Use of oxidised regenerated cellulose/collagen dressings versus standard of care over multiple wound types: A systematic review and meta-analysis.

Oxidised regenerated cellulose (ORC)/collagen dressings help maintain physiologically moist wound environments conducive to wound healing. While evidence supporting ORC/collagen dressing use exists, comprehensive assessment is needed. This systematic review/meta-analysis evaluated the performance of ORC/collagen dressings compared with standard dressings. A systematic literature search was performed using PUBMED, EMBASE, and QUOSA Virtual Library. Published studies and conference abstracts were assessed between 1 January 1996 and 27 July 2020. Comparative studies in English completed by 31 December 2019, with a study population ≥10 were included. Patient demographics, wound healing, and protease concentrations were extracted. A random-effect model was used to assess the effect of ORC/collagen dressings. Twenty studies were included following removal of duplicates and articles not meeting inclusion criteria. A statistically significant effect in favour of ORC/collagen dressings was found for wound closure (P = 0.027) and percent wound area reduction (P = 0.006). Inconclusive evidence or limited reporting prevented assessment of time to complete healing, days of therapy, number of dressing applications, pain, matrix metalloproteinase, elastase, plasmin, and gelatinase concentration. Statistically significant increase in wound closure rates and percent wound area reduction were observed in patients receiving ORC/collagen dressings compared with standard dressings in this systematic review/meta-analysis.

A systematic review and meta-analysis of randomized controlled trials for the reduction of surgical site infection in closed incision management versus standard of care dressings over closed vascular groin incisions.

OBJECTIVE: Surgical site infection after groin incision is a common complication and a financial burden to patients and healthcare systems. Closed incision negative pressure therapy (ciNPT) has been associated with decreased surgical site infection rates in published literature. This meta-analysis examines the effect of ciNPT (PREVENA™ Incision Management System; KCI, San Antonio, TX) versus traditional postsurgical dressing use in reducing surgical site infection rates over closed groin incisions following vascular surgery. METHODS: A systematic literature search using PubMed, OVID, EMBASE, and QUOSA was performed on 3 January 2019, by two independent researchers and focused on publications between 1 January 2005 and 31 December 2018. The review conformed to the statement and reporting check list of the Preferred Reporting Items for Systematic Reviews and Meta Analyses. Inclusion criteria included abstract or manuscript written in English, published studies, conference abstracts, randomized controlled trials (RCTs), ciNPT usage over closed groin incisions in vascular surgery, comparison of ciNPT use and traditional dressings, study endpoint/outcome of surgical site infection, and study population of >10. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of surgical site infection, and length of follow-up were extracted. Weighted odds ratios and 95% confidence intervals were calculated to pool study and control groups in each publication for analysis. Treatment effects were combined using Mantel-Haenszel risk ratios, and the Chi-Square test was used to assess heterogeneity. Overall, high-risk patients, normal-risk patients, and Szilagyi I, II, III outcomes were assessed between ciNPT and control groups. The Cochrane Collaboration tool was utilized to assess the risk of bias for all studies included in the analysis. RESULTS: A total of 615 articles were identified from the literature search. After removal of excluded studies and duplicates, six RCT studies were available for analysis. In these studies, a total of 362 patients received ciNPT, and 371 patients received traditional dressings (control). Surgical site infection events occurred in 41 ciNPT patients and 107 control patients. The heterogeneity test was nonsignificant (p > 0.05). The overall RCT meta-analysis showed a highly significant effect in favor of ciNPT (OR = 3.06, 95% CI [2.05, 4.58], p < 0.05). High-risk, normal-risk, Szilagyi I, and Szilagyi II meta-analyses were also statistically significant in favor of ciNPT use (p < 0.05). The varying RCT inclusion/exclusion criteria, such as differences in procedure types, and patient populations form the major limitations of this study. CONCLUSIONS: A statistically significant reduction in the incidence of surgical site infection was seen following ciNPT usage in patients undergoing vascular surgery with groin incisions.

Altered type II interferon precedes autoantibody accrual and elevated type I interferon activity prior to systemic lupus erythematosus classification.

OBJECTIVES: The relationship of immune dysregulation and autoantibody production that may contribute to systemic lupus erythematosus (SLE) pathogenesis is unknown. This study evaluates the individual and combined contributions of autoantibodies, type I interferon (IFN-α) activity, and IFN-associated soluble mediators to disease development leading to SLE. METHODS: Serial serum specimens from 55 individuals collected prior to SLE classification (average timespan=4.3 years) and unaffected healthy controls matched by age (±5 years), gender, race and time of sample procurement were obtained from the Department of Defense Serum Repository. Levels of serum IFN-α activity, IFN-associated mediators and autoantibodies were evaluated and temporal relationships assessed by growth curve modelling, path analysis, analysis of covariance and random forest models. RESULTS: In cases, but not matched controls, autoantibody specificities and IFN-associated mediators accumulated over a period of years, plateauing near the time of disease classification (p<0.001). Autoantibody positivity coincided with or followed type II IFN dysregulation, preceding IFN-α activity in growth curve models, with elevated IFN-α activity and B-lymphocyte stimulator levels occurring shortly before SLE classification (p≤0.005). Cases were distinguished by multivariate random forest models incorporating IFN-γ, macrophage chemoattractant protein (MCP)-3, anti-chromatin and anti-spliceosome antibodies (accuracy 93% >4 years pre-classification; 97% within 2 years of SLE classification). CONCLUSIONS: Years before SLE classification, enhancement of the type II IFN pathway allows for accumulation of autoantibodies and subsequent elevations in IFN-α activity immediately preceding SLE classification. Perturbations in select immunological processes may help identify at-risk individuals for further clinical evaluation or participation in prospective intervention trials.

Disparities in Access to Easy-to-Use Services for Children with Special Health Care Needs.

OBJECTIVES: Families, clinicians and policymakers desire improved delivery of health and related services for children with special health care needs (CSHCN). We analyzed factors associated with ease of use in obtaining such services. We also explored what were specific difficulties or delays in receiving services. By examining data from the National Survey of Children with Special Health Care Needs (NS-CSHCN 2009-2010) and using the revised criteria for "ease of use," we were able to assess the percentage of parents who reported that their experiences seeking services for their children met those criteria. METHODS: We performed Chi square tests to examine associations between the independent variables and their relationship to the difficulties or delays assessed in the survey; including: eligibility, availability of services, waiting lists, cost, and access to information. We used logistic regression to determine the association of meeting the "ease of use" criteria with socio-demographic, complexity of need, and access variables. RESULTS: Overall, a third of families of CSHCN (35.3 %) encounter difficulties, delays, or frustrations in obtaining health and related services. The lack of access to health and community services in this study fell most heavily on children from racial/ethnic minority backgrounds, those in poverty, and those with complex emotional/behavioral or developmental needs and functional limitations. CONCLUSIONS: for Practice CSHCN require services from a broad array of providers across multiple systems. Unfortunately, there are certain difficulties that hamper the accessibility of these systems. These findings underscore the need for both practice-level response and systems-level reform to ensure equitable distribution of health and community resources.

Peripheral blood CD8αα+CD11c+MHC-II+CD3- cells attenuate autoimmune glomerulonephritis in rats.

In an anti-glomerular basement membrane (GBM) glomerulonephritis (GN) model, GN-resistant Lewis rats naturally recover from early glomerular inflammation. Here we investigated recovery mechanisms for development of a potential immunotherapy for autoimmune GN. Our previous studies suggested that glomeruli-infiltrating leukocytes with a phenotype of CD8αα+CD11c+MHC-II+CD3- (GIL CD8αα+ cells) were responsible for recovery through induction of T-cell apoptosis. Now, we identified peripheral blood CD8αα+CD11c+MHC-II+CD3- cells (PBMC CD8αα+CD3- cells), which shared 9 markers with GIL CD8αα+ cells. Upon incubation, PBMC CD8αα+CD3- cells displayed a morphology resembling that of dendritic cells. Similar to GIL CD8αα+ cells, PBMC CD8αα+CD3- cells were capable of inducing T-cell apoptosis in vitro. Hence, PBMC CD8αα+CD3- cells were likely the precursor of GIL CD8αα+ cells. We next tested their potential in vivo function. PBMC CD8αα+CD3- cells were able to infiltrate inflamed but not normal glomeruli. Isolated PBMC CD8αα+CD3- cells of Lewis rats were transferred into GN-prone Wistar-Kyoto rats at early inflammatory stage (days 17-25). When examined at day 45, both histopathology and blood urea nitrogen/serum creatinine level showed significantly attenuated GN in 80% of cell recipient Wistar-Kyoto rats. Separate experiments verified infiltration of transferred Lewis PBMC CD8αα+CD3- into the glomeruli, accompanied with apoptotic CD4+ T cells in the glomeruli of the recipient Wistar-Kyoto rats. Thus, PBMC CD8αα+CD3- cells of Lewis rats were able to terminate ongoing autoimmune inflammation in the glomeruli.

Comparison of autoantibody specificities between traditional and bead-based assays in a large, diverse collection of patients with systemic lupus erythematosus and family members.

OBJECTIVE: Replacement of standard immunofluorescence methods with bead-based assays for antinuclear antibody (ANA) testing is a new clinical option. The aim of this study was to evaluate a large, multiethnic cohort of patients with systemic lupus erythematosus (SLE), blood relatives, and unaffected control individuals for familial aggregation and subset clustering of autoantibodies by high-throughput serum screening technology and traditional methods. METHODS: Serum samples (1,540 SLE patients, 1,154 unaffected relatives, and 906 healthy, population-based controls) were analyzed for SLE autoantibodies using a bead-based assay, indirect immunofluorescence (IIF), and immunodiffusion. Autoantibody prevalence, sensitivity for disease detection, clustering of autoantibodies, and associations between newer methods and standard immunodiffusion results were evaluated. RESULTS: The frequencies of ANAs in the sera from African American, Hispanic, and European American patients with SLE were 89%, 73%, and 67%, respectively, by BioPlex 2200 bead-based assay and 94%, 84%, and 86%, respectively, by IIF. When comparing the serum prevalence of 60-kd Ro, La, Sm, nuclear RNP A, and ribosomal P autoantibodies across assays, the sensitivity of detection ranged from 0.92 to 0.83 and the specificity ranged from 0.90 to 0.79. Autoantibody cluster analysis showed associations of autoantibody specificities in 3 subsets: 1) 60 kd Ro, 52-kd Ro, and La, 2) spliceosomal proteins, and 3) double-stranded DNA (dsDNA), chromatin, and ribosomal P. Familial aggregation of Sm/RNP, ribosomal P, and 60-kd Ro in SLE patient sibling pairs was observed (P ≤ 0.004). Simplex-pedigree SLE patients had a greater prevalence of dsDNA (P = 0.0003) and chromatin (P = 0.005) autoantibodies compared to patients with a multiplex SLE pedigree. CONCLUSION: The frequencies of ANAs detected by a bead-based assay are lower than those detected by IIF in European American patients with SLE. These assays have strong positive predictive values across ethnic groups, provide useful information for clinical care, and provide unique insights into familial aggregation and autoantibody clustering.

Sudden death and isolated right ventricular noncompaction cardiomyopathy: report of 2 autopsied adult cases.

A predominantly right ventricular variant of isolated noncompaction cardiomyopathy is a potentially lethal disease entity, which only recently has become recognized in the clinical and cardiac imaging literature. There are currently few established morphologic criteria for the diagnosis other than right ventricular dilation and presence of excessive regional trabeculation. To date, there have been no autopsy reports of cases following either clinical diagnosis or sudden death. We report 2 adult cases of sudden unexpected death in which unexplained right ventricular dilation and prominent apical hypertrabeculation were the principal findings. The gross and microscopic results suggest pathological similarities between, or coexistence of, right ventricular noncompaction and arrhythmogenic right ventricular cardiomyopathies.

Computer-based cognitive retraining for adults with chronic acquired brain injury: a pilot study.

This study evaluated the effectiveness of a computer-based cognitive retraining (CBCR) program on improving memory and attention deficits in individuals with a chronic acquired brain injury (ABI). Twelve adults with a chronic ABI demonstrating deficits in memory and attention were recruited from a convenience sample from the community. Using a quasi-experimental one-group pretest-posttest design, a significant improvement was found in both memory and attention scores postintervention using the cognitive screening tool. This study supported the effectiveness of CBCR programs in improving cognitive deficits in memory and attention in individuals with chronic ABI. Further research is recommended to validate these findings with a larger ABI population and to investigate transfer to improvement in occupational performance that supports daily living skills.

Lupus and Epstein-Barr.

PURPOSE OF REVIEW: Systemic lupus erythematosus (SLE) is a heterogeneous human disease influenced by a complex interplay of necessary, but not individually sufficient, factors. Although many genetic and environmental factors are associated with SLE, this review will focus on the evolving evidence for key Epstein-Barr virus (EBV)-specific roles in SLE, focusing on new experimental studies published during 2009, 2010, and 2011. RECENT FINDINGS: SLE patients have a dysregulated immune response against EBV. EBV antigens exhibit structural molecular mimicry with common SLE antigens and functional molecular mimicry with critical immune-regulatory components. SLE patients, from a number of unique geographic regions, are shown to have higher rates of EBV seroconversion, especially against early EBV antigens, suggesting frequent viral reactivation. SLE patients also have increased EBV viral loads and impaired EBV-specific CD8 cytotoxic T cells, with impaired cytokine responses to EBV in lupus patients. Irregular cytokine production in plasmacytoid dendritic cells and CD69 CD4 T cells after stimulation with EBV has also been demonstrated. SUMMARY: Recent advances demonstrate SLE-specific serologic responses, gene expression, viral load, T-cell responses, humoral fine specificity, and molecular mimicry with EBV, further supporting potential roles for EBV in lupus etiology and pathogenesis.

A contemporary approach to the obstetric management of women with heart disease.

OBJECTIVES: Recommendations for the peripartum obstetric management of women with heart disease have included early induction of labour, shortening the second stage of labour during vaginal delivery, and low threshold for elective Caesarean section, although such techniques may result in complications. The objective of this study was to determine whether a less aggressive approach without routine preterm induction, shortening of the second stage, or Caesarean section adversely affects the mother or neonate. METHODS: We examined peripartum obstetric management and its relationship with adverse maternal and neonatal outcomes in 1677 pregnancies: 559 in women with heart disease and 1118 in women without heart disease (control subjects). Logistic regression with propensity matching was used to compare outcomes in women with and without heart disease. RESULTS: Women with heart disease were more likely than control subjects to undergo induction of labour (P < 0.001). Induction of labour tended to be at term and for logistical reasons, not for the indication of maternal heart disease. Assisted vaginal deliveries were more common in women with heart disease (29% vs. 11%, P < 0.001) than in those without, and the second stage of labour was also more prolonged in women with heart disease. Rates of Caesarean section were similar in both groups (P = 0.66). A significant proportion of women with heart disease had unassisted vaginal deliveries. Invasive cardiac monitoring was rarely used. Adverse maternal cardiac events at delivery were rare (2% of pregnancies) and were not associated with mode of delivery. In multivariate analysis, maternal heart disease was not predictive of adverse neonatal events or third- or fourth- degree lacerations. Maternal heart disease was associated with postpartum hemorrhage, but this was not related to assisted delivery or prolonged second stage of labour. CONCLUSION: This large study has shown that in women with heart disease, avoidance of early induction of labour, rare use of Caesarean section for cardiac indications, and selective use of invasive monitoring produces safe obstetric outcomes.

Creating a culture of evidence in nursing education using student portfolios.

There has been a growing interest in the use of portfolios to assess nursing student progress in areas such as critical thinking, problem solving, and communication. The data obtained from student portfolios can be used to improve undergraduate nursing curricula; however in order for change to occur, closing the assessment feedback loop is essential. The portfolio program of one Midwestern school of nursing has successfully used portfolio evidence to effect undergraduate curricular change. This portfolio program, under the direction of the school's Portfolio Subcommittee, involves active participation by students, faculty and administration. Examples of curricular improvements based on portfolio findings included increasing rigor in course assignments, improving student self reflection, promoting students' ability to write in the discipline, and maintaining writing assignments in larger classes.

Natural recovery from antiglomerular basement membrane glomerulonephritis is associated with glomeruli-infiltrating CD8α+CD11c+MHC class II+ cells.

BACKGROUND/AIMS: In an antiglomerular basement membrane glomerulonephritis (GN) model, GN-resistant Lewis (LEW) rats naturally recover from early glomerular inflammation (days 21-23). We have previously identified a glomeruli-infiltrating CD8α(+)CD11(high)MHC II(+) cell (GIL CD8α(+) cell) in GN-prone Wistar Kyoto (WKY) rats, which terminates glomerular inflammation through inducing T cell apoptosis prior to glomerular fibrosis at days 35-40. We investigated if GIL CD8α(+) cells were also associated with the recovery in LEW rats. METHODS: GIL CD8α(+) cells in LEW rats were characterized; their infiltration was observed in connection with T cell apoptosis in glomeruli. RESULTS: An influx of GIL CD8α(+) cells into inflamed glomeruli was confirmed in the immunized LEW rats at days 17-22, which was much earlier than days 28-35 in WKY rats. Notably, LEW rats had a GIL CD8α(+)CD11(high) subpopulation after day 17, while WKY rats lacked this population until after day 30. Analyses further revealed a large number of clustered apoptotic CD4(+) or CD3(+) T cells in the glomeruli during recovery (day 23) in LEW rats, as compared to day 35 (transition to fibrosis) in WKY rats. Thus, infiltration of GIL CD8α(+) cells coincided with decline of glomerular inflammation and T cell apoptosis during recovery in LEW rats. Isolated GIL CD8α(+) cells were able to infiltrate glomeruli in both WKY and LEW rats at day 20. CONCLUSION: Our data revealed a strong association between GIL CD8a+ cells and recovery from early glomerular inflammation. It raises a possibility of involvement of GIL CD8a+ cells in the recovery.

H1N1 in pregnancy: a tertiary care centre experience.

OBJECTIVE: To elucidate factors pertinent to the course and outcome of H1N1 infection in pregnancy. METHODS: We conducted a retrospective chart review of H1N1-affected pregnant patients at Mount Sinai Hospital in Toronto, Ontario. All women who tested positive for H1N1 from June 1, 2009, to December 5, 2009, were identified. Records were reviewed to determine pregnancy status. Information from clinic and hospital charts of pregnant patients was gathered using data collection forms previously approved by the Mount Sinai Hospital Research Ethics Board. RESULTS: Of 42 patients, 12 were inpatients and 30 were outpatients. Sixty percent of patients (25/42) presented in the third trimester, 33% (14/42) had comorbidities, and 69% were afebrile and therefore did not have a condition that met the United States Centers for Disease Control and Prevention's definition of influenza-like illness. Antiviral agents were administered promptly in most patients, but delays resulted in one third of patients being treated more than 48 hours from the onset of symptoms. Seventy-one percent (30/42) did not require hospitalization, and 58% of hospitalized patients (7/12) were admitted for reasons unrelated to H1N1. Although one quarter of hospitalized patients (3/12) had delivered at the time of discharge, no deliveries occurred because of H1N1. Most patients (91%) delivered at term. One half of the deliveries (51%) were by Caesarean section, but none of these were because of H1N1 infection. Most of the infants (88%) were appropriately grown, and none were admitted to the NICU because of H1N1. CONCLUSION: Infection with H1N1 in pregnant women has the propensity to result in significant maternal and fetal morbidity and mortality, and requires vigilance in assessment and prompt treatment. In contrast to reports published to date, our cohort experienced a largely uncomplicated course of illness, with minimal fetal and maternal impact in most instances.

Prevalence of bone loss in a population with cystic fibrosis.

The adverse effect of an increased life expectancy for people with cystic fibrosis (CF) is the increased risk of complications, such as CF-related low bone mineral density (BMD). Diagnosis of CF-related low BMD is confirmed by a dual-energy X-ray absorptiometry (DXA) scan. This study reports the results of an audit of DXA scans in 108 adults with CF in our clinic. The most common risk factors for bone loss were vitamin D deficiency (89%), CF-related diabetes (53%), low body mass index (39%) and post-lung transplant (25%); half of those with bone loss were genotype homozygous DF508. Overall fracture incidence was 5.5%; low BMD was not associated with high fracture rates. Thus BMD may not be a good predictor of fracture risk. Treatment includes bisphosphonates, which are difficult to take and have uncertain long-term effects. It is unknown whether bisphosphonate therapy is justified in this already overburdened group.

Chronic Intervillositis of Unknown Etiology (CIUE): Prevalence, patterns and reproductive outcomes at a tertiary referral institution.

INTRODUCTION: the objective of this study was to evaluate the incidence of Chronic Intervillositis of Unknown Etiology (CIUE) at our institution and to report on the pregnancy outcomes based on severity of lesions. METHODS: retrospective cohort study including 29 889 perinatal specimens from 27 968 patients. The pathology database at our institution was queried for the keywords "intervillositis" and "CIUE" between February 2006 and April 2019. Histology was re-examined using a standardized diagnostic criterion to confirm diagnosis. Cases in which diagnosis was confirmed were categorized as low grade (5-49% intervillous space involvement) or high grade (≥50% involvement). Interventions and pregnancy outcomes were recorded. RESULTS: The overall prevalence of CIUE is 0.17% (47 of 27 968 patients), with significantly higher prevalence in 1st trimester products of conception compared with 2nd and 3rd trimester specimens (0.38% vs 0.09%; p < 0.0001). A total of 97 specimens were initially diagnosed with chronic intervillositis. 56 out of 97 (57.7%) specimens met our diagnostic criteria for CIUE on review. Pregnancies with confirmed CIUE had significantly higher rates of pregnancy loss compared with pregnancies with chronic intervillositis not meeting our study criteria for CIUE (94% vs 71%; p = 0.003). Pregnancy loss between low grade (42.9%; 24 out of 56 cases of CIUE) and high grade (57.1%; 32 out of 56 cases) CIUE were not significantly different. DISCUSSION: CIUE prevalence is low at 0.17%, but it is associated with pregnancy loss, particularly in the first trimester. High grade disease may be associated with worse pregnancy outcomes than low grade disease.

A primer in the evaluation of quality in acute care settings.

Nurses are in a unique position to evaluate acute care quality. The authors describe common problems and challenges related to selection of variables and choice of databases for quality evaluations. Practical strategies to address these concerns also are discussed.

Management of relocation in cognitively intact older adults.

As the older adult population grows, the rate of relocation from one home to another will also increase. To promote planning for relocation to a new home and adjustment to this stressful life event, pre-relocation and post-relocation risks need to be assessed and interventions designed to facilitate relocation decision making and adjustment. The evidence-based guideline by Hertz et al. (2005) provides detailed tools and recommendations for management of pre-relocation and post-relocation processes with cognitively intact older adults by nurses and other health care providers in community-based care, long term care, and acute care settings.

Ensuring a knowledgeable and committed gerontological nursing workforce.

There is a growing societal need for professional nurses who are knowledgeable and committed to working with older adults. In order to address this need, a small study that included self-evaluation and curriculum review was conducted by faculty at one Midwestern nursing program in the United States. A moderately positive attitude, moderately high knowledge, and moderate pursuit of knowledge of older adults were identified with the faculty in the presence of limited curricular content of gerontology. Implications for nursing education included continuing education for nursing faculty and program support in nursing curricula.

Advanced practice role characteristics of the community/public health nurse specialist.

The purpose of this qualitative study was to describe the advanced practice role of nurses with master's degrees in community/public health nursing using their experiences and perspectives. The purposive sample consisted of 10 nurses who had master's degrees in community/public health nursing and were working in a variety of community health settings. Data were collected using audiotaped interviews and 1-day observations of study participants in their workplaces. An editing analysis technique was used to analyze the data. Findings indicated that role characteristics included advocacy and policy setting at the organizational, community, and state levels; a leadership style centered on empowerment; a broad sphere of influence; and high-level skills in large-scale program planning, project management, and building partnerships. Results provide important descriptive data about significant aspects of the advanced practice role of nurses with master's degrees in community/public health nursing.

Use of SLICC criteria in a large, diverse lupus registry enables SLE classification of a subset of ACR-designated subjects with incomplete lupus.

OBJECTIVE: SLE is traditionally classified using the American College of Rheumatology (ACR) criteria. The Systemic Lupus International Collaborating Clinics (SLICC) recently validated an alternative system. This study examined large cohorts of subjects with SLE and incomplete lupus erythematosus (ILE) to compare the impact of ACR and SLICC criteria. METHODS: Medical records of subjects in the Lupus Family Registry and Repository were reviewed for documentation of 1997 ACR classification criteria, SLICC classification criteria and medication usage. Autoantibodies were assessed by indirect immunofluorescence (ANA, antidouble-stranded DNA), precipitin (Sm) and ELISA (anticardiolipin). Other relevant autoantibodies were detected by precipitin and with a bead-based multiplex assay. RESULTS: Of 3575 subjects classified with SLE under at least one system, 3312 (92.6%) were classified as SLE by both systems (SLEboth), 85 only by ACR criteria (SLEACR-only) and 178 only by SLICC criteria (SLESLICC-only). Of 440 subjects meeting 3 ACR criteria, 33.9% (149/440) were SLESLICC-only, while 66.1% (n=291, designated ILE) did not meet the SLICC classification criteria. Under the SLICC system, the complement criterion and the individual autoantibody criteria enabled SLE classification of SLESLICC-only subjects, while SLEACR-only subjects failed to meet SLICC classification due to the combined acute/subacute cutaneous criterion. The SLICC criteria classified more African-American subjects by the leucopenia/lymphopenia criterion than did ACR criteria. Compared with SLEACR-only subjects, SLESLICC-only subjects exhibited similar numbers of affected organ systems, rates of major organ system involvement (∼30%: pulmonary, cardiovascular, renal, neurological) and medication history. CONCLUSIONS: The SLICC criteria classify more subjects with SLE than ACR criteria; however, individuals with incomplete lupus still exist under SLICC criteria. Subjects who gain SLE classification through SLICC criteria exhibit heterogeneous disease, including potential major organ involvement. These results provide supportive evidence that SLICC criteria may be more inclusive of SLE subjects for clinical studies.