PMID- 27260018
OWN - NLM
STAT- MEDLINE
DCOM- 20170922
LR  - 20240325
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Print)
IS  - 0941-4355 (Linking)
VI  - 24
IP  - 8
DP  - 2016 Aug
TI  - The association between clinician-based common terminology criteria for adverse 
      events (CTCAE) and patient-reported outcomes (PRO): a systematic review.
PG  - 3669-76
LID - 10.1007/s00520-016-3297-9 [doi]
AB  - PURPOSE: Symptomatic adverse events (AEs) are monitored by clinicians as part of 
      all US-based clinical trials in cancer via the U.S. National Cancer Institute's 
      Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of 
      ensuring patient safety. Recently, there has been a charge toward capturing the 
      patient perspective for those AEs amenable to patient self-reporting via 
      patient-reported outcomes (PRO). The aim of this review was to summarize the 
      empirically reported association between analogous CTCAE and PRO ratings. 
      METHODS: A systematic literature search was conducted using PubMed, EMBASE, Web 
      of Science, and Cochrane databases through July 2015. From a total of 5658 
      articles retrieved, 28 studies met the inclusion criteria. RESULTS: Across 
      studies, patients were of mixed cancer types, including anal, breast, cervical, 
      chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, 
      pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were 
      variable, with many common across studies (e.g., dyspnea, fatigue, nausea, 
      neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., 
      erectile dysfunction, hemoptysis). Overall, the quantified association between 
      CTCAE and PRO ratings fell in the fair to moderate range and had a large 
      variation across the majority of studies (n = 21). CONCLUSIONS: The range of 
      measures used and symptoms captured varied greatly across the reviewed studies. 
      Regardless of concordance metric employed, reported agreement between CTCAE and 
      PRO ratings was moderate at best. To assist with reconciliation and 
      interpretation of these differences toward ultimately improving patient care, an 
      important next step is to explore approaches to integrate PROs with clinician 
      reporting of AEs.
FAU - Atkinson, Thomas M
AU  - Atkinson TM
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA. 
      atkinsot@mskcc.org.
FAU - Ryan, Sean J
AU  - Ryan SJ
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
AD  - City University of New York, New York, NY, USA.
FAU - Bennett, Antonia V
AU  - Bennett AV
AD  - University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
FAU - Stover, Angela M
AU  - Stover AM
AD  - University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
FAU - Saracino, Rebecca M
AU  - Saracino RM
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
FAU - Rogak, Lauren J
AU  - Rogak LJ
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
FAU - Jewell, Sarah T
AU  - Jewell ST
AD  - Rutgers, The State University of New Jersey, Newark, NJ, USA.
FAU - Matsoukas, Konstantina
AU  - Matsoukas K
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
FAU - Li, Yuelin
AU  - Li Y
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
FAU - Basch, Ethan
AU  - Basch E
AD  - Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer 
      Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
AD  - University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
LA  - eng
GR  - P30 CA008748/CA/NCI NIH HHS/United States
GR  - R25 CA116339/CA/NCI NIH HHS/United States
GR  - T32 CA009461/CA/NCI NIH HHS/United States
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20160603
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems/*standards
MH  - Antineoplastic Agents/*adverse effects
MH  - Drug Monitoring/*methods
MH  - Female
MH  - Humans
MH  - *Patient Reported Outcome Measures
MH  - Self Report
PMC - PMC4919215
MID - NIHMS793130
OTO - NOTNLM
OT  - Drug monitoring
OT  - Drug-related side effects and adverse reactions
OT  - Literature review
OT  - Neoplasms
OT  - Self report
OT  - Toxicity
COIS- All authors declare no conflicts of interest.
EDAT- 2016/06/05 06:00
MHDA- 2017/09/25 06:00
PMCR- 2017/08/01
CRDT- 2016/06/05 06:00
PHST- 2016/01/20 00:00 [received]
PHST- 2016/05/30 00:00 [accepted]
PHST- 2016/06/05 06:00 [entrez]
PHST- 2016/06/05 06:00 [pubmed]
PHST- 2017/09/25 06:00 [medline]
PHST- 2017/08/01 00:00 [pmc-release]
AID - 10.1007/s00520-016-3297-9 [pii]
AID - 10.1007/s00520-016-3297-9 [doi]
PST - ppublish
SO  - Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 
      2016 Jun 3.