Govert Veldhuijzen

95 CBE is non-inferior to nurse counselling prior to colonoscopy, a multicenter RCT The difference of -2.4%, 95% CI [–5.8; 0.9]% and -0.8%, 95% CI [- 5.1; 3.5]% in formal testing for superiority showed no statistical difference between groups in both the ITT and PP population. The number of repeat colonoscopies due to inadequate bowel preparation was not significantly different amongst groups in both the ITT and PP population, being 4 (0.6%) in nurse counselling versus 7 (1.0%) in CBE in the ITT group and 3 (0.6%) in nurse counselling versus 6 (1.2%) in CBE in the PP group. (Table 2.) Table 2. Primary Outcome: Bowel Preparation during Colonoscopy Per-protocol population Nurse counselling (n, % scoring rate) Computer Based Education (n, % scoring rate) Nurse versus Computer Based Education (statistical test) Rate of adequate bowel preparation n (%) (BBPS 6 or higher) 204 (94.0) 261 (93.2) Superiority p = 0.720 (Chi-square) Non-inferiority: delta -0.8%, 95% CI [- 5.1; 3.5] (within margin) Boston Bowel Preparation Scale (mean, 95% confidence interval) 7.995, 95% CI [7.78; 8.21] 7.811, 95% CI [7.62; 8.00] p = 0.207 (t-test) Decision to repeat colonoscopy due to inadequate bowel preparation n (%) 3 (1.4) 6 (2.1) p = 0.528 (Chi-Square) Subsegmental BBPS scores in the right, transverse and left colon were equally distributed amongst groups. In the excellent BBPS scores of 8 and higher no significant differences were observed amongst groups (73.3% in nurse counselling, versus 69.3% in CBE, p = 0.331). (See appendix tables 1s. and 2s.) Secondary end points Sickness absence leave Sickness absence leave was significantly lower in the CBE group, 28.0% in the nurse counselling group, and 4.8% in the CBE group, p < 0.001. (Table 3.) 5

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