TY - JOUR
T1 - The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury
T2 - study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial
AU - for the PEGASUS Argentina Study Group
AU - Velonjara, Julia
AU - Mills, Brianna
AU - Lujan, Silvia
AU - Petroni, Gustavo
AU - Bell, Michael J.
AU - Guadagnoli, Nahuel
AU - Mock, Charles
AU - Hughes, James P.
AU - Vavilala, Monica S.
AU - Rowhani-Rahbar, Ali
AU - Alassia, Mariela
AU - Abalos, Silvina
AU - Gómez Arriola, Natalia
AU - Castellani, Pablo
AU - Chuchuy, Sandra
AU - Cinquegrani, Karina
AU - Dávila, Carlos
AU - Diettes, Adriana
AU - López Cruz, Gabriela
AU - Mansur, Alejandro
AU - Marinelli, Ivana
AU - Medici, Paula
AU - Oliveri, Silvia
AU - Penazzi, Matías
AU - Romero, Graciela
AU - Segado, Ariel
AU - Depetris, Alejandra
AU - Giordano, Daniel
AU - Boyle, Linda Ng
AU - Moore, Megan
AU - Weiner, Bryan
AU - Segar, Karen
AU - Wang, Jin
AU - Deshpande, Shyam J.
AU - Hicks, Chelsea
AU - Graves, Janessa
N1 - Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - 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.
AB - 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.
KW - COVID-19 pandemic impact
KW - Protocol
KW - Study design changes
KW - TBI
UR - http://www.scopus.com/inward/record.url?scp=85143475350&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85143475350&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06938-x
DO - 10.1186/s13063-022-06938-x
M3 - Article
C2 - 36471399
AN - SCOPUS:85143475350
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 980
ER -