Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): data from the Peruvian Almenara Lupus Cohort

Ugarte‐Gil, Manuel F.; Gamboa-Cárdenas, Rocío V.; Reátegui-Sokolova, Cristina; Pimentel-Quiroz, Víctor R.; Zeña-Huancas, Paola A.; Elera-Fitzcarrald, Claudia; Garcia-Hirsh, Samira; Gil, Luciana; Pastor-Asurza, C.A.; Rodríguez-Bellido, Zoila; Merrill, Joan T.; Askanase, Anca; Alarcón, Graciela S.; Perich-Campos, Risto

doi:10.1136/lupus-2020-000419

Cited by 7 publications

(4 citation statements)

References 19 publications

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“…This study confirms the experience of many rheumatologists in practice: severe patient-reported symptoms do not invariably indicate active inflammation and, furthermore, often do no correlate with physician indices of disease activity. 17,33,34 These findings are consistent with our previous studies which showed that patients, who according to their rheumatologist had Type 2 SLE activity without Type 1 activity, frequently reported a recent disease flare as well as moderate-severe symptoms of dry eyes, oral/nasal ulcers, shortness of breath, and stiff and swollen joints. 17 Previous studies have shown discordance in how patients and their rheumatologists score disease activity, with many patients reporting higher levels of activity than their rheumatologists report.…”

Section: Discussionsupporting

confidence: 91%

The use of patient-reported outcome measures to classify type 1 and 2 systemic lupus erythematosus activity

Eudy

Reeve

Coles

et al. 2022

Lupus

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Objective We developed a model that categorizes systemic lupus erythematosus (SLE) activity into two dimensions: Type 1 SLE consists of inflammatory activity, including arthritis, nephritis, and rashes; Type 2 SLE includes fatigue, myalgia, mood disturbance, and cognitive dysfunction. Patient-reported outcome (PRO) measures have received attention as a way to capture symptomatology of SLE. The objective of this study was to explore the use of existing PRO measures to classify Type 1 and 2 SLE activity. Methods Systemic lupus erythematosus patients completed three questionnaires: Systemic Lupus Activity Questionnaire (SLAQ), Polysymptomatic Distress Scale (PSD), and Patient Health Questionnaire (PHQ-2). SLE Disease Activity Index (SLEDAI) and physician global assessments (PGA; 0–3) for Type 1 and Type 2 activity were also recorded. High Type 1 SLE activity was defined as cSLEDAI ≥4 (scored without labs), SLEDAI ≥6, active nephritis, or Type 1 PGA ≥1.0. High Type 2 SLE activity was defined as Type 2 PGA ≥1.0. Patients with both high Type 1 and 2 activity were defined as Mixed SLE, and patients with low Type 1 and 2 activity were defined as Minimal SLE. Data were reduced with a factor analysis. Using a reduced set of 13 variables, multinomial logistic regression models estimated the probability of Minimal, Type 1, Type 2, and Mixed SLE classification. Results The study included 208 patients with SLE. The model accurately predicted the clinician-based Type 1 and 2 SLE classification in 63% of patients; 73% of patients had their Type 1 SLE activity accurately predicted; and 83% had their Type 2 SLE activity accurately predicted. Performance varied by group: 87% of Minimal patients were correctly predicted to be in the Minimal SLE group, yet only about one-third of patients in the Type 1 group were correctly predicted to be in the Type 1 group. Conclusions Our findings indicate Type 2 SLE activity can be identified by patient-reported data. The use of PROs was not as accurate at predicting Type 1 activity. These findings highlight the challenges of using PROs to categorize and classify SLE symptoms since some manifestations of Type 1 activity (e.g., nephritis) may be essentially clinically silent while other Type 1 manifestations may cause severe symptoms.

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Section: Discussionsupporting

confidence: 91%

The use of patient-reported outcome measures to classify type 1 and 2 systemic lupus erythematosus activity

Eudy

Reeve

Coles

et al. 2022

Lupus

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“…The LFA-REAL ClinRO tries to improve the disadvantage of previous scores by trying to remain simple, like the SLEDAI or the PGA; it includes 14 domains and 1 VAS from 0 to 100 for each domain, with a score ranging from 0 to 1400, but also with the possibility of including all possible manifestations. It has been shown to correlate with the SLEDAI-2K and the PGA in several cohorts as well as in a clinical trial, 11,14,[27][28][29] but this is the first study evaluating its predictive value on damage accrual.…”

Section: Discussionmentioning

confidence: 99%

“…The first one includes only individual manifestations and does not include the global measurement of mucocutaneous and musculoskeletal involvement but rather their subdomains; it ranges from 0 to 1400 (the sum of 14 VAS). The alternative option includes only the global domains and not the individual manifestations except for others in which 3 are allowed; this gives a range of 0 to 1100 (the sum of 11 VAS) 11,14 . To be recorded in the LFA-REAL ClinRO, the manifestation should be related to SLE activity, and not to damage or comorbidities; as described in the original tool, the clinician does the attribution of all manifestations; in the present study, one of our previously trained investigators applied it.…”

Section: Methodsmentioning

confidence: 99%

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The Lupus Foundation of America—Rapid Evaluation of Activity in Lupus Clinician-Reported Outcome Predicts Damage in Patients With Systemic Lupus Erythematosus. Data From the Almenara Lupus Cohort

Ugarte-Gil,

Gamboa-Cárdenas,

Reátegui-Sokolova

et al. 2024

J Clin Rheumatol

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Objective To evaluate the predictive value of the LFA-REAL ClinRO (Lupus Foundation of America Rapid Evaluation of Activity in Lupus clinician-reported outcome) on damage accrual in systemic lupus erythematosus patients. Methods Data from a prevalent lupus cohort were used. The LFA-REAL ClinRO includes 9 domains: mucocutaneous (global and 3 subdomains), musculoskeletal (global and 2 subdomains), cardiorespiratory, neuropsychiatric, renal, hematological, constitutional, vasculitis, and other (it allows for other or rare manifestations). For each domain, a 0- to 100-mm visual analog scale is used, and global domains are included except for the mucocutaneous and musculoskeletal domains where the subdomains are included; it allows for 3 manifestations under “other,” so the score ranges from 0 to 1400 (sum of 14 in the visual analog scale). Damage was assessed with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index. Generalized estimating equations were performed, being the outcome the increase in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index; confounders from the previous visit were included; adjusted multivariable models were done. Incidence rate ratios per 10-unit increase in the LFA-REAL ClinRO were reported. Similar models were performed to evaluate the impact of the SLEDAI-2K (SLE Disease Activity Index) and physician global assessment on damage to determine which measure would better predict damage accrual. Results Three-hundred thirty-one patients and 1425 visits were included, 1.9 (SD 1.2) years of follow-up. Disease duration at baseline was 10.7 (7.4) years. The mean LFA-REAL ClinRO was 18.2 (SD 30.7). During the follow-up visits, 63 (17.9%) patients accrued damage once; 4 (1.1%) accrued damage twice. The LFA-REAL ClinRO was predictive of damage accrual even after adjustment for possible confounders (incidence rate ratio 1.10 (95% confidence interval 1.04–1.16; p < 0.001). Similar results were obtained using the SLEDAI-2K and the physician global assessment. Conclusion The LFA-REAL ClinRO is predictive of damage accrual, even after adjusting for possible confounders.

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Systemic lupus erythematosus in Latin America: Outcomes and therapeutic challenges

Ugarte-Gil,

Alarcón

2023

Clinical Immunology Communications

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Evaluation of the LFA-REAL clinician-reported outcome (ClinRO) and patient-reported outcome (PRO): data from the Peruvian Almenara Lupus Cohort

Cited by 7 publications

References 19 publications

The use of patient-reported outcome measures to classify type 1 and 2 systemic lupus erythematosus activity

The use of patient-reported outcome measures to classify type 1 and 2 systemic lupus erythematosus activity

The Lupus Foundation of America—Rapid Evaluation of Activity in Lupus Clinician-Reported Outcome Predicts Damage in Patients With Systemic Lupus Erythematosus. Data From the Almenara Lupus Cohort

Systemic lupus erythematosus in Latin America: Outcomes and therapeutic challenges

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