title: A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan.
abstract: BACKGROUND
  The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality.
  
  
  OBJECTIVE
  To describe our trial statistical analysis plan (SAP).
  
  
  METHODS
  This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ.
  
  
  RESULTS
  Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data.
  
  
  CONCLUSIONS
  We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil. ldamiani@hcor.com.br.
authors.forename: Lucas P
authors.initials: LP
authors.lastname: Damiani
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil.
authors.forename: Alexandre B
authors.initials: AB
authors.lastname: Cavalcanti
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil.
authors.forename: Frederico R
authors.initials: FR
authors.lastname: Moreira
authors.affiliation: Hospital Universitário, Universidade Federal de São Paulo, São Paulo, Brazil.
authors.forename: Flavia
authors.initials: F
authors.lastname: Machado
authors.affiliation: D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
authors.forename: Fernando A
authors.initials: FA
authors.lastname: Bozza
authors.affiliation: D'Or Institute for Research and Education, Rio de Janeiro, Brazil.
authors.forename: Jorge I F
authors.initials: JI
authors.lastname: Salluh
authors.affiliation: Hospital Samaritano, São Paulo, Brazil.
authors.forename: Valquiria P
authors.initials: VP
authors.lastname: Campagnucci
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil.
authors.forename: Karina
authors.initials: K
authors.lastname: Normilio-Silva
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil.
authors.forename: Viviane C
authors.initials: VC
authors.lastname: Chiattone
authors.affiliation: Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, United States.
authors.forename: Derek C
authors.initials: DC
authors.lastname: Angus
authors.affiliation: Research Institute, Hospital do Coração, São Paulo, Brazil.
authors.forename: Otavio
authors.initials: O
authors.lastname: Berwanger
authors.affiliation: Division of General Internal Medicine, University of Pittsburgh School of Medicine, Pittsburgh, United States.
authors.forename: Chung-
authors.initials: C
authors.lastname: Chou H Chang
mesh_terms: D000328:Adult; D015982:Bias; D001938:Brazil; D057189:Checklist; D016000:Cluster Analysis; D003422:Critical Care; D003627:Data Interpretation, Statistical; D006801:Humans; D017063:Outcome Assessment, Health Care; D058996:Quality Improvement; D012107:Research Design