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

نویسندگان

  • Leila Meghelli
  • Fabrice Narducci
  • Christophe Mariette
  • Guillaume Piessen
  • Marie Vanseymortier
  • Eric Leblanc
  • Pierre Collinet
  • Alain Duhamel
  • Nicolas Penel
چکیده

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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عنوان ژورنال:
  • Critical reviews in oncology/hematology

دوره 104  شماره 

صفحات  -

تاریخ انتشار 2016