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The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial.
Velonjara, Julia; Mills, Brianna; Lujan, Silvia; Petroni, Gustavo; Bell, Michael J; Guadagnoli, Nahuel; Mock, Charles; Hughes, James P; Vavilala, Monica S; Rowhani-Rahbar, Ali.
  • Velonjara J; University of Washington Department of Anesthesiology & Pain Medicine, Seattle, WA, USA. julialv@uw.edu.
  • Mills B; Harborview Injury Prevention & Research Center, Harborview Medical Center, Box 359660, 325 Ninth Avenue, Seattle, WA, 98104, USA. julialv@uw.edu.
  • Lujan S; Harborview Injury Prevention & Research Center, Harborview Medical Center, Box 359660, 325 Ninth Avenue, Seattle, WA, 98104, USA.
  • Petroni G; University of Washington Department of Epidemiology, Seattle, WA, USA.
  • Bell MJ; Centro de Informática e Investigación Clínica (CIIC), Rosario, Argentina.
  • Guadagnoli N; Centro de Informática e Investigación Clínica (CIIC), Rosario, Argentina.
  • Mock C; Pediatrics, Critical Care Medicine, Children's National Hospital, Washington, DC, USA.
  • Hughes JP; Centro de Informática e Investigación Clínica (CIIC), Rosario, Argentina.
  • Vavilala MS; Harborview Injury Prevention & Research Center, Harborview Medical Center, Box 359660, 325 Ninth Avenue, Seattle, WA, 98104, USA.
  • Rowhani-Rahbar A; University of Washington Department of Biostatistics, Seattle, WA, USA.
Trials ; 23(1): 980, 2022 Dec 05.
Article in English | MEDLINE | ID: covidwho-2153657
ABSTRACT

BACKGROUND:

The aim of this protocol is to describe the study protocol changes made and subsequently implemented to the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT) for care of children with severe traumatic brain injuries (TBI) imposed by the COVID-19 pandemic. The PEGASUS study group met in spring 2020 to evaluate available literature review guidance and the study design change or pausing options due to the potential interruption of research.

METHODS:

As a parallel cluster RCT, pediatric patients with severe TBIs are admitted to 8 control (usual care) and 8 intervention (PEGASUS program) hospitals in Argentina, Chile, and Paraguay. PEGASUS is an intervention that aims to increase guideline adherence and best practice care for improving patient outcomes using multi-level implementation science-based approaches. Strengths and weaknesses of proposed options were assessed and resulted in a decision to revert from a stepped wedge to a parallel cluster RCT but to not delay planned implementation.

DISCUSSION:

The parallel cluster design was considered more robust and flexible to secular interruptions and acceptable and feasible to the local study sites in this situation. Due to the early stage of the study, the team had flexibility to redesign and implement a design more compatible with the conditions of the research landscape in 2020 while balancing analytical methods and power, logistical and implementation feasibility, and acceptability. As of fall 2022, the PEGASUS RCT has been active for nearly 2 years of implementation and data collection, scheduled to be completed in in fall 2023. The experience of navigating research during this period will influence decisions about future research design, strategies, and contingencies. TRIAL REGISTRATION Pediatric Guideline Adherence and Outcomes-Argentina. Registered with ClinicalTrials.gov Identifier NCT03896789 on April 1, 2019.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Brain Injuries, Traumatic / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Limits: Child / Humans Country/Region as subject: South America / Argentina Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06938-x

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Brain Injuries, Traumatic / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials / Reviews Limits: Child / Humans Country/Region as subject: South America / Argentina Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-022-06938-x