Patient reported outcomes in the assessment of premature ejaculation.

The term 'Patient Reported Outcome', abbreviated as PRO, was introduced by the US Food and Drug Administration (FDA) which proposed guidance on the development and validation of PROs. Previously PROs were known as self-report diaries, event-logs, self-administered questionnaires, and clinician administered rating scales. PROs seek to capture the subjective perceptions of patients and/or partner's related to their specific symptoms, degree of bother, efficacy of a medication or psychotherapy intervention, and quality of life issues related to a specific condition. This article reviews the essential psychometric and regulatory agency requirements in the development of PROs. The constructs of reliability, various forms of validity, sensitivity, and specificity as well as concerns with translating a PRO into a different language are reviewed. Three PROs, the Premature Ejaculation Profile (PEP), the Index of Premature Ejaculation (IPE) and the Premature Ejaculation Diagnostic Tool (PEDT) all used in the assessment of premature ejaculation (PE) are discussed. These questionnaires meet or exceed all the psychometric requirements and have been employed in clinical trials and observational studies of men with PE. The article concludes on discussing some of the limitations of PRO use and recommendations for the future.