An Evidence Framework for Genetic Testing (2017) / Chapter Skim
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5 An Evidence Framework for Genetic Testi
5 An Evidence Framework for Genetic Testi
Pages 79-88
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From page 79... ...
The following definitions will be used in this chapter in referring to processes that lead to decisions about the use of genetic tests in a clinical setting: Decision framework: an overall plan for an evaluator to use in determining which tests should be used in evidence-based clinical care Evaluation structure: the process of determining the type of evidence that needs to be evaluated, given the desired clinical outcome of a genetic test Evidence assessment: the process of evidence review and analysis to determine the level of evidence that is available to support the use of a genetic test, depending on the desired outcome The purpose of a decision framework is to assist stakeholders (clinicians, patients, payers, public health officials, policy makers, and others) in making decisions about the balance of benefits and harms associated with using a test, whether genetic or otherwise; it defines a process by which such deliberations can be carried out and outlines the procedures used to examine evidence related to the use of a genetic test in a specific clinical scenario.
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From page 80... ...
OVERVIEW OF THE PROPOSED FRAMEWORK After reviewing different methods that have been developed for the evaluation of medical tests, some of which were specifically intended for use with genetic tests, the committee developed a hybrid system that incorporates elements of several of the methods described in Chapter 3. The system that the committee developed -- its decision framework -- consists of seven components depicted in Figure 5-1, and described in the text that follows.
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From page 81... ...
Different decisions might be made regarding the use of a particular genetic test, depending on the population and the purpose of testing. However, defining the test can be challenging, given the rapid expansion of molecular genetic tests that are now offered, which range from analysis of a single genetic variant to the whole genome sequence.
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From page 82... ...
Alternatively, DoD could utilize information from previous decisions regarding the same or similar genetic test scenarios or by using a list of standard questions like those posed by the analytical validity, clinical validity, clinical utility, and associated ethical, legal, and social implications (ACCE) or Genetic testing Evidence Tracking Tool approaches.
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From page 83... ...
If the rapid review indicates adequate evidence, cover the test unless negative contextual factors outweigh the evidence. If insufficient evidence is available after streamlined review, conduct a formal evidence review or make coverage contingent on evidence development.
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From page 84... ...
. If the triage process suggests a potential health benefit associated with genetic test scenarios that are especially promising for clinical utility but lack comprehensive evidence, or those with strong stakeholder interest but without direct evidence of clinical utility, DoD could consider allowing such genetic tests to be used in a controlled manner and would be dependent on longitudinal follow-up of outcomes.
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From page 85... ...
For genetic test scenarios that undergo a formal evidence review, the details of the process and the evidentiary thresholds required by DoD will provide transparency to the process and allow identification of evidence gaps that can be addressed through research. Component 6.
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From page 86... ...
Such a review would consist of using an evaluation structure to identify evidentiary requirements suitable for the outcome of interest and assessing the evidence that is available. Recognizing the rapid advances in genetic testing and evolving evidence regarding the role of genetics in different health conditions, the decision framework includes periodic review and revision of decisions.
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From page 87... ...
5. Publicly share resulting decisions and justification about evaluated genetic test scenarios, and retain decisions in a repository.
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