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; de Andrade, Joel; Franke, Cristiano Augusto; Guterres, Cátia Moreira; Madalena, Itiana Cardoso; Rohden, Adriane Isabel; da 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

doi:10.1186/s13063-020-04457-1

Trials

Table 1 Baseline characteristics of study participants

From: 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)

	Intervention arm	Control arm
ICU characteristics
Number of hospital beds, central tendency (dispersion), n	xx.x (xx.x)	xx.x (xx.x)
Number of ICU beds, central tendency (dispersion), n	xx.x (xx.x)	xx.x (xx.x)
Number of ICU beds/hospital beds, central tendency (dispersion), n	xx.x (xx.x)	xx.x (xx.x)
Type of ICU
Surgical, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Medical, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Mixed, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Hospital type
Public, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Private, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Teaching activity, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Transplant centre, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Number of brain death notifications per year,^a central tendency (dispersion), [n]	xx.x (xx.x)	xx.x (xx.x)
Participant characteristics
Age in years, central tendency (dispersion), [n]	xx.x (xx.x)	xx.x (xx.x)
Age > 60 years, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Female sex, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Male sex, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
SAPS 3 score at ICU admission, central tendency (dispersion), [n]	xx.x (xx.x)	xx.x (xx.x)
Comorbidities
Diabetes mellitus, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Hypertension, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Dialytic renal failure, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Chronic respiratory disease, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Heart failure, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Chronic liver disease, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Cause of brain injury
Trauma, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Stroke, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Anoxia, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Other, n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
SOFA score at enrolment, central tendency (dispersion), [n]	xx.x (xx.x)	xx.x (xx.x)
Use of antimicrobial medication,^b n/total (%)	xx/xx (xx.x)	xx/xx (xx.x)
Length of hospital stay in days before brain death diagnosis, central tendency (dispersion), [n]	xx.x (xx.x)	xx.x (xx.x)

SAPS Simplified Acute Physiology Score, SOFA Sequential Organ Failure Assessment
Chronic liver disease is defined as biopsy-proven cirrhosis or proven portal hypertension or previous history of hepatic insufficiency, encephalopathy, or coma. Chronic respiratory disease is defined as restrictive, obstructive, or vascular disease severe enough to limit performance of the activities of daily living or chronic hypoxia, hypercapnia, polycythaemia, pulmonary hypertension, or ventilator dependence
^a Number of brain death notifications per year considers the percentage of brain-dead potential organ donors clinically managed in the intensive care unit
^bIdentified at the time of first clinical examination

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ISSN: 1745-6215

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