Six Tips for Developing a Plain Language Summary

Accessibility has increasingly become a key topic for communicating clinical trial results to a broader audience. This movement has added importance to the role of developing plain language summaries to communicate clinical trial results and scientific information in a patient-centric way.

Designed for a lay audience, a plain language summary (PLS) is an overview of clinical trial results that uses language that’s easily understood without scientific or medical knowledge.1

Evidence has supported using a PLS for efficiently communicating research to broader lay audiences and shows that it can improve understanding of research results2. Further underscoring the importance, a PLS is now a mandatory requirement by the European Union Clinical Trials Regulation for all clinical trials3.

PLSs are extremely valuable for many audiences, including:

  • People with a medical condition who are looking to further their understanding of their condition
  • Caregivers, family, and friends of a person with a medical condition
  • Students, allied healthcare providers (HCPs), medical residents, and others new to the field
  • Medical professionals working in interdisciplinary care and research
  • Readers without fluent proficiency in the language used to publish information about the trial
  • Readers with low literacy or low health knowledge


Six Tips for Developing a Plain Language Summary


PLSs are an important aspect of communicating findings and furthering the reach and impact of these findings.

Therefore, it’s pivotal to develop them effectively. In this article, we outline 6 key tips to keep in mind when creating a PLS to get the most out of your clinical trial results.


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1. Break it down

Packaging clinical trial results into a well-understood PLS begins with breaking the study down into smaller, digestible pieces or ‘chunks’. Identify and separate each aspect of the study, including the purpose, findings, and overall impact. This will help readers understand the 'who, what, where, when, and why', which is key to understanding the study.

To make the PLS even more digestible, use headings and subheadings to label paragraphs. This helps readers quickly navigate through study results and grasp added context and other important information. Use bulleted lists and adequate white space to make the PLS even easier to read.

2. Clear and concise language

Language often used in clinical trial results can be technical and not easily understood by audiences outside the field. Using clear, concise language is key to avoid confusion and provide important information about the study.

To achieve clear and concise writing:

  • Write in the active voice
  • Split up run-on sentences
  • Avoid complex words and phrases
  • Avoid unnecessary adverbs or adjectives

It’s also important to keep in mind the overall length of the PLS. Ideally, keep the summary to a few paragraphs. Using these tips to achieve clear and concise language will help you cut down on the details and focus on the most important information.


3. Don't assume prior knowledge

To create an effective PLS, it's important to remember the audiences you're writing it for. A PLS is meant for audiences with little or no knowledge of the field or topic, such as someone newly diagnosed with a medical condition, caregivers, students, or those involved in interdisciplinary research.

This is why it’s important to break down complex concepts and ideas and explain them at a basic level. It helps the reader quickly gain a higher-level understanding of the study without becoming overwhelming.


4. Define complex terms and avoid jargon

When writing in plain language, it’s important to avoid jargon. The choice of words plays a pivotal role in the PLS's readability, meaning how well it’s understood—see, we just defined language-related jargon!

A general audience may not know certain technical terms or acronyms used in the study, making it difficult to follow along.

To avoid confusion, clearly define terms to ensure the reader is informed and has the knowledge to understand the findings. Think about using a small glossary of key terms and always spell out acronyms, especially the first time they’re used in the PLS.


5. Maintain scientific accuracy

It’s important to keep a PLS short and concise, but it shouldn't compromise scientific accuracy.

While it’s easy to get caught in a trap of over-simplifying information, a PLS should still contain the key scientific findings from the study. If the PLS is easy to read, but the key findings from

the study aren’t included, the reader won't have a complete picture of the trial's purpose, findings, and results. This makes it difficult to fully understand what it’s about and what the results mean.


6. Put your PLS to the test

Once you’re done writing a PLS, ask someone to read it and provide feedback. Ideally, this should be someone without any knowledge of the subject. If the PLS is written effectively, they should find it engaging, easy to understand, and see the potential impact of the research.

If your PLS passes this test, it's a good sign that others outside the field will also find it useful!


The increasing importance of plain language summaries

Creating a concise, easy-to-understand, and scientifically accurate PLS should always be a priority when presenting clinical trial results. As you can tell, there’s a high potential for impact of the study results when they’re accessible to a wider audience.

PLSs continue to grow in demand and importance. Patients and caregivers continue to become increasingly involved in disease management and conversations with doctors and the pharmaceutical industry. Plain language summaries are expected to play an important role in future clinical trials to improve reach, transparency, and overall impact.

Please reach out if you want to chat more with us about plain language summaries and communicating trial results to wider audiences.


References

1. Dawn Lobban, Jason Gardner & Robert Matheis (2022). Plain language summaries of publications of company-sponsored medical research: what key questions do we need to address?, Current Medical Research and Opinion, 38:2, 189-200, DOI: 10.1080/03007995.2021.1997221

2. Bredbenner, K., & Simon, S. M. (2019). Video abstracts and plain language summaries are more effective than graphical abstracts and published abstracts. PloS one, 14(11), e0224697. https://doi.org/10.1371/journal.pone.0224697

3. THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance) 2014. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014R0536


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