{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T20:22:15Z","timestamp":1784924535099,"version":"3.55.0"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO Oncol Adv"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Quality-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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>We 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      Among 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%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      25%; adjusted odds ratio [OR], 4.84 [95% CI, 1.74 to 14.60];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .003). Single-country scope was independently associated with lower QoL reporting (OR, 0.22 [95% CI, 0.04 to 0.83];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .04). Among trials that prespecified QoL, the association with result direction persisted (71%\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      31%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .001), and neither funding source nor journal impact factor explained the discrepancy. QoL reporting rates were similar from 2020 through 2023 (50%-61%) and dropped to 11% in 2024; in a sensitivity analysis modeling publication year categorically, only 2024 differed significantly from 2020 (OR, 0.07 [95% CI, 0.01 to 0.34];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      = .003). No trial designated QoL as a primary end point.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>QoL 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/oa-26-00044","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T19:59:09Z","timestamp":1784923149000},"source":"Crossref","is-referenced-by-count":0,"title":["Planning, Reporting, and Selective Disclosure of Quality-of-Life End Points in Phase III Genitourinary Cancer Trials"],"prefix":"10.1200","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6871-024X","authenticated-orcid":true,"given":"Shreyas","family":"Kalantri","sequence":"first","affiliation":[{"name":"Division of Medical Oncology\/Hematology, Brown Cancer Center, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3851-6403","authenticated-orcid":true,"given":"Shiva","family":"Balasubramanian","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1119-2146","authenticated-orcid":true,"given":"Jincong Q.","family":"Freeman","sequence":"additional","affiliation":[{"name":"Department of Public Health Sciences, University of Chicago, Chicago, IL"},{"name":"Cancer Prevention and Control Research Program, UChicago Medicine Comprehensive Cancer Center, Chicago, IL"},{"name":"Center for Health and the Social Sciences, University of Chicago, Chicago, IL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-0313-6282","authenticated-orcid":true,"given":"Tyler","family":"Jones","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology\/Hematology, Brown Cancer Center, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3290-1914","authenticated-orcid":true,"given":"Priyanka","family":"Sheth","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinidhi","family":"Karthik","sequence":"additional","affiliation":[{"name":"School of Medicine, Yale University, New Haven, CT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0217-8278","authenticated-orcid":true,"given":"Jason","family":"Chesney","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology\/Hematology, Brown Cancer Center, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5815-0541","authenticated-orcid":true,"given":"Rohit","family":"Kumar","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology\/Hematology, Brown Cancer Center, University of Louisville, Louisville, KY"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"e_1_3_8_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv249"},{"key":"e_1_3_8_3_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.61.6706"},{"key":"e_1_3_8_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2020.10.017"},{"key":"e_1_3_8_5_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.7156"},{"key":"e_1_3_8_6_2","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy449"},{"key":"e_1_3_8_7_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjonc-2022-000021"},{"key":"e_1_3_8_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamaoncol.2025.1002"},{"key":"e_1_3_8_9_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.291.20.2457"},{"key":"e_1_3_8_10_2","doi-asserted-by":"crossref","first-page":"e66844","DOI":"10.1371\/journal.pone.0066844","article-title":"Systematic review of the empirical evidence of study publication bias and outcome reporting bias\u2014An updated review","volume":"8","author":"Dwan K","year":"2013","unstructured":"Dwan K, Gamble C, Williamson PR, et al: Systematic review of the empirical evidence of study publication bias and outcome reporting bias\u2014An updated review. 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