Translational Cardiothoracic Surgery

Adam E.M. Eltorai, Jeffrey A. Bakal, Laura A. Scrimgeour, Thomas Ng, Frank W Sellke (Herausgeber)

Buch | Softcover

610 Seiten

2026
Academic Press Inc (Verlag)
978-0-323-90532-9 (ISBN)

Noch nicht erschienen (ca. Februar 2026)
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Translational research is essential to the advancement of medicine. This Cardiothoracic-specific instructional guide to translational medical research 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 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 cardiothoracic surgery, this volume provides a clear process for understanding, designing, executing, and analyzing clinical and translational research within the field.

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. 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. Thomas Ng is the Eastridge-Cole Professor of Thoracic Surgery and Chief of the Division of Thoracic Surgery at the University Tennessee. He received has extensive expertise in minimally invasive and robotic thoracic surgery and is a strong clinical researcher with over 80 peer-reviewed publications. He is highly committed to medical education and is a 4-time recipient of the Brown Medical School Department of Surgery-Outstanding Teaching Faculty Award and is also a 4-time winner of the Deans Excellence in Teaching Award. Dr Sellke is the Karl Karlson and Gloria Karlson Professor and Chief of Cardiothoracic Surgery at Brown Medical School and the Lifespan Hospitals. Dr Sellke is a native of Indiana and graduated from Wabash College and Indiana University School of Medicine. He is a noted clinical cardiothoracic surgeon, researcher, and author. Dr Sellke was the Chief of Cardiothoracic Surgery at Beth Israel Deaconess Medical Center and the Johnson and Johnson Professor of Surgery at Harvard Medical School prior to moving to Brown. His research interests include the regulation of the microcirculation in health and disease, ischemic injury and inflammation during cardiac surgery, collateral vascular formation and the use of growth factors and cell therapy to increase blood flow to ischemic tissue. His clinical research interests include optimizing outcomes after cardiac surgery, the reduction of bleeding and transfusion, and neurocognitive dysfunction and atrial fibrillation after surgery. Dr Sellke has been continuously funded by the National Institutes of Health for 28 years. He serves as Associate Editor for the Journal of Thoracic and Cardiovascular Surgery, Circulation Heart Failure and the Circulation Journal. He is on the editorial board of Circulation, Surgery, the Canadian Journal of Cardiology, and the Journal of Cardiac Surgery. He is the Editor of the 7th, 8th, 9th and 10th editions of Sabiston and Spencers' Surgery of the Chest, the 1st and 2nd editions of the Atlas of Cardiac Surgical Techniques, and he is completing work on a textbook on Acute Aortic Dissection and Acute Aortic Syndromes with international contributors. Dr. Sellke is the author of more than 525 peer-reviewed journal articles, as well as numerous book chapters and abstracts. He is the Past Chairman of the Executive Committee of the Council on Cardiovascular Surgery and Anesthesia of the American Heart Association and the Past Chairman of the Advisory Council on Cardiothoracic Surgery of the American College of Surgeons. Sellke has served on the Board of Governors of the American College of Surgeons and is was Chairman of its Humanitarian and Volunteerism Awards Committee, past-Chairman of the American Heart Association Committee on Scientific Sessions Program. He is the current Chairman of the Data Safety Monitoring Committee of the National Institutes of Health Cardiac Surgery Network and served on the Bioengineering, Technology and Surgical Science study section of the NIH. He is the Past-President of the Massachusetts Society of Thoracic Surgeons, past President of the Northeast Cardiothoracic Surgical Society and is a member of numerous other organizations including the American Association for Thoracic Surgery, Society of University Surgeons, and the American Surgical Association. Dr. Sellke is a fellow of the American College of Cardiology, the American College of Chest Physicians, American Heart Assocation, and the American College of Surgeons.

PRE-CLINCIAL: DISCOVERY & DEVELOPMENT
1. Defining the problem to solve
2. Types of problems
3. Drug discovery
4. Device discovery
5. Device classification
6. Other product types
7. Drug safety
8. Device prototyping
9. Device testing

CLINICAL: FUNDAMENTALS
10. Introduction to clinical research: What is it? Why is it needed?
11. The question: Types of research questions and how to develop them
12. Study population: Who and why them?
13. Outcome measurements: What data is being collected and why?

STATISTICAL PRINCIPLES
14. Presenting data
15. Common issues in analysis
16. Basic statistical principles
17. Distributions
18. Hypotheses and error types
19. Power
20. Regression
21. Continuous variable analyses: t-test, Man Whitney, Wilcoxin rank
22. Categorical variable analyses: Chi-square, fisher exact, Mantel hanzel
23. Analysis of variance
24. Correlation
25. Biases
26. Basic science statistics
27. Sample forms and templates

CLINICAL: STUDY TYPES
28. Design principles: Hierarchy of study types
29. Case series: Design, measures, classic example
30. Case-control study: Design, measures, classic example
31. Cohort study: Design, measures, classic example
32. Cross-section study: Design, measures, classic example
33. Clinical trials: Design, measures, classic example
34. Meta-analysis: Design, measures, classic example
35. Cost-effectiveness study: Design, measures, classic example
36. Diagnostic test evaluation: Design, measures, classic example
37. Reliability study: Design, measures, classic example
38. Database studies: Design, measures, classic example
39. Surveys and questionnaires: Design, measures, classic example
40. Qualitative methods and mixed methods

CLINICAL TRIALS
41. Randomized control: Design, measures, classic example
42. Nonrandomized control: Design, measures, classic example
43. Historical control: Design, measures, classic example
44. Cross-over: Design, measures, classic example
45. Withdrawal studies: Design, measures, classic example
46. Factorial design: Design, measures, classic example
47. Group allocation: Design, measures, classic example
48. Hybrid design: Design, measures, classic example
49. Large, pragmatic: Design, measures, classic example
50. Equivalence and noninferiority: Design, measures, classic example
51. Adaptive: Design, measures, classic example
52. Randomization: Fixed or adaptive procedures
53. Blinding: Who and how?
54. Multicenter considerations
55. IDEAL Framework

CLINICAL: PREPARATION
56. Optimizing the question: Balancing significance and feasibility
57. Meaningful outcome measurements
58. Sample size
59. Budgeting
60. Ethics and review boards
61. Regulatory considerations for new drugs and devices
62. Funding approaches
63. Subject recruitment
64. Data management
65. Quality control
66. Report forms: Harm and Quality of Life
67. Subject adherence
68. Survival analysis
69. Monitoring committee in clinical trials

REGULATORY
70. FDA overview
71. New drug application
72. Device pathways
73. Non-US regulatory
74. Post-Market Drug Safety Monitoring
75. Post-Market Device Safety Monitoring

Erscheint lt. Verlag	1.2.2026
Reihe/Serie	Handbook for Designing and Conducting Clinical and Translational Research
Verlagsort	Oxford
Sprache	englisch
Maße	216 x 276 mm
Themenwelt	Naturwissenschaften ► Biologie
ISBN-10	0-323-90532-3 / 0323905323
ISBN-13	978-0-323-90532-9 / 9780323905329
Zustand	Neuware