Translating a lay summary and authoring it locally
A lay summary reaches readers in other languages either by translation or by being written in the local language from the start. A translated summary passes through a chain of translation and review that has to keep it in lay language and may render its sense rather than its words. A summary written in the local language is drafted, reviewed and received differently from one translated from English.
Why the summary is translated
Accounts of the EU Clinical Trials Regulation differ on whether the summary must be translated. One account, from September 2020, states that the master summary, written in English, will need to be translated into the local languages of the region where the trial is conducted. Another gives translation into the local languages of the participating EU countries as the ideal, so that study participants can read the results in their own language.
For a plain language summary of a publication to have a global reach and be accessible to patients in different countries and cultures, it needs to be translated into local languages. Communicating the summary clearly in different languages can help readers to understand its content fully, building trust and ensuring that people receive the information accurately. In March 2024, research on the impact of translation on these summaries specifically was lacking, but earlier research had shown language to be a key barrier to engagement across the healthcare pipeline.
Translating plain language
Translating plain language into other languages brings several challenges. The same complex sentence can generally be written in plain language in different ways, and one writer's sentences may differ completely in structure and wording from another's; the same holds when plain language is translated into another language. The same words and phrases may be culturally appropriate in one culture and inappropriate in another, so they would need adapting to the target audience. A multilingual translation of plain language text may therefore not be literal, but nuanced to what makes the most sense in each language and to what is most accurate and clear.
Given these nuances, a systematic approach with multiple rounds of checks is important when creating and publishing multilingual plain language summaries of publications, to minimise errors and maximise quality. A growing number of qualified professionals specialise in plain language translation of medical publications, as do publishers that offer it as a third-party or in-house service. A professional service can help to maximise quality, because these services often have quality control built in, which may include review of the first translation by a second translator, final proofing for consistency, accuracy and completeness, back translation, localised patient review, and monolingual review against a plain language brief.
The chain of translation and review
At one medical translation agency, a lay summary goes through back translation and master review, then country review, and finally desktop publishing and a layout check. Back translation is usually a popular choice for lay summaries, or for exotic languages, when it is important to check whether the translation really reflects the content of the original. Master review compares the back translation against the original, and at country review the client's representatives in different countries can review the text in their native language and approve it. The agency very often involves translators in the layout check, to see that the layout looks clean, with no typos and no unnecessary spaces.
For lay summaries it is important that the texts are written and translated in lay language understandable to people who are not medical professionals, and that the translation memory and the terminology are in a very good, up-to-date state. The agency sometimes tries to eliminate complex language at country review, when the client's representatives step in, see that something is not very clear and, for example, spell out an abbreviation or use another word for diarrhoea, such as stomach pain. Some clients also require gendered forms, not in every language but in those where it is relevant and possible.
The agency does not include patients in the review of translated patient-facing documents, because that step is done by the vendors. The vendors are usually teams of medical writers who prepare the source texts, and the agency receives the finished lay summaries in English. The agency tries to offer patient review itself, but it has no good access to patients, so recruiting them is very difficult, and it lacks the funds to organise such a service. Much of this comes down to timelines and budgets.
Writing the summary in the local language
No patient lay summary had been developed locally in Japan until Pfizer Japan wrote one in Japanese from scratch, to tailor it better to local patients. The company's summaries for two earlier clinical trials had been drafted in English from the results published on ClinicalTrials.gov and translated into Japanese, both by an external non-profit organisation. In-house scientific experts reviewed them, and they were distributed in printed form from the clinical trial sites.
The Japanese summary was refined by a composite approach: researching lay language and patient-friendly design, ensuring scientific accuracy by consulting experts such as physicians and statisticians, exercising diligence on the regulatory and legal aspects, and bringing in the patient's voice by consulting a local patient advocacy group. The work was split between two teams, one researching the characteristics of lay language, developing a template, communicating with a patient group and considering the legal and regulatory aspects, the other drafting the summary. The two teams worked together on refining the summary and on developing a process for preparing one. The team members were medical writers and members of the document management group, and they took part voluntarily. The project produced a patient-friendly template with default text in Japanese and a process document.
The template for the Japanese summary started from patient information materials gathered at local hospitals and clinics, whose designs were critically evaluated for legibility and readability, and from relevant guidelines and design principles. It adopted the concept of universal design for effective communication. Its main font was Meiryo, a recommended Japanese font whose very clear typeface keeps high legibility even in bold. To enhance legibility, the main text was set in 12-point type, larger than the 10.5-point size normally used for the company's regulatory documents. Wider line spacing was used to optimise legibility and readability, and it also left room for a Japanese reading aid, in syllabic script, above some kanji characters to show how they should be read, as part of the attempt to keep the language level equivalent to that of a Japanese junior high school graduate. A barrier-free colour scheme was studied to make sure that even patients with colour vision abnormality could appreciate the summary without difficulty. Text headings and special messages such as the thank-you message were to be easily discernible, which also lets readers navigate the summary easily. Standard texts, such as the thank-you message and the headings for an introduction and a background, went into the template as default text. On the advice of the company's legal department, the template also carried the date of the document's creation at its end, to control document versions and prevent any revision after approval, and a cautionary statement asking patients to refrain from posting on social networking services.
Beyond the points the universal design concept suggests, the team believed the appearance of the summary's overall printed form was also important, because the summary is intended for people in already stressful situations. An image accompanying the text can appeal to the viewer's senses and stir positive emotions, which can consequently alleviate the stress associated with illness. The image chosen was of dandelions: a flower familiar to many, bright in colour, very resilient and used as a symbol of courage in many cultures, which could represent clinical trials spreading seeds of possibilities. Its Japanese text reads, in translation: "Dandelions spread their seeds when the wind blows. Clinical trials spread seeds of possibilities for a healthier world through your cooperation." The picture followed the barrier-free colour scheme, predominantly blue and yellow, and used no brand colour or image, so that it could be applied to any of the company's drugs.
The draft was based on disclosed clinical information including basic results, namely the public disclosure synopsis of the clinical study report posted on the company's website. Japanese informed consent documents served as the reference for lay Japanese. No external organisation was involved in writing the summary. In-house medical writers drafted it with attention to design, language and structure, and to keeping it non-promotional. In-house experts, among them physicians, statisticians and legal and regulatory experts, reviewed it with principal investigators for scientific accuracy and suitability for public disclosure. Feedback also came from a patient advocacy group with no direct involvement in the clinical trial.
Finally, a checklist of questions was used to make sure that the summary was patient friendly in both format and content.
- Is it easy to understand?
- Is the language level of the content equivalent to that expected of a Japanese junior high school graduate?
- Are there arbitrary statements?
- Are there any inappropriate words?
- Can patients understand the accompanying charts effectively?
- Is the text length appropriate?
- Are the font size and colour scheme appropriate?
- Are the illustrations appropriate?
The summary was posted on the company's public website as a PDF protected by a password, so access was limited to study participants, who were given the link and the password at the clinical trial sites.
What the locally written summary showed
The patient advocacy group's feedback was favourable overall. It found the summary easy to read, and very politely written and well organised, starting with the thank-you message and moving on to the background of the trial, the rationale for the research, the method and the results. It found the summary generally easy to understand, because explanations stood before or after technical terms such as placebo and adverse event. It found the warm and soft image of a dandelion in the summary suited to alleviating patients' pains due to illness. From these comments, the locally developed summary appeared more patient-centric in language, content and design than the translated ones. Using the local language from the drafting stage also made it easier to produce a summary that was more culturally and ethnically appropriate and so suited the sentiment of local patients. The two earlier summaries, translated from English, had also been highly appreciated by patients at the clinical study sites, because no other attempt had been made to give patients access to clinical trial results. The summary written in Japan received more favourable feedback because it did not only provide the information but also presented it better, so its impact on patients was stronger.
Being more patient-centric, the locally developed summary allowed clinical trial results to be communicated in a more patient-friendly manner and helped to form a better relationship with patients. Using patients' local language and being culturally sensitive is among the most patient-centric activities a pharmaceutical company can undertake. One view holds that locally developed summaries would bring more benefits to both patients and the pharmaceutical industry, especially in culturally and linguistically more diverse regions such as the European Union.
What remains to improve
Some issues remained to be solved. To prepare a lay summary more efficiently in future, a few areas need to be improved or explored.
- Establish an effective way to confirm that the summary does not violate the promotion code.
- Ensure compliance with local regulations and practices.
- Assess medical and statistical appropriateness when technical content is paraphrased in lay language.
- Find an effective way to involve principal investigators.
- Establish a good relationship with patient advocacy groups in Japan.
- Increase patient involvement in preparing informed consent documents, to promote patient centricity.
- Collaborate with regulators to establish a framework for the disclosure of clinical trial results in the industry.
- Improve medical writing skills in lay language and the local language.
One view holds that industry-wide efforts are necessary to achieve these effectively.