Clinical Research for Surgeons

Canada

Praise for this book:"Readable, relevant, and interesting...this book cuts through jargon, recapitulates key concepts, and clarifies with current examples from the literature...recommend[ed]."--Doody's ReviewA thoughtful introduction and guide to clinical research for surgeons. The book is especially useful because surgical research differs from drug and device research in matters like control treatments, blinding, regulation, and funding. -- Norman M. Goldfarb, Journal of Clinical Research Best Practices, August, 2012.

• Part I Why We Need Clinical Research1 Historical Perspective of Clinical Research2 Evidence-Based Surgery Defined3 Myths and Misconceptions about Evidence-Based Medicine4 Becoming and Evidence-Based SurgeonPart II Principles of Clinical Research5 Various Research Design Classifications6 Hierarchy of Research Studies: From Case Series to Meta-Analyses7 Randomized and Nonrandomized StudiesPart IIA Understanding Research Study Design8 The Clinical Case Series9 The Case&ndsah;Control Study10 The Prospective Cohort Study11 The Randomized Trial12 Meta-Analyses13 Economic Analysis14 The Diagnostic Study15 The Reliability StudyPart IIB Understanding Outcomes Measurement16 The Classification of Outcomes17 What Makes an Outcome Measure Useful18 Common Generic Outcome Scales for Surgeons19 Common Disease-Specific Outcome Scales for SurgeonsPart IIC Understanding Treatment Effects20 Common Ways to Present Treatment Effects21 The Confidence Interval Defined22 The P Value Defined23 Errors in Hypothesis Testing24 Clinical versus Statistical SignificancePart III Practice of Clinical ResearchPart IIIA Planning a Research Study25 The Requirements of a Clinical Research Proposal26 The Identification of a Good Research Question27 How to Conduct a Comprehensive Literature Search28 Guide to Planning a Randomized Trial29 Guide to Planning a Nonrandomized Study30 Study Sample Size31 How to Budget for a Research Study32 Research Ethics, Review Boards, and Consent Forms33 Regulatory Issues in the Evaluation of a New Device or Drug34 Strategies in Research FundingPart IIIB Conducting a Research Study35 The Roles of the Research Team36 The Role of a Central Methods Center37 The Role of a Data Monitoring Committee38 The Need for Separate Adjudication of Outcomes39 Data Management40 Study Case Report Forms41 The Study Manual of OperationsPart IIIC Practical Guide to Statistical Analysis42 Review of Basic Statistical Principles43 Statistical Means and Proportions44 Regression Analysis45 Analysis of Variance46 Correlation Defined