Critical care medicine · 2026
Results of the Pediatric Guideline Adherence and Outcomes (PEGASUS) Program Versus Usual Care Pragmatic Randomized Controlled Trial in Severe Traumatic Brain Injury.
СтатьяРандомизированное исследованиеPragmatic Clinical TrialМногоцентровое исследованиеКлиническое исследование III фазыEquivalence TrialНазвание и аннотация: Перевод в очереди
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Vavilala Monica S, Lujan Silvia, Velonjara Julia, Bell Michael J, Guadagnoli Nahuel, Wang Jin, Mock Charles, Weiner Bryan J, Petroni Gustavo, Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina study group
Аннотация
OBJECTIVES: High-quality approaches to increase evidence-based severe traumatic brain injury (TBI) practice is lacking. We examined whether a facilitated, multilevel program improves TBI guideline adherence in children with severe TBI, including extracranial injury patients. The primary outcome was first 3-day cumulative ICU TBI guideline adherence rate for all and stratified by extracranial injury.
DESIGN: This was an open-label, pragmatic, multicenter, phase 3, superiority, parallel cluster randomized controlled trial. Unadjusted and adjusted percent differences were based on intention-to-treat.
SETTING: Sixteen South American hospitals (14 Argentina, one Chile, and one Paraguay) regularly treating pediatric patients with severe TBI participated.
PATIENTS: Patient inclusion criteria were younger than 18 years, severe TBI (Glasgow Coma Scale [GCS] score ≤ 8 or, if intubated, motor GCS ≤ 5), and ICU admission.
INTERVENTIONS: Sites provided usual care ( n = 8) or the Pediatric Guideline Adherence and Outcomes (PEGASUS) intervention ( n = 8) to participating patients. The PEGASUS intervention included checklists, case reviews, and other components designed to improve adherence to Brain Trauma Foundation pediatric guidelines.
MEASUREMENTS AND MAIN RESULTS: Three hundred eighty-nine patients were enrolled (208 control and 181 intervention). Control patients had less extracranial injury than intervention patients (70.7% vs. 82.9%; p = 0.005). TBI guideline adherence rates were 83.7% for control and 84.4% for intervention arms. There was no overall difference in adjusted first 3-day cumulative guideline adherence rate between arms (0.1% [-3.3% to 3.5%]). Intervention sites achieved higher guideline adherence rates than control sites in patients with isolated severe TBI (7.9% [1.9-13.8%]; p = 0.01).
CONCLUSIONS: Implementing an evidence-based TBI program was not superior to usual care in increasing first 3-day cumulative ICU TBI guideline adherence rates in all children with severe TBI. However, implementation increased adherence rates in children with isolated severe TBI.
DESIGN: This was an open-label, pragmatic, multicenter, phase 3, superiority, parallel cluster randomized controlled trial. Unadjusted and adjusted percent differences were based on intention-to-treat.
SETTING: Sixteen South American hospitals (14 Argentina, one Chile, and one Paraguay) regularly treating pediatric patients with severe TBI participated.
PATIENTS: Patient inclusion criteria were younger than 18 years, severe TBI (Glasgow Coma Scale [GCS] score ≤ 8 or, if intubated, motor GCS ≤ 5), and ICU admission.
INTERVENTIONS: Sites provided usual care ( n = 8) or the Pediatric Guideline Adherence and Outcomes (PEGASUS) intervention ( n = 8) to participating patients. The PEGASUS intervention included checklists, case reviews, and other components designed to improve adherence to Brain Trauma Foundation pediatric guidelines.
MEASUREMENTS AND MAIN RESULTS: Three hundred eighty-nine patients were enrolled (208 control and 181 intervention). Control patients had less extracranial injury than intervention patients (70.7% vs. 82.9%; p = 0.005). TBI guideline adherence rates were 83.7% for control and 84.4% for intervention arms. There was no overall difference in adjusted first 3-day cumulative guideline adherence rate between arms (0.1% [-3.3% to 3.5%]). Intervention sites achieved higher guideline adherence rates than control sites in patients with isolated severe TBI (7.9% [1.9-13.8%]; p = 0.01).
CONCLUSIONS: Implementing an evidence-based TBI program was not superior to usual care in increasing first 3-day cumulative ICU TBI guideline adherence rates in all children with severe TBI. However, implementation increased adherence rates in children with isolated severe TBI.