By Deborah Borfitz 

February 26, 2020 | At Merck, the job of ensuring patient information about medicines and diseases is easy to understand falls to the one-person team of Global Health Literacy Director Laurie Myers, MBA, and she’s adamant that best practices in the field need to be shared. “Patients have the right to understand information to make informed and empowered decisions,” she said during her plenary keynote at the 11th Annual Summit for Clinical Ops Executives (SCOPE) last week in Orlando.     

Health literacy is “not just about reading,” Myers says, “but how individuals sift through information on the web and how to present data in a way that’s meaningful to patients.” It’s a stronger predictor of health than demographic characteristics such as age, race, education level, and socioeconomic status—although these can put certain individuals at higher risk of having low health literacy. 

Everyone, including the highly educated, are affected by health literacy, she says. As defined by the Patient Protection and Affordable Care Act of 2010, Title V, health literacy is “the degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make appropriate health decisions.” 

Patients newly diagnosed with cancer hear nothing in their shock and “we need to acknowledge this,” says Myers. “We need to practice clear communication and use familiar concepts, words, images and numbers. 

Clinical research can be particularly confusing, she adds, but health literacy principles can improve understanding and safety and support trial integrity. “Communicating about research in a health-literate way is not about doing something else or having to do something more but thinking differently about what you’re already doing.” 

Informed consent documents may be unwittingly littered with jargon, Myers says. Among her long list of not-so-obvious examples are antibiotic treatment, clinical research study, risks, evaluate, eligible, drug, IV, lifestyle, bacteria, control and annual—“words we use all the time but are meaningless [to many people].” 

Health Literacy Media has been a trusted partner in the adoption of evidence-based best practices, she says. The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard has also launched a Health Literacy in Clinical Research website with a wealth of tips and resources. 

People 65 and older don’t necessarily relate to the term “elderly,” for example, and people who opt into studies are best referred to as “participants” (suggestive of making an active choice) rather than “subjects” (impersonal) or “patients” (not all-encompassing), Myers says.  

Everyone prefers health-literate material, she continues. That means informed consent documents that plainly state what is being asked and that participation is a choice and opting for headers like “Who Can Join?” in lieu of “Inclusion/Exclusion Criteria.” The teach-back method can also help improve comprehension. 

“Learn from failure,” suggests Myers, pointing to the brochure photo for a breast cancer study that excluded African Americans. Having people in the photo that look like them would have signified the value of their participation.   

Since labeling is what drives communication with patients about medicines, Myers suggests the wording (as well as packaging) be reviewed with potential users at churches, senior facilities, and literacy centers.  

Being less detailed and focusing on the most important information can reduce the risk of litigation rather than create legal problems, she stresses. “I bring our lawyers into planning meetings [for informed consent] from day one. They want to apply health literacy best practices… and we have senior leader buy-in.”