Clinical Research Transformed

In this Information Age, the practices of clinical medicine should no longer be based on what clinical doctors actively know. Rather, all of the importantly practice-relevant knowledge should not only already exist but also be codified in cyberspace, in directly practice-guiding 'expert systems' -- for the benefit of both doctors and patients everywhere.

Each of these systems (discipline-specific) would, prompted by a particular type of case presentation, present the doctor a questionnaire specific to cases of the type at issue, and document the doctor's answers to the questions. If at issue would be a case of complaint about a (particular type of) sickness, the system would translate the resulting diagnostic profile of the case into the corresponding probabilities of the illnesses to be considered. Similarly, if at issue would be an already-diagnosed case of a particular illness, the system would ask about, and record, the relevant elements in the prognostic profile of the case and then translate this profile into the probabilities of various outcomes to be considered, probabilities specific to the choice of treatment and prospective time in addition to that profile. And besides, these systems would analogously address the causal origin -- etiogenesis -- of cases of particular types of illness.

While the requisite knowledge-base for these systems -- notably for the probabilities in them -- has not been addressed by such 'patient-oriented' clinical research as has been conducted (very extensively) up to now, this book delineates the nature of the suitably-transformed research (gnostic). The critically-transformative innovation in the research is the studies' focus on Gnostic Probability Functions -- dia-, etio-, and prognostic -- in the framework of logistic regression models. This book also presents a vision of how this critically-transformative research would most expeditiously be provided for and also conducted, among select sets of academic teaching hospitals.

This book presents the transformations that now are needed in patient-oriented clinical research for it to provide for genuinely scientific clinical medicine The authors of this book have, collectively, first-rate expertise in all of the relevant areas of scholarship The precepts in this book converge to the authors' vision of suitably-transformed clinical research on a global scale

Autorentext
Olli Miettinen was born in Piikkiö, Finland on 31 July 1936. He obtained his MD from the University of Helsinki and the MPH and PhD degrees from the University of Minnesota. He was Professor of Epidemiology and Biostatistics at Harvard School of Public Health from 1974 to 1986, and has been a Professor in the Department of Epidemiology, Biostatistics, and Occupational Health and in the Department of Medicine of the Faculty of Medicine at McGill University since 1985. He is the author of 3 textbooks and a veteran of extensive teaching internationally.

Albert Hofman, is the Stephen B. Kay Family Professor of Public Health and Clinical Epidemiology and Chair, Department of Epidemiology at the Harvard T.H. Chan School of Public Health.

Dr. Hofman received an MD in 1976 from the University of Groningen, and a PhD in 1983 from the Erasmus University Rotterdam. He was appointed in 1981 as an Assistant Professor at the Erasmus University Medical School and was promoted to Associate Professor in 1984. Since 1988 he has been full Professor and Chair in the Department of Epidemiology at the Erasmus Medical Center. In addition, Dr. Hofman has been a Science Director at the Netherlands Institute for Health Sciences since 1992, as well as an adjunct Professor of Epidemiology at our School since 1998, and a Visiting Professor of Clinical Epidemiology since January 2016. Dr. Hofman has an excellent record of teaching, including being the initiator and program director of the Erasmus Summer Program since 1991, and teaching the summer session courses on Fundamentals of Epidemiology and on Study Design in Clinical Epidemiology at Harvard.

Johann Steurer is the Director of the Horten Centre for patient oriented research and knowledge transfer. University of Zürich.

Klappentext
This book delineates the fundamental transformations that, according to its precepts,are now needed in the objects and methods of 'patient-oriented' clinical research, inorder to make it genuinely patient-relevant. These transformations are presented asproviding for transition from today's 'evidence-based' practices (advocated by 'clinicalepidemiologists') to knowledge-based succedanea of these. While those existingpractices vary according to doctors' personal opinions about the burden of the availableevidence, their knowledge-based succedanea will be essentially invariant acrossindividual doctors, as they'll be guided by 'expert systems' (imbedded in cyberspace). Atissue in this is transformation in what the authors present as the very essence of clinicalmedicine, namely clinical doctors' esoteric ad-hoc knowing: gnosis. This is clinicaldoctors' knowing probabilistic about relevant-but-hidden truths about their patients'health, and constitutes the basis for their teaching (doctoring) the patients about theseesoteric insights. The probabilities are 'personalized' in the meaning of their specificityto the cases' gnostic profiles.
Genuinely patient-relevant clinical knowledge this book presents as the requisitebasis for three species of clinical doctors' gnosis: diagnosis knowing about whether aparticular type of illness is present (though hidden) in the patient; etiognosis knowingabout whether the patient's illness was caused by a particular antecedent of it; andprognosis knowing about the patient's future health, including as to its dependenceon the choice of treatment. Pivotal in gnostic clinical research this book presents to bethe studies' objects design in terms of a statistical model for the rate of occurrence ofthe entity of health in question, in a defined domain of case presentations. Theessentials of the studies' methods designs are deduced from their objects designs.
Study of this book on the theory of meta-epidemiological clinical research isessential preparation for teaching 'patient-oriented' clinical research and for actualdesign & conduct of the studies and of their critical reviews. And by the same token,study of this book is essential preparation for the needed replacement of 'case-basedlearning' of clinical medicine, for suitably-learned teaching of the practice of clinicalmedicine focused on the status quo of the scientific knowledge-base for (gnoses in)the discipline ('specialty') at issue.

Inhalt
Foreword.- Preface.- Acknowledgements.- Essence of Clinical Medicine.- Essence of Clinical Research.- Clinical Research and Clinical Medicine at present.- Clinical Research Transformative of Clinical Medicine.- Core Concepts of Epidemiology and Epidemiological Research.- The Epidemiological Interface of Gnostic Clinical Research.- The Logistic Regression Model.- Statistics from the Model's Fitting to Gnostic Data.- The Types of Diagnostic Challenge and Needs for Knowledge.- Harvesting Experts' Diagnostic Probability Estimates.- Objects Design for a Diagnostic Probability Study.- Methods Design for a Diagnostic Probability Study.- The Bayes' Theorem Framework for Diagnostic Research.- Research Focused on Diagnostic Tests.- Introduction to Etiognostic Research.- Objects Design for an Etiognostic Study.- Methods Design for an Etiognostic Study.- Introduction to Prognostic Research.- Example: Research on 'Hormone Replacement Therapy'.- Prognostic Probability Functions from Clinical-trial Data.- Non-experimental Intervention-prognostic Studies.- Intervention-prognostic Derivative Research.- Theory of Medicine Defining the Essential Missions for Clinical Research.- Theory of Clinical Research for Its Essential - Gnosis-serving - Missions.- Toward W…