Table 2 State of evidence suggesting need for CPAD

From: Improving recommendations for genomic medicine: building an evolutionary process from clinical practice advisory documents to guidelines

Analytic validity

• Sufficient evidence of test reliability to justify clinical use (requirement for both CPAD and CPG; evidence may be more mature in case of CPG)

Clinical validity

• Expert opinion regarding an association between gene variant(s) and health condition

• Variable quality of data indicating association between gene variant(s) and health outcomes

Clinical utility

• Expert opinion regarding value of testing in health-care delivery

• Significant deficits in evidence assessing:

◦ Clinician, patient, and family views on value of testing; methods may include interviews, focus groups, surveys, and/or

◦ Outcomes of testing such as diagnostic yield, rate of false positive/false negative results, outcomes of medical decisions based on test results, health improvement deriving from actions based on test results, and costs

Ethical, legal, and social implications

• Limited or absent evaluation of ethical, legal, and social implications of testing

  1. CPAD clinical practice advisory document, CPG clinical practice guideline.
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