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Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients

Abstract : 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.
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https://www.hal.inserm.fr/inserm-02940292
Contributor : Michel Salzet <>
Submitted on : Wednesday, September 16, 2020 - 11:15:01 AM
Last modification on : Tuesday, November 3, 2020 - 3:54:06 PM

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Leila Meghelli, Fabrice Narducci, Christophe Mariette, Guillaume Piessen, Marie Vanseymortier, et al.. Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients. Critical Reviews in Oncology/Hematology, Elsevier, 2016, 104, pp.108-114. ⟨10.1016/j.critrevonc.2016.05.017⟩. ⟨inserm-02940292⟩

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