A variety of forms can be utilized to help provide the patient with the necessary information regarding his diagnosis, hospitalization, and recovery (Appendix 3). While brochures prepared by professional firms and various agencies are available, it is a relatively simple thing for surgeons to prepare such forms themselves. The forms are then more likely to be fully pertinent. Such information, however, should never be considered a substitute for direct communication between the patient and the surgeon. While patients do, to varying degrees, want to know technical and practical details, what they must know without doubt is that they trust their surgeon. That trust is the consequence of the patient having an unwavering belief that the surgeon unquestionably intends to be of benefit to the patient. The patient knows that if such sincere intent is present, the surgeon will require himself or herself to act competently. When the provision of brochures, or discussions with paramedical personnel, lead the patients to feel that those brochures or discussions are primarily to save the surgeon time and to avoid personal responsibility, they actually decrease the patient’s trust.

Informed consent or informed choice

‘Informed consent’ involves important medical and ethical considerations as well as the more strictly legal ones 1. The following discussion will deal primarily with the ethical aspects of informed consent, with the meaning of the phrase, and with its importance for the patient, the physician, and the medical profession2,3,4.

Informed consent is in many ways at the heart of all good systems of medical and surgical practice. It essentially means that the patient appropriately understands the risks and the benefits involved in a proposed procedure. Such understanding demands knowledge and discussion. It also requires a two-way contract between the patient and the surgeon. The enhancement of such knowledge, such discussion, and such contracts may be the best way to ensure high quality medical care.

In the Commonwealth of Pennsylvania informed consent is defined as ‘the consent of a patient to the performance of health care services by a physician or a podiatrist, provided: that prior to the consent having been given, the physician or podiatrist has informed the patient of the nature of the proposed procedure or treatment and of those risks and alternatives to treatment of diagnosis that a reasonable patient would consider material to the decision whether or not to undergo treatment or diagnosis.’

Exceptions to the rule exist, and the law states that physicians will not be held liable for failing to obtain informed consent in the following circumstances:

• In the case of an emergency which prevents consulting the patient

• When furnishing the information to the patient would have resulted in a seriously adverse effect on the patient or on the therapeutic process, to the material detriment of the patient’s health

• In the case of a minor, when in the physician’s judgment an attempt to secure the consent of the parent or legal guardian would result in delay of treatment which would increase the risk to the minor’s life or health.

Consent for the treatment of minors should be obtained from the patient’s parent or guardian, although exceptions may be made if the minor is (a) 18 years of age or older; (b) one who has graduated from high school; (c) one who has married; or (d) one who has been pregnant.

Informed consent is not merely the obtaining of a signature on a piece of paper. In fact, the act of having a patient sign a written consent for surgery unfortunately sometimes serves as a means to avoid obtaining truly informed consent 5.

The form can improperly substitute for the actual consent. This is rather like the practice of going to church in order to avoid the more difficult responsibilities of being a participating member of a religious faith.

Some physicians appear to believe that the major purpose for obtaining a signed ‘informed consent’ is to prevent malpractice suits. The extreme mental and emotional stress that often accompanies such lawsuits makes prevention of them a deservedly important goal. However, simply because a patient signs a form stating that he or she gives permission for a particular operation does not eliminate the chance that the patient will institute litigation 6–10. Patients may state at a later date that they did not really understand the form. Misunderstandings cannot be avoided. Some individuals hear only what they want to hear. In fact, it has been shown that patients forget more than they recall the information given to them preoperatively11–13. A properly executed informed consent may provide protection for the surgeon or institution at a later date. However, an informed consent form in itself will not effectively prevent malpractice suits from being filed14,15.

On the other hand, the process of obtaining true informed consent – that is, the meaningful interchange of information, anticipations, hopes, and fears that should precede a request for the patient to sign any form – does help limit the likelihood that suit will be brought at a later date 6–10. It must be remembered that the form is only documentation of the discussion; the form is not the consent.

Some patients, of course, will bring suit even when the physician has been expert, thorough, and caring in obtaining informed consent. There is, then, a secondary reason for obtaining informed consent, for a properly executed consent form may provide essential protection for the surgeon or his or her institution at a later date.

Failure to obtain adequate informed consent is not the basis for many malpractice claims, usually less than 2%16–18. Most plaintiffs’ lawyers plead lack of informed consent as a last-resort allegation in weak cases, and do not as a rule use it as a primary charge against a negligent doctor.

The overwhelming reason lawsuits are brought against physicians is because the patients have unfulfilled expectations 6–10. Wise surgeons do not minimize risks or maximize benefits; wise surgeons make sure that patients’ expectations are realistic, being neither inappropriately bleak nor bright. Many forms of information, including electronic, are now available. They may provide highly valuable educational material, but patients may be misled and may come to expect unreasonable outcomes.

Paradoxically, there are risks to the patient in obtaining informed consent. The individual who stands to be helped by cataract extraction, for example, may decline surgery when he hears his surgeon say, ‘You may lose your eye.’ Information itself changes people’s moods and feelings. The suggestible patients who are fully informed of the difficulties that occasionally plague persons with otherwise successful surgery, such as a ‘dry eye’ following lid procedures or glare following cataract extractions may effectively, convince themselves that they cannot be rehabilitated. Were such individuals less completely apprised of the possible risks, they might have managed quite satisfactorily. Furthermore, though the situations rarely occur, some patients who are functioning well can become incapacitated when burdened with greater knowledge of their illness 19,20. We must remember that both the manner of obtaining informed consent and the information itself can be damaging to the patient. Importantly, however, it is almost never the specific risks that dissuade patients from having surgery. Rather, it is the manner in which the discussions are held. Some physicians use the obtaining of an informed consent as a means to avoid being held accountable for the outcome – legally or ethically. Patients sense this and lose trust. Also, some surgeons use discussions of ‘informed consent’ in hopes that their patients will elect not to have the surgery, thus shifting the cause for any future worsening of the patient’s illness onto the patient. Unfortunately, this shoddy approach to patient care is not rare.

The effects on the physician, and consequently on the patient, of a litigative climate also factor strongly. The anxieties produced in the physician by this situation are certainly not conducive to good medical practice 21–26. Having acknowledged this, however, it should quickly be added that surgical care should never be based solely on medicolegal considerations. Surgeons must in each case exercise their reasonable judgment based on their understanding of the case. This is not to say that the surgeon should be unaware of what is considered to be ‘standard practice’. The surgeon is in fact unlikely to be found negligent when practicing according to accepted standard. In a case in which the surgeon chooses to deviate from this standard, he should be aware that he is making such a deviation, be able to justify it, and indicate this to the patient. When standard care is not chosen, the proper concern is not whether litigation will ensue, but rather why such a deviation is in the patient’s best interest. The history of medicine makes it clear that standard levels of care are not always optimal levels of care. Conscientious physicians must constantly be evaluating the benefits and risks of the care they are offering. Often improvement in care will result only when deviations from that standard are made. Such alterations must be reasonable and in the best interests of the patient.

One of the prerequisites to obtaining informed consent is sufficient knowledge on the part of both doctor and patient (see Box 2.1). The physician must adequately understand the medical and surgical aspects of the case under consideration. He or she must also have a reasonable comprehension of the patient’s needs and wishes. Both the patient and the surgeon should compare the anticipated risks and benefits of not performing surgery. Not only must surgeons have an adequate knowledge of the medical aspects of the case, but also they must also be aware of their own motivations with regard to such questions as why they chose to perform or not to perform surgery. Surely the major intent of the surgeon is to make the patient better. However, the surgeon is subject to the full range of influences that affect human decisions, as well as physician-specific forces. Occasionally these may be of almost overwhelming weight. Included among these are: pressures from the patient or the patient’s family and friends, economic considerations, hope of acquiring new knowledge, curiosity regarding a new instrument or procedure, prestige associated with performing particularly difficult surgery, and the pleasure of conquering a difficult challenge. On the other hand there are considerations that may put pressure on the surgeon to avoid operating; these include concern that the surgery will damage the patient, timidity based on previous unfortunate experiences with similar surgery, worry that an unfavorable result will bring damaging litigation, unwillingness to perform a procedure with which the surgeon has not had extensive experience, and reluctance to refer the patient elsewhere because of economic or psychological reasons. To perform surgery is stressful and fatiguing. Where compensation for the performance of surgery is present, whether in the form of academic promotion, public acclaim or economic reward, the surgeon will be driven toward electing to do surgery. Conversely, where compensation is inadequate, or where the physician may be penalized for operating unsuccessfully, then the desire to perform surgery is greatly diminished27,28. The latter case is by no means necessarily preferable to the former. To deny a patient the possibility for improvement by means of surgery is just as unfortunate as to perform surgery when it is not likely to help. Patients have the best chance for receiving proper treatment when: (i) surgeons are adequately knowledgeable regarding both medical care and themselves, (ii) rewards and punishments are acceptable to both patients and physicians alike, (iii) and patients are knowledgeable enough to assess reasonably the quality of their care.

Some patients do not want to be informed. Occasional patients will articulate this, saying something like, ‘Doctor, don’t tell me anything, just do what you need to do.’ In such a situation it is usually best for the physician to try to explore why it is that the patient does not want to know. There may be a significant underlying emotional difficulty that in some cases may be of more importance than the patient’s ophthalmic problem. When the patient remains adamant about not knowing the surgeons may be reluctant to proceed with recommended treatment, recognizing that while they may have the patient’s consent, it is not truly an informed consent. Under such circumstances surgeons should, however, not delay in proceeding with what in their opinion appears to be the appropriate therapy. They may wish to put a note on the patient’s chart to the effect that the patient specifically asked not to be informed of the details. In most cases such a patient’s request should be honored, for the patient may well know himself better than the physician does, and may anticipate that a recitation of the risks of the surgery, even if done compassionately, might induce such fear that the patient would decide against doing what in fact would be in his or her own best interest. Such a patient may well prefer to trust completely the physician’s recommendation. Clearly such trust should never be exploited. But it should be honored. In such a case the physician should feel free to follow his own recommendations. In situations like this, one way the patient’s autonomy can be respected – which is the major reason for obtaining informed consent – is to say to the patient directly, ‘It seems you are having a great deal of difficulty deciding what to do. Do you wish me to make this decision for you?’

One individual’s feelings about informed consent are expressed in the newspaper article in Box 2.2. Perhaps because it is an everyday part of the physician’s life, perhaps because the physician is unaware of what is occurring, or perhaps for other reasons, physicians are not always cognizant of the absolutely central role they play in patient care. Physicians and surgeons have not been replaced by computers, or CAT scanners, or surgical microscopes. These technological masterpieces can occasionally actually hamper the doctor–patient relationship.

Box 2.2

A commentary by a patient that provides insights into how many patients want their doctors to interact with them

by Donald C. Wilson

The patient looks at his doctor

When I first took my as-yet undiagnosed cancer to my doctor I was laying a time-bomb in his lap. Now looking back on that encounter I know I have put an agonizingly demanding task before him. As I come to the realization of the probable course of this illness I find myself wanting two people from the one physician. I want a technical professional. That is, I want the best medical help available Second, I want a human professional. That is, one who will deal with me not as a disease but as a human.

Until recently that was an aspect of medicine that medical schools didn’t spend much time on. But with cancer’s reminder to medicine that it still has a long way to go, the human aspects of patient care loom large. When curing is beyond the physicians’ reach, caring moves to the front burner. It would seem then, that medicine is as much an art as it is a science.

From where I sit somewhere between the initial diagnosis and whatever the end may be, my respect for the medical profession is enhanced by what I have seen in the doctors with whom I have had to do. That experience has led me to some high expectations of the physician as a human professional. Specifically, from my doctor I have come to want five things. (The second part of this commentary is not included as it does not relate to the issues discussed in the present chapter.)

1 I want my doctor to be in touch with his own or her own feelings. Before he can be aware of what I am going through, he needs to be aware of his own experience, particularly, his experience of failure. For if my case is fatal, it does mark a defeat for all that he has been trained to do. He has defined his vocation as a healer, and as Dr. S.E. Adelman writes, cancer ‘defeats my whole picture of the world, in which I am all-powerful, defying disease, knowing more than the layman, initiate into the secrets of disease, immune to old fears and superstitions.’ His tools, his education, his support system, most important, his own expectations, have equipped him for success. The dying patient confronts him with guilt and with a painful reminder of his own mortality. If the patient is ‘brave’ the doctor may be able to suppress his emotions. But when anxiety breaks through the patient’s defenses, then his demands on the physician’s own involvement increase. I don’t expect my doctor to welcome failure, but I do need him to face it – and to go on with me from there.

2 I want my doctor to be in touch with my feelings. When, for instance, he is explaining the diagnosis I am apt to hear only what I am prepared to hear. As the doctor is tempted to deny, so is the patient. The psyche has a way of censoring its own intake. My doctor needs to know that he may have to go over the same ground at a later time. Parents recognize how selective children can be in listening to instructions: ‘I didn’t hear you tell me to clean the garage.’ So my doctor needs to know where I am when he is telling me.

In a deeper sense I want my doctor to be aware of my feelings. If there is anyone who has a greater stake in my case than the doctor, it is I. I want my doctor to recognize my role in our relationship. To the extent that my physician enables me to mobilize all the resources of body. mind, and faith, he is performing the highest arts of the healing profession. Norman Cousins in The Saturday Review (2/18/78) quotes Dr Gerald Looney of the Medical College of the University of Southern California: ‘Nothing is more out of date than the notion that doctors can’t learn from their patients. I teach my students to listen very carefully to their patients. That’s what good medical practice is all about.’ I suspect that as the course of the disease progresses and the patient’s ability to function independently becomes more and more restricted, it will become correspondingly essential for the patient to have a say in making decisions about those choices still open.

Next week we will look at three other areas of ministry that my contact with competent physicians has taught me to expect.

Dr. Wilson is a former pastor in Lancaster and has been ill with cancer for more than three years. This series of columns appears each Wednesday and Friday. Questions or comments may be mailed to Dr. Wilson in care of the Intelligencer Journal, 8 W. King St., Lancaster, Pa. 17604.

(Courtesy Intelligencer Journal/Lancaster New Era, Lancaster, PA.)

It may be helpful to consider obtaining an informed ‘choice’ rather than consent from the patient 11. The word ‘choice’ emphasizes that the person making the decision is the patient, and not the doctor!

In summary, informed consent (or informed choice) is an essential part of medical practice, for five rather different reasons. First, it is the physician’s ethical responsibility to be honest with the patient 29. Second, it is the patient’s right to make decisions regarding his or her destiny, and the patient is not in a position to do this without appropriate knowledge. Third, the process of obtaining informed consent is one of the most important practical ways of assuring high standards and improving quality of medical care. Fourth, the obtaining of an informed consent, or preferably informed choice, cements the doctor–patient relationship; it can reveal significant areas of misunderstanding or lack of trust. Dealing with these in a kind, caring and knowledgeable manner helps both the doctor and the patient understand each other better, leading to the firm bond that is essential to obtaining optimal care. Finally, the physician is legally obligated to obtain such consent30–33. It is important to remember that the basis of this legal requirement is society’s belief that the practice of obtaining an informed consent is societally necessary.