Patient and physician global assessments of disease status in systemic sclerosis

Global assessments of disease by both patients and physicians are widely used in clinical studies of systemic sclerosis (SSc). They are commonly secondary endpoints in randomised controlled trials (RCTs) and are considered important items in composite measures of treatment response. A comprehensive literature review was conducted of the formats, wording, and clinimetric properties of the patient global assessments (PtGA) and physician global assessments (PhGA) used in RCTs of SSc. Marked heterogeneity was found in the wording and measurement scales of the global assessments applied in RCTs. These instruments were not developed using rigorous methodology and have not been fully validated. There is a pressing need for standardisation and validation of patient and physician global assessment tools in SSc to enable universal application of these measures to across RCTs in SSc. This article is protected by copyright. All rights reserved.