Introduction to Surgical Trials
Description
While randomized controlled trials (RCTs) remain the gold standard for evaluation of the safety and efficacy of most medical interventions, they are particularly difficult to implement successfully in the context of surgery. As a result, recruitment rates are often extremely low, crossover from non-operative to operative is common, and patients randomly allocated to surgery often simply decline to have the procedure. All of these challenges call into question the recent generalizability and fundamental quality of traditional surgical RCTs.
As such, this book explores advanced alternative trial design methods and describes the current regulatory environment around the world. Designed as a practical guide, it is a valuable tool for surgeons, epidemiologist and biostatisticians involved in this challenging field.
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Persons
Stephen Lyman has been an orthopedic sports medicine and arthroplasty researcher since 1996. He holds faculty appointments at Weill Cornell Medical College in Manhattan and Kyushu University School of Medicine in Fukuoka, Japan. His research interests focus primarily on two disparate areas: evaluation of challenges in access and quality in the musculoskeletal healthcare market and development and evaluation of patient outcomes after orthopedic surgery.
Olufemi R. Ayeni is an Associate Professor in the Orthopedic Surgery Division and Director for the Sports Medicine and Arthroscopy Fellowship at McMaster University, and is the Medical Director of the Canadian Football League team Hamilton Tiger Cats. His clinical focus is non-arthritic and athletic injuries of the hip, knee and shoulder. He has published over 230 academic, peer-reviewed articles and numerous book chapters. He acts as a reviewer or is an editorial board member of several orthopedic journals.
Dr. Jason Koh is the Mark R. Neaman Family Chair of Orthopedic Surgery; Director of the Orthopedic & Spine Institute Specialty Hospital at North Shore University Health System, Illinois, and Clinical Professor at the University of Chicago Pritzker School of Medicine. He is an internationally recognized expert in knee, shoulder, and sports medicine, and has served as team physician for the Chicago Cubs, the major league soccer team Chicago Fire, and the Joffrey Ballet.
Norimasa Nakamura is Professor of the Institute for Medical Science in Sports at Osaka Health Science University and the Global Center for the Medical Engineering and Informatics at Osaka University. He is an orthopedic surgeon at the Osaka University Hospital, specializing in arthroscopic surgery and sports medicine. His research has been focused on joint tissue repair with main focus on the regeneration of cartilage, ligament, and meniscus. He has published over 150 peer reviewed scientific papers.
Jón Karlsson is a Professor of Orthopedic Surgery at the University of Gothenburg and Senior Consultant at the Sahlgrenska University Hospital. He has published more than 400 scientific papers and over 100 book chapters, and involved as author/co-editor in 40 books. He is currently Secretary of the ISAKOS Board of Directors and Editor-in-Chief of KSSTA (Knee Surgery Sports Traumatology Arthroscopy).
Content
SECTION A: Trial Design.- Why Do We Need Surgical Trials? .- Addressing the Challenges to Surgical Randomization.- Randomization Strategies.- Surgical Trial Design: Interventions & Blinding.- Sample Size and Power Considerations for Surgical Trials.- Optimizing Recruitment in Randomized Controlled Trials.- Treatment Allocation.- Crossover and early failure in surgical trials.- Strategies to Optimize Follow-up in Surgical Trials.- Considerations in Choosing Outcomes Measures.- Length of Follow-Up.- SECTION B: Conducting a Trial.- Ethics considerations and approval in human research and in orthopaedics.- Trial Start Up Considerations: Budget, Staffing, Logistics.- Adverse Events Reporting & Data and Safety MonitoringTrial Closeout.- SECTION C: Trial Completion.- Missing Data & Imputation.- Statistical Analysis for Surgical Trials.- CONSORT Reporting Standards.- SECTION D: Regulatory Standards.- The Regulatory Pathway to Market Class III Surgical Medical Devices in the United States.- European Standards.- Regulatory Standards for Surgical Trials in Asia: the Japanese Experience.- SECTION E: Alternatives to the Classic RCT.- Pragmatic TrialsPlatform Trials.- Prospecitve Cohort StudiesSurgical Registries.- The Future of Trials.