Translational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control studies, prospective cohort studies, randomized trials, and reliability studies. Investigators will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in surgical research, and know what is needed for collaboration. Further, this title is an indispensable tool in grant writing and funding efforts.…mehr
Translational Surgery covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control studies, prospective cohort studies, randomized trials, and reliability studies. Investigators will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in surgical research, and know what is needed for collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the translational research navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in surgery, allowing the reader to learn how to evaluate the quality of such studies. Thus, they will improve at measuring outcomes; making effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every surgeon or surgical researcher who has ever had a good clinical idea, but not the knowledge of how to test it.Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Produktdetails
Produktdetails
Handbook for Designing and Conducting Clinical and Translational Research
1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research Pre-Clinical 5. Overview of Preclinical Research 6. What Problem Are You Solving? 7. Types of Interventions 8. Drug Discovery 9. Drug Testing 10. Device Discovery and Prototyping 11. Medical Device Testing 12. Diagnostic Discovery 13. Diagnostic Testing 14. Other Product Types 15. Procedural Technique Development 16. Behavioral Intervention Clinical: Fundamentals 17. Introduction to Clinical Research: What is it? Why is it needed? 18. The Question: Types of Research Questions and How to Develop Them 19. Study Population: Who and why them? 20. Outcome Measurements: What data is being collected and why? 21. Optimizing the question: Balancing significance and feasibility Statistical Principles 22. Basic Statistical Principles 23. Distributions 24. Hypotheses and Error Types 25. Power 26. Regression 27. Continuous Variable Analyses: T-test, Man Whitney, Wilcoxon Rank 28. Categorical Variable Analyses: Chi-Square, fisher exact, Mantel Hanzel 29. Analysis of Variance 30. Correlation 31. Biases 32. Basic Science Statistics Clinical: Study Types 33. Design Principles: Hierarchy of Study Types 34. Case Series: Design, Measures, Classic Example 35. Case-Control: Design, Measures, Classic Example 36. Cohort Study: Design, Measures, Classic Example 37. Cross-Section Study: Design, Measures, Classic Example 38. Longitudinal Study: Design, Measures, Classic Example 39. Clinical Trials: Design, Measures, Classic Example 40. Meta-Analysis: Design, Measures, Classic Example 41. Cost-Effectiveness Study: Design, Measures, Classic Example 42. Diagnostic Test Evaluation: Design, Measures, Classic Example 43. Reliability Study: Design, Measures, Classic Example 44. Database Studies: Design, Measures, Classic Example 45. Surveys and Questionnaires: Design, Measures, Classic Example 46. Qualitative Methods and Mixed Methods Clinical Trials 47. Randomized Control: Design, Measures, Classic Example 48. Nonrandomized Control: Design, Measures, Classic Example 49. Historical Control: Design, Measures, Classic Example 50. Cross-Over: Design, Measures, Classic Example 51. Withdrawal Studies: Design, Measures, Classic Example 52. Factorial Design: Design, Measures, Classic Example 53. Group Allocation: Design, Measures, Classic Example 54. Hybrid Design: Design, Measures, Classic Example 55. Large, Pragmatic: Design, Measures, Classic Example 56. Equivalence and Noninferiority: Design, Measures, Classic Example 57. Adaptive: Design, Measures, Classic Example 58. Randomization: Fixed or Adaptive Procedures 59. Blinding: Who and How? 60. Multicenter Considerations 61. Registries 62. Phases of Clinical Trials 63. IDEAL Framework 64. Artificial Intelligence 65. Patient Perspectives Clinical: Preparation 66. Sample Size 67. Budgeting 68. Medical Ethics and Review Boards 69. Regulatory Considerations for New Drugs and Devices 70. Funding Approaches 71. Subject Recruitment 72. Data Management 73. Quality Control 74. Statistical Software 75. Report Forms: Harm and Quality of Life 76. Subject Adherence 77. Survival Analysis 78. Monitoring Committee in Clinical Trials Regulatory Basics 79. FDA Overview 80. IND 81. New Drug Application 82. Devices 83. Radiation-emitting Electronic Products 84. Orphan Drugs 85. Biologics 86. Combination Products 87. Foods 88. Cosmetics 89. Non-US Regulatory Clinical Implementation 90. Implementation Research 91. Design and Analysis 92. Population and Setting Specific Implementation Public Health 93. Public Health 94. Epidemiology 95. Factors in Surgical Public Health and Health Disparities Research 96. Good Questions 97. Population and Environmental Specific Considerations 98. Law, Policy, and Ethics 99. Healthcare Institutions and Systems 100. Public Health Institutions and Systems Practical Resources 101. Presenting Data 102. Manuscript Preparation 103. Building a Team 104. Patent Basics 105. Venture Pathways 106. SBIR/STTR 107. Sample Forms and Templates
1. Introduction 2. Translational Process 3. Scientific Method 4. Basic Research Pre-Clinical 5. Overview of Preclinical Research 6. What Problem Are You Solving? 7. Types of Interventions 8. Drug Discovery 9. Drug Testing 10. Device Discovery and Prototyping 11. Medical Device Testing 12. Diagnostic Discovery 13. Diagnostic Testing 14. Other Product Types 15. Procedural Technique Development 16. Behavioral Intervention Clinical: Fundamentals 17. Introduction to Clinical Research: What is it? Why is it needed? 18. The Question: Types of Research Questions and How to Develop Them 19. Study Population: Who and why them? 20. Outcome Measurements: What data is being collected and why? 21. Optimizing the question: Balancing significance and feasibility Statistical Principles 22. Basic Statistical Principles 23. Distributions 24. Hypotheses and Error Types 25. Power 26. Regression 27. Continuous Variable Analyses: T-test, Man Whitney, Wilcoxon Rank 28. Categorical Variable Analyses: Chi-Square, fisher exact, Mantel Hanzel 29. Analysis of Variance 30. Correlation 31. Biases 32. Basic Science Statistics Clinical: Study Types 33. Design Principles: Hierarchy of Study Types 34. Case Series: Design, Measures, Classic Example 35. Case-Control: Design, Measures, Classic Example 36. Cohort Study: Design, Measures, Classic Example 37. Cross-Section Study: Design, Measures, Classic Example 38. Longitudinal Study: Design, Measures, Classic Example 39. Clinical Trials: Design, Measures, Classic Example 40. Meta-Analysis: Design, Measures, Classic Example 41. Cost-Effectiveness Study: Design, Measures, Classic Example 42. Diagnostic Test Evaluation: Design, Measures, Classic Example 43. Reliability Study: Design, Measures, Classic Example 44. Database Studies: Design, Measures, Classic Example 45. Surveys and Questionnaires: Design, Measures, Classic Example 46. Qualitative Methods and Mixed Methods Clinical Trials 47. Randomized Control: Design, Measures, Classic Example 48. Nonrandomized Control: Design, Measures, Classic Example 49. Historical Control: Design, Measures, Classic Example 50. Cross-Over: Design, Measures, Classic Example 51. Withdrawal Studies: Design, Measures, Classic Example 52. Factorial Design: Design, Measures, Classic Example 53. Group Allocation: Design, Measures, Classic Example 54. Hybrid Design: Design, Measures, Classic Example 55. Large, Pragmatic: Design, Measures, Classic Example 56. Equivalence and Noninferiority: Design, Measures, Classic Example 57. Adaptive: Design, Measures, Classic Example 58. Randomization: Fixed or Adaptive Procedures 59. Blinding: Who and How? 60. Multicenter Considerations 61. Registries 62. Phases of Clinical Trials 63. IDEAL Framework 64. Artificial Intelligence 65. Patient Perspectives Clinical: Preparation 66. Sample Size 67. Budgeting 68. Medical Ethics and Review Boards 69. Regulatory Considerations for New Drugs and Devices 70. Funding Approaches 71. Subject Recruitment 72. Data Management 73. Quality Control 74. Statistical Software 75. Report Forms: Harm and Quality of Life 76. Subject Adherence 77. Survival Analysis 78. Monitoring Committee in Clinical Trials Regulatory Basics 79. FDA Overview 80. IND 81. New Drug Application 82. Devices 83. Radiation-emitting Electronic Products 84. Orphan Drugs 85. Biologics 86. Combination Products 87. Foods 88. Cosmetics 89. Non-US Regulatory Clinical Implementation 90. Implementation Research 91. Design and Analysis 92. Population and Setting Specific Implementation Public Health 93. Public Health 94. Epidemiology 95. Factors in Surgical Public Health and Health Disparities Research 96. Good Questions 97. Population and Environmental Specific Considerations 98. Law, Policy, and Ethics 99. Healthcare Institutions and Systems 100. Public Health Institutions and Systems Practical Resources 101. Presenting Data 102. Manuscript Preparation 103. Building a Team 104. Patent Basics 105. Venture Pathways 106. SBIR/STTR 107. Sample Forms and Templates
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