title: Defining a patient-reported outcome measure for urethral stricture surgery.
abstract: BACKGROUND
  A systematic literature review did not identify a formally validated patient-reported outcome measure (PROM) for urethral stricture surgery.
  
  
  OBJECTIVE
  Devise a PROM for urethral stricture surgery and evaluate its psychometric properties in a pilot study to determine suitability for wider implementation.
  
  
  METHODS
  Constructs were identified from existing condition-specific and health-related quality of life (HRQoL) instruments. Men scheduled for urethroplasty were prospectively enrolled at five centres.
  
  
  METHODS
  Participants self-completed the draft PROM before and 6 mo after surgery.
  
  
  METHODS
  Question sets underwent psychometric assessment targeting criterion and content validity, test-retest reliability, internal consistency, acceptability, and responsiveness.
  
  
  CONCLUSIONS
  A total of 85 men completed the preoperative PROM, with 49 also completing the postoperative PROM at a median of 146 d; and 31 the preoperative PROM twice at a median interval of 22 d for test-retest analysis. Expert opinion and patient feedback supported content validity. Excellent correlation between voiding symptom scores and maximum flow rate (r = -0.75), supported by parallel improvements in EQ-5D visual analogue and time trade-off scores, established criterion validity. Test-retest intraclass correlation coefficients ranged from 0.83 to 0.91 for the total voiding score and 0.93 for the construct overall; Cronbach's α was 0.80, ranging from 0.76 to 0.80 with any one item deleted. Item-total correlations ranged from 0.44 to 0.63. These values surpassed our predefined thresholds for item inclusion. Significant improvements in condition-specific and HRQoL components following urethroplasty demonstrated responsiveness to change (p < 0.0001). Wider implementation and review of the PROM will be required to establish generalisability across different disease states and for more complex interventions.
  
  
  CONCLUSIONS
  This pilot study has defined a succinct, practical, and psychometrically robust PROM designed specifically to quantify changes in voiding symptoms and HRQoL following urethral stricture surgery.
authors.affiliation: Department of Urology, Newcastle upon Tyne NHS Foundation Trust, Freeman Hospital, Newcastle upon Tyne, UK. matthewjackson@me.com
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Jackson
authors.forename: John
authors.initials: J
authors.lastname: Sciberras
authors.forename: Altaf
authors.initials: A
authors.lastname: Mangera
authors.forename: Andrew
authors.initials: A
authors.lastname: Brett
authors.forename: Nick
authors.initials: N
authors.lastname: Watkin
authors.forename: James M O
authors.initials: JM
authors.lastname: N'dow
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
authors.forename: Daniela E
authors.initials: DE
authors.lastname: Andrich
authors.forename: Robert S
authors.initials: RS
authors.lastname: Pickard
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Mundy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011594:Psychometrics; D015203:Reproducibility of Results; D057566:Self Report; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014525:Urethral Stricture / Q000601:surgery*; D055815:Young Adult