Discordance Dans l'évaluation d'Activité de la Polyarthrite Rhumatoide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient's global assessment
研究概览
简要总结
Patients and physicians often differ in their perceptions of rheumatoid arthritis (RA) disease activity, as quantified by the patient's global assessment (PGA) and by the evaluator's global assessment (EGA).
The objectives of this study were:
- to explore the extent and reasons for the discordance between patients and physicians in their perception of RA disease activity
- to determine if this discordance at baseline is associated with RA outcomes at 1 year (remission, function and structure) in early arthritis (EA) in daily clinical practice.
- Patients: from the French cohort of early arthritis (EA) ESPOIR³ (at least 2 swollen joints for less than 6 months, DMARD naïve), fulfilling the ACR-EULAR criteria for RA at baseline
Analysis: At baseline, agreement between PGA and EGA (Bland-Altman plot) was assessed. Multivariate linear regression was used to determine the patient and EA features independently associated with discordance (calculated as PGA - EGA). Logistic regression was used to analyze discordance as│PGA - EGA│≥20.
Multivariate logistic models were used to determine if discordance at baseline is associated with remissions (Boolean, SDAI and DAS28), functional stability (HAQ≤0.5 and deltaHAQ≤0.25) and absence of radiographic progression (delta Sharp score<1) after 1 year of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 110 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfilling the ACR-EULAR criteria for RA
排除标准
- 未提供
结局指标
主要结局
Patient's global assessment
时间窗: day 0
The discordance between the patient's and the evaluator's global assessment will be calculated.
Evaluator's global assessment
时间窗: day 0
The discordance between the patient's and the evaluator's global assessment will be calculated.
次要结局
未报告次要终点
