Italian Linguistic Validation of the FACE-Q Instrument

Abstract

Linguistic validation is essential in translating patient-reported outcomes.

As the implementation of evidence-based medicine grows in everyday practice, there is increasing pressure to adopt survey instruments to validate patient-reported outcomes. The use of questionnaires is the only scientific and objective way to analyze patients’ perceptions of their body before and after surgical procedures. Plastic surgery medical journals with international impact should require that studies include validated patient questionnaires on patient quality of life and body perceptions. The FACE-Q instruments can be incorporated into research and routine clinical practice to better understand the recovery process and effect of facial aesthetics procedures on quality of life as well as what patients think about their decision to have surgery.

Because of the prominence of the face on overall body appearance, surgical interventions in cosmetic surgery are most popular on the face. We translated and performed a linguistic validation of the FACE-Q instrument with facial appearance for use in Italian patients.

Methods

The translation was performed with participation of the original FACE-Q instrument authors and the Mapi Research Trust and World Health Organization recommendations (http://mapi-trust.org). The main steps taken therefore included forward and backward translations, 3 expert meetings and reports, and patient testing. All processes involved translators who worked independently and unaware of the whole translation process. The project manager overviewed each step of the process, coordinating the expert meetings and compiling a report after each step. The entire translation process took approximately 3 months. The translator used a simple and clear formulation to create a translation understandable for all patients. The study was approved by the ethics committee of Campus Bio-Medico University of Rome, and the participants provided verbal informed consent; there was no financial compensation.

The forward translation (from English to Italian) was pooled from 2 independent translations after a meeting in which 5 items were discussed with experts. Then, the comparison between the back translation of the first Italian version and the original English version of the questionnaires identified 4 more items to be debated. The expert panel adequately resolved these remaining questions.

Results

The translated version was tested on 2 groups with a total of 20 preoperative patients aged 18 to 45 years. The groups differed for the two independent translations that were tested in each group. The patients were white, native Italian speakers (8 women [40%] and 12 men [60%]), and they took between 3 and 7 minutes to complete each questionnaire, including the time for questions and clarifications. The comprehension test was performed through face-to-face interviews during which the project manager verified patient difficulties in understanding the questionnaire and checked the patient interpretation of all items. A final meeting allowed for discussion of 2 items that emerged from this last phase. The items were adjusted and the definitive version was released. The linguistic translation process led to a conceptually equivalent Italian version of the FACE-Q instrument.

Discussion

In medical research, a linguistic validation must be considered an essential translation step when working on a patient-reported outcome instrument in a differing language and/or culture. A clear and linear validation process helps to prepare the best translation for patients’ comprehension. The guidelines followed in the present assessment contributed to a straightforward translation methodology of the FACE-Q instrument, which is recommendable for future translations of questionnaires in the field of plastic surgery.