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

Abstract

Background The video versus face-to-face preoperative anaesthetic assessment (VIDFACE) trial is a randomised, multicentre, two-arm, superiority, assessor- and data analyst blinded clinical trial. The routine use of preoperative assessments is accepted as the gold standard for elective surgery, reducing both morbidity and mortality. In recent years, video-based assessments have been investigated with a focus on patient satisfaction and enhancing efficacy. The VIDFACE trial aims to compare video-based preoperative anaesthetic assessment with face-to-face assessments, with a focus on patient safety and satisfaction. Objective To report the statistical analysis plan for the VIDFACE randomised clinical trial. Methods/Design We will enrol 2260 adult participants undergoing elective ear-nose-throat or oral and maxillofacial surgery. Participants will be randomised 1:1 stratified by ?trial site? and ?known or suspected malignant/haematological condition? to either intervention (video-based preoperative anaesthetic assessment) or control (face-to-face preoperative anaesthetic assessment). Two blinded statisticians will analyse the data. Before unblinding, we will write two abstracts based on the initial blinded analysis, one assuming A is intervention and B is control and one with the opposite assumption. Primary outcome is a composite outcome including five predefined serious complications. We assume a 30% relative risk reduction of the primary composite outcome. An interim analysis will take place after inclusion and follow-up on half of the intended sample size. Conclusion This statistical analysis plan of the VIDFACE trial will minimise analysis bias and add transparency to the statistics applied in the results of the trial. Trial Registration: ClinicalTrials.gov identifier: NCT0676553