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Jones E.K.,Lancaster University | Sunram-Lea S.I.,Lancaster University | Wesnes K.A.,United Biosource Corporation
Biological Psychology | Year: 2012

The role of carbohydrates on mood and cognition is fairly well established, however research examining the behavioural effects of the other macronutrients is limited. The current study compared the effects of a 25. g glucose drink to energetically matched protein and fat drinks and an inert placebo. Following a blind, placebo-controlled, randomised crossover design, 18 healthy young adults consumed drinks containing fat, glucose, protein and placebo. Cognitive performance was examined at baseline and again 15- and 60. min post drink. Mood was assessed at baseline and then 10-, 35- and 80. min post drink. Attention and speed were enhanced 15. min following fat or glucose ingestion and working memory was enhanced15. min following protein ingestion. Sixty minutes post drink memory enhancements were observed after protein and memory impairment was observed following glucose. All drinks increased ratings of alertness. The findings suggest that macronutrients: (i) have different windows of opportunity for effects (ii) target different cognitive domains. © 2012 Elsevier B.V.

Mundt J.C.,Center For Psychological Consultation | Mundt J.C.,University of Arkansas for Medical Sciences | Vogel A.P.,University of Melbourne | Feltner D.E.,Douglas E. Feltner LLC | Lenderking W.R.,United Biosource Corporation
Biological Psychiatry | Year: 2012

Background: Valid, reliable biomarkers of depression severity and treatment response would provide new targets for clinical research. Noticeable differences in speech production between depressed and nondepressed patients have been suggested as a potential biomarker. Methods: One hundred five adults with major depression were recruited into a 4-week, randomized, double-blind, placebo-controlled research methodology study. An exploratory objective of the study was to evaluate the generalizability and repeatability of prior study results indicating vocal acoustic properties in speech may serve as biomarkers for depression severity and response to treatment. Speech samples, collected at baseline and study end point using an automated telephone system, were analyzed as a function of clinician-rated and patient-reported measures of depression severity and treatment response. Results: Regression models of speech pattern changes associated with clinical outcomes in a prior study were found to be reliable and significant predictors of outcome in the current study, despite differences in the methodological design and implementation of the two studies. Results of the current study replicate and support findings from the prior study. Clinical changes in depressive symptoms among patients responding to the treatments provided also reflected significant differences in speech production patterns. Depressed patients who did not improve clinically showed smaller vocal acoustic changes and/or changes that were directionally opposite to treatment responders. Conclusions: This study supports the feasibility and validity of obtaining clinically important, biologically based vocal acoustic measures of depression severity and treatment response using an automated telephone system. © 2012 Society of Biological Psychiatry.

Blume S.W.,United Biosource Corporation | Curtis J.R.,University of Alabama at Birmingham
Osteoporosis International | Year: 2011

Summary: Prior national cost estimates of osteoporosis and fractures in the USA have been based on diverse sets of provider data or selected commercial insurance claims. Based on a random population-based sample of older adults, the US medical cost of osteoporosis and fractures is estimated at $22 billion in 2008. Introduction: National cost estimates of osteoporosis and fractures in the USA have been based on diverse sets of provider data or selected commercial insurance claims. We sought to characterize prevalence and costs for osteoporosis using a random population-based sample of older adults. Methods: A cross-sectional estimate of medical cost was made with 2002 data from the Medicare Current Beneficiary Survey (MCBS). MCBS combines health interviews with claims information from all payers to profile a random sample of 12,700 Medicare recipients. Three cohorts aged 65 or over were defined: (1) patients experiencing a fracture-related claim in 2002; (2) patients with a diagnosis, medication, or self-report for osteoporosis or past hip fracture; and (3) non-case controls. The total cost of patient claims was compared to that of controls using multiple regression. Results: Of 30.2 million elderly Medicare recipients in 2002, 1.6 million (5%) were treated for a fracture that year, and an additional 7.2 million (24%) have osteoporosis without a fracture. The estimated mean impact of fractures on annual medical cost was $8,600 (95% confidence interval, $6,400 to $10,800), implying a US cost of $14 billion ($10 to $17 billion). Half of the nonfracture osteoporosis patients received drug treatment, averaging $500 per treated patient, or $2 billion nationwide. Conclusions: The annual cost of osteoporosis and fractures in the US elderly was estimated at $16 billion, using a national 2002 population-based sample. This amount corroborates previous estimates based on substantially different methodologies. Projected to 2008, the national cost of osteoporosis and fractures was $22 billion. © International Osteoporosis Foundation and National Osteoporosis Foundation 2010.

Calvert M.,University of Birmingham | Blazeby J.,University of Bristol | Altman D.G.,University of Oxford | Revicki D.A.,United Biosource Corporation | And 2 more authors.
JAMA - Journal of the American Medical Association | Year: 2013

The CONSORT (Consolidated Standards of Reporting Trials) Statement aims to improve the reporting of randomized controlled trials (RCTs); however, it lacks guidance on the reporting of patient-reported outcomes (PROs), which are often inadequately reported in trials, thus limiting the value of these data. In this article, we describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network. Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points. These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract, that a description of the hypothesis of the PROs and relevant domains be provided (ie, if a multidimensional PRO tool has been used), that evidence of the PRO instrument's validity and reliability be provided or cited, that the statistical approaches for dealing with missing data be explicitly stated, and that PRO-specific limitations of study findings and generalizability of results to other populations and clinical practice be discussed. Examples and an updated CONSORT flow diagram with PRO items are provided. It is recommended that the CONSORT PRO guidance supplement the standard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes. Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care. ©2013 American Medical Association. All rights reserved.

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.

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.

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.

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.

Stokes M.E.,United Biosource Corporation
BMC health services research | Year: 2011

Prostate cancer (PCa) is the most common cancer affecting men in the United States. The initial treatment and subsequent monitoring of PCa patients places a large burden on U.S. health care systems. The objectives of this study were to estimate the total and disease-related per-patient lifetime costs using a phase-based model of cancer care for PCa patients enrolled in Medicare. A model was developed to estimate life-time costs for patients diagnosed with PCa. Patients ≥ 65 years old and diagnosed with PCa between calendar years 1991-2002 were selected from the SEER database. Using SEER, we estimated survival times for PCa patients from diagnosis until death. The period of time patients contributed to treatment phases was determined using an algorithm designed to model the natural history of PCa. Costs were obtained from the US SEER-Medicare database and estimated during specific phases of care. Cost estimates were then combined with survival data to yield total and PCa-related life-time costs. Overall, the model estimated life-time costs of $110,520 (95% CI 110,324-110,739) per patient. PCa-related costs made up approximately 31% of total costs ($34,432). Prostate cancer places a significant burden on U.S. health-care systems with average life-time PCa-related costs in excess of $30,000.

Mercaldi C.J.,United Biosource Corporation | Lanes S.F.,United Biosource Corporation
Chest | Year: 2013

Ultrasound guidance enables visualization of the needle insertion site for thoracentesis and paracentesis. The improved accuracy of needle placement using ultrasound may reduce risk of complications and their costs associated with these procedures. Using claims data from the Premier Perspective hospital database from January 1, 2007, through December 31, 2008, we conducted an observational cohort study examining the effect of ultrasound guidance on risk of pneumothorax among patients undergoing thoracentesis and on risk of bleeding complications after paracentesis. Patients at elevated risk of these outcomes for reasons beyond the procedure of interest were excluded. Adjusted risk of events was assessed using multivariate logistic regression controlling for patient and hospitalization characteristics. Hospitalization cost and length of stay (LOS) were estimated using multivariate ordinary least squares regression of log-transformed values. We analyzed 61,261 thoracentesis and 69,859 paracentesis patient records. Approximately 45% of these procedures were ultrasound guided. Pneumothorax occurred in 2.7% (n 5 1,670) of patients undergoing thoracentesis. Of patients undergoing paracentesis, 0.8% (n 5 565) experienced bleeding complications. After adjustment, ultrasound guidance reduced the risk of pneumothorax after thoracentesis by 19% (OR, 0.81; 95% CI, 0.74-0.90) and by 68% for bleeding complications after paracentesis (OR, 0.32; 95% CI, 0.25-0.41). Pneumothorax increased the total cost of hospitalization by $2,801 ( P , .001) and LOS by 1.5 days ( P , .001). Bleeding complications increased cost by $19,066 ( P , .0001) and LOS by 4.3 days ( P , .0001). The data indicate that ultrasound guidance is associated with decreased risk of pneumothorax with thoracentesis and of bleeding complications with paracentesis. These complications resulted in measurable increases in hospitalization costs and LOS. CHEST 2013; 143(2):532-538 © 2013 American College of Chest Physicians.

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