| Author | Giordani, Natalia Elis | |
| Author | Robinson, Caroline Cabral | |
| Author | Westphal, Glauco Adrieno | |
| Author | Rosa, Regis Goulart | |
| Author | Sganzerla, Daniel | |
| Author | Cavalcanti, Alexandre Biasi | |
| Author | Machado, Flávia Ribeiro | |
| Author | Azevedo, Luciano Cesar Pontes | |
| Author | Bozza, Fernando A. | |
| Author | Teixeira, Cassiano | |
| Author | Andrade, Joel | |
| Author | Franke, Cristiano Augusto | |
| Author | Guterres, Cátia Moreira | |
| Author | Madalena, Itiana Cardoso | |
| Author | Rohden, Adriane Isabel | |
| Author | Silva, Sabrina Souza | |
| Author | Andrighetto, Luiza Vitelo | |
| Author | Rech, Gabriela Soares | |
| Author | Gimenes, Bruna Dos Passos | |
| Author | Hammes, Luciano Serpa | |
| Author | Pontes, Daniela Ferreira Salomão | |
| Author | Meade, Maureen O. | |
| Author | Falavigna, Maicon | |
| Access date | 2020-07-24T20:59:05Z | |
| Available date | 2020-07-24T20:59:05Z | |
| Document date | 2020 | |
| Citation | 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, Jun. 2020. | pt_BR |
| ISSN | 1745-6215 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/42392 | |
| Language | eng | pt_BR |
| Publisher | BMC | pt_BR |
| Rights | open access | pt_BR |
| 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) | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1186/s13063-020-04457-1 | |
| Abstract | 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. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Gabinete de Projetos de Investigação. Porto Alegre, RS, Brasil / Federal University of Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Gabinete de Projetos de Investigação. Porto Alegre, RS, Brasil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Gabinete de Projetos de Investigação. Porto Alegre, RS, Brasil / Hospital Municipal São José. Joinville, SC, Brasil / Centro Hospitalar Unimed. Joinville, SC, Brasil. | pt_BR |
| Affilliation | HMV. Adult Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Gabinete de Projetos de Investigação. Porto Alegre, RS, Brasil. | pt_BR |
| Affilliation | Heart Hospital. Research Institute. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Federal University of São Paulo. Department of Anaesthesiology, Pain and Intensive Care. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Hospital Sírio-Libanês. Intensive Care Unit. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | 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. | pt_BR |
| Affilliation | Federal University of Health Sciences of Porto Alegre. Department of Internal Medicine and Postgraduate Programme in Rehabilitation Science. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Organ Procurement Organisation of Santa Catarina. Florianópolis, SC, Brazil. | pt_BR |
| Affilliation | Porto Alegre Clinical Hospital. Adult Intensive Care Unit. Porto Alegre, RS, Brazil / Emergency Hospital. Trauma Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | HMV. Office of the Superintendent. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Ministry of Health. General Coordination Office of the National Transplant System. Brasília, DF, Brazil. | pt_BR |
| Affilliation | McMaster University. Department of Medicine and Department of Health Research Methods, Evidence and Impact. Hamilton, Ontario, Canada. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil / Federal University of Rio Grande do Sul. Postgraduate Programme in Epidemiology. Porto Alegre, RS, Brazil. | pt_BR |
| Subject | Checklist | pt_BR |
| Subject | Donor management | pt_BR |
| Subject | Donor management goals | pt_BR |
| Subject | Organ donor | pt_BR |
| Subject | Organ transplantation | pt_BR |
