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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: Participants self-completed the draft PROM before and 6 mo after surgery. MEASUREMENTS: Question sets underwent psychometric assessment targeting criterion and content validity, test-retest reliability, internal consistency, acceptability, and responsiveness. RESULTS AND LIMITATIONS: 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.
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. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTION: Participants self-completed the draft PROM before and 6 mo after surgery. MEASUREMENTS: Question sets underwent psychometric assessment targeting criterion and content validity, test-retest reliability, internal consistency, acceptability, and responsiveness. RESULTS AND LIMITATIONS: 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: Luis A Kluth; Roland Dahlem; Andreas Becker; Marianne Schmid; Armin Soave; Clemens Rosenbaum; Tim A Ludwig; Natalie Christ; Michael Rink; Philip Reiss; Oliver Engel; Silke Riechardt; Felix K-H Chun; Margit Fisch; Sascha A Ahyai Journal: World J Urol Date: 2015-06-07 Impact factor: 4.226
Authors: Christopher A Tam; Sean P Elliott; Bryan B Voelzke; Jeremy B Myers; Alex J Vanni; Benjamin N Breyer; Thomas G Smith; Christopher D McClung; Bradley A Erickson Journal: Urology Date: 2016-04-21 Impact factor: 2.649
Authors: Nima Baradaran; Kirkpatrick B Fergus; Rachel A Moses; Darshan P Patel; Thomas W Gaither; Bryan B Voelzke; Thomas G Smith; Bradley A Erickson; Sean P Elliott; Nejd F Alsikafi; Alex J Vanni; Jill Buckley; Lee C Zhao; Jeremy B Myers; Benjamin N Breyer Journal: World J Urol Date: 2019-02-02 Impact factor: 4.226
Authors: Robert Pickard; Beatriz Goulao; Sonya Carnell; Jing Shen; Graeme MacLennan; John Norrie; Matt Breckons; Luke Vale; Paul Whybrow; Tim Rapley; Rebecca Forbes; Stephanie Currer; Mark Forrest; Jennifer Wilkinson; Elaine McColl; Daniela Andrich; Stewart Barclay; Jonathan Cook; Anthony Mundy; James N'Dow; Stephen Payne; Nick Watkin Journal: Health Technol Assess Date: 2020-11 Impact factor: 4.014
Authors: Rachel A Mann; Ramón Virasoro; Jessica M DeLong; Rafael E Estrella; Merycarla Pichardo; Ramón Rodríguez Lay; Gustavo Espino; Joshua D Roth; Sean P Elliott Journal: Can Urol Assoc J Date: 2021-02 Impact factor: 1.862