- Email: [email protected]
Consent: How Informed?
1445
Consent: How Informed? TO
that pseudohypoparathyroidism was associated with normal parathyroid glands an exploratory neck operation was conducted by a distinguished group of clinical scientists. Forty years after the publication of the classic paper from Albright’s group’ W. Parson, the junior author, confesses to some uncomfortable qualms that advantage may have been taken of an "agreeable, simple-minded subject".2 That her consent was in any reasonable sense of the term informed seems improbable and such an indication for operation would not now be accepted-an instance of the better sort of medical progress. The intervening years have seen increasing concern with informed consent, and the newer techniques of research have radically changed the context in which it is sought. With these changes new quandaries have arisen. By chance Parson’s letter is printed a few pages away from a paper that highlights these changes in attitude and the difficulties they entail for clinical research.3A large multicentre randomised study was undertaken by the North American National Surgical Adjuvant Project for Breast and Bowel Cancer (NSABP) to compare total mastectomy with segmental mastectomy in the treatment of carcinoma of the breast. It was calculated that 2500 patients were needed. After 44 months precisely 519 had been recruited. Clearly doctors were not entering many eligible patients. In an attempt to discover the reason a questionnaire was circulated amongst investigators who had agreed to participate. The major reasons given for failure to enter patients reflected difficulties in combining the role of scientific researcher and caring physician. A particular difficulty in this context was the need to obtain informed consent so that the patient understood that she would be randomly allocated to substantially different surgical procedures. A study in the United Kingdom could be interpreted as suggesting that in these circumstances the doctors may have more reservations than patients. The Cancer Research Campaign4 commissioned a survey of public 1.
substantiate
the
hypothesis
2. 3.
Albright F, Burnett CH, Smith PH, Parson W. Pseudo-hypoparathyroidism—an example of Seabright-Bantam syndrome. Endocrinology 1942; 30: 922-32. Parson W Uninformed consent in 1942. N Engl J Med 1984; 310: 1397. Taylor KM, Margolese RG, Soskolne CL. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med
4.
Kemp N, Skinner E, Toms J. Randomized clinical trials of cancer treatment—a public
the preferred treatment because both are participating in a multicentre trial?6 Not surprisingly, some doctors cope with this acute dilemma by agreeing to a trial in principle and then failing to enrol patients for it, thereby achieving a wholly irrational reconciliation between their duties to individual patients on the one hand and to medical progress on the other. Closer examination may help to resolve a dilemma which is more apparent than real. The first principle, as in other spheres of medicine is "first do no harm". More correctly if less euphoniously this should be expanded to "do nothing that, in the state of knowledge at the time, harms the patient" -since, when the outcome to the trial is known, one group may have fared less well than the other. If the doctor is convinced that one form of therapy is superior to the other before BR, Lusk EJ, Miller DS, Hurwitz S Attitudes towards clinical trials among patients and the public. JAMA 1982, 248: 968-70. 6 Schafer A The ethics of the randomized clinical trial. N Engl J Med 1982; 307: 719-24. 5. Cassileth
1984; 310: 1363-66. opinion survey. Clin Oncol
attitudes to randomised trials. Amongst 1022 adults interviewed no less than 6307o declared they would enter a randomised trial of treatment for a major illness; and even when one of the alternatives was a disfiguring surgical procedure 40% still said they would be willing to participate. It remains uncertain how far such attitudes would survive a severe illness, when perception of priorities must surely change, although another survey of public attitudes to clinical trials from the United States suggested that there was no fundamental difference between cancer patients and the healthy in this respect.5 Nevertheless the qualms felt by clinicians who conduct the trials are real and bear further consideration. The fundamental difficulty, as in so many medical dilemmas, is a conflict of roles and duties. The doctor is committed to the welfare of his patient: anything that impedes or seems to impede his promotion of the patient’s care and wellbeing is a denial of his responsibilities. His duties as an investigator are quite distinct: he has to contribute towards a valid outcome to the trial which may help later generations of patients but which is unlikely to help the patient who is currently being treated. The randomised trial is not easy to reconcile with such a concept of individualised care. Instead of stating or implying that the recommended treatment is the one best suited to the patient’s predicament, the doctor has to explain that there is uncertainty about the value of certain forms of treatment. To resolve this in the interests of future sufferers the patient will, if he agrees, be subject to one particular form of treatment: the nature of that treatment will be determined not by his doctor but by a procedure equivalent to the tossing of a coin. There is exceptional difficulty when the randomised treatments have clearly different effects upon the patient, as in mastectomy trial. Is it really compatible with the physicianly role that a patient undergoes a mutilating operation at the toss of a coin? Is it for that matter acceptable that a doctor should fail to offer his patient
1984;
10: 155-61.
1446
entering the trial he should decline to participate since infringing this principle. This position was expressed by one surgeon who failed to enter patients in the NSABP trial: "I do not want to be responsible for causing my patients to undergo unnecessary surgery, if as I believe the results will show they could have done just as well with a smaller operation". It is worth emphasising that the definition of harm extends beyond any alteration in the natural history of the disease. For instance, the normal consequences of a total mastectomy may be wholly disastrous for a particular patient and may far outweigh any possible prolongation of life: entering such a patient in a he is
randomised trial that may involve total mastectomy is clearly harmful and therefore unacceptable. Beyond such considerations are the real if less tangible difficulties produced when the doctor seems to be abandoning his caring role in seeking informed consent for a patient to participate. This is compounded when the patient is acutely ill or has just learned that he has a dangerous or even fatal disease. How far is informed consent necessary in these circumstances: indeed, can the act of seeking it be harmful in some circumstances? The legal correspondent of The Lancet took a firm view.when a coroner’s inquest was told that a patient had been subjected to a trial of cancer chemotherapy without giving consent.’ Pronouncements from other sources have been a good deal more cautious in giving blanket advice about informed consent. The Medical Research Council states that a frank description of the trial may be contraindicated in patients with a possibly fatal illness or when a placebo is to be substituted for an active drug. The Declaration of Helsinki9 allows the doctor to decide when it is essential not to obtain informed consent, although it goes on to recommend transmitting the reasons for this proposal to an independent ethical committee. The Cancer Research Campaign Working Party on Breast Conservation’o concluded that doctors have an ethical obligation to seek informed consent from prospective entrants to a trial of mastectomy, although the Working Party admitted that the question of informed consent in other clinical trials remains unresolved. Several issues need clarifying. The first is the question of harm. In some trials, particularly where surgery is involved, the possibility of harm can be resolved only by discussion between patient and doctor since the outcome must be judged in terms not only of the primary disease but also of the personal and psychological consequences of
possibly mutilating procedures. Only an adequately informed patient can reach a decision about this. Less obvious but equally important are the social consequences of patients’ being enrolled in trials of patient who was unwitting subject of randomised controlled trial of cancer treatment. Lancet 1982; i: 1028-29. 8. Medical Research Council (1963) Memorandum on clinical investigations. In: Dunstan AS, Dunstan GR, Welbourn RB, eds. Dictionary of medical ethics London: Darton, Longman and Todd, 1981: 114-15. 9. Declaration of Helsinki (revised 1975). In Dunstan AS, Dunstan GR, Welbourn RB, eds Dictionary of medical ethics. London Darton, Longman and Todd, 1981 132-34 7. Brahams D Death
without
their
term The knowledge. "experimentation" has assumed pejorative undertones
and the disclosure that secret controlled trials are being conducted without the knowledge of the patients exposed to new forms of therapy can only undermine confidence in the medical profession. The legal consequences of failure to obtain consent have not been tested’O but are probably also serious in the event of a mishap if the patient or his relatives learn only later that a clinical trial determined the nature of the treatment. Legal considerations apart, it seems indefensible to deny the patient the right to refuse to participate. Much more difficult is the nature of the information upon which the informed consent is based. Is it possible, as is implied for instance in the MRC report,8 that knowledge conveyed in seeking consent can in some cases be harmful? If this is indeed the case then the trial cannot proceed since it contravenes the principle that no harm is done. However, this difficulty is more theoretical than real. Informed consent implies that the patient will be given information sufficient to make a reasonable decision about participation. It in no sense implies a rigid check-list of all aspects of the disease and its treatment. So far, doctors in the United Kingdom have been lucky enough to avoid legal imposition of such inhumane requirements. Informed consent does imply the sort of reasonable explanation and discussion that any competent clinician conducts when seeking the acquiescence of a patient to a course of treatment. Whether or not a trial is in prospect, possible adverse effects are an important factor in determining the patient’s decision. There is, however, one aspect in which consent to a randomised trial differs from consent to routine treatment. The clinician is confronted with the uncongenial task of confessing to both ignorance and impotence. He does not know whether one treatment is better than the other (otherwise he would not be conducting a trial), and he is explicitly abandoning his normal duty of selecting and recommending a particular treatment in favour of chance. This is why many clinicians baulk at the task of enrolling patients in a randomised trial. Is it then necessary to explain the process of randomisation to the patient at all? According to one view there is a moral obligation on the clinician to do this since the fact of randomisation, however distasteful, is of fundamental relevance to the trial and therefore to the patient’s decision to participate. It is therefore wrong to withhold such information.6 Such a view is persuasive. It would not be easy to present a fair picture, complete with a description of alternative forms of treatment, and then omit to mention how one of these is to be chosen. the need to Nevertheless explain randomisation is clearly an important sticking point for doctors if not for patients. Zelen" has suggested that 10. Cancer Research Campaign Working Party in Breast Conservation. Informed consent. ethical, legal and medical implications for doctors and patients who participate in randomised clinical trials. Br Med J 1983; 286: 1117-21 11. Zelen M. A new design for randomised clinical trials. N Engl J Med 1979; 300: 1242-45
1447
this difficulty can be met by a modified trial design. Patients are randomised to two groups: one group receives the best standard treatment and consent is not sought. The other group is allocated to the alternative treatment to be tested, and informed consent to a trial is sought. If such consent is not given patients are reallocated to standard treatment. Faced with poor recruitment the NSABP adopted the Zelen model and the rate of recruitment increased sixfold,but such a change of direction is achieved at a price that is in this case both ethical and scientific. The scientific price is the increased risk of systematic bias. The ethical difficulty is that one group of patients participates in a randomised trial without giving their consent. It might be argued that if the alternative course of not participating was adopted the outcome would be the same for this group of patients. The ethical criticism remains, however, that as a result of the decision to conduct a clinical trial a group of patients received a particular form of treatment by chance and not by choice. On these grounds the Cancer Research Council Working party’° rejected the Zelen model: it is difficult to refute their conclusion. There is no wholly satisfactory alternative to the randomised controlled
trial.
Suicide Prevention: an Attempt to the Inevitable?
Stop
FOR the clinician, loss of a patient by suicide is shocking and distressing. Mercifully it is rare. On average the family doctor will encounter one case every six years’ and, even in psychiatric practice, completed suicide (by contrast with non-fatal deliberate self harm) is not commonplace. Efficient estimation of suicide risk is fraught with difficulties2 and the infrequency of the event is a further hindrance to assessment of interventions by , doctors and other agencies. Nevertheless, suicide accounts for a substantial number of deaths-over 4000 per annum in England and Wales’ -and is among the top ten causes of death in most European countries.3 It is, moreover, on the increase in England and Wales.4 Although men of middle age or beyond still have by far the highest risk, the largest rise has been among young people5—a trend noted previously in 15 other European countries.6
an "estimated" suicide rate (suicide plus undetermined deaths and accidental poisonings) McClure5 found an increase in 15-19-year-olds of 29% in males and 63% in females for the period 1978-80 compared with 1968-70. The findings on the other side of the Atlantic are similar, so that in the United States suicide is now the third most common cause of death among adolescents,’ exceeded only by accidents and homicide. What are the possible causes of these alarming changes and what can be done to stem the flow? Modern research on the epidemiology of suicide had its beginnings in the late 19th century with the studies of Durkheim,8 who took a broad perspective of the societal pressures that may be associated with the phenomenon. Durkheim particularly emphasised the influences of"normlessness" or anomie within society and tended to ignore the possible effects of mental illness (indeed, he declared that he had specifically excluded consideration of suicide due to insanity).9 In the latter half of the 20th century clinically oriented investigations have produced a quite different perspective. Three studies, each of a hundred or more completed suicides (one in Great Britain" and two in the United Statesll,12) were in complete agreement that more than 90% of cases were associated with mental illness, most commonly affective disorder or alcoholism. Robins13 in a recent monograph described the earliest of the three studies in detail. The painstaking methodology, including the use of explicit diagnostic criteria, and the excellent agreement with other investigations underline the reliability of the findings and clearly demonstrate that the association between serious psychopathology and suicide is a real one. The studies further show that most suicide victims communicate their distress and suicidal intent13 and as many as four-fifths have had medical contact for psychiatric troubles in the year before their death. 10 Given that this is so suicide ought to be preventable. However, whether the suicide rate is influenced by the efforts of psychiatrists or other helping agencies remains an open question. During the 1960s and early 1970s there was a striking fall in the annual death rate from suicide in England and Wales and a similar but more modest one in Scotland, despite increases in almost all other industrialised nations.1,6 This provoked much optimism and was variously interpreted as resulting
Taking
7.
8 1. Office of Health Economics. Suicide and deliberate self harm. London: Office of Health Economics, 1981. 2. Pallis DJ, Gibbons JS, Pierce DW. Estimating suicide risk among attempted suicides II. Efficiency of predictive scales after the attempt. Br J Psychiatry 1984; 144: 3.
4. 5. 6.
139-48. Kreitman N. Suicide and parasuicide. In: Kendell RE, Zealley AK, eds. Companion to psychiatric studies. Edinburgh: Churchill Livingstone, 1983: 396-411. McClure GMG. Recent trends in suicide among the young. BrJ Psychiatry 1984; 144: 134-38. McClure GMG. Trends in suicide rates for England and Wales, 1975-80. Br J Psychiatry 1984; 144: 119-26. Sainsbury P, Jenkins J, Levey A. The social correlates of suicide in Europe. In: Farmer R, Hirsch S, eds. The suicide syndrome. London: Croom Helm, 1980: 38-53.
9.
Hollinger PC. Violent deaths among the young: recent trends in suicide, homicide and accidents. Am J Psychiatry 1979, 136: 1144-47. Durkheim E. (1897). Suicide: A study in sociology (translated by JA Spaulding and G Simpson). London. Routledge and Kegan Paul, 1970. Tantam D. Psychiatry and the social sciences. In: McGuffin P, Shanks MF, Hodgson R, eds. Scientific principles of psychopathology. London: Academic Press, 1984: 523-55.
Barraclough B, Bunch J, Nelson B, Sainsbury P. A hundred cases of suicide: Clinical aspects. Br J Psychiatry 1974; 125: 355-73. 11. Robins E, Murphy GE, Wilkinson RH, Gassner S, Kayes J. Some clinical considerations in the prevention of suicide based on a study of 134 successful suicides. Am J Publ Health 1959; 49: 888-99. 12. Dorpat TL, Ripley HS. A study of suicide in the Seattle area. Comp Psychiatry 1960; 1: 10.
349-59. 13. Robins E. The final months. A
Oxford: Oxford
study of the lives University Press, 1981.
of 134
persons who committed suicide.
Consent: How Informed? TO
that pseudohypoparathyroidism was associated with normal parathyroid glands an exploratory neck operation was conducted by a distinguished group of clinical scientists. Forty years after the publication of the classic paper from Albright’s group’ W. Parson, the junior author, confesses to some uncomfortable qualms that advantage may have been taken of an "agreeable, simple-minded subject".2 That her consent was in any reasonable sense of the term informed seems improbable and such an indication for operation would not now be accepted-an instance of the better sort of medical progress. The intervening years have seen increasing concern with informed consent, and the newer techniques of research have radically changed the context in which it is sought. With these changes new quandaries have arisen. By chance Parson’s letter is printed a few pages away from a paper that highlights these changes in attitude and the difficulties they entail for clinical research.3A large multicentre randomised study was undertaken by the North American National Surgical Adjuvant Project for Breast and Bowel Cancer (NSABP) to compare total mastectomy with segmental mastectomy in the treatment of carcinoma of the breast. It was calculated that 2500 patients were needed. After 44 months precisely 519 had been recruited. Clearly doctors were not entering many eligible patients. In an attempt to discover the reason a questionnaire was circulated amongst investigators who had agreed to participate. The major reasons given for failure to enter patients reflected difficulties in combining the role of scientific researcher and caring physician. A particular difficulty in this context was the need to obtain informed consent so that the patient understood that she would be randomly allocated to substantially different surgical procedures. A study in the United Kingdom could be interpreted as suggesting that in these circumstances the doctors may have more reservations than patients. The Cancer Research Campaign4 commissioned a survey of public 1.
substantiate
the
hypothesis
2. 3.
Albright F, Burnett CH, Smith PH, Parson W. Pseudo-hypoparathyroidism—an example of Seabright-Bantam syndrome. Endocrinology 1942; 30: 922-32. Parson W Uninformed consent in 1942. N Engl J Med 1984; 310: 1397. Taylor KM, Margolese RG, Soskolne CL. Physicians’ reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. N Engl J Med
4.
Kemp N, Skinner E, Toms J. Randomized clinical trials of cancer treatment—a public
the preferred treatment because both are participating in a multicentre trial?6 Not surprisingly, some doctors cope with this acute dilemma by agreeing to a trial in principle and then failing to enrol patients for it, thereby achieving a wholly irrational reconciliation between their duties to individual patients on the one hand and to medical progress on the other. Closer examination may help to resolve a dilemma which is more apparent than real. The first principle, as in other spheres of medicine is "first do no harm". More correctly if less euphoniously this should be expanded to "do nothing that, in the state of knowledge at the time, harms the patient" -since, when the outcome to the trial is known, one group may have fared less well than the other. If the doctor is convinced that one form of therapy is superior to the other before BR, Lusk EJ, Miller DS, Hurwitz S Attitudes towards clinical trials among patients and the public. JAMA 1982, 248: 968-70. 6 Schafer A The ethics of the randomized clinical trial. N Engl J Med 1982; 307: 719-24. 5. Cassileth
1984; 310: 1363-66. opinion survey. Clin Oncol
attitudes to randomised trials. Amongst 1022 adults interviewed no less than 6307o declared they would enter a randomised trial of treatment for a major illness; and even when one of the alternatives was a disfiguring surgical procedure 40% still said they would be willing to participate. It remains uncertain how far such attitudes would survive a severe illness, when perception of priorities must surely change, although another survey of public attitudes to clinical trials from the United States suggested that there was no fundamental difference between cancer patients and the healthy in this respect.5 Nevertheless the qualms felt by clinicians who conduct the trials are real and bear further consideration. The fundamental difficulty, as in so many medical dilemmas, is a conflict of roles and duties. The doctor is committed to the welfare of his patient: anything that impedes or seems to impede his promotion of the patient’s care and wellbeing is a denial of his responsibilities. His duties as an investigator are quite distinct: he has to contribute towards a valid outcome to the trial which may help later generations of patients but which is unlikely to help the patient who is currently being treated. The randomised trial is not easy to reconcile with such a concept of individualised care. Instead of stating or implying that the recommended treatment is the one best suited to the patient’s predicament, the doctor has to explain that there is uncertainty about the value of certain forms of treatment. To resolve this in the interests of future sufferers the patient will, if he agrees, be subject to one particular form of treatment: the nature of that treatment will be determined not by his doctor but by a procedure equivalent to the tossing of a coin. There is exceptional difficulty when the randomised treatments have clearly different effects upon the patient, as in mastectomy trial. Is it really compatible with the physicianly role that a patient undergoes a mutilating operation at the toss of a coin? Is it for that matter acceptable that a doctor should fail to offer his patient
1984;
10: 155-61.
1446
entering the trial he should decline to participate since infringing this principle. This position was expressed by one surgeon who failed to enter patients in the NSABP trial: "I do not want to be responsible for causing my patients to undergo unnecessary surgery, if as I believe the results will show they could have done just as well with a smaller operation". It is worth emphasising that the definition of harm extends beyond any alteration in the natural history of the disease. For instance, the normal consequences of a total mastectomy may be wholly disastrous for a particular patient and may far outweigh any possible prolongation of life: entering such a patient in a he is
randomised trial that may involve total mastectomy is clearly harmful and therefore unacceptable. Beyond such considerations are the real if less tangible difficulties produced when the doctor seems to be abandoning his caring role in seeking informed consent for a patient to participate. This is compounded when the patient is acutely ill or has just learned that he has a dangerous or even fatal disease. How far is informed consent necessary in these circumstances: indeed, can the act of seeking it be harmful in some circumstances? The legal correspondent of The Lancet took a firm view.when a coroner’s inquest was told that a patient had been subjected to a trial of cancer chemotherapy without giving consent.’ Pronouncements from other sources have been a good deal more cautious in giving blanket advice about informed consent. The Medical Research Council states that a frank description of the trial may be contraindicated in patients with a possibly fatal illness or when a placebo is to be substituted for an active drug. The Declaration of Helsinki9 allows the doctor to decide when it is essential not to obtain informed consent, although it goes on to recommend transmitting the reasons for this proposal to an independent ethical committee. The Cancer Research Campaign Working Party on Breast Conservation’o concluded that doctors have an ethical obligation to seek informed consent from prospective entrants to a trial of mastectomy, although the Working Party admitted that the question of informed consent in other clinical trials remains unresolved. Several issues need clarifying. The first is the question of harm. In some trials, particularly where surgery is involved, the possibility of harm can be resolved only by discussion between patient and doctor since the outcome must be judged in terms not only of the primary disease but also of the personal and psychological consequences of
possibly mutilating procedures. Only an adequately informed patient can reach a decision about this. Less obvious but equally important are the social consequences of patients’ being enrolled in trials of patient who was unwitting subject of randomised controlled trial of cancer treatment. Lancet 1982; i: 1028-29. 8. Medical Research Council (1963) Memorandum on clinical investigations. In: Dunstan AS, Dunstan GR, Welbourn RB, eds. Dictionary of medical ethics London: Darton, Longman and Todd, 1981: 114-15. 9. Declaration of Helsinki (revised 1975). In Dunstan AS, Dunstan GR, Welbourn RB, eds Dictionary of medical ethics. London Darton, Longman and Todd, 1981 132-34 7. Brahams D Death
without
their
term The knowledge. "experimentation" has assumed pejorative undertones
and the disclosure that secret controlled trials are being conducted without the knowledge of the patients exposed to new forms of therapy can only undermine confidence in the medical profession. The legal consequences of failure to obtain consent have not been tested’O but are probably also serious in the event of a mishap if the patient or his relatives learn only later that a clinical trial determined the nature of the treatment. Legal considerations apart, it seems indefensible to deny the patient the right to refuse to participate. Much more difficult is the nature of the information upon which the informed consent is based. Is it possible, as is implied for instance in the MRC report,8 that knowledge conveyed in seeking consent can in some cases be harmful? If this is indeed the case then the trial cannot proceed since it contravenes the principle that no harm is done. However, this difficulty is more theoretical than real. Informed consent implies that the patient will be given information sufficient to make a reasonable decision about participation. It in no sense implies a rigid check-list of all aspects of the disease and its treatment. So far, doctors in the United Kingdom have been lucky enough to avoid legal imposition of such inhumane requirements. Informed consent does imply the sort of reasonable explanation and discussion that any competent clinician conducts when seeking the acquiescence of a patient to a course of treatment. Whether or not a trial is in prospect, possible adverse effects are an important factor in determining the patient’s decision. There is, however, one aspect in which consent to a randomised trial differs from consent to routine treatment. The clinician is confronted with the uncongenial task of confessing to both ignorance and impotence. He does not know whether one treatment is better than the other (otherwise he would not be conducting a trial), and he is explicitly abandoning his normal duty of selecting and recommending a particular treatment in favour of chance. This is why many clinicians baulk at the task of enrolling patients in a randomised trial. Is it then necessary to explain the process of randomisation to the patient at all? According to one view there is a moral obligation on the clinician to do this since the fact of randomisation, however distasteful, is of fundamental relevance to the trial and therefore to the patient’s decision to participate. It is therefore wrong to withhold such information.6 Such a view is persuasive. It would not be easy to present a fair picture, complete with a description of alternative forms of treatment, and then omit to mention how one of these is to be chosen. the need to Nevertheless explain randomisation is clearly an important sticking point for doctors if not for patients. Zelen" has suggested that 10. Cancer Research Campaign Working Party in Breast Conservation. Informed consent. ethical, legal and medical implications for doctors and patients who participate in randomised clinical trials. Br Med J 1983; 286: 1117-21 11. Zelen M. A new design for randomised clinical trials. N Engl J Med 1979; 300: 1242-45
1447
this difficulty can be met by a modified trial design. Patients are randomised to two groups: one group receives the best standard treatment and consent is not sought. The other group is allocated to the alternative treatment to be tested, and informed consent to a trial is sought. If such consent is not given patients are reallocated to standard treatment. Faced with poor recruitment the NSABP adopted the Zelen model and the rate of recruitment increased sixfold,but such a change of direction is achieved at a price that is in this case both ethical and scientific. The scientific price is the increased risk of systematic bias. The ethical difficulty is that one group of patients participates in a randomised trial without giving their consent. It might be argued that if the alternative course of not participating was adopted the outcome would be the same for this group of patients. The ethical criticism remains, however, that as a result of the decision to conduct a clinical trial a group of patients received a particular form of treatment by chance and not by choice. On these grounds the Cancer Research Council Working party’° rejected the Zelen model: it is difficult to refute their conclusion. There is no wholly satisfactory alternative to the randomised controlled
trial.
Suicide Prevention: an Attempt to the Inevitable?
Stop
FOR the clinician, loss of a patient by suicide is shocking and distressing. Mercifully it is rare. On average the family doctor will encounter one case every six years’ and, even in psychiatric practice, completed suicide (by contrast with non-fatal deliberate self harm) is not commonplace. Efficient estimation of suicide risk is fraught with difficulties2 and the infrequency of the event is a further hindrance to assessment of interventions by , doctors and other agencies. Nevertheless, suicide accounts for a substantial number of deaths-over 4000 per annum in England and Wales’ -and is among the top ten causes of death in most European countries.3 It is, moreover, on the increase in England and Wales.4 Although men of middle age or beyond still have by far the highest risk, the largest rise has been among young people5—a trend noted previously in 15 other European countries.6
an "estimated" suicide rate (suicide plus undetermined deaths and accidental poisonings) McClure5 found an increase in 15-19-year-olds of 29% in males and 63% in females for the period 1978-80 compared with 1968-70. The findings on the other side of the Atlantic are similar, so that in the United States suicide is now the third most common cause of death among adolescents,’ exceeded only by accidents and homicide. What are the possible causes of these alarming changes and what can be done to stem the flow? Modern research on the epidemiology of suicide had its beginnings in the late 19th century with the studies of Durkheim,8 who took a broad perspective of the societal pressures that may be associated with the phenomenon. Durkheim particularly emphasised the influences of"normlessness" or anomie within society and tended to ignore the possible effects of mental illness (indeed, he declared that he had specifically excluded consideration of suicide due to insanity).9 In the latter half of the 20th century clinically oriented investigations have produced a quite different perspective. Three studies, each of a hundred or more completed suicides (one in Great Britain" and two in the United Statesll,12) were in complete agreement that more than 90% of cases were associated with mental illness, most commonly affective disorder or alcoholism. Robins13 in a recent monograph described the earliest of the three studies in detail. The painstaking methodology, including the use of explicit diagnostic criteria, and the excellent agreement with other investigations underline the reliability of the findings and clearly demonstrate that the association between serious psychopathology and suicide is a real one. The studies further show that most suicide victims communicate their distress and suicidal intent13 and as many as four-fifths have had medical contact for psychiatric troubles in the year before their death. 10 Given that this is so suicide ought to be preventable. However, whether the suicide rate is influenced by the efforts of psychiatrists or other helping agencies remains an open question. During the 1960s and early 1970s there was a striking fall in the annual death rate from suicide in England and Wales and a similar but more modest one in Scotland, despite increases in almost all other industrialised nations.1,6 This provoked much optimism and was variously interpreted as resulting
Taking
7.
8 1. Office of Health Economics. Suicide and deliberate self harm. London: Office of Health Economics, 1981. 2. Pallis DJ, Gibbons JS, Pierce DW. Estimating suicide risk among attempted suicides II. Efficiency of predictive scales after the attempt. Br J Psychiatry 1984; 144: 3.
4. 5. 6.
139-48. Kreitman N. Suicide and parasuicide. In: Kendell RE, Zealley AK, eds. Companion to psychiatric studies. Edinburgh: Churchill Livingstone, 1983: 396-411. McClure GMG. Recent trends in suicide among the young. BrJ Psychiatry 1984; 144: 134-38. McClure GMG. Trends in suicide rates for England and Wales, 1975-80. Br J Psychiatry 1984; 144: 119-26. Sainsbury P, Jenkins J, Levey A. The social correlates of suicide in Europe. In: Farmer R, Hirsch S, eds. The suicide syndrome. London: Croom Helm, 1980: 38-53.
9.
Hollinger PC. Violent deaths among the young: recent trends in suicide, homicide and accidents. Am J Psychiatry 1979, 136: 1144-47. Durkheim E. (1897). Suicide: A study in sociology (translated by JA Spaulding and G Simpson). London. Routledge and Kegan Paul, 1970. Tantam D. Psychiatry and the social sciences. In: McGuffin P, Shanks MF, Hodgson R, eds. Scientific principles of psychopathology. London: Academic Press, 1984: 523-55.
Barraclough B, Bunch J, Nelson B, Sainsbury P. A hundred cases of suicide: Clinical aspects. Br J Psychiatry 1974; 125: 355-73. 11. Robins E, Murphy GE, Wilkinson RH, Gassner S, Kayes J. Some clinical considerations in the prevention of suicide based on a study of 134 successful suicides. Am J Publ Health 1959; 49: 888-99. 12. Dorpat TL, Ripley HS. A study of suicide in the Seattle area. Comp Psychiatry 1960; 1: 10.
349-59. 13. Robins E. The final months. A
Oxford: Oxford
study of the lives University Press, 1981.
of 134
persons who committed suicide.