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. 2010 Apr 15;13(4):215–223. doi: 10.1159/000279623

Table 1.

Contributors to clinical utility

Component Definition Relevance to clinical utility
Analytic validity Accuracy of test assay compared to gold standard measure Determines whether test meets acceptable analytic standard

Clinical validity Association of genetic characteristic with specified health condition or risk, and sensitivity, specificity and predictive value in the population groups and clinical setting proposed for testing Determines potential clinical uses of test

Test setting and purpose Clinical and/or demographic description of group(s) to be offered testing, health condition tested for, and specific clinical goal of testing, including any associated services Determines outcomes sought from testing

Societal legitimacy Consistency of testing and associated services with ethical principles, values, norms, mores, laws and regulations Determines whether test is compatible with societal expectations

Efficacy and effectiveness The ability of the test and any associated services to achieve the intended health purpose under the most favorable circumstances (efficacy) and under routine conditions (effectiveness) Determines the potential for the test to achieve the health outcomes sought

Balance of outcomes Assessment of negative relative to positive outcomes of testing and associated services for the person tested Determines whether testing provides a net benefit to the person tested

Patient and family acceptability Consistency of testing and associated services with the wishes, desires, and expectations of patients and their families Determines whether testing is compatible with patient and family preferences

Economic measures The ability of the test and associated services to lower the costs of care without diminishing benefits and/or provide an appropriate health value for the investment of resources Determines benefits provided by testing relative to investment of resources

Equity Access to test and associated services among patients who can benefit Determines whether testing is compatible with equitable health care delivery

Adapted from Burke et al., 2007 [12]; Burke and Zimmern, 2007 [13]; and Zimmern and Kroese, 2007 [14].