Clinical measurement, statistical analysis, and risk-benefit: controversies from trials of spinal injury

J Trauma. 2000 Mar;48(3):558-61. doi: 10.1097/00005373-200003000-00036.

Abstract

Background: The National Acute Spinal Cord Injury Studies have been a series of trials assessing the role of pharmacologic agents in the prevention of secondary neuronal damage after acute spinal cord injury.

Methods: The trials were multicenter randomized, controlled studies.

Results: Two trials have demonstrated the efficacy of high-dose methylprednisolone in improving neurologic and functional recovery and have shown a reassuring safety profile.

Conclusion: This study responds to a recent commentary on these trials and examines in particular the roles of clinical measurement, statistical analysis, and risk benefit in assembling evidence for or against innovative therapies.

Publication types

  • Comment

MeSH terms

  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Data Interpretation, Statistical
  • Dose-Response Relationship, Drug
  • Evidence-Based Medicine
  • Humans
  • Methylprednisolone / adverse effects
  • Methylprednisolone / therapeutic use*
  • Neurologic Examination / drug effects
  • Randomized Controlled Trials as Topic
  • Risk Assessment
  • Spinal Cord Injuries / drug therapy*
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents
  • Methylprednisolone