Department of Epidemiology and Biostatistics, Xi'an Jiaotong University College of Medicine, Xi'an, Shaanxi, P. R., China.
J Viral Hepat. 2013 Apr;20(4):e47-55. doi: 10.1111/jvh.12030. Epub 2012 Nov 26.
The purpose of the study was to evaluate reliability, validity and sensitivity of the Chinese (simple) SF-36v2 in patients with chronic hepatitis B (CHB). Four hundred and sixty patients were recruited and allocated to CHB (CHB without cirrhosis) (n = 323) and CHB-related cirrhosis (n = 137) groups. Internal consistency reliability was estimated with Cronbach's α-coefficient. Convergent and discriminant validity were assessed by item-scale-component correlation. Factorial validity was explored by principal component factor analysis with varimax rotation. Sensitivity was measured with Cohen's effect size (ES), and independent sample t-test between the CHB and CHB-related cirrhosis groups and between alanine aminotransferase (ALT) normal and abnormal groups after stratifying illness stages. The results showed that Cronbach's α of the total SF-36v2 was 0.92, with the range from 0.72 to 0.87 in the eight scales and 0.76 to 0.77 in the two summary components. Most of the hypothesized item-scale-component correlations were 0.40 or over, and all of such hypothesized correlations were higher than the alternative ones, indicating satisfactory convergent and discriminant validity. Two and seven factors were extracted after varimax rotation at the scale level and item level. The eligible ES with statistically significant independent sample t-test was found in the physical component summary (PCS) and physical function (PF), role-physical (RP), general health (GH), vitality (VT), social functioning (SF) scales by comparison between CHB and CHB-related cirrhosis groups, and in the PCS and PF, GH, SF scales by comparison between the ALT normal and abnormal groups in the stratification of patients with CHB. In conclusion, the Chinese (simple) SF-36v2 has acceptable reliability, validity and sensitivity in patients with CHB.
本研究旨在评估中文（简体）SF-36v2 在慢性乙型肝炎（CHB）患者中的信度、效度和灵敏度。共招募了 460 名患者，分为 CHB（无肝硬化）（n=323）和 CHB 相关肝硬化（n=137）两组。内部一致性可靠性用 Cronbach's α 系数评估。收敛和判别效度通过项目-量表-成分相关性评估。因子有效性通过主成分因子分析（最大方差旋转）进行探索。灵敏度通过 Cohen's 效应量（ES）和独立样本 t 检验进行测量，比较 CHB 和 CHB 相关肝硬化组、丙氨酸氨基转移酶（ALT）正常和异常组，同时对疾病阶段进行分层。结果显示，SF-36v2 总分的 Cronbach's α 为 0.92，8 个分量表的范围为 0.72-0.87，两个综合分量表的范围为 0.76-0.77。大多数假设的项目-量表-成分相关性为 0.40 或更高，所有这些假设的相关性均高于替代相关性，表明具有良好的收敛和判别效度。在量表和项目水平进行最大方差旋转后，提取了两个和七个因子。在 CHB 和 CHB 相关肝硬化组之间的比较中，以及在 CHB 患者的分层中，在生理成分综合评分（PCS）和生理功能（PF）、角色生理（RP）、一般健康（GH）、活力（VT）、社会功能（SF）量表中，发现具有统计学意义的独立样本 t 检验的合格 ES；在 PCS 和 PF、GH、SF 量表中，在 ALT 正常和异常组之间的比较中，也发现了具有统计学意义的独立样本 t 检验的合格 ES。综上所述，中文（简体）SF-36v2 在 CHB 患者中具有可接受的信度、效度和灵敏度。
