PMID- 27323658
OWN - NLM
STAT- MEDLINE
DCOM- 20170112
LR  - 20181202
IS  - 1879-0461 (Electronic)
IS  - 1040-8428 (Linking)
VI  - 104
DP  - 2016 Aug
TI  - Reporting adverse events in cancer surgery randomized trials: A systematic review 
      of published trials in oesophago-gastric and gynecological cancer patients.
PG  - 108-14
LID - S1040-8428(16)30124-X [pii]
LID - 10.1016/j.critrevonc.2016.05.017 [doi]
AB  - BACKGROUND: Few reports describe how adverse events (AEs) are reported in cancer 
      surgery trials. MATERIALS AND METHODS: We systematically reviewed 179 consecutive 
      study reports issued between January 1, 1990 and November 15, 2014, which 
      investigated surgery in oesophago-gastric (OG) or gynecologic (GY) cancer 
      patients. Based on the reviewed reports, we assessed how AEs were reported 
      according to CONSORT statement. RESULTS: Morbidity assessment was the primary 
      objective of 56 studies (31.3%). Postoperative AEs were described in 161 studies 
      (90%). Definition of AEs and grading scale (NCI-CTC AE, Dindo-Clavien scale, etc 
      ...) were given in 27.3% and 16.8% of studies, respectively. AEs were reported by 
      event and grade in 8.3% of studies. Definition of expectedness, seriousness, 
      causality and safety population were present in 0.5%, 1.1%, 7.8%, and 7.2% of the 
      studies, respectively. Reporting of AEs did not improve over time nor better in 
      high-impact factor journals. CONCLUSION: The reporting of AEs in cancer trials 
      investigating surgery needs to be improved.
CI  - Copyright (c) 2016 Elsevier Ireland Ltd. All rights reserved.
FAU - Meghelli, Leila
AU  - Meghelli L
AD  - Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, 
      France.
FAU - Narducci, Fabrice
AU  - Narducci F
AD  - Gynecological Cancer Departement, Oscar Lambret Cancer Centre, Lille, France.
FAU - Mariette, Christophe
AU  - Mariette C
AD  - Department of Digestive and Oncological Surgery, Claude Huriez University 
      Hospital, Lille, France; SIRIC OncoLille Consortium, Lille, France.
FAU - Piessen, Guillaume
AU  - Piessen G
AD  - Department of Digestive and Oncological Surgery, Claude Huriez University 
      Hospital, Lille, France.
FAU - Vanseymortier, Marie
AU  - Vanseymortier M
AD  - Clinical Research Unit, Oscar Lambret Cancer Centre, Lille, France.
FAU - Leblanc, Eric
AU  - Leblanc E
AD  - Gynecological Cancer Departement, Oscar Lambret Cancer Centre, Lille, France.
FAU - Collinet, Pierre
AU  - Collinet P
AD  - Department of Gynecology, Hopital Jeanne de Flandre, Lille, France.
FAU - Duhamel, Alain
AU  - Duhamel A
AD  - Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, 
      France; SIRIC OncoLille Consortium, Lille, France.
FAU - Penel, Nicolas
AU  - Penel N
AD  - Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, 
      France; SIRIC OncoLille Consortium, Lille, France; Clinical Research Unit, Oscar 
      Lambret Cancer Centre, Lille, France. Electronic address: n-penel@o-lambret.fr.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20160607
PL  - Netherlands
TA  - Crit Rev Oncol Hematol
JT  - Critical reviews in oncology/hematology
JID - 8916049
SB  - IM
MH  - Digestive System Surgical Procedures/*adverse effects
MH  - Esophageal Neoplasms/*surgery
MH  - Female
MH  - Genital Neoplasms, Female/*surgery
MH  - Gynecologic Surgical Procedures/*adverse effects
MH  - Humans
MH  - *Randomized Controlled Trials as Topic
MH  - Stomach Neoplasms/*surgery
OTO - NOTNLM
OT  - Adverse events reporting
OT  - Cancer surgery
OT  - Clinical trials
OT  - Post-operative complications
OT  - Toxicity
EDAT- 2016/06/22 06:00
MHDA- 2017/01/14 06:00
CRDT- 2016/06/22 06:00
PHST- 2016/01/13 00:00 [received]
PHST- 2016/04/11 00:00 [revised]
PHST- 2016/05/25 00:00 [accepted]
PHST- 2016/06/22 06:00 [entrez]
PHST- 2016/06/22 06:00 [pubmed]
PHST- 2017/01/14 06:00 [medline]
AID - S1040-8428(16)30124-X [pii]
AID - 10.1016/j.critrevonc.2016.05.017 [doi]
PST - ppublish
SO  - Crit Rev Oncol Hematol. 2016 Aug;104:108-14. doi: 
      10.1016/j.critrevonc.2016.05.017. Epub 2016 Jun 7.