Patient Experience of Systemic Sclerosis-Related Calcinosis: An International Study Informing Clinical Trials, Practice, and the Development of the Mawdsley Calcinosis Questionnaire.

Lesley Ann Saketkoo, Jessica K Gordon, Kim Fligelstone, Anne Mawdsley, Humza A Chaudhry, Antonia Valenzuela, Angela Christensen, Samara M Khalique, Kelly Jensen, Sophia C Weinmann, Evan Busman, Lorinda Chung, Vivien M Hsu, Anne-Marie Russell, Virginia D Steen

Journal: Rheumatic diseases clinics of North America 2023;49(2):463-481

PMID: 37028847

Abstract

Systemic sclerosis (SSc) -related calcinosis can be a debilitating, constantly painful, poorly understood vascular complication of calcium hydroxyapatite deposition in soft tissue structures that affects approximately 40% of both limited and diffuse cutaneous SSc subtypes. This publication describes the iterative and multitiered international qualitative investigations that yielded remarkable insights into natural history, daily experience, and complications of SSc-calcinosis providing pivotal information for health management. Patient-driven question development and field testing, according to Food and Drug Administration guidance, propelled the development of a patient-reported outcome measure for SSc-calcinosis, the Mawdsley Calcinosis Questionnaire.

Copyright © 2023 Elsevier Inc. All rights reserved.

Address: New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, LA, USA; University Medical Center-Comprehensive Pulmonary Hypertension Center and Interstitial Lung Disease Clinic Programs, New Orleans, LA, USA; Section of Pulmonary Medicine, Louisiana State University School of Medicine, New Orleans, LA, USA; Tulane University School of Medicine, New Orleans, LA, USA. Electronic address: [email protected].; Department of Rheumatology, Hospital for Special Surgery, New York, NY, USA.; Scleroderma & Raynaud Society, UK (SRUK); Federation of European Scleroderma Associations, UK.; Raynaud's & Scleroderma Association-Care and Support, London, UK.; New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, LA, USA; Tulane University School of Medicine, New Orleans, LA, USA.; Department of Rheumatology and Clinical Immunology, Pontificia Universidad Católica de Chile, Santiago, Chile.; Doctors Hospital, Renaissance, TX, USA.; Department of Rheumatology, Virginia Tech Carilion Clinic School of Medicine, Roanoke, VA, USA.; New Orleans Scleroderma and Sarcoidosis Patient Care and Research Center, New Orleans, LA, USA; Tulane University School of Medicine, New Orleans, LA, USA; University of Colorado School of Medicine, Denver, CO, USA.; Department of Medicine, Division of Rheumatology and Immunology, Duke University Hospital, Durham, NC, USA.; Healthcare Patient Advocate, Atlanta, GA, USA.; Department of Medicine, Division of Immunology and Rheumatology, Stanford University School of Medicine and Palo Alto VA Healthcare System, Palo Alto, CA, USA; Department of Dermatology, Division of Immunology and Rheumatology, Stanford University School of Medicine and Palo Alto VA Healthcare System, Palo Alto, CA, USA.; RWJ-Scleroderma Program, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.; Respiratory Institute, University of Exeter, Exeter, UK; Respiratory Medicine, Royal Devon University Healthcare NHS Foundation Trust, UK.; Division of Rheumatology, Department of Medicine, Georgetown University, Washington, DC, USA.
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