Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

Michael A Feuerstein; Marc Jacobs; Alfonso Piciocchi; Bernard Bochner; Andrea Pusic; Peter Fayers; Jane Blazeby; Fabio Efficace; Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry

doi:10.1016/j.urolonc.2015.04.002

Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review

Urol Oncol. 2015 Jul;33(7):331.e17-23. doi: 10.1016/j.urolonc.2015.04.002. Epub 2015 May 5.

Authors

Michael A Feuerstein¹, Marc Jacobs², Alfonso Piciocchi³, Bernard Bochner⁴, Andrea Pusic⁴, Peter Fayers⁵, Jane Blazeby⁶, Fabio Efficace³; Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry

Affiliations

¹ Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: mfeuerste1@nshs.edu.
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 Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY.
⁵ 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.
⁶ Centre for Surgical Research, School of Social & Community Medicine, University of Bristol and University Hospitals Bristol NHS Foundation Trust, Bristol, UK.

Abstract

Objectives: 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.

Keywords: Bladder cancer; Clinical decision making; Clinical trials; Patient-reported outcomes; Quality of life.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review
Systematic Review

MeSH terms

Clinical Decision-Making
Clinical Trials as Topic / methods*
Humans
Quality of Life / psychology*
Self Report
Treatment Outcome
Urinary Bladder Neoplasms / diagnosis*
Urinary Bladder Neoplasms / psychology*

Abstract

Publication types

MeSH terms

Grants and funding