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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. Source

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. Source

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. Source

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. Source

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. Source

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