Open AccessFeasibility Assessment of Using the Complete Patient‐Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE) Item Library
Author(s) -
Shepshelovich Daniel,
McDonald Kate,
Spreafico Anna,
Razak Albiruni R.A.,
Bedard Philippe L.,
Siu Lillian L.,
Minasian Lori,
Hansen Aaron R.
Publication year - 2019
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2018-0332
Subject(s) - medicine , common terminology criteria for adverse events , adverse effect , terminology , medline , clinical trial , family medicine , philosophy , linguistics , political science , law
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.