Patient-Reported Outcome Design and Analysis in Randomized Controlled Trials of Renal Cell Carcinoma: A Systematic Review
In brief
Only one-third of RCC trial registrations pre-specify patient-reported outcomes
In a review of 55 renal cell carcinoma randomized trials, published reports met patient-reported outcome design criteria 61% of the time, but registrations and protocols did so in only 26% and 36% respectively. Common omissions included hypothesis direction, meaningful thresholds, and missing-data plans, suggesting the need for stricter prospective PRO planning.
- Journal
- Clinical genitourinary cancer (Q1)
- Published
- 30 June 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- David Chen, Sherry Chen, Daisy Sun, Edward Chow, Shing Fung Lee, Henry C Y Wong, et al.
- PMID
- 42468185
- DOI
- 10.1016/j.clgc.2026.102607
Why clinicians should know about it
- Picked for Oncology and Radiation Oncology (top studies of the week, 19 July 2026): Systematic review of PRO design in RCC trials
- Picked for Nephrology (top studies of the week, 19 July 2026).
- Picked for Urology (top studies of the week, 19 July 2026).
Abstract
The clinical utility of patient-reported outcome (PRO) endpoints in renal cell carcinoma (RCC) trials depends on prespecification, clinically meaningful thresholds, and transparent analysis. We evaluated PRO design, analysis, and reporting in RCC randomized controlled trials using the independently developed PRO Endpoint Analysis Score (PROEAS), a 24-item framework based on SISAQOL recommendations. We searched Embase, MEDLINE, Web of Science Core Collection, CENTRAL, CINAHL, and PsycINFO through December 31, 2025, for RCC-only randomized controlled trial reports including at least 1 PRO measured with a patient-reported outcome measure. Linked protocols and registrations were sought. Eligible PROEAS items were assessed in reports, protocols, and registrations. Subgroup analyses were descriptive. We included 55 RCC randomized trial reports, 26 protocols, and 49 registrations. Reports showed moderate PROEAS concordance of 61% (95% CI, 55%-67%), while registrations at 26% (95% CI, 17%-35%) and protocols at 36% (95% CI, 29%-44%) showed low concordance. Frequent gaps included hypothesis direction, clinically meaningful thresholds, multiplicity handling, and missing-data planning. Initial all-rater agreement was 90.3% for reports, 86.5% for protocols, and 49.0% for registrations. Descriptive subgroup analyses suggested higher report concordance in trials with PROs as primary endpoints, PROs mentioned in the abstract, and larger sample sizes. RCC trials commonly collect PROs, but prespecification and missing-data methods are often incompletely reported. These findings support more consistent prospective PRO planning and reporting in trial registrations, protocols, and publications.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.