title: Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire.
abstract: OBJECTIVE
  The impact of treatment on the health related quality of life (HRQOL) of patients is being recognized with increasing importance, particularly in those with urological malignancies. However, a validated disease and treatment specific instrument to assess HRQOL following radical cystectomy (RC) and urinary diversion (UD) is currently lacking. We report the results of a new questionnaire designed specifically to measure HRQOL in these patients.
  
  
  METHODS
  A 45-item questionnaire consisting of the Functional Assessment of Cancer Therapy (FACT)-General and 17 additional items designed to measure disease and treatment specific health outcomes were combined to form the Vanderbilt Cystectomy Index (FACT-VCI). FACT-VCI and the generic RAND 36-Item Health Survey (SF-36) were administered to 50 patients from our institution RC data base who were more than 1 year from the time of surgery. Each patient was asked to complete the survey at 1 and 4 weeks. The results of the SF-36 and FACT-VCI were correlated along with the first and second administration of the FACT-VCI.
  
  
  RESULTS
  Overall FACT-VCI was found to have adequate internal consistency (Cronbach's alpha >0.70). Furthermore, intraclass correlation for the first and second administration of the VCI was 0.79. In addition, there was good correlation between the validated SF-36 and FACT-VCI (r = 0.81). The result was initial validation of a questionnaire for the assessment of HRQOL in patients following RC and UD.
  
  
  CONCLUSIONS
  Instruments designed to measure accurately HRQOL following RC and UD are in early development. We have now constructed and validated a disease and treatment specific questionnaire that can objectively assess HRQOL following RC and UD. A prospective longitudinal study of FACT-VCI is currently ongoing.
authors.affiliation: Department of Urologic Surgery, Vanderbilt University School of Medicine, VU Medical Center, A-1302 Medical Center North, Nashville, TN 37232-2765, USA. michael.cookson@vanderbilt.edu
authors.forename: Michael S
authors.initials: MS
authors.lastname: Cookson
authors.forename: Sajal C
authors.initials: SC
authors.lastname: Dutta
authors.forename: Sam S
authors.initials: SS
authors.lastname: Chang
authors.forename: Travis
authors.initials: T
authors.lastname: Clark
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Smith
authors.forename: Nancy
authors.initials: N
authors.lastname: Wells
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002295:Carcinoma, Transitional Cell / Q000523:psychology / Q000601:surgery*; D015653:Cystectomy / Q000523:psychology*; D005260:Female; D005500:Follow-Up Studies; D006306:Health Surveys; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000523:psychology*; D011594:Psychometrics; D011788:Quality of Life / Q000523:psychology*; D015203:Reproducibility of Results; D018434:Sickness Impact Profile; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000523:psychology / Q000601:surgery*; D014547:Urinary Diversion / Q000523:psychology*; D016476:Urinary Reservoirs, Continent