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. Author manuscript; available in PMC: 2019 Nov 1.

Published in final edited form as: Lancet Gastroenterol Hepatol. 2018 Sep 18;3(11):768–777. doi: 10.1016/S2468-1253(18)30266-8

Table 2.

Intention-to-treat analysis comparing bowel symptoms and stool diary data between home biofeedback and office biofeedback groups

		Home Biofeedback (n=50)	Office Biofeedback (n=50)	Test of non-inferiority
Subjective parameters	Time	Mean (SEM or 95% CI)	Mean (SEM or 95% CI)	Ho: Bound	Mean Difference or ratio¹	90% CI	p-value
No. of CSBM/week	Baseline	0.68 (0.17)	1.20 (0.29)
	Post	3.34 (0.37)	4.74 (0.57)	<0.70	0.70	(0.54, 0.92)	0.484
	Ratio²	4.91 (3.19, 7.56)^*	3.95 (2.55, 6.12)^*	<0.70	1.24	(0.75, 2.07)	0.032
No. of stools/week	Baseline	5.06 (0.49)	5.71 (0.71)
	Post	5.94 (0.53)	8.36 (0.86)	<0.75	0.71	(0.57, 0.89)	0.654
	Ratio²	1.17 (0.96, 1.43)	1.46 (1.09, 1.96)^*	<0.75	0.80	(0.60, 1.07)	0.352
Stool strain score (1–3)	Baseline	1.89 (0.08)	1.98 (0.09)
	Post	1.68 (0.08)	1.72 (0.08)	>0.25	−0.04	(−0.22, 0.14)	0.004
	Change²	−0.21 (−0.36, −0.06)^*	−0.26 (−0.45, −0.07)^*	>0.25	0.05	(−0.15, 0.25)	0.050
Stool consistency (1–7)	Baseline	3.41 (0.15)	3.24 (0.20)
	Post	3.45 (0.14)	3.41 (0.19)	<−0.50	0.04	(−0.35, 0.43)	0.012
	Change²	0.04 (−0.27, 0.34)	0.17 (−0.27, 0.60)	<−0.50	−0.13	(−0.57, 0.31)	0.083
Bowel satisfaction-VAS (mm)	Baseline	16.3 (2.4)	18.4 (2.9)
	Post	56.3 (3.9)	57.5 (3.8)	<−13	−1.2	(−10.2, 8.0)	0.017
	Change²	40.0 (31.0, 49.0)^*	39.1 (30.7, 47.5)^*	<−13	0.9	(−9.3, 11.1)	0.013
Digital assistance (%)	Baseline	24 (48%)	24 (48%)
	Post	6 (12%)^*	5 (10%)^*	>5%	2%	(−9%, 13%)	0.317

¹

Difference=Home-Office; Ratio=Home/Office

²

Ratio=Post/Baseline; Change=Post-Baseline

^*

Significant change from baseline