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.

Outcomes for a comprehensive school-based asthma management program.

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.

Increasing adherence to inhaled steroid therapy among schoolchildren: randomized, controlled trial of school-based supervised asthma therapy.

OBJECTIVE: We aimed to determine the effectiveness of school-based supervised asthma therapy in improving asthma control. The primary hypothesis was that the supervised-therapy group would have a smaller proportion of children experiencing an episode of poor asthma control each month, compared with those in the usual-care group. 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 peak flowmeter. The trial used a 2-group, randomized, longitudinal design with a 15-month follow-up period. A total of 290 children from 36 schools were assigned randomly to either school-based, supervised therapy or usual care. Ninety-one percent of the children were black, and 57% were male. The mean age was 11 years (SD: 2.1 years). An episode of poor asthma control was defined as > or =1 of the following each month: (1) an absence from school attributable to respiratory illness/asthma; (2) average use of rescue medication >2 times per week (not including preexercise treatment); or (3) > or =1 red or yellow peak flowmeter reading. RESULTS: Two hundred forty children completed the study. There were no differences in the likelihood of an episode of poor asthma control between the baseline period and the follow-up period for the usual-care group. For the supervised-therapy group, however, the odds of experiencing an episode of poor asthma control during the baseline period were 1.57 times the odds of experiencing an episode of poor asthma control during the follow-up period. Generalized estimating equation modeling revealed a marginally significant intervention-time period interaction, 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 patients with asthma with poor outcomes that may be attributable to nonadherence should consider supervised therapy.

Validation of a multistage asthma case-detection procedure for elementary school children.

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.

A multi-stage asthma screening procedure for elementary school children.

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.