Patient and Physician Global Assessments of Disease Status in Systemic Sclerosis
- PMID: 36342397
- DOI: 10.1002/acr.25056
Patient and Physician Global Assessments of Disease Status in Systemic Sclerosis
Abstract
Global assessments of disease by both patients and physicians are widely used in clinical studies of systemic sclerosis (SSc). They are commonly secondary end points in randomized 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 assessment of disease status (PtGA) and physician global assessment of disease status (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 standardization and validation of patient and physician global assessment tools in SSc to enable universal application of these measures across RCTs in SSc.
© 2022 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.
References
REFERENCES
-
- Nikiphorou E, Radner H, Chatzidionysiou K, et al. Patient global assessment in measuring disease activity in rheumatoid arthritis: a review of the literature. Arthritis Res Ther 2016;18:251.
-
- Clements P, Furst DE, Wong WK, et al. High-dose versus low-dose D-penicillamine in early diffuse systemic sclerosis: analysis of a two-year, double-blind, randomized, controlled clinical trial. Arthritis Rheum 1999;42:1194-203.
-
- Gruber BL, Kaufman LD. A double-blind randomized controlled trial of ketotifen versus placebo in early diffuse scleroderma. Arthritis Rheum 1991;34:362-6.
-
- Casas JA, Saway PA, Villarreal I, et al. 5-fluorouracil in the treatment of scleroderma: a randomised, double blind, placebo controlled international collaborative study. Ann Rheum Dis 1990;49:926-8.
-
- Van den Hoogen F, Boerbooms AM, Swaak AJ, et al. Comparison of methotrexate with placebo in the treatment of systemic sclerosis: a 24 week randomized double-blind trial, followed by a 24 week observational trial. Br J Rheumatol 1996;35:364-72.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical