Development and content validation of a competency-based assessment tool for penile prosthesis surgery.

The aim of this study was to identify potential hazards for the inflatable penile prosthesis (IPP) surgical procedure and from this develop and content validate an IPP intraoperative competency-based assessment tool. A multi-institutional longitudinal prospective observational study was conducted over a 6-month period. Healthcare Failure Mode and Effects Analysis (HFMEA) methodology was used to prospectively risk assess the IPP procedure using a collaborative multidisciplinary team (MDT) approach. International content validation of the developed tool was then undertaken via face-to-face meetings and WebEx seminars. A total of 22 h of observation led to the construction of a detailed process map consisting of 11 stages and 49 sub-stages. HFMEA identified 50 failure modes and 45 failure mode effects, nine failure modes were excluded after analysis leaving 41 key failure modes included in the checklist. The high-risk steps identified were related to corporal dilatation, incorrect sizing of the prosthesis cylinders and incorrect localisation of the superficial inguinal ring for blind reservoir placement. The final content validated IPP assessment tool (PPAT) consisted of 13 processes and 27 sub-processes. We concluded that HFMEA methodology successfully allowed for the identification of key steps within the IPP procedure from which the PPAT was developed. Formal international content validation confirmed that all key procedural steps were included in the PPAT and that completion of all steps would indicate trainee competency in the procedure. Further validation is required before the tool can be used to assess learning curves for the IPP procedure.