Effects of and resilience to COVID-19
EAGLE recruited and randomised the first batch of hospitals in December 2019, as ‘phase 1’, and the second in February 2020, ‘phase 2’, prior to the start of the COVID-19 pandemic. The pandemic rapidly shut down global surgical services and a decision was made to suspend the EAGLE study, just five weeks after launch, on 13Clusters in ‘phase 1’ that had implemented the intervention but then paused due to COVID-19 were offered a 2-week ‘refresher’ intervention period for teams to review e-modules and intervention components before embarking on post-intervention data collection. Several clusters reported structural or organisational changes related to the pandemic and EAGLE adapted to ensure inclusivity despite these circumstances. One hospital that had previously performed both elective and emergency colorectal surgery was re-structured with its sister hospital to separate emergency operating at one site and elective operating at the other, but with a single, cross-site surgical team. On resumption of the study, local approvals were amended to include both sites as a single cluster. Conversely, in another site where there were two entirely separate surgical teams, each team was randomised as a separate cluster.Although the interruption to the first batches impacted on the conduct of the trial and thus potentially the interpretation of the data in these batches, this impact was contained and did not compromise later batches, illustrating a more general robustness in the batched approach to design. When the trial data are analysed it may be necessary to perform a sensitivity analysis excluding phases 1 and 2.