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Health Literacy in Clinical Trials Can Impact Primary Endpoints

August 17, 2016
Posted by: Jamie Zacher, PharmD

Health literacy is especially important in clinical trials. Any misunderstanding of information by patients may lead to medication errors, failure to follow protocol instructions, lower compliance rates, and poor outcomes for the study. An estimated 90 million American adults have poor health literacy and struggle with reading, understanding, and using the health information presented to them (1).

Upon hearing the word “literacy,” most people only think of its definition: the ability to read. Health literacy, however, also encompasses a number of other factors. Health literacy is defined as “the degree to which individuals have the capacity to obtain, process, and understand the basic health information and services needed to make appropriate health decisions.” (2) Health literacy not only includes the ability to read health information, but also the ability to listen to oral directions and information, to talk about health information presented, and to clearly understand all the information provided.

There are a number of ways to improve health literacy for patients participating in clinical trials. To begin, patients in clinical trials must fully understand the informed consent form (ICF) before participating in a study. Results from the 2003 National Assessment of Health Literacy conducted by the U.S. Department of Education show that only 12% of American adults have proficient health literacy and that one-third of adults have basic to below basic health literacy skills (3). This means that, for the majority of Americans, written information in an ICF needs to be clear and easy to understand, preferably at a fifth-grade reading level or below. Also, for non-native English speakers, the ICF should be written in their native language to ensure patients understands what they are reading.

Next, study personnel should review the ICF, all study documents, the directions for use of the study medication or devices, and the protocol instructions with patients in their preferred language. An important part of health literacy is that the patient understands all of the information they learned at the site so that they can apply this knowledge correctly after they return home. Moreover, conversations should be two way between the patient and study personnel to confirm the understanding of all information presented.

Finally, pharmacists, who are experts in medication counseling and deploying their expertise in the clinical research setting, can further enhance patient understanding of study requirements and proper use of study medication. Studies have shown that patients immediately forget 40 to 80 percent of the medical information they receive, and of the information retained, nearly half is incorrect (4). The teach-back method is one way that pharmacists can confirm that a patient has retained all of the information presented (5). In this method, the pharmacist poses open-ended questions to ascertain what information the patient retained about the study medication after leaving the clinical site. The pharmacist then corrects any misinformation about the use of the study medication and has the patient repeat back what they just learned. By using the teach-back method, pharmacists are able to increase patient confidence and compliance because they are both educating patients and confirming that the patients clearly understand the information presented.

By presenting easy-to-read information and involving a variety of health care professionals, health literacy of patients participating in clinical trials can be improved, leading to an increase in medication compliance and enhance study outcomes.


1. Nielsen-Bohlman, L.N., et al. Health literacy: a prescription to end confusion. National Academies Press, Washington, DC; 2004
2. Nielsen-Bohlman, L.N., et al. Health literacy: a prescription to end confusion. National Academies Press, Washington, DC; 2004
3. Kunter, M., et al. The health literacy of American adults. Results from the 2003 National assessment of adult literacy. U.S. Department of Education NCES 2006-483; Sep 2006.
4. Dewalt, D.A., et al. Health literacy universal precautions toolkit. U.S. Department of Health and Human Services. ARHQ Publication No. 10-0046-EF; Apr 2010.
5. Dewalt, D.A., et al. Health literacy universal precautions toolkit. U.S. Department of Health and Human Services. ARHQ Publication No. 10-0046-EF; Apr 2010.

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