Translational Cardiology (eBook, ePUB)

Redaktion: Bakal, Jeffrey A.; Eltorai, Adam E. M.; Gibson, Michael

• Format: ePub

Produktbeschreibung

Translational Cardiology provides a cardiology-specific instructional guide to translational medical research that will serve 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 aims to help bridge the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in cardiology, this book provides a clear process for understanding, designing, executing, and analyzing clinical and translational research. - Focuses on translational cardiovascular research, covering the principles of evidence-based medicine and applies these principles to the design of translational investigations - Provides a practical, straightforward approach that will help aspiring cardiovascular researchers navigate challenging considerations in study design and implementation - Details valuable discussions of the critical appraisal of published studies in cardiology, 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

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Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 465
• Erscheinungstermin: 24. Januar 2025
• Englisch
• ISBN-13: 9780323986106
• Artikelnr.: 72816722

Inhaltsangabe

Section 1. INTRODUCTION 1. Introduction
2. Translational Process
3. Scientific Method
4. Basic Research Section 2: PRE-CLINCIAL: DISCOVERY & DEVELOPMENT 5. Overview of Preclinical Research
6. What problem are you Solving?
7. Types of Structural Interventions
8. Drug discovery
9. Drug Testing
10. Device Testing
11. Diagnostic Discovery
12. Diagnostic Testing
13. Other product types
14. Procedural Technique Development
15. Behavioral Intervention Section 3: CLINICAL: FUNDAMENTALS 16. Introduction to clinical research: What is it? Why is it needed?
17. The question: Types of research questions and how to develop them
18. Study population: Who and why them?
19. Outcome measurements: What data is being collected and why?
20. Optimizing the Question: Balancing Significance and Feasibility Section 4: STATISTICAL PRINCIPLES 21. Common issues in analysis
22. Basic statistical principles
23. Distributions
24. Hypotheses and error types
25. Power
26. Regression
27. Continuous Variable Analyses: Student's t-test, Mann-Whitney U Test, Wilcoxon Signed-Rank Test
28. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel
29. Analysis of variance
30. Correlation
31. Biases
32. Basic science statistics
33. Sample Size
34. Statistical Software Section 5: CLINICAL: STUDY TYPES 35. Design principles: Hierarchy of study types
36. Case series: Design, measures, classic example
37. Case-control study: Design, measures, classic example
38. Cohort study: Design, measures, classic example
39. Cross-section study: Design, measures, classic example
40. Longitudinal Study: Design, Measures, Classic Example
41. Meta-analysis: Design, measures, classic example
42. Cost-effectiveness study: Design, measures, classic example
43. Diagnostic test evaluation: Design, measures, classic example
44. Reliability study: Design, measures, classic example
45. Database studies: Design, measures, classic example
46. Surveys and questionnaires: Design, measures, classic example
47. Qualitative methods and mixed methods Section 6: CLINICAL TRIALS 48. Randomized control: Design, measures, classic example
49. Nonrandomized control: Design, measures, classic example
50. Historical control: Design, measures, classic example
51. Cross-over: Design, measures, classic example
52. Withdrawal studies: Design, measures, classic example
53. Factorial design: Design, measures, classic example
54. Group allocation: Design, measures, classic example
55. Hybrid design: Design, measures, classic example
56. Large, pragmatic: Design, measures, classic example
57. Equivalence and noninferiority: Design, measures, classic example
58. Adaptive: Design, measures, classic example
59. Blinding: Who and how?
60. Phases of Clinical Trials
61. IDEAL Framework Section 7: CLINICAL: PREPARATION 62. Patient Perspectives
63. Budgeting
64. Ethics and review boards
65. Regulatory considerations for new drugs and devices
66. Funding approaches
67. Conflicts of Interest
68. Subject recruitment
69. Data management
70. Quality control
71. Research in Acute Settings
72. Special Populations
73. Report forms: Harm and Quality of Life
74. Subject adherence
75. Survival analysis
76. Monitoring committee in clinical trials Section 8: REGULATORY BASICS 77. FDA overview
78. IND/New Drug Application
79. Radiation-Emitting Electronic Products
80. Orphan Drugs
81. Combination Products
82. CMC and GxP
83. Non-US Regulatory
84. Post-Market Drug Safety Monitoring
85. Post-Market Device Safety Monitoring Section 9: CLINICAL IMPLEMENTATION 86. Implementation Research
87. Design and Analysis
88. Mixed-Methods Research
89. Population- and Setting-Specific Implementation
90. Guideline Development Section 10: PUBLIC HEALTH 91. Public Health
92. Epidemiology
93. Factors
94. Good Questions
95. Population- and Environmental-Specific Considerations
96. Law, Policy, and Ethics
97. Healthcare Institutions and Systems
98. Public Health Institutions and Systems Section 11: PRACTICAL RESOURCES 99. Presenting Data
100. Manuscript Preparation
101. Promoting Research
102. Quality Improvement
103. Team Science and Building a Team
104. Patent Basics
105. SBIR/STTR