Because a PLS needs to be comprehended by this target audience, it is written at a US 6th to 8th grade reading level.
In this article, we will discuss the key challenges that PLS writers face, how to overcome them, and tips for writing better lay summaries.
Balance accuracy and completeness
Health literacy principles dictate that PLS need to be concise but accurate. Because of this, a balance must be struck between completely summarizing what happened during a study and telling the participant what they need or want to know.
The translation of medical terms into lay language needs to be done thoughtfully in order to maintain accuracy without using technical or scientific terms that participants and caregivers might not understand.
Examples of translating medical terms into lay language
- Intravenous (IV) = Given through a needle in the vein
- Intramuscular (IM) = Injection (known as a “shot”) into the muscle
- Subcutaneous (SC) = Injection into the fat under the skin
- Intradermal (ID) = Injection just under the skin
It may be best to give a very high-level explanation of complex concepts rather than providing all details. For example, it may be best to leave out the details on the molecular mechanism of an investigational drug in favor of a high-level cause-and-effect explanation such as “Molecule X helps cancer cells grow. The investigational drug blocks Molecule X, so it may help slow the growth of cancer cells.” This avoids overwhelming the reader while providing what they ultimately need to understand to comprehend the study results.
Use the correct tone
The use of previously vetted blanket statements can be useful to ensure that the results are presented in an informative, balanced, and non-promotional way. For example, “The results for any individual could have been better or worse than the overall results for the group.”
Statements of study results should be fact-based and non-emotional but still written in a proper compassionate tone for patients. Some examples of language that could be construed as promotional and alternative non-promotional wording are provided below.
Examples of non-promotional language
DON’T: 40% of patients in the treatment group reported improvement, while ONLY 10% of patients in the placebo group reported improvement
DO: 40% of patients in the treatment group and 10% of patients in the placebo group reported improvement.
DON’T: People taking Drug A lived longer after they had [therapy] for [disease], EVEN WITH more adverse reactions.
DO: People who took Drug A lived longer than those that took Drug B. The patients who took Drug A also had more side effects.
Use sensitive language
Consider that plain language summaries are often written for patients with life-threatening conditions who survived a study or for family members of patients who did not survive a study. The use of language that is compassionate and respectful is critical. Sensitivity is of particular importance when writing pediatric lay summaries, as the intended audience for these documents is typically the parent of a child who participated in the study.
Difficult outcomes such as death can be addressed in a more considerate manner through word choice. An example is provided below.
Examples of sensitive language:
DON’T: 72 patients in the study group died before the end of the study
DO: 72 patients in the study group passed away before the end of the study
DO: 192 patients in the study group lived beyond the study
Tips for PLS Authors
As a writer, it is critical to always consider the intended audience for a document to ensure that it is fit-for-purpose. Always consider the patient perspective when writing plain language summaries.
Plain language studies can seem deceptively simple but require real skill on the part of the writer to ensure accuracy while maintaining non-promotional intent and thoughtful tone for the participants of the study. The skills employed by writers of high-quality plain language summaries take time and experience to develop and are akin to becoming ‘bilingual’ in both technical language and plain language. A writer needs to become comfortable with the use of simple words, short sentences, and a ‘forest-through-the-trees’ approach to summarizing complex concepts.
Tools for Writing
Maintaining glossaries of lay terms for technical concepts such as MedDRA Preferred Terms can reduce effort when authoring multiple plain language summaries.
Consult medical dictionaries that have plain language descriptions of diseases states, including NIH online resources such as the National Cancer Institute or the National Institute of Diabetes and Digestive and Kidney Diseases. In addition, it may be helpful to review literature and websites from patient organizations that focus on the disease state in the trial being summarized.
Use readability tools like the Flesch Reading Ease score (should be at least 60) or the Flesch-Kincaid Grade Level score (6.0 – 8.0). These tools are built into Microsoft Word and can be useful for quickly checking the readability of text in a plain language summary.
Use these tips, and the the information from our webinar “Tips and Tricks for Lay Summary Writing,” to ensure your lay summaries are understandable and easy to write.
By: Michelle Reed, Associate Manager of Regulatory and Medical Writing
For more information about plain language summary writing, email info@mmsholdings.com.
Learn more about MMS plain language summary writing services here.
