Health literacy and informed consent for clinical trials: a systematic review and implications for nurses

Abstract

The informed consent process for consideration of clinical trials is a complex process that requires the understanding of the potential trial risk, benefits, and alternatives of treatment. The aim of this systematic review was to explore the available literature related to health literacy and the informed consent process for clinical trials. Articles were included if they focused on health literacy and patient comprehension of informed consent, had perceptions related to the informed consent process, or assessed the impact of health literacy on patients' willingness to participate in clinical trials. Eight articles were selected for this review. Limited health literacy was determined to be related to a lack of comprehension of clinical trial consent documents and heightened anxiety surrounding the informed consent process. Conflicting evidence exists around the relationship between health literacy and clinical trial enrollment. Limited health literacy levels may impact the ability for nurses to have effective informed consent processes. Health literacy refers to the ability to comprehend, as well as the ability to obtain, critically evaluate, and integrate health-related information. 1 A patient's health literacy level is an important element of high-quality care that can impact decisions and actions of patients and providers. Educational background is not always pre-dictive of health literacy levels; as an individual's health literacy level may be lower than his or her general literacy, meaning that even highly educated adults may have limited health literacy. 2 An estimated 20-36% of all adults in the United States have limited health literacy. 1,3 Limited health literacy is associated with disadvantages in health care including access to information, capacity to process and understand information, and adverse health outcomes. 4 Adult patients with limited health literacy levels are at greater risk for limited comprehension in the health care setting, leading to stigma and a lack of engagement in shared decision-making. 5,6 When patients are faced with a serious diagnosis with multiple treatment options they may take longer to understand information presented to them due to increased emotional stress. 7 Limited health literacy levels can compound this stress, adding to the difficulty of comprehension of the extent of their illness as well as the available treatment options. Clinical trials are becoming increasingly more common as treatment options for patients with serious illnesses, but the research process is often unfamiliar to patients. 8 Components of the research process that may lead to confusion include voluntary participation, freedom to withdraw, availability of alternative treatments, randomization, unclear survival benefits, unclear risk of adverse events, and the