目的以眼表疾病指数(OSDI)量表作为参照，评估中文版干眼症状评估(SANDE)问卷在人群中的适用性。
方法采用横断面研究方法，于2020年6月将上海市虹口区某中学323名在校高中生纳入研究。采用OSDI问卷及中文版SANDE问卷进行干眼症状评估并计算评分。根据OSDI评分分为正常对照组87人、轻度干眼组82人、中度干眼组87人和重度干眼组67人。采用Cronbach α系数评估2种问卷的内部一致性；采用Kruskal-Wallis检验分析不同严重程度干眼组间的SANDE问卷评分差异以评价区分效度；采用Spearman秩相关分析评估SANDE问卷和OSDI问卷总分的相关性以评价效标效度；采用因子分析评价结构效度；绘制受试者工作特征曲线(ROC)，计算ROC曲线下面积(AUC)，找到SANDE问卷的诊断阈值。
结果SANDE问卷评分和OSDI问卷评分的Cronbach α系数分别为0.856和0.829。依照OSDI问卷评分进行干眼严重等级划分后，正常对照组的SANDE问卷评分为7.0(2.5，16.9)，轻度干眼组为17.0(8.4，31.0)，中度干眼组为29.2(14.6，49.4)，重度干眼组为49.1(24.4，60.7)，评分依次升高，总体比较差异有统计学意义( H＝113.213， P<0.001)，组间两两比较差异均有统计学意义(均 P<0.05)。2种问卷评分得分呈中度正相关( r s ＝0.615， P<0.001)。因子分析结果显示，SANDE问卷2个题目在公共因子上的因子负荷均较高(>0.5)，其中干眼症状发作频率为0.936，严重程度为0.936。SANDE问卷AUC为0.815( P<0.001，95% CI：0.770~0.860)，干眼诊断阈值为23，对应的敏感度为60.59%，特异度为88.51%。
结论中文版SANDE问卷具有良好信度、效度及干眼鉴别能力，虽然其敏感度较低，但作为一种简单的症状评估问卷，其在人群中仍有很好的适用性及临床应用价值。
ObjectiveTo assess the applicability of the Chinese version of the symptom assessment in dry eye (SANDE) questionnaire refer to the ocular surface disease index (OSDI) questionnaire.
MethodsA cross-sectional study was conducted.Three hundred and twenty-three students from a senior high school in Hongkou District in Shanghai were enrolled in June 2020.The Chinese version of the SANDE and the OSDI questionnaires were answered by the students to assess the dry eye symptom and were collected on-site.Scores of the two questionnaires were calculated.According to the OSDI score, the students were divided into the normal control group ( n=87), mild dry eye group ( n=82), moderate dry eye group ( n=87) and severe dry eye group ( n=67). Cronbach α was obtained to evaluate the internal consistency.Kruskal-Wallis test was used to analyze the difference in SANDE scores among dry eye groups with different severities and evaluate the discriminative validity.Correlation between the total scores of the two questionnaires was analyzed by using Spearman rank correlation analysis to evaluate the criterion validity.Factor analysis was used to evaluate the construct validity.Receiver operating characteristic curve (ROC) was drawn to obtain the area under the ROC curve (AUC) and cut-off point to evaluate the diagnostic threshold for dry eye.This study protocol adhered to the Declaration of Helsinki and was approved by an Ethics Committee of Shanghai General Hospital (No.2020KY026). Written informed consent was obtained from guardians of each subject.
ResultsThe Cronbach α of the SANDE and OSDI questionnaires were 0.856 and 0.829, respectively.SANDE score of the four groups classified according to the OSDI score was 7.0 (2.5, 16.9) for the normal control group, 17.0 (8.4, 31.0) for the mild dry eye group, 29.2 (14.6, 49.4) for the moderate dry eye group and 49.1 (24.4, 60.7) for the severe dry eye group, respectively, which was increased in turn.There was a statistically significant overall difference in the SANDE score among the four groups ( H=113.213, P<0.001), and statistically significant pairuise differences were found (all at P<0.05). The SANDE score was moderately positively associated with the OSDI score ( r s =0.615, P<0.001). The factor analysis revealed that for the SANDE questionnaire, factor loadings of its two items on the common factors were higher than 0.5, among which the frequency of dry eye symptoms was 0.936, and the severity of dry eye symptoms was 0.936.The AUC of the SANDE questionnaire was 0.815 ( P<0.001, 95% CI: 0.770-0.860). When using 23 as the diagnostic threshold for dry eye, the sensitivity and specificity of the SANDE questionnaire were 60.59% and 88.51%, respectively.
ConclusionsThe Chinese version of the SANDE questionnaire shows good reliability, validity, discrimination ability and slightly poor sensitivity in detecting dry eye.As a simple assessment questionnaire, it is applicable to the Chinese population and is of good clinical application value.
林丰,蔡羽莹,王艺敏,等. 中文版SANDE与OSDI干眼问卷信度和效度比较[J]. 中华实验眼科杂志,2022,40(02)：144-150.
DOI:10.3760/cma.j.cn115989-20200817-00592版权归中华医学会所有。
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