Informing the Development of a Conceptual Framework for a Diagnostic Radiology-Specific Patient-Reported Outcome Measure: A Systematic Review of Concepts, Instruments, and Gaps.
RATIONALE AND OBJECTIVES Radiology is central to clinical care, yet its value is described predominantly through metrics such as diagnostic accuracy, safety, and utilization, which do not capture the impact of imaging on patients. Despite growing evidence that imaging produces meaningful informational, emotional, physical, and logistical effects, radiology lacks a broadly applicable, psychometrically sound patient-reported outcome measure (PROM) for routine adult diagnostic imaging. The aim of this article is to synthesize the literature on patient-reported outcomes (PROs) and PROMs in adult diagnostic radiology, characterize current measurement approaches, and derive an evidence-based conceptual framework to inform development of CLARITY (Clinical and Life-impact Assessment of RadiologY), a new modular radiology-specific PROM. MATERIALS AND METHODS A prospectively registered, PRISMA-compliant systematic review searched MEDLINE, Embase, PsycINFO, and Web of Science from inception to February 2026. Eligible studies addressed adult diagnostic radiology and reported PROs relevant to imaging experience, uncertainty, result communication, or imaging-related burden. Structured narrative synthesis was performed, given methodological heterogeneity. RESULTS Of 21,693 records identified, 32 studies met eligibility criteria. Five recurrent patient-centered outcome domains emerged: informational outcomes, emotional outcomes, physical and procedural effects, burden, and perceived contribution to the healthcare trajectory. No existing instrument demonstrated content validity for routine adult diagnostic radiology; current approaches relied predominantly on generic quality-of-life tools, ad-hoc single-domain measures, and pathway-specific surveys. CONCLUSION The radiology patient-centered outcome space is sufficiently well-characterized to justify dedicated PROM development, yet no broadly applicable instrument has demonstrated content validity for routine adult diagnostic radiology. These findings provide the empirical and conceptual foundation for the development and future validation of the proposed CLARITY PROM program.