Health Technology Assessments of Diagnostic Tests

Evidence-informed decision making with respect to health technology involves considering the best evidence, including the evidence on efficacy, effectiveness and cost-effectiveness of that technology. Health technology assessment (HTA) provides a mechanism to bridge the gap between evidence and decision making through a standard process of formal assessment of this evidence. HTA has been defined by the International Network of Agencies for Health Technology Assessment “as the systematic evaluation of properties, effects, and/or impacts of health care technology, that is, safety, effectiveness, feasibility, cost, cost-effectiveness, and potential social, legal and ethical impact of a technology. It may address the direct, intended consequences of technologies as well as their indirect, unintended consequences”. This chapter provides an overview on HTA, its history and methods to conduct a HTA. It also describes how HTAs can be used to assess screening and diagnostic tests to reduce uncertainty and improve appropriateness. A case study on the clinical effectiveness and cost-effectiveness of transcutaneous bilirubin devices for screening and diagnosis of hyperbilirubinemia jaundice illustrates how HTA was applied to assess the evidence on this screening test.