Implementing and Evaluating Genomic Screening Programs in Health Care Systems Proceedings of a Workshop (2018) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-8
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Of particular interest are genomicsbased screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions (see Box 1-1)
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However, some health care systems are screening for additional variants that lack strong evidence of clinical validity (i.e., the accuracy and reliability of a test in identifying or predicting the biological and medical significance of the test result) and clinical utility.
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. One goal of the workshop was to further develop the ideas presented at previous Roundtable workshops that covered the economics of genomic medicine,6 genomics-enabled learning health care systems,7 implementation science– based approaches to genomic medicine,8 and data sharing.9 This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access.
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Developing evidence of clinical validity and clinical utility remains a challenge that might be met by collaboration across large health care systems, Feero said. Workshop participants were asked to look to the future, and to think about how to leverage existing programs to develop more robust data on how genomics may or may not improve the health of populations.
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Many of the workshop participants also discussed incentives for collaboration and data sharing, including funding, statistical power, economies of scale, risk mitigation, and shared solutions. Measuring the Value of Genomics-Based Screening Programs The value of genomic testing from a traditional economic perspective was discussed at length during the workshop, and individual speakers emphasized the need to develop quantitative measures and data to demonstrate to health care system leadership and decision makers the clinical utility and return on investment of genomic screening.
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The size of the current genetic counseling workforce may not be large enough to meet the needs associated with a broad implementation of genomic screening programs in health care systems, and workshop participants discussed the perceived shortage of genetic counselors, which could be due in part to resource-intensive service delivery models. Potential solutions to this challenge include exploring new care delivery models, and training other health care system and community members to deliver screening results.
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However, there are still barriers associated with implementing genomics programs into health care delivery systems, Ginsburg said, and additional evidence will be needed to convince physicians to adopt, payers to reimburse, and patients to accept this new paradigm of health care. He called upon workshop participants to identify the action items needed to develop a learning health care system focused on genomic medicine and evidence development.
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