Evaluation of meaningful change in bowel movement frequency for patients with carcinoid syndrome

Journal of Patient-Reported Outcomes

Table 2 Summary of Responsiveness Results

Parameter	Threshold for Acceptability	Analysis Population	Average Daily BMs
			Overall Change from Baseline		Change from Baseline at Week 12
			N	SES	N	SES
Responsiveness (SES)
Adequate relief (changed to Yes at Week 12)^a	Standard Effect Size: -Small (≥ 0.2) -Moderate (≥ 0.5) -Large (≥ 0.8)	ITT	19	−0.99	18	−1.40
Perception of change in BMs^b
A great deal better		ISP	9	−1.44	8	−1.80
Much better		ISP	4	−0.50	4	−0.60
Satisfaction with study medication—Relief of CS^c
Very satisfied		ISP	12	−1.18	12	−1.38
Somewhat satisfied		ISP	7	−0.15	6	−0.38

BM Bowel movement, CS Carcinoid syndrome, ISP Interview subpopulation, ITT Intent-to-treat, SES Standardized effect size
^aThere were n = 75 “not changed to yes at Week 12”
^bThere were n = 10 “a little better”; n = 10 “the same”; and n = 1 “a little worse”
^cThere were n = 8 “neither satisfied nor dissatisfied”; n = 3 “somewhat dissatisfied”; and n = 3 “very satisfied”