Foucault makes three very interesting points about this imperious, death-infiltrated, gaze. The first is that "The 'glance' has become a complex organization with a view to a spatial assignation of the invisible".31 "The structure, at once perceptual and epistemological, that commands clinical anatomy, and all medicine that derives from it, is that of *invisible visibility*".32 A doctor (and this is the second point) is drawing a 3D picture, not learning,

30 1978.

31 Foucault 1994, p. 164.

32 Foucault 1994, p. 165.

explained in the previous paragraph, the patient a) obscures and b) distorts the ideal picture the doctor is trying to bring into bold relief, although the patient also, perhaps reluctantly, reveals the disease. Using shingles (Herpes Zoster) as an example, the patient may obscure the disease by presenting with pain in the renal area. Many doctors make the wrong diagnosis before the characteristic rash arrives on about the fourth day. With regard to the distortion each patient makes, a doctor may be accustomed to seeing shingles in elderly patients. But if the patient with a painful rash is ten 10 years old, the diagnosis is difficult. (Of course, if the correct diagnosis is made, then the patient has revealed the disease.) Continuing with my assertion that the diagnostic process makes it hard to practise patient-centered care, Foucault explains that the doctor is constantly seeking lacunae. She thinks in the space between true and false (for example, hyperventilation due to anxiety *or* metabolic acidosis), and in the space between viral and bacterial, and in the space between benign and malignant, and in other spaces. This difficult thinking, which surely distracts from thinking about the patient only or the patient at the centre of the process, can be pictured in a space between obscurity and clarity of the disease. In this space is the interaction between the body and the disease. It does not fit the ideal forms captured in the canonical texts and treated with canonical methods. Thus I have postulated a tension between the primary space of pathology and the secondary space of

Canguilhem30 and Foucault extensively develop the space of perception. The term used here is "gaze". The gaze is the perception of the doctor, perceiving the patient, and is scopic or visual. This is because, since the end of the eighteenth century, the post-mortem examination--which is visual--has fundamentally determined how doctors view the diseased patient. Doctors look back from death, in which medical truth is revealed, to life. Secondarily, Foucault allows both auditory and tactile modes of perception to intertwine with vision in the gaze so that a doctor examining a patient's chest might look at the breathing rate, touch the pulsation of the lowermost, leftmost point of distinct cardiac pulsation, and listen to the breath sounds, the three forms of perception functioning together. However, the sight--hearing--touch perception system is subject to the absolute gaze of knowledge. This latter is dominated by death, in that, as previously explained, the

the individual person, as set out by Foucault in *The Birth of the Clinic.*

post-mortem examination is the foundation stone of medical epistemology.

**2.2.2 Pathology dominates the gaze. A new role for death. Medical epistemology**

Foucault makes three very interesting points about this imperious, death-infiltrated, gaze. The first is that "The 'glance' has become a complex organization with a view to a spatial assignation of the invisible".31 "The structure, at once perceptual and epistemological, that commands clinical anatomy, and all medicine that derives from it, is that of *invisible visibility*".32 A doctor (and this is the second point) is drawing a 3D picture, not learning,

**2.2 The medical gaze in more detail**

**2.2.1 History**

**modernised**

31 Foucault 1994, p. 164. 32 Foucault 1994, p. 165.

 30 1978. when she steadies her gaze on the patient. Obviously, the doctor detects from the 2D surface (usually: sometimes the doctor conducts an internal examination, for example of the rectum, after which she is no longer limited to a 2D assessment) of the body a few clues, through sight, hearing and touch. (When a doctor hears a certain type of murmur between the first and second heart sounds, she may visualise a narrowed space between the cusps of the mitral valve. When she palpates the lowermost, leftmost point of distinct cardiac pulsation and finds it is further to the left than normal, she visualises an enlarged heart.) The gaze uses knowledge of human life, derived from post-mortem examination, to build a 3D (functional) model of the body's disease. This aspect of the Foucaldian gaze is important with regard to EBM because its epistemology assumes that the 3D picture is objective. But it implicitly undermines EBM evidence in that EBM evidence provides *a* truth, rather than *the* truth. After all, each doctor might build a different 3D model. A third interesting point made by Foucault about the gaze is that it medicalises the human world. This means that people are now viewed in a dichotomy of diseased--healthy whereby "....one did not think first of the internal structure of *the organized being*, but of the *medical bipolarity of the normal and the pathological*".33 EBM has inherited this powerful bias, this binary thinking, not that of life and health and normal living.

I have indicated that the post-mortem examination laid the foundation of the medical gaze which henceforth would establish disease as individual and require a nuanced use of the old language to express the newly perceived realities of pathological anatomy in combination with the age-old symptoms. However, Foucault explains two other developments arising from the use of the post-mortem examination. One is that death, as well as being individualised, was also concretised. It moved into the space previously occupied by the gods and immortality. There was a decrease in theory and systems that had befuddled earlier generations of doctors.

Early in the nineteenth century in France, the belief that disease had an essence which "was both nature and counter-nature",34 was removed from the medical gaze. To constitute the new gaze then, the post-mortem examination had to form or inform the foundation of medical epistemology--

*In anatomical perception, death was the point of view from the height of which disease opened up onto truth; the life/disease/death trinity was articulated in a triangle whose summit culminated in death; perception could grasp life and disease in a single unity only insofar as it invested death in its own gaze.*35

From early in the nineteenth century, death built into the gaze a better understanding of life and disease, using the anatomical--clinical model. Death also built into the gaze the dissolution of disease, and the limited nature of disease as that which enabled death, rather than death being the consequence of disease. Thus the medical gaze is henceforth structured to regard death as more fundamental than disease, which death elucidates (through postmortem examination) and terminates (hence it is basilisk-like).

33 Foucault 1994, p. 35.

34 Foucault 1994, p. 155.

35 Foucault 1994, p. 158.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 65

I have alluded obscurely to an issue which needs clarifying. In Foucault, a distinction is made between a statement and the visible. I have explained that when the post-mortem examinations were first used to provide knowledge, it was necessary to develop a language- -statements--to match the visible. Foucault provides an account of the difference in the nature of these two, the visible and the articulable. Read what Deleuze explains regarding

*...there is a difference in nature between the form of content and the form of expression, between the visible and the articulable (although they continually overlap and spill into one another in order to compose each stratum or form of knowledge). ...Between the two there is no isomorphism or conformity, in spite of a mutual presupposition and the primacy of the statement. ...there is neither causality from one to the other nor symbolization between the two, and that if the statement has an object, it is a discursive object which is unique to the statement and is not*

I consider that all this eludes EBM. Does this matter? I argue that EBM rides rapidly over some deep and obscure issues yet urges us to change the way we treat sick people. EBM moves the articulable around from paper to paper and book to book to guidelines, but I suspect that these writers assume that the object of the statement is the visible object: I am sure that EBM protagonists assume that what we are saying matches what we are seeing. In simple terms, then, I am arguing that such complex, underlying issues make the strident

The other consequence of the new perceptual structure was that this visual system rested on an opaque base. This means that what lay beyond the base was not available for the constitution of knowledge. This is of enormous importance for EBM. Foucault postulates that a change in doctor/patient relationship has occurred over recent centuries in which the key element is epistemology. He uses the metaphor of a grid. By now doctor, patient and their interaction take place in this new grid. This is like children moving their game to a jungle gym. However, no analogy is complete, and, in fact, the children are newly configured (their bodies can go through different sequences), as well as playing by different rules which have resulted from a fundamentally different knowledge that the jungle gym prescribes. This

*isomorphic with the visible object. Of course we dream of isomoprhism, …."*41

**2.2.5 Reconfiguration of the doctor, patient, consultation and epistemology**

is like a discipline that introduces a new habitas, like the posture associated with ballet.

Previously the doctor and patient were taken as given, not as problematic, although this is an exaggeration. Medical progress was considered to have occurred between the two

*feeling like a piece of soft leather.*40

assertions of EBM protagonists seem too strident.

40 Laennec, R. 'De l'auscultation mediate', vol. 1, p. 368.

Foucaldian theory:

41 Deleuze 2006, p. 61.

*The liver...when cut, it seemed to be made up entirely of a mass of small seeds, round or oval in shape, varying in size from a millet seed to a hemp seed. These seeds, which can be easily separated, left almost no gap between them in which one might be able to make out some remaining part of the real tissue of the liver; they were fawn or reddish-yellow in colour, verging in parts on the greenish; their fairly moist, opaque tissue was slack, rather than soft, to touch, and when one squeezed the grains between one's fingers only a small part was crushed, the rest*

The epistemological foundation stone for this view of disease is, by now, the post-mortem examination and from that origin the gaze proceeds to construct the individual. Previously, clinical medicine had dealt with cases. But the new gaze is to be different. The post-mortem examination provides information about the individual so disease is primarily the disease of an individual. It is no longer the case that each individual presents a variation on a general phenomenon. Thus the idea that the individual is an exemplar of a general phenomenon is now problematised.

#### **2.2.3 The gaze is multifaceted**

The gaze is "not content to observe what was self-evident".36

Foucault explains that the gaze involves possibilities and probabilities, risks--and experience. He reminds us that society confers authority on the doctor, so that the doctor from her gaze, announces the truth (The doctor says she has cancer: so she has cancer).

*In the clinic, it was a question of a much more subtle and complex structure in which the integration of experience occurred in a gaze that was at the same time knowledge, a gaze that exists, that was master of its truth .... . . At this level there was no distinction to be made between theory and experience, method and results; one had to read the deep structures of visibility in which field and gaze are bound together by codes of knowledge;...the linguistic structure of the sign and the aleatory structure of the case.*37

#### **2.2.4 Disease is now visible, but needs to be articulated**

Here Foucault draws attention to the need for a language that relates the signs and symptoms of diseases to human understanding and communication. This matter belongs in linguistic and semiological spaces. Bear in mind that the gaze includes questioning the patient, in language. The patient answers verbally and non-verbally. Foucault explains that language needed to adapt to the new knowledge so that the disease of the individual could be seen. Doctors who conducted the post-mortem examinations needed to clothe the new knowledge in words that would convey it to absent clinicians:-

*It is no longer a question of correlating a perceptual sector and a semantic element, but of bending language back entirely towards that region in which the perceived, in its singularity, runs the risk of eluding the form of the word and of becoming finally imperceptible because incapable of being said.*38

Foucault tells us how the language was adapted to express the new perceptions "to introduce language into that penumbra where the gaze is bereft of words".39 He mentions the use of colour, metaphor, empirical comparisons, the value of intersensorial qualities, and references to the normal and everyday. Many of these ways of making the perceived expressible were deployed by Laennec, whose early description of one cirrhotic liver, quoted by Foucault, exemplifies these linguistic developments.

36 Foucault 1994, p. 89.

37 pps. 81, 90.

38 Foucault 1994, p. 169.

39 1994, p. 169.

The epistemological foundation stone for this view of disease is, by now, the post-mortem examination and from that origin the gaze proceeds to construct the individual. Previously, clinical medicine had dealt with cases. But the new gaze is to be different. The post-mortem examination provides information about the individual so disease is primarily the disease of an individual. It is no longer the case that each individual presents a variation on a general phenomenon. Thus the idea that the individual is an exemplar of a general phenomenon is

Foucault explains that the gaze involves possibilities and probabilities, risks--and experience. He reminds us that society confers authority on the doctor, so that the doctor from her gaze,

Here Foucault draws attention to the need for a language that relates the signs and symptoms of diseases to human understanding and communication. This matter belongs in linguistic and semiological spaces. Bear in mind that the gaze includes questioning the patient, in language. The patient answers verbally and non-verbally. Foucault explains that language needed to adapt to the new knowledge so that the disease of the individual could be seen. Doctors who conducted the post-mortem examinations needed to clothe the new

*It is no longer a question of correlating a perceptual sector and a semantic element, but of bending language back entirely towards that region in which the perceived, in its singularity, runs the risk of eluding the form of the word and of becoming finally imperceptible because*

Foucault tells us how the language was adapted to express the new perceptions "to introduce language into that penumbra where the gaze is bereft of words".39 He mentions the use of colour, metaphor, empirical comparisons, the value of intersensorial qualities, and references to the normal and everyday. Many of these ways of making the perceived expressible were deployed by Laennec, whose early description of one cirrhotic liver,

*In the clinic, it was a question of a much more subtle and complex structure in which the integration of experience occurred in a gaze that was at the same time knowledge, a gaze that exists, that was master of its truth .... . . At this level there was no distinction to be made between theory and experience, method and results; one had to read the deep structures of visibility in which field and gaze are bound together by codes of knowledge;...the linguistic*

now problematised.

**2.2.3 The gaze is multifaceted**

*incapable of being said.*38

36 Foucault 1994, p. 89.

38 Foucault 1994, p. 169.

37 pps. 81, 90.

39 1994, p. 169.

The gaze is "not content to observe what was self-evident".36

announces the truth (The doctor says she has cancer: so she has cancer).

*structure of the sign and the aleatory structure of the case.*37

**2.2.4 Disease is now visible, but needs to be articulated**

knowledge in words that would convey it to absent clinicians:-

quoted by Foucault, exemplifies these linguistic developments.

*The liver...when cut, it seemed to be made up entirely of a mass of small seeds, round or oval in shape, varying in size from a millet seed to a hemp seed. These seeds, which can be easily separated, left almost no gap between them in which one might be able to make out some remaining part of the real tissue of the liver; they were fawn or reddish-yellow in colour, verging in parts on the greenish; their fairly moist, opaque tissue was slack, rather than soft, to touch, and when one squeezed the grains between one's fingers only a small part was crushed, the rest feeling like a piece of soft leather.*40

I have alluded obscurely to an issue which needs clarifying. In Foucault, a distinction is made between a statement and the visible. I have explained that when the post-mortem examinations were first used to provide knowledge, it was necessary to develop a language- -statements--to match the visible. Foucault provides an account of the difference in the nature of these two, the visible and the articulable. Read what Deleuze explains regarding Foucaldian theory:

*...there is a difference in nature between the form of content and the form of expression, between the visible and the articulable (although they continually overlap and spill into one another in order to compose each stratum or form of knowledge). ...Between the two there is no isomorphism or conformity, in spite of a mutual presupposition and the primacy of the statement. ...there is neither causality from one to the other nor symbolization between the two, and that if the statement has an object, it is a discursive object which is unique to the statement and is not isomorphic with the visible object. Of course we dream of isomoprhism, …."*41

I consider that all this eludes EBM. Does this matter? I argue that EBM rides rapidly over some deep and obscure issues yet urges us to change the way we treat sick people. EBM moves the articulable around from paper to paper and book to book to guidelines, but I suspect that these writers assume that the object of the statement is the visible object: I am sure that EBM protagonists assume that what we are saying matches what we are seeing. In simple terms, then, I am arguing that such complex, underlying issues make the strident assertions of EBM protagonists seem too strident.

#### **2.2.5 Reconfiguration of the doctor, patient, consultation and epistemology**

The other consequence of the new perceptual structure was that this visual system rested on an opaque base. This means that what lay beyond the base was not available for the constitution of knowledge. This is of enormous importance for EBM. Foucault postulates that a change in doctor/patient relationship has occurred over recent centuries in which the key element is epistemology. He uses the metaphor of a grid. By now doctor, patient and their interaction take place in this new grid. This is like children moving their game to a jungle gym. However, no analogy is complete, and, in fact, the children are newly configured (their bodies can go through different sequences), as well as playing by different rules which have resulted from a fundamentally different knowledge that the jungle gym prescribes. This is like a discipline that introduces a new habitas, like the posture associated with ballet.

Previously the doctor and patient were taken as given, not as problematic, although this is an exaggeration. Medical progress was considered to have occurred between the two

40 Laennec, R. 'De l'auscultation mediate', vol. 1, p. 368.

41 Deleuze 2006, p. 61.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 67

observational studies. Suitable treatment is available, and affordable. The modern (EBM) doctor is steeped in the studies and/or their downstream proliferations. She sees her patient against a background of groups of experimental subjects whose similarity to her patient she is assessing. Where possible, she is applying clinical guidelines. The space between doctor and patient is infiltrated with research/statistics, and the computer/internet. This is how the grid is constructed. Doctor and patient have moved towards the model of experimenter and

All parties work in a grid of knowledge that has been, or should have been, reconceived, not just increased. The legitimated knowledge is computerised biomedicine, connecting a biomedical patient with a guidelined doctor. This legitimated knowledge has been produced by biomedicine's emblematic group, the protagonists of EBM―a group that has determined what counts as knowledge, who speaks authoritatively, and in particular, what counts as evidence, and what does not. Critically important are the reliability of evidence, the strength of the recomendations flowing from the evidence, and the power/knowledge supporting these. Foucault makes the point that the sciences of Man and the notion of the uniqueness of Man and his individual qualities, separating him from nature and so on, were not so-called groundbreaking "discoveries". The "Enlightenment" did not "roll back the frontiers of ignorance" and provide a means of knowing the "truth". The "truth" was the product of discourse. Discourses may be understood as bodies of knowledge or disciplines, in themselves the form of disciplinary practices.46 A discourse enables and limits what can be thought, said and written during a period of time. Discourses produce knowledges and knowledge is made known historically. The historical constitution of knowledge undermines any claim that knowledge is impartial or better than previous knowledge. Foucault does not see an extradiscourse point from which we can assess the correctness of any discourse. Thus the truth about "Man" is not a pale reflection of a real, natural man, idealised in form and content but the actual, engaged, situated human beings described in social sciences and works of art.

It is my contention that EBM does not acknowledge the Foucaldian insight that EBM does not investigate and treat an objective patient, through an objective doctor. Foucault would argue that EBM has constructed the patient, the doctor, and the consultation space. As stated above, EBM has not just added to our knowledge, EBM has set up a new knowledge. And not only that. EBM has established itself as the creator of knowledge, has decided how knowledge is legitimated (through RCTs and observational studies leading on to an hierarchy of evidence and the strength of recommendations flowing from the evidence). It is my contention that all this floats free of evidence, and that the medical profession has not debated it to an agreed conclusion.47 You could say that EBM has not just altered the goalposts. It has moved us to a new football field and reconfigured the teams and the rules. And yet in some ways EBM plays as if we were on the old field (realistically or mindindependently construed). It's proponents do not acknowledge the constructed status of the patient, the doctor and the consultation space. They do not acknowledge that the patient is set up in terms of variables and mechanisms which EBM can investigate and treat. The investigating gaze of the EBM doctor takes itself to be dividing even to the joints and

marrow of nature itself ("cutting nature at the joints"), armed with the spirit of truth.

experimental subject.

46 Coveney 2006, p. 4. 47 Miles et al. 2008, p. 621.

"givens". For example, early in the twentieth century it became possible for a doctor to arrange for the patient's chest to be X-Rayed. But against this given-ness of the doctor and patient, both were constructions in flux. Late-twentieth-century patients began to manage their own asthma and diabetes, and the doctors also changed. Early in the twentieth century a chest physician had skills to map out the tuberculous cavities in the chest, with whispering pectoriloquy, percussion, and auscultation for bronchial breathing. The late-twentiethcentury chest physician had lost some of these skills, but become expert in reading a chest X-Ray film. The chest physician had become subject--in turn--to the gaze. This applies with more force to the cardiologist and neurologist with electrocardiograms, ectroencephalograms, ultrasound, magnetic resonance imaging and computerised axial tomography.

The space between doctor and patient changed to further complexify the shifting relationships. The physician moved closer to the patient, beginning to examine the rectum and vagina, and to pass a sigmoidoscope into the colon. These procedures brought the interior more directly under the scopic gaze.42 But further even again to these profound changes from a more subtle and profound level, Foucault challenges this "given", unproblematic nature of the doctor, patient, and consultation space. In the last two decades, EBM has further reconstructed the patient, doctor and intervening space reconstructing the smooth and striated yet again:--43

*A more precise historical analysis reveals a quite different principle of adjustment beyond these adjustments: it bears jointly on the type of objects to be known, on the grid that makes it appear, isolates it, and carves up the elements relevant to a possible epistemic knowledge (savoir), on the position that the subject must occupy in order to map them, on the instrumental mediations that enables it to grasp them, on the modalities of registration and memory that it must put into operation, and on the forms of conceptualization that it must practice and that qualify it as a subject of legitimate knowledge. What is modified in giving place to anatomo-clinical medicine is not, therefore, the mere surface contact between the knowing subject and the known object; it is the more general arrangement of knowledge that determines the reciprocal positions and connexion between the one who must know and that which is to be known. The access of the medical gaze into the sick body was not... it was the result of a recasting at the level of epistemic knowledge (savoir) itself, and not at the level of accumulated, refined, deepened, adjusted knowledge (connaissances).*44

The EBM clinician makes little use of herself as a person.45 Although her reality is with her patient, she quickly sets out on a conceptual trajectory which distances her from her patient. She first asks what group of **P**atients or experimental subjects her patient can be placed in. Then her mind continues to function at a distance from her patient by asking what **I**ntervention she should consider. Third, her mind continues at a distance by asking what intervention is probably less suitable, for **C**omparison. Lastly, she projects herself out of the here and now by asking what **O**utcome, in the future, she is planning. This is the scheme for the PICO question, the start of the EBM process.

The modern (EBM) patient is biomedical, hopefully has one acute disease, depictable though the science of pathology, and is viewed against a background of one or more groups of similar patients whose disease has been investigated through one or more RCTs and/or

42 The physician moved to the other side.

43 Of course, Foucault is writing of the early nineteenth century in France.

44 Foucault 1994, p. 137.

45 I draw on Wifstad 2008 for this line of thinking.

"givens". For example, early in the twentieth century it became possible for a doctor to arrange for the patient's chest to be X-Rayed. But against this given-ness of the doctor and patient, both were constructions in flux. Late-twentieth-century patients began to manage their own asthma and diabetes, and the doctors also changed. Early in the twentieth century a chest physician had skills to map out the tuberculous cavities in the chest, with whispering pectoriloquy, percussion, and auscultation for bronchial breathing. The late-twentiethcentury chest physician had lost some of these skills, but become expert in reading a chest X-Ray film. The chest physician had become subject--in turn--to the gaze. This applies with more force to the cardiologist and neurologist with electrocardiograms, ectroencephalograms, ultra-

The space between doctor and patient changed to further complexify the shifting relationships. The physician moved closer to the patient, beginning to examine the rectum and vagina, and to pass a sigmoidoscope into the colon. These procedures brought the interior more directly under the scopic gaze.42 But further even again to these profound changes from a more subtle and profound level, Foucault challenges this "given", unproblematic nature of the doctor, patient, and consultation space. In the last two decades, EBM has further reconstructed the patient, doctor and intervening space reconstructing the smooth and striated yet again:--43

*A more precise historical analysis reveals a quite different principle of adjustment beyond these adjustments: it bears jointly on the type of objects to be known, on the grid that makes it appear, isolates it, and carves up the elements relevant to a possible epistemic knowledge (savoir), on the position that the subject must occupy in order to map them, on the instrumental mediations that enables it to grasp them, on the modalities of registration and memory that it must put into operation, and on the forms of conceptualization that it must practice and that qualify it as a subject of legitimate knowledge. What is modified in giving place to anatomo-clinical medicine is not, therefore, the mere surface contact between the knowing subject and the known object; it is the more general arrangement of knowledge that determines the reciprocal positions and connexion between the one who must know and that which is to be known. The access of the medical gaze into the sick body was not... it was the result of a recasting at the level of epistemic knowledge (savoir) itself, and not at the level of accumulated, refined, deepened, adjusted knowledge (connaissances).*44 The EBM clinician makes little use of herself as a person.45 Although her reality is with her patient, she quickly sets out on a conceptual trajectory which distances her from her patient. She first asks what group of **P**atients or experimental subjects her patient can be placed in. Then her mind continues to function at a distance from her patient by asking what **I**ntervention she should consider. Third, her mind continues at a distance by asking what intervention is probably less suitable, for **C**omparison. Lastly, she projects herself out of the here and now by asking what **O**utcome, in the future, she is planning. This is the scheme for

The modern (EBM) patient is biomedical, hopefully has one acute disease, depictable though the science of pathology, and is viewed against a background of one or more groups of similar patients whose disease has been investigated through one or more RCTs and/or

sound, magnetic resonance imaging and computerised axial tomography.

the PICO question, the start of the EBM process.

43 Of course, Foucault is writing of the early nineteenth century in France.

42 The physician moved to the other side.

45 I draw on Wifstad 2008 for this line of thinking.

44 Foucault 1994, p. 137.

observational studies. Suitable treatment is available, and affordable. The modern (EBM) doctor is steeped in the studies and/or their downstream proliferations. She sees her patient against a background of groups of experimental subjects whose similarity to her patient she is assessing. Where possible, she is applying clinical guidelines. The space between doctor and patient is infiltrated with research/statistics, and the computer/internet. This is how the grid is constructed. Doctor and patient have moved towards the model of experimenter and experimental subject.

All parties work in a grid of knowledge that has been, or should have been, reconceived, not just increased. The legitimated knowledge is computerised biomedicine, connecting a biomedical patient with a guidelined doctor. This legitimated knowledge has been produced by biomedicine's emblematic group, the protagonists of EBM―a group that has determined what counts as knowledge, who speaks authoritatively, and in particular, what counts as evidence, and what does not. Critically important are the reliability of evidence, the strength of the recomendations flowing from the evidence, and the power/knowledge supporting these.

Foucault makes the point that the sciences of Man and the notion of the uniqueness of Man and his individual qualities, separating him from nature and so on, were not so-called groundbreaking "discoveries". The "Enlightenment" did not "roll back the frontiers of ignorance" and provide a means of knowing the "truth". The "truth" was the product of discourse. Discourses may be understood as bodies of knowledge or disciplines, in themselves the form of disciplinary practices.46 A discourse enables and limits what can be thought, said and written during a period of time. Discourses produce knowledges and knowledge is made known historically. The historical constitution of knowledge undermines any claim that knowledge is impartial or better than previous knowledge. Foucault does not see an extradiscourse point from which we can assess the correctness of any discourse. Thus the truth about "Man" is not a pale reflection of a real, natural man, idealised in form and content but the actual, engaged, situated human beings described in social sciences and works of art.

It is my contention that EBM does not acknowledge the Foucaldian insight that EBM does not investigate and treat an objective patient, through an objective doctor. Foucault would argue that EBM has constructed the patient, the doctor, and the consultation space. As stated above, EBM has not just added to our knowledge, EBM has set up a new knowledge. And not only that. EBM has established itself as the creator of knowledge, has decided how knowledge is legitimated (through RCTs and observational studies leading on to an hierarchy of evidence and the strength of recommendations flowing from the evidence). It is my contention that all this floats free of evidence, and that the medical profession has not debated it to an agreed conclusion.47 You could say that EBM has not just altered the goalposts. It has moved us to a new football field and reconfigured the teams and the rules. And yet in some ways EBM plays as if we were on the old field (realistically or mindindependently construed). It's proponents do not acknowledge the constructed status of the patient, the doctor and the consultation space. They do not acknowledge that the patient is set up in terms of variables and mechanisms which EBM can investigate and treat. The investigating gaze of the EBM doctor takes itself to be dividing even to the joints and marrow of nature itself ("cutting nature at the joints"), armed with the spirit of truth.

46 Coveney 2006, p. 4.

47 Miles et al. 2008, p. 621.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 69

The medical gaze has been said to discriminate against some patients. Such issues as social class, gender, race and whether the patient is paying, have received comment. The medical gaze struggles with comorbidity, and with poorly defined problems and language problems. The medical gaze also struggles with the fact that the modern equivalent of the Hippocratic airs and spaces is to widen our gaze to the socio-culturo-politico-historical contexts of disease. As stated above, this last struggle has implications for patients with

The gaze surely includes the higher valuation which doctors place on signs as distinct from symptoms. This is described by Foucault,51who explains how numerous chest diseases can be heralded by such symptoms as cough and shortness of breath. However, early in the nineteenth century, Laennec focused on examination of the chest. He found that, in a few patients, the voice was transmitted surprisingly well to a small area of the chest wall. He called this clinical sign "pectoriloquy", and made the (epistemological) decision that this, rather than the symptoms, would establish the diagnosis (of Pulmonary Tuberculosis). To this day doctors prioritise signs (and particularly images and the results of laboratory investigations with their attached figures) over symptoms if they point to different diagnoses. In passing I note the very interesting point that Laennec made an epistemological leap. However, the point of this paragraph is simply to flesh in Foucault's medical gaze with

EBM exaggerates the importance of its "gold standard" evidence in the EBM gaze. During the (PICO) conceptual excursion, the doctor needs look back at her patient and assess the patient's suitability for this research-based intervention. EBM leaders have, in 2008, provided detailed guidance on this. There is a complex issue regarding the judgment as to whether the patient is suitable for the intervention, the alternative, and even the outcome proposed. The doctor must know something of the patient, her attitudes, values, preferences, and perhaps even her social situation. With increasing emphasis on the business aspect of medicine and also the scientific aspect and the computer, this detailed understanding of the patient is declining in comparison to what it was in the time when most people lived in a country district and saw one doctor over many years. The knowledge of the patient, who is reified, is incomplete and inaccurate. Whatever assessment the doctor makes, the knowledge of the patient is fallible and not based on an RCT. *The knowledge of the patient is different in kind from the RCT knowledge.* This surely limits the entire EBM discursive practice which projects the image that it is based on the results of clinical studies. Even so, as stated by numerous authors, the gap between the group data and the individual's suitability cannot be reduced beyond a certain, unknown, distance. *The actual susceptibility of the patient for the researched intervention cannot be precisely known.* If the clinical doctor follows the study results and invokes the intervention for her patient, we can, at best, hope and believe that that the intervention will be helpful. Regrettably, if the patient improves, we still do not *actually know* whether the intervention

AIDS, for example.

more detail.

51 1994, pp. 159-161.

**2.2.6 EBM rhetoric**

caused the improvement, or was coincidental.

With regard to health care research, the topics selected for investigation will need to fall within the area of intersection of the gaze and health care. The EBM doctor will look for problems suitable for investigation (which assumes funding) through RCT or observational study. Typically this will involve holding one or more variables constant while altering one or more other variables. Obviously, this assumes that such variables can be isolated and dealt with. But there are many aspects of health care which would struggle to fit into this model. For example, palliative care has developed a discourse of dying. There is now a right way to die: quietly. Patients should realise that there comes a stage when definitive treatment should yield to symptomatic treatment. Patients should be actively involved in decisions. But some patients reject this modern discourse on dying. I am not sure that EBM investigates ways a team steeped in the palliative care discourse can work together to support this recalcitrant patient. An issue here for EBM is that the team may be divided as to how to proceed.

Gillett48 gives an account of HIV/AIDS as a postmodern illness which reveals the limitations of biomedicine, and therefore EBM. In the West, at any rate, the illness follows a period in which traditional values were challenged. This means that some men formed sexual relationships with other men. Other people injected drugs intravenously. These choices confronted the power of biology, in that some people developed HIV/AIDS. Despite extensive research, the (biomedical) treatment for this condition is only partly effective. Sufferers were forced together to try to deal with prevention and education and to support each other in grief. This group of people, accustomed to challenging the social hierarchy, developed partnerships with their health providers, negotiating treatment. Doctors and sufferers had to face the question of whether to tell the partner that the patient had tested positive. Ethical questions arose over testing people for the virus. Although I have referred to the West, the condition spread extensively in the third world. In Africa, Gillett49 tells us, some men enjoyed their sex with or without the preparedness of the woman. Women often have little education, political power, or rights within the marriage. This all facilitated the spread of infection among women, and therefore among men and children. An ethical issue arose over research into this condition. Largely led by Western organisations, any such research in third world countries was bedevilled by the fact that those who took part in the research were unlikely to be able to afford its benefits. In one study, some desperate research subjects managed to decipher the code in the RCT and break protocol by handing around the active moiety. The point I am making is that there is a (disease) space in which culture and biomedicine meet. With Gillett,50 I submit that much of what I have described is poorly handled by EBM, whose gaze is restricted―EBM is blind to certain aspects of the problem that is human disease and therefore it may be blind to critical determinants that will make a real difference to the suffering caused. Then with Foucault, I draw attention to the dominance of the narrow EBM discourse and to the association of knowledge and power. The western biomedical gaze constructed our solutions in terms of pharmaceutical remedies rather than in terms of socio-political change, revealing the hegemony of the biomedical, pathological anatomy gaze.

48 2004, Chapter 8.

49 2004.

50 2004.

The medical gaze has been said to discriminate against some patients. Such issues as social class, gender, race and whether the patient is paying, have received comment. The medical gaze struggles with comorbidity, and with poorly defined problems and language problems. The medical gaze also struggles with the fact that the modern equivalent of the Hippocratic airs and spaces is to widen our gaze to the socio-culturo-politico-historical contexts of disease. As stated above, this last struggle has implications for patients with AIDS, for example.

The gaze surely includes the higher valuation which doctors place on signs as distinct from symptoms. This is described by Foucault,51who explains how numerous chest diseases can be heralded by such symptoms as cough and shortness of breath. However, early in the nineteenth century, Laennec focused on examination of the chest. He found that, in a few patients, the voice was transmitted surprisingly well to a small area of the chest wall. He called this clinical sign "pectoriloquy", and made the (epistemological) decision that this, rather than the symptoms, would establish the diagnosis (of Pulmonary Tuberculosis). To this day doctors prioritise signs (and particularly images and the results of laboratory investigations with their attached figures) over symptoms if they point to different diagnoses. In passing I note the very interesting point that Laennec made an epistemological leap. However, the point of this paragraph is simply to flesh in Foucault's medical gaze with more detail.

#### **2.2.6 EBM rhetoric**

68 Evidence Based Medicine – Closer to Patients or Scientists?

With regard to health care research, the topics selected for investigation will need to fall within the area of intersection of the gaze and health care. The EBM doctor will look for problems suitable for investigation (which assumes funding) through RCT or observational study. Typically this will involve holding one or more variables constant while altering one or more other variables. Obviously, this assumes that such variables can be isolated and dealt with. But there are many aspects of health care which would struggle to fit into this model. For example, palliative care has developed a discourse of dying. There is now a right way to die: quietly. Patients should realise that there comes a stage when definitive treatment should yield to symptomatic treatment. Patients should be actively involved in decisions. But some patients reject this modern discourse on dying. I am not sure that EBM investigates ways a team steeped in the palliative care discourse can work together to support this recalcitrant patient. An issue here for EBM is that the team may be divided as to

Gillett48 gives an account of HIV/AIDS as a postmodern illness which reveals the limitations of biomedicine, and therefore EBM. In the West, at any rate, the illness follows a period in which traditional values were challenged. This means that some men formed sexual relationships with other men. Other people injected drugs intravenously. These choices confronted the power of biology, in that some people developed HIV/AIDS. Despite extensive research, the (biomedical) treatment for this condition is only partly effective. Sufferers were forced together to try to deal with prevention and education and to support each other in grief. This group of people, accustomed to challenging the social hierarchy, developed partnerships with their health providers, negotiating treatment. Doctors and sufferers had to face the question of whether to tell the partner that the patient had tested positive. Ethical questions arose over testing people for the virus. Although I have referred to the West, the condition spread extensively in the third world. In Africa, Gillett49 tells us, some men enjoyed their sex with or without the preparedness of the woman. Women often have little education, political power, or rights within the marriage. This all facilitated the spread of infection among women, and therefore among men and children. An ethical issue arose over research into this condition. Largely led by Western organisations, any such research in third world countries was bedevilled by the fact that those who took part in the research were unlikely to be able to afford its benefits. In one study, some desperate research subjects managed to decipher the code in the RCT and break protocol by handing around the active moiety. The point I am making is that there is a (disease) space in which culture and biomedicine meet. With Gillett,50 I submit that much of what I have described is poorly handled by EBM, whose gaze is restricted―EBM is blind to certain aspects of the problem that is human disease and therefore it may be blind to critical determinants that will make a real difference to the suffering caused. Then with Foucault, I draw attention to the dominance of the narrow EBM discourse and to the association of knowledge and power. The western biomedical gaze constructed our solutions in terms of pharmaceutical remedies rather than in terms of socio-political change, revealing the hegemony of the

how to proceed.

biomedical, pathological anatomy gaze.

49 2004. 50 2004.

48 2004, Chapter 8.

EBM exaggerates the importance of its "gold standard" evidence in the EBM gaze. During the (PICO) conceptual excursion, the doctor needs look back at her patient and assess the patient's suitability for this research-based intervention. EBM leaders have, in 2008, provided detailed guidance on this. There is a complex issue regarding the judgment as to whether the patient is suitable for the intervention, the alternative, and even the outcome proposed. The doctor must know something of the patient, her attitudes, values, preferences, and perhaps even her social situation. With increasing emphasis on the business aspect of medicine and also the scientific aspect and the computer, this detailed understanding of the patient is declining in comparison to what it was in the time when most people lived in a country district and saw one doctor over many years. The knowledge of the patient, who is reified, is incomplete and inaccurate. Whatever assessment the doctor makes, the knowledge of the patient is fallible and not based on an RCT. *The knowledge of the patient is different in kind from the RCT knowledge.* This surely limits the entire EBM discursive practice which projects the image that it is based on the results of clinical studies. Even so, as stated by numerous authors, the gap between the group data and the individual's suitability cannot be reduced beyond a certain, unknown, distance. *The actual susceptibility of the patient for the researched intervention cannot be precisely known.* If the clinical doctor follows the study results and invokes the intervention for her patient, we can, at best, hope and believe that that the intervention will be helpful. Regrettably, if the patient improves, we still do not *actually know* whether the intervention caused the improvement, or was coincidental.

 51 1994, pp. 159-161.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 71

the theory that the trialled treatment will, overall, be beneficial for the next patient. Therefore the relationship between group research (in striated space) and clinical care (in

The vexed issue of how apply the findings from population research to the individual patient is partly clarified by attention to patient characteristics (including age, severity of disease, comorbidity, ethnicity, and compliance with treatment regimens), healthcare system characteristics (skills of treating doctors, treatment or test availability, monitoring) and outcome characteristics (do study outcomes matter to the present doctor/patient dyad, surrogate endpoints, such as bone density rather than fractures, and so on).58 The clinical doctor treating the individual patient on the basis of population research needs to notice the number needed to treat figure "for a group of individuals resembling their patient",59 and to carefully look into relative risks and absolute risks as they exist for the unselected people who walk into the clinic rather than the select group in whom study effects are seen. What is more, even though subgroup analyses reflect "patient diversity in risk for disease, responsiveness to treatment, vulnerability to adverse effects, and utility for different outcomes",60 subgroups of one are not part of that kind of science even though they are the norm in the nomadic space of real world clinical medicine. When we add ethical considerations of patient choice and the acceptability of treatment to the mix61 it is no wonder that results produced in a striated world do not apply at the contested margins of striation where nomadic knowledge charts its paths through smooth spaces of unstructured

EBM does not tell us how to mix and match the five warrants that plausibly should attend clinical decision-making. (These are: the results of clinical research, pathophysiological reasoning, clinical experience, patient preferences and actions, and system factors {such as the availability of a test or treatment.}) Differences in ontology, methodology, epistemology and ethicality criss cross the field.63 Firstly, there is an ontological difference between pathophysiology and system factors. For example, while pathophysiology may be anchored in the biology of antibacterials, system factors may be anchored in health economics such that a general practitioner is not allowed to prescribe certain drugs. The difference in these two warrants is ontological in that they belong to different orders of reality. Second, an epistemological difference exists between clinical experience and the results of an RCT – one depends on judgments of similarity and difference between particular instances of illness (the last spinal empyema and this one) and the other on the adequacy of inclusion and application criteria relating particular cases to a general category (this pneumonia as an

62 I must admit that the frequent emphasis in my work on the chaotic nature of clinical practice is perhaps excessive, and intended to contrast with EBM. I am aware that Descartes and many other great thinkers have been struck by orderliness in the universe, and its susceptibility to mathematical modeling. And there was some structure in the clinical consultation before EBM. For example,the

results of pathophysiological experiments have guided doctors for a very long time.

smooth or nomadic space) is not self-evident despite voices to the contrary.57

and sometimes chaotic experience.62

57 Silva & Wyer 2009.

63 Kerridge 2010.

58 Bassler, Busse, Karanicolas & Guyatt 2008. 59 Bassler, Busse, Karanicolas & Guyatt 2008, p. 2. 60 Bassler, Karanicolas, Busse & Guyatt 2008, p. 1. 61 Bassler, Karanicolas, Busse & Guyatt 2008.

#### **2.2.7 The docile body**

Foucault's *gaze* has been problematised. The trouble is that the patient does not look back! (This has been called "the docile body", and does not square with phenomenology.) There is an air of dominance here. My comments on the sufferers from AIDS are a suitable antidote. I represent these patients as active in the medical relationship.

Bloor and McIntosh noted that the subjects of the surveying therapeutic gaze responded in various ways, including direct rejection and attack on the value and legitimacy of the health worker's52 attentions, non-cooperation, silence, escape, avoidance, and most-common of all, concealment.53

In my work as a Police Medical Officer, I need permission to examine every patient in police custody. Sometimes this is not granted, even when the patient asked for a doctor, and I have travelled 22 kilometers during the night. In my third year I was challenged as to whether I was a Police Medical Officer (as I had stated) or "just a doctor off the street". I always have a constable with me, so questions about the intake of drugs and aclohol, intended to help me assess the state of the brain, receive a variety of responses. Recently, in obtaining a history as to how the patient gained an incised wound in front of his patella tendon, I was given completely different accounts by the patient and constable. These police patients, then, sometimes show up one limitation of the medical gaze.

#### **3. The medical /EBM gaze meets the smooth space of the doctor-patient consultation which includes the patient and her problems**

I now bring the EBM gaze, which includes the results of epidemiological research, conducted on large groups of experimental subjects, into the smooth space of the patient. However, the reticulated knowedge of the EBM gaze is a poor fit for the smooth space of the patient. As the reticulated gaze arrives in smooth space, it leaves gaps between the laminae of the framework. Thus it fails to deal adequately with the smooth space of the patient. Consider the wild suffering and wellness that escapes medical surveillance because its flows of energy are not easily categorized into the diagnoses and tests that yield currency for EBM.

EBM has forced us to develop our understanding of the application of evidence derived from large groups of experimental subjects to the individual patient and so has addressed one of its most frequently cited problems. "The inferential leap necessary for treating an individual based on aggregate findings is mostly assumed away".54 But in an RCT, some patients are excluded, subjects actually take their medication, the treatment period is likely to be short and closely monitored in comparison with future widespread use of the treatment, and the control condition often uses placebo treatment, not a realistic option for the "nomadic" clinician.55 The end points of the research may differ from the outcomes of interest to the doctor and/or patient, a problem not always captured in terms of internal versus external validity.56 The theory which the RCT provides evidence for is therefore *not*

 52 Strictly speaking, this quote refers to British health visitors calling on mothers, not actually to doctors. 53 Lupton 1997, p. 104.

54 Tanenbaum 1999, p. 757.

55 Worrall 2010.

Foucault's *gaze* has been problematised. The trouble is that the patient does not look back! (This has been called "the docile body", and does not square with phenomenology.) There is an air of dominance here. My comments on the sufferers from AIDS are a suitable antidote. I

Bloor and McIntosh noted that the subjects of the surveying therapeutic gaze responded in various ways, including direct rejection and attack on the value and legitimacy of the health worker's52 attentions, non-cooperation, silence, escape, avoidance, and most-common of all,

In my work as a Police Medical Officer, I need permission to examine every patient in police custody. Sometimes this is not granted, even when the patient asked for a doctor, and I have travelled 22 kilometers during the night. In my third year I was challenged as to whether I was a Police Medical Officer (as I had stated) or "just a doctor off the street". I always have a constable with me, so questions about the intake of drugs and aclohol, intended to help me assess the state of the brain, receive a variety of responses. Recently, in obtaining a history as to how the patient gained an incised wound in front of his patella tendon, I was given completely different accounts by the patient and constable. These police patients, then,

**3. The medical /EBM gaze meets the smooth space of the doctor-patient**

I now bring the EBM gaze, which includes the results of epidemiological research, conducted on large groups of experimental subjects, into the smooth space of the patient. However, the reticulated knowedge of the EBM gaze is a poor fit for the smooth space of the patient. As the reticulated gaze arrives in smooth space, it leaves gaps between the laminae of the framework. Thus it fails to deal adequately with the smooth space of the patient. Consider the wild suffering and wellness that escapes medical surveillance because its flows of energy are not easily categorized into the diagnoses and tests that yield currency for EBM. EBM has forced us to develop our understanding of the application of evidence derived from large groups of experimental subjects to the individual patient and so has addressed one of its most frequently cited problems. "The inferential leap necessary for treating an individual based on aggregate findings is mostly assumed away".54 But in an RCT, some patients are excluded, subjects actually take their medication, the treatment period is likely to be short and closely monitored in comparison with future widespread use of the treatment, and the control condition often uses placebo treatment, not a realistic option for the "nomadic" clinician.55 The end points of the research may differ from the outcomes of interest to the doctor and/or patient, a problem not always captured in terms of internal versus external validity.56 The theory which the RCT provides evidence for is therefore *not*

52 Strictly speaking, this quote refers to British health visitors calling on mothers, not actually to doctors. 53 Lupton 1997, p. 104.

represent these patients as active in the medical relationship.

sometimes show up one limitation of the medical gaze.

**consultation which includes the patient and her problems**

**2.2.7 The docile body**

concealment.53

54 Tanenbaum 1999, p. 757.

55 Worrall 2010. 56 Bluhm 2010.

the theory that the trialled treatment will, overall, be beneficial for the next patient. Therefore the relationship between group research (in striated space) and clinical care (in smooth or nomadic space) is not self-evident despite voices to the contrary.57

The vexed issue of how apply the findings from population research to the individual patient is partly clarified by attention to patient characteristics (including age, severity of disease, comorbidity, ethnicity, and compliance with treatment regimens), healthcare system characteristics (skills of treating doctors, treatment or test availability, monitoring) and outcome characteristics (do study outcomes matter to the present doctor/patient dyad, surrogate endpoints, such as bone density rather than fractures, and so on).58 The clinical doctor treating the individual patient on the basis of population research needs to notice the number needed to treat figure "for a group of individuals resembling their patient",59 and to carefully look into relative risks and absolute risks as they exist for the unselected people who walk into the clinic rather than the select group in whom study effects are seen. What is more, even though subgroup analyses reflect "patient diversity in risk for disease, responsiveness to treatment, vulnerability to adverse effects, and utility for different outcomes",60 subgroups of one are not part of that kind of science even though they are the norm in the nomadic space of real world clinical medicine. When we add ethical considerations of patient choice and the acceptability of treatment to the mix61 it is no wonder that results produced in a striated world do not apply at the contested margins of striation where nomadic knowledge charts its paths through smooth spaces of unstructured and sometimes chaotic experience.62

EBM does not tell us how to mix and match the five warrants that plausibly should attend clinical decision-making. (These are: the results of clinical research, pathophysiological reasoning, clinical experience, patient preferences and actions, and system factors {such as the availability of a test or treatment.}) Differences in ontology, methodology, epistemology and ethicality criss cross the field.63 Firstly, there is an ontological difference between pathophysiology and system factors. For example, while pathophysiology may be anchored in the biology of antibacterials, system factors may be anchored in health economics such that a general practitioner is not allowed to prescribe certain drugs. The difference in these two warrants is ontological in that they belong to different orders of reality. Second, an epistemological difference exists between clinical experience and the results of an RCT – one depends on judgments of similarity and difference between particular instances of illness (the last spinal empyema and this one) and the other on the adequacy of inclusion and application criteria relating particular cases to a general category (this pneumonia as an

57 Silva & Wyer 2009.

58 Bassler, Busse, Karanicolas & Guyatt 2008.

59 Bassler, Busse, Karanicolas & Guyatt 2008, p. 2.

60 Bassler, Karanicolas, Busse & Guyatt 2008, p. 1.

61 Bassler, Karanicolas, Busse & Guyatt 2008.

62 I must admit that the frequent emphasis in my work on the chaotic nature of clinical practice is perhaps excessive, and intended to contrast with EBM. I am aware that Descartes and many other great thinkers have been struck by orderliness in the universe, and its susceptibility to mathematical modeling. And there was some structure in the clinical consultation before EBM. For example,the results of pathophysiological experiments have guided doctors for a very long time. 63 Kerridge 2010.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 73

If this is an accurate analysis, then it follows that rational integration eludes us with regard to the desire of EBM to resolve the conflict between the results of clinical research and

There is another way of seeing why we cannot rationally reticulate smooth space and develop a method to overcome the difference because in the multiplicities we deal with in human life a kind of tacit knowledge, similar to clinical intuition/expertise, is indispensable.

*packs; of magnitude and of distance; of breaks and of frequency; striated and smooth.*69

While it is possible to create rules to deal with entities that are part of the same order, it is not rationally possible to reticulate or divide up a commodity which is heterogeneous and intensive. Take pain. Although doctors ask patients to rate pain on a scale of ten, we cannot move from there to arguing that if a treatment leads a patient to change the rating of the pain intensity from 10 to five, the pain (as an orderly variable) has been halved. There are many areas of medicine not amenable to rational metrication and biostatistics because they

In the last few paragraphs I argue that there is no rational way to merge the results of epidemiological research with clinical intuition. I heralded an epistemological crisis in medicine, though I am not the first to do this. So what are doctors doing? The method of mixing these disparate inputs lies not in any codified system. They are joined through implicit, not explicit, knowledge, as is learned by a house surgeon from her senior. The judgments involved are learned by the less experienced doctor. Thus the epistemological crisis moves into the field of tacit knowledge. A lengthy and detailed explanation, which draws on Wittgenstein and Kuhn, of the way in which all codifiable knowledge rests in a sea of implicit knowledge is developed by Tim Thornton70 who argues that both scientific research results and clinical expertise rest, in fact, on tacit knowledge. Whatever codified knowledge is to be used, *judgement* is required as to which codified knowledge and whether and when to use it. For example, judgment is required in selecting a theory to apply to several diverse scientific problems. Thornton points out that the best and fullest accounts of EBM make this clear, but EBM does lend itself to distortion in which evidence-*based* medicine quickly slips into codified knowledge, paying little attention to the backgound use of judgement or implicit knowledge. The devil is in the detail as to the wise use of the term

If Deleuze and Guattari71 are right, a method for reticulating decision-making warrants into evidential form is bound to fail72 in that new forms of evidence would suffer under the

*We have on numerous occasions encountered all kinds of differences between two types of multiplicities: metric and non-metric; extensive and qualitative; centred and acentred; arborescent and rhizomatic; numerical and flat; dimensional and directional; of masses and of*

*according to entirely different movements.*67

are intrinsically relational rather than objectively fixed.

clinical experiences/intuition.68

"based".

68 Braude 2009.

70 2006. 71 1987.

67 Deleuze and Guattari 1987, pp. 474-475.

69 Deleuze and Guattari 1987, pp. 483-484.

*sometimes causing a passage from smooth to striated, sometimes from striated to smooth,*

instance of bacterial infection). Thirdly, there is a difference between patient preferences and and the clinical experience of the doctor as in the choice for abortion and the doctor's judgment that it will turn out badly for the woman concerned. There is a major ethical component in the way the decision is arrived at in that the patient chooses and the doctor can only advise on the basis of experience. Somehow these two warrants must be combined and how to do so is unclear.

We can draw two conclusions from this analysis of the difficulty in combining warrants for decision. One is that there is an epistemological crisis in medicine, since we now realise that we do not know how to amalgamate five streams of very different kinds of knowledge. The second is that we no longer know what (in real life) EBM is: 100 different doctors may combine the multiple warrants for decision in different ways and in this task of integrating the warrants, no schema has been agreed or even proposed.

I now direct more attention to the difficulty of combining the five warrants for decision. I actually simplify the problem by selecting just two of the five warrants. The problem then simplifies to: *how to combine the result of epidemiological research with clinical experience.* (I allow myself to wander a little between clinical experience and clinical intuition). Note that EBM uses the term "integrate" for the warrants for decision.

Deleuze and Guattari64 provide an analysis of the impasse. (Note that there is a difference between clinical experience and clinical expertise.) Consider clinical research results and clinical expertise and recall the 200265 model of decision making whereby clinical expertise brokers the possibly conflicting claims of research evidence, patient preferences and actions, and clinical state and circumstances. The EBM desire to bring the results of clinical research into clinical decision making can be viewed as an attempt to striate smooth space—the epidemiological evidence is used to reticulate the smooth space of clinical experience/intuition and patient management.66

*Smooth space and striated space—nomad space and sedentary space—the space in which the war machine develops and the space instituted by the state apparatus--are not of the same nature. No sooner do we note a simple opposition between the two kinds of space than we must indicate a much more complex difference by virtue of the successive terms of the oppositions fail to coincide entirely. And no sooner have we done that than we must remind ourselves that the two spaces in fact exist only in mixture: smooth space is constantly being translated, traversed into a striated space; striated space is constantly being reversed, returned to a smooth space. In the first case, one organises even the desert; in the second, the desert gains and grows; and the two can happen simultaneously. But the de facto mixes do not preclude a de jure, or abstract, distinction between the two spaces. That there is such a distinction accounts for the fact that the two spaces do not communicate with each other in the same way: it is the de jure distinction that determines the forms assumed by a given de facto mix and the direction or meaning of the mix (is a smooth space captured, enveloped by a striated space or does a striated space dissolve into a smooth space, allow a smooth space to develop?). This raises a number of simultaneous questions: the simple oppositions between the two spaces; the complex differences; the de facto mixes, and the passages from one to another; the principles of the mixture, which are not at all symmetrical,*

66 Braude 2009.

64 1987.

65 Haynes, Devereux & Guyatt 2002.

instance of bacterial infection). Thirdly, there is a difference between patient preferences and and the clinical experience of the doctor as in the choice for abortion and the doctor's judgment that it will turn out badly for the woman concerned. There is a major ethical component in the way the decision is arrived at in that the patient chooses and the doctor can only advise on the basis of experience. Somehow these two warrants must be combined

We can draw two conclusions from this analysis of the difficulty in combining warrants for decision. One is that there is an epistemological crisis in medicine, since we now realise that we do not know how to amalgamate five streams of very different kinds of knowledge. The second is that we no longer know what (in real life) EBM is: 100 different doctors may combine the multiple warrants for decision in different ways and in this task of integrating

I now direct more attention to the difficulty of combining the five warrants for decision. I actually simplify the problem by selecting just two of the five warrants. The problem then simplifies to: *how to combine the result of epidemiological research with clinical experience.* (I allow myself to wander a little between clinical experience and clinical intuition). Note that EBM

Deleuze and Guattari64 provide an analysis of the impasse. (Note that there is a difference between clinical experience and clinical expertise.) Consider clinical research results and clinical expertise and recall the 200265 model of decision making whereby clinical expertise brokers the possibly conflicting claims of research evidence, patient preferences and actions, and clinical state and circumstances. The EBM desire to bring the results of clinical research into clinical decision making can be viewed as an attempt to striate smooth space—the epidemiological evidence is used to reticulate the smooth space of clinical experience/intuition

*Smooth space and striated space—nomad space and sedentary space—the space in which the war machine develops and the space instituted by the state apparatus--are not of the same nature. No sooner do we note a simple opposition between the two kinds of space than we must indicate a much more complex difference by virtue of the successive terms of the oppositions fail to coincide entirely. And no sooner have we done that than we must remind ourselves that the two spaces in fact exist only in mixture: smooth space is constantly being translated, traversed into a striated space; striated space is constantly being reversed, returned to a smooth space. In the first case, one organises even the desert; in the second, the desert gains and grows; and the two can happen simultaneously. But the de facto mixes do not preclude a de jure, or abstract, distinction between the two spaces. That there is such a distinction accounts for the fact that the two spaces do not communicate with each other in the same way: it is the de jure distinction that determines the forms assumed by a given de facto mix and the direction or meaning of the mix (is a smooth space captured, enveloped by a striated space or does a striated space dissolve into a smooth space, allow a smooth space to develop?). This raises a number of simultaneous questions: the simple oppositions between the two spaces; the complex differences; the de facto mixes, and the passages from one to another; the principles of the mixture, which are not at all symmetrical,*

the warrants, no schema has been agreed or even proposed.

uses the term "integrate" for the warrants for decision.

and how to do so is unclear.

and patient management.66

65 Haynes, Devereux & Guyatt 2002.

 64 1987.

66 Braude 2009.

*sometimes causing a passage from smooth to striated, sometimes from striated to smooth, according to entirely different movements.*67

If this is an accurate analysis, then it follows that rational integration eludes us with regard to the desire of EBM to resolve the conflict between the results of clinical research and clinical experiences/intuition.68

There is another way of seeing why we cannot rationally reticulate smooth space and develop a method to overcome the difference because in the multiplicities we deal with in human life a kind of tacit knowledge, similar to clinical intuition/expertise, is indispensable.

*We have on numerous occasions encountered all kinds of differences between two types of multiplicities: metric and non-metric; extensive and qualitative; centred and acentred; arborescent and rhizomatic; numerical and flat; dimensional and directional; of masses and of packs; of magnitude and of distance; of breaks and of frequency; striated and smooth.*69

While it is possible to create rules to deal with entities that are part of the same order, it is not rationally possible to reticulate or divide up a commodity which is heterogeneous and intensive. Take pain. Although doctors ask patients to rate pain on a scale of ten, we cannot move from there to arguing that if a treatment leads a patient to change the rating of the pain intensity from 10 to five, the pain (as an orderly variable) has been halved. There are many areas of medicine not amenable to rational metrication and biostatistics because they are intrinsically relational rather than objectively fixed.

In the last few paragraphs I argue that there is no rational way to merge the results of epidemiological research with clinical intuition. I heralded an epistemological crisis in medicine, though I am not the first to do this. So what are doctors doing? The method of mixing these disparate inputs lies not in any codified system. They are joined through implicit, not explicit, knowledge, as is learned by a house surgeon from her senior. The judgments involved are learned by the less experienced doctor. Thus the epistemological crisis moves into the field of tacit knowledge. A lengthy and detailed explanation, which draws on Wittgenstein and Kuhn, of the way in which all codifiable knowledge rests in a sea of implicit knowledge is developed by Tim Thornton70 who argues that both scientific research results and clinical expertise rest, in fact, on tacit knowledge. Whatever codified knowledge is to be used, *judgement* is required as to which codified knowledge and whether and when to use it. For example, judgment is required in selecting a theory to apply to several diverse scientific problems. Thornton points out that the best and fullest accounts of EBM make this clear, but EBM does lend itself to distortion in which evidence-*based* medicine quickly slips into codified knowledge, paying little attention to the backgound use of judgement or implicit knowledge. The devil is in the detail as to the wise use of the term "based".

If Deleuze and Guattari71 are right, a method for reticulating decision-making warrants into evidential form is bound to fail72 in that new forms of evidence would suffer under the

67 Deleuze and Guattari 1987, pp. 474-475.

68 Braude 2009.

69 Deleuze and Guattari 1987, pp. 483-484.

70 2006.

71 1987.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 75

include meaning, motivation and values. However, De Caro and Macarthur79 allude to a chapter by Huw Price, which draws attention to the "metaphysically substantial conceptions of reference and truth" supporting this object world. These authors note an asymmetry in this naturalism: it is heavy on the object but light on the subject. Explaining this, De Caro and Macarthur draw attention to the negligible attention paid to use of linguistic terms and expressions. This subject naturalism is strangely omitted. There is also their tendency to accept a fundamentally foundational and exclusively true and well-ordered scheme of knowledge with a unitary structure of justification and principles of validity and worth.

I consider that epidemiology and biostatistics exemplify scientific naturalism and cannot cope adequately with some aspects (such as intentional states, freedom, personal identity) of the lives of patients. From here it is a short step (via psycho-neuro-humero-immunology) to denying epidemiology and biostatistics supreme authority in medicine. This is an example of my application of philosophy to EBM. I hope this approach savours more of providing a viewpoint than the authority of philosophy. In any event, I am comforted by the last sentence in De Caro and Macarthur's "Introduction",80 ending..." the distinction between

In further consideration of what authority science has in medicine I now provide an answer to the question I asked two paragraphs back: *Is medicine a science or an art?* Montgomery, in her book, "How doctors think",81 tells us it is neither: it is a *practice.* By now I have argued that medicine is a practice which draws on science. If this is right we need be circumspect regarding any claim which science may make as to its authority, epistemically, in medicine. This matter has been dealt with extensively by many authors such as Miles, Loughlin and Polychronis. Rather than reiterate their viewpoints, I will limit myself to post--structuralist comment. According to Foucault, knowledge and power are inseparable. And from the point of view of Deleuze and Guattari, now that EBM has been so extensively problematised at the conceptual level by the above-mentioned authors, we are not in a position to anoint this approach to medicine as "the truth". In fact post-structuralist thinkers allow a range of pathways to knowledge, including the provision of knowledge by one doctor about one patient. Even patients can conrtibute knowledge. To what extent is the patient's pain reduced by the treatment? Heidegger, admittedly not a post-structuralist philosopher, tells us that *being* cannot be investigated as if it were an entity, using "positive" sciences like biology. Rather *being* has the struture of meaning, and is best investigated

phenomenologically. It seems to me that pain is nearer to being than to an entity.

Much of what I have written has been written before. I beleive that the cutting edge of my own contribution lies in the following points. The EBM process starts in smooth space, proceeds into codified knowledge, and returns to try to striate or organise smooth space. I have highlighted the rapid distancing from the patient involved in the PICO question and I look forward to providing an existential/phenomenological account of this in a later paper

81 Montgomery, K. *How doctors think. Clinical judgement and the practice of medicine.* Oxford: Oxford

**5. Conclusion**

79 2004, p. 10. 80 2004, p. 17.

University Press, 2006.

science and philosophy is one that is constantly being negotiated."

tyranny of data,73 and the whole approach of reticulating the warrants for decision into evidential form ignores the argument that the inputs cannot be construed as evidence. The attempt itself is a totalising tendency suited to a striated domain of action and not nomadic science and it marginalises the idiosyncratic aspects of patients, doctors, and their interaction so that "the movement challenges professionalism by disputing what and how physicians know, and especially by marginalising what one physician can know about one patient".74 This encounter-based knowledge is smooth or nomadic and does not have a settled scientific home.

The assertions of EBM, focused on the importance of clinical research, falter because medicine is at the intersection of several sciences and even of diverse scholarly disciplines each with its own mode of knowing. For example, the humanities, such as anthropology and history, emphasize qualitative evidence and argument. Ethics draws heavily on rational thought and the critical examination of claims to good practice. Therefore placing evidence from epidemiology and biostatistics in the dominant position for clinical understanding is hegemonic.75 Post-structuralist writers interweave "evidence" with issues arising when one takes note of power and regimes of truth. Misak,76 for instance, explains that narrative evidence can provide insight into what it is like to be sick, or to receive investigation and/or treatment that is likely to escape RCTs. She gives detailed comment on how we all assess what we are told and incorporate it into our stories and provides a framework for a still better assessment of the multiplicity and richness of clinical phenomena.

#### **4. Reflections on science in medicine**

EBM attempts to put medicine on a more scientific footing, using clinical epidemiology. As is well-known, the early protagonists were concerned about variation in medical practice, cost, and the clear possiblity that even expert opinion may not square with the evidence derived from clinical research. One issue here is whether medicine can be classed as a science. The relationship between medicine and science is complex and much debated (Is medicine a science or an art? EBM protagonists have said that they will help provide the art of medicine with a scientific basis.). I take the view that medicine draws on a number of disciplines, including physiology, ethics, law, epidemiology and biostatistics, anthropology and so on. I have positioned my work to be alert to any tendency of epidemiology and biostatistics to dictate its rules of evidence to the whole of medicine. In this regard, I note that De Caro and Macarthur77 introduce a volume which explains the difficulties scientific naturalism has in dealing with a number of issues which occur in medicine. For example, scientific naturalism, "where causes are thought of as mind-independent"78 is under strain when it attempts to provide convincing accounts of intentional states, human freedom and personal identity, of patients, doctors and researchers. Scientific naturalism provides us with an account of objects placed in a world-as-studied-by-science. These objects can even

72 Tanenbaum 2006.

73 Tonelli 2007, p. 505.

74 Tanenbaum 1999, pp. 757-758.

75 Holmes, Murray, Perron & Rail 2006.

76 Misak 2010.

77 2004.

78 De Caro and Macarthur 2004, pp. 10-13.

tyranny of data,73 and the whole approach of reticulating the warrants for decision into evidential form ignores the argument that the inputs cannot be construed as evidence. The attempt itself is a totalising tendency suited to a striated domain of action and not nomadic science and it marginalises the idiosyncratic aspects of patients, doctors, and their interaction so that "the movement challenges professionalism by disputing what and how physicians know, and especially by marginalising what one physician can know about one patient".74 This encounter-based knowledge is smooth or nomadic and does not have a

The assertions of EBM, focused on the importance of clinical research, falter because medicine is at the intersection of several sciences and even of diverse scholarly disciplines each with its own mode of knowing. For example, the humanities, such as anthropology and history, emphasize qualitative evidence and argument. Ethics draws heavily on rational thought and the critical examination of claims to good practice. Therefore placing evidence from epidemiology and biostatistics in the dominant position for clinical understanding is hegemonic.75 Post-structuralist writers interweave "evidence" with issues arising when one takes note of power and regimes of truth. Misak,76 for instance, explains that narrative evidence can provide insight into what it is like to be sick, or to receive investigation and/or treatment that is likely to escape RCTs. She gives detailed comment on how we all assess what we are told and incorporate it into our stories and provides a framework for a still

EBM attempts to put medicine on a more scientific footing, using clinical epidemiology. As is well-known, the early protagonists were concerned about variation in medical practice, cost, and the clear possiblity that even expert opinion may not square with the evidence derived from clinical research. One issue here is whether medicine can be classed as a science. The relationship between medicine and science is complex and much debated (Is medicine a science or an art? EBM protagonists have said that they will help provide the art of medicine with a scientific basis.). I take the view that medicine draws on a number of disciplines, including physiology, ethics, law, epidemiology and biostatistics, anthropology and so on. I have positioned my work to be alert to any tendency of epidemiology and biostatistics to dictate its rules of evidence to the whole of medicine. In this regard, I note that De Caro and Macarthur77 introduce a volume which explains the difficulties scientific naturalism has in dealing with a number of issues which occur in medicine. For example, scientific naturalism, "where causes are thought of as mind-independent"78 is under strain when it attempts to provide convincing accounts of intentional states, human freedom and personal identity, of patients, doctors and researchers. Scientific naturalism provides us with an account of objects placed in a world-as-studied-by-science. These objects can even

better assessment of the multiplicity and richness of clinical phenomena.

**4. Reflections on science in medicine**

settled scientific home.

72 Tanenbaum 2006. 73 Tonelli 2007, p. 505.

76 Misak 2010. 77 2004.

74 Tanenbaum 1999, pp. 757-758. 75 Holmes, Murray, Perron & Rail 2006.

78 De Caro and Macarthur 2004, pp. 10-13.

include meaning, motivation and values. However, De Caro and Macarthur79 allude to a chapter by Huw Price, which draws attention to the "metaphysically substantial conceptions of reference and truth" supporting this object world. These authors note an asymmetry in this naturalism: it is heavy on the object but light on the subject. Explaining this, De Caro and Macarthur draw attention to the negligible attention paid to use of linguistic terms and expressions. This subject naturalism is strangely omitted. There is also their tendency to accept a fundamentally foundational and exclusively true and well-ordered scheme of knowledge with a unitary structure of justification and principles of validity and worth.

I consider that epidemiology and biostatistics exemplify scientific naturalism and cannot cope adequately with some aspects (such as intentional states, freedom, personal identity) of the lives of patients. From here it is a short step (via psycho-neuro-humero-immunology) to denying epidemiology and biostatistics supreme authority in medicine. This is an example of my application of philosophy to EBM. I hope this approach savours more of providing a viewpoint than the authority of philosophy. In any event, I am comforted by the last sentence in De Caro and Macarthur's "Introduction",80 ending..." the distinction between science and philosophy is one that is constantly being negotiated."

In further consideration of what authority science has in medicine I now provide an answer to the question I asked two paragraphs back: *Is medicine a science or an art?* Montgomery, in her book, "How doctors think",81 tells us it is neither: it is a *practice.* By now I have argued that medicine is a practice which draws on science. If this is right we need be circumspect regarding any claim which science may make as to its authority, epistemically, in medicine. This matter has been dealt with extensively by many authors such as Miles, Loughlin and Polychronis. Rather than reiterate their viewpoints, I will limit myself to post--structuralist comment. According to Foucault, knowledge and power are inseparable. And from the point of view of Deleuze and Guattari, now that EBM has been so extensively problematised at the conceptual level by the above-mentioned authors, we are not in a position to anoint this approach to medicine as "the truth". In fact post-structuralist thinkers allow a range of pathways to knowledge, including the provision of knowledge by one doctor about one patient. Even patients can conrtibute knowledge. To what extent is the patient's pain reduced by the treatment? Heidegger, admittedly not a post-structuralist philosopher, tells us that *being* cannot be investigated as if it were an entity, using "positive" sciences like biology. Rather *being* has the struture of meaning, and is best investigated phenomenologically. It seems to me that pain is nearer to being than to an entity.

#### **5. Conclusion**

Much of what I have written has been written before. I beleive that the cutting edge of my own contribution lies in the following points. The EBM process starts in smooth space, proceeds into codified knowledge, and returns to try to striate or organise smooth space. I have highlighted the rapid distancing from the patient involved in the PICO question and I look forward to providing an existential/phenomenological account of this in a later paper

79 2004, p. 10.

80 2004, p. 17.

81 Montgomery, K. *How doctors think. Clinical judgement and the practice of medicine.* Oxford: Oxford University Press, 2006.

A Post-Structuralist View of Evidence-Based Medicine (EBM) 77

Colebrook, C. *Understanding Deleuze.* Crows Nest, NSW, Australia: Allen and Unwin.

Coveney, J. *Food, Morals and Meaning: the pleasure and anxiety of eating.* 2nd ed, London:

De Caro, M., & Macarthur, D. 'Introduction: The nature of naturalism'. In M. De Caro and

Deleuze, G. *Foucault* (S. Hand & P. Bove, trans.). Minneapolis and London: University of

Deleuze, G., & Guattari, F. *A Thousand Plateaus: capitalism and schizophrenia* (B.Massumi, trans.). Minneapolis and London: University of Minnesota Press, 1987. Foucault, M. *The Birth of the Clinic: an archaeology of medical perception.* (A. M. Sheridan

Gillett, G.R. *Bioethics in the Clinic: Hippocratic reflections.* Baltimore and London: The Johns

Haynes, R.B., Devereaux, P.J, & Guyatt, G.H. 'Clinical expertise in the era of evidencebased medicine and patient choice'. *ACP Journal Club,* v. 136 (2), 2002, p. A11. Holmes, D., Murray, S.J., Perron, A., & Rail, G. 'Deconstructing the evidence-based

Kerridge, I. 'Ethics and EBM: Acknowledging bias, accepting difference and embracing politics'. *Journal of Evaluation in Clinical Practice,* v.16, 2010, pp. 365-373. Lupton, D. 'Foucault and the medicalisation critique', in Alan Petersen and Robyn Bunton

Miles, A., Loughlin, M., & Polychronis, A. 'Evidence-based healthcare, clinical knowledge

Misak, C.J. 'Narrative evidence and evidence-based medicine'. *Journal of Evaluation in*

Nietzsche, F. *Thus Spoke Zarathustra: a book for everyone and nobody.* (G. Parkes, Trans.).

Silva, S.A. & Wyer, P.C., 'Where is the wisdom? II -- Evidence-based medicine and the

Tanenbaum, S.J. 'Evidence and Expertise: The challenge of the outcomes movement to medical professionalism'. *Academic Medicine,* v. 74 (7), 1999, pp. 757-763. Tanenbaum, S.J. 'Evidence by any other name. Commentary on Tonelli (2006), Integrating

Tonelli, M.R. 'Advancing a casuistic model of clinical decision making: A response to

*Journal of Evaluation in Clinical Practice*, v. 15(6), 2009, pp. 899-906.

discourse in health sciences: Truth, power and fascism'. *International Journal of*

(eds) *Foucault, Health and Medicine.* London and New York: Routledge, 1997, pp.

and the rise of personalised medicine'. *Journal of Evaluation in Clinical Practice,* v.

epistemological crisis in clinical medicine. Exposition and commentary on Djulbegovic, B., Guyatt, G.H. & Ashcroft, R.E. (2009) *Cancer Control,* 16, 158-168.'

evidence into clinical practice: an an alternative to evidence-based approaches. *Journal of Evaluation in Clinical Practice* 12, 248-256'. *Journal of Evaluation in Clinical*

commentators'. *Journal of Evaluation in Clinical Practice,* v. 13 (4), 2007, pp. 504-507.

England: Harvard University Press, 2004, pp. 1-17.

Smith, Trans.). New York: Random House, 1994.

*Evidence-based Healthcare,* v. 4, 2006, pp. 180-186.

D. Macarthur (eds) *Naturalism in Question.* Cambridge, Mass., and London,

2002.

94-110.

Routledge, 2006.

Minnesota Press, 2006.

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14 (5), October 2008, pp. 621-649.

*Clinical Practice,* v.16, 2010, pp. 392-397.

Oxford: Oxford University Press, 2005.

*Practice*, v.12 (3), 2006, pp. 273-276.

on Heidegger. As the doctor assesses the suitability of the patient for the intervention she hopefully takes account of detailed advice provided by EBM leaders in 2008. Even so, I suggest that the more we focus on science, on business and on the computer, the more we move away from the relationship of yesteryear when a doctor, ideally, knew her patient. When all has been said and done, the *knowledge* which the doctor has of her patient's suitability for the intervention is of a different kind from the much-vaunted knowledge derived from clinical research. I take the view that this provides EBM with a scarcelyacknowedged soft underbelly.

I have drawn on the writings of Kerridge and Deleuze and Guattari to argue that the warrants for decision are heterogenous with reagrd to ontology, methodology, ethicality and epistemology and that they cannot be *integrated,* rationally. I have presented the process as warrants for decision being *mixed* through tacit knowledge, often learned from a senior doctor. I have presented clinical research as an example of striated space and clinical experience as an example of partly smooth space (intuition). Deleuze and Guattari explain that it is not possible to integrate smooth space and striated space. Not rationally. Thornton moves the issue into tacit knowledge.

I consider that EBM has scarcely noticed that it has partly constructed the (guidelined) doctor, the patient (consortium of variables) and the (research-infiltrated) consultation space. And it has scarcely noticed the meta-epistemological issue that it has set itself up to determine what constitutes medical knowledge and that it assumes the the visble and articulable are isomorphic. It has given no account of nomadic science and works with the belief that smooth space should be striated and that it can be striated. Never mind infinity, the smallest deviation and the space between the laminating parallel lines. EBM seems unaware that we know more than we can descibe (this relates to the way in which tacit knowledge extends beyond the explicit knowledge in which EBM trades) and that whatever does not get into the medical/EBM/gaze is not a candidate for knowledge/research.

#### **6. References**

http://www.springerlink.com.ezproxy.otago.ac.nz/content/f60127577661t2q0/f ulltext.html. Last retrieved 29/08/2010.

Canguilhem, G. *On the Normal and the Pathological.* Dordrecht, Holland / Boston, USA / London , Great Britain: D. Reidel Publishing Company, 1978.

on Heidegger. As the doctor assesses the suitability of the patient for the intervention she hopefully takes account of detailed advice provided by EBM leaders in 2008. Even so, I suggest that the more we focus on science, on business and on the computer, the more we move away from the relationship of yesteryear when a doctor, ideally, knew her patient. When all has been said and done, the *knowledge* which the doctor has of her patient's suitability for the intervention is of a different kind from the much-vaunted knowledge derived from clinical research. I take the view that this provides EBM with a scarcely-

I have drawn on the writings of Kerridge and Deleuze and Guattari to argue that the warrants for decision are heterogenous with reagrd to ontology, methodology, ethicality and epistemology and that they cannot be *integrated,* rationally. I have presented the process as warrants for decision being *mixed* through tacit knowledge, often learned from a senior doctor. I have presented clinical research as an example of striated space and clinical experience as an example of partly smooth space (intuition). Deleuze and Guattari explain that it is not possible to integrate smooth space and striated space. Not rationally. Thornton

I consider that EBM has scarcely noticed that it has partly constructed the (guidelined) doctor, the patient (consortium of variables) and the (research-infiltrated) consultation space. And it has scarcely noticed the meta-epistemological issue that it has set itself up to determine what constitutes medical knowledge and that it assumes the the visble and articulable are isomorphic. It has given no account of nomadic science and works with the belief that smooth space should be striated and that it can be striated. Never mind infinity, the smallest deviation and the space between the laminating parallel lines. EBM seems unaware that we know more than we can descibe (this relates to the way in which tacit knowledge extends beyond the explicit knowledge in which EBM trades) and that whatever

does not get into the medical/EBM/gaze is not a candidate for knowledge/research.

*ACP Journal Club,* v.149, July 15 2008, pp. JC1-2.

*Clinical Practice,* v.16, 2010, pp. 363-364.

ulltext.html. Last retrieved 29/08/2010.

Bassler, D., Busse, J.W., Karanicolas, P.J., & Guyatt, G.H. 'Evidence-based medicine targets

optimal individual care'. *ACP Journal Club,* v.148, Jun. 15 2008, pp. JC4-2. Bassler, D., Karanicolas, P.J., Busse, J.W., & Guyatt, G.H. 'Evidence-based medicine targets

Bluhm, R. 'Evidence-based medicine and philosophy of science.' *Journal of Evaluation in*

Braude, H.D. 'Clinical intuition versus statistics: Different modes of tacit knowledge in

Canguilhem, G. *On the Normal and the Pathological.* Dordrecht, Holland / Boston, USA /

London , Great Britain: D. Reidel Publishing Company, 1978.

the individual patient. Part 1: How clinicians can use study results to determine

the individual patient. Part 2. Guides and tools for individual decision-making'.

clinical epidemiology and evidence-based medicine.' *Theoretical Medicine and Bioethics: Philosophy of Medical Research and Practice*, published on line 23 June

http://www.springerlink.com.ezproxy.otago.ac.nz/content/f60127577661t2q0/f

acknowedged soft underbelly.

moves the issue into tacit knowledge.

**6. References**

2009,

**5**

*USA*

**Information Mastery –**

*1University of North Carolina-Chapel Hill*

*3Allen Shaughnessy Tufts University*

*2University of Virginia*

**Changing the Paradigm of Patient Care with**

Shepard Hurwitz1, David Slawson2 and Allen Shaughnessy3

**Patient-Oriented Evidence That Matters (POEM)**

In many ways, physicians and surgeons practice in a manner reminiscent of individual care provided in the late nineteenth century. The patient presents with a complaint or condition, the physician queries the patient, gathers physical evidence from examination and other

first at an answer of what the problem is, then what caused the problem then a solution (treatment) is selected from a menu of options. Though the patient presents with a problem, the approach to solving the problem was entirely driven by the education and training of the clinician. In earlier times, diagnoses and treatment were often lacking, and the role of the

In the early part of the 21st century more is expected of those physicians providing diagnostic and treatment services. There is a greater understanding of physiology and pathological process affecting human health, and there is a greater array of treatments for injuries and conditions. Among the contemporary patient expectations are 1) the physician is actively listening and placing the wants and needs of the patient above all else, 2) the healthcare provider is delivering the most effective means of arriving at an accurate diagnosis then providing the most appropriate care and 3) does the expected outcome of treatment meet the needs of the patient while remaining affordable. These new rules of

EBM is patient centered, that is the patient is the center of the decision process starting with choice of diagnostic procedures, then the selection of treatment and is the evaluator of the success of treatment. Outcomes that matter to patients also matter to physicians and can be characterized as Patient Oriented Evidence that Matters (POEM). Reduction of pain, improved function, improved quality of life, reduced mortality, and reasonable cost are the cornerstone of value added to the lives of individuals who seek treatment. This might seem

engagement are woven into the framework of evidence-based medicine (EBM).

**1. Introduction**

**2. Patient centered care**

measures, performs a mental exercise that arrives

clinician became one of educator or comforter rather than healer.

## **Information Mastery – Changing the Paradigm of Patient Care with Patient-Oriented Evidence That Matters (POEM)**

Shepard Hurwitz1, David Slawson2 and Allen Shaughnessy3 *1University of North Carolina-Chapel Hill 2University of Virginia 3Allen Shaughnessy Tufts University USA*

#### **1. Introduction**

78 Evidence Based Medicine – Closer to Patients or Scientists?

Thornton, T. 'Tacit knowledge as the unifying factor in evidence based medicine and

Wifstad, A. 'External and internal evidence in clinical judgment: The evidence-based

Worrall, J. 'Evidence: philosophy of science meets medicine.' *Journal of Evaluation in*

March 17, 2006. Retrieved 5 April, 2011, available from

http://www.peh-med.com/content/1/1/2.

*Clinical Practice*, v. 16, 2010, pp. 356-362.

clinical judgement'. Online *Journal of Philosophy, Ethics and Humanities in Medicine*,

medicine attitude'. *Philosophy, Psychiatry & Psychology,* v.15 (2), 2008, pp. 135-139.

In many ways, physicians and surgeons practice in a manner reminiscent of individual care provided in the late nineteenth century. The patient presents with a complaint or condition, the physician queries the patient, gathers physical evidence from examination and other measures, performs a mental exercise that arrives

first at an answer of what the problem is, then what caused the problem then a solution (treatment) is selected from a menu of options. Though the patient presents with a problem, the approach to solving the problem was entirely driven by the education and training of the clinician. In earlier times, diagnoses and treatment were often lacking, and the role of the clinician became one of educator or comforter rather than healer.

In the early part of the 21st century more is expected of those physicians providing diagnostic and treatment services. There is a greater understanding of physiology and pathological process affecting human health, and there is a greater array of treatments for injuries and conditions. Among the contemporary patient expectations are 1) the physician is actively listening and placing the wants and needs of the patient above all else, 2) the healthcare provider is delivering the most effective means of arriving at an accurate diagnosis then providing the most appropriate care and 3) does the expected outcome of treatment meet the needs of the patient while remaining affordable. These new rules of engagement are woven into the framework of evidence-based medicine (EBM).

#### **2. Patient centered care**

EBM is patient centered, that is the patient is the center of the decision process starting with choice of diagnostic procedures, then the selection of treatment and is the evaluator of the success of treatment. Outcomes that matter to patients also matter to physicians and can be characterized as Patient Oriented Evidence that Matters (POEM). Reduction of pain, improved function, improved quality of life, reduced mortality, and reasonable cost are the cornerstone of value added to the lives of individuals who seek treatment. This might seem

Information Mastery –

the Latin 'teacher'.

**3. Sources of evidence**

diagnostic and treatment evidence.

and better evidence is still needed.

textbook discusses only one problem at a time.

analysis and generation of evaluation or treatment guidelines.

Changing the Paradigm of Patient Care with Patient-Oriented Evidence That Matters (POEM) 81

in texts and manuscripts- often the idealized patient in a study is not very similar to the patient in the doctor's practice, or the real world patient has multiple problems while the

Decision-making is another key element of evidence based medicine. There is the continual need to remind ourselves that patient care is about patients making decisions that affect outcome. The earlier notion of shared decision making has now shifted with the EBM paradigm to patient-centered decision making. The physician is once again a 'doctor'- from

There are three main sources of medical information that can be used in generating evidence. First is primary sources material. This is the collection of original publications that answer questions about patient care. Next are the review articles, textbooks, synopses and curriculum of courses that are the first attempt to synthesize evidence with opinions. Most of the teaching at the Medical School level is in this second level, as are the popular texts and review courses. Third is the assimilation of best evidence via systematic reviews, meta-

The first level of primary source is the substrate that is entered into the evidence production cycle. The production cycle creates evidence in response to a clinical need, refines the results of investigations to craft an answer to the question raised by the clinical need. Once meaning is added to the data gathered, this evidence is now disseminated via publications or presentations, the evidence is put into practice and lastly the evidence is evaluated to determine if further evidence is needed to better solve the original need. The role of generating evidence is fundamental, however, the need for dissemination and implementation

The second level of information is the synthesis of opinions and creation of literature that informs clinicians about what is available. This group includes review articles, textbooks, online texts and review lectures. As a source of evidence, this second level is highly variable in that expert opinion may supersede the synthesis of the best evidence, and other bias may creep into the review product. The third level is the combination of best evidence with critical analysis provided by experts in methods of providing statistical support for best evidence. These are the systematic reviews of evidence and meta-analysis. Studies that combine first level evidence into stronger support statements, or non-support statements of

Medical knowledge is stratified in a pyramidal formula created by Bloom in the 1950s (see figure 1). Recall or remembering is the entry level of knowledge with understanding and applying the next two levels that are necessary in medical practice. Most clinicians operate mostly in the first three levels of knowledge and rely on sources than can analyze, evaluate and create the understanding and application for improving medical knowledge. This taxonomy of learning is similar to the creation of best evidence and application to patient care. The importance again of disseminating the evidence is essential for improving quality of care, and later on an evaluation of care after implementation is needed to determine if more

become almost as important if the evidence is to be used to improve quality of care.

commonsensical and physicians traditionally think that the 19th century way of providing care has been meeting the needs outlined above. In the United States and other countries with advanced medical knowledge systems, the evidence is mounting that the needs of patients are not addressed in a patient centered way, nor are outcomes as good as physicians believe.

The fundamental process of Evidence Based-Medicine (EBM) consists of five-steps: 1) developing a question using the populations-intervention-comparison-outcome (PICO) format, 2) finding research that may answer the question, 3) evaluating the research for validity, impact, and applicability, 4) applying the information to clinical decision making, and 5) periodically evaluating one's outcomes after implementation and performance of the previous four steps.5 The development of the question to be answered is patient centered and the EBM process focuses on issues that matter to the patient. This is a labor intense process that involves finding several sources of evidence, analyzing, evaluating and then making the product understandable by the patient.

The introduction of EBM shifted the decision making to the patient while having the physician analyze the patient within the context of evidence that is relevant to that patient and their condition. After the analysis, the diagnosis is expressed in a relativistic way using likelihood or probability to the patient in a way he or she can understand. Offering treatment is more of a menu with expected outcomes and possible unwanted outcomes freely discussed with the patient. The treatment options are based upon the highest order of evidence available, and when possible treatment guidelines based upon best evidence is given as the most reliable means to predict outcome. At times there will be good evidence to cite in the discussions with the patient, other times there will be a paucity of good evidence and the patient's decision may reflect the lack of evidence, relying more on expert opinion.

One reason physicians and surgeons rely on textbooks and content experts is the time factor. It is very easy and quick to call a colleague for an opinion or formally consult a colleague for either input on evaluation or treatment- or to assume care of a challenging patient problem. When clinicians do spend their time searching for answers to questions or problems, the easiest sources are textbooks, review articles, audio reproductions of lectures and information provided by pharmaceutical and implant companies. Again, easy location of didactic information consumes less time and energy than a thorough search and analysis of possibly relevant, possibly useful information.

Clinicians develop idiosyncratic ways of evaluating, communicating and interacting with their patients- often a direct reflection of residency/fellowship training. One tactic is not providing answers to patient's questions or questions of care, probably due to a combination of factors- lack of time and little knowledge. Many feel that by reading current literature and attending CME courses that they are indeed keeping up with meaningful change and offering their patients the best practice based upon the best current knowledge. The clinician's sense of security by maintaining exposure to relevant topics in the literature is a culture of habit- reading familiar journal articles, reliance on consultants, compliance with local customs or referral patterns and reliance on quick sources of informationtextbooks, review articles, electronic media, colleagues etc. While these sources may be of great value, there is a high probability that they are out of date or biased. One of the most ingrained biases in all medical literature is the highly selective patient population described in texts and manuscripts- often the idealized patient in a study is not very similar to the patient in the doctor's practice, or the real world patient has multiple problems while the textbook discusses only one problem at a time.

Decision-making is another key element of evidence based medicine. There is the continual need to remind ourselves that patient care is about patients making decisions that affect outcome. The earlier notion of shared decision making has now shifted with the EBM paradigm to patient-centered decision making. The physician is once again a 'doctor'- from the Latin 'teacher'.

#### **3. Sources of evidence**

80 Evidence Based Medicine – Closer to Patients or Scientists?

commonsensical and physicians traditionally think that the 19th century way of providing care has been meeting the needs outlined above. In the United States and other countries with advanced medical knowledge systems, the evidence is mounting that the needs of patients are not addressed in a patient centered way, nor are outcomes as good as

The fundamental process of Evidence Based-Medicine (EBM) consists of five-steps: 1) developing a question using the populations-intervention-comparison-outcome (PICO) format, 2) finding research that may answer the question, 3) evaluating the research for validity, impact, and applicability, 4) applying the information to clinical decision making, and 5) periodically evaluating one's outcomes after implementation and performance of the previous four steps.5 The development of the question to be answered is patient centered and the EBM process focuses on issues that matter to the patient. This is a labor intense process that involves finding several sources of evidence, analyzing, evaluating and then

The introduction of EBM shifted the decision making to the patient while having the physician analyze the patient within the context of evidence that is relevant to that patient and their condition. After the analysis, the diagnosis is expressed in a relativistic way using likelihood or probability to the patient in a way he or she can understand. Offering treatment is more of a menu with expected outcomes and possible unwanted outcomes freely discussed with the patient. The treatment options are based upon the highest order of evidence available, and when possible treatment guidelines based upon best evidence is given as the most reliable means to predict outcome. At times there will be good evidence to cite in the discussions with the patient, other times there will be a paucity of good evidence and the patient's decision may reflect the lack of evidence, relying more on

One reason physicians and surgeons rely on textbooks and content experts is the time factor. It is very easy and quick to call a colleague for an opinion or formally consult a colleague for either input on evaluation or treatment- or to assume care of a challenging patient problem. When clinicians do spend their time searching for answers to questions or problems, the easiest sources are textbooks, review articles, audio reproductions of lectures and information provided by pharmaceutical and implant companies. Again, easy location of didactic information consumes less time and energy than a thorough search and analysis of

Clinicians develop idiosyncratic ways of evaluating, communicating and interacting with their patients- often a direct reflection of residency/fellowship training. One tactic is not providing answers to patient's questions or questions of care, probably due to a combination of factors- lack of time and little knowledge. Many feel that by reading current literature and attending CME courses that they are indeed keeping up with meaningful change and offering their patients the best practice based upon the best current knowledge. The clinician's sense of security by maintaining exposure to relevant topics in the literature is a culture of habit- reading familiar journal articles, reliance on consultants, compliance with local customs or referral patterns and reliance on quick sources of informationtextbooks, review articles, electronic media, colleagues etc. While these sources may be of great value, there is a high probability that they are out of date or biased. One of the most ingrained biases in all medical literature is the highly selective patient population described

physicians believe.

expert opinion.

making the product understandable by the patient.

possibly relevant, possibly useful information.

There are three main sources of medical information that can be used in generating evidence. First is primary sources material. This is the collection of original publications that answer questions about patient care. Next are the review articles, textbooks, synopses and curriculum of courses that are the first attempt to synthesize evidence with opinions. Most of the teaching at the Medical School level is in this second level, as are the popular texts and review courses. Third is the assimilation of best evidence via systematic reviews, metaanalysis and generation of evaluation or treatment guidelines.

The first level of primary source is the substrate that is entered into the evidence production cycle. The production cycle creates evidence in response to a clinical need, refines the results of investigations to craft an answer to the question raised by the clinical need. Once meaning is added to the data gathered, this evidence is now disseminated via publications or presentations, the evidence is put into practice and lastly the evidence is evaluated to determine if further evidence is needed to better solve the original need. The role of generating evidence is fundamental, however, the need for dissemination and implementation become almost as important if the evidence is to be used to improve quality of care.

The second level of information is the synthesis of opinions and creation of literature that informs clinicians about what is available. This group includes review articles, textbooks, online texts and review lectures. As a source of evidence, this second level is highly variable in that expert opinion may supersede the synthesis of the best evidence, and other bias may creep into the review product. The third level is the combination of best evidence with critical analysis provided by experts in methods of providing statistical support for best evidence. These are the systematic reviews of evidence and meta-analysis. Studies that combine first level evidence into stronger support statements, or non-support statements of diagnostic and treatment evidence.

Medical knowledge is stratified in a pyramidal formula created by Bloom in the 1950s (see figure 1). Recall or remembering is the entry level of knowledge with understanding and applying the next two levels that are necessary in medical practice. Most clinicians operate mostly in the first three levels of knowledge and rely on sources than can analyze, evaluate and create the understanding and application for improving medical knowledge. This taxonomy of learning is similar to the creation of best evidence and application to patient care.

The importance again of disseminating the evidence is essential for improving quality of care, and later on an evaluation of care after implementation is needed to determine if more and better evidence is still needed.

Information Mastery –

elements of best evidence.

equation:

Changing the Paradigm of Patient Care with Patient-Oriented Evidence That Matters (POEM) 83

fundamental principles of information mastery- the usefulness principle, expressed as an

Usefulness = Relevance x Validity/ Work Where **relevance** is the similarity of the real world patient to that portrayed in the guideline and general applicability of the evidence, **validity** is the scientific truthfulness of the information and **work** is the amount of time spent finding the answer to a question in clinical

Simply stated, the Usefulness Equation is a form of Occam's Razor- finding the simplest solution to a problem with the important features of the process being 1) likelihood of success and 2) ease of access to the information needed to make judgments and decisions. This is not a quantitative equation but gives a sense of the relationship between the key

Learning mastery is a means of educating students in a linear fashion. Students are taught basics or fundamentals, and then they are shown how to apply process to the fundamentals to solve problems and create higher cognitive functioning. An example is learning numbers and then learning to make sentences with numbers- i.e. equations- applying addition, subtraction etc. Similar to learning mastery is information mastery. A process in which adult learners are instructed in basic functions about finding information that is used to solve problems and answer questions. An example is using the Internet to search for the best treatment of a 40 year-old woman who smokes, has a BMI of 34 and presents with pneumonia. With the patient care issue, the best use of the internet is not to have a search engine deliver thousands of journal articles that would take countless hours and a great deal of analytic skill to synthesize a treatment. The Internet can now provide rapid access to treatment guidelines, protocols and algorithm based upon high level of evidence that will produce good outcomes at reasonable

With the advent of information technology and the availability of sources of reliable evidence vetted by experts in the EBM it is now feasible to instruct clinicians in where to find and how to implement usable best evidence. Rather than frustrate busy practitioners with the laborious process of generating their own best evidence, the time is best spent

Slawson and Shaugnessy (2003) have created and tested a curriculum to teach the principles

 Level 1 is for clinicians who can use the concepts to make better patient-care decision; Level 2 is for teachers and writers who teach clinicians the curriculum and provide

 Level 3 is for researchers who are adept at conducting decision analysis, meta-analysis, and other techniques of synthesizing raw research information into useable clinical

Finding the information at the point of care (just in time) is at the core of how the application of evidence-based medicine can transform the practice of medicine in ways that

diagnosis or treatment. Validity is of prime importance with relevance a close second.

cost, if the patient agrees with the recommended treatment.

of information management. The curriculum has three levels:

evidence-based reviews of original research; and

**6. Locating information from available sources**

gathering evidence and EBM guidelines.

information.

#### **4. Information mastery**

EBM has created several concepts and principles that are embodied in "a hierarchy of evidence and that conclusions related to evidence from controlled experiments are accorded

(University of Texas, Arlington, Center for Learning accessed via Google, 10/21.2011) Fig. 1.

greater credibility than conclusions grounded in other sorts of evidence." In this hierarchy there is a (unproven) belief by advocates of EBM that randomized control trials- the highest level of evidence- should trump evidence from non-randomized trials and case-comparison studies. The lowest levels of evidence consist of case series and expert opinion. Though logical, there remains a great deal of reluctance on the part of practicing physicians to abandon their comfort zone in the reliance on expert opinion and studies that do not use comparative cohorts of patients. And the unaddressed problem of relevance, that is most studies do not include the complexity seen in most 'real world' patients.

#### **5. The usefulness of evidence**

With the advent of new and better evidence have come guidelines based upon evidence. Having guidelines is a shortcut for doctors who can follow key elements of evidence-based practice without having to do extensive literature research and analyses. This is one of the

EBM has created several concepts and principles that are embodied in "a hierarchy of evidence and that conclusions related to evidence from controlled experiments are accorded

(University of Texas, Arlington, Center for Learning accessed via Google, 10/21.2011)

studies do not include the complexity seen in most 'real world' patients.

**5. The usefulness of evidence**