Dataset Information

Derivation and Validation of a Scoring System to Stratify Risk for Advanced Colorectal Neoplasia in Asymptomatic Adults: A Cross-sectional Study.

ABSTRACT: BACKGROUND:Several methods are recommended equally strongly for colorectal cancer screening in average-risk persons. Risk stratification would enable tailoring of screening within this group, with less invasive tests (sigmoidoscopy or occult blood tests) for lower-risk persons and colonoscopy for higher-risk persons. OBJECTIVE:To create a risk index for advanced neoplasia (colorectal cancer and adenomas or serrated polyps ?1.0 cm, villous histology, or high-grade dysplasia) anywhere in the colorectum, using the most common risk factors for colorectal neoplasia. DESIGN:Cross-sectional study. SETTING:Multiple endoscopy units, primarily in the Midwest. PATIENTS:Persons aged 50 to 80 years undergoing initial screening colonoscopy (December 2004 to September 2011). MEASUREMENTS:Derivation and validation of a risk index based on points from regression coefficients for age, sex, waist circumference, cigarette smoking, and family history of colorectal cancer. RESULTS:Among 2993 persons in the derivation set, prevalence of advanced neoplasia was 9.4%. Risks for advanced neoplasia in persons at very low, low, intermediate, and high risk were 1.92% (95% CI, 0.63% to 4.43%), 4.88% (CI, 3.79% to 6.18%), 9.93% (CI, 8.09% to 12.0%), and 24.9% (CI, 21.1% to 29.1%), respectively (P < 0.001). Sigmoidoscopy to the descending colon in the low-risk groups would have detected 51 of 70 (73% [CI, 61% to 83%]) advanced neoplasms. Among 1467 persons in the validation set, corresponding risks for advanced neoplasia were 1.65% (CI, 0.20% to 5.84%), 3.31% (CI, 2.08% to 4.97%), 10.9% (CI, 8.26% to 14.1%), and 22.3% (CI, 16.9% to 28.5%), respectively (P < 0.001). Sigmoidoscopy would have detected 21 of 24 (87.5% [CI, 68% to 97%]) advanced neoplasms. LIMITATIONS:Split-sample validation; results apply to first-time screening. CONCLUSION:This index stratifies risk for advanced neoplasia among average-risk persons by identifying lower-risk groups for which noncolonoscopy strategies may be effective and efficient and a higher-risk group for which colonoscopy may be preferred. PRIMARY FUNDING SOURCE:National Cancer Institute, Walther Cancer Institute, Indiana University Simon Cancer Center, and Indiana Clinical and Translational Sciences Institute.

SUBMITTER: Imperiale TF

PROVIDER: S-EPMC4840411 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Derivation and Validation of a Scoring System to Stratify Risk for Advanced Colorectal Neoplasia in Asymptomatic Adults: A Cross-sectional Study.

Imperiale Thomas F TF Monahan Patrick O PO Stump Timothy E TE Glowinski Elizabeth A EA Ransohoff David F DF

Annals of internal medicine 20150901 5

<h4>Background</h4>Several methods are recommended equally strongly for colorectal cancer screening in average-risk persons. Risk stratification would enable tailoring of screening within this group, with less invasive tests (sigmoidoscopy or occult blood tests) for lower-risk persons and colonoscopy for higher-risk persons.<h4>Objective</h4>To create a risk index for advanced neoplasia (colorectal cancer and adenomas or serrated polyps ≥1.0 cm, villous histology, or high-grade dysplasia) anywhe ...[more]

PMID: 26259154

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Project description:BackgroundModels estimating risk for advanced proximal colorectal neoplasia (APN) may be used to select colorectal cancer (CRC) screening test, either prior to knowing distal colorectal findings or afterward. Current models have only fair discrimination and nearly all require knowing distal findings.ObjectiveDerive and test risk prediction models for APN with and without distal findings.SettingSelected endoscopy centers within central Indiana, USA.ParticipantsAverage-risk persons undergoing first-time screening colonoscopy.InterventionsDemographics, personal and family medical history, lifestyle factors and physical measures were linked to the most advanced finding in proximal and distal colorectal segments. For both models, logistic regression identified factors independently associated with APN on a derivation set. Based on equation coefficients, points were assigned to each factor, and risk for APN was examined for each score. Scores with comparable risks were collapsed into risk categories. Both models and their scoring systems were tested on the validation set.Main outcomeAPN, defined as any adenoma or sessile serrated lesion ≥1 cm, one with villous histology or high-grade dysplasia, or CRC proximal to the descending colon.ResultsAmong 3025 subjects in the derivation set (mean age 57.3 ± 6.5 years; 52% women), APN prevalence was 4.5%; 2859 (94.5%) had complete data on risk factors. Independently associated with APN were age, sex, cigarette smoking, cohabitation status, metabolic syndrome, non-steroidal anti-inflammatory drug use and physical activity. This model (without distal findings) was well-calibrated (P = 0.62) and had good discrimination (c-statistic = 0.73). In low-, intermediate- and high-risk groups that comprised 21, 58 and 21% of the sample, respectively, APN risks were 1.47% (95% CI, 0.67-2.77%), 3.09% (CI, 2.31-4.04%) and 11.6% (CI, 9.10-14.4%), respectively (P < 0.0001), with no proximal CRCs in the low-risk group and 2 in the intermediate-risk group. When tested in the validation set of 1455, the model retained good metrics (calibration P = 0.85; c-statistic = 0.83), with APN risks in low- (22%), intermediate- (56%) and high-risk (22%) subgroups of 0.62% (CI, 0.08-2.23%) 2.20% (CI, 1.31-3.46%) and 13.0% (CI, 9.50-17.2%), respectively (P < 0.0001). There were no proximal CRCs in the low-risk group, and two in the intermediate-risk group. The model with distal findings performed comparably, with validation set metrics of 0.18 for calibration, 0.76 for discrimination and APN risk (% sample) in low-, intermediate-, and high-risk groups of 1.1 (69%), 8.3 (22%) and 22.3% (9%).ConclusionThese models stratify large proportions of average-risk persons into clinically meaningful risk groups, and could improve screening efficiency, particularly for noncolonoscopy-based programs.

Project description:OBJECTIVE:To derive and validate a new clinical prediction rule to risk-stratify emergency department (ED) patients admitted with suspected sepsis. DESIGN:Retrospective prognostic study of prospectively collected data. SETTING:ED. PARTICIPANTS:Patients aged ?18 years who met two Systemic Inflammatory Response Syndrome criteria or one Red Flag sepsis criteria on arrival, received intravenous antibiotics for a suspected infection and admitted. PRIMARY OUTCOME MEASURE:In-hospital all-cause mortality. METHOD:The data were divided into derivation and validation cohorts. The simplified-Mortality in Severe Sepsis in the ED score and quick-SOFA scores, refractory hypotension and lactate were collectively termed 'component scores' and cumulatively termed the 'Risk-stratification of ED suspected Sepsis (REDS) score'. Each patient in the derivation cohort received a score (0-3) for each component score. The REDS score ranged from 0 to 12. The component scores were subject to univariate and multivariate logistic regression analyses. The receiver operator characteristic (ROC) curves for the REDS and the components scores were constructed and their cut-off points identified. Scores above the cut-off points were deemed high-risk. The area under the ROC (AUROC) curves and sensitivity for mortality of the high-risk category of the REDS score and component scores were compared. The REDS score was internally validated. RESULTS:2115 patients of whom 282 (13.3%) died in hospital. Derivation cohort: 1078 patients with 140 deaths (13%). The AUROC curve with 95% CI, cut-off point and sensitivity for mortality (95% CI) of the high-risk category of the REDS score were: derivation: 0.78 (0.75 to 0.80); ?3; 85.0 (78 to 90.5). VALIDATION:0.74 (0.71 to 0.76); ?3; 84.5 (77.5 to 90.0). The AUROC curve and the sensitivity for mortality of the REDS score was better than that of the component scores. Specificity and mortality rates for REDS scores of ?3, ?5 and ?7 were 54.8%, 88.8% and 96.9% and 21.8%, 36.0% and 49.1%, respectively. CONCLUSION:The REDS score is a simple and objective score to risk-stratify ED patients with suspected sepsis.

Project description:BackgroundFirst-degree relatives (FDR) of patients with colorectal cancer have a higher risk of developing colorectal cancer than the general population. For this reason, screening guidelines recommend colonoscopy every 5 or 10 y, starting at the age of 40, depending on whether colorectal cancer in the index-case is diagnosed at <60 or ?60 y, respectively. However, studies on the risk of neoplastic lesions are inconclusive. The aim of this study was to determine the risk of advanced neoplasia (three or more non-advanced adenomas, advanced adenoma, or invasive cancer) in FDR of patients with colorectal cancer compared to average-risk individuals (i.e., asymptomatic adults 50 to 69 y of age with no family history of colorectal cancer).Methods and findingsThis cross-sectional analysis includes data from 8,498 individuals undergoing their first lifetime screening colonoscopy between 2006 and 2012 at six Spanish tertiary hospitals. Of these individuals, 3,015 were defined as asymptomatic FDR of patients with colorectal cancer ("familial-risk group") and 3,038 as asymptomatic with average-risk for colorectal cancer ("average-risk group"). The familial-risk group was stratified as one FDR, with one family member diagnosed with colorectal cancer at ?60 y (n = 1,884) or at <60 y (n = 831), and as two FDR, with two family members diagnosed with colorectal cancer at any age (n = 300). Multiple logistic regression analysis was used for between-group comparisons after adjusting for potential confounders (age, gender, and center). Compared with the average-risk group, advanced neoplasia was significantly more prevalent in individuals having two FDR with colorectal cancer (odds ratio [OR] 1.90; 95% confidence interval [CI] 1.36-2.66, p < 0.001), but not in those having one FDR with colorectal cancer diagnosed at ?60 y (OR 1.03; 95% CI 0.83-1.27, p = 0.77) and <60 y (OR 1.19; 95% CI 0.90-1.58, p = 0.20). After the age of 50 y, men developed advanced neoplasia over two times more frequently than women and advanced neoplasia appeared at least ten y earlier. Fewer colonoscopies by 2-fold were required to detect one advanced neoplasia in men than in women. Major limitations of this study were first that although average-risk individuals were consecutively included in a randomized control trial, this was not the case for all individuals in the familial-risk cohort; and second, the difference in age between the average-risk and familial-risk cohorts.ConclusionsIndividuals having two FDR with colorectal cancer showed an increased risk of advanced neoplasia compared to those with average-risk for colorectal cancer. Men had over 2-fold higher risk of advanced neoplasia than women, independent of family history. These data suggest that screening colonoscopy guidelines should be revised in the familial-risk population.

Project description:ObjectivesTo assess detection rates for colorectal cancer (CRC) and advanced adenomas in asymptomatic CRC screening participants and bowel symptoms in association with CRC and advanced adenoma.DesignCross-sectional study.SettingTwo screening centres.Participants42 554 men and women, aged 50-74 years, participating in a randomised CRC screening trial. 36 059 participants underwent a sigmoidoscopy (and follow-up colonoscopy if positive sigmoidoscopy) and 6495 underwent a colonoscopy after a positive faecal immunochemical test (FIT).Primary and secondary outcome measuresProportion of asymptomatic participants diagnosed with CRC or advanced adenomas. Prevalence of bowel symptoms (rectal bleeding, change in bowel habits, diarrhoea, constipation, bloating, alternating bowel habits, general symptoms, other bowel symptoms) recorded by the endoscopist and their association with CRC and advanced adenomas.ResultsAmong sigmoidoscopy participants, 7336 (20.3%) reported at least one symptom. 120 (60%) out of 200 individuals with screen-detected CRC and 1301 (76.5%) out of 1700 with advanced adenoma were asymptomatic. Rectal bleeding was associated with detection of CRC and advanced adenoma (OR 4.3, 95% CI 3.1 to 6.1 and 1.8, 95% CI 1.5 to 2.1, respectively), while change in bowel habits only with CRC detection (OR 3.8, 95% CI 2.4 to 6.1). Among the FIT positives, 2173 (33.5%) reported at least one symptom. Out of 299 individuals with screen-detected CRC and 1639 with advanced adenoma, 167 (55.9%) and 1 175 (71.7%) were asymptomatic, respectively. Detection of CRC was associated with rectal bleeding (OR 1.8, 95% CI 1.4 to 2.3), change in bowel habits (OR 2.2, 95% CI 1.4 to 3.5) and abdominal pain (OR 1.8, 95% CI 1.2 to 2.7).ConclusionsSome bowel symptoms increased the likelihood of being diagnosed with CRC or advanced adenoma. However, the majority of individuals with these findings were asymptomatic. Asymptomatic individuals should be encouraged to participate in CRC screening.Trial registration numberClinicaltrials.gov Identifier: NCT01538550.

Dataset Information

Derivation and Validation of a Scoring System to Stratify Risk for Advanced Colorectal Neoplasia in Asymptomatic Adults: A Cross-sectional Study.

Publications

Derivation and Validation of a Scoring System to Stratify Risk for Advanced Colorectal Neoplasia in Asymptomatic Adults: A Cross-sectional Study.

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