{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T05:57:53Z","timestamp":1790661473364,"version":"4.1.0"},"reference-count":23,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bjui-journals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJU International"],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the frequency at which patient\u2010reported outcomes (PROs) are incorporated as nonmuscle\u2010invasive bladder cancer (NMIBC) clinical trial endpoints.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>\n                      Interventional trials limited to patients with NMIBC were queried from clinicaltrials.gov from 1994 to 2025 (start of trial). Observational studies or those without a discrete intervention were excluded. The incorporation of all PROs as primary and secondary endpoints was recorded. PROs were not limited to validated tools. They were defined according to United States Food and Drug Administration (FDA) guidance as any information about a patient's health\/experience coming directly from the patient without interpretation by a provider\/investigator. Categorical variables were analysed with chi\u2010square and Fisher's exact tests, when applicable, and continuous variables were analysed with the Mann\u2013Whitney\n                      <jats:italic>U<\/jats:italic>\n                      test.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 94 clinical trials were included, of which 21 (22%) incorporated PROs. PROs were included in 3% and 20% of trials as primary and secondary endpoints, respectively. The most commonly used PROs include the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire\u2010Core 30 (EORTC QLQ\u2010C30) and EORTC QLQ\u2010Nonmuscle\u2010Invasive Bladder Cancer 24 module (incorporated in 48% and 43% of NMIBC trials using PROs, respectively). Trials that incorporated PROs as endpoints included higher median anticipated patient enrolments (median [interquartile range] number of patients 166\u2009[461] vs 46\u2009[101],\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.002) and were more likely to be randomised controlled trials (62% vs 41%,\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.057). There was no difference in funding mechanism (industry\u2010sponsored vs cooperative group\/federally funded) between trials that did and did not incorporate PROs. There was little change in PRO incorporation as trial endpoints over time.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Despite recent emphasis from the FDA, patient advocacy groups, and the scientific community on the use of PRO measurements to capture the holistic, lived experience of patients on investigational cancer therapeutics, there is limited incorporation of PROs in NMIBC interventional trials. These data serve as a call to action for PRO tool harmonisation and universal incorporation in NMIBC clinical trial design.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bju.70461","type":"journal-article","created":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T05:12:46Z","timestamp":1790658766000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient\u2010reported outcomes as non\u2010muscle\u2010invasive bladder cancer clinical trial endpoints"],"prefix":"10.1111","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-9469-1773","authenticated-orcid":false,"given":"Kimberly","family":"Toumazos","sequence":"first","affiliation":[{"name":"Department of Urology University of Kentucky College of Medicine  Lexington KY 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K.","family":"Bree","sequence":"additional","affiliation":[{"name":"Department of Urology The University of Texas MD Anderson Cancer Center  Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish M.","family":"Kamat","sequence":"additional","affiliation":[{"name":"Department of Urology The University of Texas MD Anderson Cancer Center  Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4207-7490","authenticated-orcid":false,"given":"Sarah P.","family":"Psutka","sequence":"additional","affiliation":[{"name":"Department of Urology University of Washington Fred Hutchinson Cancer Center  Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8098-901X","authenticated-orcid":false,"given":"Patrick J.","family":"Hensley","sequence":"additional","affiliation":[{"name":"Department of Urology University of Kentucky College of Medicine  Lexington KY 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