Patient-Reported Outcome Design and Analysis in Randomized Controlled Trials of Renal Cell Carcinoma: A Systematic...

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.