Canadian researchers are developing a patient-reported assessment tool designed for diagnostic imaging, according to a paper published March 26 in Academic Radiology.
The instrument is called CLARITY (Clinical and Life-impact Assessment of RadiologY) and will allow clinicians to "compare diagnostic strategies on patient-relevant endpoints," wrote a team led by Rakhshan Kamran, MD, DPhil, of the University of Toronto.
"CLARITY [will address] a critical gap in radiology by providing the first patient-reported outcome measure specifically designed to evaluate patient-centered outcomes of diagnostic imaging," the group noted. "It [will offer] a robust and practical framework for advancing patient-centered research, quality improvement, and value-based evaluation in radiology."
Radiology is key to disease diagnosis and to determining treatment, but its impact is primarily evaluated via technical and operational values rather than outcomes that matter to patients, Kamran and colleagues explained, writing that "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."
The team plans to develop CLARITY over six phases:
- Systematic review of radiology-relevant, patient-reported outcomes;
- Elicitation of qualitative concept information from adults undergoing imaging;
- Gathering evidence-informed feedback;
- Confirming the validity of patient-generated content through expert review and patient interviews;
- Performing prospective field testing; and
- Performing psychometric validation (cognitive abilities, behaviors, and motivations).
The tool will consist of two components: CLARITY-Core, a pre/post patient-reported outcome module that will assess any changes in patients with regard to their understanding, uncertainty, and confidence following imaging and communication of exam results; and CLARITY-Impact, a post-results module that will evaluate patients' perception of the diagnostic contribution imaging offers, any imaging-related burdens, and patients' appraisal of the benefit/burden of imaging.
The tool will be offered to patients through a free mobile and web application, the authors wrote. Psychometric evaluation will assess CLARITY's structural soundness, internal consistency, test-retest reliability, responsiveness, and interpretability, they explained.
"By capturing outcomes that matter to patients, CLARITY [will provide] a framework for evaluating radiology in a manner that is clinically meaningful, methodologically rigorous, and aligned with contemporary expectations for patient-centered care," the group concluded.
Access the full study details here.
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnieeurope.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
