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- IMMPACT-XXII Slide Presentations
- 1. The history of research on the mechanisms, efficacy, and safety of spinal cord stimulation
- Richard North, MD
- 2. SCS clinical trial objectives and research designs, including comparison groups and testing superiority vs. non-inferiority
- Rod Taylor, PhD
- 3. Sources of bias in RCTs of SCS and their mitigation
- Nathaniel Katz, MD
- 4. Evidence standards for device approval: US regulatory perspectives
- Carlos Peña, PhD (CDRH)
- 5. Evidence standards for device approval: UK regulatory perspectives
- Rahul Singh, MD (MHRA)
- 6. Systematic review of methodologic characteristics and outcomes in RCTs of SCS for pain
- Ewan McNicol, PharmD
- 7. Inclusion/exclusion criteria (e.g., diagnoses, pain severity, pain duration, psychosocial vulnerabilities; treatment history, concomitant analgesics)
- John Markman, MD
- 8. Primary and secondary outcomes (e.g., pain, function, opioid sparing; duration of follow up)
- Ali Rezai, MD
- 9. Adverse events: assessment and reporting
- Salim Hayek, MD
- 10. Study execution (e.g., controlling non-specific factors; programming standards; sponsor involvement; site and patient training; outcome assessment procedures)
- Simon Thomson, MD
- 11. Data analysis, interpretation, and reporting (e.g., pre-specification, estimands, missing data, multiplicity, clinical meaningfulness; responder definitions; "discerning hype from substance")
- Jennifer Gewandter, PhD
- 12. Economic outcomes and cost-effectiveness analyses
- Brian Kopell, MD
- 13. Special issues in RCTs of SCS, including sham stimulation and programming comparisons
- Sam Eldabe, MD