Khan Nasim Ahmed, Spencer Horace Jack, Nikiphorou Elena, Naranjo Antonio, Alten Rieki, Chirieac Rodica M, Drosos Alexandros A, Géher Pál, Inanc Nevsun, Kerzberg Eduardo, Ancuta Codrina Mihaela, Müller Rüediger, Ørnbjerg Lykke, Sokka Tuulliki
Division of Rheumatology, University of Arkansas for Medical Sciences.
Central Arkansas Veterans Healthcare System.
Rheumatology (Oxford). 2017 Aug 1;56(8):1395-1400. doi: 10.1093/rheumatology/kex076.
To assess intercentre variability in the ACR core set measures, DAS28 based on three variables (DAS28v3) and Routine Assessment of Patient Index Data 3 in a multinational study.
Seven thousand and twenty-three patients were recruited (84 centres; 30 countries) using a standard protocol in the Quantitative Standard Monitoring of Patients with RA study. Analysis of variance (ANOVA) and mixed-effect analysis of covariance models were used to model the relationship between study centre and different patient-reported and physician-reported RA activity measures. These models were built to adjust for the remaining ACR core set measure (for each ACR core set measure or each composite index), socio-demographics and medical characteristics. ANOVA and analysis of covariance models yielded similar results, and ANOVA tables were used to present variance attributable to recruiting centre.
The proportion of variances attributable to recruiting centre was lower for patient reported outcomes (PROs: pain, HAQ, patient global) compared with objective measures (joint counts, ESR, physician global) in all models. In the full model, variance in PROs attributable to recruiting centre ranged from 1.53% for patient global to 3.71% for HAQ compared with objective measures that ranged from 5.92% for physician global to 9.25% for ESR; and was lower for Routine Assessment of Patient Index Data 3 (2.6%) compared with DAS28v3 (11.75%).
Intercentre variability in PROs is lower than objective measures of RA activity demonstrating that PROs may be more comparable across centres, and the need for standardization of objective measures.
在一项跨国研究中评估美国风湿病学会(ACR)核心指标、基于三个变量的28关节疾病活动评分(DAS28v3)以及患者指数数据3常规评估(RAPID3)的中心间变异性。
在类风湿关节炎患者定量标准监测研究中,采用标准方案招募了7023例患者(84个中心;30个国家)。使用方差分析(ANOVA)和协方差模型的混合效应分析来模拟研究中心与不同的患者报告和医生报告的类风湿关节炎活动指标之间的关系。构建这些模型以调整其余的ACR核心指标(针对每个ACR核心指标或每个综合指数)、社会人口统计学和医学特征。ANOVA和协方差模型得出了相似的结果,并且使用ANOVA表来呈现归因于招募中心的方差。
在所有模型中,与客观指标(关节计数、红细胞沉降率、医生整体评估)相比,患者报告结局(PROs:疼痛、健康评估问卷、患者整体评估)归因于招募中心的方差比例更低。在完整模型中,PROs归因于招募中心的方差范围从患者整体评估的1.53%到健康评估问卷的3.71%,而客观指标的方差范围从医生整体评估的5.92%到红细胞沉降率的9.25%;并且患者指数数据3常规评估(2.6%)的方差低于DAS28v3(11.75%)。
PROs的中心间变异性低于类风湿关节炎活动的客观指标,这表明PROs在各中心之间可能更具可比性,并且客观指标需要标准化。