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Table 6 Responder analysis based on various MID methods

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

FACT-M Subscales and Summary scores

 

Percentage of responders[a] at Week 7 by MID calculation method

 

SEM[b]

Anchor[c]

Minimum threshold

Maximum threshold

FACT-G subscales

 Physical well-being (PWB)

18.4

32.7

32.7

18.4

 Social/Family well-being (SWB)

22.4

53.1

53.1

18.4

 Emotional well-being (EWB)

34.7

34.7

44.9

26.5

 Functional well-being (FWB)

30.6

30.6

34.7

22.4

Melanoma-specific subscales

 Melanoma Subscale (MS)

22.4

26.5

34.7

20.4

 Melanoma surgery scale (MSS)

22.4

22.4

30.6

20.4

Summary scales

 FACT-M TOI

24.5

22.4

30.6

14.3

 FACT-G total score

30.6

34.7

34.7

20.4

 FACT-M total score

28.6

28.6

28.6

14.3

MCC-Specific scores

 Physical Function score (PF)

18.4

26.5

26.5

12.2

 Psychological Impact score (PI)

38.8

51.0

51.0

26.5

 MCC summary score

24.5

30.6

30.6

18.4

  1. MCC Merkel cell carcinoma, MID Minimally important difference, PAS PRO analysis set, SEM Standard error of measurement, TOI Trial Outcome Index
  2. Percentage of responders were assessed in the PAS (N = 70)
  3. [a]A responder is defined as a patient whose score had changed relative to baseline by an amount greater than or equal to the MID; [b]SEM was calculated using Cronbach's alpha for internal consistency reliability; [c]Reduction in tumor size ≥30% was used as the anchor for MID thresholds