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Translational Cardiothoracic Surgery

  • 1st Edition - February 15, 2026
  • Latest edition
  • Editors: Adam E.M. Eltorai, Jeffrey A. Bakal, Thomas Ng, Frank W Sellke, Laura A. Scrimgeour
  • Language: English

Translational research is essential to the advancement of medicine. This Cardiothoracic-specific instructional guide to translational medical research serves as a practical, step… Read more

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Description

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.

Key features

  • Focusing on translational cardiothoracic surgery and research, this volume covers the principles of evidence-based medicine and applies these principles to the design of translational investigations
  • Provides a practical, straightforward approach that will help the aspiring cardiothoracic 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

Readership

Cardiothoracic surgeons, clinicians, cardiologists, cardiovascular researchers, basic scientists interested in translating their research into clinical practice

Table of contents

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

Product details

  • Edition: 1
  • Latest edition
  • Published: February 17, 2026
  • Language: English

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, USA

JB

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, Canada

TN

Thomas Ng

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.
Affiliations and expertise
Eastridge-Cole Professor of Thoracic Surgery and Chief of the Division of Thoracic Surgery, University Tennessee, USA

FS

Frank W Sellke

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.
Affiliations and expertise
Karl Karlson and Gloria Karlson Professor, Brown Medical School Chief of Cardiothoracic Surgery, Lifespan Hospitals

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