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Cella D, Wilson H, Shalhoub H, et al. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019;3(1):30doi: 10.1186/s41687-019-0115-4.
Cella, D., Wilson, H., Shalhoub, H., Revicki, D. A., Cappelleri, J. C., Bushmakin, A. G., Kudlacz, E., & Hsu, M. A. (2019). Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. Journal of patient-reported outcomes, 3(1), 30. https://doi.org/10.1186/s41687-019-0115-4
Cella, David, et al. "Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis." Journal of patient-reported outcomes vol. 3,1 (2019): 30. doi: https://doi.org/10.1186/s41687-019-0115-4
Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4. PMID: 31111255; PMCID: PMC6527714.
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J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

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

Journal of patient-reported outcomes

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

Affiliations

  1. Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA. [email protected].
  2. Evidera, Bethesda, MD, USA.
  3. Evidera, Waltham, MA, USA.
  4. Pfizer Inc, Groton, CT, USA.

PMID: 31111255 PMCID: PMC6527714 DOI: 10.1186/s41687-019-0115-4

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

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