(A) Parameters for potential clinical validity | (B) Clinical validity | (C) Clinical utility |
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(1) Association: What is the association between the genotype and an adverse drug response? (2) Prevalence: What is the prevalence of the relevant genotype and adverse drug response? |
(1) Sensitivity: How often is the test positive when an adverse drug response is present? (2) Specificity: How often is the test negative when an adverse drug response is not present? (3) Positive predictive value: Among people with a positive test for the relevant genotype, what proportion has an adverse drug response? (4) Negative predictive value: Among people with a negative test for the relevant genotype, what proportion has an adverse drug response? |
(1) Impact: What is the impact of the test result on patient care, i.e., how many adverse drug responses are caused by the genotype (PAF)? (2) Population: How many tests need to be administered for one successful intervention (NNTG)? (3) Intervention: Is there an effective remedy, acceptable action, or other measurable benefit? (4) Pilot trials: What are the results of pilot trials? (5) Health risks: What health risks can be identified for follow-up testing and/or intervention? (6) Economic: What are the economic benefits associated with actions resulting from testing? |