Department of otorhinolaryngology, University General Hospital, Valencia, Spain
Med Oral Patol Oral Cir Bucal. 2022 May 1;27(3):e294-e300. doi: 10.4317/medoral.25265.
The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any action performed on them and dental or medical doctors are obliged to obtain their patient's prior written informed consent (IC) before undertaking any healthcare procedures.
Here we reviewed the legality and jurisprudence in Spain regarding IC. We also used INFLESZ text readability analysis software to analyse a sample of official Spanish informed consent documents (ICDs) from different surgical and interventional procedures related to dentistry and oral cavity interventions.
It is a mistake to confound IC with ICDs. This error prevents physicians from considering the former as a care process in which the patient's authorisation signature is the last link in a chain formed, almost in its entirety, by the informative process and deliberation alongside the patient. Multiple factors can influence communication between practitioners and their patients. Importantly, treatment adherence is greater when patients feel involved and autonomous in shared decision-making and when the circumstances of their lives are adequately considered. We concluded that although the ICDs we analysed conformed to the requirements set out in international law, they were somewhat difficult to read according to the reading habits of the general Spanish population.
Knowledge about the legality of IC helps professionals to understand the problems that may arise from their non-compliance. This is because the omission or defective fulfilment of IC obligations is the origin of legal responsibility for medical practitioners. In this sense, to date, there have been more convictions for defective ICs than for malpractice. The information provided in ICs should include the risks, benefits, and treatment alternatives and must be tailored to the needs and capabilities of the patient to enable autonomous decision-making.
牙科医疗实践以及医学都处于法律环境之中。患者有权了解与他们所接受的任何治疗相关的所有信息,牙医和医生有义务在进行任何医疗程序之前获得患者事先签署的书面知情同意书(IC)。
在这里,我们回顾了西班牙关于 IC 的合法性和判例法。我们还使用了 INFLESZ 文本可读性分析软件,分析了来自不同牙科和口腔干预手术相关的西班牙官方知情同意书(ICD)样本。
将 IC 与 ICD 混淆是错误的。这个错误使医生无法将前者视为一个护理过程,在这个过程中,患者的授权签名是由信息过程和与患者协商几乎完全形成的链条中的最后一个环节。许多因素会影响医生与患者之间的沟通。重要的是,当患者感到参与和自主决策,并充分考虑他们的生活状况时,他们对治疗的依从性会更高。我们得出结论,尽管我们分析的 ICD 符合国际法规定的要求,但根据西班牙普通民众的阅读习惯,它们有些难以阅读。
了解 IC 的合法性有助于专业人员了解不遵守规定可能带来的问题。这是因为,IC 义务的遗漏或不履行是医疗从业者承担法律责任的根源。在这方面,迄今为止,因缺陷的 IC 而被判有罪的案例比因医疗事故被判有罪的案例更多。IC 中提供的信息应包括风险、收益和治疗替代方案,并且必须根据患者的需求和能力进行定制,以实现自主决策。