Wordbee Translator is a translation management and linguistic tooling system. We have developed special features for customers in the Life Sciences, including back translation workflows, compliance tracking & reporting, and more. Check out our webinar on linguistic validation or information about Wordbee for Life Sciences.

You don’t have to go abroad to face a potential situation of mutual incomprehension. Browsing a medical publication or website may be enough to be overwhelmed by jargon and specialized terminology. And if you’re googling those symptoms you have been experiencing, you might also feel the additional frisson of thinking your life is being threatened by some obscure disease.

Lay Summary: Advocating Greater Transparency

In 2014, the European Parliament released the Regulation 536/2014 for clinical trials conducted on medicinal products for human use in order to reach a higher degree of transparency, protect the rights, safety, dignity and well-being of individuals as well as produce solid data.

This regulation provides for a lay summary to be released for every research project and clinical trial. The lay summary is meant to give a brief but clear explanation of complex ideas and technical and scientific terms for laymen, i.e. people who have no prior knowledge about the subject. These people include members of the general public, caregivers, and potential funders and collaborators. A lay summary is meant to explain the reason and purpose of the research or clinical trial being suggested and the possible impact. Lay summaries might also discuss the methodology.

A clear and plain language can in fact play a significant role when health professionals need to describe the reason and purpose of a clinical trial or the effects of a drug or treatment to the people involved, especially patients.

Writing a Lay Summary 

While for the authoring and translation of product information it’s mandatory to use specific EMA templates, there are until now no specific instructions to follow for lay summaries. It’s useful to know, though, that Annex V of the EU CTR specifies the 10 essential elements that must be included in a lay summary. 

As in any good-writing approach, the main element to keep present at every time is your readership. Your readership could include members of the general public, participants in a study and their relatives, donors, healthcare professionals and even potential funders who may be interested in the study but are not experts on the subject. And because it’s a varied audience, it’s generally useful to write in plain language, to communicate in the simplest and most effective way.

Before dealing with the language, let’s deal with the structure of a lay summary, which should always answer the usual questions, “who/what/where/when/how many/why?”. Always anticipate possible “so what?” questions and provide answers to support the subject of the summary. Establish a logical order and don’t forget to read other summaries of the same organization to follow the same style and that of the publisher.

A checklist for plain language - like the one maintained by the Plain Language Action and Information Network, might come in handy. For those who write in languages other than English, the website Plain Language Europe offers guidelines and tools in 4 languages (Dutch, French, German, Italian, Spanish) in addition to English.

Another element to keep in mind is the readability index, which is an estimation of how difficult a text is to read. The index is usually calculated by measuring attributes as word lengths, sentence lengths, syllable counts, and so on. Information and tools for most readability formulas are available online for free. For the lazy among us, Microsoft Word offers a readability feature, too.

All the above information can be complemented by the recommendations contained in a consultation document authored by an expert group. In addition to analyzing the use of plain language, visuals and numbers, the document focuses on readability indexes to be applied for English, Dutch, French, German, Italian, Spanish and Swedish.

A final useful strategy comes from Catherine Richards Golini, a language consultant. In a podcast interview for the Wordbee International Buzz, Golini advises to turn to corpus linguistics and corpus analysis to analyze the terminology used for a specific clinical trial and spot special words like, for example, somnolence, fatigue, cephalalgy, which will need to be replaced with sleepiness, tiredness and headache, respectively.

Translation strategies for lay summaries

The Clinical Trial Regulation EU 536/2014 will come into effect in the second half of 2020. Consequently, together with all other clinical trial documentation, lay summaries will also have to be posted to the EU portal within one year after the end of the trial for studies in adults, and within 6 months after the end of the trial for studies in the pediatric population. With this clause, the EU Regulation aims to give patients access to those results of clinical trials that might change their lives.

The translation of lay summaries is another important consideration. The EU Regulation requires, in fact, translated versions of lay summaries to be submitted in the language of each European country in which the study has been conducted. 

It is, therefore, important to be aware of the potential risk of introducing differences between the original lay summary and its translations.

Be cautious with using colloquial language. It may sometimes be useful for effectively conveying information to a lay audience, but it may also be a challenge: the language of the translation will have to be neutral, consistent, and culturally-appropriate. 

Lay summary: the translation workflow 

You could entrust the translation of your summaries to your preferred (local or global) language service provider (LSP). The review could also be provided by your language service provider. Alternatively, the translation could be sent to an in-country reviewer (for example, a local representative of your company or a trusted subject-matter expert), whose task will be to assess whether the meaning of the translated summary has been correctly reproduced. 

In any case, make sure all parties involved receive reference material (e.g., plain language guidelines in the target language), ad-hoc translation memories and terminology database.

Back translation (translation from the target language to the source language) is another useful step in the translation workflow. It’s important to verify that the translated text is similar to the source text, and that no errors or ambiguities have arisen in the translation process. If the back translation shows inconsistencies, you should proceed to a new translation of the original text into the target language (with a new translator), redo the back translation, and repeat this procedure until you get a flawless translation. Alternatively, you could perform or request from your LSP a reconciliation step, during which the original source is compared to the back translation to look for discrepancies or unclear/confusing portions of text.

Finally, for an efficient comparative review of the translations in various languages, a feature like the Column Manager will allow you to display the different translations segment by segment, with the bonus possibility for translators and reviewers to add comments and feedback.