The process of translation and cross cultural adaptation of the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire, as part of the Phoenix Registry

Introduction & Objectives: According to the EAU guidelines, a penile prosthesis implant (PPI) is indicated as third line option in patients non responding to other treatments for Erectile Dysfunction (ED) or preferring a permanent solution to their problem. In patients receiving a PPI as well as their partners high satisfaction rates have been reported. To date however a validated multi language questionnaire to assess prosthesis specific satisfaction is missing. In 2014 the Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire was published (J Sex Med. 2014;11:1005-12), but is lacking linguistic and cross-cultural validation in other languages than Italian. As part of the Phoenix registry (prospective registry that aims to follow-up 1000 patients with a PPI), the QoLSPP is undergoing a robust validation process in English and in six other languages. Materials & Methods: The translation process is performed according to the international ISPOR guidelines (the professional society for health economics and outcomes research), including multiple forward and backward translations, as well as cognitive debriefing, by means of patient interviews. Results: The original Italian QoLSPP was first translated into English. Two independent forward translations were performed, which were compared by a third independent linguist to create a unified translation. This reconciled document was translated back, and after review of all versions by the project team qualitative interviews with 5 patients with ED were conducted and the translation was finalized. During discussions however with local interviewers there appeared to be differences in the interpretation of the meaning of some questions. These issues were discussed with the QoLSPP designers and led to a modified English version of the QoLSPP. Because of the modifications a new round of cognitive debriefing was needed. Five English patients with a PPI were interviewed. The interview results were discussed with the designers and the English QoLSPP was modified again. After another round of three interviews the English version was finalized. This modified version was used for translations from English into Spanish, Dutch, French, German, Portuguese and Swedish. The Italian QoLSPP has also been adapted based on the modified English version. Currently the translated questionnaires are being tested by means of patient interviews in the different countries. Conclusions: The gap of a dedicated tool that allows to assess QoL in recipients of a PPI is close to be filled. The QoLSPP has been linguistically and culturally validated in several languages and will be shortly available to different countries. It is expected that this questionnaire will prove instrumental in comparing short and long term QoL results of penile prosthetic surgery, performed in different regions, with different devices.