Perioperative medicine & outcomes

Video Versus Face‐To‐Face Preoperative Anaesthetic Assessment: The VIDFACE Trial—A Statistical Analysis Plan

Acta Anaesthesiol ScandPublished Statistical analysis plan of a randomised controlled trial

Study context

Population
Adults undergoing elective ear-nose-throat or oral and maxillofacial surgeryplanned enrolment
Participants
2,260 adults
Planned comparison
Video-based vs face-to-face preoperative anaesthetic assessment
Primary endpoint
Composite of five predefined serious complications
Methodological detailsmulticentre, two-arm, superiority, assessor- and data analyst blinded, stratified 1:1 randomisation, planned interim analysis, Assumed 30% relative risk reduction of the primary composite outcome, Interim analysis after inclusion and follow-up of half the intended sample size, Two blinded statisticians; two abstracts written before unblinding (A as intervention, and the opposite)
  • Multicentre
  • Two-arm
  • Superiority
  • Assessor- and data analyst blinded
  • Stratified 1:1 randomisation
  • Planned interim analysis
  • Assumed 30% relative risk reduction of the primary composite outcome
  • Interim analysis after inclusion and follow-up of half the intended sample size
  • Two blinded statisticians; two abstracts written before unblinding (A as intervention, and the opposite)

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Video Versus Face‐To‐Face Preoperative Anaesthetic Assessment: The VIDFACE Trial—A Statistical Analysis Plan. Acta Anaesthesiol Scand. Published 4 June 2025. doi:10.1111/aas.70068

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