Psychometric evaluation of the 12-Item Short-Form Health Survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials
Psychometric evaluation of the 12-Item Short-Form Health Survey (SF-12) in osteoarthritis and rheumatoid arthritis clinical trials
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DOI：
10.1016/s0149-2918(01)80093-x
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发表时间：
2001-07-01
影响因子：
3.2
通讯作者：
Conrad, K
中科院分区：
文献类型：
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作者：
Gandhi, SK;Salmon, JW;Conrad, K
背景资料。12项简明健康调查(SF-12)的心理测量学性质，是医疗结果研究36项简明健康调查(SF-36)的子集，目的：本研究的目的是在临床试验中评估SF-12作为健康相关生活质量(HRQL)的通用测量工具在骨性关节炎(OA)和类风湿性关节炎(RA)患者人群中的应用。方法：收集5项临床试验的数据，评估非类固醇抗炎药在骨性关节炎(OA)和类风湿关节炎(RA)患者中的疗效。在这些试验中，患者评估是使用SF-36和常用的临床测量OA和RA在基线和治疗后长达6周进行的。对于SF-12中包含的SF-36条目，评估了条目缺失率、分数的可计算性、底限和天花板效应、因素结构和条目-成分相关性。同时对SF-12的身体成分总分(PCS-12)、心理成分总分(MCS-12)与SF-36各成分总分(PCS-36、MCS-36)的临床变量进行相关性分析。结果：在基线时，个体SF-12条目缺失率较低(0.29%~2.30%)，得分可计算性较高(90.9%~94.3%)。基线时没有观察到地板或天花板的影响。Scree图证实了SF-12条目的2因素结构。属于身体部分的条目与PCS-12的相关比与MCS-12的相关更强；同样，属于精神部分的条目与MCS-12的相关比与PCS-12的相关更强。在治疗前、治疗第2、4、6周时，各量表的相关系数分别为0.001.92~0.96(P<0.0 5)和-0.0 9~-0.5 8(P<0.0 5)。
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 nonsteroidal 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.