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)

Table 2 Primary and secondary study outcomes

Outcomes	Intervention arm	Control arm	Type of effect estimate	Effect estimate (CI)	P value^a
Primary
Potential organ donors lost due to cardiac arrest, n/total (%)^b	x/x (xx.x)	x/x (xx.x)	HR	x.xx (x.xx-x.xx)^c	x.xx
Secondary
Actual organ donors, n/total (%)	x/x (xx.x)	x/x (xx.x)	RR RD	x.xx (x.xx-x.xx)^d x.xx (x.xx-x.xx)^d	x.xx
Organs recovered per actual donor, central tendency (dispersion)	xx.x (xx.x)	xx.x (xx.x)	MD	x.xx (x.xx-x.xx)^d	x.xx

Abbreviations: CI Confidence interval, HR Hazard ratio, MD Mean difference RD Risk difference, RR Risk ratio
^aAdjusted for multiple comparisons with Bonferroni correction when appropriate
^bIntracluster correlation coefficient
^c95% confidence interval
^d97.5% confidence interval

ISSN: 1745-6215