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. A convenience sample of 15 participants (71% females, 87% white and mean (SD) age 45 (13) years was recruited to obtain feedback in order to revise the Adult/Adolescent VRC. Based on the feedback received, the following were slightly revised: ruler for the measurements of local systemic reactions, severity ratings, and general instructions. The revised VRC is currently being used in Merck vaccine clinical trials.

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. Because asthma is a complex disease affected by physiological, social, environmental, and behavioral factors, interventions to reduce its morbidity burden need to address multiple determinants of health. In response to this need, the Centers for Disease Control and Prevention developed a multisite cooperative agreement for the Controlling Asthma in American Cities Project (CAAC), with the primary goal of developing innovative, effective community-based interventions. All CAAC sites found a need for family and home asthma services (FHAS) and developed multicomponent (e.g., asthma self-management, social services, coordinated care) and multitrigger environmental interventions. This paper presents a synthesis of key program variables and process indicators for six CAAC FHAS interventions for consideration by communities, coalitions, or programs planning to implement similar activities.

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. Outcomes included asthma symptoms, albuterol use, emergency department visits, hospitalizations, and trigger reduction. RESULTS: A total of 264 primarily Black (94%) children were enrolled. The mean number of emergency visits decreased by 30% and inpatient visits decreased by 53% (P < .001) after the intervention. Reductions were seen in pests, presence of carpets in bedrooms, and dust. Nighttime wheezing was significantly reduced after the intervention in both groups (P < .001). CONCLUSIONS: Lay health educators effectively reduced asthma triggers and increased caregiver asthma knowledge, which resulted in reduced emergency department visits, hospitalizations, and asthma symptoms. The relationships formed between the caregivers and the lay health educators appeared to positively impact asthma outcomes in this disadvantaged population.