Table 3

Summary of 12-month primary outcome results

Difference (95% CI)p Value
Patient safety thermometer
 Primary analysis−0.03 (−3.59 to 3.53)0.99
 No adjustment for minimisation factors≈0.00 (−3.22 to 3.22)1.00
 With adjustment for ward characteristics−1.03 (−4.63 to 2.57)0.56
 Inclusion of previously excluded ward 0.06 (−3.30 to 3.42)0.97
 Repeated measure logistic regression model−0.05 (−0.53 to 0.44)*0.84
 CACE (50% compliance cut-off)−0.06 (−5.61 to 5.50)0.98
 CACE (75% compliance cut-off)−0.12 (−11.70 to 11.46)0.98
 New harm1.60 (−0.62 to 3.83)0.15
 Repeated measure logistic regression model−0.49 (−1.19, 0.22)*0.17
 New harm CACE (50% compliance cut-off)2.42 (−1.38 to 6.22)0.19
 New harm CACE (75% compliance cut-off)5.38 (−3.89 to 14.64)0.24
Patient measure of safety
 Primary analysis0.08 (−0.01, 0.17)0.09
 With adjustment for ward characteristics0.05 (−0.04, 0.14)0.27
 With adjustment for method of completion0.08 (−0.01, 0.16)0.08
 CACE analysis (50% compliance cut-off)0.15 (−0.05, 0.36)0.13
 CACE analysis (75% compliance cut-off)0.43 (−0.28, 1.14)0.23
  • *Results on the logit scale.

  • CACE, complier average causal effect.