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Table 3 Sample size estimations

From: Protocol for a randomised trial on the effect of group education on skin-protective behaviour versus treatment as usual among individuals with newly notified occupational hand eczema – the Prevention of Hand Eczema (PREVEX) Trial

Outcome

Minimum relevant difference

Risk of type I error

Risk of type II error

Total number of participants needed

Total sick days

5 days (SD* 21 days)

1.67%

20%

742

DLQI

1.2 points (SD 4.8 points)

1.67%

20%

672

Subjective assessment of hand eczema severity

20% risk reduction from 60% event rate in the control group

1.67%

20%§

720

  1. *Standard deviation of the mean.
  2. Dermatology Life Quality Index.
  3. Will be reduced to 15.7% when 742 participants are included.
  4. §Will be reduced to 18.6% when 742 participants are included.