title: Using digital multimedia to improve parents' and children's understanding of clinical trials.
abstract: OBJECTIVE
  Data show that many research subjects have difficulty understanding study information using traditional paper consent documents. This study, therefore, was designed to evaluate the effect of an interactive multimedia program on improving parents' and children's understanding of clinical trial concepts and participation.
  
  
  METHODS
  Parents (n=148) and children (n=135) were each randomised to receive information regarding clinical trials using either a traditional paper format (TF) or an interactive iPad program (IP) with inline exercises. Participants' understanding of the information was assessed using semistructured interviews prior to (pretest) and after (post-test) receiving the information. Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process.
  
  
  RESULTS
  Regardless of the mode of information delivery, all participants demonstrated improved pretest to post-test understanding. While there were no statistical differences in parents' post-test understanding between the TF and IP groups, children in the IP group had significantly greater post-test understanding compared with children in the TF group (11.65 (4.1) vs 8.85 (4.1) (2.8, 1.4, 4.2) 0-18 scale where 18=complete understanding). Furthermore, the IP was found to be significantly 'easier to follow' and 'more effective' in presenting information compared with the TF.
  
  
  CONCLUSIONS
  Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children. Importantly, the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery, particularly among children, supports this approach as a novel and effective vehicle for enhancing the informed consent process.
authors.affiliation: Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA Center for Bioethics and Social Sciences in Medicine, University of Michigan.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Tait
authors.affiliation: Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA.
authors.forename: Terri
authors.initials: T
authors.lastname: Voepel-Lewis
authors.affiliation: Emergency Care Center, Jackson Memorial Hospital, Miami, Florida, USA ArchieMD, Inc., Boca Raton, Florida, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Levine
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002986:Clinical Trials as Topic; D032882:Comprehension; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D008297:Male; D019212:Multimedia; D010290:Parents; D010353:Patient Education as Topic / Q000379:methods*
keywords: Ethics; Information Technology; Medical Education
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