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Ethics of surgical innovation G. Gillett Otago Bioethics Centre, University of Otago Medical School, PO Box 913, Dunedin, New Zealand Clinical surgery typically aims to correct an abnormality producing an illness. The risks and varying bene®ts that result create an ethical imperative to try to improve surgical practice by research and innovation. Most operations are intellectually fairly simple. Surgeons remove lumps, relieve stenoses, alleviate pressure compromising function or causing pain, and eradicate infection. Sometimes the corrective intervention is so obvious in its effect that there is no uncertainty about its worth, for instance removing a subdural haematoma causing pressure on the brain, resecting a tumour obstructing the bowel, treating a septicaemia, or unblocking an artery. In such cases the clinician can see that he or she has done what was needed. However, in other cases, while the immediate effect is accepted as good treatment, the overall or long-term ef®cacy is less clear; carotid endarterectomy is an example. What is more, some surgical techniques are supported by theories that are subject to criticism, such as gastric ulcer surgery and radical mastectomy. In such circumstances trials must be done. Finally, some surgical innovations are technical improvements on accepted treatments. If an innovation is more than a technical improvement on an existing technique it may be regarded as a new approach to a problem. In such circumstances one can identify two possible situations. First, the aim of the operation in terms of correction of abnormal structure is itself well proven to be effective in treating the disease, for instance removal of a life-threatening tumour of the brain. Second, the aim of the operation has never itself been well proven but is a matter of accepted practice. In both cases the new technique should be compared with best current treatment. In the second situation it is evident that the currently accepted treatment should also be validated against no intervention at all to determine whether that treatment is advantageous to the sufferer of the disease or merely a sop to clinical activism. It is useful to compare the assessment of surgery using clinical trials to the phases of introduction of drug treatments. Phase I studies of drugs are comparable to investigations of safety in surgery; surgeons do not operate on healthy volunteers and so must show that no harm is done by an innovation in suitable patients. Some ancillary investigations, such as mechanical testing or testing in vitro, may be needed before this stage. Phase II studies of drugs are related to ef®cacy in a clinical situation and, because the interventions used in surgery are often introduced because they appeal to the `educated eye', a phase II equivalent may not be reached. Surgeons do not often ask whether correcting an obvious anomaly actually helps the patient. Surgical techniques, therefore, can move from safety testing direct to widespread clinical use on the basis of little more than intuition. This is far from satisfactory: a number of questions that ought to be asked when surgical innovation is being undertaken can be identi®ed. Is this operation a modi®cation of an existing and widely accepted treatment or an alternative to such a treatment? There has often been a gradual shift in operative technique for a given problem, such that it is a question of degree as to when a modi®cation becomes an innovation. A surgeon might do an operation in a certain way and believe that it is superior in technical terms to standard practice, but have neither good evidence that the standard practice is clearly bene®cial nor, by implication, that the modi®cation is a genuine improvement. Why was this modi®cation introduced? There are a number of reasons related to safety or ease of performing a procedure that lead to modi®cations. Some of these become accepted as reasons why the new method is better without any adequate testing as to whether, in fact, it is. One must ask whether a modi®cation is likely to introduce signi®cant new risks and answer that question by careful monitoring of cases in which it is used. Should a prospective randomized double-blind con- trolled trial be done? Such a trial requires the investigator to be in a state of equipoise. Equipoise means that the investigator has no valid reason to believe that using one or other of two treatments will confer any advantage. In surgery, however, disturbances of equipoise may be based not only on clinical outcome but on factors proximate to the surgery pain, time of operation, worries based on the `educated eye'). Because of this it has been suggested that something like the principle of uncertainty might be a better way to go for surgeons 1 . This allows the doctor to re¯ect on the standard of evidence he or she has for the beliefs held and, where the evidence is inconclusive, to participate in a well designed trial to address the uncertainty. The dif®culties with randomized and blinded trials of surgical techniques are well known. First, the surgeon has usually introduced the modi®cation or new technique for a good set of reasons so that he or she is not in a state of equipoise, Leading article ã 2001 Blackwell Science Ltd British Journal of Surgery 2001, 88, 897±898 897

Ethics of surgical innovation

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