title: Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review.
abstract: OBJECTIVE
  Patient-reported outcomes (PRO) help patients, caretakers, clinicians, and policy makers make informed decisions regarding treatment effectiveness. Our objective was to assess the quality of PRO reporting and methodological strengths and weaknesses in randomized controlled trials (RCT) in bladder cancer.
  
  
  METHODS
  A systematic literature search of bladder cancer RCT published between January 2004 and March 2014 was performed. Relevant studies were evaluated using a predetermined extraction form that included trial demographics, clinical and PRO characteristics, and standards of PRO reporting based on recommendations of the International Society for Quality of Life Research.
  
  
  RESULTS
  In total, 9 RCTs enrolling 1,237 patients were evaluated. All studies were in patients with nonmetastatic disease. In 5 RCTs, a PRO was the primary end point. Most RCTs did not report the mode of administration of the PRO instrument or the methods of collecting data. No RCT addressed the statistical approaches for missing data.
  
  
  CONCLUSIONS
  We found that few RCTs in bladder cancer report PRO as an outcome. Efforts to expand PRO reporting to more RCTs and improve the quality of PRO reporting according to recognized standards are necessary for facilitating clinical decision making.
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: mfeuerste1@nshs.edu.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Feuerstein
authors.affiliation: Department of Medical Psychology, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: Jacobs
authors.affiliation: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Disease (GIMEMA), Rome, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Piciocchi
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Bernard
authors.initials: B
authors.lastname: Bochner
authors.affiliation: Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
authors.forename: Andrea
authors.initials: A
authors.lastname: Pusic
authors.affiliation: Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Technology and Science, Trondheim, Norway.
authors.forename: Peter
authors.initials: P
authors.lastname: Fayers
authors.affiliation: Centre for Surgical Research, School of Social & Community Medicine, University of Bristol and University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Blazeby
authors.affiliation: Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Disease (GIMEMA), Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Efficace
mesh_terms: D000066491:Clinical Decision-Making; D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D011788:Quality of Life / Q000523:psychology*; D057566:Self Report; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000523:psychology*
keywords: Bladder cancer; Clinical decision making; Clinical trials; Patient-reported outcomes; Quality of life