Health Literacy:
A Necessary Tool for Communicating the Science
of Clinical Trials

Catina O’Leary
President and CEO
Health Literacy Media

Andrew Pleasant
Senior Director for Health Literacy and Research
Canyon Ranch Institute

Deborah Collyar
Founder and President
Patient Advocates in Research (PAIR)


ealth literacy is a powerful concept that successfully communicates the complex design, methods, processes, and outcomes of clinical trials to assure the information is understandable, relevant, and useful.

Key health literacy concepts include the following:

  • Health literacy and plain language principles are based on related yet distinct ideas and approaches. The essential goal is to first “meet people where they are,” and then build up their knowledge and skills.
  • There is no step in the process of designing, conducting, and reporting a clinical trial that cannot be improved by introducing health literacy principles.
  • Science needs public engagement just as much as the public can benefit from a better understanding of scientific research.

Recent European Union (EU) regulations have drawn increased attention to the communication of scientific research, specifically clinical trials, around the world. Ethically, this is a welcome leap forward. Many wonder why this hasn’t always been the case. Clinical trial participants are foundational for study implementation and, like all key stakeholders, deserve to learn the outcomes of the studies in which they participate. In addition, clear and understandable information may also improve public support for science, create much-needed goodwill for sponsors of clinical trials and actually increase patient participation in the clinical trials themselves.

People with medical conditions rarely find opportunities that offer hope for a healthier life or to contribute to society. Many study participants live with complex health conditions that significantly impact their own quality of life and that of others. In addition to meeting new regulatory requirements, sharing research findings with participants creates an opportunity to thank them for their significant contribution and to share hope for current or future treatments.

On the surface, communication of clinical trial results seems simple: to provide a written summary in “lay language” of the ten elements, listed below as they appear in Regulation (EU) No 536/2014, Annex V.

  1. Clinical trial identification.
  2. Name and contact details of the sponsor.
  3. General information about the clinical trial.
  4. Population of subjects.
  5. Investigational medicinal product used.
  6. Description of adverse reactions and their frequency.
  7. Overall results of the clinical trial.
  8. Comments on the outcome of the clinical trial.
  9. Whether follow-up clinical trials are foreseen.
  10. Where additional information can be found.

This entry point has encouraged many to begin creating “plain language” summaries. Practically, however, the ability to communicate these elements – in a way that is understandable, relevant, and usable to the diverse audience of specific trial participants – in languages that reflect widely varying literacy skills is an incredibly complex task.

Health Literacy Is More Than Plain Language

Plain language provides a strategy for clearly communicating written and spoken material. Health literacy expands the concept beyond the complexity of words and sentences, to address the processes, relationships and experiences when individuals interact with health professionals, health organizations and systems; and the complexity of evidence-based information about medicine, health, and wellness.

Health literacy has evolved from an effort to simply introduce plain language to health, to its current definition as a social determinant of health – influenced not only by the skills of individuals but also by the competencies of health professionals and the complexity of health systems and health information.

Most frequently, the desired outcome of plain language is understanding, while the desired outcome of health literacy is an informed decision. Simply put, people can’t sustain their health without informed, healthy behaviors.

Despite the conceptual evolution in the understanding of health literacy, many organizations and individuals in the field continue to maintain a more narrow focus. It’s not uncommon, for instance, to see plain language principles used without consideration of the true meaning and power of a full health literacy approach. For example, “lay summary”—a still overused phrase––inherently devalues the importance of the audience’s role in extracting meaning and underestimates their expertise. An overly simplistic approach to health literacy also negates the global philosophy of the health literacy movement that values all stakeholders in the complex process of introducing science and society to each other.

A strict and outdated approach to plain language also adheres to some measure of reading grade level – for example, the use of the Flesch-Kincaid measure of reading difficulty with an arbitrary threshold, such as 5th grade level or lower. Meeting that goal can serve as a helpful mental exercise, but when writing about a clinical trial there are some words that must be included but inevitably fall above the 5th grade level, such as the name of the study drug.

An effective health literacy approach does not throw away all the complex ideas and words associated with a clinical trial. Instead, an effective health literacy approach to communicating the complex information inherent to clinical trials uses language to help readers build and connect concepts. The goal is to help them understand and use increasingly complex words and ideas. Plain language may introduce a complex concept, but that’s only the beginning. Health literacy embraces complexity in a way that helps all readers fully understand the complexity of both the practice and the language of clinical trials.

Here is a published example that illustrates how communication about antibiotics provides factually correct information from a large population study, but stops short of contextualizing the information in a health literate manner to make it usable for the public:

“Almost two thirds (64 percent) of approximately 10,000 people who were surveyed across 12 countries say they know antibiotic resistance is an issue that could affect them and their families, but how it affects them and what they can do to address it are [sic] not well understood. For example, 64 percent of respondents believe antibiotics can be used to treat colds and flu, despite the fact that antibiotics have no impact on viruses. Close to one third (32 percent) of people surveyed believe they should stop taking antibiotics when they feel better, rather than completing the prescribed course of treatment.”

A health literacy approach would offer recommendations to address this issue, including:

  1. Plain language edit of the published paragraph.
  2. Inclusion of additional need-to-know information to clarify when and how antibiotics should be used.
  3. Use of the data to inform need-to-know written content and preferred terms. For example, from these data we can glean that, perhaps, more important than the words bacteria or virus, readers need to know if the disease was infectious or not, and what behavioral steps to take. The vast misunderstanding of the roles and functions of bacteria and viruses desperately needs to be addressed, but a plain language summary of a clinical trial is not the place to do that.
  4. The complete health literacy approach can then be used in public facing materials, including clinical trial summaries.

With these points in mind, the published example can be re-written using our first health literacy principle above:

“A survey asked around 10,000 people about antibiotic resistance. Antibiotic resistance is when germs like bacteria aren’t affected by the drugs made to kill them. About two out of three people (64 percent) said they knew about the issue, but about the same number of people didn’t know how antibiotics work. They didn’t know antibiotics can’t treat colds or the flu, because they are caused by a virus, not by bacteria. About one out of three (32 percent) thought they should stop taking antibiotics when they feel better instead of finishing their prescription.”

We Don’t Need Simpler Words, We Need to Increase People’s Skills

Our goal in using a health literacy approach is to build understanding to explain complex ideas in understandable, relevant, and useful ways. Complexity in language exists because a large amount of meaning is often built into a single word or phrase.

For instance, genomics is a word – and an entire body of science – that is relatively recent. The Flesch-Kincaid measure of reading difficulty tells us that genomics is roughly at a 6th grade level or lower. Almost everyone should be able to read and understand it. However, while most adults may be able to read the word, few—including some health professionals—are likely to understand it. The complex information embedded into the word “genomics” takes ever-expanding volumes of words to fully explain.

If we turn to a dictionary, the definition of genomics is often akin to: “The branch of molecular biology concerned with the structure, function, evolution, and mapping of genomes.” This definition registers at a 12th grade reading level, doesn’t give the reader any context, and uses the unhelpful reference to a “genome” which very few people know. Other complex concepts in this definition that need to be explained include “branch of molecular biology,” “structure,” “function,” “evolution,” and “mapping.”

Instead, health literacy suggests that writers make definitions understandable, relevant, and usable without sacrificing scientific accuracy. This is a complex, yet entirely possible process.

Health Literacy and Clinical Trials

There is not a stage in the process of designing, conducting, and reporting a clinical trial that cannot be improved by introducing health literacy principles. This means planning, recruitment, informed consent, retention, reporting of results, evaluation of the process, and communication throughout the trial can all be improved by applying the best evidence-based practices of health literacy.

In the end, health literacy is not only focused on the simple communication of scientific concepts. Health literacy strongly suggests that professionals build the required connections with people to successfully communicate science, remembering that, by definition, communication is a two-way process. Doing so will increase the sustainability of the scientific enterprise within society. Without social support and participation, there will be no scientific research. Without scientific research, there will be no steady progress of human society. Health literacy is the pathway to making those connections real, vital, and sustainable.