Introduction

This chapter will discuss the legal and ethical considerations that govern and guide us in our practice in the cardiothoracic surgical environment. In all our practice the overriding objective must be to ‘do no harm’ (Brazier & Cave 2016) not only during surgical intervention but also in the preoperative planning and postoperative stage of the patient’s journey. We are governed by the legal system in the United Kingdom which guides us on matters relating to criminal and civil law. There are many laws relating to professional work in healthcare. There are also professional codes that govern and regulate practice, such those of the Nursing and Midwifery Council (NMC 2015) and the Health and Care Professions Council (HCPC 2016). All professional frameworks are of course underpinned by an ethical code. However, the subject of ethics will now be considered in much broader terms, illustrating how ethical theories and principles are used to support and guide our decision-making processes.

We know that surgical care has been part of healthcare worldwide for over a century (WHO 2008). Surgical intervention is intended to save lives, alleviate symptoms and improve quality of life. Unfortunately, there can be complications during the surgical journey, a point that is highlighted by the WHO initiative Safe Surgery Saves Lives (WHO 2008) which cited a complication rate for inpatient surgery of ‘up to 25%’. As practitioners there are some key factors that we adopt to try to reduce these complications to a minimum. These key factors apply not only in the operating room but throughout the patient’s perioperative journey. Some are set out by our statutory bodies (HCPC, NMC, General Medical Council), and some by Acts of Parliament; many are established by locally agreed protocols and National Health Service Local Trust guidance. There are some international initiatives (such as WHO, Safe Surgery Saves Lives) and in the UK we are also guided by the National Institute for Health and Care Excellence (2015). However, many of our decisions are governed by our personal principles and what we feel we ought to do, utilising our own ethical code that has been developed throughout our private and professional life.

These ethical decisions start long before the patient arrives at the operating theatre. The surgeon and the multidisciplinary team first need to decide if it is possible to operate, and if so, if surgery is the correct treatment for the patient? There are guidelines to help us evaluate the evidence, so the MDT can make an informed decision, one example being the 2014 European Society of Cardiology and the European Association for Cardiothoracic Surgery (Windecker et al. 2013) guidelines on myocardial revascularisation. These guidelines cover the risk stratification and scoring systems that are relevant to the decision either to operate (coronary artery bypass grafting) or to perform a percutaneous coronary intervention.

Fortunately, major clinical decisions (such as whether to offer a patient surgery) are not left to one individual – there is a team approach. The ‘heart team’, a multidisciplinary group that is utilised for decision making, not only on who to operate on but also when and by whom, offers a balanced decision-making process (Head et al. 2013). The team can follow guidelines and evaluate the current evidence relating to individual patients and this can help reduce the incidence of inappropriate treatments. However, just because the patient’s case has been discussed and the most appropriate treatment agreed by the heart team, this does not mean that we automatically go ahead and take this course of action. There still needs to be clear discussion with the patient to inform them of the options available for treating their condition. This discussion will also form part of the process of obtaining informed consent, which is both a legal requirement and also an opportunity for the patient to be involved in considering not only the proposed procedure but also any other related factors.

Ethical values in perioperative practice

Ethics is an enormous subject, and a detailed discussion of all the available theories is largely beyond the scope of this chapter. Instead the aim here will be to highlight certain ethical theories and principles and relate them to our everyday practice and the perioperative journey taken by cardiothoracic surgery patients. As professionals we must seek to practise ethically, which means that we must understand and balance the relevant ethical considerations, legal requirements and professional values. We need to apply all these requirements to our decision-making in order to reach a solution that is caring, compassionate and of high quality.

A range of ethical theories exist and can be applied in different situations to guide our decision-making. For instance, utilitarian ethics is concerned with obtaining the greatest good for the greatest number. The commissioning bodies in the NHS, which have to decide on which treatments will be funded and which will not, tend to use this approach. To help them in their decisions, they may use formulas such as Quality-Adjusted Life Years to produce data to help them consider the cost: benefit ratio, in relation to a particular population demographic. Examples of utilitarianism in this sense include certain decisions on cancer drug funding implications by NICE (Johnston & Slowther 2004). Likewise, NHS England (2016) recently considered the evidence for robotic assisted lung resection and decided that this treatment would not currently be funded.

Professional values

The National Health Service Constitution for England (DH 2015) sets out the values on which the NHS is based. Its stated aim is to put compassion and care, respect and dignity at the heart of how both patients and staff are treated. It seeks to provide care that is transparent and accountable, promotes equality and respects human rights. The Constitution echoes the values published by the regulatory bodies of healthcare professionals: Standards of conduct, performance and ethics (HCPC 2016), Standards of conduct, performance and ethics for nurses and midwives (NMC 2015) and Good Medical Practice (GMC 2013). Healthcare may be ever-changing but the human values which underpin that care should remain constant. In 2012, the GMC and NMC published a Joint Statement of Professional Values (NMC 2012) which stressed that compassion and kindness in our dealings with patients and each other are as important as our knowledge and skills.

Informed consent

Before any procedure can be performed upon a patient, their consent to that action must be obtained. If a patient is operated on without their consent, the surgeon would be guilty of assault (except in cases of emergency) (Lord Scarman 1985). Obtaining consent is therefore a legal obligation as well as an ethical obligation. An important aspect of the doctor–patient relationship is the need for mutual trust and respect, and this is incorporated into the process of obtaining informed consent. Ethically, the need for consent comes under the principle of patient autonomy (Beauchamp & Childress 2013), where the patient has full rights over their own body to decide what should and should not happen to it. The patient’s doctor can advise and facilitate the patient’s decision-making but cannot coerce the patient to decide in a certain way.

The previous paragraph raises some interesting questions which will be discussed in more detail. These include (Care Quality Commission 2017):

• What precisely is informed consent?

• How can we define ‘capacity to give consent’?

• What about the role of advance statements in end of life care?

• What about the moral conflict that arises when a patient’s decision is detrimental to the welfare?

What is informed consent?

The requirements for valid consent are that it is given voluntarily, that the patient has capacity and that the patient has had enough information offered to them to enable them to understand the nature of the treatment and the consequences of both accepting and declining it. The Department of Health has produced standardised consent forms for use in practice although there is no legal requirement that consent should be written or in a particular form. Proper documentation of consent in written form would seem to be prudent and is certainly in line with most, if not all, local NHS policies on the subject. In surgery, checking that the patient has completed a consent form is also part of the World Health Organisation Surgical Safety Checklist (WHO 2009) that was implemented to ensure safer surgery protocols worldwide and has been incorporated into NHS practice via National Safety Standards for Invasive Procedures and subsequent local policies (NHS England 2015).

The amount of information given to a patient to obtain their consent will necessarily vary from one patient to another, and according to individual circumstances. A doctor must judge the level of information that will be understood by a patient and modify their communication accordingly. Some patients may wish to know about every aspect of their surgery while others may say that they do not want to know anything about it. However, doctors are required to inform the patient of the risks of a particular procedure or they themselves could be accused of being negligent. There are examples of case law where doctors have been found negligent because they have not informed patients of the risk when they have been specifically asked about it, when the risk carries a serious consequence or if the risk is greater than 1% (e.g. Chatterton v Gerson 1981). It should be noted that the patient can revoke their consent at any time: consent is a process, rather than a one-off decision, as circumstances can change.

Capacity to give consent

Ethically, it would seem that it is a basic human right to be able to either give or withhold consent to a treatment on oneself. However, in England and Wales the Mental Capacity Act 2005 (Care Quality Commission 2017), which applies only to individuals over 16 years old, sets out specific criteria to establish whether an individual has the capacity to give or withhold their consent. If these criteria are not met, that individual will be unable to formally consent to a treatment and different procedures will then be followed. To have capacity to give consent, an individual must be able to understand the information that is given to them, must be able to retain the information long enough to consider it and make a choice, and must finally be able to communicate their decision.

If a patient does not have capacity to give consent, their surgical team will follow local policy to obtain consent to a treatment that is deemed to be in their ‘best interests’ – if that treatment is thought to be required before it is expected that their capacity will return.

Under the Mental Capacity Act 2005 (Care Quality Commission 2017), advance decisions are a legally binding expression of an individual’s wishes concerning their end of life care and specifically which treatments they wish to accept or decline, e.g. being placed on ventilatory support or receiving cardiopulmonary resuscitation. The decisions are written into a formal document at the time that the patient is deemed to have capacity – in expectation of a time when they will not have the capacity to express their wishes. The advance decision should be in written format and be signed by the patient and then signed by a witness.

An advance decision document is a way for a patient to express their right to autonomy although it may also bring up a moral conflict for the healthcare practitioners who care for them at the end of their life, who may believe that different treatments would be beneficial.

Moral conflict

A competent adult has the right to refuse treatment, even against the advice of their surgical team. This is the case with any treatment, even that which could be considered life-sustaining. This is often a difficult area for healthcare professionals who may believe that the patient is choosing a wrong course of action that will be detrimental to their welfare. In practice it has occasionally been seen that a patient’s capacity will only be questioned if their wishes are in opposition to that of their surgical team; this behaviour illustrates the difficulty experienced by professionals seeking to balance the desire to promote the welfare of the patient while also respecting the patient’s right to make a free choice.

Safer surgery globally

Once the legal obligation of consenting the patient has been performed and documented, it is the whole team’s responsibility, both legally and ethically, to ensure that the surgery is carried out in the safest manner possible. We are guided in this by local protocols but also by national and global initiatives. Safe surgery saves lives (WHO 2008) was the second global patient safety challenge; the first concentrated on healthcare-associated infections. Through the World Alliance on Patient Safety Working Group, WHO reached a consensus on four areas where there could be a dramatic improvement in patient safety (WHO 2008): surgical site infection prevention, safe anaesthesia, safe surgical teams and measurement of surgical services. Ten essential objectives, to reduce the complications of surgery, were then identified. These objectives come under the ethical heading of non-maleficence, and they should all be observed by the surgical team.

Ten essential objectives for safe surgery (WHO 2008)

1. The team will operate on the correct patient at the correct site.

2. The team will use methods to prevent harm from anaesthetic administration.

3. The team will recognise and effectively prepare for life-threatening loss of airway or respiratory function.

4. The team will recognise and effectively prepare for risk of high blood loss.

6. The team will consistently use methods known to minimise risk of surgical site infection.

7. The team will prevent inadvertent retention of sponges or instruments in surgical wounds.

8. The team will securely and accurately identify all surgical specimens.

9. The team will effectively communicate and exchange critical patient’s information for the safe conduct of the operation.

10. Hospitals and public health systems will establish routine surveillance of surgical capacity volume and results.

WHO Surgical Safety Checklist