title: Assessment of the quality of surgery within randomised controlled trials for the treatment of gastro-oesophageal cancer: a systematic review.
abstract: Multicentre, randomised, controlled trials (RCTs) provide level 1 evidence for surgery in the treatment of gastro-oesophageal cancer. This systematic review investigated whether standardisation of surgical techniques in RCTs reduces the variation in lymph-node harvest, in-hospital mortality, and locoregional cancer recurrence. The range in the coefficients of variation for lymph-node harvest (0.07-0.61), proportion of patients with locoregional cancer recurrence (1.1-46.2%), and in-hospital mortality (0-10%) was wide. Credentialing of surgeons through assessment of operative reports and monitoring of their performance through data collection were important factors that reduced the variation in lymph-node harvest. Factors that reduced adjusted in-hospital mortality included credentialing surgeons through procedural volume and operative reports, and standardisation of surgical techniques. Future RCTs should include an assessment of surgical performance as an important aspect of study design to reduce variation in clinical outcomes.
authors: Division of Surgery, Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
authors: Sheraz R
authors: SR
authors: Markar
authors: Division of Surgery, Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
authors: Tom
authors: T
authors: Wiggins
authors: Division of Surgery, Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK.
authors: Melody
authors: M
authors: Ni
authors: Centre for Medical Decision Sciences, Department of Public Health, Erasmus MC-University Medical Centre, Rotterdam, Netherlands.
authors: Ewout W
authors: EW
authors: Steyerberg
authors: Department of Surgery, Erasmus MC-University Medical Centre, Rotterdam, Netherlands.
authors: J Jan B
authors: JJ
authors: Van Lanschot
authors: Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
authors: Mitsuru
authors: M
authors: Sasako
authors: Division of Surgery, Department of Surgery and Cancer, St Mary's Hospital, Imperial College, London, UK. Electronic address: g.hanna@imperial.ac.uk.
authors: George B
authors: GB
authors: Hanna
mesh_terms: D059186:Chemoradiotherapy, Adjuvant / Q000592:standards; D017024:Chemotherapy, Adjuvant / Q000592:standards; D002983:Clinical Competence / Q000592:standards; D003406:Credentialing / Q000592:standards; D004938:Esophageal Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016629:Esophagectomy / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D005743:Gastrectomy / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D017052:Hospital Mortality; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects / Q000401:mortality / Q000592:standards*; D020360:Neoadjuvant Therapy / Q000592:standards; D009364:Neoplasm Recurrence, Local; D058996:Quality Improvement / Q000592:standards; D019984:Quality Indicators, Health Care / Q000592:standards*; D018714:Radiotherapy, Adjuvant / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design / Q000592:standards*; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome