Translational Surgery

Translational Surgery is a surgery-specific instructional guide to translational medical research that serves as a practical, step-by-step roadmap for taking a biomedical device, potential therapeutic agent, or research question from idea through demonstrated clinical benefit. Fundamentally, the volume bridges the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in general surgery, this book provides a clear process for understanding, designing, executing and analyzing clinical and translational research within the field. Focuses on translational general surgery and research, covering the principles of evidence-based medicine and applying these principles to the design of translational investigations Provides a practical, straightforward approach that will help aspiring general surgeons and researchers navigate challenging considerations in study design and implementation Details valuable discussions on the critical appraisal of published studies in general surgery, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care INDICE: 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

• ISBN: 978-0-323-90300-4
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 510
• Fecha Publicación: 01/02/2023
• Nº Volúmenes: 1
• Idioma: Inglés