Challenging clinical decisions

The title of this post is deliberately ambiguous. It contains both the issue – how should you make a challenging clinical decision – and the answer – challenge each decision to check that it is sound and justified. Using four recent legal judgments, I will argue that the best way to make a difficult decision is to question your decision, repeating this until it remains unchanged. Complex or finely balanced decisions require external challenges to ensure they are made robustly. Rehabilitation experts should be better than most other specialities. Our training includes having a framework and capability for analysing complex clinical situations and taking responsibility for managing them.

Not infrequently, I face a situation where a patient wants care delivered that carers are reluctant to give or an inappropriate treatment. Sometimes, the person has capacity; on other occasions, when someone lacks capacity, a family advocates for the treatment or care. Examples include wanting to eat food which carries a (perceived) high risk of choking, giving or not giving care against advice or guideline standards, and committing to cardiopulmonary resuscitation even though it seems futile. The reasons supporting the request include human rights and respecting a person’s autonomy, best interests, or right to choose. Any justification provided may be dismissed as showing discrimination against disability, biased use of information and evidence, or deciding on considerations such as costs or convenience. The courts are asked to make the decisions in a few cases; this post considers what we might learn from their approach.

Introduction

Healthcare professionals make many clinical decisions daily; most are or seem straightforward. A few decisions are more complex, and less experienced staff usually approach more experienced colleagues or, in any team, other team members for advice. Yet more complex choices may be made at a formally convened meeting, such as a case conference or best interests meeting. Doctors are usually involved in high-stakes decisions and situations where the patient or family disputes the proposed decision.

Can we be reassured that healthcare professionals recognise decisions that require more thought? The evidence suggests not. For example, the House of Lords: Select Committee on the Mental Capacity Act 2005 found that it was rarely used when it should have been, with serious decisions made without legal due process.

Can we be reassured that complex decisions are made considering the relevant significant information? My experience of reading clinical records suggests not; one of the cases reported below (Hydration but not nutrition) suggests not, and the number of successful claims against the NHS suggests that decision-making could be better.

I will review four legal judgements concerning clinical decisions to investigate how the legal system arrives at a decision when clinical teams have not succeeded. However, before doing so, it is vital to consider what factors influence clinical decisions.

Making challenging clinical decisions.

Much literature considers decision support tools, and Reed Sutton and colleagues have reviewed their benefits, risks, and strategies. I will discuss something other than this aspect of decision-making. Another tranche of studies concerns diagnostic or prognostic decisions, such as cognitive biases associated with medical decisions or factors affecting physician prognosis, and I will not discuss them either.

My concern is with factors that influence clinical decisions relating to treatment. I will use a framework derived from Veena Manja and colleagues, who studied cardiologists’ perceptions of factors influencing clinical practice decisions. The Mind Map below (available as a .pdf for download) shows some clinical, organisational, and socio-political factors influencing a clinical treatment decision.

In their cardiological study, Veena Manjay et al. found that guidelines had only a limited effect and that individual, interpersonal, organisational and sociopolitical factors had much more impact on their decisions.

Ian Pope and colleagues undertook a qualitative study exploring the factors influencing admission to hospital from the emergency department. They identified a wide range of influencing items, including:

Politically-imposed targets
Availability of alternative care options such as home care
Availability of alternative diagnostic and treatment options, such as outpatient services
Staffing levels and workload
Departmental culture
Patient expectations and preferences

Ami Schattner asked, are Physicians' Decisions Affected by Multiple Nonclinical Factors? The answer was that “decision-making by physicians appears to be often affected by multiple, ubiquitous, and potentially inappropriate nonclinical factors.” A review of studies in 2010 by FM Hajjaj and colleagues found that factors such as a person’s socio-economic status, perceived quality of life, and local management policies influenced treatment decisions. Verity Longley and colleagues reviewed studies investigating access to stroke rehabilitation services, finding that “patient-level and organisational factors as well as characteristics of individual clinicians contributed to decisions about rehabilitation.”

This blog post mainly concerns end-of-life decision-making. David Frost and colleagues completed a systematic review of patient and healthcare professional factors influencing end-of-life decision-making during critical illness. After considering the 102 studies found in 2011, they concluded that “patients and clinicians may approach end-of-life discussions with different expectations and preferences, inﬂuenced by religion, race, culture, and geography.”

In summary, Most investigations find that clinical treatment decisions vary considerably, influenced by a broad range of factors unrelated to the specific clinical facts.

Treatment availability

When discussing options with a patient or with advocates when a person lacks capacity, clinical teams will only provide information about the treatments they are willing or able to provide. Sometimes, they may also explain why they are not offering a treatment expected or used in similar situations.

This leads to the concept of available treatments, which is critical. Legally, no one can insist on having a specific treatment. People may refuse treatments or choose between treatments offered, but if a treatment is not offered, they can force the clinical team to provide it. The patient may ask the clinical team why a particular treatment is not offered and should expect a reasoned justification. If the decision to refuse to provide treatment is contrary to the evidence, the patient may seek treatment elsewhere, seek a second opinion, or appeal the decision.

The factors influencing a decision will be most apparent when a decision is finely balanced. If the evidence, including guidelines, overwhelmingly supports the benefit or harm of an intervention, then most clinical teams will make the same decision. However, many clinical dilemmas are not so clear-cut. This is unsurprising given the usual range of uncertainty associated with critical determinants such as the likelihood of benefit or harm, the prognosis of the disorder, and the weak and unpredictable links between impairments and function.

The uncertainty leaves room for other discretionary influences. Some, such as a critical evaluation of the team's clinical experience, are helpful and relatively free of bias. On the other hand, many different influences will reflect personal, organisational, or societal values and attitudes.

This is illustrated in the figure shown as a .pdf file by clicking here, which concerns whether a team believes treatment should be considered; if not, the treatment will not be offered and is unavailable. The figure shows that the probability of benefit or harm will lie on a spectrum of clinical and cost-effectiveness considerations. There will be other axes, too, and the figure shows the principle. In the area of uncertainty, other influences will affect the final decision about the availability of the intervention.

The critical nature of availability in challenging clinical situations will be discussed later. The essential point is that the decision to make a treatment unavailable is not necessarily free from non-clinical influences.

Case A: hydration but not nutrition.

The patient’s son brought this case, EWCOP [2024] 3, heard by Mr Justice Hayden on 22-25 January 2024; he was not given public funds to support him, contrary to natural justice. His mother, EUP, was in her late eighties and was moderately frail before admission to the hospital on 21 October 2023 with a left middle cerebral artery area stroke. Her condition deteriorated.

On December 15^th, she stopped receiving nutrition because it could not be given as the nasogastric tube kept coming out. Frequent attempts to pass a nasogastric tube failed, and they stopped on 22 December. The treatment doctors’ evidence was summarised: ” The medical advice is clear, unanimous and long-standing: there is no viable way to give nutritional support.”

Nevertheless, intravenous hydration was continued, though the judge was “unable to identify a cogent rationale.” He added, “I do not consider it has been in the best interests of EUP.”

The court case on 22-25 January 2024 was to decide on discontinuing the hydration. There was evidence that EUP might wish to continue living. “When EUP’s husband was at the very end of his life, unable to swallow, in consequence of his advanced dementia, she was dogged in her determination that he should be provided with artificial nutrition.” But the judge also noted that “the evidence does not provide any clear indication of what EUP would have wanted other than every opportunity to see more of her children and grandchild.”

The judge concluded, “the providing of nutrition is not a medically ethical option nor, in my judgement of the available evidence, has it been for some time. It cannot be achieved without further burden and there is no prospect of it changing the prognosis. In any event, even if I were unpersuaded by the medical evidence, I certainly could not compel the doctors to undertake treatment contrary to their own medical ethics.”

This led him “to the clear conclusion that neither provision of nutrition nor hydration is in EUP’s best interests

Case A: comment

The vital parts of this judgment concern the NHS Trust (the hospital). Justice Hayden drew attention to guidance published in 2020 highlighting when and how the Court of Protection should be involved when a dispute arose about continuing life-sustaining treatment. The hospital needed to adhere to the guidance to quickly bring the case to Court (i.e., in December).

Further, the judge said, “The Official Solicitor expressly deprecates the fact that GUP was required to bring this application before the court himself.” The British Medical Association’s (BMA) guidance on withdrawing clinically assisted nutrition and hydration states, “Where an application to court is needed, proceedings should be initiated and funded by the relevant NHS body responsible for commissioning or providing the patient’s treatment.”

Next, coming to the topic of this post, the clinical team agreed in mid-December that continued feeding was not an option. The judgment recorded the opinion of the treating team, “The medical advice is clear, unanimous and long-standing: there is no viable way to give nutritional support.“ In other words, on or shortly after December 15 2023, continued nutritional support, which must include water, was no longer an available treatment. If so, it should not have been given, and it was not a matter where a best interests decision was needed because there was no choice.

Nevertheless, the clinical team continued to give fluids. The legal report implies but does not state that this was decided without consideration of her interests. The judge wrote, “In other words, the treatment plan has an air of compromise about it, a negotiation between the family and the medical team. There may, sometimes, be a place for that, but not if the person at the centre of it becomes marginalised. P (the protected party) must always be afforded care, which is identifiably in her own best interests. The family’s views are relevant only insofar as they provide a conduit for P’s own wishes and feelings. Families, however loving and well-meaning gain no dominion over their dying and incapacitous relatives. The family’s role, which is crucial, is to promote and not subvert P’s autonomy.”

The lessons to be learned are:

If a treatment is considered inappropriate and unavailable, then a best interests decision is not needed concerning the unavailable treatment
- A management plan that focuses on a patient’s interests is needed, but the unavailable treatment cannot be included in any discussion.
In a dispute, one should obtain a second opinion only if there is significant doubt about the availability of the treatment.

Case B: Anaesthesia for renal dialysis.

The second, [2023] EWCOP 45, was also heard by Mr Justice Hayden. It concerns Jordan Tooke (his name was given in the report), who was 29 years old and had autism, severe learning disabilities, and William’s syndrome. He developed renal failure in 2022 and required renal dialysis to maintain life when the case was heard on 12 October 2023. He had been placed on the list of people awaiting transplantation in April 2023.

The clinical challenge arose from his long-standing phobia of hospitals, especially needles. All agreed that renal dialysis could only succeed if he were able to remain still for the three hours needed three times a week. A desensitisation (to hospitals) process started in April 2023, and he showed considerable progress. Nonetheless, he was judged incapable of complying consistently.

The only options were (a) not to provide dialysis, offering palliative and end-of-life care to manage his inevitable death from renal failure or (b) to provide dialysis enabled by intravenous sedation for the whole procedure. The latter requires a consultant anaesthetist and nurse to be present during dialysis, which is a considerable resource.

The written judgement provides a wealth of detail from the medical experts, who had differing opinions about the proposed treatment plan’s practicality, safety, sustainability, and balance of risks and benefits. Interestingly, resources were not mentioned.

The hospital approached this case as one concerning disputed best interests; however, on reading the evidence from the treating doctor, he could equally well have considered the treatment unavailable. The judge commented on the evidence, saying, “Dr V, in both his oral evidence and reports, sets out his firm view that haemodialysis, with sedation, is not in Jordan’s best interests. I found his evidence to be carefully considered and clearly expressed. I did, however, note that he was inclined to argue a case, rather than conduct a balancing exercise.” [My emphasis.]

The judge stressed the difference between a judge and the experts: “Whilst careful attention must, obviously, be afforded to the opinions and analysis of experienced medical professionals, these opinions always require to be considered in the context of all the other evidence. The roles of the court and the clinician or expert are entirely distinct. It is, ultimately, the court that is usually best placed to weigh expert evidence against and alongside the other available evidence. It will be rare for the evidence of one doctor or indeed one area of specialism to be determinative of the outcome of a case. At the end of the day, it is the Judge, not the doctor, who determines the case and, always, on the totality of the available evidence.”

He then said: “Thus, when considering Jordan’s best interests, I weigh into the balance his unique value as a human being, the obligation of the State to ensure that he is afforded the same opportunities as those who do not share his disabilities and his fundamental right to life where that can either be achieved or, where it can be strenuously promoted.”

His comments summarise what, in the medical literature, is sometimes called phronesis and can be considered wisdom; the ability to take an overview considering every aspect of humanity. I have written a post on wisdom in rehabilitation, which expands upon this.

Case B: comment

Alex Ruck Keene has commented on this case, concluding that it illustrates the importance of the Equality Act and the Mental Capacity Act 2005. He stresses that the judgment “shows what it means to make reasonable adjustments in order to respond to the needs of a person with both cognitive and physical impairments.”

Several experts referred to sedation as chemical restraint, and Mr Justice Hayden observed:

“But in the context of what is being contemplated here, I find it an emotive term which does not, to my mind, really do justice to the skill and subtlety of what the general anaesthetists can provide.”

The judgment is well-argued and well-evidenced, and Mr Justice Hayden is entirely person-centred in his approach. He describes Jordan vividly; few will disagree with his decision based on the facts and opinions presented.

However, the case illustrates the hazy borderline between availability and unavailability. It would have been quite possible for Dr V, the treating physician, to state that renal dialysis cannot be provided under these circumstances; he could have said that the treatment is unavailable. For example, the considerable cost of providing this treatment, potentially for many months or years, could have influenced his decision. If the money came from his budget, he would know that he might be unable to offer dialysis to several other patients.

Case C: Life in intensive care.

This case, [2023] EWCOP 57, held before Mrs Justice Judd on 13 December 2023, concerns a young woman with “a rare inherited condition which progressively destroys the nerve cells in the brain and spinal cord.” She was in an intensive care unit (ICU) with oral tracheal intubation, giving her continuous breathing support. Three options existed:

remain in the intensive care unit for the remainder of her life, estimated to be months, not years,
extubate her and provide palliative care,
perform a tracheostomy; it is unclear whether this would enable her to leave the ICU.

The patient (K) had pulled her endotracheal tube out on several occasions and was thought likely to pull out a tracheostomy tube.

Her sister’s request was for a move to another hospital. Her sister (B) wrote to the judge saying:

“with the right treatment and proper management I have full faith she will recover I have seen this”. She also suggested: “that K was being discriminated against because of her disability and that she would not have been treated in this way had she not had the condition she does.” The judge noted that:

“B believes that with proper treatment K will improve and be able to manage without ventilation.”

The judge, Mrs Justice Judd, immediately excluded Option One, remaining in the intensive care unit, saying: “The Trust is not prepared to offer Option 1, and none of the experts considered that this is appropriate. The court cannot order treatment for someone who does not have capacity any more than it can for someone who does not.”

She then stated that: “the prospects of K being able to obtain any benefit from a longer life and/or interaction with her family following a tracheostomy are too poor to outweigh the significant burdens that this will entail.”

Consequently, she ruled in favour of palliative care and extubation, even though it would “also carry with it the potential for distress and discomfort to K with symptoms that will require careful management. It will mean that the time with her family will be very short and realistically it seems there is no alternative to remaining in the ICU.”

Case C: comment

This case illustrates the influence of beliefs on family members who reportedly considered the patient to do better than predicted. They held this belief despite two other sisters dying from the same condition. Their beliefs were not discussed in Court, although they determined the family’s approach; I have recently published a blog post on beliefs and treatment decisions.

This case also considers an unavailable treatment; the patient had been ventilated using an endotracheal tube for about 11 days and

The case confirms the long-standing position that the Best Interests process cannot choose an unavailable treatment that the clinical team is not prepared to offer as an option.

The reasons for its unavailability were not explored. The judge accepted and did not question “The Trust’s case is that it is not prepared to offer option 1, a stance with which the other experts agree. To continue the status quo is against all accepted current practice as oral tracheal intubation is only used as a temporary measure. If breathing support is clinically indicated on longer term basis, a tracheostomy is the usual treatment.”

She added later, “… none of the experts considered that this [i.e. Option One] is appropriate. The court cannot order treatment for someone who does not have capacity any more than it can for someone who does not.”

This case suggests that the legal process accepts the decision if sufficient experts agree a treatment is unavailable. I am curious to know how a person or an advocate challenges this.

Case D: Boiled sweets – a medical treatment?

The Court of Appeal (Civil Division) heard the last case, [2023] EWCA Civ 885. It concerns a prisoner, JJ, who is quadriplegic and is fed by carers. He wishes to be given boiled sweets, biscuits, and crisps. The carers have been advised not to by a speech and language therapist.

The preamble noted that “The issue before the court is whether a medical professional is acting lawfully in restricting the foods which are to be offered to a patient because, in their medical opinion, to do so would expose the patient to a high risk of choking and aspiration which might lead to his death.

Put the other way around, is a patient entitled to demand medical treatment which is not clinically indicated and therefore not offered to him by the doctor?”

The patient has X-linked hypophosphataemia, is quadriplegic, and lacks teeth. “his physical capacity is limited to pushing a button with one finger. Since 2016 he has been bed-bound and wholly dependent on care staff for all his personal cares and for feeding. He is nursed in a supine position.”

Since 2016, he has had difficulties swallowing, and the care team were worried about choking and aspiration. In May 2021, a speech and language therapist considered that because he was fed supine, he was at high risk of aspiration and choking. Although he had not choked, he remained at high risk.

He has the mental capacity to decide. In December 2021, he made an Advance Decision to Refuse Treatment for cardiopulmonary resuscitation and ventilation.

Spectrum is the organisation employing his carers, and the written judgment notes that “In a letter dated 23 May 2022, Spectrum rehearsed the fact that the SALT specialists had said that JJ should not be given boiled sweets and that JJ wanted to be fed them contrary to their advice. Were JJ to die as a result of eating boiled sweets ‘or anything other than a ‘level 6’ soft diet’, the letter said, ‘the relevant individual could be at risk of both criminal proceedings and disciplinary proceedings’. The letter concludes by saying that whilst JJ is free to articulate his choice in the matter, ‘it is not an option available to him’.”

The original judge had “dismissed the claim on 30 September 2022, concluding that Spectrum’s feeding policy was rational, necessary, and proportionate given the clinical risks posed by reintroducing non-soft foods into JJ’s diet.”

The appeal judges noted, “The provision of food is treatment or care for the purposes of medical treatment decisions. Where, as here, the patient is unable to feed themselves, all foods such as boiled sweets are part of treatment or care.” This was established in the original judgement concerning the withdrawal of clinically assisted nutrition and hydration in people lacking mental capacity.

Lady Justice King wrote in this judgment: “JJ cannot feed himself. He cannot obtain boiled sweets from the prison shop, unwrap them and put them in his own mouth. The provision of boiled sweets in circumstances where JJ cannot even put a sweet into his mouth is different; it is treatment or care carrying with it the considerable risk that on any given day, giving JJ that boiled sweet may cause him to choke to death and in circumstances where JJs advance decision would prevent all but the most basic life-saving intervention on the part of the person who had given him the boiled sweet.

In my judgement the judge was right having considered the well-established authorities, to conclude that it was lawful for Spectrum to refuse to provide JJ with boiled sweets in those circumstances, and that had they done so and JJ had choked to death or suffered serious harm as a consequence of aspiration, they were at a more than fanciful risk of prosecution under regulation 12 CQC or in the criminal courts for gross negligence manslaughter.”

Case D: comment

This case adds another perspective. In this case, the plaintiff, JJ, put forward two arguments:

Autonomy
As a person, he could choose what he did and what others should do for him if he wanted them to. He did not think that Spectrum could overrule his autonomy.
Article 8 of the European Convention on Human Rights.
This states that “Everyone has the right to respect for his private and family life, his home and his correspondence.”

When faced with similar situations before, I have argued that the patient’s right to demand unsafe food must be balanced by the undoubted stress choking may cause the carer to suffer. I then say that we cannot expose carers to the moral harm of feeling responsible for another person’s suffering or death. So, I arrive at the same decision by a different route.

Until I read this judgment, I had not considered giving a person food directly into the mouth constituted treatment. The courts have clearly shown that there are limits on autonomy and human rights. The appeal court countered the argument on autonomy by finding the care medical treatment and accepting the clinical conclusion that this treatment was unavailable. The court cannot compel healthcare to provide a therapy deemed unavailable.

The Human Rights argument was dismissed because the convention allows exceptions in certain circumstances: “ … except such as is in accordance with the law … or for the protection of the rights and freedoms of others.” The likely legal consequences of any severe harm, including death, and the reaction of the Care Quality Commission and professional regulatory bodies were sufficient to allow an exception.

Discussion

These cases suggest helpful strategies for anyone facing a complex clinical decision or when the patient or their advocates do not accept a clinical decision.

First, obtain independent clinical advice from other suitable experts, especially if components of your decision are based on assumptions concerning activities undertaken by different specialists. For example, the availability of renal dialysis (Case B) partly depended on the availability of anaesthetic input. The evidence from the anaesthetists may have been quite significant in determining the outcome.

A component of getting others to review the situation is their advantage of avoiding pre-existing assumptions and taking a holistic overview. Judges often provide this, but many clinicians can also provide it. We would benefit from identifying a cadre of wise clinicians who are used to thinking about the most complex clinical problems.

Second, consider whether you are still determining whether a treatment is available for the specific patient in their situation or is in their best interests. The availability of a therapy will primarily rely on evidence of an acceptable risk-benefit ratio. In contrast, a best interests decision depends mainly on patient values, attitudes, and other personal factors, a construct I have already discussed.

If you decide a treatment is unavailable, you should be prepared to justify its unavailability without referencing it as not being ‘in their best interests’; the decision should apply to all patients in the same clinical situation.

Third, when faced with a patient asking for an aspect of the care you consider inappropriate, consider the degree of risk and, if high, consider whether the care is a medical treatment. This will mainly concern feeding at risk.

Conclusion

Reading judgments made on medical matters helps develop a better, more informed and consistent approach to analysing complex clinical problems. I started this post about seven days ago, and finding, reading, and thinking about the four cases has changed my understanding and, I hope, improved my ability to reach better and well-justified decisions. I have been writing this post for approximately 12 hours, which is not a quick way to learn, but I hope it will allow me to be more efficient when facing a challenging decision. I hope fewer of my choices will be questioned, and I respond positively when they are.

Quick links

Challenging clinical decisions

Table of Contents

Introduction

Making challenging clinical decisions.

Treatment availability