FRI0475 Systemic Sclerosis (SSC) Related Calcinosis: Patients Provide what Specialists Want to Learn – Development of a Calcinosis Patient Reported Outcome Measure (PROM)
Authors: A.M. Christensen, S. Khalique, S. Cenac, K. Fligelstone, V. Jaeger, A. Mawdsley, R. Kaufman, T. Frech, J.K. Gordon, V. Steen, A. Aubin, M. Baron, E. Busman, L.A. Saketkoo
Journal: Annals of the Rheumatic Diseases (2015)

<h3>Background</h3> Calcinosis is a disabling, rarely discussed manifestation of SSc for which the natural history and management is poorly understood. This investigation is the 1st phase of a multi-tiered project to understand calcinosis from patients9 perspectives creating the groundwork for a SSc-calcinosis PROM. <h3>Methods</h3> Five focus groups and individual interviews in the US and UK were recorded and transcribed verbatim. Pathophysiologic and life impact were elicited with: 1. Since developing calcinosis how has your life changed over time? 2. How has calcinosis changed over time? A final probe was a request for questions that a clinician could ask to understand if calcinosis was better, worse or same. Transcripts were analysed by hand (highest method) by an iterative inductive process (content drives coding) by at least 5 independent analysts including at least one patient research partner. Concepts were triangulated until a comprehensive set of concepts emerged. Occurrence was quantified per participant. <h3>Results</h3> Twenty-three patients (29/31 female, 27/31 white, with mean disease duration 18.1 years) were consented and interviewed. Responses spanned broadly to include concepts of self-management strategies and recurrent hypotheses relating calcinosis development to trauma, Raynaud9s and cold exposure (tables 1 &amp; 2). Cold exposure and Raynaud9s were a perceived association to calcinosis severity - “when they are cold mine always open back up”. A majority of patients engage in strategies to extrude calcinosis with either pressure +/- soaking or at home surgical techniques. “I actually have homemade surgical tools to get these out.” The following anchors were consistently suggested for physicians to assess calcinosis severity: pain level, size, frequency, number and functional impairment. A 2-step question was suggested to help differentiate ulcer, infection and calcinosis symptoms: 1st regarding predomiant wound character and then target the related calcinosis. <h3>Conclusions</h3> These results provide the groundwork for and conclude the 1st steps (item collection) in PROM development. As suggested by patients, a composite of scales anchored in pain, size, frequency, number and related impairment may reasonably serve as an interim instrument for SSc calcinosis. Next steps are validating content with a large subject base and questionniare development with subsequent validation. Very importantly, patients9 observations and self-management behavior provide opportunities to learn from and to preemptively educate physicians and patients. Patients are eager for self-management guidance. An essential deliverable of this work will be a patient-physician education guide on calcinosis management. <h3>Acknowledgements</h3> <i>In memory of Anne Mawdsley, founder: Raynaud9s &amp; Scleroderma Association UK – tireless engine for education and advocacy raising &gt;£10 million for SSc research.</i> <h3>Disclosure of Interest</h3> A. Christensen: None declared, S. Khalique: None declared, S. Cenac: None declared, K. Fligelstone: None declared, V. Jaeger: None declared, A. Mawdsley: None declared, R. Kaufman: None declared, T. Frech: None declared, J. Gordon: None declared, V. Steen: None declared, A. Aubin: None declared, M. Baron: None declared, E. Busman: None declared, L. A. Saketkoo Grant/research support from: ACR/EULAR Exchange Awardee