Medical/Pharmaceutical Translation Principles
From Mart Production

Medical/Pharmaceutical Translation Principles

Written by:

Brenda Onyango

The healthcare industry, like other industries, has undergone massive changes as a result of globalization. There is increased access to medicine, medical equipment, and medical knowledge to populations that were not previously able to access medical care.

Besides globalization, the modern healthcare system emphasizes patient education as a strategy for optimizing positive patient outcomes. Equipping patients with health education helps influence lifestyle changes essential in managing chronic diseases and keeping adverse outcomes at bay.?

Language barrier remains a major impediment in globalizing healthcare and providing effective patient education. A mismatch between the languages used by the developers and the target users of medicine, medical technologies, and medical knowledge can lead to miscommunication of medical information.

Given the risk of such miscommunication and misinformation (i.e., it can lead to improper use of medicine and medical equipment that can hurt the users and result in adverse consequences), medical translation is crucial.

Similarly, language differences between the patient or client and the healthcare provider can lead to miscommunication that can adversely affect patient outcomes. As such, Earthwide Translation Services is keen on addressing these challenges.

Language barriers can lead to misdiagnosis and failure to establish patient needs accurately. Besides, the differences in language between the patient and the provider can lead to misunderstanding of instructions that could harm the patient or reduce the effectiveness of the treatment plan.

The highlighted circumstances are quite unfortunate as they compromise patient safety and undermine the efficacy of the healthcare system. Read on to discover how accurate and balanced pharmaceutical translation could help save the day (and lives!).

The Importance of Medical Translation Principles

Translation comes in handy to resolve language barrier challenges in the medical field. Medical translation enables effective communication between patients and providers so as to enhance patient outcomes. Through translation, providers can accurately identify patients’ needs, and patients can understand providers’ recommendations.

A variety of documents are included in medical translation. These documents include application dossiers, instruction manuals for medical equipment, clinical trials, health surveys, and clinical protocols.

Other documents include production manuals, patents for drugs and vaccines, consent forms, posters, leaflets, brochures, and articles in scientific journals. Besides, medical translation is essential in communicating medical knowledge among stakeholders in the medical field.

Healthcare providers often require to use medicine, equipment, and knowledge developed in countries to diagnose and treat their patients. The instruction and other information on those medicines or equipment may be originally written in different languages than the languages used locally, making it difficult to comprehend.

Therefore, medical translation is essential as it helps providers and patients understand medical knowledge effectively for the purpose of enhancing healthcare outcomes.

Epic Examples of Fails in Medical Translation

This article would be incomplete if we didn't mention real-world examples of pharmaceutical translation, or lack thereof, gone wrong. Here are examples of incidences where medical translation (errors and lack of services) compromised patient safety.

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From Tima Miroshnichenk


Example 1- Mr Francisco Torres's Nephrectomy Surgery

Mr Francisco Torres, a Spanish-speaking man, underwent a nephrectomy procedure in 2010 at Riverside Parkview Community Hospital Medical Center in California to remove his damaged kidney. Ironically, Mr Torres was only provided with an English-language copy of the surgery consent form and was not granted access to a translator.

As a result, the surgical procedure ended up removing the wrong kidney. Later, the diseased kidney was also removed, leaving the patient with no kidney. Failure to provide translation services compromised the patient’s safety.

Example 2- Deadly Radiation In France

Between 1986 and 1987, six patients in France were subjected to massive radiation overdoses due to transition errors. Wrong medical translation of instructions in the use of Therac-25 radiation equipment left four people dead and two with life-long injuries.

Example 3- Failed Knee Replacement Surgeries in Germany

A minor translation error in the translation of device package information resulted in surgical errors that saw forty-seven patients undergo knee replacement surgery twice for no reason.

The source language of the prosthesis package information prescribed the surgery as "non-modular cemented," which was wrongfully translated as "non-cemented" or "without cement."

From the examples above, you can clearly see the impact of translation errors and lack of translation on patient safety. Earthwide Translation Services is committed to providing excellent medical translation services that guarantee accuracy in translation to enable patients and providers to understand medical information in their own language.

Pharmaceutical Translation Principles ?

There are several principles that you can use in medical translation to enhance accuracy and reduce the risks associated with incorrect translations. These principles outline the steps that should be followed in medical translation.

Additionally, each step in the medical translation process will inform you of the critical components in that step, the rationale for the step, the person or organization responsible for the task, and the risks of omitting the step.

1.????Preparation

This step involves a series of preparatory work that is done before the translation process can start. One of the critical tasks in preparation is to obtain permission to use the instrument from the copyright owner.

This step is done by the project manager for the purpose of respecting copyright. Omitting this step can lead to prosecution for unauthorized use of copyright material.

The second task in the preparation process is to invite the instrument developer to be involved in the translation process. Inviting the instrument developer helps clarify any ambiguities and other concepts behind the items.

The project manager or client is responsible for inviting the instrument developer. Failure to invite the instrument developer can lead to problems of misinterpreting concepts.

The other task involved in the preparation step is to develop an explanation of the concepts in the instrument. This task aims at strengthening the conceptual equivalence of the forward translation and avoiding any ambiguities.

The project manager is responsible for this process with the help of the instrument developer. The task helps in preventing misinterpreting items or concepts.

The last task in the preparation principle is to recruit an in-country person for the project. The rationale for this recruitment is to have the person in the target country work closely with the project manager during the translation process. The project manager is responsible for this recruitment.

2.????Forward Translation

The second principle of medical translation is developing at least two independent translations. The rationale for this task is to allow comparison of different comparisons so as to identify translation errors and ambiguity in translation.

This task is performed by two or more translators, and it helps avoid translation that is subjected to one person’s writing style.

Also, the forward-translation process entails explaining the key concepts in the instrument to the key forward translators. This task helps the forward translators understand the basic concept of the instrument to enable them to capture the conceptual meaning before literal translation.

This task is done by the project manager, and failure to do it can lead to a lack of conceptual equivalence in the translated work.

3.????Reconciliation

This step involves the merging or reconciliation of the two or more forward translations into a single forward translation. The rationale for this process is to resolve discrepancies between the original independent translations.

It also entails seeking an agreement between individual speech habits and preferences. A reconciliation may require another alternative translation, but the end goal is to have one translation.

The reconciliation process should be carried out in a discussion forum by the in-country translator and the forward second translator. The project manager also has input in the reconciliation process.

Failure to reconcile translations will make you have a biased translation due to the translator's personal style of writing and speech habit and the risk of mistranslation.

4.????Back Translation

This translation principle involves back reconciliation of the reconciled translation into the original language of the instrument. The rationale of this process is to provide quality control to ensure the forward translation gives the same meaning when translated back to the source language.

Back translators should be used to carry at least one translation with the input of the project manager. Omitting the back translation step can result in the translation having a different meaning from the source language.

The back-translation process provides a psychometric measure to evaluate equivalence in conceptual and literal meaning. Also, failure to translate back can result in a translation that does not respect the normal speech patterns of the target culture.

5.????Back Translation Review

This process involves a review of the back translations against the source language. It is essential in ensuring conceptual equivalence of the translation. This task is done by the project manager and the key in-country person who reviews the translation against the source language.

Also, the project manager can involve the developer of the original instrument to resolve difficult issues. Failure to conduct a back translation review can result in a mistranslation or overlooking of omissions that could distort meaning from that in the source instrument.

6.????Harmonization

The critical component in this process is the harmonization of all new translations with each other and the source version. The purpose of this process is to identify and deal with any translation discrepancies that may arise within the different language versions.

The process also ensures conceptual equivalence between the source and the target version, an additional quality-control process.

The harmonization process is chaired by the project manager, where translators representing the source and the target language provide verbal feedback that is used to improve the quality of the translation. Omitting this step can result in translations that are inconsistent with the meaning of the source version.

7.????Cognitive Debriefing

The primary purpose of this step is to ensure that the translation is comprehensible to the target population. For example, if the translated information was meant for the patient population, cognitive debriefing would involve drawing patients from the target population and briefing them on the new translation.

The primary purpose of this step is to assess the level of comprehensibility and cognitive equivalence of the translation.

Additionally, cognitive debriefing allows you to test translation alternatives that the translators may not have resolved. The step is also vital in identifying items that may be inappropriate at a conceptual level and issues that may cause confusion.

The cognitive debriefing process is done by the key in-country translator or another in-country consultant, who tests cognitive equivalence to a sample of patients in the target country.

The respondents should be native speakers representing the target population in terms of sex, education, age and diagnosis. The risks of not doing cognitive debriefing include missing and inaccurate data that could lead to misunderstanding of information.

8.????Review of the Cognitive Debriefing Result and Finalization

The critical component involved in this step is to take into account the results of the debriefing process to enhance the effectiveness of translation.

The project manager analyzes the findings from cognitive debriefing and determines the translation changes required for advancement. Items and response options may be changed if the comments of responders support the change.

Omitting this review can result in the risk of having a translation with words or phrases that are not familiar to or frequently used by the respondents. Also, reviewing the results of the cognitive debriefing can help identify missing information or words and phrases inappropriate for the target audience.

9.????Proofreading

You will need to proofread the translation to check for minor errors that could have been missed out during the translation process. The key in-country translator or another qualified person should proofread the final translation and correct for minor errors such as spelling mistakes and grammatical errors.

Failing to proofread the final translation can result in having a final translation that contains grammatical errors, spelling mistakes, and other errors.

10. Final Report

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This step involves writing a report on the development of the translation process. The reason you need to write this report is to clearly explain the reason for all translations and the choice of wording in the translation.

Also, this translation report is essential for future translations of the same measure to be harmonized with language versions previously developed.

The final report writing is done by the project manager, who provides a thorough explanation of the methodology employed as well as a list of each translation decision made throughout the process.

What happens if you fail to have a final draft for the translation process? You will have inadequate reporting of the translation process. Also, it increases the risk of having future translations that are not consistent with earlier language versions.

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From Tima Miroshnichenko


Closing Thoughts on Medical/Pharmaceutical Translation Principles

Language translation is essential in order for medical supplies, equipment, and medical knowledge to be shared effectively across different societies that speak different languages. ─

However, medical mistranslation or omitting some information in the translation process can result in misinformation that can adversely affect patient outcomes. The examples highlighted earlier demonstrate the implications of wrong translations on patient safety.

Additionally, medical translation can lead to wordings or phrases that are not appropriate for the target audience.

Earthwide Translation Services shares critical principles in medical translation that can improve translation accuracy and produce versions that are conceptually equivalent to the source equipment. Using these principles will greatly enhance the effectiveness of medical translation.

For more information about our language services, drop us an email at [email protected] or text us on WhatsApp here: https://wa.me/message/YX2FILPMOGHOH1 Want to order a translation, proofreading, or interpreting service? We are here for you! Please tell us your language pair(s), and we'll give you a free quote within minutes. We have professional and native linguists worldwide ready to handle your task. Send your request to Contact - Earthwide Translation Services.

References

1.????Medical & Pharmaceutical Translation – Expectations, Challenges, Solutions

2.????Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: Report of the ISPOR Task Force for Translation and Cultural Adaptation

3.????The 9 Biggest Medical Translation Services Blunders You Need to Know!

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