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.

Background

Aerobic exercise appears to have clinical benefits for many asthmatics, yet a complete understanding of the mechanisms underlying these benefits has not been elucidated at this time.

Purpose

The objective of this study was to determine feasibility for a larger, future study that will define the effect of aerobic exercise on cellular, molecular, and functional measures in adults with mild-moderate asthma.

Design

Recruited subjects were randomized into usual care (sedentary) or usual care with moderate intensity aerobic exercise treatment groups.

Setting / Participants

Nineteen adults with mild-moderate asthma but without a recent history of exercise were recruited at the UAB Lung Health Center, Birmingham, AL.

Intervention

The exercise group underwent a 12 week walking program exercising at 60 – 75% of maximum heart rate (HRmax). Subjects self-monitored HRmax levels using heart rate monitors; exercise diaries and recreation center sign-in logs were also used.

Main outcome measures

Functional measures, including lung function and asthma control scores, were evaluated for all subjects at pre- and post-study time-points; fitness measures were also assessed for subjects in the exercise group. Peripheral blood and nasal lavage fluid were collected from all subjects at pre- and post-study visits in order to evaluate cellular and molecular measures, including cell differentials and eosinophilic cationic protein (ECP).

Results

Sixteen subjects completed the prescribed protocol. Results show that subjects randomized to the exercise group adhered well (80%) to the exercise prescription and exhibited a trend toward improved fitness levels upon study completion. Both groups exhibited improvements in ACQ scores. No changes were observed in lung function (FEV1, FEV1/FVC), cell differentials, or ECP between groups.

Conclusions

Results indicate that a moderate intensity aerobic exercise training program may improve asthma control and fitness levels without causing asthma deterioration in adult asthmatics. As such, these findings demonstrate the feasibility of the study protocol in preparation for a larger, clinical trial that will elucidate the functional consequences of aerobic exercise on asthmatic cellular and molecular responses.

Background

Inhaled corticosteroids, when properly used, can offer considerable protection against asthma-related morbidity. However, adherence to prescribed inhaled steroids among children is low and rates differ markedly by population. The lowest rates of adherence and highest rates of morbidity are among inner-city and low income populations.

Purpose

To describe the design of a school-based clinical trial in a largely minority population that is examining the efficacy of a school-based intervention intended to increase adherence to daily inhaled corticosteroids.

Methods

The supervised asthma therapy study is a two-group randomized longitudinal trial. Children were randomly assigned to either school-based supervised asthma therapy or parent supervised asthma therapy. Children were followed longitudinally for 15 months. The primary outcome of the study is the time-averaged difference between the two groups in the percentage of children experiencing at least one asthma exacerbation each month.

Results

A web-based data collection system was designed to capture data at school. A total of 295 students, recruited from community and school sites, who attended one of 36 urban elementary schools enrolled in the study and 290 were randomized. The average age of the students was 10.0 years (sd=2.1), 91% were African American, 8% were white, and 1% were of other racial groups. 57% of students were male. The study has been recently completed and results are being analyzed.

Conclusions

Intervention studies requiring daily medication supervision and daily data collection can be successfully conducted within the elementary school environment.

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.

Background

Asthma is the most common chronic childhood disease and has significant impact on morbidity and mortality in children. Proper adherence to asthma medication has been shown to reduce morbidity among those with asthma; however, adherence to medications is known to be low, especially among low-income urban populations. We conducted a randomized clinical trial to examine the effectiveness of an intervention designed to increase adherence to asthma medication among children with asthma that required daily collection of data.

Purpose and Methods

A specifically designed web-based data collection system, the Asthma Agents System, was used to collect daily data from participant children at school. These data were utilized to examine the intervention’s effectiveness in reducing the frequency of asthma exacerbations. This study examines the Asthma Agents System’s effect on the frequency of missing data. Data collection methods are discussed in detail, as well as the processes for retrieving missing data.

Results

For the 290 children randomized, 97% of the daily data expected were available. Of the outcome data retrieved via the Asthma Agents System, 5% of those expected were missing during the period examined.

Limitations

Challenges encountered in this study include issues regarding the use of technology in urban school settings, transfer of data between study sites, and availability of data during school breaks.

Conclusions

Use of the Asthma Agents System resulted in lower rates of missing data than rates reported elsewhere in the literature.

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.

Rationale

The burden of obstructive lung disease is increasing, yet there are limited data on its natural history in young adults.

Objectives

To determine in a prospective cohort of generally healthy young adults the influence of early adult lung function on the presence of airflow obstruction in middle age.

Methods

Longitudinal study of 2,496 adults who were 18-30 years of age at entry, did not report having asthma, and returned at Year 20. Airflow obstruction was defined as an FEV1/FVC ratio less than the lower limit of normal.

Measurements and Main Results

Airflow obstruction was present in 6.9% and 7.8% of participants at Years 0 and 20. Less than 10% of participants with airflow obstruction self-reported COPD. In cross sectional analyses airflow obstruction was associated with less education, smoking, and self-reported COPD. Low FEV1 and FEV1/FVC and airflow obstruction in young adults were associated with low lung function and airflow obstruction 20 years later. Of those with airflow obstruction at Year 0, 52% had airflow obstruction 20 years later. The FEV1/FVC at Year 0 was highly predictive of airflow obstruction 20 years later (c-statistic 0.91; 95% CI 0.89-0.93). The effect of cigarette smoking on lung function decline with age was most evident in young adults with pre-existing airflow obstruction.

Conclusions

Airflow obstruction is mostly unrecognized in young and middle age adults. A low FEV1, low FEV1/FVC and airflow obstruction in young adults, in addition to smoking, are highly predictive of low lung function and airflow obstruction in middle age.

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.

Objective

Few patients take inhaled corticosteroids as recommended. This study aimed to determine the effectiveness of school-based supervised asthma therapy in improving asthma control. The primary hypothesis was that the supervised asthma therapy group would have a lower proportion of children experiencing an episode of poor asthma control (EPAC) each month compared to the usual care group.

Patients and Methods

Children were eligible if they had physician-diagnosed persistent asthma, the need for daily controller medication, and the ability to use a dry-powder inhaler and a PFM. The trial used a two-group randomized longitudinal design with 15 month follow-up. 290 children from 36 schools were randomly assigned to either: school-based supervised asthma therapy or usual care. Ninety-one percent of children were African American and 57% were male. Mean age was 11 years (SD = 2.1). An EPAC was defined as one or more of the following each month: 1) an absence from school due to respiratory illness/asthma; 2) average use of rescue medication more than two times per week (not including pre-exercise treatment); or 3) at least one red or yellow PFM reading.

Results

240 children completed the study. There were no differences in the likelihood of an EPAC between the baseline and follow-up period in the usual care group (p=0.77); however, among those in the supervised therapy group, the odds of experiencing an EPAC during the baseline period were 1.57 times the odds of experiencing an EPAC during the follow-up period (90% CI: 1.20, 2.06, p=0.006). GEE modeling revealed a marginally significant interaction between the intervention and time period (p=0.065) indicating that children in the supervised therapy group showed greater improvement in asthma control.

Conclusions

Supervised asthma therapy improves asthma control. Clinicians who have pediatric asthma patients with poor outcomes that may be due to non-adherence should consider supervised therapy.

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

Objective

The purpose of this study was to validate a 3-stage asthma case-detection procedure for elementary school-aged children.

Methods

The study was performed in 10 elementary schools in 4 inner-city school systems, with a total enrollment of 3539 children. Results of the case-detection procedure were compared with the diagnosis of an asthma specialist study physician, to determine the sensitivity and specificity of the case-detection procedure.

Results

Ninety-eight percent of children returned the asthma symptoms questionnaires, and 79% of those children consented to additional testing. Results indicated that the 3-stage procedure had good validity, with sensitivity, specificity, and predictive value of 82%, 93%, and 93%, respectively. A 2-stage procedure using questionnaires and spirometry had similar validity, with sensitivity, specificity, and predictive value of 78%, 93%, and 93%, respectively. However, given the time and expense associated with the 2- or 3-stage procedure and the difficulty of obtaining physician follow-up evaluation of the case-detection diagnosis, schools may prefer to use a 2-item questionnaire that has a lower sensitivity (66%) but higher specificity (96%) and predictive value (95%).

Conclusions

Case-detection programs are generally well received by school personnel and can identify children with unrecognized or undiagnosed disease, as well as those with a current diagnosis but poorly controlled disease. This study yields substantial information regarding the validity, yield, and specific types of children who might be identified with the use of such procedures. For the choice of the method of case detection used in a school, the strengths and weaknesses of each procedure, as well as the resources available for case detection, physician referral, and follow-up procedures, must be considered.

This article describes the evaluation of a comprehensive school-based asthma management program in an inner-city, largely African-American school system. All 54 elementary schools (combined enrollment 13,247 students) from a single urban school system participated in this study. Schools were randomly divided between immediate and delayed intervention programs. The intervention consisted of 3 separate educational programs (for school faculty/staff, students with asthma, and peers without asthma) and medical management for the children with asthma (including an Individual Asthma Action Plan, medications, and peakflow meters). Children with asthma were identified using a case detection program and 736 were enrolled into the intervention study. No significant differences were observed in school absences, grade point average, emergency room visits, or hospitalizations between the immediate and delayed intervention groups. Significant increases in knowledge were observed in the immediate intervention group. This study of a school-based asthma management education and medical intervention program did not show any differences between the intervention and control groups on morbidity outcomes. Our experience leads us to believe that such measures are difficult to impact and are not always reliable. Future researchers should be aware of the problems associated with using such measures. In addition, connecting children with a regular source of health care in this population was difficult. More intensive methods of medical management, such as school-based health centers or supervised asthma therapy, might prove more effective in inner-city schools.

This paper describes an asthma screening procedure developed to identify children with asthma for an intervention study. Students were classified into three categories based on questionnaire responses (previous asthma, suspected asthma, and no evidence of asthma). Those classified as suspected asthma by questionnaire underwent further testing including spirometry and exercise challenge. Using the questionnaire alone, the measured asthma prevalence was 32%; the addition of spirometry and step testing reduced this estimate to 9.89%. The diagnosis of asthma was confirmed in 96% of children who saw the study physician. This screening procedure can identify school children with suspected undiagnosed asthma.

Background

Health departments require an efficient strategy to investigate individuals exposed to Mycobacterium tuberculosis. The contact priority model (CPM) uses a decision rule to minimize testing of low-risk contacts; however, its impact on costs and disease control is unknown.

Methods

A cost-effectiveness analysis compared the CPM with the traditional concentric circle approach (CCA) in a simulated population of 1000 healthy, community-dwelling adults with a 10% background rate of latent tuberculosis (TB) infection. The analysis was conducted from the perspective of the Alabama Department of Public Health. Model inputs were derived from the literature and the Alabama Department of Public Health. Lifetime costs (2004 dollars) and outcomes were discounted 3 percent annually. Incremental cost-effectiveness ratios were used to compare the strategies.

Results

Over the lifetime of 1000 simulated contacts, the CPM saved $45 000 but led to 0.5 additional TB cases and 0.24 fewer years of life. The CCA is more effective than the CPM, but it costs $92 934 to prevent one additional TB case and $185 920 to gain one additional life year.

Conclusions

The CPM reduces costs with minimal loss of disease control and is a viable alternative to the CCA under most conditions.

This study compared parent and child responses to a symptom questionnaire as a means of determining whether child and parent responses are equally valuable in case-detection procedures. We completed a study validating a multistage case-detection procedure. The case-detection procedure classified students into 3 categories based on their parents' questionnaire responses (probable asthma, possible asthma, and negative for asthma). Those who were classified as possible asthma by questionnaire underwent further testing, including spirometry and exercise challenge. The children with abnormal testing results were considered to have probable asthma. McNemar's test cnd kappa coefficients were used to examine parent-child agreement. Sensitivity and specificity of the case-detection procedure were compared using either the parent's or the child's responses to the questionnaire. The data indicated moderate agreement between parent and child responses to questions regarding previous diagnosis of asthma and past asthma therapy (p < .001, kappa coefficients of 0.603 and 0.597, respectively). Sensitivity, speciicity, and predictive values in the multistage case-detection procedure were similar when using either parent or child responsees to the questionnaire. Among the false negatives, the distribution of asthma severity was consistent whether using child or parent responses. Parent-child agreement did not differ significantly by gender or age of the child or whether the child had a previous diagnosis of asthma. These results suggest that the use of child responses is a viable option for case detection, particularly in identifying those with a previous diagnosis of asthma.