Zhou Yu, Zhuang Linli, He Xiaoqin, Xu Li, He Qi, Li Xuemei, Ye Yali
Department of Rheumatology and Immunology, West China Hospital of Sichuan University/West China School of Nursing, Sichuan University, Chengdu, Sichuan, People's Republic of China.
PLoS One. 2024 Dec 5;19(12):e0313839. doi: 10.1371/journal.pone.0313839. eCollection 2024.
The quality of life(QoL) of patients with primary Sjögren's syndrome(PSS) is affected by a variety of symptoms, and it is important to comprehensively assess the factors affecting patients' QoL.The PSS-QoL is a specific tool for the assessment of patients' QoL in the PSS. The purpose of this study was to cross-culturally adapt the PSS-QoL for the Chinese language,to establish a QoL assessment tool for PSS patients in Chinese culture and to test the reliability and validity of the PSS-QoL.
Our study period was from January 17, 2024 to June 15, 2024. The study was designed as a two-stage observational study. Double forward and backward translations of the PSS-QoL were performed for cultural adaptation to the Chinese language,and the specific steps included forward and backward translations, coordination, expert correspondence, small-sample surveys, and corrections to form the final draft of the Chinese version of the PSS-QoL. From January 29, 2024 to June 15, 2024,for the evaluation of psychometric properties, 135 patients with PSS completed the Chinese version of the PSS-QoL,Short Form-12(SF-12) and EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).After 2 to 4 weeks,15 patients with PSS completed the Chinese version of the PSS-QoL for the second time.We used SPSS 26.0 software to statistically analyze the data, including item analysis and reliability and validity tests.
The Chinese version of the PSS-QoL consists of 25 questions and can be divided into two main categories: physical (discomfort and dryness) and psychosocial. The mean score on the Chinese version of the PSS-QoL was 40.46±15.00. Among the 135 patients with PSS,92.60% were female, the mean (±SD) age was 52.76±12.74 years, and the disease duration was 5 (1.5, 9) years. There was good differentiation between the individual items and the Chinese version of the PSS-QoL,as the decision value of all the items ranged from -3.223 to -12.234 (p < 0.05), the correlation coefficient between the individual items and the whole questionnaire ranged from 0.315 to 0.730 (p < 0.05), the Chinese version of the PSS-QoL had good reliability and validity,as Cronbach's α = 0.886, the Spearman-Brown coefficient was 0.782,the reliability of the individual items was 0.89,and the values of the I-CVI and S-CVI/AVE were all 1, indicating good psychometric properties. The construct validity between the Chinese version of the PSS-QoL and the ESSPRI was excellent (p = 0.506 ~0.687), and that between the PSS-QoL and the SF-12 was good(p = -0.464 ~ -0.673).
The Chinese version of the PSS-QoL possesses good reliability and validity, and all the indicies meet the metrics and satisfy the psychometrically acceptable range;therefore, it can be used as a reliable instrument for assessing the QoL of patients with PSS in China.
原发性干燥综合征（PSS）患者的生活质量（QoL）受到多种症状的影响，全面评估影响患者生活质量的因素很重要。PSS-QoL是评估PSS患者生活质量的一种特定工具。本研究的目的是对PSS-QoL进行跨文化的中文改编，建立一种适合中国文化背景下PSS患者的生活质量评估工具，并测试PSS-QoL的信效度。
我们的研究时间为2024年1月17日至2024年6月15日。本研究设计为两阶段观察性研究。对PSS-QoL进行双向翻译以适应中文文化，具体步骤包括正向和反向翻译、协调、专家通信、小样本调查以及校正，以形成PSS-QoL中文版的最终草案。2024年1月29日至2024年6月15日，为评估心理测量学特性，135例PSS患者完成了PSS-QoL中文版、简短健康调查问卷12项简表（SF-12）和欧洲抗风湿病联盟干燥综合征患者报告指数（ESSPRI）。2至4周后，15例PSS患者再次完成PSS-QoL中文版。我们使用SPSS 26.0软件对数据进行统计分析，包括项目分析以及信效度检验。
PSS-QoL中文版由25个问题组成，可分为两大类：身体方面（不适和干燥）和心理社会方面。PSS-QoL中文版的平均得分为40.46±15.00。在135例PSS患者中，92.60%为女性，平均（±标准差）年龄为52.76±12.74岁，病程为5（1.5，9）年。各个项目与PSS-QoL中文版之间有良好的区分度，所有项目的决断值范围为-3.223至-12.234（p<0.05），各个项目与整个问卷的相关系数范围为0.315至0.730（p<0.05），PSS-QoL中文版具有良好的信效度，Cronbach's α = 0.886，Spearman-Brown系数为0.782，各项目的信度为0.89，I-CVI和S-CVI/AVE值均为1，表明具有良好的心理测量学特性。PSS-QoL中文版与ESSPRI之间的结构效度极佳（p = 0.5060.687），与SF-12之间的结构效度良好（p = -0.464-0.673）。
PSS-QoL中文版具有良好的信效度，所有指标均符合标准并满足心理测量学可接受范围；因此，它可以作为评估中国PSS患者生活质量的可靠工具。
