Risk-benefit ratio: the soft underbelly of patient autonomy.

• Author: Gunn, Albert E.

On the face of it, nothing could be more reasonable than for a patient to weigh the risks attendant to a medical treatment against any benefits it might be expected to produce. Everyone supports the idea of informed consent, so appropriate to the autonomy of the individual. No one should have done to him anything he does not approve. In law, when someone touches another without his consent, it is assault and battery. (1) It is also assault and battery if the consent to touching has been obtained by misrepresentation. (2) The physician is given no special exemption by reason of his professional status. He must obtain consent from the patient before touching him. If the patient is not fully informed about the consequences of this encounter, he has the right to seek redress. The law and common sense dictate that the patient be made aware of the ramifications of his decision to allow treatment.

Even when patients have been informed of the possible consequences of medical intervention, they may not adequately understand what is involved. Natural intelligence, level of education, and vocabulary all may limit the patient's comprehension. To meet this problem, physicians try to put informed consent into "plain" English. Medical terminology is replaced by lay expressions in the hope of truly informing the patient. The tendency is to simplify. The requirement for informed consent is not satisfied by merely recounting risks and benefits to a patient, but by doing so in a way that is intelligible to a particular patient in view of his individual capacities. But it is here that problems arise. In some cases medical information may be translated into a format that can be assimilated by the listener. This is probably what happens in most cases. It is almost impossible for a physician trained over a course of many years to convey his level of knowledge of a medical treatment and its untoward effects. While something may be lost in the translation, the expectation is that the patient will pick up enough to have some understanding of what is about to take place, what could go awry, and probable negative side effects.

In some instances it is clear that adequate communication is not possible between physician and patient. A baby who requires an operation obviously cannot give informed consent, so we look to the parents to represent the baby's interests. But there are limitations here. Society looks over the parents' shoulders to make sure they make a decision truly in the child's interests. They can authorize a blood transfusion, but they cannot refuse one on religious grounds. If they do, then the courts are consulted. There seens to be almost universal approbation within the medical community for recourse to the courts when a parent refuses treatment for a child based on the parent's religious belief. Court rulings authorizing treatment under such circumstances are accepted as a proper exercise of judicial function. This is an interesting phenomenon, since in other circumstances many in the medical community believe that medical decision should be left to family or next friends and physicians. Here judicial intervention is not welcomed. The courts are not the place, according to the common view, to work out these "private" and intimate decisions. The standard seems to be that the courts should be involved when medical professionals agree with what they will decide, but not when they might reach an outcome we do not like.

This attitude may be a spillover from the medical malpractice crisis. Here many physicians blame plaintiffs' lawyers for a problem that may be largely the result of physician negligence or incompetence. The contingency fee that gives the poor man access to the legal system is not regarded by physicians as an enlightened measure but as a cause of exposing their colleagues' ineptitude. Perhaps there is also fear that the contingency fee in law may set a precedent for the medical profession, and that patients may begin to refuse to pay fees when a case is botched. In any event, a certain wariness seems to have arisen in the medical profession about legal or judicial intervention in medical situations, with the single exception noted.

If a patient for whatever reason cannot speak for himself, a straightforward answer might be to have a court speak for him or designate someone to act on his behalf, even though courts are usually much more comfortable in areas relating to property and asset management. (3) Although medical decisions have traditionally been left to the patient or family and physician, courts have been increasingly -- albeit reluctantly--drawn into this area with the advance of technology and the accompanying ability to modify physiological processes. This trend has been accelerated by the tendency of our contemporary society to become more litigious.

The increased participation of courts in medical decisionmaking is not altogether bad. Courts generally throw light on a situation: hearings are held, witnesses are placed under oath, questions are asked, experts are cross-examined. This approach brings everything out in the open. Motivation, credibility, bias, and all the other factors important in evaluating each person's role in a decision can be examined in an impartial forum. Those involved in such situations should welcome scrutiny from an outside source, unless they have something to hide.

But as a practical matter, it would be cumbersome to hold a court hearing on every issue requiring a decision about a patient unable to decide for himself. Most such decisions are fairly straightforward. The assumption is fair that a person found unconscious would like to be restored to consciousness. No one troubles unduly about getting consent to give glucose to a comatose patient in order to restore him to normalcy. But problems arise as the procedures grow more complex. Suppose, for instance, that a brain biopsy is thought necessary in a patient with some apparent mental impairment, but no family is available to give consent. Recourse to a court might be unwieldy, time-consuming, and, for that matter, expensive. Some method of divining the patient's intent seems advisable. As with so many things medical, the literature provides an avenue of recourse. Dr. Loren H. Roth and his colleagues developed some tests of competency to be used in situations in which consent is needed for a procedure in the patient with ostensibly impaired cognitive ability. (4) One of the important considerations in evaluating the patient's ability to consent is the risk-benefit ratio. If the benefits, in the judgment of the evaluator, clearly outweigh the risks, then the assent of a patient in a mentally impaired state can be inferred. The case can be pushed further. What if, after brain biopsy, a cytotoxic drug is indicated. Again, the physicians can make the judgment that the patient's assent is valid and proceed if the benefits outweigh the risks. If the patient refuses permission in a case where the risk-benefit ratio is so pronounced in his favor, this would present a different problem.

What is noteworthy about this approach is that it maintains the appearance of patient autonomy, while in effect shifting the real decisionmaking to the phsicians. It is they who make the risk-benefit analysis and decide what is and is not in the patient's best interest. They come to the conclusion that the patient would or would not profit by a particular course of action. The risk-benefit calculation gives credibility to a decision that, if only the patient's mental condition were considered, might appear to be beyond his capacity to make. Like the dummy in a bridge game, the patient has had his cards turned up, and someone else, the physician, plays his hand for him.

Given such situations, what is the alternative? Something is needed for a patient's benefit when circumstances prevent the usual informed consent. Putting risk-benefit into determinations of mental ability to consent enables diagnosis and treatment to proceed without the laborious, time-consuming process of going to court. Using risk-benefit to bolster a possibly incompetent patient's decision is especially alluring if one has a basic distrust of court process. However, this approach to the problem has implications beyond situations in which a patient requires some obvious intervention that has clear beneficent effects. As a precedent, extended to other situations where risk-benefit is more debatable, it has another aspect. Carried to conclusions its proponents probably never contemplated, it amounts to a Trojan horse in the fortress of patient autonomy, otherwise a bulwark of our civilization and law.

It has become customary, in discussing whether to treat patients, to introduce issues related to "quality of life." In the assessment of...