Study protocol for Women of Color and Asthma Control: A randomized controlled trial of an asthma-management intervention for African American women

<p>Abstract</p> <p>Background</p> <p>Among adults in the United States, asthma prevalence is disproportionately high among African American women; this group also experiences the highest levels of asthma-linked mortality and asthma-related health care utilization. Factors linked to biological sex (e.g., hormonal fluctuations), gender roles (e.g., exposure to certain triggers) and race (e.g., inadequate access to care) all contribute to the excess asthma burden in this group, and also shape the context within which African American women manage their condition. No prior interventions for improving asthma self-management have specifically targeted this vulnerable group of asthma patients. The current study aims to evaluate the efficacy of a culturally- and gender-relevant asthma-management intervention among African American women.</p> <p>Methods/Design</p> <p>A randomized controlled trial will be used to compare a five-session asthma-management intervention with usual care. This intervention is delivered over the telephone by a trained health educator. Intervention content is informed by the principles of self-regulation for disease management, and all program activities and materials are designed to be responsive to the specific needs of African American women. We will recruit 420 female participants who self-identify as African American, and who have seen a clinician for persistent asthma in the last year. Half of these will receive the intervention. The primary outcomes, upon which the target sample size is based, are number of asthma-related emergency department visits and overnight hospitalizations in the last 12 months. We will also assess the effect of the intervention on asthma symptoms and asthma-related quality of life. Data will be collected via telephone survey and medical record review at baseline, and 12 and 24 months from baseline.</p> <p>Discussion</p> <p>We seek to decrease asthma-related health care utilization and improve asthma-related quality of life in African American women with asthma, by offering them a culturally- and gender-relevant program to enhance asthma management. The results of this study will provide important information about the feasibility and value of this program in helping to address persistent racial and gender disparities in asthma outcomes.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01117805">NCT01117805</a></p

Use of computerized tomography and chest X-rays in evaluating efficacy of aerosolized recombinant human DNase in cystic fibrosis patients younger than age 5 years: A preliminary study * Presented in part at the International Conference for the American Thoracic Society, April 23–28, 1999, and at the North American Annual Cystic Fibrosis Conference, October 7–10, 1999.

The aim of this study was to evaluate the ability of high-resolution computerized tomography (HRCT) of the chest and chest x-rays (CXR) to determine efficacy of inhaled recombinant human DNase (rhDNase) in cystic fibrosis (CF) patients younger than 5 years of age. A randomized, double-blind, placebo-controlled pilot study of 12 patients with CF younger than 5 years of age, attending the University of Michigan Cystic Fibrosis Center (Ann Arbor, MI) was conducted. The changes in the HRCT and CXR score from baseline to day 100 of therapy were assessed using a previously validated scoring system. The mean changes of HRCT scores between the rhDNase and placebo groups were found to be significant at the 95% level, with mean change ±  SE mean of − 1.00  ±  0.53 and 0.58  ±  0.24 for rhDNase and placebo groups, respectively ( P   =  0.02). The difference in CXR score was not significant between the two groups. An analysis was performed to relate HRCT subscores to CXR score; only thickening of the intra-interlobular septae was significantly correlated with the total CXR score (r  =  − 0.7, P  < 0.01). There was improvement in the parents' assessments of the patients' well-being, with improvement in physical activity, decreased cough, sleep quality, and appetite in those subjects receiving rhDNase. We conclude that the administration of rhDNase was associated with improvement in the HRCT scan in CF patients younger than 5 years of age. Findings indicate that HRCT of the chest is useful and sensitive in studying responses to therapy in patients with CF lung disease. To our knowledge, this is the first report of the use of HRCT to assess the effectiveness of a therapeutic modality in so young a CF patient population. Pediatr Pulmonol. 2001; 31:377–382. © 2001 Wiley-Liss, Inc.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/35318/1/1061_ftp.pd

sj-tiff-1-jic-10.1177_08850666231201836 - Supplemental material for Stress Symptoms Among Children and Their Parents After ICU Hospitalization

Supplemental material, sj-tiff-1-jic-10.1177_08850666231201836 for Stress Symptoms Among Children and Their Parents After ICU Hospitalization by Hannah R. Daughtrey, Justin Lee, Derek B. Boothroyd, Georgiana M. Burnside, Richard J. Shaw, Kanwaljeet J.S. Anand and Lee M. Sanders in Journal of Intensive Care Medicine</p

E-cigarette use among students and e-cigarette specialty retailer presence near schools

Objective. This study examined the association between presence of e-cigarette specialty retailers near schools and e-cigarette use among middle and high school students in Orange County (OC), CA. Methods. The OC subsample of the 2013-2014 California Healthy Kids Survey (N=67,701) was combined with geocoded e-cigarette retailers to determine whether a retailer was present within one-quarter mile of each public school in OC. Multilevel logistic regression models evaluated individual-level and school-level e-cigarette use correlates among middle and high school students. Results. Among middle school students, the presence of an e-cigarette retailer within one-quarter mile of their school predicted lifetime e-cigarette use (OR = 1.70, 95% CI=1.02, 2.83), controlling for confounders but no effect for current use. No significant effect was found for high school students. Conclusions. E-cigarette specialty retailers clustered around schools may be an environmental influence on student e-cigarette experimentation

AR101 Oral Immunotherapy for Peanut Allergy

BACKGROUND Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions. METHODS In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic oral immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms. RESULTS Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; P CONCLUSIONS In this phase 3 trial of oral immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo