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将 Bath 问卷和 HAQ-S 翻译成印地语并在印度强直性脊柱炎患者中进行文化调适和验证。

Translation, cultural adaptation, and validation of the Bath questionnaires and HAQ-S in Hindi for Indian patients with ankylosing spondylitis.

机构信息

Department of Clinical Immunology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 226014, India.

出版信息

Clin Rheumatol. 2012 Oct;31(10):1511-5. doi: 10.1007/s10067-012-2043-z. Epub 2012 Jul 25.

DOI:10.1007/s10067-012-2043-z
PMID:22829065
Abstract

The disease activity and functional impact of ankylosing spondylitis (AS) is currently measured through various questionnaire instruments, the most popular of which are the Bath indices. However, Hindi versions for use in Indian patients are not available. This study aimed to fill this lacuna. Translation and cross-cultural adaptation of the instruments--Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitits Metrology Index (BASMI), Bath Ankylosing Spondylitis Patient Global Score (BAS-G), and Health Assessment Questionnaire-Spondyloarthropathy (HAQ-S)--were done using standard guidelines. These were then self-administered to patients. The BASMI measurements, occiput-to-wall distance, chest expansion (in centimeters), total enthesis count, ESR, and C reactive protein (CRP) were measured. To assess reliability, the patient was called back on day 14, and the questionnaires were again self-administered, and the intra-class correlation coefficient was calculated to assess reliability. Correlation of questionnaire scores with acute phase reactants, measurements, and enthesitis index were used to assess for construct validity. Some modifications were done in the Bath indices and HAQ-S for cross-cultural adaptation. For validation, 41 patients of ankylosing spondylitis with a mean age of 34 years (±10.2) and disease duration of 5.8 years (±6.2) were included. The Bath Ankylosing Spondylitis Functional Index (BASFI), BASDAI, and HAQ-S showed good correlation among themselves (r = 0.69 to 0.84, p < 0.001), except for BAS-G with HAQ-S (r = 0.53, p < 0.001). Correlation between BASDAI and ESR (0.31, p = 0.05), CRP (0.48, p < 0.001), and enthesitis score (0.32, p = 0.045) was fair. Similarly, there was fair correlation of BASFI with ESR (0.55, p < 0.001), CRP (p = 0.60, p < 0.001), and various metrological measurements. These suggest convergent validity. However, there was a lack of correlation between metrological measurements and BASDAI, demonstrating divergent validity. The intra-class correlation coefficients between baseline and retest were acceptable: BASDAI intra-class correlation coefficients (ICC) 0.87 (0.78-0.93), BASFI ICC 0.90 (0.82-0.94), BAS-G ICC 0.75 (0.58-0.86), and HAQ-S ICC 0.91 (0.84-0.95). The Hindi versions of the BASDAI, BASFI, BAS-G, and HAQ-S were found to be valid and reliable for use in Hindi-speaking Indian patients with ankylosing spondylitis.

摘要

目前,通过各种问卷工具来衡量强直性脊柱炎(AS)的疾病活动度和功能影响,其中最受欢迎的是巴斯量表。然而,针对印度患者的印地语版本尚不可用。本研究旨在填补这一空白。使用标准指南对工具进行翻译和跨文化调适:巴斯强直性脊柱炎疾病活动指数(BASDAI)、巴斯强直性脊柱炎计量指数(BASMI)、巴斯强直性脊柱炎患者全球评分(BAS-G)和健康评估问卷-脊柱关节病(HAQ-S)。然后让患者自行填写。测量 BASMI、枕墙距离、胸廓扩张度(厘米)、总附着点计数、红细胞沉降率(ESR)和 C 反应蛋白(CRP)。为了评估可靠性,在第 14 天召回患者,再次让他们自行填写问卷,并计算组内相关系数以评估可靠性。通过与急性时相反应物、测量值和附着点指数的相关性来评估结构效度。对巴斯量表和 HAQ-S 进行了一些文化调适修改。为了验证,纳入了 41 名强直性脊柱炎患者,平均年龄 34 岁(±10.2),疾病持续时间 5.8 年(±6.2)。巴斯强直性脊柱炎功能指数(BASFI)、巴斯强直性脊柱炎疾病活动指数(BASDAI)和 HAQ-S 之间具有良好的相关性(r = 0.69 至 0.84,p < 0.001),除了 BAS-G 与 HAQ-S(r = 0.53,p < 0.001)之间的相关性较差。BASDAI 与 ESR(r = 0.31,p = 0.05)、CRP(r = 0.48,p < 0.001)和附着点评分(r = 0.32,p = 0.045)之间的相关性为中等。类似地,BASFI 与 ESR(r = 0.55,p < 0.001)、CRP(p = 0.60,p < 0.001)和各种计量测量值之间具有中等相关性。这表明具有收敛效度。然而,计量测量值与 BASDAI 之间缺乏相关性,表明具有发散效度。基线和复测之间的组内相关系数是可以接受的:BASDAI 组内相关系数(ICC)为 0.87(0.78-0.93),BASFI ICC 为 0.90(0.82-0.94),BAS-G ICC 为 0.75(0.58-0.86),HAQ-S ICC 为 0.91(0.84-0.95)。发现巴斯强直性脊柱炎疾病活动指数(BASDAI)、巴斯强直性脊柱炎功能指数(BASFI)、巴斯强直性脊柱炎患者全球评分(BAS-G)和健康评估问卷-脊柱关节病(HAQ-S)的印地语版本在印度语为母语的强直性脊柱炎患者中是有效和可靠的。

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Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials.用于跨国临床试验的与健康相关的生活质量问卷翻译方法的文献综述。
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