Translation, Cross-Cultural Adaptation and Validation of the Central Sensitization Inventory for Patients with Rheumatoid Arthritis

M. Stanislavchuk, V. Bombela, Y. Shkarivskyy
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Abstract

Introduction. Pain syndrome is one of the leading disabilitating factors in patients with rheumatoid arthritis (RA). Recently the heterogeneity of pathogenetic mechanisms of pain formation in the patients with joints inflammatory diseases has been demonstrated. The phenomenon of central sensitization is among the leading mechanisms of pain perception. In 2012 T. G. Mayer et al. created the Central Sensitization Inventory (CSI), which makes it possible rapid identification of patients whose symptoms may be related to the phenomenon of central sensitization. Currently the Ukrainian version of this questionnaire is not available. The aim of the study. Our investigation was directed towards translation, cross-cultural adaptation, validation, and testing of Central Sensitization Inventory Ukrainian version in rheumatoid arthritis patients. Materials and methods. Translation and cross-cultural adaptation of CSI were carried out according to the standard Guidelines for the process of cross-cultural adaptation of self-report measures. 75 patients diagnosed with RA according to ACR/EULAR (2010) criteria and 15 control group patients were involved in the study. RA activity was determined due to Disease Activity Score – 28 (DAS-28), the Simplified Disease Activity Index (SDAI), the Clinical Disease Activity Index (CDAI), and the functional ability of patients – by Health Assessment Questionnaire – Disability Index (HAQ-DI). Visual analog scoring (VAS) from 0 to 10 points were used to evaluate the intensity of pain. Statistical analysis of the results was performed using the methods of variation statistics in the application package SPSS22 (© SPSS Inc.). The results are presented as the mean value with standard deviation (M ± SD). Results. According to DAS-28, patients had a predominance of moderate and high disease activity (4.99 ± 0.87). Also, high RA activity in most patients was confirmed by CDAI (32.96 ± 9.46) and SDAI (35.90 ± 9.56). Impairment of functional ability in the examined patients according to the HAQ-DI index was 1.36 ± 0.70 points. Severe functional impairment (HAQ-DI value more than 2 points) was observed in 19.0 % of patients. The intensity of pain assessed in patients was 6,92 ± 1,55 points. The reliability of the Ukrainian-language version of the CSI questionnaire was evaluated by a “test-retest” with an interval of 7 days in 65 patients with RA. The obtained data demonstrated the high reliability of the CSI questionnaire – intraclass correlation coefficient was 0.914, and the L. Cronbach’s alpha coefficient was 0.914. The CSI questionnaire in RA patients demonstrated the phenomenon of central sensitization in this category of patients. The CSI value in our patients was 36.32 ± 14.67 versus 15.60 ± 12.10 in controls. At the same time, an indicator of more than 40 (central sensitization present) was detected in 40.0 % of patients. Conclusions. Translation, cross-cultural adaptation and validation of the Central Sensitization Inventory questionnaire were accomplished. The Ukrainian version of the questionnaire showed sufficient reliability and internal consistency. This questionnaire can be useful in both – scientific purposes and clinical practice – regarding the Ukrainian-speaking population with rheumatoid arthritis.
类风湿关节炎患者中心致敏量表的翻译、跨文化适应和验证
介绍。疼痛综合征是类风湿性关节炎(RA)患者致残的主要因素之一。近年来,关节炎性疾病患者疼痛形成的病理机制的异质性已经得到证实。中枢致敏现象是痛觉的主要机制之一。2012年,T. G. Mayer等人创建了中枢致敏量表(CSI),使快速识别症状可能与中枢致敏现象相关的患者成为可能。目前还没有乌克兰文版的这份调查表。研究的目的。我们的研究针对类风湿关节炎患者的中心致敏清单乌克兰版的翻译、跨文化适应、验证和测试。材料和方法。CSI的翻译和跨文化适应按照标准的《自我报告措施跨文化适应过程指南》进行。本研究纳入75例根据ACR/EULAR(2010)标准诊断为RA的患者和15例对照组患者。通过疾病活动评分-28 (DAS-28)、简化疾病活动指数(SDAI)、临床疾病活动指数(CDAI)和患者的功能能力-健康评估问卷-残疾指数(HAQ-DI)来确定RA活动。采用0 ~ 10分视觉模拟评分(VAS)评价疼痛程度。采用SPSS22应用程序包(©SPSS Inc.)中的方差统计方法对结果进行统计分析。结果以标准差(M±SD)的平均值表示。结果。根据DAS-28,患者以中高疾病活动度为主(4.99±0.87)。此外,CDAI(32.96±9.46)和SDAI(35.90±9.56)也证实了大多数患者的高RA活性。HAQ-DI指数为1.36±0.70分。19.0%的患者出现严重功能障碍(HAQ-DI值大于2分)。患者疼痛强度评分为6.92±1.55分。在65例RA患者中,通过间隔7天的“重新测试”来评估乌克兰语版CSI问卷的可靠性。所得数据表明,CSI问卷具有较高的信度,类内相关系数为0.914,L. Cronbach’s alpha系数为0.914。RA患者CSI问卷显示这类患者存在中枢致敏现象。本组患者的CSI值为36.32±14.67,对照组为15.60±12.10。同时,在40.0%的患者中检测到超过40(存在中枢致敏)的指标。结论。完成了中心敏感化量表的翻译、跨文化改编和验证。乌克兰版本的调查表显示出足够的可靠性和内部一致性。这份调查问卷可以在科学目的和临床实践中有用-关于乌克兰语人群类风湿关节炎。
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