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1.  Availability of Asthma Quick Relief Medication in Five Alabama School Systems 
Objectives
This paper documents individual asthma action plan presence and quick relief medication (albuterol) availability for elementary students enrolled in five Alabama school systems.
Patients and Methods
Data were obtained during baseline data collection (fall 2005) of a school-based supervised asthma medication trial. All students attended 1 of 36 participating elementary schools across five school systems in Jefferson County, Alabama. In addition, they had to have physician-diagnosed asthma requiring daily controller medication. Each school system had its own superintendent and elected school board. Asthma action plan presence and albuterol availability was confirmed by study personnel. Asthma action plans had to contain daily and acute asthma management instructions. Predictors of asthma action plan presence and albuterol availability were also investigated. Associations between albuterol availability and self-reported characteristics including health care utilization prior to study enrollment and outcomes during the study baseline period were also investigated.
Results
Enrolled students had a mean (SD) age of 11.0 (2.1) years, 91% were African American, and 79% had moderate persistent asthma. No student had a complete asthma action plan on file and only 14% had albuterol physically available at school. Albuterol availability was not predicted by gender, race, insurance status, second-hand smoke exposure, need for pre-exercise albuterol, asthma severity, or self-reported health care utilization prior to study enrollment. Albuterol availability did not predict school absences, red/yellow peak flow recordings, or medication adherence during the study's baseline period.
Conclusion
Despite policies permitting students to possess albuterol, few elementary students across five independent school systems in Alabama actually had it readily available at school.
doi:10.1089/ped.2011.0118
PMCID: PMC3306583  PMID: 22454787
2.  Can a school-based hand hygiene program reduce asthma exacerbations among elementary school children? 
Background
Viral upper respiratory infections have been implicated as a major cause of asthma exacerbations among school age children. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections but, effective hand washing practices are difficult to establish in schools.
Objectives
This randomized controlled trial evaluated whether a standardized regimen of hand washing plus alcohol-based hand sanitizer could reduce asthma exacerbations more than schools’ usual hand hygiene practices.
Methods
This was a two year, community-based, randomized controlled crossover trial. Schools were randomized to usual care then intervention (Sequence 1) or intervention then usual care (Sequence 2). Intervention schools were provided with alcohol-based hand sanitizer, hand soap, and hand hygiene education. The primary outcome was the proportion of students experiencing an asthma exacerbation each month. Generalized estimating equations were used to model the difference in the marginal rate of exacerbations between sequences while controlling for individual demographic factors and the correlation within each student and between students within each school.
Results
527 students with asthma were enrolled among 31 schools. The hand hygiene intervention did not reduce the number of asthma exacerbations as compared to the schools’ usual hand hygiene practices (p=0.132). There was a strong temporal trend as both sequences experienced fewer exacerbations during Year 2 as compared to Year 1 (p<0.001).
Conclusions
While the intervention was not found to be effective, the results were confounded by the H1N1 influenza pandemic that resulted in substantially increased hand hygiene behaviors and resources in usual care schools. Therefore, these results should be viewed cautiously.
doi:10.1016/j.jaci.2012.08.031
PMCID: PMC3511646  PMID: 23069487
asthma; schools; children; hand hygiene; hand sanitizer
3.  Asthma Morbidity Among Children Evaluated by Asthma Case Detection 
Pediatrics  2009;124(5):e927-e933.
OBJECTIVE
Population-based asthma detection is a potential strategy to reduce asthma morbidity in children; however, the burden of respiratory symptoms and health care use among children identified by case detection is not well known.
METHODS
Data come from a school-based asthma case detection validation study of 3539 children. Respiratory symptoms, emergency department (ED) visits, and hospitalizations were assessed by questionnaire for children whose case detection result and physician study diagnosis agreed.
RESULTS
Physician evaluation of 530 case detection results yielded 420 cases of agreement (168 children with previously diagnosed asthma, 39 with undiagnosed asthma, and 213 without asthma). Children with previously diagnosed asthma were more likely to be male (P < .0001). No differences in severity were observed in children with previously and undiagnosed asthma (P = .31). Children with undiagnosed asthma reported less frequent daytime and nighttime symptoms than children with previously diagnosed asthma but more than those without asthma (P < .0001). The proportion of children with at least 1 respiratory-related ED visit in the past year was 32%, 3%, and 3% for those with previously diagnosed, undiagnosed, and no asthma, respectively (P < .0001). The proportion with at least 1 respiratory-related hospitalization was 8%, 0%, and 0%, respectively (P < .0001). There were no differences in nonrespiratory ED visits (P = .93).
CONCLUSIONS
Despite similar physician-rated severity, children with undiagnosed asthma reported significantly less frequent respiratory symptoms and health care use than children with previously diagnosed asthma. These findings suggest that the potential health gains from case detection may be smaller than expected.
doi:10.1542/peds.2008-2798
PMCID: PMC2787878  PMID: 19841121
asthma; mass screening; child; hospitalization; signs and symptoms (respiratory); emergency department
4.  Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study 
Background
The Veterans Health Administration (VHA) oversees the largest integrated healthcare system in the United States. The feasibility of a large-scale, nationwide, group-randomized implementation trial of VHA outpatient practices has not been reported. We describe the recruitment and enrollment of such a trial testing a clinician-directed, Internet-delivered intervention for improving the care of postmyocardial infarction patients with multiple comorbidities.
Methods
With a recruitment goal of 200 eligible community-based outpatient clinics, parent VHA facilities (medical centers) were recruited because they oversee their affiliated clinics and the research conducted there. Eligible facilities had at least four VHA-owned and -operated primary care clinics, an affiliated Institutional Review Board (IRB), and no ongoing, potentially overlapping, quality-improvement study. Between December 2003 and December 2005, in two consecutive phases, we used initial and then intensified recruitment strategies.
Results
Overall, 48 of 66 (73%) eligible facilities were recruited. Of the 219 clinics and 957 clinicians associated with the 48 facilities, 168 (78%) clinics and 401 (42%) clinicians participated. The median time from initial facility contact to clinic enrollment was 222 days, which decreased by over one-third from the first to the second recruitment phase (medians: 323 and 195 days, respectively; p < .001), when more structured recruitment with physician recruiters was implemented and a dedicated IRB manager was added to the coordinating center staff.
Conclusions
Large group-randomized trials benefit from having dedicated physician investigators and IRB personnel involved in recruitment. A large-scale, nationally representative, group-randomized trial of community-based clinics is feasible within the VHA or a similar national healthcare system.
doi:10.1186/1748-5908-6-105
PMCID: PMC3184080  PMID: 21906278
5.  Redesigning a large school-based clinical trial in response to changes in community practice 
Background
Asthma exacerbations are seasonal with the greatest risk in elementary-age students occurring shortly after returning to school following summer break. Recent research suggests that this seasonality in children is primarily related to viral respiratory tract infections. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections; unfortunately, achieving hand washing recommendations in schools is difficult. Therefore, we designed a study to evaluate the effect of hand sanitizer use in elementary schools on exacerbations among children with asthma.
Purpose
To describe the process of redesigning the trial in response to changes in the safety profile of the hand sanitizer as well as changes in hand hygiene practice in the schools.
Methods
The original trial was a randomized, longitudinal, subject-blinded, placebo-controlled, community-based crossover trial. The primary aim was to evaluate the incremental effectiveness of hand sanitizer use in addition to usual hand hygiene practices to decrease asthma exacerbations in elementary-age children. Three events occurred that required major modifications to the original study protocol: (1) safety concerns arose regarding the hand sanitizer’s active ingredient; (2) no substitute placebo hand sanitizer was available; and (3) community preferences changed regarding hand hygiene practices in the schools.
Results
The revised protocol is a randomized, longitudinal, community-based crossover trial. The primary aim is to evaluate the incremental effectiveness of a two-step hand hygiene process (hand hygiene education plus institutionally provided alcohol-based hand sanitizer) versus usual care to decrease asthma exacerbations. Enrollment was completed in May 2009 with 527 students from 30 schools. The intervention began in August 2009 and will continue through May 2011. Study results should be available at the end of 2011.
Limitations
The changed design does not allow us to directly measure the effectiveness of hand sanitizer use as a supplement to traditional hand washing practices.
Conclusions
The need to balance a rigorous study design with one that is acceptable to the community requires investigators to be actively involved with community collaborators and able to adapt study protocols to fit changing community practices.
doi:10.1177/1740774511403513
PMCID: PMC3145214  PMID: 21730079
6.  Changes in Environmental Tobacco Smoke Exposure and Asthma Morbidity Among Urban School Children 
Chest  2008;135(4):911-916.
Background:
Environmental tobacco smoke (ETS) exposure is associated with poor asthma outcomes in children. However, little is known about natural changes in ETS exposure over time in children with asthma and how these changes may affect health-care utilization. This article documents the relationship between changes in ETS exposure and childhood asthma morbidity among children enrolled in a clinical trial of supervised asthma therapy.
Methods:
Data for this analysis come from a large randomized clinical trial of supervised asthma therapy in which 290 children with persistent asthma were randomized to receive either usual care or supervised asthma therapy. No smoking cessation counseling or ETS exposure education was provided to caregivers; however, children were given 20 min of asthma education, which incorporated discussion of the avoidance of asthma triggers, including ETS. Asthma morbidity and ETS exposure data were collected from caregivers via telephone interviews at baseline and at the 1-year follow-up.
Results:
At baseline, 28% of caregivers reported ETS exposure in the home and 19% reported exposure outside of the primary household only. Among children whose ETS exposure decreased from baseline, fewer hospitalizations (p = 0.034) and emergency department (ED) visits (p ≤ 0.001) were reported in the 12 months prior to the second interview compared to the 12 months prior to the first interview. Additionally, these children were 48% less likely (p = 0.042) to experience an episode of poor asthma control (EPAC).
Conclusions:
This is the first study to demonstrate an association between ETS exposure reduction and fewer EPACs, respiratory-related ED visits, and hospitalizations. These findings emphasize the importance of ETS exposure reduction as a mechanism to improve asthma control and morbidity. Potential policy implications include supporting ETS reductions and smoking cessation interventions for parents and caregivers of children with asthma. Research to identify the most cost-effective strategy is warranted.
Trial registration:
Clinicaltrials.gov Identifier: NCT00110383
doi:10.1378/chest.08-1869
PMCID: PMC2763557  PMID: 19017893
asthma; children; environmental tobacco smoke; tobacco smoke pollution
7.  Redesigning a large school-based clinical trial in response to changes in community practice 
Background Asthma exacerbations are seasonal with the greatest risk in elementary-age students occurring shortly after returning to school following summer break. Recent research suggests that this seasonality in children is primarily related to viral respiratory tract infections. Regular hand washing is the most effective method to prevent the spread of viral respiratory infections; unfortunately, achieving hand washing recommendations in schools is difficult. Therefore, we designed a study to evaluate the effect of hand sanitizer use in elementary schools on exacerbations among children with asthma.
Purpose To describe the process of redesigning the trial in response to changes in the safety profile of the hand sanitizer as well as changes in hand hygiene practice in the schools.
Methods The original trial was a randomized, longitudinal, subject-blinded, placebo-controlled, community-based crossover trial. The primary aim was to evaluate the incremental effectiveness of hand sanitizer use in addition to usual hand hygiene practices to decrease asthma exacerbations in elementary-age children. Three events occurred that required major modifications to the original study protocol: (1) safety concerns arose regarding the hand sanitizer’s active ingredient; (2) no substitute placebo hand sanitizer was available; and (3) community preferences changed regarding hand hygiene practices in the schools.
Results The revised protocol is a randomized, longitudinal, community-based crossover trial. The primary aim is to evaluate the incremental effectiveness of a two-step hand hygiene process (hand hygiene education plus institutionally provided alcohol-based hand sanitizer) versus usual care to decrease asthma exacerbations. Enrollment was completed in May 2009 with 527 students from 30 schools. The intervention began in August 2009 and will continue through May 2011. Study results should be available at the end of 2011.
Limitations The changed design does not allow us to directly measure the effectiveness of hand sanitizer use as a supplement to traditional hand washing practices.
Conclusions The need to balance a rigorous study design with one that is acceptable to the community requires investigators to be actively involved with community collaborators and able to adapt study protocols to fit changing community practices.
doi:10.1177/1740774511403513
PMCID: PMC3145214  PMID: 21730079

Results 1-7 (7)