A Prospective Six Sigma Quality Improvement Trial to Optimize Universal Screening for Genetic Syndrome Among Patients With Young-Onset Colorectal Cancer

Restricted access

Background: Improving the quality of health care is a national priority, and providing patient-centered care is one of the 6 key areas for quality improvement. In the setting of patients with young-onset colorectal cancer (CRC), appropriate genetic workup and testing for potential underlying inherited CRC syndromes is fundamental to patient-centered care. Lynch syndrome (LS) is the most common of these inherited syndromes, and current recommendations from the NCCN and other professional societies advocate universal screening for LS among young patients with CRC. However, practical implementation of these guidelines often falls short. Methods: We conducted a prospective quality improvement intervention trial to optimize universal screening for LS in young (age <50 years) patients, involving 356 eligible patients during the 12-month preintervention period and 299 patients during the postintervention. Results: Applying the Six Sigma conceptual framework, we demonstrated a significant increase in use of tumor-based molecular testing and subsequent confirmatory germline mutation testing for LS. This led to identification of more patients to be managed as having LS and of more first- and second-degree relatives to benefit from the testing results. Conclusions: This study demonstrated the successful application of a quality improvement conceptual framework for the universal adoption of molecular biomarker testing in patients with cancer, and for improving adherence to NCCN Clinical Practice Guidelines in Oncology for CRC Screening. As molecular and genetic testing is becoming increasingly common, we present a prototype study for improving the adoption of molecular studies and the provision of guideline-based patient-centered care.

Correspondence: Y. Nancy You, MD, MHSc, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, 1400 Pressler Street, Unit 1484, PO Box 301402, Houston, TX 77230. E-mail: ynyou@mdanderson.org
  • 1.

    Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press; 2001.

    • Search Google Scholar
    • Export Citation
  • 2.

    O'ConnellJBMaggardMALiuJH. Rates of colon and rectal cancers are increasing in young adults. Am Surg2003;69:866872.

  • 3.

    AhnenDJWadeSWJonesWF. The increasing incidence of young-onset colorectal cancer: a call to action. Mayo Clin Proc2014;89:216224.

  • 4.

    SiegelRLJemalAWardEM. Increase in incidence of colorectal cancer among young men and women in the United States. Cancer Epidemiol Biomarkers Prev2009;18:16951698.

    • Search Google Scholar
    • Export Citation
  • 5.

    YouYNXingYFeigBW. Young-onset colorectal cancer: is it time to pay attention?Arch Intern Med2012;172:287289.

  • 6.

    HampelH. NCCN increases the emphasis on genetic/familial high-risk assessment in colorectal cancer. J Natl Compr Canc Netw2014;12:829831.

    • Search Google Scholar
    • Export Citation
  • 7.

    LynchPM. When and how to perform genetic testing for inherited colorectal cancer syndromes. J Natl Compr Canc Netw2013;11:15771583.

  • 8.

    LadabaumUWangGTerdimanJ. Strategies to identify the Lynch syndrome among patients with colorectal cancer: a cost-effectiveness analysis. Ann Intern Med2011;155:6979.

    • Search Google Scholar
    • Export Citation
  • 9.

    LynchHTde la ChapelleA. Hereditary colorectal cancer. N Engl J Med2003;348:919932.

  • 10.

    MoreiraLBalaguerFLindorN. Identification of Lynch syndrome among patients with colorectal cancer. JAMA2012;308:15551565.

  • 11.

    Recommendations from the EGAPP Working Group: genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives. Genet Med2009;11:3541.

    • Search Google Scholar
    • Export Citation
  • 12.

    BeamerLCGrantMLEspenschiedCR. Reflex immunohistochemistry and microsatellite instability testing of colorectal tumors for Lynch syndrome among US cancer programs and follow-up of abnormal results. J Clin Oncol2012;30:10581063.

    • Search Google Scholar
    • Export Citation
  • 13.

    MvunduraMGrosseSDHampelH. The cost-effectiveness of genetic testing strategies for Lynch syndrome among newly diagnosed patients with colorectal cancer. Genet Med2009;12:93104.

    • Search Google Scholar
    • Export Citation
  • 14.

    SturgeonDMcCutcheonTGeigerTM. Increasing Lynch syndrome identification through establishment of a hereditary colorectal cancer registry. Dis Colon Rectum2013;56:308314.

    • Search Google Scholar
    • Export Citation
  • 15.

    ProvenzaleDJaspersonKAhnenDJ. NCCN Clinical Practice Guidelines in Oncology: Colorectal Cancer Screening. Version 12015. Available at: NCCN.org. Accessed June 15 2015.

    • Search Google Scholar
    • Export Citation
  • 16.

    LindorNMPetersenGMHadleyDW. Recommendations for the care of individuals with an inherited predisposition to Lynch syndrome: a systematic review. JAMA2006;296:15071517.

    • Search Google Scholar
    • Export Citation
  • 17.

    WeissmanSMBurtRChurchJ. Identification of individuals at risk for Lynch syndrome using targeted evaluations and genetic testing: National Society of Genetic Counselors and the Collaborative Group of the Americas on Inherited Colorectal Cancer joint practice guideline. J Genet Couns2012;21:484493.

    • Search Google Scholar
    • Export Citation
  • 18.

    BurtRWCannonJADavidDS. Colorectal cancer screening. J Natl Compr Canc Netw2013;11:15381575.

  • 19.

    BurtRWBarthelJSDunnKB. NCCN Clinical Practice Guidelines in Oncology. Colorectal cancer screening. J Natl Compr Canc Netw2010;8:861.

    • Search Google Scholar
    • Export Citation
  • 20.

    BensonABIIIVenookAPBekaii-SaabT. Colon cancer, version 3.2014. J Natl Compr Canc Netw2014;12:10281059.

  • 21.

    AnningLKooNNeelyJ. Management of young onset colorectal cancer: divergent practice in the East of England. Colorectal Dis2011;13:e297302.

    • Search Google Scholar
    • Export Citation
  • 22.

    SinghHSchiesserRAnandG. Underdiagnosis of Lynch syndrome involves more than family history criteria. Clin Gastroenterol Hepatol2010;8:523529.

    • Search Google Scholar
    • Export Citation
  • 23.

    OverbeekLIHoogerbruggeNvan KriekenJH. Most patients with colorectal tumors at young age do not visit a cancer genetics clinic. Dis Colon Rectum2008;51:12491254.

    • Search Google Scholar
    • Export Citation
  • 24.

    NicolayCRPurkayasthaSGreenhalghA. Systematic review of the application of quality improvement methodologies from the manufacturing industry to surgical healthcare. Br J Surg2012;99:324335.

    • Search Google Scholar
    • Export Citation
  • 25.

    SedlackJD. The utilization of six sigma and statistical process control techniques in surgical quality improvement. J Healthc Qual2010;32:1826.

    • Search Google Scholar
    • Export Citation
  • 26.

    ChassinMR. Is health care ready for Six Sigma quality?Milbank Q1998;76:565591510.

  • 27.

    AboelmagdMG. Six Sigma quality: a structured review and implications for future research. Int J Qual Reliab Manage2010;27:268317.

  • 28.

    KhanMHHowardTJFogelEL. Frequency of biliary complications after laparoscopic cholecystectomy detected by ERCP: experience at a large tertiary referral center. Gastrointest Endosc2007;65:247252.

    • Search Google Scholar
    • Export Citation
  • 29.

    FrankelHLCredeWBTopalJE. Use of corporate Six Sigma performance-improvement strategies to reduce incidence of catheter-related bloodstream infections in a surgical ICU. J Am Coll Surg2005;201:349358.

    • Search Google Scholar
    • Export Citation
  • 30.

    VasenHFAAbdirahmanMBrohetR. One to 2-year surveillance intervals reduce risk of colorectal cancer in families with Lynch syndrome. Gastroenterology2010;138:23002306.

    • Search Google Scholar
    • Export Citation
  • 31.

    ParrySWinAKParryB. Metachronous colorectal cancer risk for mismatch repair gene mutation carriers: the advantage of more extensive colon surgery. Gut2010;60:950957.

    • Search Google Scholar
    • Export Citation
  • 32.

    SchmelerKMLynchHTChenLM. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome. N Engl J Med2006;354:261269.

    • Search Google Scholar
    • Export Citation
  • 33.

    HealdBPlesecTLiuX. Implementation of universal microsatellite instability and immunohistochemistry screening for diagnosing lynch syndrome in a large academic medical center. J Clin Oncol2013;31:13361340.

    • Search Google Scholar
    • Export Citation
  • 34.

    BannonSAMorkMVilarE. Patient-reported disease knowledge and educational needs in Lynch syndrome: findings of an interactive multidisciplinary patient conference. Hered Cancer Clin Pract2014;12:1.

    • Search Google Scholar
    • Export Citation
  • 35.

    VestJRGammLD. A critical review of the research literature on Six Sigma, Lean and StuderGroup's Hardwiring Excellence in the United States: the need to demonstrate and communicate the effectiveness of transformation strategies in healthcare. Implement Sci2009;4:35.

    • Search Google Scholar
    • Export Citation
  • 36.

    CoitDGAndtbackaRAnkerCJ. Melanoma, version 2.2013: featured updates to the NCCN guidelines. J Natl Compr Canc Netw2013;11:395407.

  • 37.

    TheriaultRLCarlsonRWAllredC. Breast cancer, version 3.2013: featured updates to the NCCN guidelines. J Natl Compr Canc Netw2013;11:753760; quiz 761.

    • Search Google Scholar
    • Export Citation
  • 38.

    GreeneRABeckmanHChamberlainJ. Increasing adherence to a community-based guideline for acute sinusitis through education, physician profiling, and financial incentives. Am J Manag Care2004;10:670678.

    • Search Google Scholar
    • Export Citation
  • 39.

    GrolR. Improving the quality of medical care: building bridges among professional pride, payer profit, and patient satisfaction. JAMA2001;286:25782585.

    • Search Google Scholar
    • Export Citation
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 443 443 15
PDF Downloads 30 30 5
EPUB Downloads 0 0 0