1859 - LupusPRO: Cross Cultural Validation Study for Lupus in the Philippines

Tuesday, November 8, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
S. Navarra1, Rachel A. Mikolaitis2, Joel A. Block2 and Meenakshi Jolly2, 1University of Santo Tomas Hospital, Manila, Philippines, 2Rush University Medical Center, Chicago, IL
Presentation Number: 1859

Background/Purpose: LupusPRO is a disease-targeted Patient Reported Outcome measure that was developed and validated from and among US patients with systemic lupus erythematosus (SLE). We herein report the results of the cross-cultural validation study of the English language version of LupusPRO among SLE patients in the Philippines.

Method:  The 43-item LupusPRO was pretested in 15 SLE individuals. It was then self administered to 106 SLE patients meeting ACR classification criteria (T1), along with generic tools SF36 and EQ5D visual analogue scale. A mail/drop back LupusPRO and change in health status item survey were given to the patients to be completed within 2-3 days (T2). Data on demographics, clinical and serological characteristics were collected. Disease activity was measured using Physician Global Assessment (PGA), SELENA-SLEDAI and LFA Flare (yes/no and severity of flare). Disease damage was determined using SLICC-ACR SLE damage index (SDI). Internal consistency reliability (ICR), test-retest reliability (TRT), convergent validity (corresponding SF36 domains), and criterion validity (against various general health and disease activity measures) were tested. All reported p values are two tailed.

Results: 121 SLE subjects (95% women) with at least high school level of English instruction medium education participated. Mean age ± SD was 34.7 ± 10.7 yrs and  mean ± SD disease duration  6.2 ±4.9 yrs; 97% Asians, 75 % had more than high school education, and 42% were currently married. Mean ± SD PGA 0.81 ± 1.1, mean ± SD SLEDAI 5.3 ± 7.6 and mean ± SD SDI 0.8 ± 1.2. Table 1 outlines the psychometric properties. ICR and TRT were fair to excellent. Convergent validity ranged from moderate to strong. Criterion validity was established against general health and/or disease activity measures on most domains.  The tool was well received by the patients.

Conclusion: English LupusPRO has fair psychometric properties among SLE patients in the Philippines. Validation studies on a Filipino version of LupusPRO are being planned.

LupusPRO Domain

ICR

TRT

Convergent Validity

(correlation coefficient r, p value)

Criterion Validity

(p value)

Lupus Symptoms

0.66

0.95

LFA Flare (p 0.001), Flare severity (0.001), Patient-Change in Health (0.04), PGA (0.0001), SLEDAI (0.007), EQ5D VAS (0.001)

Cognition

0.79

0.95

Patient-Change in Health (0.03)

Lupus Medications

0.72

0.86

Physical Health

0.88

0.90

Physical Function (0.35, 0.001), Role Physical (0.21, 0.02)

LFA Flare (0.04), Flare severity (0.01),  Patient-Change in Health (0.0001), SF36-Overall Health (0.03),PGA (0.07), SLEDAI (0.0001), PGA (0.09)

Pain-Vitality

0.85

0.91

Bodily Pain (0.69, 0.001), Vitality (0.48, 0.001)

LFA Flare (0.05), Flare severity (0.09),  Patient-Change in Health (0.0001),SF36-Overall Health (0.006), SLEDAI (0.004),PGA (0.03),  EQ5D VAS (0.002)

Body Image

0.88

0.96

Flare severity (0.07),  Patient-Change in Health (0.06), SF36-Overall Health (0.02),PGA (0.02), EQ5D VAS (0.02)

Emotional Health

0.88

0.93

Mental Health (0.46, 0.001), Role Emotional (0.33, 0.001)

Patient-Change in Health (0.06), EQ5D VAS (0.08)

Procreation

0.82

0.94

PGA (0.006),  Patient-Change in Health (0.05)

Desires-Goals

0.86

0.89

Patient-Change in Health (0.01), SF36-Overall Health (0.04)

Social Support

0.80

0.95

SLEDAI (0.09),  Patient-Change in Health (0.01)

Cope

0.72

0.91

SF36-Overall Health (0.006), EQ5D VAS (0.002)

Satisfaction Med Care

0.91

0.96


Keywords: quality of life, questionnaires and systemic lupus erythematosus (SLE)

Disclosure: S. Navarra, None; R. A. Mikolaitis, None; J. A. Block, None; M. Jolly, None.