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

David Cella, William R Lenderking, Peter Chongpinitchai, Andrew G Bushmakin, Oluwaseyi Dina, Lisy Wang, Joseph C Cappelleri, Victoria Navarro-Compán, David Cella, William R Lenderking, Peter Chongpinitchai, Andrew G Bushmakin, Oluwaseyi Dina, Lisy Wang, Joseph C Cappelleri, Victoria Navarro-Compán

Abstract

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 α ≥ 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.

Trial registration: ClinicalTrials.gov; NCT01786668 (registered 6 February 2013, https://ichgcp.net/clinical-trials-registry/NCT01786668 ) and NCT03502616 (registered 11 April 2018, https://ichgcp.net/clinical-trials-registry/NCT03502616 ).

Keywords: Ankylosing; Arthritis; Patient-reported outcome measures; Spondylitis.

Conflict of interest statement

D Cella has acted as a consultant for AbbVie, Alexion Pharmaceuticals, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis Oncology, Evidera, Exelixis, Horizon Therapeutics, Janssen, Merck/Schering-Plough, National Academy of Sciences, Novartis Pharma K.K. (Japan), Pfizer Inc, PledPharma, and Regeneron. WR Lenderking is an employee of Evidera and shareholder of Pfizer Inc. P Chongpinitchai is an employee of Evidera. AG Bushmakin, O Dina, L Wang, and JC Cappelleri are employees and stockholders of Pfizer Inc. V Navarro-Compán has received grant/research support from AbbVie and Novartis, and has acted as a consultant for, and been a member of the speakers’ bureau for, AbbVie, Janssen, Lilly, MSD, Pfizer Inc, and UCB.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Relationship between change from baseline in FACIT-F Experience domain, Impact domain, and total scores, and change from baseline in PtGA scores in patients with active AS in a Study 1* and b Study 2†. *NCT01786668 (phase 2 study). †NCT03502616 (phase 3 study). AS, ankylosing spondylitis; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; PtGA, Patient Global Assessment

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Source: PubMed

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