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Infrastructure To Monitor Utilization and Outcomes of Gene-Based Applications: An Assessment

机译：基础设施监测基因应用的利用和结果：评估

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With the completion of the human genome sequence, the development and utilization of gene-based tests are expected to proliferate. These tests may be used to help make early diagnosis, improve risk prediction, and target therapies for both traditional gene-based disorders as well as common chronic diseases. Thus, data are needed for public health surveillance of the utilization of gene-based tests to be able to monitor trends in use, appropriateness of use, and potential disparities in utilization. Health care policymakers, providers, and payers need data on how specific genetic tests and related interventions impact short- and long-term health outcomes, including information on cost-effectiveness. Information, however, is currently lacking on the use of gene-based tests and the outcomes of clinical interventions based on these tests. Our objectives were twofold: (1) to conduct an assessment of existing databases in the US health care system for monitoring the utilization and outcomes of gene-based applications (including tests and related interventions) in the health care system; and (2) to provide recommendations to establish appropriate and practical systems to assess use and outcomes of gene-based clinical applications. The assessment included targeted reviews of the published and gray literature, discussions with key informants (some of whom formed a Technical Expert Panel (TEP) to provide additional guidance to the project), and information gathering about the capabilities of specific databases and surveillance systems. The project also included a small workshop in which experts and stakeholders discussed the initial findings of the assessment, gave their input on the strengths and weaknesses of different options and approaches for monitoring gene-based applications, and developed recommendations for future research and development.

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