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Multitarget stool DNA testing for the prevention of colon cancer: outcomes in a large integrated healthcare system

  • Nimish Vakil
    Correspondence
    Reprint requests: Nimish Vakil, MD, Aurora Medical Center Summit, 36500 Aurora Dr, Summit, WI 53066.
    Affiliations
    Department of Medicine, Division of Gastroenterology, University of Wisconsin School of Medicine and Public Health, Madison Wisconsin, USA

    Department of Medicine, Division of Gastroenterology, Advocate Aurora Health, Milwaukee Wisconsin, USA
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  • Kristin Ciezki
    Affiliations
    Department of Medicine, Division of Gastroenterology, Advocate Aurora Health, Milwaukee Wisconsin, USA
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  • Nadia Huq
    Affiliations
    Department of Medicine, Division of Gastroenterology, Advocate Aurora Health, Milwaukee Wisconsin, USA
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  • Maharaj Singh
    Affiliations
    Department of Medicine, Division of Gastroenterology, Advocate Aurora Health, Milwaukee Wisconsin, USA

    Department of Biostatistics, Marquette University, Milwaukee Wisconsin, USA
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Published:January 02, 2020DOI:https://doi.org/10.1016/j.gie.2019.12.027

      Background and Aims

      Multitarget stool DNA (MT-sDNA) testing is used in primary care as a screening test for colon cancer. Test effectiveness and patient compliance were examined in clinical practice.

      Methods

      We assessed outcomes of MT-sDNA testing in a cohort study conducted in a large integrated healthcare system comprising 15 hospitals and 150 outpatient clinics using advanced electronic data capture (Clarity2 [Epic, Verona, Wisc, USA] and REDCap [Encinitas, Calif, USA]) followed by manual chart review to confirm MT-sDNA test results and to monitor the outcomes of subsequent colonoscopy.

      Results

      A total of 6835 MT-sDNA tests were performed over 1 year between 2017 and 2018. Of 1242 patients (18%) who tested positive, 1109 (89%) were referred for colonoscopy, and 905 of them (73%) underwent colonoscopy. Eleven patients (<1%) with a positive test had colorectal cancer, 215 (17%) had advanced adenomas, 110 (9%) had serrated adenomas, and 546 (60%) patients had an adenoma. Of the 6835 patients tested, adenoma or cancer was found in 557 patients (8%). An advanced adenoma or cancer was found in 226 of 1242 patients with a positive test (18%). Nonadherence with colonoscopy after a positive test was high (21%), and the cost to detect 1 advanced adenoma or cancer was $38,849.

      Conclusions

      The frequency of adenoma detection by an MT-sDNA screening strategy is low, and many positive tests are not associated with significant findings at colonoscopy. Failure to follow a positive test with colonoscopy is a significant problem that needs to be considered when this screening strategy is adopted.

      Graphical abstract

      Abbreviations:

      MT-sDNA (multitarget stool DNA), SD (standard deviation)
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      References

        • Johnson D.H.
        • Kisiel J.B.
        • Burger K.N.
        • et al.
        Multitarget stool DNA test: clinical performance and impact on yield and quality of colonoscopy for colorectal cancer screening.
        Gastrointest Endosc. 2017; 85: 657-665
        • Prince M.
        • Lester L.
        • Chiniwala R.
        • et al.
        Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant Medicare patients.
        Word J Gastroenterol. 2017; 23: 464-471
        • Rex D.K.
        • Boland C.R.
        • Dominitz J.A.
        • et al.
        Colorectal cancer screening: recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal cancer.
        Gastroenterology. 2017; 153: 307-323
        • Rex D.K.
        • Johnson D.A.
        • Anderson J.C.
        • et al.
        American College of Gastroenterology guidelines for colorectal cancer screening.
        Am J Gastroenterol. 2009; 104: 739-750
        • Exact Sciences Corporation
        Cologuard.
        (Available at:)
        https://www.cologuardtest.com/hcp
        Date accessed: December 1, 2019
        • Imperiale T.F.
        • Ransohoff D.F.
        • Itzkowitz S.H.
        • et al.
        Multitarget stool DNA testing for colorectal-cancer screening.
        N Engl J Med. 2014; 370: 1287-1297
        • Klair J.S.
        • Ashat M.
        • Johnson D.
        • et al.
        Serrated polyp detection rate and advanced adenoma detection rate from a US multicenter cohort.
        Endoscopy. 2020; 52: 61-67
        • Rees C.J.
        • Gibson S.
        • Rutter M.
        • et al.
        UK key performance indicators and quality assurance standards for colonoscopy.
        Gut. 2016; 65: 1923-1929
        • Centers for Disease Control and Prevention
        Cost-effectiveness analysis. Outcomes in natural units.
        (Available at:)
        • Centers for Disease Control and Prevention
        Economic evaluation: alternatives to return on investment to show societal benefits.
        (Available at:)
      1. Health care costs: Aurora’s standard charges.
        (Available at:)
        • Sackett D.
        • Straus S.
        • Richardson W.
        • et al.
        Evidence based medicine.
        2nd ed. Churchill Livingstone, New York2000: 246
        • Calderwood A.H.
        • Jacobson B.C.
        Comprehensive validation of the Boston Bowel Preparation Scale.
        Gastrointest Endosc. 2011; 72: 686-692
        • Rex D.K.
        • Schoenfeld P.S.
        • Cohen J.
        • et al.
        Quality indicators for colonoscopy.
        Gastrointest Endosc. 2015; 81: 31-53
        • Redwood D.G.
        • Asay E.D.
        • Blake I.D.
        • et al.
        Stool DNA testing for screening detection of colorectal neoplasia in Alaska Native people.
        Mayo Clin Proc. 2016; 91: 61-70
        • Kim N.H.
        • Park J.H.
        • Park D.I.
        • et al.
        Risk factors for false fecal immunochemical test results in colorectal cancer screening.
        J Clin Gastroenterol. 2017; 51: 151-159
        • van Turenhout S.T.
        • Oort F.A.
        • Terhaar sive Droste J.S.
        • et al.
        Hemorrhoids detected at colonoscopy: an infrequent cause of false-positive fecal immunochemical test results.
        Gastrointest Endosc. 2012; 76: 136-143
        • Penz D.
        • Ferlitsch A.
        • Waldmann E.
        • et al.
        Impact of adenoma detection rate on detection of advanced adenomas and endoscopic adverse events in a study of over 200,000 screening colonoscopies.
        Gastrointest Endosc. 2020; 91: 135-141
        • Corley D.A.
        • Jensen C.D.
        • Marks A.R.
        • et al.
        Adenoma detection rate and risk of colorectal cancer and death.
        N Engl J Med. 2014; 370: 1298-1306
        • Anderson J.C.
        • Butterly L.F.
        • Weiss J.E.
        • et al.
        Providing data for serrated polyp detection rate benchmarks: an analysis of the New Hampshire Colonoscopy Registry.
        Gastrointest Endosc. 2017; 85: 1188-1194
        • Lund M.
        • Trads M.
        • Njor S.H.
        • et al.
        Quality indicators for screening colonoscopy and colonoscopist performance and the subsequent risk of interval colorectal cancer: a systematic review.
        JBI Database System Rev Implement Rep. 2019; 17: 2265-2300
        • Doubeni C.A.
        • Fedewa S.A.
        • Levin T.R.
        • et al.
        Modifiable failures in the colorectal cancer screening process and their association with risk of death.
        Gastroenterology. 2019; 156: 63-74
        • Robertson D.
        • Ladabaum U.
        Opportunities and challenges in moving from current guidelines to personalized colorectal cancer screening.
        Gastroenterology. 2019; 156: 904-917
        • Lo S.H.
        • Halloran S.
        • Snowball J.
        • et al.
        Colorectal cancer screening uptake over three biennial invitation rounds in the English bowel cancer screening programme.
        Gut. 2015; 64: 282-291
        • Somsouk M.
        • Rachocki C.
        • Mannalithara A.
        • et al.
        Effectiveness and cost of organized outreach for colorectal cancer screening: a randomized controlled trial.
        J Natl Cancer Inst. 2019;
        • Naber S.K.
        • Knudsen A.B.
        • Zauber A.G.
        • et al.
        Cost-effectiveness of a multitarget stool DNA test for colorectal cancer screening of Medicare beneficiaries.
        PLoS One. 2019; 14e0220234
        • Lundh A.
        • Lexchin J.
        • Mintzes B.
        • et al.
        Industry sponsorship and research outcome.
        Cochrane Database Syst Rev. 2017; 2MR000033

      Linked Article

      • Test meets world: results of multitargeted stool DNA testing in the United States
        Gastrointestinal EndoscopyVol. 92Issue 2
        • Preview
          Reports on the real-world implementation of novel treatments and diagnostic tests rarely receive the same fanfare as initial reports. The use of multitargeted stool DNA (MT-sDNA) screening for colon cancer was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2014 based on the work of Imperiale et al1 published in the New England Journal of Medicine. MT-sDNA has subsequently been added to a menu of recommended options for colon cancer screening. However, in the 6 years since the report by Imperiale et al,1 very little has been learned about MT-sDNA testing in the real world.
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