BACKGROUND: Little is known about specific psychological factors that affect parents' decisions to take part in clinical studies. We examined factors, related to health-related quality of life (HRQoL), that may influence parents' decision to allow their children to participate in research on clinical food allergy.
METHODS: Parents of children with food allergies were offered investigational oral immunotherapy (OIT) in a regular outpatient clinic. Forty parents (group A) declined, and 25 parents (group B) agreed to take part. Both groups agreed to complete the Food Allergy Quality of Life Parent Form and the Food Allergy Independent Measure.
RESULTS: Children were aged between 1 and 12 years (mean: 6.5 years). Groups A and B displayed a similar and typical distribution for gender, age, number of foods, severity and number of symptoms, and socioeconomic variables. Parents who chose to enroll their children in the OIT trial reported a similar impact of food allergy on the HRQoL of their children as parents of children who did not volunteer for the study. Participating parents perceived a significantly higher likelihood (odds ratio: 6.753) of their child having a severe reaction and dying if food is ingested. By using this model, the likelihood of taking part in immunotherapy could be predicted accurately in 90% of cases.
CONCLUSIONS: Parents who had higher anxiety about negative outcomes from accidental ingestion were more likely to consent to experimental therapy for their child. This finding has ethical implications for investigators and supports the need to create mechanisms to avoid unintended coercion in vulnerable groups. Pediatrics 2009; 124: e503-e509
- clinical trials
- health-related quality of life
- food allergy
- psychological predictors of participation
- parents and children
- ethical considerations