{"id":"https://openalex.org/W7202069617","doi":"https://doi.org/10.1007/s10549-026-08051-y","title":"Patient-reported outcomes in clinical trials leading to breast cancer drug approvals: are we making them count?","display_name":"Patient-reported outcomes in clinical trials leading to breast cancer drug approvals: are we making them count?","publication_year":2026,"publication_date":"2026-08-01","ids":{"openalex":"https://openalex.org/W7202069617","doi":"https://doi.org/10.1007/s10549-026-08051-y","pmid":"https://pubmed.ncbi.nlm.nih.gov/42573832","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/13457446"},"language":"en","primary_location":{"id":"doi:10.1007/s10549-026-08051-y","doi":"https://doi.org/10.1007/s10549-026-08051-y","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10549-026-08051-y","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10549-026-08051-y.pdf","source":{"id":"https://openalex.org/S142211178","display_name":"Breast Cancer Research and Treatment","issn_l":"0167-6806","issn":["0167-6806","1573-7217"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Breast Cancer Research and Treatment","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://link.springer.com/content/pdf/10.1007/s10549-026-08051-y.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5133827760","display_name":"Samuel Jacob Margolis","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Samuel Margolis","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5137219513","display_name":"Andre Naguib Guirguis","orcid":"https://orcid.org/0009-0001-0477-3444","observed_orcids":["https://orcid.org/0009-0001-0477-3444"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Andre Naguib Guirguis","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5123017390","display_name":"Catherine Lee","orcid":"https://orcid.org/0000-0003-0008-9052","observed_orcids":["https://orcid.org/0000-0003-0008-9052"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Catherine Lee","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5137300409","display_name":"Saiya Smith","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Saiya Smith","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072193671","display_name":"Alexis Ann LeVee","orcid":"https://orcid.org/0000-0001-9821-8144","observed_orcids":["https://orcid.org/0000-0001-9821-8144"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Alexis LeVee","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022530360","display_name":"Marla D. Lipsyc-Sharf","orcid":"https://orcid.org/0000-0002-4071-6383","observed_orcids":["https://orcid.org/0000-0002-4071-6383"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Marla D. Lipsyc-Sharf","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034972183","display_name":"Aditya Bardia","orcid":"https://orcid.org/0000-0003-4885-1157","observed_orcids":["https://orcid.org/0000-0003-4885-1157"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Aditya Bardia","raw_affiliation_strings":["Department of Medicine, University of California, Los Angeles, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA","institution_ids":["https://openalex.org/I161318765"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5036139011","display_name":"Mina S. Sedrak","orcid":"https://orcid.org/0000-0002-8379-391X","observed_orcids":["https://orcid.org/0000-0002-8379-391X"]},"institutions":[{"id":"https://openalex.org/I161318765","display_name":"University of California, Los Angeles","ror":"https://ror.org/046rm7j60","country_code":"US","type":"education","lineage":["https://openalex.org/I161318765"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Mina S. Sedrak","raw_affiliation_strings":["David Geffen School of Medicine at UCLA, 650 Charles Young Drive South, Room A2-125 CHS, Los Angeles, CA, 90095-6900, USA. msedrak@mednet.ucla.edu","Department of Medicine, University of California, Los Angeles, CA, USA. msedrak@mednet.ucla.edu"],"raw_orcid":"https://orcid.org/0000-0002-8379-391X","affiliations":[{"raw_affiliation_string":"David Geffen School of Medicine at UCLA, 650 Charles Young Drive South, Room A2-125 CHS, Los Angeles, CA, 90095-6900, USA. msedrak@mednet.ucla.edu","institution_ids":["https://openalex.org/I161318765"]},{"raw_affiliation_string":"Department of Medicine, University of California, Los Angeles, CA, USA. msedrak@mednet.ucla.edu","institution_ids":["https://openalex.org/I161318765"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5036139011"],"corresponding_institution_ids":["https://openalex.org/I161318765"],"apc_list":{"value":4190,"currency":"USD","value_usd":4190},"apc_paid":{"value":4190,"currency":"USD","value_usd":4190},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.58761304,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"218","issue":"3","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.42899999022483826,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.42899999022483826,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10178","display_name":"Cancer survivorship and care","score":0.3359000086784363,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.05979999899864197,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/patient-reported-outcomes","display_name":"patient-reported outcomes","score":1.0},{"id":"https://openalex.org/keywords/breast-cancer","display_name":"breast cancer","score":0.8870000243186951},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.7379999756813049},{"id":"https://openalex.org/keywords/registration-trials","display_name":"registration trials","score":0.6470000147819519},{"id":"https://openalex.org/keywords/publication-delay","display_name":"time to publication","score":0.9710000157356262},{"id":"https://openalex.org/keywords/reporting-quality","display_name":"reporting quality","score":0.5379999876022339},{"id":"https://openalex.org/keywords/risk-benefit-trade-off","display_name":"risk-benefit trade-off","score":0.6169999837875366}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8636000156402588},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.76910001039505},{"id":"https://openalex.org/C530470458","wikidata":"https://www.wikidata.org/wiki/Q128581","display_name":"Breast cancer","level":3,"score":0.7247999906539917},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.5291000008583069},{"id":"https://openalex.org/C9357733","wikidata":"https://www.wikidata.org/wiki/Q6878417","display_name":"Missing data","level":2,"score":0.5095000267028809},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.5041000247001648},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.4821000099182129},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.46810001134872437},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.4641000032424927},{"id":"https://openalex.org/C2992672634","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Drug trial","level":3,"score":0.42179998755455017},{"id":"https://openalex.org/C502991105","wikidata":"https://www.wikidata.org/wiki/Q5133849","display_name":"Clinical research","level":2,"score":0.39809998869895935},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.39480000734329224},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.38609999418258667},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.38190001249313354},{"id":"https://openalex.org/C2780439572","wikidata":"https://www.wikidata.org/wiki/Q919364","display_name":"Publication bias","level":3,"score":0.37700000405311584},{"id":"https://openalex.org/C148482608","wikidata":"https://www.wikidata.org/wiki/Q17007018","display_name":"Clinical study design","level":3,"score":0.376800000667572},{"id":"https://openalex.org/C2779318504","wikidata":"https://www.wikidata.org/wiki/Q1438035","display_name":"Research design","level":2,"score":0.3767000138759613},{"id":"https://openalex.org/C2992293740","wikidata":"https://www.wikidata.org/wiki/Q4781752","display_name":"Drug approval","level":3,"score":0.3555000126361847},{"id":"https://openalex.org/C121608353","wikidata":"https://www.wikidata.org/wiki/Q12078","display_name":"Cancer","level":2,"score":0.33410000801086426},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.3296999931335449},{"id":"https://openalex.org/C95190672","wikidata":"https://www.wikidata.org/wiki/Q815382","display_name":"Meta-analysis","level":2,"score":0.3098999857902527},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.3034999966621399},{"id":"https://openalex.org/C64903051","wikidata":"https://www.wikidata.org/wiki/Q2198549","display_name":"Drug development","level":3,"score":0.302700012922287},{"id":"https://openalex.org/C189708586","wikidata":"https://www.wikidata.org/wiki/Q1504425","display_name":"Systematic review","level":3,"score":0.29350000619888306},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.2815000116825104},{"id":"https://openalex.org/C2780385302","wikidata":"https://www.wikidata.org/wiki/Q367158","display_name":"Protocol (science)","level":3,"score":0.28040000796318054},{"id":"https://openalex.org/C3020340455","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Cancer drugs","level":3,"score":0.26489999890327454},{"id":"https://openalex.org/C141341695","wikidata":"https://www.wikidata.org/wiki/Q2368661","display_name":"Surrogate endpoint","level":2,"score":0.2500999867916107}],"mesh":[{"descriptor_ui":"D000071066","descriptor_name":"Patient Reported Outcome Measures","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D001943","descriptor_name":"Breast Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1007/s10549-026-08051-y","doi":"https://doi.org/10.1007/s10549-026-08051-y","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10549-026-08051-y","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10549-026-08051-y.pdf","source":{"id":"https://openalex.org/S142211178","display_name":"Breast Cancer Research and Treatment","issn_l":"0167-6806","issn":["0167-6806","1573-7217"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Breast Cancer Research and Treatment","raw_type":"journal-article"},{"id":"pmh:oai:pubmedcentral.nih.gov:13457446","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13457446/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13457446/pdf/10549_2026_Article_8051.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Breast Cancer Res Treat","raw_type":"Text"},{"id":"pmid:42573832","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42573832","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Breast cancer research and treatment","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1007/s10549-026-08051-y","doi":"https://doi.org/10.1007/s10549-026-08051-y","is_oa":true,"landing_page_url":"https://doi.org/10.1007/s10549-026-08051-y","pdf_url":"https://link.springer.com/content/pdf/10.1007/s10549-026-08051-y.pdf","source":{"id":"https://openalex.org/S142211178","display_name":"Breast Cancer Research and Treatment","issn_l":"0167-6806","issn":["0167-6806","1573-7217"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Breast Cancer Research and Treatment","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9763000011444092,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Systematic Review","id":"https://openalex.org/study-designs/systematic-review"}],"awards":[{"id":"https://openalex.org/G4347142474","display_name":"Using Senolytics to Improve Physical Function in Older Breast Cancer Survivors","funder_award_id":"R21CA277660","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"},{"id":"https://openalex.org/G5047779123","display_name":"Targeting Senescence to Improve Frailty in Older Cancer Survivors","funder_award_id":"K76AG074918","funder_id":"https://openalex.org/F4320337337","funder_display_name":"National Institute on Aging"},{"id":"https://openalex.org/G9000874987","display_name":"Targeting Senescence to Mitigate Chemotherapy-induced Functional Decline","funder_award_id":"R01CA280088","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"}],"funders":[{"id":"https://openalex.org/F4320306260","display_name":"Breast Cancer Research Foundation","ror":"https://ror.org/0348ff195"},{"id":"https://openalex.org/F4320337337","display_name":"National Institute on Aging","ror":"https://ror.org/049v75w11"},{"id":"https://openalex.org/F4320337351","display_name":"National Cancer Institute","ror":"https://ror.org/040gcmg81"},{"id":"https://openalex.org/F4320337362","display_name":"National Institute of Arthritis and Musculoskeletal and Skin Diseases","ror":"https://ror.org/006zn3t30"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7202069617.pdf","grobid_xml":"https://content.openalex.org/works/W7202069617.grobid-xml"},"referenced_works_count":13,"referenced_works":["https://openalex.org/W2051315590","https://openalex.org/W2070309415","https://openalex.org/W2113464761","https://openalex.org/W2238083898","https://openalex.org/W2770773573","https://openalex.org/W2782908833","https://openalex.org/W2915228510","https://openalex.org/W3003402209","https://openalex.org/W3153861271","https://openalex.org/W4385337077","https://openalex.org/W4400779721","https://openalex.org/W4405847501","https://openalex.org/W4406638465"],"related_works":["https://openalex.org/W7162662923","https://openalex.org/W2947109022","https://openalex.org/W7166007936","https://openalex.org/W3153861271","https://openalex.org/W4385337077","https://openalex.org/W2915228510","https://openalex.org/W2132820254","https://openalex.org/W7213982280","https://openalex.org/W4416192546","https://openalex.org/W2159086448"],"abstract_inverted_index":{"PURPOSE:":[0],"Patient-reported":[1],"outcomes":[2],"(PROs)":[3],"inform":[4],"benefit-risk":[5],"tradeoffs":[6],"in":[7,29,78,164,172],"breast":[8,34,109],"cancer":[9,35,110],"treatment,":[10],"yet":[11],"reporting":[12,28,94,205],"quality":[13],"across":[14,95],"registration":[15],"trials":[16,31,149,192],"remains":[17],"incompletely":[18,189],"characterized.":[19],"METHODS:":[20],"We":[21,63,105],"conducted":[22],"a":[23,128,151],"scoping":[24,177],"review":[25],"of":[26,153,166],"PRO":[27,65,71,102,141,195],"randomized":[30,117],"supporting":[32],"FDA":[33,44,108],"drug":[36,111],"approvals":[37,112],"(January":[38],"2011-December":[39],"2024),":[40],"identified":[41,106],"via":[42],"the":[43,76,81],"Oncology":[45],"Approval":[46],"Notifications":[47],"database.":[48],"Associated":[49],"manuscripts":[50,167],"were":[51,162,180],"retrieved":[52],"through":[53],"systematic":[54],"PubMed":[55],"and":[56,85,91,100,168,188,200],"EBSCO":[57],"searches":[58],"using":[59],"trial-specific":[60],"NCT":[61],"identifiers.":[62],"assessed":[64],"endpoint":[66],"prespecification":[67],"status,":[68],"instruments":[69],"used,":[70],"publication":[72,89,142,198],"delay":[73,143,152],"(defined":[74],"as":[75,127],"interval":[77],"months":[79],"between":[80],"primary":[82,97,129],"trial":[83,124],"manuscript":[84,88],"corresponding":[86],"PRO-dedicated":[87],"date),":[90],"missing":[92,203],"data":[93,159,204],"eligible":[96,121],"trial,":[98],"PRO-dedicated,":[99],"subpopulation-specific":[101],"manuscripts.":[103,122],"RESULTS:":[104],"34":[107],"supported":[113],"by":[114],"36":[115],"unique":[116],"trials,":[118],"yielding":[119],"45":[120],"No":[123],"designated":[125],"PROs":[126,179],"or":[130,155],"co-primary":[131],"endpoint;":[132],"nine":[133],"(25%)":[134],"did":[135],"not":[136],"explicitly":[137],"prespecify":[138],"them.":[139],"Median":[140],"was":[144],"18":[145],"months,":[146],"with":[147],"eight":[148],"experiencing":[150],"two":[154],"more":[156],"years.":[157],"Missing":[158],"handling":[160],"methods":[161],"described":[163],"33%":[165],"reasons":[169],"for":[170],"missingness":[171],"11%.":[173],"CONCLUSION:":[174],"In":[175],"this":[176],"review,":[178],"commonly":[181],"collected":[182],"but":[183],"inconsistently":[184],"prespecified,":[185],"often":[186],"delayed,":[187],"reported.":[190],"Registration":[191],"should":[193],"strengthen":[194],"prespecification,":[196],"reduce":[197],"delay,":[199],"adhere":[201],"to":[202],"standards.":[206],"CLINICAL":[207],"TRIAL":[208],"NUMBER:":[209],"Not":[210],"applicable.":[211]},"counts_by_year":[],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2026-08-10T00:00:00"}
