Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis

Journal of Patient-Reported Outcomes

Andrew G. Bushmakin¹  Elizabeth Kudlacz¹  Ming-Ann Hsu¹  Joseph C. Cappelleri¹  David Cella²  Dennis A. Revicki³  Hilary Wilson³  Huda Shalhoub⁴ 

[1] 0000 0000 8800 7493, grid.410513.2, Pfizer Inc, Groton, CT, USA;0000 0001 2299 3507, grid.16753.36, Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA;0000 0004 0510 2209, grid.423257.5, Evidera, Bethesda, MD, USA;0000 0004 0510 2209, grid.423257.5, Evidera, Waltham, MA, USA;

关键词: FACIT-Fatigue;    Psoriatic arthritis;    Content validity;    Tofacitinib;    Psychometric properties;   

DOI  :  10.1186/s41687-019-0115-4

来源: publisher

【 摘 要 】

BackgroundTo evaluate the measurement properties (e.g., content validity, reliability, and ability to detect change) of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with active psoriatic arthritis (PsA).MethodsOne-on-one semi-structured qualitative interviews with adult patients with active PsA evaluated the content validity of FACIT-Fatigue. Quantitative measurement properties were evaluated using data from phase III tofacitinib randomized controlled trials (RCTs) in PsA: OPAL Broaden (NCT01877668) and OPAL Beyond (NCT01882439).ResultsOf 12 patients included in the qualitative study, 2 (17%) had mild, 8 (67%) had moderate, and 2 (17%) had severe PsA disease activity; 7 (58%) attributed fatigue to PsA, and 7 (58%) rated fatigue as important or extremely important. Most patients considered the FACIT-Fatigue items relevant to their PsA experience, and understood item content and response options as intended. In the psychometric analysis of RCT data, a second-order confirmatory factor model fit the data well (Bentler’s Comparative Fit Index ≥0.92). FACIT-Fatigue demonstrated good internal consistency (Cronbach’s coefficient α ≥ 0.90), test-retest reliability (Intraclass Correlation Coefficient ≥ 0.80) and a strong correlation with SF-36 Vitality (r > 0.80). A robust relationship between disease activity (based on Patient’s Global Assessment of Psoriasis and Arthritis) and FACIT-Fatigue was observed (effect sizes > 1.4), with clinically important difference for the FACIT-Fatigue total score estimated as 3.1 points, and the responder definition estimated as a 4-point improvement for FACIT-Fatigue total score.ConclusionFatigue was confirmed to be an important symptom to patients with PsA, and FACIT-Fatigue was found to be a reliable and valid measure in this population.

【 授权许可】

CC BY