The ethical authority of clinical protocols

Gonzalo Herranz, department de Bioética, Universidad de Navarra.
lecture Delivered in Bogotá, 1997.
Text published in 1996, El Médico magazine, nº 594, pages 40-50.

The clinical protocols or guidelines of internship are a very ambitious business . They aim to improve the quality of medical care in no less than three relevant aspects.

First, in its quality, creating a new and better style of clinical decision-making. It will no longer be the individual doctor who, with hours of study and years of experience, will painstakingly work out what works best, but it will be the experts who, in the light of well-tested data , will reach a consensus and authoritatively propose which medical interventions are the most appropriate for the various clinical situations.

Second, in its extension, by universalising new and better quality, levelling the differences in medical internship care between primary care and specialist, between rich and poor, between town and village.

Third, in its cost, by reducing it without rationing it, and improving its efficiency through the rational use of prescriptions, and by eliminating diagnostic or therapeutic interventions of no or doubtful utility.

The ethical congruence of these aims is obvious: it would be a great advance if all doctors treated their patients with the skill of their most expert colleagues; if they did so everywhere and in all social strata; and, to top it all, if they managed their always insufficient resources wisely and thus worked the marvel of doing better while spending less.

A controversial issue

Despite such attractive promises, some physicians have reacted with indifference, even hostility, to the publication of the clinical protocols. They have ignored them or, with more instinct than reason, have repudiated them as dogmatic and authoritarian. These doctors do not want to give up their clinical freedom, which for them is not so much the ability to choose what is best for their patient, but the unbridled claim that all doctors' decisions are, by definition, correct.

Doctors working in national health systems, for their part and not without reason, have the intuition that clinical protocols can become powerful tools of control in the service of bureaucratic dirigisme. And in a climate of fear of malpractice suits, there is a growing suspicion that judges and lawyers may confer on protocols the odious status of official metro-patron saint of the lex artis.

These objections point to some possible weaknesses in the application of clinical protocols, but above all they reveal a blatant misunderstanding of their nature and functions. It is therefore worth pausing for a moment to reflect on the ethical authority of clinical protocols.

The technical authority

Protocols have ethical authority to the extent that they are technically correct, i.e. they are an authoritative, objective, critical and unbiased expression of the value of current medical interventions. The preparation of a protocol requires a scrupulous separation between what is proven and what is assumed, between what is evident and what is merely intuited. To recommend the best, advise against the marginal, and discard the less useful, the protocol clinician needs to honestly and realistically weigh the risks, benefits, and costs of the interventions he or she evaluates.

The consensus conferences in which many protocols are prepared are not exercises in pie-in-the-sky diplomacy, but in accurate, honest and independent appraisal. Clinical guidelines are made by human beings who, being up to their eyeballs in the subject they are experts in, might in some cases not be able to distinguish between subjective conviction and objective certainty, between doubt staff and scientific uncertainty. As there are no omniscient and infallible experts in this world, a fundamental endorsement of the technical authority of protocol is its public discussion, its transparency. Clinical guidelines must disclose the sources of their data, the process of their selection and evaluation, the strength of each of their conclusions. They must also declare their limitations and biases, and acknowledge their provisionality.

Disseminate the protocols and keep them up to date.

A good clinical protocol has, intellectually and organisationally, a high production cost. But that is not all.

It is not enough to prepare good protocols: they must be disseminated, made convincing and, with reasons and incentives, teachers must be encouraged to teach them, doctors must be encouraged to study them, and everyone must be encouraged to put them on internship.

It is utopian to expect that all doctors without exception fulfil their duty of continuous self-education, that they all know how to select what to incorporate into their regular internship . Many programs of study reveal that protocols are coldly received. Many important clinical internship guidelines are ignored by more than half of the physicians for whom they are intended; and while half of the physicians who read them are often satisfied with the document's recommendations, less than a third adopt them.

The authors of a protocol cannot do what the lazy servant in the parable who buried the talent he had received and left it unproductive. They have to consider how to get the message to its recipients, what format to give it, through which channels to transmit it, how to encourage its assimilation and facilitate the changes that the protocol wants to induce. It is not enough to publish protocols in journals. It has been seen that, to be effective, dissemination must be capillary, face-to-face, personalised and participatory, better in small local or regional groups than in large national assemblies.

A massive launch operation is not enough either: the validity of protocol must be periodically re-demonstrated with facts and evidence, with content audits and follow-up controls. It is also necessary to ensure that obsolete protocols are withdrawn from circulation and replaced by new versions, as clinical guidelines internship begin to suffer the erosion of time as soon as they are published. Some become outdated in a few months or a few years. Those who have promoted them have a duty to remain active, and to remove what is outdated, maintain what is current, and add what is new. A protocol left to its own devices, lazily followed, discredits itself, loses its authority.

Clinical protocols and physician freedom

The existence of clinical protocols forces us to reconsider the essence and limits of the freedom to prescribe: are all styles of medical practice legitimate per se, or are there better ones that are therefore obligatory? Is the doctor's professional freedom a matter of mere discretion, of clinical instinct, of autocratic preference? Is it always and everywhere valid to invoke the unrepeatable individuality of the patient as a shield for the doctor's therapeutic individualism? Does saying that there are no diseases, there are only sick people, authorise to ignore the rules of good internship in order, for example, to treat peptic ulcers, opportunistic infections of AIDS, tuberculosis, or hypertension as one pleases?

People are astonished to see how different, and even contrary, doctors' ideas are about the same patient, the same problem. Sometimes they have the well-founded suspicion that there is no objective, shared knowledge base in medicine. We must make them understand that many differences of opinion are due to situations of invincible uncertainty or legitimate doubt, and that in medicine the principle of freedom in doubt, exercised rationally, also applies. Doctors should never invoke their freedom to prescribe as a justification for their conduct report or capriciousness.

To exercise clinical freedom, protocols are an excellent financial aid, as they make it clear that not everything is the same, that not everything is permissible, that not all styles of internship are equally correct. Clinical protocols tend to refute deep-rooted fallacies: that, for example, more intensity means better results, that more expensive is more effective, that more modern is safer.

To be dismissive or rebellious in the face of protocols is a sign of ethical and professional immaturity. So is blind acceptance of them. The truth should never be exaggerated: neither that of the physician's freedom nor that of the authority of the clinical protocol . The doctor manager of his freedom to prescribe receives the guidelines of internship with interest, examines them with critical curiosity, and decides to what extent he adopts them. He is happy to be assisted by experts whose advice he takes seriously. And, whether he decides to accept or reject them, he is prepared to give a sincere and defensible justification for his decision.

Clinical protocols and patient freedom

By aiming for homogeneous quality, clinical protocols eliminate differences by standardising the professional internship . Medical egalitarianism is a great advantage if it means that all patients will receive a higher quality of care: but it could also happen that, by targeting protocols at standard patients, the peculiarities of the individual patient are not taken into account. Protocols may also be invoked as a compelling reason to deny certain treatments to certain categories of patients: for example, the elderly person with dementia is denied cataract surgery, or a very low birth weight newborn is deprived of intensive care. The line between the provision of services of uncertain benefit and rationing disguised as suspension or non-initiation of interventions of marginal value is a fine one.

Clinical protocols may reinforce the paternalistic bias of predisposed doctors, who would make expert judgement prevail over the patient's legitimate preferences. We could even imagine that, in a hypothetical culture of dirigisme, it would no longer be the doctor who proposes to his individual patient what should be done and negotiates with him the corresponding consent, but it would be the protocol, with the gravitational force of its expert authority, who would imprison doctor and patient in the orbit of the inflexible official rule . If the protocols were applied as if they were ucases, the internship of medicine would become a gigantic essay phase IV clinical , and, worse, it would become increasingly impoverished in personal values: it would consist of average doctors treating average patients.

For patients, the ethical authority of the protocols comes from their offer of technical quality: it shines an authoritative light on the preferable option. It does not kill freedom, it makes it more manager and lucid: freer.

The legal and social authority of clinical protocols

What legal authority can be given to the protocols, and can lawyers, and also judges, take them as a term of reference letter to judge the conduct of physicians in tort litigation?

Where there is sufficient judicial precedent, and specifically in the United States, clinical protocols have been invoked as patron saint- gold of medical performance in only a small issue of cases. And they have been invoked in both directions: sometimes, less often, to exonerate the doctor; sometimes, more often, to incriminate him.

The latter could spread an unfavourable image of the judicial role of protocols among doctors. But that is only part of the story. Looking at status in its entirety, the picture is more encouraging. The protocols have a strong influence on pre-trial conciliation proceedings, which is where many lawsuits are decided presentation or withdrawn. Lawyers are not in favour of going to trial in cases where doctors have their backs covered by following the protocols. Moreover, some states, and others will follow suit, have already legislated that both the correct application of a clinical protocol and following the advice of the hospital's ethics committee committee confer immunity from malpractice suits on physicians. This assigns an extraordinary authority to clinical protocols.

Conclusion

Clinical protocols have an important role to play in the improvement and universalisation of the quality of medical attendance . They are standards that develop the ethical principle of doing what is best for the patient. They help the physician to fulfil the deontological commitment, imposed by article 21.1 of the current Code of Medical Ethics and Deontology, to satisfy the right of patients "to medical care of a scientific and humane quality [...] to use the resources of medical science in a manner appropriate to their patient, according to the medical art of the moment".

Protocols should never be blunt and rigid orders, but rather prudent and authoritative advice addressed to intelligent and free beings. Endowed, by their very nature, with validity provisional and openness to progress and criticism, those who draft and promulgate them have the duty to imbue them with objective rationality, with permanent update , and with ethical respect for their addressees: patients and doctors.

They have a moral obligation to know them, as a qualified part of their ongoing Education , and to follow them freely manager.