Addressing Therapeutic Inertia: Development and Implementation of an Electronic Health Record-Based Diabetes Intensification Tool.

Objective: To assess whether an electronic health record (EHR)-based diabetes intensification tool can improve the rate of A1C goal attainment among patients with type 2 diabetes and an A1C ≥8%. Methods: An EHR-based tool was developed and sequentially implemented in a large, integrated health system using a four-phase, stepped-wedge design (single pilot site [phase 1] and then three practice site clusters [phases 2-4]; 3 months/phase), with full implementation during phase 4. A1C outcomes, tool usage, and treatment intensification metrics were compared retrospectively at implementation (IMP) sites versus nonimplementation (non-IMP) sites with sites matched on patient population characteristics using overlap propensity score weighting. Results: Overall, tool utilization was low among patient encounters at IMP sites (1,122 of 11,549 [9.7%]). During phases 1-3, the proportions of patients achieving the A1C goal (<8%) were not significantly improved between IMP and non-IMP sites at 6 months (range 42.9-46.5%) or 12 months (range 46.5-53.1%). In phase 3, fewer patients at IMP sites versus non-IMP sites achieved the goal at 12 months (46.7 vs. 52.3%, P = 0.02). In phases 1-3, mean changes in A1C from baseline to 6 and 12 months (range -0.88 to -1.08%) were not significantly different between IMP and non-IMP sites. Times to intensification were similar between IMP and non-IMP sites. Conclusion: Utilization of a diabetes intensification tool was low and did not influence rates of A1C goal attainment or time to treatment intensification. The low level of tool adoption is itself an important finding highlighting the problem of therapeutic inertia in clinical practice. Testing additional strategies to better incorporate, increase acceptance of, and improve proficiency with EHR-based intensification tools is warranted.

Erratum: Addressing Therapeutic Inertia: Development and Implementation of an Electronic Health Record-Based Diabetes Intensification Tool. Diabetes Spectrum 2023;36:161-170 (https://doi.org/10.2337/ds22-0031).

[This corrects the article DOI: 10.2337/ds22-0031.].

Vectorial capacities for malaria in eastern Amazonian Brazil depend on village, vector species, season, and parasite species.

BACKGROUND: The vector species in the Amazon River Basin are regionally and locally diverse, which makes it imperative to understand and compare their roles in malaria transmission to help select appropriate methods of intervention and evaluation. The major aim of this study was to measure the vectorial capacity of five Anopheles species in three neighbouring villages, for two Plasmodium parasite species affecting humans. METHODS: From 32 consecutive months of sampling in three villages, 1.5-7.0 km apart, on the Matapi River, Amapá State, Brazil, vectorial capacities (C) were estimated as time series for An. darlingi, An. marajoara, An. nuneztovari, An. triannulatus, and An. intermedius. Monthly parity measurements for each vector species were used to estimate daily survivorship and compared to estimates of survivorship from mark-release-recapture experiments. Gonotrophic cycle lengths were estimated through a time-series analysis of parity data, and durations of sporogony at study site temperatures for the two malaria parasite species were estimated from previous literature. RESULTS: The absolute abundances of five vector species were strongly tracked by the spatial variation in C among villages. Temporally, C varied between wet and dry seasons, with An. darlingi, An. marajoara and An. triannulatus exhibiting higher C in the dry season from August to December, and An. nuneztovari its highest C early in the rainy season in January and February. Anopheles intermedius exhibited higher C in the rainy season from April to June than in the dry season. Significant differences in overall survival for each independent variable, and a significant difference in C between wet and dry seasons, among villages, and among vector species for both Plasmodium falciparum and Plasmodium vivax. A generalized linear mixed model (GLMM) analysis by village showed significant effects of vector species on C in only one village, but significant effects of parasite species in all three. Although the GLMM analysis detected no significant parasite x vector species interaction effects on C, effects on C of spline regressions of C dynamics x vector species interactions were significant in all villages. CONCLUSIONS: These detailed analyses of entomological and parasitological variables revealed hidden complexities of malaria epidemiology at local scales in neighbouring riverine villages of the Amazon Region.

Associations of weight loss with obesity-related comorbidities in a large integrated health system.

AIMS: To determine the health outcomes associated with weight loss in individuals with obesity, and to better understand the relationship between disease burden (disease burden; ie, prior comorbidities, healthcare utilization) and weight loss in individuals with obesity by analysing electronic health records (EHRs). MATERIALS AND METHODS: We conducted a case-control study using deidentified EHR-derived information from 204 921 patients seen at the Cleveland Clinic between 2000 and 2018. Patients were aged ≥20 years with body mass index ≥30 kg/m2 and had ≥7 weight measurements, over ≥3 years. Thirty outcomes were investigated, including chronic and acute diseases, as well as psychological and metabolic disorders. Weight change was investigated 3, 5 and 10 years prior to an event. RESULTS: Weight loss was associated with reduced incidence of many outcomes (eg, type 2 diabetes, nonalcoholic steatohepatitis/nonalcoholic fatty liver disease, obstructive sleep apnoea, hypertension; P < 0.05). Weight loss >10% was associated with increased incidence of certain outcomes including stroke and substance abuse. However, many outcomes that increased with weight loss were attenuated by disease burden adjustments. CONCLUSIONS: This study provides the most comprehensive real-world evaluation of the health impacts of weight change to date. After comorbidity burden and healthcare utilization adjustments, weight loss was associated with an overall reduction in risk of many adverse outcomes.

Breast conserving surgery with targeted intraoperative radiotherapy for the management of ductal carcinoma in situ.

BACKGROUND: A prospective randomized controlled trial has established the efficacy of targeted intraoperative radiotherapy (TARGIT) in the management of invasive breast cancer treated with breast-conserving surgery (BCS). The purpose of this analysis is to evaluate the efficacy of TARGIT in the management of ductal carcinoma in situ (DCIS). METHODS: A prospective nonrandomized trial was designed to evaluate the success of TARGIT in the management of DCIS, as measured by a low risk of requiring additional surgery or radiotherapy and an acceptable local recurrence rate (LRR). RESULTS: Fifty-five patients with DCIS received BCS and TARGIT from November 2007 to March 2017. Median patient age was 57 years (range, 42-83 years) and median histological lesion size was 14.4 mm (range, 2-51 mm). Four patients required either re-excision and/or whole breast irradiation, yielding a rate of additional therapy of 7.3% (4 of 55). Among 46 women administered TARGIT at the time of initial BCS, two local recurrences were observed yielding a 4.3% (2 of 46) LRR at 46 months median follow-up (range, 4-116 months). There were no clinically significant adverse events. CONCLUSIONS: Preliminary evidence indicates TARGIT can be performed with a low risk of requiring additional therapy (7.3%) and an acceptable LRR (4.3%) when administered at the time of BCS.

Quality measures in acute kidney injury.

PURPOSE OF REVIEW: Quality measure assessment and reporting is evolving in end-stage renal disease care and is inchoate in ambulatory nephrology clinic care. Acute kidney injury (AKI) quality measures have not received sufficient attention, yet deserve consideration in view of the substantial proportion of effort nephrology providers devote to AKI care. RECENT FINDINGS: Accumulating literature permits consideration of timing of nephrology consultation, follow-up after AKI hospitalization, early detection, medication dosing, hospital readmissions and length of stay, cost, and mortality as potential AKI quality measures. SUMMARY: We review candidate AKI quality measures and assess the strength of evidence supporting the use of each measure as a standard for AKI care.

Antidiabetic treatment patterns and specialty care utilization among patients with type 2 diabetes and cardiovascular disease.

BACKGROUND: To evaluate real-world patient characteristics, medication use, and health care utilization patterns in patients with type 2 diabetes with established cardiovascular disease (CVD). METHODS: Cross-sectional analysis of patients with type 2 diabetes seen at Cleveland Clinic from 2005 to 2016, divided into two cohorts: with-CVD and without-CVD. Patient demographics and antidiabetic medications were recorded in December 2016; department encounters included all visits from 1/1/2016 to 12/31/2016. Comorbidity burden was assessed by the diabetes complications severity index (DCSI) score. RESULTS: Of 95,569 patients with type 2 diabetes, 40,910 (42.8%) were identified as having established CVD. Patients with CVD vs. those without were older (median age 69.1 vs. 58.2 years), predominantly male (53.8% vs. 42.6%), and more likely to have Medicare insurance (69.4% vs. 35.3%). The with-CVD cohort had a higher proportion of patients with a DCSI score ≥ 3 than the without-CVD cohort (65.0% vs. 10.3%). Utilization rates of glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors were low in both with-CVD (4.1 and 2.5%) and without-CVD cohorts (5.4 and 4.1%), respectively. The majority of patient visits (75%) were seen by a primary care provider. During the 1-year observation period, 81.9 and 62.0% of patients with type 2 diabetes and CVD were not seen by endocrinology or cardiology, respectively. CONCLUSIONS: These data indicated underutilization of specialists and antidiabetic medications reported to confer CV benefit in patients with type 2 diabetes and CVD. The impact of recently updated guidelines and cardiovascular outcome trial results on management patterns in such patients remains to be seen.

Association of glucagon-like peptide-1 receptor agonist use and rates of acute myocardial infarction, stroke and overall mortality in patients with type 2 diabetes mellitus in a large integrated health system.

AIMS: To assess the potential impact of glucagon-like peptide-1 receptor agonist (GLP-1RA) exposure on cardiovascular disease (CVD) and mortality outcomes in patients with type 2 diabetes (T2D), using a large retrospective cohort. RESEARCH DESIGN AND METHODS: Patients who had T2D between 2005 and 2014 (N = 105 862) were identified from the electronic health record system at Cleveland Clinic using a validated electronic phenotype. A time-dependent, Cox, multiple regression analysis was used to assess the association between GLP-1RA exposure and risk of acute myocardial infarction (AMI), stroke/cerebrovascular accident (CVA), and overall mortality, as well as the composite of all three outcomes. The findings were further evaluated by assessing the effect of GLP-1RAs on the same variables in patients with and without prior CVD. The model adjusted for differences in demographic information, hypertension, laboratory/vital signs, history of outcomes, and T2D medications. RESULTS: There were significantly lower rates of AMI (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.65 to 0.99; P = .045), CVA (HR 0.82, 95% CI 0.74 to 0.91, P < .001), overall mortality (HR 0.48, 95% CI 0.41 to 0.57; P < .001), and the composite outcome (HR 0.82, 95% CI 0.74 to 0.91; P < .002) during the consolidated time that patients were exposed to GLP-1RAs compared to corresponding rates during intervals without GLP-1RA exposure. GLP-1RA treatment was associated with a significant decrease in CVA, mortality, and the composite outcome in patients with and without established CVD, not significantly affecting AMI in these subgroups. CONCLUSIONS: GLP-1RA exposure was found to be associated with a reduction in the risk of cardiovascular events observed and overall mortality among patients with T2D with and without established CVD, after adjusting for potential confounders.

Intraoperative radiotherapy: Patient selection, management, and follow-up.

Intraoperative partial breast radiotherapy is an alternative or an adjunct to fractionated whole breast irradiation for the administration of adjuvant radiotherapy in breast cancer following breast conserving surgery. Establishing intraoperative radiotherapy as a therapeutic modality requires a multidisciplinary approach to patient selection, workup, surgery, radiation protocols, chemotherapy, and patient follow up. In this article, we review the published evidence for best clinical practice, as a guide to the introduction of intraoperative radiotherapy for breast cancer treatment.

Posttransfusion Increase of Hematocrit per se Does Not Improve Circulatory Oxygen Delivery due to Increased Blood Viscosity.

BACKGROUND: Blood transfusion is used to treat acute anemia with the goal of increasing blood oxygen-carrying capacity as determined by hematocrit (Hct) and oxygen delivery (DO2). However, increasing Hct also increases blood viscosity, which may thus lower DO2 if the arterial circulation is a rigid hydraulic system as the resistance to blood flow will increase. The net effect of transfusion on DO2 in this system can be analyzed by using the relationship between Hct and systemic blood viscosity of circulating blood at the posttransfusion Hct to calculate DO2 and comparing this value with pretransfusion DO2. We hypothesized that increasing Hct would increase DO2 and tested our hypothesis by mathematically modeling DO2 in the circulation. METHODS: Calculations were made assuming a normal cardiac output (5 L/min) with degrees of anemia ranging from 5% to 80% Hct deficit. We analyzed the effects of transfusing 0.5 or more units of 300 cc of packed red blood cells (PRBCs) at an Hct of 65% and calculated microcirculatory DO2 after accounting for increased blood viscosity and assuming no change in blood pressure. Our model accounts for O2 diffusion out of the circulation before blood arriving to the nutritional circulation and for changes in blood flow velocity. The immediate posttransfusion DO2 was also compared with DO2 after the transient increase in volume due to transfusion has subsided. RESULTS: Blood transfusion of up to 3 units of PRBCs increased DO2 when Hct (or hemoglobin) was 60% lower than normal, but did not increase DO2 when administered before this threshold. CONCLUSIONS: After accounting for the effect of increasing blood viscosity on blood flow owing to increasing Hct, we found in a mathematical simulation of DO2 that transfusion of up to 3 units of PRBCs does not increase DO2, unless anemia is the result of an Hct deficit greater than 60%. Observations that transfusions occasionally result in clinical improvement suggest that other mechanisms possibly related to increased blood viscosity may compensate for the absence of increase in DO2.

Financial Incentives and Diabetes Disease Control in Employees: A Retrospective Cohort Analysis.

BACKGROUND: Many employers offer worksite wellness programs, including financial incentives to achieve goals. Evidence supporting such programs is sparse. OBJECTIVE: To assess whether diabetes and cardiovascular risk factor control in employees improved with financial incentives for participation in disease management and for attaining goals. DESIGN: Retrospective cohort study using insurance claims linked with electronic medical record data from January 2008-December 2012. PARTICIPANTS: Employee patients with diabetes covered by the organization's self-funded insurance and propensity-matched non-employee patient comparison group with diabetes and commercial insurance. INTERVENTION: Financial incentives for employer-sponsored disease management program participation and achieving goals. MAIN MEASURES: Change in glycosylated hemoglobin (HbA1c), low-density lipoprotein (LDL), systolic blood pressure (SBP), and weight. RESULTS: A total of 1092 employees with diabetes were matched to non-employee patients. With increasing incentives, employee program participation increased (7 % in 2009 to 50 % in 2012, p < 0.001). Longitudinal mixed modeling demonstrated improved diabetes and cardiovascular risk factor control in employees vs. non-employees [HbA1c yearly change -0.05 employees vs. 0.00 non-employees, difference in change (DIC) p <0.001]. In their first participation year, employees had larger declines in HbA1c and weight vs. non-employees (0.33 vs. 0.14, DIC p = 0.04) and (2.3 kg vs. 0.1 kg, DIC p < 0.001), respectively. Analysis of employee cohorts corresponding with incentive offerings showed that fixed incentives (years 1 and 2) or incentives tied to goals (years 3 and 4) were not significantly associated with HbA1c reductions compared to non-employees. For each employee cohort offered incentives, SBP and LDL also did not significantly differ in employees compared with non-employees (DIC p > 0.05). CONCLUSIONS: Financial incentives were associated with employee participation in disease management and improved cardiovascular risk factors over 5 years. Improvements occurred primarily in the first year of participation. The relative impact of specific incentives could not be discerned.

Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial.

BACKGROUND: Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery. METHODS: Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase-myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization. RESULTS: We randomly assigned 128 patients to remote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31). INTERPRETATION: Remote ischemic precnditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT01071265.

Total colonic aganglionosis and imperforate anus in a severely affected infant with Pallister-Hall syndrome.

Pallister-Hall syndrome is a complex malformation syndrome characterized by a wide range of anomalies including hypothalamic hamartoma, polydactyly, bifid epiglottis, and genitourinary abnormalities. It is usually caused by truncating frameshift/nonsense and splicing mutations in the middle third of GLI3. The clinical course ranges from mild to lethal in the neonatal period. We present the first patient with Pallister-Hall syndrome reported with total colonic aganglionosis, a rare form of Hirschsprung disease with poor long-term outcome. The patient also had an imperforate anus, which is the third individual with Pallister-Hall syndrome reported with both Hirschsprung disease and an imperforate anus. Molecular testing via amniocentesis showed an apparently de novo novel nonsense mutation c.2641 C>T (p.Gln881*). His overall medical course was difficult and was complicated by respiratory failure and pan-hypopituitarism. Invasive care was ultimately withdrawn, and the patient expired at three months of age. This patient's phenotype was complex with unusual gastrointestinal features ultimately leading to a unfavorable prognosis and outcome, highlighting the range of clinical severity in patients with Pallister-Hall syndrome.

Importance of guiding catheter disengagement during measurement of fractional flow reserve in patients with an isolated proximal left anterior descending artery stenosis.

OBJECTIVE: To determine the impact of ostial guiding catheter disengagement during measurement of fractional flow reserve (FFR) in patients with an isolated proximal left anterior descending artery (LAD) stenosis. METHODS: Measurements of FFR were performed in 21 patients with an isolated intermediate lesion of the proximal LAD. Proximal aortic pressure (Pa), distal post stenotic pressure (Pd), and Pd/Pa were recorded at baseline, after at least 90 sec of intravenous (IV) adenosine infusion with the guiding catheter still engaged in the coronary ostium (Pa1 , Pd1 , FFReng ), and after at least 30 sec of guiding catheter disengagement back to the aorta (Pa2 , Pd2 , FFRdis ). RESULTS: The average value of Pd/Pa at baseline was 0.92 ± 0.04. After 110 ± 8 sec of IV adenosine infusion, FFReng was 0.81 ± 0.07, which decreased to 0.77 ± 0.08 (FFRdis ) after 38 ± 6 sec of guiding catheter disengagement. The mean ΔFFR (FFReng - FFRdis ) was 0.05 ± 0.04. As compared to baseline values, the mean change in FFR values was significantly increased after disengagement of the guiding catheter (Pd/Pabaseline - FFRdis vs. Pd/Pabaseline - FFReng , 0.15 ± 0.05 vs. 0.10 ± 0.04, P < 0.0001). Before guiding catheter disengagement, eight patients (38%) had an FFR value ≤ 0.8. Following disengagement of the guiding catheter, the new FFR values decreased below 0.8 in six additional patients (28%), with subsequent change in treatment strategy. CONCLUSIONS: During FFR assessment of isolated intermediate proximal LAD lesions, guiding catheter disengagement is associated with a decrease in mean FFR values. In patients with FFR values lying close to the treatment threshold, this can have an impact on treatment strategy.

Revisiting neuroimaging of abusive head trauma in infants and young children.

OBJECTIVE: The purpose of this article is to use a mechanism-based approach to review the neuroimaging findings of abusive head trauma to infants. Advanced neuroimaging provides insights into not only the underlying mechanisms of craniocerebral injuries but also the long-term prognosis of brain injury for children on whom these injuries have been inflicted. CONCLUSION: Knowledge of the traumatic mechanisms, the key neuroimaging findings, and the implications of functional imaging findings should help radiologists characterize the underlying causes of the injuries inflicted, thereby facilitating effective treatment.

Childhood encephalitis: relationship between diffusion abnormalities and clinical outcome.

INTRODUCTION: The impact of restricted diffusion on clinical outcome has not been well studied in childhood encephalitis. We hypothesized that the patients with lesions with restricted diffusion (LRD) would have worse clinical outcome. METHODS: We reviewed the MR studies of 83 children with encephalitis for LRD. An MRI scoring system (0-12) based on fluid-attenuated inversion recovery (FLAIR) imaging was created to evaluate the extent of imaging abnormality. Clinical outcome was graded by using Glasgow outcome scale (GOS) (1-5) in 1st and 12th month: 1 for death and five for full recovery. With respect to diffusion, the correlation between imaging score and GOS was assessed. Logistic regression analysis was used to explore the impact of diffusion and imaging score on clinical outcome. The patients were divided into three subgroups regarding imaging score: I, 0-4; II, 5-8; and III, 9-12. RESULTS: LRD was found in 28 patients. Negative significant correlation was found between imaging score and GOS in the group with LRD in both 1st month (R = -0.67, P < 0.001) and 12th month (R = -0.56, P = 0.001). Multivariate logistic regression showed that LRD (P < 0.001) and age (P = 0.026) were significant independent risk factors for unfavorable outcome in 1st month, and both LRD (P = 0.001) and imaging score (P = 0.043) were significant risk factors for unfavorable outcome in 12th month. CONCLUSIONS: Patients with LRD have a worse clinical outcome than those without LRD. In patients with LRD, those with a greater extent of abnormality have a poorer outcome.

Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up.

OBJECTIVE: The aim of this study is to evaluate the feasibility and safety of the Glidesheath Slender in routine transradial (TR) coronary angiography and intervention. BACKGROUND: In recent years, The TR approach has gained in popularity because of several advantages such as reduced vascular access site complications and immediate patient mobilization. Procedural success has been further improved through technological innovations and the development of less invasive devices. The Glidesheath Slender (Terumo, Tokyo, Japan) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with 6Fr guiding catheter with an outer diameter close to current 5Fr sheaths. Its use has the potential to decrease invasiveness and access site complications during TR procedures. METHODS: A total of 114 consecutive patients undergoing TR coronary angiography and/or PCI using the Gidesheath Slender were included in a prospective single-center feasibility and safety study. RESULTS: Procedural success was 99.1% with only one case requiring conversion to femoral access. There were six minor hematomas but none of the patients experienced major vascular complications. The rate of symptomatic radial spasm was 4.4%. No case of major sheath kinking was noted. Doppler ultrasound examination of the radial artery at 1 month follow-up was available in 113/114 patients with only one case of radial artery occlusion (RAO) (0.88%). CONCLUSIONS: Routine use of the Glidesheath Slender for TR coronary angiography and interventions is safe and feasible with a high rate of procedural success and a low rate of RAO. © 2013 Wiley Periodicals, Inc.

Cognitive dysfunction in antiphospholipid antibody (aPL)-negative systemic lupus erythematosus (SLE) versus aPL-positive non-SLE patients.

OBJECTIVES: The aim of this study was to compare the cognitive function of antiphospholipid antibody (aPL)-negative systemic lupus erythematosus (SLE) and aPL-positive non-SLE patients. METHODS: Twenty aPL-negative SLE and 20 aPL-positive non-SLE female patients with no history of overt neuropsychiatric manifestations took standardised cognitive tests of learning and memory, attention and working memory, executive functions, verbal fluency, visuoconstruction, and motor function. The primary outcome measure was an established global cognitive impairment index (CII). Cranial magnetic resonance imaging (MRI) was also obtained on all patients. RESULTS: Twelve of 20 (60%) of the SLE and 8/20 (40%) of the aPL-positive patients had global cognitive impairment on CII; there were no group differences on CII or on individual measures. Cognitive impairment was not associated with duration of disease, level of disease activity, or prednisone use. No correlations were found between clinical disease factors and cognitive impairment, and neither group showed an association between incidental or major MRI abnormalities and cognitive dysfunction. CONCLUSIONS: Both aPL-negative SLE and aPL-positive non-SLE patients, without other overt neuropsychiatric disease, demonstrated high levels of cognitive impairment. No clinical, serologic, or radiologic characteristics were associated with cognitive impairment. Cognitive dysfunction is common in APS and in SLE, but its mechanisms remain unknown.