Table 1Fryback and Thornbury hierarchical model of efficacy21

Level 1: Technical Efficacy
  In the laboratory setting, does the test measure what it purports to measure?
Level 2: Diagnostic Accuracy Efficacy
  What are the medical test characteristics of the test (e.g., sensitivity, specificity)?

  Does the test result distinguish patients with and without the target disorder among patients in whom it is clinically reasonable to suspect that the disease is present?
Level 3: Diagnostic Thinking efficacy
  Does the medical test help clinicians come to a diagnosis?

  Does the test change clinician's pretest estimate of the probability of a specific disease?
Level 4: Therapeutic Efficacy
  Does the medical test aid in planning treatment?

  Does the medical test change or cancel planned treatments?
Level 5. Patient Outcome Efficacy
  Do patients benefit from the use of the test?

  Do patients who undergo this medical test fare better than similar patients who are not tested?
Level 6. Societal Efficacy
  Cost–benefit and cost-effectiveness

From: Results

Cover of Addressing Challenges in Genetic Test Evaluation
Addressing Challenges in Genetic Test Evaluation: Evaluation Frameworks and Assessment of Analytic Validity [Internet].
Sun F, Bruening W, Erinoff E, et al.

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