by Sylvia Baedorf Kassis, MPH
Early in the ongoing coronavirus pandemic, my 7-year-old was terrified when my husband, a critical care doctor, notified us that his COVID test was negative. Believing that a negative result meant bad news, my son feared Dad would be hospitalized with the illness. While on the flipside, a positive test would have meant good news and that Dad didn’t have COVID.
For me, this misunderstanding in our household was just more proof that you can never assume what anyone, regardless of age or environment, already knows or understands about a topic. Attention to health literacy and use of plain language are both critical to understanding.
Plain Language in Clinical Research
Recently, there has been renewed interest in plain language and applying it in the clinical research context. The Plain Writing Act of 2010 requires federal agencies to create clear communications that the public can understand. Plus, diversity efforts work to increase representation in research, and plain language can support inclusion. Also, the European Union mandates that study sponsors provide plain language end-of-study summaries to participants in research studies. As a result, clear communication techniques must be considered in the creation of all public-facing messages throughout the lifecycle of a research study.
Tips for Integrating Plain Language Into Clinical Research Communications
How can plain language be integrated into clinical research communications when scientific and medical concepts can be so technical and complicated to explain? These 3 tips can help you get started.Tip 1: Explain any medical, research, or legal concepts and phrases that absolutely must be included in a communication.
Using plain language does not mean removing all technical terms. But documents should be reviewed critically so that only essential technical language remains.
Once you are certain a specific term is necessary, share additional information within the document itself or in a separate resource that defines the complex concept in a clear and understandable way. For instance:
- Use visuals and word/picture pairings to help explain a concept.
- Explain a concept using a few short, simple sentences.
- Use analogies as examples to show how a concept works.
Here’s an example of a plain language clinical research definition of the word “phase” from the Clinical Research Glossary, which was recently piloted by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.
Tip 2: Consider how specific words might be interpreted by people who are not as familiar with the research topic.
There are many opportunities for misunderstanding, like the one I noted above about my son. For example, the word “negative” can be misinterpreted to mean sick instead of healthy. Likewise, the word “trial” can be misinterpreted as a legal proceeding instead of a research study. Thus, it’s important to help people navigate new and unfamiliar information.
To this end, you might want to include an explanation. For instance: “A negative COVID test result means the patient does not have the virus.” This takes up more space on the page, but the meaning is clearer.
Tip 3: Organize information in chunks to help with understanding and retention.
Prioritize key information and present it in the most logical order. Let’s say a study involves an initial screening to find out if someone meets the criteria to participate. You might start with that detail first. (“To find out if you are able to join the study, we will first do some screening tests. The screening includes answering some questions and taking some blood.”) You can then share the rest of the study procedures.
Using the Clinical Research Glossary
If you’re involved in the creation of participant-facing research materials, consider using the Clinical Research Glossary mentioned above. This resource was co-developed with patients and patient advocates. Here are 3 ways to integrate the glossary into your clinical research efforts.
Method 1: Use the glossary to raise awareness of plain language in clinical research.
For example, at my organization—which is part of the Mass General Brigham hospital system in Boston—the glossary was advertised to various hospitals and community health centers throughout the month of October for Health Literacy Month. This helped patients and staff see plain language research information as part of a normal clinical care experience.
Method 2: Use the glossary to conduct targeted participant outreach and recruitment activities.
For example, include the link to the glossary (or specific words) in a study recruitment communication or a consent form packet.
Method 3: Use the glossary to draft participant-facing clinical research communications.
For example, use the glossary’s plain language definitions and supporting information to replace or explain words and concepts in your public-facing research materials. Whenever possible, user-test the content with people who represent your intended audience, and implement any changes they suggest.
To Learn More About Health Literacy in Clinical Research
You can learn more about health literacy in clinical research here.
Attention to health literacy and the use of plain language can help everyone better understand science and medicine—whether they’re 7 or 70 years old.
About the Author
Sylvia Baedorf Kassis, MPH has over twenty years of clinical research experience in Canada and the USA, including research management, ethics board review, and workforce capacity building. Since 2018 she has led a Health Literacy in Clinical Research initiative at the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard in Boston. Sylvia is passionate about engaging with participants and creating resources that support positive clinical research experiences. .