Background An easy, quick tool, requiring minimal training or physician input for disease activity (DA) assessment in SLE, would have potentially greater uptake for routine use among rheumatologists and primary care physicians. Furthermore, integration into busy work flow processes would be easier for the same reason. Most DA tools for SLE are complex, require training and physician time; and are not performed during routine care visits for most SLE patients. SIMPLE (Simple Disease Assessment for People with Lupus Erythematosus) 1 is a numeric composite index based on patient reported questions and two laboratory values, and requires minimal input from health care provider which can be provided by nurse or a physician extender. Here, we prospectively evaluate the correlation of SIMPLE index with physician based DA measure.
Objectives Prospectively validate SIMPLE index as a DA measure compared to traditional physician based DA assessment tools.
Methods 72 consenting patients meeting ACR classification criteria for SLE were recruited from two academic center clinics. Primary outcome of interest was correlation between Simple Index (SI) and SELENA-SLEDAI (SS). Secondary outcome of interest was correlation between SI and Physician Global Assessment (PGA). Patients filled the self-reported components of SI in the waiting room prior to their visit. PGA and SS were assessed at the same visit by the physician. Descriptive and spearman correlational analyses were obtained. Stratified analysis by fibromyalgia status (FMS) was also conducted. P value of ≤0.05 was considered significant on two tailed tests. We considered correlation coefficient of <0.30, 0.30 to 0.49 and >0.50 as weak, moderate and strong correlation, respectively.
Results Mean (SD) age was 40.8+12.4 yrs, and 87.5% participants were women. Ethnic background of the participants was as follows: 52.8% Blacks, 25% Whites, 8.3% Hispanic, 6.9% Asians and 6.9% others. Median (IQR) SI was 21.7 (17.2). Median (IQR) values of PGA and total SS were 0.5 (1.0) and 4.0 (6.0), respectively. Spearman correlation coefficient between SI and PGA and SS were 0.507 (p 0.001), 0.568 (p 0.001), respectively. In a sub analysis excluding fibromyalgia patients, these correlations were 0.538 (p 0.001, n=60), 0.633 (p 0.001, n=59) respectively.
Conclusions SIMPLE index is strongly correlated with PGA and SS in SLE patients, and the correlation is even stronger in SLE patients without FMS. SIMPLE index is quick, easy and requires negligible health care team input, which can be from a physician extender or a nurse or any physician. SIMPLE Index has the potential to be widely used in varied health care access levels and systems in different parts of the world. SIMPLE Index can potentially serve as a quality of care measure. Larger and longitudinal studies that include patients with greater DA and to test its responsiveness are currently ongoing.
Simple Disease Assessment for People with Lupus Erythematosus. A&R. 2014; 66 (11):s312
Disclosure of Interest N. Gandhi: None declared, M. Jolly Grant/research support from: Pfizer Inc, A. Nevares: None declared, W. Sequeira: None declared