Neurosurgery Department, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy.
Besta NeuroSim Center, Fondazione IRCCS Istituto Neurologico Nazionale "C. Besta", Milan, Italy.
Acta Neurochir (Wien). 2021 Feb;163(2):301-308. doi: 10.1007/s00701-020-04303-y. Epub 2020 Apr 3.
The informed consent is a defining moment that should allow patients to understand their condition, what procedure they are undergoing, and what consequences may follow. This process should foster trust and promote confidence, without increasing patients' anxiety. New immersive 3D imaging technologies may serve as a tool to facilitate this endeavor.
In a prospective, single-center, randomized controlled clinical trial (SPLICE Study: Surgical Planning and Informed Consent Study; ClinicalTrials.gov NCT03503487), 40 patients undergoing surgery for intracranial tumors were enrolled. After undergoing a traditional surgical informed consent acquisition, 33 patients were randomized 1:1:1 to 3 groups: in 2 experimental groups, patients underwent a 3D, immersive informed consent with two different surgical planners (group 1 and group 2); in the control group, patients underwent an informed consent supported by traditional 2D radiological images.
Patients in the experimental groups appreciated this communication experience, while their objective comprehension was higher ((score mean (SD)): group 1 82.65 (6.83); group 2 77.76 (10.19)), as compared with the control group (57.70 (12.49); P < 0.001). Subjective comprehension and anxiety levels did not differ between experimental groups and control group.
3D virtual reality can help surgeons and patients in building a better relationship before surgery; immersive 3D-supported informed consent improves patients' comprehension of their condition without increasing anxiety. This new paradigm may foster trust between surgeons and patients, possibly restraining medical-legal acts.
ClinicalTrials.gov NCT03503487.
知情同意是一个决定性的时刻，应该让患者了解自己的病情、正在接受的手术程序以及可能出现的后果。这一过程应该增进信任并增强信心，而不会增加患者的焦虑。新的沉浸式 3D 成像技术可以作为一种辅助手段来促进这一目标的实现。
在一项前瞻性、单中心、随机对照临床试验（SPLICE 研究：手术计划和知情同意研究；ClinicalTrials.gov NCT03503487）中，纳入了 40 名接受颅内肿瘤手术的患者。在接受传统的手术知情同意采集后，33 名患者被随机分为 1:1:1 三组：在两组实验组中，患者接受了两种不同手术计划者的沉浸式 3D 知情同意（组 1 和组 2）；在对照组中，患者接受了传统 2D 放射影像支持的知情同意。
实验组患者对这种沟通体验表示赞赏，而他们的客观理解程度更高（（评分均值（标准差））：组 1 82.65（6.83）；组 2 77.76（10.19）），与对照组（57.70（12.49）；P<0.001）相比。实验组和对照组的主观理解和焦虑水平没有差异。
3D 虚拟现实技术可以帮助外科医生和患者在手术前建立更好的关系；沉浸式 3D 支持的知情同意可以提高患者对自身病情的理解，而不会增加焦虑。这种新方法可能会增进医患之间的信任，从而可能减少医疗法律行为。
ClinicalTrials.gov NCT03503487。
