ArticleEClinicalMedicine2024
15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis.
Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Functional Outcomes and Quality of Life for Patients With Cachexia and Solid Tumour Cancers: Findings of a Systematic Literature Review.Journal of cachexia, sarcopenia and muscle · 2026Pooled it
- The quality of life assessment of breast cancer patients.Breast disease · 2024Pooled it
- Physical activity and quality of life in breast cancer survivors.Breast disease · 2024Pooled it
- Two decades of kidney stone interventional trials on clinicaltrials.gov: a registry-based landscape analysis of design, endpoints, and dissemination.Urolithiasis · 2026Article
- Survivorship Challenges in Metastatic Prostate Cancer in the Era of Prolonged Survival: A Review.Cancers · 2026Review
- Locked-Window EQ-5D-5L (Index and VAS) Benchmarking in Sarcoma Care: Rule-Based Traffic-Light Classification Across Two Institutions.Diseases (Basel, Switzerland) · 2026Article
- The opportunities and barriers for developing tumour-infiltrating lymphocyte therapy for patients with advanced genitourinary cancers.Nature reviews. Urology · 2026Review
- Unraveling assumptions about clinical relevance in patient-reported outcome data : A qualitative study on perspectives of different interest groups.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Harnessing patient health data to benefit individuals and advance research: a focus on rheumatoid arthritis - a narrative review.BMJ digital health & AI · 2026Review
- Prospective Psychometric Validation of the Swahili Translated and Adapted Pediatric Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE).Measurement and evaluations in cancer care · 2025Article
- From patient voices to optimal PROMs: a mixed methods framework for cancer survivorship care.Journal of cancer survivorship : research and practice · 2025Article
- Remote monitoring in older adults with cancer, opportunities and challenges: a narrative review.Aging clinical and experimental research · 2025Review
- Understanding molecular mechanism of diabetic wound healing: addressing recent advancements in therapeutic managements.Journal of diabetes and metabolic disorders · 2025Review
- Health-related quality of life outcomes in randomized controlled trials in metastatic hormone-sensitive prostate cancer: a systematic review.EClinicalMedicine · 2024Review
- [Patient-reported outcomes-the role of the patient's subjective perspective for research and clinical care].Urologie (Heidelberg, Germany) · 2024Review
- Feasibility of a Smartphone Application for Education and Symptom Management of Patients With Renal Cell Carcinoma on Combined Tyrosine Kinase and Immune Checkpoint Inhibitors.JCO clinical cancer informatics · 2024Article
- Planning, Reporting, and Selective Disclosure of Quality-of-Life End Points in Phase III Genitourinary Cancer Trials.JCO oncology advancesArticle
Corrections and comments
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Authors and funding
16 authors.
Funding
Abstract
Background: Standardized, high-quality PRO data reporting is crucial for patient centered care in the field of oncology, especially in clinical trials that establish standard of care. This study evaluated PRO endpoint design, conduct and reporting methods in FDA approved drugs for GU malignancies. Methods: A systematic review of the FDA archives identified GU cancer drug approvals from Feb 2007 to July 2022. ClinicalTrials.gov and PubMed were used to retrieve relevant data. PRO data was screened, and analytic tools, interpretation methods in the published papers and study protocols were reviewed. Compliance with PRO reporting standards were assessed using PRO Endpoint Analysis Score (PROEAS), a 24-point scoring scale from Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium (SISAQOL). Findings: We assessed 40 trial protocols with 27,011 participants, resulting in 14 renal cell cancer (RCC), 16 prostate cancer (PC), and 10 urothelial cancer (UC) approvals. PRO data was published for 27 trials, with 23 PRO publications (85%) focusing solely on PRO data, while 4 (15%) included PRO data in the original paper. Median time between primary clinical and secondary paper with PRO data was 10.5 months (range: 9-25 months). PROs were not planned as primary endpoints for any study but 14 (52%) reported them as secondary, 10 (37%) as exploratory outcomes, and 3 (11%) lacked any clarity on PRO data as endpoint. Mean PROEAS score of all GU cancers was 11.10 (range: 6-15), RCC (11.86, range: 6-15), UC (11.50, range: 9-14), and PC (10.56, range: 6-15). None met all the SISAQOL recommendations. Interpretation: Low overall PROEAS score and delays in PRO data publication in GU cancer drug trials conducted in the past decade emphasize the need for improvement in quality of design and conduct of PRO endpoint in future trials and accelerated publication of PRO endpoints, using standardized analysis, and prespecified hypothesis driven endpoint. These improvements are essential for facilitating interpretation and application of PRO study findings to define patient care. Funding: None.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.