Category Archives: Life Sciences

Linguistic validation services in the Life Sciences localization industry

by Nicola Kotoulia, Project Coordinator at Commit

Among the multiple specialized localization services available in the Life Sciences sector we also come across those referred to as Cognitive debriefing, Backtranslation & Reconciliation and Readability testing. How familiar are you with these methods? What does each mean, why is it required and what does it entail?

Translation errors can change the meaning of important content in clinical trial settings resulting in medical complications or the rejection of an entire clinical research project. Ambiguity in translated health questionnaires or instruments can mean that items or questions can be interpreted in more than one way, jeopardizing patient safety and clinical trial data integrity. Unclear and hard to use translated drug leaflets mean that users may not be able to take safe and accurate decisions about their medicines.

In order to help avoid such hazards, IRBs, medical ethical committees, regulatory authorities and applicable legislation require that validation methods in accordance with FDA and ISPOR (International Society for Pharmacoeconomics and Outcomes Research) guidelines are put in place for translated documentation, such as Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), Quality of Life (QOL) questionnaires and package leaflets (PL) of medicinal products.

Cognitive debriefing (also known as pilot testing) is a qualitative method for assessing respondents’ interpretation of an assessment, using a small sample of patients. It helps determine if the respondents understand the questionnaire the same as the original would be understood and tests the level of comprehension of a translation by the target audience. The goal is to ensure that data collected from PROs can be comparable across various language groups used during trials. Steps of the process include:

  • Developing a debriefing protocol tailored to the target questionnaires/instruments, subject pool, mode of administration, anticipated problem items etc.
  • Recruiting respondents including in-country professionals experienced in interviewing techniques and patients that match the target population.
  • Conducting the interview (in person or otherwise) during which respondents complete the questionnaire/instrument and answer questions to explain their understanding of each question or item. They restate in their own words what they think each translated item means. This way the interviewer discovers errors and difficulties and locates points that are confusing or misunderstood.
  • Generating a report with demographic and medical details of the interviewees, a detailed account of patients’ understanding of all items, including information about the number of subjects interviewed, their age, time for completing the task and any difficulties that came up. It may also include investigator recommendations or solutions for resolving confusion or difficulties.
  • Review and finalization during which a project manager checks the reports completeness, and ensures that the detected problems are addressed by making revisions as needed for clear, precise and well understood final translations.
  • Creation of summary report where the service provider details the methodology used, as well as the results of the cognitive debriefing.

Backtranslation and reconciliation is a very effective and stringent process that provides additional quality and accuracy assurance for sensitive content, such as Informed Consent Forms (ICFs), questionnaires, surveys and PROs used in clinical trials. It is a process for checking the faithfulness of the target text against the source, focusing mainly on the conceptual and cultural equivalence and less on the linguistic equivalence.

In a back translation, the translated content (forward translation) is translated back into the original language by a separate independent translator. The back translator must be a native speaker of the source language and have excellent command of the target language. He/She should stick more closely to the source that he/she would for a regular translation to accurately reflect the forward translator’s choices, without attempting to explain or clarify confusing statements or to produce a “polished” output.

The next step, “reconciliation”, refers to the process of noting any differences in meaning between the two source versions. The original text is compared to the back translated text and any discrepancies are recorded in a discrepancy report. Discrepancies may be due to ambiguity in the source text, errors introduced by the forward translator, or back translation errors. The reconciler flags issues such as differences in meaning, inconsistent/incorrect terminology, unsuitable register, missing/added information, ambiguities or errors in the backtranslation. Several back and forth between the linguists may be needed to reconcile the versions so that edits and adjustments are made as needed to optimize the final translation.

Readability testing in the fields of pharmaceutics qualifies that the medical information contained in the drug leaflet is usable by potential users of the medication, that is, that they can understand and act upon the information provided. It is a critical step in the process of designing product literature.

Since 2005, manufacturers of medicinal products are legally required to have their patient information leaflets (PILs) readability-tested in order to acquire product approval. According to Directive 2004/27/EC, these leaflets should be “legible, clear and easy to use”, and the manufacturer has to deliver a readability test report to the authorities.

Readability testing may be carried out by the sponsor or CRO, or a language service provider undertaking the localization of the documentation. The process steps can vary, but stages may include:

  • Preparation of the PL, during which the text of the leaflet is carefully edited and checked, spelling and grammatical errors are corrected, and sentences are rephrased to ensure compliance with the appropriate EMA template.
  • Drafting of questionnaires with questions covering the most important details of the product and its use. These questions that must be answered correctly by any user to ensure correct use of the product.
  • Pilot testing for assessing the prototype in terms of clarity, simplicity, safety, non-ambiguity, etc. Results are used to further revise the leaflet.
  • Actual readability testing conducted using subjects of different ages who are native speakers of the language of the leaflet. Participants are interviewed on key questions about the product. They should be able to answer most questions correctly and no question should consistently cause problems. The goal is to achieve a 90% correctness in the responces.
  • Generating reports that detail the test result based on which final edits are made.

The above processes provide an additional safety net for clients in the clinical and pharmaceutical industry helping them meet regulatory requirements and allowing them to focus on their registration and marketing preparation plans.

A look back at your favorite posts from 2016!

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Now that 2016 has come to an end, we thought it would be a good idea to do a round-up of our most popular content from last year. So here it is:

The contribution of linguists in times of crisis

Refugee crisis, terrorist attacks, so many unfortunate crisis situations seem to have happened last year that affected everyone in our globalized world: civilians, governments, businesses. However, how often do we think of the importance of communication in times of crisis?

How glossaries improve the quality of your translations

This post explains exactly what a glossary is, what we should include in it and how and why we should create one.

10 tips on expanding your business globally

Are you considering taking your first steps in the global market, in an attempt to reach international audiences with your products or services? With the use of social media and the Internet, the world has become a much smaller place. Our society is globally connected and many people around the world can now access your products or services. But going global is no easy task! It requires time, effort and money. Read our 10 tips and make sure you’re on the right track.

ISO 17100: Ensuring quality translations for your business

This blog post explains exactly what the ISO 17100 standard is, what are its main differences from the EN 15038 standard and what are its added benefits.

Localizing mHealth apps: Do special regulatory terms and conditions apply?

As mHealth apps are changing the standards of healthcare services and open up new possibilities for patients and doctors alike through a constant evolution of innovative technologies and brilliant ideas, the regulatory standards and localization processes are called to take a step further and grow in tandem, putting the spotlight on the safety and accessibility of mHealth app users. In this post, we take a look at all the special regulatory terms and conditions that apply to the localization of mHealth apps.

What is machine translation and how can your business benefit from it

In this post, we take a deep dive into the world of machine translation explaining exactly what it is and how it can help businesses all around the world.

Crowdsourcing translation: Pro or Con?

An important advantage of the “connected world”, apart from the unlimited access to all kinds of information, is that it brought together previously “disconnected” people, groups or crowds – giving them the opportunity to become more active and engaged in the world around them. Read this post and learn more about the advantages and disadvantages of this method.

Localizing mHealth Apps: Do special regulatory terms and conditions apply?

Commit_mHealthApps

by Nikoletta Kaponi, Project Manager at Commit

The rapid technological advances and the ever expanding use of mobile devices, from smartphones and tablets to wearables and wireless sensors, have not left the healthcare sector unaffected.

Mobile health (mHealth), which is defined as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices” by the EU Green Paper on mobile health, is expected to reach the equivalent of US$26 billion at a global level by 2017. With over 100,000 mHealth software apps currently available on the market, and their constantly growing popularity in developed and developing countries around the globe, mobile technology is changing the rules in the way healthcare professionals and patients interact.

The range of mHealth apps is broad and under constant expansion, including useful and valuable tools for both the individuals/patients and the medical staff: apps for vital sign measurement (e.g. blood pressure, heart rate, temperature etc.), blood glucose monitoring and diabetes management, photo-based skin lesion tracking or diagnosis, sensor-based medication compliance monitoring, diary-based pain management. These are just a few examples of how mobile device technology is contributing to the enhancement of healthcare services, allowing for a more evidence-based and patient-centric approach to healthcare, both of which have become more possible than ever via the use of mobile health apps.

While the possibilities for innovative healthcare apps and better healthcare services are ample, an important question arises regarding the reliability and safety of such apps in relation to their users. In answer to this question, the regulatory frameworks that apply to medical devices come to the foreground, setting down requirements and guidelines for the medical app developers and manufacturers to take into account and comply with.

In the US, the FDA has issued a guidance document for mobile medical applications, which are therein defined as “software applications that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server” and which meet the definition of a “medical device” and are to be used:

– “as an accessory to a regulated medical device”, or

– “to transform a mobile platform into a regulated medical device”.

Within the frame of this guidance, if the intended use of an mHealth app, as stated in the relevant labeling materials, “is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man”, then such an app is to be considered, and regulated, as a medical device.

While not all mHealth apps are medical devices, even for those that are, the FDA presents the option of “enforcement discretion” towards apps that pose a lower risk to their users, and intends to regulate more strictly those apps that could pose a higher risk to their users if they were “to not function as intended”. As part of this regulatory framework, the same classification requirements apply (Class I, Class II, and Class III), as with the “traditional” medical devices, in order to ensure users’ safety and their function as per the manufacturers’/developers’ intentions.

On the other side of the ocean, EU has laid out three directives for medical devices: one on Active Implantable Medical Devices (AIMDD), one on Medical Devices (MDD) and one on In Vitro Diagnostic Medical Devices (IVDMD). These directives are currently all in the process of being revised and are soon to be replaced by two regulations, one for medical devices and another for in vitro diagnostic (IVD) medical devices, following a proposal adopted by the European Commission in September 2012. According to this proposal:

“medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:

– diagnosis, prevention, monitoring, treatment or alleviation of disease,

– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,

– investigation, replacement or modification of the anatomy or of a physiological process or state,

– control or support of conception,

– disinfection or sterilisation of any of the above-mentioned products, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”

The European Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices (MEDDEV 2.1/6) set out the criteria for “stand alone software” (i.e. software that is not integrated within a medical device) which qualifies as a medical device, therein referred to by means of the term “Software as a Medical Device (SaMD)” and further defined as a “software intended to be used for one or more medical purposes that performs these purposes without being part of a hardware medical device”. Apps that fall under the SaMD definition are required to receive a CE mark, same as with other medical devices, and are also subject to the EU medical device classification (Class I, Class IIa, Class IIb, and Class III), for safety and appropriate development and use to be ensured.

Apart from the need for certain mHealth apps to be regulated as medical devices, the manufacturers of such apps also face the need to make their products accessible to as many people as possible worldwide. With over 2.6 billion smartphone users across the globe, 87% of whom always carry their smartphone with them, the potential of introducing a new product in as many markets as possible is very alluring, but also challenging, given the language and culture diversity of the receiving markets.

Surveys have shown that people primarily prefer to download mobile apps in their own native tongue, i.e. the version localized for their own locale, and this preference should perhaps be re-iterated as a need of paramount importance in the case of mHealth apps, given the nature of their functions and the sensitivity of the data processed. But, apart from user-defined needs, specific localization requirements are also prescribed by the regulatory standards of each country, which determine what must be localized in the country’s official language(s) and what may not. Therefore, the localization step becomes a highly important part of mHealth app launches worldwide, in order to ensure not only an improved end-user experience, but also compliance as far as “apps regulated as medical devices” are concerned.

mHealth app localization specifics include the typical elements of medical translation, which focus upon accuracy, terminology consistency, subject matter expertise and optimal quality assurance processes, and also some more technical tasks. Such tasks are the functional testing of the localized app within the mobile operating system(s) (e.g. iOS, Android, etc.) for which it is designed, followed by the fixing of any identified bugs, and the linguistic review of the localized app, i.e. the review of the translated content within-context in order to ensure the correctness of the translations used and to check for any character corruptions or overflowing/truncated text or misplaced content. These tasks allow for a hands-on validation of the localized apps and aim at eliminating functional and linguistic issues which could reduce the usability of the apps, as well as the clarity and precision of their content.

As mHealth apps are changing the standards of healthcare services and open up new possibilities for patients and doctors alike through a constant evolution of innovative technologies and brilliant ideas, the regulatory standards and localization processes are called to take a step further and grow in tandem, putting the spotlight on the safety and accessibility of mHealth app users.

The Importance of Accuracy in Medical translations

Medicine

by Effie Salourou, Customer Operations Manager at Commit

Grammatical errors and inaccurate translations can jeopardize any company’s image and reputation, but when it comes to the medical industry, where inaccuracy may have direct effect on patients’ lives, quality and accuracy are not just important, they are imperative.

Medical translation is defined as the translation of technical, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Most countries in the world require that documents and labelling associated with medical devices or pharmaceuticals be translated into the country’s national language to ensure the safety of the patients using them. You see, when the safety of a patient depends on understanding of directions, clear communication and the correct operation of medical devices, there is no room for errors and misunderstandings.

Because of this highly technical, sensitive and regulated nature of medical texts, there has been a need for translators and interpreters who not only have linguistic skills but are subject-matter experts in a specific medical field. These translators meet the industry’s strict scientific and linguistic criteria and produce translated content to guarantee that medical device software, documentation, and marketing texts will be understood without errors by all users, patients and physicians. The use of non-professional and non-expert translators could have particularly dire consequences on multiple levels: it could negatively impact the corporate image of a company, it could result in the clinical trial failure of a drug or a vaccine or in worst cases, it could put a patient’s life/health at risk.

To prove that, we are going to give you an example of how the wrong translation of a single word by a non-professional resulted in a medical malpractice compensation of $71 million.

Many of you might be familiar with the story of the 18-year old Willie Ramirez. Back in 1980, Willie was admitted to a Florida hospital in a comatose state. His family, who only spoke Spanish, described his condition to the paramedics as “intoxicado”. Translation was provided by a bilingual staff member who translated “intoxicado” as “intoxicated”. Among Cubans, “intoxicado” is kind of an umbrella term that means there’s something wrong with you because of something you ate or drank, a meaning closer to the term “poisoned”. A professional translator or interpreter would have known that despite the similarity of the two words, the Spanish word is NOT equivalent to the English word “intoxicated”, that implies alcohol or drug use. His family believed he was suffering from food poisoning, while he was actually suffering from an intracerebral hemorrhage. The doctors believed he was suffering from an intentional drug overdose, which can lead to some of the symptoms he displayed. Because of the delay in his treatment, Ramirez was left quadriplegic.

OK, this example might be extreme, but it shows how important it is for the translator/interpreter to fully understand medical terminology in both languages.  It is imperative that the translations are as precise as possible so that the patient receives the proper care. In each medical translation project, the linguist should make sure that:

  • he/she fully understands the source text and the medical terminology used,
  • all instructions and directions are communicated correctly,
  • all content is properly localized to the target language and culture,

because when it comes to medical translations and human safety, one single word can make a great difference.