TY - JOUR
T1 - RETRACTED ARTICLE
T2 - Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis
AU - Cella, David
AU - Wilson, Hilary
AU - Shalhoub, Huda
AU - Revicki, Dennis A.
AU - Cappelleri, Joseph C.
AU - Bushmakin, Andrew G.
AU - Kudlacz, Elizabeth
AU - Hsu, Ming Ann
N1 - Funding Information:
Editorial support under the guidance of the authors was provided by Paul Scutt, PhD, of CMC Connect, a division of Complete Medical Communications Ltd., Macclesfield, UK and was funded by Pfizer Inc., New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461–464). The authors would like to thank Dr. Vibeke Strand for her critical review of this manuscript.
Funding Information:
Editorial support under the guidance of the authors was provided by Paul Scutt, PhD, of CMC Connect, a division of Complete Medical Communications Ltd., Macclesfield, UK and was funded by Pfizer Inc., New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461?464). The authors would like to thank Dr. Vibeke Strand for her critical review of this manuscript. This study was funded by Pfizer Inc. The data collected during this study is kept in a locked, secure facility and is unavailable to the public due to confidentiality concerns. Reasonable requests to review the data for scientific and/or research purposes may be considered. Ethics approval and consent to participate. Ethical & Independent Review (E&I) Services approved the research study (study #16154) on January 24th, 2017. IRB Approval number #IRB00007807. Written informed consent was obtained for all study participants prior to participation in the research. No consent for publication is required.
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/12/1
Y1 - 2019/12/1
N2 - 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.
AB - 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.
KW - Content validity
KW - FACIT-fatigue
KW - Psoriatic arthritis
KW - Psychometric properties
KW - Tofacitinib
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U2 - 10.1186/s41687-019-0094-5
DO - 10.1186/s41687-019-0094-5
M3 - Article
C2 - 30680661
AN - SCOPUS:85078013447
VL - 3
JO - Journal of Patient-Reported Outcomes
JF - Journal of Patient-Reported Outcomes
SN - 2509-8020
IS - 1
M1 - 5
ER -