Sage Journals: Discover world-class research

Abstract

Doctors owe a legal duty of care to patients, of which legal standard of care, especially on advice, evolves over time. With the modified Montgomery test, informed consent involves a process of best interests decision-making accompanied by disclosure of relevant information in a comprehensible fashion, to the patient. Ethical issues confronting treatment decision and advice are also manifold and have to be confronted. For example, in amyotrophic lateral sclerosis (ALS), an incurable disease, death is usually due to respiratory failure. Tracheostomy ventilation (TV) may be the only alternative to death, yet patients on TV may be subject to the relentless progression of ALS resulting in a locked-in state. Through a case vignette of invasive ventilation for ALS, we examine the ethical and legal issues regarding choice of assisted ventilation in these patients, especially for TV, to ensure reasoned and defensible methodology in patient care. We also include a tracheostomy counselling info kit applicable for use prior to tracheostomy insertion.

Keywords

Best interests disclosure duty of care informed consent shared decision making standard of care advice amyotrophic lateral sclerosis tracheostomy ventilation

Introduction

Amyotrophic lateral sclerosis (ALS) is an incurable, gradual and progressive degeneration of motor neurons, which accounts for its four main symptoms: (i) limb weakness and muscle atrophy, (ii) dysphagia, (iii) dysarthria and (iv) respiratory difficulties.¹

In ALS, death is usually due to respiratory failure in the advanced stages of disease.^2,3 Such deaths can be delayed through assisted ventilation, either non-invasive ventilation (NIV) or invasive mechanical ventilation (IMV). Patients can receive care at home via either option.⁴ Assisted ventilation also improves sleep-related hypoventilation and daytime somnolence.⁵

IMV is usually prescribed when a patient refuses or is intolerant of NIV, e.g. when there is a large amount of secretions or in severe bulbar weakness.⁶ IMV provides more effective ventilator pressures and better gas exchange with less leakage of air than NIV,⁶ and also avoids NIV mask-related skin lesions and ulcerations.⁷ Most ALS patients requiring long-term ventilation will be put on tracheostomy ventilation (TV),⁸ a form of IMV where a tracheostomy tube is inserted for direct access to the lower respiratory tract.⁹

In advanced ALS, IMV via TV may be the only alternative to death; however, this also can result in a locked-in state.⁶ In part due to doctors’ diverse views, there is a wide variance in TV use worldwide,^10–14 even within regions of the same country.^15,16 The legal standard of care for doctors has also evolved over time. There is therefore a pressing need to examine the ethical and legal issues regarding informed consent for TV in ALS patients. Boxes 1 and 5 describe two parts of a case on which the following discussion is based.

Box 1.

First part of case description.

Mr Michael Tan*, a Chinese Singaporean aged 50, was recently diagnosed with ALS three months ago. Without a known history of respiratory insufficiency or dysphagia, he was admitted to our hospital for pneumonia. He was started on intravenous (IV) antibiotics and chest physiotherapy, which were not effective. Subsequently he required NIV intermittently and frequent respiratory care to cope with the respiratory secretions. A nasogastric tube was also inserted for feeding in view of concurrent dysphagia.
He continued to deteriorate over the next four weeks, requiring continuous NIV. He had copious amounts of secretions, which did not abate, and recurrent desaturations while off NIV. He was sent to the intensive care unit (ICU) for more intensive respiratory care, with a view to endotracheal intubation if he required further assistance in ventilation or secretion management. It was clear to the team that Mr Tan should be given a trial of endotracheal ventilation and not TV at that point, as his pneumonia may still have been reversible. However due to the underlying ALS, he might not be able to wean off mechanical ventilation should he be intubated.
Ultimately, the team determined that the primary cause for his severe respiratory failure was not the pneumonia but ALS itself. In assessing the appropriate treatment option for ALS, the views of Mr Tan and his primary caretaker were sought.
When asked about his values, beliefs and preferences, he said that he was a ‘fiercely’ independent person, and that family was most important to him. He was worried about the medical costs in the ICU (due to co-payment for healthcare bills in Singapore), and his biggest worry for the future was not to be a financial burden.
In another conversation, his wife mentioned that she was worried that if he required continuous nursing support she would have to quit her job and care for him, as the alternative of domestic help would cost more than her current earnings. Their teenage sons would be unable to care round-the-clock for him, as they were both attending school.
A multidisciplinary team meeting was convened to discuss the option of long-term IMV via tracheostomy, in the event that he could not be weaned off endotracheal ventilation. It was agreed that it would not be in Mr Tan’s best interests for the team to recommend TV, due to financial and social reasons (social reasons refers to actual or prospective caregivers). The team also took into account Mr Tan’s personal values and beliefs.
What remained was for the primary doctor to discuss the way forward with Mr Tan, and convey the team’s recommendation.
*Name and identifiers changed to protect confidentiality

Comment and analysis

The following questions need to be answered in considering treatment options for any patient: How should the team have come to a recommendation in the best interests of the patient? Is the doctor’s role to present options and his recommendation? Or is his role to present options without a recommendation, leaving the patient to decide? How much should the doctor elaborate on each option? Should the amount and extent of detail of information be determined absolutely or relatively? Should a doctor withhold information on an option that might not be available or suited to the patient given the doctor’s understanding of the patient’s situation? The legal issues pertaining to the case study define the boundaries of concern, and hence would be logically examined before the ethical issues.

Legal issues

Legal duty of care

A caregiver (professional or otherwise, such as a doctor) treating a patient owes a legal duty to the patient to take care and to act diligently towards him. This legal duty of care, as explained in Caparo Industries plc v. Dickman,¹⁷ arises when three elements are present between the parties: (1) it is foreseeable that a negligent act or omission by the first party (doctor/caregiver) can cause harm to the second party (patient), (2) there is sufficient proximity (legal term for the relationship as concluded from the facts) existing between the first party and the second party (whether from contractual, physical relationship or otherwise) and (3) it is just and reasonable to impose liability on the first party and there is no policy reason not to impose such liability.

These principles are universally recognised including in Singapore, as seen in Spandeck Engineering (S) Pte Ltd v. Defence Science & Technology Agency.¹⁸ Such duty and standard of care can apply to all areas of medical practice including caregivers. Using the doctor as an example, duty of care includes providing an accurate diagnosis, provision of safe and effective treatment, giving information on the disease and treatment and ensuring the patient understands, obtaining the consent of the patient throughout the relationship, and maintaining patient confidentiality. While the discussion below is in the context of doctors, it is applicable with modification for use in the context of other caregivers.

Legal test for breach of duty of care and standard of care: Bolam and Bolitho tests

Breach of the duty of care occurs when the doctor’s conduct falls below the standard expected by law. Initially, the standard expected by law for a doctor, was the Bolam test as seen in Bolam v. Friern Hospital Management Committee,¹⁹ meaning to act ‘in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art’.

The Bolitho test, as in Bolitho v. City and Hackney Health Authority,²⁰ refined the Bolam test by clarifying that in order to qualify as being representative of a ‘responsible’ body of medical opinion, the doctors or medical experts have to (1) consider the ‘comparative risks and benefits’ and (2) arrive at a ‘defensible conclusion’. These requirements removed the sovereignty of correctness of medical treatment away from the medical practitioners to the court. The Bolitho test also received judicial acceptance in other jurisdictions, such as Singapore in Khoo James, Dr and Another v. Gunapathy d/o Muniandy and Another. Appeal,²¹ where it was further clarified that ‘defensible’ meant that the medical opinion ‘must be internally consistent’, not contrary to ‘proven extrinsic facts’ of the matter, and must not ‘ignore or controvert known medical facts or advances in medical knowledge’.

Causation and damage

If the above is not observed and reasonably foreseeable harm occurs as a result of a breach of the duty of care, a doctor would be found negligent. In order to claim for the harm suffered, causation has to be proven, on a ‘balance of probabilities’, which entails demonstrating that there is a greater than 50% chance that the breach of duty caused the harm.²² If the doctor’s conduct caused harm, or was a necessary element in the chain of causation, the patient would receive damages. Damages would then be approximated using the principle of reasonable foreseeability,^23,24 which assesses whether the doctor could have reasonably foreseen that the breach of duty would have caused harm, and therefore should have taken more care to meet the standard of care.

Informed consent: the duty of care on advice

The law of Singapore adopts the view that ‘informed consent’ is subsumed under the rubric of duty of care and negligence.

The change of standard of care relating to advice through Montgomery v. Lanarkshire (‘Montgomery’)

We now turn to Montgomery which was a case which marked the change in the legal standard of care relating to advice.²⁵ Factually, Montgomery involved a pregnancy with a small increased the risk of shoulder dystocia in vaginal delivery. Although the patient had expressed concerns over safety of vaginal birth, her physician did not warn of the shoulder dystocia or offer the option of caesarean section. Ultimately, although the medical manoeuvres were correctly performed, shoulder dystocia still occurred with morbidity to the neonate. The patient told the court that if she had been told about shoulder dystocia, unlikely as it was, she would have chosen caesarean birth, which would have avoided such injury. She was awarded 5.25 million pounds for the doctor’s negligence.

The Supreme Court in Montgomery raised 6 main points: that the doctor’s duty is to (1) ensure that the ‘patient understands the seriousness of her condition’; (2) ‘take reasonable care’ to ensure that the patient is aware of ‘any material risks involved in any recommended treatment’ and (3) ‘any reasonable alternative or variant treatments’; (4) ensure that the ‘information provided is comprehensible’. The court also said (5) that the patient should take ‘responsibility for the ultimate choice to undergo that treatment’. To avoid abuse of this new principle, (6) a ‘therapeutic exception’ was introduced such that the doctor is legally entitled to withhold information from the patient as to a risk ‘if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health’, or ‘in circumstances of necessity … where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision’.

The test of what constitutes a material risk has been revised to that of ‘a reasonable person in the patient’s position’ ‘in the circumstances of the particular case’ or if the doctor can reasonably foresee that ‘the particular patient would be likely to attach significance to it’ ‘so that she is then in a position to make an informed decision’.

The shift to the ‘reasonable patient’ from the ‘reasonable doctor’ thus represents a movement away from paternalistic decision-making by the doctor.

Hii Chii Kok v. Ooi Peng Jin London Lucien and another: modified Montgomery test

Montgomery has since received judicial acceptance elsewhere; in Singapore in Hii Chii Kok v. Ooi Peng Jin London Lucien and another,²⁶ a three-stage inquiry on the standard of care on advice (the modified Montgomery test) was set out: (1) the patient must identify the exact nature of the information not disclosed and why it would be regarded as relevant and material to him. (2) The Court must then determine whether the doctor was in possession of such information, and if so (3) the Court must then examine the reasons why the doctor chose to withhold such information from the patient to see if legal excuse could be found. The Court also emphasised that in the event of future disputes, future courts/judges should guard against hindsight and outcome bias.

From the case, it is established that doctors should inform the patient of information relevant and material to a reasonable patient in the patient’s condition, and information that a doctor would know (from interaction with the patient) to be important to that particular patient. As examples, these include diagnosis of the underlying condition, prognosis with or without treatment, nature and risks of treatment options and their alternatives. However the doctor is also not expected to flood the patient with information to such an extent as to confuse the patient and make them less able to make a decision.

The judgement clarified that there was no change in the standard of care outside of advice. Should the doctor not be in possession of the above-mentioned information he would be judged on whether he was negligent in not obtaining the information, after Bolam¹⁹ and Bolitho²⁰. However ‘the doctor has no open-ended duty to proactively elicit information from the patient, and will not be at risk of being found liable owing to idiosyncratic concerns of the patient unless this was made known to the doctor or the doctor has reason to believe it to be so’.

Best interests decision-making

The judgements in Montgomery v. Lanarkshire and Hii Chii Kok v. Ooi Peng Jin London Lucien and another reflect present judicial mind-sets that a patient is usually considered the best judge of his own interests,^25,26 though there may be exceptional circumstances where he lacks the ability to make such a decision. Under the Singapore Mental Capacity Act (MCA), section 5(1), a person with capacity is expected to be able to (1) ‘understand the information relevant to the decision’, (2) ‘retain’ it, (3) ‘use or weigh that information as part of the process of making the decision’ and (4) ‘communicate (whether by talking, using sign language or any other means)’ it back to the doctor.

In cases where the patient is incapable of making his own decision, section 3(5) of MCA states that ‘an act done or decision made … for or on behalf of a person who lacks capacity must be done or made, in his best interests’. Where there is mental incapacity, steps to take to decide on a patient’s best interests as in as in section 6 of the MCA are shown in Box 2.

Box 2.

Determination of best interests as set out in section 6 of the Singapore MCA.

(1) In determining for the purposes of this Act what is in a person’s best interests, the person making the determination must not make it merely on the basis of:
a. the person’s age or appearance, or
b. condition of his, or an aspect of his behaviour, which might lead others to make unjustified assumptions about what might be in his best interests.
(2) The person making the determination must consider all the relevant circumstances and, in particular, take the following steps specified in subsections (3) to (8).
(3) He must consider:
a. whether it is likely that the person will at some time have capacity in relation to the matter in question, and
b. if it appears likely that he will, when that is likely to be.
(4) He must, so far as reasonably practicable, permit and encourage the person to participate, or to improve his ability to participate, as fully as possible in any act done for him and any decision affecting him.
(5) Where the determination relates to life-sustaining treatment he must not, in considering whether the treatment is in the best interests of the person concerned, be motivated by a desire to bring about his death.
(6) Where the determination relates to the disposition or settlement of the person’s property, he must be motivated by a desire to ensure, so far as is reasonably practicable, that the person’s property is preserved for application towards the costs of the person’s maintenance during his life.
(7) He must consider, so far as is reasonably ascertainable:
a. the person’s past and present wishes and feelings (and, in particular, any relevant written statement made by him when he had capacity),
b. the beliefs and values that would be likely to influence his decision if he had capacity, and
c. the other factors that he would be likely to consider if he were able to do so.
(8) He must take into account, if it is practicable and appropriate to consult them, the views of:
a. anyone named by the person as someone to be consulted on the matter in question or on matters of that kind,
b. anyone engaged in caring for the person or interested in his welfare,
c. any donee of a lasting power of attorney granted by the person, and
d. any deputy appointed for the person by the court,
as to what would be in the person’s best interests and, in particular, as to the matters mentioned in subsection (7).
(9) The duties imposed by subsections (1) to (8) also apply in relation to the exercise of any powers which:
a. are exercisable under a lasting power of attorney, or
b. are exercisable by a person under this Act where he reasonably believes that another person lacks capacity.
(10) In the case of an act done, or a decision made, by a person other than the court, there is sufficient compliance with this section if (having complied with the requirements of subsections (1) to (8)) he reasonably believes that what he does or decides is in the best interests of the person concerned.

Ethical issues

In medical ethics, a ‘four principles plus scope’ approach has been developed based on the four prima facie moral principles – respect for autonomy, beneficence, non-maleficence and justice.^27,28 These four moral principles are expected to be of universal application, regardless of personal philosophy, politics or religion. Ethical dilemmas in Mr Tan’s case arise under these four principles. Each will be explained and examined in turn.

How should the team have come to a recommendation in the best interests of the patient?

Returning to Mr Tan, bearing in mind the legal principles discussed, the team could fulfil their legal duty of care by performing the following: evaluating his treatment options including withholding of treatment, in accordance with practice accepted by a respectable body of similar professionals, up to date and currently practiced (Bolam test).¹⁹ The team then could present the relevant options and make a recommendation which the patient can then seek more clarification about if he/ she chooses, before making a decision. To come to a recommendation, they should consider the benefits and risks including long-term harms of each option (specific to the patient), and weigh their importance to the patient. For assessing the importance of benefits and risks to the patient, we recommend considering, as per the MCA, the patient’s past and present wishes and feelings, beliefs and values likely to influence his decision, and other factors that he would be likely to consider, although these were meant to apply only when the patient does not have capacity. Ultimately the medical conclusion on the recommendation as well as options should be defensible by reason (Bolitho test).²⁰ The benefits and risks specific to TV in ALS patients are summarised in Box 3. Further, in Box 4, we propose a tracheostomy counselling info kit that consolidates advice for patients prior to TV that is indicative of what the team could have used.

Box 3.

Benefits and risks specific to TV for ALS patients.

Benefits	Risks
Survival
TV could prolong survival for more than 10 years in almost 10% of cases.²⁹	This prolonged survival also results in a greater likelihood of the eventual progression to a ‘locked-in’ state,⁶ with the patient losing all methods of conventional communication, including eye movements, and being totally dependent on others for survival.
Speech
TV does not preclude speech. In patients with adequate lung capacity whose speech was still intelligible prior to the procedure, voice can be enabled by allowing them to breathe through a fenestrated tracheostomy tube, with the inner cannula removed, cuff deflated, and the normal passage of air occluded. This produces phonation by permitting air to pass by the vocal cords,³⁰ and can also be facilitated using a (one-way) speaking valve which closes upon exhalation therefore occluding the normal passage of air, causing a redirection of exhaled air into the upper airway.³¹	Due to the relentless progression of the underlying neurodegenerative disease, patients would eventually lose verbal speech.⁶
Eating
Oral feeding is also possible with a tracheostomy in situ,³² in patients without previous swallowing impairment. The tracheostomy itself could predispose patients to dysphagia,³³ although this may be reversible and therefore requires a Speech Therapist assessment.^34,35	Due to the reduced nasal breathing as a result of the tracheostomy, patients may also have reduced smell and taste.³⁶ Due to the relentless progression of the underlying neurodegenerative disease, patients would eventually lose swallowing capabilities.⁶
Secretion management
Apart from facilitating ventilation, tracheostomy tubes are also optimal for suctioning of secretions.³⁷ Suctioning of subglottic secretions minimises aspiration past the cuff, and thus decreases the risk of ventilator-associated pneumonia.³⁰ Tracheostomy may be necessary for secretion clearance in patients with severe bulbar dysfunction and who are unable to achieve effective peak cough flow even with mechanically assisted cough.³⁸	It generates more bronchial secretions; and there is an increased risk of infection.⁶ Uncuffed tubes are used unless it is necessary to use a cuffed tube due to excessive air leak and hypoventilation.³⁹ This is because cuffed tubes have higher complication rates than uncuffed tubes such as Gram-negative colonisation with local infection, atelectasis and pneumonia; tracheoesophageal fistula, granulation formation and tracheal stenosis, tracheomalacia; haemorrhage, pneumothorax and subcutaneous emphysema.⁵
Quality of life
With mobile ventilators and medical support, it is possible for patients with tracheostomy to be at home, the preferred place of care for many.⁴⁰ In terms of quality of life, patients in general reported a satisfactory quality of life, despite severe limitation in activity,^8,41 likely due to their ability to adapt with change and their spirituality.⁹ Over 80% of patients said they would choose TV again and would advise other patients to do the same.⁴¹	However, improvements in quality of life after TV have not been seen despite more effective ventilation.⁴² The quality of life of as many as 30% of their caregivers has been self-rated as lower than that of their patient’s, with only 50% of their caregivers keen to consider TV for themselves.⁴¹ Caregiving is resource-intensive, and a full-time commitment by well trained personnel, with up to 14.4 hours per day of patient care and waking up of an average of 2.4 times per night.⁴¹ Caregivers who fared better were those with other paid carers to look after the patient most of the time, allowing the family members time for other activities.⁴³
Tracheostomy
	Complications are generally rare with tracheostomy, although there would be surgical and anaesthesia risks as with most other surgeries. The risk of death from tracheostomy is <1%.⁴⁴ The most common risks include bleeding and infection (5%), and rarely (<1%), early complications such as subcutaneous emphysema, pneumothorax, oesophageal perforation, recurrent laryngeal nerve injury, and dislodgement and/or blockage of the tracheostomy tube which may cause hypoxia; and late complications such as tracheal stenosis and trachea-cutaneous fistula formation. Although these figures were derived from a Singapore-based tracheostomy patient information sheet used in the Singapore General Hospital, the risks estimates are similar to that currently used in University College London Hospital in the UK, with the exception of more modest estimates in terms of dislodgement of the tube (<3%), hypoxia (1%), and tracheal stenosis (<3%).

Box 4.

Tracheostomy counselling info kit.

What is tracheostomy ventilation (TV)? TV is a form of invasive mechanical ventilation (IMV) where a tracheostomy tube is inserted for direct access to the lower respiratory tract.⁹ What are the complications of tracheostomy insertion? Complications are generally rare with tracheostomy, although there would be surgical and anaesthesia risks as with most other surgeries. The risk of death from tracheostomy is <1%.⁴⁴ The most common risks include bleeding and infection (5%), and rarely (<1%), early complications such as subcutaneous emphysema, pneumothorax, oesophageal perforation, recurrent laryngeal nerve injury, and dislodgement and/or blockage of the tracheostomy tube which may cause hypoxia; and late complications such as tracheal stenosis and trachea-cutaneous fistula formation.What are the indications for TV? TV is usually prescribed when a patient refuses or is intolerant of non-invasive ventilation (NIV) for example when there is a large amount of secretions or in severe bulbar weakness.⁶ What are the benefits of TV? - TV prolongs survival in patients who would otherwise pass on from respiratory failure.- TV provides more effective ventilator pressures and better gas exchange with less leakage of air than NIV.⁶ - TV avoids NIV mask-related skin lesions and ulcerations.⁷ - TV provides better secretion clearance compared to NIV.^30,37,38 - TV patients in general reported a satisfactory quality of life, despite severe limitation in activity.^8,41 What are the risks of TV? - Despite the prolongation of survival, patients whose respiratory failure is due to a progressive neurodegenerative disease would have its underlying neurodegenerative process continue, giving rise to the possibility of a locked-in state,⁶ with the patient losing all methods of conventional communication, including eye movements, and being totally dependent on others for survival.- Although patients with adequate lung capacity can initially speak as long as air passes by the vocal cords,³⁰ speech might eventually be lost in patients as the underlying neurodegenerative process continues to progress- Although patients could initially swallow, swallowing capability might eventually be lost in patients with an underlying neurodegenerative process.⁶ - Patients may have reduced smell and taste due to the reduced nasal breathing.³⁶ - Although TV provides better secretion clearance compared to NIV, there is still an increased risk of pneumonia due to more bronchial secretions being generated.⁶ The sensation of shortness of breath may persist despite adequate ventilation.- The quality of life of as many as 30% of TV caregivers has been self-rated as lower than that of their patient’s, with only 50% of their caregivers keen to consider TV for themselves (vs 94% of the NIV caregivers).⁴¹ - Caregiving is resource intensive:⁴¹ with TV patients requiring secretion clearance 2–4 hourly. If a patient requires maximum assistance, the patient will require at least two full-time caregivers. If the patient requires minimal assistance, one full-time caregiver might be adequate.- The expected care needs required are: suctioning, learning the patient’s response especially if the patient is unable to speak clearly, basic hygiene, and mobilising the patient. The expected cost is 2000–3000 SGD/month. An alternative to home care is institutionalisation at a Voluntary Nursing Home which costs about 2000–3000 SGD/month (for basic), while a Private Nursing Home costs about 5000–8000 SGD/month (The nursing home charges indicated excludes consumables). The quality of care may be lower in Nursing Homes due to lower caregiver (nurse) to patient ratio. Currently, few Nursing Homes are equipped to care for TV patients.Other equipment required by TV patients would include: hospital bed, home ventilator, oxygen concentrator, suctioning equipment, and cough assist machine (about 20,000 SGD to procure). Subsidies are available based on means testing. Alternative equipment would be second hand equipment though these are in short supply. The costs of servicing of equipment would require few hundreds to thousands SGD.

Justice

Rights-based justice (respect for people’s rights)

In considering the treatment options, the patient’s rights must be respected, even if personally disapproved of by the doctor concerned. Similarly, the doctor’s personal views on the benefits or risks of treatment options cannot obscure the patient’s right to choose, where the patient has mental capacity.

Distributive justice (fair distribution of scarce resources)

Ideally all ALS patients should have access to TV if they need it. However, this also requires resources of personnel, equipment, and services that can support an intensive level of care. The hefty costs of TV demand distributive justice in a world of finite resources. Although all criteria for horizontal (equal access by all ALS patients) and vertical (more access for ALS patients versus the general public because they need it more) equity can be morally justified, not all can be met simultaneously. However, the issue of distributive justice is beyond the scope of this essay.

Autonomy (right of the patient to choose/self-rule)

How much should the doctor elaborate?

As emphasised in Montgomery and the modified Montgomery test,^25,26 the principle of autonomy, also referred to as ‘deliberate self-rule’,²⁸ is respected in the process of advice. The doctor has to elaborate as much as is required for a reasonable patient with capacity to make the decision voluntarily.

As clarified in the modified Montgomery test,²⁶ unless in the exceptional case that particular disclosure would be extremely damaging to Mr Tan’s health, the doctor ought to provide comprehensible information to ensure that Mr Tan is aware of his diagnosis, prognosis with and without treatment, nature of the proposed treatment, and the material and relevant risks involved in each treatment option and their probabilities, enabling Mr Tan to make an informed decision. The certainty of hastened death should Mr Tan decide to go with the recommendation of withholding tracheostomy has to be clearly conveyed. Mr Tan would then be expected to communicate his decision to the team of doctors, and bear the responsibility of the decision that he has voluntarily made, although he is at liberty to revoke his decision as long as he has mental capacity.

Is the doctor’s role to present options and his recommendation? Or is his role to present options without a recommendation, leaving the patient to decide?

The modified Montgomery test suggests that the doctor should advise on a proposed medical treatment, thereby make a recommendation.²⁶ This does not compromise autonomy, as autonomy can be considered on a spectrum, representing a spread of difference in degree of autonomy, as opposed to a difference in kind. In the face of information asymmetry, with the doctor’s professional experience and knowledge of the experiences of other similar patients, the doctor is in the better position to make an informed recommendation and to defend such a recommendation. This partnership process of shared decision-making if done well,⁴⁵ allows the patient to decide as if he had been imbued with all the necessary medical foreknowledge and experience (contributed to by capable explanation and proper analysis by the doctor).

Another reason for the doctor to make a recommendation is the question of voluntariness, and its difference in degree, in the patient who could be under coercive pressure, as he has to make a decision on which his life hangs upon. News of a possible imminent demise could cause distress and skew the patient’s objectivity in decision-making and leave weak-willed people paralysed in the decision-making process. This might be a reason why up to 13% of palliative care patients, albeit in Western contexts,⁴⁶ chose to delegate the responsibility of decision making to their doctor, waiving their consent. This is also a reminder that patients should be consulted on how much they want to know, and how much participation they want to have, before embarking on disclosure to facilitate a decision-making process.

However, although patients like Mr Tan would be medically (being ill and dependent on healthcare) and institutionally (being inpatients) vulnerable to making the ‘right’ decision, in other words, being considered unable to decide rationally given their illness/being in a hospital environment where they are not in control; vulnerability does not necessarily preclude voluntariness. The decision Mr Tan makes during such difficult circumstances could nevertheless be genuine, free of interference from irrelevant concerns,⁴⁷ congruent with his personality and expressive of his character.⁴⁸

As medical paternalism could be more rampant in Mr Tan’s case,⁴⁹ given that Confucianism is one of the main influencing forces in the Chinese culture, it is important to present options, as the choice is likely to stop patients from automatically accepting what doctors recommend, in turn distinguishing informed consent from informed compliance.

Lastly, it would also be critical to conduct the discussion not only with Mr Tan, but also his key family caregivers who would be taking care of him. Patients’ and caregivers’ opinions may differ,⁵⁰ and it would not only enhance patient-centred care but also minimise unwanted impact of his decision on his family members.⁵¹ Mr Tan’s interests are also served by considering the interests of those who he cares about, as one’s autonomy is to be respected so far as it does not encroach on another’s.

Trial of treatment option

Other than the option of whether or not to take up TV, another option is withdrawal of TV following a trial.

Despite the lack of moral difference between withdrawing and withholding, there are emotional, religious and cultural differences that make withdrawing treatment such as TV more difficult than withholding,⁵² and vice versa. Some view withdrawal as a form of suicide such that it is illegal to stop ventilation support in Italy.⁵³ In Singapore where withdrawal is not viewed as suicide, as the cause of death remains the underlying advanced neurological disease, and hence is not illegal, the patient’s and his family’s religious and moral convictions on life sustenance may nevertheless make withholding more difficult than withdrawal. Given their Chinese cultural environment and Confucian values,⁵⁴ Mr Tan’s children may feel an obligation to do, and be seen to do, their utmost for their parent,⁵⁵ to fulfil filial piety as an appreciation for the care they had received, and to avoid disapproval from the rest of their community.⁵⁶ The team therefore needs to ensure that Mr Tan’s children do not exert coercive influence and reduce his autonomy for their own interests.

Symptom control

Regardless of whether Mr Tan chooses TV, palliative care strategies for symptom control should be instituted. His fears should also be explored, including reassuring regarding the low likelihood of choking or suffocating to death.⁵⁷

Should a decision on withdrawal of TV be made, the patient should also receive palliative care.⁵⁸

Advance care planning

Patients who decide on withdrawal after a trial of TV would need to discuss the circumstances for withdrawal especially when capacity is lost. This was most commonly defined as the condition of, apart from that of permanent unconsciousness, when the ability to communicate is lost.⁵⁹ Patients should make their wishes known early, or decide whom they would like to delegate their decisions to in the future when they lose capacity. The need for advance care planning (ACP) is underscored by the high incidence of cognitive impairment in as many as 50% of ALS patients.⁶⁰

Even if the patient is unable to make a decision before capacity is lost, the process of discussion allows the doctor to build up an understanding of what the patient’s preferences may be, and make the doctor better informed in the best interests decision-making process. ACP therefore is a process of communication that gives patients a higher chance at avoiding interventions that they would not have wanted.⁵⁹

Although decisions made in advance directives were usually stable over time,^50,61 advanced decisions are less accurate than contemporaneous decisions, due to an affective forecasting error of quality of life in future health status by healthier people who rate more negatively than when they become ill. This is explained by the prospect theory, which suggests that two prospects, for example, total dependence or death, would be more easily told apart the more imminent they are.⁶²

The unpredictable disease course indicates that decisions have to be made in a cyclical fashion, as symptoms change,⁶³ and as patients go through life-stage transitions.⁶⁴ Patients should also be reassured that as long as they have capacity and are able to communicate, they can change their mind.

What if TV is not an option?

Consent taking also needs to be distinguished from giving explanation, in which there is no decision making required from the patient, for example where TV is not medically or distributively viable. For example, if the medical team had decided that tracheostomy was out of the question for Mr Tan for certain reasons, an explanation on why tracheostomy is not available to him should be given, instead of embarking on an informed consent process, and recommending that he refuse to give consent for tracheostomy when he has no other choice. This will assist Mr Tan in understanding the medical team’s decision-making process and help him consider if he would reach the same conclusion. As one’s right to autonomy is restricted by the options available, when there are no options available, be it due to cultural, legal, health policy or financial reasons, an explanation, rather than consent, should be offered.

Withholding information

Respect for autonomy also includes the right not to be lied to, also known as truth telling, as a patient needs to believe the information given to use the information to come to a decision. Trust builds a collaborative relationship that enhances autonomy.⁶⁵ As in Montgomery,²⁵ a doctor is only is legally entitled to withhold information from the patient ‘if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health’.

The decision to withhold information would also have to be weighed against possible consequences should the non-disclosure be discovered. There could be a loss of trust by the patient and loss of public trust in health care professionals. For the professional involved, emotional distress may be incurred from the difficult task of balancing the potential harms and benefits of deliberate omission of information, or regulation of self-bias.⁶⁶

Justifications for withholding should outweigh the objections to disclosure, and be consistent with Mr Tan’s consent to non-disclosure if he had been aware of the facts.⁶⁶ As mentioned previously, such conduct needs to be defensible at a hearing of the professional body or at the court of law.^25,66

Beneficence (to do good, other things being equal) and non-maleficence (to avoid harm, other things being equal)

The principles of beneficence and non-maleficence are inextricable from autonomy. It has been demonstrated that doctors can only act in the patients’ best interests, doing good and not harm, by knowing the patients’ wishes. Further, the act of empowerment, a beneficent act that shifts patients from an external health locus of control to an internal locus, enhances autonomy by enabling patients to be more in control of their own health and health care when they believe that the choice to accept or refuse a recommendation is ultimately theirs. Thus, patients who made the decision of starting TV, either on their own or together with their family, did not regret their decision.⁶⁷

Conclusion

We have explained the elements of the tort of negligence and the evolution of the legal duty and standard of care of a doctor from acceptance by peers, to representation of a responsible body of medical opinion that is logically defensible. In relation to advice, there is further shift in the legal standard of care from the ‘reasonable doctor’ to the ‘reasonable patient’. The standard of care recommended of a doctor now extends to ensuring relevant and comprehensible information is provided to the patient, in order that the patient may make an informed decision which he will take responsibility for. In considering what constitutes relevant information, the patient’s best interests may be considered as per the decision-making process under the MCA. We therefore find that the process of informed consent in Singapore can be understood as a process of best interests decision-making coupled with relevant disclosure of information (see Box 5).

Box 5.

Second part of case description.

After verifying with Mr Tan that he would like his wife to be present during shared decision-making on his care, the doctor held a family conference and updated Mr Tan and his wife on the current diagnosis of severe pneumonia on the background of ALS, its prognosis with and without TV, and the recommendation of withholding TV should he be unable to wean off IMV, the options would be withdrawal of ventilation, TV, or a trial of TV followed by withdrawal. The doctors had offered TV as an option, but pointed out it may not be in Mr Tan’s best interests to do so for financial and social reasons based on their understanding. The doctor presented the benefits and risks including long term harms of each option, and ensured that they had understood what he meant to say. The certainty of hastened death should Mr Tan decide to go with the recommendation of withholding tracheostomy was clearly conveyed. Mr Tan and his wife made a joint decision to withhold TV, in the event of prolonged intubation, and reinforced that they would like Mr Tan’s death to be as comfortable as possible.Fortunately, Mr Tan did not require intubation, and was discharged home with NIV following recovery from the pneumonia. His underlying ALS continued to progress, and he and his wife persisted in their decision not for TV. He subsequently passed on 6 months later.

Footnotes

Acknowledgements

We would like to thank Lydia Soon Hse Yin, Yingxiang Khoo and Rob George for their assistance and guidance in this research.

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Availability of data

Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.

Authors’ contributions

KA and LMY researched literature and wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript

Conflict of interest

The authors declare that there are no conflicts of interest.

Informed consent

Not applicable

Ethical approval

Not applicable

Author Biographies

Dr Ang Kexin joined the Neurology department at the National Neuroscience Institute (NNI) in 2010. There, she developed a keen interest in improving the lives of patients with long term neurological conditions. In 2015, during her HMDP training, she completed a Master’s in Palliative care at the Cicely Saunders Institute in London, as well as various attachments in Palliative care in the UK. She is currently leading the NNI Neuro-palliative service that was started in 2016.

Lim Ming Yi has practised law since 2006 and was with a big four law firm for the first 6 years of his career where he worked with 4 Senior Counsels, with an additional 2 year stint in the Attorney-General’s Chambers, before returning to practice with I.N.C. Law LLC. He specialises in litigation and also provides advisory and corporate/transactional work to institutional and individual clients alike. He currently heads the litigation practice at I.N.C. Law LLC which he developed from scratch after his joining.

Dr Sheila Srinivasan has been employed at National Neuroscience Institute (NNI) since 2011 and is currently actively involved in care of patients in general neurology and epilepsy. She has recently completed an overseas training (HMDP) at Duke University Hospital on intraoperative neurophysiological monitoring and is leading the Epilepsy and Intraoperative monitoring service at NNI.

References

Kiernan

Vucic

Cheah

, et al. Amyotrophic lateral sclerosis. Lancet 2011; 377: 942–955.

Radunovic

Annane

Rafiq

, et al. Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease. Cochrane Database Syst Rev 2013; 3: CD004427

Roche

Rojas-Garcia

Scott

, et al. A proposed staging system for amyotrophic lateral sclerosis. Brain 2012; 135: 847–852.

King

AC.

Long-term home mechanical ventilation in the United States. Respir Care 2012; 57: 921–932.

Pinto

Carvalho

Breathing new life into treatment advances for respiratory failure in amyotrophic lateral sclerosis patients. Neurodegener Dis Manag 2014; 4: 83–102.

Andersen

Abrahams

Borasio

, et al. EFNS guidelines on the clinical management of amyotrophic lateral sclerosis (MALS): revised report of an EFNS task force. Eur J Neurol 2012; 19: 360–375.

Heritier Barras

Adler

Iancu Ferfoglia

, et al. Is tracheostomy still an option in amyotrophic lateral sclerosis? Reflections of a multidisciplinary work group. Swiss Med Wkly 2013; 143: w13830.

Vianello

Arcaro

Palmieri

, et al. Survival and quality of life after tracheostomy for acute respiratory failure in patients with amyotrophic lateral sclerosis. J Crit Care 2011; 26: 329.e7-329.e14.

Morris

Whitmer

McIntosh

Tracheostomy care and complications in the intensive care unit. Crit Care Nurs 2013; 33: 18–30.

10.

Bae

Hong

Baek

, et al. Current status of the diagnosis and management of amyotrophic lateral sclerosis in Korea: a multi-center cross-sectional study. J Clin Neurol 2012; 8: 293–300.

11.

Ritsma

Berger

Charland

, et al. NIPPV: prevalence, approach and barriers to use at Canadian ALS centres. Can J Neurol Sci 2010; 37: 54–60.

12.

Tollefsen

Midgren

Bakke

, et al. Amyotrophic lateral sclerosis: gender differences in the use of mechanical ventilation. Eur J Neurol 2010; 17: 1352–1357.

13.

Vender

Mauger

Walsh

, et al. Respiratory systems abnormalities and clinical milestones for patients with amyotrophic lateral sclerosis with emphasis upon survival. Amyotroph Lateral Scler 2007; 8: 36–41.

14.

Borasio

Gelinas

Yanagisawa

Mechanical ventilation in amyotrophic lateral sclerosis: a cross-cultural perspective. J Neurol 1998; 245: S7–S12.

15.

Spataro

Bono

Marchese

, et al. Tracheostomy mechanical ventilation in patients with amyotrophic lateral sclerosis: clinical features and survival analysis. J Neurol Sci 2012; 323: 66–70.

16.

Chio

Calvo

Ghiglione

, et al. Tracheostomy in amyotrophic lateral sclerosis: a 10-year population-based study in Italy. J Neurol Neurosurg Psychiatry 2010; 81: 1141–1143.

17.

Caparo Industries plc v. Dickman. [1990] 2 AC 605.

18.

Spandeck Engineering (S) Pte Ltd v. Defence Science & Technology Agency. [2007] 4 SLR 100.

19.

Bolam v. Friern Hospital Management Committee. [1957] 1 WLR 528.

20.

Bolitho v. City and Hackney Health Authority. [1988] AC 232.

21.

Khoo and another v. Gunapathy and another. Appeal. [2002] 2 SLR 414.

22.

Quan

Chew

LSC

Goh

, et al. Essentials of medical law. Singapore: Thomson Sweet & Maxwell Asia, 2004, p. 374.

23.

Overseas Tankship (U.K.) Ltd. v. Morts Dock and Engineering Co. [1961] AC 388.

24.

Overseas Tankship (U.K.) Ltd. v. Miller Steamship Co. Pty. Ltd. [1967] 1 AC 617.

25.

Montgomery v. Lanarkshire. [2015] UKSC 11.

26.

Hii v Ooi, Lucien and another [2017] SGCA 38.

27.

Beauchamp

Childress

Principles of biomedical ethics. 3rd ed. Oxford: Oxford University Press, 1989, p.470.

28.

Gillon

Medical ethics: four principles plus attention to scope. BMJ 1994; 309: 184–188.

29.

Hayashi

Oppenheimer

EA.

ALS patients on TPPV: totally locked-in state, neurologic findings and ethical implications. Neurology 2003; 61: 135–137.

30.

Hess

DR.

Tracheostomy tubes and related appliances. Respir Care 2005; 50: 497–510.

31.

Lichtman

Birnbaum

Sanfilippo

, et al. Effect of a tracheostomy speaking valve on secretions, arterial oxygenation, and olfaction: a quantitative evaluation. J Speech Lang Hear Res 1995; 38: 549–555.

32.

Rodrigues

Machado

Chiari

, et al. Swallowing rehabilitation of dysphagic tracheostomized patients under mechanical ventilation in intensive care units: a feasibility study. Rev Bras Ter Intensiva 2015; 27: 64–71.

33.

Goldsmith

Evaluation and treatment of swallowing disorders following endotracheal intubation and tracheostomy. Int Anesthesiol Clin 2000; 38: 219–242.

34.

Ceriana

Carlucci

Schreiber

, et al. Changes of swallowing function after tracheostomy: a videofluoroscopy study. Minerva Anestesiol 2015; 81: 389–397.

35.

Ding

Logemann

JA.

Swallow physiology in patients with trach cuff inflated or deflated: a retrospective study. Head Neck 2005; 27: 809–813.

36.

Tsikoudas

Barnes

White

. The impact of tracheostomy on the nose. Eur Arch Otorhinolaryngol 2011; 268: 1005–1008.

37.

Bach

Amyotrophic lateral sclerosis: communication status and survival with ventilatory support. Am J Phys Med Rehab 1993; 72: 343–349.

38.

Sancho

Servera

Diaz

, et al. Home tracheotomy mechanical ventilation in patients with amyotrophic lateral sclerosis: causes, complications and 1-year survival. Thorax 2011; 66: 948–952.

39.

Sancho

Servera

Banuls

, et al. Prolonging survival in amyotrophic lateral sclerosis: efficacy of noninvasive ventilation and uncuffed tracheostomy tubes. Am J Phys Med Rehab 2010; 89: 407–411.

40.

Woodman

Baillie

Sivell

The preferences and perspectives of family caregivers towards place of care for their relatives at the end-of-life. A systematic review and thematic synthesis of the qualitative evidence. BMJ Support Palliat Care 2016; 6: 418–429.

41.

Kaub-Wittemer

van Steinbuchel

Wasner

, et al. Quality of life and psychosocial issues in ventilated patients with amyotrophic lateral sclerosis and their caregivers. J Pain Symptom Manage 2003; 26: 890–896.

42.

Rousseau

Pietra

Blaya

, et al Quality of life of ALS and LIS patients with and without invasive mechanical ventilation. J Neurol 2011; 258: 1801–1804.

43.

Veronese

Valle

Chio

, et al. The last months of life of people with amyotrophic lateral sclerosis in mechanical invasive ventilation: a qualitative study. Amyotroph Lateral Scler Frontotemporal Degener 2014; 15: 499–504.

44.

Simon

Metschke

Braune

, et al. Death after percutaneous dilatational tracheostomy: a systematic review and analysis of risk factors. Crit Care 2013; 17: R258.

45.

Towle

Godolphin

Framework for teaching and learning informed shared decision making. BMJ 1999; 319: 766–771.

46.

Belanger

Rodriguez

Groleau

Shared decision-making in palliative care: a systematic mixed studies review using narrative synthesis. Palliat Med 2011; 25: 242–261.

47.

Janssens

Gordijn

Clinical trials in palliative care: an ethical evaluation. Patient Educ Couns 2000; 41: 55–62.

48.

Agrawal

Voluntariness in clinical research at the end of life. J Pain Symptom Manage 2003; 25: S25–S32.

49.

Tsai

DF.

Ancient Chinese medical ethics and the four principles of biomedical ethics. J Med Ethics 1999; 25: 315–321.

50.

Stutzki

Schneider

Reiter-Theil

, et al. Attitudes toward assisted suicide and life-prolonging measures in Swiss ALS patients and their caregivers. Front Psychol 2012; 3: 443.

51.

Hogden

Greenfield

Nugus

, et al. What influences patient decision-making in amyotrophic lateral sclerosis multidisciplinary care? A study of patient perspectives. Patient Prefer Adher 2012; 6: 829.

52.

Blackhall

Frank

Murphy

, et al. Ethnicity and attitudes towards life sustaining technology. Social Sci Med 1999; 48: 1779–1789.

53.

Spataro

La Bella

Ethical issues: invasive ventilation in amyotrophic lateral sclerosis. BMJ Support Palliat Care 2012; 2: 85–86.

54.

Department of Statistics, Ministry of Trade and Industry, Singapore. Population trends 2014. Report, Department of Statistics, Ministry of Trade and Industry, Singapore, 2014.

55.

Kwak

Salmon

. Attitudes and preferences of Korean-American older adults and caregivers on end-of-life care. J Am Geriatr Soc 2007; 55: 1867–1872.

56.

Kagawa-Singer

Blackhall

LJ.

Negotiating cross-cultural issues at the end of life: you got to go where he lives. JAMA 2001; 286: 2993–3001.

57.

Maessen

Veldink

van den Berg

, et al. Requests for euthanasia: origin of suffering in ALS, heart failure, and cancer patients. J Neurol 2010; 257: 1192–1198.

58.

Borasio

Voltz

Discontinuation of mechanical ventilation in patients with amyotrophic lateral sclerosis. J Neurol 1998; 245: 717–722.

59.

Moss

Oppenheimer

Casey

, et al. Patients with amyotrophic lateral sclerosis receiving long-term mechanical ventilation: advance care planning and outcomes. Chest J 1996; 110: 249–255.

60.

Phukan

Elamin

Bede

, et al. The syndrome of cognitive impairment in amyotrophic lateral sclerosis: a population-based study. J Neurol Neurosurg Psychiatry 2012; 83: 102–108.

61.

Wittink

Morales

Meoni

, et al. Stability of preferences for end-of-life treatment after 3 years of follow-up: the Johns Hopkins Precursors Study. Arch Intern Med 2008; 168: 2125–2130.

62.

Winter

Moss

Hoffman

Affective forecasting and advance care planning: anticipating quality of life in future health statuses. J Health Psychol 2009; 14: 447–456.

63.

King

Duke

O’Connor

BA.

Living with amyotrophic lateral sclerosis/motor neurone disease (ALS/MND): decision-making about ‘ongoing change and adaptation’. J Clin Nurs 2009; 18: 745–754.

64.

Foley

Timonen

Hardiman

Acceptance and decision making in amyotrophic lateral sclerosis from a life-course perspective. Qual Health Res 2014; 24: 67–77.

65.

O’Neill

Autonomy and trust in bioethics. Cambridge: Cambridge University Press, 2002, p.213.

66.

Sokol

DK.

Can deceiving patients be morally acceptable?

BMJ 2007; 334: 984–986.

67.

Hirano

Yamazaki

Ethical issues in invasive mechanical ventilation for amyotrophic lateral sclerosis. Nurs Ethics 2010; 17: 51–63.

Ethical and legal issues of tracheostomy ventilation in patients with amyotrophic lateral sclerosis

Abstract

Keywords

Introduction

Comment and analysis

Legal issues

Legal duty of care

Legal test for breach of duty of care and standard of care: Bolam and Bolitho tests

Causation and damage

Informed consent: the duty of care on advice

The change of standard of care relating to advice through Montgomery v. Lanarkshire (‘Montgomery’)

Hii Chii Kok v. Ooi Peng Jin London Lucien and another: modified Montgomery test

Best interests decision-making

Ethical issues

How should the team have come to a recommendation in the best interests of the patient?

Justice

Rights-based justice (respect for people’s rights)

Distributive justice (fair distribution of scarce resources)

Autonomy (right of the patient to choose/self-rule)

How much should the doctor elaborate?

Is the doctor’s role to present options and his recommendation? Or is his role to present options without a recommendation, leaving the patient to decide?

Trial of treatment option

Symptom control

Advance care planning

What if TV is not an option?

Withholding information

Beneficence (to do good, other things being equal) and non-maleficence (to avoid harm, other things being equal)

Conclusion

Footnotes

Acknowledgements

Funding

Availability of data

Authors’ contributions

Conflict of interest

Informed consent

Ethical approval

Author Biographies

References