Development of a new patient‐reported outcome measure to assess activities and participation in people with systemic sclerosis: the Cochin 17‐item Scleroderma Functional scale

Abstract

Background Patient-reported outcome measures (PROMs) aimed at assessing people with systemic sclerosis (SSc) have rarely involved the target population in the item-and domain-generation stage of the instrument construction. Objectives To develop a new PROM assessing activities and participation in people with SSc. Methods A provisional International Classification of Functioning, Disability and Health (ICF)-based 65-item questionnaire previously developed from interviews of people with SSc was sent by email to all patients followed in the internal medicine department of Cochin hospital (n = 184) and enrolled in the Scleroderma Patient-centered Intervention Network Cohort. Items were reduced according to their metric properties. Dimensional structure of the questionnaire was assessed by principal component analysis, convergent and divergent validities by Spearman's rank correlation coefficient, internal consistency by Cronbach's a, and reliability by a test-retest method using the intraclass correlation coefficient (ICC) and Bland-Altman analysis. Results Overall, 113 of 184 patients (61Á4%) completed the provisional questionnaire. The item-reduction process resulted in a 17-item questionnaire, the Cochin 17-item Scleroderma Functional scale (CSF-17). Principal component analysis extracted two dimensions: 10 items related to mobility (CSF-17 section A) and seven items related to general tasks (CSF-17 section B). We observed convergent

Development and validation of a patient-reported outcome measure for systemic sclerosis: the EULAR Systemic Sclerosis Impact of Disease (ScleroID) questionnaire

“…However, these questionnaires have only been partially validated, mostly lacking a discriminant validity analysis, and are partly not validated in English (SysQ and SAQ). The recently published PROM CSF-17 (Cochin Scleroderma Functional scale 17), a 17 item PROM that focused on mobility and general task aspects of SSc, was also developed with involvement of SSc patients [43]. It has been evaluated in a smaller cohort than the ScleroID and in French only, with data on discriminant validity (sensitivity to change) still missing.…”

Differences in Disability Perception in Systemic Sclerosis: A Mirror Survey of Patients and Health Care Providers

“…In total, 53/105 (51%) included care providers who were women and 34/105 (32%) were between 35 and 44 years old, and there were 75/105 (71%) and 92/105 (88%) care providers who followed less than 50 patients with LcSSc or DcSSc a year, respectively ( Table 1 ). Overall, 184 patients were approached in the SCISCIF II study, 113 patients (61%) participated and 109 (60%) completed the survey [ 27 ]. The mean age was 55.9 (14.7) years, the mean disease duration was 10.1 (7.5) years, 57/109 (52%) had LcSSc and 41 (38%) had DcSSc ( Table 2 ).…”

20 Years of ICF—International Classification of Functioning, Disability and Health: Uses and Applications around the World

“…ICF Core Sets are selections of ICF categories agreed on as relevant for specific conditions or clinical areas [ 23 , 24 , 25 , 26 , 27 , 28 ]. The most widely used ICF-based assessment tool is the WHODAS 2.0, used in a variety of setting and countries [ 29 , 30 , 31 ], but many others exist which are intended to measure disability in specific clinical populations: (e.g., patients with psychiatric and cognitive disorders [ 32 ], multiple sclerosis [ 33 ] or myasthenia gravis [ 34 ]). In our survey, some CCs report examples of ICF introduction in routine clinical activity, the most known being rehabilitation hospitals for either adults or children [ 35 , 36 ].…”