Sources of patient uncertainty when reviewing medical disclosure and consent documentation.

Objectives: Despite evidence that medical disclosure and consent forms are ineffective at communicating the risks and hazards of treatment and diagnostic procedures, little is known about exactly why they are difficult for patients to understand. The objective of this research was to examine what features of the forms increase people's uncertainty.

Methods: Interviews were conducted with 254 individuals.

Health literacy, self-efficacy, and patients' assessment of medical disclosure and consent documentation.

Informed consent documents are designed to convey the risks of medical procedures to patients, yet they are often difficult to understand; this is especially true for individuals with limited health literacy. An important opportunity for advancing knowledge about health literacy and informed consent involves examining the theoretical pathways that help to explain how health literacy relates to information processing when patients read consent forms. In this study, we proposed and tested a model that positioned self-efficacy as a mediator of the association between health literacy and patients' comprehension and assessment of informed consent documentation.