PRACTICE GUIDELINES, PATIENT INTERESTS, AND RISKY PROCEDURES

Biwthus ISSN 0269-9702 Volume IONumbnll996

Discussion

PRACTICE GUIDELINES, PATIENT INTERESTS, AND RISKY PROCEDURES

ISOBEL A. ROSS

ABSTRACT

A clinical scenario is described where an anaesthetist is concerned about the seemingly high risk/benejit ratio relating to laparoscopic versus standard inguinal hernia operations. Some options for further action by the anaesthetist are introduced. The remainder o f the paper explores the question of who can legitimately assess the acceptability o f risk/benejit ratios, and defends the use of practice guidelines at the expense of so called clinical freedom. It is argued that respect f o r persons is not breached by limiting the lreatment options offered to patients to those therapies which have a ‘reasonable’ risk/benejit ratio. This ‘reasonableness’ is context dependent, and should be properly decided those with expertise in thefield.

A CLINICAL SCENARIO

I am a consultant anaesthetist and have provided anaesthetic services for Mr Smith’s patients once a month in a private hospital. Mr Smith is a specialist gastrointestinal surgeon, but has super specialised as an endoscopic surgeon (one specialising in ‘keyhole’ or endoscopic surgery). Over the last eighteen months he has been performing the operation of laparoscopic hernia repair to repair defects in the groin area (‘ruptures’) using endoscopic technology. This way of repairing the hernia has some potential advantages over the standard operation, which involves a moderately painful groin wound and necessitates several weeks off work for those involved in physically strenuous occupations. Its advantages in people with sedentary jobs are less apparent. Time in hospital is not noticeably different between the two techniques, as, nowadays, most patients having an open

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DISCUSSION: PRACTICE GUIDELINES 31 1

hernia operation would go home the day after surgery (the same as with the laparoscopic method) - some are even able to be operated on as day cases.

Proponents of the new technique assert that the majority ofpatients who have a laparoscopic procedure are much happier with the outcome than those who have the open procedure. Patients who have had both types of surgery reputedly demonstrate a strong preference for the laparoscopic technique. In terms of overall cost to the patient, laparoscopic repairs are very much more expensive than the open alternatives.

For some laparoscopic operations (e.g. cholecystectomy or removal of gall bladder), the high costs of equipment and longer theatre time are to some extent defrayed by the reduced costs of a shorter hospital stay. This is not the case with laparoscopic hernia operations. I t may be that indirect costs, such as loss of earnings, are reduced in a certain subgroup of patients i.e. those doing a lot of physical work.

However, there appears to be a substantial different in complication rate between the two types of surgery. The open procedure has traditionally been thought of as ‘minor surgery’, as it does not involve breaching the abdominal cavity. The laparoscopic procedure, on the other hand, is performed inside the abdomen and as such, has a much greater potential for serious (potentially life-threatening) complications, such as bowel perforation and peritonitis.

Recently, I was involved, as an anaesthetist, in an emergency operation to correct an iatrogenic complication of a laparoscopic hernia operation. I t was this experience that prompted me to take a closer look at Mr Smith’s complication rate for this operation.

Mr Smith has carried out approximately 150 of these procedures and, according to his audit of his results, his incidence of serious complications is 3%, while that of moderately serious complications (all of which would necessitate a return to the operating theatre) is in the order of 7% (giving a combined total of 10%). Although the open operation can occasionally be complicated by nerve damage, life threatening complications are virtually non existent.

MY OPTIONS

This case raises many ethical issues, not least of which is what action I should take when confronted with such a situation. Thc options, which are not mutually exclusive, might include the following.

I can do nothing. Mr Smith is a qualified surgeon and this particular field is his presumed area of expertise. My own area of expertise is anaesthesia, not surgery. I can assume, rightly or wrongly,

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that Mr Smith acquaints all his patients with the above facts about the two operations and lets them make up their own minds. Undcr such circumstances, any interference on my part might be considered presumptuous and inimical to another doctor’s relationship with his patients.

My second option might be to act as an ‘ethical watchdog’. During the pre-anaesthetic interview it might be possible to quiz the patient as to his knowledge of risks and complications associated with hernia surgery; if this knowledge were found to be deficient, I could then acquaint him with ‘the facts’ and try to persuade him to have an open procedure instead of a laparoscopic one. There are reasons, both non- moral and moral, why I believe this would be the wrong approach. I usually see the patient at too late a stage to be able to substantially influence his decision making; advocating alternative treatment options at a late stage is only likely to leave the patient worried and confused. Obviously, there are circumstances in which it may be necessary to interfere in the patientlsurgeon relationship in order to protect the patient’s interests, but it seems intuitively wrong to undermine another doctor’s relationships with his patients as a matter of deliberate policy rather than as a last resort.

A third opinion is to ‘vote with my feet’. Having established my own ethical position on this matter, I can tell Mr Smith that I no longer feel able to participate in these procedures. Such an action is unlikely to have very much effect on Mr Smith’s practice, but may have a major effect on my own, because a) Mr Smith will probably not wish to continue working with me, and b) other surgeons may consider my actions meddlesome. However the moral duty to protect patients’ interests should take precedence over duties of collegial loyalty and professional etiquette. Financial self-interest will have an even lower priority.

My last option is to see that a formal expression of concern is made to an appropriate disciplinary body. This raises issues of who should determine whether or not the laparoscopic procedure exceeds an acceptable risk/benefit ratio and whether Mr Smith’s complication rate, in particular, is acceptable.

I t is this latter issue of who should determine the acceptability of risk/benefit ratios that I wish to examine more closely in the remainder of this paper.

1

’ The issue of whether or not any particiilar surgeon’s complication rate for an established operation is acceptable is worthy ofinspection, but it is not my purpose to do so in this paper.

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DISCUSSION: PRACTICE GUIDELINES 313

PRACTICE GUIDELINES

I will defend the use of practice guidelines in surgery, with their consequent restrictions on professional autonomy, and even on patient autonomy, in order to ensure that dangerous or unnecessarily risky procedures are excluded from practice.

( a ) Which standard?

I begin by considering which standard for risklbenefit ratio should be accepted. At first glance there would appear to be four possible levels of standard. These are:

the subjective patient standard, the subjective doctor standard, the reasonable patient standard, and the reasonable doctor standard.

I have borrowed this taxonomy from the literature on informed consent, and I believe there are some close connections between informed consent and the assessment of risk/benefit ratio. However, whereas the norm in matters of informed consent is the reasonable patient2 or even the subjective patient ~ t a n d a r d , ~ I wish to argue that the norm for risk/benefit ratio should be based on a version of the reasonable doctor standard. It does seem correct to assume that medical procedurcs must be scrutinised for risk and for efficacy by experts, i.e. those practitioners who have direct involvement in and a reasonable experience of the particular field in question. However, it is important to adduce evidence to support such a contention.

What if the subjective patient standard were to become the norm? My misgivings are as follows. In this situation, if a doctor proffers a certain treatment to a patient, it would be acceptable for the paticnt to request or decline the treatment if he had been apprised of the benefits and risks of the procedure along with those of the alternatives, no matter how risky the particular treatment is. In theory, such a ‘consumer’ driven system would weed out those procedures that are inherently too risky, because no one would want to try them. In practice, however, this might not occur for several reasons.

(1 ) The first reason why risky procedures may not be weeded out is that medical risks and benefits are rarely ascertainable in precise terms. Beneficial effects of various treatment options are commonly

Faden, R. and Beauchamp, T: A History and Theory ofZn+ned Consent, Oxford: Oxford University Press, 1986, Chapter 8.

Rogers v Whittaker, 1992, AustralianLuw Reports, 109,625637.

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not known with any exactitude. For instance, many commonly used therapeutic drugs have not been subjected to critical evaluation by controlled trial against other drugs. Risks also may not be known with accuracy. In general terms, the lower the risk from a procedure, the less accurately its actual incidence is known. This is because to determine the incidence of a rare event requires the study ofvery large numbers of patients. Such multi-centre trials are both logistically difficult to organise and very expensive to run; consequently, thcy are infrequently undertaken. There are other ways of assessing risk/ benefit and cost/benefit ratios, such as meta analysis and qualitative research, but they tend to give less definitive answers.

(2) The second reason involves attitude to risk, which is recognised as a very personal thing4 with a wide spectrum of behaviour which can be considered rational - from refusing to have one’s child immunised against whooping cough because of a minute risk of brain damage, to leaping offa high bridge with only an elasticated rope around your ankles (bungy jumping!). It is also recognised that various factors can affect decision making concerning risk. The most important of these is probably the perception of the expected benefits related to the decision. Others include ‘thc degree of dreadfulness of the risk’, how well the risk is understood by the person, and the cxtent to which the risk is assumed ~oluntar i ly .~

(3) There is also the related, but even more difficult question of uncertainty. According to Katz, doctors are constantly exposed to uncertainty, viz.

(a) Uncertainty as to their personal command of current scientific

(b) Uncertainty as to the scientific validity of much of current

(c) Uncertainty as to their ability to distinguish between the two.

medical practices,

medical practice, and

‘these three related kinds of uncertainty regularly lead physicians to overstate their own certitude in dealing with patients’.“

(4) Lastly, there is the question of autonomy. It has been argued by strong libertarians that autonomy is a moral trump, and must always be respected, because autonomy alone can protect patients’

Brock, D.W. and Wartman, S.A.: ‘When Competent Patients Make Irrational

Morgan, M.G.: ‘Risk Analysis and Management’, Scientific American: 1993, ’ Katz, J . in Burt, R.A.: ‘Uncertainty and Medical Authority in the World of

Choices’ TheNew Englandjournal of Medicine May: 1990,322, 1595-1599.

ul , 2 4 3 0 .

Jay Katz’, Law, Medicine and Health Care, 1988, 16, 190-1 96.

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interests. The reasons why I believe that autonomy often fails to safeguard patients’ interests are:

(A) An autonomous choice is not always the best choice. Even the most independent minded and rational amongst us are still constrained by other social, cultural and psychological factors, such as denial, fear of pain and the medical experience, and bias towards the present and near future’ from making what appears to be objectively the best choice every time. (Whose objectivity? The doctor’s? The reasonable patient’s? The judge’s?)

(B) Faden and Beauchamp suggest that the criterion required for ‘informed consent’ is that the decision be ‘substantially autonomous’.* Unfortunately, all too often patient decision making is much less than substantially autonomous because there is inadequate understanding on the patient’s part, frequently due to insufficient information or deficient processing of information. The reasons for such failure are numerous and include factors such as a) poor communication by doctors, whether due to time restraints, lack of communication skills, strong personal bias, or lack of respect for patient autonomy and b) inability or lack of will on the part of the patient to understand the material aspects of risks and alternatives, which are not always as straightforward and unambiguous as somc commentators would suggest .

(C) Strong advocates of clinical freedom and patient autonomy might argue that a subjective standard is appropriate and that surgeons should be allowed to undertake any procedure they see fit as long as they respect patient autonomy by discussing the nature of the problem, the alternative therapies, the probable benefits and risks of each with the patient and by obtaining informed consent from the patient. Such an attitude presupposes certain features of the surgeon/ patient relationship. Firstly it implies a collegialg model of the relationship where there is an equality of power between patient and surgeon; the surgeon brings his technical knowledge, which he duly shares with the patient; the patient brings his knowledge ofself, values and beliefs, which he shares with the surgeon, and together they come to a shared decision about the best course of action. Secondly it presupposes a dyadic relationship, where the patient and surgeon are the only moral agents involved.

’ Brock and Wartman 1990, op. cit. Faden and Beauchamp 1986, op. cit. Veatch, R.M.: Models for Ethical Medicine in a Revolutionary Age in

Biomedical Ethics, Mappes, T.A. and Zemblay, J.S. (eds), McGraw-Hill hoCCo., 1981,51-55.

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THE SUBJECTIVE STANDARD AND THE SURGEON/ PATIENT RELATIONSHIP

If such suppositions are accurate, a subjective standard for risk/ benefit ratio might be appropriate. However, in reality, the nature of the surgeon/patient relationship is usually very different from this. There is a great power imbalance between surgeon and patient by virtue of the surgeon’s far greater expert knowledge and related professional authority. The patient is dependent on the surgeon for information and thus on what information the surgeon chooses to impart. There is no such thing as a value free account of the facts, and with the best will in the world the surgeon will undoubtedly influence the patient’s choice by a) the content of the information he imparts as well as that which he consciously or unconsciously omits from his account,” and b) the way in which he relays the information. Such elements as the ordering of what is said and ‘framing effects’” may exert considerable psychological influence on the patient’s decision making processes. The very fact that the surgeon suggests a procedure as a therapeutic alternative will probably invest it with some degree of legitimacy from the patient’s perspective. If the advantages of an operation are emphasised to the point where the patient has decided to go ahead with it, and at that point the risks and disadvantages are mentioned, it is common for the initial decision to prevail, in spite of the newly acquired knowledge of potential hazards. l 2

A subjective standard is thus likely to represent the surgeon’s values more readily than the patient’s. I t might be argued by advocates of virtue ethics that as long as the doctor concerned is of a virtuous disposition, and motivated only by the pursuit of the patient’s best interests, such a standard would be adequate. The patient’s interests will be protected by the character and motivation of the doctor concerned. However deontologists such as Robert VeatchI3 argue that virtuous character does not always lead to right conduct, and that patient interests are more likely to be served by reference to

l o The Cartwright Enquiry of 1986 in New Zealand demonstrated that, at the time of ‘The Unfortunate Experiment’, a sizable proportion of the medical profession did not respect autonomy in medical decision making. Although things have improved in recent years, I do not believe that autonomy is adequate to the task of defending patients’ interests. Bunkle, P. and Conley, S.: “An Unfortunate Ex eriment at National Women’s Hospital”, Metro, 1987, June, 46-65.

Faden and Beauchamp 1986, p. 241, op. cit. ’‘ ibid. p. 366-367. l 3 Veatch, R.M., ‘Against Virtue: A Deontological Critique ofvirtue Theory in

Medical Ethics’, p. 329-345 in Virtueand Medicine, Shelp, E.E. (ed), Dordrecht, D. Reidel Publishing Co., 1985.


DISCUSSION: PRACTICE GUIDELINES 31 7

ethical principles and rules. The pragmatic argument against the virtuous character of the doctor being an adequate safeguard of patients' interests is that not all doctors aspire to virtuousness - there is a spectrum of ethical behaviour and sensitivity within the medical community which, Pellegrino says, ranges from a legally based minimalist ethic, through an ethic of rights and duties to a virtue based ethic.14 This differentiation is not widely recognised within or outside the medical community. A reliance on the virtuous character of the physician to protect patients will obviously be misplaced if the physician in question does not aspire to virtue in his dealings with patients.

A DYADIC O R TEAM RELATIONSHIP?

The supposition about thc dyadic nature of the moral relationship between patient and surgeon is also wrong. The reality is that surgery requires the participation of many health professionals from the nursing staff in the wards to theatre staff and anaesthetists. These persons cannot be dismissed as of only technical importance in the surgical procedure. They are all moral agents in their own right, and, as such, have moral responsibilities to the patient. Certainly, they should not feel obligated to participate in procedures, about which there is no consensus and which they perceive to have an adverse risk/benefit ratio. A subjective standard would increase the risk of this happening.

ARGUMENTS AGAINST A SUBJECTIVE STANDARD

Thus, the main arguments against a subjective standard are:

(1) I t is open to abuse and may lead to patient harm. (2) If offers no protection to other medical and nursing staff from

involvement in unorthodox and morally questionable procedures.

ARGUMENTS FOR AN OBJECTIVE STANDARD

Unfortunately, a more objective standard for risk/benefit ratio is also fraught with difficulty. First of all I will consider the case for an objective standard.

l4 Pellegrino, E. 'The Virtuous Physician and the Ethics of Medicine' in Beauchamp, T.L. and Walters, L. (eds) Contemporary Zssucs in Biosthics, 3rd ed. Belrnont: Wadsworth Publishing Co., 1982. p. 249.


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The argument for an objective standard is correlative with the argument against the subjective one.

An objective standard may help provide a framework for assessing physician performance, and improving physician accountability. If an objective standard is laid down, any doctor who chooses to use a less conventional therapy will have to justify his approach prospectively both to the patient, and to any of his professional colleagues who are required to participate in the procedure, and retrospectively to the abovc and also to any review body who may audit his practice if his outcomes seem to be demonstrably worse than those of his colleagues.

An objective standard will lend itsclf to assessment of surgeon performance both in terms of process and outcome. l5

ARGUMENTS AGAINST AN OBJECTIVE STANDARD

There are at least three forceful arguments against an objective standard:

(1) The first of these is a practical rather than an ethical one and relates to the enormous difficulties involved in finding an objective standard. An objective standard presupposes at least partial consensus, although unanimity would be more desirable. How can such consensus be achieved? In medical science, the double blind, randomised, controlled trial is the exemplar. For most diseases and ailments there is a paucity of controlled trials comparing different treatment modalities and, all too often, new treatments are introduced into clinical practice without a direct comparison being made with existing treatments. Confounding factors such as the belief that ‘new is better’ and lack of appreciation of placebo effects may influence practitioners to embrace unproven therapies. Often ethical concerns contribute to the lack of proper trials.

‘Firmly convinced that their new technique is unquestionably beneficial, they cannot bring themselves to deny the public its benefits during the period of several years’ stringent testing that would be required to validate it - or even, to put it bluntly, to make quite sure that they are not really doing more harm than good. From this springs the second difficulty: the new but still

l 5 Margaret Stacey asserts that whereas the public is concerned with outcome, the medical profession has more traditionally been concerned with process. Stacey argues that it is becoming more widely accepted that the profession must place greater emphasis on monitoring outcome in medical audits. Stacey, M., ‘Medical Accountability: a Background Paper’ in Grubb, A. (ed) Challenges in Medical Care, Chichester: Wiley, 1992. p. 124.



unproved method is not only introduced into practice by its progenitors but attracts wide publicity. Demand is created, and pressures from specially interested sections of the profession and from the public lead to premature policy decisions. Once the still unauthorised technique is incorporated into routine practice, even by a minority of the profession, it is virtually impossible to conduct the controlled trial that alone can furnish truly reliable evaluation, since the deliberate exclusion of some people from its hypothetical benefits can so easily be pilloried as unethical.’16

Recently the members of our anaesthetic department were asked to take part in a multi centre trial to critically compare the benefits and risks of epidural analgesia and another form of analgesia following major bowel surgery. Many anaesthetists in the department felt that the perceived benefits of epidural anaesthesia were such that it would be unethical to randomise patients into the two groups, and so participation was declined. This, in my judgment, is wrong because:

(a) no individual anaesthetist can have a sufficiently wide overview to

(b) often our ‘gut feelings’ and intuitions are proved wrong in the cold

Because of such problems, much of modern medical practice is not scientifically rigorous but based on tradition and individual experience and preference. This leads to two practical difficulties in the pursuit of an objective standard:

(a) Consensus may be very difficult to achieve, as noted above. (b) Even if consensus is achieved it may be based on specious

reasoning and may be wrong. Just because a lot of people believe something, does not make that thing true.

(2) The second argument against an objective standard relates to the difficulties associated with treating patients as populations rather than as individuals. Science deals with populations, whereas medicine deals with particulars, If too rigid an objective standard is laid down there will always be some patients who, for some reason or another, require some form of therapy out with such a standard. Much decision making in medicine involves quite complex and often ambiguous judgment calls, as opposed to following recipes or adhering to strict rules. Thus any objective standard must be considered presumptive rather than absolute. However, there will be an onus of justification

know ‘whether he is doing more harm than good’.

light of scientific analysis.

Miller, H. MedicineandSociety, London: OUP, 1973. p. 39.


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on doctors who decide to employ treatments out with the objective standard.

(3) The third argument relates to the fear that increasing regulation of clinical practice may inhibit innovation and lead to the stagnation ofmedicine. There is some truth in this, and it is important that the correct balance be sought between encouraging beneficial new treatments and accepting too high a risk/benefit ratio.

The subjective/objective dispute can be distilled down to an ethical analysis of which is the lesser evil, that of a curtailment of doctors’ clinical freedom with its consequences for reduced patient choices in tcrms of treatment options, or that of exposing patients to harms caused by the use of unvalidated and potentially dangerous treatment options, whether by enthusiasts, by the unscrupulous out for financial gain, or by well meaning doctors who are persuaded by public demand to provide the latest wonder of medical technology.

I believe that well formulated ‘practice uidelines’, such as are currently gaining popularity in the USA,“ are an ethically valid expression of an objective standard, and as such, will be an effective tool to safeguard patients. This concept relies on a panel of experts reviewing the relevant literature and current practices, and then drawing up guidelines. Their introduction must be tempered by an acknowledgement from practice reviewers that some degree of clinician discretion must be conceded. I t is important in this regard that the emphasis is on the word guidelines, rather than protocols, as the latter will be too circumscribed to accommodate the ‘ragged edge’ of inter patient variability. I t is also necessary to guard against such guidelines being ‘hi’acked’ to promote economic efficiency ahead of patients’ interests. Although practice guidelines may not be able to be formulated for all procedures in all branches of medicine, I believe they are an ideal to be strived for.

Id

MY OWN POSITION

The ethos of my training as an anaesthetist has been the principle of ‘safety first’, which might be considered a loose translation ofprimum non nocere.

I find myself defending a model of paternalism in this instance because I do not consider that autonomy, in the clinical as opposed to the theoretical setting, will prove an adequate safeguard against the harms that may be caused by imprudent decisions made on

l7 Shomaker, T.S., ‘Practice Policies in Anaesthesia: a Foretaste of Practice in the 2 1st Century’, Anesthesia and Analgesia, 1995,80,388403.

See Macklin, R., EnemiesofPatients, New York: OUP, Inc., 1993. p. 19.



inadequate information. Procedures which exceed a certain risk/ benefit ratio should not be offered to patients ifother procedures with much lesser risk/benefit ratios exist. I do not see this as a failure of respect for person^;'^ rather it is an acknowledgement that in certain situations in medicine, other primafacie principles (e.g. beneficence and non-maleficence) can override the principle of respect for autonomy. What Alastair Campbell refers to as respect for dependency“ will be realised. Respect for persons is still paramount and has not been infringed. In the biomedical context I regard respect for persons as the value which subsumes all the above mentioned principles and allows for their differential weighting in particular situations. However, it is not exactly equivalent to the principle of respect for autonomy, but is rather a broader concept which also has room for beneficence and dependency.

There are many examples of this sort of paternalism in our lives e.g. the statutory proscription of drugs such as cocaine and heroin is an instance of substitution of one (or many) person’s judgment for another’s. Gerald Dworkin has suggested that one way to guide judgments about such paternalistic acts is ‘to ask under what conditions does A’s attempts to substitute his or her judgment for B’s constitute treating B as less than a moral equal’.“

Paternalism, like autonomy, has a plurality of conceptualisations. Personally, I believe paternalism is not in and of itself a moral iniquity; rather, I prefer to think in terms ofjustified and unjustified paternalism, the former of which is a moral good, the latter a moral evil.

This paper began with an account of a moral dilemma which I faced as an anaesthetist, where I was unsure of what action to take when confronted with a situation where I believed that an unsafe operation was being performed by a surgical colleague. I contend that had a system of practice guidelines been in place I would have known or been able to find out whether or not the operation was an

l9 Respect for persons is the norm which James Childress has proposed as an alternative to Respect for Autonomy in the medical context. Childress believes that respect for the autonomous acts ofpatients is only one aspect ofRespect for Persons, though perhaps its main aspect. Childress, J.F., ‘The Place of Autonomy in Bioethics’, Hartings Cent. Rep. 1990. Jan/Feb: 20, 13-16. See also Yeide, H., ‘The Many Faces of Autonomy’, ThcJournal of Clinical Ethics, 1992. Winter: 269-273.

*’ Campbell, A., ‘Dependency: the Foundational Value in Medical Ethics’, in Fulford, K.W.M., Gillett, C . and Soskice, J.M., Medicine and Moral Reasoning, Cambridge: Cambridge University Press, 1994.

Dworkin, G., The Theory and Practice .f Autonomy, Cambridge: Cambridge University Press, 1988. p. 124.

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acceptable one under the circumstances, and so would have been able to ascertain the correct course of action more easily.

In summary, there is a tension between so called clinical freedom and the regulation of clinical practice by such mechanisms as practice guidelines. I have argued that patients’ interests will be best served by the widespread adoption of the latter.

Wellington, New zealand


PRACTICE GUIDELINES, PATIENT INTERESTS, AND RISKY PROCEDURES

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