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. 2023 Jun 26;42(19):3529–3546. doi: 10.1002/sim.9818

TABLE 2.

Type I error and power (%) across simulation scenarios comparing an unadjusted analysis, adjusting for the randomisation strata and adjusting for the true strata when the treatment effect is of interest and all stratification errors are discovered.

Type I error (%) (βT=0) Power (%) (βT=0.2)
Stratification error rate Errors across strata Covariate effect (β X) Unadjusted Randomisation strata True strata a Unadjusted Randomisation strata True strata a
1% Equal 1 2.85 4.90 4.85 83.05 88.13 88.40
1% Equal 3 0.07 4.92 5.12 36.64 85.59 88.80
1% Unequal 1 3.13 5.38 5.39 82.96 87.89 88.30
1% Unequal 3 0.05 4.66 5.01 35.94 85.48 88.11
20% Equal 1 4.21 5.09 4.98 81.80 83.79 88.37
20% Equal 3 2.74 5.68 4.68 39.81 51.88 88.54
20% Unequal 1 4.04 4.74 4.71 81.78 83.86 89.10
20% Unequal 3 2.16 5.00 5.25 40.31 52.89 88.87

Note: The maximum Monte Carlo SE across all methods and scenarios was 0.23 for type I error and 0.50 for power.

a

Matches the updated strata in this setting where all stratification errors are discovered.