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. 2022 Sep 23;6(1):100.
doi: 10.1186/s41687-022-00508-0.

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

David Cella  1 , William R Lenderking  2 , Peter Chongpinitchai  3 , Andrew G Bushmakin  4 , Oluwaseyi Dina  5 , Lisy Wang  4 , Joseph C Cappelleri  4 , Victoria Navarro-Compán  6
Affiliations

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

David Cella et al. J Patient Rep Outcomes. .

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://clinicaltrials.gov/ct2/show/NCT01786668 ) and NCT03502616 (registered 11 April 2018, https://clinicaltrials.gov/ct2/show/NCT03502616 ).

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

Plain language summary

Ankylosing spondylitis (AS) is a disease that causes pain and stiffness in the spine. AS is a chronic disease. Most people with AS experience fatigue (a feeling of being very tired or exhausted). People with more severe AS tend to have more fatigue and a lower level of well-being. Because of this, fatigue is an important symptom to measure in studies of AS. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a questionnaire that measures fatigue. It has 13 questions that assess level of fatigue over a week’s time. The FACIT-F has not been studied in depth in people with AS. Therefore, we analyzed results from two clinical trials. We found that FACIT-F was a reliable and valid way to measure fatigue in adults with AS. This makes it a suitable tool to use in AS clinical trials.

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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.

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
See this image and copyright information in PMC

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