Legal and political considerations of clinical practice guidelines

In the 4th century bc, Plato explored the difference between skills grounded in practical expertise and those based solely on following instructions or obeying rules. Using the clinician as his model, he set up a thought experiment: doctors would be stripped of their clinical freedom—“no longer allowed unchecked authority”—but would form themselves into councils to determine majority views about how to practise medicine in all situations.¹

Plato’s notion of codifying the majority decisions of panels (composed of clinical and non-clinical members) and publishing their work in order to influence (Plato says to dictate) “the ways in which the treatment of the sick is practised”¹ prefigures many of the impulses which animate the clinical guidelines movement today.

In Plato’s view, important hallmarks of expertise include flexible responsiveness and “improvisatory ability”—an approach to practice endangered, he believed, by use of guidelines.¹ However effective health care by guideline turned out to be—and Plato was prepared to concede its potential—it remained in his view a debased form of practice, firstly because guidelines presuppose an average patient rather than the particular patient whom a doctor is endeavouring to treat, and secondly because the knowledge and analysis that go into the creation of guidelines are not rooted in the mental processes of clinicians, but in the minds of guideline developers distant from the consultation. Similar concerns trouble present day clinicians (box).

Summary points

• Clinical guidelines cannot offer doctors thoughtproof mechanisms for improving medical care

• However well linked to evidence, clinical guidelines need to be interpreted sensibly and applied with discretion

• Under UK common law, minimum acceptable standards of clinical care derive from responsible customary practice, not from guidelines

• If clinicians implement faulty guidelines it is they, rather than the authors of such guidelines, who are likely to increase their liability in negligence

• The NHS Executive has stated that clinical guidelines cannot be used to mandate, authorise, or outlaw treatment options

“There is a fear that in the absence of evidence clearly applicable to the case in hand a clinician might be forced by guidelines to make use of evidence which is only doubtfully relevant, generated perhaps in a different grouping of patients in another country and some other time and using a similar but not identical treatment. This is ... to use evidence in the manner of the fabled drunkard who searched under the street lamp for his door key because that is where the light was, even though he had dropped the key somewhere else.”²

Once the profession committed itself to providing health care through guidelines (a position now demanded by government³), Plato could see no alternative but to ensure professional compliance, even if this entailed resorting to legal action. Such guidelines, he believed, have to be understood almost as clinical laws: once expertise no longer resides in the clinician but in guidelines, corruption of or deviation from such guidelines would result in medical treatments being based on personal whim or quackery.

Plato’s reference to the legal arena was remarkable in its prescience: only comparatively recently have guidelines begun to feature in healthcare regulations and case law.^4–8 That bias could creep into guideline development is a modern day concern in France, where formal complaints have been laid before the Fraud Squad alleging improper conduct by participants in the French guidelines programme.⁹

Guidelines and legislation

Legislation in Europe and the United States has harnessed guidelines to a wide variety of regulatory tasks.¹⁰,¹¹ In the United Kingdom the Human Fertilisation and Embryology Act 1990 established a regulatory authority empowered to develop guidelines.¹² The authority’s decision to restrict to three the number of fertilised eggs that can be placed in a woman’s uterus during treatment by in vitro fertilisation is an example of a guideline that is unambiguously clear; its mandatory nature in the event of transgression is made plain by enforceable penalties, including revocation of the licence to practise in vitro fertilisation. Though criticised as too restrictive, the guideline nevertheless carries the force of a prescriptive legal rule; indeed, it has become almost an integral part of the legal framework itself (though the Human Fertilisation and Embryology Authority retains the power to alter it).

In France, some 147 mandatory practice guidelines have been introduced under a 1993 statute, Loi Teulade 93-8, covering investigations, prescribing, and certain medical procedures. Initially guidelines were developed by the social security administration responsible for reimbursing private practitioners and the doctors’ unions, but this task has now been taken over by an independent organisation, the Agence Nationale pour le Développement de l’Evaluation Médicale. Once published, the guidelines constitute an enforceable agreement between doctors and the social security administration.⁹,¹³

Standards of medical care

In the United Kingdom the legally required standard of medical care a doctor generally owes to a patient derives from the case of Bolam v Friern Hospital Management Committee (1957). In the words of the judge of this case, “the test is the standard of the ordinary skilled man exercising and professing to have that special skill.”¹⁴ The judge in Bolam recognised that there can be two or more schools of thought regarding proper medical treatment, so doctors can usually rebut a charge of negligence if they act in conformity with a body of other responsible doctors.¹⁴

Negligence

Medical negligence is a composite of three essential elements. A plaintiff (the person bringing the action) must show that:

• the defendant doctor owed the plaintiff a duty of care, and

• the doctor breached this duty of care by failing to provide the required standard of medical care, and

• this failure actually caused the plaintiff harm, a harm that should have been foreseeable and reasonably avoidable.¹⁵

• Clinical guidelines could, in theory, influence the manner in which the courts establish the second element. ¹⁶

Expert testimony helps the courts to ascertain what is accepted and proper practice in specific cases, ensuring that professionally generated standards from real clinical situations are generally applied, rather than standards enunciated in the rhetoric of clinical guidelines.⁵ In Cranley v Medical Board of Western Australia (1990), an Australian general practitioner stood accused of misconduct because he had prescribed injectable diazepam to heroin users, contrary to the Australian national methadone guidelines. He was initially found guilty of “infamous and improper conduct,” but after the Supreme Court of Western Australia heard of a minority medical opinion supporting treatment of opiate addicts within the harm reduction framework followed by Dr Cranley, it upheld his appeal.¹⁷

The “Bolam test” legally enshrines a standard of customary care and clinical judgment informed by scientific evidence and professional experience. It takes account of evolving standards of care, and it is a professionally led, though legally imposed, standard. It allows for differences of opinion and encompasses a range of medical practice. However, it seems to be a descriptive test based on what is done in practice, rather than a normative one that stipulates what should be done.

Widespread adoption of guidelines could therefore result in clinical care informed by guidelines becoming viewed as the norm. Departure from guidelines could then be seen as prima facie evidence of a case to answer.¹⁸ The main justification for judicial reliance on customary care standards has been the belief that medical technical matters are best left to “experts.” Guidelines—which offer doctors, patients, and purchasers explicit, detailed examples of standards of care—could be thought to remove the need for expert testimony in court, as the courts would have direct access to relevant standards from guidelines.¹⁹

Role of guidelines in court

Guidelines could be introduced to a court by an expert witness as evidence of accepted and customary standards of care, but they cannot be introduced as a substitute for expert testimony. Courts are unlikely to adopt standards of care advocated in clinical guidelines as legal “gold standards” because the mere fact that a guideline exists does not of itself establish that compliance with it is reasonable in the circumstances, or that non-compliance is negligent.

However, guidelines may not reflect customary standards of care. Indeed, some seem designed to hasten the incorporation of research findings into routine practice.²⁰ Adoption of a strong research and development strategy in the NHS which values rapid implementation of research inevitably challenges the law’s use of a customary care standard that does little to narrow gaps between everyday clinical practices and evidence based practice. But though Bolam is clearly coming under pressure from a variety of sources, it is unlikely to be superseded by a legal standard entirely determined without reference to a responsible body of medical practitioners.¹⁹

Author or sponsor liability

I have not found any UK common law cases in which the courts have had to consider whether authors of clinical guidelines could be liable for incorrect or misleading statements in circumstances where patients have suffered harm.¹⁶,²¹ Courts have, however, decided non-medical questions where people have undergone economic loss after relying on written statements of advice.²²

There can be no duty of care between the author of a document or book and its myriad potential readers, unless the authors could foresee that their written advice would be directly communicated to a reader who would have little choice but to rely on it without independent enquiry. Such advice would need extraordinary authority for doctors to be expected to follow clinical guidelines without further inquiry.²³

Author/sponsor liability

“While an action could be taken against a clinician for not keeping up to date, a College is probably not actionable, as it would be difficult to show it owes a duty or obligation directly to the patient.”²⁴

The legal status of guidelines could be made clear to clinicians if guidelines were prefaced with statements such as the one that introduces the 1997 guidelines for the prevention of malaria in travellers from the United Kingdom: “The views expressed in these guidelines reflect experienced professional opinion, since the data are inadequate for unequivocal views to be given on several issues. There is often a range of acceptable options .... Decisions on the terms under which different drugs are licensed for use are the responsibility of the Licensing Authority ... (not of these guidelines). The guidelines should be read as a supplement to and not as a substitute for the relevant data sheets.”²⁵

Though this statement reads like the disclaimer which it is clearly designed to be, the authors emphasise that users of the guideline are expected to behave as learned intermediaries, exercising customary clinical discretion and consulting other sources of relevant information.

Discretion

Clinicians fear that the proliferation of guidelines will increase their medicolegal exposure,²⁶ but the only published study of the use of guidelines in litigation (in the United States, where guidelines are widely used) found that guidelines played “a relevant or pivotal role in the proof of negligence” in less than 7% of malpractice actions.²⁷ Some health service lawyers have commented that, as guidelines become accepted in the clinical community, acting in accordance with a clinical guideline could in itself be viewed as acceptable medical practice. A recent court case confirms, however, that there is currently no expectation, on the part of the courts, that guidance from works of reference with the standing of Martindale’s Extra Pharmacopoeia or the British National Formulary should be automatically translated into clinical practice.²⁸ Doctors are expected to use appropriate clinical discretion, and the courts continue to place the testimony of expert witnesses about what constitutes reasonable practice above the recommendations of prestigious works of reference. Even where a guideline has been laid down as a legal standard, courts require sensible discretion to be used in applying it.²⁹

In administrative law the essence of discretion is “a readiness to deal with each case on its merits.”³⁰ The NHS Executive acknowledges that, when endorsed by prestigious professional bodies or even commended by the NHS Executive: “clinical guidelines can still only assist the practitioner; they cannot be used to mandate, authorise or outlaw treatment options. Regardless of the strength of the evidence, it will remain the responsibility of the practising clinicians to interpret their application .... It would be wholly inappropriate for clinical guidelines to be used as a means of coercion of the individual clinician, by managers and senior professionals.”³¹

Rigid, uncritical adherence to guidelines is not the formal, administrative or managerial expectation in the NHS. Though purchasers have been urged no longer to buy treatments but to buy treatment protocols,³² they need to recognise that translation of precepts into action involves interpretation,³³ as emphasised in guidelines on the treatment of hypertension produced by the World Health Organisation: “Guidelines should provide extensive, critical, and well balanced information on benefits and limitations of the various diagnostic and therapeutic interventions so that the physician may exert the most careful judgement in individual cases.”³⁴

Concern remains, however, that guidelines will erode clinical abilities, diminish clinical judgment, and reduce medical practice to “cookbook medicine.”³⁵ In the United States, tensions between treatment protocols and doctors’ clinical judgment have led the courts to rule that clinicians may not claim as a defence to negligence that their clinical judgment has been corrupted by guidelines.³⁶

Clinical judgments often go beyond explicit input information, adding considerations of feeling, attitude, and value to the output.³⁷ Researchers, health service managers, and those involved in audit need to bear this complexity in mind when reporting wide variations in healthcare practices not accounted for by differences in case mix or the circumstances of practice. Inherent uncertainties, lack of evidence, poor consensus, and differences in patients’ choices and expectations may all underpin such variation.³⁷ Applying guidelines to individual care is always likely to require judgment, even when recommendations are properly linked to evidence.³⁸

Conclusions

Guidelines are not credited by the courts with a special “self evident” status, and clinical guidelines currently have a subservient role to that of the expert witness in court proceedings. However, since guidelines are set to become more influential in both the way we practise and our accountability, doctors need to pay attention to how we wish guideline and user to interact.³⁹ If partnership between user and guideline is the preferred relationship, then we must create possibilities for productive dialogue between guideline developers and users.

We also need to know more about the cognitive processes involved in using guidelines actively and interactively, the sort of discretion exercised in their use, and how this may differ from that exercised in using other aids to decision making, such as textbooks, lecture notes, or expert systems.

Officially, there may be no managerial or legal expectation that doctors should automatically follow guidelines, but purchasers may adopt a different view. Unlike the consensus guidelines of Plato, modern, evidence linked clinical guidelines seek to make the strengths, weaknesses, and relevance of research findings transparent to clinicians. Even where such guidelines are formulated as rules for behaviour, their appropriate interpretation and application are likely to generate better clinical care and a safer medicolegal strategy than either uncritical disregard or unthinking compliance.⁴⁰