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Table 5 Ability of the FACT-M to detect change and MIDs in the mMCC population

From: Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma

FACT-M Subscales and Summary scores Comparison of change in score from baseline to Week 7
Percent change in tumor size (mean change in score [ES[a]])
  MIDs assessed at Week 7 Published MIDs in melanoma population
Change in tumor size   0.2 x SDBL 0.5 x SDBL SEM[d] Range(min-max)
Reduction ≥ 30%[b]
(N = 14)
Reduction between 0-30%
(N = 7)
Increase >0% (N = 16) p-value[c]
FACT-G subscales
 Physical well-being (PWB) 0.21 (0.05) -1.00 (-0.18) -1.75 (-0.31) 0.631 1.14 2.85 2.15 0.21 - 2.85 2.00-3.00[e]
 Social/Family well-being (SWB) -0.49 (-0.10) -0.45 (-0.12) -1.74 (-0.28) 0.624 1.01 2.52 2.21 -0.49 - 2.52 -
 Emotional well-being (EWB) 1.07 (0.22) 1.29 (0.20) -0.25 (-0.09) 0.596 0.91 2.28 1.87 0.91 - 2.28 2.00[e]
 Functional well-being (FWB) 2.64 (0.42) -0.14 (-0.02) -2.81 (-0.42) 0.005 1.27 3.19 2.26 1.27 - 3.19 2.00-3.00[e]
Melanoma-specific subscales
 Melanoma Subscale (MS) 2.71 (0.26) -2.43 (-0.36) -2.94 (-0.42) 0.051 1.80 4.50 3.46 1.80 - 4.50 2.00-4.00[f]
 Melanoma surgery scale (MSS) 2.07 (0.34) -3.00 (-1.02) -3.13 (-0.49) 0.036 1.22 3.05 2.46 1.22 - 3.05 1.00-2.00[f]
Summary scales
 FACT-M TOI 5.57 (0.31) -3.57 (-0.21) -7.50 (-0.42) 0.038 3.86 9.64 4.84 3.86 - 9.64 5.00-9.00[f]
 FACT-G total score 3.44 (0.21) -0.31 (-0.02) -6.55 (-0.35) 0.155 3.54 8.85 4.24 3.44 - 8.85 3.00-7.00[e]
 FACT-M total score 6.15 (0.26) -2.74 (-0.12) -9.49 (-0.38) 0.074 5.05 12.62 5.26 5.05 - 12.62 -
 MCC-Specific scores
 Physical Function score (PF) 0.71 (0.14) -1.86 (-0.33) -2.13 (-0.34) 0.153 1.15 2.87 1.88 0.71 - 2.87 -
 Psychological Impact score (PI) 0.79 (0.15) 2.29 (0.39) 0.31 (0.10) 0.609 0.95 2.38 1.98 0.79 - 2.38 -
 MCC summary score 1.50 (0.17) 0.43 (0.04) -1.81 (-0.21) 0.530 1.91 4.76 2.91 1.50 - 4.76 -
  1. ES effect size, MCC Merkel cell carcinoma, MID Minimally important difference, PAS PRO analysis set, SD BL Standard deviation of the score at baseline, SEM Standard error of measurement, TOI Trial Outcome Index
  2. Ability to detect change and MIDs of the FACT-M were assessed in the PAS (N = 70).
  3. [a]ES around 0.20: small change; ES around 0.50: moderate change; ES around 0.80: large change; [b]Reduction in tumor size ≥30% was used as the anchor for MID thresholds; [c] p-value from ANOVA comparing score change from baseline to week 7 between the three groups based on change in tumor size [d]SEM was calculated using Cronbach's alpha for internal consistency reliability; [e]Askew et al. 2009; [f]Cella et al 2002