Empowerment for CDG Professionals

Plain Lay Language & Health Literacy

Why should professionals use Plain Lay Language? What are the benefits?

Effective communication is essential in any business but even more so in Healthcare. Bad communication between doctors and patients, and even within medical staff, can have very serious repercussions, resulting in misdiagnoses and other medical mistakes that can easily lead to avoidable health complications and, in the worst cases, the death of patients. As we explained in the section above, lay language is a way to provide greater transparency and understanding between healthcare services, patients and every person interested in clinical/scientific studies.

For example, when a clinical trial (CT) is finished a Plain Lay Language Summary (PLS) should always be written. Lay summaries are plain language descriptions of the design and aggregate results of individual clinical studies.

These documents are written for study participants and everyone with an interest in clinical study results, but who may have limited health literacy or scientific expertise.

• More so, in some scenarios, the practice of Lay Language and elaborating a PLS is not only advisable but it may be a requirement. Just as we showed you in the previous section, new legislation and regulatory measures on Lay Language have been implemented in the last years. 
• To know more about Clinical Trials, check out our section.
• If you’d like to read about clinical Lay Summaries and the legislation involved you can download this article from Pharmaceutical Medicine, 2019.

Regulatory framework for Lay Language

In the last years, an international effort to promote lay language throughout the Medicine world has been verified, for instants, in the European Union, the CT regulation (Regulation (EU) No 536/20143), stipulates that a layperson summary should accompany the summary of CT results. Both are to be submitted to the database within 1 year from the end of a CT in all member states.
See https://ec.europa.eu/health/human-use/clinical-trials/regulation_en

Also, in the U.S.A., the Plain Writing Act of 2010 (H.R. 946/Public Law 111-274) requires federal agencies to train staff and use plain language when they communicate with the public. 
You can read the act at https://www.govinfo.gov/app/details/PLAW-111publ274