Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines

Abstract

Objective

LupusPRO is a disease-targeted patient-reported outcome measure that was developed and validated among US patients with systemic lupus erythematosus (SLE). We report the cross-cultural validation results of the LupusPRO English-language version among Filipino SLE patients.

Method

The 43-item LupusPRO was pretested in 15 SLE individuals, then administered to 106 SLE patients, along with short-form SF36 and the EQ5D visual analogue scale. A mail/drop-back LupusPRO and change in health status item survey were returned within two to three days. Demographics, clinical and serological characteristics, disease activity and damage measured by PGA, SELENA-SLEDAI, LFA Flare, and SLICC-ACR SLE damage index (SDI) were collected. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent validity (corresponding SF36 domains) and criterion validity (against general health and disease activity measures) were tested. Reported p values are two tailed.

Results

A total of 121 Filipino SLE subjects (95% women, median age 31.0 ± 16 years) with at least a high school level of English instruction participated. Median (IQR) PGA, SLEDAI and SDI were 0.0 (1.0), 2.0 (10) and 0 (1), respectively. ICR exceeded 0.7 for all domains except the lupus symptoms domain. TRT was greater than 0.85 for all LupusPRO domains. Convergent and criterion validity were observed against corresponding SF36 domains and disease activity measures. The tool was well received by patients. Confirmatory factor analysis showed good fit.

Conclusion

English LupusPRO has fair psychometric properties among SLE patients in the Philippines, and is now available for inclusion in clinical trials and longitudinal studies to test responsiveness to change.

Keywords

Systemic lupus erythematosus quality of life patient-reported outcomes Philippines

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References

Jolly

Utset

. Health related quality of life among outpatient systemic lupus erythematosus University of Chicago cohort. Arthritis Rheum 2003; 48: 3642– 3642.

Jolly

Pickard

Mikolaitis

Rodby

Sequeira

Block

. LupusQoL-US benchmarks for US patients with systemic lupus erythematosus. J Rheumatol 2010; 37: 1828–1833.

Jolly

Utset

. Can disease specific measures for systemic lupus erythematosus predict patients health related quality of life? Lupus 2004; 13: 924–926.

Moldovan

Katsaros

Carr

Cooray

Torralba

. The Patient Reported Outcomes in Lupus (PATROL) study: Role of depression in health-related quality of life in a Southern California lupus cohort. Lupus 2011; 20: 1285–1292.

Hyphantis

Palieraki

Voulgari

Tsifetaki

Drosos

. Coping with health-stressors and defence styles associated with health-related quality of life in patients with systemic lupus erythematosus. Lupus 2011; 20: 893–903.

Gallop

Nixon

Swinburn

Sterling

Naegeli

Silk

. Development of a conceptual model of health-related quality of life for systemic lupus erythematosus from the patient's perspective. Lupus 2012; 21: 934–943.

Thumboo

Fong

. Health-related quality of life of patients with systemic lupus erythematosus in Asia: How can this be improved? Lupus 2010; 19: 1430–1435.

Alarcón

McGwin

Jr Brooks

. Systemic lupus erythematosus in three ethnic groups. XI. Sources of discrepancy in perception of disease activity: A comparison of physician and patient visual analog scale scores. Arthritis Rheum 2002; 47: 408–413.

Food and Drug Administration. Guidance for industry on patient-reported outcome measures: Use in medical product development to support labeling claims, http://www.fda.gov/ohrms/dockets/98fr/06d-0044-gdl0001.pdf (2006, accessed 23.03.2012).

10.

Jolly

Pickard

Block

. Disease-specific patient reported outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum 2012; 42: 56–65.

11.

Hochberg

. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997; 40: 1725–1725.

12.

Ware

. The SF-36 Health Survey. In: Spiker

(ed.) Quality of life and pharmacoeconomics in clinical trials. 2nd edn. Philadelphia: Lippincott-Raven, pp. 337–345, 1996.

13.

EuroQoL

Group

. EuroQoL — a new facility for the measurement of health related quality of life. Health Policy 1990; 16: 199–208.

14.

Aggarwal

Wilke

Pickard

. Psychometric properties of the EuroQol-5D and Short Form-6D in patients with systemic lupus erythematosus. J Rheumatol 2009; 36: 1209–1216.

15.

Petri

Kim

Kalunian

. Combined oral contraceptives in women with systemic lupus erythematosus. N Engl J Med 2005; 353: 2550–2558.

16.

Ruperto

Hanrahan

Alarcón

. International consensus for a definition of disease flare in lupus. Lupus 2011; 20: 453–462.

17.

Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum 1996; 39: 363–369.

18.

Hays

Anderson

Revicki

. Psychometric considerations in evaluating health-related quality of life measures. Qual Life Res 1993; 2: 441–449.

19.

Thakkar

Mikolaitis

Block

Jolly

. Caregiver burden is associated with worse dyadic relationship and health outcomes in lupus? Arthritis Rheum Suppl 2011; 63: 1422–1422.

20.

Mplus User's Guide. Version 1. Los Angeles: Muthén & Muthén, 1998.

21.

Bentler

. Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Struct Equ Modeling 1999; 6: 1–55.

22.

Jolly

. How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatology 2005; 32: 1706–1708.