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Table 5 Effect of POD+death on sample size estimates

From: Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials

Choice of primary outcome (effect size)

Number required per group

POD + death at 28 days (25% RRR from 46.0%)

286

28-day mortality (25% RRR from 27.2%)

616

VFD at 28-days with SD = 10.2

 

   (1 day difference)

1,635

   (2 day difference)

410

   (3 day difference)

183

   (4 day difference)

104

   (5 day difference)

67

OFFD at 28 days with SD = 11.6

 

   (1 day difference)

2,114

   (2 day difference)

530

   (3 day difference)

236

   (4 day difference)

133

   (5 day difference)

86

  1. Projected sample sizes required to achieve 80% power at a two-sided alpha = 0.05 using control rates and standard deviations observed for the REDOXS Study with arbitrary but typical effect sizes.
  2. OFFD, organ failure free days; POD, Persistent Organ Dysfunction Score; VFD, ventilator-free days.
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Critical Care

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