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
Nephrology and Transplantation, John Hunter Hospital, Newcastle, New South Wales, Australia.
Kidney Health Service, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.
Clin J Am Soc Nephrol. 2025 Apr 9;20(6):835-843. doi: 10.2215/CJN.0000000702.
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.
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).
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.
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.
Video-assisted eConsent improves patient comprehension of PKB compared with the usual consent practice without affecting patient experience, anxiety, or satisfaction.
: Australian New Zealand Clinical Trials Registry (ACTRN12621000768897).
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。
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。
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。
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。
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。
澳大利亚新西兰临床试验注册中心（ACTRN12621000768897）。
