Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review |
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| Affiliation: | 1. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY;2. Department of Medical Psychology, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands;3. Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Disease (GIMEMA), Rome, Italy;4. Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK;5. Department of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Technology and Science, Trondheim, Norway;6. Centre for Surgical Research, School of Social & Community Medicine, University of Bristol and University Hospitals Bristol NHS Foundation Trust, Bristol, UK |
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| Abstract: | ObjectivesPatient-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.MethodsA 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.ResultsIn 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.ConclusionsWe 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. |
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| Keywords: | Bladder cancer Patient-reported outcomes Clinical trials Quality of life Clinical decision making |
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