Translational Sports Medicine

Translational Sports Medicine

1st Edition - August 1, 2023

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  • Editors: Adam Eltorai, Jeffrey Bakal, Steve DeFroda, Brett Owens
  • Paperback ISBN: 9780323912594

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Description

Translational Sports Medicine covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. This title is an indispensable tool in grant writing and funding efforts with its practical, straightforward approach that will help aspiring investigators navigate challenging considerations in study design and implementation. It provides valuable discussions of the critical appraisal of published studies in translational sports medicine, 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. In short, this practical guidebook will be of interest to every medical researcher or sports medicine clinician who has ever had a good clinical idea but not the knowledge of how to test it. Readers 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 translational sports medicine, and know what is needed in collaboration.

Key Features

  • Focuses on the principles of evidence-based medicine and applies these principles to translational investigations within sports medicine
  • Details discussions of the critical appraisal of published studies in translational sports medicine, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
  • Written by experts in the sports medicine field

Readership

Clinicians in sports medicine, basic scientists interested in translating their research into clinical practice, Graduate level programs in clinical investigation

Table of Contents

  • PART I: INTRODUCTION
    1 Introduction
    Eltorai, Brigham & Women’s
    2 Translational Process
    Michael G. Ciccotti, Rothman Institute
    3 Scientific Method
    Adam Blair Yanke, Rush
    4 Basic Research
    James J. Irrgang, Pitt

    PART II: PRE-CLINICAL
    5 Overview of preclinical research
    Hollis G. Potter, Hospital for Special Surgery
    6 What Problem Are You Solving?
    Kurt P. Spindler, Cleveland Clinic
    7 Types of Interventions
    Mary Lloyd Ireland, U Kentucky
    8 Drug Discovery
    Mark Miller, UVA
    9 Drug Testing
    Larry S. Bowman, Blue Ridge
    10 Device Discovery and Prototyping
    Robert Burks, U Utah
    11 Device Testing
    Brian D. Busconi, U Mass
    12 Diagnostic Discovery
    Andrew J. Cosgarea, Hopkins
    13 Diagnostic Testing
    Eric McCarty, U Colorado
    14 Other Product Types
    George J. Davies, Georgia Southern U
    15 Procedural Technique Development
    James Bradley, Pitt
    16 Behavioral Intervention
    David R. Diduch, UVA

    PART III: CLINICAL: FUNDAMENTALS
    17 Introduction to Clinical Research: What is it? Why is it Needed?
    Neal S. ElAttrache, Kerlan-Jobe
    18 The Question: Types of Research question and How to Develop Them
    John D. Kelly, U Penn
    19 Study Population: Who and Why Them?
    Michael D. Maloney, U Rochester
    20 Outcome Measurements: What data is being Collected and Why?
    E. Lyle Cain, Jr., Andrews Sports Medicine and Orthopedic Center
    21 Optimizing the Question: Balancing Significance and Feasibility
    Augustus D. Mazzocca, UConn

    PART IV: CLINICAL TRIALS
    22 Common Issues in Analysis
    Alan M. Getgood, U Western Ontario
    23 Basic Statistical Principles
    NiCole Keith, Indiana University
    24 Distributions
    Martha M. Murray, Boston Children’s
    CH25 Hypotheses and Error Types
    Kurt P. Spindler, Cleveland Clinic
    26 Power
    Michael J. Stuart, Mayo
    27 Regression
    Cassandra A. Lee, UC Davis
    28 Continuous Variable Analyses: T-Test, Man Whitney, Wilcoxin Rank
    Edward R. McDevitt, Annapolis Hand Center
    29 Categorical Variable Analyses: Chi-square, Fisher Exact, Mantel Hanzel
    Vishal Mehta, Fox Valley
    30 Analysis of Variance
    L. Bruce Gladden, Auburn University
    31 Correlation
    Keith Kenter, Wester Michigan U
    32 Biases
    Alfred Atanda, Dupont Hospital for Children
    33 Basic Science Statistics
    Oladapo Michael Babatunde, City Orthopedics and Sports Medicine 

    PART V: CLINICAL: STUDY TYPES
    34 Design Principles: Hierarchy of Study Types
    Brandon J. Bryant, Inova
    35 Case Series: Design, Measures, Classic Example
    Bruce Reider, American Orthopedic Society for Sports Medicine
    36 Case-control Study: Design, Measures, Classic Example
    William Kraus, Duke
    37 Cohort Study: Design, Measures, Classic Example
    Charles Bush-Joseph, Rush
    38 Cross-section Study: Design, Measures, Classic Example
    Katherine J. Coyner, UConn
    39 Longitudinal Study: Design, Measures, Classic Example
    Robert A. Arciero, UConn
    40 Clinical Trials: Design, Measures, Classic Example
    Kathryn Schmitz, Penn State
    41 Meta-analysis: Design, Measures, Classic Example
    Grant L. Jones, Ohio State
    42 Cost-effectiveness Study: Design, Measures, Classic Example
    Elizabeth A. Arendt, U Minnesota
    43 Diagnostic Test Evaluation: Design, Measures, Classic Example
    Michael T. Freehill, Stanford
    44 Reliability Study: Design, Measures, Classic Example
    Anastasia Fischer, Ohio State University
    45 Database Studies: Design, Measures, Classic Example
    Ashley Bee Anderson, Walter Reed
    46 Surveys and Questionnaires: Design, Measures, Classic Example
    Kevin Vincent, University of Florida
    47 Qualitative Methods and Mixed Methods
    Jo A. Hannafin, Hospital for Special Surgery

    PART VI: CLINICAL: TRIALS
    48 Randomized Control: Design, Measures, Classic Example
    Karin Allor Pfeiffer, Michigan Sate
    49 Nonrandomized Control: Design, Measures, Classic Example
    Champ L. Baker, Hughston Clinic
    50 Historical Control: Design, Measures, Classic Example
    Edward M. Wojtys, UMich
    51 Cross-over: Design, Measures, Classic Example
    Mindy Millard-Stafford, Georgia Institute of Technology
    52 Withdrawal Studies: Design, Measures, Classic Example
    Asheesh Bedi, U Mich
    53 Factorial Design: Design, Measures, Classic Example
    Olivia Affuso, University of Alabama
    54 Group Allocation: Design, Measures, Classic Example
    Michael Baria, Ohio State
    55 Hybrid Design: Design, Measures, Classic Example
    Aman Dhawan, Penn State
    56 Large, Pragmatic: Design, Measures, Classic Example
    Robert H. Brophy, Wash U
    57 Equivalence and Noninferiority: Design, Measures, Classic Example
    Brandon J. Erickson, Rothman
    58 Adaptive: Design, Measures, Classic Example
    Jorge Chahla, Rush
    59 Randomization: Fixed or Adaptive Procedures
    Jonathan David Gelber, Conn Children’s
    CH60 Blinding: Who and How?
    Randhir Mascarenhas, U Texas
    61 Multicenter Consideration
    Timothy Lee Miller, Ohio State
    62 Registries
    Jonathan F. Dickens, Walter Reed
    63 Phases of Clinical Trials
    Marcas Bamman, University of Alabama
    64 IDEAL Framework
    Theodore B. Shybut, Baylor
    65 Artificial Intelligence
    Austin V. Stone, U Kentucky
    66 Patient Perspectives
    Robert W. Westermann, U Iowa 

    VII. CLINICAL PREPARATION
    67 Sample Size
    Stephen F. Brockmeier, UVA
    68 Budgeting
    Brandon J. Erickson, Rothman
    69 Ethics and Review Boards
    Geoffrey Scott Baer, U Wisc
    70 Regulatory Considerations for New Drugs and Devices
    Molly Conroy, University of Utah
    71 Funding Approaches
    Kelly Evenson, University of North Carolina
    72 Subject Recruitment
    Michael B. Banffy, Kerlan-Jobe
    73 Data Management
    Rachel M. Frank, U Colorado
    74 Quality Control
    Michael Christopher Ciccotti, Northwestern
    75 Statistical Software
    Thomas M. DeBerardino, San Antonio Ortho
    76 Report Forms: Harm and Quality of Life
    Margo Mountjoy, McMaster University
    77 Subject Adherence
    Jorunn Sundgot-Borgen, Norwegian School of Sport Sciences
    78 Survival Analysis
    Scott Paluska, University of Illinois
    79 Monitoring Committee in Clinical Trials
    Kevin B. Freedman, Rothman

    VIII. REGULATORY BASICS
    80 FDA Overview
    Brian Forsythe, Rush
    81 IND
    Thomas Trojian, Drexel
    82 New Drug Application
    Jan Fronek, Scripps
    83 Devices
    Thomas J. Kremen, UCLA
    84 Radiation-emitting Electronic Products
    Drew A. Lansdown, UCSF
    85 Orphan Drugs
    Sommer Hammoud, Rothman
    86 Biologics
    Thay Q. Lee, Congress Medical Associates
    87 Combination Products
    Brian C. Lau, Duke
    88 Foods
    Albert Lin, Pitt
    89 Cosmetics
    Matthew J. Matava, Wash U
    90 CMC and GxP
    Craig S. Mauro, Pitt
    91 Non-US Regulatory
    Chunbong Benjamin Ma, UCSF
    92 Post-Market Drug Safety Monitoring
    Timothy Lee Miller, Ohio State
    93 Post-Market Device Safety Monitoring
    Bradley J. Nelson, Tria

    IX. CLINICAL IMPLEMENTATION
    94 Implementation Research
    Richard Ma, U Missouri
    95 Design and Analysis
    Eric C. Makhni, Henry Ford Hospital
    96 Mixed-methods Research
    Ollie Jay, University of Sydney
    97 Population and Setting Specific Implementation
    Ashish M. Rawal, Ortho Team Clinic

    X. PUBLIC HEALTH
    98 Public Health
    Mary K. Mulcahey, Tulane
    99 Edpidemiology
    Jeffrey J. Nepple, Wash U
    100 Factors
    Barry Braun, Colorado State
    101 Good Questions
    Luke S. Oh, MGH
    102 Population and Environmental Specific Considerations
    Jorge Franchella, University of Buenos Aires
    103 Law, Policy, and Ethics
    Robert L. Parisien, Pennsylvania Hospital
    104 Healthcare Institutions and Systems
    Rebecca Hasson, University of Michigan
    105 Public Health Institutions and Systems
    Mark W. Rodosky, Pitt

    APPENDIX
    106 Presenting Data
    Heather Hays Betz, Albion College
    107 Manuscript Preparation
    Andrew J. Sheean, San Antonio Military Medical Center
    108 Building a Team
    Lanay Mudd, National Institutes of Health
    109 Patent Basics
    Karen Michelle Sutton, Hospital for Special Surgery
    110 Venture Pathways
    Jonathan C. Riboh, Duke
    111 SBIR/STTR
    Brian Robert Waterman, Wake Forest
    112 Sample Forms and Templates
    Brian C. Werner, UVA

Product details

  • No. of pages: 700
  • Language: English
  • Copyright: © Academic Press 2023
  • Published: August 1, 2023
  • Imprint: Academic Press
  • Paperback ISBN: 9780323912594

About the 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

Steve DeFroda

Steven DeFroda currently works as a sports medicine fellow at Rush University Medical Center. Steven does research in Orthopedic Surgery, with specific interest in athletic injuries of the knee, shoulder, and elbow. Specific interests include clinical and functional outcomes, biomechanics, and patient quality of life.

Affiliations and Expertise

Sports Medicine Fellow, Rush University Medical Center, Columbia, MO, USA

Brett Owens

Dr. Owens is a fellowship-trained, board certified orthopedic sports medicine surgeon, specializing in arthroscopic repair of sports-related injuries as well as complex knee and shoulder reconstructions. He is Chief of Sports Medicine at the Miriam Hospital in Providence, RI and Director of the Rhode Island Cartilage Repair Center. He is Professor of Orthopaedic Surgery at Brown University Alpert Medical School. He is currently a Team Physician for Brown University and the Providence Bruins. He serves as a consultant for URI Athletics. Dr. Owens was named by fellow orthopedists in Orthopedics This Week as one of the “Top 28 North American Knee Surgeons.” He has published over 200 articles in peer-reviewed medical journals, given over 200 national or international presentations, co-edited three textbooks on orthopedic injuries, and serves as Associate Editor for the American Journal of Sports Medicine. His research has garnered awards from the American Orthopedic Society for Sports Medicine.

Affiliations and Expertise

Chief of Sports Medicine at the Miriam Hospital in Providence, RI; Director of the Rhode Island Cartilage Repair Center; Professor of Orthopaedic Surgery at Brown University Alpert Medical School; Team Physician for Brown University and the Providence Bruins

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