Nacci A, Ursino F, La Vela R, Matteucci F, Mallardi V, Fattori B
Chair of Audiology and Phoniatrics, Department of Neurosciences, Pisa University, Italy.
Acta Otorhinolaryngol Ital. 2008 Aug;28(4):206-11.
Fiberoptic endoscopic evaluation of swallowing (FEES) is now a first choice method for studying swallowing disorders on account of the various advantages it offers: easy to use, very well tolerated, allows bedside examination and is economic. Nevertheless, this diagnostic procedure is not without risks, the most probable consequences of which include discomfort, gagging and/or vomiting, vasovagal syncope, epistaxis, mucosal perforation, adverse reactions to topical anaesthetics and laryngospasm. The risks involved with FEES stress the importance of informing the patient of these; this is an important aspect in medicine that necessarily and immediately implies receiving the patient's so-called "informed consent". Informed consent should be obtained not only by means of specific printed forms but also after the patient has had an interview with the physician who will be performing the procedure and who will offer information according to the personal clinical, psychological, cultural and linguistic situation of the patient and in keeping with the type of procedure proposed. In the case of FEES, as with other invasive or non-invasive diagnostic procedures, therefore, routine written and signed consent, together with a patient/physician interview should fulfil what is known as "complete information". In this report, a specific form for informed consent to FEES procedures, is proposed.
由于纤维内镜吞咽功能评估(FEES)具有诸多优点:使用方便、耐受性良好、可在床边进行检查且经济实惠,因此它现在是研究吞咽障碍的首选方法。然而,这种诊断程序并非没有风险,最可能的后果包括不适、恶心和/或呕吐、血管迷走性晕厥、鼻出血、黏膜穿孔、对局部麻醉剂的不良反应以及喉痉挛。FEES相关的风险凸显了告知患者这些风险的重要性;这是医学中的一个重要方面,必然且立即意味着要获得患者所谓的“知情同意”。不仅应通过特定的打印表格获取知情同意,而且在患者与将进行该程序的医生面谈后也应获取,医生将根据患者个人的临床、心理、文化和语言状况,并结合所提议程序的类型提供信息。因此,就FEES而言,与其他侵入性或非侵入性诊断程序一样,常规的书面签署同意书以及患者/医生面谈应满足所谓的“完整信息”要求。在本报告中,提出了一份FEES程序知情同意的特定表格。