Patient Experience of Systemic Sclerosis-Related Calcinosis An International Study Informing Clinical Trials, Practice, and the Development of the Mawdsley Calcinosis Questionnaire
No Thumbnail Available
Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
The patient experience of SSc-calcinosis was explored iteratively in a diverse and repre-sentative international cohort, reaching concept saturation. Pervasive disability, frustra-tion, symptom distress, and uncertainty created largely by complex, severe pain sensations are related to daily living with SSc-calcinosis. Patient observations and self-management behavior provide opportunities to educate clinicians and patients. Pa-tients are eager for self-management guidance. This investigation informed the develop-ment of a novel PROM, the MCQ, developed according to FDA guidance20,21 to assess the severity and impact of SSc-calcinosis for use in clinical studies and clinical practice. Further validation and translation studies of the MCQ are underway.
Description
Keywords
Scleroderma, Calcinosis, Raynaud phenomenon, Digital ulcers, Qualitative research, Patient-reported outcomes, Self-Management, Qualtiy of LIfe