Psychometric Properties of the Asthma Symptom Diary (ASD), a Diary for Use in Clinical Trials of Persistent Asthma

被引：14

作者：

Globe, Gary ^{[1
]}

Wiklund, Ingela ^{[2
]}

Lin, Joseph ^{[3
]}

Chen, Wen-Hung ^{[4
]}

Martin, Mona ^{[5
]}

Mattera, Maria S. ^{[4
]}

von Maltzahn, Robyn

Feng, Jing Yuan ^{[1
]}

Chon, Yun ^{[1
]}

Viswanathan, Hema N. ^{[1
]}

Schatz, Michael ^{[6
]}

机构：

[1] Amgen Inc, Thousand Oaks, CA 91320 USA

[2] Evidera, London, England

[3] Gilead Sci Inc, 353 Lakeside Dr, Foster City, CA 94404 USA

[4] Evidera, Bethesda, MD USA

[5] Hlth Res Associates Inc, Mountlake Terrace, WA USA

[6] Kaiser Permanente Med Ctr, Dept Allergy, San Diego, CA USA

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE | 2016年 / 4卷 / 01期

关键词：

Asthma; Symptoms; Patient-reported outcome; Psychometrics; Validity; SEVERITY;

D O I：

10.1016/j.jaip.2015.07.008

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

BACKGROUND: No currently available asthma symptom diary has sufficient validation to be recommended for use as a core asthma outcome measure. OBJECTIVE: The objective of this study was to provide validation data for the 10-item asthma symptom diary (ASD). METHODS: Data were collected in a 4-week prospective, observational study. Subjects completed 3 study visits, completing the ASD twice daily at home for 28 days. Psychometric properties in terms of dimensionality, reliability, validity, and responsiveness were assessed. RESULTS: Data from 276 subjects were analyzed; mean age was 42.9 (standard deviation [SD] = 16.4) years, mean asthma duration was 23.3 (SD = 16.8) years, and 69.6% were female. Confirmatory factor and Rasch analysis supported the ASD as unidimensional and adequately measuring the spectrum of asthma symptom severity. High Cronbach's alpha (0.94) and intraclass correlation coefficients (0.89-0.95) supported reliability. A high correlation between the 7-day average ASD score and the Asthma Control Questionnaire (ACQ) total score (r = 0.75) and Asthma Quality of Life Questionnaire total scores (r = -0.76), and a moderate correlation with FEV1% predicted (r = -0.30) supported convergent validity. Significant differences (P < .001) between groups classified by ACQ scores supported known-group validity. The 7-day average ASD scores were responsive to change, with significantly higher score changes (P < .001) in responders versus nonresponders. Minimally important differences were calculated and found to be in the range of 0.1-0.3. CONCLUSION: Results of this study indicated that the ASD is a reliable and valid asthma symptom measure for use in adult and adolescent asthma patients to evaluate the effect of treatment on asthma in clinical trials. (C) 2015 American Academy of Allergy, Asthma & Immunology

引用

页码：60 / +

页数：11

共 23 条

[21] A new perspective on concepts of asthma severity and control [J].

Taylor, D. R. ;

Bateman, E. D. ;

Boulet, L-P. ;

Boushey, H. A. ;

Busse, W. W. ;

Casale, T. B. ;

Chanez, P. ;

Enright, P. L. ;

Gibson, P. G. ;

de Jongste, J. C. ;

Kerstjens, H. A. M. ;

Lazarus, S. C. ;

Levy, M. L. ;

O'Byrne, P. M. ;

Partridge, M. R. ;

Pavord, I. D. ;

Sears, M. R. ;

Sterk, P. J. ;

Stoloff, S. W. ;

Szefler, S. J. ;

Sullivan, S. D. ;

Thomas, M. D. ;

Wenzel, S. E. ;

Reddel, H. K. .

EUROPEAN RESPIRATORY JOURNAL, 2008, 32 (03) :545-554

[22] The Association Between Asthma Control and Health Care Utilization, Work Productivity Loss and Health-Related Quality of Life [J].

Williams, Setareh A. ;

Wagner, Samuel ;

Kannan, Hema ;

Bolge, Susan C. .

JOURNAL OF OCCUPATIONAL AND ENVIRONMENTAL MEDICINE, 2009, 51 (07) :780-785

[23]

Zumbo B.D., 1999, HDB THEORY METHODS D

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