Sheri D Schully1, Tram Kim Lam1, W David Dotson2, Christine Q Chang1, Naomi Aronson3, Marian L Birkeland4, Stephanie Jo Brewster5, Stefania Boccia6, Adam H Buchanan7, Ned Calonge8, Kathleen Calzone9, Benjamin Djulbegovic10, Katrina A B Goddard11, Roger D Klein12, Teri E Klein13, Joseph Lau14, Rochelle Long15, Gary H Lyman16, Rebecca L Morgan17, Christina G S Palmer18, Mary V Relling19, Wendy S Rubinstein20, Jesse J Swen21, Sharon F Terry22, Marc S Williams23, Muin J Khoury24. 1. Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland, USA. 2. Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. 3. Technology Evaluation Center, Blue Cross Blue Shield Association, Chicago, Illinois, USA. 4. National Comprehensive Cancer Network, Fort Washington, Pennsylvania, USA. 5. Boston Children's Hospital, Boston, Massachusetts, USA. 6. Institute of Public Health, Section of Hygiene, Università Cattolica del Sacro Cuore, Rome, Italy. 7. Duke Cancer Institute, Durham, North Carolina, USA. 8. The Colorado Trust, Denver, Colorado, USA. 9. Genetics Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA. 10. 1] University of South Florida, Tampa, Florida, USA [2] H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, USA. 11. Kaiser Permanente Northwest, Portland, Oregon, USA. 12. Department of Molecular Pathology, Cleveland Clinic, Cleveland, Ohio, USA. 13. Department of Genetics, Stanford University, Palo Alto,California, USA. 14. Brown University, Providence, Rhode Island, USA. 15. National Institute of General Medical Sciences, National Institutes of Health, Bethesda, Maryland, USA. 16. Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. 17. Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. 18. University of California, Los Angeles, Los Angeles, California, USA. 19. Department of Pharmaceutical Sciences, St. Jude Children's Research Hospital, Memphis, Tennessee, USA. 20. National Center for Biotechnology Information, National Institutes of Health, Bethesda, Maryland, USA. 21. Leiden University Medical Center, Leiden, The Netherlands. 22. Genetic Alliance, Washington, D.C., USA. 23. Genomic Medicine Institute, Geisinger Health System, Danville, Pennsylvania, USA. 24. 1] Epidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, Maryland, USA [2] Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
Abstract
PURPOSE: With the accelerated implementation of genomic medicine, health-care providers will depend heavily on professional guidelines and recommendations. Because genomics affects many diseases across the life span, no single professional group covers the entirety of this rapidly developing field. METHODS: To pursue a discussion of the minimal elements needed to develop evidence-based guidelines in genomics, the Centers for Disease Control and Prevention and the National Cancer Institute jointly held a workshop to engage representatives from 35 organizations with interest in genomics (13 of which make recommendations). The workshop explored methods used in evidence synthesis and guideline development and initiated a dialogue to compare these methods and to assess whether they are consistent with the Institute of Medicine report "Clinical Practice Guidelines We Can Trust." RESULTS: The participating organizations that develop guidelines or recommendations all had policies to manage guideline development and group membership, and processes to address conflicts of interests. However, there was wide variation in the reliance on external reviews, regular updating of recommendations, and use of systematic reviews to assess the strength of scientific evidence. CONCLUSION: Ongoing efforts are required to establish criteria for guideline development in genomic medicine as proposed by the Institute of Medicine.
PURPOSE: With the accelerated implementation of genomic medicine, health-care providers will depend heavily on professional guidelines and recommendations. Because genomics affects many diseases across the life span, no single professional group covers the entirety of this rapidly developing field. METHODS: To pursue a discussion of the minimal elements needed to develop evidence-based guidelines in genomics, the Centers for Disease Control and Prevention and the National Cancer Institute jointly held a workshop to engage representatives from 35 organizations with interest in genomics (13 of which make recommendations). The workshop explored methods used in evidence synthesis and guideline development and initiated a dialogue to compare these methods and to assess whether they are consistent with the Institute of Medicine report "Clinical Practice Guidelines We Can Trust." RESULTS: The participating organizations that develop guidelines or recommendations all had policies to manage guideline development and group membership, and processes to address conflicts of interests. However, there was wide variation in the reliance on external reviews, regular updating of recommendations, and use of systematic reviews to assess the strength of scientific evidence. CONCLUSION: Ongoing efforts are required to establish criteria for guideline development in genomic medicine as proposed by the Institute of Medicine.
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