From Syllables to Readability, Preparing for Lay Summaries

Translating medical documents is often the right thing to do from an ethics perspective. In addition, successful outcomes to medical treatment are strongly influenced by linguistic and cultural access to care. Further, the translation of clinical and regulatory documents during the drug approval process is required and regulated by agencies around the globe.

However, medical concepts and language can be difficult to grasp. Patients and subjects should have access to easily understandable health information regardless of age, background or reading level, a concept that is addressed and formalized in the European Medicines Agency (EMA) Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

Summary of Clinical Trial Results for Laypersons

The new regulation, which recently was postponed from a 2018 roll-out to 2019, requires a Lay Summary. The goal of the document is to increase the transparency of clinical trial data. Translation into all European languages will be required. There is a guideline document, which includes several strict requirements (e.g. readability tests including syllable count, sentence length, etc.). Below is an overview of the guidelines and requirements for drafting summaries of clinical trial results for laypersons, which are published here. It also includes examples of readability tests by country.

  • Keep the document as short as possible. Don’t copy text from the technical summary, but rather rewrite it. Note: Explaining technical terms in simple language and translation to 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. The average proficiency level in Europe is 2 -3. According to “Summaries of Clinical Trial Results for
    Laypersons” 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.
  • Avoid long and complex sentences.  that include many clauses. These can be difficult to understand.
  • 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”.
  • Be consistent in the use of terms and words throughout the document, and then define them.
  • Ensure that the underlying concepts are clear and easy to understand. Where necessary, explain the underlying concept in further detail.
  • Avoid ambiguous words and phrases. For example, “felt badly” can be subjective and have different meanings from one person to another.
  • Use active, rather than passive, voice. The Summaries of Clinical Trial Results for
    Laypersons” gives this example:

Active voice: “Researchers studied the effect of tamoxifen on breast cancer.”

Passive voice: “The effect of tamoxifen on breast cancer was studied by researchers.”

Production of Summary of Clinical Trial Results for Laypersons

To address the forthcoming requirements and ensure quality, Welocalize Life Sciences has designed a workflow for the translation and validation of Lay Summaries, which includes creation of pre-production project-specific instructions and an internal quality assurance step.

Contact Welocalize Life Sciences for information on translation of summaries of clinical trial results for laypersons and other patient-facing medical and clinical documents.