Consent in the Post-COVID-19 Era

By Bertie Leigh
Hempsons, London, UK

Published 20 May 2020

Obviously there has been a remarkable change in the law and good medical practice governing consent to treatment. Within the last 60 years we have moved a long way from the era of Sir Lancelot Spratt which was characterised by extreme paternalism, “Don’t you worry, my man, this has nothing to do with you” as he drew a massive line across the abdomen to describe the proposed laparotomy incision to a gaggle of medical students. In the post Montgomery era doctors are expected to describe the alternatives reasonably available to the patient who has to be helped to make their own autonomous decision. This revolution in the expectations of the law and the General Medical Council has yet to be fully digested by mainstream medical practice, judging from the clinical records that I am asked to defend routinely. I have previously argued¹ that the demands of the law cannot be discharged in the ordinary out-patient clinic and we need to supplement such consultations by on line IT records in which a downloadable record of the patient’s learning experience is created and absorbed into the clinical record.

However that evolution has taken place against a comparatively stable background. The rise of evidence based medicine and the levelling of the playing field of knowledge between doctor and patient have been transcendent, but the direction of travel has been clear and steady, even if many doctors and managers have not yet absorbed the implications. We are now faced with a sudden revolution in which one of the key assumptions underlying the transaction is being challenged. We need to understand and prepare for those changes if we are to discharge the new obligations that the law and the General Medical Council will impose upon the Service and the professionals.

The underlying assumption has been that the doctor knows best and that he is able to deliver the best that he knows. If either of those premises is disappointed the clinician will be liable in negligence for failing to act as a reasonable practitioner in their position would act. The clinical care will be found wanting for reasons that do not concern the present argument.

This assumption finds its expression most obviously in the law concerning those aged between 16 and 18. Under the common law, either parent can give a valid consent to treatment that a surgeon is prepared to perform up to the age of 18. If either consents the other cannot forbid the treatment, even if the child does not agree. They may be able to go to court to get an injunction prohibiting the treatment; if both the child and the other parent disagree the doctor will certainly be unwise to go ahead unless there are very good reasons for doing so, and may be liable in negligence for that lack of wisdom. But under the law of trespass the surgeon will be immune from suit.

However, if the child has reached the age of 16, they may consent to treatment under statute even if both parents oppose the decision. Again the doctor is expected to advise the child to talk matters over with their parents and will be unwise to go ahead with major surgery otherwise: the leading case of Gillick was concerned with the prescription of oral contraception and different issues will be raised, for example where the child is offered above knee amputation for osteo-sarcoma. But the underlying assumption remains the same: anyone of the three people – that is the child or either parent can consent to treatment that a doctor proposes to perform, none of the three can prohibit it. The reason is that we assume the treatment is right because the doctor knows best.

In the case of the osteosarcoma we have taken additional steps to ensure that the doctor is right. There is a panoply of governance which has grown up behind the scenes: in no NHS hospital will such advice be given without it having been considered by a Multi-Disciplinary Team Meeting at which all of the issues will have been considered. Where there is such a division of views within the family, the case may well have been considered by an Ethics Committee; lawyers may well have been consulted and the case may be placed before the court. But none of these steps are necessary as a matter of pure law and where less mutilating surgery is proposed they usually do not happen.

The reason why I suggest that COVID-19 will force us to rethink our attitudes to consent is because it seems that doctors may for some time be operating in an environment where they will be unable to offer the treatment that they would have regarded as optimal. There are a number of reasons for this and at the time of writing, (April 2020), I am well aware that I am responding to a moving picture and may offer different advice six or even three months hence: I remember using those words to caveat several opinions that I provided to the MDU and the BMA at the height of the AIDS epidemic in the 1980s, when we were faced with a similar challenge to conventional thinking. For example, until then it had been supposed that any patient who presented themselves to a hospital implicitly consented to every precautionary investigation that the doctor thought appropriate on the blood that they donated for the purpose. After all, we argued, doctors had been able to perform WR tests long before there was any effective treatment for syphilis, notwithstanding the social stigma attached to the diagnosis. The arrival of a virtually untreatable and usually fatal infection that seemed to be mostly transmitted by homosexual activity changed that suddenly, and our advice had to be sensitive to the changing social mores. Today we must be similarly sensitive to the ramifications of COVID-19.

At the moment we know that there is virtually no elective surgery being performed in most hospitals in the UK. The position is exacerbated because patients who are referred are simply not attending for assessment or investigations. This is partly because of a desire to spare the NHS, more often from what we know to a well-founded fear of hospital acquired infection. Neither of these concerns will evaporate when the advice changes. This includes many diseases such as cancer which have for many years been accorded a higher degree of urgency than most elective musculo-skeletal disease (MSK). Thus when the present restrictions are eased, we must anticipate that MSK will not be at the top of many queues.

This in turn suggest that many patients will be treated when there has ben considerable progression of their disease: in most cases MSK surgery which is performed later than would be seen as ideal will achieve the same technical result, but that will not always be the case. We should anticipate that in many cases the operations will take longer, both because the precautions now being taken at the time of induction of anaesthesia and because of the progression of the disease. So will the length of stay on ITU be longer as will the length of stay in hospital. Some of the operations will be more likely to encounter complications: patients who have been lying around longer waiting for their operations will have a higher incidence of bed sores and venous thrombo-embolic complications.

All of these things add to cost. In most lines of surgery it is generally accepted that 50% of the costs come from the relatively small minority who do not make a smooth recovery as expected. That minority may be expected to increase. Potentially more important than all the factors I have identified, the pre-operative delays of disabled patients will have led to more disuse atrophy and much greater delays in recovery and rehabilitation.

There will also be limitations on techniques that are permitted, for the protection of the staff as well as the patient. These are still evolving and we may anticipate they will be sharply modified as new dangers are appreciated and precautions are developed to confront those we have presently identified. Today the RCS website suggests that most minimal access surgery should be avoided, partly because it is thought the CO₂ released from the deflating abdomen may infect those in theatre. For the same reason colonoscopy is to be avoided. Upper endoscopy is out of favour because of the danger of the operator being contaminated by exhaled air. None of these are mainstays of MSK surgery but we must anticipate that many optimal techniques will not be available either because they are thought to carry increased risk or because they are seen as too expensive.

That leads to the next awkward factor that the surgeon must consider. Our society is going to be significantly poorer for the foreseeable future. Some of the issues I have raised may be controlled by systematic testing of all healthcare staff on a daily basis, as well as the patients. We may even have the vaccine that we are promised, despite the fact that we have yet to see vaccines for either SARS or MERS, the last such viruses to come our way. But the damage to the economy seems sure to be much longer. So we have a poorer society trying to provide an intrinsically more expensive range of interventions in a more expensive setting. It seems like that the threshold set by NICE will have to change to reflect this new relative poverty: if a treatment costs more than, say £5,000 for each added quality adjusted year of life, there will be many who will say that the UK cannot afford it.

It may of course be the case that clinicians concerned with MSK diseases will be effective advocates for their patients. Certainly we know that it is a false economy to fail to provide effective treatment for these patients: immobility and the consequent loss of autonomy makes both elderly and younger patients far more expensive to care for and is associated with a decline in cognitive function and other diseases. However the reality is that for the next few years the competition from other patient groups will be formidable. MSK will do very well to preserve its present resources and that means it will have to do more with less.

All of this imposes totally new burdens on the individual clinician counselling the individual patient. In many settings it seems likely that you will not be able to offer optimal treatment. The delays will be too long. The range of interventions that are available will be much narrower than the surgeon will like to be able to offer in an ideal world.

It is against that background that we must consider the obligations placed upon the individual doctor counselling an individual patient. I say doctor because this probably includes everyone concerned with the chain of referral. Where the queues are long and the treatment available at the local NHS hospital is sub-optimal, the obligation on the referring general practitioner may also have changed. But let us stick to the MSK surgeon. It goes without saying that detailed records need to be made of this advice and in the modern context the proper place for that advice to be recorded is in a letter addressed to the patient.

1. It goes without saying that counselling about the outcomes must be candid, realistic and embrace all of the alternatives available to the patient.
2. The advice about the risks must include all the risks of the whole process: if the risk of death is increased by the chance of COVID-19 then it is the duty of those seeking consent on behalf of the institution to explain this to the patient. If the surgeon does not know what that risk may be for their institution at that time, they are not competent to counsel their patient. Since at the moment it seems that the danger of this hospital acquired infection is far greater than the risks of any orthopaedic procedure, it is a matter of the first importance and you may be wise to enlist the help of a microbiologist. Since the risk is likely to change considerably as the pandemic evolves, this is not a matter for amateur guidance from a surgeon.
3. The advice must include a candid description of the shortcomings of the service that the doctor is able to offer. Where the patient might wish to consider treatment that the Trust is no longer able to offer, this must be made clear.
4. The patient should be made aware of treatment that other NHS trusts are offering as well as treatment that is not available on the NHS.
5. The ethical objections to offering private treatment to patients in NHS clinics have not changed, even though many Trust have taken a more relaxed view in recent years. This is an area where we may anticipate new guidance that will have to be followed diligently: the NHS might say that if surgeons cannot offer optimal treatment within a reasonable time, it will be pleased to see the patients being removed from the queue. On the other hand the NHS or the GMC might move in the opposite direction and  in a new spirit of egalitarianism discourage such referrals; the fact that fewer patients are likely to be able to afford private medical insurance may lead to a resurgence of belief in whatever the NHS can afford must be the standard of care. For the time being it seems safer to advise that the wise surgeon will describe what is available elsewhere and offer to refer, but not to attend to the patient in the private sector themselves, If that is so, reciprocal arrangements, however informal should be avoided.
6. Many patients are elderly, cognitively impaired, suffering from complex comorbidities or unwilling to address such issues. They may be illiterate or share no common language with the doctor who is trying to advise the, The doctor’s obligation is to address each of those problems as they present, in the same fashion as they have been doing hitherto. They may be gain assistance from younger members of the family, or translators or by using visual aids to communication or explanation. In some cases they will recognise that the patient really does not wish to be troubled with these issues and that there is no alternative but to accept the fact. None of this is new, but the knowledge that the doctor is not able to offer what they would regard as an optimal service will doubtless increase the burdens upon the professional.

Reference

1. Leigh B. Progress Towards A Decision Record Is Lamentable. Clinical Risk. 2016;22(1-2);16-20.

Bertie Leigh is the lay Council member of the BOA. Formerly he has been Senior Partner at Hempsons, Chair of NCEPOD and a NED at the RNOH.