title: Standards for Clinical Trials in Male and Female Sexual Dysfunction: II. Patient-Reported Outcome Measures.
abstract: The second article in this series, Standards for Clinical Trials in Male and Female Sexual Dysfunction, focuses on measurement of patient-reported outcomes (PROs). Together with the design of appropriate phase I to phase IV clinical trials, the development, validation, choice, and implementation of valid PRO measurements-the focus of the present article-form the foundation of research on treatments for male and female sexual dysfunctions. PRO measurements are assessments of any aspect of a patient's health status that come directly from the patient (ie, without the interpretation of the patient's responses by a physician or anyone else). PROs are essential for assessing male and female sexual dysfunction and treatment response, including symptom frequency and severity, personal distress, satisfaction, and other measurements of sexual and general health-related quality of life. Although there are some relatively objective measurements of sexual dysfunction (ie, intravaginal ejaculatory latency time, frequency of sexual activity, etc), these measurements do not comprehensively assess the occurrence and extent of sexual dysfunction or treatment on the patient's symptoms, functioning, and well-being. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient's perspective.
authors.affiliation: Department of Psychology and Department of Obstetrics and Gynaecology, Western University, London, ON, Canada. Electronic address: fisher@uwo.ca.
authors.forename: William A
authors.initials: WA
authors.lastname: Fisher
authors.affiliation: Department of Urology, Director, Neuro-urology Unit, Rambam Medical Center, Haifa, Israel.
authors.forename: Ilan
authors.initials: I
authors.lastname: Gruenwald
authors.affiliation: Endocrinology and Medical Sexology, Department of Systems Medicine, University of Rome, Tor Vergata, Italy.
authors.forename: Emmanuele A
authors.initials: EA
authors.lastname: Jannini
authors.affiliation: Department of Obstetrics and Gynecology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
authors.forename: Ahinoam
authors.initials: A
authors.lastname: Lev-Sagie
authors.affiliation: Department of Obstetrics and Gynecology, Rambam Medical Center, Haifa, Israel.
authors.forename: Lior
authors.initials: L
authors.lastname: Lowenstein
authors.affiliation: Pykonsult, LLC, New Fairfield, CT, USA.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Pyke
authors.affiliation: Medical Director Sexuality Clinics, Amstelland Hospital, Amstelveen, The Netherlands.
authors.forename: Yakov
authors.initials: Y
authors.lastname: Reisman
authors.affiliation: Outcomes Research, Evidera, Bethesda, MD, USA.
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Revicki
authors.affiliation: Asociación Mexicana para la Salud Sexual, AC, and Universidad Nacional Autónoma de México, Mexico City, Mexico.
authors.forename: Eusebio
authors.initials: E
authors.lastname: Rubio-Aurioles
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D012725:Sexual Behavior; D020018:Sexual Dysfunctions, Psychological / Q000628:therapy*
keywords: Clinical Trials; Patient-Reported Outcomes; Sexual Dysfunction