ASSESSING PEDIATRIC QUALITY OF LIFE IN A CLINICAL TRIAL

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The Childhood Asthma Management Program (CAMP), a NHLBI-funded multi- center clinical trial, provides comprehensive asthma treatment to a large and ethnically diverse sample of children (ages 5-12). The trial was designed to determine the long-term effects of 3 treatments (two classes of anti-inflammatory agents and placebo) on such natural history outcome measures as lung function, bronchial hyperresponsiveness, asthma morbidity, physical growth and development, and psychosocial growth and development (i.e., quality of life). The recently developed Pediatric Quality of Life Questionnaire is a disease-specific measure assessing quality of life in children with asthma. The following proposal will examine the relationship between a general multidimensional approach to quality of life measurement and a disease-specific approach to measuring quality of life in asthmatic children. The following proposal is seeking funding to complete a project that would provide invaluable information to researchers working in the area of childhood asthma at very little cost. This proposal represents a major increase in the important scientific aims evaluated by CAMP and by other studies of quality of life in the pediatric population. The two different methods of assessing quality of life will be examined by administering the PQLQ to asthmatic children and parents at the 12-month follow-up visit at 5 of the CAMP centers (N=120 subjects per center). The PQLQ administration will occur in conjunction with the administration of the current CAMP quality of life questionnaire battery and other clinical information obtained at each visit (e.g., sociodemographic information and asthma severity ratings), allowing the investigators to examine disease-specific quality of life in the context of the multidimensional measures currently employed in CAMP. Discriminant function analyses will be employed in the data analysis, as an overriding objective of this study is to discern clinically meaningful relationships between the disease-specific quality of life measure and the CAMP measures of quality of life.