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## Complete Summary

#### GUIDELINE TITLE

Colorectal cancer screening and surveillance: clinical guidelines and
rationale-update based on new evidence.

#### BIBLIOGRAPHIC SOURCE(S)

Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T,
Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C,
Gastrointestinal Consortium Panel. Colorectal cancer screening and
surveillance: clinical guidelines and rationale. Update based on new
evidence. Gastroenterology 2003 Feb;124(2):544-60. \[102 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12557158)

#### GUIDELINE STATUS

This is the current release of the guideline.

It updates a previously published version: Winawer SJ, Fletcher RH,
Miller L, Godlee F, Stolar MH, Mulrow CD, Woolf SH, Glick SN, Ganiats
TG, Bond JH, Rosen L, Zapka JG, Olsen SJ, Giardiello FM, Sisk JE, Van
Antwerp R, Brown-Davis C, Marciniak DA, Mayer RJ. Colorectal cancer
screening: clinical guidelines and rationale. Gastroenterology 1997
Feb;112(2):594-642.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Colorectal cancer

#### GUIDELINE CATEGORY

Screening

#### CLINICAL SPECIALTY

Family Practice\
Gastroenterology\
Internal Medicine\
Oncology\
Preventive Medicine\
Radiology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To incorporate updated evidence into clinical practice
    recommendations

-   To summarize new developments in the field and suggest how they
    should change practice

#### TARGET POPULATION

-   People in the United States (U.S.) at average risk for colorectal
    cancer (asymptomatic, age [\>]{.underline} 50 years, no other risk
    factors)

-   People in the U.S. at increased risk for colorectal cancer (history
    of adenomatous polyps or colorectal cancer; family history of colon
    cancer, an adenomatous polyp, familial adenomatous polyposis, or
    hereditary nonpolyposis colorectal cancer)

**Note**: People with symptoms or signs that suggest the presence of
colorectal cancer or polyps fall outside the domain of screening and
should be offered an appropriate diagnostic evaluation (see Table 2 in
the original guideline document).

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Risk stratification based on personal, family, and medical history

2.  Patient education regarding screening options

3.  Screening tests, including:

    -   Fecal occult blood test (FOBT) 

    -   Sigmoidoscopy

    -   Combined FOBT and sigmoidoscopy

    -   Colonoscopy

    -   Double-contrast barium enema

4.  Follow-up of positive screening test including further testing and
    referral for surgery as appropriate

5.  Surveillance of patients at increased risk

#### MAJOR OUTCOMES CONSIDERED

-   Rates of screening for colorectal cancer

-   Morbidity and mortality due to colorectal cancer

-   Incidence of colorectal cancer

-   Sensitivity and specificity of screening procedures

-   Cost-effectiveness of screening

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Appropriate members of the guidelines panel, based on their individual
interests and expertise, were assigned 1 or more sections of the
guidelines previously published by the Gastrointestinal (GI) Consortium.
They conducted a literature search on the assigned topic and prepared
evidence tables summarizing scientifically strong studies that were
relevant to colorectal cancer screening and surveillance.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Evidence tables, with associated citations, were circulated to the
Gastrointestinal (GI) Consortium panel for comments. A meeting was held
at which the important new evidence was presented and critiqued.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

A meeting of the gastrointestinal consortium panel was held at which the
supporting evidence was presented and critiqued. Following this,
guidelines were drafted based on the meeting consensus, with an
accompanying discussion of the rationale, new evidence (since close of
evidence gathering for the earlier guidelines in 1996), and
recommendations for future research.

These guidelines, like their predecessor, take into consideration the
full range of issues that should go into a policy decision. The size of
the effect and the strength of the research evidence on which it is
based are major considerations. But so also are the complications and
inconvenience of screening, patient acceptance, and cost. Individual
patients and providers may value some of these elements over others.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

Cost-effectiveness analyses have shown that the cost per year of life
saved by screening with any of the tests recommended is reasonable by
U.S. standards. Although the specific results vary among analyses, in
general, the marginal cost-effectiveness of this screening is less than
\$25,000 per year of life saved. Screening for colorectal cancer was
among the highest ranked services in an analysis of the value of
preventive services based on the burden of disease prevented and cost
effectiveness. Although the up-front costs vary by screening modality,
the long-term cost-effectiveness is apparently similar across screening
programs, so that decisions about which options to include, in the long
run and from the perspective of society, do not need to be heavily
affected by costs. Costs increase out of proportion to benefits with
shorter intervals between screening examinations. One analysis suggested
that screening sigmoidoscopy might be cost-saving over a long period of
time.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

A draft of the guideline document was edited by the GI Consortium Panel
co-chairs and the task force chair and circulated to the members for
comments. The final draft was then circulated to appropriate committees
of the sponsoring organizations. The final draft was also reviewed and
endorsed by the American Cancer Society.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

*Excerpted by the National Guideline Clearinghouse (NGC)*

***Note from the guideline developers:** These guidelines differ from
those published in 1997 in several ways:*

-   *They recommend against rehydrating fecal occult blood tests*

-   *The screening interval for double-contrast barium enema has been
    shortened to 5 years*

-   *Colonoscopy is the preferred test for the diagnostic investigation
    of patients with findings on screening and for screening patients
    with a family history of hereditary nonpolyposis colorectal cancer*

-   *Recommendations for people with a family history of colorectal
    cancer make greater use of risk stratification*

-   *Guidelines for genetic testing are included*

-   *Guidelines for surveillance are also included*

-   *Follow-up of postpolypectomy patients relies now on colonoscopy,
    and the first follow-up examination has been lengthened from 3 to 5
    years for low-risk patients*

**[General Recommendations]{.underline}**

Screening programs should begin by classifying the individual patient´s
level of risk based on personal, family, and medical history, which will
determine the appropriate approach to screening in that person.

Men and women at average risk should be offered screening for colorectal
cancer and adenomatous polyps beginning at age 50 years.

They should be offered options for screening, with information about the
advantages and disadvantages associated with each approach, and should
be given an opportunity to apply their own preferences in selecting how
they should be screened.

If the result of a screening test is abnormal, physicians should
recommend a complete structural examination of the colon and rectum by
colonoscopy (or flexible sigmoidoscopy and double contrast barium enema
if colonoscopy is not available).

Surveillance with colonoscopy should be considered for patients who are
at increased risk because they have been treated for colorectal cancer,
have an adenomatous polyp diagnosed, or have a disease that predisposes
them to colorectal cancer, such as inflammatory bowel disease.

Health care providers who perform the tests should have appropriate
proficiency, and the tests should be performed correctly. To achieve
these aims, care systems should establish standards and operating
procedures.

Screening should be accompanied by efforts to optimize the participation
of patients and health care providers\--both with screening tests and
appropriate diagnostic evaluation of abnormal screening test
results\--and to remind patients and providers about the need for
rescreening at recommended intervals.

**Risk Stratification**

Clinicians should determine an individual patient´s risk status well
before the earliest potential initiation of screening (typically around
age 20 years, but earlier if there is a family history of familial
adenomatous polyposis) (see figure 1 in the original guideline
document). The individual´s risk status determines when screening should
be initiated and what tests and frequency are appropriate. Risk
stratification can be accomplished by asking several questions aimed at
uncovering the risk factors for colorectal cancer:

1.  Has the patient had colorectal cancer or an adenomatous polyp?

2.  Does the patient have an illness (e.g., inflammatory bowel disease)
    that predisposes him or her to colorectal cancer?

3.  Has a family member had colorectal cancer or an adenomatous polyp?
    If so, how many, was it a first-degree relative (parent, sibling, or
    child), and at what age was the cancer or polyp first diagnosed?

A positive response to any of these questions should prompt further
efforts to identify and define the specific condition associated with
increased risk.

**[Recommendations for Screening People at Average Risk]{.underline}**

Men and women at average risk should be offered screening with one of
the following options beginning at age 50 years. The rationale for
presenting multiple options is that no single test is of unequivocal
superiority and that giving patients a choice allows them to apply
personal preferences and may increase the likelihood that screening will
occur. The strategies are not equal with regard to evidence of
effectiveness, magnitude of effectiveness, risk, or up-front costs.
Reviewing the rationale section for each screening test (presented in
the original guideline document) will provide clinicians with
information that they can use in presenting the relative effectiveness
of each test to patients.

**Fecal Occult Blood Testing**

Offer yearly screening with fecal occult blood test (FOBT) using a
guaiac-based test with dietary restriction or an immunochemical test
without dietary restriction. Two samples from each of 3 consecutive
stools should be examined without rehydration. Patients with a positive
test on any specimen should be followed up with colonoscopy.

**Sigmoidoscopy**

Offer flexible sigmoidoscopy every 5 years.

**Combined FOBT and Flexible Sigmoidoscopy**

Offer screening with FOBT every year combined with flexible
sigmoidoscopy every 5 years. When both tests are performed, the FOBT
should be done first.

**Colonoscopy**

Offer colonoscopy every 10 years.

**Double-Contrast Barium Enema**

Offer double-contrast barium enema (DCBE) every 5 years.

**[Recommendations for Screening People at Increased Risk]{.underline}**

**People With a Family History of Colorectal Cancer or Adenomatous
Polyps**

People with a first-degree relative (parent, sibling, or child) with
colon cancer or adenomatous polyps diagnosed at age \<60 years or 2
first-degree relatives diagnosed with colorectal cancer at any age
should be advised to have screening colonoscopy starting at age 40 years
or 10 years younger than the earliest diagnosis in their family,
whichever comes first, and repeated every 5 years (see Table 3 in the
original guideline document).

People with a first-degree relative with colon cancer or adenomatous
polyp diagnosed at age [\>]{.underline}60 years or 2 second-degree
relatives with colorectal cancer should be advised to be screened as
average risk persons, but beginning at age 40 years.

People with 1 second-degree relative (grandparent, aunt, or uncle) or
third-degree relative (great-grandparent or cousin) with colorectal
cancer should be advised to be screened as average risk persons.

**Familial Adenomatous Polyposis**

People who have a genetic diagnosis of familial adenomatous polyposis
(FAP), or are at risk of having FAP but genetic testing has not been
performed or is not feasible, should have annual sigmoidoscopy,
beginning at age 10-12 years, to determine if they are expressing the
genetic abnormality. Genetic testing should be considered in patients
with FAP who have relatives at risk. Genetic counseling should guide
genetic testing and considerations of colectomy.

**Hereditary Nonpolyposis Colorectal Cancer**

People with a genetic or clinical diagnosis of hereditary nonpolyposis
colorectal cancer (HNPCC) or who are at increased risk for HNPCC should
have colonoscopy every 1-2 years beginning at age 20-25 years, or 10
years earlier than the youngest age of colon cancer diagnosis in the
family\--whichever comes first. Genetic testing for HNPCC should be
offered to first-degree relatives of persons with a known inherited
mismatch repair (MMR) gene mutation. It should also be offered when the
family mutation is not already known, but 1 of the first 3 of the
modified Bethesda Criteria is met (see Table 5 in the original guideline
document).

**[Surveillance of People at Increased Risk]{.underline}**

**People with a History of Adenomatous Polyps**

Patients who have had 1 or more adenomatous polyps removed at
colonoscopy should be managed according to the findings on that
colonoscopy. Patients who have had numerous adenomas, a malignant
adenoma (with invasive cancer), a large sessile adenoma, or an
incomplete colonoscopy should have a short interval follow-up
colonoscopy based on clinical judgment. Patients who have advanced or
multiple adenomas ([\>]{.underline}3) should have their first follow-up
colonoscopy in 3 years. Patients who have 1 or 2 small (\<1 cm) tubular
adenomas should have their first follow-up colonoscopy at 5 years. It is
not unreasonable, given available evidence, to choose even longer
intervals. However, the evidence is still evolving. Future evidence may
clarify the intervals more precisely.

The timing of the subsequent colonoscopy should depend on the pathology
and number of adenomas detected at follow-up colonoscopy. For example,
if the first follow-up colonoscopy is normal or only 1 or 2 small (\<1
cm) tubular adenomas are found, the next colonoscopy can be in 5 years.

**People With a History of Colorectal Cancer**

Patients with a colon cancer that has been resected with curative intent
should have a colonoscopy around the time of initial diagnosis to rule
out synchronous neoplasms. If the colon is obstructed preoperatively,
colonoscopy can be performed approximately 6 months after surgery. If
this or a complete preoperative examination is normal, subsequent
colonoscopy should be offered after 3 years, and then, if normal, every
5 years.

**People With Inflammatory Bowel Disease**

In patients with long-standing, extensive inflammatory bowel disease,
surveillance colonoscopy with systematic biopsies should be considered.
This applies to both ulcerative colitis and Crohn´s colitis because the
cancer risk is similar in both diseases.

#### CLINICAL ALGORITHM(S)

A clinical algorithm is provided for colorectal cancer screening.

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

Specific guideline recommendations are accompanied by a discussion of
the rationale and new evidence supporting their use.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Increased rates of appropriate and timely colorectal cancer
    screening based on patient and physician collaboration

-   Improved physician and patient understanding of the rationale and
    evidence supporting colorectal cancer screening options (refer to
    the rationale section in the original guideline document for the
    relative effectiveness of each screening test)

-   Reduced morbidity and mortality due to colorectal cancer

-   Reduced health care costs

#### POTENTIAL HARMS

-   Currently available tests for fecal occult blood fail to detect many
    polyps and some cancers. Also, most people who test positive will
    not have colorectal neoplasia (have a false positive test result)
    and thus will undergo the discomfort, cost, and risk of colonoscopy
    without benefit.

-   Colonoscopy involves greater cost, risk, and inconvenience to the
    patient than other screening tests, and not all examinations
    visualize the entire colon.

-   Genetic testing can have psychological effects and subject persons
    with positive tests to the risks of discrimination. Therefore, it
    should only be performed after genetic counseling of patients and
    parents of children.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   In applying the recommendations in the guidelines to patients, the
    individual circumstances of the patient must be considered in
    addition to the guideline recommendations.

-   The recommendations in this guideline are based on the clinical
    literature or reports accepted for publication and available to the
    Panel in complete form as of June 1, 2002. Evidence that appears
    after this date should be taken into account when applying these
    guidelines. Clinical judgment should be used to tailor
    recommendations to the individual patient\'s special circumstances.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

For screening programs to be successful, a cascade of events must be
negotiated from beginning to end. Physicians must remember to offer
screening, patients must accept this advice, insurers must pay for
screening and follow-up testing, and patient care organizations must
have systems to track whether screening has taken place and provide
reminders if it has not. Therefore, those who care about effective
screening programs must be concerned with all of these elements of
success.

#### IMPLEMENTATION TOOLS

Clinical Algorithm

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T,
Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C,
Gastrointestinal Consortium Panel. Colorectal cancer screening and
surveillance: clinical guidelines and rationale. Update based on new
evidence. Gastroenterology 2003 Feb;124(2):544-60. \[102 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12557158)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1997 Feb (revised 2003 Feb)

#### GUIDELINE DEVELOPER(S)

American College of Gastroenterology - Medical Specialty Society\
American College of Physicians - Medical Specialty Society\
American Gastroenterological Association Institute - Medical Specialty
Society\
American Society for Gastrointestinal Endoscopy - Medical Specialty
Society

#### GUIDELINE DEVELOPER COMMENT

The original guidelines were prepared by a panel convened by the U.S.
Agency for Health Care Policy and Research and published in 1997 under
the sponsorship of a consortium of gastroenterology societies. The
original GI Consortium Panel was comprised of experts in primary care,
gastroenterology, surgery, oncology, epidemiology, behavioral science,
clinical economics, and nursing, as well as a patient advocate. The
panel responsible for the current guidelines was comprised of
representatives from the original panel and of the U.S. Multisociety
Task Force on Colorectal Cancer, a combined effort of the American
College of Gastroenterology, the American Society of Gastrointestinal
Endoscopy, the American Gastroenterological Association, and the
American College of Physicians/Society of Internal Medicine. This group
was asked to review the original guidelines, prepare appropriate
revisions with rationale, highlight new evidence since 1997, and suggest
research questions\--the answers to which seem critical to progress in
colorectal cancer screening and surveillance. Societies with
representatives on the panel included the American Academy of Family
Practice, American College of Gastroenterology, American College of
Physicians-American Society of Internal Medicine, American College of
Radiology, American Gastroenterological Association, American Society of
Colorectal Surgeons, and American Society for Gastrointestinal
Endoscopy.

#### SOURCE(S) OF FUNDING

This work was supported by the American College of Gastroenterology,
American College of Physicians/American Society of Internal Medicine,
American Gastroenterological Association Institute, and the American
Society for Gastrointestinal Endoscopy.

#### GUIDELINE COMMITTEE

U.S. Multisociety Task Force on Colorectal Cancer

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Members of the U.S. Multisociety Task Force on Colorectal Cancer*:
Randall Burt, M.D., Huntsman Cancer Institute at the University of Utah,
Salt Lake City, Utah; John Bond, M.D., University of Minnesota,
Minneapolis, Minnesota; Joseph T. Ferrucci, M.D., Boston University
School of Medicine, Boston, Massachusetts; Robert Fletcher, M.D.,
Harvard Medical School and Harvard Pilgrim Health Care, Boston,
Massachusetts (Panel Co-Chair); Theodore Ganiats, M.D., University of
California San Diego, La Jolla, California; David A. Johnson, M.D.,
Eastern Virginia School of Medicine, Norfolk, Virginia; Lynne M. Kirk,
M.D., University of Texas Southwestern Medical Center, Dallas, Texas;
Theodore R. Levin, M.D., Kaiser Permanente Medical Center, Walnut Creek,
Oakland, California; Scott Litin, M.D., Mayo Clinic, Rochester,
Minnesota; Douglas K. Rex, M.D., Indiana University School of Medicine,
Indianapolis, Indiana (Task Force Chair); Clifford Simmang, University
of Texas Southwestern Medical School, Dallas, Texas; Sidney J. Winawer,
M.D., Memorial Sloan-Kettering Cancer Center, New York, New York (Panel
Co-Chair); and Steven H. Woolf, M.D., MPH, Virginia Commonwealth
University, Fairfax, Virginia

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### ENDORSER(S)

American Cancer Society - Disease Specific Society\
American College of Gastroenterology - Medical Specialty Society\
American Society for Gastrointestinal Endoscopy - Medical Specialty
Society\
American Society of Colon and Rectal Surgeons - Medical Specialty
Society\
Crohn\'s and Colitis Foundation of America - Disease Specific Society\
Oncology Nursing Society - Professional Association\
Society of American Gastrointestinal and Endoscopic Surgeons - Medical
Specialty Society

#### GUIDELINE STATUS

This is the current release of the guideline.

It updates a previously published version: Winawer SJ, Fletcher RH,
Miller L, Godlee F, Stolar MH, Mulrow CD, Woolf SH, Glick SN, Ganiats
TG, Bond JH, Rosen L, Zapka JG, Olsen SJ, Giardiello FM, Sisk JE, Van
Antwerp R, Brown-Davis C, Marciniak DA, Mayer RJ. Colorectal cancer
screening: clinical guidelines and rationale. Gastroenterology 1997
Feb;112(2):594-642.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Gastroenterological
Association Institute (AGAI) Web
site](http://download.journals.elsevierhealth.com/pdfs/journals/0016-5085/PIIS0016508502158951.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on June 30, 1998. It was verified by
the guideline developer on December 1, 1998. This summary was updated by
ECRI on May 20, 2003. The updated information was verified by the
guideline developer on June 24, 2003.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
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Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/10/2008