Translational Surgery
- 1st Edition - March 22, 2023
- Latest edition
- Editors: Adam E.M. Eltorai, Jeffrey A. Bakal, Paige C. Newell, Adena J. Osband
- Language: English
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… Read more
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Description
Description
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.
Key features
Key features
- 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
Readership
Readership
Surgeons, basic scientists interested in translating their research into clinical practice to your primary audience area alongside clinicians, Professional Associations
Table of contents
Table of contents
1. Introduction
2. Translational Process
3. Scientific Method
4. Basic Research
Pre-Clinical
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
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
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
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
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
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
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
102. Manuscript Preparation
103. Building a Team
104. Patent Basics
105. Venture Pathways
106. SBIR/STTR
107. Sample Forms and Templates
Product details
Product details
- Edition: 1
- Latest edition
- Published: March 23, 2023
- Language: English
About the editors
About the editors
AE
Adam E.M. Eltorai
Dr Adam E. M. Eltorai, MD, PhD completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University. His work has spanned the translational spectrum with a focus on medical technology innovation and development. Dr. Eltorai has published numerous articles and books.
Affiliations and expertise
Harvard Medical School, Boston, MA, USAJB
Jeffrey A. Bakal
Dr Jeff Bakal PhD, P.Stat. is the Program Director for Provincial Research Data Services at Alberta Health Services which operates the Alberta Strategy for Patient Oriented Research (SPOR) data platform and Health Service Statistical & Analytics Methods teams. He has over 10 years of experience working with Health Services data and Randomized Clinical Trials. He completed his PhD jointly with the Department of Mathematics and Statistics and the School of Physical Health and Education at Queen's University. He has worked on the methodology and analysis of several international studies in business strategy, ophthalmology, cardiology, geriatric medicine and the analysis of kinematic data resulting in several peer reviewed articles and conference presentations. His current interests are in developing statistical methodology for time-to-event data and the development of classification tools to assist in patient decision making processes.
Affiliations and expertise
Division General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton Alberta, CanadaPN
Paige C. Newell
Paige Newell MD received her Bachelor of Arts in History of Art and Architecture from Harvard University, and subsequently received her Doctor of Medicine from Lewis Katz School of Medicine at Temple University. She started general surgery residency at Brigham and Women's Hospital in Boston, MA in 2018, and spent her two years of dedicated research time from June 2020 - June 2022 as the Vicky and Joseph Safra Cardiac Surgery Clinical Outcomes Research Fellow within the Division of Cardiac Surgery at Brigham and Women's Hospital and as a research fellow for the Center for Surgery and Public Health. Her research interests include socioeconomic disparities in cardiac surgery outcomes and barriers to access to high quality care. After completing general surgery residency she plans to complete a fellowship in cardiothoracic surgery.
Affiliations and expertise
Brigham and Women’s Hospital, Boston, MA, USAAO
Adena J. Osband
Adena Osband, MD is a graduate of the University of Pennsylvania and New Jersey Medical School. She is currently a transplant surgeon and director of the living donor program at Rhode Island Hospital, with over 15 years in practice. She also holds the positions of associate professor of surgery and director of surgical intern education at the Warren Alpert Medical School of Brown University.
Affiliations and expertise
Department of Surgery, Warren Alpert Medical School of Brown University, Providence, RI, USAView book on ScienceDirect
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