Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis

Bartlett, Susan J.; Gutierrez, Anna Kristina; Butanis, Alessandra; Bykerk, Vivian P.; Curtis, Jeffrey R.; Ginsberg, Stephen D.; Leong, Amye; Lyddiatt, Anne; Nowell, W. Benjamin; Orbai, Ana‐Maria; Smith, Karen C.; Bingham, Clifton O.

doi:10.1007/s11136-018-1880-x

Cited by 21 publications

(20 citation statements)

References 38 publications

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“…This can be used as either a computerized adaptive test or a fixed-length short form, and was designed to compare differences across a range of chronic conditions, enabling comparative effectiveness research [46]. The use of fatigue short forms from PROMIS has been validated in RA [47], and the current research provides strong evidence supporting the validity of the FACIT-Fatigue scale and its measurement properties in patients with PsA, which opens up the possibility for including PsA data in the unifying PROMIS metric.…”

Section: Discussionmentioning

confidence: 99%

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

Cella

Wilson

Shalhoub

et al. 2019

J Patient Rep Outcomes

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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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Section: Discussionmentioning

confidence: 99%

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

Cella

Wilson

Shalhoub

et al. 2019

J Patient Rep Outcomes

View full text Add to dashboard Cite

show abstract

“…This can be used as either a computerized adaptive test or a fixed-length short form, and was designed to compare differences across a range of chronic conditions, enabling comparative effectiveness research [45]. The use of fatigue short forms from PROMIS has been validated in RA [46], and the current research provides strong evidence supporting the validity of the FACIT-Fatigue scale and its measurement properties in patients with PsA, which opens up the possibility for including PsA data in the unifying PROMIS metric.…”

Section: Discussionmentioning

confidence: 99%

RETRACTED ARTICLE: Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis

Cella

Wilson

Shalhoub

et al. 2019

J Patient Rep Outcomes

View full text Add to dashboard Cite

BackgroundTo 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).MethodsOne-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).ResultsOf 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.ConclusionFatigue 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 materialThe online version of this article (10.1186/s41687-019-0094-5) contains supplementary material, which is available to authorized users.

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“…While in this study we used PROMIS Fatigue items that are from the 13-and 10-item FACIT-F instruments, other PROMIS Fatigue short forms will probably perform similarly. For example, evidence of the content validity, construct validity, and reliability of fixed 7-and 8-item PROMIS Fatigue short forms in a large cohort of patients with RA has been recently published (10)(11)(12)(13)(14). PROMIS Fatigue computer-adaptive testing scores were shown to be responsive to interventions with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) (14).…”

Section: Discussionmentioning

confidence: 99%

“…While developing items for the PROMIS Fatigue item bank, questions from existing instruments, including all 13 items from FACIT-F, were selected (10). PROMIS Fatigue instruments (computer-adaptive tests and fixed 7-or 8-item short forms) have been used and validated in small observational studies of RA (10)(11)(12)(13)(14), but there are no studies to date reporting the performance of PROMIS Fatigue in RA randomized clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Conversion of Functional Assessment of Chronic Illness Therapy–Fatigue to Patient‐Reported Outcomes Measurement Information System Fatigue Scores in Two Phase III Baricitinib Rheumatoid Arthritis Trials

Bingham

Bartlett

Kannowski

et al. 2021

Arthritis Care & Research

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Objective. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is validated for measuring fatigue in rheumatoid arthritis (RA). However, 10 of 13 FACIT-F items are identified as relevant to patients with RA. The Patient-Reported Outcomes Measurement Information System (PROMIS) uses an item response theorycalibrated T score metric. The PROMIS Fatigue item bank includes the FACIT-F items, enabling score conversion. The performance of converted PROMIS Fatigue scores has not been evaluated in RA populations or clinical trials. Our objective was to assess the performance of converted PROMIS Fatigue scores in 2 RA clinical trials of baricitinib. Methods. Crosswalk tables and pattern-scoring methods converted FACIT-F scores to PROMIS Fatigue for both the 13-item FACIT-F and the 10-item RA-optimized FACIT-F instrument, in 2 RA clinical trials evaluating baricitinib, RA-BEAM, and RA-BEACON. RA-BEAM patients had an inadequate response to methotrexate. RA-BEACON patients had an inadequate response or intolerance to ≥1 tumor necrosis factor inhibitor. Baricitinib was compared to all treatment arms via analysis of covariance on PROMIS Fatigue score conversions. Results. Baseline FACIT-F-derived PROMIS Fatigue scores reflected severe fatigue across treatment groups and were similar using different scoring methods. At week 24 in both studies, baricitinib was associated with clinically meaningful improvements in PROMIS Fatigue scores. PROMIS Fatigue scores were consistent for conversion methods and for the 13-item or 10-item FACIT-F. Conclusion. All 4 conversion methods showed differentiation of active treatment compared with placebo from week 12, supporting the use of the PROMIS Fatigue and converting the 10-item FACIT-F to assess fatigue and demonstrate treatment benefit in RA clinical trials on a standardized metric. ClinicalTrials.gov identifiers: NCT01710358 and NCT01721044.

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Combining online and in-person methods to evaluate the content validity of PROMIS fatigue short forms in rheumatoid arthritis

Abstract: Results suggest that items in the single-score PROMIS Fatigue SFs demonstrate content validity and can adequately capture the wide range of fatigue experiences of people with RA.

Cited by 21 publications

References 38 publications

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

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

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

Conversion of Functional Assessment of Chronic Illness Therapy–Fatigue to Patient‐Reported Outcomes Measurement Information System Fatigue Scores in Two Phase III Baricitinib Rheumatoid Arthritis Trials

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