Informing the uninformed: optimizing the consent message using a fractional factorial design
Alan R Tait1, Terri Voepel-Lewis, Vijayan N Nair
1Department of Anesthesiology, University of Michigan, Ann Arbor, MI 48109, USA. atait@umich.edu
JAMA Pediatrics
|May 24, 2013
Summary
Improving research communication is vital for informed consent. Clearer consent documents with graphics and simpler language significantly enhance parental understanding of study details and risks.
Area of Science:
- Medical research communication
- Informed consent processes
- Patient and family education
Background:
- Many parents and research subjects struggle to understand complex research information, hindering informed decision-making.
- Effective communication is crucial for promoting comprehension in research settings.
Purpose of the Study:
- To evaluate how different communication strategies impact parental understanding of research information.
- To identify optimal methods for presenting research trial details to parents.
Main Methods:
- An observational study utilizing a fractional factorial design was conducted over two years.
- Six hundred forty parents of children undergoing elective surgery were randomized to receive information via consent documents employing varied communication strategies.
- Parental comprehension of study elements, risks, and benefits was assessed through interviews.
Main Results:
- Communication strategies including document processability, readability (eighth-grade level), and graphical displays significantly improved both gist and verbatim understanding.
- Specifically, documents with high processability, simpler reading levels, and graphics led to substantially greater comprehension compared to those lacking these features.
- Main effects on understanding were observed for processability, readability, message length, graphics, and verbal discussion.
Conclusions:
- Several combinations of communication strategies were identified that effectively enhance parents' understanding of research information.
- Implementing these strategies offers a practical and cost-effective method to optimize consent messages.
- Adoption by researchers, clinicians, and review boards can improve participant understanding and the overall informed consent process.
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