Development and validation of the Lupus Impact Tracker: a patient-completed tool for clinical practice to assess and monitor the impact of systemic lupus erythematosus.

OBJECTIVE: To derive and validate a brief patient-completed instrument, the Lupus Impact Tracker (LIT), to assess and monitor the impact of systemic lupus erythematosus (SLE). METHODS: Items for the LIT were selected from the LupusPRO, a validated patient-reported outcomes measure, using 3 approaches: confirmatory factor analysis (CFA), stepwise regression, and patient focus groups. CFA was conducted to find items from the LupusPRO that fit a unidimensional structure to allow scoring as a single index. Stepwise regression methods identified items with the strongest relationship (convergent validity) with disease activity measures and patient health rating. Focus groups (n = 26 patients) identified the most important items describing SLE impact. Selected items were evaluated for reliability and validity. RESULTS: CFA found 21 items that fit a unidimensional structure. Stepwise regressions identified 15 of 21 items having good convergent validity with clinical measures. Patient focus groups identified 9 of 15 items as best capturing the impact of SLE. Overall, 7 items were selected across all 3 approaches (CFA, stepwise regression, and focus groups). Another 15 items were selected across 2 approaches. Through consensus with rheumatology clinician experts, a final set of 10 items was selected for the LIT. The LIT items showed good internal consistency (0.89) and test-retest reliabilities (0.87). Mean LIT scores differed significantly (P < 0.05) across criterion groups in the hypothesized direction, providing evidence of discriminant validity and responsiveness. CONCLUSION: The LIT is reliable and valid in SLE patients and offers a practical way for physicians and patients to assess and monitor the impact of SLE.

Burden of systemic lupus erythematosus on employment and work productivity: data from a large cohort in the southeastern United States.

OBJECTIVE: To examine the burden of systemic lupus erythematosus (SLE) on work loss, unemployment, and work productivity impairment in an SLE cohort from the southeastern US. METHODS: We examined 689 SLE patients ages 18-64 years from the Georgians Organized Against Lupus (GOAL) cohort. GOAL is a longitudinal cohort predominantly derived from the Georgia Lupus Registry, a population-based registry established in metropolitan Atlanta. We used the Kaplan-Meier method to assess the proportion of patients who self-reported work loss since diagnosis. We compared unemployment between SLE patients and the general population from the same geographic area, calculating the standardized unemployment ratio (SUR) within demographic and disease strata. We also calculated the percentage of work productivity impairment by disease outcomes. RESULTS: Of 511 patients employed at diagnosis, 249 (49%) experienced work loss within an average disease duration of 13 years. The proportion of patients who lost their jobs since diagnosis was almost twice for African Americans than for whites. However, the SURs were similar across demographic characteristics, including race. Patients with severe disease activity and severe organ damage had the highest SUR at 4.4 and 5.6, respectively. Among those that remained employed, patients with severe fatigue, neurocognitive symptoms, and musculoskeletal symptoms had the highest impairment of work productivity. CONCLUSION: SLE imposes a substantial toll on individuals and burden on society. Major factors that negatively impact work outcomes are fatigue, disease activity, and organ damage. More effective treatments along with coping strategies at the workplace are needed to reduce the burden of SLE on work outcomes.

Healthcare utilization and cost of systemic lupus erythematosus in a US managed care health plan.

OBJECTIVE: To assess healthcare resource utilization and costs in a cohort of US managed care patients with systemic lupus erythematosus (SLE). METHODS: Claims data from a large managed care plan were used to identify patients of 18-64 years old with SLE-related claims from 2004-2005. Algorithms were developed to retrospectively categorize patients by disease severity and identify flare episodes by flare severity. Descriptive and multivariate analyses were performed to estimate healthcare resource utilization and costs over a 2-year period for the cohort overall and by disease and flare severity. RESULTS: Among the 2990 patients in the study cohort, disease severity was mild in 789 (26.4%), moderate in 1558 (52.1%), and severe in 643 (21.5%). During the 2-year follow-up period, SLE patients utilized the following categories of care: office visit (99.7%), laboratory service (99.5%), outpatient hospital visit (76.0%), emergency room visit (45.6%), and inpatient hospital stay (26.4%). Mean total unadjusted healthcare cost per patient was $30,010 over the 2-year follow-up period, with medical and pharmacy costs comprising 76.5% and 23.5% of total expenditures, respectively. Additionally, 95.7% of patients had one or more flares, with a mean (SD) of 6.7 (3.6) flares during the 2-year follow-up period. The average unadjusted cost per mild, moderate, and severe flare, respectively, was $909, $1539, and $17,059, most of which was for medical cost rather than pharmacy cost. The frequency and cost of flares increased with disease severity. LIMITATIONS: The disease severity and flare severity algorithms were based upon managed care claims data; the algorithm was not verified clinically and may not be generalizable to other health plans. CONCLUSIONS: SLE is associated with high levels of healthcare utilization and costs in a managed care health plan. Inpatient hospital stays were the primary medical cost drivers, followed by physician office visits and outpatient hospital visits.

Incidence and US costs of corticosteroid-associated adverse events: a systematic literature review.

OBJECTIVE: The objective of this systematic literature review was to evaluate the incidences and risks for adverse events (AEs) associated with oral and parenteral corticosteroids. An assessment was performed to estimate the costs of such AEs. METHODS: A systematic review of literature published from 2007 to 2009 was conducted to identify the incidence rates and risk ratios of corticosteroid-related AEs. The review protocol was developed according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The literature search was expanded to include additional search terms for psychiatric conditions, infections, and peptic ulcers. Costs obtained from a separate narrative literature review were applied to AEs likely to affect third-party payers in the United States. RESULTS: A total of 357 publications were identified from the primary (n = 323) and secondary (n = 34) searches. Of these, 310 were excluded because they did not evaluate AEs related to corticosteroids, were an excluded publication type, or for other reasons. A final list of 47 studies were used for data extraction. Across patient populations, the most frequently reported corticosteroid-associated AEs were psychiatric events, infections, gastric conditions, and fractures. Corticosteroid-associated AEs reported to occur at an incidence >30% were sleep disturbances, lipodystrophy, adrenal suppression, metabolic syndrome, weight gain, and hypertension. Vertebral fractures were reported at an incidence of 21% to 30%. Dose-response relationships were documented for fractures, acute myocardial infarction, hypertension, and peptic ulcer. The costs of managing AEs that may occur with corticosteroids can be substantial. The literature reported 1-year per-patient costs of up to $26,471.80 for nonfatal myocardial infarction, and per-event costs as high as $18,357.90 for fracture. The findings from the present review should be interpreted cautiously due to several limitations, including the retrospective design of most of the studies identified, risk for confounding due to underlying disease activity or patient population, and the relatively small number of studies that reported each AE association. As this cost analysis was preliminary, a comprehensive pharmacoeconomic analysis should be undertaken to confirm the findings. CONCLUSION: Based on the findings from this review, systemic corticosteroids are a common cause of AEs that may be costly to payers.

Legal implications of understaffing of specialty departments of veterinary teaching hospitals.

When a case is referred to a specialty practice, the assumption is that the practice has the appropriate specialists, equipment, staff, and facility necessary to provide the required medical care. But what if the appropriate specialist is not available when the patient arrives?

HIV among African-born persons in the United States: a hidden epidemic?

BACKGROUND: Although a large proportion of HIV diagnoses in Western Europe occur in African-born persons, analyses of US HIV surveillance data do not routinely assess the proportion of diagnoses occurring in African-born US residents. OBJECTIVE: To determine the percentage of newly reported HIV diagnoses occurring in African-born persons in selected areas of the United States with large African-born immigrant populations. METHODS: We collated and analyzed aggregate data on persons diagnosed with HIV in 2003-2004 and reported to HIV surveillance units in the states of California, Georgia, Massachusetts, Minnesota, and New Jersey and in King County, Washington; New York City; and the portion of Virginia included in the Washington, DC, metropolitan area. RESULTS: African-born persons accounted for 0.6% of the population and 3.8% of HIV diagnoses in participating areas (HIV diagnoses range: 1%-20%). Across all areas, up to 41% of diagnoses in women (mean: 8.4%, range: 4%-41%) and up to 50% of diagnoses in blacks (mean: 8.0%, range: 2%-50%) occurred among African-born individuals. CONCLUSIONS: In some areas, classifying HIV cases among foreign-born blacks as occurring in African Americans dramatically alters the epidemiological picture of HIV. Country of birth should be consistently included in local and national analyses of HIV surveillance data.