Translational Surgery

Translational Surgery

1st Edition - February 1, 2023

Write a review

  • Editors: Adam Eltorai, Jeffrey Bakal, Ernest Moore, Paige Newell, Adena Osband
  • Paperback ISBN: 9780323903004

Purchase options

Purchase options
Available for Pre-Order
Sales tax will be calculated at check-out

Institutional Subscription

Free Global Shipping
No minimum order

Description

Translational Surgery is a surgery-specific instructional guide to translational medical research that 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 bridges the gap between current research and practice. Written by a team of expert medical, biomedical engineering, and clinical research experts in general surgery, this book provides a clear process for understanding, designing, executing and analyzing clinical and translational research within the field.

Key Features

  • Focuses on translational general surgery and research, covering the principles of evidence-based medicine and applying these principles to the design of translational investigations
  • Provides a practical, straightforward approach that will help aspiring general surgeons and researchers navigate challenging considerations in study design and implementation
  • Details valuable discussions on the critical appraisal of published studies in general surgery, 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

Surgeons, basic scientists interested in translating their research into clinical practice to your primary audience area alongside clinicians, Professional Associations

Table of Contents

  • 1. Introduction
    2. Translational Process
    3. Scientific Method
    4. Basic Research

    Pre-Clinical
    5. Overview of Preclinical Research
    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
    17. Introduction to Clinical Research: What is it? Why is it needed?
    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
    33. Design Principles: Hierarchy of 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
    47. Randomized Control: Design, Measures, Classic Example 
    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
    66. Sample Size
    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
    79. FDA Overview
    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
    90. Implementation Research
    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
    101. Presenting Data
    102. Manuscript Preparation
    103. Building a Team
    104. Patent Basics
    105. Venture Pathways
    106. SBIR/STTR
    107. Sample Forms and Templates

Product details

  • No. of pages: 510
  • Language: English
  • Copyright: © Academic Press 2023
  • Published: February 1, 2023
  • Imprint: Academic Press
  • Paperback ISBN: 9780323903004

About the Series Volume Editors

Adam Eltorai

Adam Eltorai, MD, PhD, completed his graduate studies in Biomedical Engineering and Biotechnology along with his medical degree from Brown University.  He has invented several medical technologies (from immunotherapies to medical devices) and developed innovations from in vitro studies and animal work through randomized clinical trials. Dr. Eltorai has published over 200 scientific journal articles, abstracts, books, book chapters.

Affiliations and Expertise

Brown University Warren Alpert Medical School, Connecticut, USA

Jeffrey Bakal

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

Program Director, Provincial Research Data Services, Data Integration Management and Reporting of Alberta Health Services, Edmonton, Alberta, Canada

Ernest Moore

Ernest E. “Gene” Moore, MD, was the Chief of Trauma at the Denver General Hospital for 36 years, Chief of Surgery for 28 years, and the first Bruce M. Rockwell Distinguished Chair in Trauma Surgery. He continues to serve as Vice Chairman for Research and is a Distinguished Professor of Surgery at the University of Colorado Denver (UCD), and has been the Editor of the Journal of Trauma since 2011. Under Dr. Moore’s leadership, the Rocky Mountain Regional Trauma Center at Denver General became internationally recognized for innovative care of the injured patient, and its trauma research laboratory has been funded by the NIH for 35 consecutive years. In July 2018, the center was renamed the Ernest E Moore Shock Trauma Center at Denver Health. Dr. Moore has served as president of nine academic societies, including the Society of University Surgeons, American Association for the Surgery of Trauma, International Association for the Trauma and Surgical Intensive Care, and the World Society of Emergency Surgery; and as Vice President for the American Surgical Association. His awards include the Robert Danis Prize from the Society of International Surgeons, Orazio Campione Prize from the World Society of Emergency Surgery, Philip Hench Award from the University of Pittsburgh, Florence Sabin Award from the University of Colorado, Lifetime Achievement Award from the Society of University Surgeons, Lifetime Achievement Award for Resuscitation Science from the American Heart Association, Distinguished Investigator Award from the American College of Critical Medicine, Distinguished Investigator Award from the Shock Society, Lifetime Service Award from the International Association for Trauma and Surgical Intensive Care, and the Medallion for Scientific Achievement from the American Surgical Association. He has honorary fellowships in the Royal College of Surgeons of Edinburgh, the Royal College of Surgeons in Ireland, the Royal College of Surgeons of Thailand, and the American College of Emergency Physicians; and is an honorary member of the Brazilian Trauma Society, Colombian Trauma Society, Eastern Association for the Surgery of Trauma, European Society for Trauma and Emergency Surgery, North Pacific Surgical Association, and Trauma Association of Canada. Dr. Moore is coeditor of the textbook Trauma, in its 9th edition, Surgical Secrets in its 7th edition, and Trauma Induced Coagulopathy, in its 2nd edition; he has >1700 publications and has lectured extensively throughout the world.

Affiliations and Expertise

Vice Chairman for Research and Distinguished Professor of Surgery, University of Colorado Denver (UCD), Denver and Aurora, CO, USA

Paige 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, USA

Adena 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, USA

Ratings and Reviews

Write a review

There are currently no reviews for "Translational Surgery"