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Table 2 Comparison of the simulation-based approach with the analytical formulae of HH. The cells in the table are the estimated number of clusters as a function of the ICC and outcome type (continuous, binary and rate) to obtain 80 % power

From: Sample size calculation for a stepped wedge trial

ICC

Analytical power based on HH

Simulation-based calculations

 

K=20,J=6

K=20,J=6

Continuous outcomea

0

9

9

0.1

13

13

0.2

14

13

0.3

14

14

0.4

14

14

0.5

14

14

Binary outcomeb

0

11

15

0.1

17

16

0.2

18

17

0.3

18

18

0.4

18

18

0.5

18

18

Count outcomec

0

8

8

0.1

13

12

0.2

13

12

0.3

13

12

0.4

13

11

0.5

13

11

  1. aIntervention effect = −0.3785; σ e =1.55.
  2. bBaseline outcome probability = 0.26; OR = 0.56.
  3. cBaseline outcome rate = 1.5; RR = 0.8.
  4. Notation: K= number of subjects per cluster; J= total number of time points, including one baseline