Development and Validation of CLARITY (Clinical and Life-impact Assessment of RadiologY): A Patient-Reported Outcome Measure for Medical Imaging - Study Protocol

Rationale and Objectives: Radiology plays a central role in diagnosis and clinical decision-making, yet its impact is still primarily evaluated using technical and operational metrics rather than outcomes that matter directly to patients.For patients, medical imaging can influence understanding of their condition, diagnostic uncertainty, and confidence in next steps, while also imposing burdens such as preparation, discomfort, claustrophobia, contrast-related effects, and disruption to daily life.Despite the clinical relevance of these outcomes, and their potential to differ across imaging modalities, radiology lacks a validated patient-reported outcome measure (PROM) designed to capture them.Purpose: To describe the development and validation of CLARITY (Clinical and Life-impact Assessment of RadiologY), a patientreported instrument suite designed to measure patient-centered outcomes and perceived impact of diagnostic imaging.Methods: CLARITY will be developed using a mixed-methods approach aligned with international standards for PROM development.The program comprises six phases: (1) systematic review of radiology-relevant patient-reported outcomes; (2) qualitative concept elicitation with adults undergoing imaging; (3) evidence-informed item generation; (4) content validity evaluation through expert review and cognitive interviewing; (5) prospective field testing; and (6) psychometric validation.CLARITY includes two components: CLARITY-Core, an evaluative pre-post PROM assessing change in understanding, uncertainty, and confidence following imaging and results communication; and CLARITY-Impact, a post-results module assessing perceived diagnostic contribution, imaging-related burden, and benefit-burden appraisal.CLARITY will be delivered through a mobile/web application.Psychometric evaluation will assess structural validity, internal consistency, test-retest reliability, construct validity, responsiveness, measurement invariance, and interpretability, including estimation of minimal important change.Expected outcomes: CLARITY will provide a rigorously developed, radiology-specific PROM for measuring outcomes that matter to patients' experiences in radiology and for comparing diagnostic strategies on patient-relevant endpoints. Conclusion:CLARITY addresses a critical gap in radiology by providing the first PROM specifically designed to evaluate patientcentered outcomes of diagnostic imaging.It offers a robust and practical framework for advancing patient-centered research, quality improvement, and value-based evaluation in radiology.