Abstract | BACKGROUND: METHODS: Qualitative patient interviews were conducted in the United States to evaluate content validity. The psychometric properties of the FACIT- fatigue scale were investigated using data from a phase 3 clinical trial assessing ferumoxytol in patients with a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. The statistical analysis assessed the acceptability, reliability, validity and responsiveness of the FACIT- fatigue scale. RESULTS: Qualitative interviews showed that fatigue is a central concern to IDA patients and that the FACIT- fatigue scale sufficiently assessed this construct. Psychometric assessment demonstrated that the FACIT- fatigue scale was stable over time (ICC = 0.87) and internally consistent (α = 0.93). The scale demonstrated convergence with other conceptually relevant scales such as SF-36 Vitality (r = 0.74), and distinguished between known groups [i.e., treatment arms (mean difference (95 % CI) = 3.56 (1.68, 5.43), p <0.001) and high vs. low hemoglobin groups (mean difference (95 % CI) = 5.51 (8.59, 2.44) p <0.001)]. Responsiveness was also demonstrated; significant improvements in FACIT- fatigue scale scores corresponded with significant differences between minimal, moderate, and much improved vitality cohorts (p < 0.05). CONCLUSIONS: This research demonstrated that the FACIT- fatigue scale has sound measurement properties and is an appropriate and interpretable assessment of fatigue among IDA patients with various underlying conditions.
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Authors | Sarah Acaster, Rene Dickerhoof, Kendra DeBusk, Kristine Bernard, William Strauss, Lee F Allen |
Journal | Health and quality of life outcomes
(Health Qual Life Outcomes)
Vol. 13
Pg. 60
(May 17 2015)
ISSN: 1477-7525 [Electronic] England |
PMID | 25980742
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't, Validation Study)
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Chemical References |
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Topics |
- Adult
- Anemia, Iron-Deficiency
(diagnosis, drug therapy, physiopathology)
- Cross-Sectional Studies
- Fatigue
(diagnosis, physiopathology)
- Female
- Ferrosoferric Oxide
(therapeutic use)
- Humans
- Male
- Middle Aged
- Psychometrics
- Quality of Life
- Reproducibility of Results
- Severity of Illness Index
- Surveys and Questionnaires
- United States
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