Lupus Impact Tracker Research Articles

Impact of disease activity patterns on health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE)

ObjectiveTo assess the impact of different disease activity patterns—long quiescent (LQ), chronically active (CA) and relapsing-remitting (RR)—on health-related quality of life (HRQoL) in a cohort of patients with systemic lupus...

Vision-Related Quality of Life in Patients with Systemic Lupus Erythematosus.

To assess vision-related quality of life (VRQoL) in patients with systemic lupus erythematosus (SLE) under treatment with hydroxychloroquine (HCQ), and to find the influencing factors. Cross-sectional study enrolling SLE patients for less than ten years (Group 1), SLE patients for more than ten years (Group 2), and healthy controls (Group 3). SLE patients should be under treatment with HCQ but without ophthalmological affection. Schirmer test, best-corrected visual acuity (BCVA), axial length (AL) with optical biometry, and swept-source optical coherence tomography-angiography (OCTA) Triton (Topcon) were performed. All participants fulfilled the Impact of Visual Impairment questionnaire, and SLE patients answered the Lupus Impact Tracker (LIT) questionnaire. Additional data were obtained from clinical records. A totals of 41 eyes (41 patients), 31 eyes (31 patients) and 45 eyes (45 volunteers) were enrolled in the study groups. The mean ages were 41.09 ± 9.56, 45.06 ± 8.47 and 40.25 ± 10.83 years, respectively (p = 0.10). The LIT outcomes were 33.49 ± 20.74 and 35.98 ± 22.66 (p = 0.63), respectively. Group 3 referred to a better VRQoL than Group 2 in all categories and than Group 1 in some of them. A linear regression analysis showed that serum ferritin, SLE activity scales, body-mass index (BMI), age, and BCVA influenced VRQoL. The LIT questionnaire was correlated to two categories of the Impact of Visual Impairment questionnaire (IVI). Despite no ophthalmological affection, SLE patients refer to poorer VRQoL because of disease activity and a low health-related quality of life, which has a negative influence on VRQoL. This masks the effect of other ophthalmological conditions such as dry eyes. Other variables influencing VRQoL are age and BMI, and BCVA, to a lesser extent.

Impact of adherence to EULAR quality indicators on the quality of life of patients with systemic lupus erythematosus

ObjectiveQuality indicators (QIs) for systemic lupus erythematosus (SLE) management based on the 2019 update of European League Against Rheumatism (EULAR) recommendations have been recently proposed. We aimed to determine whether adherence to QIs was associated with patient reported outcome (PRO). MethodsAdherence to a set of 18 EULAR-based QIs and correlation with PRO assessed by Lupus Impact Tracker (LIT) was tested in a cohort of 162 SLE patients. ResultsOn average, SLE patients received 41% (33; 52.5) of recommended care. Higher adherence to monitoring-related QIs was associated with an older age, a shorter SLE disease duration and a more severe disease (i.e. Class III/IV/V nephritis). LIT demonstrated that the average impact of lupus on patients’ life was of 30% (12.5;47.5). In multivariable analysis, patients of female gender (OR 0.25, 95% 0.05–0.94; p = 0.05), with lupus CNS (OR 0.33, 95%CI 0.08–1.05; p = 0.08) and skin involvements (OR 0.49, 95%CI 0.23–1.04; p = 0.07) had higher odds of experiencing a negative impact of the lupus on their life. No association were found between adherences to QIs by physicians and reported quality of life in lupus patients. ConclusionOur study confirms a variable degree of clinicians’ adherence to QIs for SLE and shows no clear association between QIs adherence and patient reported outcome. Adherence to QIs by physicians are not enough to impact the quality of life of patients.

Self-Reported Anxiety and Depression in a Monocentric Cohort of Patients With Systemic Lupus Erythematosus: Analysis of Prevalence, Main Determinants, and Impact on Quality of Life.

Aims of the studyTo analyze the prevalence of self-reported anxiety and depression in a monocentric cohort of patients with Systemic Lupus Erythematosus (SLE); to study the main determinants and the impact on quality of life (QoL).MethodsA cross-sectional observational study including adult outpatients with SLE. Demographic and clinical data were analyzed: indices of disease activity (SELENA-SLEDAI); damage (SLICC-DI); comorbidities and concomitant therapies. The definitions for remission (DORIS) and “Lupus Low Disease Activity State” (LLDAS) were applied. At enrollment, each patient completed the following questionnaires: SF-36, FACIT-Fatigue, Lupus Impact Tracker (LIT), Systemic Lupus Activity Questionnaire (SLAQ), and the Hospital Anxiety and Depression Scale (HADS) in order to self-assess anxiety and depression symptoms. The Student t-test and Chi2 tests were conducted for univariate analysis. The Spearman test was used for linear correlation between continuous data. Multivariate analysis was performed by multiple linear and logistic regression.ResultsOne hundred fifty-four consecutive patients with SLE were enrolled, the majority female and Caucasian with a mean age = 43.3 ± 13.7 years. 79.9% were in LLDAS or remission. 36.4% had a SDI > 1. 13.7% of patients had concomitant fibromyalgia. 37.4% had symptoms indicating anxiety and 25% of depression according to the HADS questionnaire. In the multivariate analysis, patients with active disease were significantly more anxious and depressed (p < 0.01) compared to patients in LLDAS or remission. Fibromyalgia and older age were independently associated with anxiety and depression, respectively (p < 0.05). Active skin involvement was significantly linked to depression (p < 0.05). Higher scores on the HADS questionnaire (higher levels of anxiety and depression) were found to be significantly linked to patients’ perception of higher disease activity and worse quality of life, irrespective of disease activity, age and fibromyalgia.ConclusionSymptoms of anxiety and depression are frequent in SLE patients, including outpatients with mild/moderate disease. Such symptoms have a significant negative impact on QoL and perception of disease activity, regardless of other factors. Moreover, disease activity, advanced age and fibromyalgia appear to be significantly linked to mood disorders. Assessing symptoms of the anxious-depressive spectrum in patients with SLE could lead to improvement in patients’ perception of health status and quality of life.

53 Attainment of Complete Renal Response Results in Significant Improvements in Lupus Impact Tracker in the AURORA 1 Study of Voclosporin in Lupus Nephritis

53 Attainment of Complete Renal Response Results in Significant Improvements in Lupus Impact Tracker in the AURORA 1 Study of Voclosporin in Lupus Nephritis

Does hydroxychloroquine improve patient reported outcomes in patients with lupus?

Hydroxychloroquine (HCQ) use is associated with less disease activity, flares, damage and improved survival in Systemic Lupus Erythematosus (SLE). However, its effect on patient reported health outcomes (PROs) such as quality of life (QOL) is not known. International data from Study on Outcomes of Lupus (SOUL) from 2,161 SLE patients were compared by HCQ use. Disease activity and damage were assessed using SELENA-SLEDAI and SLICC-ACR/SDI. QOL was evaluated using LupusPRO and Lupus Impact Tracker (LIT). Linear regression analyses were performed with LupusPRO summary scores health related HRQOL, non-health related NHRQOL and LIT as dependent and HCQ use as independent variable. Analyses were undertaken to test mediation of effects of HCQ use on QOL through disease activity. Mean age was 40.5 ± 12.8 years, 93% were women. Sixty-three (1363/2161) percent were on HCQ. On univariate analysis, HCQ use was associated with (a) better QOL (LupusPRO-HRQOL: β 6.19, 95% CI 4.15, 8.24, P ≤ 0.001, LupusPRO NHRQOL: β 5.83, 95% CI 4.02, 7.64, P ≤ 0.001) and less impact on daily life (LIT: β -9.37, 95% CI -12.24, -6.50, P ≤ 0.001). On multivariate and mediational analyses, the effects of HCQ on QOL were indirectly and completely mediated through disease activity. HCQ use in SLE is associated with better patient reported health outcomes (LupusPRO-HRQOL and NHRQOL and impact on daily life), and the effects are mediated through disease activity. This information can facilitate patients and physician's communication with decision-making regarding the use of HCQ for SLE management.

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

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). 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. 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). 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.

Patient-reported flare frequency is associated with diminished quality of life and family role functioning in systemic lupus erythematosus.

To understand the influence of the systemic lupus erythematosus (SLE)-related flares on patient's health-related quality of life (HRQoL). An online survey included individuals with self-reported physician's diagnosis of SLE or lupus nephritis (LN). Lupus impact tracker (LIT) assessed lupus symptoms and HRQoL, SLE-Family questionnaire measured family role functioning, and Healthy Days Core Module (HDCM) measured overall mental and physical health. Chi-square and analysis of variance evaluated differences by flare frequency. Multivariable linear regression and generalized linear models evaluated the independent relationships of flare frequency to HRQoL. 1066 respondents with SLE or LN completed the survey. Mean (SD) duration of illness was 12.4 (10.1) years. 93.4% (n = 996) were women, 82.3% (n = 830) were White, and 49.7% (n = 530) were employed or students. More frequent flares were associated with significantly worse scores on all HRQoL measures: LIT (adjusted means: 0 flares, 31.8; 1-3 flares, 47.0; 4-6 flares, 56.1; ≥ 7 flares, 63.6; P < 0.001); SLE-Family (adjusted means: 0 flares, 3.1; 1-3 flares 3.8; 4-6 flares, 4.3; ≥ 7 flares, 4.6, P < 0.001); HDCM unhealthy days (0 flares, 8.7; 1-3 flares, 17.4; 4-6 flares, 21.5; ≥ 7 flares, 26.2days, P < 0.001). Lupus flares contributed to impaired functional and psychological well-being, family functioning, and number of monthly healthy days. Better understanding of the burden of flare activity from the patient's perspective will support a holistic approach to lupus management.

Impact of fatigue on health-related quality of life and illness perception in a monocentric cohort of patients with systemic lupus erythematosus

BackgroundFatigue is a very common and debilitating symptom in patients with systemic lupus erythematosus (SLE), even among those with a mild or inactive disease. The objective of this study is...

Measuring and monitoring health-related quality of life responsiveness in systemic lupus erythematosus patients: current perspectives

ObjectiveLittle is known about health-related quality of life (HRQoL) responsiveness in systemic lupus erythematosus (SLE) patients, compared to other chronic diseases. This review summarizes the available data in HRQoL responsiveness and sensitivity to change in SLE, and recommends directions for research and clinical application.MethodsA review of the literature was conducted reporting on HRQoL responsiveness in adult SLE patients between 1984 and 2018. HRQoL studies were assessed for responsiveness, sensitivity of change, minimal important differences, minimal clinical important differences, or change in improvement or deterioration.ResultsResponsiveness or sensitivity to change in health-related status was observed in Medical Outcome Survey Short Form-36, SLE Symptom Checklist, EuroQoL, and Medical Outcomes Study Short Form 6D. SLE-specific quality of life questionnaire demonstrated greater responsiveness than the individual domains of SF-36. Lupus quality of life showed large responsiveness when there was improvement. LupusPRO and its derivative Lupus Impact Tracker were found to be responsive to change in disease activity, reflecting both improvement and worsening. Lupus Impact Tracker and physical health and pain domains of Lupus quality of life were responsive to SLE composite responder index.ConclusionThis review highlights the need for further studies that capture responsiveness and change in HRQoL that are clinically meaningful and sustained. Most importantly, the choice of one measure over another is influenced by the purpose of the HRQoL measure, the particular HRQoL domain, and the SLE disease state that are relevant to the research question.

Patient-reported outcome measures for use in clinical trials of SLE: a review

Inclusion of patient-reported outcomes is important in SLE clinical trials as they allow capture of the benefits of a proposed intervention in areas deemed pertinent by patients. We aimed to...

External Validation of the Lupus Impact Tracker in a Southeastern US Longitudinal Cohort With Systemic Lupus Erythematosus.

To examine the external validity of the Lupus Impact Tracker (LIT), a systemic lupus erythematosus (SLE)-specific, health-related quality of life (HRQoL) tool in a population-based cohort of patients with SLE in Atlanta, Georgia. We modeled the association of LIT scores with patient-reported measures of SLE activity (Systemic Lupus Activity Questionnaire [SLAQ]) and organ damage (self-administered Brief Index of Lupus Damage [SA-BILD]). We investigated the association of LIT scores with general HRQoL using the Short Form 12 (SF-12). Correlation, multivariable regression, and longitudinal analyses using general linear modeling with fixed effects were performed to investigate the association between the LIT and patient-reported disease activity (SLAQ); patient-reported disease damage (SA-BILD); mental health (mental component summary [MCS] of the SF-12); and physical health (physical component summary [PCS] of the SF-12). Demographic trends related to the LIT were also assessed using cross-sectional analysis. The LIT was significantly associated with disease activity (SLAQ), organ damage (SA-BILD), MCS scores, and PCS scores in both adjusted and unadjusted regression analysis (P < 0.0001). Longitudinal analysis demonstrated a significant association between the LIT and disease activity (SLAQ), MCS scores, and PCS scores (P < 0.0001), but not organ damage (SA-BILD). The LIT is a simple, patient-centered tool that can be used to assess HRQoL in patients with SLE. This study provides external validity of the LIT in a population-based cohort with a large number of African American patients with a relatively high disease burden.

Perceived stress and reported cognitive symptoms among Georgia patients with systemic lupus erythematosus.

Objective To examine associations of perceived stress with cognitive symptoms among adults with systemic lupus erythematosus (SLE). Methods Among 777 adult (≥18 years) SLE patients, the association of Perceived Stress Scale (PSS) scores with two self-reported cognitive symptoms was examined: forgetfulness (severe/moderate vs. mild/none; from the Systemic Lupus Activity Questionnaire) and difficulty concentrating (all/most vs. some/little/none of the time; from the Lupus Impact Tracker). The study used multivariable logistic regression to estimate the odds ratios (ORs) per minimal important difference (MID = 0.5*SD) of PSS score and cognitive symptoms. Results Forgetfulness and difficulty concentrating were reported by 41.7% and 29.5%, respectively. Women and those with less education and high disease activity had higher PSS scores and were more likely to report cognitive symptoms than their counterparts. With adjustment for age, race, sex, education, and disease activity, each MID increase in PSS score was associated with higher prevalence of forgetfulness (OR = 1.43, 95% CI 1.29-1.47) and difficulty concentrating (OR = 2.19, 95% CI 1.90-2.52). No substantial differences in this association by age, race, sex, or disease activity were noted. Conclusions SLE patients, particularly those with high disease activity, report a high burden of cognitive symptoms, for which stress may be a modifiable risk factor.

Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings.

The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives. A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method. Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5 (13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8 (10.8) and mental component summary 43.0 (12.3). Mean LIT score was 34.2 (22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo- R 2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P < 0.035) and absence of flares (P = 0.004). The LIT showed a strong association with SF-36 physical and social role functioning, vitality, bodily pain and mental health (P < 0.001). The LIT was well accepted by patients and physicians. It was reliable, with Cronbach α coefficients ranging from 0.89 to 0.92 among countries. The LIT is validated in the five participating European countries. The results show its reliability and cultural invariability across countries. They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction.

Importance of health-related quality of life and its current assessment tools in patients with systemic lupus erythematosus

The paper presents an overview of studies assessing health-related quality of life (HRQoL) in patients with systemic lupus erythematosus (SLE). It describes the HRQoL concept and prerequisites for its creation. The classification of questionnaires used in patients with SLE is considered in relation to the study objectives. The main key triad (fatigue, pain, and depression), which causes a reduction in HRQoL in SLE patients, is derived on the basis of many studies. The paper provides brief comparative characteristics of eight specific HRQoL questionnaires in SLE patients: Symptom checklist (SSC), SLEQol, LupusQol, L-QoL, LupusPRO, and Lupus Impact Tracker (LIT), LUP-QoL, and SMILEY. Special attention is paid to HRQoL assessment in patients receiving different treatment options: glucocorticoids, cytostatic and anti-B-cell therapy.

The lupus impact tracker is responsive to changes in clinical activity measured by the systemic lupus erythematosus responder index.

Objective The lupus impact tracker (LIT) is a 10-item patient reported outcome tool to measure the impact of systemic lupus erythematosus or its treatment on patients' daily lives. Herein, we describe the responsiveness of the LIT and LupusQoL to changes in disease activity, using the systemic lupus erythematosus responder index (SRI). Methods A total of 325 adult systemic lupus erythematosus patients were enrolled in an observational, longitudinal, multicentre study, conducted across the USA and Canada. Data (demographics, LIT, LupusQoL, BILAG, SELENA-SLEDAI) were obtained three months apart. Modified SRI was defined as: a decrease in SELENA-SLEDAI (4 points); no new BILAG A, and no greater than one new BILAG B; and no increase in the physician global assessment. Standardised response mean and effect size for LIT and LupusQoL domains were calculated among SRI responders and non-responders. Wilcoxon's test was used to compare the LIT and LupusQoL variation by SRI responder status. Results Of the participants 90% were women, 53% were white, 33% were of African descendant and 17% were Hispanic. Mean (SD) age and SELENA-SLEDAI at baseline were 42.3 (16.2) years and 4.3 (3.8), respectively. Mean (SD) LIT score at baseline was 39.4 (22.9). LIT standardised response mean (effect size) among SRI responders and non-responders were -0.69 (-0.36) and -0.20 (-0.12), respectively ( P = 0.02). For LupusQoL, two domains were responsive to SRI: standardised response mean (effect size) for physical health and pain domains were 0.42 (0.23) and 0.65 (0.44), respectively. Conclusions LIT is moderately responsive to SRI in patients with systemic lupus erythematosus. Inclusion of this tool in clinical care and clinical trials may provide further insights into its responsiveness. This is the first systemic lupus erythematosus patient reported outcome tool to be evaluated against composite responder index (SRI) used in clinical trials.

Validation of the Lupus Impact Tracker in an Australian patient cohort.

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. 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. 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. 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.

Prospective Validation of the Lupus Impact Tracker: A Patient-Completed Tool for Clinical Practice to Evaluate the Impact of Systemic Lupus Erythematosus.

To evaluate the reliability, validity, responsiveness, and utility of the Lupus Impact Tracker (LIT). This was a prospective longitudinal study with 20 North American sites participating. Consenting patients completed the LIT, Medical Outcomes Study Short Form 36 (version 2), Patient Health Questionnaire 9 (PHQ-9), LupusQoL, and patient LIT feedback questionnaire. Rheumatologists completed the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, and physician LIT feedback questionnaire. The reliability, convergent validity, construct validity, and responsiveness of the LIT were evaluated. Of the 325 SLE patients enrolled, 90% were female, 53% were white, and 33% were African American. Their mean age was 42 years. The mean ± SD baseline physician's global assessment and total SELENA-SLEDAI scores were 1.04 ± 0.8 and 4.28 ± 3.8, respectively, while 3-month scores were 0.94 ± 0.73 and 4.09 ± 3.79, respectively. Internal consistency reliability was high (>0.9) at both visits. LIT scores correlated highly with other measures of patient-reported outcomes, and construct validity was established against clinical measures. The LIT was highly responsive to patient-reported changes in SLE health status; however, LIT scores were not as responsive to changes in the SELENA-SLEDAI score. The majority of patients and physicians found LIT to be acceptable and feasible to administer in a clinical setting. The LIT is a reliable and valid instrument for assessing the impact of SLE on patients and captures unique and important information not included in physician assessments of disease. It may be useful in clinical practice to facilitate communication between the physician and the patient and enable efficient incorporation of the patient's perspective in disease management.

Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus.

To evaluate the responsiveness of Lupus Impact Tracker (LIT) to changes in physician and patient disease activity assessments over time. Available longitudinal data from routine patient care visits on LIT, physician assessed disease activity (physician global assessment (PGA), SELENA-SLEDAI score, SELENA Flare Index (SFI)), and patient-reported changes in systemic lupus erythematosus (SLE) health status were analyzed. Significant, clinically important change (worsening or improvement) in physician disease activity assessment or patient-reported SLE health status were judged using the following criteria: change of 0.3 on PGA, 4 on SELENA-SLEDAI, change in SFI status over time, and change of 2 in either direction in patient-reported SLE health status. Mixed model regression analysis was used to compare changes in LIT using the above criteria. There were 1184 observations with significant changes in physician disease activity or patient-reported measure for 182 patients' data across 1364 visits. Patients' mean (SD) age and SELENA-SLEDAI were 43.5 (13.2) years and 6.4 (7.3) respectively. LIT mean scores decreased by more than 3 with improvement in PGA (standardized response mean -0.26, p < 0.05), while it increased by more than 5 with worsening in SELENA-SLEDAI (standardized response mean 0.42, p = 0.01). Mean change in LIT of greater than ±3 was noted with change in SFI status (p < 0.05). Mean LIT score decreased by greater than 4 and increased by greater than 2 with patient-reported improvement and worsening in SLE health status respectively (p < 0.05). LIT is responsive to physician-assessed and patient-assessed changes in disease status. A mean LIT change of 2-4 may represent a significant clinical change in LIT. It is an effective tool that may be used by patients and physicians in tracking disease impact in SLE patients.

Development and validation of the Lupus Impact Tracker: a patient-completed tool for clinical practice to assess and monitor the impact of systemic lupus erythematosus.

To derive and validate a brief patient-completed instrument, the Lupus Impact Tracker (LIT), to assess and monitor the impact of systemic lupus erythematosus (SLE). Items for the LIT were selected from the LupusPRO, a validated patient-reported outcomes measure, using 3 approaches: confirmatory factor analysis (CFA), stepwise regression, and patient focus groups. CFA was conducted to find items from the LupusPRO that fit a unidimensional structure to allow scoring as a single index. Stepwise regression methods identified items with the strongest relationship (convergent validity) with disease activity measures and patient health rating. Focus groups (n = 26 patients) identified the most important items describing SLE impact. Selected items were evaluated for reliability and validity. CFA found 21 items that fit a unidimensional structure. Stepwise regressions identified 15 of 21 items having good convergent validity with clinical measures. Patient focus groups identified 9 of 15 items as best capturing the impact of SLE. Overall, 7 items were selected across all 3 approaches (CFA, stepwise regression, and focus groups). Another 15 items were selected across 2 approaches. Through consensus with rheumatology clinician experts, a final set of 10 items was selected for the LIT. The LIT items showed good internal consistency (0.89) and test-retest reliabilities (0.87). Mean LIT scores differed significantly (P < 0.05) across criterion groups in the hypothesized direction, providing evidence of discriminant validity and responsiveness. The LIT is reliable and valid in SLE patients and offers a practical way for physicians and patients to assess and monitor the impact of SLE.