Validation of the LupusPRO version 1.8: an update to a disease-specific patient-reported outcome tool for systemic lupus erythematosus

Objectives The objective of this article is to validate the Lupus Impact Tracker (LIT), a disease-specific patient-reported outcome (PRO) tool, in systemic lupus erythematosus (SLE) patients in a multi-ethnic Australian cohort. Methods Patients attending the Monash Lupus Clinic were asked to complete the LIT, a 10-item PRO. Psychometric testing assessing criterion validity, construct validity, test-retest reliability (TRT) and internal consistency reliability (ICR) were performed. We compared the LIT scores across patient characteristics, and correlations between LIT scores and SLEDAI-2k, PGA, and SLICC-SDI were examined. Results LIT data were obtained from 73 patients. Patients were 84% female with a median age of 41 years, and 34% were Asian. The cohort had mild-moderate disease activity with a median (IQR) Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2k) of 4 (IQR 2–6). The median LIT score was 32.5 (IQR 17.5–50). LIT demonstrated criterion validity against SLEDAI-2k and SDI. Construct validity assessed by confirmatory factor analysis demonstrated an excellent fit (Goodness of fit index 0.95, Comparative Fit Index 1, Root Mean Square Error of Approximation <0.0001). The LIT demonstrated TRT with an overall intraclass correlation coefficient of 0.986 (95% CI 0.968–0.995). ICR was demonstrated with a Cronbach’s alpha of 0.838. Patients with disability, low socioeconomic status, or higher disease activity had significantly worse LIT scores. Conclusion The LIT demonstrated properties consistent with its being valid in this population. Lower socioeconomic status appears to have a significant impact on patient-reported health-related quality of life in SLE.

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Psychometric validation of patient-reported outcome measures of pain in united states patients with systemic lupus erythematosus

Value in Health ◽

10.1016/j.jval.2014.03.1131 ◽

2014 ◽

Vol 17 (3) ◽

pp. A194

Author(s):

A.N. Naegeli ◽

S. Al Sawah ◽

E.L. Tomaszewski ◽

E. Gemmen

Keyword(s):

United States ◽

Systemic Lupus Erythematosus ◽

Outcome Measures ◽

Lupus Erythematosus ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Psychometric Validation ◽

Systemic Lupus ◽

Patient Reported

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Patient-reported outcome measures for systemic lupus erythematosus clinical trials: a review of content validity, face validity and psychometric performance

Health and Quality of Life Outcomes ◽

10.1186/s12955-014-0116-1 ◽

2014 ◽

Vol 12 (1) ◽

Cited By ~ 43

Author(s):

Laura Holloway ◽

Louise Humphrey ◽

Louise Heron ◽

Claire Pilling ◽

Helen Kitchen ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trials ◽

Outcome Measures ◽

Lupus Erythematosus ◽

Content Validity ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Face Validity ◽

Systemic Lupus ◽

Patient Reported

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Relationship between remission, disease activity and patient-reported outcome measures in patients with recent-onset systemic lupus erythematosus

Lupus ◽

10.1177/0961203320912338 ◽

2020 ◽

Vol 29 (6) ◽

pp. 625-630

Author(s):

Rebecca Heijke ◽

Mathilda Björk ◽

Martina Frodlund ◽

Laura McDonald ◽

Evo Alemao ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Pain Intensity ◽

Lupus Erythematosus ◽

Well Being ◽

Patient Reported Outcome Measures ◽

Patient Reported Outcome ◽

Systemic Lupus ◽

Recent Onset ◽

Patient Reported

Objective Definitions of remission in systemic lupus erythematosus (SLE; DORIS (1A/1B/2A/2B)), disease activity assessments and patient-reported outcome measures (PROMs) are useful in shared decision making between patients with SLE and physicians. We used longitudinal registry data from well-characterized Swedish patients with recent-onset SLE to explore potential correlations between DORIS status or disease activity, and PROMs. Methods Patients from the Clinical Lupus Register in North-Eastern Gothia, Sweden, who fulfilled the 1982 American College of Rheumatology and/or the 2012 Systemic Lupus International Collaborating Clinics classification criteria without prior organ damage, were enrolled at diagnosis. Data on treatments, serology, remission status (DORIS), disease activity (SLE Disease Activity Index-2000 (SLEDAI-2K)) and PROMs (quality of life: EuroQoL-5 Dimensions (EQ-5D); pain intensity, fatigue and well-being: visual analog scale (VAS) 0–100 mm) were collected during rheumatology clinic visits at months 0 (diagnosis), 6, 12, 24, 36, 48 and 60. Correlations were assessed using Pearson correlation and/or beta regression coefficients. Results A total of 41 patients were enrolled (median age = 39 years, 80% female, 85% white). Achievement of DORIS 1A and 2A (neither of which includes serology) significantly correlated with all PROMs (EQ-5D: p ≤ 0.02; pain: p = 0.0001; fatigue: p = 0.0051; well-being: p < 0.0001). Disease activity measures were correlated with VAS pain intensity ( p < 0.03) and VAS well-being ( p < 0.04). Conclusions Our findings illustrate the importance of the interplay between remission, disease activity assessments and PROMs. PROMs may be a useful tool in clinical practice, being administered prior to patient visits to streamline clinical care.

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Cross-cultural Validation of a Disease-specific Patient-reported Outcome Measure for Systemic Lupus Erythematosus in Canada

The Journal of Rheumatology ◽

10.3899/jrheum.121129 ◽

2013 ◽

Vol 40 (8) ◽

pp. 1327-1333 ◽

Cited By ~ 13

Author(s):

Josiane Bourré-Tessier ◽

Ann E. Clarke ◽

Rachel A. Mikolaitis-Preuss ◽

Mark Kosinski ◽

Sasha Bernatsky ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Discriminant Validity ◽

Outcome Measure ◽

Patient Reported Outcome ◽

Systemic Lupus ◽

Convergent And Discriminant Validity ◽

Sf 36 ◽

Patient Reported

Objective.The LupusPRO, a disease-targeted patient-reported outcome measure, was developed and validated in US patients with systemic lupus erythematosus (SLE). We report the results of the cross-cultural validation study of the English version of the LupusPRO among patients in Canada with SLE.Method.The LupusPRO was administered to English-speaking Canadian patients with SLE. Demographic, clinical, and serological characteristics were obtained, and the Medical Outcomes Study Short Form-36 (SF-36) and LupusPRO were administered. Disease activity was ascertained using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) and the Lupus Foundation of America definition of flare (Yes/No). Damage was assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Physician disease activity and damage assessments were also ascertained using visual analog scales. A mail-back LupusPRO form was completed within 2–3 days of the index visit. Items tested were internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity or health status), and known-groups validity.Results.Participants were 123 Canadian patients with SLE (94% women); mean age was 47.7 (SD 14.8) years. The median (interquartile range) SELENA-SLEDAI and SDI were 4 (6) and 1 (3), respectively. The ICR of the LupusPRO domains ranged from 0.60 to 0.93, while the TRT range was 0.62–0.95. Measures observed were convergent and discriminant validity with corresponding domains of SF-36, criterion validity, and known-groups validity against disease activity, damage, and health status. Confirmatory factor analysis showed a good fit.Conclusion.The LupusPRO has fair psychometric properties among Canadian patients with SLE, and prospective studies to establish minimally important difference are continuing.

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