title: Quality of life in patients with non-muscle-invasive bladder cancer: one-year results of a multicentre prospective cohort study.
abstract: OBJECTIVE
  Few studies describe the effect of non-muscle-invasive bladder cancer (NMIBC) on health-related quality of life (HRQL), although patients are mostly diagnosed at this stage of the disease. Taking into account this current evidence gap and the high incidence rates in Spain, we aimed to describe the evolution over time of HRQL in Spanish patients with NMIBC and to examine the clinical and treatment-related factors associated with HRQL change during the first year of management.
  
  
  METHODS
  Observational multicenter prospective inception cohort study conducted in urology departments of 7 Spanish hospitals. A consecutive sample of 244 patients with anatomopathologically confirmed NMIBC, recruited from October 2010 to September 2011, was followed during the diagnostic process, and 6 and 12 months later. HRQL was assessed by generic and disease-specific instruments: the Short Form-36 (covering physical and mental health) and the Bladder Cancer Index, measuring urinary, bowel, and sexual domains (summary scores: 0-100). Bivariate analysis was performed and generalized estimating equation models were constructed to assess HRQL score change.
  
  
  RESULTS
  Almost 52% of the patients were diagnosed at stage I, and 84% were men. The number of patients treated only with transurethral resection (TUR) was 144, and 82 also received intravesical therapy with bacillus Calmette-Guérin (BCG) or mitomycin C. Mental health was significantly worse than Short Form-36 reference norms at diagnosis (mean of 49.7 vs. 53.3, 95% CI: 52.5-54.2). Urinary domain improved significantly from diagnosis (85.2, 95% CI: 82.9-87.4) to 12-month evaluation (90.2, 95% CI: 87.7-92.8), whereas sexual domain showed deterioration from 56.4 (95% CI: 52.8-59.9) to 53.7 (95% CI: 50.0-57.4). Adjusted HRQL score changes from baseline to 12-month follow-up estimated with generalized estimating equation models showed improvement on the following parameters: urinary domain after TUR with or without intravesical therapy (+3.9, 95% CI: 0.1-7.7), bowel domain among patients treated with TUR and BCG (+7.0, 95% CI: 2.4-11.5), and sexual domain among those treated with TUR and mitomycin C (+13.1, 95% CI: 5.9-20.2).
  
  
  CONCLUSIONS
  For the first time, a distinctive HRQL pattern of bladder cancer treatment benefits emerges for TUR alone, and in combination with BCG or mitomycin C, which deserves further research. Treatment differences cannot be interpreted in terms of efficacy but can be useful to generate hypotheses to test in future studies.
authors.affiliation: Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Department of Experimental and Health Sciences, Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Spain.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schmidt
authors.affiliation: Department of Urology, Hospital del Mar, Barcelona, Spain.
authors.forename: Albert
authors.initials: A
authors.lastname: Francés
authors.affiliation: Department of Urology, Hospital del Mar, Barcelona, Spain.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Lorente Garin
authors.affiliation: Department of Pathology, Hospital del Mar, Barcelona, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Juanpere
authors.affiliation: Department of Experimental and Health Sciences, Universitat Pompeu Fabra (UPF), Barcelona, Spain; Department of Pathology, Hospital del Mar, Barcelona, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Lloreta Trull
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain; Department of Pediatric, Obstetrics and Gynecology and Preventive Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Bonfill
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
authors.forename: María José
authors.initials: MJ
authors.lastname: Martinez-Zapata
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Unit of Public Health and Environmental Care, Department of Preventive Medicine, University of Valencia, Valencia, Spain; Center for Public Health Research (CSISP), Valencia, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Morales Suarez-Varela
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Clinical Research Unit, Hospital 12 de Octubre, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: de la Cruz
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Clinical Epidemiology Unit, Hospital Universitario Donostia, BioDonostia, San Sebastian, Spain.
authors.forename: José Ignacio
authors.initials: JI
authors.lastname: Emparanza
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Escuela Andaluza de Salud Pública, Instituto de Investigación Biosanitaria ibs.GRANADA, Hospitales Universitarios de Granada/Universidad de Granada, Granada, Spain.
authors.forename: María-José
authors.initials: MJ
authors.lastname: Sánchez
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Clinical Biostatistics Unit, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Zamora
authors.affiliation: CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Clinical Epidemiology Unit, Hospital Universitario Cruces, BioCruces, Barakaldo, Spain.
authors.forename: José Ignacio
authors.initials: JI
authors.lastname: Pijoan
authors.affiliation: Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Department of Experimental and Health Sciences, Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Spain.
authors.forename: Jordi
authors.initials: J
authors.lastname: Alonso
authors.affiliation: Health Services Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Spain; Department of Pediatric, Obstetrics and Gynecology and Preventive Medicine, Universitat Autònoma de Barcelona (UAB), Barcelona, Spain. Electronic address: mferrer@imim.es.
authors.forename: Montse
authors.initials: M
authors.lastname: Ferrer
mesh_terms: D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D009367:Neoplasm Staging; D011446:Prospective Studies; D011788:Quality of Life; D001749:Urinary Bladder Neoplasms / Q000503:physiopathology* / Q000523:psychology* / Q000601:surgery
keywords: Bladder cancer; Non–muscle-invasive; Quality of life; Therapeutics