重症哮喘问卷(SAQ)的构建与获批
2018/08/16
摘要
背景：美国食品和药品管理局的规模验证程序需要记录详细的定性和定量数据。本文的目的是提供最终的定量验证数据。
方法：160名重症哮喘患者完成重症哮喘问卷（SAQ），哮喘控制测试（ACT），MiniAQLQ评分和EQ-5D-5L评分; 51名重症哮喘患者两次完成重症哮喘问卷（SAQ）以进行重测信度分析。 SAQ产生两个分数，基于16个项目的平均值的SAQ分数和来自单一百分制全球生活质量量表的SAQ全局分数。
结果：建构效度由16个项目的因子分析，SAQ、SAQ-全局和其他问卷之间相关性> 0.6的聚合效度，以及SAQ和SAQ-全局区分不同治疗水平的能力的区别效度共同阐明。 SAQ的重测信度（类内相关性）为0.93，SAQ-全局为0.93，SAQ的α系数为0.93。
结论：SAQ是使用推荐的定性和定量程序开发的，可用于深入了解患者对重症哮喘及其治疗对其生活影响的看法。
The construction and validation of the Severe Asthma Questionnaire (SAQ)
Hyland, M. E. et al.
Eur Respir J. 2018 May 24.
Abstract
Background：The USA's Food and Drug Administration's procedure for scale validation requires a documented stepwise process of qualitative and quantitative data. The aim of this paper is to provide the final quantitative validating data.
Methods：The severe asthma questionnaire (SAQ), asthma control test (ACT), MiniAQLQ, and EQ-5D-5L were completed by 160 patients attending a severe asthma clinic; 51 patients completed the SAQ on two occasions for test-retest reliability analysis. The SAQ produces two scores, an SAQ score based on the average of 16 items and a SAQ-global score from a single 100-point global quality of life scale.
Results：Construct validity was demonstrated through factor analysis of the 16 items, convergent validity by correlations of > 0.6 between the SAQ, SAQ-global and other questionnaires, and discriminant validity by the ability of the SAQ and SAQ-global to distinguish between different treatment levels. Test-retest reliability (intra-class correlation) was 0.93 for the SAQ and 0.93 for the SAQ-global, and the alpha coefficient for the SAQ was 0.93.
Conclusion：The SAQ was developed using recommended qualitative and quantitative procedures for scale development, and can be used to gain insight into patients' perceptions of the impact of severe asthma and its treatment on their lives.
背景：美国食品和药品管理局的规模验证程序需要记录详细的定性和定量数据。本文的目的是提供最终的定量验证数据。
方法：160名重症哮喘患者完成重症哮喘问卷（SAQ），哮喘控制测试（ACT），MiniAQLQ评分和EQ-5D-5L评分; 51名重症哮喘患者两次完成重症哮喘问卷（SAQ）以进行重测信度分析。 SAQ产生两个分数，基于16个项目的平均值的SAQ分数和来自单一百分制全球生活质量量表的SAQ全局分数。
结果：建构效度由16个项目的因子分析，SAQ、SAQ-全局和其他问卷之间相关性> 0.6的聚合效度，以及SAQ和SAQ-全局区分不同治疗水平的能力的区别效度共同阐明。 SAQ的重测信度（类内相关性）为0.93，SAQ-全局为0.93，SAQ的α系数为0.93。
结论：SAQ是使用推荐的定性和定量程序开发的，可用于深入了解患者对重症哮喘及其治疗对其生活影响的看法。
（复旦大学附属中山医院呼吸内科 罗锦龙 摘译 杨冬 审校）
（Eur Respir J. 2018 May 24.）
（Eur Respir J. 2018 May 24.）
The construction and validation of the Severe Asthma Questionnaire (SAQ)
Hyland, M. E. et al.
Eur Respir J. 2018 May 24.
Abstract
Background：The USA's Food and Drug Administration's procedure for scale validation requires a documented stepwise process of qualitative and quantitative data. The aim of this paper is to provide the final quantitative validating data.
Methods：The severe asthma questionnaire (SAQ), asthma control test (ACT), MiniAQLQ, and EQ-5D-5L were completed by 160 patients attending a severe asthma clinic; 51 patients completed the SAQ on two occasions for test-retest reliability analysis. The SAQ produces two scores, an SAQ score based on the average of 16 items and a SAQ-global score from a single 100-point global quality of life scale.
Results：Construct validity was demonstrated through factor analysis of the 16 items, convergent validity by correlations of > 0.6 between the SAQ, SAQ-global and other questionnaires, and discriminant validity by the ability of the SAQ and SAQ-global to distinguish between different treatment levels. Test-retest reliability (intra-class correlation) was 0.93 for the SAQ and 0.93 for the SAQ-global, and the alpha coefficient for the SAQ was 0.93.
Conclusion：The SAQ was developed using recommended qualitative and quantitative procedures for scale development, and can be used to gain insight into patients' perceptions of the impact of severe asthma and its treatment on their lives.
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哮喘对生活质量量表（A-IQOLS）的影响在不同哮喘研究人群和人群亚群中的表现
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了解患者对哮喘控制的观念：一项定性研究
