Estimate of Increase in Colorectal Cancer Diagnoses with Expansion of Fecal Immunochemical Testing in an Urban Safety-Net Population.

BACKGROUND: Fecal immunochemical test (FIT) is less effective in detecting advanced adenomas (AA) than colonoscopy. Increase in FIT for colorectal cancer (CRC) screening may lead to an increased number of undetected AAs which may develop into future CRCs. AIM: We determined the potential impact of FIT expansion on missed AAs and future CRC diagnoses in an urban, tertiary-care, safety-net hospital. METHODS: CRC and AA diagnoses were identified in patients undergoing colonoscopy for average-risk CRC screening or positive FIT between 2017 and 2019 at Boston Medical Center. Poisson regression modeling was used to estimate the frequency of AAs per year by age group using data from 2017 to 2019, assuming average outpatient volume and proportion of screening colonoscopies. Total number of patients who received FIT was extrapolated from those who underwent colonoscopy for positive FIT. We estimated AAs per year if 'one-time' FIT was used for screening in 75% and 100% of the population and subtracted this from the estimated AAs per year under the Poisson model to determine missed AAs. We used previously described, age and gender specific estimates of the annual progression of AA to CRC. RESULTS: The estimated number of CRCs detected per year is 4.6/1785 males and 4.6/2086 females screened. With 75% FIT expansion, we estimate an additional 3.5 (95% CI 1.3, 9.5) and 2.2 (95% CI 0.64, 7.6) CRCs; with 100% FIT expansion, we estimate an additional 7.4 (95% CI 3.7, 14.9) and 4.2 (95% CI 1.7, 10.5) CRCs, in 5 years, in males and females, respectively. CONCLUSION: Expansion of FIT may substantially increase CRC incidence.

Inadequate Boston Bowel Preparation Scale scores predict the risk of missed neoplasia on the next colonoscopy.

BACKGROUND AND AIMS: The risks of missed findings after inadequate bowel preparation are not fully characterized in a diverse cohort. We aimed to evaluate the likelihood of missed polyps after an inadequate preparation as assessed by using the Boston Bowel Preparation Scale (BBPS). METHODS: In this observational study of prospectively collected data within a large, national, endoscopic consortium, we identified patients aged 50 to 75 years who underwent average-risk screening colonoscopy (C1) followed by a second colonoscopy for any indication within 3 years (C2). We determined the polyp detection rates (PDRs) and advanced PDRs during C2 stratified by C1 BBPS scores. RESULTS: Among segment pairs without polyps at C1 (N = 601), those with inadequate C1 BBPS segment scores had a higher PDR at C2 (10%) compared with those with adequate bowel preparation at C1 (5%; P = .04). Among segment pairs with polyps at C1 (N = 154), segments with inadequate bowel preparation scores at C1 had higher advanced PDRs at C2 (20%) compared with those with adequate bowel preparation scores at C1 (4%; P = .03). In multivariable analysis, the presence of advanced polyps at C1 (adjusted odds ratio [OR] 3.5; 95% confidence intervals [CIs], 1.1-10.8) but not inadequate BBPS scores at C1 (adjusted OR 1.8; 95% CI, 0.6-5.1) was associated with a significantly increased risk of advanced polyps at C2. CONCLUSIONS: Inadequate BBPS segment scores generally are associated with higher rates of polyps and advanced polyps at subsequent colonoscopy within a short timeframe. The presence of advanced polyps as well as inadequate BBPS segment scores can inform the risk of missed polyps and help triage which patients warrant a timely repeat colonoscopy.

Understanding the contribution of family history to colorectal cancer risk and its clinical implications: A state-of-the-science review.

Persons with a family history (FH) of colorectal cancer (CRC) or adenomas that are not due to known hereditary syndromes have an increased risk for CRC. An understanding of these risks, screening recommendations, and screening behaviors can inform strategies for reducing the CRC burden in these families. A comprehensive review of the literature published within the past 10 years has been performed to assess what is known about cancer risk, screening guidelines, adherence and barriers to screening, and effective interventions in persons with an FH of CRC and to identify FH tools used to identify these individuals and inform care. Existing data show that having 1 affected first-degree relative (FDR) increases the CRC risk 2-fold, and the risk increases with multiple affected FDRs and a younger age at diagnosis. There is variability in screening recommendations across consensus guidelines. Screening adherence is <50% and is lower in persons under the age of 50 years. A provider's recommendation, multiple affected relatives, and family encouragement facilitate screening; insufficient collection of FH, low knowledge of guidelines, and poor family communication are important barriers. Effective interventions incorporate strategies for overcoming barriers, but these have not been broadly tested in clinical settings. Four strategies for reducing CRC in persons with familial risk are suggested: 1) improving the collection and utilization of the FH of cancer, 2) establishing a consensus for screening guidelines by FH, 3) enhancing provider-patient knowledge of guidelines and communication about CRC risk, and 4) encouraging survivors to promote screening within their families and partnering with existing screening programs to expand their reach to high-risk groups. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2633-2645. © 2016 American Cancer Society.

A Risk Prediction Index for Advanced Colorectal Neoplasia at Screening Colonoscopy.

OBJECTIVES: Eliciting patient preferences within the context of shared decision making has been advocated for colorectal cancer screening. Risk stratification for advanced colorectal neoplasia (ACN) might facilitate more effective shared decision making when selecting an appropriate screening option. Our objective was to develop and validate a clinical index for estimating the probability of ACN at screening colonoscopy. METHODS: We conducted a cross-sectional analysis of 3,543 asymptomatic, mostly average-risk patients 50-79 years of age undergoing screening colonoscopy at two urban safety net hospitals. Predictors of ACN were identified using multiple logistic regression. Model performance was internally validated using bootstrapping methods. RESULTS: The final index consisted of five independent predictors of risk (age, smoking, alcohol intake, height, and a combined sex/race/ethnicity variable). Smoking was the strongest predictor (net reclassification improvement (NRI), 8.4%) and height the weakest (NRI, 1.5%). Using a simplified weighted scoring system based on 0.5 increments of the adjusted odds ratio, the risk of ACN ranged from 3.2% (95% confidence interval (CI), 2.6-3.9) for the low-risk group (score ≤2) to 8.6% (95% CI, 7.4-9.7) for the intermediate/high-risk group (score 3-11). The model had moderate to good overall discrimination (C-statistic, 0.69; 95% CI, 0.66-0.72) and good calibration (P=0.73-0.93). CONCLUSIONS: A simple 5-item risk index based on readily available clinical data accurately stratifies average-risk patients into low- and intermediate/high-risk categories for ACN at screening colonoscopy. Uptake into clinical practice could facilitate more effective shared decision-making for CRC screening, particularly in situations where patient and provider test preferences differ.

Good is better than excellent: bowel preparation quality and adenoma detection rates.

BACKGROUND: Inadequate bowel cleansing is associated with missed lesions, yet whether polyp and adenoma detection rates (PDR, ADR) increase at the highest levels of bowel cleanliness is unknown. OBJECTIVE: To evaluate the association between bowel preparation quality by using the Boston Bowel Preparation Scale (BBPS) and PDR and ADR among colonoscopies with adequate preparation. DESIGN: Cross-sectional analysis. SETTING: Boston Medical Center (BMC) and the Clinical Outcomes Research Initiative (CORI). PATIENTS: Average-risk ambulatory patients attending screening colonoscopy with adequate bowel preparation defined as BBPS score ≥6. INTERVENTIONS: Colonoscopy. MAIN OUTCOME MEASUREMENTS: PDR and ADR stratified by BBPS score. RESULTS: Among the 3713 colonoscopies at BMC performed by 19 endoscopists, the PDR, ADR, and advanced ADR were 49.8%, 37.7%, and 6.0%, respectively. Among the 5532 colonoscopies in CORI performed by 85 endoscopists at 41 different sites, the PDR was 44.5%, and the PDR for polyps >9 mm (surrogate for advanced ADR) was 6.2%. The PDR associated with total BBPS scores of 6, 7, and 8 were higher than those associated with a BBPS score of 9 at BMC (BBPS 6, 51%; BBPS 7, 53%; BBPS 8, 52% vs BBPS 9, 46%; P = .002) and CORI (BBPS 6, 51%; BBPS 7, 48%; BBPS 8, 45% vs BBPS 9, 40%; P < .0001). This trend persisted after we adjusted for age, sex, and race and/or ethnicity and was observed for ADR and advanced ADR. PDR was higher among good compared with excellent preparations at BMC (odds ratio [OR] 1.3; 95% confidence interval [CI], 1.0-1.5) and CORI (OR 4.7; 95% CI, 3.1-7.1). LIMITATIONS: Retrospective study. CONCLUSION: The PDR and ADR decreased at the highest levels of bowel cleanliness. Endoscopists finding a pristine bowel preparation should avoid a sense of overconfidence for polyp detection during the inspection phase of screening colonoscopy and still perform a careful evaluation for polyps. Furthermore, endoscopists expending additional effort to maximize cleansing of the bowel should never sacrifice on their inspection technique or inspection time.

Risk assessment and clinical decision making for colorectal cancer screening.

BACKGROUND: Shared decision making (SDM) related to test preference has been advocated as a potentially effective strategy for increasing adherence to colorectal cancer (CRC) screening, yet primary care providers (PCPs) are often reluctant to comply with patient preferences if they differ from their own. Risk stratification advanced colorectal neoplasia (ACN) provides a rational strategy for reconciling these differences. OBJECTIVE: To assess the importance of risk stratification in PCP decision making related to test preference for average-risk patients and receptivity to use of an electronic risk assessment tool for ACN to facilitate SDM. DESIGN: Mixed methods, including qualitative key informant interviews and a cross-sectional survey. PARTICIPANTS: PCPs at an urban, academic safety-net institution. MAIN MEASURES: Screening preferences, factors influencing patient recommendations and receptivity to use of a risk stratification tool. KEY RESULTS: Nine PCPs participated in interviews and 57 completed the survey. Despite an overwhelming preference for colonoscopy by 95% of respondents, patient risk (67%) and patient preferences (63%) were more influential in their decision making than patient comorbidities (31%; P < 0.001). Age was the single most influential risk factor (excluding family history), with <20% of respondents choosing factors other than age. Most respondents reported that they would be likely to use a risk stratification tool in their practice either 'often' (43%) or sometimes (53%). CONCLUSIONS: Risk stratification was perceived to be important in clinical decision making, yet few providers considered risk factors other than age for average-risk patients. Providers were receptive to the use of a risk assessment tool for ACN when recommending an appropriate screening test for select patients.

Epidemiology of goblet cell and microvesicular hyperplastic polyps.

OBJECTIVES: Serrated polyps compromise both typical hyperplastic polyps as well as sessile serrated adenomas and dysplastic serrated polyps. Hyperplastic polyps exhibit two histological patterns: microvesicular hyperplastic polyps (MVHPs) and goblet cell hyperplastic polyps (GCHPs). MVHPs and GCHPs differ in their molecular signature. MVHPs have been frequently found to have the BRAF(V600E) mutation as well as aberrant methylation. In contrast, GCHPs have been associated with the KRAS mutation (KRAS-mut), which are infrequently seen in dysplastic serrated sessile adenomas. The particular risk factors that are associated with development of the types of hyperplastic polyps have not been previously studied. The purpose of this study is to characterize the associations between particular risk factors and the development of goblet cell or microvesicular hyperplastic polyps. METHODS: We conducted a cross-sectional analysis of 3,543 asymptomatic, mostly average risk patients 50 and 79 years of age undergoing open-access screening colonoscopy between March 2005 and January 2012. Each patient was given a survey regarding 25 reputed risk factors for colorectal neoplasia and the responses were correlated with findings at colonoscopy. Associations between putative risk factors for colorectal neoplasia and MVHPs and GSHPs were examined using multiple logistic regression. RESULTS: MVHPS and GCHPs were identified in 5.3% and 8.7% of patients, respectively. The results of the statistical analysis indicate that a history of smoking greater than 20 years is associated with an increased risk of MVHPs (P<0.005) and GCHPs (P<0.005). An elevated BMI >30 kg/m(2) was also associated with the presence of MVHP at colonoscopy (P<0.005). Blacks and Asians appear to be protected from the development of MVHPs. In contrast, there was a positive association with the presence of GCHP at colonoscopy in blacks. CONCLUSIONS: The study suggests that the development of the distinct histological types of hyperplastic polyps are associated with distinct modifiable and non-modifiable lifestyle factors.

Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness.

BACKGROUND: Establishing a threshold of bowel cleanliness below which colonoscopies should be repeated at accelerated intervals is important, yet there are no standardized definitions for an adequate preparation. OBJECTIVE: To determine whether Boston Bowel Preparation Scale (BBPS) scores could serve as a standard definition of adequacy. DESIGN: Cross-sectional observational analysis of colonoscopy data from 36 adult GI endoscopy practices and prospective survey showing 4 standardized colonoscopy videos with varying degrees of bowel cleanliness. SETTING: The Clinical Outcomes Research Initiative. PATIENTS: Average-risk patients attending screening colonoscopy. INTERVENTIONS: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Recommended follow-up intervals among average-risk, screening colonoscopies without polyps stratified by BBPS scores. RESULTS: We evaluated 2516 negative screening colonoscopies performed by 74 endoscopists. If the BBPS score was ≥2 in all 3 segments (N = 2295), follow-up was recommended in 10 years in 90% of cases. Examinations with total BBPS scores of 3 to 5 (N = 167) had variable recommendations. Follow-up within 1 year was recommended for 96% of examinations with total BBPS scores of 0 to 2 (N = 26). Similar results were noted among 167 participants in a video survey with pre-established BBPS scores. LIMITATIONS: Retrospective study. CONCLUSION: BBPS scores correlate with endoscopist behavior regarding follow-up intervals for colonoscopy. A total BBPS score ≥6 and/or all segment scores ≥2 provides a standardized definition of adequate for 10-year follow-up, whereas total scores ≤2 indicate that a procedure should be repeated within 1 year. Future work should focus on finding consensus for management of examinations with total scores of 3 to 5.

Validity of a Web-based educational program to disseminate a standardized bowel preparation rating scale.

GOALS: Our goal was to assess the validity of a Web-based educational program on the Boston Bowel Preparation Scale (BBPS). BACKGROUND: Data on Web-based education for improving the practice and quality of colonoscopy are limited. STUDY: Endoscopists worldwide participated in the BBPS Educational Program. We assessed program completion rates, satisfaction, short-term (0 to 90 d) and long-term (91 to 180 d) uptake of the BBPS, and the validity of the program by measuring the reliability of the BBPS among participants. RESULTS: A total of 207 endoscopists completed the program. Overall, 93% found the content relevant, 89% felt confident in using the BBPS, and 97% thought the quality was good or excellent. Uptake of the BBPS into clinical practice was robust with 91% and 98% of colonoscopy reports containing the BBPS at short-term and long-term follow-up, respectively. The interobserver and test-retest reliability of BBPS segment and total scores were both substantial. CONCLUSIONS: A BBPS Web-based educational program facilitates adoption into clinical practice and teaches the BBPS to be used reliably by a diverse group of endoscopists worldwide.

Whites and blacks have similar risk of metachronous advanced colorectal neoplasia.

BACKGROUND: Current guidelines for surveillance of colonic neoplasia are based on data from predominantly white populations, yet whether these recommendations are applicable to blacks is unknown. AIM: To define the prevalence of advanced colorectal neoplasia (ACN) among whites and blacks undergoing surveillance colonoscopy. METHODS: This was a retrospective, cross-sectional analysis of asymptomatic, average-risk non-Hispanic white (N = 246) and non-Hispanic black (N = 203) patients with colorectal neoplasia who underwent baseline screening colonoscopy between January 1, 2000, and December 31, 2007, and a surveillance colonoscopy before December 31, 2010, at an academic safety-net hospital. The main outcome measure was the prevalence of ACN, defined as a tubular adenoma or sessile serrated adenoma (SSA) ≥ 10 mm, any adenoma with villous histology or high-grade dysplasia, any serrated lesion with dysplasia, or invasive cancer at surveillance. RESULTS: During a median follow-up of 4.3 years, the overall prevalence of ACN at surveillance was similar among blacks and whites (11.3 vs. 9.8 %; P = 0.59) with an odds ratio of 1.18 (95 % CI 0.65-2.16) [corrected]. Blacks and whites with non-advanced neoplasia had similar rates of ACN at the 1-3, 4-5, and >5 year follow-up intervals. Blacks with ACN or multiplicity at baseline had higher rates of ACN at the 1- to 3-year interval compared with whites, but the difference was non-significant (26.7 vs. 12.5 %; P = 0.32). No interval cancers were observed for either group. CONCLUSIONS: The overall prevalence of ACN was similar between non-Hispanic blacks and non-Hispanic whites undergoing surveillance in a safety-net healthcare setting suggesting that current surveillance guidelines are appropriate for both blacks and whites.

Provider perspectives on the utility of a colorectal cancer screening decision aid for facilitating shared decision making.

BACKGROUND: Decision aids for colorectal cancer (CRC) screening have been shown to enable patients to identify a preferred screening option, but the extent to which such tools facilitate shared decision making (SDM) from the perspective of the provider is less well established. OBJECTIVE: Our goal was to elicit provider feedback regarding the impact of a CRC screening decision aid on SDM in the primary care setting. METHODS: Cross-sectional survey. PARTICIPANTS: Primary care providers participating in a clinical trial evaluating the impact of a novel CRC screening decision aid on SDM and adherence. MAIN OUTCOMES: Perceptions of the impact of the tool on decision-making and implementation issues. RESULTS: Twenty-nine of 42 (71%) eligible providers responded, including 27 internists and two nurse practitioners. The majority (>60%) felt that use of the tool complimented their usual approach, increased patient knowledge, helped patients identify a preferred screening option, improved the quality of decision making, saved time and increased patients' desire to get screened. Respondents were more neutral is their assessment of whether the tool improved the overall quality of the patient visit or patient satisfaction. Fewer than 50% felt that the tool would be easy to implement into their practices or that it would be widely used by their colleagues. CONCLUSION: Decision aids for CRC screening can improve the quality and efficiency of SDM from the provider perspective but future use is likely to depend on the extent to which barriers to implementation can be addressed.

Prevalence of advanced colorectal neoplasia in white and black patients undergoing screening colonoscopy in a safety-net hospital.

UNLABELLED: Chinese translation BACKGROUND: Black persons are more likely than white persons to be diagnosed with colorectal cancer and to die from it. The extent to which genetic or biological factors versus disparities in screening rates explain this variance remains controversial. OBJECTIVE: To define the prevalence and location of presymptomatic advanced colorectal neoplasia (ACN) among white and black persons undergoing screening colonoscopy, controlling for other epidemiologic risk factors. DESIGN: Cross-sectional survey between 22 March 2005 and 31 January 2012. SETTING: Urban, open-access, academic, safety-net hospital in Massachusetts. PARTICIPANTS: Asymptomatic, average-risk white (n = 1172) and black (n = 1681) persons aged 50 to 79 years undergoing screening colonoscopy. MEASUREMENTS: Adjusted prevalence and location of ACN, defined as a tubular adenoma 10 mm or more in size, any adenoma with villous features or high-grade dysplasia, any dysplastic serrated lesion, or invasive cancer. RESULTS: The prevalence of ACN was higher among white patients than black patients (6.8% vs. 5.0%; P = 0.039) but varied by sex (white vs. black men, 9.3% vs. 5.7%; white vs. black women, 3.5% vs. 4.3%; interaction P = 0.034). After controlling for many risk factors, black men were 41% less likely than white men (adjusted odds ratio [AOR], 0.59 [95% CI, 0.39 to 0.89]) to have ACN. No statistically significant difference was seen for women (AOR, 1.32 [CI, 0.73 to 2.40]). Black patients with ACN had a higher percentage of proximal disease (52% vs. 39%) after adjustment for age and sex (P = 0.055). LIMITATION: Single-institution study with inadequate statistical power for subgroup analyses and recall bias. CONCLUSION: Black men are less likely than white men to have ACN at screening colonoscopy in a safety-net health care setting. Disparities in access to screening and differential exposure to modifiable risk factors rather than genetic or biological factors may be largely responsible for the higher incidence of CRC among black men. Genetic or biological factors may explain the predilection for proximal disease.

Performance of a risk index for advanced proximal colorectal neoplasia among a racially/ethnically diverse patient population (risk index for advanced proximal neoplasia).

OBJECTIVES: Tailoring the use of screening colonoscopy based on the risk of advanced proximal neoplasia (APN) has been advocated as a strategy for reducing demand and optimizing effectiveness. A 7-point index based on age, sex, and distal findings at sigmoidoscopy has been proposed that stratifies individuals into low, intermediate, and high-risk categories. The aim of this cross-sectional analysis was to determine the validity of this index, which was originally derived and validated among mostly whites, for black and Hispanic patients. METHODS: Data, including age, sex, colonoscopic findings, and pathology, were collected retrospectively from 1,481 white, 1,329 black, and 689 Hispanic asymptomatic, average-risk patients undergoing screening colonoscopy between 2000 and 2005. Cumulative scores ranging from 0 to 7 were derived for each subject and categorized as low, intermediate, or high risk. Rates of APN were assessed for each risk category after stratification by race/ethnicity. Index performance was assessed using the C-statistic and compared across the three racial groups. RESULTS: Rates of APN among patients categorized as low, intermediate, or high risk increased from 1.0 to 2.8 to 3.7% for whites, 1.0 to 2.2 to 4.2% for blacks, and 0.6 to 1.9 to 3.7% for Hispanics. The index performed similarly for all three groups, but showed limited ability to discriminate low from intermediate-risk patients, with C-statistic values of 0.62 for whites, 0.63 for blacks, and 0.68 for Hispanics. CONCLUSIONS: A risk index based on age, sex, and distal endoscopic findings has limited ability to discriminate low from intermediate-risk white, black, and Hispanic patients for APN.

The quality of colonoscopy services--responsibilities of referring clinicians: a consensus statement of the Quality Assurance Task Group, National Colorectal Cancer Roundtable.

Primary care clinicians initiate and oversee colorectal screening for their patients, but colonoscopy, a central component of screening programs, is usually performed by consultants. The accuracy and safety of colonoscopy varies among endoscopists, even those with mainstream training and certification. Therefore, it is a primary care responsibility to choose the best available colonoscopy services. A working group of the National Colorectal Cancer Roundtable identified a set of indicators that primary care clinicians can use to assess the quality of colonoscopy services. Quality measures are of actual performance, not training, specialty, or experience alone. The main elements of quality are a complete report, technical competence, and a safe setting for the procedure. We provide explicit criteria that primary care physicians can use when choosing a colonoscopist. Information on quality indicators will be increasingly available with quality improvement efforts within the colonoscopy community and growth in the use of electronic medical records.

A cost-effectiveness analysis of subject recruitment strategies in the HIPAA era: results from a colorectal cancer screening adherence trial.

BACKGROUND: Changes in regulatory standards that restrict use of identifiable health information can reduce patient recruitment to clinical trials and increase recruitment costs. PURPOSE: To compare subject accrual rates and costs of three recruitment strategies that comply with new regulatory standards within the context of a clinical trial evaluating the impact of shared decision-making on colorectal cancer screening adherence. METHODS: Sequential cohorts of English-speaking, average-risk patients due for colorectal cancer screening were allocated to one of three recruitment strategies: (1) a provider-initiated electronic 'opt-in' referral (Click) method; (2) a provider-mediated 'opt-in' referral letter (Letter) method; and (3) an investigator-initiated direct contact 'opt-out' (Call) method. RESULTS: During distinct 6-month recruitment periods between March 2005 and April 2006, 100 potential subjects were identified using the Click method, 847 by the Letter method, and 758 by the Call method. After excluding ineligible prescreened patients, accrual rates were higher for the Call method (188 of 531 [35.4%]) than either the Click (12 of 72 [16.7%]; p = 0.002) or Letter (17 of 816 [2.1%]; p < 0.001) methods. The average cost per patient enrolled for the Call ($156) method was competitive with the Click ($129) and substantially lower than the Letter ($1967) methods; the Call method was least expensive if combined with automated patient identification ($99). Data extrapolation suggest it would take 2.4 years at an overall cost of $138,518 to recruit a target sample of 900 patients by the Call method, 40.5 years at $62,419 for the Click method and 27.9 years at $1,737,757 for the Letter method. LIMITATIONS: The study was nonrandomized and findings may not be generalizable to other research settings. CONCLUSION: The investigator-initiated direct contact 'opt-out' strategy is significantly more cost-effective and feasible than provider-initiated and provider-mediated 'opt-in' strategies for patient recruitment to clinical trials.

A simplified, noninvasive stool DNA test for colorectal cancer detection.

BACKGROUND: As a noninvasive colorectal cancer (CRC) screening test, a multi-marker first generation stool DNA (sDNA V 1.0) test is superior to guaiac-based fecal occult blood tests. An improved sDNA assay (version 2), utilizing only two markers, hypermethylated vimentin gene (hV) and a two site DNA integrity assay (DY), demonstrated in a training set (phase 1a) an even higher sensitivity (88%) for CRC with a specificity of 82%. AIM: To validate in an independent set of patients (phase 1b) the sensitivity and specificity of sDNA version 2 for CRC. METHODS: Forty-two patients with CRC and 241 subjects with normal colonoscopy (NC) provided stool samples, to which they immediately added DNA stabilizing buffer, and mailed their specimen to the laboratory. DNA was purified using gel-based capture, and analyzed for hV and DY using methods identical to those previously published. RESULTS: Using the same cutpoints as the 1a training set (N = 162; 40 CRCs, 122 normals), hV demonstrated a higher and DY a slightly lower sensitivity, for a combined sensitivity of hV + DY of 86%. Optimal cutpoints based on the combined phase 1a + 1b dataset (N = 445; 82 CRCs, 363 normals) yielded a CRC sensitivity of 83%. The vast majority of cancers were detected regardless of tumor stage, tumor location, or patient age. Assay specificity in the phase 1b dataset for hV, DY, and hV + DY was 82%, 85%, and 73%, respectively, using the phase 1a cutpoints. Optimal cutpoints based on the combined phase 1a + 1b dataset yield a specificity of 82%. CONCLUSIONS: This study provides validation of a simplified, improved sDNA test that incorporates only two markers and that demonstrates high sensitivity (83%) and specificity (82%) for CRC. Test performance is highly reproducible in a large set of patients. The use of only two markers will make the test easier to perform, reduce the cost, and facilitate distribution to local laboratories.

An effective educational strategy for improving knowledge, risk perception, and risk communication among colorectal adenoma patients.

BACKGROUND: We have previously shown that most adenoma patients are unaware of the personal and familial implications of their diagnosis. Our goal was to determine whether a brief, computer-based educational program (CBEP) administered alone after polypectomy, or in combination with a personalized letter (PL), was more effective than standard care (SC) for heightening awareness and improving risk communication. METHODS: Using a quasi-randomized design, adenoma-bearing subjects were assigned to the CBEP +PL (n=99), CBEP (n=96), or SC (n=120) arms. The CBEP was administered before discharge from the endoscopy unit. All subjects completed a phone survey 3 months postpolypectomy assessing knowledge, risk perception, and notification of first-degree relatives. RESULTS: Composite knowledge scores were higher (P<0.05) for the CBEP+PL group than CBEP and SC groups. Subjects in the CBEP+PL group were more likely (P<0.05) than those in the SC group to know that adenomas but not hyperplastic polyps were precancerous, that patients with adenomas were at increased risk of future adenomas, and that the siblings and children of adenoma patients may be at increased colorectal cancer risk. Subjects in the CBEP+PL group were also more likely (P<0.05) to know their polyp's histology, perceive themselves and their siblings/children to be at increased risk of colorectal neoplasia, and notify a first-degree relative. These associations remained significant after adjusting for age, sex, race/ethnicity, education, and endoscopist. No differences were observed between the CBEP and SC groups. CONCLUSIONS: The CBEP+PL intervention is an effective strategy for improving knowledge, risk perception, and risk communication among adenoma patients.