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

David Cella, Hilary Wilson, Huda Shalhoub, Dennis A Revicki, Joseph C Cappelleri, Andrew G Bushmakin, Elizabeth Kudlacz, Ming-Ann Hsu, David Cella, Hilary Wilson, Huda Shalhoub, Dennis A Revicki, Joseph C Cappelleri, Andrew G Bushmakin, Elizabeth Kudlacz, Ming-Ann Hsu

Abstract

Background: To 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).

Methods: One-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).

Results: Of 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.

Conclusion: Fatigue 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.

Keywords: Content validity; FACIT-Fatigue; Psoriatic arthritis; Psychometric properties; Tofacitinib.

Conflict of interest statement

David Cella has served on the board of directors for Cancer Wellness Center and PROMIS Health Organization, has received consultancy fees of <$10,000 from AbbVie, Alexion Pharmaceuticals, Astellas Pharma, Bayer AG, Bristol-Myers Squibb, Celgene Corporation, Clovis Oncology Inc., Evidera, Exelixis Inc., FibroGen Inc., Helsinn Therapeutics (U.S.) Inc., Horizon Pharma Inc., ImmunoGen Inc., Janssen Pharmaceuticals Inc., Merck/Schering-Plough Pharmaceuticals, National Academy of Sciences, Novartis Pharma K.K. (Japan), PatientsLikeMe, Pfizer Inc., Pled Pharma, Puma Biotechnology Inc., Regeneron Pharmaceuticals Inc., and Shire PLC, and has ownership or investment interests in FACITtrans LLC (FACIT.org) and Functional Assessment of Chronic Illness Therapy (FACIT.org). Hilary Wilson, Huda Shalhoub and Dennis A. Revicki are employees of Evidera Inc. Joseph C. Cappelleri, Andrew G. Bushmakin, Elizabeth Kudlacz, and Ming-Ann Hsu are employees of Pfizer Inc. and own stock in Pfizer Inc.

Figures

Fig. 1
Fig. 1
Relationship between FACIT-Fatigue total score and PtGA as a continuous or categorical anchor. FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue; PtGA: Patient’s Global Assessment of Psoriasis and Arthritis

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