Multicenter lupus register from Argentina, the RELESSAR database: Influence of ethnicity on disease phenotype.

OBJECTIVE: The objective is to describe the main characteristics of patients with systemic lupus erythematosus (SLE) in Argentina and to examine the influence of ethnicity on the expression of the disease. PATIENTS AND METHODS: RELESSAR is a multicentre register carried out by 106 researchers from 67 rheumatologic Argentine centres. It is a cross-sectional study of SLE (1982/1997 ACR) patients. RELESSAR electronic database includes demographic, cumulative SLE manifestations, SELENA-SLEDAI, SLICC-SDI, Katz's severity and Charlson's comorbidity indexes and treatment patterns. RESULTS: We included 1,610 patients, 91.7% were female with a median age at diagnosis of 28.1 ± 12.8; 96.2% met ≥4 ACR 1982/97 criteria. Frequent manifestations were arthritis (83.5%), malar rash (79.5%), photosensitivity (75.3%), haematological (63.8%) and renal disease (47.4%), antinuclear antibodies (96%), anti-dsDNA (66.5%) and anti-Smith antibodies (29%). The mean Selena-SLEDAI score at last visit was 3.18 (SD 4.3) and mean SDI was 1 (SD 1.3). The accumulated treatments most frequently used were antimalarials (90.4%), corticosteroids (90%), azathioprine (31.8%), intravenous cyclophosphamide (30.2%), mycophenolate mofetil or mycophenolic acid (24.5%), methotrexate (19.3%), belimumab 5.3% and rituximab 5.1%. Refractory lupus was diagnosed in 9.3% of the cases. The main causes of death were lupus activity (25.0%), activity and concomitant infections (25.0%), infections (18.2%), vascular disease (13.6%) and cancer (4.5%). Mortality was associated with higher SLEDAI, Katz, damage indexes and comorbidities. Of the 1610 patients included, 44.6% were Caucasian, 44.5% Mestizo, 8.1% Amerindian and 1.2% Afro-Latin American. Mestizo patients had higher male representation, low socioeconomic status, more inadequate medical coverage, fewer formal years of education and shorter disease duration. Polyadenopathies and Raynaud's phenomenon were more frequent in Caucasians. In the logistic regression analysis higher damage index (OR 1.28, CI 95% 1.02-1.61, p = 0.03) remained associated to mestizo ethnicity. CONCLUSIONS: This study represents the largest number of adult patients with SLE studied in Argentina. Caucasian patients were differentiated by having Raynaud's phenomenon and polyadenopathy more frequently, while patients of Mestizo origin had higher damage indexes.

Performance of the RABBIT infection risk score in an Argentinian rheumatoid arthritis cohort.

Patients with rheumatic autoimmune diseases have a higher risk of infections compared with age-and sex-matched controls. In Latin America, there are no validated tools to assess the risk of serious infection. The objectives were to estimate the incidence of serious infections in a cohort of rheumatoid arthritis (RA) patients followed for 12 months and to validate the RABBIT risk score for serious infections. Patients with RA were included and followed for 12 months. Baseline sociodemographic data, comorbidities, RA characteristics, and vaccination status were recorded. The baseline RABBIT risk score was calculated. Serious infections were documented, describing site and time since enrollment. Six hundred five patients were included (13 centers). The incidence of serious infection was 5% (95% CI 3-7). The most frequent sites were respiratory and urinary (90%). Performance of RABBIT risk score: patients with no infection during follow-up had a median score of 1.2 (IQR 0.8-2.1) and patients with infection 5.1 (IQR 2.15-12.6) p 0.00001. ROC curve analysis: AUC 0.86 (95% CI 0.8-0.94), best cut-off 2.85 (sensibility 75%, specificity 85%). The incidence of serious infections was 5% during the follow-up. The RABBIT score performed excellently in our patients. Key Points • The RABBIT risk score for serious infections showed an excellent performance in a population different (Latin America) from the original one included in the German registry. • This may assist rheumatologists in selecting drugs for patients according to the individual risk of infection, in a fast and simple way.

Validation of the adjusted global antiphospholipid syndrome score in systemic lupus erythematosus patients in Argentina.

INTRODUCTION: Assessment of risk both for pregnancy morbidity and thrombosis in the presence of anti-phospholipid antibodies (aPL) is still a challenge in Systemic Lupus Erythematosus (SLE) patients. The Global Antiphospholipid Syndrome Score (GAPSS) takes into account the aPL profile (criteria and non-criteria aPL), the conventional cardiovascular risk factors and the autoimmune antibody profile. An adjusted model of the score (aGAPSS) excluding anti-phosphatidylserine/Prothrombin (aPS/PT), suggests that the score is able to stratify patients for their rate of events making it widely applicable in daily clinical practice. OBJECTIVE: To validate the aGAPSS in a multicentric cohort of SLE patients in Argentina. PATIENTS AND METHODS: consecutive SLE patients with and with andwithout thrombotic events from seven Rheumatologist centers were included. Traditional cardiovascular risk factors, aPL antibodies and medications received (aspirin, hydroxychloroquine and anticoagulation) were collected. The score aGAPSS was calculated for each patient at the last visit by adding together the points corresponding to the risk factors: 1 for hypertension, 3 for dyslipidemia, 4 for LA and B2GPI (IgM or IgG) antibodies and 5 for aCL (IgM or IgG) antibodies. The discriminative ability of the aGAPSS was calculated by measuring the area under the receiver operating characteristic curve (AUC). Multivariate logistic regression analysis was performed to examine the impact of multiple cardiovascular risk factors and laboratory parameters on the occurrence of thrombosis. RESULTS: Two hundred and ninety-six SLE patients were included. One-hundred and twenty-one patients (40.9%) presented thrombotic and/or pregnancy complications. Median aGAPSS was significantly higher in patients who experienced an event (thrombosis and/or pregnancy morbidity) compared with those without [4 (IQR 1-9) versus 1 (IQR 0-5); p < 0.001]. The best cut off point for the diagnosis of thrombosis and/or pregnancy complications was aGAPSS ≥4. Multivariate logistic regression analysis showed that aCL antibodies [OR 2.1 (95% CI 1.16-3.90); p = 0.015] were an independent risk factors for thrombotic events. CONCLUSIONS: This score is a simple tool, easy to apply to SLE patients in daily practice. The use of the aGAPSS could change the non-pharmacologic and pharmacologic treatment in higher risk patients to improve their survival.

La aplicación de planificación estratégica y de herramientas genéricas ISO 9001: 2008 en el control integral de los factores de riesgo para enfermedad cardiovascular determinan una mayor tasa de éxito a largo plazo / The application of strategic planning and generic tools ISO 9001: 2008 in the comprehensive control of risk factors for cardiovascular disease determine a higher long-term success rate

Antecedentes: una adecuada planificación estratégica (PE) y la utilización de herramientas genéricas de las normas ISO 9001:2008, aplicadas en medicina, ha demostrado mejorar la eficacia y la eficiencia de los procesos tanto en áreas administrativas como asistenciales. Objetivo: alcanzar y sostener en el tiempo el control integral de los factores de riesgo para enfermedad cardiovascular (FRCV), implementando y aplicado un seguimiento por procesos (SPP) y evaluando su respuesta por el lapso de tres años en pacientes de alto riesgo clínico, comparándolo con el manejo habitual conocido hasta ahora. Método: 310 pacientes con múltiples FRCV iniciaron el programa de seguimiento (192 varones y 118 mujeres, con edad de 59±11 años, 206 en prevención primaria y 104 en secundaria), divididos aleatoriamente en dos grupos, según el sistema de seguimiento: grupo 1 (n:160: SPP) y grupo 2 (n:150, seguimiento según criterios de sus profesionales asistentes). La PE en cuanto a tiempo y plazos se objetivó previamente mediante gráfica de Gantt, el primer año en cuatro trimestres, segundo y tercer año en dos semestres cada uno, y su implementación mediante herramienta de suceso real PERT (evaluación de programa y técnica de revisión); se evaluaron los resultados comparativos entre ambos grupos, teniendo, como objetivo de calidad, el control integral y sostenido de los FRCV. Test de t para datos apareados, con nivel de rechazo de hipótesis nula: p<0,05. Resultado: 294 pacientes (95%) completaron el seguimiento a tres años, lograron alcanzar y mantener las metas de control previstas, para el grupo 1: 58%, 56% y 55%, y para el grupo 2: 32%, 28% y 25%, para cada año respectivamente (p<0,01). Conclusión: el cumplimiento y sostenimiento de objetivos de calidad mediante planificación estratégica y utilización de herramientas de gestión genéricas ISO 9001:2008 logra a largo plazo una tasa de éxito elevada en el control integral de los FRCV.

The application of strategic planning and generic tools ISO 9001:2008 in the integral control of risk factors for cardiovascular disease, improve efficiency and efficacy of administrative and care processes. Background: adequate strategic planning (SP) and the use of generic tools of ISO 9001:2008, applied in medicine has been shown to improve the effectiveness and efficiency of processes, both in administrative areas such as healthcare. Objective: to achieve and sustain over time the integral control of risk factors for cardiovascular disease (CVRF), implementing and applying a tracking process (TPP) and evaluating their response for a period of 3 years in high clinical risk patients, compared with standard management known so far. Methods: 310 patients with multiple CVRF began the monitoring program (192 men and 118 women, aged 59 ± 11 years , 206 in primary prevention and 104 in secondary), were randomly divided into two groups according to the tracking system Group 1 (n = 160 : TPP) and Group 2 (n = 150, follow criteria of professional assistants). The SP in terms of time and deadlines previously studied using Gantt chart, the first year in 4 quarters, second and third year of 2 semesters each, and deployment tool real event PERT (program evaluation and technique review) , the comparative results between the two groups were evaluated, taking aim quality, integrated control and sustained CVRF. T test for paired data, with the level of rejection of null hypothesis: p: < 0.05. Results: 294 patients (95%) completed follow-up to 3 years, managed to achieve and maintain control targets planned: for Group 1: 58%, 56% and 55%, for Group 2 : 32%, 28% and 25% for each year respectively (p: <0.01). Conclusion: the implementation and maintenance of quality objectives through strategic planning and use of generic management tools ISO 9001:2008 , achieved long-term success rate in the comprehensive control of CVRF.