Document Detail

Parental perceptions of research after completion of placebo-controlled trials in pediatric gastroenterology.
MedLine Citation:
PMID:  20479689     Owner:  NLM     Status:  In-Process    
BACKGROUND AND OBJECTIVES: Investigators may have concerns that parents will not allow their children to participate in placebo-controlled trials (PCTs). The aim of the present study was to identify potential differences between parental perceptions in families who successfully completed (CO) a clinical trial compared with those who were noncompleters (NC).
PATIENTS AND METHODS: Parents of both CO and NC children enrolled in pediatric gastrointestinal studies performed in the previous year were eligible. NC were defined as those who were screen failures or treatment nonresponders or had adverse events. One hundred seven parents were identified and mailed a 26-item questionnaire eliciting perceptions regarding participation in research. Questionnaires were sent 6 months after participation in research ended.
RESULTS: Seventy-eight (69%) parents returned the survey. Characteristics included maternal responders (98%), English as primary language (97%), and education beyond high school (85%). Five parents (4.7%) had children involved in previous research trials. There were no significant differences in responses found between CO (n = 49; 63%) and NC (n = 29; 37%) in regard to importance of research, perceptions of risk to child, benefits to child, and more attention in the study. Statistical significance was approached in regard to the comfort with the research team, with a greater portion of CO stating that the researcher put the parent at ease and the NC feeling less positive about the interaction (P = 0.05).
CONCLUSIONS: A positive perception about participation in research is not stratified by successful completion of a PCT. These results should encourage investigators and institutional review boards that if properly designed and conducted, pediatric PCTs can result in a positive experience for parents.
Maria E Perez; Annette Langseder; Eric Lazar; Nader N Youssef
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of pediatric gastroenterology and nutrition     Volume:  51     ISSN:  1536-4801     ISO Abbreviation:  J. Pediatr. Gastroenterol. Nutr.     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8211545     Medline TA:  J Pediatr Gastroenterol Nutr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  309-13     Citation Subset:  IM    
Department of Pediatrics, Goryeb Children's Hospital, Atlantic Health System, Morristown, NJ, USA.
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