Deviating from clinical guidelines – the medicolegal question

Introduction 

It is easy to see how many doctors can look at rigid clinical guidelines as a direct route to providing ‘cookbook’ medicine, whereby a strict ‘recipe’ of care is required for every patient to ensure the most positive outcome. However, clinical guidelines provide reliability in the provision of care, and medical practitioners can expose themselves to significant medicolegal risks when deviating from them. In this article, I will explore the importance of reliability, when it is justified to deviate from guidelines, and how doctors can limit their exposure to risk.

The concept of reliability 

Reliability simply means that medical care should consistently meet the expectations of patients, medical institutions, and the wider profession, with minimal unwarranted variability in patient care. It’s important to note, this is not the same as standardisation. While there are benefits to providing a standardised practice amongst clinicians derived from evidence-based research, this is not the same as providing reliability in practice.

Doctors will be aware that each patient is unique and evidence is not always clear, and as such, uniform care does not automatically mean good care. That being said, it should be obvious that there is a significant difference between legitimately exercising professional autonomy by varying the usual process of care in a patient’s best interests, based on the understanding of the unique circumstances presented, and a failure to meet patient, institutional and professional expectations.

The drive for increasing reliability 

So, what makes reliability so important? Firstly, patients are very aware of the benefits available via modern healthcare. Their expectations are that they can rely on these benefits to be delivered consistently and, regardless of how significant or complex a medical intervention is, if the results do not meet these expectations, they are likely to seek redress. What is considered an unsatisfactory outcome is also changing, with clinicians increasingly being held to account for acts of commission rather than acts of omission. 

Secondly, as healthcare professionals become more specialised, coordinating care effectively across the team of doctors that might be involved in a single patient’s care has become increasingly difficult. Providing a framework by which teams can operate minimises the risks of communication failures. 

The extent and cost of preventable harm are also driving the need for greater reliability in care delivery. There have now been over a dozen studies conducted in high-income countries showing between 30 to 50% of adverse outcomes in hospitals are avoidable. Analysis in the US has placed medical error as now the third commonest cause of death in their hospitals – lower than cancer and cardiovascular disease but higher than respiratory or renal disease.¹ Governments are also increasingly linking funding to reliability metrics, meaning the ability of health services to practice effectively is hinged on consistency. 

There are many benefits to increasing reliability through adherence to clinical guidelines. Chief among them is delivering high-quality care to patients, through increased safety measures and greater efficiency in time and resources. Delivering higher quality care not only decreases the risk of a patient taking action against a clinician but also improves mental health outcomes across the profession by reducing the time spent on the painful work of “mopping up” after process, system or human performance failure. 

The reliability afforded by clinical guidelines also reduces the cognitive load on medical practitioners and their teams by creating clarity during high stress and high demand situations. This further boosts work satisfaction as clinicians can limit stresses while improving patient outcomes.

Deviating from clinical guidelines 

As stated, increasing reliability does not mean a total absence of variation, but ensuring any variation is justified. So, how can doctors be confident that a deviation in care they deem as appropriate would not be considered negligence? Let’s take a look at what the law says.

The ‘Bolam test’ for medical negligence says that the standard of care provided by a doctor has to be the standard of the ordinary skilled practitioner in the specialty. This suggests that a doctor is not negligent if they are acting in accordance with a practice supported by a responsible body of medical practitioners experienced in the relevant specialty, even if there is another body of opinion that takes a contrary view. The case from which this test arose involved a patient who was not warned of the risks of a procedure, and it was held that if there is a body of responsible opinion that would not warn of a particular risk, then a doctor who decides not to warn a patient about that risk is unlikely to be negligent.² Later case law, however, established that doctors can be held as negligent in spite of a body of professional opinion in support of a course of action or inaction if the court does not find that it is reasonable or responsible.³ 

The precedent set here grants doctors considerable scope when departing from established standards. In fact, it could be argued it creates a duty on healthcare professionals to deviate where the standard care practices are unreasonable in a specific case. However, clinical guidelines reliably provide justification for a course of action, so deviating from them does expose doctors to medicolegal risks. 

Ensuring appropriate safeguards are in place is essential to minimising this risk. Practitioners should keep accurate records of their discussions with patients and fellow practitioners. Records should include the reasons behind their decision-making, establishing the reasonable body of opinion – founded in robust evidence-based research – that justifies their deviation, alongside patients’ informed consent to ensure that in the event of adverse outcomes, they have a defensible course of action.

Members can contact Medical Protection to seek advice and support on the issues raised in this article. 

References 

1 Makary MA, Daniel M. “Medical error—the third leading cause of death in the US.” BMJ. 2016;353:i2139. 

2 Bolam v Friern Hospital Management Committee [1957] 2 All ER 

3 Administratrix of the estate of Bolitho (deceased) v City and Hackney Health Authority [1997] 4 All ER