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

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 inte...

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Autores principales: Cella, David, Wilson, Hilary, Shalhoub, Huda, Revicki, Dennis A., Cappelleri, Joseph C., Bushmakin, Andrew G., Kudlacz, Elizabeth, Hsu, Ming-Ann
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527714/
https://www.ncbi.nlm.nih.gov/pubmed/31111255
http://dx.doi.org/10.1186/s41687-019-0115-4
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author Cella, David
Wilson, Hilary
Shalhoub, Huda
Revicki, Dennis A.
Cappelleri, Joseph C.
Bushmakin, Andrew G.
Kudlacz, Elizabeth
Hsu, Ming-Ann
author_facet Cella, David
Wilson, Hilary
Shalhoub, Huda
Revicki, Dennis A.
Cappelleri, Joseph C.
Bushmakin, Andrew G.
Kudlacz, Elizabeth
Hsu, Ming-Ann
author_sort Cella, David
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s41687-019-0115-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-65277142019-06-07 Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis Cella, David Wilson, Hilary Shalhoub, Huda Revicki, Dennis A. Cappelleri, Joseph C. Bushmakin, Andrew G. Kudlacz, Elizabeth Hsu, Ming-Ann J Patient Rep Outcomes Research 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s41687-019-0115-4) contains supplementary material, which is available to authorized users. Springer International Publishing 2019-05-20 /pmc/articles/PMC6527714/ /pubmed/31111255 http://dx.doi.org/10.1186/s41687-019-0115-4 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Research
Cella, David
Wilson, Hilary
Shalhoub, Huda
Revicki, Dennis A.
Cappelleri, Joseph C.
Bushmakin, Andrew G.
Kudlacz, Elizabeth
Hsu, Ming-Ann
Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title_full Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title_fullStr Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title_full_unstemmed Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title_short Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
title_sort content validity and psychometric evaluation of functional assessment of chronic illness therapy-fatigue in patients with psoriatic arthritis
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6527714/
https://www.ncbi.nlm.nih.gov/pubmed/31111255
http://dx.doi.org/10.1186/s41687-019-0115-4
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