Enhancing Use and Quality of Colorectal Cancer Screening: Systematic Review Protocol

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Appendix A. Colorectal Cancer (CRC) Screening Systematic Review Project: Draft Indicators of Use and Quality

Suggested screening strategies for people ages 50 to 75 years at average risk (USPSTF, 2008). [Note: We will examine these strategies in two ways. The first is just what percentage in the appropriate population has been screened in the suggested time. The other assumes that no one should have screening without a discussion of options first. That starts with what percentage of people in the appropriate groups have had a discussion; then, of those, how many have had actual screening.]
1. Colonoscopy every 10 years.
2. Sigmoidoscopy every 5 years.
3. Home-based fecal occult blood test using guaiac (gFOBT), SENSA, or fecal immunochemical testing (FIT) every year.
4. Sigmoidoscopy every 5 years and SENSA/FIT every 5 years and once in between.
Other strategies to examine (not recommended by USPSTF; uncertain interval):
1. Computed tomography (CT) colonography.
2. DNA stool tests.
Screening and surveillance for individuals with a history of polyps at prior colonoscopy (from U.S. Multi-Society Task Force [USMSTF] as described in Winawer, et al., 2006 and Levin, et al., 2008):
1. Patients with 1-2 tubular adenomas <1.0 cm with low-grade dysplasia: colonoscopy at 5-10 years; if negative, usual screening.
2. Patients with at least one adenoma >1 cm or any adenoma with villous features or high-grade dysplasia, or 3-10 small adenomas <1.0 cm: colonoscopy at 3 years; if negative or small adenomas, colonoscopy at 5 years.
3. Patients with >10 small adenomas on a single exam: colonoscopy in 3 years or less.
4. Patients with sessile adenomas that are removed piecemeal: colonoscopy within 2-6 months to verify complete removal; subsequent surveillance individualized.

Indicators of "use"

Indicator No.	Indicator	Rationale or Reference
1a.	Percentage of eligible people who seek screening, refuse screening, or were advised to be screened	Indicator of patient and provider interest
1b.	Percentage of people ages 50-75 at average risk who have had any A strategies (with/without discussion) in most recent appropriate interval	(USPSTF, 2008)
1c.	Percentage of African-Americans ages 45 to 49 having screening	Controversial suggestion about screening age, not recommended by USPSTF
2.	Percentage of people ages 50-75 who have had "adequate" screening (defined by receiving A strategies) over entire past 10 years	For tests other than colonoscopy, this is a more valid measure of adequate screening than one time, recent testing
3.	Percentage of people with positive FOBT (any type) who had work-up colonoscopy within 6 months (work-up is part of screening cascade)	No benefit if + tests are not worked up
4.	Percentage of people with adenomatous polyp of 1.0 cm or larger found at sigmoidoscopy who had a work-up colonoscopy within 6 months of screening	Submaximal benefit if + tests are not worked up; size of adenoma is most important risk factor for cancer
5.	Percentage of people with adenomatous polyp either 1.0 cm or larger, or smaller adenomatous polyp with high-grade dysplasia or villous features, found at sigmoidoscopy, who had work-up colonoscopy within 6 months of screening	Submaximal benefit if + tests are not worked up; many include high-grade dysplasia or villous features into concept of "advanced adenoma"
6.	Percentage of people who have been given any type of FOBT and returned cards within 6 months	No benefit unless FOBT test is completed
7.	Percentage of people who have a history of polyps at prior colonoscopy with C surveillance (first time)	(Winawer, et al., 2006); concern that polyp may recur if not completely removed; concern that individual may have higher risk of developing new significant polyps or cancer

Indicators of "quality"

Indicator Category	Indicator No.	Indicator	Rationale or Reference
Underuse	8.	Percentage of people not meeting "use" indicators, including nondiscussion	(USPSTF, 2008)
Overuse	9.	Percentage of people <age 50 without high-risk condition having screening	(USPSTF, 2008)
	10a.	Percentage of people age 75 to 85 with no previous history of CRC or recent (5 years) polyp >1.0 cm having routine screening, without assessment of need and discussion (e.g., tailoring)	(USPSTF, 2008)
	10b.	Percentage of people >age 85 who are currently being screened	(USPSTF, 2008)
	11.	Percentage of people having polypectomy for lesions <6 mm; rate of biopsy/polypectomy for lesions >6 mm; percentage of biopsies/polypectomies for lesions <6 mm	The use of villous elements and high-grade dysplasia as part of the definition of "advanced adenoma" is under debate (See, e.g., Am J Gastroenterol 2008;103:1327-33, NEJM 2007;357:1403-12, and Cancer 2007;109:2213-21); many biopsies and some complications could potentially be avoided if polyps <6 mm were not biopsied
	12.	Percentage of biopsies with pathology not reporting polyps or cancer	If endoscopists are attempting to detect very small polyps, they may sometimes biopsy areas that are not polyps at all
	13a.	Surveillance more frequent than C guidelines	(Winawer, et al., 2006); there is some evidence that surveillance is being done too often, with insufficient expected benefit
	13b.	Surveillance for lesions not deserving of surveillance (1-2 tubular adenomas <1 cm without villous features without high-grade dysplasia)	(Winawer, et al., 2006)
Misuse	14.	Low positivity rate for FOBT	Suggests inadequate development or use of inadequate cards
	15.	Use of in-office FOBT	(Levin, et al., 2008)
	16.	Other gFOBT or FIT quality issues: Nonadherence to discontinuing use of nonsteroidal anti-inflammatory drugs (NSAIDs) 7 days prior to gFOBT (unless for cardioprotective regimen) Rehydration of FOBT Follow up of positive stool test (gFOBT, FIT) with any test other than colonoscopy unless patient refuses colonoscopy	(Levin, et al., 2008)
	17.	Use of FOBT in post-polypectomy surveillance	(Winawer, et al., 2006)
	18.	Flexible sigmoidoscopy (FSIG)/colonoscopy quality issues:	(Levin, 2005; Levin, et al., 2008; Rex, 2006; Lieberman, 2007)
	18a.	Adequate documentation of all lesions found on FSIG, allowing the colonoscopist to complete removal of lesions
	18b.	Average depth of FSIG/colonoscope Insertion stating whether level reached is maximal insertion or after straightening the endoscope
	18c.	Documentation in endoscopic report of depth of insertion in cm
	18d.
	18e.	Documentation of quality of bowel preparation
	18f.	Complication, perforation, surgery, hospitalization, severe bleeding; bleeding requiring transfusion rates following procedure with or without biopsy and polypectomy
	18g.
	18h.	Patient discomfort rates
	18i.	Patient problems from preparation
	18j.	Patient time required from usual occupation, activities
	18k.	Appropriate training of endoscopists
	18l.	Satisfactory exam rates to beyond 40 cm (FSIG) or to cecum (colonoscopy)
	18m.	Adenoma detection rates Adequate withdrawal time; withdrawal time documented Adequate training of endoscopist
	19.	Follow up of positive sigmoidoscopy by any means other than colonoscopy unless patient refuses colonoscopy	(Levin, et al., 2008)

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