Leila Meghelli1, Fabrice Narducci2, Christophe Mariette3, Guillaume Piessen4, Marie Vanseymortier5, Eric Leblanc2, Pierre Collinet6, Alain Duhamel7, Nicolas Penel8. 1. Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, France. 2. Gynecological Cancer Departement, Oscar Lambret Cancer Centre, Lille, France. 3. Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France; SIRIC OncoLille Consortium, Lille, France. 4. Department of Digestive and Oncological Surgery, Claude Huriez University Hospital, Lille, France. 5. Clinical Research Unit, Oscar Lambret Cancer Centre, Lille, France. 6. Department of Gynecology, Hopital Jeanne de Flandre, Lille, France. 7. Lille Nord de France University, Medical School (Research Unit EA 2694), Lille, France; SIRIC OncoLille Consortium, Lille, France. 8. 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.
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.
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) cancerpatients. 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.
Authors: Angela MacCarthy; Shona Kirtley; Jennifer A de Beyer; Douglas G Altman; Iveta Simera Journal: Br J Cancer Date: 2018-02-22 Impact factor: 7.640