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经皮肾活检视频辅助电子知情同意书与标准知情同意书的随机对照试验

A Randomized Controlled Trial of Video-Assisted Electronic Consent versus Standard Consent for Percutaneous Kidney Biopsy.

作者信息

Franca Gois Pedro H, Miao Vera Y, Saunderson Rebecca B, Wainstein Marina, Jefferis Julia, Hudson Rebecca, Chandler Shaun, Mallitt Kylie-Ann, Wolley Martin, Elford Belinda, Bonner Ann, Healy Helen G

机构信息

Nephrology and Transplantation, John Hunter Hospital, Newcastle, New South Wales, Australia.

Kidney Health Service, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.

出版信息

Clin J Am Soc Nephrol. 2025 Apr 9;20(6):835-843. doi: 10.2215/CJN.0000000702.

Abstract

KEY POINTS

Video-assisted electronic consent significantly improved patient comprehension of percutaneous kidney biopsy without affecting patient-reported experience. Audiovisual aids support clinicians in delivering patient-centered informed consent, enhancing comprehension and engagement.

BACKGROUND

Informed consent is crucial in health care because it respects and honors patient autonomy. However, the process of consenting a patient to a procedure or intervention is often unstandardized, leading to gaps in comprehension, which in turn affects decision making. The aim of this study was to assess the patient-reported benefits of video-assisted electronic consent (eConsent) compared with the usual consent practices for percutaneous kidney biopsies (PKBs).

METHODS

In this single-center, open-label, randomized controlled trial, consecutive patients undergoing PKB between July 2021 and January 2024 were randomized (1:1) to either video-assisted eConsent (intervention) or usual practice of consent (control). The intervention group accessed an eight-minute explanatory animation on an online platform covering the procedure, its risks, and pre- and postbiopsy care before providing digital consent. The control group was consented to by clinicians in the usual manner and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience, anxiety, and satisfaction with the consent process.

RESULTS

Of 178 eligible patients, 120 were enrolled (60 in each group), with a median age of 52 (interquartile range, 34–65) years; 56% were female; and 59% had <12 years of education. Comprehension scores were significantly higher in the eConsent group, with participants answering on average three more questions correctly out of nine compared with the control group ( < 0.001). Comprehension did not differ significantly by sex or education level, but younger patients scored higher. The eConsent group also had better comprehension of pre- and post-PKB care. No significant differences were observed in patient-reported experience, anxiety, or satisfaction between groups.

CONCLUSIONS

Video-assisted eConsent improves patient comprehension of PKB compared with the usual consent practice without affecting patient experience, anxiety, or satisfaction.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

: Australian New Zealand Clinical Trials Registry (ACTRN12621000768897).

摘要

要点

视频辅助电子同意书显著提高了患者对经皮肾活检的理解,且不影响患者报告的体验。视听辅助工具有助于临床医生提供以患者为中心的知情同意,增强理解和参与度。

背景

知情同意在医疗保健中至关重要,因为它尊重患者的自主权。然而,让患者同意进行某项手术或干预的过程往往不规范,导致理解上的差距,进而影响决策。本研究的目的是评估与经皮肾活检(PKB)的常规同意做法相比,视频辅助电子同意书(电子同意书)在患者报告方面的益处。

方法

在这项单中心、开放标签、随机对照试验中,2021年7月至2024年1月期间连续接受PKB的患者被随机(1:1)分为视频辅助电子同意书组(干预组)或常规同意做法组(对照组)。干预组在提供数字同意之前,在在线平台上观看一段八分钟的解释性动画,内容涵盖手术、风险以及活检前后的护理。对照组由临床医生以常规方式进行同意,并签署纸质表格。主要结局是基于问卷的患者理解情况,次要结局包括患者报告的体验、焦虑以及对同意过程的满意度。

结果

在178名符合条件的患者中,120名患者入组(每组60名),中位年龄为52岁(四分位间距,34 - 65岁);56%为女性;59%的患者受教育年限<12年。电子同意书组的理解得分显著更高,与对照组相比,参与者在九个问题中平均多答对三个问题(<0.001)。理解情况在性别或教育水平上无显著差异,但年轻患者得分更高。电子同意书组对PKB前后护理的理解也更好。两组在患者报告的体验、焦虑或满意度方面未观察到显著差异。

结论

与常规同意做法相比,视频辅助电子同意书提高了患者对PKB的理解,且不影响患者体验、焦虑或满意度。

临床试验注册名称和注册号

澳大利亚新西兰临床试验注册中心(ACTRN12621000768897)。

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