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Table 1 Summary of Meaningful Change Thresholds

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

Parameter

Threshold for Acceptability

Analysis Population

Average Number of Daily BMs

Overall Change from Baseline

Change from Baseline at Week 12

N

ES

Mean

N

ES

Mean

Anchor-based Meaningful Change Thresholds

Adequate relief (changed to Yes at Week 12)

Effect Size:

-Small (≥ 0.2)

-Moderate (≥ 0.5)

-Large (≥ 0.8)

ITT

19

−1.20

−1.90

18

−1.58

−2.52

EORTC QLQ-C30 Diarrhea (Responder)

ITT

45

−0.83

−1.71

40

−1.24

−2.56

EORTC GI.NET21 GI Symptoms (Responder)

ITT

30

−1.25

−1.88

25

−1.49

−2.27

Distribution-based Meaningful Change Thresholds

−1/2 Baseline SD

N/A

ITT

135

N/A

0.62

108

N/A

0.86

  1. BM Bowel movement, EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire, ES Effect size, ITT Intent-to-treat, N/A Not applicable, SD Standard deviation