The University of Melbourne at St Vincent's Hospital and St Vincent's Hospital, Melbourne, Victoria, Australia.
The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Arthritis Care Res (Hoboken). 2023 Jul;75(7):1443-1451. doi: 10.1002/acr.25056. Epub 2023 Jan 6.
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.
全球评估疾病患者和医生都广泛应用于系统性硬化症（SSc）的临床研究。它们通常是随机对照试验（RCTs）的次要终点，并且被认为是治疗反应综合指标中的重要项目。对系统性硬化症 RCT 中使用的患者疾病总体评估（PtGA）和医生疾病总体评估（PhGA）的格式、措辞和临床计量学特性进行了全面的文献回顾。在 RCT 中应用的全球评估的措辞和测量量表存在显著的异质性。这些工具不是使用严格的方法开发的，也没有得到充分验证。迫切需要对 SSc 中的患者和医生整体评估工具进行标准化和验证，以便在 SSc 的 RCT 中普遍应用这些措施。
