The tides are shifting when it comes to the life sciences research and development clinical trial multi-national process by making patient voices heard at earlier stages. The tides are also carrying with them the need for linguistic validation and this is causing some pharma companies, clinical trial sponsors and contract research organizations (CROs) to wallow in the receding waves a bit. With routine clinical outcome assessments (COAs) such as patient reported outcomes and clinician reports, certain steps need to be taken so that all clinical study efforts are not beached.
The problem companies encounter stem from not understanding the importance of subtleties when asking patients targeted questions assessing the effects of the condition on their ability to function in their daily lives. Being aware and trained to recognize the issues and appropriate ways to word questions will protect the integrity and value of international COA data. If this step is overlooked or pushed aside and the data is called into question, the entire clinical trial could be jeopardized. Although there is no standard approach to translation and linguistic validation, all major health authorities support best practice in the interests of quality and patient safety and this includes linguistic validation. So, keep a keen eye on the horizon for these subtilties.
So, why is it so important?
Simply put, linguist validation is the process by which an instrument or patient questionnaire is simultaneously translated by different translators, turned into a single version and then back-translated into the original language. This is done to ensure that the translation still states in the target language what the original source intended. Most importantly, the goal is to be sure the questionnaire behaves statistically in the same way across all languages. It is the extra step needed to guarantee high quality translations, but it is also more than these textbook definitions.
Unlike translating for marketing efforts which concentrate on translation and transcreation to get their point across to widen their customer base, researchers in the medical field need to pinpoint the right words to use to reach their target audience and obtain the most genuine answers in order to best assess patients’ condition(s). Yes, you could ask patients to rate their pain on a scale from 1 and 10, but there are better options. For example, what does their pain inhibit them from doing? This will vary greatly from culture to culture, even different ages and sexes within the same culture. So, adapting the questions to various language, cultures and populations within these cultures is critically important to gathering the right data for valid analysis.
So, change the questions, but beware.
For a COA to assess a patient’s shoulder mobility, a more original answer to a question might be “I am able to shovel snow.” But consider how well this example would be in parts of the world that never receive snow. The patients might be confused and most likely answer ‘don’t know” or “not applicable,’ which in turn will skew the results of the international picture and threaten the value of total patient evidence.
For linguistic validation to be effective, every inch of cross cultural adaptation needs to be scrutinized. So, in tropical climates, perhaps changing this question to “I am able to carry grocery bags and lift them onto the counter” would be a better option in that country’s language.
Other things to consider is local diet. If the COA is interested in digestive health, the questions need to change slightly to match the region. In the USA, “I am able to eat soft foods such as mashed potatoes and apple sauce’ is acceptable. Farther east, perhaps ‘I am able to eat kefir and rice’ is a more suitable option.
Being sensitive to the way cultures view their conditions should also be taken into consideration. Some cultures may say, ‘I am embarrassed by my appearance’ due to my disease. Other cultures may need it worded slightly different, such as: “I am self-conscious about my appearance.”
Paying close attention to the semantics of a COA is vital to avoiding costly mistakes that could happen if an entire clinical study is invalidated at a late stage. The best part? It doesn’t cost a lot to bring in a translation company to determine the appropriate wording and phrasing that will not only preserve the integrity of the document but will help your COA find the answers it seeks. And, in turn, leave your clinical trial sailing on smooth seas.