Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis

被引:10
作者
Cella, David [1 ]
Lenderking, William R. [2 ]
Chongpinitchai, Peter [3 ]
Bushmakin, Andrew G. [4 ]
Dina, Oluwaseyi [5 ]
Wang, Lisy [4 ]
Cappelleri, Joseph C. [4 ]
Navarro-Compan, Victoria [6 ]
机构
[1] Northwestern Univ, Dept Med Social Sci, Feinberg Sch Med, 625 North Michigan Ave,Suite 2100, Chicago, IL 60611 USA
[2] Evidera, Waltham, MA USA
[3] Evidera, Bethesda, MD USA
[4] Pfizer Inc, Groton, CT 06340 USA
[5] Pfizer Inc, New York, NY USA
[6] Univ Hosp La Paz, IdiPAZ, Madrid, Spain
关键词
Arthritis; Patient-reported outcome measures; Spondylitis; Ankylosing; QUALITY-OF-LIFE; PREVALENCE; OUTCOMES; SCALE;
D O I
10.1186/s41687-022-00508-0
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Background: The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale has demonstrated good internal consistency and responsiveness to changes in clinical status among patients with ankylosing spondylitis (AS). We aimed to further evaluate the psychometric properties of the FACIT-F scale in adult patients with AS. Methods: Measurement properties of the FACIT-F scale were evaluated using data from tofacitinib phase 2/3 (NCT01786668/NCT03502616) studies in adult patients with active AS. Results: Second-order confirmatory factor modeling supported the measurement structure of the FACIT-F scale (Bentler's comparative fit index >= 0.91), and FACIT-F demonstrated excellent internal consistency (Cronbach's coefficient alpha >= 0.88) and test-retest reliability (Intraclass Correlation Coefficient >= 0.75). Correlation coefficients between FACIT-F and other patient-reported outcomes generally exceeded 0.40, supporting convergent validity. Meaningful within-patient change was estimated as 3.1-6.3 for FACIT-F total score, and 1.4-2.8 and 1.7-3.6 for FACIT-F Experience and Impact domain scores, respectively. Large (effect size >= 1.17 standard deviation units), statistically significant differences in FACIT-F domain/total scores between 'no disease activity' (Patient Global Assessment of Disease Activity [PtGA] = 0) and 'very active disease' (PtGA =10) patient groups supported known-groups validity. Ability to detect change was evidenced by an approximately linear relationship between changes in FACIT-F and PtGA scores. Conclusions: FACIT-F is a reliable and valid measure for evaluating fatigue in adult patients with active AS.
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页数:10
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