Limitations
STAGGERED
Implementing the design in batches had a number of practical benefits [The staggered start dates for data collection and introduction of the intervention meant that collaborators, e.g. Surgical Trainee Principal Investigators could miss participating in the study itself despite garnering the appropriate approvals, because the lead-in time after randomisation could be up to 20 weeks. This affected trainees or other collaborators moving between hospitals/departments, particularly in sequence 3. The risks with such a long lead in time include reduced motivation and engagement by the time study activities begin; however, this may also be seen in the context of studies that recruit many clusters to start at the same time, as those recruited first may have lost motivation by the time enough teams are prepared to start. Where long delays mean collaborators have changed departments or hospitals, the local team also needs to recruit new core team members who may not be as familiar with the study.A further risk associated with long lead-in times before pre-intervention data collection is the risk that participants will, in the meantime, access educational materials from elsewhere. This will, at worst, attenuate our estimate of the effect of the intervention.EAGLE sequence 3 collaborators must also rely on internal rather than external motivation to complete e-learning, (since there was no post-intervention data collection for this group therefore core EAGLE team members would have less reason to urge surgeon colleagues to complete the modules). While this would not affect the study’s primary objective (as no post-intervention data collection planned), it would reduce the dissemination of evidence-based education content which is designed to be delivered at every EAGLE participating cluster.The e-modules contained extensive evidence-based content for surgeons that were presented in English. Most surgeons in the ESCP are accustomed to working in English however the resource was offered to all surgeons at participating hospitals and this monolingual resource may have excluded selected surgeon users. In some countries (South Korea, Romania), surgeons formed working groups to undertake the e-modules together. A lead surgeon could translate and interpret the modules, and cross the language barrier for colleagues with more limited English.One further drawback is that this study did not examine the longer-term effects of the intervention. Individual surgeons or surgical teams could slip back into older less evidence-based practice, team members will inevitably change, and without deliberate maintenance of the practice change, any beneficial intervention effects may be lost. There is a strong case for a follow-up cohort study to assess longer-term adherence and patient outcomes, should the study show a patient benefit.