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Patient-Reported Outcome Design and Analysis in Randomized Controlled Trials of Renal Cell Carcinoma: A Systematic
David Chen1, Sherry Chen2, Daisy Sun2
1Radiation Medicine Program, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada; Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; Division of Radiation Oncology, Department of Surgery, University of British Columbia, Vancouver, Ontario, Canada.
Clinical Genitourinary Cancer
|July 17, 2026
Summary
Patient-reported outcomes (PROs) are collected in renal cell carcinoma (RCC) trials, but their reporting lacks consistency. Improved prospective planning and transparent reporting in trial registrations, protocols, and publications are needed for clinical utility.
Area of Science:
- Oncology
- Clinical Trials Methodology
- Health Outcomes Research
Background:
- Patient-reported outcomes (PROs) are crucial for assessing treatment effects in renal cell carcinoma (RCC) trials.
- The clinical utility of PRO endpoints hinges on robust prespecification, meaningful thresholds, and transparent analysis.
- Existing literature highlights variability in PRO integration and reporting within clinical trial research.
Purpose of the Study:
- To evaluate the design, analysis, and reporting quality of PRO endpoints in randomized controlled trials (RCTs) for renal cell carcinoma (RCC).
- To assess concordance with the PRO Endpoint Analysis Score (PROEAS) framework across trial reports, protocols, and registrations.
- To identify common gaps in PRO prespecification and reporting to inform future trial conduct.
Main Methods:
- A systematic search of multiple databases (Embase, MEDLINE, Web of Science, CENTRAL, CINAHL, PsycINFO) was conducted for RCC RCTs published up to December 31, 2025.
- The PRO Endpoint Analysis Score (PROEAS), a 24-item framework based on SISAQOL recommendations, was used to evaluate PRO items in trial reports, protocols, and registrations.
- Descriptive subgroup analyses explored factors associated with higher PROEAS concordance.
Main Results:
- Fifty-five RCC RCT reports, 26 protocols, and 49 registrations were included.
- Moderate PROEAS concordance (61%) was observed in reports, while registrations (26%) and protocols (36%) showed low concordance.
- Frequent deficiencies included lack of hypothesis direction, undefined clinically meaningful thresholds, inadequate multiplicity handling, and insufficient missing-data plans.
Conclusions:
- While RCC trials frequently incorporate PROs, critical aspects like prespecification and handling of missing data are often incompletely reported.
- Trial registrations and protocols demonstrate significant gaps in PRO planning compared to published reports.
- Enhanced prospective planning and transparent reporting of PROs in trial registrations, protocols, and publications are essential to improve their clinical utility and inform patient care.
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