Translating patient-reported outcome measures: a multi-step process is essential

http://dx.doi.org/10.1590/S1806-37132014000300002 PRO measures and can meet the regulators’ requirements stated above. Usually, the process of translating PRO measures involves the following steps: translation of the original instrument into the target language by two independent translators and reconciliation into one version (forward step); translation of the reconciled version back into the language of the original instrument (backward step); review of the reconciled version with the participation of the developer of the original instrument; test on a panel of patients living in the target country (cognitive interview step); review of the test by a panel of experts; and finalization of the translated version of the instrument. Of course, all of those steps should always be preceded by one crucial step: one should always request permission to translate from the developer of the original instrument, to prevent any misuse or modifications that would impair the right of the original developer to the integrity of the instrument.(7) As previously mentioned, equivalence in content validity between the original and the translated versions is crucial. Validating the content of a PRO measure requires providing evidence that the questionnaire contains all the problems that are most important to the patients who are going to complete the questionnaire. Cultural and environmental (i.e., climate) issues have to be taken into consideration (e.g., going to market/ doing one’s shopping may be a problem in many countries but not so much in the United States, where most people drive; in tropical countries, asthma patients do not have to contend with snow and icy winds). Therefore the cognitive interviews with the patients must cover not only issues of comprehension but also cultural and environmental issues. Relevance of the questions to respondents should be checked and those that are obviously lacking from the perspective of content validity should be changed. For example, in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ), which Translating patient-reported outcome measures: a multi-step process is essential