Profiling families enrolled in food allergy immunotherapy studies.
Authors
DunnGalvin, AudreyChang, Wen Chin
Laubach, Susan
Steele, Pamela H
Dubois, Anthony E J
Burks, A Wesley
Hourihane, Jonathan O'B
Affiliation
Department of Pediatrics and Child Health, University College, Cork, Ireland. a.dunngalvin@ucc.ieIssue Date
2009-09MeSH
ChildChild, Preschool
Clinical Trials as Topic
Family
Female
Food Hypersensitivity
Humans
Immunotherapy
Infant
Male
Questionnaires
Metadata
Show full item recordCitation
Profiling families enrolled in food allergy immunotherapy studies. 2009, 124 (3):e503-9 PediatricsJournal
PediatricsDOI
10.1542/peds.2008-3642PubMed ID
19706573Abstract
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.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.
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.
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.
Item Type
ArticleLanguage
enISSN
1098-4275ae974a485f413a2113503eed53cd6c53
10.1542/peds.2008-3642
Scopus Count
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