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This electronic thesis or dissertation has been downloaded from the King’s Research Portal at https://kclpure.kcl.ac.uk/portal/ Clinical Judgement in the era of Evidence Based Medicine Flores Sepulveda, Luis Jose Awarding institution: King's College London The copyright of this thesis rests with the author and no quotation from it or information derived from it may be published without proper acknowledgement. END USER LICENCE AGREEMENT This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International licence. https://creativecommons.org/licenses/by-nc-nd/4.0/ You are free to: Share: to copy, distribute and transmit the work Under the following conditions: Attribution: You must attribute the work in the manner specified by the author (but not in any way that suggests that they endorse you or your use of the work). Non Commercial: You may not use this work for commercial purposes. No Derivative Works - You may not alter, transform, or build upon this work. Any of these conditions can be waived if you receive permission from the author. Your fair dealings and other rights are in no way affected by the above. Take down policy If you believe that this document breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. Download date: 06. Nov. 2017 Clinical judgment in the era of Evidence Based Medicine Submitted to the Department of Philosophy of King’s College London, in partial fulfilment of the requirements for the degree of Doctor of philosophy Luis Flores MD. MA. Department of Philosophy, King’s College London September 2016 1 Copyright © by Luis J. Flores 2016 2 Abstract “Evidence Based Medicine” (EBM) urges that medical recommendations be based on the best research evidence, rather than on clinical judgement. While I strongly endorse attention to relevant research evidence, I argue that the related downplaying of clinical judgement is a step backwards. This is because actual models of EBM encourage physicians to focus exclusively on research probabilities and so to neglect relevant information about patients. I call this feature of EBM the “Problem of Extra Information” (PEI), and contend that it leads to predictions and prescriptions based on the wrong probabilities. The PEI has been largely neglected by EBM, which has construed the challenge of clinical care as a matter of developing better research evidence, and of reminding physicians to attend to patients’ preferences and values. And although meritorious attempts have been made to connect research with individuals through sophisticated methodological improvements, these only address the PEI partially, and do not eliminate the need for clinical discretion. In this dissertation I contend that, in response to the PEI, clinical medicine requires a more Discretionary Approach (DA). This approach recognizes that the objective probabilities that matter for clinical recommendations are those in the reference class defined by everything the physician knows about the patient, and argues that the central role for judgment in clinical practice is to estimate these probabilities. So understood, the DA has two main advantages over the EBM approach: prudential adequacy and evidential flexibility. My defence of the DA consists of addressing criticisms of the role ascribed to judgment and clinical experience within this approach. The final two chapters of this doctoral dissertation complement my arguments with two meta- analytical empirical studies: one which compares “therapeutic guidelines based on evidence” with “usual care” with respect to patients’ outcomes, and another which examines the relative predictive performance of statistical models and physicians’ judgment in the context of diagnosis and prognosis. These studies refute previous evidence cited against judgment and vindicate the plausibility of the Discretionary Approach to clinical care. 3 “Having turned a cold shoulder to the hoary (overused) notion of the intuitive “art of medicine,” it might be the case that clinical judgment can now far more productively be seen as that critical faculty that is brought to bear when faced with uncertainty.” Goodman, 2003 4 Acknowledgments I owe my gratitude to David Papineau for accepting me as a graduate student and providing me with insightful guidance over four years. I was very fortunate to have him as supervisor. His keen intellect and extensive philosophical experience made every meeting instructive and stimulating. I am also grateful for his intellectual flexibility and approach to scholarship, which allow me to pursue an interdisciplinary doctoral project that is fundamentally philosophical, but also involved the conduction of empirical research to inform clinical care. This dissertation would not have been possible without the continuous love, closeness, support, affection, and criticism of my wife, Carolina. She is not only an intelligent and competent epidemiologist who shares many of my academic interests, but also (and fortunately) someone who usually looks at methodological and philosophical problems from a different perspective than mine. I am deeply grateful for her feedback and countless comments on every chapter of this thesis. Carolina also coauthored the article versions of the empirical work presented in chapters five and six. I dedicate this dissertation to my father, whose constant support has been essential to complete my doctorate. He stimulated my interest in pursuing this project to address the questions that first emerged throughout the course of my medical training and further developed during my first years of practice as clinical psychiatrist. I am also thankful for the assistance of my mother and my parents-in-law. Their support was fundamental in allowing my wife and me to carry out our respective doctoral projects, while simultaneously raising two wonderful children: Magdalena who is now five-years-old, and one-year-old Manuel José. My children have been a constant source of inspiration and meaning, even during the most difficult periods of this project. Special mention deserves my friend and co-author Jonathan Fuller. He not only collaborated with the empirical research presented in chapters four and five, but also provided me with feedback on various topics of this thesis. My earliest versions of the content presented in chapters 1, 3 and 4 were published in the article “Therapeutic inferences for individuals” (Flores, 2015) and presented in the conferences “Interdisciplinary workshop in the philosophy of medicine: medical knowledge, medical duties” (KCl, 2014)1, “The concept of clinical Judgement in the era of Evidence Based Medicine.”(VU, Amsterdam, 2015) and “Diagnostic reasoning in Psychiatry: The case for analytical methods.” (AAPP, New York, 2014) 1 Summary available in Bullock and Kingma, 2014 5 Finally, part of my thoughts on the problem of external validity and extra information were previously expressed, “The Risk GP Model: the standard model of prediction in medicine” (Fuller and Flores 2015), and “Translating Trial Results in Clinical Practice: the Risk GP Model” (Fuller and Flores, 2016). 6 Table of Contents Introduction ........................................................................................................................... 10 Chapter 1: EBM: a critical appraisal and a positive proposal .......................................... 16 1.1. Abstract ........................................................................................................................ 16 1.2. The scope of clinical medicine ..................................................................................... 17 1.3. Rational clinical recommendations .............................................................................. 18 1.3.1. Expected utility theory .......................................................................................... 18 1.3.2. Clinical recommendations: predictions and prescriptions .................................... 20 1.3.3. Causal and non-causal correlations ....................................................................... 20 1.3.4. Subjective and objective probabilities .................................................................. 22 1.4. Evidence-based clinical recommendations .................................................................. 23 1.4.1. The EBM argument .............................................................................................. 23 1.4.2. The case of Mr. Smith and the problem of extra information............................... 25 1.4.3. Is this a straw-man? .............................................................................................. 28 1.4.4. The problem of outliers......................................................................................... 29 1.5. The Discretionary Approach ........................................................................................ 31 1.5.1. Prudential adequacy .............................................................................................. 32 1.5.2. Evidential flexibility ............................................................................................. 33 1.5.2.1. External validity .......................................................................................................... 34 1.5.2.2. Mechanisms ................................................................................................................. 35 1.5.2.3.