Could you defend your clinical practice if it differed from that recommended by a guideline? Dr Gerard Panting explains the legal position

As far as the law is concerned, medical practice must be evidence based if it is to be defensible. The proof of that statement lies in the Bolam test – the test applied to standards of practice in English courts. This requires doctors to "act in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”

Provided the defendant doctor can call on experts in the field who will support the clinical management provided, the case should be successfully defended.

What is defensible?

The Bolam test permits more than one approach to any given problem, allowing that the case is defensible even though "an adverse body also exists amongst medical men”.

To date, the evidence base relied upon in the courts is the testimony of expert witnesses. Once, the experts might have been seen as hired guns providing an opinion to suit their instructing solicitor, but since the advent of the clinical procedure rules in 1999, the duty of the expert has been put beyond doubt. The expert’s primary duty is to the court not to the side paying his or her fee.

To reinforce this point, all experts submitting opinions in legal proceedings must endorse that opinion with a statement along the following lines:

"I understand my duty to the court and I have complied with that duty. I also believe that the facts that I have stated in this report are true and that the opinions I have expressed are correct.”

The Bolam test has been an integral part of English law since 1957. It has been endorsed periodically by the Court of Appeal and by the House of Lords in a variety of cases, but since 1957 there have been considerable changes.

The beauty of the Bolam test is its timelessness. It is not embedded in the standards of 1957 but automatically adapts to the state of clinical practice at the time of the incident under scrutiny. As Mr Justice McNair put it in the original case:

"At the same time, that does not mean that a medical man can obstinately and pigheadedly carry on with some old technique if it is proved to be contrary to what is really substantially the whole of informed medical opinion. Otherwise you might get men today saying ‘I don’t believe in anaesthetics. I don’t believe in antiseptics. I am going to continue to do my surgery the way it was done in the 18th century.’ That clearly would be wrong.”

Over the past few years, the number of clinical protocols and guidelines has mushroomed, which begs the question: What if your established management for a given condition fails to conform with authoritative guidelines on the subject?

Protocols and guidelines

Before tackling that question, it is worth considering what difference, if any, there may be between protocols and guidelines. The dictionary definition of ‘protocol’ runs as follows – "original draft of diplomatic document especially if terms of treaty agreed to in conference and signed by the parties; formal statement of transaction … official formulas at beginning and end of charter, papal bulls etc.”

The term ‘guideline’ is not defined in many dictionaries, but common English usage does distinguish between guidelines and protocols, with protocol generally being taken to mean a rigid set of steps to follow where deviation is not permitted or anticipated. Guidance or guidelines, on the other hand, are normally taken to mean a general indicator, which might normally be expected to be followed but which might be varied in certain circumstances.

However, in English law we have had no case that distinguishes between the two and in this context they may be seen as interchangeable.

Following a set standard

So is it defensible to deviate from the management advised in protocols or guidelines?

The defensibility of any given case will depend upon its precise facts, but where there is a requirement to follow a set standard, failing to adhere to that standard will inevitably make the case difficult to defend. Take, for example, the subject of consent.

In 1998, the GMC published guidance on consent, entitled Seeking patients’ consent: the ethical considerations and distributed it to all registered medical practitioners in the United Kingdom. Under the heading ‘Guidance for Doctors’, the Council states,"This booklet sets out the principles of good practice which all registered doctors are expected to follow when seeking patients’ informed consent for investigations, treatment, screening or research.”

The document goes on to list the type of information patients want or ought to know before they decide whether to consent to treatment or an investigation (Box 1, below).

Box 1: Information patients may be given before consenting to examination or treatment
  • Details of the diagnosis and prognosis, and the likely prognosis if the condition is left untreated
  • Uncertainties about the diagnosis including options for further investigation prior to treatment
  • Options for treatment or management of the condition, including the option not to treat
  • The purpose of a proposed investigation or treatment; details of the procedures or therapies involved, including subsidiary treatment such as methods of pain relief; how the patient should prepare for the procedure; and details of what the patient might experience during or after the procedure including common and serious side-effects
  • For each option, explanations of the likely benefits and the probabilities of success; and discussion of any serious or frequently occurring risks, and of any lifestyle changes which may be caused by, or necessitated by, the treatment
  • Advice about whether a proposed treatment is experimental
  • How and when the patient’s condition and any side-effects will be monitored or re-assessed
  • The name of the doctor who will have overall responsibility for the treatment and, where appropriate, names of the senior members of his or her team
  • Whether doctors in training will be involved, and the extent to which students may be involved in an investigation or treatment
  • A reminder that patients can change their minds about a decision at any time
  • A reminder that patients have a right to seek a second opinion
  • Where applicable, details of costs or charges which the patient may have to meet

It then goes on:

"When providing information, you must do your best to find out about patients’ individual needs and priorities. For example, patients’ beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision.You should not, therefore, make assumptions about patients’ views but discuss these matters with them and ask whether they have any concerns about the treatment or the risks it may involve. You should provide patients with appropriate information which should include explanations of any risks to which they may attach particular significance. Ask patients whether they have understood the information and whether they would like more before making a decision.”

So here the regulatory body sets out standards which it expressly states doctors are expected to follow. Failure to do so could result in disciplinary proceedings and the finding of serious professional misconduct.

As those standards have been set by the regulatory body, defending a claim based on a failure to abide by those standards will prove exceptionally difficult, if not impossible, particularly since the Department of Health has itself published similar guidance.

Consent, it may be argued, is a special case. Since the Sidaway case in 1985, the courts have held that the degree of information provided to patients before seeking consent is primarily a matter of clinical judgement, the use of the word ‘primarily’ allowing the court to trump expert opinion if it believes that opinion is not valid.

However, not all guidelines and protocols come with the sledgehammer authority of the General Medical Council and the Department of Health. Many are composed within individual units and practices to standardise the management of given clinical situations.

Guidelines in Practice, May 2004, Volume 7(5)
© 2004 MGP Ltd
further information | subscribe