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数字化与面对面术前评估的效果比较:一项随机、非劣效性临床试验。

Effectiveness of a digital vs face-to-face preoperative assessment: A randomized, noninferiority clinical trial.

机构信息

Department of General Surgery, University of Utrecht, Utrecht, the Netherlands.

Department of General Surgery, University of Utrecht, Utrecht, the Netherlands.

出版信息

J Clin Anesth. 2023 Nov;90:111192. doi: 10.1016/j.jclinane.2023.111192. Epub 2023 Jul 18.

Abstract

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.

摘要

研究目的

数字化术前评估诊所可以是满足手术需求增长的解决方案。数字化术前评估诊所在患者健康结果和体验方面是否与面对面咨询一样安全有效,目前仍不清楚。本研究旨在比较数字术前评估与常规面对面咨询在接受手术的患者中的恢复质量和心理状态。

设计

这是一项单中心、随机(1:1)、平行、开放标签、非劣效性试验。

设置

城市二级保健医院的术前诊所和术前病房。

患者

所有需要手术的成年、讲荷兰语、ASA I-IV 级患者,且能够使用在线计算机。

干预

数字化术前筛查,包括电子筛查问卷和基于网络的平台,提供与手术相关的个性化信息和建议,或面对面筛查,包括两次 20 分钟的院内咨询。

测量

主要终点是术后 48 小时的恢复质量。分析遵循方案原则,仅包括接受预期筛查的患者。非劣效性边界设定为-6。该试验于 2022 年 8 月 9 日在 ClinicalTrials.gov 上注册,在研究期间,结果分析前进行。

主要结果

2021 年 3 月 1 日至 2021 年 8 月 30 日,对 480 名患者进行了资格评估。400 名患者被随机分配至数字组(n=200)或面对面组(n=201),其中分别有 117 名和 124 名患者最终纳入主要分析。接受数字筛查的患者的平均恢复质量评分(158)与接受面对面筛查的患者相当(155),平均差异为 3.2 分,97.5%置信下限为-2.1 分。无不良事件。

结论

在接受主要为低至中度风险手术的患者中,数字化术前筛查并不逊于面对面咨询。鉴于其减少医生工作量、重新分配医疗资源和降低医疗成本的潜力,数字化术前筛查可能是术前评估的更好选择。

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