title: Development of a questionnaire specifically for patients with Ileal Orthotopic Neobladder (IONB).
abstract: BACKGROUND
  The ileal orthotopic neobladder (IONB) is often used in patients undergoing radical cystectomy. The IONB allows to void avoiding the disadvantages of the external urinary diversion.In IONB patients the quality of life (QoL) appears compromised by the need to urinate voluntarily. The patients need to wake up at night interrupting the sleep-wake rhythm with consequences on social and emotional life.At present the QoL in IONB patients is evaluated by generic questionnaires. These are useful when IONB patients are compared with patients with different urinary diversions but they are less effective when only IONB patients are evaluated. To address this problem a specific questionnaire-the IONB-PRO-was developed.
  
  
  METHODS
  A) Based on a conceptual framework, narrative-based interviews were conducted on 35 IONB patients. A basic pool of 43 items was produced and organized throughout two clinical and four QoL dimensions. An additional 15 IONB patients were interviewed for face validity testing.B) Psychometric testing was conducted on 145 IONB patients. Both classic test strategy and Rasch analysis were applied. Psychometric properties of the resulting scales were comparatively tested against other QoL-validated scales.
  
  
  RESULTS
  The IONB-PRO questionnaire includes two sections: one on the QoL and a second section on the capability of the patient to manage the IONB. For evaluation of the QoL, three versions were delivered: 1) a basic 23-item QoL version (3 domains 23-items; alpha 0.86÷ 9.69), 2) a short-form 12-item QoL scale (alpha = 0.947), and 3) a short-form 15-item Rasch QoL scale (alpha = 0.967). Correlations of the long version scales with the corresponding dimensions of the EORTC-QLQ C30 and the EORTC-BLM30 were significant. The short forms exhibited significant correlations with the global health dimension of the EORTC-QLQ and with the urinary subscales of the EORTC-BLM30. The effect size was approximately 1.00 between patients at the 1-year follow-up period and those with 3, 5, and > 5-year follow-up periods for all scales. No relevant differences were observed between the 12-item short-form and the Rasch scale.
  
  
  CONCLUSIONS
  The IONB-PRO long and short-forms demonstrated a high level of internal consistency and reliability with an excellent discriminanting validity.
authors.affiliation: Department of Urology, Trieste University, Cattinara Hospital Via Strada di Fiume 447, Trieste, 34100, Italy. siracus@units.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Siracusano
authors.forename: Mauro
authors.initials: M
authors.lastname: Niero
authors.forename: Cristina
authors.initials: C
authors.lastname: Lonardi
authors.forename: Maria Angela
authors.initials: MA
authors.lastname: Cerruto
authors.forename: Stefano
authors.initials: S
authors.lastname: Ciciliato
authors.forename: Laura
authors.initials: L
authors.lastname: Toffoli
authors.forename: Francesco
authors.initials: F
authors.lastname: Visalli
authors.forename: Davide
authors.initials: D
authors.lastname: Massidda
authors.forename: Massimo
authors.initials: M
authors.lastname: Iafrate
authors.forename: Walter
authors.initials: W
authors.lastname: Artibani
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Bassi
authors.forename: Ciro
authors.initials: C
authors.lastname: Imbimbo
authors.forename: Marco
authors.initials: M
authors.lastname: Racioppi
authors.forename: Renato
authors.initials: R
authors.lastname: Talamini
authors.forename: Carolina
authors.initials: C
authors.lastname: D'Elia
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cacciamani
authors.forename: Davide
authors.initials: D
authors.lastname: De Marchi
authors.forename: Tommaso
authors.initials: T
authors.lastname: Silvestri
authors.forename: Paolo
authors.initials: P
authors.lastname: Verze
authors.forename: Emanuele
authors.initials: E
authors.lastname: Belgrano
mesh_terms: D000328:Adult; D000368:Aged; D015653:Cystectomy; D005260:Female; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D007082:Ileum / Q000601:surgery; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014547:Urinary Diversion / Q000379:methods / Q000523:psychology