Types of Evidence Needed to Assess the Clinical Value of Diagnostic Imaging.

AbstractThe evidence underlying the use of advanced diagnostic imaging is based mainly on diagnostic accuracy studies and not on well-designed trials demonstrating improved patient outcomes. This has led to an expansion of low-value and potentially harmful patient care and raises ethical issues around the widespread implementation of tests with incompletely known benefits and harms. Randomized clinical trials are needed to support the safety and effectiveness of imaging tests and should be required for clearance of most new technologies. Large, diverse cohort studies are needed to quantify disease risk associated with many imaging findings, especially incidental findings, to enable evidence-based management. The responsibility to minimize the use of tests with unknown or low value requires engagement of clinicians, medical societies, and the public.