Titolo: Translational Interventional Radiology

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Epidemiologia e Statistica Medica

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Translational Interventional Radiology

Editore

Elsevier

Anno

2023

Pagine

598

ISBN

9780128230268

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Description:

Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. The reader will come to fully understand important concepts including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist who has ever had a good clinical idea but not the knowledge of how to test it.

Features:

Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within interventional radiology
Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation
Details discussions of the critical appraisal of published studies in interventional radiology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care

INTRODUCTION
1. Translational Process; 2. Scientific Method; 3. Basic research

PRE-CLINICAL: DISCOVERY AND DEVELOPMENT
4. Overview of preclinical research; 5. Defining the problem to solve; 6. Types of problems; 7. Types of Interventions; 8. Drug discovery; 9. Drug safety; 10. Device discovery; 11. Device prototyping; 12. Device classification; 13. Device testing; 14. Diagnostic testing; 15. Other product types; 16. Procedural technique development; 17. Behavioral intervention

CLINICAL: FUNDAMENTALS
18. Introduction to clinical research: What is it? Why is it needed?; 19. The question: Types of research questions and how to develop them; 20. Study population: Who and why them?; 21. Outcome measurements: What data is being collected and why?; 22. Optimizing the question: Balancing significance and feasibility

STATISTICAL PRINCIPLES
23. Common issues in analysis; 24. Basic statistical principles; 25. Distributions; 26. Hypotheses and error types; 27. Power; 28. Regression; 29. t-test; 30. Chi-square; 31. Analysis of variance; 32. Correlation; 33. Biases; 34. Basic science statistics

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. Clinical trials: Design, measures, classic example; 42. Meta-analysis: Design, measures, classic example; 43. Cost-effectiveness analysis: Design, measures, classic example; 44. Diagnostic test evaluation: Design, measures, classic example; 45. Reliability study: Design, measures, classic example; 46. Surveys and questionnaires: Design, measures, classic example; 47. Qualitative methods and mixed methods

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. 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. Meaningful outcome measurements; 67. Sample size; 68. Budgeting; 69. Ethics and review boards; 70. Regulatory considerations for new drugs and devices; 71. Funding approaches; 72. Subject recruitment; 73. Data management; 74. Quality control; 75. Statistical software; 76. Report forms: Harm and Quality of Life; 77. Subject adherence; 78. Monitoring committee in clinical trials

REGULATORY
79. FDA overview; 80. IND; 81. New drug application; 82. Device pathways; 83. Radiation-emitting electronic products; 84. Combination products; 85. Cosmetics; 86. CMC and GxP; 87. Non-US regulatory; 88. Post-Market Drug Safety Monitoring; 89. Post-Market Device Safety Monitoring

CLINICAL IMPLEMENTATION
90. Implementation Research; 91. Design and analysis; 92. Mixed-methods research; 93. Population- and setting-specific implementation

PUBLIC HEALTH
94. Public Health; 95. Epidemiology; 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

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