Salaffi F, Stancati A, Carotti M
Department of Rheumatology, University of Ancona, Italy.
Clin Rheumatol. 2002 Nov;21(6):478-87. doi: 10.1007/s100670200119.
The aim of the study was to compare the responsiveness of disease-specific (Arthritis Impact Measurement Scale 2, AIMS2), generic (Medical Outcome Study Short Form Health Survey, SF-36) and preference-based instruments (rating scale, RS and time tradeoff, TTO) to changes in articular status and perceived health in patients with rheumatoid arthritis (RA). Seventy-eight consecutive patients with RA, attending the care facilities of the Department of Rheumatology of Ancona, were recruited in this longitudinal study. In order to assess the responsiveness three strategies were used: effect size (ES), standardised response mean (SRM) and receiver operating characteristic (ROC). There were 55 women and 23 men with a mean age of 56 years (range 19-78) and arthritis duration of 7.1 years (range 6 months to 24 years). Using three-category EULAR criteria as external indicators of improvement/response, 21 patients (27%) reported a significant improvement, 23 (29.5%) moderate improvement, and 34 (43.5%) no change over the 12-month period. The mean change scores in generic and specific health status instruments and utility measures were significantly related to response category. The AIMS2 subscales (physical function, pain, psychological function and social interaction) were slightly more responsive than those of SF-36. The physical and pain dimensions were most sensitive for measuring change over a 12-month period, followed by psychological and social dimensions. For the utility measurement, RS scores were found to be significantly more responsive in detecting changes in preferences than TTO scores. These results may have implications for the application of the health status and utility measures in clinical trials in patients with RA.
本研究的目的是比较疾病特异性工具（关节炎影响测量量表2，AIMS2）、通用工具（医学结局研究简明健康调查，SF - 36）和基于偏好的工具（评分量表，RS和时间权衡法，TTO）对类风湿关节炎（RA）患者关节状态变化和感知健康的反应性。在这项纵向研究中，招募了78例连续就诊于安科纳风湿病科护理机构的RA患者。为了评估反应性，采用了三种策略：效应量（ES）、标准化反应均值（SRM）和受试者工作特征曲线（ROC）。共有55名女性和23名男性，平均年龄56岁（范围19 - 78岁），关节炎病程7.1年（范围6个月至24年）。以三类欧洲抗风湿病联盟（EULAR）标准作为改善/反应的外部指标，21例患者（27%）报告有显著改善，23例（29.5%）中度改善，34例（43.5%）在12个月期间无变化。通用和特定健康状况工具及效用测量的平均变化分数与反应类别显著相关。AIMS2分量表（身体功能、疼痛、心理功能和社会交往）的反应性略高于SF - 36分量表。身体和疼痛维度在测量12个月期间的变化时最敏感，其次是心理和社会维度。对于效用测量，发现RS分数在检测偏好变化方面比TTO分数反应性显著更高。这些结果可能对健康状况和效用测量在RA患者临床试验中的应用具有启示意义。
