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Appendix J
Recent Findings on Test Performance Brian P.Mulhall, M.D., M.P.H.

SLIDE 1

SLIDE 1 NOTES: I was asked to cover recent evidence on test performance for all the major colorectal cancer screening tests.

I tried to take a meta-analytic approach to every test I examined, but was frustrated by the quality, quantity and heterogeneity of the various studies examining each individual test. So, my review will be largely descriptive, followed by a summary of what, in my opinion, we know about the various tests.



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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary Appendix J Recent Findings on Test Performance Brian P.Mulhall, M.D., M.P.H. SLIDE 1 SLIDE 1 NOTES: I was asked to cover recent evidence on test performance for all the major colorectal cancer screening tests. I tried to take a meta-analytic approach to every test I examined, but was frustrated by the quality, quantity and heterogeneity of the various studies examining each individual test. So, my review will be largely descriptive, followed by a summary of what, in my opinion, we know about the various tests.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 2 SLIDE 2 NOTES: Here is a list of what I consider tests that are viable for colorectal cancer screening. They begin with FOBTs and barium enema. These are to some extent viewed by both clinicians and the public as part of the past. Flexible sigmoidoscopy and, more importantly, colonoscopy, are where clinicians and the public currently see the state-of-the-art for colorectal cancer screening. Virtual colonoscopy and Stool DNA tests are largely in the future, from an operational point of view, though they have recently received a good amount of attention in the press.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 3 SLIDE 3 NOTES: Fecal Occult Blood Tests (FOBTs) have been in use for several decades and provide some of the best data supporting the indication for CRC screening in order to prevent colorectal cancer (Ederer et al., 1997; Mandel et al., 1993). There are over a half-dozen different tests that are GUAIAC-based and even more that have been developed using immunochemical assays to address some of the limitations of GUAIAC-based stool studies Fecal occult blood tests can also be immunological (e.g., HemoQuant). Ideally, we would want to see a study that compares all of these various types of tests head-to-head. In the mid-1990’s Dr. Gopalswamy and colleagues attempted to do just that. (See this slide.) Unfortunately, that study suffers from a too-small sample size as well as uncertainty about the definition of the outcome measures used. Consequently, we are left with a variety of studies of individual tests and must try to compare their outcomes.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 4 SLIDE NOTES 4: FOBTs—There is a range of results reported for the GUAIAC-based stool studies, with sensitivity for detection of polyps ranging from 5–98% and sensitivity for detection of cancer of 18–92 percent. Specificity for cancer and/or polyps ranges from 90–100 percent, but large cohort studies emphasize that a significant number of CRCs are missed by FOBTs (Bouvier et al., 2001; Lieberman et al., 2001). Results differ based on the design of the study, number of tests used, method of follow-up and the cut-off used for positive results, for example, all adenomas, adenomas > 1 cm or actual colorectal cancer (Brevinge et al., 1997; Favennec, 1992; Gopalswamy et al., 1994; Greenberg et al., 2000; Hope et al., 1996; Kewenter et al., 1988; Ko et al., 2003; Niv et al., 1995; Rockey et al., 1998; Rosen et all., 1997; Sung et al., 2003). In general, the overall sensitivity of GUAIAC-based FOBTs is low and they are frequently positive as a result of upper gastrointestinal lesions (Lieberman et al., 2001; Rockey et al., 1998). There is no clearly superior test among the FOBT alternatives, but rehydration of FOBTs does appear to improve sensitivity in several studies but decreases the specificity (Kewenter et al., 1988; Walter et al., 1991).

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 5 SLIDE 5 NOTES: IFOBTS—There is a broad range of results for Immunochemical FOBTs (IFOBTs) impacted by the number of studies used, the population screened, the ‘gold standard’ used and the lesion (and size) used to define a positive result (Gopalswamy et al., 1994; Greenberg et al, 2000; Ito et al, 1996; Jeanson et al, 1994; Ko et al., 2003; Miyoshi et al., 2000; Nakama et al., 1997; Nakama et al., 1999; Nakama et al., 2001; Rosen et al., 1997; Rosen et al., 2000; Rosen et al., 1995; Sieg et al., 1998; Wong et al., 2003). For IFOBTs, the range of sensitivities for detection of polyps ranges from 4–98 percent and for colorectal cancer ranges from 18–100 percent. Reported specificity for CRC is generally greater than 95 percent. Based on the review of the literature, there is also no clearly superior IFOBT at present time, but it does appear to have improved performance characteristics compared to GUAIC-based FOBTs in a number of studies. A recent study has argued against the assertion that IFOBTs are superior to FOBTs (Ko, et al., 2003), and others have also not demonstrated a conclusive advantage (Rosen et al. 1997; Rosen et al., 2000).

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 6 SLIDE 6 NOTES: A new article published by Ko and colleagues (Ko et al., 2003) looked at a population of veterans at varied risk for colorectal cancer, almost all male. The purpose of the study was to compare the overall performance of IFOBTs and FOBTs. In this study, 3,000 of each test type were ordered, but only half of those in each group were returned by the patient. That equates to a 48 percent return rate. That rate is consistent with other studies in our population. Of those who had a positive result on the test, only 66 percent were referred to colonoscopy, and of that number, only 50 percent actually received that colonoscopy. Dr. Ko’s study showed that the overall Positive Predictive Value (PPV) of IFOBT and FOBT for either adenomas or cancers was about the same. For large adenomas or cancer, IFOBT was not as good as FOBT, but the difference was not statistically significant.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 7 SLIDE 7 NOTES: Barium Enema—Though more widely used in the past, double-contrast barium enema (DCBE) has fallen out of favor with primary care providers, radiologists and gastroenterologists. The reason for this bias against BE is unclear, but may be related to published concerns about sensitivity (Rex et al., 1997). Over 60 studies have looked at DCBE in a variety of settings. Studies that have examined symptomatic or high-risk patients, have determined that BE has sensitivity for polyps of 48–100 percent and for CRC of 62–100 percent (Glick et al., 1998; deZwart et al., 2001). Retrospective studies in cohorts of patients known to have CRC have shown that DCBEs done prior to the eventual diagnosis were 70–96 percent sensitive for CRC (Jensen et al., 1990; Johnson et al., 1983; Loose et al., 1974; Rex et al., 1997). Though no study has been done in a truly asymptomatic, average-risk screening population, the studies that have examined patients undergoing surveillance for polyps or in those with positive findings on previous studies have demonstrated a sensitivity of 30–81 percent, varying greatly depending on the size threshold used for detection of polyps (Steine et al., 1993; Saito et al., 1989; Brewster et al., 1994). Sensitivity for CRC was 80 percent in one study (Kewenter et al., 1995). There is limited data on the specificity of DCBE, but one study that evaluated tagged polyps determined the specificity for polyps > 10 mm to be 96 percent (Rex et al., 1986). Several additional studies showed the sensitivity to be 90–96 percent for polyps, depending on size thresholds, and for cancer or polyps the sensitivity was 98 percent in one study (Williams et al., 1974). In general, the gold standard in these studies was optical colonoscopy or flexible sigmoidoscopy (for left-sided lesions).

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary One study that compared DCBE to Flexible Sigmoidoscopy showed a clear superiority for Flexible Sigmoidoscopy (sensitivity for CRC 62 percent vs. 85 percent, whole bowel vs. rectosigmoid visualization, respectively) (Jensen et al., 1990). When used in combination, these studies had a sensitivity of 96 percent for all neoplasms > 1 cm and a specificity of 99 percent. Performance may be improved with multiple readings (Markus et al., 1990). There are many biases inherent to the studies of DCBE for detection of polyps and cancer, most that would have biased estimates of sensitivity upwards (Glick et al., 1998). The most important deficit in the literature regarding this technology is the lack of studies on test performance in average-risk screening populations. Nonetheless, the studies cited suggest acceptable sensitivity and specificity that make the inadequate study of, and under-utilization of, this screening modality perplexing. In summary, I would suggest that the sensitivity of the DCBE is somewhere in the 50–70 percent range for polyps, and perhaps higher than that for cancer. The specificity is 80 percent plus if you look at polyps and cancers combined.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 8 SLIDE 8 NOTES: Flexible Sigmoidoscopy: This test has long been used for CRC screening, but has obvious limitations based on the length of insertion of the traditional Flexible Sigmoidoscopy (FlexSig) endoscope. It limits examination to the rectosigmoid, as fewer than 50 percent of FlexSigs are able to examine beyond the sigmoid colon (Ott et al., 1982; Osgard et al., 1998; Painter et al., 1999; Stewart et al., 1999). A great number of well-designed studies have examined the performance of this test, and it has a proven ability to reduce the incidence of CRC and improve mortality (Brenner et al., 2001; Newcomb et al., 2003; Walsh et al. 2003; Wherry et al., 1994). As such, data from FlexSig studies has been extrapolated to support the efficacy of Colonoscopy (Khullar et al., 1997; Rex et al., 2002). In summary, overall sensitivity is probably 60 to 70 percent, but sensitivity for distal lesions within the reach of the FlexSig, it is in the 85 to 95 percent range, and specificity is reasonably high at 85 to 98 percent.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 9 SLIDE 9 NOTES: Colonoscopy—Long considered the ‘gold standard’ for CRC screening, this test provides visualization of the entire colon and allows for removal of specimens for histopathologic assessment. Because it has been the intervention that has followed most of the aforementioned tests, the reduction in CRC and mortality from cancer has been attributed to colonoscopy. Its sensitivity compared to radiographic studies and autopsy findings has been reported to range from 80–100 percent for CRC and from 70–100 percent for polyps (Brewster et al., 1994; Irvine et al., 1988; Pickhardt et al., 2003; Postic et al., 2002; Saito et al., 1989). Colonoscopy has a miss rate for colonic polyps ranges from 0 to 27 percent, but ranges according to size of the adenoma or cancer used as criteria and the endoscopic technique (Hixson et al., 1990; Hixson et al., 1991; Leinicke et al., 1977; Rex et al., 1997; Rex et al., 2000; Sheheda et al., 2002). The cecum cannot be reached in 0 to 18 percent of cases (Cirocco and Rusin, 1995; Lichtenstein et al., 1999; Nelson et al., 2002; Obrecht et al. 1984; Shumaker et al., 2002). Because there has been no clear standard against which to compare colonoscopy, its true specificity has not been adequately described. However, using radiographic methods and segmentally unblinded colonoscopy, we can estimate that the specificity of colonoscopy is in the range of 90–98 percent. Use of chromoendoscopy may improve performance characteristics of colonoscopy (Eisen et al., 2002; Kiesslich et al., 2001; Lee et al., 2003; Tsuda et al., 2002).

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary To summarize, sensitivity for polyps is somewhat greater than 75 percent, and for cancer, closer to 100 percent. Specificity for polyps is unknown; for cancer it is in the 90–96 percent range. SLIDE 10 SLIDE 10 NOTES: STOOL DNA—Stool DNA is a provocative new technology. Its development was based on a number of observations about the natural history of colorectal cancer. The progression of normal colonic mucosa through a series of mutational events that eventually leads to dysplastic and later neoplastic tissue is well-described. Dysplastic tissues exfoliate intact viable colonocytes. Those colonocytes have a representative genetic signature, and may manifest some of these abnormalities. The observation of this process has led to studies attempting to isolate either individual or combined sets of tumor markers from stool in order to define the risk of colorectal cancer in populations. Most studies to date have focused on groups with known colorectal cancer or those at higher risk.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 24 SLIDE 24 NOTES: This table shows the broad range of sensitivity and specificity for polyps and cancer across all of the technologies reviewed here.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 25 SLIDE 25 NOTES: No notes.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 26 SLIDE 26 NOTES: To summarize the entire literature, I would say that at present we have no clear gold standard for overall analysis. However, the segmentally unblinded colonoscopy using complementary studies is probably the best approach to defining the gold standard. FOBTs and IFOBTs have a wide range of sensitivity, but even at low sensitivity, they have demonstrated a benefit in reducing colorectal cancer. Although barium enema has acceptable sensitivity and specificity, it is in my opinion a technology on the wane, with fewer people trained to perform the procedure. Colonoscopy has high sensitivity and specificity, but it is impacted by a significant miss rate, incomplete examinations and complications. Virtual colonoscopy still has a broad range of sensitivity and specificity, and practical issues such as the hardware and software used, the inter-observer reliability, and radiologist training has to be addressed before it is ready for prime time.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary SLIDE 27 SLIDE 27 NOTES: No notes. REFERENCES Adamsen, S. and O.Kronborg, Acceptability and compliance in screening for colorectal cancer with fecal occult blood test. Scand J Gastroenterol, 1984. 19(4): p. 531–4. Ahlquist, D.A. and A.P.Shuber, Stool screening for colorectal cancer: evolution from occult blood to molecular markers. Clinica Chimica Acta, 2002. 315(1–2): p. 157–68. Ahlquist, D.A., J.E.Skoletsky, K.A.Boynton, J.J.Harrington, D.W.Mahoney, W.E.Pierceall, S.N.Thibodeau, and A.P.Shuber, Colorectal cancer screening by detection of altered human DNA in stool: feasibility of a multitarget assay panel. Gastroenterol, 2000. 119(5): p. 1219–27. Ahlquist, D.A., Molecular stool screening for colorectal cancer. Using DNA markers may be beneficial, but large scale evaluation is needed. BMJ, 2000. 321(7256): p. 254–5. Beeker, C., J.M.Kraft, B.G.Southwell, et al., Colorectal cancer screening in older men and women: qualitative research findings and implications for intervention. J Community Health, 2000. 25(3): p. 263–78.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary Bond, J.H., Colorectal Cancer Update. Prevention, Screening, Treatment and Surveillance for High-Risk Groups. Med Clin N Am, 2000. 84: p. 1163–82. Bouvier, V., C.Herbert, H.Lefevre, and G.Launoy, Stage of extension and treatment for colorectal cancer after a negative test and among non-responders in mass screening with guaiac faecal occult blood test: a French experience. Eur J Cancer Prev, 2001. 10(4): p. 323–326. Boyle, P., D.G.Zaridze, and M.Smans, Descriptive epidemiology of colorectal cancer. Int J Cancer, 1985. 36: p. 9–15. Brenes, G.A. and E.D.Paskett, Predictors of stage of adoption for colorectal cancer screening. Prev Med, 2000. 31(4): p. 410–6. Brenner, H., V.Arndt, T.Sturmer, C.Stegmaier, H.Ziegler, and G.Dhom, Long-lasting reduction of risk of colorectal cancer following screening endoscopy. Br J Cancer, 2001. 85(7): p. 972–6. Brevinge, H., E.Lindholm, S.Buntzen, and J.Kewenter, Screening for colorectal neoplasia with faecal occult blood testing compared with flexible sigmoidoscopy directly in a 55–56 years’ old population. Int J Colorectal Dis, 1997. 12(5): p. 291–5. Brewster, N.T., D.C.Grieve, and J.H.Saunders, Double-contrast barium enema and flexible sigmoidoscopy for routine colonic investigation. Br J Surg, 1994. 81(3): p. 445–7. Byrne, M.F., Primary Screening With Colonoscopy for Colorectal Cancer: A Targeted Algorithm? Am J Gastroenterol, 2003. 98(12): p. 2587–8. Chu, K.C., R.E.Tarone, W.H.Chow, B.F.Hankey, and L.A.Ries, Temporal patterns in colorectal cancer incidence, survival, and mortality from 1950 through 1990. [see comment]. J Natl Cancer Inst, 1994. 86(13): p. 997–1006. Cirocco, W.C. and L.C.Rusin, Factors that predict incomplete colonoscopy. Dis Colon Rect, 1995. 38(9): p. 964–8. Cooper, G.S., Z.Yuan, A.Chak, and A.A.Rimm, Patterns of endoscopic follow-up after surgery for nonmetastatic colorectal cancer. Gastrointest Endosc, 2000. 52(1): p. 33–8. Dachman, A.H., Diagnostic performance of virtual colonoscopy. Abdom Imaging, 2002. 27(3): p. 260–7. de Zwart, I.M., G.Griffioen, M.P.Shaw, C.B.Lamers, and A.de Roos, Barium enema and endoscopy for the detection of colorectal neoplasia: sensitivity, specificity, complications and its determinants. Clin Radiol, 2001. 56(5): p. 401–9. Drenth, J.P., F.M.Nagengast, and W.J.Oyen, Evaluation of (pre-)malignant colonic abnormalities: endoscopic validation of FDG-PET findings. Eur J Nucl Med, 2001. 28(12): p. 1766–9. Ederer, F., T.R.Church, and J.S.Mandel, Fecal occult blood screening in the Minnesota study: role of chance detection of lesions. [see comment]. J Natl Cancer Inst, 1997. 89(19): p. 1423–8. Eisen, G.M., C.Y.Kim, D.E.Fleischer, R.A.Kozarek, D.L.Carr-Locke, T.C.Li, C.J.Gostout, S.J.Heller, E.A.Montgomery, F.H.Al-Kawas, J.H.Lewis, and S.B.Benjamin, High-resolution chromoendoscopy for classifying colonic polyps: a multicenter study. Gastrointest Endosc, 2002. 55(6): p. 687–94. Erban, S., J.Zapka, E.Puleo, and M.Vickers-Lahti, Colorectal cancer screening in Massachusetts: measuring compliance with current guidelines. Eff Clin Pract, 2001. 4(1): p. 10–7. Favennec, L., N.Kapel, D.Meillet, C.Chochillon, and J.G.Gobert, Detection of occult blood in stools: comparison of three gaiac tests and a latex agglutination test. [erratum appears in Ann Biol Clin (Paris) 1992. 50(8):618]. Ann Biol Clin (Paris), 1992. 50(5): p. 311–3. Gann, P.H., J.E.Manson, R.J.Glynn, et al., Low-dose aspirin and incidence of colorectal tumors in a randomized trial. J Natl Cancer Inst, 1993. 85(15): p. 1220–24.

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Economic Models of Colorectal Cancer Screening in Average-Risk Adults: Workshop Summary Giovanucci, E., E.B.Rimm, M.J.Stampfer, et al., Aspirin use and the risk of colorectal cancer and adenoma in male health professionals. Ann Intern Med, 1994. 121: p. 241–8. Glick, S., J.L.Wagner, and C.D.Johnson, Cost-effectiveness of double-contrast barium enema in screening for colorectal cancer. AJR. Am J Roengenol, 1998. 170(3): p. 629–36. Gluecker, T., G.Dorta, W.Keller, P.Jornod, R.Meuli, and P.Schnyder, Performance of multidetector computed tomography colonography compared with conventional colonoscopy. Gut, 2002. 51(2): p. 207–11. Gopalswamy, N., H.P.Stelling, R.J.Markert, H.N.Maimon, S.D.Wahlen, and R.I.Haddy, A comparative study of eight fecal occult blood tests and HemoQuant in patients in whom colonoscopy is indicated. Arch Fam Med, 1994. 3(12): p. 1043–8. Greenberg, P.D., L.Bertario, R.Gnauck, O.Kronborg, J.D.Hardcastle, M.S.Epstein, D. Sadowski, R.Sudduth, G.R.Zuckerman, and D.C.Rockey, A prospective multicenter evaluation of new fecal occult blood tests in patients undergoing colonoscopy. Am J Gastroenterol, 2000. 95(5): p. 1331–8. Greenlee, R.T., M.B.Hill-Harmon, T.Murray, et al., Cancer Statistics, 2001. CA Cancer J Clin, 2001(51): p. 15–36. Hixson, L.J., M.B.Fennerty, R.E.Sampliner, and H.S.Garewal, Prospective blinded trial of the colonoscopic miss-rate of large colorectal polyps. Gastrointest Endosc, 1991. 37(2): p. 125–7. Hixson, L.J., M.B.Fennerty, R.E.Sampliner, D.McGee, and H.Garewal, Prospective study of the frequency and size distribution of polyps missed by colonoscopy. J Natl Cancer Inst, 1990. 82(22): p. 1769–72. Hope, R.L., G.Chu, A.H.Hope, R.G.Newcombe, P.E.Gillespie, and S.J.Williams, Comparison of three faecal occult blood tests in the detection of colorectal neoplasia. Gut, 1996. 39(5): p. 722–5. Irvine, E.J., J.O’Connor, R.A.Frost, P.Shorvon, S.Somers, G.W.Stevenson, and R.H.Hunt, Prospective comparison of double contrast barium enema plus flexible sigmoidoscopy v colonoscopy in rectal bleeding: barium enema v colonoscopy in rectal bleeding. [comment]. Gut, 1988. 29(9): p. 1188–93. Itoh, M., K.Takahashi, H.Nishida, K.Sakagami, and T.Okubo, Estimation of the optimal cut off point in a new immunological faecal occult blood test in a corporate colorectal cancer screening programme. J Med Screen, 1996. 3(2): p. 66–71. Jeanson, A., J.Jamart, J.M.Maisin, R.Vanheuverzwyn, P.Gohy, J.C.Debongnie, and B. Rentier, Assessment of the new immunological test Hemoblot for detecting occult blood in faeces. Eur J Cancer Prev, 1994. 3(5): p. 407–12. Jensen, J., J.Kewenter, M.Asztely, G.Lycke, and J.Wojciechowski, Double contrast barium enema and flexible rectosigmoidoscopy: a reliable diagnostic combination for detection of colorectal neoplasm. Br J Surg, 1990. 77(3): p. 270–2. Johnson, C.D., A.Y.Toledano, B.A.Herman, A.H.Dachman, E.G.McFarland, M.A.Barish, J.A.Brink, R.D.Ernst, J.G.Fletcher, R.A.Halvorsen, Jr., A.K.Hara, K.D.Hopper, R.E. Koehler, D.S.Lu, M.Macari, R.L.Maccarty, F.H.Miller, M.Morrin, E.K.Paulson, J. Yee, M.Zalis, and American College of Radiology Imaging Network, Computerized tomographic colonography: performance evaluation in a retrospective multicenter setting. Gastroenterol, 2003. 125(3): p. 688–95. Johnson, C.D., H.C.Carlson, W.F.Taylor, and L.P.Weiland, Barium enemas of carcinoma of the colon: sensitivity of double- and single-contrast studies. AJR Am J Roentgenol, 1983. 140(6): p. 1143–9. Johnson, C.D., W.S.Harmsen, L.A.Wilson, R.L.Maccarty, T.J.Welch, D.M.Ilstrup, and D.A.Ahlquist, Prospective blinded evaluation of computed tomographic colonography for screen detection of colorectal polyps, [comment]. Gastroenterol, 2003. 125(2): p. 311–9.

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