骨关节炎和类风湿关节炎临床试验中12项简短健康调查问卷（SF-12）的心理测量学评估。
Psychometric evaluation of the 12-item short-form health survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials.
作者信息
Gandhi S K, Salmon J W, Zhao S Z, Lambert B L, Gore P R, Conrad K
机构信息
University of Illinois at Chicago, USA.
出版信息
Clin Ther. 2001 Jul;23(7):1080-98. doi: 10.1016/s0149-2918(01)80093-x.
BACKGROUND
The psychometric properties of the 12-Item Short-Form Health Survey (SF-12), a subset of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), have been tested in the general population and certain disease states.
OBJECTIVE
The purpose of this study was to evaluate the psychometric properties of the SF-12 as a generic measure of health-related quality of life (HRQoL) in osteoarthritis (OA) and rheumatoid arthritis (RA) patient populations in clinical trials.
METHODS
Data were aggregated from 5 clinical trials evaluating the efficacy of non-steroidal anti-inflammatory drugs in OA (n = 651) and RA (n = 693) patients. Patient assessments in these trials were made using the SF-36 and commonly used clinical measures of OA and RA at baseline and after up to 6 weeks of treatment. For the items of the SF-36 contained in the SF-12, the item missing rate, computability of scores, floor and ceiling effects, factor structure, and item-component correlations were evaluated. Clinical variables and correlations of physical component summary (PCS-12) and mental component summary (MCS-12) scores of the SF-12 with the corresponding SF-36 component summary scores (PCS-36 and MCS-36) were also examined. Analyses were conducted separately for OA and RA patients.
RESULTS
A low individual SF-12 item missing rate (0.29% to 2.30%) and a high percentage score computability (90.9%-94.3%) were observed at baseline. No floor or ceiling effects at baseline were observed. The scree plot confirmed the 2-factor structure of the SF-12 items. Items belonging to the physical component correlated more strongly with the PCS-12 than with the MCS-12; similarly, items belonging to the mental component correlated more strongly with the MCS-12 than with the PCS-12. The correlations between the PCS-12 and PCS-36 and between the MCS-12 and MCS-36 ranged from 0.92 to 0.96 (P < 0.001) at baseline and at week 2, 4, or 6. Significant correlations ranging from -0.09 to -0.58 (P < 0.05) were observed between the SF-12 scores and clinical variables.
CONCLUSION
The SF-12 appears to be a psychometrically sound tool for the assessment of HRQoL in OA and RA patients.
背景
12项简明健康调查量表（SF - 12）是医疗结局研究36项简明健康调查量表（SF - 36）的一个子集，其心理测量特性已在普通人群和某些疾病状态中进行了测试。
目的
本研究的目的是评估SF - 12作为骨关节炎（OA）和类风湿关节炎（RA）患者人群在临床试验中健康相关生活质量（HRQoL）的通用测量工具的心理测量特性。
方法
汇总了5项评估非甾体抗炎药对OA患者（n = 651）和RA患者（n = 693）疗效的临床试验数据。这些试验中的患者评估在基线时以及长达6周的治疗后使用SF - 36以及OA和RA常用的临床测量方法进行。对于SF - 12中包含的SF - 36项目，评估了项目缺失率、得分的可计算性、地板效应和天花板效应、因子结构以及项目与分量表的相关性。还检查了临床变量以及SF - 12的身体成分汇总得分（PCS - 12）和心理成分汇总得分（MCS - 12）与相应的SF - 36成分汇总得分（PCS - 36和MCS - 36）之间的相关性。对OA和RA患者分别进行分析。
结果
在基线时观察到单个SF - 12项目的低缺失率（0.29%至2.30%）和高百分比得分可计算性（90.9% - 94.3%）。在基线时未观察到地板效应或天花板效应。碎石图证实了SF - 12项目的两因子结构。属于身体成分的项目与PCS - 12的相关性比与MCS - 12的相关性更强；同样，属于心理成分的项目与MCS - 12的相关性比与PCS - 12的相关性更强。在基线以及第2、4或6周时，PCS - 12与PCS - 36之间以及MCS - 12与MCS - 36之间的相关性范围为0.92至0.96（P < 0.001）。在SF - 12得分与临床变量之间观察到显著相关性，范围为 - 0.09至 - 0.58（P < 0.05）。
结论
SF - 12似乎是评估OA和RA患者HRQoL的一种心理测量学上可靠的工具。
Zotero 插件