Rho Federal Systems Division Inc.

Federal Way, NC, United States

Rho Federal Systems Division Inc.

Federal Way, NC, United States
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Lara M.,RAND Corporation | Morales-Reyes B.,University of Puerto Rico at San Juan | Mitchell H.,Rho Federal Systems Division Inc
Pediatrics | Year: 2013

BACKGROUND AND OBJECTIVE: Although children living in Puerto Rico have the highest asthma prevalence of all US children, little is known regarding the quality-of-care disparities they experience nor the adaptability of existing asthma evidence-based interventions to reduce these disparities. The objective of this study was to describe our experience in reducing quality-of-care disparities among Puerto Rican children with asthma by adapting 2 existing evidence-based asthma interventions. METHODS: We describe our experience in adapting and implementing 2 previously tested asthma evidence-based interventions: the Yes We Can program and the Inner-City Asthma Study intervention. We assessed the feasibility of combining key components of the 2 interventions to reduce asthma symptoms and estimated the potential cost savings associated with reductions in asthma-related hospitalizations and emergency department visits. A total of 117 children with moderate and severe asthma participated in the 12-month intervention in 2 housing projects in San Juan, Puerto Rico. A community-academic team with the necessary technical and cultural competences adapted and implemented the intervention. RESULTS: Our case study revealed the feasibility of implementing the combined intervention, henceforth referred to as La Red intervention, in the selected Puerto Rican communities experiencing a disproportionately high level of asthma burden. After 1-year follow-up, La Red intervention significantly reduced asthma symptoms and exceeded reductions of the original interventions. Asthma-related hospitalizations and emergency department use, and their associated high costs, were also significantly reduced. CONCLUSIONS: Asthma evidence-based interventions can be adapted to improve quality of care for children with asthma in a different cultural community setting. Copyright © 2013 by the American Academy of Pediatrics.

Krishnan J.A.,University of Illinois at Chicago | Lemanske Jr. R.F.,University of Wisconsin - Madison | Canino G.J.,University of Puerto Rico at San Juan | Elward K.S.,Family Medicine of Albermarle | And 5 more authors.
Journal of Allergy and Clinical Immunology | Year: 2012

Background: Respiratory symptoms are commonly used to assess the impact of patient-centered interventions. Objective: At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to propose which measurements of asthma symptoms should be used as a standardized measure in future clinical research studies. Methods: Asthma symptom instruments were classified as daily diaries (prospectively recording symptoms between research visits) or retrospective questionnaires (completed at research visits). We conducted a systematic search in PubMed and a search for articles that cited key studies describing development of instruments. We classified outcome instruments as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011. Results: Four instruments (3 daily diaries, 1 for adults and 2 for children; and 1 retrospective questionnaire for adults) were identified. Minimal clinically important differences have not been established for these instruments, and validation studies were only conducted in a limited number of patient populations. Validity of existing instruments may not be generalizable across racial-ethnic or other subgroups. Conclusions: An evaluation of symptoms should be a core asthma outcome measure in clinical research. However, available instruments have limitations that preclude selection of a core instrument. The working group participants propose validation studies in diverse populations, comparisons of diaries versus retrospective questionnaires, and evaluations of symptom assessment alone versus composite scores of asthma control.

Kattan M.,Columbia University | Kumar R.,Childrens Memorial Hospital | Bloomberg G.R.,Washington University in St. Louis | Mitchell H.E.,Rho Federal Systems Division Inc | And 11 more authors.
Journal of Allergy and Clinical Immunology | Year: 2010

Background: There is an association between adiposity and asthma prevalence, but the relationship to asthma control is unclear. Objectives: We sought to understand the relationships among adiposity, sex, and asthma control in inner-city adolescents with asthma. Methods: We prospectively followed 368 adolescents with moderate-to-severe asthma (ages 12-20 years) living in 10 urban areas for 1 year. Asthma symptoms and exacerbations were recorded, and pulmonary function and exhaled nitric oxide levels were measured every 6 weeks. Adiposity measures (body mass index [BMI] and dual-energy X-ray absorptiometric scans) were made, and blood was collected for measurement of allergy markers, adiponectin, leptin, TNF-α, IL-6, and C-reactive protein levels. Results: More than 60% of female subjects and 50% of male subjects were above the 85th percentile of BMI for age. Higher BMI was associated with more symptom days (R = 0.18, P = .02) and exacerbations (R = 0.18, P = .06) among female subjects only. Adiponectin was inversely related to asthma symptoms (R = -0.18, P < .05) and exacerbations (R = -0.20, P < .05) and positively with FEV1/forced vital capacity ratio (R = 0.15, P < .05) in male subjects only independent of body size. There was no relationship between adiposity or adipokines and total IgE levels, blood eosinophil counts, and exhaled nitric oxide levels. Dual-energy X-ray absorptiometry provided little additional value in relating adiposity to asthma outcome in this population of adolescents. Conclusion: Adiposity is associated with poorer asthma control in female subjects. Adiponectin is associated with improved asthma control in male subjects.

Sorkness C.A.,University of Wisconsin - Madison | Wildfire J.J.,Rho Federal Systems Division Inc | Calatroni A.,Rho Federal Systems Division Inc | Mitchell H.E.,Rho Federal Systems Division Inc | And 11 more authors.
Journal of Allergy and Clinical Immunology: In Practice | Year: 2013

Background: Treatment regimens for omalizumab are guided by a dosing table that is based on total serum IgE and body weight. Limited data exist about onset and offset of omalizumab efficacy in children and adolescents or subgroups that most benefit from treatment. Objectives: Post hoc analyses were conducted to (1) examine patient characteristics of those eligible and ineligible for omalizumab, (2) describe onset of effect after initiation of omalizumab and offset of treatment effect after stopping therapy, and (3) determine whether the efficacy differs by age, asthma severity, dosing regimen, and prespecified biomarkers. Methods: Inner-city children and adolescents with persistent allergic asthma were enrolled in the Inner-City Anti-IgE Therapy for Asthma trial that compared omalizumab with placebo added to guidelines-based therapy for 60 weeks. Results: Two hundred ninety-three of 889 participants (33%) clinically suitable for omalizumab were ineligible for dosing according to a modified dosing table specifying IgE level and body weight criteria. Baseline symptoms were comparable among those eligible and ineligible to receive omalizumab, but other characteristics (rate of health care utilization and skin test results) differed. The time of onset of omalizumab effect was <30 days and time of offset was between 30 and 120 days. No difference in efficacy was noted by age or asthma severity, but high exhaled nitric oxide, blood eosinophils, and body mass index predicted efficacy. Conclusions: A significant portion of children and adolescents particularly suited for omalizumab because of asthma severity status may be ineligible due to IgE >1300 IU/mL. Omalizumab reduced asthma symptoms and exacerbations rapidly; features associated with efficacy can be identified to guide patient selection. © 2013 American Academy of Allergy, Asthma & Immunology.

Gergen P.J.,National Institute of Allergy and Infectious Diseases | Teach S.J.,Childrens National Medical Center | Mitchell H.E.,Rho Federal Systems Division Inc. | Freishtat R.F.,Childrens National Medical Center | And 13 more authors.
American Journal of Clinical Nutrition | Year: 2013

Background: Decreased 25-hydroxyvitamin D [25(OH)D] concentrations have been associated with an increased prevalence and severity of asthma and a lower response to inhaled corticosteroids. Objective: The objective was to determine the association between serum 25(OH)D concentrations and asthma prevalence, severity, and response to asthma treatment. Design: Secondary analyses were conducted in 2 samples of adolescents 12-20 y of age: 1) NHANES 2001-2006 (n = 6487), a cross-sectional nationally representative sample of the US population, and 2) a cohort of inner-city adolescents with asthma managed prospectively for 46 wk with guidelines-based therapy in the Asthma Control Evaluation (ACE; n = 226) trial. Results: Mean (±SD) serum 25(OH)D concentrations in the NHANES and ACE samples were lower in African Americans than in non-African Americans (NHANES: 14.9 ± 6.5 compared with 23.0 ± 8.4 ng/mL, P < 0.0001; ACE: 11.2 ± 6.9 compared with 15.8 ± 7.1 ng/mL, P < 0.0001). In the NHANES sample, mean concentrations did not differ between participants without and with asthma (African Americans: 14.9 ± 6.4 compared with 15.0 ± 6.6 ng/mL, respectively, P = 0.87; non-African Americans: 23.0 ± 8.5 compared with 23.6 ± 8.2 ng/mL, respectively, P = 0.16). In the ACE models that used either a predefined cutoff (<20 ng/mL) or linear regression, 25(OH)D concentrations showed either no relation or minor contradictory correlations with indicators of asthma severity, treatment requirements, spirometry, or atopy/inflammation. Conclusion: In 2 samples of adolescents, overall serum 25(OH)D concentrations were low and were not consistently associated with the presence of asthma, multiple asthma characteristics, asthma morbidity, or response to treatment. The ACE trial was registered at clinicaltrials. gov as NCT0011441. © 2013 American Society for Nutrition.

Arbes S.J.,Rho Federal Systems Division Inc. | Calatroni A.,Rho Federal Systems Division Inc. | Mitchell H.E.,Rho Federal Systems Division Inc. | Gergen P.J.,National Institute of Allergy and Infectious Diseases
Clinical and Experimental Allergy | Year: 2013

Background: Atopy is an established risk factor for asthma, and an elevated eosinophil level is a hallmark of atopic and non-atopic asthma. Whether atopy and eosinophils act independently or interact to influence asthma has clinical and public health implications. Objective: To investigate the relationship between atopy and eosinophils in asthma. Methods: Data on current asthma, atopy (IgE positive to ≥ 1 allergen), and blood eosinophil percent (dichotomized at the median) were obtained for persons aged ≥ 6 years from the National Health and Nutrition Examination Survey 2005-2006. Interaction on an additive scale was evaluated by estimating the prevalences of asthma for combinations of atopy (yes or no) and eosinophil percent (high or low) and calculating the excess prevalence due to interaction. Results: For all ages combined, the adjusted prevalences of asthma were 4.6%, 7.6%, 6.9% and 17.2% for persons with neither factor, atopy alone, a high eosinophil percent alone and both factors respectively. The excess prevalence of asthma due to interaction was 7.2%, indicating synergism. The excess prevalence was greatest in children aged 6-17 years (15.3%), and it decreased with each older age category until it was absent in adults aged ≥ 55 years (-0.2%). In children, 94% of asthma cases attributable to the 2 factors were attributable to the interaction, whereas in the oldest adults, no cases were attributable to the interaction. Conclusions and Clinical Relevance: Interaction between atopy and an elevated eosinophil level in asthma cases was very strong in children but absent in the oldest adults, which suggests different mechanistic pathways for these factors by age and supports the notion that asthma is a heterogeneous disease. In addition, the age-dependent interaction between the factors has potential implications for the selection of asthma patients for treatments that would target either IgE or a high eosinophil level. © 2013 Blackwell Publishing Ltd.

Long S.A.,Benaroya Research Institute | Rieck M.,Benaroya Research Institute | Sanda S.,Benaroya Research Institute | Bollyky J.B.,Benaroya Research Institute | And 15 more authors.
Diabetes | Year: 2012

Rapamycin/interleukin-2 (IL-2) combination treatment of NOD mice effectively treats autoimmune diabetes. We performed a phase 1 clinical trial to test the safety and immunologic effects of rapamycin/ IL-2 combination therapy in type 1 diabetic (T1D) patients. Nine T1D subjects were treated with 2-4 mg/day rapamycin orally for 3 months and 4.5 × 10 6 IU IL-2 s.c. three times per week for 1 month. β-Cell function was monitored by measuring C-peptide. Immunologic changes were monitored using flow cytometry and serum analyses. Regulatory T cells (Tregs) increased within the first month of therapy, yet clinical and metabolic data demonstrated a transient worsening in all subjects. The increase in Tregs was transient, paralleling IL-2 treatment, whereas the response of Tregs to IL-2, as measured by STAT5 phosphorylation, increased and persisted after treatment. No differences were observed in effector T-cell subset frequencies, but an increase in natural killer cells and eosinophils occurred with IL-2 therapy. Rapamycin/IL-2 therapy, as given in this phase 1 study, resulted in transient β-cell dysfunction despite an increase in Tregs. Such results highlight the difficulties in translating therapies to the clinic and emphasize the importance of broadly interrogating the immune system to evaluate the effects of therapy. © 2012 by the American Diabetes Association.

Wood R.A.,Johns Hopkins University | Bloomberg G.R.,University of Washington | Kattan M.,Columbia University | Conroy K.,Boston University | And 7 more authors.
Journal of Allergy and Clinical Immunology | Year: 2011

Background: The Urban Environment and Childhood Asthma study was established to investigate the immunologic and environmental causes of asthma in inner-city children. Objective: We sought to evaluate potential atopic outcomes in the first 12 months and their relationships to environmental exposures and immune development. Methods: A birth cohort of 560 children with at least 1 parent with allergy or asthma was established in Baltimore, Boston, New York, and St Louis. Wheezing is assessed every 3 months, allergen-specific IgE yearly, and mononuclear cell cytokine responses at birth and yearly; environmental assessments include dust allergen and endotoxin, maternal stress, and indoor nicotine and nitrogen dioxide levels. Results: Key outcomes in the first year include wheeze in 49%, 2 or more episodes of wheeze in 23%, eczema in 30%, and detectable IgE to milk, egg, and/or peanut in 32% and to cockroach in 4%. Household dust revealed levels of greater than 2 μg/g to cockroach in 40%, mite in 19%, cat in 25%, and mouse in 29%, and 66% of homes housed at least 1 smoker. Positive associations were detected between multiple wheeze and cotinine levels, maternal stress, and maternal depression, whereas cytokine responses to a variety of innate, adaptive, and mitogenic stimuli were inversely related to eczema. Conclusions: This high-risk cohort of inner-city infants is exhibiting high rates of wheeze, eczema, and allergic sensitization. Low cytokine responses at birth might be a risk factor for eczema, whereas a variety of adverse environmental exposures contribute to the risk of wheezing in infancy. These findings provide evidence of specificity in the interactions between immune development, environmental exposures, and the development of early features that might predict future asthma. © 2010 American Academy of Allergy, Asthma & Immunology.

Vesper S.J.,U.S. Environmental Protection Agency | Wymer L.,U.S. Environmental Protection Agency | Kennedy S.,Rho Federal Systems Division Inc | Faye Grimsley L.,Tulane University
Open Respiratory Medicine Journal | Year: 2013

Background: Exposures to water-damaged homes/buildings has been linked to deficits in respiratory health. However, accurately quantifying this linkage has been difficult because of the methods used to assess water damage and respiratory health. Purpose: The goal of this analysis was to determine the correlation between the water-damage, as defined by the Environmental Relative Moldiness Index (ERMI) value in an asthmatic child's home, and the child's pulmonary function measured by spirometry, "forced expiratory volume in one second, percent predicted" or FEV1%. Methods: This analysis utilized data obtained from the "Heads-off Environmental Asthma in Louisiana" (HEAL) study. The children (n= 109), 6 to 12 years of age, who had completed at least one spirometry evaluation and a dust sample collected for ERMI analysis from the home at approximately the same time as the spirometry testing, were included in the analysis. Statistical evaluation of the correlation between ERMI values and FEV1% was performed using the Spearman's Rank Correlation analysis. The relationship between ERMI values and FEV1% was performed using B-spline regression. Results: The average ERMI value in the HEAL study homes was 7.3. For homes with ERMI values between 2.5 and 15, there was a significant inverse correlation with the child's lung function or FEV1% measurement (Spearman's rho -0.23; p= 0.03), i.e. as the ERMI value increased, the FEV1% value decreased. Conclusions: Measures of water-damage (the ERMI) and clinical assessments of lung function (FEV1%) provided a quantitative assessment of the impact of water-damaged home exposures on children's respiratory health. © Vesper et al.

Wang J.,Mount Sinai Hospital | Calatroni A.,Rho Federal Systems Division Inc | Visness C.M.,Rho Federal Systems Division Inc | Sampson H.A.,Mount Sinai Hospital
Journal of Allergy and Clinical Immunology | Year: 2011

Background: Studies have demonstrated that IgE-binding cross-reactive epitopes between shrimp, cockroach, and house dust mite tropomyosins can account for the presence of detectable IgE to shrimp in patients with cockroach and dust mite allergies. Objective: We investigated the correlation between IgE-mediated sensitization to shrimp, cockroach, and dust mite in relation to allergen exposure in inner-city children. Methods: Five hundred four serum samples from the National Cooperative Inner-City Asthma Study were evaluated for specific IgE to shrimp, and the results were compared with specific IgE to cockroach (Blattella germanica) and dust mite (Dermatophagoides farinae). Associations between IgE sensitization to these allergens and environmental exposures were determined. Results: There was a strong positive correlation between shrimp, cockroach, and dust mite IgE levels. High exposure to cockroach (B germanica) in the home, particularly in the bedroom and television room, was significantly correlated with higher shrimp and cockroach IgE levels. In contrast, high exposure to dust mite in the home was highly correlated with IgE levels to D farinae but not with shrimp IgE levels. There is a synergistic relationship between cockroach IgE levels and exposure in predicting shrimp IgE levels. Conclusions: For children with evidence of IgE-mediated sensitization to cockroach and shrimp, having high exposure to cockroach in the home can contribute to higher shrimp IgE levels, which might not correlate with clinical reactivity. Further patient evaluations with clinical histories of shrimp exposure and reactions, as well as oral food challenges, would have to be performed to confirm these findings. © 2011 American Academy of Allergy, Asthma & Immunology.

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