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International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer
Corneel Coens1, Madeline Pe1, Amylou C Dueck2
1European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
The Lancet. Oncology
|February 3, 2020
Summary
Patient-reported outcomes (PROs) analysis in cancer trials lacks consensus. This review establishes recommendations for PRO data analysis, improving interpretation of treatment benefits and risks.
Area of Science:
- Oncology
- Biostatistics
- Health Outcomes Research
Background:
- Patient-reported outcomes (PROs) are crucial for evaluating cancer treatments in clinical trials.
- Current methods for analyzing PRO data in cancer randomized controlled trials (RCTs) lack standardization, hindering result interpretation.
Purpose of the Study:
- To establish consensus-based recommendations for analyzing PRO data in cancer RCTs.
- To address key issues including research objectives, statistical methods, terminology for missing data, and data management.
Main Methods:
- A literature review and collaborative process with international stakeholders.
- Development of a taxonomy for research objectives and identification of appropriate statistical methods.
- Standardization of terminology and methods for managing missing PRO data.
Main Results:
- Recommendations for PRO analysis in cancer RCTs have been developed.
- A framework for matching research objectives with statistical methods is proposed.
- Guidelines for handling missing PRO data are presented.
Conclusions:
- Standardized PRO analysis methods are essential for reliable interpretation of cancer trial results.
- These recommendations provide a foundation for consistent PRO data analysis and future research.
- Ongoing development will ensure recommendations remain current with evolving research practices.
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