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<p>Randomized controlled trials (RCTs) are the gold standard for clinical care. Acute conditions such as traumatic brain injury, intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and spinal cord injury are associated with high morbidity and mortality, yet guidelines are based on limited Class I evidence. This study aimed to examine the design, funding, outcomes, and reporting quality of phase III RCTs in neurosurgical critical care published since 1990. MEDLINE and Cochrane Central were searched for phase III RCTs published since January 1, 1990, with at least one arm in the U.S. and published in selected high-impact journals. Eligible studies included adult patients with common critical care neurosurgical pathologies evaluating interventions with clinically relevant outcomes. Two reviewers independently screened and extracted data with adjudication by a third. Analyses included χ² tests, ANOVA or Kruskal-Wallis tests, and linear regression. Among 586 records screened, 27 phase III RCTs (28,291 patients) met inclusion criteria. Most evaluated medical therapies; only three (11%) assessing surgical interventions. Six trials (22%) demonstrated significant benefit. The modified Rankin Scale or Glasgow Coma Scale were primary endpoints in 74% of studies. Quality-of-life measures were included in 37% but never showed significant improvement. Industry funding (33%) was not associated with positive outcomes (P = .62). Modern CONSORT fulfillment was observed in 22%, improving over time (P = .02). Phase III RCTs in neurosurgical critical care are limited, highlighting the need for greater emphasis on patient-centered outcomes and transparency in future research.</p><p>Clinical trial number: Not applicable.</p>

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Evolution of randomized controlled trials in adult neurosurgical critical care from 1990 to 2024 in the United States

  • 期刊论文

  • 发表日期：

    2026年7月14日

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  • Tristen McGee James,
  • Mohamed-Yahia Monawar,
  • Eric Shaker,
  • Aden P. Haskell-Mendoza,
  • Ariel Gonzalez,
  • Pakawat Chongsathidkiet,
  • Tara Dalton,
  • Caroline C. Folz,
  • Vijay Krishnamoorthy,
  • Anoop Patel,
  • Jordan M. Komisarow

摘要

Randomized controlled trials (RCTs) are the gold standard for clinical care. Acute conditions such as traumatic brain injury, intracerebral hemorrhage, aneurysmal subarachnoid hemorrhage, and spinal cord injury are associated with high morbidity and mortality, yet guidelines are based on limited Class I evidence. This study aimed to examine the design, funding, outcomes, and reporting quality of phase III RCTs in neurosurgical critical care published since 1990. MEDLINE and Cochrane Central were searched for phase III RCTs published since January 1, 1990, with at least one arm in the U.S. and published in selected high-impact journals. Eligible studies included adult patients with common critical care neurosurgical pathologies evaluating interventions with clinically relevant outcomes. Two reviewers independently screened and extracted data with adjudication by a third. Analyses included χ² tests, ANOVA or Kruskal-Wallis tests, and linear regression. Among 586 records screened, 27 phase III RCTs (28,291 patients) met inclusion criteria. Most evaluated medical therapies; only three (11%) assessing surgical interventions. Six trials (22%) demonstrated significant benefit. The modified Rankin Scale or Glasgow Coma Scale were primary endpoints in 74% of studies. Quality-of-life measures were included in 37% but never showed significant improvement. Industry funding (33%) was not associated with positive outcomes (P = .62). Modern CONSORT fulfillment was observed in 22%, improving over time (P = .02). Phase III RCTs in neurosurgical critical care are limited, highlighting the need for greater emphasis on patient-centered outcomes and transparency in future research.

Clinical trial number: Not applicable.