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What sort of bioethical values are the evidence-based medicine and the GRADE approaches willing to deal with?
  1. Joseph Watine
  1. Correspondence to Dr Joseph Watine, Laboratoire de biologie polyvalente, Hôpital de la Chartreuse, 12200 Villefranche-de-Rouergue, France; joseph.watine{at}ch-villefranche-rouergue.fr

Abstract

The concept of evidence-based medicine (EBM) has been invented by physicians mostly from English Canada, mostly from McMaster University, Ontario, Canada. The term EBM first appeared in the biomedical literature in 1991 in an article written by a prominent member of this group—Gordon Guyatt from McMaster University. The inventors of EBM have also created the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) working group, which is a prominent international organisation whose main purpose is to develop evidence-based clinical practice guidelines (CPGs). CPGs that are based on the GRADE approach are becoming increasingly adopted worldwide, in particular by many professional or governmental organisations. This group of thinkers being thus identified, we have retrieved and read many of their publications in order to try and understand how they intend to incorporate bioethical values into their concept. The author of this little essay did also spend a few years on the internet as an active member of the GRADE group discussion list. The observations thus gathered suggest that although some of the inventors of EBM, at least Gordon Guyatt, wish to incorporate core principles of biomedical ethics into their concept (ie, non-malevolence, beneficence and maybe to a lesser extent respect for autonomy, and justice), some clarifications are still necessary in order to better understand how they intend to more explicitly incorporate bioethical values into their concept and, perhaps more importantly, into evidence-based CPGs.

  • Evidence-based medicine
  • clinical practice guidelines
  • bioethics
  • values
  • applied and professional ethics
  • history of health ethics/bioethics

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The concept of evidence-based medicine (EBM) was created in the early 1990s by English-speaking university physicians from English-Canada, mostly in McMaster University, the term EBM itself being specifically the invention of Gordon Guyatt.1 Since then, the adjective ‘evidence-based’ has spread to other sectors of science and humanities, for example, sociology, psychology, education, crime prevention, history. It is, however, in medicine that the adjective has met with its greatest popularity.

Many of the creators of this concept are still in professional activity, and some of them, including Gordon Guyatt, have also created the Grading of Recommendations, Assessment, Development and Evaluations GRADE) group which is a prominent international organisation whose main purpose is to develop evidence-based clinical practice guidelines (CPGs). The GRADE group has proposed a new approach to grade quality of evidence and strength of recommendations in CPGs.2 The GRADE approach is becoming increasingly adopted worldwide, in particular by many professional or governmental organisations.

The purpose of this little essay is to demonstrate that the lack of explicitness of the afore-mentioned thinkers about the bioethical values that they wish to incorporate into the definition of their concept (ie, the EBM and GRADE approaches), may raise some suspicion as to their concepts' ability, at least in its present form, to deal with bioethical values. In our view it sounds logical to believe that the more bioethical values will be properly incorporated into this concept, then the more bioethical values will be incorporated into the daily practice of those who are willing to adopt this concept. In being read by the afore-mentioned inventors, and by some of their followers, may we humbly hope that our little essay could modestly help to improve the situation in this direction?

As shown by the bioethicists Tom Beauchamp and James Childress,3 moral reasoning in healthcare is based on four core principles: (1) respect for autonomy, (2) non-malevolence, (3) beneficence and (4) justice. These four core principles are general guides that leave considerable room for judgement in specific cases. The first principle (respect for autonomy) means respecting the decision-making capacities of individuals, thus enabling them to make their own choices. The second principle (non-malevolence) means that healthcare professionals should not harm the patient. Many interventions may cause some harm, but the harm should not be disproportionate to the benefits of interventions. The third principle (beneficence) means that healthcare professionals should act in a way that benefits the patient in a way that makes sense to the patient. The fourth principle (justice, also called equity) means that patients in similar positions should be treated in a similar manner. In order to introduce a fair allocation of care services into their decisions, medical doctors may have to be aware of geopolitical, socio-economic and cultural circumstances that can vary according to different environments. The medical doctor cannot master such problems on his own, but he has to know them in order to deal with them.4

When EBM was created it aimed at de-emphasising intuition, unsystematic clinical experience and patho-physiologic rationale as sufficient grounds for clinical decision making and stressed the examination of evidence from clinical research. Thus in 1996 some of the creators of the concept defined EBM this way: ‘Evidence based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.’5

Right from the start, the evidence that EBM was looking for was obviously the evidence about both clinical benefits and clinical harms of medical interventions. Therefore the creators of the EBM concept intended to take into consideration, at least implicitly, two of four core principles of bioethics: non-malevolence and beneficence. The two other principles were not formally part of the first definitions of EBM, unless perhaps the words ‘making decisions about the care of individual patients’ were to be understood as some kind of support for the first bioethical principle.

The inventors of the concept of EBM seem to have quite rapidly acknowledged that the core principles of bioethics should be more clearly part of their definition, probably because of the many criticisms that were rapidly expressed, for example by Ian Kerridge et al,6 when they quite convincingly argued that:

  • many important outcomes of interventions are hardly measurable, or even definable, for example, justice or quality of life,

  • application of results of clinical trials to individual care can disadvantage some patients.

This is perhaps with such criticisms in mind that in their subsequent definitions, the inventors of the EBM and GRADE approaches wisely introduced terms that remind more explicitly the principle of autonomy such as ‘patients' values and preferences’, and also the notions of ‘costs’, ‘resource utilisation’ or other words related to justice issues.2 7 8

Gordon Guyatt, as one of the reviewers of the present essay, also insisted that ‘EBM broadly functions within three major ethical theories (duty-oriented, utilitarian, and right-based) as evident by insistence for respect for individual patient autonomy and values, peoples' rights to participate in their own care, and concerns for just distribution of resources. As no ethical theory is superior to any other, they can only be used in combination in order to obtain the most ethically correct answer possible for a given medical scenario.’

This might have led us to conclude that as time goes by, the inventors of EBM and of the GRADE approach, particularly Gordon Guyatt, intend to incorporate into their definition some principles of bioethics, even if they do so with their own words.

However, in our view more explicitness still seems to be necessary.

First, among the many people who advocate EBM approaches, it is more than likely that all do not share the same views of what is just, and of what is equitable, within a healthcare system, just like many of them probably do not share the same views about what are the most important health outcomes as expressed in terms of benefits and harms, and about what autonomy exactly means. When it comes to making evidence-based CPGs and evidence-based medical decisions, such an heterogeneity of views is likely to lead to heterogeneous interpretations of the evidence.2 How can doctors and the autonomous patient make their own informed opinions and decisions if those who make the evidence-based CPGs for them are not explicit about their own opinions and values? For example, even in very recent CPGs co-authored by Gordon Guyatt and a few others it is not possible to precisely know how, and which, ideas about justice were incorporated into the recommendations except perhaps for costs issues but this is more theoretical than explicit and the same applies to patients preferences and values.8 Besides, the wording used by the inventors of EBM when it comes to justice issues is mostly limited to ‘costs’, or ‘resource utilisation’ except for a very few and very recent and theoretical papers.9 10 The concept of justice however extends far beyond costs and resource utilisation. Likewise Gordon Guyatt, as one of the reviewers of the present essay, claims that, ‘with insistence that rational decision-makers should weigh benefits and harms before making their decisions, EBM is probably closest to John Rawls' concept of moral choice by linking it with theory of rational choice’. Such a claim adds some weight to the fact that EBM is supposed to, and should, be concerned with justice issues. Indeed, Rawls, a philopospher who belongs to the social contract tradition (like Hobbes or Rousseau) develops principles of justice through the use of a device he calls the original position in which everyone decides principles of justice from behind a veil of ignorance. This ‘veil’ is one that essentially blinds people to facts about themselves that might cloud their notions of justice. However, when it comes to deal with such principles, for example in co-authoring the afore-mentioned CPGs, it might be said that Gordon Guyatt and/or his co-authors do have some practical difficulty. The afore-mentioned CPGs, which are co-authored by many high-profile professionals from many countries worldwide, intend, at least implicitly, to be applicable at an international level, thus suggesting that medical practice could, and maybe should, be the same worldwide. Justice depending, to quite a large extent, on resources, on legal codes and on other political or cultural values of societies, the simple fact that the inventors of both EBM and GRADE co-author CPGs that are supposed to be universally applicable across various societies, and that are indeed adopted by many professional societies worldwide,8 suggests that their concept not only does not incorporate justice issues into CPGs, but also is probably unable to do so, at least in its present form.

Second, regarding the principle of autonomy, the wording generally used by the inventors of EBM, that is, ‘taking into account patients' values and preferences when making medical decisions’ is perhaps also not explicit enough ethically speaking. For example, autonomy can come into conflict with beneficence when patients disagree with recommendations that healthcare professionals believe are in the patient's best interest. In such situations different people and societies settle the conflict in different manners. Many bio-ethicists in Western countries consider that the doctor has to defer to the wishes of a mentally competent patient to make his own decisions, even in cases where the medical team believes that he is not acting in his own best interests. Others cultures may prioritise beneficence over autonomy. To the best of our knowledge, the creators of the concept of EBM never took an explicit and public position on this important ethical point. Likewise, autonomy is widely acknowledged as being the first core bioethical principle. Why in EBM, words such as ‘taking into account patients' values and preferences’ generally come after benefits and harms? Again, a lack of explicitness about bioethical values might allow supporters, and maybe some inventors, of EBM and GRADE, to feel free, and maybe to feel encouraged, to have no approach at all, when it comes to deal with these values.

Third, the original bioethical principles of non-malevolence and of beneficence seem to be inverted in the definition of EBM where the benefits generally come before the harms, which might perhaps suggest, again, that the inventors of EBM do not have exactly the same priorities as many bioethicists (primum non nocere). This may suggest that there is a significant gap between the words used in the definition of EBM (ie, the theoretical principles) and the practical use of these principles by some of the inventors of the concept. And this kind of gap is almost bound to be deeper among those who adopt the concept than among those who invented the concept, not only because the former are far more numerous than the latter, but also because the lack of explicitness of the latter about biothecial values could easily lead the former to overlook and not incorporate biothecial considerations when they practice EBM on a daily basis.

Finally, the words ‘autonomy’, ‘non-malevolence’, ‘beneficence’ and ‘justice’ (or equity) were already well established in the biomedical literature quite some time before the concept of EBM was created. Why did the creators of EBM avoid, and are still avoiding,9 10 the use of such clear, concise and well established words?

In conclusion, although with time the creators of EBM and GRADE, and more particularly Gordon Guyatt, seem to more formally introduce the core principles of bioethics into the definition of their concept, this introduction seems to be more theoretical than practical. It remains therefore to be seen whether or not these thinkers are able to explicitly incorporate core bioethical values not only into their concept, but also, and perhaps more importantly, into their own practice, particularly when, as GRADErs, they co-author CPGs that are adopted by many professional or governmental organisations worldwide. Until then, and as argued above, we shall have good reasons to believe that the inventors of EBM either do not wish to deal with bioethical values, except perhaps in academic papers, or more likely, are practically unable to do so. And if the inventors of EBM themselves are unable to do so, then how many of their numerous supporters worldwide will be able to?

Acknowledgments

To Gordon Guyatt (McMaster University, Hamilton, Ontario, Canada) and to the other colleagues who gave us the idea of the present paper during discussions on the internet inside or outside the GRADE group discussion list.

References

Footnotes

  • Competing interests Dr Joseph Watine is member of the working group ‘Clinical Practice Guidelines’ of the European Federation of Clinical Chemistry (EFCC), and chairman of the working group ‘Clinical Practice Guidelines and Evidence-Based Laboratory Medicine’ of the Société Française de Biologie Clinique.

  • Patient consent Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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