Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)

Giordani, Natalia Elis; Robinson, Caroline Cabral; Westphal, Glauco Adrieno; Rosa, Regis Goulart; Sganzerla, Daniel; Cavalcanti, Alexandre Biasi; Machado, Flávia Ribeiro; Azevedo, Luciano Cesar Pontes; Bozza, Fernando Augusto; Teixeira, Cassiano; Andrade, Joel; Franke, Cristiano Augusto; Guterres, Cátia Moreira; Madalena, Itiana Cardoso; Rohden, Adriane Isabel; Silva, Sabrina Souza; Andrighetto, Luiza Vitelo; Rech, Gabriela Soares; Gimenes, Bruna Dos Passos; Hammes, Luciano Serpa; Pontes, Daniela Ferreira Salomão; Meade, Maureen O.; Falavigna, Maicon

Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)

Detalhes bibliográficos
Autor(a) principal:	Giordani, Natalia Elis
Data de Publicação:	2020
Outros Autores:	Robinson, Caroline Cabral, Westphal, Glauco Adrieno, Rosa, Regis Goulart, Sganzerla, Daniel, Cavalcanti, Alexandre Biasi, Machado, Flávia Ribeiro, Azevedo, Luciano Cesar Pontes, Bozza, Fernando Augusto, Teixeira, Cassiano, Andrade, Joel, Franke, Cristiano Augusto, Guterres, Cátia Moreira, Madalena, Itiana Cardoso, Rohden, Adriane Isabel, Silva, Sabrina Souza, Andrighetto, Luiza Vitelo, Rech, Gabriela Soares, Gimenes, Bruna Dos Passos, Hammes, Luciano Serpa, Pontes, Daniela Ferreira Salomão, Meade, Maureen O., Falavigna, Maicon
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/42392
Resumo:	Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Universidade Federal do Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil.

Metadados do item

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spelling	Giordani, Natalia ElisRobinson, Caroline CabralWestphal, Glauco AdrienoRosa, Regis GoulartSganzerla, DanielCavalcanti, Alexandre BiasiMachado, Flávia RibeiroAzevedo, Luciano Cesar PontesBozza, Fernando AugustoTeixeira, CassianoAndrade, JoelFranke, Cristiano AugustoGuterres, Cátia MoreiraMadalena, Itiana CardosoRohden, Adriane IsabelSilva, Sabrina SouzaAndrighetto, Luiza ViteloRech, Gabriela SoaresGimenes, Bruna Dos PassosHammes, Luciano SerpaPontes, Daniela Ferreira SalomãoMeade, Maureen O.Falavigna, Maicon2020-07-24T20:59:05Z2020-07-24T20:59:05Z2020GIORDANI, Natalia Elis et al. Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). Trials, v. 21, n. 1, p. 1-8, 2020.1745-6215https://www.arca.fiocruz.br/handle/icict/4239210.1186/s13063-020-04457-1engBMCStatistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Universidade Federal do Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Hospital Municipal São José. Joinville, SC, Brazil / Centro Hospitalar Unimed. Joinville, SC, Brazil.HMV. Adult Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital do Coração. Research Institute. São Paulo, SP, Brazil.Universidade Federal de São Paulo. Department of Anaesthesiology, Pain and Intensive Care. São Paulo, SP, Brazil.Hospital Sírio-Libanês. Intensive Care Unit. São Paulo, SP, Brazil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / D'Or Institute for Research and Education. Department of Critical Care and Postgraduate Programme in Translational Medicine. Rio de Janeiro, RJ, Brazil.Universidade Federal de Ciências da Saúde de Porto Alegre. Department of Internal Medicine and Postgraduate Programme in Rehabilitation Science. Porto Alegre, RS, Brazil.Organ Procurement Organisation of Santa Catarina. Florianópolis, SC, Brazil.Hospital de Clínicas de Porto Alegre. Adult Intensive Care Unit. Porto Alegre, RS, Brazil / Hospital de Pronto de Socorro. Trauma Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.HMV. Office of the Superintendent. Porto Alegre, RS, Brazil.Ministério da Saúde. General Coordination Office of the National Transplant System. Brasília, DF, Brazil.McMaster University. Department of Medicine and Department of Health Research Methods, Evidence and Impact. Hamilton, Ontario, Canada.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Universidade Federal do Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil.Background: The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest. Methods/design: The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial. Discussion: The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.ChecklistDonor managementDonor management goalsOrgan donorOrgan transplantationinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83099https://www.arca.fiocruz.br/bitstream/icict/42392/1/license.txt586c046dcfeef936e32f0323bb9a47c0MD51ORIGINALStatistical_Fernando_Bozza_etal_INI_2020.pdfStatistical_Fernando_Bozza_etal_INI_2020.pdfapplication/pdf569421https://www.arca.fiocruz.br/bitstream/icict/42392/2/Statistical_Fernando_Bozza_etal_INI_2020.pdf2e78120f84364794d4f6944438668bf7MD52TEXTStatistical_Fernando_Bozza_etal_INI_2020.pdf.txtStatistical_Fernando_Bozza_etal_INI_2020.pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
title	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
spellingShingle	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study) Giordani, Natalia Elis Checklist Donor management Donor management goals Organ donor Organ transplantation
title_short	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
title_full	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
title_fullStr	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
title_full_unstemmed	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
title_sort	Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
author	Giordani, Natalia Elis
author_facet	Giordani, Natalia Elis Robinson, Caroline Cabral Westphal, Glauco Adrieno Rosa, Regis Goulart Sganzerla, Daniel Cavalcanti, Alexandre Biasi Machado, Flávia Ribeiro Azevedo, Luciano Cesar Pontes Bozza, Fernando Augusto Teixeira, Cassiano Andrade, Joel Franke, Cristiano Augusto Guterres, Cátia Moreira Madalena, Itiana Cardoso Rohden, Adriane Isabel Silva, Sabrina Souza Andrighetto, Luiza Vitelo Rech, Gabriela Soares Gimenes, Bruna Dos Passos Hammes, Luciano Serpa Pontes, Daniela Ferreira Salomão Meade, Maureen O. Falavigna, Maicon
author_role	author
author2	Robinson, Caroline Cabral Westphal, Glauco Adrieno Rosa, Regis Goulart Sganzerla, Daniel Cavalcanti, Alexandre Biasi Machado, Flávia Ribeiro Azevedo, Luciano Cesar Pontes Bozza, Fernando Augusto Teixeira, Cassiano Andrade, Joel Franke, Cristiano Augusto Guterres, Cátia Moreira Madalena, Itiana Cardoso Rohden, Adriane Isabel Silva, Sabrina Souza Andrighetto, Luiza Vitelo Rech, Gabriela Soares Gimenes, Bruna Dos Passos Hammes, Luciano Serpa Pontes, Daniela Ferreira Salomão Meade, Maureen O. Falavigna, Maicon
author2_role	author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Giordani, Natalia Elis Robinson, Caroline Cabral Westphal, Glauco Adrieno Rosa, Regis Goulart Sganzerla, Daniel Cavalcanti, Alexandre Biasi Machado, Flávia Ribeiro Azevedo, Luciano Cesar Pontes Bozza, Fernando Augusto Teixeira, Cassiano Andrade, Joel Franke, Cristiano Augusto Guterres, Cátia Moreira Madalena, Itiana Cardoso Rohden, Adriane Isabel Silva, Sabrina Souza Andrighetto, Luiza Vitelo Rech, Gabriela Soares Gimenes, Bruna Dos Passos Hammes, Luciano Serpa Pontes, Daniela Ferreira Salomão Meade, Maureen O. Falavigna, Maicon
dc.subject.en.pt_BR.fl_str_mv	Checklist Donor management Donor management goals Organ donor Organ transplantation
topic	Checklist Donor management Donor management goals Organ donor Organ transplantation
description	Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Universidade Federal do Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil.
publishDate	2020
dc.date.accessioned.fl_str_mv	2020-07-24T20:59:05Z
dc.date.available.fl_str_mv	2020-07-24T20:59:05Z
dc.date.issued.fl_str_mv	2020
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	GIORDANI, Natalia Elis et al. Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). Trials, v. 21, n. 1, p. 1-8, 2020.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/42392
dc.identifier.issn.pt_BR.fl_str_mv	1745-6215
dc.identifier.doi.none.fl_str_mv	10.1186/s13063-020-04457-1
identifier_str_mv	GIORDANI, Natalia Elis et al. Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). Trials, v. 21, n. 1, p. 1-8, 2020. 1745-6215 10.1186/s13063-020-04457-1
url	https://www.arca.fiocruz.br/handle/icict/42392
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	BMC
publisher.none.fl_str_mv	BMC
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
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Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)

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