The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis - Relative validity of scales in relation to clinical measures of arthritis severity
The SF-36 Health Survey as a generic outcome measure in clinical trials of patients with osteoarthritis and rheumatoid arthritis - Relative validity of scales in relation to clinical measures of arthritis severity
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DOI：
10.1097/00005650-199905001-00003
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发表时间：
1999-05-01
期刊：
影响因子：
3
通讯作者：
Kong, SXD
中科院分区：
文献类型：
--
作者：
Kosinski, M;Keller, SD;Kong, SXD
OBJECTIVE.评价SF-36健康调查量表（SF-36）评分和综合测量评分在描述关节炎健康负担方面的有效性，并对4项临床试验中关节炎严重程度的临床指标作出反应。参与骨关节炎或类风湿性关节炎治疗的4项双盲、安慰剂对照临床试验的成人患者接受SF-36评估，同时进行疾病严重程度的临床测量（n = 1，016）。在治疗前和治疗后2周收集数据。将所有关节炎患者基线时的平均SF-36评分与社会人口统计学等效的国家标准进行比较，以测试SF-36描述关节炎负担的能力。为了测试SF-36评分对关节炎严重程度临床测量的反应性，在治疗前比较关节炎严重程度不同的患者的平均SF-36量表评分。比较关节炎严重程度改善的患者（应答者）与未改善的患者（无应答者）的两周平均SF-36变化评分。计算F-统计量和相对有效性系数，以确定每个SF-36量表和汇总指标在关节炎严重程度水平之间的区分程度，以及相对于最佳量表区分治疗应答者和无应答者的程度。发现平均SF-36量表评分和汇总指标存在较大且具有统计学显著性的差异，因此试验受试者的健康状况评分低于社会人口统计学等效的美国一般人群标准。此外，发现最大SF-36量表评分在临床定义的关节炎严重程度水平之间存在显著差异。最后，研究发现，SF-36量表最能区分关节炎严重程度组的横断面，也最能区分治疗应答者和无应答者。本研究的结果支持SF-36记录关节炎健康负担的有效性，并可作为骨关节炎和类风湿关节炎患者替代治疗临床试验的一般健康结局指标。
OBJECTIVE. TO evaluate the validity of SF-36 Health Survey (SF-36) scale scores and summary measure scores to describe the health burden of arthritis and to be responsive to clinical indicators of arthritis severity used in four clinical trials.METHODS. Adults participating in four double-blinded, placebo-controlled clinical trials of therapy for osteoarthritis or rheumatoid arthritis were administered the SF-36 concurrent with clinical measures of disease severity (n = 1,016). Data were collected before treatment and 2 weeks after treatment. Mean SF-36 scores for all patients with arthritis at baseline were compared to a sociodemographically equivalent national norm to test the ability of the SF-36 to describe the burden of arthritis. To test the responsiveness of SF-36 scores to clinical measures of arthritis severity, mean SF-36 scale scores were compared across patients differing in arthritis severity before treatment. Two-week mean SF-36 change scores were compared across patients who improved in arthritis severity (responders) versus patients who did not improve (nonresponders). F-statistics and relative validity co-efficients were computed to determine how well each SF-36 scale and summary measure discriminated among arthritis severity levels and distinguished treatment responders from nonresponders, relative to the best scale.RESULTS. Large and statistically significant differences in mean SF-36 scale scores and summary measures were found such that trial participants scored in worse health than a sociodemographically equivalent US general population norm. In addition, the largest SF-36 scale scores were found to significantly differ across clinically defined levels of arthritis severity. Finally, it was found that the SF-36 scales that best discriminate among arthritis severity groups cross-sectionally were also best at discriminating treatment responders from nonresponders.CONCLUSION. Results of this study support the validity of the SF-36 to document the health burden of arthritis and as a measure of generic health outcome for clinical trials of alternative treatments for osteoarthritis and rheumatoid arthritis patients.