PMID- 30728278
OWN - NLM
STAT- MEDLINE
DCOM- 20200520
LR  - 20200520
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 24
IP  - 4
DP  - 2019 Apr
TI  - Feasibility Assessment of Using the Complete Patient-Reported Outcomes Version of 
      the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library.
PG  - e146-e148
LID - 10.1634/theoncologist.2018-0332 [doi]
AB  - The patient-reported outcomes version of the Common Terminology Criteria for 
      Adverse Events (PRO-CTCAE) complements capture of symptomatic adverse events 
      (AEs) by clinicians. Previous trials have typically used a limited subset of 
      relevant symptomatic AEs to reduce patient burden. We aimed to determine the 
      feasibility of administering all 80 AEs included in the PRO-CTCAE library by 
      approaching consecutive patients enrolled in a large academic phase I program at 
      three points in time. Here, we report a preplanned analysis after enrolling the 
      first 20 patients. All items were answered on 51 of 56 potential visits 
      (adherence 91%). Three (5%) additional PRO-CTCAE assessments were partially 
      completed, and two (4%) were missed because of conflicting appointments. No 
      patient withdrew consent or chose not to complete the assessments once enrolled 
      on study. Future trials of experimental drugs that incorporate the PRO-CTCAE 
      should consider using this unselected approach to identify adverse events more 
      completely.
CI  - (c) AlphaMed Press 2019.
FAU - Shepshelovich, Daniel
AU  - Shepshelovich D
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
AD  - Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
FAU - McDonald, Kate
AU  - McDonald K
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
FAU - Spreafico, Anna
AU  - Spreafico A
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
FAU - Razak, Albiruni R A
AU  - Razak ARA
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
FAU - Bedard, Philippe L
AU  - Bedard PL
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
FAU - Siu, Lillian L
AU  - Siu LL
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
FAU - Minasian, Lori
AU  - Minasian L
AD  - Division of Cancer Prevention, National Cancer Institute, National Institutes of 
      Health, Bethesda, Maryland, USA.
FAU - Hansen, Aaron R
AU  - Hansen AR
AD  - Princess Margaret Cancer Centre, Drug Development Program, University Health 
      Network, Toronto, Canada aaron.hansen@uhn.ca.
AD  - Department of Medicine, University of Toronto, Toronto, Canada.
LA  - eng
PT  - Journal Article
DEP - 20190206
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects
MH  - Canada/epidemiology
MH  - Clinical Trials, Phase I as Topic
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis/etiology
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - National Cancer Institute (U.S.)
MH  - Neoplasms/*drug therapy/epidemiology
MH  - *Patient Reported Outcome Measures
MH  - Prognosis
MH  - Surveys and Questionnaires
MH  - United States
PMC - PMC6459233
COIS- Disclosures of potential conflicts of interest may be found at the end of this 
      article.
EDAT- 2019/02/08 06:00
MHDA- 2020/05/21 06:00
PMCR- 2019/04/01
CRDT- 2019/02/08 06:00
PHST- 2018/06/07 00:00 [received]
PHST- 2018/11/27 00:00 [accepted]
PHST- 2019/02/08 06:00 [pubmed]
PHST- 2020/05/21 06:00 [medline]
PHST- 2019/02/08 06:00 [entrez]
PHST- 2019/04/01 00:00 [pmc-release]
AID - theoncologist.2018-0332 [pii]
AID - ONCO12829 [pii]
AID - 10.1634/theoncologist.2018-0332 [doi]
PST - ppublish
SO  - Oncologist. 2019 Apr;24(4):e146-e148. doi: 10.1634/theoncologist.2018-0332. Epub 
      2019 Feb 6.