Does higher quality of care in systemic lupus erythematosus translate to better patient outcomes?

PURPOSE: To assess if high quality of care (QOC) in SLE results in improved outcomes of quality of life (QOL) and non-routine health care utilization (HCU). METHODS: One hundred and forty consecutive SLE patients were recruited from the Rheumatology clinic at an academic center. Data on QOC and QOL were collected along with demographics, socio-economic, and disease characteristics at baseline. LupusPRO assessing health-related (HR) QOL and non (N)HRQOL was utilized. Follow up QOL and HCU were collected prospectively at 6 months. High QOC was defined as those meeting ≥80% of the eligible quality indicators. Univariate and multivariate regression analyses were performed with QOC and high QOC as independent variables and HRQOL and NHRQOL as dependent variables at baseline and follow up. Multivariable models were adjusted for demographics and disease characteristics. Secondary outcomes included non-routine HCU and disease activity at follow up. RESULTS: Baseline and follow up data on 140 and 94 patients, respectively, were analyzed. Mean (SD) performance rate (QOC) was 78.6 (13.4) with 52% patients in the high QOC group. QOC was associated with better NHRQOL at baseline and follow up but not with HRQOL. Of all the NHRQOL domains, QOC was positively associated with treatment satisfaction. QOC or high QOC were not associated with non-routine HCU and were instead associated with higher disease activity at follow up. CONCLUSION: Higher QOC predicted better NHRQOL by directly impacting treatment satisfaction in SLE patients in this cohort. Higher QOC, however, was not associated with HRQOL, HCU, or improvement in disease activity at follow up.

Pneumococcal Vaccination Among Lupus Patients: Who Are the Recipients?

PURPOSE: Pneumococcal vaccination (PV) is indicated for the elderly (age ≥65 years) and those with chronic disease or who are immunosuppressed. We aimed to study the rate and predictors of recommendation/receipt of 23 valent pneumococcal polysaccharide vaccine (PPSV23) in immunosuppressed systemic lupus erythematosus (SLE) patients. METHODS: Data were obtained through self-report questionnaires and medical chart review of 150 SLE patients. Information on rheumatologist recommendation or receipt of PPSV23 in the preceding 5 years was collected if self-reported in a questionnaire or documented in the medical chart. Chart review was also done to collect data on patient demographics, physician characteristics (if patients had a primary care physician and rheumatologist's SLE patient volume), and the disease characteristics of SLE. Comparisons using χ2 or t tests and logistic regression analyses were conducted for predictors of recommendation/receipt of PV. RESULTS: The mean (SD) age was 47.4 (15.9) years; 90% were women. Sixty-five of 94 eligible patients for PV (based on immunosuppressive medications use or age) had been either recommended or administered PPSV23. On univariate logistic regression analysis, age, duration of disease, current use of hydroxychloroquine or mycophenolate, and rheumatologist's SLE patient volume were significant correlates of recommendation/receipt of PPSV23. However, on multivariate analysis, the only significant predictor was rheumatologist's SLE patient volume after adjusting for the above correlates such that with every 50 patients increase in SLE patient clinic volume, the odds of recommendation/receipt of PPSV23 increased by 2.37 times. CONCLUSIONS: The volume of lupus patients that rheumatologists see is strongly associated with the likelihood that their SLE patients will have PPSV23 recommended and delivered, suggesting a volume outcome relationship.

Validation of SIMPLE Index for Lupus Disease Activity.

OBJECTIVE: An easy, quick tool requiring minimal training or health care provider input would potentially have greater uptake for clinical use among rheumatologists and primary care physicians for assessment of disease activity in systemic lupus erythematosus (SLE). SIMPLE (SIMple Disease Assessment for People with Lupus Erythematosus) index is a composite numeric tool that is easy and quick to calculate. We prospectively assessed the performance of the SIMPLE index as a disease activity surrogate against physician-based disease activity measures. METHODS: Ninety-nine consenting patients meeting American College of Rheumatology SLE classification criteria were recruited. Safety of Estrogen in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI), physician global assessment, and SIMPLE index were obtained during routine visits. SIMPLE index is a 17-item patient-reported questionnaire that includes 2 laboratory tests. Health care provider input is needed only to provide laboratory results (normal/abnormal) and confirming patient-reported current use and dosing of glucocorticoids. We performed Spearman test to assess correlation of SIMPLE index with SELENA-SLEDAI and physician global assessment. RESULTS: Mean age (SD) was 39.7 (12.3) years. The correlation coefficient between SIMPLE index and SELENA-SLEDAI was 0.56 (P = 0.0001), and that between SIMPLE index and physician global assessment was 0.54 (P = 0.0001). In SLE patients without fibromyalgia (FM), the correlation of SIMPLE index with SELENA-SLEDAI and physician global assessment was 0.58 (P = 0.0001) and 0.57 (P = 0.0001), respectively. CONCLUSIONS: SIMPLE index is strongly correlated with formal physician assessments of disease activity in SLE, and correlation was marginally higher among those without FM. SIMPLE index can be performed easily in places with limited physician and laboratory resources.

Validation of the Cutaneous Lupus Disease Area and Severity Index (CLASI) using physician- and patient-assessed health outcome measures.

BACKGROUND: The Cutaneous Lupus Disease Area and Severity Index (CLASI) has not been validated using rheumatologist-conducted disease activity and damage assessments, especially cutaneous assessments. Active skin disease and skin damage may have substantial effects on patient-reported outcomes and on body image. OBJECTIVE: We sought to validate the CLASI against: (1) physician-assessed disease activity and damage measures; and (2) patient-reported assessment of quality of life and body image. METHODS: Cross-sectional data were collected from 31 patients with cutaneous lupus erythematosus. Cutaneous disease activity and damage were measured by using the CLASI. Disease activity (using the Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus [SLE] Disease Activity Index [SLEDAI}), damage (Systemic Lupus International Collaboration Clinics-American College of Rheumatology Damage Index [SDI]), quality of life (LupusPRO), and body image (Body Image Quality of Life Inventory) were obtained. Descriptive statistics and Spearman correlations were ascertained. RESULTS: Mean (SD) age was 42.3 (12.8) years; 97% were women. The mean (SD) CLASI activity and damage scores were 10.5 (7.4) and 9.9 (9.5). Correlations noted were: total CLASI activity and SLEDAI-rash (r = 0.42, P = .02), CLASI-mucosal and SLEDAI-mucosal (r = 0.65, P = .001), CLASI-recent hair loss and SLEDAI-alopecia (r = 0.61, P = .001), and total CLASI activity and LupusPRO symptoms domain (r = -0.38, P = .04). Total CLASI-damage correlated with SDI-scarring/alopecia (r = 0.51, P = .004), SDI-extensive scarring/panniculum (r = 0.55, P = .003), and SDI-skin ulceration (r = 0.36, P = .05). CLASI scalp scarring correlated with SDI-skin scarring/alopecia (r = 0.94, P = .001). CLASI activity on the face and nose was associated with significant concerns on the Body Image Quality of Life Inventory. LIMITATIONS: Limitations include small sample size. CONCLUSION: CLASI activity and damage scores correlate with physician-assessed cutaneous activity and damage in cutaneous lupus erythematosus in patients with SLE. Cutaneous activity in visible areas may generate body image concerns.

Posterior reversible encephalopathy syndrome in systemic lupus erythematosus.

BACKGROUND/OBJECTIVE: Posterior reversible encephalopathy syndrome (PRES) is an underrecognized and reversible condition in systemic lupus erythematosus (SLE) that could mimic neuropsychiatric lupus. Identification of any distinct clinical patterns is important as one would need to escalate rather than decrease or discontinue immune suppression in neuropsychiatric lupus. METHODS: We retrospectively identified and described 5 patients with SLE who were hospitalized and diagnosed with PRES from 2008 to 2013 in a tertiary medical center and reviewed relevant literature. RESULTS: Posterior reversible encephalopathy syndrome in SLE occurred in young women with age distribution from 19 to 37 years. At the time of presentation, all had hypertension (systolic blood pressures ranging from 150 to 220), moderate to severe disease activity (Systemic Lupus Erythematosus Disease Activity Index scores ranging from 11 to 41), and prototypical magnetic resonance imaging findings of PRES and nephritis (4 of 5 patients had biopsy-proven lupus nephritis). Seizures, headache, and confusion were the most common clinical symptoms. One patient had intracerebral hematoma, and 2 patients had cerebral petechial hemorrhages. All patients improved without any neurological deficits, with a mean hospital stay of 11.2 days. CONCLUSIONS: Systemic lupus erythematosus should be considered in the differential diagnosis of patients who present with PRES. One should have a low threshold for magnetic resonance imaging especially when neurological symptoms occur in young women with or without an established diagnosis of SLE and especially among those with active SLE, lupus nephritis, renal failure, and/or poorly controlled hypertension. Given the good prognosis of PRES in SLE patients with early supportive treatment, prompt recognition is crucial to institute appropriate management.

Does Higher Quality of Care in Systemic Lupus Erythematosus Improve Quality of Life?

OBJECTIVE: To study the association between high quality of care (QOC) and quality of life (QOL) and nonroutine health care use (HCU) in systemic lupus erythematosus. METHODS: Data were derived from 814 participants from the Lupus Outcomes Study sample. Data on sociodemographic information, disease status, medications, and health care variables were collected through annual interviews. QOC was measured at baseline on 13 quality indices amenable to self-report. Follow-up QOL was measured using the Short Form 36 health survey (SF-36) 2 years later. Univariate and multivariate regression analyses assessed the relationship between QOC and SF-36 scores at baseline, and logistic regression analyses evaluated QOC at baseline as a predictor of minimal clinically important difference (MCID) improvements in SF-36 scores, emergency room (ER) visits, and hospitalizations at follow-up. RESULTS: Higher QOC was associated with worse scores on SF-36 domains on univariate analysis at baseline, which was mediated by comorbidities and high disease activity. QOC and the number of years in high QOC were not predictive of MCID improvements in SF-36 scores at follow-up, which were driven by baseline SF-36 scores, disease activity, and nonroutine HCU. A similar pattern was noted for ER visits and hospitalizations, for which disease activity, damage, and glucocorticoid dose were significant predictors and not QOC. CONCLUSION: High QOC at baseline and the number of years with high QOC are not associated with MCID improvement in SF-36 scores and nonroutine HCU on follow-up. High QOC, as determined by currently defined criteria, serves as a surrogate of greater disease activity, morbidity, and nonroutine HCU.

Body image in patients with systemic lupus erythematosus.

BACKGROUND: Systemic lupus erythematosus (SLE), a multisystemic disease of young women may be disfiguring and affect physical and emotional health. Body image literature in SLE is scant and controversial. PURPOSE: We compared body image-related quality of life in subjects with (n = 87) and without (n = 78) SLE and determined its correlates using the body image quality of life inventory (BIQLI). METHOD: The tool was self-administered to consenting individuals. Demographic information along with disease activity and damage assessments for SLE patients were obtained. T test, chi square test, correlational, and regression analyses were used to make comparisons. RESULTS: Mean age (±SD) were 42.4 ± 13.1 and 38.7 ± 13.2 years for SLE and non-SLE subjects, respectively. Mean (±SD) BIQLI scores were significantly worse in SLE than non-SLE subjects: 19.9 ± 33.2 and 41.6 ± 24.8 (p = 0.001). In SLE, BIQLI scores correlated inversely with overall damage, irreversible cutaneous damage, alopecia, and self-reported depression, and directly with age and health status. CONCLUSION: Body image in SLE is poor, and effective interventions may be directed at cutaneous disease activity, damage, and depression.

Treatment of lupus: impact on quality of life.

Systemic lupus erythematosus (SLE) is an autoimmune disease that disproportionately affects women of childbearing age during their most productive years. Current therapeutic measures have improved patient survival; however, the impact of interventions on general and specific domains of health-related quality of life requires further study. Medical Outcomes Survey Short Form 36 (SF-36), the most commonly used measure, has been included in some SLE randomized controlled trials, but the observed effect sizes were generally small and in some cases negligible. An SLE patient's quality of life is known to be significantly worse than that of someone in the general population and perhaps worse than those with most other common chronic diseases. SF-36, although useful as a general measure, may not be the most sensitive way to gauge changes perceived by patients with SLE. Ongoing trials and observational longitudinal studies using lupus-specific health-related quality-of-life measures may help better determine health-related quality-of-life responses and determine the domains most amenable to interventions.

Ulcerative cutaneous sarcoidosis successfully treated with infliximab.

Sarcoidosis is a systemic inflammatory disorder with cutaneous involvement present in 25% of cases. We present a patient with ulcerative sarcoidosis to highlight this unusual presentation of a relatively rare cutaneous condition that was treated successfully using infliximab. The drug is effective in cutaneous sarcoidosis, but relapses can occur after discontinuation. In this article, we reviewed the clinical features and therapeutic modalities for ulcerative cutaneous sarcoidosis.

Sleep Disturbance and Depression Symptoms Mediate Relationship Between Pain and Cognitive Dysfunction in Lupus.

OBJECTIVE: To determine whether sleep disturbance and symptoms of depression mediate the relationship between pain and cognitive dysfunction (CD) in a sample of 115 patients with systemic lupus erythematosus (SLE). METHODS: A total of 115 patients with SLE completed questionnaires regarding pain, perceived stress, depression, sleep, and CD. Relationships among pain, sleep, depression, and CD were assessed using bootstrap mediation models, controlling for race/ethnicity, fibromyalgia diagnosis, current corticosteroid use, disease activity and damage, and perceived stress. RESULTS: Mediation analyses indicated that the effect of pain on CD was mediated by sleep disturbance (ß = 0.30) and depression symptoms (ß = 0.33). These effects were maintained even after controlling for the aforementioned covariates, of which only disease activity (ß = 0.20) and stress (ß = 0.22) remained significantly linked to CD (overall model R2 = 0.53; all P < 0.05). CONCLUSION: After controlling for disease activity and perceived stress, the relationship between pain and CD was explained by sleep disturbance and depression symptoms. Although these relationships need validation in longitudinal studies with additional measurement modalities, our findings may indicate promising, nonpharmacologic intervention avenues for SLE patients with pain and CD. Specifically, cognitive behavioral therapies for depression and sleep are known to reduce distress and enhance functioning across various psychosocial domains. Given the symptom burden of SLE, interventions that maximize potential benefits without the use of additional pharmacologic treatments may be of particular utility.

Drivers of Satisfaction With Care for Patients With Lupus.

OBJECTIVE: Quality of life (QOL) and quality of care (QOC) in systemic lupus erythematosus (SLE) remains poor. Satisfaction with care (SC), a QOC surrogate, correlates with health behaviors and outcomes. This study aimed to determine correlates of SC in SLE. METHODS: A total of 1262 patients with SLE were recruited from various countries. Demographics, disease activity (modified Systemic Lupus Erythematosus Disease Activity Index for the Safety of Estrogens in Lupus Erythematosus: National Assessment trial [SELENA-SLEDAI]), and QOL (LupusPRO version 1.7) were collected. SC was collected using LupusPRO version 1.7. Regression analyses were conducted using demographic, disease (duration, disease activity, damage, and medications), geographic (eg, China vs United States), and QOL factors as independent predictors. RESULTS: The mean (SD) age was 41.7 (13.5) years; 93% of patients were women. On the univariate analysis, age, ethnicity, current steroid use, disease activity, and QOL (social support, coping) were associated with SC. On the multivariate analysis, Asian participants had worse SC, whereas African American and Hispanic patients had better SC. Greater disease activity, better coping, and social support remained independent correlates of better SC. Compared with US patients, patients from China and Canada had worse SC on the univariate analysis. In the multivariate models, Asian ethnicity remained independently associated with worse SC, even after we adjusted for geographic background (China). No associations between African American or Hispanic ethnicity and SC were retained when geographic location (Canada) was added to the multivariate model. Canadian patients had worse SC when compared with US patients. Higher disease activity, better social support, and coping remained associated with better SC. CONCLUSION: Greater social support, coping, and, paradoxically, SLE disease activity are associated with better SC. Social support and coping are modifiable factors that should be addressed by the provider, especially in the Asian population. Therefore, evaluation of a patient's external and internal resources using a biopsychosocial model is recommended. Higher disease activity correlated with better SC, suggesting that the latter may not be a good surrogate for QOC or health outcomes.

Sex Differences in Quality of Life in Patients With Systemic Lupus Erythematosus.

OBJECTIVE: Systemic lupus erythematosus (SLE) predominantly affects women. Clinical phenotype and outcomes in SLE may vary by sex and are further complicated by unique concerns that are dependent upon sex-defined roles. We aimed to describe sex differences in disease-specific quality of life (QoL) assessment scores using the Lupus Patient-Reported Outcome (LupusPRO) tool in a large international study. METHODS: Cross-sectional data from 1,803 patients with SLE on demographics, self-identified sex status, LupusPRO, and disease activity were analyzed. The LupusPRO tool has 2 constructs: health-related QoL (HRQoL) and non-HRQoL. Disease activity and damage were evaluated using the Safety of Estrogens in Lupus Erythematosus National Assessment version of the Systemic Lupus Erythematosus Disease Activity Index and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index, respectively. Nonparametric tests were used to compare QoL and disease activity by sex. RESULTS: A total of 122 men and 1,681 women with SLE participated. The mean age was similar by sex, but the damage scores were greater among men. Men fared worse on the non-HRQoL social support domain than women (P = 0.02). When comparing disease and QoL among men and women ages ≤45 years, men were found to have greater damage and worse social support than women. However, women fared significantly worse on lupus symptoms, cognition, and procreation domains with trends for worse functioning on physical health and pain-vitality domains. CONCLUSION: In the largest study of a diverse group of SLE patients, utilizing a disease-specific QoL tool, sex differences in QoL were observed on both HRQoL and non-HRQoL constructs. Although men performed worse in the social support domain, women (especially those in the reproductive age group) fared worse in other domains. These observations may assist physicians in appropriately addressing QoL issues in a sex-focused manner.

Does Systemic Lupus Erythematosus Care Provided in a Lupus Clinic Result in Higher Quality of Care Than That Provided in a General Rheumatology Clinic?

OBJECTIVE: To compare the quality of care received by patients with systemic lupus erythematosus (SLE) in 2 settings within the academic institution (a dedicated lupus clinic and a general rheumatology clinic) using validated SLE quality measures. METHODS: One hundred fifty consenting, consecutive SLE patients receiving longitudinal care at the Rush University general rheumatology clinic (n = 73) or the subspecialty lupus clinic (n = 77) were recruited. An updated quality measure survey and retrospective medical chart review were used to evaluate each quality measure (n = 20). The overall and individual quality measure performance was calculated and compared between the 2 groups. Data on the number of SLE patients seen by each rheumatologist were collected to assess the relationship between SLE patient volume and quality measures. RESULTS: Overall quality measure performance was significantly better in SLE patients receiving care at the lupus clinic (85.8% versus 70.2% of patients receiving care at the general rheumatology clinic; P = 0.001). Differences between the 2 groups were observed for sunscreen counseling (98.7% and 83.6%, respectively; P = 0.001), antiphospholipid antibody testing (71.4% and 37%, respectively; P < 0.001), pneumococcal vaccination (84.8% and 48.8%, respectively; P < 0.001), bone mineral density testing (94.2% and 54.5%, respectively; P < 0.001), drug counseling (92.2% and 80.8%, respectively; P = 0.04), use of a steroid-sparing agent (100% and 82%, respectively; P < 0.007), use of an angiotensin-converting enzyme inhibitor (94.4% and 58.3%, respectively; P = 0.03), and cardiovascular disease risk assessment (40.3% and 15.1%, respectively; P = 0.01). There was a moderate correlation between physician volume and quality measure performance (ρ = 0.48, P < 0.001). CONCLUSION: Compared with the general rheumatology clinic, the dedicated lupus clinic had better quality measure performance in this cross-sectional single-center study. In our health care system, we also observed indicators suggesting that rheumatologists with a higher volume of SLE patients provide higher quality of care.

SLE and Non-Hodgkin's Lymphoma: A Case Series and Review of the Literature.

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disorder punctuated by varied multiorgan complications all along the course of its natural history. Lymphoma represents a relatively well-recognized malignant phenomenon associated with lupus. The cause and effect relationships of lymphoma in SLE have been subject to extensive scrutiny with several studies reporting on clinic-pathologic characteristics and risk factors predicting lymphoma development in SLE. However, the pathogenic role of immunosuppressives in SLE-related lymphoma still remains unclear, and indices to help guide diagnosis, prognostication, therapy, and posttreatment monitoring are yet to be established. In this review, we describe 3 SLE patients who developed non-Hodgkin's lymphoma at different time points of their disease. Through a careful dissection of the aforementioned cases, we intend to apprise readers of the currently available literature surrounding risk factors, management, and prognosis in SLE-related lymphoma. We will also review and discuss the implications of immunosuppressives in SLE-related lymphoma and the role of mycophenolate mofetil in SLE-related primary CNS lymphoma development.

Teaching cardiac examination skills. A controlled trial of two methods.

OBJECTIVE: To determine if structured teaching of bedside cardiac examination skills improves medical residents' examination technique and their identification of key clinical findings. DESIGN: Firm-based single-blinded controlled trial. SETTING: Inpatient service at a university-affiliated public teaching hospital. PARTICIPANTS: Eighty Internal Medicine residents. METHODS: The study assessed 2 intervention groups that received 3-hour bedside teaching sessions during their 4-week rotation using either: (1) a traditional teaching method, "demonstration and practice" (DP) (n=26) or (2) an innovative method, "collaborative discovery" (CD) (n=24). The control group received their usual ward teaching sessions (n=25). The main outcome measures were scores on examination technique and correct identification of key clinical findings on an objective structured clinical examination (OSCE). RESULTS: All 3 groups had similar scores for both their examination technique and identification of key findings in the preintervention OSCE. After teaching, both intervention groups significantly improved their technical examination skills compared with the control group. The increase was 10% (95% confidence interval [CI] 4% to 17%) for CD versus control and 12% (95% CI 6% to 19%) for DP versus control (both P<.005) equivalent to an additional 3 to 4 examination skills being correctly performed. Improvement in key findings was limited to a 5% (95% CI 2% to 9%) increase for the CD teaching method, CD versus control P=.046, equivalent to the identification of an additional 2 key clinical findings. CONCLUSIONS: Both programs of bedside teaching increase the technical examination skills of residents but improvements in the identification of key clinical findings were modest and only demonstrated with a new method of teaching.

Rheumatologists' quality of care for lupus: comparison study between a university and county hospital.

OBJECTIVE: Quality of care received from physicians may impact health outcomes in systemic lupus erythematosus (SLE). We compared physician quality of care (P-QOC), health-related quality of life (HRQOL), and disease activity and damage between SLE patients receiving outpatient care at a university and a county rheumatology clinic. METHODS: Forty-two university and 41 county clinic SLE patients provided data on 5 P-QOC parameters and HRQOL health outcomes (Short Form 36 [SF-36] health survey and EuroQol 5-domain instrument [EQ-5D]). Disease activity and damage were measured. Chi-square analysis and Student's t-tests were used for comparisons. RESULTS: Overall satisfaction with medical care was similar; however, university patients had higher P-QOC scores than county patients in "perception of doctor's understanding of impact of SLE on patient's life" (P = 0.02) and "providing education/educational information to understand their disease" (P = 0.05). HRQOL, disease activity, and damage were similar in the 2 groups. Overall satisfaction with medical care was directly related SF-36 general health (r = 0.34, P = 0.03) and EQ-5D visual analog scale on state of health (r = 0.39, P = 0.01), and inversely related EQ-5D pain (r = -0.37, P = 0.02). CONCLUSION: Patient perceptions of P-QOC differed across the 2 centers despite similar demographics, clinical and HRQOL outcomes, and significant overlap in the physicians serving each clinic. Patients' overall satisfaction with medical care is associated with better HRQOL.

A brief assessment tool for body image in systemic lupus erythematosus.

Systemic lupus erythematosus (SLE) may adversely affect body image in multitude ways. Development and validation of a brief and valid SLE specific body image tool were undertaken. Eleven items were identified on interview of 21 SLE patients for the Body Image Lupus Scale (BILS v1.0). The tool was administered to 70 SLE patients. Based on analysis, feedback, and refinement of items, the final iteration BILS v1.2 with five items was administered to 233 SLE patients along with validated body image measures (Situational Inventory of Body Image Dysphoria and Body Image Quality of Life Inventory) and health-related quality of life measures for a subsample. The BILS scores' had an internal consistency reliability of .94. It correlated with both the referent body image measures, and with health-related quality of life. It differentiated participants by health status and disease activity. Test-retest reliability estimates exceeded .90. These results support the psychometric properties of BILS.

Disease-specific patient reported outcome tools for systemic lupus erythematosus.

PURPOSE: Systemic lupus erythematosus (SLE) can significantly affect both health and non-health-related quality of life (HRQOL and non-HRQOL). However, of the existent published patient-reported outcome (PRO) tools, none were developed from US patients, an ethnically diverse population. Furthermore, these tools do not address men with SLE or assess non-HRQOL issues. Herein, we present the development and validation of the Lupus Patient-Reported Outcome tool (LupusPRO) and discuss its clinical utility and research value compared with other PRO tools currently available for SLE. METHODS: Beginning with a conceptual framework, items for LupusPRO were generated using feedback from women and men with SLE. The tool underwent iterations based on patient feedback and clinimetric and psychometric analyses. Validity (content, construct, and criterion) and reliability (internal consistency and test-retest) for the 44-item LupusPRO tool are presented. RESULTS: Consistent with the conceptual framework, items were identified that were related to HRQOL and non-HRQOL constructs. HRQOL domains included (1) lupus symptoms; (2) physical health (physical function, role physical); (3) pain-vitality; (4) emotional health (emotional function and role emotional); (5) body image; (6) cognition; (7) procreation; and (8) lupus medications. Non-HRQOL domains were (1) available social support and coping; (2) desires-goals; and (3) satisfaction with medical care. Internal consistency reliability (0.68-0.94), test-retest reliability (0.55-0.92), content, construct (r > 0.50 with SF-36), and criterion (r > -0.35 with disease activity) validity were fair to good. CONCLUSIONS: LupusPRO is a valid and reliable disease-targeted patient-reported health outcome tool that is generalizable to SLE patients in the United States of varied ethnic backgrounds and either gender.