- Email: [email protected]
Making decisions about medical treatment for mentally incapable adults in the UK
THE LANCET Manning WJ, Weintraub RM, Waksmonski CA, et al. Accuracy of transesophageal echocardiography for identifying left atrial thrombi: a propsective, intraoperative study. Ann Intern Med 1995; 123: 817–22. Rubin DN, Katz SE, Riley MF, Douglas PS, Manning WJ. Evaluation of left atrial appendage anatomy and function in recent-onset atrial fibrillation by transesophageal echocardiography. Am J Cardiol 1996; 78: 774–78.
Therapy of AF Coumel P, Thomas O, Leenhardt A. Drug therapy for the prevention of atrial fibrillation. Am J Cardiol 1996; 77 (3): 3–9A. Echt DS, Leibson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781–88. Guiraudon GM, Campbell CS, Jones DL, McLellan JL, MacDonald JL. Combined sino-atrial node atrioventricular node isolation: a surgical alternative to His bundle ablation in patients with atrial fibrillation. Circulation1985; 72: 220 (abstr). Kopecky SL, Schaff HV, Hammill SC, Cragun T, Dearani JA, Bailey KR. Decreased incidence of stroke in atrial fibrillation after a MAZE procedure. J Am Coll Cardiol 1997; 29 (suppl): 105A (abstr). Levy S, Ricard P, Guenoun M, et al. Low-energy cardioversion of spontaneous atrial fibrillation: immediate and long-term results. Circulation 1997; 96: 253–59. Levy S. Intravenous digoxin: still the drug of choice for acute termination of atrial fibrillation? Eur Heart J 1997; 18: 546–47. Schreck DM, Rivera AR, Tricarico VJ. Emergency management of atrial fibrillation and flutter: intravenous diltiazem versus intravenous digoxin. Ann Emerg Med 1997; 29: 135–40. Stuehlinger HG, Domanovits H, Gamper G, et al. The DIGAF study (Digoxin and Atrial Fibrillation): reversion of atrial fibrillation with high dose digoxin (preliminary results). J Am Coll Cardiol 1997; 29 (suppl): 177A (abstr). Weinberg BA, Miles WM, Klein LS, et al. Five-year follow-up of 589 patients treated with amiodarone. Am Heart J 1993; 125: 109–20.
Treatment of stroke in AF The Atrial Fibrillation Investigators. The efficacy of aspirin in patients
with atrial fibrillation: analysis of pooled data from 3 randomized trials. Arch Intern Med 1997; 157: 1237–40. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med 1990; 323: 1505–11. Cerebral Embolism Study Group. Cardoembolic stroke, early anticoagulation and brain hemorrhage. Arch Intern Med 1987; 147: 636–40. Connolly SJ, Laupacis A, Gent M, et al for the CAFA study coinvestigators. Canadian Atrial Fibrillation Anticoagulation (CAFA) study. J Am Coll Cardiol 1991; 18: 349–55. Gottlieb LK, Salem-Schatz S. Anticoagulation in atrial fibrillation: does efficacy in clinical trials translate into effectiveness in practice. Arch Intern Med 1994; 154: 1945–53. Petersen P, Boysen G, Godtfredsen J, et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: the Copenhagen AFASAK study. Lancet 1989; i: 175–78. Stroke Prevention in Atrial Fibrillation Investigators. Preliminary report of the Stroke Prevention in Atrial Fibrillation study. N Engl J Med 1990; 322: 863. Stroke Prevention in Atrial Fibrillation Investigators. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II study. Lancet 1994; 343: 687–91.
Emerging therapy Omran H, Jung W, Rabahieh R, et al. Left atrial chamber and appendage function after internal atrial fibrillation: a prospective and serial transesophageal echocardiographic study. J Am Coll Cardiol 1997; 29: 131–38. Schmidt C, Alt E, Plewan A, et al. Low energy intracardiac cardioversion after failed conventional external cardioversion of atrial fibrillation. J Am Coll Cardiol 1996; 28 (4): 994–99. Daoud EG, Pariseau B, Niebauer M, et al. Response of type I atrial fibrillation to atrial pacing in humans. Circulation 1996; 94: 1036–40. Sgarbossa EB, Pinski SL, Maloney JD, et al. Chronic atrial fibrillation and stroke in paced patients with sick sinus syndrome. Circulation 1993; 88: 1045–53.
Department of law
Making decisions about medical treatment for mentally incapable adults in the UK Steven Luttrell The law in the UK with respect to the medical treatment of mentally incompetent adults is fragmented and unsatisfactory. Here, I examine the present law as it applies to the treatment of mentally incapable adults and consider the reforms suggested by the Law Commission and the Scottish Law Commission. I have dealt only with the law as it relates to the treatment of physical illness and not mental illness, which is governed by the Mental Health Act 1983 in England and Wales and the Mental Health (Scotland) Act 1984 in Scotland.
Who should make decisions? Present law The present law in respect of mentally incompetent adults in the UK has grown in a haphazard way without logical planning or structure. In England and Wales, if a patient lacks the mental capacity necessary to give or Lancet 1997; 350: 950–53 University College London Medical School Centre for Geriatric Medicine, St Pancras Hospital, 4 St Pancras Way, London NW1 0PE, UK (Steven Luttrell MRCP)
950
withhold consent to medical treatment, the final arbiter of whether treatment is given is the treating doctor, who must make a decision in the patient’s best interests. No other person can give or withhold consent to medical treatment. Furthermore, a court in England or Wales cannot give consent for medical treatment, but merely form a declaratory judgment as to the legality of any steps which the treating doctor proposes to undertake. 1 Although in Scotland, the Court of Session can appoint “tutors” to make such decisions, the antiquity of the case law leaves this mechanism unclear.2 The UK therefore differs from other jurisdictions, such as New Zealand, the Australian state of Victoria, and Germany, where specific legal reforms have done much to clarify this area of the law.3
Advance statements Mentally capable adults may wish to indicate by way of an advance statement (living will or advance directive) what medical treatment they would want or not want if they were to become mentally incapable. Article 9 of the Council of Europe’s Convention on Human Rights and Vol 350 • September 27, 1997
THE LANCET
Biomedicine indicates that such statements should be “taken into account”. Although patients cannot demand a particular form of therapy, various judicial statements indicate that the English courts are likely to follow the precedent set in the landmark Canadian case of Malette v Schulman, where a doctor was found liable in battery for ignoring the advance refusal of therapy carried by a Jehovah’s Witness.4,5 The legally binding nature of applicable advance refusals of therapy has been supported by the Law Commission and the Scottish Law Commission. 6,7 Both suggest legislation to clarify the law and support the view that a patient should be able to refuse life-supporting treatment in advance if he or she makes an explicit statement to this effect, but that the patient will not be able to refuse basic care, including care to maintain body cleanliness and alleviate severe pain. In the Netherlands, the Dutch Civil Code already explicitly provides that doctors are obliged to abide by a written advance refusal and can ignore such only in the presence of well-founded grounds.8
Family members Traditionally, the family has been accepted as the natural place to seek authorisation when undertaking medical interventions. This is a view which was clearly taken by the New Jersey Supreme Court ruling in the case of Mrs Jobes, where it was stated: “Generally it is the patient’s family or other loved ones who support and care for the patient, and who best understand the patient’s personal values and beliefs. Hence they will be best able to make a substituted medical judgment for the patient”, 9 and by the US President’s Commission, which stated: “the family deserves recognition as an important social unit that ought to be treated, within limits, as a responsible decisionmaker in matters that intimately affect its members”.10 However, several studies suggest that family members cannot accurately predict patients’ preferences for life-sustaining interventions.11–15 In the UK, family members cannot give consent for medical treatment for mentally incapable relatives, and neither the Law Commission nor the Scottish Law Commission supports the use of a legally predetermined list of family members as proxy decision makers.16 Patient selected proxy decision makers Over the past 2 decades, many states in the USA have enacted legislation enabling a mentally capable adult to nominate another to make health-care decisions should he or she become mentally incapable. Although it might be envisaged that such proxies would make choices that reflect the wishes of the patients that they represent, studies that have looked at decisions made by patients and their selected proxies reveal a poor level of correlation.17–19 Despite this difficulty, it is arguable that the decision of such a proxy should be respected simply because he or she was selected by the patient. However, in 1994, the House of Lords Select Committee on Medical Ethics concluded that it did not favour the development of such proxies on the basis of the concerns summarised below. l A person’s choice of proxy might become out of date. l The proxy might not make the same choice as the patient would have made. l The proxy might lack objectivity whether as a result of financial self-interest or psychological stress. Vol 350 • September 27, 1997
The use of a proxy for a young person who has never thought of the issues raised by grave illness “seems to stretch the concept of patient autonomy to breaking point”.20 In response, the Law Commission stated that “exactly the same arguments could be made against allowing people to delegate their financial powers. They appear to us to be arguments in favour of adequate safeguards rather than arguments against the extension of the popular (enduring power of attorney) scheme to personal and medical matters”, and proposes the use of a patientselected proxy (attorney) with substantial powers. 6 Such an attorney may be allowed to give or withhold consent to many therapies including life-sustaining treatments such as artificial feeding and hydration if the power is appropriately worded. The Scottish Law Commission proposes an attorney with considerably less power than its English counterpart,7 in that the doctor can proceed with treatment to which the attorney has refused consent, if he or she obtains an appropriate opinion from another consultant, a step that surely represents an inappropriate intrusion of medical paternalism. l
Guardians Many countries have legislation which enables courtappointed guardians to make decisions in respect of the personal welfare of mentally incapable adults. Some of the most traditional laws have, however, been criticised as draconian and stigmatising and reforms have taken place in order to produce more flexible forms of guardianship that acknowledges that mental capacity is not absolute, but relates to particular decisions at particular times. Under proposals passed by the German Government in 1990 the concept of guardianship was replaced by one of care and assistance, the “care-taker” having an obligation to assist the person concerned to make use of appropriate health care or rehabilitative measures.3 In the UK, both Law Commissions suggest that the courts have the power to appoint guardians with powers similar to those of patient selected attorneys. In summary, the Law Commissions suggest four tiers of decision-making. A valid advance refusal takes precedence. If this does not exist, a patient-appointed proxy or a court-appointed guardian is entitled to make the decision. In the absence of any of these, the doctor must make the decision. Finally, in cases of dispute or where a court ruling on the matter would be appropriate the court will have the authority to make decisions in the best interest of a patient.6,7
How should decisions be made? The best-interests test Over the past decade, the concept of best interests has been reviewed by the House of Lords in two major cases involving mentally incapable adults,1,4 and has been considered by the lower courts in many cases involving children. It is, fundamentally, a paternalistic test, viewing the issue from the decision-maker’s standpoint. Moreover the House of Lords, in defining best interests, adopted the “Bolam test”, a test arising from negligence law, thereby stating the medical profession itself would be the ultimate arbiter of best interests. In that a decision on best interests is not simply a medical one—and certainly amounts to more than simply not treating negligently—this is surely the wrong approach, and the 951
THE LANCET
use of the Bolam test for determining best interests was rejected by the Law Commission in its recent report6 and subsequently avoided by the Court of Session in a Scottish case involving a patient in a persistent vegetative state.21 It is clear that the issue of benefit is fundamental to the question of best interests. Beyond this, however, the case law gives fragmented and sometimes contradictory advice on which factors are relevant to a decision. For example, in re F a case involving the sterilisation of a mentally incapable adult woman, Lord Brandon took an unduly narrow view of best interests when he stated: “The operation or other treatment will be in their best interest if, but only if, it is carried out in order either to save their lives, or to ensure improvement or prevent deterioration in their physical health”.22 By contrast, in Airedale NHS Trust v Bland, a case involving a young man in persistent vegetative state, Lord Goff stated: “it is reasonable that account should be taken of the invasiveness of the treatment and of the indignity to which . . . a person has to be subjected if his life is prolonged by artificial means”.23 Lord Justice Taylor, inre J, a case concerning the cardiac-resuscitation status of a child born prematurely, indicated that the quality of life following treatment was a relevant consideration when making a decision on best interests.24 This was the approach followed in re R, a later case concerning the cardiopulmonary resuscitation status of a 23-year-old man with a serious malformation of the brain and cerebral palsy.25
The substituted judgment test Various US courts have looked favourably on another mechanism for making decisions for mentally incapable adults, known as “substituted judgment”. The test is clearly explained in one of the judgments of the Illinois Supreme Court: “Under substituted judgment, a surrogate decisionmaker attempts to establish, with as much accuracy as possible, what decision the patient would make if he were competent to do so. Employing this theory, the surrogate first tries to determine if the patient had expressed explicit intent regarding this type of medical treatment prior to becoming incompetent . . . Where no clear intent exists, the patient’s personal value system must guide the surrogate”.26 Although superficially attractive, it is a test with inherent difficulties. The person may never have thought of the particular circumstances which have since developed. The evidence of previous wishes and feelings may be scant. There may be conflicts of evidence as to the persons previous wishes and feelings and some of the evidence may be presented by people who have ulterior motives for desiring a particular course of action. Furthermore, it is a test that is inappropriate for the mentally incompetent adult who has never been mentally competent. The Law Commission suggests that the best-interests test and the substituted judgment test are not mutually exclusive27 and recommends the use of a test based on best interest with a strong element of substituted judgment. It proposes a list of relevant factors that ought to be taken into consideration. l The ascertainable past and present wishes and feelings of the person concerned, and the factors that person would consider if able to do so; l the need to permit and encourage the person to 952
participate or to improve his or her ability to participate, as fully as possible in anything done for and any decision affecting him or her; l the views of other people whom it is appropriate and practicable to consult about the person’s wishes and feelings and what would be in his or her best interests; and l whether the purpose for which any action or decision is required can be as effectively achieved in a manner less restrictive of the person’s freedom of action. 6
Conclusion In the UK the common law governing the medical treatment of patients who are mentally incapable is fragmented and uncertain. There is a need for legislation to clarify this area of the law. In 1995, the Law Commission and the Scottish Law Commission proposed such legislation, covering best interests, advance statements, powers of attorney and guardianship. However, in 1996, the Lord Chancellor announced that the government does not intend to introduce such legislation in its current form adding that it would be inappropriate to make any proposals to Parliament without full public consultation. Until such times as parliament chooses to legislate, doctors in the UK will have to struggle on with the vague rules set down in the common law cases and patients will have to make do with the present ill-defined and paternalistic bestinterests test. I thank Prof James Malone-Lee (Centre for Geriatric Medicine, University College, London Medical School), Ann Sommerville (British Medical Association), and Martyn Evans (Centre for Philosophy and Health Care, University of Wales) for their help.
References 1 2 3 4 5 6 7 8 9 10
11
12
13
14
15
16
17
Re F (1990) 2 AC 1. Ward A. Revival of Tutors-Dative (Morris, Petitioner) 1987 SLT (News) 69–72. Law Commission Consultation Paper 119. Mentally incapacitated adults and decision-making: an overview. 1991: 111–36. Airedale NHS Trust v Bland (1993) 1 All ER 821. Re C (Adult: Refusal of Treatment) (1994) 1 WLR 290. The Law Commission. Mental incapacity. London: HM Stationery Office, 1995. Scottish Law Commission. Report on Incapable Adults. Scotland: HM Stationery Office, 1995. Dutch Civil Code, book 7, article 450. In Re Jobes (1987), 529 A 2d 434. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research. Deciding to forego life-sustaining treatment. Washington DC: US Government Printing Office, 1983 at 128. Sonnenblick M, Friedlander Y, Steinberg A. Dissociation between the wishes of terminally ill parents and decisions by their offspring. J Am Geriatr Soc 1993; 41: 599–604. Zweibel N, Cassel C. Treatment choices at the end of life: a comparison of decisions by older patients and their physician-selected proxies. Gerontologist 1989; 29: 615–21. Uhlmann R, Pearlman R, Cain K. Physicians’ and spouses’ predictions of elderly patients’ resuscitation preferences. J Gerontol 1988; 48: M115–121. Ouslander J, Tymchuk A, Rahbar B. Health decisions among elderly long-term care residents and their potential proxies. Arch Intern Med 1989; 149: 1367–72. Sulmasy D, Haller K, Terry P. More talk, less paper: predicting the accuracy of substituted judgements. Am J Med 1994; 96: 432–38. The Law Commission. Mentally incapacitated adults and decisionmaking: medical treatment and research. Consultation paper 129. London: HM Stationery Office, 1993, at 65. Hare J, Pratt C, Nelson C. Agreement between patients and their selfselected surrogates on difficult medical decisions. Arch Intern Med 1992; 152: 1049–54.
Vol 350 • September 27, 1997
THE LANCET 18 Seckler A, Meier D, Mulvihill M, Cammer Paris B. Substituted judgement: how accurate are proxy predictions? Ann Intern Med 1991; 115: 92–98. 19 Tomlinson T, Howe K, Notman M, Rossmiller D. An empirical study of proxy consent for elderly persons. Gerontologist 1990; 30: 54–64. 20 House of Lords. Report of the Select Committee on Medical Ethics HL 21-I. London: HM Stationery Office, 1994: 55–56. 21 Law Hospital NHS Trust v Lord Advocate (1996) SLT 848.
22 per Lord Brandon in re F (Mental Patient: Sterilisation) (1990) 2 AC 1 at 55. 23 per Lord Goff in Airedale Trust v Bland (1993) 1 All ER 821 at 870. 24 per Lord Justice Taylor in re J (1991) Fam. 33 at 55. 25 re R (1996) 2 FLR 99–110. 26 In re Estate of Longeway (1989) 549 NE 2d 292 at 299. 27 The Law Commission. Mentally incapacitated adults and decisionmaking: a new jurisdiction. Consultation paper no 128. London: HM Stationery Office, 1993 at para 2.14.
Hypothesis
Impaired synthesis of elastin in walls of aorta and large conduit arteries during early development as an initiating event in pathogenesis of systemic hypertension C N Martyn, S E Greenwald There is much evidence that people who had low birthweight tend to have higher blood pressure in later life. However, the mechanisms that mediate this relation are unknown. We argue that, in fetuses whose growth is impaired, synthesis of elastin in the walls of the aorta and large arteries may be deficient, and that this deficiency would lead to permanent changes in the mechanical properties of these vessels. Over a lifetime, such changes could predispose an individual to higher blood pressure, increased left-ventricular mass, and cardiovascular disease.
Lancet 1997; 350: 953–55 MRC Environmental Epidemiology Unit, Southampton University, Southampton General Hospital, SO16 6YD, UK (C N Martyn FRCP); and Institute of Pathology, Royal London Hospital, London E1 1BB, UK (S E Greenwald PhD) Correspondence to: Dr C N Martyn
Vol 350 • September 27, 1997
50 40 Concentration (% by weight)
The aorta acts as a conduit to convey blood from the left ventricle to the arteries that distribute blood to the body’s organs. Less obvious, but equally important, is its function as an impedance matching device. With each contraction, the left ventricle pumps about 70 mL of blood into a closed circulatory system that is filled with incompressible fluid at high pressure. Ejection of blood from the ventricle is only possible because the aorta is able to expand in volume. Most of the energy of leftventricular contraction is stored briefly in the stretch of the aortic wall. In diastole, elastic recoil of the wall maintains the forward flow of blood against a closed aortic valve. The aorta’s elastic properties are important in keeping to a minimum the load on the left ventricle and the rise in arterial pressure during systole. Blood flow in the coronary circulation, which occurs only in diastole, depends on the elastic recoil of the aortic wall. At a given cardiac output, reduced aortic compliance results in a widening of pulse pressure, a rise in mean arterial pressure, and a rise in the circumferential stress in the walls of the aorta and the vessels that branch from it. Simultaneously, the work that must be done by the left ventricle increases while the force driving coronary blood flow is lessened. Although this function of the aorta has long been recognised, its clinical relevance has only lately been appreciated. With the development of non-invasive techniques for measurement of aortic compliance, investigators have shown associations between decreased compliance and both systemic hypertension and left-
30 20 10
Elastin Collagen
birth 0 0
20
40
2
4
6
8
10 12
Gestational age Time after birth (weeks) (months) Figure 1: Changes in scleroprotein content of human aorta in fetal and early life Adapted from reference 7.
ventricular hypertrophy.1,2 Decreased aortic compliance has been recognised as a marker of cardiovascular disease.3
Molecular basis of aortic compliance The aorta’s elastic properties depend largely on the presence of a long-lived scleroprotein—elastin—in the vessel wall. Elastin accounts for 40–50% of the dry weight of the tissue in the thoracic aorta, and is a major component in the abdominal aorta and carotid arteries.4 Aortic elastin is arranged in multiple concentric lamellae, interspersed with smooth muscle and collagen. The number of elastic lamellae is greatest in the proximal part of the aorta. They begin to develop early in fetal life, and rates of elastin synthesis in blood vessels increase to a maximum in the perinatal period;5–7 thereafter, these rates fall rapidly (figure 1). Mature, cross-linked elastin has remarkable longevity. 953
Therapy of AF Coumel P, Thomas O, Leenhardt A. Drug therapy for the prevention of atrial fibrillation. Am J Cardiol 1996; 77 (3): 3–9A. Echt DS, Leibson PR, Mitchell LB, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo: the Cardiac Arrhythmia Suppression Trial. N Engl J Med 1991; 324: 781–88. Guiraudon GM, Campbell CS, Jones DL, McLellan JL, MacDonald JL. Combined sino-atrial node atrioventricular node isolation: a surgical alternative to His bundle ablation in patients with atrial fibrillation. Circulation1985; 72: 220 (abstr). Kopecky SL, Schaff HV, Hammill SC, Cragun T, Dearani JA, Bailey KR. Decreased incidence of stroke in atrial fibrillation after a MAZE procedure. J Am Coll Cardiol 1997; 29 (suppl): 105A (abstr). Levy S, Ricard P, Guenoun M, et al. Low-energy cardioversion of spontaneous atrial fibrillation: immediate and long-term results. Circulation 1997; 96: 253–59. Levy S. Intravenous digoxin: still the drug of choice for acute termination of atrial fibrillation? Eur Heart J 1997; 18: 546–47. Schreck DM, Rivera AR, Tricarico VJ. Emergency management of atrial fibrillation and flutter: intravenous diltiazem versus intravenous digoxin. Ann Emerg Med 1997; 29: 135–40. Stuehlinger HG, Domanovits H, Gamper G, et al. The DIGAF study (Digoxin and Atrial Fibrillation): reversion of atrial fibrillation with high dose digoxin (preliminary results). J Am Coll Cardiol 1997; 29 (suppl): 177A (abstr). Weinberg BA, Miles WM, Klein LS, et al. Five-year follow-up of 589 patients treated with amiodarone. Am Heart J 1993; 125: 109–20.
Treatment of stroke in AF The Atrial Fibrillation Investigators. The efficacy of aspirin in patients
with atrial fibrillation: analysis of pooled data from 3 randomized trials. Arch Intern Med 1997; 157: 1237–40. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med 1990; 323: 1505–11. Cerebral Embolism Study Group. Cardoembolic stroke, early anticoagulation and brain hemorrhage. Arch Intern Med 1987; 147: 636–40. Connolly SJ, Laupacis A, Gent M, et al for the CAFA study coinvestigators. Canadian Atrial Fibrillation Anticoagulation (CAFA) study. J Am Coll Cardiol 1991; 18: 349–55. Gottlieb LK, Salem-Schatz S. Anticoagulation in atrial fibrillation: does efficacy in clinical trials translate into effectiveness in practice. Arch Intern Med 1994; 154: 1945–53. Petersen P, Boysen G, Godtfredsen J, et al. Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: the Copenhagen AFASAK study. Lancet 1989; i: 175–78. Stroke Prevention in Atrial Fibrillation Investigators. Preliminary report of the Stroke Prevention in Atrial Fibrillation study. N Engl J Med 1990; 322: 863. Stroke Prevention in Atrial Fibrillation Investigators. Warfarin versus aspirin for prevention of thromboembolism in atrial fibrillation: Stroke Prevention in Atrial Fibrillation II study. Lancet 1994; 343: 687–91.
Emerging therapy Omran H, Jung W, Rabahieh R, et al. Left atrial chamber and appendage function after internal atrial fibrillation: a prospective and serial transesophageal echocardiographic study. J Am Coll Cardiol 1997; 29: 131–38. Schmidt C, Alt E, Plewan A, et al. Low energy intracardiac cardioversion after failed conventional external cardioversion of atrial fibrillation. J Am Coll Cardiol 1996; 28 (4): 994–99. Daoud EG, Pariseau B, Niebauer M, et al. Response of type I atrial fibrillation to atrial pacing in humans. Circulation 1996; 94: 1036–40. Sgarbossa EB, Pinski SL, Maloney JD, et al. Chronic atrial fibrillation and stroke in paced patients with sick sinus syndrome. Circulation 1993; 88: 1045–53.
Department of law
Making decisions about medical treatment for mentally incapable adults in the UK Steven Luttrell The law in the UK with respect to the medical treatment of mentally incompetent adults is fragmented and unsatisfactory. Here, I examine the present law as it applies to the treatment of mentally incapable adults and consider the reforms suggested by the Law Commission and the Scottish Law Commission. I have dealt only with the law as it relates to the treatment of physical illness and not mental illness, which is governed by the Mental Health Act 1983 in England and Wales and the Mental Health (Scotland) Act 1984 in Scotland.
Who should make decisions? Present law The present law in respect of mentally incompetent adults in the UK has grown in a haphazard way without logical planning or structure. In England and Wales, if a patient lacks the mental capacity necessary to give or Lancet 1997; 350: 950–53 University College London Medical School Centre for Geriatric Medicine, St Pancras Hospital, 4 St Pancras Way, London NW1 0PE, UK (Steven Luttrell MRCP)
950
withhold consent to medical treatment, the final arbiter of whether treatment is given is the treating doctor, who must make a decision in the patient’s best interests. No other person can give or withhold consent to medical treatment. Furthermore, a court in England or Wales cannot give consent for medical treatment, but merely form a declaratory judgment as to the legality of any steps which the treating doctor proposes to undertake. 1 Although in Scotland, the Court of Session can appoint “tutors” to make such decisions, the antiquity of the case law leaves this mechanism unclear.2 The UK therefore differs from other jurisdictions, such as New Zealand, the Australian state of Victoria, and Germany, where specific legal reforms have done much to clarify this area of the law.3
Advance statements Mentally capable adults may wish to indicate by way of an advance statement (living will or advance directive) what medical treatment they would want or not want if they were to become mentally incapable. Article 9 of the Council of Europe’s Convention on Human Rights and Vol 350 • September 27, 1997
THE LANCET
Biomedicine indicates that such statements should be “taken into account”. Although patients cannot demand a particular form of therapy, various judicial statements indicate that the English courts are likely to follow the precedent set in the landmark Canadian case of Malette v Schulman, where a doctor was found liable in battery for ignoring the advance refusal of therapy carried by a Jehovah’s Witness.4,5 The legally binding nature of applicable advance refusals of therapy has been supported by the Law Commission and the Scottish Law Commission. 6,7 Both suggest legislation to clarify the law and support the view that a patient should be able to refuse life-supporting treatment in advance if he or she makes an explicit statement to this effect, but that the patient will not be able to refuse basic care, including care to maintain body cleanliness and alleviate severe pain. In the Netherlands, the Dutch Civil Code already explicitly provides that doctors are obliged to abide by a written advance refusal and can ignore such only in the presence of well-founded grounds.8
Family members Traditionally, the family has been accepted as the natural place to seek authorisation when undertaking medical interventions. This is a view which was clearly taken by the New Jersey Supreme Court ruling in the case of Mrs Jobes, where it was stated: “Generally it is the patient’s family or other loved ones who support and care for the patient, and who best understand the patient’s personal values and beliefs. Hence they will be best able to make a substituted medical judgment for the patient”, 9 and by the US President’s Commission, which stated: “the family deserves recognition as an important social unit that ought to be treated, within limits, as a responsible decisionmaker in matters that intimately affect its members”.10 However, several studies suggest that family members cannot accurately predict patients’ preferences for life-sustaining interventions.11–15 In the UK, family members cannot give consent for medical treatment for mentally incapable relatives, and neither the Law Commission nor the Scottish Law Commission supports the use of a legally predetermined list of family members as proxy decision makers.16 Patient selected proxy decision makers Over the past 2 decades, many states in the USA have enacted legislation enabling a mentally capable adult to nominate another to make health-care decisions should he or she become mentally incapable. Although it might be envisaged that such proxies would make choices that reflect the wishes of the patients that they represent, studies that have looked at decisions made by patients and their selected proxies reveal a poor level of correlation.17–19 Despite this difficulty, it is arguable that the decision of such a proxy should be respected simply because he or she was selected by the patient. However, in 1994, the House of Lords Select Committee on Medical Ethics concluded that it did not favour the development of such proxies on the basis of the concerns summarised below. l A person’s choice of proxy might become out of date. l The proxy might not make the same choice as the patient would have made. l The proxy might lack objectivity whether as a result of financial self-interest or psychological stress. Vol 350 • September 27, 1997
The use of a proxy for a young person who has never thought of the issues raised by grave illness “seems to stretch the concept of patient autonomy to breaking point”.20 In response, the Law Commission stated that “exactly the same arguments could be made against allowing people to delegate their financial powers. They appear to us to be arguments in favour of adequate safeguards rather than arguments against the extension of the popular (enduring power of attorney) scheme to personal and medical matters”, and proposes the use of a patientselected proxy (attorney) with substantial powers. 6 Such an attorney may be allowed to give or withhold consent to many therapies including life-sustaining treatments such as artificial feeding and hydration if the power is appropriately worded. The Scottish Law Commission proposes an attorney with considerably less power than its English counterpart,7 in that the doctor can proceed with treatment to which the attorney has refused consent, if he or she obtains an appropriate opinion from another consultant, a step that surely represents an inappropriate intrusion of medical paternalism. l
Guardians Many countries have legislation which enables courtappointed guardians to make decisions in respect of the personal welfare of mentally incapable adults. Some of the most traditional laws have, however, been criticised as draconian and stigmatising and reforms have taken place in order to produce more flexible forms of guardianship that acknowledges that mental capacity is not absolute, but relates to particular decisions at particular times. Under proposals passed by the German Government in 1990 the concept of guardianship was replaced by one of care and assistance, the “care-taker” having an obligation to assist the person concerned to make use of appropriate health care or rehabilitative measures.3 In the UK, both Law Commissions suggest that the courts have the power to appoint guardians with powers similar to those of patient selected attorneys. In summary, the Law Commissions suggest four tiers of decision-making. A valid advance refusal takes precedence. If this does not exist, a patient-appointed proxy or a court-appointed guardian is entitled to make the decision. In the absence of any of these, the doctor must make the decision. Finally, in cases of dispute or where a court ruling on the matter would be appropriate the court will have the authority to make decisions in the best interest of a patient.6,7
How should decisions be made? The best-interests test Over the past decade, the concept of best interests has been reviewed by the House of Lords in two major cases involving mentally incapable adults,1,4 and has been considered by the lower courts in many cases involving children. It is, fundamentally, a paternalistic test, viewing the issue from the decision-maker’s standpoint. Moreover the House of Lords, in defining best interests, adopted the “Bolam test”, a test arising from negligence law, thereby stating the medical profession itself would be the ultimate arbiter of best interests. In that a decision on best interests is not simply a medical one—and certainly amounts to more than simply not treating negligently—this is surely the wrong approach, and the 951
THE LANCET
use of the Bolam test for determining best interests was rejected by the Law Commission in its recent report6 and subsequently avoided by the Court of Session in a Scottish case involving a patient in a persistent vegetative state.21 It is clear that the issue of benefit is fundamental to the question of best interests. Beyond this, however, the case law gives fragmented and sometimes contradictory advice on which factors are relevant to a decision. For example, in re F a case involving the sterilisation of a mentally incapable adult woman, Lord Brandon took an unduly narrow view of best interests when he stated: “The operation or other treatment will be in their best interest if, but only if, it is carried out in order either to save their lives, or to ensure improvement or prevent deterioration in their physical health”.22 By contrast, in Airedale NHS Trust v Bland, a case involving a young man in persistent vegetative state, Lord Goff stated: “it is reasonable that account should be taken of the invasiveness of the treatment and of the indignity to which . . . a person has to be subjected if his life is prolonged by artificial means”.23 Lord Justice Taylor, inre J, a case concerning the cardiac-resuscitation status of a child born prematurely, indicated that the quality of life following treatment was a relevant consideration when making a decision on best interests.24 This was the approach followed in re R, a later case concerning the cardiopulmonary resuscitation status of a 23-year-old man with a serious malformation of the brain and cerebral palsy.25
The substituted judgment test Various US courts have looked favourably on another mechanism for making decisions for mentally incapable adults, known as “substituted judgment”. The test is clearly explained in one of the judgments of the Illinois Supreme Court: “Under substituted judgment, a surrogate decisionmaker attempts to establish, with as much accuracy as possible, what decision the patient would make if he were competent to do so. Employing this theory, the surrogate first tries to determine if the patient had expressed explicit intent regarding this type of medical treatment prior to becoming incompetent . . . Where no clear intent exists, the patient’s personal value system must guide the surrogate”.26 Although superficially attractive, it is a test with inherent difficulties. The person may never have thought of the particular circumstances which have since developed. The evidence of previous wishes and feelings may be scant. There may be conflicts of evidence as to the persons previous wishes and feelings and some of the evidence may be presented by people who have ulterior motives for desiring a particular course of action. Furthermore, it is a test that is inappropriate for the mentally incompetent adult who has never been mentally competent. The Law Commission suggests that the best-interests test and the substituted judgment test are not mutually exclusive27 and recommends the use of a test based on best interest with a strong element of substituted judgment. It proposes a list of relevant factors that ought to be taken into consideration. l The ascertainable past and present wishes and feelings of the person concerned, and the factors that person would consider if able to do so; l the need to permit and encourage the person to 952
participate or to improve his or her ability to participate, as fully as possible in anything done for and any decision affecting him or her; l the views of other people whom it is appropriate and practicable to consult about the person’s wishes and feelings and what would be in his or her best interests; and l whether the purpose for which any action or decision is required can be as effectively achieved in a manner less restrictive of the person’s freedom of action. 6
Conclusion In the UK the common law governing the medical treatment of patients who are mentally incapable is fragmented and uncertain. There is a need for legislation to clarify this area of the law. In 1995, the Law Commission and the Scottish Law Commission proposed such legislation, covering best interests, advance statements, powers of attorney and guardianship. However, in 1996, the Lord Chancellor announced that the government does not intend to introduce such legislation in its current form adding that it would be inappropriate to make any proposals to Parliament without full public consultation. Until such times as parliament chooses to legislate, doctors in the UK will have to struggle on with the vague rules set down in the common law cases and patients will have to make do with the present ill-defined and paternalistic bestinterests test. I thank Prof James Malone-Lee (Centre for Geriatric Medicine, University College, London Medical School), Ann Sommerville (British Medical Association), and Martyn Evans (Centre for Philosophy and Health Care, University of Wales) for their help.
References 1 2 3 4 5 6 7 8 9 10
11
12
13
14
15
16
17
Re F (1990) 2 AC 1. Ward A. Revival of Tutors-Dative (Morris, Petitioner) 1987 SLT (News) 69–72. Law Commission Consultation Paper 119. Mentally incapacitated adults and decision-making: an overview. 1991: 111–36. Airedale NHS Trust v Bland (1993) 1 All ER 821. Re C (Adult: Refusal of Treatment) (1994) 1 WLR 290. The Law Commission. Mental incapacity. London: HM Stationery Office, 1995. Scottish Law Commission. Report on Incapable Adults. Scotland: HM Stationery Office, 1995. Dutch Civil Code, book 7, article 450. In Re Jobes (1987), 529 A 2d 434. President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research. Deciding to forego life-sustaining treatment. Washington DC: US Government Printing Office, 1983 at 128. Sonnenblick M, Friedlander Y, Steinberg A. Dissociation between the wishes of terminally ill parents and decisions by their offspring. J Am Geriatr Soc 1993; 41: 599–604. Zweibel N, Cassel C. Treatment choices at the end of life: a comparison of decisions by older patients and their physician-selected proxies. Gerontologist 1989; 29: 615–21. Uhlmann R, Pearlman R, Cain K. Physicians’ and spouses’ predictions of elderly patients’ resuscitation preferences. J Gerontol 1988; 48: M115–121. Ouslander J, Tymchuk A, Rahbar B. Health decisions among elderly long-term care residents and their potential proxies. Arch Intern Med 1989; 149: 1367–72. Sulmasy D, Haller K, Terry P. More talk, less paper: predicting the accuracy of substituted judgements. Am J Med 1994; 96: 432–38. The Law Commission. Mentally incapacitated adults and decisionmaking: medical treatment and research. Consultation paper 129. London: HM Stationery Office, 1993, at 65. Hare J, Pratt C, Nelson C. Agreement between patients and their selfselected surrogates on difficult medical decisions. Arch Intern Med 1992; 152: 1049–54.
Vol 350 • September 27, 1997
THE LANCET 18 Seckler A, Meier D, Mulvihill M, Cammer Paris B. Substituted judgement: how accurate are proxy predictions? Ann Intern Med 1991; 115: 92–98. 19 Tomlinson T, Howe K, Notman M, Rossmiller D. An empirical study of proxy consent for elderly persons. Gerontologist 1990; 30: 54–64. 20 House of Lords. Report of the Select Committee on Medical Ethics HL 21-I. London: HM Stationery Office, 1994: 55–56. 21 Law Hospital NHS Trust v Lord Advocate (1996) SLT 848.
22 per Lord Brandon in re F (Mental Patient: Sterilisation) (1990) 2 AC 1 at 55. 23 per Lord Goff in Airedale Trust v Bland (1993) 1 All ER 821 at 870. 24 per Lord Justice Taylor in re J (1991) Fam. 33 at 55. 25 re R (1996) 2 FLR 99–110. 26 In re Estate of Longeway (1989) 549 NE 2d 292 at 299. 27 The Law Commission. Mentally incapacitated adults and decisionmaking: a new jurisdiction. Consultation paper no 128. London: HM Stationery Office, 1993 at para 2.14.
Hypothesis
Impaired synthesis of elastin in walls of aorta and large conduit arteries during early development as an initiating event in pathogenesis of systemic hypertension C N Martyn, S E Greenwald There is much evidence that people who had low birthweight tend to have higher blood pressure in later life. However, the mechanisms that mediate this relation are unknown. We argue that, in fetuses whose growth is impaired, synthesis of elastin in the walls of the aorta and large arteries may be deficient, and that this deficiency would lead to permanent changes in the mechanical properties of these vessels. Over a lifetime, such changes could predispose an individual to higher blood pressure, increased left-ventricular mass, and cardiovascular disease.
Lancet 1997; 350: 953–55 MRC Environmental Epidemiology Unit, Southampton University, Southampton General Hospital, SO16 6YD, UK (C N Martyn FRCP); and Institute of Pathology, Royal London Hospital, London E1 1BB, UK (S E Greenwald PhD) Correspondence to: Dr C N Martyn
Vol 350 • September 27, 1997
50 40 Concentration (% by weight)
The aorta acts as a conduit to convey blood from the left ventricle to the arteries that distribute blood to the body’s organs. Less obvious, but equally important, is its function as an impedance matching device. With each contraction, the left ventricle pumps about 70 mL of blood into a closed circulatory system that is filled with incompressible fluid at high pressure. Ejection of blood from the ventricle is only possible because the aorta is able to expand in volume. Most of the energy of leftventricular contraction is stored briefly in the stretch of the aortic wall. In diastole, elastic recoil of the wall maintains the forward flow of blood against a closed aortic valve. The aorta’s elastic properties are important in keeping to a minimum the load on the left ventricle and the rise in arterial pressure during systole. Blood flow in the coronary circulation, which occurs only in diastole, depends on the elastic recoil of the aortic wall. At a given cardiac output, reduced aortic compliance results in a widening of pulse pressure, a rise in mean arterial pressure, and a rise in the circumferential stress in the walls of the aorta and the vessels that branch from it. Simultaneously, the work that must be done by the left ventricle increases while the force driving coronary blood flow is lessened. Although this function of the aorta has long been recognised, its clinical relevance has only lately been appreciated. With the development of non-invasive techniques for measurement of aortic compliance, investigators have shown associations between decreased compliance and both systemic hypertension and left-
30 20 10
Elastin Collagen
birth 0 0
20
40
2
4
6
8
10 12
Gestational age Time after birth (weeks) (months) Figure 1: Changes in scleroprotein content of human aorta in fetal and early life Adapted from reference 7.
ventricular hypertrophy.1,2 Decreased aortic compliance has been recognised as a marker of cardiovascular disease.3
Molecular basis of aortic compliance The aorta’s elastic properties depend largely on the presence of a long-lived scleroprotein—elastin—in the vessel wall. Elastin accounts for 40–50% of the dry weight of the tissue in the thoracic aorta, and is a major component in the abdominal aorta and carotid arteries.4 Aortic elastin is arranged in multiple concentric lamellae, interspersed with smooth muscle and collagen. The number of elastic lamellae is greatest in the proximal part of the aorta. They begin to develop early in fetal life, and rates of elastin synthesis in blood vessels increase to a maximum in the perinatal period;5–7 thereafter, these rates fall rapidly (figure 1). Mature, cross-linked elastin has remarkable longevity. 953