New Series, Vol. 1
Edited By Barbara Lewandowska-Tomaszczyk, Marcel Thelen, Gys-Walt van Egdom, Dirk Verbeeck and Łukasz Bogucki
Cognitive Debriefing of Patient Questionnaires: How to Capture Meaning as Understood by Respondents?
Abstract: Patient questionnaires are widely used in clinical trials as instruments for measuring the efficacy of new drugs or treatments. Therefore, the requirements with respect to the quality of translation of such questionnaires are extremely high. The paper describes the results of a linguistic experiment that was carried out in order to evaluate the advantages and disadvantages of an alternative method for testing the comprehension of patient questionnaires by respondents. Preliminary results show that the new method may be used as an optional tool together with the existing methods. More research is needed in order to investigate possible cultural differences between respondents from different cultural and linguistic groups.
Keywords: clinical trials, cognitive debriefing, cognitive interviewing, language of medicine, linguistic validation, medical translation, patient questionnaires, patient-reported outcomes (PRO), PRO questionnaires, translation quality assessment.
Few would disagree that medical translation belongs to the most challenging types of translation, both in terms of the required subject matter expertise and the associated ethical and legal considerations. There is a wide variety of source texts that belong to the field of medical translation, including patient information leaflets, user manuals for medical devices, pharmacovigilance reports, clinical trial protocols and many others. Some medical documents, e.g. investigator brochures and summaries of product characteristics, are intended for an expert audience only, whereas others, such as informed consent forms and patient information leaflets, are developed for the general public. Patient questionnaires belong to the latter group; however, they have...
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