This statement summarizes the current U.S. Preventive Services Task Force (USPSTF) recommendation on screening for colorectal cancer and the supporting scientific evidence, and it updates the 1996 recommendations contained in the Guide to Clinical Preventive Services, Second Edition.1 At that time, the USPSTF recommended screening for colorectal cancer with annual fecal occult blood testing (FOBT), periodic sigmoidoscopy, or the combination of FOBT and sigmoidoscopy but concluded that the evidence was insufficient to recommend for or against colonoscopy or barium enema. Explanations of the current ratings and of the strength of overall evidence are given in Tables 1 and 2, respectively. The complete recommendations and rationale statement on this topic, which includes a brief review of the supporting evidence, is available through the USPSTF Web site (www.uspreventiveservicestaskforce.org), through the National Guideline Clearinghouse (www.guideline.gov), and in print through the AHRQ Publications Clearinghouse (telephone: 800-358-9295; e-mail: firstname.lastname@example.org). The information on which this statement is based, including evidence tables and references, is available in the summary of the evidence2 and the systematic evidence review3 on this topic, which can be obtained through the USPSTF Web site. This abridgment of the USPSTF recommendations and rationale statement originally appeared in Annals of Internal Medicine 137;2:129–31.4
|The USPSTF grades its recommendations according to one of five classifications (A, B, C, D, or I) reflecting the strength of evidence and magnitude of net benefit (benefits minus harms).|
|A.||The USPSTF strongly recommends that clinicians provide [the service] to eligible patients. The USPSTF found good evidence that [the service] improves important health outcomes and concludes that benefits substantially outweigh harms.|
|B.||The USPSTF recommends that clinicians provide [the service] to eligible patients. The USPSTF found at least fair evidence that [the service] improves important health outcomes and concludes that benefits outweigh harms.|
|C.||The USPSTF makes no recommendation for or against routine provision of [the service]. The USPSTF found at least fair evidence that [the service] can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation.|
|D.||The USPSTF recommends against routinely providing [the service] to asymptomatic patients. The USPSTF found at least fair evidence that [the service] is ineffective or that harms outweigh benefits.|
|I.||The USPSTF concludes that the evidence is insufficient to recommend for or against routinely providing [the service]. Evidence that [the service] is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.|
Summary of Recommendation
The USPSTF strongly recommends that clinicians screen men and women 50 years of age or older for colorectal cancer.A recommendation.
The USPSTF found fair to good evidence that several screening methods are effective in reducing mortality from colorectal cancer. The USPSTF concluded that the benefits from screening substantially outweigh potential harms, but that the quality of evidence, magnitude of benefit, and potential harms vary with each method.
The USPSTF found good evidence that periodic FOBT reduces mortality from colorectal cancer and fair evidence that sigmoidoscopy alone or in combination with FOBT reduces mortality. The USPSTF did not find direct evidence that screening colonoscopy is effective in reducing colorectal cancer mortality; efficacy of colonoscopy is supported by its integral role in trials of FOBT, extrapolation from sigmoidoscopy studies, limited case-control evidence, and the ability of colonoscopy to inspect the proximal colon. Double-contrast barium enema offers an alternative means of whole-bowel examination, but it is less sensitive than colonoscopy, and there is no direct evidence that it is effective in reducing mortality rates. The USPSTF found insufficient evidence that newer screening technologies (for example, computed tomographic colography) are effective in improving health outcomes.
There are insufficient data to determine which strategy is best in terms of the balance of benefits and potential harms or cost-effectiveness. Studies reviewed by the USPSTF indicate that colorectal cancer screening is likely to be cost-effective (less than $30,000 per additional year of life gained), regardless of the strategy chosen.
It is unclear whether the increased accuracy of colonoscopy compared with alternative screening methods (for example, the identification of lesions that FOBT and flexible sigmoidoscopy would not detect) offsets the procedure's additional complications, inconvenience, and costs.
|The USPSTF grades the quality of the overall evidence for a service on a three-point scale (good, fair, or poor).|
|Good:||Evidence includes consistent results from well-designed, well-conducted studies in representative populations that directly assess effects on health outcomes.|
|Fair:||Evidence is sufficient to determine effects on health outcomes, but the strength of the evidence is limited by the number, quality, or consistency of the individual studies; generalizability to routine practice; or indirect nature of the evidence on health outcomes.|
|Poor:||Evidence is insufficient to assess the effects on health outcomes because of limited number or power of studies, important flaws in their design or conduct, gaps in the chain of evidence, or lack of information on important health outcomes.|
Potential screening options for colorectal cancer include home FOBT, flexible sigmoidoscopy, the combination of home FOBT and flexible sigmoidoscopy, colonoscopy, and double-contrast barium enema. Each option has advantages and disadvantages that may vary for individual patients and practice settings. The choice of specific screening strategy should be based on patient preferences, medical contraindications, patient adherence, and available resources for testing and follow-up. Clinicians should talk to patients about the benefits and potential harms associated with each option before selecting a screening strategy.
The optimal interval for screening depends on the test. Annual FOBT offers greater reductions in mortality rates than biennial screening but produces more false-positive results. A 10-year interval has been recommended for colonoscopy on the basis of evidence regarding the natural history of adenomatous polyps. Shorter intervals (five years) have been recommended for flexible sigmoidoscopy and double-contrast barium enema because of their lower sensitivity, but there is no direct evidence with which to determine the optimal interval for tests other than FOBT. Case-control studies have suggested that sigmoidoscopy every 10 years may be as effective as sigmoidoscopy performed at shorter intervals.
The USPSTF recommends initiating screening at 50 years of age for men and women at average risk for colorectal cancer, based on the incidence of cancer above this age in the general population. In persons at higher risk (for example, those with a first-degree relative who receives a diagnosis of colorectal cancer before 60 years of age), initiating screening at an earlier age is reasonable.
Expert guidelines exist for screening very high-risk patients, including those with a history suggestive of familial polyposis or hereditary nonpolyposis colorectal cancer, or those with a personal history of ulcerative colitis.5 Early screening with colonoscopy may be appropriate, and genetic counseling or testing may be indicated for patients with genetic syndromes.
The appropriate age at which colorectal cancer screening should be discontinued is not known. Screening studies have generally been restricted to patients younger than 80 years of age, with colorectal cancer mortality rates beginning to decrease within five years of initiating screening. Yield of screening should increase in older persons (because of higher incidence of colorectal cancer), but benefits may be limited as a result of competing causes of death. Discontinuing screening is therefore reasonable in patients whose age or comorbid conditions limit life expectancy.
Proven methods of FOBT screening use guaiac-based test cards prepared at home by patients from three consecutive stool samples and forwarded to the clinician. Whether patients need to restrict their diet and avoid certain medications is not established. Rehydration of the specimens before testing increases the sensitivity of FOBT but substantially increases the number of false-positive test results. Neither digital rectal examination (DRE) nor the testing of a single stool specimen obtained during DRE is recommended as an adequate screening strategy for colorectal cancer.
The combination of FOBT and sigmoidoscopy may detect more cancers and more large polyps than either test alone, but the additional benefits and potential harms of combining the two tests are uncertain. In general, FOBT should precede sigmoidoscopy because a positive test result is an indication for colonoscopy, obviating the need for sigmoidoscopy.
Colonoscopy is the most sensitive and specific test for detecting cancer and large polyps but is associated with higher risks than other screening tests for colorectal cancer. These include a small risk of bleeding and risk of perforation, primarily associated with removal of polyps or biopsies performed during screening. Colonoscopy also usually requires more highly trained personnel, overnight bowel preparation, sedation, and longer recovery time, which may necessitate transportation for the patient. It is not certain whether the potential added benefits of colonoscopy relative to screening alternatives are large enough to justify the added risks and inconvenience for all patients.
Initial costs of colonoscopy are higher than the costs of other tests. However, estimates of cost-effectiveness suggest that, from a societal perspective, compared with no screening, all methods of colorectal cancer screening are likely to be as cost-effective as many other clinical preventive services—less than $30,000 per additional year of life gained.
The brief review of the evidence that is normally included in USPSTF recommendation statements is available in the complete Recommendations and Rationale statement on the USPSTF Web site (www.uspreventiveservicestaskforce.org).
Recommendations of Others
The American Cancer Society recommends screening people at average risk for colorectal cancer beginning at 50 years of age by (1) FOBT annually; (2) flexible sigmoidoscopy every five years; (3) annual FOBT plus flexible sigmoidoscopy every five years; (4) double-contrast barium enema every five years; or (5) colonoscopy every 10 years.6 The American Cancer Society does not recommend DRE as a stand-alone screening test for colorectal cancer. Similar recommendations are issued by the American College of Surgeons, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians.7–9 The American Gastroenterological Association, as part of a consortium of related professional organizations, also issues similar recommendations, which are currently being updated.5 The American College of Physicians-American Society of Internal Medicine does not have current guidelines on screening. The Canadian Task Force on Preventive Health Care concludes that there is good evidence to recommend annual or biennial FOBT and fair evidence to recommend sigmoidoscopy as part of the periodic health examination in average-risk adults after age 50 years; evidence is insufficient to recommend for or against colonoscopy or combined FOBT and sigmoidscopy.10