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Effectiveness of a digital vs face-to-face preoperative assessment: A randomized, noninferiority clinical trial
Bastiaan T van Hoorn1, Daniel J Tromp1, Rosalie C M van Rees2
1Department of General Surgery, University of Utrecht, Utrecht, the Netherlands.
Study Objective:
Digitalizing the preoperative assessment clinic can be a solution to keep up with the growing demand for surgery. It remains unclear if a digital preoperative assessment clinic is as safe, and effective in terms of patient health outcomes and experience compared to face-to-face consultations. This study aimed to compare quality of recovery and mental state in patients undergoing a digital preoperative assessment versus regular face-to-face consultations.
Design:
This was a single centre, randomized (1:1), parallel, open-label, noninferiority trial.
Setting:
The preoperative clinic and preoperative unit of an urban secondary care hospital.
Patients:
All adult, Dutch speaking, ASA I-IV patients with access to an online computer who required surgery.
Interventions:
Digital preoperative screening, consisting of an electronic screening questionnaire and web-based platform with personalized information and recommendations related to the procedure, or face-to-face screening, consisting of two 20-min in-hospital consultations.
Measurements:
The primary endpoint was quality of recovery, measured 48 h after surgery. The analysis followed a per-protocol principle, and only patients who underwent the intended screening were included in the analysis. The noninferiority margin was set at -6. The trial was registered at ClinicalTrials.gov, NCT05535205, during the study on 09/08/2022, before analysing results.
Main Results:
Between March 1, 2021 and 30 august 2021, 480 patients were assessed for eligibility. 400 patients were randomly assigned to the digital group (n = 200) or face-to-face group (n = 201), of which respectively 117 and 124 patients were eventually included in the primary analysis. The mean quality of recovery score of patients undergoing digital screening (158) was non-inferior to that of patients undergoing face-to-face screening (155), with a mean difference of 3·2 points and a 97.5% lower confidence limit of -2.1 points. There were no adverse events.
Conclusions:
A digital preoperative screening is not inferior to face-to-face consultations in patients undergoing predominantly low to moderate risk surgery. Given its potential to reduce physician workload, reallocate healthcare resources, and lower healthcare costs, a digital preoperative screening may be a better choice for preoperative assessments.
