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Improving Health Literacy to Transform Clinical Trials

The healthcare industry struggles with resolving fundamental patient communication challenges. Approximately 50% of adults cannot read at a high school level and 88% of adults are not proficient in health literacy.1 Health literacy is defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.’’2 As a result, more than 80% of health information provided in the doctor’s office is forgotten before patients or their parents get home, and more than 50% of the recalled information is remembered incorrectly.3

Paucity of knowledge, misunderstandings and forgotten information have led to poor healthcare outcomes and the erosion of patients’ trust in medicine. Traditional approaches to medical education clearly have not worked. A fresh approach is required, both to improve health outcomes and curb costs from poor communications resulting in reduced patient recruitment and retention, and avoidable delays. Within clinical trials alone, the numbers are staggering: every day that a trial is delayed, due to slower than expected patient recruitment or other issues, costs an additional $600,000 to $8 million.4

There is a global need to develop culturally sensitive, relatable medical education resources for patients, caregivers, and their families. This article will discuss successful strategies that have been employed to improve patient recruitment and retention in clinical trials.

Low patient recruitment and retention rates pose considerable challenges to the success of clinical studies and advancing medical science and healthcare practices. Worldwide, 90% of studies fail to enrol the target number of participants within the proposed time.5 Slow recruitment can prolong the enrollment period, inflate costs, and possibly result in early trial termination. A 2013 analysis of listings posted on found that 12% of studies were terminated early, and 57% of those studies were ended prematurely due to insufficient patient enrollment.6 Dropout rates can reach 30% or higher in some studies, which may lead to biased results and impact the validity of the study findings.7 Enrolling minorities can also be a challenge, and patients with minority racial/ethnic backgrounds are considerably underrepresented in clinical studies.8,9

Poor health literacy is a significant part of the problem in recruiting and retaining participants for clinical studies. Nearly half of Americans have limited health literacy10 and as a result are less informed about how to manage their condition, have poorer health, and are less likely to be involved in health promotion and disease prevention.11,12,13 Exacerbating this issue, healthcare materials are often written at the tenth-grade level or higher, and yet the average reading level of U.S. adults is eighth-grade.12,13,14 Furthermore, even people who are highly health literate may have difficulty understanding health information presented to them while they are feeling stressed or anxious.

Providing Accessible Educational Materials

A lack of understanding of their health condition and of how participating in a clinical study could benefit them presents a significant hurdle to recruiting and retaining patients in clinical studies. One proven strategy to address this issue is to provide accessible patient educational materials at appropriate reading levels throughout the clinical trial process.15,16,17,18,19 With access to clear information, patients can better understand their health, its management, and the benefits and risks of joining a clinical study.

Engaging patients with educational materials that are clear, easy to comprehend, and age-appropriate equips them with the tools they need to make an educated choice about how to best manage their health.12,20,21,22,23

Supporting Informed Consent

Some patient materials, such as the Informed Consent document, can be particularly difficult to understand. The Informed Consent Form is not only a legal document confirming that the patient agrees to participate in the clinical study, but it also serves as a tool to educate them about the study purpose, procedures, and risks and benefits, thereby making an educated choice about whether participating in the study is right for them. Unfortunately, in many cases the Informed Consent document is too long and uses medical jargon, making it challenging for non-experts to read and understand, further reducing the number of people that can absorb and process the information.