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Journal of critical care · Oct 2022
Hierarchical endpoint analysis using win ratio in critical care: An exploration using the balanced solutions in intensive care study (BaSICS).
- Fernando G Zampieri, Lucas P Damiani, Rodrigo S Biondi, FreitasFlávio G RFGRDepartment of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo, São Paulo, Brazil., Viviane C Veiga, Rodrigo C Figueiredo, Ary Serpa-Neto, Airton L O Manoel, Tamiris A Miranda, Thiago D Corrêa, AzevedoLuciano C PLCPBrazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil; Hospital Sírio Libanês, São Paulo, Brazil., Nilton B Silva, Flavia R Machado, Alexandre B Cavalcanti, and BRICNet.
- HCor Research Institute, São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), São Paulo, Brazil. Electronic address: fzampieri@hcor.com.br.
- J Crit Care. 2022 Oct 1; 71: 154113.
PurposeTo reanalyze the results of the Balanced Solutions in Intensive Care Study (BaSICS) through hierarchical endpoint analysis with win ratio.MethodsAll patients with full data in BaSICS trial were elected for the analysis. BaSICS compared balanced solutions (Plasma Lye 148) versus 0.9% saline in critically ill patients requiring fluid challenge. The win ratio was defined as a hierarchical endpoint of 90-day mortality, recepit of kidney replacement therapy, hospital length-of-stay (LOS), and intensive care unit (ICU) LOS. Both unstratified and stratified (by admission type: planned admission, unplanned admission with sepsis, and unplanned admission without sepsis) approaches were used. A subgroup analysis was performed in patients with traumatic brain injury.ResultsA total of 10,490 patients were included in the analysis, resulting in 27,587,566 unique combinations for unstratified WR. Unstratified Win ratio was 1.02 (95% confidence interval 0.97; 1.07), which was similar to stratified WR. No stratum in the stratified analysis resulted in significant results. Subgroup analysis confirmed the possible harm of balanced solutions in traumatic brain injury patients (WR 0.80; 95% confidence interval 0.64; 0.99).ConclusionIn this reanalysis of BaSICS, a win ratio analysis largely replicated the results of the main trial, yielding neutral results except for the subgroup of patients with traumatic brain injury where a signal of harm was found.Copyright © 2022 Elsevier Inc. All rights reserved.
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