PMID- 30840079
OWN - NLM
STAT- MEDLINE
DCOM- 20200226
LR  - 20220409
IS  - 1527-974X (Electronic)
IS  - 1067-5027 (Print)
IS  - 1067-5027 (Linking)
VI  - 26
IP  - 4
DP  - 2019 Apr 1
TI  - Patient free text reporting of symptomatic adverse events in cancer clinical 
      research using the National Cancer Institute's Patient-Reported Outcomes version 
      of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
PG  - 276-285
LID - 10.1093/jamia/ocy169 [doi]
AB  - OBJECTIVE: 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. MATERIALS AND METHODS: Patients in 3 
      multicenter trials electronically completed surveys during cancer treatment. Each 
      survey included a prespecified subset of items from the National Cancer 
      Institute's 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. RESULTS: 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. DISCUSSION: 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. CONCLUSIONS: Patient reporting of symptomatic AEs using 
      a text box functionality with mapping to existing terminologies is both feasible 
      and informative.
CI  - (c) The Author(s) 2019. Published by Oxford University Press on behalf of the 
      American Medical Informatics Association. All rights reserved. For permissions, 
      please email: journals.permissions@oup.com.
FAU - Chung, Arlene E
AU  - Chung AE
AD  - Department of Medicine, University of North Carolina School of Medicine, Chapel 
      Hill, North Carolina, USA.
AD  - Program on Health and Clinical Informatics, University of North Carolina School 
      of Medicine, Chapel Hill, North Carolina, USA.
AD  - Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel 
      Hill, Chapel Hill, North Carolina, USA.
FAU - Shoenbill, Kimberly
AU  - Shoenbill K
AD  - Program on Health and Clinical Informatics, University of North Carolina School 
      of Medicine, Chapel Hill, North Carolina, USA.
AD  - Department of Family Medicine, University of North Carolina School of Medicine, 
      Chapel Hill, North Carolina, USA.
FAU - Mitchell, Sandra A
AU  - Mitchell SA
AD  - National Cancer Institute, Rockville, Maryland, USA.
FAU - Dueck, Amylou C
AU  - Dueck AC
AD  - Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, Arizona, USA.
FAU - Schrag, Deborah
AU  - Schrag D
AD  - Division of Population Sciences, Department of Medical Oncology, 
      Dana-Farber/Harvard Cancer Center, Brookline, Massachusetts, USA.
FAU - Bruner, Deborah W
AU  - Bruner DW
AD  - Nell Hodgson Woodruff School of Nursing, Winship Cancer Institute, Emory 
      University, Atlanta, Georgia, USA.
FAU - Minasian, Lori M
AU  - Minasian LM
AD  - National Cancer Institute, Rockville, Maryland, USA.
FAU - St Germain, Diane
AU  - St Germain D
AD  - National Cancer Institute, Rockville, Maryland, USA.
FAU - O'Mara, Ann M
AU  - O'Mara AM
AD  - National Cancer Institute, Rockville, Maryland, USA.
FAU - Baumgartner, Paul
AU  - Baumgartner P
AD  - Semantic Bits, LLC, Herndon, Virginia, USA.
FAU - Rogak, Lauren J
AU  - Rogak LJ
AD  - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer 
      Center, New York, New York, USA.
FAU - Abernethy, Amy P
AU  - Abernethy AP
AD  - Department of Medicine, Duke Cancer Institute, Durham, North Carolina, USA.
AD  - Flatiron Health, New York, New York, USA.
FAU - Griffin, Ashley C
AU  - Griffin AC
AD  - Program on Health and Clinical Informatics, University of North Carolina School 
      of Medicine, Chapel Hill, North Carolina, USA.
FAU - Basch, Ethan M
AU  - Basch EM
AD  - Department of Medicine, University of North Carolina School of Medicine, Chapel 
      Hill, North Carolina, USA.
AD  - Program on Health and Clinical Informatics, University of North Carolina School 
      of Medicine, Chapel Hill, North Carolina, USA.
AD  - Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel 
      Hill, Chapel Hill, North Carolina, USA.
AD  - Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer 
      Center, New York, New York, USA.
LA  - eng
GR  - HHSN261201000063C/CA/NCI NIH HHS/United States
GR  - HHSN261201000043C/CA/NCI NIH HHS/United States
GR  - P30 CA016086/CA/NCI NIH HHS/United States
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - KL2 TR001109/TR/NCATS NIH HHS/United States
GR  - T15 LM012500/LM/NLM NIH HHS/United States
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PL  - England
TA  - J Am Med Inform Assoc
JT  - Journal of the American Medical Informatics Association : JAMIA
JID - 9430800
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*adverse effects
MH  - Drug Evaluation
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Humans
MH  - Internet
MH  - Male
MH  - Middle Aged
MH  - National Cancer Institute (U.S.)
MH  - Neoplasms/*drug therapy
MH  - *Patient Reported Outcome Measures
MH  - Self Report
MH  - *Software
MH  - United States
MH  - User-Computer Interface
PMC - PMC6402312
OTO - NOTNLM
OT  - MedDRA
OT  - PRO-CTCAE
OT  - free text
OT  - patient-reported outcomes
OT  - symptomatic adverse events
EDAT- 2019/03/07 06:00
MHDA- 2020/02/27 06:00
PMCR- 2020/02/20
CRDT- 2019/03/07 06:00
PHST- 2018/05/03 00:00 [received]
PHST- 2018/10/17 00:00 [revised]
PHST- 2018/11/26 00:00 [accepted]
PHST- 2019/03/07 06:00 [entrez]
PHST- 2019/03/07 06:00 [pubmed]
PHST- 2020/02/27 06:00 [medline]
PHST- 2020/02/20 00:00 [pmc-release]
AID - 5320658 [pii]
AID - ocy169 [pii]
AID - 10.1093/jamia/ocy169 [doi]
PST - ppublish
SO  - J Am Med Inform Assoc. 2019 Apr 1;26(4):276-285. doi: 10.1093/jamia/ocy169.