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Participants
Agenda
Background Materials
  • 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)
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  • 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
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  • 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