Cost Effectiveness of Fecal DNA Screening for Colorectal Cancer: A Systematic Review and Quality Appraisal of the Literature
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Fecal DNA (fDNA) testing is a noninvasive potential alternative to current colorectal cancer screening tests.
We conducted a systematic review and quality assessment of studies of cost-effectiveness of fDNA as a colorectal cancer screening tool (compared with no screening and other screening modalities), and identified key variables that impinged on cost-effectiveness.
We searched MEDLINE, Embase, and the Centre for Reviews and Dissemination for cost-effectiveness studies of fDNA-based screening, published in English by September 2011.
Studies that undertook an economic evaluation of fDNA, using either a cost-effectiveness or cost-utility analysis, compared with other relevant screening modalities and/or no screening were included. Additional inclusion criteria related to the presentation of data pertaining to model variables including time horizon, costs, fDNA performance characteristics, screening uptake, and comparators. A total of 369 articles were initially identified for review. After removing duplicates and applying inclusion and exclusion criteria, seven articles were included in the final review.
Data was abstracted on key descriptor variables including screening scenarios, time horizon, costs, test performance characteristics, screening uptake, comparators, and incremental cost-effectiveness ratios. Quality assessment was undertaken using a standard checklist for economic evaluations. Studies cited by cost-effectiveness articles as the source of data on fDNA test performance characteristics were also reviewed.
Seven cost-effectiveness studies were included, from the USA (4), Canada (1), Israel (1), and Taiwan (1). Markov models (5), a partially observable Markov decision process model (1) and MISCAN and SimCRC (1) microsimulation models were used. All studies took a third-party payer perspective and one included, in addition, a societal perspective. Comparator screening tests, screening intervals, and specific fDNA tests varied between studies. fDNA sensitivity and specificity parameters were derived from 12 research studies and one meta-analysis. Outcomes assessed were life-years gained and quality-adjusted life-years gained. fDNA was cost-effective when compared with no screening in six studies. Compared with other screening modalities, fDNA was not considered cost-effective in any of the base-case analyses: in five studies it was dominated by all alternatives considered. Sensitivity analyses identified cost, compliance, and test parameters as key influential parameters. In general, poor presentation of “study design” and “data collection” details lowered the quality of included articles.
Although the literature searches were designed for high sensitivity, the possibility cannot be excluded that some eligible studies may have been missed. Reports (such as Health Technology Assessments produced by government agencies) and other forms of grey literature were excluded because they are difficult to identify systematically and/or may not report methods and results in sufficient detail for assessment.
On the basis of the available (albeit limited) evidence, while fDNA is cost-effective when compared with no screening, it is currently dominated by most of the other available screening options. Cost and test performance appear to be the main influences on cost-effectiveness.
- Lieberman, D (2010) Progress and challenges in colorectal cancer screening and surveillance. Gastroenterology 138: pp. 2115-2126 CrossRef
- Ferlay, JP, Parkin, DM, Steliarova-Foucher, E (2010) Estimates of cancer incidence and mortality in Europe in 2008. EJC 46: pp. 765-781 CrossRef
- Richter, S (2008) Fecal DNA screening in colorectal cancer. Can J Gastroenterol 22: pp. 631-633
- Kanavos, P, Schurer, W (2010) The dynamics of colorectal cancer management in 17 countries. Eur J Health Econ 10: pp. S115-S129 CrossRef
- Hoff, G, Dominitz, JA (2010) Contrasting US and European approaches to colorectal cancer screening: which is best?. Gut 59: pp. 407-414 CrossRef
- Levin, B, Lieberman, DA, McFarland, B (2008) Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA Cancer J Clin 58: pp. 130-160 CrossRef
- Rex, DK, Johnson, DA, Anderson, JC (2009) American College of Gastroenterology guidelines for colorectal cancer screening 2009 (corrected). Am J Gastroenterol 104: pp. 739-750 CrossRef
- Whitlock, EP, Lin, JS, Liles, E (2008) Screening for colorectal cancer: a targeted, updated systematic review for the US Preventive Services Task Force. Ann Intern Med 149: pp. 638-658 CrossRef
- U.S. Preventive Services Task Force. Screening for colorectal cancer: US preventive services task force recommendation statement. Ann Intern Med. 2008;149(9):627–637.
- von Karsa L, Julietta P, Segnan N. European guidelines for quality assurance in colorectal screening and diagnosis, 1st edn. (Executive summary): XXXVI–XLVIII.
- Itzkowitz, S, Brand, R, Jandorf, L (2008) A simplified, noninvasive stool DNA test for colorectal cancer detection. Am J Gastroenterol 103: pp. 2862-2870 CrossRef
- Ahlquist, DA (2009) Next-generation stool DNA testing: expanding the scope. Gastroenterology 136: pp. 2068-2073 CrossRef
- Loganayagam, A (2008) Faecal screening of colorectal cancer. Int J Clin Pract 62: pp. 454-459 CrossRef
- Lansdorp-Vogelaar, I, Knudsen, AB, Brenner, H (2011) Cost-effectiveness of colorectal cancer screening. Epidemiol Rev 33: pp. 88-100 CrossRef
- Kisiel, JB, Ahlquist, DA (2011) Stool DNA screening for colorectal cancer: opportunities to improve value with next generation tests. J Clin Gastroenterol 45: pp. 301-308 CrossRef
- Pharmacoeconomics. Checklist for authors of modelling studies submitted to Pharmacoeconomics (online). http://adisonline.com/pharmacoeconomics/documents/PEC-modellingchecklist.pdf. Accessed 12 Dec 2011.
- Pharmacoeconomics (online). http://adisonline.com/pharmacoeconomics/Documents/PEC-econ-eval-list.pdf.
- Song, K, Fendrick, AM, Ladabaum, U (2004) Fecal DNA testing compared with conventional colorectal cancer screening methods: a decision analysis. Gastroenterology 126: pp. 1270-1279 CrossRef
- Parekh, M, Fendrick, AM, Ladabaum, U (2008) As tests evolve and costs of cancer care rise: reappraising stool-based screening for colorectal neoplasia. Aliment Pharmacol Ther 27: pp. 697-712 CrossRef
- Lansdorp-Vogelaar, I, Kuntz, KM, Knudsen, AB (2010) Stool DNA testing to screen for colorectal cancer in the Medicare population: a cost-effectiveness analysis. Ann Intern Med 153: pp. 368-377 CrossRef
- Ahlquist, D, Sargent, D, Loprinzi, C (2008) Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med 149: pp. 441-450 CrossRef
- Ahlquist, DA, Skoletsky, JE, Boynton, KA (2000) Colorectal cancer screening by detection of altered human DNA in stool: feasibility of a multitarget assay panel. Gastroenterology 119: pp. 1219-1227 CrossRef
- Tagore, KS, Lawson, MJ, Yucaitis, JA (2003) Sensitivity and specificity of a stool DNA multitarget assay panel for the detection of advanced colorectal neoplasia. Clin Colorectal Cancer 3: pp. 47-53 CrossRef
- Imperiale, TF, Ransohoff, DF, Itzkowitz, SH (2004) Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population. N Engl J Med 351: pp. 2704-2714 CrossRef
- Wu, GH, Wang, YM, Yen, AM (2006) Cost-effectiveness analysis of colorectal cancer screening with stool DNA testing in intermediate-incidence countries. BMC Cancer 24: pp. 136 CrossRef
- Telford, JJ, Levy, AR, Sambrook, JC (2010) The cost-effectiveness of screening for colorectal cancer. CMAJ 182: pp. 1307-1313 CrossRef
- Ladabaum, U, Song, K (2005) Projected national impact of colorectal cancer screening on clinical and economic outcomes and health services demand. Gastroenterology 129: pp. 1151-1162 CrossRef
- Leshno, M, Halpern, Z, Arber, N (2003) Cost-effectiveness of colorectal cancer screening in the average risk population. Health Care Manag Sci 6: pp. 165-174 CrossRef
- ISPOR-Consolidated Health Economic Evaluation Reporting Standards (still in draft) (online). http://www.ispor.org/TaskForces/EconomicPubGuidelines.asp.
- Fan, JB, Chee, MS, Gunderson, KL (2006) Highly parallel genomic assays. Nat Rev Genet 7: pp. 632-644 CrossRef
- Wong CK, Fedorak RN, Prosser CI, et al. The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. Int J Colorectal Dis. 2012;27(12):1657–64.
- Allison, JE, Sakoda, LC, Levin, TR (2007) Screening for colorectal neoplasms with new fecal occult blood tests: update on performance characteristics. J Natl Cancer Inst 99: pp. 1462-1470 CrossRef
- Osborn, NK, Ahlquist, DA (2005) Stool screening for colorectal cancer: molecular approaches. Gastroenterology 128: pp. 192-206 CrossRef
- Exact sciences. Exact sciences 2010 annual report (online). http://investor.exactsciences.com/2010AR/index.html. Accessed 20 Oct 2011.
- Wilson J, Junger G. Principles and practice of screening for disease (online). http://whqlibdoc.who.int/php/WHO_PHP_34.pdf. Accessed 24 Jan 2012.
- Weller, D, Coleman, D, Robertson, R (2007) The UK colorectal cancer screening pilot: results of the second round of screening in England. Br J Cancer 97: pp. 1601-1605 CrossRef
- Kewenter, J, Brevinge, H, Engaras, B (1994) Results of screening, rescreening, and follow-up in a prospective randomized study for detection of colorectal cancer by fecal occult blood testing. Results for 68,308 subjects. Scand J Gastroenterol 29: pp. 468-473 CrossRef
- Kronborg, O, Fenger, C, Olsen, J (1996) Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 348: pp. 1467-1471 CrossRef
- Cole, SR, Young, GP (2001) Effect of dietary restriction on participation in faecal occult blood test screening for colorectal cancer. Med J Aust 175: pp. 195-198
- Deutekom, M, Rossum, LG, Rijn, AF (2010) Comparison of guaiac and immunological fecal occult blood tests in colorectal cancer screening: the patient perspective. Scand J Gastroenterol 45: pp. 1345-1349 CrossRef
- Hol, L, Leerdam, ME, Ballegooijen, M (2010) Screening for colorectal cancer: randomised trial comparing guaiac-based and immunochemical faecal occult blood testing and flexible sigmoidoscopy. Gut 59: pp. 62-68 CrossRef
- Whitney, D, Skoletsky, J, Moore, K (2004) Enhanced retrieval of DNA from human fecal samples results in improved performance of colorectal cancer screening test. J Mol Diagn 6: pp. 386-395 CrossRef
- Levin, B, Lieberman, DA, McFarland, B (2008) Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. Gastroenterology 134: pp. 1570-1595 CrossRef
- Schroy PC, 3rd, Lal S, Glick JT, et al. Patient preferences for colorectal cancer screening: how does stool DNA testing fare? Am J Manag Care. 2007;13(7):393–400.
- Itzkowitz, SH, Jandorf, L, Brand, R (2007) Improved fecal DNA test for colorectal cancer screening. Clin Gastroenterol Hepatol 5: pp. 111-117 CrossRef
- Duffy, MJ, Rossum, LG, Turenhout, ST (2011) Use of faecal markers in screening for colorectal neoplasia: a European group on tumor markers position paper. Int J Cancer 128: pp. 3-11 CrossRef
- Li, M, Chen, WD, Papadopoulos, N (2009) Sensitive digital quantification of DNA methylation in clinical samples. Nat Biotechnol 27: pp. 858-863 CrossRef
- Zou, H, Taylor, WR, Harrington, JJ (2009) High detection rates of colorectal neoplasia by stool DNA testing with a novel digital melt curve assay. Gastroenterology 136: pp. 459-470 CrossRef
- Cost Effectiveness of Fecal DNA Screening for Colorectal Cancer: A Systematic Review and Quality Appraisal of the Literature
Applied Health Economics and Health Policy
Volume 11, Issue 3 , pp 181-192
- Cover Date
- Print ISSN
- Online ISSN
- Springer International Publishing
- Additional Links
- Industry Sectors