Clinical Research Methods for Surgeons (eBook)

David F. Penson (Herausgeber)

eBook Download: PDF
2007 | 2007
350 Seiten
Humana Press (Verlag)
978-1-59745-230-4 (ISBN)

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With his keen analytical mind and penchant for organization, Charles Darwin would have made an excellent clinical investigator. Unfortunately for surgery, his early exposure at Edinburgh to the brutality of operations in 1825 convinced him to reject his father's plan for his career and pursue his interest in nature. His subsequent observations of how environmental pressures shaped the development of new species provided the essential mechanism to explain evolution and the disappearance of those species that failed to adapt. Today, surgeons face the same reality as new technology, progressive regulation by government and payers, medico-legal risks, and public demands for proof of performance force changes in behavior that our predecessors never imagined. We know that surgeons have always prided themselves on accurate documentation of their results, including their complications and deaths, but observational studies involving a single surgeon or institution have given way to demands for controlled interventional trials despite the inherent difficulty of studying surgical patients by randomized, blinded techniques. That is why this book is so timely and important. In a logical and comprehensive approach, the authors have assembled a group of experienced clinical scientists who can demonstrate the rich variety of techniques in epidemiology and statistics for reviewing existing publications, structuring a clinical study, and analyzing the resulting data.
With his keen analytical mind and penchant for organization, Charles Darwin would have made an excellent clinical investigator. Unfortunately for surgery, his early exposure at Edinburgh to the brutality of operations in 1825 convinced him to reject his father's plan for his career and pursue his interest in nature. His subsequent observations of how environmental pressures shaped the development of new species provided the essential mechanism to explain evolution and the disappearance of those species that failed to adapt. Today, surgeons face the same reality as new technology, progressive regulation by government and payers, medico-legal risks, and public demands for proof of performance force changes in behavior that our predecessors never imagined. We know that surgeons have always prided themselves on accurate documentation of their results, including their complications and deaths, but observational studies involving a single surgeon or institution have given way to demands for controlled interventional trials despite the inherent difficulty of studying surgical patients by randomized, blinded techniques. That is why this book is so timely and important. In a logical and comprehensive approach, the authors have assembled a group of experienced clinical scientists who can demonstrate the rich variety of techniques in epidemiology and statistics for reviewing existing publications, structuring a clinical study, and analyzing the resulting data.

Foreword 6
Preface 8
Contents 10
Contributors 12
I BUILDING A FOUNDATION FOR CLINICAL RESEARCH 14
Planning the Research 15
Ethical Issues in Clinical Research 42
Budget Development and Staffing 58
II CLINICAL RESEARCH DESIGN AND STATISTICAL TECHNIQUES 72
Nonrandomized Interventional Study Designs (Quasi- Experimental Designs) 73
Randomized Clinical Trials of Surgical Procedures 87
Use of Observational Databases (Registries) in Research 104
Risk Adjustment 114
Basic Statistical Methods 132
Survival Analyses 149
Assessing the Performance and Validity of Diagnostic Tests and Screening Programs 164
Secondary Data Analyses 182
III OUTCOME MEASUREMENT 208
Traditional Outcome Measures 209
Health- Related Quality of Life 242
Measuring Patient Satisfaction 257
IV SPECIAL TOPICS IN SURGICAL CLINICAL RESEARCH 270
Quality of Care 271
Cost- Effectiveness Analyses 285
Qualitative Research Techniques 299
Systematic Reviews and Meta- Analyses 313

Erscheint lt. Verlag 6.11.2007
Zusatzinfo 350 p. 33 illus.
Verlagsort Totowa
Sprache englisch
Themenwelt Medizin / Pharmazie Medizinische Fachgebiete Chirurgie
Medizin / Pharmazie Medizinische Fachgebiete Urologie
Schlagworte Behavior • clinical research • complication • Diseases • documentation • epidemiology • Ethical Issues • Health • Organizations • patients • Planning • quality • quality of life • Statistics • Surgery
ISBN-10 1-59745-230-0 / 1597452300
ISBN-13 978-1-59745-230-4 / 9781597452304
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