Prospective Observational Cohort Study of Tenecteplase Versus Alteplase in Routine Clinical Practice.

BACKGROUND: A 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of potential workflow advantages and reported noninferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduced thrombolytic workflow times with noninferior clinical outcomes. METHODS: We designed a prospective registry-based observational, sequential cohort comparison of tenecteplase- (n=234) to alteplase-treated (n=354) stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door-to-needle time and transfer door-in-door-out time, and (2) noninferior favorable (discharge to home with independent ambulation) and unfavorable (symptomatic intracranial hemorrhage, in-hospital mortality or discharge to hospice) in the tenecteplase group. Total hospital cost associated with each treatment was also compared. RESULTS: Target door-to-needle time within 45 minutes for all patients was superior for tenecteplase, 41% versus 29%; adjusted odds ratio, 1.85 (95% CI, 1.27-2.71); P=0.001; 58% versus 41% by Get With The Guidelines criteria. Target door-in-door-out time within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); adjusted odds ratio, 3.62 (95% CI, 1.30-10.74); P=0.02. Favorable outcome for tenecteplase fell within the 6.5% noninferiority margin; adjusted odds ratio, 1.26 (95% CI, 0.89-1.80). Unfavorable outcome was less for tenecteplase, 7.3% versus 11.9%, adjusted odds ratio, 0.77 (95% CI, 0.42-1.37) but did not fall within the prespecified 1% noninferior boundary. Net benefit (%favorable-%unfavorable) was greater for the tenecteplase sample: 37% versus 27%. P=0.02. Median cost per hospital encounter was less for tenecteplase cases ($13 382 versus $15 841; P<0.001). CONCLUSIONS: Switching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter door-to-needle time and door-in-door-out times, noninferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.

Neuroimaging evolution of ischemia in men and women: an observational study.

Objective: We present an exploratory study for identification of sex differences in imaging biomarkers that could further refine selection of patients for acute reperfusion therapy and trials based on sex and imaging targets. Methods: The Lesion Evolution in Stroke and Ischemia On Neuroimaging (LESION) study included consecutive acute stroke patients who underwent MRI within 24 h of time from last known well and prior to therapy. Those demonstrating a potential therapeutic target on imaging were identified by presence of: (1) arterial occlusion on angiography, (2) focal ischemic region on perfusion maps, or (3) a mismatch of perfusion versus diffusion imaging lesion size. The prevalence of imaging targets within clinically relevant time intervals was calculated for each patient and examined. The relationship of time from stroke onset to probability of detection of imaging targets was evaluated. Results: Of 7007 patients screened, of which 86.7% were scanned with MRI, 1092 patients (477/615 men/women) were included in LESION. The probability of imaging target detection was significantly different between men and women, with women more likely to present with all assessed imaging targets, odds ratios between 1.36 and 1.59, P < 0.02, adjusted for NIHSS, age, and time from last known well to MRI scan. This trend held for the entire 24-h studied. Interpretation: Women present more often with treatable ischemic stroke than men. The greater probability of potentially viable and/or treatable imaging targets in women at all time points suggests that tissue injury is slower to evolve in women.

Initiation of Disease-Modifying Therapies in Rheumatoid Arthritis Is Associated With Changes in Blood Pressure.

PURPOSE: This study reports the effect of disease-modifying therapies for rheumatoid arthritis (RA) on systolic and diastolic blood pressure (SBP, DBP) over 6 months and incident hypertension over 3 years in a large administrative database. METHODS: We used administrative Veterans Affairs databases to define unique dispensing episodes of methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, tumor necrosis factor inhibitors, and prednisone among patients with RA. Changes in SBP and DBP in the 6 months before disease-modifying antirheumatic drug initiation were compared with changes observed in the 6 months after initiation. The risk of incident hypertension within 3 years (new diagnosis code for hypertension and prescription for antihypertensive) was also assessed. Multivariable models and propensity analyses assessed the impact of confounding by indication. RESULTS: A total of 37,900 treatment courses in 21,216 unique patients contributed data. Overall, there were no changes in SBP or DBP in 6 months prior to disease-modifying antirheumatic drug initiation (all P > 0.62). In contrast, there was a decline in SBP (ß = -1.08 [-1.32 to -0.85]; P < 0.0001) and DBP (ß = -0.48 [-0.62 to -0.33]; P < 0.0001) over the 6 months following initiation. The greatest decline was observed among methotrexate and hydroxychloroquine users. Methotrexate users were 9% more likely to have optimal blood pressure (BP) after 6 months of treatment. Patients treated with leflunomide had increases in BP and a greater risk of incident hypertension compared with patients treated with methotrexate (hazard ratio, 1.53 [1.21-1.91]; P < 0.001). CONCLUSIONS: Blood pressure may improve with treatment of RA, particularly with methotrexate or hydroxychloroquine. Leflunomide use, in contrast, is associated with increases in BP and a greater risk of incident hypertension.

Body Mass Index, Weight Loss, and Cause-Specific Mortality in Rheumatoid Arthritis.

OBJECTIVE: To examine associations of body mass index (BMI) and weight loss with cause-specific mortality in rheumatoid arthritis (RA). METHODS: A cohort of US veterans with RA was followed until death or through 2013. BMI was categorized as underweight, normal, overweight, and obese. Weight loss was calculated as the 1) annualized rate of change over the preceding 13 months, and 2) cumulative percent. Vital status and cause of death were obtained from the National Death Index. Multivariable competing-risks regression models were utilized to assess the time-varying associations of BMI and weight loss with cause-specific mortality. RESULTS: Among 1,600 participants and 5,789 patient-years of followup, 303 deaths occurred (95 cardiovascular, 74 cancer, and 46 respiratory). The highest weight-loss rate and weight-loss percent were associated with a higher risk of cardiovascular mortality (rate: subdistribution hazard ratio [sHR] 2.27 [95% confidence interval (95% CI) 1.61-3.19]; percent: sHR 2.31 [95% CI 1.06-5.01]) and cancer mortality (rate: sHR 2.36 [95% CI 1.11-5.01]; percent: sHR 1.90 [95% CI 1.00-3.62]). Overweight BMI was protective of cardiovascular mortality (sHR 0.59 [95% CI 0.38-0.91]), while underweight BMI was associated with a near 3-fold increased risk of respiratory mortality (sHR 2.93 [95% CI 1.28-6.67]). Incorporation of time-varying BMI and weight loss in the same models did not substantially alter individual associations for cardiovascular and cancer mortality, but an association between weight-loss percentage and respiratory mortality was attenuated after BMI adjustment. CONCLUSION: Both BMI and weight loss are predictors of cause-specific mortality in RA. Weight loss is a strong predictor of cardiovascular and cancer mortality, while underweight BMI is a stronger predictor of respiratory mortality.

User Perceptions of ¡Protéjase!: An Intervention Designed to Increase Protective Equipment Use Among Mexican Immigrant and Mexican American Farmworkers.

BACKGROUND: Farmworkers' exposures to pesticides are reduced when they wear personal protective equipment (PPE), and mobile health (mHealth) platforms can potentially deliver information to farmworkers to help promote PPE use. However, little is known about the feasibility of using mHealth platforms to promote farmworkers' use of PPE. OBJECTIVE: The objective of the study was to describe the development and feasibility-testing of Protect Yourself! (¡Protéjase!), an intervention designed to increase PPE use. As the vast majority of farmworkers in the United States are from Mexico, we examined the intervention in a primarily Mexican-origin farmworker population. METHODS: ¡Protéjase was developed in several steps. First, we performed ethnographic observations to understand what prevents PPE use. Next, we developed program components that met the challenges uncovered in the ethnographic observations, seeking direct feedback from farmworkers on each component. Feasibility was assessed using surveys and focus groups. Material was provided in Spanish or English at the preference of the participant. Finally, we pilot tested each component of the intervention, including: (1) PPE that was provided to each worker for their personal use during the intervention trial, and (2) delivery of an application-based tool that promoted the use of PPE through daily individualized messaging. RESULTS: 55 farmworkers enrolled in the study, but only 41 of 55 (75%) completed the entire pilot intervention trial. Results focus on the evaluation of the intervention, and include only those who completed the entire trial. Among farmworkers who completed the entire intervention trial, all but two farmworkers were born in Mexico and were Spanish speaking. Still, all study participants self-identified as Mexican or Mexican-American. When asked what changes were needed in the intervention's messaging or delivery to increase user satisfaction, 22 out of 41 participants (54%) felt that no changes were needed. However, 16 of 41 participants (39%) suggested small changes to messaging (eg, refer to long pants as pants only) to improve their understanding of the messages. Finally, a small number (3 of 41 participants, 7%) felt that messages were difficult to read, primarily due to low literacy. CONCLUSIONS: The ¡Protéjase! mHealth program demonstrated very good feasibility, satisfaction, and acceptance; potential improvements (eg, small modifications in messaging to increase farmworkers' use) were noted. Overall, the PPE provided to workers as well as the mHealth platform were both perceived as useful for promoting PPE use.

Associations of Circulating Cytokines and Chemokines With Cancer Mortality in Men With Rheumatoid Arthritis.

OBJECTIVE: To examine the potential of circulating cytokines and chemokines as biomarkers of cancer mortality risk in patients with rheumatoid arthritis (RA). METHODS: Male participants in the Veterans Affairs RA registry were followed up from the time of enrollment until death or December 2013. Cytokines and chemokines were measured in banked serum obtained at the time of enrollment, using a bead-based multiplex assay, and a previously developed cytokine score was calculated. Vital status and cause of death were determined through the National Death Index. Associations of cytokines with cancer mortality were examined using multivariable competing-risks regression. RESULTS: Among 1,190 men with RA, 60 cancer deaths (30 of which were attributable to lung cancer) occurred over 5,307 patient-years of follow-up. The patients had a mean age of 64.5 years, had established disease (median duration 8.7 years), were seropositive for rheumatoid factor (81%) or anti-cyclic citrullinated peptide antibody (77%), and frequently had a history of smoking (82% current or former). Seven of 17 analytes examined were individually associated with cancer mortality. The cytokine score was associated with overall cancer (subhazard ratio [SHR] 1.42, 95% confidence interval [95% CI] 1.08-1.85) and lung cancer (SHR 1.86, 95% CI 1.57-2.19) mortality in multivariable analyses. Those in the highest quartile of cytokine scores had a >2-fold increased risk of overall cancer mortality (P = 0.039) and a 6-fold increased risk of lung cancer mortality (P = 0.028) relative to the lowest quartile. A synergistic interaction between current smoking and high cytokine score was observed. CONCLUSION: Serum cytokines and chemokines are associated with cancer and lung cancer mortality in men with RA, independent of multiple factors including age, smoking status, and prevalent cancer.

Cause-Specific Mortality in Male US Veterans With Rheumatoid Arthritis.

OBJECTIVE: There has been limited investigation into cause-specific mortality and the associated risk factors in men with rheumatoid arthritis (RA). We investigated all-cause and cause-specific mortality in men with RA, examining determinants of survival. METHODS: Men from a longitudinal RA registry were followed from enrollment until death or through 2013. Vital status and cause of death were determined using the National Death Index. Crude mortality rates and standardized mortality ratios (SMRs) were calculated for all-cause, cardiovascular disease (CVD), cancer, and respiratory mortality. Associations with all-cause and cause-specific mortality were examined using multivariable Cox proportional hazards and competing-risks regression. RESULTS: There were 1,652 men with RA and 332 deaths. The leading causes of death were CVD (31.6%; SMR 1.77 [95% confidence interval (95% CI) 1.46-2.14]), cancer (22.9%; SMR 1.50 [95% CI 1.20-1.89]), and respiratory disease (15.1%; SMR 2.90 [95% CI 2.20-3.83]). Factors associated with all-cause mortality included older age, white race, smoking, low body weight, comorbidity, disease activity, and prednisone use. Rheumatoid factor concentration and nodules were associated with CVD mortality. There were no associations of methotrexate or biologic agent use with all-cause or cause-specific mortality. CONCLUSION: Men in this RA cohort experienced increased all-cause and cause-specific mortality, with a 3-fold risk of respiratory-related deaths compared to age-matched men in the general population. Further studies are needed in order to examine whether interventions targeting potentially modifiable correlates of mortality might lead to improved long-term survival in men with RA.

Clinically Available Medicines Demonstrating Anti-Toxoplasma Activity.

Toxoplasma gondii is an apicomplexan parasite of humans and other mammals, including livestock and companion animals. While chemotherapeutic regimens, including pyrimethamine and sulfadiazine regimens, ameliorate acute or recrudescent disease such as toxoplasmic encephalitis or ocular toxoplasmosis, these drugs are often toxic to the host. Moreover, no approved options are available to treat infected women who are pregnant. Lastly, no drug regimen has shown the ability to eradicate the chronic stage of infection, which is characterized by chemoresistant intracellular cysts that persist for the life of the host. In an effort to promote additional chemotherapeutic options, we now evaluate clinically available drugs that have shown efficacy in disease models but which lack clinical case reports. Ideally, less-toxic treatments for the acute disease can be identified and developed, with an additional goal of cyst clearance from human and animal hosts.

Decisional support to prevent adverse drug reactions of long latency: pilot randomized controlled intervention for glucocorticoid-induced diabetes.

RATIONALE, AIMS, AND OBJECTIVES: Long-term exposure to glucocorticoids can cause adverse drug reactions of long latency (ADRLLs), including glucocorticoid-induced diabetes mellitus (GID). Providers can monitor for GID using the glycosylated haemoglobin blood (HbA1C) test. This study examined the utility of decisional support to improve HbA1C-based screening for GID. US veterans were identified as chronic users of oral glucocorticoids (>120 days of oral glucocorticoids in the last 2 years). The primary care providers caring for these patients were the target of the intervention. Providers were randomized to receive automatic HbA1C orders for their patients receiving chronic glucocorticoid or usual care. METHODS: This study was a pilot two-arm, group-randomized, controlled trial (n = 12 providers, n = 38 patients). Data collection occurred from 5 May 2013 until 10 January 2014. A pharmacist generated the order for an HbA1C through the electronic medical record. The time between the intervention start date and the date on which an HbA1C order was signed were compared using Cox proportional and hierarchical linear regression. RESULTS: The time to sign HbA1C orders (mean 12.0 days for the intervention arm; 104.0 days for control arm) was associated with significant differences favouring the intervention [HR (Hazard Ratio) 50.2, P < 0.001, confidence interval (CI) 6.3 to 398.7]. For the intervention group, 95% of orders were signed, whereas only 12% of control providers signed orders (odds ratio 150, P < 0.001, CI 12.4 to 1812.9). CONCLUSIONS: The results of this study strongly suggest that the clinical pharmacist-triggered order intervention is effective. This method of computerized decisional support may be useful in improving screening for GID and ADRLLs.

Vascular calcifications on hand radiographs in rheumatoid arthritis and associations with autoantibodies, cardiovascular risk factors and mortality.

OBJECTIVE: To examine whether vascular calcifications on hand films in RA might aid in determining mortality risk. METHODS: Hand radiographs from 906 RA patients were scored as positive or negative for vascular calcifications. Patient characteristics associated with vascular calcifications were assessed using multivariable logistic regression, and associations with mortality were examined using Cox proportional hazards regression. Cytokines and multiplex ACPA were measured in both groups. RESULTS: A total of 99 patients (11%) demonstrated radiographic vascular calcifications. Factors independently associated with vascular calcifications included diabetes [odds ratio (OR) 2.85; 95% CI 1.43, 5.66], cardiovascular disease at enrolment (OR 2.48; 95% CI 1.01, 6.09), prednisone use (OR 1.90; 95% CI 1.25, 2.91), current smoking (OR 0.06; 95% CI 0.01, 0.23) and former smoking (OR 0.36; 95% CI 0.27, 0.48) vs never smoking. In cytokine and ACPA subtype analysis, IL-4 and anti-citrullinated apolipoprotein E were significantly increased in patients with vascular calcifications in fully adjusted multivariable models. After multivariable adjustment, vascular calcifications were associated with an increase in all-cause mortality (hazard ratio 1.41; 95% CI 1.12, 1.78; P = 0.004). CONCLUSION: Vascular calcifications on hand radiographs were independently associated with increased all-cause mortality in RA. Mechanisms underpinning the associations of IL-4 and select ACPA with vascular calcifications and their utility as biomarkers predictive of cardiovascular disease risk in RA merit further study.

Validation of disease activity and functional status questionnaires in spondyloarthritis.

OBJECTIVES: Patients naïve to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and to the Ankylosing Spondylitis Disease Activity Score (ASDAS) have voiced confusion in our clinics over the use of the term "AS" in these instruments. It is unknown whether these tools may be applied to other related forms of spondyloarthritis (SpA). The Bath Ankylosing Spondylitis Functional Index (BASFI) questionnaire also requires more definitive validation. We 1) validated the BASFI against a standard definition of disability; and 2) validated slightly modified versions of the BASDAI and ASDAS questionnaires that replace references to "AS" with the term "inflammatory arthritis" for use in non-AS SpA. METHODS: Adult patients with SpA enrolled in the Veterans Affairs Program to Understand the Longterm outcomes in Spondylo-ARthritis (PULSAR) completed the BASFI, BASDAI, ASDAS and altered versions of the BASDAI (PULSAR-modified Bath Disease Activity Index [PuBaDAI]) and ASDAS (PULSAR-modified Ankylosing Spondylitis Disease Activity Score [PuASDAS]). Spearman correlations and logistic regression were used to analyse the scores. RESULTS: The correlation between BASDAI and PuBaDAI and between ASDAS and PuASDAS scores was high (Spearman's rho=0.92, p<0.001 and Spearman's rho=0.85, p<0.001, respectively). The test-retest correlation of BASFI was also high (Spearman's rho=0.92, p<0.001). The BASFI (OR 1.67, 95% C.I. 1.12-2.47), ASDAS (OR 1.34, 95% C.I. 1.02-1.76) and PuASDAS (OR 1.62, 95% C.I. 1.07-2.49) predicted federally-determined disability. CONCLUSIONS: Preliminary data suggest that BASDAI and ASDAS scores correlate well with modified forms of these questionnaires and that the ASDAS, PuASDAS and BASFI are associated with disability.

Practices and preferences for detecting chronic medication toxicity: a pilot cross-sectional survey of health care providers focusing on decision support systems.

RATIONALE, AIMS, AND OBJECTIVES: Adverse drug reactions (ADRs) are a critical concern: they are costly, both in dollars and in diminishing patients' quality of life. ADRs that occur due to prolonged exposure to a pharmaceutical agent (adverse drug reactions of long latency, ADRLLs) may be easier to prevent than acute ADRs, as ADRLLs inherently require continued medication exposures. This pilot study used glucocorticoid-induced osteoporosis (GIO) as an example ADRLL. The aims were to survey health care providers' current practices in avoiding ADRLLs and the perceived utility of decisional support systems (DSS) to aid them in preventing GIO. METHODS: We administered an anonymous, cross-sectional survey to health care providers (fellows, doctor assistants, nurse practitioners and attending doctors) focusing on their methods to monitor for and prevent ADRLLs. The questionnaire also gauged usage of electronic medical records (EMRs) and each provider's perceived utility of specific DSS-based approaches to monitoring for GIO. Data were interpreted using descriptive statistics and histograms. RESULTS: A majority of the 33 responding providers (84.8%) reported that their primary ADRLL avoidance technique is simply remembering that a patient is on chronic glucocorticoids. The most favourably perceived DSS options included tracking medications on a flow sheet (84.8%) and digital tracking of cumulative glucocorticoid exposure with real-time prompts (83.9%). CONCLUSIONS: Surveyed providers reported that additional DSS implementation may help in the avoidance of ADRLLs such as GIO. Providers ranked both digital and non-digital DSS favourably, but a computerized approach is appealing in that it may be integrated into extant EMR systems.

Association of rheumatoid arthritis susceptibility gene with lipid profiles in patients with rheumatoid arthritis.

OBJECTIVE: RA patients have an increased risk of cardiovascular (CV) disease, although the mechanisms are unclear. As RA and CV disease may be associated through lipid profiles, we examined whether single nucleotide polymorphisms (SNPs) associated with RA susceptibility were associated with low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglyceride (TG) levels in RA subjects. METHODS: Patients (n = 763) enrolled in the Veterans Affairs RA registry who were not on hydroxymethylglutaryl-CoA reductase inhibitor were genotyped for human leukocyte antigen shared epitope (HLA-DRB1-SE) and SNPs in the following genes: CTLA-4 (cytotoxic T-lymphocyte antigen 4), IL-10, PTPN22 (protein tyrosine phosphatase, non-receptor type 22), REL (c-Rel), STAT4 (signal transducer and activator of transcription protein), TNF- and TRAF1 (TNF receptor-associated factor 1). Other covariates included patient characteristics (age, gender, race, smoking status, education, BMI, modified CharlsonDeyo comorbidity index), CV characteristics (hypertension, diabetes, alcohol abuse), pharmacologic exposures (MTX, anti-TNF, glucocorticoids) and RA severity/activity markers (RA disease duration, mean DAS, CRP, RF positivity, anti-CCP positivity). Multivariate linear regression was performed to determine the factors associated with LDL, HDL and TG levels. RESULTS: The REL SNP rs9309331 homozygous minor allele was associated with higher LDL levels. Caucasian race and increasing BMI were associated with lower HDL. Factors associated with higher TG were diabetes, Caucasian race and higher BMI. CONCLUSION: The REL SNP rs9309331 was associated with LDL levels in our study. This association is a possible explanation of the increased risk of RA patients for CV disease and requires further inquiry.

Myocardial infarction risk among patients with fractures receiving bisphosphonates.

OBJECTIVE: To determine if bisphosphonates are associated with reduced risk of acute myocardial infarction (AMI). PATIENTS AND METHODS: A cohort of 14,256 veterans 65 years or older with femoral or vertebral fractures was selected from national administrative databases operated by the US Department of Veterans Affairs and was derived from encounters at Veterans Affairs facilities between October 1, 1998, and September 30, 2006. The time to first AMI was assessed in relationship to bisphosphonate exposure as determined by records from the Pharmacy Benefits Management Database. Time to event analysis was performed using multivariate Cox proportional hazards regression. An adjusted survival analysis curve and a Kaplan-Meier survival curve were analyzed. RESULTS: After controlling for atherosclerotic cardiovascular disease risk factors and medications, bisphosphonate use was associated with an increased risk of incident AMI (hazard ratio, 1.38; 95% CI, 1.08-1.77; P=.01). The timing of AMI correlated closely with the timing of bisphosphonate therapy initiation. CONCLUSION: Our observations in this study conflict with our hypothesis that bisphosphonates have antiatherogenic effects. These findings may alter the risk-benefit ratio of bisphosphonate use for treatment of osteoporosis, especially in elderly men. However, further analysis and confirmation of these findings by prospective clinical trials is required.

Health literacy predicts discrepancies between traditional written patient assessments and verbally administered assessments in rheumatoid arthritis.

OBJECTIVE: Patient assessments of disease activity (PtGA) and general health (GH) measured by visual analog scale (VAS) are widely used in rheumatoid arthritis (RA) clinical practice and research. These require comprehension of the question's wording and translation of disease activity onto a written VAS, which is problematic for patients with limited health literacy (HL) or difficulty completing forms. This study's objective was to validate verbally administered versions of patient assessments and identify factors that might explain discrepancies between verbal and written measures. METHODS: We enrolled patients with RA at the Denver Health rheumatology clinic (n = 300). Subjects were randomized to complete the traditional written PtGA and GH and one of the verbal assessments. Subjects provided a verbal numeric response after reading the question, having the question read to them in person, or hearing the question over the phone. Spearman and Lin correlations comparing written and verbal assessments were determined. Multivariate logistic regression was performed to explain any discrepancies. RESULTS: The instruments administered verbally in-person showed good, but not excellent, correlation with traditional written VAS forms (Spearman coefficients 0.59 to 0.70; p < 0.001 for all correlations). Twenty-three percent of subjects were unable to complete 1 of the written VAS assessments without assistance. HL predicted missing written data and discrepancies between verbal and written assessments (p < 0.05 for all correlations). CONCLUSION: Providers should use verbal versions of PtGA and GH with caution while caring for patients unable to complete traditional written version. Limited HL is widely prevalent and a barrier to obtaining patient-oriented data.

Factors associated with calcium absorption in postmenopausal women: a post hoc analysis of dual-isotope studies.

Reduced calcium absorption is a risk factor for osteoporosis. This study examined factors associated with fractional calcium absorption (FCA) and net calcium absorption in postmenopausal women in a post hoc analysis of three completed dual-isotope studies. Data were analyzed from 50 postmenopausal women undergoing 121 inpatient research visits in three studies evaluating changes in FCA related to correction of vitamin D insufficiency (n=19), use of proton pump inhibitors (n=21), and use of aromatase inhibitors to treat breast cancer (n=10). Net calcium absorption was the product of FCA and total calcium intake in milligrams per day. Variables included subjects' age, race, body mass index, serum calcium, creatinine, parathyroid hormone, 1,25-dihydroxyvitamin D, 25-hydroxyvitamin D, and habitual intake of kilocalories, protein, fat, carbohydrate, fiber, calcium, iron, magnesium, oxalate, phosphorus, potassium, and vitamin D based on outpatient diet diaries. In multivariate models, subjects' age, dietary intake of kilocalories, carbohydrates, fat, fiber, calcium, and potassium were significant predictors of FCA. In multiple variable models predicting net calcium absorption, dietary intake of kilocalories, fat, fiber, calcium, potassium, and serum 1,25-dihydroxyvitamin D were significant. The square of the correlation between actual and predicted values (an approximation of R(2)) was 0.748 for FCA and 0.726 for net calcium absorption. Similar to other studies, this study found that age, 1,25-dihydroxyvitamin D, and dietary calcium and fat were associated with calcium absorption. Dietary intake of kilocalories, carbohydrates, and potassium were new factors that were significantly associated with FCA and net calcium absorption. In summary, the study suggests that several dietary habits play a role in calcium absorption, beyond vitamin D and calcium.

Stroke treatment academic industry roundtable: research priorities in the assessment of neurothrombectomy devices.

BACKGROUND AND PURPOSE: The goal of the Stroke Treatment Academic Industry Roundtable (STAIR) meetings is to advance the development of stroke therapies. At STAIR VIII, consensus recommendations were developed for clinical trial strategies to demonstrate the benefit of endovascular reperfusion therapies for acute ischemic stroke. SUMMARY OF REVIEW: Prospects for success with forthcoming endovascular trials are robust, because new neurothrombectomy devices have superior reperfusion efficacy compared with earlier-generation interventions. Specific recommendations are provided for trial designs in 3 populations: (1) patients undergoing intravenous fibrinolysis, (2) early patients ineligible for or having failed intravenous fibrinolysis, and (3) wake-up and other late-presenting patients. Among intravenous fibrinolysis-eligible patients, key principles are that CT or MRI confirmation of target arterial occlusions should precede randomization; endovascular intervention should be pursued with the greatest rapidity possible; and combined intravenous and neurothrombectomy therapy is more promising than neurothrombectomy alone. Among patients ineligible for or having failed intravenous fibrinolysis, scientific equipoise was affirmed and the need to randomize all eligible patients emphasized. Vessel imaging to confirm occlusion is mandatory, and infarct core and penumbral imaging is desirable in later time windows. Additional STAIR VIII recommendations include approaches to test multiple devices in a single trial, utility weighting of disability end points, and adaptive designs to delineate time and tissue injury thresholds at which benefits from intervention no longer accrue. CONCLUSIONS: Endovascular research priorities in acute ischemic stroke are to perform trials testing new, highly effective neuro thrombectomy devices rapidly deployed in patients confirmed to have target vessel occlusions.

Predictors of acute stroke mimics in 8187 patients referred to a stroke service.

BACKGROUND: Some patients seen by a stroke team do not have cerebrovascular disease but a condition that mimics stroke. The purpose of this study was to determine the rate and predictors of stroke mimics in a large sample. METHODS: This is an analysis of data from consecutive patients seen by the National Institutes of Health Stroke Program over 10 years. Data were collected prospectively as a quality improvement initiative. Patients with a cerebrovascular event or a stroke mimic were compared with the Student t or Pearson chi-square test as appropriate, and logistic regression was done to identify independent predictors. RESULTS: The analysis included 8187 patients: 30% had a stroke mimic. Patients with a stroke mimic were younger, and the proportion of patients with a stroke mimic was higher among women, patients without any risk factors, those seen as a code stroke or who arrived to the emergency department via personal vehicle, and those who had the onset of symptoms while inpatients. The proportion of patients with a stroke mimic was marginally higher among African-Americans than Caucasians. Factors associated with the greatest odds of having a stroke mimic in the logistic regression were lack of a history of hypertension, atrial fibrillation or hyperlipidemia. CONCLUSIONS: One third of the patients seen by a stroke team over 10 years had a stroke mimic. Factors associated with a stroke mimic may be ascertained by an emergency physician before calling the stroke team.