This book is designed to meet the needs of both novice and senior researchers in Orthopaedics by providing the essential, clinically relevant knowledge on research methodology that is sometimes overlooked during training. Readers will find a wealth of easy-to-understand information on all relevant aspects, from protocol design, the fundamentals of statistics, and the use of computer-based tools through to the performance of clinical studies with different levels of evidence, multicenter studies, systematic reviews, meta-analyses, and economic health care studies. A key feature is a series of typical case examples that will facilitate use of the volume as a handbook for most common research approaches and study types. Younger researchers will also appreciate the guidance on preparation of abstracts, poster and paper presentations, grant applications, and publications. The authors are internationally renowned orthopaedic surgeons with extensive research experience and the book is published in collaboration with ISAKOS.
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Part I Evidence Based Medicine in Orthopaedics |
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1 What Is Evidence-Based Medicine? |
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3 | (8) |
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2 What Is the Hierarchy of Clinical Evidence? |
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11 | (12) |
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23 | (10) |
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4 Ethical Consideration in Orthopedic Research |
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33 | (10) |
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43 | (6) |
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6 Ethics in Clinical Research |
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49 | (8) |
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Part II How to Get Started with Clinical Research? |
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7 How to Get Started: From Idea to Research Question |
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57 | (8) |
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8 How to Write a Study Protocol |
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65 | (10) |
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9 The Ethical Approval Process |
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75 | (8) |
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10 How to Assess Patient's Outcome? |
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83 | (6) |
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11 Basics of Outcome Assessment in Clinical Research |
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89 | (8) |
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12 Types of Scoring Instruments Available |
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97 | (14) |
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13 Health Measurement Development and Interpretation |
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111 | (10) |
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14 How to Document a Clinical Study and Avoid Common Mistakes in Study Conduct? |
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121 | (12) |
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15 Framework for Selecting Clinical Outcomes for Clinical Trials |
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133 | (10) |
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16 Advances in Measuring Patient-Reported Outcomes: Use of Item Response Theory and Computer Adaptive Tests |
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143 | (10) |
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Part III Basics in Statistics: Statistics Made Simple! |
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17 Common Statistical Tests |
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153 | (10) |
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163 | (8) |
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19 Does No Difference Really Mean No Difference? |
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171 | (14) |
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Marcio Bottene Villa Albers |
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185 | (8) |
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193 | (16) |
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Part IV Basic Toolbox for the Young Clinical Researcher |
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22 How to Prepare an Abstract |
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209 | (10) |
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23 How to Make a Good Poster Presentation |
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219 | (8) |
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24 How to Prepare a Paper Presentation? |
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227 | (8) |
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25 How to Write a Clinical Paper |
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235 | (8) |
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26 How to Write a Book Chapter |
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243 | (6) |
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27 How to Write a Winning Clinical Research Proposal? |
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249 | (6) |
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28 How to Review a Clinical Research Paper? |
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255 | (10) |
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Part V How to Perform a Clinical Study: A Case Based Approach |
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29 Level 1 Evidence: A Prospective Randomized Controlled Study |
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265 | (20) |
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30 Level 1 Evidence: Long-Term Clinical Results |
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285 | (4) |
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31 Level 2 Evidence: Prospective Cohort Study |
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289 | (6) |
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32 Level III Evidence: A Case-Control Study |
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295 | (6) |
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33 Level 4 Evidence: Clinical Case Series |
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301 | (6) |
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34 How to Perform a Clinical Study: Level 4 Evidence---Case Report |
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307 | (6) |
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313 | (10) |
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Part VI How to Perform a Review Article? |
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36 Type of Review and How to Get Started |
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323 | (8) |
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Part VII How to Perform a Systematic Review or Meta-analysis? |
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37 What Is the Difference Between a Systematic Review and a Meta-analysis? |
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331 | (12) |
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38 Reliability Studies and Surveys |
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343 | (16) |
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359 | (14) |
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Part VIII How to Perform an Economic Health Care Study? |
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40 How to Perform an Economic Healthcare Study |
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373 | (10) |
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Part IX Multi-Center Study: How to Pull It Off? |
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41 Conducting Multicenter Cohort Studies: Lessons from MOON |
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383 | (8) |
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42 MARS: The Why and How of It |
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391 | (12) |
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43 Multicenter Study: How to Pull It Off? The PIVOT Trial |
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403 | (12) |
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44 Conducting a Multicenter Trial: Learning from the JUPITER (Justifying Patellar Instability Treatment by Early Results) Experience |
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415 | (12) |
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45 How to Organise an International Register in Compliance with the European GDPR: Walking in the Footsteps of the PAMI Project (Paediatric ACL Monitoring Initiative) |
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427 | (10) |
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Part X Helpful Further Information |
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46 Common Scales and Checklists in Sports Medicine Research |
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437 | (34) |
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47 A Practical Guide to Writing (and Understanding) a Scientific Paper: Meta-Analyses |
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471 | (28) |
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48 A Practical Guide to Writing (and Understanding) a Scientific Paper: Clinical Studies |
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499 | (8) |
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49 Reporting Complications in Orthopaedic Trials |
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507 | (8) |
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50 Understanding and Addressing Regulatory Concerns in Research |
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515 | (18) |
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51 What Is Needed to Make Collaboration Work? |
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533 | (4) |
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52 A Clinical Practice Guideline |
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537 | (14) |
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53 How to Navigate a Scientific Meeting and Make It Worthwhile? A Guide for Young Orthopedic Surgeons |
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551 | (10) |
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54 How to Write a Scientific Article |
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561 | (18) |
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55 Common Mistakes in Manuscript Writing and How to Avoid Them |
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579 | |
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Volker Musahl, MD, is Associate Professor of Orthopaedic Surgery at the University of Pittsburgh School of Medicine, Associate Professor of Bioengineering at the University of Pittsburgh's Swanson School of Engineering, Program Director of the Sports Medicine fellowship program, and Medical Director of the UPMC Center for Sports Medicine. Dr. Musahl has received various honors and awards and in 2015 was appointed Assistant Editor-in-Chief of Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA). His research interests include knee and shoulder biomechanics.
Jon Karlsson, MD, PhD, is Professor of Orthopaedics and Sports Traumatology at Sahlgrenska Academy, Gothenburg University, Sweden, where he is a Senior Consultant and Academic Head of the Orthopaedic Department. He is the editor or author of more than 300 papers and 30 textbooks in Orthopaedics and Sports Traumatology. He has held important positions in both ESSKA and ISAKOS and is currently Editor-in-Chief of Knee Surgery, Sports Traumatology, Arthroscopy (KSSTA).
Michael T. Hirschmann, MD, is Leading Consultant in Head and Knee Surgery, Department of Orthopaedic Surgery and Traumatology, Kantonsspital Baselland, Switzerland. He was awarded his Habilitation venia docendi from the University of Basel in 2012. Dr. Hirschmann is a member of the Executive Committee of the Gesellschaft für Arthroskopie und Gelenkchirurgie and Secretary General of European Knee Associates. He is a member of the editorial boards of various journals, including KSSTA and World Journal of Orthopedics.
Olufemi R. Ayeni, MD, MSc, FRCSC, is Associate Professor in the Department of Surgery, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada. He is also Director of MacSports, Division of Orthopaedic Surgery, McMaster University. Dr. Ayeni is an ISAKOS Scientific Committee Member. He acts as a reviewer for a number of leading journals in Orthopaedics and Sports Medicine and is lead or co-author of over 150 peer-reviewed journal articles.
Robert G. Marx, MS, MSc, is Attending Orthopaedic Surgeon at the Hospital for Special Surgery, Weill Cornell Medical College, New York, where he is Professor of Orthopaedic Surgery and Professor of Public Health. He is also Director of the Foster Center for Clinical Outcome Research, Hospital for Special Surgery. He is a former member of the Board of Directors of ISAKOS and has served as Chair of the ISAKOS Scientific Advisory Committee. Dr. Marx is the author of four books and 210 peer-reviewed articles.
Jason Lee Koh, MD, MBA, is Chairman of the Department of Orthopaedic Surgery and Clinical Director of the Orthopaedic Institute at NorthShore University HealthSystem, Chicago. He is also Clinical Professor of Surgery at University of Chicago Pritzker School of Medicine. In 2012 he received the prestigious Charles Neer Award from the American Shoulder and Elbow Society. Dr. Koh has sat on numerous committees and is a member of the Board of Councilors of the American Academy of Orthopaedic Surgery.
Norimasa Nakamura, MD, PhD, is an orthopaedic surgeon and Professor at the Institute for Medical Science in Sports, Osaka Health Science University, Osaka City, Japan. Dr. Nakamura is a Fellow of the Royal College of Surgeons (FRCS) (England). He is President of the International Cartilage Repair Society (ICRS) and a former chair of the Scientific Committee of ISAKOS. He is a member of the editorial boards of various leading journals in the field of Orthopaedics and author of more than 120 peer-reviewed papers.