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大型腹部手术的在线视频与面对面术前咨询(VIDEOGO):一项多中心、开放标签、随机、对照、非劣效性试验。

Online video versus face-to-face preoperative consultation for major abdominal surgery (VIDEOGO): a multicentre, open-label, randomised, controlled, non-inferiority trial.

作者信息

Ten Haaft Britte H E A, Janssen Boris V, Barsom Esther Z, Hehenkamp Wouter J K, van Berge Henegouwen Mark I, Busch Olivier R, van Dieren Susan, Erdmann Joris I, Eshuis Wietse J, Gisbertz Suzanne S, Luyer Misha D P, Damman Olga C, de Bruijne Martine C, Kazemier Geert, Schijven Marlies P, Besselink Marc G

机构信息

Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, Netherlands; Amsterdam Public Health, Digital Health, Amsterdam UMC, Amsterdam, Netherlands.

Department of Surgery, Amsterdam UMC, location University of Amsterdam, Amsterdam, Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, Netherlands.

出版信息

Lancet Digit Health. 2025 Jun;7(6):100867. doi: 10.1016/j.landig.2025.02.007. Epub 2025 Jun 15.

Abstract

BACKGROUND

Online video consultation between patients and health-care providers rapidly gained popularity during the COVID-19 pandemic. However, to our knowledge, there is no high-quality comparative evidence regarding patient satisfaction and quality of information recall with online video consultation and traditional face-to-face consultation. This lack of evidence is especially concerning in the most demanding consultations. We aimed to assess whether online video consultation between patients and surgeons before major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction, and to assess effects on patient information recall.

METHODS

This open-label, randomised, controlled, non-inferiority trial (VIDEOGO) was conducted at two hospitals (one academic and one regional) in the Netherlands. Adult patients (aged ≥18 years) who required consultation with a surgeon to discuss major abdominal surgery and were able and willing to interact via both online video and face-to-face consultation were eligible for inclusion; patients were excluded if they were unable or unwilling to start or maintain online video consultation. Eligible patients were randomly allocated (1:1) to online video or face-to-face consultation by the study coordinator, using a computer-generated, concealed, permuted-block randomisation method with varying block sizes (two, four, and six patients), stratified by study site. Masking of patients and health-care providers was not possible owing to the nature of the study. The primary outcomes were patient satisfaction (score 0-100; assessed for non-inferiority with a predefined margin of -10%) and information recall (score 0-11), both of which were assessed with online questionnaires and analysed in the intention-to-treat population for whom outcome data were available. Technical adverse events were assessed directly after the consultation as part of the satisfaction questionnaire. This trial is registered with the International Clinical Trial Registry Platform and the Central Committee on Research Involving Human Subjects registry, NL-OMON20092, and is complete.

FINDINGS

Between Feb 13, 2021, and Oct 2, 2023, 120 patients were randomly assigned: 60 to online video consultation and 60 to face-to-face consultation. Outcome data were available for 57 patients in the online video consultation group (20 [35%] female and 37 [65%] male; median age 64·0 [54·5-72·5] years) and 55 patients in the face-to-face group (22 [40%] female and 33 [60%] male; median age 62·0 [56·0-70·0] years). The mean patient satisfaction score was 85·4 out of 100 (SD 12·3) in the online video consultation group and 85·2 (14·2) in the face-to-face group (mean difference 0·2, 95% CI -4·8 to 5·1), which was within the non-inferiority margin of -10% (p<0·0001). The mean information recall score was 7·30 out of 11 (SD 1·60) in the online video consultation group and 7·25 (1·48) in the face-to-face group (mean difference 0·05, 95% CI -0·53 to 0·63). Technical adverse events occurred for two (7%) of 29 patients for whom data were available: one patient experienced a problem with the video connection and one experienced a problem with audio, both of which were resolved during the consultation without affecting the conversation.

INTERPRETATION

The use of online video consultation during surgical consultation for major abdominal surgery was non-inferior to face-to-face consultation in terms of patient satisfaction and did not substantially affect information recall. These findings suggest that online video consultation can be implemented confidently in surgical outpatient clinics.

FUNDING

The Netherlands Organization for Health Research and Development.

摘要

背景

在新冠疫情期间,患者与医疗服务提供者之间的在线视频咨询迅速普及。然而,据我们所知,目前尚无关于在线视频咨询与传统面对面咨询在患者满意度和信息回忆质量方面的高质量比较证据。在最需要的咨询中,这种证据的缺乏尤其令人担忧。我们旨在评估在进行腹部大手术前,患者与外科医生之间的在线视频咨询在患者满意度方面是否不劣于面对面咨询,并评估其对患者信息回忆的影响。

方法

这项开放标签、随机、对照、非劣效性试验(VIDEOGO)在荷兰的两家医院(一家学术医院和一家地区医院)进行。成年患者(年龄≥18岁),需要与外科医生讨论腹部大手术,并且能够且愿意通过在线视频和面对面咨询进行互动的患者符合纳入标准;如果患者无法或不愿意开始或维持在线视频咨询,则被排除。符合条件的患者由研究协调员使用计算机生成的、隐藏的、可变区组大小(两名、四名和六名患者)的排列区组随机化方法,按研究地点分层,随机分配(1:1)至在线视频咨询或面对面咨询。由于研究的性质,患者和医疗服务提供者无法进行盲法。主要结局是患者满意度(评分0 - 100;使用预先定义的-10%的非劣效性边际评估)和信息回忆(评分0 - 11),两者均通过在线问卷进行评估,并在意向性分析人群中进行分析,该人群可获得结局数据。在咨询后,将技术不良事件作为满意度问卷的一部分直接进行评估。这项试验已在国际临床试验注册平台和涉及人类受试者研究中央委员会注册,注册号为NL-OMON20092,且已完成。

结果

在2021年2月13日至2023年10月2日期间,120名患者被随机分配:60名接受在线视频咨询,60名接受面对面咨询。在线视频咨询组的57名患者(20名[35%]女性和37名[65%]男性;中位年龄64.0[54.5 - 72.5]岁)和面对面组的55名患者(22名[40%]女性和33名[60%]男性;中位年龄62.0[(56.0 - 70.0)]岁)可获得结局数据。在线视频咨询组的患者满意度平均评分为85.4分(满分100分,标准差12.3),面对面组为85.2分(14.2)(平均差异0.2,95%置信区间-4.8至5.1),在-10%的非劣效性边际范围内(p<0.0001)。在线视频咨询组的信息回忆平均评分为11分中的7.30分(标准差1.60),面对面组为7.25分(1.48)(平均差异0.05,95%置信区间-0.53至(0.63))。在可获得数据的29名患者中,有两名(7%)发生了技术不良事件:一名患者视频连接出现问题,一名患者音频出现问题,两者均在咨询期间得到解决,未影响对话。

解读

在腹部大手术的外科咨询中使用在线视频咨询在患者满意度方面不劣于面对面咨询,并且对信息回忆没有实质性影响。这些发现表明,在线视频咨询可以在外科门诊自信地实施。

资助

荷兰卫生研究与发展组织。

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