Translation Guy Blog
Linguistic validation is a process that ensures a translated instrument has the same psychometric properties as the original. It is done so that clinical researchers can create useful datasets from different groups, which is especially important for international and multi-country clinical trials. In a recent blog post, we took a translator’s look at cognitive debriefing. We examined how it helps researchers ask the right questions and receive relevant, meaningful answers with instruments like patient-reported outcomes (PROs) for use in clinical trials. Cognitive debriefing is a key step in linguistic validation, but what exactly is linguistic validation and what does it consist of?Read more
What if patients completed questionnaires without understanding the words or context used in the questions? What if patients were offended by a particular word? Or what if patients gave responses thinking the questions were asking something else instead? These dangers quickly undermine instruments like patient-reported outcomes (PROs), a common type of questionnaire where primary responses can be gathered for clinical trials. Even when an instrument has been expertly designed for patient understanding, when translation becomes involved those original psychometric properties can get lost. It isn’t just a matter of language and context, but of culture as well. For these reasons, cognitive debriefing becomes an invaluable step in the linguistic validation of translated instruments, essential to the integrity of clinical trials, both overseas and in the USA.Read more
Clinical trials play an important role in getting new drugs, treatments and medical devices to market. During these trials, patient-reported outcomes (PROs) are common instruments used to gather patient perspectives. The importance of accurate translation and cultural adaptation of PROs for international clinical trials cannot be overestimated. To get the most accurate patient-reported outcome (PRO) translations for your clinical trial, follow these 10 steps:Read more
Clinical outcome assessments (COAs) are an important component of any clinical trial and getting new drugs, devices and therapies to market. And when it comes to multinational clinical trials, accurate translation is essential to the process. But how can it be easier?Read more
Global trial translation—blessing or curse?* Sponsors and contract research organizations (CROs) now launch trials in markets around the world. Regulators want larger population pools, longer-term monitoring, and more trials. Pharmaceutical companies are developing relationships with clinicians and physicians in locales around the world to build advocacy for new products in new markets. Translation is the cutting edge of the communication scalpel for this new global community of clinical trial stakeholders. This issue of language is as critical to the process as patient screening or any other trial-planning element. The fail in "fail to plan" For such serious business, it is a good idea to consider translation at the start to avoid trials at the end. Planning for translation is most successful when it come early, so that everyone involved understands the costs, time-lines, and requirements essential to good risk management of a translation effort. Translation as an afterthought often results in stretched timelines and renegotiated budgets. Poor planning can delay execution and makes outsourcing organizations look bad. While clinical trial cost may be lower in some markets, budgets need to include the cost of communicating with all of the participants in a trial. Most of the materials involved in the clinical trial, such as the investigator’s brochure, the clinical study protocol, subject information and informed consent form, clinical study reports, patient reported outcomes (PRO), and the case report form will need to be translated into language easily grasped by participants. During the trial, patient diaries, adverse event and other in-country trial materials will need to be translated back into the control language (usually English) to ensure accurate data collection and analysis. Clinical trial translation is uniquely challenging for translators. Terminology is often specific to the individual trial, and content always reflects the cutting edge of life science research, expressed by writers deeply involved in the industry. This complexity has to be expressed simply enough so that patient participants with limited health literacy can understand. Finding linguists who understand the language of investigators and can communicate the same to end-user is the most challenging part of the translation process. Linguists have to know their medicine and their audience. Translation goes global In a global effort, economic models and risk profiles cannot ignore the complexities introduced by language and culture. If inputs do not consider the cost, complexity, and risk associated with translation, trial goals could be jeopardized. As trial elements are designed, consideration has to be given to localization. This could be something as simple as making sure that there is enough room on the form to fit a text that has expanded in the translated language, or as complex as mapping out the cognitive category of each word used. As a first step, a decision has to be made on what to translate. Most important are the materials that will be read by patient populations and physician sponsors. If these documents are translated on demand, even linguistically correct translations may miss nuance or author intentions that will make the content harder to understand or decrease accuracy. While it is possible to recruit English-bilingual study participants in many markets, this can skew the patient pool, complicate recruitment efforts. Since English ability is often over-reported, English-only studies using bilingual participants can sometimes lead to greater risks from misunderstanding. The cost of translation is a small share of overall study cost, but the cost of delays in translation can be staggeringly high. Translation bottlenecks can get very expensive if time to market is delayed. Next time: Best practice *Blessing. All the translation tribulations of global trials are a blessing. Saving lives is a blessing.Read more
Since the Clark family genetic code seems to be a double-helix habitrail cancer, I'm a hater. A cancer hater. Too many times I've witnessed those rogue cells steal my family from me with mindless ruthlessness, while I sit beside the hospital bed, helpless, fit only to wring my hands in the face of this terrible onslaught.
Which is why, of all the translation that we do at CliniTrans and 1-800-Translate, I like the cancer business best. Because it gives me a chance to fight back. We translate the good fight, and our actions―something, anything that might help―we do just to do our bit.
This is also why one of my favorite clients is CureSearch for Children's Cancer, whose goal "is to unite and mobilize as many voices as possible in order to raise awareness and ensure childhood cancer is a national public policy priority." CureSearch for Children's Cancer and Children's Oncology Group are partners in the search to cure childhood cancer, each with vital responsibilities concerning research, care, public awareness and fundraising.
I wanted to give them a shout-out for all their great work and the efforts they are making to reach out to non-English speaking families caught up in the calamity of childhood cancer. I can only imagine the helplessness and isolation that those families must confront in the absence of information and support in their own language. And the tacit exclusion of non-English speakers from clinical trials is a deadly injustice to those with limited English proficiency. It is our privilege to work with many in the oncology community who care deeply about these issues. I mean it is a matter of life and death.
You will be hearing more on this from me in the future. For more information, click here.Read more
Informed consent in clinical trials means different things to different people. Sometimes it means consent is given with full knowledge, and sometimes it just seems that way.
Nearly half of all U.S.-based clinical trials are now conducted overseas―many in countries where the native language is not English, where literacy in local languages is low, and health literacy is even lower.
Informed consent forms for international research are generally written first in English and then translated into the local language. In the latest IRB: Ethics & Human Research, researchers Caroline Lithinji and Nancy Kass question the assumption that if an English language consent form is simplified, then the translated version will resemble the original form in its readability.
'The Kenya Medical Research National Ethical Review Committee determines readability of English consent forms before translation; however, it is neither their policy nor practice to determine whether the forms, once translated into Kiswahili, are of comparable readability to the English forms."
Turns out they aren't. The two did a study to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili.
The authors used a readability formula called the cloze procedure, which measures a reader's ability to make sense of the text.
Cloze procedure is a technique in which words are deleted from a passage according to a word-count formula or various other criteria. The passages are presented to students, who insert words as they read to complete and construct meaning from the text. Cloze tests require the ability to understand context and vocabulary in order to identify the correct words or type of words that belong in the deleted passages of a text. This exercise is commonly administered for the assessment of native and second language learning and instruction.
For the study, volunteers in Kenya read 10 consent forms written in simplified English and the same forms translated into Kiswahili—which, with English, is one of the two official languages of Kenya. Seven out of 10 translated versions had a significant mean difference, suggesting they were less comprehensible in Kiswahili than in English. Using a "cloze pass mark" as a score of above 38 percent, for six of the 10 forms a greater percentage of respondents "failed" the Kiswahili form than the English version.
The findings raise questions about the quality of the translations of consent forms used in clinical trials. "Ethics review committees should pause before asking only for simplified English language forms without scrutinizing the language or translation approach that will be used to translate those forms into the local language," the authors wrote.
It’s hard to see the rationale behind this practice, other than the ease and convenience of the review board. It really doesn't have much to do with what the participants may be experiencing. Once you run out of excuses, limited English proficient, limited native-language proficiency, limited literacy, limited health literacy... what's left? Is the participant still competent to participate? Well, look, they signed right here...Read more