Redesigning a large school-based clinical trial in response to changes in community practice.

ABSTRACT:

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 s

SUBMITTER: Gerald LB 

PROVIDER: S-EPMC3145214 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature