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

On behalf of 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

On behalf of Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

12 Citations (Scopus)

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.

Original language	English
Pages (from-to)	331.e17-331.e23
Number of pages	7
Journal	Urologic Oncology: Seminars and Original Investigations
Volume	33
Issue number	7
Early online date	5 May 2015
DOIs	https://doi.org/10.1016/j.urolonc.2015.04.002
Publication status	Published - Jul 2015

Bibliographical note

We are grateful to the EORTC Quality of Life Group for having supported the development of the PROMOTION Registry. We also acknowledge the essential contribution of Alessandro Perreca and Salvatore Soldati, from the GIMEMA Health Outcomes Research Unit, for data management. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Keywords

Bladder cancer
Clinical decision making
Clinical trials
Patient-reported outcomes
Quality of life

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Quality of life and symptom assessment in randomized clinical trials of bladder cancer: A systematic review. / On behalf of Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry.
In: Urologic Oncology: Seminars and Original Investigations, Vol. 33, No. 7, 07.2015, p. 331.e17-331.e23.

Research output: Contribution to journal › Article › peer-review

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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",

author = "Feuerstein, {Michael A.} and Marc Jacobs and Alfonso Piciocchi and Bernard Bochner and Andrea Pusic and Peter Fayers and Jane Blazeby and Fabio Efficace and {On behalf of Patient-Reported Outcome Measurements Over Time In Oncology-PROMOTION Registry}",

note = "We are grateful to the EORTC Quality of Life Group for having supported the development of the PROMOTION Registry. We also acknowledge the essential contribution of Alessandro Perreca and Salvatore Soldati, from the GIMEMA Health Outcomes Research Unit, for data management. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.",

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N2 - 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.

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KW - Clinical decision making

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

Abstract

Bibliographical note

Keywords

UN SDGs

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