Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance.

The Adult/Adolescent Vaccination Report Card (VRC) was developed and validated by Merck in 1998 for use in vaccine clinical trials to collect information from trial subjects on complaints for both local and systemic events after vaccination. This short report describes the revision to the original validated VRC in order to align with the guidelines outlined in the 2007 FDA Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Since the VRC elicits trial subjects' self-reports of any adverse experiences (AE) occurring post vaccination, it was important that subsequent modifications of the VRC retained the original user-friendly characteristics while gathering the appropriate information to align with the FDA Guidance.

Family and home asthma services across the Controlling Asthma in American Cities Project.

Asthma is among the most common chronic childhood diseases, affecting 6.8 million children nationwide. The highest rates of morbidity and mortality associated with the disease occur among those living in the inner city.

Impact of a household environmental intervention delivered by lay health workers on asthma symptom control in urban, disadvantaged children with asthma.

Objectives: We examined whether a home-based educational and environmental intervention delivered by lay health educators would improve asthma symptom control in inner-city children with asthma.

Methods: Children 2 to 16 years of age with diagnosed asthma and at least 1 asthma-related hospitalization or 2 emergency visits in the prior year were randomly assigned into 2 groups (immediate and delayed intervention) in a crossover study. Each group participated in the active phase (intervention) and the inactive phase.