Bentley M J, Reed G W
Biostatistics Research Group, Department of Medicine, Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.
Clin Exp Rheumatol. 2008 Mar-Apr;26(2):358-66.
To examine the validity, reliability, and predictive value of two recently developed composite disease activity measures, the Simplified Disease Activity Index (SDAI) and the Clinical Disease Activity Index (CDAI) in rheumatoid arthritis (RA) patients.
A systematic review of the published literature was performed between February 2003 and November 2007. Data was extracted regarding correlations of the SDAI and CDAI with standard clinical trial measures, the predictive ability of the measures and correlations with changes in radiographic scores. The ability of the measures to categorize patients according to their disease activity status compared to standard categories was also examined.
Among 17 studies initially identified, 12 provided information on the validity and reliability of the SDAI and CDAI. These measures were found to be strongly correlated with the Disease Activity Score (DAS28) with correlation coefficients ranging from 0.80 to 0.93. Areas under the curve (AUC), from receiver operating characteristic (ROC) curve analysis predicting physician responses, varied from 0.821 to 0.923. Moderate association with changes in the HAQ and radiographic scores was found with correlation coefficients ranging from 0.30 to 0.59. Several studies reported mixed results between the measures when categorizing patients according to disease severity with the SDAI and CDAI the more stringent at remission.
The SDAI and the CDAI were found to have concurrent validity and were highly predictive of a change in therapy, but not predictive of future functional capacity or joint damage. Differences were found when categorizing patients according to disease activity level. Further studies should be conducted, especially at remission and low disease activity status, before these measures are used independently in a clinical setting.
检验两种最近开发的综合疾病活动度测量方法,即简化疾病活动指数(SDAI)和临床疾病活动指数(CDAI)在类风湿关节炎(RA)患者中的有效性、可靠性和预测价值。
于2003年2月至2007年11月对已发表的文献进行系统综述。提取了关于SDAI和CDAI与标准临床试验测量方法的相关性、测量方法的预测能力以及与放射学评分变化的相关性的数据。还检验了这些测量方法与标准类别相比,根据患者疾病活动状态进行分类的能力。
在最初确定的17项研究中,12项提供了关于SDAI和CDAI有效性和可靠性的信息。发现这些测量方法与疾病活动评分(DAS28)密切相关,相关系数范围为0.80至0.93。预测医生反应的受试者工作特征(ROC)曲线分析得出的曲线下面积(AUC)在0.821至0.923之间。发现与健康评估问卷(HAQ)和放射学评分变化存在中度关联,相关系数范围为0.30至0.59。几项研究报告称,在根据疾病严重程度对患者进行分类时,这些测量方法的结果不一,SDAI和CDAI在缓解期更为严格。
发现SDAI和CDAI具有同时效度,对治疗变化具有高度预测性,但对未来功能能力或关节损伤没有预测性。根据疾病活动水平对患者进行分类时发现了差异。在这些测量方法在临床环境中独立使用之前,应进行进一步研究,尤其是在缓解期和低疾病活动状态下。