The British journal of surgery
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The complexity of surgical interventions has major implications for the design of RCTs. Trials need to consider how and whether to standardize interventions so that, if successful, they can be implemented in practice. Although guidance exists for standardizing non-pharmaceutical interventions in RCTs, their application to surgery is unclear. This study reports new methods for standardizing the delivery of surgical interventions in RCTs. ⋯ The typology provides a framework for use during trial design to standardize the delivery of surgical interventions and document these details within protocols. Application of this typology to future RCTs may clarify details of the interventions under evaluation and help successful interventions to be implemented.
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The Swedish National Register for Oesophageal and Gastric Cancer (NREV) was launched in 2006. Data are reported at diagnosis (diagnostic survey), at the time of surgery (surgical survey) and at first outpatient follow-up (follow-up survey). The aim of this study was to evaluate data originating from NREV in terms of comparability, completeness, accuracy and timeliness. ⋯ NREV has reached a position with good coverage of those with the relevant diagnoses, and contains comparable and valid data. Quality data on each variable are available. Timeliness is an area with potential for improvement.