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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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E-Patient Counseling Trial (E-PACO): Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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Development and pilot testing of a video-assisted informed consent process.

Susan C Sonne1, Jeannette O Andrews, Stephanie M Gentilin

  • 1Medical University of South Carolina, Charleston, SC 29425, USA. sonnesc@musc.edu

Contemporary Clinical Trials
|June 11, 2013
PubMed
Summary

Video clips can enhance research informed consent. This study found that while videos improved participant understanding and preference, comprehension levels were similar across video-assisted and paper formats.

Keywords:
Electronic formsInformed consent processTablet computingVideos

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Area of Science:

  • Clinical Research
  • Health Literacy
  • Informed Consent

Background:

  • Informed consent documents are often lengthy and difficult for participants to understand.
  • Innovations are needed to improve comprehension and ensure the research consent process is truly informed.

Purpose of the Study:

  • To develop and pilot test video clips to improve understanding of research procedures during the informed consent process.
  • To assess participant preference and comprehension between paper-based and video-assisted electronic consent formats.

Main Methods:

  • Developed 15 video clips explaining common research procedures/concepts based on expert and community input.
  • Embedded videos into mock-informed consent documents delivered via an online electronic consent system on iPads.
  • Assessed participant preference and comprehension using quizzes after exposure to either paper or video-assisted consent formats (n=61).

Main Results:

  • A significant majority of participants (78.7%) preferred the video-assisted format over paper (12.9%).
  • Nearly all participants (96.7%) reported improved understanding of procedures due to the videos.
  • No significant difference in material comprehension was found between the video-assisted and paper consent formats.

Conclusions:

  • Video clips show promise in making information about study procedures more accessible and understandable.
  • Further research is warranted to evaluate video consents for complex protocols and participants with lower literacy levels.