Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients.
BACKGROUND
Few reports describe how adverse events (AEs) are reported in cancer surgery trials.


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.


CONCLUSIONS
The reporting of AEs in cancer trials investigating surgery needs to be improved.
Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, France.
Leila
L
Meghelli
Gynecological Cancer Departement, Oscar Lambret Cancer Centre, Lille, France.
Fabrice
F
Narducci
Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France; SIRIC OncoLille Consortium, Lille, France.
Christophe
C
Mariette
Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France.
Guillaume
G
Piessen
Clinical Research Unit, Oscar Lambret Cancer Centre, Lille, France.
Marie
M
Vanseymortier
Gynecological Cancer Departement, Oscar Lambret Cancer Centre, Lille, France.
Eric
E
Leblanc
Department of Gynecology, Hopital Jeanne de Flandre, Lille, France.
Pierre
P
Collinet
Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, France; SIRIC OncoLille Consortium, Lille, France.
Alain
A
Duhamel
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.
Nicolas
N
Penel
D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D004938:Esophageal Neoplasms / Q000601:surgery*; D005260:Female; D005833:Genital Neoplasms, Female / Q000601:surgery*; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D013274:Stomach Neoplasms / Q000601:surgery*
Adverse events reporting; Cancer surgery; Clinical trials; Post-operative complications; Toxicity