Easy-to-Understand Clinical Trial Lay Summaries

welocalize February 2, 2021

Medical concepts and language can be complex. Patients need easily understandable health information that is inclusive of all ages, backgrounds and reading levels. Lay summaries are a requirement of the new EMA Regulation (EU) No 536/2014. Welocalize has compiled several tools and recommendations to assist CROs and medical writers with health literacy for patient comprehension, in accordance with the new regulation.

Easy-to-Understand Clinical Trial Lay Summaries

The following information as to how to create easy-to-understand clinical trial summaries is based on Welocalize’s over 20 years of experience preparing patient-facing material, and input from the EU’s Summaries of Clinical Trial Results for LaypersonsU.S. Centers for Disease Control, the Fernandez-Huerta Formula, and the World Health Organization.

  • Reduce technical jargon. Don’t copy text from the technical summary. Instead, rewrite it and explain technical terms in simple language. Note: translation into some languages may increase the number of words and result in longer documents.
  • Text should be understood by people with a low to average level of literacy. According to “Summaries of Clinical Trial Results for Laypersons,” the average proficiency level in Europe is 2 -3. A proficiency level of 2 is defined as being able to identify words and numbers in a context and being able to respond with simple information. In the U.S., most health agencies recommend material written for an audience no higher than 6th grade reading level.
  • Avoid long and complex sentences,  that include many clauses. These can be difficult to understand.
  • Consider font style. Choose fonts that are easy to read. Avoid fancy scripts and all-caps. Limit your use of italics and underlined words, however do use bold-faced font to call attention to critical terms.

Localization Tip: Font selection and usage. Font style also matters when translating your materials. Welocalize recommends choosing fonts that cover a wide variety of writing systems when designing source file content. Fonts that support Unicode characters are best, also staying away from very complex, artistic fonts as these font styles typically do not support special characters.

  • Use vocabulary that will be familiar to non-medical persons. Avoid jargon, technical or medical language. For example, use the phrase “high blood pressure” rather than the medical term “hypertension.”
  • Reduce the number of unnecessary words. And, remove what could be considered complex words. For example, “use” rather than “utilize.”
  • Consistent and specific. Be consistent in the use of terms and words throughout the document, and then define them. In addition, avoid ambiguous words and phrases. For example, “felt badly” can be subjective and have different meanings from one person to another.
  • Use images and symbols. Visuals can improve your communication materials when used correctly. Pictures help grab an audience’s attention and help tell a story. The CDC provides several examples of how (and how not) to incorporate symbols and images. It also points out that many symbols are not universally understood. It also recommends testing visuals to ensure they are appropriate for the intended audience. Access the CDC library for a variety of images related to public health.
  • Test for readability. There are several readability tools writers can use to determine a document’s readability (how easy it is to read). For English text, using Microsoft Word, you can test the readability by using the Flesch Reading Ease Test or the Flesch-Kincaid Grade Level Test based on counting syllables and sentence length. This can be helpful in multi-country studies where summaries are first drafted in English and then translated into other languages. The Flesch Reading Ease Test assesses readability on a scale from 1 to 100. Anything that scores 70 and above is easy to read.

Lay Summary Translations

The new regulation requires a lay summary translated into all European languages. Welocalize has designed the following workflow for the translation and validation of lay summaries:

Pre-production: 

  • Conduct translatability check (revision of the master file to detect potentially tricky or ambiguous passages)
  • Create project-specific instructions (based on translatability check and client requirements)
  • Select linguist team (experienced in clinical research, specifically patient-facing documents)

Production:

  • Translate and edit lay summary
  • Final read of the translated lay summary by a native speaker without medical background to assess comprehension
  • Final internal quality control

We’re Here to Help

The impending EU Clinical Trials Regulation (Regulation EU No 536/2014) is set to make significant changes to the way clinical trial applications are managed in Europe once implemented later this year. For more information on how Welocalize can assist with your company’s readiness, including medical writing and translation services, please contact us.

To find out more about the new regulation, read this article published by Clinical Trials Arena highlighting ‘EU Clinical Trial Regulations: The Long Path to Implementation.’