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Table 6 Known-Groups Validity – ASDD by HDSS, Gravimetry, and DLQI/CDLQI severity thresholds at Week 4

From: Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity

  

Phase 2:

DRM04-HH02

(N = 105)

Phase 3 Pooled: ATMOS-1 & ATMOS-2

Age 9–15 Years (N = 32)

Age ≥ 16 Years (N = 665)

ASDD Item 2 (Week 4 Average)

HDSS, mean (SD)

Grade 1

0.9 ± 1.2 (n = 35)

2.0 ± 0.6 (n = 5)

1.1 ± 1.6 (n = 208)

Grade ≥ 3

5.3 ± 1.4 (n = 14)

6.8 ± 1.86 (n = 13)

6.5 ± 2.1 (n = 154)

p-value

< 0.001

< 0.001

< 0.001

Sweat Production,a mean (SD)

1st Quartile

1.8 ± 1.7 (n = 19)

4.1 ± 3.2 (n = 3)

2.6 ± 2.6 (n = 166)

4th Quartile

3.4 ± 2.0 (n = 20)

6.3 ± 1.9 (n = 15)

4.2 ± 2.8 (n = 168)

p-value

0.009

0.125

< 0.001

DLQI/C-DLQI, mean (SD)

No to moderate impact

N/A

4.4 ± 2.5 (n = 27)

2.9 ± 2.5 (n = 571)

Very large to extremely large impact

N/A

9.8 (n = 1)

7.3 ± 2.4 (n = 7)

p-value

N/A

N/Ab

< 0.001

ASDD Item 3 (Week 4 Average)

HDSS, mean (SD)

Grade 1

0.2 ± 0.4 (n = 35)

N/A

0.2 ± 0.3 (n = 182)

Grade ≥ 3

1.5 ± 0.7 (n = 14)

N/A

2.1 ± 1.0 (n = 114)

p-value

< 0.001

N/A

< 0.001

Sweat Production,a mean (SD)

1st Quartile

0.5 ± 0.6 (n = 19)

N/A

0.7 ± 0.8 (n = 146)

4th Quartile

1.0 ± 0.7 (n = 20)

N/A

1.2 ± 1.0 (n = 134)

p -value

0.026

N/A

< 0.001

DLQI/C-DLQI, mean (SD)

No to moderate impact

N/A

N/A

0.8 ± 0.9 (n = 508)

Very large to extremely large impact

N/A

N/A

3.0 ± 1.0 (n = 5)

p -value

N/A

N/A

< 0.001

ASDD Item 4 (Week 4 Average)

HDSS, mean (SD)

Grade 1

0.2 ± 0.3 (n = 35)

N/A

0.2 ± 0.3 (n = 182)

Grade ≥ 3

1.7 ± 0.7 (n = 14)

N/A

2.3 ± 1.0 (n = 114)

p -value

< 0.001

N/A

< 0.001

Sweat Production,a mean (SD)

1st Quartile

0.5 ± 0.5 (n = 19)

N/A

0.8 ± 0.8 (n = 146)

4th Quartile

1.2 ± 0.7 (n = 20)

N/A

1.3 ± 1.0 (n = 134)

p -value

0.002

N/A

< 0.001

DLQI/C-DLQI, mean (SD)

No to moderate impact

N/A

N/A

0.9 ± 0.9 (n = 508)

Very large to extremely large impact

N/A

N/A

3.0 ± 1.1 (n = 5)

p -value

N/A

N/A

< 0.001

  1. ASDD Axillary Sweating Daily Diary, HDSS Hyperhidrosis Disease Severity Scale, SD Standard deviation
  2. a Measured gravimetrically; bNot calculable due to sample size (N = 1)
  3. P value for two sample t-test
  4. HDSS Grade 1 = My sweating is never noticeable and never interferes with my daily activities; Grade 3 = My sweating is barely tolerable and frequently interferes with my daily activities; Grade 4 = My sweating is intolerable and always interferes with my daily activities
  5. Quartiles for gravimetric measurement of sweat production at Week 4 defined as 25th percentile (8.7 mg/axilla/5 min) and 75th percentile (34.95 mg/axilla/5 min)
  6. DLQI: no to moderate impact = range 0–10; large to extremely large impact = range 21–30; CDLQI: no to moderate impact = range 0–12; large to extremely large impact = range 19–20