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.

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• Ortopedia e fracturas
• Epidemiologia e estatística médica
• Biologia, ciências da vida
• Modelagem computacional e simulação

surgical outcome;research outcome;randomized controlled trials;clinical epidemiology;research methods;Pragmatic Trials;Platform Trials;Prospective Cohort Studies