Browsing by Author "Mawdsley, Anne"

Now showing 1 - 1 of 1
  • No Thumbnail Available
    Item
    Patient Experience of Systemic Sclerosis-Related Calcinosis An International Study Informing Clinical Trials, Practice, and the Development of the Mawdsley Calcinosis Questionnaire
    (2023) Saketkoo, Lesley Ann; Gordon, Jessica K.; Fligelstone, Kim; Mawdsley, Anne; Chaudhry, Humza A.; Valenzuela, Antonia; Christensen, Angela; Khalique, Samara M.; Jensen, Kelly; Weinmann, Sophia C.; Busman, Evan; Chung, Lorinda; Hsu, Vivien M.; Russell, Anne-Marie; Steen, Virginia D.
    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.