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. 2017 Sep 5;7(3 Suppl):116S–137S. doi: 10.1177/2192568217706366

Table 1.

Inclusion and Exclusion Criteria.

Study Component Inclusion Exclusion
Participants
  • Adults with traumatic acute spinal cord injury (complete or incomplete)

  • Pediatric patients <13 years old

  • Pregnancy

  • Penetrating injuries to spinal cord

  • Cord compression due to tumor, hematoma or degenerative disease (eg, CSM)

  • Patients without neurological deficit following trauma

Intervention
  • MPSS

Comparators
  • Placebo

  • Standard care without pharmacologic intervention

Outcomes Efficacy/effectiveness
  • Change in motor scores

  • Change in sensation (light touch, pinprick)

Safety
  • Complications, adverse events

  • Death

  • Nonclinical outcomes

Study design
  • KQs 1, 2, 3: Comparative studies (RCTs and observational studies with concurrent controls)

  • Follow-up rate of at least 50%

  • n ≥ 10 per group

  • Observational comparative studies must control for severity of spinal cord injury as evaluated by motor status at baseline and/or complete or incomplete injury

  • KQ 3: Subgroup analyses from comparative studies

  • Animal studies

  • Nonclinical studies

  • Follow-up rate of at <50%

  • n < 10 per group

  • No control for injury severity

Publication
  • Studies published or translated into English in peer reviewed journals

  • Abstracts, editorials, letters

  • Duplicate publications of the same study that do not report on different outcomes

  • Single reports from multicenter trials

  • White papers

  • Narrative reviews

  • Articles identified as preliminary reports when results are published in later versions

Abbreviations: CSM, cervical spondylotic myelopathy; MPSS, methylprednisolone sodium succinate; KQ, key question; RCT, randomized controlled trial.