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Journal of Patient-Reported Outcomes

Table 4 Known groups validity analysis with MP and reference measures (monthly sum scores)

From: Validation of a menstrual pictogram and a daily bleeding diary for assessment of uterine fibroid treatment efficacy in clinical studies

Time period

Groups

N

Mean (SD)

Test statistic/P valuea

Test statistic/P valueb

Differences in MP SAP-c v3 monthly sum scores between groups defined by AH method (MBL severity thresholds of 2 mL and 80 mL defined by clinical rationale)

 RND

Group 1

(AH monthly sum score < 2 mL)

12

85.84 (102.89)

7374.0 / <.0001

46.5 / <.0001

Group 2

(2 ≤ AH monthly sum score < 80 mL)

42

137.46 (142.08)

Group 3

(AH monthly sum score ≥ 80 mL)

161

224.92 (130.08)

 EOT

Group 1

(AH monthly sum score < 2 mL)

144

0.72 (6.38)

8078.0 / <.0001

167.0 / <.0001

Group 2

(2 ≤ AH monthly sum score < 80 mL)

25

73.24 (45.53)

Group 3

(AH monthly sum score ≥ 80 mL)

27

210.19 (158.00)

Known groups validity: Differences in MP monthly sum scores between groups defined by AH method (thresholds defined by AH tertiles)

 RND

Group 1

(AH monthly sum score Tertile 1)

72

129.19 (118.69)

12,791.0 / <.0001

98.6 / <.0001

Group 2

(AH monthly sum score Tertile 2)

72

173.04 (72.45)

Group 3

(AH monthly sum score Tertile 3)

71

299.36 (150.48)

 EOT

Group 1/2c

(AH monthly sum score Tertile 1 + Tertile 2)

136

0.61 (6.53)

8127.0 / <.0001

177.8 / <.0001

Group 3

(AH monthly sum score Tertile 3)

60

125.44 (135.40)

Differences in MP monthly sum scores between groups defined by PGI-S

 RND

Group 1

(PGI-S = 1,2 [None/Very mild])

15

159.40 (94.96)

17,216.5 / <.0001

19.2 / 0.0007

Group 2

(PGI-S = 3 [Mild])

24

169.23 (67.59)

Group 3

(PGI-S = 4 [Moderate])

92

200.22 (130.95)

Group 4

(PGI-S = 5 [Severe])

98

202.27 (136.39)

Group 5

(PGI-S = 6 [Very severe])

52

287.05 (199.23)

 EOT

Group 1

(PGI-S = 1,2 [None/Very mild])

98

12.80 (45.40)

15,628.0 / <.0001

30.5 / <.0001

Group 2

(PGI-S = 3 [Mild])

56

28.30 (54.07)

Group 3

(PGI-S = 4 [Moderate])

62

54.98 (97.59)

Group 4

(PGI-S = 5 [Severe])

35

116.31 (186.47)

Group 5

(PGI-S = 6 [Very severe])

9

54.13 (122.29)

  1. “All patients with AH measurements from ASTEROID 1” refers to all patients enrolled with an existing date of visit and AH or PGI-S measurements
  2. RND Tertile 1: (0.00 to 101.24), Tertile 2: (> 101.24 to 203.73), Tertile 3: (> 203.73 to 1164.18)
  3. EOT Tertile 1 and Tertile 2: (0.00 to 0.00), Tertile 3: (> 0.00 to 747.94)
  4. AH Alkaline hematin method, EOT End of treatment, MBL Menstrual blood loss, MP (MP SAP-c v3) Menstrual pictogram superabsorbent polymer-containing version 3, N Number of patients, PGI-S Patient Global Impression of Severity, RND Randomization, SD Standard deviation
  5. aJonckheere-Terpstra test
  6. bKruskal-Wallis test
  7. cAs the first and the second tertile are the same at EOT, only two groups based on tertiles were defined
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