Qualitative validation of the FACIT-fatigue scale in systemic lupus erythematosus.

OBJECTIVE: Fatigue in systemic lupus erythematosus (SLE) is burdensome and must be assessed using validated scales. Although the psychometric properties of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in SLE have been evaluated previously, its content validity in this disease remains to be evaluated. The study objective was, therefore, to evaluate content validity of the FACIT-Fatigue in SLE. METHODS: Three SLE focus groups (n=21) in the United States were conducted using semi-structured interviews. Participant comments were categorized by response type, and relative response strength was qualitatively assessed. RESULTS: Participants were mostly female (90%; n=19), white (57%; n=12) with a mean age of 43.7 years (range=28-70). Most scale items were considered relevant with the exception of four items for which participant interpretations varied. Consistent with the scale's measurement model, "listless" on item 3 ("I feel listless ('washed out')") was interpreted as physical or mental impairment. Participant responses to item 8 ("I am able to do my usual activities") sometimes included influence of other health conditions, which is acceptable because it is difficult to separate disease-specific and general fatigue. Some participants found item 7 ("I have energy") irrelevant and most could not relate to item 10 ("I am too tired to eat"). However, both items were intended to capture the extreme ends of fatigue (item 7, ceiling; item 10, floor). CONCLUSIONS: From a content perspective, items of the FACIT-Fatigue scale were relevant for measuring fatigue in SLE.

Resource utilization and direct medical costs in adult systemic lupus erythematosus patients from a commercially insured population.

OBJECTIVE: Our aim was to estimate annual health care resource use and medical costs associated with systemic lupus erythematosus (SLE) in a large US managed care health plan. METHODS: Subjects at least 18 years of age and with claims-based evidence of SLE (ICD-9-CM 710.0x) were identified from a health plan database. Subjects were matched on the basis of demographic and clinical characteristics to unaffected controls. Resource use and costs were determined during a fixed 12-month period. A generalized linear model (GLM) was used to adjust costs for demographic and clinical characteristics. RESULTS: In total, 1278 newly diagnosed SLE subjects were matched to 3834 controls, and 10,152 subjects with existing SLE were matched to 30,456 controls. Health care resource use was significantly higher among SLE subjects than matched controls, including average annual numbers of ambulatory visits, specialist visits, and inpatient hospital stays (all p < 0.001). SLE subjects had significantly higher overall mean annual medical costs than matched controls (newly diagnosed: $19,178 vs. $4909; existing: $15,487 vs. $5156; both p < 0.001). Evidence of specific organ involvement including renal failure and central nervous system complications, were each associated with increased costs (both p < 0.001). CONCLUSIONS: Subjects with SLE have high resource use and medical costs relative to controls.

Abatacept improves both the physical and mental health of patients with rheumatoid arthritis who have inadequate response to methotrexate treatment.

OBJECTIVE: To examine the impact of added abatacept treatment on health related quality of life (HRQoL) in patients with rheumatoid arthritis (RA) who have inadequate response to methotrexate (MTX). METHODS: The impact of abatacept treatment on HRQoL was examined in a longitudinal, randomised double blind, placebo controlled clinical trial. Effects of treatment on HRQoL were examined using repeated measures analysis of covariance and comparing rates of change in HRQoL across treatment groups. The relationship between American College of Rheumatology (ACR) clinical markers and disease duration with changes in HRQoL indicators was also examined. Finally, a responder analysis was used to examine the percentage of patients who improved by 0.5 SD in 12 months or who reached the normative levels seen in the US general population. RESULTS: Statistically significant improvements in the abatacept group relative to controls were observed across a range of HRQoL measures, including physical function, fatigue, all eight domains of the SF-36, and the physical and mental component summaries (PCS and MCS). Improvements were seen as early as day 29 for fatigue and for five out of eight SF-36 domains. By day 169, all HRQoL measures were significantly better with abatacept than with placebo. HRQoL gains were associated with greater ACR clinical improvement, and the effects were consistent for patients with different disease duration. A significantly greater percentage of patients treated with abatacept reached normative levels of PCS, MCS, physical functioning, and fatigue compared with patients treated with MTX alone. CONCLUSION: Combined abatacept and MTX treatment produces significant improvements across a wide range of HRQoL domains in patients with RA.