A proposal of a new evaluation framework towards implementation of genetic tests.

作者: Erica Pitini , Elvira D’Andrea , Corrado De Vito , Annalisa Rosso , Brigid Unim

DOI: 10.1371/JOURNAL.PONE.0219755

关键词:

摘要: BACKGROUND The existing frameworks for the evaluation of genetic and genomic applications clearly address technical clinical value a test, but are less concerned with way services delivered organized. We therefore aimed to develop comprehensive new framework that includes an assessment service delivery. METHODS A was built on dimensions identified through systematic review Delphi survey Italian experts in public health genomics. RESULTS Our has four sections. first two sections, respectively, guide evidence collection process test (analytic validity; utility; personal utility) its delivery models (organizational aspects; economic evaluation; ethical, legal social implications; patient perspective). third section guides formulation research priorities be addressed future research. Finally, fourth suggests three criteria summarize collected (net benefit, cost-effectiveness, feasibility). CONCLUSION have successfully developed tests It also introduces some neglected such as utility perspective.

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