Please use this identifier to cite or link to this item: http://repositorio.ufla.br/jspui/handle/1/57162
Title: Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial
Keywords: Length of stay
Patient care team
Research design
Data interpretation
Statistical
Telemedicine
Hospital mortality
Critical care
Intensive care units
Equipe de atendimento ao paciente
Projeto de pesquisa
Interpretação de dados
Telemedicina
Mortalidade hospitalar
Cuidados intensivos
Issue Date: 2022
Publisher: Associação Brasileira de Medicina Intensiva/ Sociedade Portuguesa de Cuidados Intensivos
Citation: RANZANI, O. et al. Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial. Revista Brasileira de Terapia Intensiva, São Paulo, v. 34, n. 1, Jan./Mar. 2022. DOI: 10.5935/0103-507X.20220003.
Abstract: Objective: The TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE) trial aims to assess whether a complex telemedicine intervention in intensive care units, which focuses on daily multidisciplinary rounds performed by remote intensivists, will reduce intensive care unit length of stay compared to usual care. Methods: The TELESCOPE trial is a national, multicenter, controlled, open label, cluster randomized trial. The study tests the effectiveness of daily multidisciplinary rounds conducted by an intensivist through telemedicine in Brazilian intensive care units. The protocol was approved by the local Research Ethics Committee of the coordinating study center and by the local Research Ethics Committee from each of the 30 intensive care units, following Brazilian legislation. The trial is registered with ClinicalTrials. gov (NCT03920501). The primary outcome is intensive care unit length of ABSTRACT stay, which will be analyzed accounting for the baseline period and cluster structure of the data and adjusted by prespecified covariates. Secondary exploratory outcomes included intensive care unit performance classification, in-hospital mortality, incidence of nosocomial infections, ventilator-free days at 28 days, rate of patients receiving oral or enteral feeding, rate of patients under light sedation or alert and calm, and rate of patients under normoxemia. Conclusion: According to the trial’s best practice, we report our statistical analysis prior to locking the database and beginning analyses. We anticipate that this reporting practice will prevent analysis bias and improve the interpretation of the reported results.
URI: http://repositorio.ufla.br/jspui/handle/1/57162
Appears in Collections:DMV - Artigos publicados em periódicos

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