The implications of Montgomery vs. Lanarkshire Health Board for NHS patient information services

Executive summary

English law around the sufficiency of the information provided to a patient as part of the consent process has evolved over time from being a decision for the clinician to make about what to disclose to one where the information must be bespoke to the individual patient about risks that would be material to them personally, but perhaps not necessarily to the next person. Failure to provide sufficient information for decision making could result in a clinical negligence claim for ‘failure to warn’.

The recent case of Montgomery vs. Lanarkshire Health Board ¹ has significant implications for clinicians obtaining a patient’s consent to treatment. The outcome of this case makes the planning of care truly patient-centred and puts the onus on the clinician to ascertain exactly what would be a material risk to that individual and ensure that they are given sufficient information on which to base an informed decision.

This article discusses this step change in the legal requirements for the provision of information and how clinicians at The Christie, an English tertiary cancer centre, supported by our information services, have grasped this challenge of ensuring that patients are adequately informed about their treatment options.

This article considers only competent adults being prepared for treatment.

Legal context

The provision of information for treatment falls under English ‘Common Law’ where the standards are built and refined on a case-by-case basis according to judgements made by the courts. The framework for exactly what information should be provided, and who is the arbiter of what is reasonable information has evolved over time.

A competent adult has an absolute right in law to decide what happens to their body, including the refusal of lifesaving treatment, ² unless that decision is based on a misperception of reality. This means that sufficient information must be provided to enable a patient with capacity to give ‘valid’ consent to the intervention in question and to voluntarily make an appropriately informed decision. Acquiescence where the person does not know what the intervention entails is not ‘consent’. ³

A competent individual will understand, retain and process the information given ⁴ in order to make a decision about the treatment they are being asked to consent to. If the patient did not understand the nature and purpose of the procedure because the clinician failed to provide sufficient information and they subsequently suffered harm as a result of treatment, they may be able to make a successful claim for negligence against the healthcare professional. Any misrepresentation of the information will invalidate consent.

In 1985, the House of Lords decided that the ‘Bolam’ test should be the one used to assess whether the information provided was sufficient or not. ⁵ This test states that a doctor would not be considered negligent if their practice conformed to that of a responsible body of medical opinion skilled in the field. In practice, this meant that the medical profession would arbitrate on what was reasonable information to provide or withhold. There was a caveat in this judgement, however, whereby, if a risk to the patient were obvious, then it would be negligent not to provide the information, even if the responsible body of opinion would not have done so.

In 2004, the House of Lords decided that the courts, not the medical profession, would decide what constitutes responsible practice for the provision of information, albeit still based on the standards set by the healthcare professions ⁶ and the types of risks that should be discussed. It had been common practice to inform a patient according to the percentage risk that it would materialise. A key change in this case was that a patient should be informed of any risk of injury inherent in the surgery, however small the probability of the risk occurring. If this did not happen, the patient would be denied the chance to make a fully informed decision or to seek a second opinion. In this case, a patient developed cauda equine syndrome following spinal surgery. This was a random risk that would materialise no matter how competently the surgery was performed. The claimant argued successfully that they would probably still have had the procedure, but would have sought a second opinion before doing so, and hence the chance element of the risk would possibly not have materialised.

The Supreme Court judgement in the case of Montgomery vs. Lanarkshire Health Board further strengthened the need to inform of all risks material to an individual, even if someone else would not want that information. Mrs Montgomery was small in stature, but diabetic and there was a significant risk of her baby would have a high birth weight. Her risk of shoulder dystocia was between 9% and 10%, but despite the woman expressing concern about her ability to deliver vaginally her consultant did not warn her of the risk of her baby having a high birth weight or offer her a caesarean delivery. Her son’s birth was complicated by shoulder dystocia, he was deprived of oxygen for 12 minutes and thereafter diagnosed with cerebral palsy; this injury carried a 0.1% risk of materialising.

The court ruling was that this risk should have been explained to Mrs Montgomery. This is a marked change from the situation where the decision was based on that of a responsible body of medical opinion. It is now determined on whether a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor should reasonably be aware of the fact that the particular patient would be likely to attach significance to it.

How the change will affect clinicians preparing patients for treatment

As a result of the Montgomery ruling, doctors now have to take ‘reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment and of reasonable alternative or variant treatments’. ⁷

It is clear from the Supreme Court ruling that this judgement no longer lies with a ‘reasonable body of medical opinion’, but in fact is determined by what a ‘reasonable person in the patient’s position’ would consider material, i.e. would find that information important when making decisions about medical treatment. ⁸ The assessment of whether a risk is material therefore cannot be reduced to mere percentage thresholds.

As Sokhol outlines in his observation on the topic published in the British Medical Journal, ⁹ doctors must now ask themselves the following three questions:

Does the patient know about the material risks of the treatment being proposed to them? In practical terms, when obtaining a patient’s consent, doctors should ask themselves what sort of risk a reasonable person in the patient’s circumstances would want to know about. They should also ask themselves what sort of risk this particular patient would want to know about. The onus is ultimately on the person obtaining consent to provide this information on material risk by ascertaining from the patient what is pertinent to them, not on passively waiting for the patient to ask for it.

The law now requires more dialogue and time to be taken over consent, with a demonstrable, and documented, process as opposed to a pro-forma type consent form that a patient is asked to sign. Probably the best way to do this is to invite a patient to a clinic where they see an expert who spends time going through the options, including the ‘doing nothing’ option. The risks of each option should be communicated at this point and documented. The law on consent stresses the need to give this information to patients clearly without overloading them with technical information which they cannot be expected to grasp.

Finally, whilst the process of seeking consent may be delegated to suitably trained individuals, the overall responsibility for this process lies with the patient’s consultant. This has been made much more difficult by the Montgomery ruling. The person obtaining consent must not only be suitably trained and qualified with sufficient knowledge of the proposed procedure but must also be able to make the judgement on what represents a ‘material risk’ to the patient. This is a challenging situation to address but at the very least, suggests that consultants delegating the process of seeking consent to others need to formally assess those individuals obtaining consent, and ensure they are satisfied that the information being given to the patient on their behalf is appropriate and focussed on the patient’s needs. Furthermore, they should be directly involved in some part of the consent process itself.

Ultimately, what this all translates to is a move away from basing the consent process around a form and towards a process that involves taking more time, recording the advice offered, questions asked and decisions made. The law has in essence aligned itself to the General Medical council’s guidance on consent. ¹⁰

Information services

One method of assisting bespoke patient decision making is by incorporating into the consent process the provision of written information that is accurate, balanced and clear to patient users. This written information should give patients a foundation of knowledge to build on and facilitate discussions between them and their healthcare provider. Patients are given this information at their initial appointment to consider the treatment offered to them and to weigh up the rationale and side effects of this treatment to inform the consent process and prompt questions.

The provision of written information also helps refresh the memories of discussions which often happen at very stressful times for the individual and which may only be partially retained. Information must therefore be as accessible and available to as many patients as reasonably possible, and written information should be translated into other languages if appropriate. The information is made available to all our hospitals’ wards, peripheral clinics and information centres. It is also circulated to those hospitals that refer patients into our tertiary services. Free and easy access to downloadable versions of the information documents is available on the hospital internet website.

The consent process is explained within all of our documentation about specific treatments, and patients are advised to consider discussing the possibility of alternative treatments and second opinions with their treating physician if they wish. Information on consent will include encouraging patients to ask questions to clarify when they are unsure about the information they are given and also to highlight their own priorities to the consenting clinician to aid a meaningful personalised consent process.

At The Christie, the written information is initially compiled by the treating clinical team who are mandated to write high-quality, evidence-based, peer-reviewed and up-to-date information. This information is formatted into a user friendly layout. It is then submitted to the patient information committee for review. This committee is made up of representatives of most departments of the hospital together with lay patient representatives. Authors of the documents attend the information committee meeting to clarify any queries and to receive feedback. Corrections and suggestions are documented and relayed back to the treating teams.

Documents are reviewed on a regular basis, and occasionally these reviews are sooner than planned at the request of the treating clinician if changes are needed to update the information. Reviews also highlight all discontinued or outdated information which are taken out of circulation.

The Christie Information Committee is a member of the Information Standard certification scheme which validates our commitment to trustworthy and high-quality health and care information. Any organisation achieving The Information Standard has undergone a rigorous assessment of the information production process to ensure that the information they produce is clear, accurate, balanced, evidence-based and up-to-date. The committee provides assurances of the quality of our internal processes mainly by continual internal audits. An annual audit is undertaken to maintain our membership with the Information Standard which is also reported to the committee itself and action plans are made.

Conclusion

The recent ruling in Montgomery vs. Lanarkshire Health Board has mandated that patients are given information that is bespoke to their individual needs, namely what a reasonable person in the patient’s position would deem important when making decisions about medical treatment. Different information sets may be needed by different individuals, according to the context of their lives and the onus is on the clinician, doctor of other healthcare professional, obtaining consent from the patient to ensure that they understand the information needs of the patient.

Montgomery also reinforces the need for consent to be obtained within a process where the patient is given time to reflect on the information provided in both verbal, electronic and written formats in order to decide which the best treatment option for them is and whether to proceed with this, or seek a second opinion or even not proceed at all. Good documentation is therefore paramount to maintain an audit trail of exactly what has been explained to the patient at each step of the way.

Good supporting information services will become ever more essential, providing information in accessible locations, formats and languages.