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Using digital multimedia to improve parents’ and children's understanding of clinical trials
  1. Alan R Tait1,2,
  2. Terri Voepel-Lewis1,
  3. Robert Levine3,4
  1. 1Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan, USA
  2. 2Center for Bioethics and Social Sciences in Medicine, University of Michigan
  3. 3Emergency Care Center, Jackson Memorial Hospital, Miami, Florida, USA
  4. 4ArchieMD, Inc., Boca Raton, Florida, USA
  1. Correspondence to Dr Alan R Tait, Department of Anesthesiology, University of Michigan Health System, 1500 E. Medical Center Drive, Ann Arbor, MI 48109, USA; atait{at}


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.

  • Information Technology
  • Medical Education
  • Ethics

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