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  • Writer's pictureAna Sofia Correia

Involving patients and translators in Plain Language Summaries

Updated: Nov 1, 2022

Organizations and people are quickly becoming aware of the importance of providing Plain Language Summaries in different languages, rather than just in English. In this article, I shed a light on how you can involve patients and translators in the development and translation of Plain Language Summaries.

Capturing the patient’s voice in translation - Part Two: Translating and localizing for patients

In August 2021, I had the pleasure of hosting a Multilingual Summer Series panel with Anna Richards, Kokoro Yoshikawa, and Trishna Baradia about “Capturing the patient’s voice in translation.”

This is the third part of a series of articles I have written on the topic, entirely derived from Anna, Kokoro, and Trishna’s insights:

Part three – Involving patients and translators in Plain Language Summaries

What is a Plain Language Summary

Plain language summaries are plain language versions of technical documents. Within healthcare settings, there are two broad types of plain language summaries:

Plain Language Summaries of Clinical Trial Results

The European Clinical Trial Regulation (EU) No. 536/2014 mandates that any clinical trial run within a European site has to have a lay summary of the clinical trial results produced in the language of where the site is within 12 months of the end of the trial (6 months for pediatric trials).

Plain Language Summaries of Publications

Materials like congress abstracts, conference posters, journal manuscripts will also start to be translated because the value of plain language summaries for not only patients and the general public but also medical journalists and non-specialist healthcare professionals like nurses and general practitioners.

In both settings, if plain language summaries are made available in different languages, we will have a much better informed patient community.

Keeping Plain Language Summaries (PLS) in English is a missed opportunity since you're not allowing a vast population to know what is going on, to learn about the results of a study to which they contributed.

Hopefully, what is now a mandatory requirement will trigger a domino effect, a change in the mindset that will make way to sharing medical or health information in a truly inclusive way.

Involving patients and translators in the development of PLS

The translation steps occur very much towards the end of the process. At this point, there is the potential need to make lot of corrections and adjustments.

Just because the summary was developed using plain language, it does not mean that that the translation will. The translator must be aware of plain language principles, and implementing them takes practice, cultural knowledge, and awareness of literacy – and health literacy – levels.

Together, translators and patient advocacy groups have the necessary knowledge to produce the best quality translation possible.

In this regard, the Plain Language Summary translation process may resemble the linguistic validation of Patient-Reported Outcome measures. You have to make sure that the outcome is not only true to the original in conceptual terms, but also idiomatic and easily understood by the target patient population.

There are two ways you can achieve this:

  • Include a back translation step in the process so that the translated PLS can be checked by the developers;

  • Share the translated PLS with native patients and ask for their feedback.

Notwithstanding the above, you should strive to include the translation step right from the start. If you know in advance the languages in which you will have to make the PLS available, you can’t go wrong if you involve translators in the PLS development as in-country consultants.

This will allow you to spot potential issues and address them from the get-go, hence streamlining the whole translation and validation process.

There are already many great initiatives of co-creation of PLS with patients, both in the clinical trials and publications spheres. The next step should be bringing linguists to the table.


Ana Sofia is an English to Portuguese medical translator and writer working with Life Sciences companies, Contract Research Organizations, and Medical Communication agencies. She has experience translating and writing content for clinical trials, medical devices, regulatory submissions, education and marketing campaigns, and scientific publications.

Med & Mark - A blog about medical and marketing translation
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