ArticleJCO oncology advances
Planning, Reporting, and Selective Disclosure of Quality-of-Life End Points in Phase III Genitourinary Cancer Trials.
Article in JCO oncology advances. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
purposeQuality-of-life (QoL) end points are essential for treatment decisions and value assessment in genitourinary (GU) cancer, yet the extent of QoL planning-reporting concordance and outcome reporting bias is unknown. We evaluated the frequency, correlates, and concordance of QoL end point planning and reporting in phase III GU cancer trials.
methodsWe conducted a systematic review of phase III randomized clinical trials evaluating systemic therapies for GU malignancies published from 2020 through 2024 (PubMed, EMBASE). QoL prespecification was ascertained from ClinicalTrials.gov or protocols. Associations with QoL reporting were assessed using univariable and multivariable logistic regression.
resultsAmong 80 clinical trials, QoL was prespecified in 68 (85%) yet reported in only 38 (47.5%). Of the 68 trials that prespecified QoL, 30 (44.1%) did not report results. Positive primary end point results were the strongest correlate of QoL reporting (63%
conclusionQoL end points in GU cancer trials are frequently planned but selectively reported, with findings consistent with result-dependent disclosure. This pattern may compromise value assessment frameworks and shared decision making. Enforcement of CONSORT-PRO, SPIRIT-PRO, and SISAQOL standards is needed.
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