Obtaining valid patient consent is one of the most fundamental pre-operative responsibilities of surgeons. In 2015 there was an important development in the UK case law – the now well-known Montgomery decision – which resulted in a sharp increase in claims against healthcare professionals generally arising from the consenting process.
Understanding the current legal landscape and the practical challenges will help surgeons keep their processes updated to promote good practice in obtaining consent. In turn, this should help prevent unnecessary claims or regulatory proceedings from arising in the first place and, provided it is properly documented, will make it easier to defend any claims that do arise.
This guide has been broken down into 4 parts and is intended to help busy surgeons deal with issues arising from Montgomery and informed consent:
We think that this information is worthwhile even now, nearly four years after Montgomery was decided. We still regularly come across current examples of surgeons misunderstanding their obligations. We have assisted in cases where the surgeon simply omitted to warn of or consent for certain risks because they ‘didn’t want to worry the patient’, or thought that a risk was ‘pretty unlikely’ to manifest. All these matters required notification to insurers, and some required fee refunds or compensation payments to resolve them, because the surgeons mistakenly used an approach to consent that is no longer legally acceptable.
In 2015 the UK Supreme Court decided that ‘informed consent’ is now the correct approach. There is no higher court in the UK than the Supreme Court, so there is no prospect of any big departure from this key principle for the foreseeable future.Montgomery v Lanarkshire Health Board  UKSC 11 (“Montgomery”) clarifies that healthcare professionals have a duty to discuss with the patient the “material risks” involved in the proposed treatment and any alternative treatment options.
‘Materiality’ is to be judged by reference to the individual circumstances of the patient. A risk of the procedure is ‘material’ if a reasonable person in the patient’s position would be likely to attach significance to the risk, or if the doctor is or should be aware that the particular patient would be likely to attach significance to it. This requires consideration of the patient as an individual – a holistic approach.
There will be situations where it is not possible to obtain informed consent before treatment, for example where the patient lacks the capacity to provide consent, where emergency treatment is to be provided or where disclosure of risks would be seriously detrimental to the patient’s health. However, those situations will be rare.
There has been a small amount of case-law to help understand what ‘materiality’ means. For example, in A v East Kent Hospitals University NHS Foundation Trust (2015) the judge found that a risk that was “theoretical, negligible or background” did not have to be communicated to a patient. In that case expert evidence in that case had estimated the particular risk under consideration at 1:1000. In another reported case that same year, Tasmin v Barts Health NHS Trust (2015), the judge made a similar point that a 1:1000 risk is ‘too low to be material’.
These cases give some comfort to surgeons that they will not always be obliged to waste valuable consulting time providing reams of information about every ‘theoretical, negligible or background’ risk that might exist. However, we would strongly caution against taking these two cases literally. Surgeons should not assume that they never need to mention risks that are below a notional 1:1000 threshold.
This is because the test will always be as stated in Montgomery – “…a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it”. This means that there will be patients whose particular individual position means that they would be unwilling to take even a 1:1,000,000 chance of a particular adverse outcome.
The practical challenge that this throws up for busy surgeons is how to remain alert to ‘outlier’ patients who will need to be counselled in relation to very marginal risks as well as all the more likely ones. In the part of this guide we suggest some approaches to help surgeons identify the instances where they do need to go into more detail with a patient on remote risks.
A risk that is material for one patient may not be so for another. Therefore a ‘one size fits all’ approach to advising patients is no longer safe or appropriate. Surgeons will need to update their practice to ensure they obtain informed consent from every patient for every intervention or procedure.
In our view, following Montgomery, it is vital to think of consent as a process rather than a single event. The process of consent will often be best approached in these broad stages and further commentary on each is provided in the next section:
Ideally, and particularly for elective surgery, there should be sufficient time between each stage for the patient to think about the risks and a realistic opportunity for them to pull out of surgery entirely at each stage. The potential risks of patients who feel ‘committed’ to a procedure before they have had a chance to evaluate the full implications are analysed later in this guide.
We appreciate that, in some situations, all stages of the consent process will have to take place within one meeting between the patient and the healthcare professional. If the procedure is quite urgent, or the clinic very busy, there may not be much time for the discussion. Nevertheless, if surgeons keep these stages in mind they are more likely to obtain valid informed consent from their patient, even when they are working under significant time pressures. It is essential that each stage of the process is carefully documented in the patient’s notes, as this will be vital evidence in defending any subsequent claim.
Consent that is obtained orally and not recorded in writing is technically valid, so carrying out investigations or treatment based on oral consent only is not going to be a criminal assault.
However, from the legal perspective of defending compensation claims, there is simply no substitute for written records. We have assisted surgeons who believed that it was sufficient to have a clinic letter that stated, “all the potential complications were discussed”, and their recollection of what their practice was at the time in terms of explaining potential complications to patients. It is not.
If there is no written record that a particular risk was warned of, then in a hypothetical trial the judge would be faced with a surgeon whose evidence is, ‘I don’t have a specific record, but I believe I must have warned of this’ and a patient whose evidence is ‘no he didn’t’. The judge will virtually always prefer the evidence of the patient in that situation. The received wisdom is that the consultation will have been an unusual or significant event for the patient such that their recollection of the particulars is likely to be better than that of the surgeon, for whom this will have been a routine meeting very similar to dozens of others. Also, the judge will be unwilling to give a surgeon the benefit of the doubt when documentation of the meeting is always the surgeon’s responsibility, rather than the patient’s.
Well-designed template forms can help with the consent process and thereby reduce the risk of expensive complaints and claims arising in the first place.
For example, while a ‘checklist mentality’ is not necessarily helpful, a standard document can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient. They can be particularly helpful as a prompt to mention newly-discovered or unusual risks of a procedure. They also help ensure that complete records are kept by providing a convenient and consistent way to make the necessary notes, which is vital in defending any claims which arise.
Effective forms are those that have been designed or adapted for the surgeon’s particular practice. They should be regularly reviewed and updated to make sure they capture all the necessary information and to reflect any changes in the known risks for the procedure. They should be written in clear and straightforward language.
When designing or adapting forms, surgeons need to consider not just the content of the form but also the layout and format. For example, in my experience too few surgeons give sufficient thought in advance to whether their standard forms include sufficient space to record all the necessary details. Poorly designed forms often leave so little room for answers that important information is either not recorded or becomes illegible.
We have spoken to some surgeons who have gained the impression that if the surgery is essential and will certainly go ahead, then the consent process is less important because the patient is going to have to take the surgical risk. In our view, that is a potentially risky mischaracterisation of the legal position.
Even where a surgery is essential and will certainly go ahead, then there could still be a consenting issue over when exactly it goes ahead (except for emergency surgery, of course).
The difficulty arises because of a somewhat controversial case called Chester v Afshar. That case decided that in a situation where a patient was not adequately consented, the patient only has to prove that they would have delayed the surgery. If they do that they have demonstrated the legal causation between the inadequate consent and the injury suffered and are entitled to compensation. In other words, even if the patient would only have taken an extra day to think about the risks, the court has to ‘deem’ the causation of injury to be proven. This is a legal fiction of course, there is no reason why the adverse outcome would have been avoided if the surgery was delayed by a day but still went ahead. Unfortunately, that is the legal reality we are all stuck with. The patient does not have to prove that the surgery would never have gone ahead to be entitled to compensation.
While some patients would allege that if they had been warned about the risks more fully they would have taken an extra day or so to think about them, other patients might have actual practical reasons for delaying or deferring surgery. For example, a parent of small children might want to delay surgery until all the children are at school to better manage the recovery process and any risk of delayed healing. A patient facing surgery with a significant mortality risk might want to wait a few days to make a will. A patient facing surgery that could prevent them from driving afterwards might want to wait until they have changed jobs to one that does not rely on them driving.
The practical upshot of the legal landscape for surgeons is that in the consent process they need to get the patient to think about not just whether they will ever have surgery, but if so when. There could be lots of practical reasons why a patient might want to delay or defer the surgery – whether for a short time or many years – until a point where they are better able to accept or cope with the risks that are material to them.
Surgeons care deeply about their patients. While most agree that driving up standards is essential, some feel frustrated that this has caused the growth in process-driven care that risks depersonalising patients. In this context, Montgomery should be considered a cause for optimism because it requires healthcare professionals to consider each patient from a holistic point of view and to understand how a proposed procedure will affect them personally.
Nevertheless, this case has created an increased risk for surgeons because it is now rare for a claimant’s pleaded case to not contain allegations about a failure to obtain informed consent. Documentation is key and following the above processes will help protect you. If the documentation is lacking or does not exist at all, it will be impossible for your lawyer to defend you against such allegations.
A recap on the current UK law was provided in Part 1 of this guide. The upshot of the legal changes is that the process of consent will often be best approached in these broad stages:
In this section we focus on the practicalities of obtaining the patient’s medical and social history.
Montgomery makes it clear that surgeons need to give advice about the risks material to that individual patient. It will be almost impossible to do that without a detailed medical and social history that allows the surgeon to gauge what is material to the particular patient.
For example, if the surgeon does not know that the patient is a professional singer, they would not advise of any potential risk (however rare) of permanent damage to the vocal cords during surgery (perhaps due to the need to ventilate under general anaesthetic). In turn, they could be sued in negligence if the patient’s voice is permanently damaged during the procedure and the patient contends that they would not have consented to the procedure had they known of that risk.
Each healthcare professional needs to give careful thought to which medical or social factors could potentially make a difference to the advice about the consequences and risks of a procedure for that particular patient.
While this is necessary for all types of surgery, even those where the only alternatives would inevitably lead to death or serious disability, the process is perhaps particularly important for the following types of surgery:
After Montgomery surgeons simply must ensure that sufficient information is obtained from each patient to allow them and the patient to assess what risks are most ‘material’ to them in the particular context.
Surgeons must also document that information as part of the evidence on which their clinical judgement and advice was based. The medical and social history process is a key part of this process.
Often, the most convenient method for taking a patient’s medical and social history is to have a standard written questionnaire for the patient to fill in before or at the consultation. While a ‘checklist mentality’ is not necessarily helpful, well-designed forms can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient, to give the best possible chance that the surgeon identifies what risks will be particularly ‘material’ to that patient.
The following is certainly not a prescriptive statement of what a surgeon’s questionnaire should contain. Instead it is intended as guidance and ‘food for thought’ to help you review your current documentation and assess whether improvements can be made to help protect you from complaints and claims.
In addition to thinking about the content of your template documents for use in the medical and social history-taking process, you should also think about the layout and format. Even a form with a perfectly optimised set of questions could be rendered useless if there is so little space left for the answers that incomplete information is actually obtained or recorded.
We hope that this guide contains helpful guidance about designing or optimising your template forms or documents for use in the process of taking a patient’s medical and social history.
If you would like additional assistance in updating your documents, you have various options. We understand that various companies offer consenting ‘systems’ that aim to ensure that healthcare professionals use compliant consenting documents and processes. By way of an example only (we do not endorse this or any other provider), here is the website of one such provider https://www.eidohealthcare.com/.
In this section we focus on the practicalities of consultations with patients, providing patient information leaflets to support that process, and obtaining the final consent to go ahead.
In this stage, the patient is given information about the nature and purpose of the proposed intervention or procedure and the potential risks. Depending on the exact procedure, this could be a lengthy and complex discussion and it is important that wherever possible the discussion is led, and documented, by the surgeon who will actually performing the procedure. The risks of ‘delegating’ parts of that process are reviewed in part 4 of this guide.
It is very important indeed that the process includes a detailed discussion about any potential alternative treatment options, and the relative merits of such options. This includes alternatives that the surgeon may not consider to be the most appropriate, as well as the option of not proceeding with any form of treatment at all.
Failure to advise of alternatives is a particularly common allegation in consent claims. For example, where a patient who was consented for surgery alleges that he or she was not appropriately informed of the option of conservative treatment.
Obtaining effective consent depends on ensuring that the patient receives all of this information in a format and manner that makes it comprehensible to them. Each surgeon needs to give careful thought to what information the patient needs about each procedure they offer. They also need to design an effective process for ensuring that all of the information is provided to the patient and that records are kept.
Therefore, any template forms used for consultations should be individually drafted to deal with each type of procedure offered. The template forms should also have enough flexibility to be adapted to the particular situation of each individual patient.
While conveying all the potential ‘material’ risks and the pros and cons of all the alternatives is necessary for all types of surgery, even those where the only alternatives would inevitably lead to death or serious disability, the process is perhaps particularly important for the following types of surgery:
After Montgomery, surgeons simply must ensure that sufficient information is provided to each patient to allow the patient to make a fully informed decision about whether to go ahead. Particularly, bearing in mind any risks that are particularly ‘material’ to them personally.
I have heard surgeons quibble with that on the basis that too many patients will be put off from going ahead with surgery that might benefit them. It is fair to say that if a surgeon does the consenting process properly, some patients will certainly be put off from the procedure entirely, or will elect to defer it for a long time. The surgeon might not agree with or understand the patient’s rationale – they may even find the patient’s decision irrational – but that is the upshot of Montgomery. The ‘paternalistic’ model no longer holds good and the patient must be given all the necessary information about the risks they will be running, so that they can make their own subjective decision about what risks are acceptable to them.
Surgeons must also document the advice and information they provided. This is partly to help ensure that a surgeon has a record to use in follow up or future treatment. It is also necessary in order to be able to defend the surgeon in the event of a complaint or claim.
Depending on the type of procedure, and particularly whether it is an elective procedure, it may be appropriate to provide the patient with information leaflets about the proposed procedure.
Good information sheets help the surgeon to present generic information about the procedure to the patient in a clear way. They are an important support and complement to the advice the surgeon gives the patient in consultation, especially as written information can allow space for the patient to reflect, often after the consultation, in a way that the face-to-face consultation may not.
By the time a claim is made, it can be difficult to prove whether an information sheet was provided to the patient at all, and if so which information sheet was provided. Therefore it is vital to find a robust way to record which information sheet each individual patient received.
Also, almost needless to say, information leaflets are only as helpful as the information they contain. If a leaflet contains incomplete or outdated information then it could arguably do more harm than good. If a surgeon decides to use information leaflets as part of the standard consenting process, then the surgeon must accept that this will entail investing time every so often in reviewing and updating those documents.
Some surgeons who have ceased using physical leaflets and instead direct their patients to their websites, which contain regularly updated information about the procedures they offer. The benefit of using a website rather than physical leaflets is that the cost of printing physical leaflets is saved. Also, a website can be quickly and regularly updated for all the patients (indeed often the whole world) to see. The potential downsides are that even today not all patients can get online or are comfortable doing so. Also, it can be somewhat more difficult to ensure that the patient has actually gone to the website and read the right parts of it. In some cases the surgeon might need to print off the relevant pages for a patient who would not otherwise be willing or able to access them.
In this stage, the patient, having been provided with all the necessary information, records his or her final consent to go ahead with the procedure, usually by signing a form to that effect. Such a form is often referred to as ‘the consent form’. Such terminology is unhelpful because it suggests that consent is an event that simply involves the signature of a form, when in reality obtaining consent is a process culminating in the signature of a form.
Often, a very convenient method for structuring a patient consultation and obtaining final consent is to use standard written documents. While a ‘checklist mentality’ is not necessarily helpful, well-designed forms can be a helpful aide memoire for a busy surgeon to help ensure that all the necessary material is covered with every patient, to give the best possible chance that the surgeon does give advice about everything that is ‘material’ to that patient.
The guides in the two appendices to this section are certainly not a prescriptive statement of what that documentation should contain. Instead it is intended as guidance and ‘food for thought’ to help you review your current documentation and assess whether improvements can be made to help protect you from complaints and claims.
In addition to thinking about the content of your template documents for use in the consultation process, you should also think about the layout and format. Even a form with a perfectly optimised set of questions could be rendered useless if there is so little space left for the answers that incomplete information is actually obtained or recorded.
In this final section of our guide to informed consent, we look at some particular practical situations where obtaining valid consent can present a challenge.
Clinical photographs of the patient may need to be taken. At an appropriate point in the consent process, the surgeon should explain the purpose of taking photographs and the fact that they will form part of the patient’s medical records. The patient’s consent to the photographs being taken should be recorded in writing, ideally by the patient signing a suitable form, before any photographs are taken.
In the vast majority of cases, getting consent to take clinical photographs of the patient is extremely straightforward as the vast majority of patients understand that they are a necessary part of clinical recordkeeping and will consent straight away.
Nevertheless, we know of surgeons who have been faced with practical difficulties even in this aspect of the process. For example, one surgeon had a patient who simply refused to allow clinical photographs to be taken of her lower body (where the surgery was to take place), on the basis that she found the idea of the photographs “intrusive” and was worried it would exacerbate her clinically diagnosed PTSD.
We gave guidance that without consent to the photographs they could simply not be taken. Without clinical photographs the surgery could not properly go ahead, given the importance of those records in complying with the duty to make and keep proper records. We recommended that the patient be referred to her existing mental health team to assist with ascertaining whether she could or would consent to the photographs with the necessary support and if not then it would be much safer for the surgeon to not go ahead with surgery for that patient.
While examples such as this are rare, they do highlight how important it is to avoid treating consent as a ‘rubber stamping’ exercise and be alert for patients that have unusual needs that give them problems with even routine aspects of their care.
In our view, yes it can.
We have dealt with a number of cases where a patient paid for the procedure upfront on a non-refundable basis after only a preliminary consultation (a cynic would say ‘sales pitch’) from an employee of a private healthcare provider company. Only then was the patient allocated to a self-employed surgeon to actually carry out the surgery. While more detailed consultations with the surgeon did follow before the actual surgery, the purported consent for surgery was very questionable because by then the patient had made a financial commitment. The particular examples we have seen have arisen in the context of elective eye surgery or aesthetic surgery, in relation to companies that specialise in marketing certain procedures to the general public, and contract with self-employed surgeons to carry out the actual surgery. In principle the problem could arise in any situation where the surgeon does not have control over the whole consenting process.
The General Medical Council and the law are clear that it is the surgeon who ultimately has the responsibility for obtaining valid consent. This is the case even if in practice the majority of the informing and consenting process is purportedly taken care of by other healthcare professionals. This is also the case even if the self-employed surgeon does not have any real control over when he or she sees the patient for the first time or how long he or she has with the patient to deal with consent before surgery. If a patient brings a claim for compensation alleging a lack of consent, the surgeon’s defence team will of course endeavour to ‘pass on’ some of the legal liability to the company that actually took conduct of the initial stages of the consenting process. Ultimately, the best outcome in that situation is sharing liability with another defendant, rather than being able to completely defend the claim.
While it is possible to ‘delegate’ the consent process, this should only be done if the treating surgeon is confident that i) the person obtaining consent is suitably trained and qualified, ii) the person obtaining consent has sufficient knowledge of the proposed investigation or treatment and understands the risks involved.
Therefore we would recommend that all self-employed surgeons should endeavour to find out exactly what the ‘patient pathway’ is for private patients in the organisations they work within, and particularly what information patients are provided with (if any) by others before they reach the surgeon. The surgeons should ideally review that material (which could include ‘sales scripts’, patient information leaflets or even patient information videos) and decide what else the patients need to be able to give valid consent. This is particularly important if the other healthcare provider makes it a contractual obligation to use patient information materials or consent forms produced by them.
The surgeon should also consider whether the financial arrangements between the patient and the other healthcare provider will make it difficult to ensure that valid consent is actually being obtained in each case. Based on that, the surgeon can make a better informed decision about whether it will be safe to provide self-employed surgical services through that organisation, or whether they will be at risk of taking the consequences of another organisation’s inadequate patient consenting process.
Other examples of how the ‘patient pathway’ can affect the quality of the consent process and the vulnerability of the surgeon comes from observations that surgeons have made about certain differences between the NHS consenting process and that in many private hospitals.
In the NHS the patients are often sent for an assessment appointment led by nurses and anaesthetists who will specifically assess the anaesthetic risks for the patient and advise them in preparation to be consented for surgery later on. By contrast, it is often the case in private hospitals that there is no equivalent process to deal with anaesthetic risks specifically. The surgeon has to take charge of consenting the patient for the anaesthetic risks and the patient may not even meet the anaesthetist until the day of surgery itself.
The upshot for surgeons in these situations is that they need to be sufficiently well informed to be able to ensure that the patient is warned of any material anaesthetic risks, as well as surgical ones, or risk being liable for a consent failure if an anaesthetic risk manifests.
Surgeons care deeply about their patients. While most agree that driving up standards is essential, some feel frustrated that this has caused the growth in process-driven care that risks depersonalising patients. In this context, Montgomery should be considered a cause for optimism because it requires healthcare professionals to consider each patient from a holistic point of view and to understand how a proposed procedure will affect them personally. Nevertheless, this has created an increased risk for surgeons because it is now rare for a claimant’s pleaded case to not contain allegations about a failure to obtain informed consent. Documentation is key and following the above processes will help protect you. If the documentation is lacking or does not exist at all, it will be impossible for your lawyer to defend you against such allegations.