Informed consent: lessons from Australia

BMJ 2002; 324 doi: http://dx.doi.org/10.1136/bmj.324.7328.39 (Published 5 January 2002)
Cite this as: BMJ 2002;324:39

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EDITOR--Skene and Smallwood seem prescient.1 The Court of Appeal, unanamously has upheld the lower court's ruling in Chester v Afshar2 in which it followed the Australian High Court case of Chappell v Hart.3 In both cases, the surgeon was held to have a duty to warn which was breached. The failure to warn resulted in the patient deciding to have an operation in which she was injured, and in each case the surgeon was liable for damages.

This would seem especially applicable in all cases in which the surgery is elective, such as male circumcisions. Male circumcisions frequently cause permanent injury to sexual functioning,4 because of the excision of great amounts of skin and erogenous mucosa from the penis,5 yet few, if any, surgeons warn patients of this probability. One would expect that this information would deter many patients from undergoing this elective surgery if the facts were fully disclosed.

Although the court of appeal has adopted a tough new standard for Britain, the American standard of disclosure is even more rigourous:

"...Thus, before obtaining consent to a medical procedure, a physician must provide adequate information to the patient in a manner that the patient can comprehend. "Adequate" means the amount and kind of information that the average person in the patient's position would want to have in reaching an informed decision. Typically this means that the clinician must fully explain the proposed procedure, the expected short-term risks and long-term consequences, the available alternatives and their risks and benefits and the consequences of declining or delaying treatment. The patient should be made aware of both short-term costs - for example pain, length of confinement in a hospital, recovery time and potential complications. - and long term costs - such as loss of functioning, restriction of activities and physical scarring. In general, the test "for determining whether a potential peril must be divulged is its materiality to the patient's decision." Physicians must disclose all material information, that is, all "information which the physician knows or should know would be regarded as material by a reasonable person when deciding to accept or reject a recommended medical procedure." Importantly, the physician has an obligation to provide all significant information that is available, even if he or she were previously unaware of it. In other words, the duty of disclosure entails an obligation on the part of the physician to acquire information as it becomes available...." 6

No court in Britain has followed this American standard. It remains to be seen if this standard will ever be adopted in Britain. However, the standard for American practitioners is clear.

George Hill
Executive Secretary
Doctors Opposing Circumcision
Suite 42
2442 NW Market Street
Seattle, Washington 98107
Web: http://www.doctorsopposingcircumcision.org/

References:

    2002;324:39-41

Competing interests:   None declared

Competing interests: E

George Hill, Executive Secretary

Doctors Opposing Circumcision, Suite 42, 2442 NW Market Street, Seattle, Washington, 98107, USA

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To the Editor.

I recently came across an article published in the Journal - Informed consent: lessons from Australia.1 This well researched article, outlines various recent changes in Australia as to what constitutes "informed" consent, and in particular noting the abandonment of the "Bolam test"2, which held that practitioners are not negligent if they acted in accordance with practice accepted by a responsible body of medical opinion. Unfortunately, the article contains a gross factual error which, given that the topic is currently the subject of much debate within the medical and legal professions, both here and in the United Kingdom3, I feel the error should be corrected.

The authors claim that the Australian High Court held that a procedural specialist - however well qualified - has a duty of care to advise patients before undertaking the procedure, that there are other, more senior colleagues who have undertaken the proposed procedure more frequently, and hence have greater experience. Failure to tender such advice, the authors claim, deprives the patient of "informed consent", and will be held to be negligent if a recognised complication arises: ( "... patients who required surgery that could safely be delayed, such as a patient who needed surgery but could have reduced the risk by taking time to consult a more experienced surgeon if she had been told about the risk"). The authors cite the decision in Chappel v Hart4 for this exotic proposition.

In that case, an expert witness for the plaintiff claimed in evidence to have performed the particular procedure many times without a single incidence of the complication which the plaintiff suffered (mediastinitis), which was the subject of the action. However, the unchallenged evidence in the case established that the defendant surgeon had carried out the procedure with skill and competence, leading one of the judges - McHugh J - to state: "I do not think it is possible to read Prof Benjamin's evidence as asserting that either he or other unidentified surgeons could perform the procedure with greater care or more skill than the defendant ordinarily performed it." It is submitted that on that finding, some stray observation by two judges in the case - seized on by the authors in support of their assertion - are clearly obiter and not part of Australian law.

What the case did decide is that had the patient been warned of the possible complication of mediastinitis, she would have decided against the operation. Her claim therefore succeeded. And that, of course, has been the law for some time.

P Gerber
Hon Reader, Dept of Community Medicine
Medical School, University of Queensland, Herston, Australia

1 BMJ 2002; 324: 39-41.

2 Bolam v Friern Hospital Committee [1957] 1 WLR 582.

3 cf Lord Scarman in Sidaway v the Maudsley Hospital & Ors [1985] 2 WLR 480 (House of Lords)

4 (1998) 195 CLR 232

Competing interests: None declared

P Gerber, Hon Reader, Dept of Community Medicine

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Like Alex Mirnezami(1), I found Skene and Smallwood's article about recent changes in case law relating to informed consent very worrying(2). It was particularly worrisome to me, as I have recently returned from two years working in Australia as an anaesthetist.

In Australia, it was clear to me that highly informed patient consent for surgery and anaesthesia, as described by Smallwood and Skene, in fact rarely took place, at least in public hospitals. Alex Mirnezami(1) and Peter Young(3) have nicely described many of the reasons why this would be the case.

The result is that doctors are daily playing Russian Roulette by inadequately discussing all 'reasonable' risks and their incidences with every patient. A patient only has to suffer an adverse outcome which they believe was not adequately discussed beforehand (or at least believe that they can convince a court that this was indeed the case) in order to pursue a negligence claim.

Unfortunately, despite the absurdity of this situation in medical and NHS terms, we as doctors have little influence over legal rulings. The situation needs clarification from the Department of Health and from the legal advisors to the Medical Defence organizations. The public at large must be informed that every medical procedure carries an element of risk, even if no-one does anything wrong!

If no action is taken, the millions the NHS is already spending an litigation costs(2) will continue rising exponentially. The arguments are becoming compelling for instituting a no-fault compensation system for victims of medical complications.

Competing Interests: None

References:

1. Mirnezami AH. The impractical nature of informed consent. bmj.com/cgi/eletters/324/3728/39

2. Skene L. and Smallwood R. Informed Consent: Lessons from Australia. BMJ 2002; 324: 39-41 (5 January)

3. Young PJ. What is reasonable informed consent? bmj.com/cgi/eletters/324/7328/39

Competing interests: None declared

David J Campbell, Consultant Anaesthetist

Brighton Healthcare BN2 5BE

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To the Editor

I read with interest the article by Skene and Smallwood outlining the risks doctors must disclose to patients prior to treatment1. There is a shift from what a “reasonable body of doctors” to what “a reasonable body of patients” might expect to be told. As ever these changes seem, at least in part, to be driven by case law. The case of Rogers v Whitaker is cited where an ophthalmologist failed to mention the possibility of sympathetic ophthalmia, a rare (1:14000 risk) but devastating condition, following eye surgery. A patient unfortunate enough to suffer this complication would perhaps retrospectively feel that if they had known that there was such risk they would not have consented to the operation. If I am obliged to inform all patients of such rare occurrences, then 14000 patients will be worried pre-operatively for each complication occurring. This and other such rare complications may never have been seen in many district hospitals. Some patients may refuse the benefit of surgery due to a failure to understand the concept of risk. It appears that some sections of the public and the media assume that only (an unattainable) no risk is acceptable.

I believe that patients equally have the right not to know about rare serious complications and some complications should only be discussed if specifically asked for by the patient. During patient consultations following discussion of consent I use a sentence such as “ there are of course possible serious complications but because of their rarity I don’t usually discuss these in detail unless specifically asked”. This gives the patient the opportunity to choose the details that he or she wishes to hear.

If I were to discuss the rare risks of anaesthesia, my patients would be presented with a myriad of possible frightening complications to mull over during their wait for theatre. Following discussion of post-operative pain, nausea and sore throat do I need to mention tracheal stenosis or even unrecognised oesophageal intubation leading to brain damage or death? Should I carry the handy patient information inserts documenting the side effects of the half dozen or so drugs that I will be using during the procedure, and also the inserts for the few hundred drugs that I may need to use? The intravenous cannula may bruise, cause extra-vasation, become infected, cause arterial damage, accidental intra-arterial injection or nerve injury. There are over ten complications of the central venous catheter that could lead to injury or death. The discussion of the possible complications of the blood that may need to be given will be both time-consuming for the anaesthetist and worrisome for the patient and that’s before I begin with the crystalloid/colloid debate. The epidural might well improve both post-operative analgesia and mortality but may cause hypotension, and headaches, and rarely cause nerve injury or paralysis. The arterial cannula that might be required could lead to loss of the limb. The urinary catheter might cause strictures, paraphimosis and urinary tract infections. If I am able to secure a post-operative high dependency bed then should I discuss in detail hospital acquired infections, “superbugs”, occasional drug errors and the possibility and risks of early discharge to the ward if the bed is required for a more needy patient? Following the discussion of anaesthetic related risks, the surgeon will then need to discuss in detail the surgical risks.

Some patients will wish to know everything and have the right to this information. However, experience shows that some patients still put faith in the character, education and experience of their doctors and nurses. The provision of patient information pamphlets to supplement verbal consent discussions allows the patient the choice to extract only the information that they wish to see. This would be more appropriate than forcing a mass of unsolicited and potentially frightening information onto those patients who do not want it.

1. Skene L, Smallwood R. Informed consent: Lessons from Australia. BMJ 2001;324:39-41. (5 January.)

There are no competing interests.

Peter J Young MD FRCA
Consultant in Anaesthesia and Intensive Care

Competing interests: None declared

Peter J Young, Consultant in Anaesthesia and Intensive Care

Queen Elizabeth Hospital, King's Lynn, PE30 4ET

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Editor- I find Skene and Smallwoods account of the changing nature of case law regarding informed consent exceptionally alarming.1

The implications of these changes are truly considerable. Modifying the Bolam test to refer to "the reasonable patient" rather than "the reasonable doctor" or the "responsible body of medical opinion" makes the issue of what information doctors must provide to obtain informed consent truly impossible. How can any medical professional obtain consent for any procedure when a "reasonable patient" would want to be informed of risks as unlikely as 1:14000 (Box 2 in their article)? Moreover, they state that doctors cannot "discharge their duty by providing pamphlets about proposed procedures". Waghorn and Mckee however, have shown that almost one third of patients attending surgical outpatients would have liked an explanatory leaflet, so it would appear that while patients find leaflets useful and they aid doctors in their explanations, they do not provide an adequate defence in the eyes of the courts.2

To add to the difficulties, recently Ellis noted that patients raise claims against surgeons for complications of complications as well.3 Thus over a five-year stretch, 10% of complaints dealt with by the MDU as a consequence of laparotomy were due to the complaints of pain, dyspareunia, and infertility, all consequent to intra-abdominal adhesions. So although many doctors would quite logically warn patients of adhesions as a complication of a laparotomy, not many would see the need to warn about complications of adhesions in themselves.

Another point that we must not forget is that no matter how long a list of complications (and perhaps complications of complications) we must mention to patients, for a proper informed consent the patient must clearly understand what these risks may mean for him or her should the unfortunate happen and this by its very nature necessitates much more than a simple mention of the list of complications.

In their paper, Skene and Smallwood also emphasise the importance of good note taking, stressing that doctors cannot rely on evidence of their "usual practise" for their defence. Thus not only must an exhaustive list of complications and complications of complications be described, one must also document each and every one of them in the notes it would seem.

Of course the answer to these difficulties are alluded to by the GMC in the booklet Seeking patients' consent: The ethical considerations, and involves doing "your best to find out about patients' individual needs and priorities". 4This statement however clearly does not do justice to the magnitude of the problem we are facing. Doctors cannot read the minds of patients and I doubt if it possible for doctors (other than general practitioners) to reliably get to know their patients (in ever shortening consultation times) to such an extent as to be able to make decisions regarding which risks the patient may or may not want to know about. And would many patients turn down the opportunity to claim against complications they were correctly not warned about should they occur, particularly with ever increasing incentives to pursue claims such as "no win no fee" offered by many legal representatives?

The lack of clarity and common sense in all this is deeply troubling for trainees like myself let alone for consultants and general practitioners on the frontlines. If we are to tackle endemic problems such as low morale, and difficulties in recruiting and retaining doctors, our representative bodies must address such problems as fully as possible. With the NHS already facing a bill for almost £4bn to address clinical negligence claims, it would also make sound financial sense. Whilst I would never condone the paternalistic type of consent common in the past, I wonder if we are going too far and leaving common sense behind? Perhaps with more thought to the problems we might yet find a happy medium between the "reasonable doctor" and the "reasonable patient"…

Alex Mirnezami
MRC Clinical Research Fellow
University Surgical Unit, Mail point 816, Southampton General Hospital, SO16 6YD.
Email: ahm@soton.ac.uk

Competing interests: None.

References

1. Skene L,.Smallwood R. Informed consent: lessons from Australia. BMJ 2002;324:39-41.

2. Waghorn A,.McKee M. Understanding patients' views of a surgical outpatient clinic. J.Eval.Clin.Pract. 2000;6:273-9.

3. Ellis H. Medicolegal consequences of postoperative intra- abdominal adhesions. J R Soc Med 2001;94:331-2.

4. General Medical Council. Seeking patients' consent: the ethical considerations. London: 1998.

Competing interests: None declared

Alex H Mirnezami, MRC Clinical Research Fellow

University Surgical Unit, University of Southampton, Southampton General Hospital, SO16 6YD

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18 January 2002

Levelling the playing field

Editor – An audio or video tape of the doctor/patient consultation would obviate many of the disputes identified by Skene and Smallwood. (1) Sadly some doctors have argued that this would undermine patient trust. Nonsense. It would provide both parties with the same physical evidence of who said what to whom.

Just as importantly, the institution of the practice would support the Department of Health’s new Good Practice in Consent announced in the NHS Plan. The objective is to improve communication, understanding and thus genuinely informed agreement to treatment. All NHS Trusts have to implement the procedure and new consent forms by 1 October 2002.

Roger M. Goss
Director – Patient Concern

(1) Skene L. and Smallwood R: Informed Consent: lessons from Australia. BMJ 2002; 324: 39-41 (5 January)

Competing interests: None declared

Roger M Goss, Director

Patient Concern SW5 9FY

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Dear Editor,

Skene and Smallwood illustrate the extent to which failure to stay abreast of current opinions on informed consent may be a source of future medical negligence claims against many doctors. One of their key points is that information provided should be based on what a reasonable patient might expect, rather than what a reasonable body of doctors might think1. In addition the article recommends that risks should be quantified objectively (by the use of percentages, or ranges of figures) rather than describing them subjectively as ‘small’, ‘slight’ or ‘rare’.

Pharmaceutical medicine, like most branches of medicine, is not an exact science. Phase 1 clinical trials are primarily concerned with ascertaining the safety, tolerability and pharmacokinetics of medicines, many of which have never been administered to humans before (new chemical entities or NCEs). There are strict guidelines regarding the conduct of these trials and regular audits are performed to ensure that these are adhered to. Consequently documentation of consent regarding participation in phase 1 clinical trials is complex. However, since by definition there is no clinical data regarding the incidence of adverse events for NCEs, risks cannot be quantified objectively. Some extrapolation from animal data may be possible but quantification of such events may be erroneous and potentially misleading. Is it therefore more appropriate to retain subjective descriptions regarding the likelihood of adverse reactions with NCEs until objective data is available? A further problem exists, however when trying to compare incidences of adverse events between different populations. Thus, if a drug has a particular incidence of an adverse event in healthy volunteers, it does not follow that the same drug will produce the same adverse effect with equal incidence in the target patient population. Indeed, such extrapolation may again be misleading.

At present, we update our consent documentation to ensure that volunteers participating in such trials are in possession of current information. The most recent version of the consent document is clearly marked with any changes to previous versions discussed with volunteers. Would it be possible to conduct a similar system in hospital medicine, for endoscopies or surgical procedure for example? Consent forms would be identified with a version number detailing the latest local audit results and subsequently updated when new data becomes available. Consent on old version forms would not therefore be a reflection of current risks associated with the procedure. In this way both physicians and patients could be kept up to date with local practices.

1 Skene L, Smallwood R. Informed consent: lessons from Australia BMJ 2002; 324: 39-41. (5 January.)

Yours sincerely,

Julian Dimech
Pharmaceutical Physician
Covance Clinical Research Unit Ltd, Springfield House, Hyde Street, Leeds LS2 9NG
Email: julian.dimech@covance.com

Competing interests: None declared

JULIAN DIMECH, Pharmaceutical Physician

Covance Clinical Research Unit, Springfield House, Hyde Street, Leeds, LS2 9NG, UK.

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The paper on consent by Skene and Smallwood clearly reflects the ascendant and currently dominant position of the ethical principle of (patient) autonomy, the right to self-determination, over the previously held superior ethical principle of (medical) beneficence which could be loosely interpreted on occasions as paternalism. Such changes in position of these ethical principles have a significant consequence of how patients, healthcare professionals and lawyers interact. There is a consequence of such a change in position. One cannot have control of a decision and associated power, yet abrogate the responsibility when things do not occur as hoped, planned or perceived.

Decision making (the legal capacity test) sits at the heart of consent. English law presumes that all adults have capacity. If the patient has been provided with quality information in an appropriate style befitting the patient then they can offer a decision based on that knowledge - "knowledgeable consent". However, when exercising their autonomy, patients and their advocates must accept the responsibilities that go with these decisions. Such responsibilities include the consequences of that decision, which may include events that transpire, and are against the hopes of the patient, so-called adverse events. Those who advocate for patients, and patients themselves, need to be aware that the use of autonomy as a leading ethical principle carries these heavy responsibilities. Patients, their advocates and the courts cannot have it both ways; with appropriate information concerning consent (knowledgeable consent) the patient's decision, and any consequences flowing from that decision, must include responsibility for that decision. Consequent events are not necessarily the responsibility, or fault of, healthcare professionals or healthcare unless clinical negligence has occurred.

Competing interests: None declared

Jeffrey C McILwain, Consultant, Clinical Risk Management

Whiston Hospital, Prescot, Merseyside L35 5DR

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To the Editor;

Putting patients’ rights in proper context in modern health systems is a main concern nowadays worldwide. Aligned with this trend, a growing number of countries (e.g. Finland, Iceland, Denmark, Hungary, Israel) have enacted patients’ rights Laws, assuming it will empower patients’ rights, clarify heath-care providers legal duties and collectively improve patient -physician relationship. This contentions still need to proved, as many physicians feel the legal system is unfairly biased, taking patients’ side, ignoring the over-complexed modern medicine, the every-day hardship of practicing medicine, lack of funds and more. Nevertheless, if one is to engage in such legislation, it is worthwhile to explore the implementation of the legal regulation by the main addressee of such a law – the physicians.

A recent study [1] pointed out the fact that doctors seem to regard such laws as another negative expression of patient-physician relationship transformation, changes attributed partly to the development of autonomy concepts, consumers’ attitudes, and frequent malpractice litigation. Their proficiency of the Law was poor - 96% of physicians failed to answer correctly more than 2 out of four multiple-choice questions. In order to encourage a real impact of Patients’ Rights Laws on health care delivery, proper methods should be used to ensure physicians’ collaboration. It should start in Medical schools. As reported by Doyal and Gillon [2], Britain’s GMC recommended a radical reform of medical education. In it, medical law and ethics are to become core components of the curriculum. Furthermore, teaching health law and ethics should be pursued throughout one’s entire medical career (e.g. CME programs). It is of great importance to include a comprehensive survey of international /European declarations and conventions on human rights and patients’ rights, and World Medical Association statements and declarations. Modern methodology should be applied, in order to promote active learning.

Improving communication skills to improve patient-physician relations need to be addressed [3]. These needs require multidisciplinary input by communication and pedagogy experts.

Additionally, legislation should be initiated and followed by the assistance and collaboration of appropriate medical associations to enable meaningful implementation of Patients’ Rights laws. As stated by Cook and Dickens: ”The credibility of law often depends on the respect it enjoys among those expected to obey it, since there are limits to the ability of non-military governments to enforce their will by coercive means. The habit of popular obedience to rules depends on their general acceptability.”[4] Likewise, The need for public’s education should be addressed. Augmenting patients’ knowledge of their legal and ethical rights will encourage a more up-to-date patient-physician relationship. This in turn will require, among other tools, accessible patient advocates and advisors to help realize patients’ autonomy and health-care providers’ participation and proper conduct. We should all strive for an ameliorated relationship among the partners, while rendering medical services.

[1] Siegal G. et al.Physicians' attitudes towards patients' rights legislation. Med Law. 2001;20(1):63-78

[2]Doyal L., Gillon R. Medical ethics and law as a core subject in medical education. British Medical Journal 1998: 316: 1623-4.

[3] Parker MH, Price DA, Harris PG. Teaching of medical ethics: implications for an integrated curriculum. Medical Education 1997: 31(3); 181-7.

[4]Makoul G, Curry RH et al. The future of medical school courses in professional skills and perspectives. Acad Med. 1998:73(1);48-51.

[5]see Cook R.J., Dickens B.M. Consideration for Formulating Reproductive Health Laws-a discussion paper, World Health Organization, 1998, p. 9.

No competing interests !

Competing interests: None declared

Gil Siegal MD LLB, International Center for Health Law and Ethics

Haifa University Law School, Israel

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