 Our Linguistic Validation Process Before finalizing any of the translations, a linguistic validation with patients representative of the population who will be enrolled in the clinical trial is performed. This linguistic validation consists of a pilot test to evaluate the patient's understanding of the target language in the instructions and questionnaires. Each patient will be interviewed to confirm that his or her answers corresponded to an understanding of the questions as intended by the developers of the questionniares. This ensures that all completed questionnaires from a study are balanced and equivalent across all languages and can be pooled for statistical analysis. | Statistical Validation of Questionniares The Health Outcomes Group methodology for validating a questionnaire in multiple languages: First, we look for linguistic equivalence between the questionnaires in all required languages. Our goal is that patients in the target population reading a translation of the questionnaire have an understanding that is functionally equivalent to that of similar patients reading the questions in the source language. Next, we measure statistical equivalence by performing a statistical assessment of the performance characteristics of two or more samples of patients completing linguistically equivalent questionnaires. When performing the statistical assessment we are looking for: internal consistency equivalence, reliability equivalence, responsiveness equivalence of both positive changes and negative changes and meaningfulness equivalence. |
