General Implementation January 1998
Copyright © 1998 by Institute for Clinical Systems Integration
The information contained in this web site, including the ICSI Health Care
Guidelines ("ICSI Guidelines"), is intended primarily for health
professionals and the following expert audiences:
Neither the ICSI Guidelines nor any other information in this web site should be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting the materials in this web site and applying the materials in your individual case.
The ICSI Guidelines contained in this web site are designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and are not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. An ICSI Guideline rarely will establish the only approach to a problem.
The ICSI Guidelines may be downloaded by any individual or organization. Copies of the ICSI Guidelines may be distributed by any organization to the organization's employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Integration, Inc. If the ICSI Guidelines are downloaded by a legally constituted medical group, they may be used by the medical group in any of the following ways:
All other copyright rights in the ICSI Guidelines are reserved by the Institute for Clinical Systems Integration, Inc. The Institute for Clinical Systems Integration, Inc. assumes no liability for any adaptations or revisions or modifications made to the ICSI Guidelines.
Work Group Leader
Robert Titzler, MD, HealthPartners
Adult Nursing
Geri Bergeron, RN, HealthPartners
Family Practice
Robert Titzler, MD, HealthPartner
Internal Medicine
Peter Ganzer, MD, HealthSystem Minnesota
Gastroenterology
Mark Larson, MD, Mayo Clinic
Michael Shaw, MD, HealthSystem Minnesota
George Logan, MD, HealthPartners
Health Education
Jackie Labat, Center for Health Promotion, Health Partners
Measurement Advisor
Rick Carlson, MS, HealthPartners
BHCAG Representative
Paula Roe, Norwest Corporation
Facilitator
Katie Conlin, RN, ICSI
Patients aged 50-80 years old.
Potential Aims for Medical Groups When Using This Guideline
1. Increase the percent of people aged 50-80 who are up-to-date with colorectal screening.
Possible measure of accomplishing this aim:
a. Percentage of people aged 50-80 who are up-to-date with colorectal cancer screening.
2. Increase patient participation in screening for colorectal cancer.
Possible measures of accomplishing this aim:
a. Percentage of those aged 50-80 with counseling on colorectal cancer screening, whether or not the screening test was done.
b. Percentage of FOBT kits returned of those handed out to patients.
3. Increase the percent of positive screening tests that have follow-up tests.
Possible measure of accomplishing this aim:
a. Percentage of positive screening tests that have a follow-up colonoscopy.
4. Reduce wasteful, unproductive processes for colorectal cancer screening.
Possible measures of accomplishing this aim:
a. Percentage of patients who receive FOBT who have a history of colorectal cancer.
b. Percentage of patients with Flex Sigmoidoscopy who had history of colon cancer.
c. Percentage of patients with Flex Sigmoidoscopy who are over 80.
Clinical Algorithm & Annotation
1. Prescreening
Education and Counseling
2. Prevention
Opportunity
3. Meets
Criteria for Routine Screening for Colorectal Cancer?
4. Increased
Risk for Development of Colorectal Cancer?
5. Increased
Risk Surveillance
6. Provider
and Patient Choose Screening Test Pathway
7. Conduct
a 60 cm Flex Sig Exam or Combination Flex Sig and Barium Enema or Air Contrast
Barium Enema
8. Exam Adequate?
9. Schedule
Re-examination
10. Positive Findings?
11. Biopsy
12. Refer for Colonoscopy
13. Hyperplastic Polyp?
15. Colonoscopy Exam Adequate?
16. Positive Findings?
21. Confirmed Diagnosis of Colorectal Cancer?
22. Adenomatous Polyp?
23. Refer
to Increased Risk Surveillance
24. Care
Management: Out of Guideline
25. Patient
Submit 3 FOBT Test Slides
26. Any Positive Tests
27. Refer
for Coloscopy (After Positive FOBT)
1. Prescreening Education and Counseling
This guideline represents its work group's contribution to colon cancer screening and must be seen within the larger context of all preventive health activities. The work group acknowledges the important role played by education and outreach efforts in helping to increase the number of risk-appropriate individuals who present themselves for colon cancer screening, thereby increasing the rate of early detection of this disease.
Both providers and employers are expected to take an active and substantial role in the recruitment of men and women for colorectal cancer screening. This recruitment should take place as part of comprehensive screening activities.
Employer annual responsibilities are as outlined:
First year of membership One
Awareness Initiative
One
Educational Initiative
6 months from membership Two Awareness
Initiatives
Three
Educational Initiatives
12 months from membership Two Awareness Initiatives
Three
Educational Initiatives
Two
Behavioral Change Initiatives
24 months from membership Two Awareness Initiatives
Three
Educational Initiatives
Three
Behavioral Change Initiatives
Awareness Initiative Programming includes:
Educational Initiative Programming includes:
Behavioral Change Initiative Programming includes:
Information conveying the importance of risk-appropriate colorectal cancer screening can be included as part of broader health promotion/disease prevention initiatives.
Some employers and HMOs have also launched gender-specific health campaigns which include colorectal cancer screening with other gender-related health issues. This is believed to be the most effective approach.
Health Care Provider Activities
Materials such as brochures, posters, "special message" prescription pads, chart reminders and the like can support the primary care provider in her/his role as patient counselor/educator. Face-to-face opportunities to encourage risk-appropriate individuals to undergo colorectal cancer screening tests and procedures are instrumental in improving screening rates.
Suggested health care provider prescreening activities include: - Brochures, posters and direct-mail materials to inform patients about the availability of colon cancer screening.
Back to Algorithm Annotation List
Back to Contents
A prevention opportunity may be any scheduled visit to a provider which provides the opportunity for conducting the screening process, a preventive services visit or no visit.
3. Meets Criteria for Routine Screening for Colorectal Cancer?
All three of the screening criteria must be met to advance individuals in the guideline for colorectal cancer screening:
o Between the ages of 50 and 80 years old
o No personal history of polyps and/or colorectal cancer (see Discussion and References #3)
o No family history of colorectal cancer involving:
- one first order relative* diagnosed before age 65
or
- two first order relatives* diagnosed at any age
* First order relatives include only parents, siblings and children.
Back to Algorithm Annotation List
Back to Contents
4. Increased Risk for Development of Colorectal Cancer?
Patients with the following history are considered to be at increased risk:
o Prior polyp (adenoma with villous component, or any adenomatous polyp > 10mm).
o Prior colorectal cancer.
o Family history of colorectal cancer involving:
- one first order relative* diagnosed before age 65;
or
- two first order relatives* diagnosed at any age.
Certain patients are considered to be at high risk for development of colorectal cancer. Relevant conditions include familial polyposis coli and variants, long-standing chronic ulcerative colitis, and non-polyposis hereditary colorectal cancer. Surveillance of patients with these disorders lies outside the scope of this screening guideline.
* First order relatives include only parents, siblings and children.
Back to Algorithm Annotation List
Back to Contents
5. Increased Risk Surveillance
Patients at increased risk of developing colorectal cancer as indicated in Annotation #4 require colonoscopic surveillance at a 3 to 5 year interval, and are outside the scope of this guideline.
Whenever colonoscopy is utilized, it should begin at age 50 or five years before the index carcinoma, whichever comes first. Follow-up intervals should be dictated by the results of colonoscopy but should occur at least every five years.
Patients with only one first order relative with a history of colorectal cancer could be followed using combined barium enema and flexible sigmoidoscopy at five year intervals.
Back to Algorithm Annotation List
Back to Contents
6. Provider and Patient Choose Screening Test Pathway
These screening intervals apply to patients between 50 and 80 years old without clinical factors that place them at increased risk for colorectal cancer.
Possible screening pathways include:
o 60 cm flexible sigmoidoscopy every 5 years (see annotation 7)
or
o Fecal Occult Blood Test (FOBT) annually (see annotation 26)
or
o Combination of flexible sigmoidoscopy every 5 years and FOBT annually. When this path is chosen, FOBT should be completed before the flexible sigmoidoscopy.
or
o Total colon evaluation. Within this choice, options include colonoscopy, flexible sigmoidoscopy combined with fluoroscopic barium enema or double contrast barium enema (DCBE). If the sigmoid is not well visualized on DCBE, a flexible sigmoidoscopy should be obtained. The interval between exams within this choice is 5 years as well (5-10 years for colonoscopy).
Clinical groups may decide internally as to which pathway will be offered routinely at their site. Alternatively, individual clinicians may advise each patient as to which pathway might be most suitable, and with the patient's preference in mind, choose one of the above pathways.
Back to Algorithm Annotation List
Back to Contents
7. Conduct a 60 cm Flex Sig Exam or Combination Flex Sig and Barium Enema or Air Contrast Barium Enema
Flexible Sigmoidoscopy
Direct examination of the colon is recommended using a 60 cm flexible sigmoidoscope, preferably with the capacity for performing a biopsy. A digital rectal examination (DRE) may be performed just prior to insertion of the scope.
Suggested minimal preparation may include two phosphasodyl enemas (e.g., Fleet's) on the morning of the procedure and nothing by mouth (NPO) for four to six hours prior to the procedure. Special attention may need to be directed to the diabetic patient who is NPO or the anticoagulated patient.
Barium Enema
Barium enema may be performed with either double contrast technique or a fluoroscopic barium enema study conducted by a radiologist with advanced specialized training in gastrointestinal procedures. There are no studies evaluating whether screening by barium enema alone reduces mortality from colorectal cancer in people at average risk for the disease. This option is based on evidence that screening DCBEs can image the entire colon and detect cancers and large polyps almost as well as colonoscopy and better than FOBT or flexible sigmoidoscopy. The fluoroscopic barium enema is performed at Mayo Rochester. At that site, approximately 15,000 colon contrast studies are performed annually. The fluoroscopic barium enema is performed in conjunction with a proctoscopy or flexible sigmoidoscopy.
Colonoscopy
Colonoscopy, which can visualize the entire colon, is analogous in performance to flexible sigmoidoscopy which has been shown to reduce colorectal cancer mortality. Colonoscopy has been shown to reduce the incidence of colorectal cancer in a population of patients with adenomatous polyps. There is however, no evidence of reduction of colorectal cancer mortality in an average risk population by randomized trial, non-randomized trial or case-control studies through the use of colonoscopy. National consensus guidelines suggest an interval of 5-10 years between colonoscopy examinations for an average risk population.
Back to Algorithm Annotation List
Back to Contents
Flexible Sigmoidoscopy
The decision with respect to the adequacy of a Flexible Sigmoidoscopy exam is at the discretion of the provider. Reasons for which an exam would be inadequate include:
- inadequate bowel prep
- limited distance of scope insertion due to patient discomfort
- other technical difficulties
- uncertainty as to the significance of findings
- unsuccessful biopsy
Barium Enema
The decision with respect to the adequacy of a Barium enema is at the discretion of the provider. Reasons for which an exam would be inadequate include:
- inadequate bowel prep
- inadequate evaluation of recto-sigmoid
- other technical difficulties
- uncertainty as to the significance of findings
The provider may reschedule the examination with an altered bowel preparation, suggest a proctoscopy, flexible sigmoidoscopy or colonoscopy depending on the nature of the findings and/or limitations of the study.
Colonoscopy
See Annotation 15.
Back to Algorithm Annotation List
Back to Contents
A re-examination could be performed immediately after adequate prepping or at the discretion of the provider dependent on individual patient factors.
A positive finding on screening flexible sigmoidoscopy or double contrast barium enema includes an invasive cancer, polyp, bleeding source or mucosal abnormality. From the standpoint of colorectal cancer screening, diverticula, hyperplastic polyps, and single tubular adenomas less than 10 mm are not precursors to cancer. (As a frame of reference, a standard biopsy forceps fully opens to a diameter of 7 mm.)
Obvious hyperplastic polyps do not need to be biopsied.
Back to Algorithm Annotation List
Back to Contents
11. Biopsy
12. Refer
for Colonoscopy
13. Hyperplastic Polyp?
Attempt biopsy of every polyp under 5 mm in diameter. Polyps larger than 10 mm should be referred for complete excision at colonoscopy (no biopsy needed). Intermediate-sized polyps (> 5 mm and < 10 mm) may be referred for colonoscopic removal. If the polyp was biopsied at flexible sigmoidoscopy and is hyperplastic on histology, no further exam is needed at this screening.
Completion of a biopsy may be dependent upon the operator's comfort or skill level. If a biopsy is indicated but not performed, the patient should be referred.
15. Colonoscopy Exam Adequate?
The decision with respect to the adequacy of a colonoscopy is at the discretion of the provider. Reasons for which an exam would be inadequate include:
- inadequate bowel prep
- limited distance of scope insertion due to patient discomfort
- other technical difficulties
- uncertainty as to the significance of findings
- unsuccessful biopsy
A positive finding on screening colonoscopy includes an invasive cancer, polyp, bleeding source or mucosal abnormality. From the standpoint of colorectal cancer screening, diverticula, hyperplastic polyps, and single tubular adenomas less than 10 mm are not precursors to cancer. (As a frame of reference, a standard biopsy forceps fully opens to a diameter of 7 mm.)
Obvious hyperplastic polyps do not need to be biopsied.
Back to Algorithm Annotation List
Back to Contents
21. Confirmed Diagnosis of Colorectal Cancer?
Positive pathology from the biopsy specimen report confirms the diagnosis of colorectal cancer.
When the biopsy report is normal mucosa/hyperplastic polyp, return to screening activities and intervals as per the main algorithm. Patient education and communication should occur at this time.
Adenomatous polyps should be removed as part of the colonoscopy procedure. Confirmation of the presence of adenomatous polyps places the patient in an increased risk group. Such patients should be followed according to the increased risk surveillance protocol. (See Annotation #5).
23. Refer to Increased Risk Surveillance
Due to the pre-cancerous nature of certain adenomatous polyps, patients with such polyps should be monitored more closely than patients in the screening algorithm, and are outside the scope of this guideline.
24. Care Management: Out of Guideline
Management of confirmed colorectal cancer is beyond the scope of this guideline, and should be undertaken via appropriate specialty referral and care management.
Back to Algorithm Annotation List
Back to Contents
25. Patient
Submits 3 FOBT Test Slides
26. Any
Positive Tests
A minimum of 3 FOBT cards should be submitted by a patient annually. Standard protocols for obtaining the specimens should be followed as specified by the manufacturer and/or individual testing lab (usually based on 2 samples from 3 different stool specimens). Slide rehydration as an option when testing specimen is not strongly recommended.
A positive result on any one of the submitted test cards constitutes a "positive" result, but requires additional testing with total colon examination to determine if colon cancer or an adenomatous polyps are present.
27. Refer for Colonoscopy (after positive FOBT)
Colonoscopy is the most accurate additional test in pursuing a positive FOBT. Air contrast barium enema plus Flex sig is an acceptable alternative at the discretion of the provider.
Back to Algorithm Annotation List
Back to Contents
Grade A: Conclusion based on a randomized, controlled trial that has been published in a peer-reviewed journal.
Grade B: Conclusion based on one of the following study types published in a peer-reviewed journal (but not on a randomized, controlled trial):
o a trial using historical or other non-randomized controls;
o a prospective cohort study;
o a case-control study; or
o a meta-analytic study.
Grade C: Conclusion based on one of the following (but not on any studies of the types mentioned above):
o an uncontrolled case series; or
o expert opinion.
Guidelines obtained from the Agency for Health Care Policy and Research (AHCPR) or other sources, position statements, panel consensus statements from the National Institutes of Health (NIH) or elsewhere, review articles, and textbook chapters that cite primary evidence are not assigned a grade because they are not primary evidence. The individual studies cited in such secondary sources can be graded according to the categories presented above.
Instructions
for Downloading PDF Version of This Guideline
Click here to download the
full version of this Guideline in PDF format. You will need ADOBE Acrobat
reader to view the file. The reader may be found here.