Using Plain Language for Clinical Trial Content
According to the Institute of Medicine, there is a large disparity between the health information people receive and actually understand. Even those in the health care industry can become vulnerable to not comprehending health information. When experiencing poor health or worry and stress about an unfamiliar condition for themselves or a loved one, even medical experts can struggle with comprehension. The problem becomes more acute for those with limited literacy skills.
Using the principles of plain language fosters the creation of clear and understandable communication with the goal of increased comprehension and engagement for all literacy and educational levels. Many studies have shown that plain language improves the bottom line by saving time, personnel resources, and money. And you will give better service to your readers.
The U.S. government’s Plain Writing Act, which was enacted in 2010, requires federal agencies to communicate in a clear, straightforward, and concise manner. Many different government departments have plain language guidelines to foster compliance with the act, which are largely applicable and helpful for any type of medical communication.
The consensus of these guidelines is that in plain written documents, the audience can:
- Find what they need
- Understand what they find
- Act appropriately on that understanding
When writing content for clinical research materials, following the plain language helpful hints below will provide clear, direct, and understandable communications that are targeted to your audience. And, in clinical trials, the audience is diverse ranging from all age groups of patients, to health care providers. This form of writing is not intended to dumb down or oversimplify information. The goal is for the text to be compelling and vibrant as well as understood by the intended consumer. The following information is a concise list drawn from many sources regarding plain language writing:
- Think about the intended audience for each material, research and make notes while taking into consideration their current level of knowledge and demographics
- Note the purpose of the material(s) and the information the audience needs in each material
- Organize the information to have a logical flow
- Write for your reader
- Use headers and logical order
- State major points before going into detail and make sure the main message is at the beginning of the document
- Include only details needed for reader understanding
- Stick to one theme per paragraph and one idea per sentence (each sentence <20 words)
- Break the content up and organize with lists and tables
- Avoid acronyms and abbreviations or explain them the first time used (maybe more than once)
- Stick to everyday language as much as possible, be precise and concise
- If uncommon terms must be used, define and use them consistently; you may need to lead the audience to understanding with a comprehensive definition
- Use the most direct, strongest form of the verb possible, preferably in present tense
- Use “must” instead of “shall” for required items or to indicate an obligation
- Consider using contractions with discretion to improve readability
- Use an active voice – write the actions the reader should do and make sure they know who-does-what
- Use pronouns such as “you” so the materials feel relevant and draw the reader in; be sure to clearly define “you”
- Keep the subject, verb, and object close to each other
- Proofread your work with fresh eyes a few days after you finish, and ask a colleague to review and edit
- Check for visual appeal
- Ask target audience members to read it to make sure it is appealing and logical to that group
By following these principles, your clinical trial materials will make sense to the level of reader you are trying to reach and will convey your intended content in an understandable and usable way.
This blog was created to provide practical guidance and points to consider, but there’s no mistaking the fact that creating clinical trial content is a huge undertaking. In many cases, it makes sense to bring in an expert. Imperial has a vast amount of experience writing engaging and protocol compliant materials for study participants and professionals. Feel free to call on us to create content for recruitment and retention materials, professional referral and networking materials, and site tools.