Wouter Leclercq

Chapter 10 170 Table 10.2 Primary outcomemeasure. Intervention group Control group Difference Patients (cases censored) Median return to normal activities (95% CI) Patients (cases censored) Median return to normal activities (95% CI) Hazard ratio (95% CI) p-value Primary analysis* 163 (8) 21.00 (17.29–24.71) 167 (8) 26.00 (20.43–31.57) 1.38 (1.09–1.73) 0.007 Sensitivity analysis† - - 1.36 (1.08–1.72) 0.008 Per-protocol analysis‡ 132 (4) 20.00 (18.31–21.69) 167 (8) 26.00 (20.43–31.57) 1.43 (1.12–1.83) 0.004 *Intention-to-treat analysis, adjusted for factors on which randomisation was stratified: hospital, surgical procedure, and sex. †Intention-to-treat analysis, adjusted for stratification factors and factors that could affect the length of the recovery period (score of the Recovery Index short version form [RI5], which is focused on pain, fatigue, and physical functioning), recovery expectations on baseline (length in days), and work status.5 ‡In the intervention group only, participants who made a convalescence plan were included; analysis adjusted for factors on which randomisation was stratified.