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Informed Consent. Effective Communication: A Necessary Pre-requisite?
Des McMahon B.C.L., 4th year Medicine
"Good communication is not just an esoteric theoretical objective, nor is it just about becoming a more understanding and approachable doctor (though that is a likely bonus). It is about being a more efficient doctor. Communication is, to put it simply, the key to effectiveness for the doctor as a professional."1
Most medical students approach their training with a desire to help people, and look forward to clinical involvement – to meeting patients and learning to interact effectively. After qualification, most doctors spend a great deal of their working time communicating with patients: explaining, listening and responding.1 If doctors are to be truly successful in their work, then this process of communication is essential. It is central to most of the aspects of doctor patient interaction, but effective communication is of particular and vital importance in the field of informed consent.
Informed consent, What is it?
The law has long recognised the principle that every person has the right to have his bodily integrity protected against invasion by others. The seriousness with which the law views any invasion of physical integrity is based on the strong moral conviction that everyone has the right of self determination with regard to his body. Only in certain narrowly defined circumstances may an individual’s bodily integrity be compromised without his consent, e.g. lawful arrest, self defence.2
In medical treatment every touching of the patient is potentially an invasion of this bodily integrity. It is the patient’s consent – either implied or expressed – which makes this touching legally innocuous. Consent may be implied in certain circumstances (for example the unconscious patient brought to Accident & Emergency), but it is proposed to concentrate here on the more usual and common situation where consent must be sought and obtained.2
The classic expression of this legal requirement to obtain the consent of a patient was given in a judgement by Cardozo J in a case brought against a New York hospital in 1914:
"Every human being of adult years and sound mind has a right to determine what should be done with his body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages."3
The concept of patient consent has been considered by the courts over the years, and has been developed and expanded so that the notion of informed consent has come into usage. Consent must now be based on a knowledge of the nature, consequences and alternatives associated with the proposed therapy. These days a doctor or surgeon following the principles of good medical and surgical practice will do his or her best to inform the patient fully of the advantages and disadvantages, the risks, benefits and alternatives of any proposed course of treatment.4 Simply put, if the patient does not understand or appreciate the implications and consequences of a consent, or if all necessary facts have not been made available to him, then the consent is not an informed one.
Informed consent is more than a form; it is a process that includes:
Frank and open dialogue with patients is the most important step in the informed consent process, providing an opportunity for doctors to establish a rapport with, and engage patients in making decisions about their own care.
Educational pamphlets, videos, handouts, and pre/post-treatment instructions will help patients make an informed decision and remember what they have consented to should any complications occur. These materials are usually much easier for patients to understand and are less intimidating than most consent forms.
Obtaining written consent:
The consent form should provide written information that will help patients remember the risks, benefits, and alternatives that have been discussed. It also serves as documentation of the discussion which may prove useful in the future.
Informed consent – what is the legal requirement?
The law recognises that doctors owe a duty to disclose potential risks of complications when advising their patients in relation to medical treatment. But over the last decade, the Irish courts have disagreed over the appropriate test to determine the scope of this duty. Essentially either of two approaches may be adopted; one has been followed in the UK, while the second has been the test of choice in the USA and Canada. These approaches are as follows:
The professional standard approach:
This reflects the professional point of view. In this view, the health provider's responsibility is limited to the disclosures that a health professional, practicing as a specialist in the field, would make under the same or similar circumstances.
The "reasonable patient" approach:
This test reflects the patient's point of view. A patient-oriented standard of disclosure means that the health provider is required to disclose all facts, risks, and alternatives that a reasonable person in the patient's situation would consider important, in deciding to have, or not have, a recommended treatment.
The distinction may not seem important but strikingly different results can be obtained depending on the test applied. An examination of a few important legal decisions may serve to illustrate the difference between the approaches.
The celebrated North American decision of Cantebury v Spence 5 in 1972 was the first case internationally in which informed consent was fully articulated as a legal doctrine.6 The 19 year old patient (and plaintiff) had been suffering shoulder pain and it was suspected by Dr. Spence that the cause was a ruptured disc. A laminectomy was advised (the removal of a number of bony vertebral arches to expose the spinal cord), but some hours after the operation the patient experienced paralysis from the waist down. At the trial, it was argued by Dr. Spence that the disclosure of minute risks of complication was not sound medical practice since it potentially deterred patients from availing of necessary surgery. This was rejected by the trial judge who found that a doctor must disclose all risks which might materially affect the patient’s decision. In essence, the judge looked not at what was the accepted professional standard, but looked at the question from the patient’s perspective. He felt the patient had a right to know.
By contrast, The UK House of Lords had to consider this very question in 1985. They were hearing a case in which it was contended that the doctor owed a legal duty to his patient to inform him of all material risks in the course of a treatment, and that if he failed to do so, the doctor would have been guilty of a breach of his duty of care to the patient. In this case ("The Sidaway Case")7, the majority of the members of The House of Lords gave the following guidance on the law and practice in such cases:
"….An issue whether non-disclosure of a particular risk or cluster of risks in a particular case should be condemned as a breach of the doctor’s duty of care is an issue to be decided on the basis of expert medical evidence. In the event of a conflict of evidence the judge will have to decide whether a responsible body of medical opinion would have approved of non-disclosure in the case before him."
As can be seen the court did not examine the question from the point of view of what the patient felt he should be told, but accepted the considered opinion of experts in the field as to the professional standard adopted.
Which route have we chosen in Ireland?
The Walsh Case
The Irish Supreme court has only analysed the issue once, in 1992, in the case of Walsh v Family Planning Services & ors.8 In 1984 James Walsh, the plaintiff, then aged forty-four considered having a vasectomy. He had seen an advertisement in a newspaper by the defendant clinic, and he made an appointment. The plaintiff gave evidence that a doctor explained that the operation was painless and safe but emphasised that it was irreversible. His wife raised the question as to whether the operation would interfere with their sexual relations in any way. They were told that it would not; on the contrary, they were told that it could improve the situation for some people. The plaintiff said that the doctor had not warned him of any long term side-effects but placed emphasis on the fact that the operation was irreversible.
After the operation the plaintiff said that he felt "shattered" and that he was in pain. He rested for the next few days but continued to suffer pain, bruising and soreness. The bruising went after a number of weeks. Then he noticed that he got sudden pain on ejaculation, running from the left groin area and up his side. For the rest of that year he continued to have pain especially in the left scrotal area and the pain on ejaculation increased. He returned to the defendant’s clinic and on examination his left testicle appeared to be smaller and softer. Mr. Walsh continued to have a significant amount of pain, felt extremely tired and was unable to resume work. In April 1987, he had a left orchidectomy (removal of the left testicle). By August 1987, he said that his sex life had ground to a halt due to the pain that he felt on ejaculation. By that stage, he regarded himself as impotent. Expert evidence pinpointed Mr. Walsh as suffering from orchialgia, a known but exceptionally rare condition and one not properly accounted for as a consequence of vasectomies. There was no general and approved practice of warning patients as to its incidence.
It was found by the Supreme Court that the vasectomy had been carried out properly and without negligence. The resulting complaint was an unfortunate and rare, but unavoidable, side effect. The court did, however, have to decide whether Mr. Walsh should have been warned about the possibility of such an unusual potential consequence. The members of the court disagreed as to the test to be applied. The Chief Justice favoured the application of the‘professional standard approach’, while other members favoured the ‘reasonable patient test’. The Walsh case itself was not affected by this lack of agreement, as the case didn’t depend on this point. The Court was able to decide the matter on the basis that they accepted the defendants oral evidence and that Mr. Walsh had in fact been warned that long term pain could occur. Unfortunately the lack of agreement between the members of the court made it difficult for subsequent cases to isolate the dominant finding of law.
The Geoghegan Case
Following the Walsh case, the High Court appeared to be unclear as to which test to apply in such (informed consent) cases. A November 1994 decision applied the professional standard test, but a similar case a month later seemed to favour the reasonable patient model. Against this backdrop the High Court was obliged to tackle the question head on in 2000 in the case of Peter Geoghegan v David Harris.9 As a result there was a clear preference for the latter approach.
Mr. Geoghegan was missing 16 or 17 teeth, including many at the back of his mouth and was doing most of his chewing with his front teeth. In 1992 he decided to have dental implants. In essence, a dental implant is a pillar which is inserted into the jaw bone to constitute a post over which an artificial crown or bridge attachment can be fitted. The treatment is divided into three main stages. Firstly, the implants are placed in the jaw bone in an operation usually carried out in hospital under a general or local anaesthetic, depending on patient preference and the number of implants to be inserted. The second stage, six months later, involves a minor procedure carried out under local anaesthesia in which special titanium pillars (abutments) are attached to the implants onto which the tooth replacements are then fixed. The construction of the tooth replacements can usually be completed and fitted within six to seven weeks.
Following an examination, Mr. Harris (the defendant) informed the plaintiff that there appeared to be a shortage of bone at the site of one of the proposed implants. Mr. Harris explained how bone could be harvested from the plaintiff's chin to be placed at the jaw bone for the purpose of bedding-in and securing the implant. The operation was carried out, however, the plaintiff subsequently developed chronic neuropathic pain in his lower jaw. It transpired that the plaintiff’s incisive nerve had been damaged during the operation.
Mr. Geoghagan contended that Mr. Harris had assured him prior to the operation that the procedure would cause no pain whatsoever. He further contended that Mr. Harris had failed to warn him that the procedure could result in chronic pain. Mr. Geoghagan claimed that if he had been told that there was even a one in a thousand chance that such a complication could occur, he would not have consented.
The question became whether Mr. Geoghegan should have been warned about the possibility of neuropathic pain. It was a statistically very remote possibility (much less than 1%), yet was a known and foreseeable consequence of damaging a nerve. Ultimately, the judge favoured the reasonable patient test of disclosure. None of the expert witnesses testified that they would give such a warning, yet the judge found that Mr. Geoghegan had been entitled to one. This complication was not insignificant; it involved permanent pain. The judge found that in such an elective procedure, the practitioner must disclose all known risks, of grave consequence or severe pain, no matter how remote. He felt that such a test would ensure that the patient could make a "real" choice.
Is the standard of disclosure too onerous?
The decision detailed above in the Geoghegan case may initially appear harsh and unduly onerous on doctors. The following points however must be borne in mind:
The standard is a tough one so how do we get it right?
None of the above cases concerned patients of diminished cognitive ability, or cases when warnings were given but not understood. In each, there was a disparity between what the doctors thought they should tell and what the patients thought they were entitled to be told. A greater understanding of the needs and expectations of the individual patient may serve to bridge some of the gap. Such a greater understanding may be achieved by more effective and cooperative communication.
Traditionally, doctors honed their communication skills by trial and error in daily practice. Increasingly of late the need has been recognised for doctors to be trained both in the necessary communication skills, and the scientific basis for them.1 Specific training in communication skills for medical students is now almost universally recognised as essential. For example, a 1993 survey of British medical schools found that only one medical school did not provide a specific course in communication skills.1 However, it also found that only two schools had staff who were specifically trained for such teaching.1
Good communication between doctor and patient directly influence patients’ feelings of satisfaction after a consultation. Patients value a doctor’s openness, understanding of their expectations, and ability to handle their worries and concerns. Effective communication also affords a further important benefit.1 It makes it much less likely that dissatisfaction with the doctor’s professional services will end in litigation. No doctor is immune from making a mistake, but legal proceedings are more likely to follow when doctor/patient (or doctor/doctor) communication has been poor.1 The 1991 report of the NHS ombudsman, in the UK, stressed that 90% of the cases dealt with stemmed from failures of communication rather than poor medicine.1
The standard required is not going to be the same in each case, and it is going to be essential to communicate meaningfully with each patient to establish his respective communication needs. Patients’ wishes play a role. Many patients will indicate that they wish to leave all decisions to the doctor, and in these cases the obligation to inform will generally be very different from that in which a patient asks for information about the proposed procedure, or any alternatives.10 Where the proposed procedure is thought to be essential for the patient’s health, the obligation to disclose information about, for example, the risks involved, will generally be much less than it is where the procedure is not essential.10 There may be instances where as a matter of medical knowledge, notwithstanding substantial risks of harmful consequence, the carrying out of a particular surgical procedure is so necessary to maintain the life or health of the patient, and the consequences of failing to carry it out are so clearly disadvantageous, that limited discussion or warning concerning possible harmful side effects may be appropriate and proper.10
On a practical note, putting systems and procedures in place to ensure patients get the information they are entitled to will help. For example, in elective procedures the preparation of a written explanation sheet which the patient may be given at the first consultation will help. They will then have time to re-read it and consider it before consent is sought. In such cases consent discussions can take place at a second consultation before admission to the hospital.
Commenting on his own particular field of cardiothoracic surgery, Professor G.H. Smith MB FRCS advised that
"units practising in the area should be aware of the general difficulties of obtaining consent which is truly informed and should have organised a system which will reduce the possibility of providing insufficient or poor information. There can be no acceptable alternative to the surgeon who is going to perform the operation to be responsible for obtaining the patient’s understanding and written consent to the proposed operation. If that surgeon is not the consultant in charge of the patient, then the consultant must make the opportunity to talk to the patient as well." 4
The following details may serve as an example of the type of information appropriate for an information sheet:
Why ensure the patient is fully informed?
In contemporary practice, more and more patients want to be involved in decisions about their bodies, and to participate intelligently in their own care and treatment. This is a consequence of better health education and improved health consciousness among the public. It is not only inevitable but desirable.1
However acquiescent patients may have been in the past, or may have been expected to be, in contemporary practice many patients expect to be given a full account of their condition and to be asked for their consent in relation to all decisions relating to the provision of health care to them. This is a natural result not only of better public education about health, but also of prevailing social attitudes about the autonomy of the individual.1
We should ensure effective communication and informed consent, not because we are legally bound to, but because both we and our patients desire it and are entitled to it. It is a vital and necessary part of the job.
1. Talking with patients, Keys to good communication. Myerscough & Ford, Oxford Medical Publications (1996)
2. Law and Medical Ethics. Mason & McCall Smith. Butterworths 1994.
3. Schloendorf v Society of New York Hospital 103 NE 92 (1914) at 92-93
4. Medical Negligence, Powers & Harris. Butterworths 1990
5. Cantebury v Spence 464 F 2d 772 (1972)
6. Medical Negligence: Common Law Perspectives, Healy. Sweet & Maxwell 1999
7. Sidaway v Bord of Governers of Bethlem Hospital and the Maudsley Hospital  AC 871
8. James Walsh Family Planning Services Ltd & ors  IR 496
9. Peter Geoghegan v David Harris  IR 536
10. Irish Medical Law, Tomkin & Hanafin. The Round Hall Press 1995