“Advice, not orders”? The evolving legal status of clinical guidelines

By David Metcalfe

Clinical guidelines aim to reduce unnecessary variation, help clinicians make evidence-based decisions, and ultimately improve patient outcomes¹. However, the practice of trauma and orthopaedic surgery often diverges from recommendations made by professional bodies^2-4. For example, NICE Clinical Guideline 124 (CG124) recommends that surgeons “offer total hip replacement rather than hemiarthroplasty to patients with a displaced intracapsular hip fracture who were able to walk independently out of doors with no more than the use of a stick and are not cognitively impaired and are medically fit for anaesthesia and the procedure”⁵. However, national clinical audit data show that only 32% of patients that satisfy these criteria receive a total hip replacement (THR)⁴.

Possible reasons for low guideline uptake include logistical barriers, surgeon preference, varying interpretations of study data, and lack of awareness about specific guidelines¹. One survey found that clinicians caring for a single hip fracture patient are beholden to 75 individual guideline documents³. The full version of NICE CG124 alone runs to 938 pages^5,6. However, it is also possible that surgeons consider professional guidelines to be mere recommendations: “advice, not orders”⁷. This essay considers the THR recommendation in NICE CG124 and argues that such a view is being steadily eroded by developments in English common law.

The legal basis of NICE recommendations

The origins of NICE began in a policy white paper, The New NHS (1997)⁸. It was established as an NHS special health authority to provide “a strong lead on clinical and cost-effectiveness, drawing up new guidelines and ensuring they reach all parts of the health service”⁸. This was a response to the rapidly expanding landscape of available healthcare treatments and to reduce unexplained variation in care across the NHS, the so-called “postcode lottery”⁹. The NHS Constitution for England (2015)¹⁰ subsequently guaranteed patients access to all “drugs and treatments that have been recommended by NICE for use in the NHS”.

Recommendations arising from NICE technology appraisals and specialized technology appraisals impose a duty on NHS England to make approved treatments available within 3 months of publication. This duty has a statutory basis under s.7 and s.8 of The National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013. Other NICE recommendations are governed by s.5 of the Regulation, which, unlike s.7 and s.8, does not explicitly impose a duty on NHS organizations to comply. Although such guidelines are often therefore assumed to be voluntary, their status is evolving in English case law towards a situation in which they too may bind commissioners, providers, and even individual clinicians.

The general principle that governs the behaviour of state organizations in relation to national guidance is set out in Fisher (1997)¹¹. In this case, which preceded the creation of NICE, Mr Justice Dyson found that the decision of a public sector organization not to follow guidance from the Secretary of State could only be lawful when there is some “special factor which it considered exceptionally justified departure”. In Rose (2014)¹², Mr Justice Jay found that NICE guidance “has the same status as that of the Secretary of State in ex parte Fisher... [and] it would surely follow that the CCG could not disagree with NICE; it would need to find an exceptional basis for not following the NICE recommendation”. Providers and commissioners cannot, therefore, lawfully restrict access to treatments that are approved or recommended by NICE without exceptional justification.

The extent to which individual clinicians are bound by NICE is less clear. NICE clinical guidelines typically lead with the statement that recommendations “represent the view of NICE, arrived at after careful consideration of the evidence available... when exercising their judgement, healthcare professionals are expected to take these recommendations fully into account... however, the [recommendations do] not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer”⁵. Sir Michael Rawlins, while Chair of NICE, reiterated this point when writing “there appears to be confusion about the circumstances in which it is obligatory for... [doctors] to follow NICE guidance... the quick answer is ‘never’”¹³. Sir Michael accepted that it is not possible for guidelines to regulate every clinical encounter and that treatments shown to be effective at a population level might not be best for individual patients. He also accepted that some guidelines are aspirational and so it might not be immediately possible for clinicians to provide NICE-compliant treatment to all eligible patients¹³. There are nevertheless two ways in which NICE guidelines might limit the actions of individual clinicians: defining the minimum standard of care and ensuring informed consent.

Standard of care in the tort of negligence

Liability for negligence in English law requires (1) a duty of care, (2) breach of that duty, (3) that the breach caused harm and (4) that the harm was not too remote a consequence of that breach¹⁴. Whether a duty of care is breached depends on whether or not the plaintiff’s actions fell below the relevant “standard of care”. Historically, the minimum standard of care in English tort law has been determined by recourse to accepted medical practice and not written guidelines¹⁵. In Bolam (1957)¹⁶, Mr Justice McNair found that a claim of negligence must fail if a clinician “acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art”. Under Bolam, a doctor could freely depart from guidelines as long as he could find expert witnesses willing to state that this was acceptable behaviour¹⁵. In this respect, the courts were reluctant to privilege written guidelines over the views of expert witnesses. For example, in Loveday (1991)¹⁷, Lord Justice Stuart Smith ruled that published guidelines “cannot be relied upon as though it was evidence of qualified experts not called in witness”.

However, Bolam has been revised over the last 20 years, most notably by Bolitho (1996)¹⁸ in which the House of Lords found that the minimum standard of care is a question of law to be determined by the court rather than other doctors. According to Lord Brown-Wilkinson, “the court has to subject the expert medical evidence to scrutiny and to decide whether the practice is reasonable... the issue of reasonableness is for the court and not the medical profession”¹⁸. This move towards an objective test for determining the minimum standard of care has enhanced the significance of clinical guidelines. The courts have since shown increasing willingness to follow national guidelines when determining the legal standard of care in Re C (1998)¹⁹, Penney (2000)²⁰ and Fotedar (2005)²¹. In Fotedar, the court assigned greater weight to guidance from the Royal College of Obstetricians and Gynaecologists (RCOG) than to expert witnesses when determining whether it was acceptable to perform a vacuum extraction delivery before the cervix was fully dilated. In explaining his decision, Mr Justice Gray said “protocols such as these appear to me to give valuable guidance as to what is and what is not acceptable practice”. Unsurprisingly, there is an increasing tendency for claimants to argue that divergence from guidelines is prima facie evidence of negligence²².

Although clinical guidelines are increasingly used in defining the standard of care, their role is still understood within the context of Bolam. Guidelines are considered as representing “a practice accepted as proper by a responsible body of medical men skilled in that particular art”¹⁶. For example, in Bland (1993)²³, Lord Goff said “if a doctor… acts in accordance with the medical practice now being evolved by the Medical Ethics Committee of the BMA, he will be acting with the benefit of guidance from a responsible and competent body of professional opinion, as required by the Bolam test”. The Court of Appeal adopted a similar position in relation to GMC guidance in Burke²⁴. However, there may be many different ways in which to approach a clinical case and so the existence of a guideline does not mean that clinicians cannot adopt alternative strategies. In addition, it is clear from Bolitho that the courts will subject all expert evidence to scrutiny, which includes published guidelines. In Bolitho, Lord Browne-Wilkinson said: “if it can be demonstrated that the professional opinion is not capable of withstanding logical analysis, the judge is entitled to hold that the body of opinion is not reasonable or responsible”¹⁸. It is therefore beholden on clinicians to act in a way that is “reasonable and responsible” regardless of whether or not they are following clinical guidelines. The courts have shown considerable willingness to reach conclusions that diverge from professional evidence. For example, in Marriott (1999)²⁵, the judge at first instance stated “I have concluded that if there is a body of opinion which supports the course… then such an approach is not reasonably prudent”. Similarly, although Lord Goff accepted guidance published by the Medical Ethics Committee of the BMA in Bland, he did not accept this at face value and instead preceded his endorsement of the guideline with the words “study of this document left me in no doubt that…”²³. The courts – and not expert witnesses or published guidelines – remain the final arbiter or what is “reasonable and responsible”. It therefore follows that treatment may meet the necessary standard of care even if it diverges from clinical guidelines. Similarly, treatment may be negligent even if clinical guidelines are followed perfectly should the court deem the recommendations to have been insufficiently prudent.

Surgeons may therefore meet the necessary standard of care despite not following the THR recommendation in NICE CG124. However, their reasons for doing so should be documented carefully to show that the treatment decision was “reasonable and responsible”. Failure to do so could lead to a successful claim for negligence were a patient eligible for THR to receive hemiarthroplasty and then develop a complication specific to the latter operation, such as acetabular wear requiring revision²⁶.

Components of informed consent

Even the most rational and carefully documented decision to depart from professional guidance will expose a surgeon to risk of litigation if consent is inadequate.

The standard of care required of a surgeon taking consent from a patient has historically been defined by Bolam; an approach re-affirmed by the House of Lords in Sidaway (1985)²⁷. In Sidaway, Lord Diplock warned that a frank discussion with the patient about alternative treatments could risk “deterring the patient from undergoing the treatment which in the expert opinion of the doctor it is in the patient’s interest to undergo... to decide what risks the existence of which a patient should be voluntarily warned... is as much an exercise of professional skill and judgment as any other part of the doctor’s comprehensive duty of care to the individual patient”. Perhaps unsurprisingly, the paternalistic approach in Sidaway has since been overruled by their lordships in Montgomery (2015)²⁸. In Montgomery, a pregnant woman of small stature and with diabetes was not warned about the risk of shoulder dystocia from a vaginal birth because her surgeon did not believe that the alternative mode of delivery (i.e. caesarean section) was justified. The delivery was complicated by shoulder dystocia and – during instrumented delivery – the child suffered hypoxic injury and cerebral palsy. The claimant argued that she would have pursued a caesarean section had she been warned that there was even a small risk of this outcome from a vaginal delivery. In their judgement, Lords Kerr and Reid wrote that “the doctor is... under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments”. They added that the test of “materiality” was “whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach a significant risk, or the doctor is or should be aware that the particular patient would be likely to attach significance to it”. Although this definition of materiality was formulated in relation to risk, it seems likely that the same test would be used to determine whether or not the patient should have been informed about alternative treatments²⁹.

As THR is clearly an alternative treatment to hemiarthroplasty for some patients, it should be raised as part of obtaining informed consent in this population. It would be difficult to justify not including THR as part of the consent conversation in the patient group (i.e. all cognitively intact) for whom this procedure is recommended by NICE. Although surgeons might be reluctant to discuss THR because of logistical concerns (e.g. lack of a specialist hip surgeon or the possibility of introducing delay), it is unlikely that such a justification would satisfy the principles laid down in Montgomery. A surgeon that operates on a competent patient in the absence of consent risks liability in the torts of battery or negligence³⁰.

Do NICE guidelines have special legal status?

It has been argued that NICE guidelines should be awarded special status by the courts when determining the standard of care³¹. There is evidence that solicitors have much greater awareness of NICE guidelines than those published by other organisations²². The senior courts have not yet been asked to pronounce on whether they are willing to accord NICE guidelines special status. However, accepting such guidelines without further scrutiny would effectively mean the courts ceding their role in determining the standard of care to NICE. This would amount to a dramatic departure from Bolitho, in which the standard of care was deemed to be a question of law and so only one that the courts themselves can decide.

However, the courts have shown that they may be impressed by the rigour with which guidelines are developed^23,24,32. NICE guidelines arise through a rigorous and structured process that few other organisations have the resources to replicate³³. It seems likely that the courts will afford more weight to NICE guidelines on the basis of this rigour than out of deference to any one national organisation. However, many NICE guidelines have proven controversial and diverged radically from both pragmatic medical practice and guidance published by other professional bodies³⁴. It remains the role of the courts to consider all available evidence when determining the standard of care.

Conclusion

Clinical guidelines will become increasingly important over the coming years as a result of two major developments in English common law. These are the move towards an objective standard of care (Bolitho) and the renewed legal emphasis on informed consent (Montgomery). Older adults with hip fractures are not a famously litigious population³⁵. However, the principles outlined in this essay are relevant to all orthopaedic surgeons who face the herculean task of balancing experience, research evidence, patient expectations, and independent clinical judgement with thousands of pages of guidelines from professional bodies.

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