Introduction to Surgical Trials

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.

• Erscheinungsdatum: 25.02.2025
• Autor/Autorin: Stephen Lyman
• Reihe: Medicine (R0)
• Format: E-Book
• Dateiformat: PDF
• Kopierschutz: Wasserzeichen
• Dateigröße: 12 MB
• Verlag: SPRINGER
• Sprache: Englisch
• Umfang: 260 Seiten
• ISBN: 9783031775635
• Lieferung: Sofort per Download
• Hinweis: Sofort per Download lieferbar. Kein physischer Versand.
• Kompatibilität: Lesbar auf Geräten und Apps mit PDF-Unterstützung.