Translational Surgery: Handbook for Designing and Conducting Clinical and Translational Research
Editat de Adam E.M. Eltorai Jeffrey A. Bakal, Paige C. Newell, Adena J. Osbanden Limba Engleză Paperback – 23 mar 2023
- Focuses on translational research in Surgery, covering the principles of evidence-based medicine and applying those principles to the design of translational investigations
- Provides a practical, straightforward approach to help surgeons and researchers navigate challenging aspects of study design and implementation
- Details valuable discussions on the critical appraisal of published studies in Surgery, allowing the reader to effectively use all types of evidence for patient care
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Specificații
ISBN-13: 9780323903004
ISBN-10: 0323903002
Pagini: 768
Ilustrații: Approx. 100 illustrations (100 in full color)
Dimensiuni: 216 x 276 x 40 mm
Greutate: 2.06 kg
Editura: ELSEVIER SCIENCE
Seria Handbook for Designing and Conducting Clinical and Translational Research
ISBN-10: 0323903002
Pagini: 768
Ilustrații: Approx. 100 illustrations (100 in full color)
Dimensiuni: 216 x 276 x 40 mm
Greutate: 2.06 kg
Editura: ELSEVIER SCIENCE
Seria Handbook for Designing and Conducting Clinical and Translational Research
Cuprins
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
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