Table 2.

Cousineau perceived burden scores over time

Time PointThree Times per WeekSix Times per WeekBetween-Group DifferenceaP Value
Daily Trial
 Baseline37.7±23.037.1±27.6
 Month 435.0±22.732.9±25.1
  Change from baseline−1.1±2.8−2.7±2.5−1.6 (−8.4 to 5.2)0.64
  Change (imputed)1.8±4.30.6±4.1−1.2 (−8.0 to 5.6)0.73
 Month 1231.2 ±21.930.1±22.9
  Change from baseline−2.6±3.1−4.7±2.7−2.1 (−9.4 to 5.3)0.58
  Change (imputed)1.2±4.7−1.5±4.4−2.7 (−9.8 to 4.4)0.46
Nocturnal Trial
 Baseline32.9±18.332.0±19.7
 Month 432.0±16.941.1±18.5
  Change from baseline−0.3±2.6+5.9±2.8+6.2 (−0.8 to 13.3)0.08
  Change (imputed)−0.3±2.8+9.6±3.0+9.8 (2.4 to 17.3)0.01
 Month 1226.9±15.333.9±22.0
  Change from baseline−5.7±2.7+0.5±2.7+6.1 (−0.8 to 13.1)0.08
  Change (imputed)−5.4±3.1+4.0±3.4+9.4 (0.6 to 18.3)0.04
  • Values at baseline, 4 months postrandomization, and 12 months postrandomization are observed means±SDs. Changes from baseline are adjusted means (presented as means±SEM).

  • a Treatment effect of six times per week minus three times per week (presented with 95% confidence intervals).