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Table 5 Distribution-based methods to estimate clinically important difference for ISM-SAF biweekly domain and total scores

From: Psychometric evaluation of the Indolent Systemic Mastocytosis Symptom Assessment Form (ISM-SAF) in a phase 2 clinical study

ISM-SAF biweekly domain

n

Reliabilitya

1/2 SD

SEm

Total Symptom Score

37

0.86

9.53

7.22

Gastrointestinal Symptom Score

37

0.83

3.48

2.86

Skin Symptom Score

38

0.82

3.76

3.19

  1. ISM-SAF = Indolent Systemic Mastocytosis Symptom Assessment Form; SD = standard deviation, SEm = standard error of measurement (SD at Baseline multiplied by the square root of [1-reliability])
  2. aReliability estimate from Baseline Cronbach’s alpha internal consistency reliability estimates