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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