An Experimental Test of Medical Disclosure and Consent Documentation: Assessing Patient Comprehension, Self-Efficacy, and Uncertainty

Abstract

Effectively conveying risks and hazards in medical disclosure and informed consent documentation is a crucial type of communication. However, existing protocols typically do not meet the needs of patients or practitioners. In the present study, we advance a reconceptualization of obtaining written informed consent by analyzing it as a process of uncertainty management rather than a matter of document readability and recall. Results of this randomized trial indicated that patients who reviewed a simplified consent document reported greater comprehension of medico-legal terminology and lower uncertainty about the document, although they did not evince greater self-efficacy. Health literacy was a significant moderator of the relationship between consent form version and comprehension.

Keywords:

• Informed Consent
• Disclosure
• Uncertainty
• Health Literacy