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强直性脊柱炎患者报告结局:一种新的评估功能障碍和生活质量问卷的制定和验证。

Patient reported outcomes in ankylosing spondylitis: development and validation of a new questionnaire for functional impairment and quality of life assessment.

机构信息

Rheumatology and Rehabilitation, Ain Shams University, Cairo, Egypt.

出版信息

Clin Exp Rheumatol. 2011 Sep-Oct;29(5):801-10. Epub 2011 Oct 31.

PMID:22011622
Abstract

OBJECTIVES

To assess validity, reliability and sensitivity to change of a new questionnaire for assessment of functional disability and quality of life in ankylosing spondylitis (AS) patients.

METHODS

Using Rasch analysis and 71 questions item pool, content analysis and semi structured group discussion, the combined AS questionnaire (CASQ) was developed including: 10-item scale to assess functional impairment (CASQ-FI), and 10 items to assess quality of life (CASQ-QoL). Construct validity was assessed by correlating the score of the questionnaire to parameters of disease activity namely, the BAS-FI, BAS-DAI, BAS-G, BAS-Metrology Index, and the occupational status. In addition, the CASQ was compared to both HAQS and ASQoL. Sensitivity to change of the developed CASQ was also assessed.

RESULTS

The CASQ questionnaire for functional impairment (CASQ-FI: 10 items) and quality of life (CASQ-QoL: 10 items) showed acceptable validity as it correlated significantly with clinical parameters of disease activity: BAS-FI (CASQ-FI: r=0.85, CASQ-QoL: r=0.86), BAS-DAI (CASQ-FI: r=0.71, CASQ-QoL: r=0.87) and BAS-G (CASQ-FI: r=0.64, CASQ-QoL: r=0.79). Compared to HAQS and ASQoL, the CASQ-QoL was as well or better correlated with clinical and outcome measures. The CASQ was also reliable (Cronbach's alpha for CASQ-FI 0.958, and CASQ-QoL 0.966) and had no misfitting items. In addition, both CASQ questionnaires were sensitive to change (p<0.01)

CONCLUSIONS

The CASQ is a reliable and valid tool for assessment of functional impairment and quality of life in AS. The CASQ is well accepted by patients, sensitive to change, easy to administer and score. The CASQ-FI and CASQ-QoL questionnaires can either be used and scored separately to assess for functional disability as well as quality of life or in combination as tools to assess for both parameters.

摘要

目的

评估一种新的评估强直性脊柱炎(AS)患者功能障碍和生活质量的问卷的有效性、可靠性和对变化的敏感性。

方法

使用 Rasch 分析和 71 个问题项目池、内容分析和半结构化小组讨论,开发了综合 AS 问卷(CASQ),包括:10 项功能障碍评估量表(CASQ-FI)和 10 项生活质量评估量表(CASQ-QoL)。通过将问卷的评分与疾病活动的参数(BAS-FI、BAS-DAI、BAS-G、BAS 计量指数和职业状况)相关联,评估结构效度。此外,还将 CASQ 与 HAQS 和 ASQoL 进行了比较。还评估了开发的 CASQ 的变化敏感性。

结果

功能障碍问卷(CASQ-FI:10 项)和生活质量问卷(CASQ-QoL:10 项)的 CASQ 显示出可接受的有效性,因为它与疾病活动的临床参数显著相关:BAS-FI(CASQ-FI:r=0.85,CASQ-QoL:r=0.86)、BAS-DAI(CASQ-FI:r=0.71,CASQ-QoL:r=0.87)和 BAS-G(CASQ-FI:r=0.64,CASQ-QoL:r=0.79)。与 HAQS 和 ASQoL 相比,CASQ-QoL 与临床和结果测量的相关性同样或更好。CASQ 也可靠(CASQ-FI 的 Cronbach's alpha 为 0.958,CASQ-QoL 为 0.966),并且没有不合适的项目。此外,两种 CASQ 问卷都对变化敏感(p<0.01)。

结论

CASQ 是一种可靠和有效的评估工具,用于评估 AS 患者的功能障碍和生活质量。CASQ 易于管理和评分,患者易于接受,对变化敏感。CASQ-FI 和 CASQ-QoL 问卷可以单独使用和评分,以评估功能障碍和生活质量,也可以组合使用,以评估两个参数。

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It is time for an organised, scientific approach to the application of patient-reported outcome measures in clinical studies and trials.现在是时候对患者报告的结局测量在临床研究和试验中的应用采用有组织、科学的方法了。
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