{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T08:33:18Z","timestamp":1776241998945,"version":"3.50.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2019,2,20]],"date-time":"2019-02-20T00:00:00Z","timestamp":1550620800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["HHSN261201000043C"],"award-info":[{"award-number":["HHSN261201000043C"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["HHSN261201000063C"],"award-info":[{"award-number":["HHSN261201000063C"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1KL2TR001109"],"award-info":[{"award-number":["1KL2TR001109"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,4,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>The study sought to describe patient-entered supplemental information on symptomatic adverse events (AEs) in cancer clinical research reported via a National Cancer Institute software system and examine the feasibility of mapping these entries to established terminologies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Materials and Methods<\/jats:title>\n                  <jats:p>Patients in 3 multicenter trials electronically completed surveys during cancer treatment. Each survey included a prespecified subset of items from the National Cancer Institute\u2019s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Upon completion of the survey items, patients could add supplemental symptomatic AE information in a free text box. As patients typed into the box, structured dropdown terms could be selected from the PRO-CTCAE item library or Medical Dictionary for Regulatory Activities (MedDRA), or patients could type unstructured free text for submission.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Data were pooled from 1760 participants (48% women; 78% White) who completed 8892 surveys, of which 2387 (26.8%) included supplemental symptomatic AE information. Overall, 1024 (58%) patients entered supplemental information at least once, with an average of 2.3 per patient per study. This encompassed 1474 of 8892 (16.6%) dropdowns and 913 of 8892 (10.3%) unstructured free text entries. One-third of the unstructured free text entries (32%) could be mapped post hoc to a PRO-CTCAE term and 68% to a MedDRA term.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Discussion<\/jats:title>\n                  <jats:p>Participants frequently added supplemental information beyond study-specific survey items. Almost half selected a structured dropdown term, although many opted to submit unstructured free text entries. Most free text entries could be mapped post hoc to PRO-CTCAE or MedDRA terms, suggesting opportunities to enhance the system to perform real-time mapping for AE reporting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Patient reporting of symptomatic AEs using a text box functionality with mapping to existing terminologies is both feasible and informative.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jamia\/ocy169","type":"journal-article","created":{"date-parts":[[2018,11,26]],"date-time":"2018-11-26T12:07:44Z","timestamp":1543234064000},"page":"276-285","source":"Crossref","is-referenced-by-count":58,"title":["Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute\u2019s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)"],"prefix":"10.1093","volume":"26","author":[{"given":"Arlene E","family":"Chung","sequence":"first","affiliation":[{"name":"Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"},{"name":"Program on Health and Clinical Informatics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"},{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA"}]},{"given":"Kimberly","family":"Shoenbill","sequence":"additional","affiliation":[{"name":"Program on Health and Clinical Informatics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"},{"name":"Department of Family Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"}]},{"given":"Sandra A","family":"Mitchell","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Rockville, Maryland, USA"}]},{"given":"Amylou C","family":"Dueck","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona, USA"}]},{"given":"Deborah","family":"Schrag","sequence":"additional","affiliation":[{"name":"Division of Population Sciences, Department of Medical Oncology, Dana-Farber\/Harvard Cancer Center, Brookline, Massachusetts, USA"}]},{"given":"Deborah W","family":"Bruner","sequence":"additional","affiliation":[{"name":"Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute, Emory University, Atlanta, Georgia, USA"}]},{"given":"Lori M","family":"Minasian","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Rockville, Maryland, USA"}]},{"given":"Diane","family":"St. Germain","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Rockville, Maryland, USA"}]},{"given":"Ann M","family":"O\u2019Mara","sequence":"additional","affiliation":[{"name":"National Cancer Institute, Rockville, Maryland, USA"}]},{"given":"Paul","family":"Baumgartner","sequence":"additional","affiliation":[{"name":"Semantic Bits, LLC, Herndon, Virginia, USA"}]},{"given":"Lauren J","family":"Rogak","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA"}]},{"given":"Amy P","family":"Abernethy","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke Cancer Institute, Durham, North Carolina, USA"},{"name":"Flatiron Health, New York, New York, USA"}]},{"given":"Ashley C","family":"Griffin","sequence":"additional","affiliation":[{"name":"Program on Health and Clinical Informatics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"}]},{"given":"Ethan M","family":"Basch","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"},{"name":"Program on Health and Clinical Informatics, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA"},{"name":"Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA"},{"name":"Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA"}]}],"member":"286","published-online":{"date-parts":[[2019,2,20]]},"reference":[{"issue":"4","key":"2020110613062414300_ocy169-B1","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1097\/PPO.0b013e31822c28b3","article-title":"Electronic toxicity monitoring and patient-reported outcomes","volume":"17","author":"Basch","year":"2011","journal-title":"Cancer J"},{"issue":"9","key":"2020110613062414300_ocy169-B2","doi-asserted-by":"crossref","DOI":"10.1093\/jnci\/dju244","article-title":"Development of the National Cancer Institute\u2019s patient-reported outcomes version of the common terminology 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The Medical Dictionary of Regulatory Activities. Available at: https:\/\/www.meddra.org\/sites\/default\/files\/page\/documents\/meddra2013.pdf. Accessed January 4, 2018."},{"key":"2020110613062414300_ocy169-B4","unstructured":"Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE\u2122). Available at: https:\/\/healthcaredelivery.cancer.gov\/pro-ctcae\/. Accessed January 4, 2018."},{"issue":"22","key":"2020110613062414300_ocy169-B5","doi-asserted-by":"crossref","first-page":"5618","DOI":"10.1158\/1078-0432.CCR-16-2140","article-title":"Focusing on core patient-reported outcomes in cancer clinical trials-response","volume":"22","author":"Kluetz","year":"2016","journal-title":"Clin Cancer Res"},{"issue":"8","key":"2020110613062414300_ocy169-B6","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1080\/17460441.2016.1193148","article-title":"Patient-reported outcome measurement in drug discovery: a tool to improve accuracy and completeness of efficacy and safety data","volume":"11","author":"Basch","year":"2016","journal-title":"Exp Opin Drug Discov"},{"issue":"2","key":"2020110613062414300_ocy169-B7","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1016\/j.ijrobp.2017.02.002","article-title":"Feasibility of patient reporting of symptomatic adverse events via the patient-reported outcomes version of the common terminology 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