PMID- 30838883
OWN - NLM
STAT- MEDLINE
DCOM- 20200706
LR  - 20200706
IS  - 2042-6313 (Electronic)
IS  - 2042-6305 (Linking)
VI  - 8
IP  - 5
DP  - 2019 Apr
TI  - Clinician-reported symptomatic adverse events in cancer trials: are they 
      concordant with patient-reported outcomes?
PG  - 279-288
LID - 10.2217/cer-2018-0092 [doi]
AB  - AIM: We investigate the concordance, in terms of favoring the same treatment arm, 
      between clinician-reported symptomatic adverse events (AEs) and information 
      obtained via patient-reported outcomes (PRO) measures in cancer randomized 
      controlled trials (RCTs). METHODS: We conducted a systematic literature search to 
      identify all RCTs conducted in breast, colorectal, lung and prostate cancer, 
      published between 2004 and 2017. RESULTS: We identified 207 RCTs. In the majority 
      of RCTs (n=133, 64.2%) a discordance between PROs and AEs was found. In 104 
      studies (50.2%), PRO data favored the experimental arm when AEs did not, while 
      the opposite situation was found in 29 trials (14.0%). CONCLUSION: Frequently, 
      information obtained via PRO measures and clinician-reported AEs do not favor the 
      same treatment arm in RCT settings.
FAU - Sparano, Francesco
AU  - Sparano F
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
FAU - Aaronson, Neil K
AU  - Aaronson NK
AD  - Department of Psychosocial Research, Division of Psychosocial Research & 
      Epidemiology, The Netherlands Cancer Institute, The Netherlands.
FAU - Cottone, Francesco
AU  - Cottone F
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
FAU - Piciocchi, Alfonso
AU  - Piciocchi A
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
FAU - La Sala, Edoardo
AU  - La Sala E
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
FAU - Anota, Amelie
AU  - Anota A
AD  - Quality of Life in Oncology French National Platform, Methodological & Quality of 
      Life in Oncology Unit (INSERM UMR 1098), University Hospital of Besancon, 
      Besancon, France.
FAU - Deliu, Nina
AU  - Deliu N
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
FAU - Kieffer, Jacobien M
AU  - Kieffer JM
AD  - Department of Psychosocial Research, Division of Psychosocial Research & 
      Epidemiology, The Netherlands Cancer Institute, The Netherlands.
FAU - Efficace, Fabio
AU  - Efficace F
AD  - Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center & Health 
      Outcomes Research Unit, Rome, Italy.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20190306
PL  - England
TA  - J Comp Eff Res
JT  - Journal of comparative effectiveness research
JID - 101577308
SB  - IM
MH  - Humans
MH  - Male
MH  - Neoplasms/*therapy
MH  - *Patient Outcome Assessment
MH  - Randomized Controlled Trials as Topic/*statistics & numerical data
MH  - Treatment Outcome
OTO - NOTNLM
OT  - adverse events
OT  - cancer
OT  - patient-reported outcomes
OT  - randomized controlled trials
OT  - symptoms
EDAT- 2019/03/07 06:00
MHDA- 2020/07/07 06:00
CRDT- 2019/03/07 06:00
PHST- 2019/03/07 06:00 [pubmed]
PHST- 2020/07/07 06:00 [medline]
PHST- 2019/03/07 06:00 [entrez]
AID - 10.2217/cer-2018-0092 [doi]
PST - ppublish
SO  - J Comp Eff Res. 2019 Apr;8(5):279-288. doi: 10.2217/cer-2018-0092. Epub 2019 Mar 
      6.