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Table 2 Study population characteristics of SLE population used in the development and validation of SLE-PRO measures

From: Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

 

LupusQoL

(n = 30)

LupusQoL-US

(n = N/A)

LupusPRO v1.7

(n = 18)

LupusPRO v1.8

(n = N/A)

Item generationb

Female, n (%)

30 (100%)

N/A

16 (88.9%)

N/A

Age in years, mean (SD)

48.1 (13.1)

N/A

45.1 (12.3)

N/A

Race, n (%)

    

 White

22 (73.3%)

N/A

39%

N/A

 Black/African American

0

N/A

39%

N/A

 Hispanic

0

N/A

17%

N/A

 Asian

8 (26.7%)

N/A

5%

N/A

 Other

0

N/A

0

N/A

Education years (SD)

12.7 (4.5)

N/A

 

N/A

SLE duration in years, mean (SD)

9.2 (8.4)

N/A

9.1 (6.1)

N/A

Disease activity, mean (SD)

N/A

N/A

SLEDAI 6.6 (6.5)

N/A

Disease damage, mean (SD)

N/A

N/A

SDI 2.0 (2.0)

N/A

 

(n = 20)

(n = 15)

(n = 70)

(n = N/A)

Cognitive interviewingb

Female, n (%)

20 (100%)

N/A

N/A

N/A

Age in years, mean (SD)

52 (15.2)

N/A

N/A

N/A

Race, n (%)

    

 White

18 (90%)

N/A

N/A

N/A

 Black/African American

1 (5%)

N/A

N/A

N/A

 Hispanic

0

N/A

N/A

N/A

 Asian

1 (5%)

N/A

N/A

N/A

Other

0

N/A

N/A

N/A

Education years (SD)

12.9 (3.3)

N/A

N/A

N/A

SLE duration in years, mean (SD)

11.2 (6.1)

N/A

N/A

N/A

Disease activity, mean (SD)

N/A

N/A

N/A

N/A

Disease damage, mean (SD)

N/A

N/A

N/A

N/A

 

(n = 160)

(n = 186)

(n = 323)

(n = 131)a

Other psychometric testing

Female, n (%)

152 (95%)

175 (94%)a

301 (93%)

120 (91%)

Age in years, mean (SD)

45.3 (10.8)

42.5 (12.9)

43.3 (13.3)

40.4 (14.1)

Race, n (%)

    

 White

N/A

43 (23%)a

75 (23%)a

31 (23%)a

 Black/African  American

N/A

112 (60%)a

104 (32%)a

68 (52%)a

 Hispanic

N/A

23 (12%)a

133 (41%)a

17 (13%)a

 Asian

N/A

11 (6%)a

10 (3%)a

7 (5%)a

 Other

N/A

N/A

7 (2%)a

11 (8%)a

Education < high school, n (%)

N/A

N/A

94 (29%)a

6 (4.4%)

SLE duration in years, mean (SD)

N/A

N/A

9.3 (7.6)

8.13 (6.84)

Disease activity, mean (SD)

N/A

SLEDAI 6.2 (5.8)

SLEDAI 3.9 (3.8)

SLEDAI 4.89 (4.43)

Disease damage, mean (SD)

N/A

SLICC 2.0 (2.1)

SDI 0.7 (1.1)

SDI 0.61 (1.05)

  1. N/A, not available; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index; BILAG, British Isles Lupus Assessment Group; SLICC, Systemic Lupus International Collaborating Clinics; SDI, The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (ACR) Damage Index
  2. aThe counts were derived based on percentages provided in publication, and therefore are approximate.
  3. bContent validity encompasses both item generation and cognitive interviewing