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Table 4 Ability to detect change of the FACT-M in the MCC population by comparing change in score from baseline to week 7 across change groups defined by percentage change in tumor size (n = 105) and change in EQ VAS (n = 121), respectively

From: Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma

FACT-M subscale, summary and MCC-specific scoresPercent change in tumor size; mean (effect size)Change in EQ VAS (MID = 7); mean (effect size)
Reduction  ≤ − 30%[a] (N = 47)Reduction  > − 30% to ≤0
(N = 14)
Increase > 0%
(N = 44)
p-value[b]Improved ≥7 points (n = 35)Stable > − 7 to < 7 (n = 56)Worsened ≤ − 7 points (n = 30)p-value[b]
FACT-G subscales
 Physical well-being−0.02 (− 0.01)−0.50 (− 0.11)− 1.86 (− 0.36)0.1010.46 (0.10)−0.54 (− 0.11)−3.17 (− 1.03)< 0.001
 Social/Family well-being0.47 (0.09)− 0.21 (− 0.06)− 1.55 (− 0.24)0.2090.72 (0.15)− 1.19 (− 0.21)− 0.13 (− 0.02)0.272
 Emotional well-being1.38 (0.35)0.79 (0.14)0.23 (0.05)0.2922.37 (0.63)0.99 (0.20)−2.03 (− 0.65)<.0001
 Functional well-being0.06 (0.01)− 0.43 (− 0.06)− 2.16 (− 0.30)0.1640.34 (0.05)− 0.91 (− 0.12)−2.24 (− 0.40)0.165
Melanoma-specific subscales
 Melanoma subscale1.64 (0.21)−2.64 (− 0.44)− 2.32 (− 0.27)0.0061.74 (0.24)− 0.18 (− 0.02)−4.63 (− 0.69)<.0001
 Melanoma surgery scale1.50 (0.36)−1.79 (− 0.48)−1.16 (− 0.15)0.0430.69 (0.12)0.02 (0.02)− 0.67 (− 0.09)0.619
Summary scales
 FACT-M TOI1.68 (0.10)− 3.57 (− 0.23)− 6.34 (− 0.32)0.0122.54 (0.16)− 1.63 (− 0.08)−10.04 (− 0.76)< 0.001
 FACT-G Total score1.89 (0.13)− 0.36 (− 0.02)− 5.34 (− 0.29)0.0263.90 (0.26)− 1.65 (− 0.09)−7.56 (− 0.56)0.001
 FACT-M Total score3.53 (0.17)−3.00 (− 0.14)− 7.65 (− 0.30)0.0095.64 (0.27)−1.83 (− 0.07)−12.20 (− 0.67)<.0001
MCC-Specific scores
 Physical function score (PF)−0.30 (− 0.06)−1.64 (− 0.32)−2.18 (− 0.33)0.100−0.09 (− 0.01)−0.95 (− 0.15)−3.60 (− 0.79)0.002
 Psychological impact score (PI)1.40 (0.32)1.21 (0.22)0.30 (0.07)0.3932.94 (0.71)0.98 (0.20)−2.10 (−0.62)<.0001
 MCC summary score1.11 (0.14)−0.43 (− 0.04)−1.89 (− 0.19)0.1292.86 (0.33)0.04 (0.00)−5.70 (− 0.91)<.0001
  1. MCC = Merkel cell carcinoma; MID = Minimal important difference; TOI = Trial Outcome Index
  2. [a] reduction in tumor size ≥30% was used as one anchor for MID thresholds; [b] p-value from ANOVA comparing score change from baseline to week 7 between the three groups based on change in tumor size or change in EQ VAS respectively