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. 2016 Jan 15;193(2):223–224. doi: 10.1164/rccm.1932erratum

Table E5.

Sample-Size Estimates across Outcomes

Outcome Control* (%) Intervention (%) Absolute Risk Reduction (%) Relative Risk Reduction (%) N per Group No. PICUs (1 yr) No. PICUs (3 yr)
New or progressive MODS 40 35 5 13 1,471 245 81
40 30 10 25 356 59 20
PICU mortality 24 19 5 21 1,059 177 58
24 14 10 42 241 40 13
Hospital mortality 25 20 5 20 1,094 182 60
25 15 10 40 250 42 14
At least mild disability 28 23 5 18 1,192 199 65
28 18 10 36 277 46 15
At least moderate disability§ 17 12 5 29 778 130 43
17 7 10 59 165 28 9
Death or disability|| 38 33 5 13 1,437 240 79
38 28 10 26 346 58 19

Definition of abbreviations: MODS = multiorgan dysfunction syndrome; PICU = pediatric intensive care unit.

*

Baseline estimate from SPROUT study.

Number of PICUs required to meet sample size is estimated based on a median of 16 beds per PICU and a median PICU length of stay of 15 days per patient with a 50% consent rate.

Any increase in POPC from baseline to hospital discharge in the 422 hospital survivors.

§

Discharge POPC ≥ 3 and an increase of at least 1 from baseline in the 422 hospital survivors.

||

Death or at least moderate disability at hospital discharge.