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In translation, patient questionnaires are not always as simple as they seem. These “Quality of Life” surveys are used for screening, diagnosing, measuring and/or monitoring mental health disorders like depression and anxiety. They are a key measure in the assessments of international clinical trials and for firms seeking regulatory approval for new drugs and therapies. In a certain sense, survey results go straight to label.

Also known as patient health questionnaires (PHQs), patient questionnaires are completed by the patient and then scored by health professionals and cognitive experts.

The Importance of Translation and Conceptual Equivalence

Each question on a patient questionnaire is designed for ease of understanding as well as its ability to elicit useful information related to a patient’s condition. In international clinical trials, it is likely that subjects do not share the same language and culture as the patient questionnaire’s authors. However, for good clinical practice it is important that subjects are able to understand the clinical questionnaire in the way it was intended so that the instrument is capable of capturing relevant data. This involves more than a pennies-per-word translation.

For a patient questionnaire, cross-cultural and conceptual equivalence are more important than linguistic equivalence. For example, straight translation of a patient questionnaire that lists foods and leisure activities common in one country would likely confuse subjects from a country located halfway around the world whose common foods and leisure activities are completely different. In other words, if the question isn’t clear to them, subjects won’t be able to give a relevant answer.

Cross-cultural and conceptual equivalence mean adaptive translation to ensure that the questionnaire is easy to understand and that it adequately achieves its goals by eliciting accurate responses, regardless of the translated language.

Methodologies for Translating Patient Questionnaires

There is more than one way to achieve clinically sound patient questionnaire translation, but inevitably some methodologies are more rigorous or more appropriate than others, depending on application. The best methodology will take into account clinical best practices, requirements of the governing regulatory agency and area of research. Not sure which methodology you need? Responsive Translation will serve as a strategic partner to ensure that your patient questionnaire is translated the way it should be.

One example is this methodology used by the World Health Organization for their instrument translation:

• Documentation. Each step in the process is appropriately documented with relevant details.
• Forward translation. The clinical questionnaire is initially translated by a qualified translator with experience in the field and familiarity with the instrument's terminology. The translator is instructed to seek conceptual equivalence and not a literal translation, and use clear language that is appropriate for the audience.
• Expert review. A review panel made up of relevant bilingual experts examines the translation and resolves any problems, concerns and discrepancies.
• Back translation. An independent translator back translates the instrument, emphasizing cultural and conceptual equivalence. Discrepancies in translation versions are resolved.
• Pretesting and cognitive debriefing. The instrument is pretested on a sample of the target population, who are then debriefed through interviews to check for understanding. Based on findings, appropriate changes are made.
• Final patient questionnaire. The final instrument is now ready for use in the field.

Experts in Clinical Translation

Responsive Translation has spent the last three decades building the most qualified translation teams and refining translation and validation processes for compliance-intensive industries. The result is patient questionnaire translation that meets the highest standards.

To discuss your requirements and goals, or for more information on Responsive Translation's range of clinical translation services, please contact us at +1-212-818-11025 or [email protected].