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Bethesda, MD, United States

Leidy N.K.,United Biosource Corporation
International journal of chronic obstructive pulmonary disease | Year: 2010

the 65-item Functional Performance Inventory (FPI), developed to quantify functional performance in patients with chronic obstructive pulmonary disease (COPD), has been shown to be reliable and valid. The purpose of this study was to create a shorter version of the FPI while preserving the integrity and psychometric properties of the original. secondary analyses were performed on qualitative and quantitative data used to develop and validate the FPI long form. Seventeen men and women with COPD participated in the qualitative work, while 154 took part in the mail survey; 54 completed 2-week reproducibility assessment, and 40 relatives contributed validation data. Following a systematic process of item reduction, performance properties of the 32-item short form (FPI-SF) were examined. the FPI-SF was internally consistent (total scale α = 0.93; subscales: 0.76-0.89) and reproducible (r = 0.88; subscales: 0.69-0.86). Validity was maintained, with significant (P < 0.001) correlations between the FPI-SF and the Functional Status Questionnaire (activities of daily living, r = 0.71; instrumental activities of daily living, r = 0.73), Duke Activity Status Index (r = 0.65), Bronchitis-Emphysema Symptom Checklist (r = -0.61), Basic Need Satisfaction Inventory (r = 0.61) and Cantril's Ladder of Life Satisfaction (r = 0.63), and Katz Adjustment Scale for Relatives (socially expected activities, r = 0.51; free-time activities, r = -0.49, P < 0.01). The FPI-SF differentiated patients with an FEV(l)% predicted greater than and less than 50% (t = 4.26, P < 0.001), and those with severe and moderate levels of perceived severity and activity limitation (t = 9.91, P < 0.001). results suggest the FPI-SF is a viable alternative to the FPI for situations in which a shorter instrument is desired. Further assessment of the instrument's performance properties in new samples of patients with COPD is warranted. Source

Hareendran A.,United Biosource Corporation
International journal of chronic obstructive pulmonary disease | Year: 2012

Measuring dyspnea intensity associated with exercise provides insights into dyspnea-limited exercise capacity, and has been used to evaluate treatment outcomes for chronic obstructive pulmonary disease (COPD). Three patient-reported outcome scales commonly cited for rating dyspnea during exercise are the modified Borg scale (MBS), numerical rating scale for dyspnea (NRS-D), and visual analogue scale for dyspnea (VAS-D). Various versions of each scale were found. Our objective was to evaluate the content validity of scales commonly used in COPD studies, to explore their ability to capture patients' experiences of dyspnea during exercise, and to evaluate a standardized version of the MBS. A two-stage procedure was used, with each stage involving one-on-one interviews with COPD patients who had recently completed a clinic-based exercise event on a treadmill or cycle ergometer. An open-ended elicitation interview technique was used to understand patients' experiences of exercise-induced dyspnea, followed by patients completing the three scales. The cognitive interviewing component of the study involved specific questions to evaluate the patients' perspectives of the content and format of the scales. Results from Stage 1 were used to develop a standardized version of the MBS, which was then subjected to further content validity assessment during Stage 2. Thirteen patients participated in the two-stage process (n = 6; n = 7). Mean forced expiratory volume in 1 second (FEV(1)) percent predicted was 40%, mean age 57 years, and 54% were male. Participants used a variety of terms to describe the intensity and variability of exercise-induced dyspnea. Subjects understood the instructions and format of the standardized MBS, and were able to easily select a response to report the level of dyspnea associated with their recent standardized exercise. This study provides initial evidence in support of using a standardized version of the MBS version for quantifying dyspnea intensity associated with exercise in patients with COPD. Source

Milsom I.,Sahlgrenska University Hospital | Coyne K.S.,United Biosource Corporation | Nicholson S.,Cornell University | Kvasz M.,Pfizer | And 2 more authors.
European Urology | Year: 2014

Context The prevalence and economic burden of urgency urinary incontinence (UUI) are difficult to ascertain because of overlap with data on overactive bladder and other types of incontinence. Objective To summarize the evidence on the global prevalence and economic burden of UUI. Evidence acquisition A PubMed search was performed used the following terms: (urgency urinary incontinence OR urge incontinence OR mixed incontinence OR overactive bladder) AND (burden OR cost OR economic OR prevalence). A similar search was conducted using Embase. English-language articles published from 1991 through 2013 on non-neurogenic UUI were retained. Evidence synthesis We retained 54 articles (50 studies); 22 large-scale, population-based surveys indicated varying UUI prevalence estimates with ranges of 1.8-30.5% in European populations, 1.7-36.4% in US populations, and 1.5-15.2% in Asian populations, with prevalence dependent on age and gender. Nineteen smaller-scale studies supported these findings. Despite varying methods, 11 studies estimating the costs of UUI worldwide consistently concluded that the economic burden is substantial and will increase markedly as the population ages. In a 2005 multinational study, the annual cost-of-illness estimate for UUI in Canada, Germany, Italy, Spain, Sweden, and the United Kingdom was €7 billion. A US cost-of-illness study reported a total cost of $66 billion in 2007 US dollars. The costs of routine care and nursing home admissions for UUI were major contributors to the cost. Conclusions UUI affects millions of men and women worldwide. Current evidence demonstrates the substantial economic burden of UUI to patients and society. Worldwide public health and clinical management programs are needed to improve UUI awareness and highlight the need for early diagnosis and management. © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved. Source

To assess the economic burden in direct healthcare utilization and costs for refractory epileptic patients with partial onset seizures (POS) and assess the antiepileptic drug (AED) treatment patterns among these patients. This retrospective database study analyzed administrative claims of commercially-insured patients with POS from 2004-2008. Healthcare costs and utilization were compared between refractory (defined as ≥3 AEDs) and non-refractory patients by calendar year and AED treatment patterns were described for refractory patients. Of the 79,149 patients identified (mean age 33 years; 54.8% female), 8714 (11%) were classified as refractory. In 2008, average annual healthcare costs for refractory patients were significantly higher than non-refractory patients ($33,613 vs $19,085), also by settings for inpatient ($11,780 vs $6076), outpatient ($13,431 vs $8637), and pharmacy costs ($8402 vs $4372) (all p < 0.001). Among refractory patients, close to one-third of total costs were for POS-related services. Similar trends were observed when assessing POS-related utilization and costs. The differences were consistent across all calendar years examined. Among refractory patients, 80.5% were on monotherapy at the beginning of the follow-up period. Levetiracetam is the common AED in mono/combination therapy as well as add-on/switch-to. The onset of seizure cannot be identified, and the indication of each AED could not be confirmed from the pharmacy claims. Only direct medical costs were assessed. Pattern of use was very dynamic, suggesting seizures are not well-controlled. Improving seizure control and reducing economic burden of refractory epilepsy remain important unmet medical needs in this population. Source

Murray R.E.,United Biosource Corporation
AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium | Year: 2011

Evaluating performance characteristics of analytic methods developed to identify treatment effects in longitudinal healthcare data has been hindered by lack of an objective benchmark to measure performance. Relationships between drugs and subsequent treatment effects are not precisely quantified in real-world data, and simulated data offer potential to augment method development by providing data with known, measurable characteristics. However, the use of simulated data has been limited due to its inability to adequately reflect the complexities inherent in real-world databases that are necessary for effective method development. The goal of this study was to develop and evaluate a model for simulating longitudinal healthcare data that adequately captures these complexities. An empiric design was chosen that utilizes the characteristics of a real healthcare database as simulation input. This model demonstrates the potential for simulated data with known characteristics to adequately reflect complex relationships among diseases and treatments as recorded in healthcare databases. Source

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