Stacey A Cohen1,2, Mercy Laurino3,4,5, Deborah J Bowen6, Melissa P Upton7, Colin Pritchard8, Fuki Hisama3, Gail Jarvik3,9, Alessandro Fichera10, Britta Sjoding4, Robin L Bennett3,4, Lorraine Naylor3,4, Angela Jacobson8, Wylie Burke6, William M Grady2,5,11. 1. Division of Oncology, University of Washington, Seattle, Washington. 2. Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. 3. Division of Medical Genetics, University of Washington, Seattle, Washington. 4. Genetic Counseling, Seattle Cancer Care Alliance, Seattle, Washington. 5. Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. 6. Department of Bioethics and Humanities, University of Washington, Seattle, Washington. 7. Department of Pathology, University of Washington, Seattle, Washington. 8. Department of Laboratory Medicine, University of Washington, Seattle, Washington. 9. Department of Genome Sciences, University of Washington, Seattle, Washington. 10. Department of Surgery, University of Washington, Seattle, Washington. 11. Division of Gastroenterology, University of Washington, Seattle, Washington.
Abstract
BACKGROUND: Lynch syndrome confers a hereditary predisposition to colorectal and other cancers. Universal tumor screening (UTS) for Lynch syndrome is recommended by several professional societies, but the implementation can be complex. This article describes the evaluation, process development, and initiation of Lynch syndrome UTS at a tertiary referral cancer center. METHODS: A multidisciplinary team developed the new process design. Issues in 5 themes were noted: timing, funding, second-opinion patients, result processing, and the role of genetics providers. A committee approach was used to examine each issue for process-improvement development. RESULTS: The issues related to testing were addressed individually for the successful implementation of UTS at the institutional level. In the conventional-care period, 9 of 30 cases (30%) received Lynch syndrome screening, and 4 cases were referred to medical genetics. During the 6 months following the implementation of UTS, 32 of 44 patients (73%) received Lynch syndrome screening. The 13 unscreened patients all had identified reasons for nonscreening (eg, financial limitations). Ten patients were referred to medical genetics, which identified no new cases of Lynch syndrome, but a low-risk adenomatous polyposis coli (APC) variant was detected in 1 individual. CONCLUSIONS: The implementation of effective Lynch syndrome UTS can feasibly alter practice at the institutional level. This experience with the assessment and management of issues relevant to the successful implementation of a new clinical care paradigm based on emerging technology has implications for the uptake of advances across molecular oncology into clinical practice, and this is highly relevant in the current era of rapidly evolving genomic technology.
BACKGROUND:Lynch syndrome confers a hereditary predisposition to colorectal and other cancers. Universal tumor screening (UTS) for Lynch syndrome is recommended by several professional societies, but the implementation can be complex. This article describes the evaluation, process development, and initiation of Lynch syndrome UTS at a tertiary referral cancer center. METHODS: A multidisciplinary team developed the new process design. Issues in 5 themes were noted: timing, funding, second-opinion patients, result processing, and the role of genetics providers. A committee approach was used to examine each issue for process-improvement development. RESULTS: The issues related to testing were addressed individually for the successful implementation of UTS at the institutional level. In the conventional-care period, 9 of 30 cases (30%) received Lynch syndrome screening, and 4 cases were referred to medical genetics. During the 6 months following the implementation of UTS, 32 of 44 patients (73%) received Lynch syndrome screening. The 13 unscreened patients all had identified reasons for nonscreening (eg, financial limitations). Ten patients were referred to medical genetics, which identified no new cases of Lynch syndrome, but a low-risk adenomatous polyposis coli (APC) variant was detected in 1 individual. CONCLUSIONS: The implementation of effective Lynch syndrome UTS can feasibly alter practice at the institutional level. This experience with the assessment and management of issues relevant to the successful implementation of a new clinical care paradigm based on emerging technology has implications for the uptake of advances across molecular oncology into clinical practice, and this is highly relevant in the current era of rapidly evolving genomic technology.
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