Thomas F. Imperiale, MD; Patrick O. Monahan, PhD; Timothy E. Stump, MA; Elizabeth A. Glowinski, RN; David F. Ransohoff, MD
Acknowledgment: The authors thank Curlie Morrow, BSBA, for project management and Janetta Matesan for data management.
Grant Support: By the National Cancer Institute (R01-CA104459); the Walther Cancer Institute, Indianapolis, Indiana; the Indiana University Melvin and Bren Simon Cancer Center; and a project development team within the Indiana Clinical and Translational Sciences Institute (grant UL1TR001108 from the National Center for Research Resources, National Institutes of Health), Indianapolis, Indiana.
Disclosures: Dr. Imperiale reports grants from the National Cancer Institute, the Walther Cancer Foundation, the Indiana Clinical and Translational Sciences Institute, and the Indiana University Melvin and Bren Simon Cancer Center during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?ms Num=M14-1720.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Reproducible Research Statement:Study protocol and data set: Not available. Statistical code: Available from Dr. Imperiale (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Thomas F. Imperiale, MD, Indiana University Medical Center, Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202; e-mail, email@example.com.
Current Author Addresses: Dr. Imperiale: Indiana University Medical Center, Regenstrief Institute, 1050 Wishard Boulevard, Indianapolis, IN 46202.
Dr. Monahan: Indiana University School of Medicine, 410 West 10th Street, Suite 3000, Indianapolis, IN 46202.
Mr. Stump: Department of Biostatistics, Indiana University School of Medicine, 410 West 10th Street, Suite 3000, Indianapolis, IN 46202.
Ms. Glowinski: Indianapolis Gastroenterology Research Foundation, 8051 South Emerson Avenue, Suite 200, Indianapolis, IN 46237.
Dr. Ransohoff: University of North Carolina at Chapel Hill, CB 7080, Chapel Hill, NC 27599-7080.
Author Contributions: Conception and design: T.F. Imperiale, D.F. Ransohoff.
Analysis and interpretation of the data: T.F. Imperiale, P.O. Monahan, T.E. Stump, D.F. Ransohoff.
Drafting of the article: T.F. Imperiale, P.O. Monahan, T.E. Stump.
Critical revision of the article for important intellectual content: T.F. Imperiale, P.O. Monahan, T.E. Stump, D.F. Ransohoff.
Final approval of the article: T.F. Imperiale, P.O. Monahan, T.E. Stump, E.A. Glowinski, D.F. Ransohoff.
Provision of study materials or patients: T.F. Imperiale.
Statistical expertise: P.O. Monahan, T.E. Stump.
Obtaining of funding: T.F. Imperiale.
Administrative, technical, or logistic support: E.A. Glowinski.
Collection and assembly of data: T.F. Imperiale, E.A. Glowinski.
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.
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.
Multiple endoscopy units, primarily in the Midwest.
Persons aged 50 to 80 years undergoing initial screening colonoscopy (December 2004 to September 2011).
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.
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.
Split-sample validation; results apply to first-time screening.
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.
National Cancer Institute, Walther Cancer Institute, Indiana University Simon Cancer Center, and Indiana Clinical and Translational Sciences Institute.
Thomas F. Imperiale, Patrick O. Monahan, Timothy E. Stump, Elizabeth A. Glowinski, David F. Ransohoff. Derivation and Validation of a Scoring System to Stratify Risk for Advanced Colorectal Neoplasia in Asymptomatic Adults: A Cross-sectional Study. Ann Intern Med. 2015;163:339–346. doi: 10.7326/M14-1720
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Published: Ann Intern Med. 2015;163(5):339-346.
Colonoscopy/Sigmoidoscopy, Colorectal Cancer, Gastroenterology/Hepatology, Gastrointestinal Cancer, Hematology/Oncology.
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