aportes a la gestión necesaria para la sustentabilidad de la SALUD PÚBLICA como figura esencial de los servicios sociales básicos para la sociedad humana, para la familia y para la persona como individuo que participa de la vida ciudadana.
Genomic Tests and Family History by Levels of Evidence
The CDC Office of Public Health Genomics ranks the following list for levels of evidence of genomic tests and family health history in practice . This approach was based on a paper byKhoury and updated in accordance with criteria presented by a 2014 paper in Clinical Pharmacology and Therapeutics. The criteria are shown in the following figure to provide additional information to our readers.This list is updated on an ongoing basis andprovided only for informational purposes to researchers, healthcare providers, public health programs and others.
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
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
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
*Can be reassigned to Green of Red of one or more conditions in these categories apply
Tier 1/Green category: represents genomic and family health history applications which have a base of synthesized evidence supporting implementation into practice.
Gene, Gene/Drug, Test, or Family History
Synthesized Evidence Sources
family history of breast/ovarian or other types of BRCA-related cancer
hereditary breast and ovarian cancer in women
risk prediction for referral for BRCA genetic counseling
*Pharmacogenomic applications have been classified in the Use column as either PGx (which may relate to drug choice, prevention of adverse events, or other uses of the information gained through testing), or PGx-dose (when specific dosing-related guidance is provided, or mention of a potential effect on dose is noted in the evidence sources cited). Additional Use categories include: screening, cascade testing, risk prediction, diagnostic, and prognostic.
Source Abbreviations: Agency for Healthcare Research and Quality (AHRQ), American College of Medical Genetics and Genomics (ACMG), American Society of Clinical Oncology (ASCO), Centers for Medicare and Medicaid Services (CMS), Clinical Pharmacogenetics Implementation Consortium (CPIC), Evaluation of Genomic Applications in Practice and Prevention (EGAPP), National Comprehensive Cancer Network (NCCN), National Institute for Health and Care Excellence (NICE), National Institutes of Health (NIH), Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), US Department of Health and Human Services (DHHS), US Food and Drug Administration (FDA), United States Preventive Services Task Force (USPSTF)
ver historia personal en: www.cerasale.com.ar [dado de baja por la Cancillería Argentina por temas políticos, propio de la censura que rige en nuestro medio]//
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weblog.maimonides.edu/farmacia/archives/0216_Admin_FarmEcon.pdf - //
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