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Stepped-wedge study design of the PEFLA trial. Considering the number of participating centres (16 centres) and the duration of this study (24 months), it was proposed to fix eight intervals of 3 months each. The randomisation will involve seven steps, each of them including two to three centres.

Journal: BJA Open

Article Title: Investigating the effectiveness of an intraoperative decision support guided fluid therapy intervention on postoperative outcome of high-risk patients undergoing high-risk abdominal surgery: protocol for an international multicentre stepped-wedge cluster-randomised implementation trial

doi: 10.1016/j.bjao.2025.100421

Figure Lengend Snippet: Stepped-wedge study design of the PEFLA trial. Considering the number of participating centres (16 centres) and the duration of this study (24 months), it was proposed to fix eight intervals of 3 months each. The randomisation will involve seven steps, each of them including two to three centres.

Article Snippet: Randomisation will be performed using block randomisation with a sequence generated in Stata software (version 13; StataCorp) by an independent statistician.

Techniques: