04550nam a22005895i 4500 978-3-031-77563-5 DE-He213 20251030114947.0 cr nn 008mamaa 250226s2024 sz | s |||| 0|eng d 9783031775635 978-3-031-77563-5 10.1007/978-3-031-77563-5 doi RD701-811 MNS bicssc MED065000 bisacsh MNS thema Introduction to Surgical Trials [electronic resource] / edited by Stephen Lyman, Olufemi R. Ayeni, Jason L. Koh, Norimasa Nakamura, Jón Karlsson. 1st ed. 2024. Cham : Springer Nature Switzerland : Imprint: Springer, 2024. X, 215 p. 21 illus., 13 illus. in color. online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier text file PDF rda 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. Filling a gap in literature, this book examines surgical trials with a special focus on the underlying principles, challenges, and best practices to successfully conduct rigorous surgical research. 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. Orthopedics. 70127 Epidemiology. 65983 Surgery. 72080 Bioinformatics. 64050 Orthopaedics. 70129 Epidemiology. 65983 Surgery. 72080 Bioinformatics. 64050 Lyman, Stephen. editor. edt http://id.loc.gov/vocabulary/relators/edt 90945 Ayeni, Olufemi R. editor. edt http://id.loc.gov/vocabulary/relators/edt 90946 Koh, Jason L. editor. edt http://id.loc.gov/vocabulary/relators/edt 90947 Nakamura, Norimasa. editor. edt http://id.loc.gov/vocabulary/relators/edt 90948 Karlsson, Jón. editor. edt http://id.loc.gov/vocabulary/relators/edt 90949 SpringerLink (Online service) Springer Nature eBook Printed edition: 9783031775628 Printed edition: 9783031775642 Printed edition: 9783031923043 https://doi.org/10.1007/978-3-031-77563-5 ZDB-2-SME ZDB-2-SXM 66785 66785