3.7 Withdrawal of Consent
Withdrawal of consent during an endoscopy is not uncommon.8,9,14 It is not always clear whether this is an effect of sedation-induced confusion or because the patient has genuinely withdrawn consent. If it is clear that consent has been withdrawn, the procedure should be abandoned. However, if it seems to be an effect of confusion, it is reasonable to temporarily desist and re-review after reassurance. If there is a serious risk involved in stopping the procedure, for example, major bleeding occurring during polypectomy, clinical judgment must be used. All endoscopy units should possess a written protocol prepared with input from the nursing staff who are the professionals mainly responsible for patient comfort and welfare during the procedure. This protocol should be followed in the event that consent is withdrawn.
3.8 Exceptions to the Requirement of Consent
Firstly, a doctor is not required to make disclosures to a patient if, in the reasonable exercise of medical judgment, he/she considers that it would be detrimental to the health of the patient. This is what is known as the “therapeutic exception.” However, this is a limited exception to the general principle and should not be used to enable a doctor to prevent a patient from making an informed choice which the doctor considers to be contrary to the patient’s best interests. Such would subvert the concept of patient autonomy which informed consent is intended to protect.
Secondly, a situation can arise in which the patient would rather trust their doctor to make treatment choices for them and in so doing request not to be informed of the risks arising from a recommended procedure. Under these circumstances, a doctor is not obliged to provide the information that would otherwise be required to obtain informed consent. It should be stressed that whether or not a patient falls into this category is a matter of judgment and one that should be approached with caution.
Thirdly, a doctor is excused from conferring with a patient in circumstances of necessity, for example, where the patient requires treatment urgently but the patient is unconscious or otherwise unable to make a decision. Clinical staff are often confronted by patients who may lack the capacity to make decisions. In these circumstances and in absence of preexisting consent from the patient, the approach to informed consent remains the same, although the individuals involved in deciding the course of treatment may differ, whether it is a relative with power of attorney or a court-appointed representative.
References
[1] Dunkas N. Works of Hippocrates. Paper presented at: Second European Symposium on Ethics in Gastroenterology and Digestive Endoscopy; 2006; Kos Greece
[2] Leclercq WK, Keulers BJ, Scheltinga MR, et al. A review of surgical informed consent: past, present, and future. A quest to help patients make better decisions. World J Surg. 2010; 34(7):1406–1415
[3] Pappworth MH. “Human guinea pigs”--a history. BMJ. 1990; 301(6766):1456–1460
[4] Pappworth MH. Human Guinea Pigs: Experimentation on Man. London: Routledge; 1967
[5] World Health Organization. A Declaration on the Promotion of Patients’ rights in Europe: European Consultation on the Rights of Patients Amsterdam, 28 -30 March 1994. Copenhagen: World Health Organization; 1994
[6] Triantafyllou K, Stanciu C, Kruse A, et al; European Society of Gastrointestinal Endoscopy. Informed consent for gastrointestinal endoscopy: a 2002 ESGE survey. Dig Dis. 2002; 20(3–4):280–283
[7] Kopacova M, Bures J. Informed consent for digestive endoscopy. World J Gastrointest Endosc. 2012; 4(6):227–230
[8] Everett SM, Griffiths H, Nandasoma U, et al; Guideline for obtaining valid consent for gastrointestinal endoscopy procedures. British Society of Gastroenterology Gut. 2016; 65(10):1585-1601
[9] Zuckerman MJ, Shen B, Harrison ME, III, et al; Standards of Practice Committee. Informed consent for GI endoscopy. Gastrointest Endosc. 2007; 66(2):213–218
[10] Montgomery v Lanarkshire Health Board [2015] UKSC 11
[11] Sidaway v Board of Governors of the Bethlem Royal Hospital and Maudsley Hospital [1985] AC 871
[12] Dinis-Ribeiro M, Hassan C, Meining A,, et al. European Society of Gastrointestinal Endoscopy. Live endoscopy events (LEEs): European Society of Gastrointestinal Endoscopy Position Statement - Update 2014. Endoscopy. 2015; 47(1):80–86
[13] Shepherd H, Hewitt D. Guidelines for Postal Consenting for Outpatient Endoscopic Procedures. British Society of Gastroenterology; 2009
[14] Ward B, Shah S, Kirwan P, Mayberry JF. Issues of consent in colonoscopy: if a patient says ‘stop’ should we continue? J R Soc Med. 1999; 92(3):132–133
4 Patient Preparation and Sedation for Endoscopy
T. Wehrmann
4.1 Introduction
Sedation in endoscopy is drug-induced reduction of the patients’ consciousness. The aim of sedation in endoscopic procedures is to increase the patient's comfort and to improve endoscopic performance, especially during therapeutic procedures. Traditionally, the sedation regimen most commonly used for conscious sedation during gastrointestinal endoscopy was a combination of benzodiazepines and opioids. However, the use of propofol has enormously increased during the last two decades, and several studies showed advantages of propofol over the traditional regimes in terms of faster recovery time. Conversely, one must be aware that the complication rates of endoscopic procedures might increase when using propofol sedation. Therefore, a thorough risk evaluation before the procedure and monitoring during the procedure are paramount. In addition, properly trained staff and emergency equipment are essential. Sedation can be provided by anesthesiologists, nonanesthesiologist physicians (i.e., gastroenterologists or surgeons), or a well-trained nursing staff, depending on institutional and regional restrictions. Nurse-administered sedation for low-risk endoscopic procedures and low-risk patients has become accepted in some European countries. Ideally, a sedation regimen is tailored to the individual patient after assessment of clinical risk and patient anxiety level, as well as to the complexity of planned endoscopic procedure.
Analgesia is the elimination of pain by analgesic agents. The combination of sedation and analgesia is used to achieve optimal patient tolerance during diagnostic and therapeutic endoscopic procedures. Patient tolerance, in turn, is important for successful completion and safety, which leads to better patient compliance with subsequent endoscopies.1 Procedural sedation provokes a high level of physician and patient satisfaction, and may improve the quality of an endoscopic examination.2,3 Although it is feasible to perform routine endoscopies without sedation in selected patients, for complex endoscopic procedures sedation is required.4,5,6 The sedation frequency for endoscopic procedures has risen significantly during the last two decades.7,8,9,10 As a consequence, several guidelines have been published regarding endoscopic sedation.4,5,6,11,12,13,14,15,16,17
4.2 Presedation Assessment