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

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: NCT06765538.