Comparison of the Lupus Foundation of America–Rapid Evaluation of Activity in Lupus to More Complex Disease Activity Instruments As Evaluated by Clinical Investigators or Real‐World Clinicians

Askanase, Anca; Nguyen, Samantha; Costenbader, Karen H.; Lim, S. Sam; Kamen, Diane L.; Aranow, Cynthia; Grossman, Jennifer M.; Kapoor, Teja; Frost, DeAnna Baker; Aberle, Teresa; Thanou-Stavraki, Aikaterini; Hanrahan, Leslie; Kim, Mimi; Merrill, Joan T.

doi:10.1002/acr.23445

Cited by 14 publications

(14 citation statements)

References 11 publications

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“…Thorough evaluations of each patient by trained lupus investigators, with concurrent scoring of SLEDAI and BILAG could explain the superior performance of VAS scoring. Similar results were however observed when those instruments were scored by clinicians with no prior training in disease activity instruments, with good intraclass correlations of LFA-REAL scoring between clinicians and trained lupus investigators 16. We did not examine associations of LFA-REAL subscales with BILAG organ scores or SLEDAI descriptors in the small number of patients with systemic or cardiorespiratory involvement in our study.…”

Section: Discussionsupporting

confidence: 73%

“…A previous study evaluated the LFA-REAL in relation to SLEDAI, BILAG and SSPGA in routine clinical care of patients with SLE, demonstrating significant correlations to those instruments (r=0.58–0.88, p<0.001) 16. In the current study, we compare the performance of SSPGA and LFA-REAL with other SLE trial outcome measures using blinded patient data from a clinical trial in SLE.…”

Section: Introductionmentioning

confidence: 93%

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Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures

et al. 2019

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ObjectiveExisting methods for grading lupus flares or improvement require definition-based thresholds as increments of change. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. We analysed the performance of the SELENA SLEDAI Physician’s Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures of improvement or worsening in SLE.MethodsWe evaluated the agreement between prospectively collected measures of lupus disease activity [SLE Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group Index 2004 (BILAG 2004), Cutaneous Lupus Area and Severity Index (CLASI), SSPGA and LFA-REAL] and response [(SLE Responder Index (SRI)-4 and BILAG-Based Combined Lupus Assessment (BICLA)] in a clinical trial.ResultsFifty patients (47 females, mean age 45 (±11.6) years) were assessed at 528 consecutive visits (average 10.6 (±4.1) visits/patient). Changes in disease activity compared with baseline were examined in 478 visit pairs. SSPGA and LFA-REAL correlated with each other (r=0.936), and with SLEDAI and BILAG (SSPGA: r=0.742 (SLEDAI), r=0.776 (BILAG); LFA-REAL: r=0.778 (SLEDAI), r=0.813 (BILAG); all p<0.0001). Changes (∆) in SSPGA and LFA-REAL compared with screening correlated with each other (r=0.857) and with changes in SLEDAI and BILAG (∆SSPGA: r=0.678 (∆SLEDAI), r=0.624 (∆BILAG); ∆LFA-REAL: r=0.686 (∆SLEDAI) and 0.700 (∆BILAG); all p<0.0001). Changes in SSPGA and LFA-REAL strongly correlated with SRI-4 and BICLA by receiver operating characteristic analysis (p<0.0001 for all). Additionally, LFA-REAL correlated to individual BILAG organ scores (musculoskeletal: r=0.842, mucocutaneous: r=0.826 (p<0.0001 for both)).ConclusionSSPGA and LFA-REAL are reliable surrogates of common SLE trial end points and could be used as continuous or dichotomous response measures. Additionally, LFA-REAL can provide individualised scoring at the symptom or organ level.Trial registration numberNCT02270957.

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Section: Discussionsupporting

confidence: 73%

Section: Introductionmentioning

confidence: 93%

Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures

et al. 2019

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“…No data were found regarding feasibility of the PGA. In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different between an untrained physician and a trained investigator (36).…”

Section: Discussionmentioning

confidence: 99%

Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties

Chessa¹,

Piga

Floris

et al. 2020

Rheumatology

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Objective The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician’s judgement of overall SLE disease activity. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Methods This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients’ age. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Results The literature search identified 91 studies. Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). Content validity was reported in 89 studies. Construct validity was demonstrated by a good correlation (r ≥ 0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). Criterion validity was assessed exploring the PGA correlation with quality of life measurements, biomarker levels and treatment changes in 28 studies, while no study has evaluated correlation with damage. A good responsiveness for PGA was shown in eight studies. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67–0.98). Conclusion PGA is a valid, responsive and feasible instrument, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring.

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“…Instructions are brief and guide the patient to a consideration of what represents active lupus disease as opposed to longstanding symptoms that are more likely due to damage. A global score and organ-based or symptom-specific evaluations can be obtained from the patient’s perspective that is comparable to the physician’s ratings of the most common lupus features on the partnered CLINRO [29, 30].…”

Section: Discussionmentioning

confidence: 99%

“…The LFA-REAL was designed to include both the physician and patient perspectives of disease activity and allow for a simple yet comprehensive evaluation of any and all active features, individually and in composite. Unlike the LAI, which uses the landmarks as flags to suggest approximate grades of disease severity the LFA-REAL uses these landmarks as defined cut-offs (mild disease is < 1) [29, 30]. This promotes more consistency in scoring between observers and gives the same line length to adjust gradations of mild, moderate or severe manifestations.…”

Section: Discussionmentioning

confidence: 99%

Development and content validity of the Lupus Foundation of America rapid evaluation of activity in lupus (LFA-REAL™): a patient-reported outcome measure for lupus disease activity

Askanase

Daly

Okado

et al. 2019

Health Qual Life Outcomes

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Background/purpose The LFA REAL™ is a measurement system for evaluating lupus disease activity from both clinician and patient perspectives. Patients’ viewpoints are captured using a patient-reported outcome (PRO) questionnaire. A series of visual analog scales are designed to rate disease severity and progress over the past 4 weeks. Brief instructions guide the patient to distinguish between active, potentially reversible symptoms and chronic pain or discomfort that are more likely due to damage. Beyond its simplicity and efficiency, the PRO can provide versatile assessments from a global, organ-based, and symptom-specific level. This paper describes the patient-centered approach used to evaluate the content validity of the LFA-REAL PRO. Methods The PRO was developed in accordance with FDA guidance. A two-phase qualitative study was performed with 25 lupus patients, 10 who participated in concept elicitation (Phase 1) and 15 in cognitive debriefing interviews (Phase 2). Qualitative data were analyzed using ATLAS.ti software v7.5. Upon completion of the interviews, participants completed the draft PRO and additional measures to characterize the sample. Results The mean age of participants was 45.6 and 88% were female, as expected in a lupus population. The mean SF-36 physical component score was 29.8 and the mean mental component score was 46.4. Phase 1 elicited symptom saturation and mapping of the draft PRO. Fatigue was reported by 100% of patients, highlighting its importance as a measurable domain. Additionally, 100% of patients spontaneously mentioned arthritis, which may be more important to this group than previously estimated, substantiating the approach of this PRO to break down components of arthritis into joint pain, stiffness, and swelling. Shortness of breath and fever were reported more frequently than expected. Phase 2 data demonstrated that participants found the instrument easy to use and offered recommendations to improve clarity, leading to adjustments in wording and formatting. Conclusions Results suggest that the LFA-REAL PRO has content validity and, with some modifications suggested by participants, is ready for quantitative validation, including tests of reliability, validity, responsiveness to change, and performance relative to other PROs used in lupus trials. After validation, the LFA-REAL system is intended for use in clinical practice and research. Electronic supplementary material The online version of this article (10.1186/s12955-019-1151-8) contains supplementary material, which is available to authorized users.

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Comparison of the Lupus Foundation of America–Rapid Evaluation of Activity in Lupus to More Complex Disease Activity Instruments As Evaluated by Clinical Investigators or Real‐World Clinicians

Abstract: The LFA-REAL provides a reliable surrogate for more complicated disease activity measures when used by lupus clinical investigators or clinicians.

Cited by 14 publications

References 11 publications

Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures

Scoring systemic lupus erythematosus (SLE) disease activity with simple, rapid outcome measures

Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties

Development and content validity of the Lupus Foundation of America rapid evaluation of activity in lupus (LFA-REAL™): a patient-reported outcome measure for lupus disease activity

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