What roles do different kinds of knowledge play in medicine? What roles should they play? What standards (epistemic, ethical, practical) should be met before knowledge is used to develop policy or practice? Medical decision-making, whether in the clinic or at the policy level, can have serious and far-reaching consequences. It is therefore important to base decisions on the best available knowledge. Yet deciding what should count as the best available knowledge is not easy. This important book addresses philosophical questions about what kinds of knowledge should be taken into account, and how knowledge should inform practice and policy.
The chapters in this volume examine the relationship between knowledge and action in medical research, practice, and policy. "Knowledge" is broadly construed to include knowledge from clinical, laboratory, or social science research, and from the clinical encounter, as well as broader background assumptions prevalent in society that inform both the kinds of knowledge that are taken to be relevant to medicine and how that knowledge is interpreted in decision-making. Such knowledge may be relevant not only to clinical decision-making with regard to the care of individual patients, but also to the practice of scientific research, the development of policy and practice guidelines, and decisions made by patients or by patient advocacy groups.
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About the Author
Robyn Bluhm is an Associate Professor in the Department of Philosophy and Lyman Briggs College at Michigan State University. She is the co-editor of Neurofeminism: Issues at the Intersection of Feminist Theory and Cognitive Science (2012).
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Knowing and Acting in Medicine
By Robyn Bluhm
Rowman & Littlefield International, Ltd.Copyright © 2017 Robyn Bluhm
All rights reserved.
Case-based (Casuistic) Decision Making
Mark R. Tonelli
While medicine encompasses, incorporates, and is influenced by a range of disciplines, from basic science research to politics, from public health to economics, the practice of medicine remains focused on the provision of care aimed at benefiting individuals. Clinical medicine remains a personal undertaking, relating one individual in need of healing with another who professes and promises to heal (Pellegrino and Thomasma 1988). In this effort to provide care to individual patients, clinicians must seek to incorporate all relevant knowledge into the decision-making process.
Knowledge in medicine serves primarily as a guide to clinicians endeavoring to benefit individual patients. Medical knowledge utilized by clinicians can be divided into three topic areas: that derived from clinical research, that stemming from pathophysiologic understanding, and that based on clinical experience. Each of these topics produces and/or provides backing for warrants with particular strengths and weaknesses with regard to clinical decision making (Tonelli 2006).
The process of clinical reasoning closely resembles the model of argumentation described by Stephen Toulmin (2003), where warrants supporting a decision must be elucidated, examined, and weighed against one another. Clinicians begin by establishing the warrants that are relevant to the decision at hand. When warrants are consistent, for instance, when a randomized-controlled trial, the underlying pathophysiology, and a clinician's experience all support the use of a particular medication for a particular ailment, clinical judgment is straightforward. Clinicians must also incorporate other warrants derived from patient experiences, goals, and values as well as features of the medical delivery system itself into a final decision or recommendation.
When warrants derived from medical knowledge conflict, clinicians must examine the backing and weigh the relative strength of individual warrants. As the knowledge derived from each of the topics differs in kind, not degree, purported hierarchies of knowledge or evidence that seek to include all are epistemically untenable. In any particular case, the most compelling warrants may derive from any of the topic areas. Clinical reasoning must be based on the case at hand, a casuistic endeavor rather than a deductive process. As such, conclusions are only probable and remain subject to rebuttal. Clinicians who agree on the medical knowledge relevant to a clinical decision may disagree on the decision itself due to differential weighting of warrants. Patient-derived and system-derived warrants will ultimately need to be incorporated into a final decision or recommendation.
In seeking to arrive at the best decision or recommendation for an individual patient, clinicians will tend to focus their attention on a limited subset of medical knowledge. An understanding of medical history helps to clarify the major categories of medical knowledge. In the earliest forms of Western clinical medicine, the experience of the clinician was paramount. At a time when effective therapeutic interventions were scarce, the experience of a clinician aided accurate diagnosis, thereby improving prognostication, often the only real value a physician could add to the care of the patient. Trial and error were a mainstay of therapy. Yet even early in the recorded history of medicine, physicians sought to move beyond this dependence on experiential empiricism toward a more rational approach to diagnosis and treatment. Rationalism required understanding the nature of illness in order to arrive a diagnosis and/or treatment plan. That medicine's understanding of the nature of illness remained quite poor for nearly two millennia certainly led to ineffective or harmful interventions, such as bleeding and purging, that were otherwise perfectly rational. Since the mid-twentieth century, the focus of medical epistemology has shifted to a new empiricism, the use of tools designed to improve public health and to elucidate direct causation for generating knowledge relevant to clinical decisions. Empirical approaches have become particularly privileged in the realm of evaluating the direct, causative effects of new therapeutic interventions, where the mechanistic approach of pathophysiologic reasoning seemed to be particularly fallible (Howick 2011). The inclination and ability to measure outcomes allow for a more mathematical demonstration of causality seemingly not as subject to the errors caused by the incomplete and imperfect understanding of mechanism. The new empiricism found its voice and established its prominence with the development and evolution of the evidence-based medicine (EBM) movement (Evidence-based Medicine Working Group 1992). But while rationalism once largely eclipsed experiential practice and the new empiricism has sought to replace rationalism, experience and pathophysiologic reasoning remain part of clinical practice.
Clinical judgment requires the incorporation of multiple kinds of medical knowledge as well as patient-specific and contextual features. The three topic areas of medical knowledge are (1) experiential knowledge, (2) pathophysiologic (also referred to as mechanistic) reasoning, and (3) the results of clinical research. These topic areas are advanced as mutually exclusive and exhaustive (with regard to clinically relevant medical knowledge). Medical knowledge, however, is not all that needs to be considered by clinicians when arriving at a clinical judgment. A clinician must certainly elicit and incorporate the individual patient's goals, values, and experiences into recommendations and decisions. Similarly, the system (economic, political, cultural, legal) in which medicine is practiced will provide inducements and constraints upon a clinician's and patient's choices independent of medical knowledge. The primary focus of this discussion, however, will be on the value and the incorporation of the three kinds of medical knowledge into clinical decision making.
The scientific basis of evidence-based medicine, epidemiology, has its origins in public health, evolving to include controlled trials in order to more convincingly demonstrate causation (Pearce 1996). But while the notion of clinical practice as clinical epidemiology has gained acceptance with the advancement of the EBM movement, the limitations of this kind of medical knowledge for clinicians have also become clearer. The direct use of the results of epidemiology and controlled trials, results that reflect effects across populations, would seem likely to improve public health. The application of such results to individual cases is more problematic (Tonelli 1998; Naylor 1995). If the goal of clinical medicine remains defined as the attempt to improve the care of individuals, then general knowledge obtained from clinical research will only go so far. Utilizing experience and pathophysiologic reasoning will remain necessary to reach the best decision for an individual patient (Tonelli 2010).
STRENGTHS AND WEAKNESSES Of THE KINDS Of MEDICAL KNOWLEDGE
A great deal of attention over the last two decades has focused upon the value of the results of clinical research for clinical decision making. Broadly speaking, the results of clinical research provide clinicians with medical knowledge that is derived in a way that minimizes bias, can be subject to careful scrutiny, and is relatively easy to disseminate. A well-designed observational or controlled study has the ability to discern small, but clinically relevant effects that no amount of individual experience would ever be able to. These strengths are important, and clinical research results often inform clinical decision making and patient choice (Tonelli 2010).
The limitations of the results of clinical research for clinical decision making, however, have tended to get short shrift in the literature of EBM. The primary weakness of clinical research is that it has no direct applicability to individual patients. That is, the results of any population study tell us little about how the patient at hand will respond. At best, clinical research tells us something about an "average" patient, but no patient is average and clinicians should always be vigilant regarding how those individual differences affect the relevance of clinical research results (Feinstein and Horwitz 1997). Additionally, clinical research results are hardly free from bias, particularly when it comes to how they are funded (Lexchin et al. 2003). Research results are certainly fallible and, at times, untrustworthy (Upshur 2009). Even when well done, research is fixed in a time and place, while clinical medicine is context dependent and ever evolving.
While EBM has sought to deemphasize pathophysiologic reasoning in clinical medicine, finding it unreliable, biological plausibility and physiologic understanding remain crucial to the development of medical knowledge and the practice of clinical medicine. The limitations of mechanistic reasoning are very real (Howick 2011). Physiology does not always predict relevant outcomes, as demonstrated in a study that noted decreased arrhythmias but increased mortality in post-myocardial infarction patients treated with antiarrhythmics (CAST Investigators 1989). And certainly the value of pathophysiologic reasoning depends on a firm understanding of the mechanisms of disease. But interestingly, our reliance on such reasoning appears to be decreasing at a time when our understanding of disease mechanisms is accelerating.
In clinical practice, incorporating the physiologic aspects of a patient's presentation or response to therapy allows for the importance and incorporation of individual variability. How individual patients differ from the "average" patient of a clinical trial generally comes down to psychological and physiological features, including comorbidities and specific manifestations of illness. Clinicians also monitor the physiologic responses of patients to facilitate early recognition of therapeutic value or futility. In the realm of clinical research, appeals to biologic plausibility can help to provide a check on spurious findings, for instance, studies suggesting the benefit of homeopathic remedies or the value of retroactive intercessory prayer (Giacomini 2009).
As with pathophysiologic reasoning, EBM has also focused on the limitations of relying on unsystematic clinical experience, personal or pooled, as a source of medical knowledge. Certainly, clinicians as persons are subject to a wide variety of cognitive biases (Kempanien et al. 2003). In individual practice, we often see only a small number of patients with a particular problem, making assessment of response to and risk from interventions difficult. Experience tends to lead to static practice patterns, with older physicians slower to incorporate new knowledge from clinical research (Choudhry et al. 2005).
Yet, clinical experience remains vital to individualizing care (Malterud 1995; Tonelli 1999). Experience, like pathophysiologic reasoning, allows clinicians to incorporate specific aspects of an individual's presentation into a clinical decision. In diagnostics, where pattern recognition serves as a foundational skill, experience increases accuracy and efficiency (Norman 2007). For clinicians who see a large number of patients with a specific disorder, clinical expertise provides them with a rich set of cases to which a new patient can be compared. This kind of expert knowledge, founded on clinical experience, can be transmitted to others. Finally, clinical experience generally provides the first indication of change in medicine, from the appearance of new disorders to changing manifestations of old ones. An example from my own experience, the sudden appearance of multiple cases of Mycobacterium abscessus infection in our cystic fibrosis population, led us to be concerned about the possibility of person-to-person transfer of this infection. The medical literature at the time noted that there was no evidence of any person-to-person transfer of nontuberculous mycobacteria of any kind. Trusting our experience, we investigated further and determined that our new cases were due to the same genetic strain of the mycobacteria, strongly suggesting person-to-person spread. A change in infection control practices had been instituted even prior to this conclusion, based on our experience, and no new cases appeared subsequently.
In summary, clinically relevant medical knowledge comprises three different kinds of medical knowledge, none of which deserves general priority when it comes to clinical decision making. Each kind of medical knowledge has strengths and weaknesses with regard to its applicability to clinical reasoning. A clinician, then, must bring all relevant knowledge to bear upon a particular case if he or she hopes to make what is probably the best choice for that individual patient.
Clinical judgment requires elucidating and potentially negotiating between multiple warrants. Warrants represent a reason to support a particular judgment (Toulmin 2003) and in medicine are often derived from and backed by clinical research, pathophysiologic reasoning, and clinical experience. Warrants generally contain both factual and value-laden elements, and may be backed by a variety of factual and/or value-laden claims. In this way warrants differ from "evidence" as currently defined by EBM. For instance, invoking a warrant such as "use of a beta-blocker in persons who have had a recent myocardial infarction will decrease the risk of death" may be backed by relevant clinical research and pathophysiologic understanding, but must contain a value element along the lines of "decreasing the risk of death is a good thing" in order to be used to support a decision for a particular patients with epistemic backing, the strength of the ethical backing for a particular warrant will vary. In particular, the clinician will need to carefully elucidate the experiences, goals, and values of the individual patient in order to properly weigh warrants. For our example of a reduction in risk of death, the normative component of a warrant may seem indisputable, yet this goal is often not appropriate for patients whose quality of life is already below an acceptable minimum. The value-laden components of warrants need to be made explicit and examined. While we can assume that most patients would like to reduce their risk of death, not all see that as a major benefit. Often, outcomes that are easily measured (e.g., reduced cholesterol) and frequently utilized in clinical research are not by themselves seen as important by most patients. The recognition of this normative gap between clinical research results and patient values has led to a movement to encourage clinical researchers to focus on patient-centered outcomes (Selby et al. 2012). In doing so, researchers would be strengthening the backing for clinical warrants derived from their work.
Each relevant warrant, then, provides support for an argument regarding the best course of action for an individual patient. For instance, we may determine that the person before us complaining of a nonproductive cough, nasal congestion, and a sore throat has a viral respiratory tract infection. When the patient raises the possibility of antibiotics for this infection, clinicians are likely to (and should) invoke the warrant that "antibiotics are not appropriate treatment for viral upper respiratory tract infections (URIs)" (Prendergast 1995). If the patient (or a medical trainee) is not convinced of the warrant on its face, then backing for the warrant can be provided. Warrants utilized in clinical medicine will generally be backed by knowledge derived from clinical research, pathophysiologic reasoning, or clinical experience. In this particular case, each of the three kinds of knowledge would provide backing for the warrant: clinical research does not demonstrate a benefit of antibiotics in persons with viral URIs; understanding how antibiotics work leads us to believe that they will have no effect on viral replication; experience has demonstrated that such infections are self-limited and do not get better more quickly with antibiotic therapy. The value-laden (and generally unspoken) component of the warrant is a claim that clinicians ought not provide interventions that have no reasonable chance of providing benefit, particularly those that have some attendant risk, even if requested by patients. The therapeutic judgment here is relatively straightforward, though certainly the conclusion rests upon how certain we are with our initial diagnosis.
Elucidating and negotiating between warrants could be approached in several manners. A theoretical construct, one that attempts to set a pre-determined hierarchy of warrants, based on the type or backing, could be considered. Evidence-based medicine appears to represent such an approach, with a persistent assertion of and adherence to a hierarchy of "evidence" that is actually a hierarchy of research methodologies. The theoretical preference for knowledge derived from particular methodologies could be used to negotiate between conflicting warrants. In such a model, the warrant backed by the "best evidence" (i.e., the most rigorous study design) wins the argument and determines the course of action. The multiple problems with such an approach have been elucidated in convincing critiques of EBM and will not be revisited here (Tanenbaum 1993; Feinstein and Horwitz 1997; Bluhm 2005; Tonelli 2006; Goldenberg 2006).
Excerpted from Knowing and Acting in Medicine by Robyn Bluhm. Copyright © 2017 Robyn Bluhm. Excerpted by permission of Rowman & Littlefield International, Ltd..
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Table of Contents
Introduction / Robyn Bluhm / 1. Case-Based (Casuistic) Decision-Making Mark Tonelli / 2. Evidence-Based Medicine versus Expertise: knowledge, skills and epistemic actions Sophie van Baalen and Mieke Boon / 3. Phenomenology, Typification, and Ideal Types in Psychiatric Diagnosis and Classification Anthony Vincent Fernandez / 4. The Reproducibility of Epistemic Humility Abraham P. Schwab / 5. Reframing a Model – The Benefits and Challenges of Service User Involvement in Mental Health Research: Tania Gergel and Thomas Kabir / 6: The Role of Patient Perspectives in Clinical Case Reporting Rachel A. Ankeny / 7. “The Science is Clear!” Media Uptake of Health Research into Vaccine Hesitancy Maya J. Goldenberg and Christopher McCron / 8: Values as ‘Evidence For’: Mental Illness, Medicine, and Policy Susan C. C. Hawthorne / 9. RCTs and EBM as Gold Standards: A Trojan Horse for Biomedicine? Keekok Lee / 10. The Legitimacy of preventive medical advice. Is knowing enough? Delphine Olivier / 11. Translational research and the gap(s) between science and practice: treating causes or symptoms? Marianne Boenink / 12. Enacting Adherence to HIV/AIDS Care: How Multiplicity in Medicine Becomes a Singular Story Suze Berkhout / 13. Ebola and the Rhetoric of Medicine: Supportive Care and Cure James Krueger / 14. Action, Practice and Reflection: Dewey’s Pragmatist Philosophy and the Current Healthcare Simulation Movement Joseph S. Goode / Index