PD14-07 PHASE I DEVELOPMENT OF A PATIENT REPORTED OUTCOME MEASURE FOR MALE URETHRAL STRICTURE DISEASE

Abstract

You have accessJournal of UrologyTrauma/Reconstruction: Urethral Reconstruction (including Stricture) II1 Apr 2015PD14-07 PHASE I DEVELOPMENT OF A PATIENT REPORTED OUTCOME MEASURE FOR MALE URETHRAL STRICTURE DISEASE Benjamin Breyer, Todd Edwards, Donald Patrick, and Bryan Voelzke Benjamin BreyerBenjamin Breyer More articles by this author , Todd EdwardsTodd Edwards More articles by this author , Donald PatrickDonald Patrick More articles by this author , and Bryan VoelzkeBryan Voelzke More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.1336AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patient reported outcome measures (PROMs) are important for assessing aspects of urethral stricture disease that are known only to the patient. PROM-based results are tied increasingly to health care funding and management. The availability of comprehensive, valid and reliable PROMs for urethral stricture is important. Our objective is to develop a urethral stricture-specific PROM to be used for assessing treatments for urethral stricture. Here we describe a Phase I study to elicit vital content related to men with a urethral stricture. METHODS We performed concept elicitation interviews with men with urethral strictures in the pre- and post-op setting. Qualitative interviews were stopped after concept saturation was reliably noted (n=16). Interviewees included 12 men with bulbar and 4 men with penile strictures. Median age was 51 (range 29-70). The cohort included Caucasian (13), Hispanic (1), African-American (1), and Asian (1) men. The interviews were audio-recorded and transcribed. Specific content regarding impaired urinary/sexual function and quality of life were excerpted and coded by investigators using a qualitative analysis program. We organized the content into domains by consensus. Existing PROMs with content relevant for urinary and sexual function were reviewed to incorporate legacy items. RESULTS We identified 35 potential items (13 legacy and 22 new) for possible PROM inclusion. Most content pertained to urinary impact (n=15), function (n=7) and symptoms (n=6). Seven items were related to sexual impact (n=4), symptoms (n=2) and function (n=1). Urinary content included emotional impact of urethral stricture including worry (n=4), embarrassment (n=2), and depression (n=1), as well as those related to changing daily activities to manage stricture symptoms (n=4) including “I quit doing things I like to do” and “I had to plan everything ahead.” Urinary function content included obstruction (n=4) and trouble aiming the stream (n=1). Urinary symptom content related to pain (n=3), nocturia (n=1) and urgency (n=1). Of the items related to sexual activity (n=7), most related to ejaculation (n=5), both weak (n=2) and unsatisfying (n=1), while pain was also elicited (n=2). CONCLUSIONS Using qualitative inductive methodology, we have obtained patient-centered data suitable for a comprehensive urethral stricture-specific PROM. Future studies will include cognitive interviews of the draft instrument and multi-center field testing to assess the instrument's measurement properties, including its sensitivity to detect change following treatment. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e321 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Breyer More articles by this author Todd Edwards More articles by this author Donald Patrick More articles by this author Bryan Voelzke More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...