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The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study
Julia Velonjara1,2, Brianna Mills3,4, Silvia Lujan5
1University of Washington Department of Anesthesiology & Pain Medicine, Seattle, WA, USA. julialv@uw.edu.
Insights
The Pediatric Guideline Adherence and Outcomes (PEGASUS) study adapted its design during COVID-19. This change ensured continued research on severe traumatic brain injuries (TBI) in children, maintaining data collection and implementation.
Area of Science:
- Pediatric critical care research
- Implementation science in clinical trials
- Traumatic brain injury (TBI) management
Background:
- The COVID-19 pandemic necessitated protocol changes for the Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina randomized controlled trial (RCT).
- The PEGASUS study group evaluated literature and guidance to decide on study modifications or pausing research.
- The study focuses on improving care for children with severe traumatic brain injuries (TBI).
Purpose of the Study:
- To describe protocol changes implemented in the PEGASUS Argentina RCT due to the COVID-19 pandemic.
- To adapt the study design while minimizing disruption to research and data collection.
- To ensure the continued feasibility and acceptability of the trial under new global circumstances.
Main Methods:
- The study transitioned from a stepped wedge to a parallel cluster randomized controlled trial (RCT) design.
- Pediatric patients with severe TBI were enrolled in control (usual care) and intervention (PEGASUS program) hospitals.
- Multi-level, implementation science-based approaches were used to enhance guideline adherence and best practices.
Main Results:
- The parallel cluster design was adopted for increased robustness and flexibility against pandemic-related interruptions.
- The revised design was deemed acceptable and feasible by local study sites.
- The study successfully continued implementation and data collection despite the challenging research landscape.
Conclusions:
- The PEGASUS RCT successfully adapted its design to navigate research during the COVID-19 pandemic.
- The flexibility to redesign allowed for a more compatible approach to the 2020 research environment.
- Lessons learned will inform future research design, strategies, and contingency planning for clinical trials.
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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