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

一项关于视频辅助电子知情同意与标准知情同意在经皮肾活检中应用的随机对照试验

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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 (P < 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).

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