Definitions of the levels of evidence (evidence-based A-D, I and consensus-based) are provided at the end of the "Major Recommendations" field.
Problem Formulation #1: Factors Associated With An Increased Risk of Colorectal Cancer in the General Population
1A. A significant family history is associated with an increased risk of colorectal cancer. (See Problem Formulation #5, below, for screening recommendations and specific definition of family history.) (Evidence-based: A)
1B. Advancing age is associated with an increased risk of colorectal cancer. (Evidence-based: B)
1C. There is fair evidence that African-Americans are at increased risk for colorectal cancer compared with Whites. However, the magnitude of the increased risk is too small to warrant incorporation into screening recommendations.* (Evidence-based: C)
1D. There is fair evidence that a family history of advanced adenomas presenting before age 60 is associated with an increased risk of colorectal cancer. However, the magnitude of the increased risk is too small to warrant incorporation into screening recommendations. (Evidence-based: C)
1E. There is insufficient evidence for or against the association of gender with an increased risk of colorectal cancer. (Evidence-based: I)
*For African-Americans, special efforts should be made to ensure that screening occurs using any of the accepted screening modalities, as well as consideration of earlier screening than for other racial groups. Observational national data demonstrate an increased risk of colorectal cancer and a more advanced stage of disease at diagnosis among African-Americans than among Whites. It is not clear whether this disparity is due to differences in the biological behavior of colorectal cancer in African-Americans, differences in socioeconomic status, or differences in access to care.
Problem Formulation #2: Effectiveness of Colorectal Cancer Screening Tests
2A. Colorectal cancer screening is strongly recommended for all asymptomatic, average-risk adults. (Evidence-based: A)
Any of the following tests are acceptable for colorectal cancer screening in asymptomatic, average-risk adults:*
- 2B. A three-sample guaiac fecal occult blood test (FOBT) is recommended provided that patients are informed of the potential risks associated with false-positive and false-negative test results, as well as the need for prompt follow-up of a positive test result. (Evidence-based: B)
- 2C. Flexible sigmoidoscopy is recommended provided that patients are informed that the test has a small risk of complications and is not a complete examination of the entire colon. (Evidence-based: B)
- 2D. High-sensitivity fecal occult blood tests (three-sample Hemoccult SENSA) and single-sample immunochemical fecal occult blood tests (iFOBT) are options for screening, provided that patients are informed of the potential risks associated with false-positive and false-negative test results, as well as the need for prompt follow-up of a positive test result.** (Consensus-based)
- 2E. A combination of three-sample fecal occult blood test and flexible sigmoidoscopy is an option for screening provided that patients are informed of the potential risks associated with false-positive and false-negative FOBT results, as well as the need for prompt follow-up of a positive FOBT result. (Consensus-based)
The following additional screening tests either are not recommended or are less-preferred options for screening. However, an adult who has had one of the tests is considered screened. Follow-up screening using a preferred option is recommended.
- 2F. Colonoscopy is a less-preferred option for screening because of the increased risk of serious complications and the existence of other evidence-based options for screening average-risk adults.** (Evidence-based: I).
- 2G. There is insufficient evidence to recommend for or against the use of air contrast barium enema as a screening strategy for average-risk adults. (Evidence-based: I)
- 2H. Virtual colonoscopy is not recommended as a screening strategy for average-risk adults.*** (Consensus-based)
- 2I. Fecal DNA is not recommended as a screening strategy for average-risk adults.*** (Consensus-based)
*There is insufficient evidence to choose one screening test over another.
**If a patient has had a normal colonoscopy within the last 10 years, there is insufficient evidence that supplemental FOBT adds any incremental benefit.
***Please note that fecal DNA testing and virtual colonoscopy are not listed as "appropriate screening tests" in 2007 Health Plan Employer Data and Information Set (HEDIS) specifications for colorectal cancer screening, and therefore regions may choose to screen members with other appropriate tests.
Problem Formulation #3: Frequency of Colorectal Cancer Screening
The following intervals for colorectal cancer screening in asymptomatic, average-risk adults are recommended*:
- 3A. Three-sample guaiac fecal occult blood test (FOBT): every 1-2 years** (Evidence-based: B)
- 3B. Flexible sigmoidoscopy: at least every 10 years** (Consensus-based)
- 3C. Three-sample high-sensitivity guaiac FOBT and single-sample immunochemical FOBT: every 1-2 years*** (Consensus-based)
The following additional screening tests are either less-preferred options or not recommended for screening average-risk adults. However, if these tests are performed, then the recommended intervals are as indicated below. Follow-up screening using a preferred option is recommended.
- 3D. Colonoscopy: every 10 years*** (Consensus-based)
- 3E. Air contrast barium enema: every 5 years*** (Consensus-based)
- 3F. Virtual colonoscopy: every 10 years# (Consensus-based)
- 3G. Fecal DNA: every 5 years# (Consensus-based)
*The Guideline Development Team (GDT) recognizes that these screening intervals differ from current HEDIS measures. Some regions may choose to offer screening at more frequent intervals. HEDIS intervals are as follows: FOBT (annual), flexible sigmoidoscopy (every 5 years), air contrast barium enema (every 5 years), colonoscopy (every 10 years).
**There is no evidence on the effectiveness of various screening intervals for combined FOBT and flexible sigmoidoscopy.
***There is insufficient evidence to recommend for or against these modalities for screening average-risk adults (see Problem Formulation 2, above).
#These modalities are not recommended for screening average-risk adults (see Problem Formulation 2. above).
Problem Formulation #4: Age to Begin and End Colorectal Cancer Screening
In the absence of sufficient evidence, the following ages at which to begin and end colorectal cancer screening in asymptomatic average-risk adults are recommended:
- 4A. Initiation of screening is recommended at age 50. (Consensus-based)
- 4B. Discontinuation of screening is generally recommended at age 80. The decision to discontinue screening should be based on physician judgment, patient preference, the increased risk of complications in older adults, and existing comorbidities. (Consensus-based)
Problem Formulation #5: Screening In Adults At Increased Risk of Colorectal Cancer
Family History
Colonoscopy screening beginning at age 40, or 10 years younger than the earliest diagnosis in the first-degree relative, is recommended in adults with the following significant family history of colorectal cancer:
- 5A. One first-degree relative (parent, sibling, or offspring) with a diagnosis of colorectal cancer at age 60 or younger.* (Consensus-based)
- 5B. Two or more first-degree relatives diagnosed with colorectal cancer at any age.* (Consensus-based)
5C. In the absence of sufficient evidence, colonoscopy screening for this population is recommended at least every 10 years. Based on individual patient characteristics and clinical scenarios, more frequent screening may be appropriate. (Consensus-based)
5D. For evaluation and follow-up of hereditary colorectal cancer syndromes and inflammatory bowel disease, referral to Gastroenterology is recommended.** (Consensus-based)
Age, Race or Ethnicity, and Gender
5E. Special efforts are recommended to ensure screening in adults aged 60 to 75, using any of the accepted screening modalities. If colonoscopy is used for screening in adults without a family history of colorectal cancer, it is most likely to be beneficial for fit adults aged 60 to 75, where the incidence of proximal cancers is higher and the balance of benefits vs. harms is favorable. Because colonoscopy requires procedural sedation and vigorous bowel preparation and has a higher rate of complications than other tests, counseling on the benefits and risks of screening is recommended, especially in older adults with comorbidities. (Consensus-based)
5F. Special efforts are recommended to ensure that screening occurs among African-Americans, using any of the accepted screening modalities.*** (Consensus-based)
5G. There is insufficient evidence to recommend for or against differential screening strategies based on gender.# (Evidence-based: I)
*There is fair evidence that a family history of advanced adenomas presenting before age 60 is associated with an increased risk of colorectal cancer. However, the magnitude of the increased risk is too small to warrant incorporation into screening recommendations. (Evidence-based: C)
**Hereditary syndromes include familial adenomatous polyposis, Gardner's syndrome, and hereditary nonpolyposis colon cancer (Lynch syndrome).
***For African-Americans, special efforts should be made to ensure that screening occurs using any of the accepted screening modalities, as well as consideration of earlier screening as compared with other racial groups. Observational national data demonstrate an increased risk of colorectal cancer and a more advanced stage of disease at diagnosis among African-Americans than among Whites. It is not clear whether this disparity is due to differences in the biological behavior of colorectal cancer in African-Americans, differences in socioeconomic status, or differences in access to care.
#Women are at slightly lower risk than men for colorectal cancer, at the same age. However, this risk difference is not significant enough to justify a different approach to colorectal cancer screening for men and women.
Definitions:
Label and Language of Recommendations
| Label |
Evidence-Based Recommendations |
| Evidence-based (A) |
Language: a The intervention is strongly recommended for eligible patients.
Evidence: The intervention improves important health outcomes, based on good evidence, and the Guideline Development Team (GDT) concludes that benefits substantially outweigh harms and costs.
Evidence Grade: Good.
|
| Evidence-based (B) |
Language: a The intervention is recommended for eligible patients.
Evidence: The intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs.
Evidence Grade: Good or Fair.
|
| Evidence-based (C) |
Language: a No recommendation for or against routine provision of the intervention. (At the discretion of the GDT, the recommendation may use the language "option," but must list all the equivalent options.)
Evidence: Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of the benefits, harms, and costs is too close to justify a general recommendation.
Evidence Grade: Good or Fair.
|
| Evidence-based (D) |
Language: a Recommendation against routinely providing the intervention to eligible patients.
Evidence: The GDT found at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits.
Evidence Grade: Good or Fair.
|
| Evidence-based (I) |
Language: a The evidence is insufficient to recommend for or against routinely providing the intervention. (At the discretion of the GDT, the recommendation may use the language "option," but must list all the equivalent options.)
Evidence: Evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined.
Evidence Grade: Insufficient.
|
| Consensus-based |
Language: a The language of the recommendation is at the discretion of the GDT, subject to approval by the National Guideline Directors.
Evidence: The level of evidence is assumed to be "Insufficient" unless otherwise stated. However, do not use the A, B, C, D, or I labels which are only intended to be used for evidence-based recommendations.
Evidence Grade: Insufficient, unless otherwise stated.
|
| For the rare consensus-based recommendations which have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation, the evidence grade should point this out (e.g., "Evidence Grade: Good, supporting a different recommendation"). |
[a] All statements specify the population for which the recommendation is intended.
*Recommendations should be labeled and given an evidence grade. The evidence grade should appear in the rationale. Evidence is graded with respect to the degree it supports the specific clinical recommendation. For example, there may be good evidence that Drugs 1 and 2 are effective for Condition A, but no evidence that Drug 1 is more effective than Drug 2. If the recommendation is to use either Drug 1 or 2, the evidence is good. If the recommendation is to use Drug 1 in preference to Drug 2, the evidence is insufficient.
