Abstract
BackgroundFatigue is a burdensome symptom in iron deficiency anemia (IDA). To capture the severity and impact of fatigue appropriately it must be measured using validated scales. This study evaluated the content validity and psychometric validity of the Functional Assessment of Chronic Illness Therapy - fatigue scale (FACIT-fatigue) in IDA patients.MethodsQualitative 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.ResultsQualitative 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).ConclusionsThis 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.
Highlights
Fatigue is a burdensome symptom in iron deficiency anemia (IDA)
Research involving anemic cancer patients has found an increase in hemoglobin is associated with an improvement in fatigue, which in turn is associated with improvements in health related quality of life (HRQL) [8, 9]
The psychometric validation sample included 808 patients (intent-to-treat (ITT) population) who had any exposure to study drug and excluded 4 patients who withdrew from the study prior to administration of study drug
Summary
Fatigue is a burdensome symptom in iron deficiency anemia (IDA). According to WHO estimates two billion people worldwide, or 30 % of the world’s population, are anemic [3, 4]. Iron deficiency anemia (IDA), caused by various underlying conditions such as abnormal uterine bleeding (AUB), post partum bleeding, cancer and gastro-intestinal (GI) disorders, is the leading cause of anemia worldwide; estimates suggest that approximately five million people have IDA in the United States [5]. Research involving anemic cancer patients has found an increase in hemoglobin is associated with an improvement in fatigue, which in turn is associated with improvements in health related quality of life (HRQL) [8, 9]. There is evidence that decreases in hemoglobin are related to increases in fatigue duration [10]
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