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Accuracy of Screening for Fecal Occult Blood on a Single Stool Sample Obtained by Digital Rectal Examination: A Comparison with Recommended Sampling Practice

Judith F. Collins, MD; David A. Lieberman, MD; Theodore E. Durbin, MD; David G. Weiss, PhD, and the Veterans Affairs Cooperative Study #380 Group*
[+] Article, Author, and Disclosure Information

From Department of Veterans Affairs Medical Centers, Portland, Oregon, Long Beach, California, and Perry Point, Maryland.

*For a list of members of the Veterans Affairs Cooperative Study #380 Group, see the Appendix.

Grant Support: By the Cooperative Studies Program, Department of Veterans Affairs, Protocol #380.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Judith F. Collins, MD, Portland Veterans Affairs Medical Center, P3-GI, 3710 SW Veterans Hospital Road, PO Box 1034, Portland, OR 97239.

Current Author Addresses: Drs. Collins and Lieberman: Portland Veterans Affairs Medical Center, P3-GI, 3710 SW Veterans Hospital Road, PO Box 1034, Portland, OR 97239.

Dr. Durbin: West Anaheim Medical Offices, Suite 203, 3010 West Orange Street, Anaheim, CA 92804.

Dr. Weiss: Perry Point Veterans Affairs Medical Center, 151E, PO Box 1010, Perry Point, MD 21902.

Author Contributions: Conception and design: D.A. Lieberman, D.G. Weiss.

Analysis and interpretation of the data: J.F. Collins, D.A. Lieberman, T.E. Durbin, D.G. Weiss.

Drafting of the article: J.F. Collins, D.A. Lieberman, T.E. Durbin.

Critical revision of the article for important intellectual content: J.F. Collins, D.A. Lieberman, D.G. Weiss.

Final approval of the article: J.F. Collins, D.A. Lieberman, T.E. Durbin, D.G. Weiss.

Provision of study materials or patients: J.F. Collins, D.A. Lieberman, T.E. Durbin.

Statistical expertise: D.A. Lieberman, D.G. Weiss.

Obtaining of funding: D.A. Lieberman, D.G. Weiss.

Administrative, technical, or logistic support: D.G. Weiss.

Collection and assembly of data: J.F. Collins, D.A. Lieberman, T.E. Durbin, D.G. Weiss.

Ann Intern Med. 2005;142(2):81-85. doi:10.7326/0003-4819-142-2-200501180-00006
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Of 17 732 persons who were screened for study inclusion, 3196 met the criteria for enrollment. A complete examination of the colon was performed in 3121 eligible persons. Of these, 2885 had 6-sample at-home FOBT results (14). A total of 2665 (92.4%) had both digital FOBT and 6-sample FOBT completed before colonoscopy and are included in this analysis (Figure). The mean age (±SE) of the study group was 63.1 ± 0.14 years; 96.8% were men, and 14% reported having a first-degree relative with colorectal cancer. The demographic and pathologic characteristics of the 220 patients who were excluded on the basis of inadequate FOBT data are shown in Table 1. Reasons for incomplete FOBTs were failure to return the home-based cards or inadequate fecal material in the rectum at the time of digital examination. Included and excluded patients were similar except for a younger mean age (mean of 1.4 years younger) in the excluded group.

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Patient selection.

FOBT = fecal occult blood test.

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Another Perspective
Posted on January 20, 2005
Robert C. Kane
Conflict of Interest: None Declared

In the study by Collins et al, the initial group of 3100 became 2600 analytic cases. Some of these may represent non-compliant patients who did not complete the FOBT process. The authors should have used the intention- to-study (ITT) population for the denominator. Second, clinicians may be doing the single FOBT with the rectal exam YEARLY. Thus, this study might have examined the question: "How does the health outcome of a single FOBT test (6 samples) compare with 6 annual rectal exams including a single FOBT test each year?" Given that these were asymptomatic subjects who would only need a colonoscopy every 10 years (assuming no interval findings), a single FOBT annually as part of the rectal exam might have merit and circumvent the non-compliant "home-tester."

Conflict of Interest: None declared

Conflict of Interest:

None declared

In defense of the digital rectal exam and FOBT
Posted on February 20, 2005
Christopher A Smith
Cook County Hospital, Chicago, IL
Conflict of Interest: None Declared

Dear Editors

I read with interest the study by Collins et al which seems to provide convincing evidence that using a single stool sample obtained by digital rectal exam is an unreliable method of screening for colorectal neoplasia.

However, I propose that there is one situation in which performing this test maybe clinically useful. Using data from the authors the Likelihood Ratio for both the single FOBT and the 6-sample FOBT being positive is 7.5. Admittedly this did not occur very often, but I propose that clinicians should perform a rectal exam and FOBT when a patient presents with a positive 6-sample FOBT. One reason is to exclude a rectal mass and the second is that if the digital FOBT sample is also positive (using a LR of 7.5) the post-test probability of a colorectal neoplasm rises from about 10% to 45%.

In any situation a positive FOBT should be followed up with a colonoscopy, but faced with an approximately 50:50 chance of malignancy the situation I described gives the matter some urgency.

Yours truly

Christopher A. Smith, MD

Conflict of Interest:

None declared

The Role of the Fecal Occult Blood Test
Posted on February 26, 2005
Christian Jackson
Northwestern University
Conflict of Interest: None Declared

Feb.8, 2005

The Role of Fecal Occult Blood Test

TO THE EDITOR: We read with interest the article by Dr. Collins, et.al and the accompanying editorial by Dr. Sox(1,2).We share Dr. Sachs's concern that there has not been a more rapid decrease in colon cancer mortality associated with the emphasis on increased screening over the past 10 years. We think this is multifactorial. We should like to respond to these observations before the digital rectal examination stool for occult blood is abandoned. One reason for this might be the replacement of flexible sigmoidoscopy for total colonoscopy for people of low risk for colon carcinoma. With the exception of the Veterans Administration Health systems, this practice has produced a chasm between those that can afford total colonoscopy or insist upon it versus those who cannot.

A paucity of any screening intervention in the African-American and Hispanic populations is troubling because there are more datum available which show that African-Americans and Hispanics have an increased incidence in the diagnosis of colon cancer when compared to Caucasians(3,4).

One reason for this failure among these populations may be the abandonment of testing for fecal occult blood. The authors stress that one stool analysis obtained by rectal examination showed a very low sensitivity for the detection of advanced neoplasia when compared to three stools spontaneously passed. The authors do not stress the fact that fecal occult blood testing is done annually, and that many of these advanced neoplasms would be picked up on subsequent annual examinations, no matter what aspect of the stool is tested. We therefore support any and all fecal occult blood testing, with the caveat that rectally obtained stool should be used only if stool is obtained and should not be tested if visible blood is present. Some screening is better than no screening at all.

Christian S. Jackson M.D. Robert Craig M.D. Northwestern University, Feinberg School of Medicine Chicago,IL 60611-290

References 1.Collins, Judith F. MD; Lieberman, David A. MD; Durbin, Theodore E. MD; Weiss, David G. PhD. Accuracy of Screening for Fecal Occult Blood on a Single Stool Sample Obtained by Digital Rectal Examination: A Comparison with Recommended Sampling Practice. Annals of Internal Medicine.2005;142(2):81-85

2.Sox, Harold C. Office-Based Testing for Fecal Occult Blood: Do Only in Case of Emergency.Annals of Internal Medicine. 2005;142(2):146-148

3.Jemal A, Murray T, Samuels A, et.al Cancer statistics, 2003. CA Cancer J Clin. 2003; 53:5-26

4.Chao A, Gilliland F, Hunt W, Bulterys M, Becker T, Key C. Increasing incidence of colon and rectal cancer among Hispanics and American Indians in New Mexico( United States),1969-94.Cancer Causes and Control.1998;9:137-144

Conflict of Interest:

None declared

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Summary for Patients

What Is the Best Way To Test for Colorectal Cancer?

The summary below is from the full report titled “Accuracy of Screening for Fecal Occult Blood on a Single Stool Sample Obtained by Digital Rectal Examination: A Comparison with Recommended Sampling Practice.” It is in the 18 January 2005 issue of Annals of Internal Medicine (volume 142, pages 81-85). The authors are J.F. Collins, D.A. Lieberman, T.E. Durbin, D.G. Weiss, and the Veterans Affairs Cooperative Study #380 Group.


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