with nonalcoholic fatty liver disease (NAFLD), but their cost effectiveness is not clear. We developed a decision model to quantify the accuracy and costs of 9 single or combination strategies, including 3 noninvasive tests (fibrosis-4 [FIB-4], vibration-controlled transient elastography [VCTE], and magnetic resonance elastography [MRE]) and liver biopsy, for the detection of cirrhosis in patients with NAFLD. METHODS: Data on the diagnostic accuracy, costs, adverse events, and cirrhosis outcomes over a 5-year period were obtained from publications. The diagnostic accuracy, per-patient cost per correct diagnosis of cirrhosis, and incremental cost-effectiveness ratios (ICERs) were calculated for each strategy for base cirrhosis prevalence values of 0.27%, 2%, and 4%. RESULTS: The combination of the FIB-4 and VCTE identified patients with cirrhosis in NAFLD populations with a 0.27%, 2%, and 4% prevalence of cirrhosis with the lowest cost per person ($401, $690, and $1024, respectively) and highest diagnostic accuracy (89.3%, 88.5%, and 87.5% respectively). The combination of FIB-4 and MRE ranked second in cost per person ($491, $781, and $1114, respectively) and diagnostic accuracy (92.4%, 91.6%, 90.6%, respectively). Compared with the combination of FIB-4 and VCTE (least costly), the ICERs were lower for the combination of FIB-4 and MRE ($2864, $2918, and $2921) than the combination of FIB-4 and liver biopsy ($4454, $5156, and $5956) at the cirrhosis prevalence values tested. When the goal was to avoid liver biopsy, FIB-4 + VCTE and FIB-4 + MRE had similar diagnostic accuracies, ranging from 87.5% to 89.3% and 90.6% to 92.4% for a cirrhosis diagnosis, respectively, although FIB-4 + MRE had a slightly higher cost. CONCLUSIONS: In our cost-effectiveness analysis based on the US health care system, we found that results from FIB-4, followed by either VCTE, MRE, or liver biopsy, detect cirrhosis in patients with NAFLD with a high level of accuracy and low cost. Compared with FIB-4 + VCTE, which was the least costly strategy, FIB-4 + MRE had a lower ICER than FIB-4 + LB.

Low Incidence of Aerodigestive Cancers in Patients With Negative Results From Colonoscopies, Regardless of Findings From Multitarget Stool DNA Tests.

BACKGROUND & AIMS: We aimed to compare the incidence of aerodigestive cancers in persons with negative results from colonoscopies and positive vs negative results from multitarget stool DNA tests for colorectal cancer and vs expected incidence. METHODS: We performed a retrospective cohort study of 1216 subjects with comprehensive patient records and/or cancer registry data from 3 medical centers in North America. Subjects had no neoplasia or only nonadvanced adenomas, based on screening colonoscopy, and either negative results (concordant with colonoscopy, n = 1011) or positive results (discordant colonoscopy, n = 205) from the multitarget stool DNA test. Outcomes included aerodigestive cancers in discordant vs concordant groups and comparison of observed aerodigestive cancer incidence between the groups and compared with expected incidence for the population, based on the Surveillance, Epidemiology, and End Results (SEER) data. RESULTS: Median follow-up times were comparable between subjects in the discordant (5.3 y; interquartile range, 3.5-5.8 y) and concordant (5.4 y; interquartile range, 3.7-5.8 y) groups. Aerodigestive cancers developed in 5 subjects in the discordant group vs 11 subjects in the concordant group (crude risk ratio, 2.3; 95% CI, 0.8-6.6; adjusted risk ratio, 2.2; 95% CI, 0.8-6.2; P = .151). The incidence of aerodigestive cancer was lower in the concordant group than the expected incidence based on SEER data (risk ratio, 0.4; 95% CI, 0.2-0.6; P = .0008). The incidence of aerodigestive cancer was not significantly greater in the population in the discordant group than the expected incidence based on SEER data (risk ratio, 0.8; 95% CI, 0.3-1.9; P = .599). CONCLUSIONS: In a retrospective study with a median follow-up time of 5.4 years, incident aerodigestive cancers were uncommon among subjects with negative findings from colonoscopies, regardless of discordant or concordant results from multitarget stool DNA tests. Patients with negative results from high-quality colonoscopies therefore should not undergo further testing.

AGA White Paper: Roadmap for the Future of Colorectal Cancer Screening in the United States.

The American Gastroenterological Association's Center for Gastrointestinal Innovation and Technology convened a consensus conference in December 2018, entitled, "Colorectal Cancer Screening and Surveillance: Role of Emerging Technology and Innovation to Improve Outcomes." The goal of the conference, which attracted more than 60 experts in screening and related disciplines, including the authors, was to envision a future in which colorectal cancer (CRC) screening and surveillance are optimized, and to identify barriers to achieving that future. This White Paper originates from that meeting and delineates the priorities and steps needed to improve CRC outcomes, with the goal of minimizing CRC morbidity and mortality. A one-size-fits-all approach to CRC screening has not and is unlikely to result in increased screening uptake or desired outcomes owing to barriers stemming from behavioral, cultural, and socioeconomic causes, especially when combined with inefficiencies in deployment of screening technologies. Overcoming these barriers will require the following: efficient utilization of multiple screening modalities to achieve increased uptake; continued development of noninvasive screening tests, with iterative reassessments of how best to integrate new technologies; and improved personal risk assessment to better risk-stratify patients for appropriate screening testing paradigms.

A risk prediction tool for colorectal cancer screening: a qualitative study of patient and provider facilitators and barriers.

BACKGROUND: Despite proven effectiveness of colorectal cancer (CRC) screening, at least 35% of screen-eligible adults are not current with screening. Decision aids and risk prediction tools may help increase uptake, adherence, and efficiency of CRC screening by presenting lower-risk patients with options less invasive than colonoscopy. The purpose of this qualitative study was to determine patient and provider perceptions of facilitators and barriers to use of a risk prediction tool for advanced colorectal neoplasia (CRC and advanced, precancerous polyps), to maximize its chances of successful clinical implementation. METHODS: We conducted qualitative, semi-structured interviews with patients aged 50-75 years who were not current with CRC screening, and primary care providers (PCPs) at an academic and a U.S. Department of Veterans Affairs Medical Center in the Midwest from October 2016 through March 2017. Participants were asked about their current experiences discussing CRC screening, then were shown the risk tool and asked about its acceptability, barriers, facilitators, and whether they would use it to guide their choice of a screening test. The constant comparative method guided analysis. RESULTS: Thirty patients and PCPs participated. Among facilitators were the tool's potential to increase screening uptake, reduce patient risk, improve resource allocation, and facilitate discussion about CRC screening. PCP-identified barriers included concerns about the tool's accuracy, consistency with guidelines, and time constraints. CONCLUSIONS: Patients and PCPs found the risk prediction tool useful, with potential to increase uptake, safety, and efficiency of CRC screening, indicating potential acceptability and feasibility of implementation into clinical practice.