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Waltham, MA, United States

Matlaga B.R.,Johns Hopkins University | Meckley L.M.,Trinity Partners LLC | Kim M.,Boston Scientific Corporation | Byrne T.W.,Boston Scientific Corporation
Journal of Endourology | Year: 2014

Purpose: We conducted this study to identify differences in the re-treatment rates and ancillary procedures for the two most commonly utilized stone treatment procedures in the Medicare population: ureteroscopy (URS) and shock wave lithotripsy (SWL). Materials and Methods: A retrospective claims analysis of the Medicare standard analytical file 5% sample was conducted to identify patients with a new diagnosis of urolithiasis undergoing treatment with URS or SWL from 2009-2010. Outcomes evaluated: (1) repeat stone removal procedures within 120 days post index procedure, (2) stent placement procedures on the index date, 30 days prior to and 120 days post index date, and (3) use of general anesthesia. Results: We identified 3885 eligible patients, of which 2165 (56%) underwent SWL and 1720 (44%) underwent URS. Overall, SWL patients were 1.73 times more likely to undergo at least one repeat procedure than URS patients, and twice as likely to require multiple re-treatments compared to URS. Among those with ureteral stones, SWL patients were 2.27 times more likely to undergo repeat procedures. The difference was not statistically significant in renal stone patients. Overall, SWL patients were 1.41 times more likely than URS patients to have a stent placed prior to index procedure, and 1.33 times more likely to have a stent placed subsequent to the index procedure. The majority of URS patients (77.8%) had a stent placed at the time of index procedure. There was no significant difference in anesthetic approaches between SWL and URS. Conclusions: Patients undergoing SWL are significantly more likely to require re-treatments than URS patients. SWL patients are also significantly more likely to require ureteral stent placement as a separate event. SWL and URS patients have similar rates of general anesthesia. © 2014 Mary Ann Liebert, Inc. Source

Osipovitch D.C.,Program in Experimental and Molecular Medicine | Parker A.S.,Dartmouth | Makokha C.D.,Trinity Partners LLC | Desrosiers J.,University of Rhode Island | And 2 more authors.
Protein Engineering, Design and Selection | Year: 2012

The unparalleled specificity and activity of therapeutic proteins has reshaped many aspects of modern clinical practice, and aggressive development of new protein drugs promises a continued revolution in disease therapy. As a result of their biological origins, however, therapeutic proteins present unique design challenges for the biomolecular engineer. For example, protein drugs are subject to immune surveillance within the patient's body; this anti-drug immune response can compromise therapeutic efficacy and even threaten patient safety. Thus, there is a growing demand for broadly applicable protein deimmunization strategies. We have recently developed optimization algorithms that integrate computational prediction of T-cell epitopes and bioinformatics-based assessment of the structural and functional consequences of epitope-deleting mutations. Here, we describe the first experimental validation of our deimmunization algorithms using Enterobacter cloacae P99 β-lactamase, a component of antibody-directed enzyme prodrug cancer therapies. Compared with wild-type or a previously deimmunized variant, our computationally optimized sequences exhibited significantly less in vitro binding to human type II major histocompatibility complex immune molecules. At the same time, our globally optimal design exhibited wild-type catalytic proficiency. We conclude that our deimmunization algorithms guide the protein engineer towards promising immunoevasive candidates and thereby have the potential to streamline biotherapeutic development. © 2012 The Author. Source

Cangelosi M.J.,Boston Scientific Corporation | Ortendahl J.D.,Partnership for Health Analytic Research LLC | Meckley L.M.,Boston Scientific Corporation | Meckley L.M.,Trinity Partners LLC | And 4 more authors.
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2015

Objectives: We examined the cost-effectiveness of treating poorly controlled, severe, persistent asthma patients with bronchial thermoplasty (BT), a novel technology that uses thermal energy to reduce airway smooth muscle mass, with 5-year outcome data demonstrating a durable reduction in asthma exacerbations. Study design: We conducted a model-based cost-effectiveness analysis assessing 5-year healthcare utilization, patient quality of life and adverse events. Methods: We utilized Markov modeling to estimate the costs and quality-of-life impact of BT compared with high-dose combination therapy among poorly controlled, severe, persistent asthma patients: those requiring high-dose combination therapy and having experienced an asthma exacerbation-related ER visit in the past year. Results: The cost-effectiveness of BT was US$5495 per quality-adjusted life year; and approximately 22% of sensitivity analysis iterations estimated BT to reduce costs and increase quality of life. Conclusions: BT is a cost-effective treatment option for patients with poorly controlled, severe, persistent asthma. © 2015 Informa UK, Ltd. Source

Brewer J.V.V.,Center for Outcomes Research and Evaluation | Miyasato G.S.,Trinity Partners LLC | Gates M.A.,University at Albany | Curto T.M.,New England Research Institutes, Inc. | And 2 more authors.
Annals of Epidemiology | Year: 2013

Purpose: To understand if Hispanics report health differently than other racial and ethnic groups after controlling for demographics and risk factors for poor health. Methods: The sample (N = 5502) included 3201 women, 1767 black, 1859 white, and 1876 Hispanic subjects from the Boston Area Community Health Survey, a population-based survey of English- and Spanish-speaking residents of Boston, Massachusetts, United States, aged 30-79 years in 2002-2005. Multiple logistic regression models were used to examine the association between race/ethnicity (including interview language for Hispanics) and fair/poor self-reported health (F/P SRH) adjusting for gender, age, socioeconomic status, depression, nativity, and comorbidities. Results: Compared with whites, Hispanics interviewed in Spanish were seven times as likely to report F/P SRH (odds ratio, 7.7; 95% confidence interval, 4.9-12.2) after adjusting for potential confounders and those interviewed in English were twice as likely. In analyses stratified by depression and nativity, we observed stronger associations with Hispanic ethnicity in immigrants and nondepressed individuals interviewed in Spanish. Conclusions: Increased odds of F/P SRH persisted in the Hispanic group even when accounting for interview language and controlling for socioeconomic status, age, depression, and nativity, with interview language mitigating the association. These findings have methodological implications for epidemiologists using SRH across diverse populations. © 2013 Elsevier Inc. Source

Araujo A.B.,New England Research Institutes, Inc. | Araujo A.B.,Eli Lilly and Company | Yang M.,New England Research Institutes, Inc. | Suarez E.A.,New England Research Institutes, Inc. | And 6 more authors.
Journal of Bone and Mineral Research | Year: 2014

As men age, they lose bone and are susceptible to fracture. Despite having lower fracture rates than women, men have worse fractures than women do. Racial/ethnic and socioeconomic status (SES) disparities in fracture rates exist, yet data on rates of bone loss by race/ethnicity and SES among men are limited. We examined annualized percentage change in bone mineral density (%DBMD) at the hip (N=681), spine (N=663), and forearm (N=636) during 7 years of follow-up among men aged 30-79 years at baseline. Multivariable models tested whether race/ethnicity, income, or genetic ancestry predicted annualized%DBMD after controlling for an extensive set of covariates. Annualized %DBMD ranged from -0.65(0.04)% (femoral neck) to +0.26(0.03)% (1/3 distal radius), and changes were consistent across age groups with the exception of the ultradistal radius, where annualized declines increased with age. Neither self-identified race/ethnicity nor genetic ancestry were associated with annualized %DBMD. In contrast, income was strongly associated (dose-response) with annualized %DBMD at total hip (independent of confounders, self-identified race/ethnicity, and genetic ancestry). Fully adjusted least-square mean change in annualized %DBMD at the total hip were -0.24(0.12)% and -0.16 (0.06)% steeper among men with low and moderate incomes, respectively, than among men with higher incomes (overall p=0.0293). Results show a linear decline in bone that begins relatively early in life among men, that rates of bone loss do not vary with race/ ethnicity (self-identified or "objectively" measured), and that income plays an important role in relation to bone loss at the hip. These data suggest that fracture risk in men may be driven in part by income-related differences in bone loss, but also, that the known higher fracture risk among white men is not the result of racial/ethnic differences in bone loss, but rather, early life exposures that lead to attainment of higher peak bone mass among minorities. © 2014 American Society for Bone and Mineral Research. Source

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