sábado, 25 de marzo de 2017

Tier Table Database|Home|PHGKB

Tier Table Database|Home|PHGKB


Tier Table Database

About Tier Table Database

CDC Office of Public Health Genomics (OPHG) conducts horizon scanning (a systematic research method to find and follow novel technologies appearing in the literature) to identify and track the progress of genomic tests as they move from research into clinical and public health practice. As an aid in organizing horizon scanning results, OPHG ranks genomic tests, and family health history applications, by levels of evidence. This approach was based on a paper by Khoury and updated in accordance with criteria presented by a 2014 paper in Clinical Pharmacology and Therapeutics. The method of classification is designed to provide a high level overview, rather than a detailed analysis, of selected conclusions from available evidence sources. The classifications should not be construed as an endorsement or official position of CDC. Findings presented here may be useful as a starting point for people interested in finding relevant evidence sources, however, the corresponding full evidence sources must be consulted in order to accurately and effectively interpret and employ their findings and recommendations. The process was not intended to capture all of the information necessary to inform clinical or public health practice or policymaking, such as coverage decisions. This information is updated on an ongoing basis and provided only for informational purposes to researchers, healthcare providers, public health programs and others.

Classification Criteria

Tier 1
  • FDA label requires use of test to inform choice or dose of a drug
  • CMS covers testing
  • Clinical practice guidelines based on systematic review supports testing
Tier 2
  • FDA label mentions biomarkers
  • CMS coverage with evidence development
  • Clinical practice guideline, not based on systematic review, supports use of test
  • Clinical practice guideline finds insufficient evidence but does not discourage use of test
  • Systematic review, without clinical practice guideline, supports use of test
  • Systematic review finds insufficient evidence but does not discourage use of test
  • Clinical practice guideline recommends dosage adjustment, but does not address testing
Tier 3
  • FDA label cautions against use
  • CMS decision against coverage
  • Clinical practice guideline recommends against use of test
  • Clinical practice guideline finds insufficient evidence and discourages use of test
  • Systematic review recommends against use
  • Systematic review finds insufficient evidence and discourages use
  • Evidence available only from published studies without systematic reviews, clinical practice guidelines, FDA label or CMS labels coverage decision

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