Validation of the Lupus Impact Tracker in an Australian patient cohort

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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Construct and Criterion Validity of the Short Form-6D Utility Measure in Patients with Systemic Lupus Erythematosus

The Journal of Rheumatology ◽

10.3899/jrheum.110648 ◽

2012 ◽

Vol 39 (4) ◽

pp. 735-742 ◽

Cited By ~ 13

Author(s):

MARK J. HARRISON ◽

YASMEEN AHMAD ◽

SAHENA HAQUE ◽

NICOLA DALE ◽

LEE-SUAN TEH ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Body Image ◽

Disease Activity ◽

Lupus Erythematosus ◽

Intimate Relationships ◽

Carotid Plaque ◽

Short Form ◽

Criterion Validity ◽

Systemic Lupus ◽

Disease Specific

Objective.Preference-based measures, such as the Short Form-6D (SF-6D), allow quality-adjusted life-years, used in cost-utility evaluations, to be calculated. We investigated the construct and criterion validity of the SF-6D in patients with systemic lupus erythematosus (SLE).Methods.Female patients with SLE were recruited from outpatient clinics at 2 timepoints, 5 years apart. Cross-sectional correlation of the SF-6D with domains of the disease-specific LupusQol health-related quality of life (HRQOL) measure, the Systemic Lupus International Collaborating Clinics Damage Index (SDI; for damage) and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; for activity) measures, and patient characteristics was tested. The ability to discriminate between groups defined by smoking status, presence/absence of carotid plaque, depression, and fatigue was tested using the t-test.Results.In total 181 patients were recruited at baseline. The SF-6D correlated moderately to strongly with all domains of the LupusQoL (0.6–0.8) apart from intimate relationships (0.42) and body image (0.34). Correlations of the SF-6D with the demographic and disease-specific measures at baseline were small for the SDI score (−0.23) and age (−0.19) and in the expected direction. The SF-6D did not correlate with disease activity (SLEDAI −0.08). The SF-6D could distinguish those who smoked, had carotid plaque, had depression, and reported fatigue from those who did not, with the largest effect size being for depression (0.75).Conclusion.The SF-6D displays construct and criterion validity for use in patients with SLE, but the low correlation with aspects of intimate relationships and body image represents a concern and reinforces the need to collect disease-specific measures of HRQOL alongside generic preference-based instruments.

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THU0037 Validation of A Disease-Specific Patient-Reported Outcome Measure for Arabic Patients with Systemic Lupus Erythematosus

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2014-eular.3758 ◽

2014 ◽

Vol 73 (Suppl 2) ◽

pp. 189.2-189

Author(s):

Y. El Miedany ◽

M. El Gaafary ◽

S. Sayed ◽

I. Ahmed

Keyword(s):

Systemic Lupus Erythematosus ◽

Lupus Erythematosus ◽

Outcome Measure ◽

Patient Reported Outcome ◽

Systemic Lupus ◽

Specific Patient ◽

Patient Reported Outcome Measure ◽

Patient Reported ◽

Disease Specific

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Performance and psychometric properties of lupus impact tracker in assessing patient-reported outcomes in pediatric lupus: Report from a pilot study

Lupus ◽

10.1177/0961203320951264 ◽

2020 ◽

Vol 29 (13) ◽

pp. 1781-1789

Author(s):

Suhas K Ganguli ◽

Joyce S Hui-Yuen ◽

Meenakshi Jolly ◽

Jane Cerise ◽

Barbara Anne Eberhard

Keyword(s):

Systemic Lupus Erythematosus ◽

Pilot Study ◽

Disease Activity ◽

Lupus Erythematosus ◽

Patient Reported Outcomes ◽

Laboratory Data ◽

Damage Index ◽

Systemic Lupus ◽

Patient Reported ◽

The Mean

Objective To evaluate the reliability, validity, feasibility and psychometric performance of the Lupus Impact Tracker (LIT) as a patient reported outcome (PRO) measure tool in pediatric systemic lupus erythematosus (pSLE). Methods This is a prospective, observational, pilot study where patients aged between 12 and 25 years, fulfilling the 1997 ACR classification criteria for SLE, were enrolled. Over 3 consecutive, routine, clinical visits, the patients completed the LIT alongside the Patient-Reported Outcomes Measurement Information System-Short Forms (PROMIS-SFs), Childhood Health Assessment Questionnaire (CHAQ). Rheumatologists completed the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC-ACR) Damage Index. Demographic, clinical and laboratory data were also collected. Results Of 46 patients enrolled, 38 patients completed 2 visits and 31 completed all 3 visits. Seventy-eight percent were female, 33% African American, 28% Asian, 15% Caucasian and 17% Hispanic. The mean (SD) age was 17.2 (2.7) years, with a mean (SD) disease duration of 4.6 (3.1) years. The mean (SD) SLEDAI-2K at enrollment was 3.54 (2.96). In the 38 patients who completed two or more visits, intra-class correlation coefficient and Cronbach alpha were calculated to be 0.70 and 0.91 respectively, signifying good reliability of LIT. The LIT showed positive correlation with CHAQ-Disability Index and majority of the PROMIS-SFs parameters. Construct validity was established against clinical disease activity (SLEDAI-2K). Conclusion The preliminary results indicate that the LIT is a reliable and valid instrument to capture PRO in p-SLE. Prospective validation with a larger, multicenter cohort is the next step.

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Assessments of fatigue and disease activity in patients with systemic lupus erythematosus enrolled in the Phase 2 clinical trial with blisibimod

Lupus ◽

10.1177/0961203316654767 ◽

2016 ◽

Vol 26 (1) ◽

pp. 27-37 ◽

Cited By ~ 15

Author(s):

M A Petri ◽

R S Martin ◽

M A Scheinberg ◽

R A Furie

Keyword(s):

Systemic Lupus Erythematosus ◽

Clinical Trial ◽

Disease Activity ◽

Lupus Erythematosus ◽

Activity Index ◽

Disease Activity Index ◽

Poor Correlation ◽

Systemic Lupus ◽

Fatigue Score ◽

Patient Reported

This report evaluates the effects of blisibimod (A-623, AMG 623), a potent and selective inhibitor of B-cell activating factor (BAFF), on patient-reported fatigue and disease activity in the Phase 2b PEARL-SC clinical trial in patients with systemic lupus erythematosus (SLE). A total of 547 individuals who met the American College of Rheumatology (ACR) classification criteria for SLE, were positive for anti-double-stranded DNA or antinuclear antibodies, and had a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score ≥6 at baseline, were randomized to receive placebo or blisibimod for at least 24 weeks. Patient self-reported fatigue was evaluated using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale, and disease activity was evaluated using Physician’s Global Assessment, SELENA-SLEDAI, and British Isles Lupus Assessment Group Score. Statistically significant improvements in FACIT-Fatigue score were observed among individuals randomized to blisibimod, especially in the 200 mg QW group where favorable effects on disease activity with blisibimod compared to placebo were observed as early as Week 8. The mean improvement from baseline of 6.9 points at Week 24, compared with 4.4 points with placebo, met the criteria for minimal clinically important improvement difference defined for patients with SLE. Despite concomitant improvements in FACIT-Fatigue, SLE Responder Index (SRI) and SLE biomarkers (reported previously), FACIT-Fatigue score correlated only weakly with disease activity. While poor correlation between fatigue and disease activity is not new, the observation that correlation remains poor despite concurrent population improvements in disease and fatigue brings a new facet to our understanding of SLE.

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Categorization of Patients With Systemic Lupus Erythematosus Using Disease Activity, Patient-Reported Outcomes and Transcriptomic Signatures

10.21203/rs.3.rs-562655/v1 ◽

2021 ◽

Author(s):

Robin Arcani ◽

Elisabeth Jouve ◽

Laurent Chiche ◽

Noemie Jourde-Chiche

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Short Form ◽

Depression Symptoms ◽

Systemic Lupus ◽

Sf 36 ◽

Patient Reported

Abstract Objective Patients with systemic lupus erythematosus (SLE) display symptoms that are not always related to disease activity and may distort clinical trial results. Recently, a clinical categorization based on the presence of type 1 (inflammatory manifestations) and/or type 2 (widespread pain, fatigue, depression) symptoms has been proposed in SLE. Our aim was to develop a type 2 score derived from the Short-Form health survey (SF-36) to categorize SLE patients and to compare immunological and transcriptomic profiles between groups. Methods Seventeen items from the SF-36 were selected to build a type 2 score for 50 SLE patients (100 visits; LUPUCE cohort) and the SLEDAI was used to define type 1 symptoms. Patients were categorized in four groups: minimal (no symptoms), type 1, type 2 and mixed (both type 1 and type 2 symptoms). Clinical, immunological and transcriptomic profiles were compared between the groups. Results Type 2 scores ranged from 0 to 31, with a cut-off value of 14 (75th percentile). The sample categorization was: minimal in 39%, type 1 in 37%, type 2 in 9% and mixed in 15%. Type 2 patients were older than minimal patients and had a longer disease duration than type 1 and mixed patients. Immunological data and modular interferon signatures did not differ between the groups. Conclusion Patients with SLE can be categorized into four clinical groups using the SLEDAI score and our SF-36-derived type 2 score. This categorization is non-redundant with immunological or transcriptomic profiles and could prove useful to stratify patients in clinical trials.

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

Lupus ◽

10.1177/0961203317739128 ◽

2017 ◽

Vol 27 (5) ◽

pp. 728-737 ◽

Cited By ~ 6

Author(s):

D R Azizoddin ◽

S Weinberg ◽

N Gandhi ◽

S Arora ◽

J A Block ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Lupus Erythematosus ◽

Patient Reported Outcome ◽

Systemic Lupus ◽

Specific Patient ◽

Patient Reported ◽

Outcome Tool ◽

Disease Specific

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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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Validity and Reliability of Patient Reported Outcomes Measurement Information System Computerized Adaptive Tests in Systemic Lupus Erythematosus

The Journal of Rheumatology ◽

10.3899/jrheum.161202 ◽

2017 ◽

Vol 44 (7) ◽

pp. 1024-1031 ◽

Cited By ~ 19

Author(s):

Shanthini Kasturi ◽

Jackie Szymonifka ◽

Jayme C. Burket ◽

Jessica R. Berman ◽

Kyriakos A. Kirou ◽

...

Keyword(s):

Systemic Lupus Erythematosus ◽

Disease Activity ◽

Lupus Erythematosus ◽

Patient Reported Outcomes ◽

Measurement Information ◽

Systemic Lupus ◽

Adaptive Tests ◽

Computerized Adaptive Tests ◽

Patient Reported ◽

Test Retest Reliability

Objective.The aims of this study were to assess the construct validity and the test-retest reliability of Patient Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests (CAT) in patients with systemic lupus erythematosus (SLE).Methods.Adults with SLE completed the Medical Outcomes Study Short Form-36, LupusQoL-US version (“legacy instruments”), and 14 selected PROMIS CAT. Using Spearman correlations, PROMIS CAT were compared with similar domains measured with legacy instruments. CAT were also correlated with the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) scores. Test-retest reliability was evaluated using ICC.Results.There were 204 outpatients with SLE enrolled in the study and 162 completed a retest. PROMIS CAT showed good performance characteristics and moderate to strong correlations with similar domains in the 2 legacy instruments (r = −0.49 to 0.86, p < 0.001). However, correlations between PROMIS CAT and the SELENA-SLEDAI disease activity and SDI were generally weak and statistically insignificant. PROMIS CAT test-retest ICC were good to excellent, ranging from 0.72 to 0.88.Conclusion.To our knowledge, these data are the first to show that PROMIS CAT are valid and reliable for many SLE-relevant domains. Importantly, PROMIS scores did not correlate well with physician-derived measures. This disconnect between objective signs and symptoms and the subjective patient disease experience underscores the crucial need to integrate patient-reported outcomes into clinical care to ensure optimal disease management.

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