Urologic oncology · 2025
Measuring what matters to patients: Systematic literature review of patient-reported outcomes assessment and reporting in locally advanced or metastatic urothelial cancer real-world and clinical studies.
СтатьяСистематический обзорНазвание и аннотация: Перевод в очереди
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Kearney Mairead, Macmillan Thomas, Poritz Julia, Schreiber-Gosche Sherrie, Musat Mihaela Georgiana
Аннотация
INTRODUCTION: A systematic literature review (SLR) was conducted to evaluate patient-reported outcome (PRO) instruments used in clinical trials and real-world evidence (RWE) studies of locally advanced/metastatic urothelial cancer (la/mUC) therapies.
METHODS: Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.
RESULTS: The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.
CONCLUSIONS: PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.
METHODS: Five databases were used to identify publications up to May 29, 2024 and recent conference abstracts of phase 2/3 clinical trials and RWE studies. We reviewed reported adverse events and qualitative research to evaluate PRO instrument reporting quality using the CONSORT-PRO and ESMO-MCBS checklists.
RESULTS: The SLR identified 37 trials and 12 RWE studies. High heterogeneity in PRO instrument choice was observed (11/18 different instruments were used in 1 study each). The most common instrument was the EORTC QLQ-C30 (36 studies). Minimal clinically important difference thresholds were not consistently used (9/36 studies reporting EORTC QLQ-C30 used a 10-point threshold). Based on qualitative research findings, assessed PRO instruments did not comprehensively capture patient concerns, with symptom coverage ranging from 27% to 82%. Unexpectedly, baseline EORTC QLQ-C30 and Short Form-36 scores indicated that patients with la/mUC have a similar quality of life to the general population. In 18/37 clinical trials, PRO timepoints preceded the median clinical follow-up, with differences ranging from 0.96 to 59.4 months.
CONCLUSIONS: PROs can assist in the tailoring of treatment strategies to improve outcomes and can aid in enhancing communication between patients and healthcare professionals about treatment choice. Our evaluation of PRO reporting quality identified room for improvement in most studies, indicating a need for robust, consistent reporting of PRO data to adequately capture the experiences of patients with la/mUC.