Why you can’t afford to ignore Linguistic Validation for patient reported outcomes
06 Apr 2023
5 mins
In recent years, the life science industry has been diligently working towards providing more personalized and targeted care for individuals by adopting a more patient-centric approach to product development.
This, in part, means that, rather than relying solely on the observations of clinicians, caregivers, and trial observers, modern clinical trials are increasingly giving more weight to Patient Reported Outcomes (PROs). This shift in focus gives patients more of an active role in their care and plays an important part in advancing clinical research.
With this approach, clinical trials can more accurately measure and assess patient responses to treatments and provide data more representative of the true patient experience. However, there are many factors that can corrupt this data and make it unreliable. For example, if the patients providing the data each have a significantly different understanding of what is being asked of them, the data collected will not be comparable. The evaluations and conclusions that are derived from this data would hence be highly flawed.
The patient’s understanding is paramount in this scenario. Given most PROs are created in English and clinical research is conducted all over the world with patients and subjects of all languages and levels of comprehension, the transfer of PROs into a form that can be unequivocally understood by each patient is vital. To ensure that PROs are effectively translated and adapted across multiple languages and cultures without losing their originally intended meaning, it is necessary that they go through a specialist translation process. Namely, the highly risk averse process of Linguistic Validation.
The European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA) have both published guidance that recommends PROs be linguistically validated for patient use. Increasing regulations from the National Medical Products Administration (NMPA) China, the Pharmaceuticals and Medical Devices Agency (PMDA) Japan, and the Korean Ministry of Food and Drug Safety (MFDS) in relation to the growing movement to introduce PROs in clinical settings suggests similar guidance will impact these markets soon.
What is Linguistic Validation?
As mentioned in our earlier articles, Linguistic validation is a process designed to ensure PRO translations are linguistically accurate and culturally and conceptually equivalent to the original instrument. It ensures that translations are precise, consistent, and culturally appropriate, minimizing any risk of misunderstanding. Sponsors rely on the accuracy of these translations to have valid claims about the effectiveness of treatments.
The linguistic validation process involves several steps, including forward translation, back-translation, reconciliation, cognitive interviewing, and review by multiple individuals, such as translators, survey research analysts, quality specialists, clinicians/physicians, sponsors and their partners, and instrument developers.
The Linguistic Validation (LV) process is conducted in three parts; Harmonization, Review, and Cognitive Debriefing, which together ensure that the wording and concepts are accurately represented in the language being used by the target population.
- Harmonization: This step involves two translators producing two forward translations and then analyzing them to agree on one optimal translation.
- Review: During the review stage a separate translator takes the translation that has been harmonized and converts it back into the original language. After which, several reviews take place comparing the original language version with the back-translated version, making any necessary corrections or adjustments.
- Cognitive Debriefing: Lastly, cognitive debriefing is an interview conducted with a sample group of usually 5-8 native-speaking patients from the target region. It is a qualitative process designed to evaluate the conceptual equivalence of an assessment in a target language. It involves checking the translated text for both accuracy and suitability for the target culture. This process ensures that the target population correctly understands words and concepts of the original questionnaire.
The LV process is an important part of developing PROs for global populations. At RWS, the team diligently manages every part of this procedure, from highlighting any terms that may be misunderstood in the original language across target patients, to procuring participants for cognitive debriefing to making validation records and certifications.
Why is Linguistic Validation Important for PROs?
PROs are a type of Clinical Outcome Assessment that allow healthcare professionals to incorporate direct patient feedback into the evaluation of healthcare services and products. The use of PROs in a trial ensures the patient’s voice, describing their very personal experience, remains an intrinsic part of the drug and device development process.
Linguistic validation helps to ensure that translations of patient reported outcomes are reliable, valid and culturally appropriate and help gather accurate data from patients. Linguistically validating PROs is vital in making sure that PRO questionnaires are consistent across all languages and cultures in which the PROs will be administered. Through linguistic validation, medical professionals can ensure that PRO questionnaires are accurately translated and will be able to help gather the patient's experiences.
Our approach to Linguistic Validation
RWS offers advanced linguistic validation services and other value-added benefits to guarantee the accurate and timely collection of data for clinical trials. The RWS linguistic validation process is based on the U.S. Food and Drug Administration PRO guidance document and the International Society for Pharmacoeconomics and Outcomes Research Good Practice recommendations, and has been honed further over the past 20+ years. RWS Clinical Outcome Assessment (COA) Specialists are actively engaged in research in the COA space and are often cited in journals and papers issued by authorities, such as the FDA.
This level of understanding and experience of COAs is unrivalled in the Linguistic Validation space and has allowed RWS to build a whole suite of services and solutions for Clinical Outcome Assessments (COAs) and Linguistic Validation (LV). The mishandling of COAs can cause multiple problems and result in rejections from regulatory authorities that can create hindrances for healthcare companies. Partnering with RWS mitigates this risk. With RWS’ assistance and experience, organizations can benefit from a team of true experts in the clinical space.
The RWS approach to linguistic validation is comprehensive. We provide a dedicated team of experts, end-to-end process management and electronic COA process development to ensure that all parties involved in the linguistic validation process are managed and coordinated effectively. Our experienced survey research analyst and eCOA solutions teams, Linguistic Validation Center of Excellence for Quality, and expert licensing and Developer relationship management team provide the guidance and expertise needed to choose and process the most appropriate instruments for studies. With RWS’ years of experience and industry-leading standards, HCPs can be confident that linguistic validation will be carried out successfully. RWS also handles the translation of all clinical documents and provides extensive consulting and technology solutions in this area. Get in touch with our team to learn more about how RWS can help you.
Manchandan Kaur Sandhu
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