Bringing the Patient Perspective to the Forefront
There has been a rapid shift towards patient-centred research in the life sciences in order to inform and improve health care decisions and develop therapies and treatments that bridge the gap between patients’ expectations and clinical reality. To this end, several measures are being used to capture patients’ perspectives at early stages of healthcare research. These measures include clinical outcome assessments (COAs) such as patient-reported outcomes (PROs), clinician-reported outcomes (ClinROs) and Observer-reported outcomes (ObsROs).
In clinical research, these measures are commonly referred to as instruments and contain standardized, validated questionnaires. For instance, according to an article in BJA Education, PRO questionnaires are completed by patients “to ascertain their perceptions of their health status, perceived level of impairment, disability and health-related quality of life.” These tools play a crucial role in clinical decision making, research and development and approval of new therapies. For a COA to be approved and used in multi-national trials, it is important to ensure that they are valid and reliable. To this end, outcome assessments need to undergo the linguistic validation process.
Linguistic Validation: beyond academic translation
Linguistic validation is used in clinical research to evaluate the validity and reliability of COAs before being used in multi-national trials. LV is a process to ensure that the COA is appropriately translated in patients’ target language so that the meaning intended in the source language remains intact in the target language.
Moreover, cultural differences and linguistic nuances may lead to the patients misunderstanding the questions, which in turn may result in misleading research and trial outcomes. Therefore, it is imperative that the instruments are localized and adapted to the target culture (while retaining the original meaning) so that they can easily relate to the questions and respond appropriately. Given this added complexity, it is recommended to seek professional service providers for LV as they will ensure that the translated instrument is not only linguistically correct but also culturally appropriate.
Linguistic Validation process
LV involves a rigorous multi-step process that follows the guidelines of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
The first step of the LV process involves the simultaneous article translation of the source text by a team of two or more independent translators into the target language. The team of translators should consist of professional translators who are not only native speakers of the target language but also familiar with the field of research.
In this step, a third professional reviews and compares the different versions of the forward translation, resolves discrepancies and combines them into a new version. This step is also commonly known as target harmonization. The reconciling translator should also be a native speaker of the target language who understands the cultural as well as contextual nuances and can make necessary adaptations, making the content easy to understand for the target audience.
As the name suggests, this step involves the translation of the reconciled version from the target language back into the source language. The back translations are performed by two independent translators in parallel and are performed blindly, i.e., without the translators being aware of the original source content.
Final review and corrected translation
In this step, the independent versions of the back translation are reviewed and analyzed for discrepancies and are also compared with the original source text. This review highlights the necessary changes that need to be made in the reconciled forward translation to finally obtain a usable instrument for research.
Before the harmonized version of the instrument is used in clinical trials, there needs to be confirmation that the target audience understands the translated questions in the same way as intended in the original. This is achieved by pilot testing the instrument with a sample of the representative population. Therefore, this process is also called pilot testing. Cognitive debriefing (CD) is a crucial step of content validation as it is a rigorous evaluation of the conceptual equivalence of the two versions of the clinical instrument. The process of CD involves the following steps.
Psychologist or clinician review
Before conducting the CD interviews, the harmonized version is reviewed by psychologists or clinicians practising in the field of research and suggested changes are incorporated as necessary.
Recruitment of respondents
Respondents who represent the instrument’s target population are recruited for CD interviews. Typically, the interviews involve five respondents, meeting the following criteria:
Native speakers of the target language
Belong to the target culture
From different socioeconomic backgrounds
Men or women
Specified age range
In this step, the respondents first complete the clinical survey and are then interviewed by an experienced investigator to evaluate whether the meaning of each question/item was understood correctly by the respondents. The investigator seeks the respondents feedback on the readability and clarity of the questions, understanding of the questions, and difficult terms, if any, used in the questionnaire.
The investigator is ideally a native speaker of the target language, lives in the target country and conducts in-person interviews. Moreover, the investigator needs to be an expert or practitioner in the field of research who is experienced in probing the respondents to unravel the potential difficulties and cultural nuances in answering and understanding the instrument.
After completing the interviews, the investigator prepares a report in a set template to record the findings of the interview. The report includes all demographic and medical details of the participants, an account of their responses and recommendations for the translators.
Incorporation of recommendations
The recommendations highlighted in the interview report are reviewed and incorporated in the harmonized version by the translators. In addition, they prepare a full report giving the details of the LV and CD process confirming that the harmonized instrument is equally valid in the target language.
This is the final step of the validation process, which involves formatting the questionnaire in accordance with the original version and proofreading by a native speaker of the target language to ensure there are no typographical errors.
How we can help
With a team of professionals from around the world, we provide you with an accurate and reliable linguistic validation of your project. Your project will be completed by an expert in your field who is also a native speaker in your target language. We work with all major languages and can help you with your specific requirements.
We ensure that the process is completed rigorously and deliver a high standard of localization for your instrument. Our team of experts are experienced in understanding and interviewing the patients and ensuring a sound CD for your instruments. After the entire process of LV is completed, you will receive a certificate of quality that your translation meets the highest linguistic and professional standards.
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