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

Abstract

BACKGROUND Informed consent is crucial in healthcare, as 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. This study aimed to assess the patient-reported benefits of video-assisted electronic consent (eConsent) compared with the usual consent practices for percutaneous kidney biopsies (PKB). 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 post-biopsy 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 (IQR 34-65) years, 56% were female, and 59% had less than 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 to 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 to usual consent practice without affecting patient experience, anxiety, or satisfaction. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ACTRN12621000768897).