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- W2133550246 abstract "SummaryIn law, consent allows the patient to determine what treatments they will accept or refuse. In this article, the common law of consent relating to anaesthesia is reviewed in order to highlight more recent changes to the standard of information provision and treatment of patients without capacity, and to form the basis of a critique of the current law. Practical and conceptual problems with the three core pillars of consent—voluntariness, capacity, and information—are analysed, along with the identification of logistical problems and contemporary theoretical challenges to the notion of patient autonomy as the basis of consent, concluding that ‘assent' better describes the current legal position regarding treatment permission than ‘consent'. In spite of this, the process of consent/assent is recognized as a major incentive towards data collection about patient-, operator-, and institution-specific risk, in order to better inform patients about the risks and benefits of treatment. In law, consent allows the patient to determine what treatments they will accept or refuse. In this article, the common law of consent relating to anaesthesia is reviewed in order to highlight more recent changes to the standard of information provision and treatment of patients without capacity, and to form the basis of a critique of the current law. Practical and conceptual problems with the three core pillars of consent—voluntariness, capacity, and information—are analysed, along with the identification of logistical problems and contemporary theoretical challenges to the notion of patient autonomy as the basis of consent, concluding that ‘assent' better describes the current legal position regarding treatment permission than ‘consent'. In spite of this, the process of consent/assent is recognized as a major incentive towards data collection about patient-, operator-, and institution-specific risk, in order to better inform patients about the risks and benefits of treatment. Editor's key points•Valid consent depends on patient voluntariness and the capacity to make a treatment decision based on the information provided.•A person with capacity understands, remembers, and uses the information provided.•Information should be provided to a standard which a reasonable patient would want to know in the patient's circumstances.•There are logistical and theoretical difficulties for doctors in delivering on each of these principles of consent.•Information provision during the consent process inadvertently incentivizes data collection for perioperative outcomes research. •Valid consent depends on patient voluntariness and the capacity to make a treatment decision based on the information provided.•A person with capacity understands, remembers, and uses the information provided.•Information should be provided to a standard which a reasonable patient would want to know in the patient's circumstances.•There are logistical and theoretical difficulties for doctors in delivering on each of these principles of consent.•Information provision during the consent process inadvertently incentivizes data collection for perioperative outcomes research. In a medical setting, the process of consent allows an autonomous patient (i.e. one who has the capacity to think, decide, and act on the basis of such thought, independently and without hindrance)1White SM Baldwin TJ Consent for anaesthesia.Anaesthesia. 2003; 58: 760-774Crossref PubMed Scopus (54) Google Scholar to define and protect his or her own interests and to control bodily privacy.2White SM Seery J Consent: the law and ethical considerations.Anaesth Intensive Care Med. 2009; 10: 111-114Abstract Full Text Full Text PDF Scopus (8) Google Scholar As both an ethical premise and a legal paradigm, the importance of consent in the provision of potentially injurious medical care is without question, and correctly so. The process of seeking consent from a patient allows for a fluid, reciprocal change of information, so that the patient understands what to expect from any intervention, and the doctor is enabled to tailor a patient-specific plan of treatment. The pre-eminence of patient-centred medicine and the rejection of medical paternalism have resulted in the development of both stringent professional guidelines3Department of Health Reference Guide to Consent for Examination or Treatment.Available from http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_103653.pdfDate: 2009Google Scholar, 4General Medical Council Consent: patients and doctors making decisions together. 2008http://www.gmc-uk.org/static/documents/content/Consent_0510.pdfGoogle Scholar, 5Association of Anaesthetists of Great Britain and Ireland Consent for Anaesthesia.Available from http://www.aagbi.org/publications/guidelines/docs/consent06.pdfDate: 2006Google Scholar and an exacting body of common law6White SM Baldwin TJ Consent.in: Legal and Ethical Aspects of Anaesthesia, Critical Care and Perioperative Medicine. Cambridge University Press, Cambridge2004: 49-71Crossref Google Scholar in order to ensure that patient autonomy is respected. As such, in liberal democracies, consent has developed as a legal permission that protects individuals from physical, and increasingly non-physical,7White SM Confidentiality, ‘no blame culture’ and whistleblowing, non-physician practice and accountability.Best Prac Res Clin Anaesthesiol. 2006; 20: 525-543Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar interference by others. In fact, consent is only one of a number of defences (including, for example, necessity, self-defence, and the defence of others) that may be used to justify interference with a third party that would normally be considered unlawful. With regard to the practice of medicine, therefore, touching a person without their consent even for the purpose of administering treatment is considered unlawful, constituting battery and potentially leading to imprisonment, although in practice, issues of consent are far more commonly decided in civil negligence. This article briefly summarizes the current law relating to consent in medicine in England and Wales, analyses the problems with the current law, and suggests that although such problems limit the benefit of consent for patients, they provide a stimulus for improving research into patient outcomes. There are numerous sources of information that review the current law on consent, and several detailing the law of consent for anaesthesia,1White SM Baldwin TJ Consent for anaesthesia.Anaesthesia. 2003; 58: 760-774Crossref PubMed Scopus (54) Google Scholar, 2White SM Seery J Consent: the law and ethical considerations.Anaesth Intensive Care Med. 2009; 10: 111-114Abstract Full Text Full Text PDF Scopus (8) Google Scholar, 3Department of Health Reference Guide to Consent for Examination or Treatment.Available from http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_103653.pdfDate: 2009Google Scholar, 4General Medical Council Consent: patients and doctors making decisions together. 2008http://www.gmc-uk.org/static/documents/content/Consent_0510.pdfGoogle Scholar including the revised Association of Anaesthetists of Great Britain and Ireland guidelines from 2006,5Association of Anaesthetists of Great Britain and Ireland Consent for Anaesthesia.Available from http://www.aagbi.org/publications/guidelines/docs/consent06.pdfDate: 2006Google Scholar so it is not necessary to restate the law in depth in this article. However, to understand where problems occur and to highlight recent developments in the law, there follows a brief description of the legal principles of consent relating to adult patients, in England and Wales. Patients should be invited to give their consent to any procedure which involves them being touched or which carries a risk that might be significant to them. The clinician administering treatment is the person responsible for seeking consent from the patient, and should be of sufficient experience to be able to explain the procedure and its risks. The form of consent is irrelevant, but a written consent form provides the clinician with greater evidential defence against allegations of non-consensual treatment if legal proceedings are brought at a later date, although a signed consent form does not necessarily provide conclusive evidence that consent was, in fact, given. Consent is legally valid if it is given voluntarily by an appropriately informed person, who has the capacity to express an informed choice. A voluntary decision is the one that is made in the absence of undue influence on the patient by a third party. Information should be given about who is doing the treatment, what the treatment involves, and why it is being administered, in order to avoid civil or criminal actions in battery. Further information should be provided about the risks of treatment and the consequences for the patient if those risks ensue, in order to defend actions in civil (or rarely criminal) negligence. The standard of information provision is discussed below. Legally, competent patients understand and remember information given to them about the treatment and use that information to decide whether or not to give their consent to the treatment proposed. Patients are either competent, in that they pass all three components (understand, retain, use) or they are not competent at the time a decision needs to be made—there is no ‘spectrum of competence', as such. Competent adults (over the age of 16) may refuse any or all current or future treatment and for whatever reason at any time, even if it is life-saving, with the same legal protection as if they had consented to treatment. The law has changed recently with regard to the treatment of adult patients who are not competent to make an informed decision, with the introduction of the Mental Capacity Act 2005, enforced since April 1, 2007. The details of this Act pertaining to clinical anaesthesia have previously been described,8White SM Baldwin TJ The Mental Capacity Act, 2005. Implications for anaesthesia and intensive care.Anaesthesia. 2006; 61: 381-389Crossref PubMed Scopus (33) Google Scholar but it is worth restating the core principles and highlighting how the Act, which is otherwise merely a statutory codification of previous civil precedent, has altered the law in this area. Under the Act, adults over the age of 16 should be assumed to be competent unless they fail the three-stage test of competence described above. Unwise decisions do not necessarily indicate a lack of patient capacity. It remains the responsible clinician's duty to determine competence, but they should be prepared to justify their decision to the courts if required to do so, which suggests that written assessment of competence should be recorded as part of the consent form in the same manner as details of the discussion about information provision. Patients must be given a reasonable chance to demonstrate that they have capacity, for example, by deferring decision-making to a later date (if clinically appropriate) and facilitating a return to capacity; the treatment of adults without capacity must be both necessary and in the patient's best interests. Patients who are not competent to make decisions about treatment are administered treatment, provided that it is necessary and in their best interests. ‘Best interests' must be determined by the treating clinician (or less commonly the Courts) in a non-discriminatory manner, taking into account information outside the clinical episode, including, for example, the patients known wishes previously expressed to relatives and other third parties. The Act recognizes the legality of advanced decision-making (‘living wills'), providing that documentation (in the case of life-sustaining treatment) states what treatment is precluded and the circumstances under which the advanced decision is intended to apply, and the decision has been made voluntarily by a patient who was previously competent, based on information presented to him/her. The Act also recognizes proxy decision makers. The recipient of an Enduring Power of Attorney, if registered and correctly appointed by a previously competent patient, can make medical treatment decisions (including decisions about life-sustaining treatment if specifically empowered to do so) on behalf of the incapacitated patient, provided that they themselves are competent to make a decision. Court-appointed deputies perform a similar function on behalf of patients who have never had the capacity to appoint a proxy decision maker, but cannot make life-sustaining treatment decisions. Independent mental capacity advocates cannot make treatment decisions on behalf of patients without capacity, but can gather information that informs doctors (or the courts) about the patients known wishes or circumstances. In practice, the common law precedents and statutory principles described above have changed very little since their general introduction to the young field of medical law, some 25 yr ago. Indeed, excepting determinations in civil negligence concerning information provision about risk, comparatively few legal cases have considered consent in relation to medical practice. This is despite both the numerous problems relating to consent first identified by Brazier9Brazier M Patient autonomy and consent to treatment: the role of the law?.Leg Stud (Soc Leg Scholars). 1987; 7: 169-193Crossref Scopus (47) Google Scholar in 1987 that remain unresolved to the current day,10Maclean A From Sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of a century of judicial scrutiny?.Med Law Rev. 2012; 20: 108-129Crossref PubMed Scopus (15) Google Scholar and the marked disparity between the standards of consent expected by ethicists and medicolegal professionals and the standards which are achievable by doctors and expected by patients11Akkad A Jackson C Kenyon S Dixon-Woods M Taub N Habiba M Patients' perceptions of written consent: questionnaire study.Br Med J. 2006; 333: 528-531Crossref PubMed Scopus (94) Google Scholar in clinical practice. The premise of this paper agrees with Brazier9Brazier M Patient autonomy and consent to treatment: the role of the law?.Leg Stud (Soc Leg Scholars). 1987; 7: 169-193Crossref Scopus (47) Google Scholar and Maclean10Maclean A From Sidaway to Pearce and beyond: is the legal regulation of consent any better following a quarter of a century of judicial scrutiny?.Med Law Rev. 2012; 20: 108-129Crossref PubMed Scopus (15) Google Scholar that the scope of ‘consent' as currently formulated and protected by law is insufficiently flexible to permit meaningful discourse between doctors and patients about treatment decisions. This is not to suggest any hint of revisionist paternalism, rather than an unchallenged, if well-intentioned, liberalist respect for autonomy, may in fact inadvertently render the patient less autonomous.12Haidt J The Righteous Mind: Why Good People Are Divided by Politics and Religion. Allen Lane, London2012Google Scholar There needs to be a different (but not a lesser) standard applied when determining liability in legal cases concerning consent, which takes into account flaws inherent in the consent process that result in consent rarely being given voluntarily, by patients who are seldom more than partially autonomous, based on information that is currently speculative and generic, rather than patient and context-specific, under logistical circumstances that inhibit reciprocal discussion. These flaws are discussed in turn below. Anecdotally, logistical problems in obtaining consent from patients are by far the most common cause of concern for most anaesthetists. Professional guidance advises that the anaesthetic room is not an appropriate location in which to seek consent for proposed anaesthetic interventions,5Association of Anaesthetists of Great Britain and Ireland Consent for Anaesthesia.Available from http://www.aagbi.org/publications/guidelines/docs/consent06.pdfDate: 2006Google Scholar and that patients should be allowed sufficient time in order to process information and arrive at a decision.3Department of Health Reference Guide to Consent for Examination or Treatment.Available from http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_103653.pdfDate: 2009Google Scholar 4General Medical Council Consent: patients and doctors making decisions together. 2008http://www.gmc-uk.org/static/documents/content/Consent_0510.pdfGoogle Scholar Although consent for anaesthesia usually (but not always) requires less discussion than consent for surgery, there is often less time made available for discussion about anaesthesia, the added time pressures of maintaining a productive operating theatre forcing the anaesthetist to seek consent before an operating list starts, within a preoperative environment intent on reducing pre-admission stay. Seeking consent for anaesthesia in pre-assessment clinics allows more time for discussion, but has the potential to introduce further problems, namely that the anaesthetist seeking consent is not necessarily the same one that will be delivering anaesthesia (rendering both potentially liable in battery for failing to identify who would be performing any procedures), that the pre-assessment anaesthetist may not provide information about procedures that the operating anaesthetist administers or suggests methods of anaesthesia that the latter does not think are in the patient's best interests, and that the patient is likely to have forgotten what they have been told in the interim between pre-assessment and surgery. In fact, legal precedent appears not to recognize any period of reflection or consideration, realizing perhaps that a two-tier application—long reflective period in elective surgery, short reflective period in emergency surgery—is unworkable, and merely suggests that consent/refusal is valid if voluntarily given by a competent patient at the time the decision about treatment has to be made. Perhaps of greater concern is the increased number of procedures that anaesthetists are being asked to undertake as the sole intervention in a patient's care. Normally, anaesthesia is considered part of surgical care, because the former is ‘only' administered to facilitate the latter. As such, and despite considerable discussion within the Working Party, the current AAGBI guidance continues to recognize that specific, countersigned, written consent is not necessary before the administration of anaesthesia,5Association of Anaesthetists of Great Britain and Ireland Consent for Anaesthesia.Available from http://www.aagbi.org/publications/guidelines/docs/consent06.pdfDate: 2006Google Scholar although it is strongly recommended that a written account of the consent discussion is recorded on the anaesthetic chart or in the patient's notes. However, the extended role of the anaesthetist as general/obstetric perioperative physician,13Grocott MPW Pearse RM Perioperative medicine: the future of anaesthesia?.Br J Anaesth. 2012; 108: 723-726Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar acute/chronic pain specialist, inter/intrahospital transfer, or prehospital care provider will inevitably involve performing procedures, such as central venous catheter/nerve block insertion and intubation, that are unrelated to surgical care but carry significant risk. Of particular concern is the provision of epidural analgesia for labour, a procedure with well-established risks that is administered to a healthy, but litigious,14Chandraharan E Arulkumaran S Medico-legal problems in obstetrics.Curr Obstet Gynaecol. 2006; 16: 206-210Abstract Full Text Full Text PDF Scopus (26) Google Scholar patient population. When consenting to treatment, patients must do so voluntarily, that is, free from any coercive influence. In English law, this principle was confirmed in ReT(adult: refusal of treatment) [1992] 4 All ER 649, in which the Court of Appeal upheld the lower court's decision to allow the transfusion of blood to a critically ill Jehovah's Witness, on the basis that the patient had refused transfusion on religious grounds after undue persuasion by her mother. In practice, voluntariness is rarely considered in legal cases concerning consent. However, voluntariness as a component of patient choice and voluntariness/capacity as manifestations of autonomy are central to influential theoretical arguments that challenge the ethicolegal foundations of consent. There are a number of factors that influence voluntariness. Any utilitarian healthcare system funded through general state taxation runs the risk of being coercive in nature in order to maximize cost-effectiveness through organizational efficiency. Patients are told when and where to have an intervention, and the range of interventions is limited by rationing. Doctors, acting as employees of the state, are overtly or covertly expected to comply with this and adjust their advice to patients accordingly. Furthermore, individual doctors are likely to propose a limited choice from the range of possible interventions available, based on their personal experience and expertise. Similarly, patients rarely make decisions after closed discussion(s) with their doctor, and are influenced by any number of factors, including the thoughts and experiences of friends and relatives, religious conviction, and the circumstances under which they are asked to make a decision. In other words, the concept of patient choice as the perfect expression of a patient's autonomy is illusory, because it misleadingly implies that doctors can only respect a patient's autonomy if they recognize a patient's choice,15Agledahl KM Førde R Wifstad A Choice is not the issue. The misrepresentation of healthcare in bioethical discourse.J Med Ethics. 2011; 37: 212-215Crossref PubMed Scopus (19) Google Scholar when in fact a patient's autonomy may be better respected by challenging their decision or even disregarding it. This is the central argument advanced by the two most coherent theoretical critiques of the current law on consent. Baroness O'Neill has previously argued that there are any number of factors within the medical setting, including illness, external influence, and fear, which render a patient (or anyone in a similar situation) never more than partially autonomous, and therefore unable to give ‘true' consent.16O'Neill O Paternalism and partial autonomy.J Med Ethics. 1984; 10: 173-178Crossref PubMed Scopus (72) Google Scholar In later work, she elaborates this position to suggest that what happens in practice is that patients effectively assent to treatment, giving permission to the doctor to treat based on their understanding of what is involved, but trust that the doctor will act beneficently towards them.17Manson NC O'Neill O Rethinking Informed Consent in Bioethics. Cambridge University Press, Cambridge2007Crossref Scopus (419) Google Scholar She contends that the anti-elitist stance taken by successive governments against the medical profession (amongst others) has eroded this trust, worsening the healthcare ‘experience' for patients who are still partially autonomous, but cannot now trust their doctors' beneficence. To counter allegations of paternalism from pro-autonomists, she identifies the duty of care for doctors as that which undoubtedly still happens in clinical practice, namely that doctors act in a benevolently paternalistic fashion in order to best return their patients to their pre-illness state of health. Subtly different from O'Neill's view, Maclean has suggested a relational model of consent which recognizes that doctors and patients are both autonomous, but have different roles and duties.18Maclean A Autonomy, Informed Consent and Medical Law: A Relational Challenge. Cambridge University Press, Cambridge2009Crossref Scopus (63) Google Scholar This model proposes that, in fact, doctors have a greater duty to act benevolently than they do to respect a patient's autonomy, and therefore should strive to rationally influence a patient's decision towards what course of action is most likely to have the best outcome for the patient. Effectively, this implies a ‘best interests' approach similar to O'Neill's, but imposes a burden on doctors to discuss how medical treatment would affect the patient holistically, with consent being sought as an agreement rather than a permission. Finally, it has been argued that voluntariness per se is not really possible in the surgical setting.1White SM Baldwin TJ Consent for anaesthesia.Anaesthesia. 2003; 58: 760-774Crossref PubMed Scopus (54) Google Scholar If it is assumed that a healthy adult would never volunteer for unnecessary surgery, then the very fact of requiring surgery in order to cure or ameliorate an illness insists that a patient submit to an intervention (and all the attendant possible complications) that they would have otherwise avoided. Furthermore, even if they consent to have surgery, it is often the prospect of anaesthesia (particularly the rare possibilities of death or awareness under anaesthesia) that frightens them more, and yet they are unable to access the therapeutic former without the latter, which unavoidably introduces an element of coercion into their decision-making. It has been argued that the necessity of a suggested treatment is not coercive in the truest sense of the word, because that necessity is an immutable fact of life,19The President's CommissionMaking health care decisions: a report on the ethical and legal implications of informed consent in the patient-practitioner relationship.Hosp Commun Psychiatry. 1983; 34: 465bGoogle Scholar but this is disputable: with increasing technology, there is often a range of treatments available for any given condition, but patients are likely to be ‘advised' to have one treatment in preference to others, depending on which clinician they consult or prefer, and which of their relatives' or friends' advice they accept. Under these influences, it is hard to accept that patients give their consent ‘voluntarily', the word having connotations of patients being happy to undergo an intervention. In fact, the legal standard is met by patients giving their consent ‘not involuntarily', in so much as they do so because they have to in order to access treatment and relieve pain or illness. Adult patients are deemed competent if they pass a three-stage test of: understanding the information presented to them, retaining it, and using it to arrive at a decision about treatment. This precedent is derived from the case of ReC (adult: refusal of medical treatment) [1994] 1 All ER 819 (Fam Div), in which a chronic paranoid schizophrenic refused below-knee amputation for gangrene and was found by the Courts to be competent to refuse treatment, and modified subsequently in the case of ReMB (an adult: medical treatment) [1997] 2 FLR 426 (CA) in which MB was found competent on appeal to refuse cannulation before Caesarean section, citing needlephobia. In fact, the three-stage test derives from the evidence given by a forensic psychiatrist who assessed C, and suggested that for a patient to make a decision about treatment, they should be able to ‘take in and retain treatment information, to believe it and to weigh that information, balancing risks and needs', modified by Butler-Sloss LJ in ReMB by omission of the necessity for belief in the information. The fact that legal precedent was determined by one person, and has persisted through legal endorsement initially in civil cases and then in statute, has probably contributed to uncertainties in the clinical determination of capacity. Anecdotally, capacity is determined in much the same way as an ASA physical status score, that is, not as a formal three-stage test, but more as an ‘end of bed', capacity yes-or-no determination. In the majority of cases, this is likely to be sufficient, but there are numerous instances where patients are of questionable capacity (e.g. fluctuating consciousness, after anaesthesia, when intoxicated, with dementia),20Moye J Karel MJ Azar AR Gurrera RJ Capacity to consent to treatment: empirical comparison of three instruments in older adults with and without dementia.Gerontologist. 2004; 44: 166-175Crossref PubMed Scopus (104) Google Scholar where more formal assessment is needed. Several areas of uncertainty are immediately apparent.21White SM Incapacity—learning impaired, dementia, mental and emotional disturbance.in: Hardmann JG Moppett IK Aitkenhead AR Consent, Benefit and Risk in Anaesthetic Practice. Oxford University Press, Oxford2009: 103-116Google Scholar 22Worthington R Clinical issues on consent: some philosophical concerns.J Med Ethics. 2002; 28: 377-380Crossref PubMed Scopus (37) Google Scholar What information, for example, does a patient have to understand, and to what degree? Precedent varies. In most cases, only a broad understanding of the intended treatment is required, but the Courts appear to apply a higher standard of understanding in refusals of life-saving treatment, particularly involving younger adults, or children who would be considered competent to consent to treatment. How much should patients remember about the information presented to them and for how long? Patients often have little memory of information presented to them before operation23Rosique I Pérez-Cárceles MD Romero-Martín M Osuna E Luna A The use and usefulness of information for patients undergoing anaesthesia.Med Law. 2006; 25: 715-727PubMed Google Scholar and immediately after operation,24Blandford CM Gupta BC Montgomery J Stocker ME Ability of patients to retain and recall new information in the post-anaesthetic recovery period: a prospective clinical study in day surger" @default.
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