ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1432

The EULAR Systemic Sclerosis Impact of Disease Score – a New Patient-Reported Outcome Measure for Patients with Systemic Sclerosis Under Development

Rucsandra Dobrota1, Mike Becker2, Kim Fligelstone3,4, Jaap Fransen5, Ann Kennedy6, Yannick Allanore7, Patricia Carreira8, László Czirják9, Christopher Denton10, Roger Hesselstrand11, Gunnel Sandqvist11, Otylia Kowal-Bielecka12, Marco Matucci Cerinic13, Carina Mihai14, Ana Maria Gheorghiu15, Ulf Müller-Ladner16, Marc Frerix17, Turid Heiberg18 and Oliver Distler1, 1Department of Rheumatology, University Hospital Zurich, Zurich, Switzerland, 2Division of Rheumatology, University Hospital Zurich, Zurich, Switzerland, 3Royal Free Hospital, Scleroderma Unit and Scleroderma Society, London, United Kingdom, 4Federation of European Scleroderma Associations (FESCA), London, United Kingdom, 5Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands, 6Federation of European Scleroderma Associations (FESCA), Tournai, Belgium, 7Department of Rheumatology, University Paris Descartes and Cochin Hospital, Paris, France, 8Department of Rheumatology, Hospital Universitario 12 de Octubre, Madrid, Spain, 9Department of Rheumatology and Immunology, University of Pécs, Faculty of Medicine, Pécs, Hungary, 10Division of Medicine, Centre for Rheumatology and Connective Tissue Disease, University College London, London, United Kingdom, 11Department of Rheumatology, Lund University, Lund, Sweden, 12Department of Rheumatology and Internal Medicine, Medical University of Bialystok, Bialystok, Poland, 13Department of Rheumatology, University of Florence, Florence, Italy, 14Department of Internal Medicine and Rheumatology, Carol Davila University of Medicine and Pharmacy, Cantacuzino Hospital, Bucharest, Romania, 15Carol Davila University of Medicine and Pharmacy, Internal Medicine and Rheumatology Department, Cantacuzino Clinical Hospital, Bucharest, Romania, 16Department of Internal Medicine and Rheumatology, Justus-Liebig-University Giessen, Kerckhoff-Klinik, Bad Nauheim, Germany, 17Department of Rheumatology and Clinical Immunology, Justus-Liebig-University Giessen, Kerckhoff-Klinik, Bad Nauheim, Germany, 18Department of Health and Social Sciences, Oestfold University College, Oslo, Norway

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , ,

Session Information

Date: Monday, November 14, 2016

Title: Quality Measures and Quality of Care - Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Patient reported outcome measures (PROM) are required as key outcomes in disease modifying therapeutic trials in systemic sclerosis (SSc). A PROM tool in SSc, covering the different features of this multi-organ autoimmune disease, is lacking. In this study, we aim to develop and validate a brief, disease-specific, patient-derived, composite disease impact score for scientific and clinical use in SSc.

Methods: This multi-center project endorsed by EULAR involves SSc patients and experts from 11 European countries. Firstly, using the nominal group technique, patients with SSc selected the health dimensions where the disease has the most significant impact. The dimensions were subsequently given numeric priority by an international group of SSc patients. Patients were asked to rank the dimensions in order of their importance by giving a rank from 1(most important) to 17 (least important). Each rank could only be used once. The dimensions with the top 10 median ranks, as ranked by the patients, were used to construct the ScleroID questionnaire using numeric rating scales. An observational study to weight the dimensions in order to calculate the ScleroID score and to validate the questionnaire is currently ongoing and aims to target a larger cohort of patients from all participating countries.

Results: 24 SSc patients selected 17 health dimensions in the nominal group exercise. The prioritization cohort included 108 SSc patients from 11 centers (female:male 82:25, limited: diffuse SSc subset 53:54). The top 10 health dimensions which were ranked most relevant by the patients were Raynaud’s phenomenon, hand function, upper and lower gastrointestinal tract symptoms, pain, fatigue, limitation of life choices and activities, body mobility, breathlessness and digital ulcers. Based on this, the ScleroID questionnaire was constructed (Figure 1).

Conclusion: The EULAR ScleroID score is a novel, patient-derived, tool under development designed for use in clinical practice and clinical trials to display the disease impact of SSc.  A large scale observational study for weighting of the dimensions and validation of this new instrument is ongoing. Figure 1. The ScleroID questionnaire.

 

Disclosure: R. Dobrota, None; M. Becker, None; K. Fligelstone, None; J. Fransen, None; A. Kennedy, None; Y. Allanore, Bristol-Myers Squibb,Roche/Genentech, Inventiva, Pfizer, Sanofi, and Servier, 2,Actelion, Bayer, Roche/Genentech, Inventiva,Medac, Pfizer, Sanofi, Servier, and UCB, 5; P. Carreira, None; L. Czirják, None; C. Denton, None; R. Hesselstrand, None; G. Sandqvist, None; O. Kowal-Bielecka, None; M. Matucci Cerinic, None; C. Mihai, None; A. M. Gheorghiu, None; U. Müller-Ladner, None; M. Frerix, None; T. Heiberg, None; O. Distler, Bayer, Sanofi, Ergonex, Boehringer Ingelheim, Actelion, Pfizer, 2,4 D Science, Actelion, Active Biotec, Bayer, BiogenIdec, BMS, Boehringer Ingelheim, EpiPharm, Ergonex, espeRare foundation, Genentech/Roche, GSK, Inventiva, Lilly, medac, MedImmune, Pharmacyclics, Pfizer, Serodapharm, Sinoxa, 5.

To cite this abstract in AMA style:

Dobrota R, Becker M, Fligelstone K, Fransen J, Kennedy A, Allanore Y, Carreira P, Czirják L, Denton C, Hesselstrand R, Sandqvist G, Kowal-Bielecka O, Matucci Cerinic M, Mihai C, Gheorghiu AM, Müller-Ladner U, Frerix M, Heiberg T, Distler O. The EULAR Systemic Sclerosis Impact of Disease Score – a New Patient-Reported Outcome Measure for Patients with Systemic Sclerosis Under Development [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/the-eular-systemic-sclerosis-impact-of-disease-score-a-new-patient-reported-outcome-measure-for-patients-with-systemic-sclerosis-under-development/. Accessed .

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