Informed consent for suspension microlaryngoscopy: what should we tell the patient? A consensus statement of the European Laryngological Society

In the USA, the concept of informed consent started in 1905 in a judicial decision concerning a case with an otologic intervention. This laid the foundation for the principle of patient autonomy [1]. This first judicial decision was made with the case of Mohr v Williams [1]. The plaintiff, Ms. Mohr, consented to surgery on her right ear. Once she had been anesthetized, her surgeon, Dr. Williams, determined that her left ear was more seriously ill. Dr. Williams then decided to operate on the left ear only. Ms. Mohr’s hearing further deteriorated as a result of the operation. She sued the surgeon for battery and assault for altering the laterality of the operation without permission. The Minnesota Supreme Court agreed with the plaintiff that the surgeon should have obtained explicit consent before performing surgery on the other ear [2].

The required standard for informed consent is determined per state within the USA. However, the following are the required elements for documentation of the informed consent discussion: the nature of the procedure, the risks and benefits of the procedure, reasonable alternatives, risks and benefits of alternatives, and assessment of the patient’s understanding of these elements [3]. The process of informed consent is nowadays shifting to focus more on communication and less on signatures, so the emphasis of a patient signature as an indication of understanding ahead of an elective procedure is currently being called into question [3].

In Australia, a 3-page document has to be filled in before performing SML [4]. The final step in documenting a patient’s decision about consent for microlaryngoscopy is obtained by completing the document. Its domains consist (in this sequence): interpreter and cultural needs, condition and treatment, risks of a microlaryngoscopy, significant risks and procedure options, risks of not having this procedure, anesthetic, patient consent, doctor statement and, if necessary, interpreter’s statement. The doctor has to undersign the statement ‘I have explained to the patient all the above points under the Patient Consent section and I am of the opinion that the patient/substitute decision maker has understood the information.’ There is no explicit definition of significant risks.

In the Netherlands, the care provider must inform the patient in a clear and comprehensible manner about the intended treatment and be guided by what the patient should reasonably know about the expected consequences and risks of the treatment, the alternatives and the outlook [5]. In doing so, the care provider must ensure that the patient has understood what has been discussed with him. The patient’s consent is required for procedures in execution of a treatment agreement. A signature of the patient is not obligatory. Although it is generally recommended to provide the patient with the best possible insight into what to expect, especially if the potential complications are serious, there is no legal obligation to do so if the probability of complications is less than 1% [6]. The surgeon is obliged to document the statements he has made concerning risks, alternatives, complications and expectations in the patient’s file. However, when it comes to non-invasive interventions, the presumed consent of the patient is enough.

In Colombia, informed consent is mandatory for any in-office or operating room procedure, no matter what the magnitude of it might be. It is regulated and overseen by health authorities. Every possible adverse event must be clearly specified in the document, that includes known risks related to SML, any specific potential risks or complications secondary to the use of technologies such as laser, and personalized risks (depending on the clinical conditions of a specific patient), and a final statement about the fact that all questions the patient might have, were satisfactorily answered. An independent informed consent must be signed for the anesthetic procedure.

In France, there is an information document published by the Centre National Professionnel ORL which describes minor and major complications. It is recommended that this document be given to patients who require SML. A statement in the file is not mandatory; it is highly recommended to have one.

In Luxembourg, the procedure and the name of the surgeon must be clearly mentioned. The consent is provided in three languages, reflecting the local population. The patient must confirm that he (she) was informed about the objectives, the possible emergency, the possible complications, the alternatives for the treatment, and the risks of not performing the treatment. Acceptance or refusal of blood transfusion must be mentioned in any intervention. Translation in a fourth language must be provided if necessary.

In South Africa, information should be provided to the patient during the informed consent process in a language that the patient understands and should include details of the diagnosis, prognosis, purpose of the procedure, and discussion of any serious or frequently occurring risks. Consent should be obtained by the health care practitioner undertaking the procedure, but where this is not practicable, the task can be delegated to a health care practitioner who is suitably educated, trained and qualified, has sufficient knowledge of the proposed procedure and understands the risks involved. Written consent must be obtained for all cases where the treatment or procedure is complex or involves significant risks and/or side effects, such a SML [7].

In the United Kingdom, based on guidance from the General Medical Council, for consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. This means the patient must understand the information given to them and can use it to make an informed decision. Therefore, the information given to the patient must be clear, accurate and up-to-date, based on the best available evidence. Discussion should include the potential benefits and any risks of harm that the patient would consider significant. In the UK ‘implied’ consent is used for most ‘in-office’ laryngeal examinations but SML requires ‘written’ consent, obtained by a clinician who understands and can perform the intervention.

It is clear that deviations of these protocols exist worldwide. In the nine countries where the procedure of informed consent was examined, laryngologists in just one country have to discuss the informed consent of anesthetics themselves. Details highlighting mandatory demands can be found in Table 1.

Table 1 Shortened and summarized details on laryngologist’s mandatory informed consent for suspension microlaryngoscopy in nine different countries. Items that are not mandatory but recommended have not been included

留言 (0)

沒有登入
gif