{"id":1478,"date":"2012-08-23T14:53:19","date_gmt":"2012-08-23T18:53:19","guid":{"rendered":"http:\/\/blogs.cdc.gov\/genomics\/?p=1478"},"modified":"2024-04-08T16:05:57","modified_gmt":"2024-04-08T20:05:57","slug":"evidence-matters-in-genomic-medicine-round-2","status":"publish","type":"post","link":"https:\/\/blogs.cdc.gov\/genomics\/2012\/08\/23\/evidence-matters-in-genomic-medicine-round-2\/","title":{"rendered":"Evidence Matters in Genomic Medicine- Round 2: Integrating Cancer Genomic Tests"},"content":{"rendered":"<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/blogs.cdc.gov\/genomics\/files\/2012\/08\/stacked_boxes.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-medium wp-image-1489\" src=\"https:\/\/blogs.cdc.gov\/genomics\/files\/2012\/08\/stacked_boxes-300x174.jpg\" alt=\"stacked boxes with lettering\" width=\"300\" height=\"174\" srcset=\"https:\/\/blogs.cdc.gov\/genomics\/wp-content\/uploads\/sites\/20\/2012\/08\/stacked_boxes-300x174.jpg 300w, https:\/\/blogs.cdc.gov\/genomics\/wp-content\/uploads\/sites\/20\/2012\/08\/stacked_boxes.jpg 987w\" sizes=\"(max-width: 300px) 100vw, 300px\" \/><\/a>In a previous blog, <a href=\"https:\/\/www.cdc.gov\/genomics\/\" target=\"_blank\" rel=\"noopener noreferrer\">CDC\u2019s Office of Public Health Genomics<\/a> announced a list of health-related genomic tests and applications, stratified into three tiers according to the availability of scientific evidence and <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/21406285\/\" target=\"_self\" rel=\"noopener noreferrer\">evidence-based recommendations as a result of systematic reviews<\/a>.\u00a0\u00a0The list is intended to promote information exchange and dialogue among researchers, providers, policy makers, and the public. We have <a href=\"https:\/\/phgkb.cdc.gov\/PHGKB\/phgHome.action?action=home\" target=\"_blank\" rel=\"noopener noreferrer\">updated the list to include tests<\/a> that have been discussed in a recent article by the <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/22138009\/\" target=\"_blank\" rel=\"noopener noreferrer\">National Comprehensive Cancer Network (NCCN)<\/a>. For these tests, we have considered NCCN recommendations and other evidence-based reviews, reports or assessments from Blue Cross Blue Shield Association Technical Evaluation Center (TEC) and guidelines from the <a href=\"https:\/\/www.nice.org.uk\/\">National Institute for Health and Clinical Excellence<\/a> in the placement of individual tests within the OPHG tier list.\u00a0<!--more--><\/p>\n<p>NCCN guidelines have been described as \u201cthe most comprehensive and widely used oncology standard in clinical practice in the world\u201d (6).\u00a0 Recently, the level of evidence behind the formulation of these guidelines was systematically investigated by <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/21149653\/\" target=\"_blank\" rel=\"noopener noreferrer\">Poonacha, 2011<\/a>.\u00a0 They report \u201c\u2026[NCCN] guidelines are developed by a select group of disease-oriented panel members with representations from each of the NCCN member institutions.\u00a0 Algorithmic pathways are derived for the following four major areas of clinical decision making: staging, initial treatment, salvage treatment, and surveillance. The preliminary guidelines are then reviewed by non-panel experts from the NCCN institutions and revised accordingly to form the final guidelines.\u201d Poonacha et al. noted that the guidelines are based on review of pertinent literature, although it is unclear how systematic or extensive the process is (e.g. literature search strategy, inclusion and exclusion criteria, and data extraction are not described in detail). Furthermore, <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/21149653\/\">Poonacha et al<\/a>. found that only 6% of the recommendations found in NCCN guidelines for the 10 most common cancers are based on high-level evidence. (6)<\/p>\n<p>The BCBSA Technology Evaluation Center writes evidence-based assessments of medical technologies, producing 20 to 25 assessments each year. The assessments are described as \u201ca comprehensive evaluation of the clinical effectiveness and appropriateness of a given medical technology\u2026 guided by the Medical Advisory Panel composed of nationally respected physician experts.\u00a0 The TEC Program uses five criteria to assess whether a technology improves health outcomes such as length of life, quality of life and functional ability\u2026 [and] uses a formal approach to reviewing the evidence.\u201d (8)<\/p>\n<p>The <a href=\"https:\/\/www.nice.org.uk\/standards-and-indicators\" target=\"_blank\" rel=\"noopener noreferrer\">NICE quality standards<\/a> are described as \u201ccentral to supporting the [UK] Government&#8217;s vision for an NHS [National Health Service] and Social Care system focused on delivering the best possible outcomes for people who use services, as detailed in the <a href=\"https:\/\/www.legislation.gov.uk\/ukpga\/2012\/7\/contents\" target=\"_blank\" rel=\"noopener noreferrer\">Health and Social Care Act (2012).\u201d<\/a>\u00a0 NICE quality standards for the NHS are described as focusing on the \u201ctreatment and prevention of different diseases and conditions\u201d and they \u201cenable health and social care professionals and public health professionals to make decisions about care based on the latest evidence and best practices.\u201d\u00a0 Additional, NICE quality standards are available on their <a href=\"https:\/\/www.nice.org.uk\/standards-and-indicators\" target=\"_blank\" rel=\"noopener noreferrer\">web site<\/a>.<\/p>\n<p>In our classification of genomic applications we decided to err on the side of being conservative in labeling genomic applications as tier 1 since we primarily rely on systematic evidence reviews. Furthermore, we have provided links to recommendations and references in support of the applicable tier 1 genomic test recommendation.<\/p>\n<p>Our goal is to encourage conversation on the appropriate use of genomic applications in practice and to promote the translational research needed to fill evidence gaps. The tables also highlight some mature genomic applications in <a href=\"https:\/\/phgkb.cdc.gov\/PHGKB\/tierFinder.action?Mysubmit=init&amp;query=tier+1\" target=\"_blank\" rel=\"noopener noreferrer\">tier 1<\/a> that if implemented could save thousands of lives and reduce morbidity among affected people and their families. Evaluating the population-level balance of benefits and harms will require further research.<\/p>\n<p>We invite comments and suggestions from our readers about our classification scheme, specific genomic tests and applications, and sources of evidence.\u00a0<span lang=\"EN\" style=\"line-height: 115%; font-family: 'Georgia','serif'; color: black; font-size: 12pt;\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&nbsp; In a previous blog, CDC\u2019s Office of Public Health Genomics announced a list of health-related genomic tests and applications, stratified into three tiers according to the availability of scientific evidence and evidence-based recommendations as a result of systematic reviews.\u00a0\u00a0The list is intended to promote information exchange and dialogue among researchers, providers, policy makers, and<\/p>\n","protected":false},"author":152,"featured_media":1489,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5761,5236],"tags":[5739,5726,31856,170],"_links":{"self":[{"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/posts\/1478"}],"collection":[{"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/users\/152"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/comments?post=1478"}],"version-history":[{"count":23,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/posts\/1478\/revisions"}],"predecessor-version":[{"id":6688,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/posts\/1478\/revisions\/6688"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/media\/1489"}],"wp:attachment":[{"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/media?parent=1478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/categories?post=1478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.cdc.gov\/genomics\/wp-json\/wp\/v2\/tags?post=1478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}