(281) Linguistic and Cultural Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI) for Brazilian Portuguese and Tri-Continental Spanish Speakers

Abstract

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) has been validated in English. No validated Portuguese and Spanish versions currently exist. Objective We aimed to linguistically validate SSIPI in Portuguese and Spanish to evaluate satisfaction outcomes with a validated instrument. Methods Our methodology adhered to best practices established by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and involved: forward translation of the 16-item SSIPI into Portuguese and Spanish by 2 independent IPP surgeons, reconciliation, back translation into English by 2 different independent bilingual IPP surgeons, and comparison to the original SSIPI for conceptual equivalence. The translated SSIPI versions underwent in-parallel cognitive debriefing (CD) at the US, Colombia, Spain, and Brazil centers. All interviews were recorded in person or via secure video conference to determine if misunderstandings or modifications were needed. Results 12 and 17 native Portuguese and Spanish speakers, respectively, with IPPs, participated in the CD process for their native language SSIPI. Interviews lasted approximately 1 hour each. The Portuguese SSIPI validation was conducted at 2 different centers in Brazil, resulting in 83% of the patients reporting that the survey was easy to answer. Of 16 questions, only 3 (Q7, Q11, and Q16) raised concerns for 6 patients. 5 patients had issues with the concept of the word “naturalness” and “spontaneity” from Q7 and Q16. One patient struggled with interpreting the word “conceal” in Q11. Regarding the duration taken to answer, 10/12 patients said it was acceptable. The Spanish SSIPI was tested at 4 US, Colombia, and Spain academic centers. 63% indicated the survey was easy to answer. In most cases, replacing a single word in the item with another was proposed. 53% had difficulties comprehending the answer choice options with Q3; however, all participants perceived the time required to complete the SSIPI as reasonable. Conclusions While the Portuguese SSIPI has been demonstrated to be easier to read and interpret than the Spanish SSIPI, with minor changes to wording/phrasing, both versions have the potential to improve IPP outcomes literature globally. Concerning questions will be modified before conducting the final validation steps. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman.