Cindy Garris

Reliability, validity, and responsiveness of the Rhinitis Control Assessment Test in patients with rhinitis

BACKGROUND The Rhinitis Control Assessment Test (RCAT) is a brief, patient-completed tool to evaluate rhinitis symptom control. OBJECTIVE We sought to test the reliability, validity, and responsiveness of RCAT and to estimate a cut-point score and minimal important difference (MID). METHODS A total of 402 patients 12 years of age and older with allergic or nonallergic rhinitis were enrolled in a noninterventional study. Patients completed the RCAT (6 items; score range, 6-30) and had Total Nasal Symptom Scores (TNSSs) measured at baseline and 2 weeks later. Physicians completed a global assessment of rhinitis symptom control (Physicians Global Assessment) and disease severity. Internal consistency, test-retest reliability, convergent validity, known-groups validity, and responsiveness were evaluated. The MID was determined by using distribution- and anchor-based methods. Content validity of the RCAT was assessed in individual interviews with a separate group of 58 adult patients. RESULTS Internal consistency and test-retest reliability of RCAT scores were 0.77 and 0.78, respectively. Convergent validity correlation between RCAT and TNSS scores was 0.57, and that between RCAT and Physicians Global Assessment scores was 0.34. Mean RCAT scores differed significantly (P < .001) across patient groups, differing in TNSS (F = 72.7), Physicians Global Assessment score (F = 28.6), and disease severity (F = 34.1) in the hypothesized direction. Results suggested a cut-point score of 21 or less can be used to identify patients who are experiencing rhinitis symptom control problems. The preliminary estimate of the MID was 3 points. Patients found RCAT items comprehensive, easy to understand, and relevant. CONCLUSION The RCAT demonstrated adequate reliability, validity, and responsiveness and was deemed acceptable and appropriate by patients. This tool can facilitate the detection of rhinitis symptom control problems, and its brevity supports its usefulness in clinical care.

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.

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).

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

Abstract 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

Prospective Validation of the Lupus Impact Tracker: A Patient‐Completed Tool for Clinical Practice to Evaluate the Impact of Systemic Lupus Erythematosus

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

Evaluation of Sex Differences of Fosamprenavir (With and Without Ritonavir) in HIV-Infected Men and Women

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Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study

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Comparison of corticosteroid nasal sprays in relation to concomitant use and cost of other prescription medications to treat allergic rhinitis symptoms: retrospective cohort analysis of pharmacy claims data.

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.

Safety profile and tolerability of amprenavir in patients enrolled in an early access program

To evaluate the reliability, validity, responsiveness, and utility of the Lupus Impact Tracker (LIT).

A comparison of the psychometric properties of the Mini-Rhinitis Quality of Life Questionnaire and the Rhinitis Control Assessment Test.

Abstract Purpose: Recent studies focusing on HIV-1—infected women have suggested the existence of sex-related differences in natural history, antiretroviral pharmacokinetics, efficacy, and tolerability. This article analyzes three pivotal trials of the protease inhibitor (PI) fosamprenavir (FPV) with a view to providing a better understanding of potential sex differences in efficacy and safety. Method: A post hoc, descriptive analysis was performed on data from 700 subjects (26% women) in three trials of FPV to evaluate sex differences with regard to efficacy, rates of discontinuation, and treatment-related adverse events. Results: No major sex differences were found. Men and women had similarly good antiviral responses, with greater than 60% of treatment-naïve subjects achieving virologic suppression (<400 copies/mL) at 48 weeks. PI-experienced women in CONTEXT receiving once-daily FPV/r experienced the highest rates of discontinuations due to virologic failure (29% in women vs. 8% in men). Women generally had slightly lower rates of liver enzyme elevations and fewer abnormalities of total cholesterol and triglycerides. Conclusion: The absence of major sex differences provides reassurance, but the small number of women in these trials limited the ability to draw conclusions. Future trials should be specifically powered to detect sex differences in safety and efficacy. Key words: antiretroviral efficacy, antiretroviral safety, fosamprenavir, sex differences

The prevalence and burden of systemic lupus erythematosus in a medicare population: retrospective analysis of medicare claims

BACKGROUND Intranasal corticosteroids are first-line treatment for moderate-to-severe seasonal allergic rhinitis (AR). OBJECTIVES To compare preferences for fluticasone furoate and fluticasone propionate nasal sprays after 1 week of treatment in patients with symptomatic seasonal AR. METHODS Patients with seasonal AR were enrolled (n = 360) and randomized 1:1 to active treatment (fluticasone furoate, 110 microg, or fluticasone propionate, 200 microg, followed by crossover treatment for 1 week each) or matched placebo sequence with a 1-week washout before crossover dosing. Fluticasone furoate and fluticasone propionate efficacy was measured by change from baseline during 1 week in daily reflective total nasal symptom score (rTNSS) that assessed severity of rhinorrhea, nasal congestion, nasal itching, and sneezing. Patient preference for fluticasone furoate or fluticasone propionate was assessed at the end of the study by questionnaire. RESULTS Three hundred sixty patients from 29 clinical sites in the Unites States were randomized and treated between August 1, 2007 and November 30, 2007. Most patients were white (73%) and female (59%), with a mean age of 38.3 years, and had had seasonal AR for at least 10 years (74%). Fluticasone furoate and fluticasone propionate each reduced the daily rTNSS compared with their respective placebos (least squares mean [SD] difference, -0.8 [0.24], P < .001, and -0.6 [0.24], P = .01, respectively). More patients (P < .001) preferred fluticasone furoate to fluticasone propionate based on attributes of scent or odor (58% vs 27%), aftertaste (60% vs 18%), leaking out of the nose and down the throat (59% vs 21%), and mist gentleness (57% vs 26%). No statistically significant differences were seen in preferences regarding ease of use, delivery method, or device comfort. CONCLUSION Both fluticasone furoate and fluticasone propionate significantly improved symptoms in adult patients with seasonal AR. Most patients preferred the sensory attributes of fluticasone furoate to those of fluticasone propionate after 1 week of treatment.