Correction: Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study.

[This corrects the article DOI: 10.2196/31862.].

Patient empowerment brochures to increase gabapentinoid deprescribing: protocol for the prospective, controlled before-and-after GABA-WHY trial.

BACKGROUND: Off-label use of gabapentinoids is common among patients admitted to hospital medical wards, who are at risk of adverse drug events. In this study, we will assess if educational brochures can increase rates of gabapentinoid deprescription among medical inpatients, compared with usual care. METHODS: We describe the protocol for a prospective before-and-after trial that will take place on 5 medical wards of 2 tertiary care hospitals in Montréal, Canada. The study intervention will include distribution of educational brochures to users of gabapentinoids during hospital admission, as well as short educational sessions for medical staff on safe gabapentinoid prescribing practices. We will include patients with a gabapentinoid prescription before admission who are aged 60 years or older. Exclusion criteria are known seizure disorder, severe cognitive impairment, expected prognosis less than 3 months and inability to read English or French. The primary outcome is the rate of gabapentinoid deprescription at 8 weeks postdischarge. We aim to recruit 160 participants, with a 1:1 distribution between intervention and control groups. INTERPRETATION: If successful, the use of educational brochures and staff education represents a scalable intervention to reduce gabapentinoid overuse by encouraging deprescription conversations between patients and their health care providers. Results of the study will be disseminated through publication in peer-reviewed journals and presentations at conferences. TRIAL REGISTRATION: ClinicalTrials.gov, no. NCT04855578.

Evaluating the perceived utility of an artificial intelligence-powered clinical decision support system for depression treatment using a simulation center.

Aifred is a clinical decision support system (CDSS) that uses artificial intelligence to assist physicians in selecting treatments for major depressive disorder (MDD) by providing probabilities of remission for different treatment options based on patient characteristics. We evaluated the utility of the CDSS as perceived by physicians participating in simulated clinical interactions. Twenty physicians who were either staff or residents in psychiatry or family medicine completed a study in which they had three 10-minute clinical interactions with standardized patients portraying mild, moderate, and severe episodes of MDD. During these scenarios, physicians were given access to the CDSS, which they could use in their treatment decisions. The perceived utility of the CDSS was assessed through self-report questionnaires, scenario observations, and interviews. 60% of physicians perceived the CDSS to be a useful tool in their treatment-selection process, with family physicians perceiving the greatest utility. Moreover, 50% of physicians would use the tool for all patients with depression, with an additional 35% noting that they would reserve the tool for more severe or treatment-resistant patients. Furthermore, clinicians found the tool to be useful in discussing treatment options with patients. The efficacy of this CDSS and its potential to improve treatment outcomes must be further evaluated in clinical trials.

Evaluating the Clinical Feasibility of an Artificial Intelligence-Powered, Web-Based Clinical Decision Support System for the Treatment of Depression in Adults: Longitudinal Feasibility Study.

BACKGROUND: Approximately two-thirds of patients with major depressive disorder do not achieve remission during their first treatment. There has been increasing interest in the use of digital, artificial intelligence-powered clinical decision support systems (CDSSs) to assist physicians in their treatment selection and management, improving the personalization and use of best practices such as measurement-based care. Previous literature shows that for digital mental health tools to be successful, the tool must be easy for patients and physicians to use and feasible within existing clinical workflows. OBJECTIVE: This study aims to examine the feasibility of an artificial intelligence-powered CDSS, which combines the operationalized 2016 Canadian Network for Mood and Anxiety Treatments guidelines with a neural network-based individualized treatment remission prediction. METHODS: Owing to the COVID-19 pandemic, the study was adapted to be completed entirely remotely. A total of 7 physicians recruited outpatients diagnosed with major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Patients completed a minimum of one visit without the CDSS (baseline) and 2 subsequent visits where the CDSS was used by the physician (visits 1 and 2). The primary outcome of interest was change in appointment length after the introduction of the CDSS as a proxy for feasibility. Feasibility and acceptability data were collected through self-report questionnaires and semistructured interviews. RESULTS: Data were collected between January and November 2020. A total of 17 patients were enrolled in the study; of the 17 patients, 14 (82%) completed the study. There was no significant difference in appointment length between visits (introduction of the tool did not increase appointment length; F2,24=0.805; mean squared error 58.08; P=.46). In total, 92% (12/13) of patients and 71% (5/7) of physicians felt that the tool was easy to use; 62% (8/13) of patients and 71% (5/7) of physicians rated that they trusted the CDSS. Of the 13 patients, 6 (46%) felt that the patient-clinician relationship significantly or somewhat improved, whereas 7 (54%) felt that it did not change. CONCLUSIONS: Our findings confirm that the integration of the tool does not significantly increase appointment length and suggest that the CDSS is easy to use and may have positive effects on the patient-physician relationship for some patients. The CDSS is feasible and ready for effectiveness studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04061642; http://clinicaltrials.gov/ct2/show/NCT04061642.

Eating green for health or social benefits? Interactions of attitudes with self-identity on the consumption of vegetarian meals among U.S. and Chinese college students.

Encouraging greater consumption of vegetarian foods could be a strategy to improve plant-based food intake among non-vegetarians. Prior research on vegetarianism has focused mostly on people's motivations to be a vegetarian. However, the factors that motivate non-vegetarians to consume vegetarian meals remain largely unknown. The current research tested associations between attitudes, self-identity, and vegetarian meal consumption among 746 U.S. college students and 484 Chinese college students. Two types of attitudes were assessed: attitudes towards vegetarian food (ATF), which represents the personal benefits (including healthiness, tastiness, and enjoyableness) and attitudes towards people who are vegetarians (ATP), which represents the social benefits (perceived as being environmentally friendly, nice, and good-looking). Results showed that U.S. college students were more likely to be either vegetarians or non-vegetarians, while more Chinese college students tended to report being semi-vegetarians. In both samples, ATF and ATP were positively associated with self-identity and vegetarian meal consumption. Moderation analyses suggested that associations between attitudes and consumption were significant only among people who do not hold a definite self-identity as a vegetarian. In addition, ATP was significantly associated with vegetarian meal consumption among U.S. non- and semi-vegetarians alike, but among Chinese non-vegetarians only. These findings suggest that self-identity and cross-cultural differences are important to consider in promoting consumption of vegetarian meals through improving the public's attitudes towards vegetarian food and vegetarians.

Using a simulation centre to evaluate preliminary acceptability and impact of an artificial intelligence-powered clinical decision support system for depression treatment on the physician-patient interaction.

BACKGROUND: Recently, artificial intelligence-powered devices have been put forward as potentially powerful tools for the improvement of mental healthcare. An important question is how these devices impact the physician-patient interaction. AIMS: Aifred is an artificial intelligence-powered clinical decision support system (CDSS) for the treatment of major depression. Here, we explore the use of a simulation centre environment in evaluating the usability of Aifred, particularly its impact on the physician-patient interaction. METHOD: Twenty psychiatry and family medicine attending staff and residents were recruited to complete a 2.5-h study at a clinical interaction simulation centre with standardised patients. Each physician had the option of using the CDSS to inform their treatment choice in three 10-min clinical scenarios with standardised patients portraying mild, moderate and severe episodes of major depression. Feasibility and acceptability data were collected through self-report questionnaires, scenario observations, interviews and standardised patient feedback. RESULTS: All 20 participants completed the study. Initial results indicate that the tool was acceptable to clinicians and feasible for use during clinical encounters. Clinicians indicated a willingness to use the tool in real clinical practice, a significant degree of trust in the system's predictions to assist with treatment selection, and reported that the tool helped increase patient understanding of and trust in treatment. The simulation environment allowed for the evaluation of the tool's impact on the physician-patient interaction. CONCLUSIONS: The simulation centre allowed for direct observations of clinician use and impact of the tool on the clinician-patient interaction before clinical studies. It may therefore offer a useful and important environment in the early testing of new technological tools. The present results will inform further tool development and clinician training materials.

Final 5-Year Results in Unselected Patients Implanted With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study).

PROMUS Element (PE) Plus post-approval study was a large prospective, observational, all-comers study designed to evaluate the safety and performance of a thin-strut platinum chromium everolimus-eluting PE Plus stent in everyday clinical practice. A total of 2,683 "real-world" patients with limited clinical or anatomic exclusion criteria were enrolled at 52 clinical sites in the United States. The study met its primary end point of 12-month cardiac death or myocardial infarction (CD/MI) compared with a prespecified performance goal (p <0.0001). Five-year clinical outcomes were evaluated in overall PE Plus post-approval study patients and high-risk subgroups. During the 5-year follow-up period, CD/MI and stent thrombosis related to the PE Plus stent occurred in 9% and 2.2% overall patients, respectively. The reported all-cause mortality rate was 15%, with 7% classified as cardiac-related. A total of 18% patients underwent target vessel revascularization, and 11% were reported as target lesion revascularization. The rates of PE Plus stent-related CD/MI remained low in patients with medically treated diabetes (13%), small vessels (9%), and long stents (10%). PE Plus stent-related thrombosis through 5 years in patients with diabetes, small vessels and long stents was 4.2%, 2.2%, and 2.6%, respectively. The occurrence of target lesion revascularization was numerically higher in patients with diabetes (16%) and long lesions (18%) than the small vessels subgroup (11%). In conclusion, the final 5-year results establish the long-term safety and efficacy of the PE Plus stent in a broad, unselected patient population representative of "real-world" clinical practice.

Blinded outcomes and angina assessment of coronary bioresorbable scaffolds: 30-day and 1-year results from the ABSORB IV randomised trial.

BACKGROUND: Previous studies showed more adverse events with coronary bioresorbable vascular scaffolds (BVS) than with metallic drug-eluting stents (DES), although in one randomised trial angina was reduced with BVS. However, these early studies were unmasked, lesions smaller than intended for the scaffold were frequently enrolled, implantation technique was suboptimal, and patients with myocardial infarction, in whom BVS might be well suited, were excluded. METHODS: In the active-controlled, blinded, multicentre, randomised ABSORB IV trial, patients with stable coronary artery disease or acute coronary syndromes aged 18 years or older were recruited from 147 hospitals in five countries (the USA, Germany, Australia, Singapore, and Canada). Enrolled patients were randomly assigned (1:1) to receive polymeric everolimus-eluting BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) with optimised implantation technique or cobalt-chromium everolimus-eluting stents (EES; Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetic status, whether patients would have been eligible for enrolment in the previous ABSORB III trial, and site. Patients and clinical assessors were masked to randomisation. The primary endpoint was target lesion failure (cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation) at 30 days, tested for non-inferiority with a 2·9% margin for the risk difference. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02173379, and is closed to accrual. FINDINGS: Between Aug 15, 2014, and March 31, 2017, we screened 18 722 patients for eligibility, 2604 of whom were enrolled. 1296 patients were assigned to BVS, and 1308 patients were assigned to EES. Follow-up data at 30 days and 1 year, respectively, were available for 1288 and 1254 patients with BVS and for 1303 and 1272 patients with EES. Biomarker-positive acute coronary syndromes were present in 622 (24%) of 2602 patients, and, by angiographic core laboratory analysis, 78 (3%) of 2893 of lesions were in very small vessels. Target lesion failure at 30 days occurred in 64 (5·0%) patients assigned to BVS and 48 (3·7%) patients assigned to EES (difference 1·3%, upper 97·5% confidence limit 2·89; one-sided pnon-inferiority=0·0244). Target lesion failure at 1 year occurred in 98 (7·8%) patients assigned to BVS and 82 (6·4%) patients assigned to EES (difference 1·4%, upper 97·5% confidence limit 3·4; one-sided pnon-inferiority=0·0006). Angina, adjudicated by a central events committee at 1 year, occurred in 270 (20·3%) patients assigned to BVS and 274 (20·5%) patients assigned to EES (difference -0·3%, 95% CI -3·4% to 2·9%; one-sided pnon-inferiority=0·0008; two-sided psuperiority=0·8603). Device thrombosis within 1 year occurred in nine (0·7%) patients assigned to BVS and four (0·3%) patients assigned to EES (p=0·1586). INTERPRETATION: Polymeric BVS implanted with optimised technique in an expanded patient population resulted in non-inferior 30-day and 1-year rates of target lesion failure and angina compared with metallic DES. FUNDING: Abbott Vascular.

Access to Developmental Pediatrics Evaluations for At-Risk Children.

OBJECTIVE: To determine a national average wait time for developmental pediatric evaluations and to understand differences in access based on whether an appointment is requested by an English or Spanish-speaking caller. METHODS: We conducted a mystery shopper study in which a bilingual research assistant called developmental pediatrics programs affiliated with US children's hospitals listed on a public directory requesting an appointment for his simulated child experiencing a developmental problem. If an appointment was not provided, a wait time estimate was requested. Programs that provided an estimate in English were called within 24 hours using a translated script. We excluded programs that did not include a developmental pediatrician, only accepted referrals from within their health system or plan, focused on specific disorders, or did not conduct initial evaluations. RESULTS: Of 244 hospitals listed, 140 unique programs were identified and called in English. One hundred four programs were reached. Ninety programs met inclusion criteria, 75 provided an estimated wait time. The mean estimate was 5.4 months (standard deviation: 4.5). Among these 75 programs, 62 were reached in Spanish but only 55% provided a wait time estimate; 31% did not provide language accommodations. The difference between average estimates obtained in English and Spanish was not statistically significant. CONCLUSION: Among a national sample of US children's hospitals, we identified barriers to evaluations conducted by developmental pediatricians including long wait times and inadequate Spanish language accommodations at some programs. More work is needed to identify optimal strategies to connect children with developmental concerns to evaluations when necessary.

One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]).

The PROMUS Element Plus US Post-Approval Study (PE-Plus PAS) was a prospective, open-label, multicenter, observational study designed to examine outcomes in everyday clinical practice in patients treated with everolimus-eluting, platinum-chromium PROMUS Element Plus stents at 52 centers in the United States. This is the first report of results from this large study. The primary end point of the PE-Plus PAS was 12-month cardiac death or myocardial infarction in the more restricted population of "PLATINUM-like" patients pooled from the PE-Plus PAS, PE-PROVE (PROMUS Element European post-approval study), and PLATINUM Workhorse/Small Vessel trials. Additional clinical end points were tested in the overall PE-Plus PAS patient population. Of the 2,683 patients enrolled in PE-Plus PAS, 70% were men, mean age was 64 years, 33% had diabetes, and 29% were "PLATINUM-like." Among the PLATINUM-like patients, 12-month cardiac death or myocardial infarction was 1.8% (33 of 1,855) with an upper 1-sided 95% confidence interval of 2.3%, which was significantly less than the prespecified performance goal of 3.2% (pnoninferiority <0.001). In the overall PE-Plus population, 12-month target vessel failure (defined as death, MI, or revascularization related to the target vessel) was 6.7% (170 of 2,554), cardiac death was 1.4% (37 of 2,554), MI was 1.1% (28 of 2,554), and ARC-definite/probable stent thrombosis was 0.7% (19 of 2,554). A prespecified secondary end point of 12-month target vessel failure in diabetic patients demonstrated a rate of 4.2% (14 of 332) with an upper 1-sided 95% confidence interval of 6.03%, which was significantly less than the performance goal of 12.6% (pnoninferiority <0.001). In conclusion, in this large registry of unselected patients, coronary artery revascularization with the PROMUS Element Plus everolimus-eluting stent demonstrates favorable results with low 1-year clinical event rates.

Failure to acknowledge high suicide risk among veterinarians.

A high suicide risk has been reported among veterinarians in comparison to the general population. Postulated causes have included depression, substance abuse, work-related stress, reluctance to admit psychiatric problems, and access to lethal drugs and/or familiarity with euthanasia. Members of the Student Chapter of the American Veterinary Medical Association (AVMA), all veterinarians licensed in Alabama, and all US veterinary-association executive directors were surveyed regarding their attitudes concerning mental health issues, including veterinarian suicide. Only 10% of veterinary student respondents (N=58) believed that suicide risk is higher among veterinarians than in the general population. Of the 22 state associations' executive directors who participated in the survey, 37% believed that suicide is a significant concern for veterinarians and only 44% indicated that a veterinary wellness program was available in their respective states. Of the 1,455 licensed veterinarians in Alabama, 701 responded to the survey; 11% of respondents believed that suicide among veterinarians was a problem. In addition, 66% of respondents indicated that they had been "clinically depressed," but 32% of those with depression had not sought treatment. More females (27%) than males (20%) admitted that they had "seriously considered suicide" (p<.01). Female veterinarians were more likely than male veterinarians (15% versus 7%) to indicate that they were "not sure they'd made the right career choice" (p<.001), and 4% of all respondents indicated "definitely not being happy with their career." It is of concern that veterinarians not only have a higher risk of suicide but that they also have fewer support structures. The wide discrepancies between the published risk of suicide for veterinarians and their own views of their risk suggests an inadequate awareness of their own mental health vulnerability which could put them at higher risk.

The role of food culture and marketing activity in health disparities.

Marketing activities have attracted increased attention from scholars interested in racial disparities in obesity prevalence, as well as the prevalence of other preventable conditions. Although reducing the marketing of nutritionally poor foods to racial/ethnic communities would represent a significant step forward in eliminating racial disparities in health, we focus instead on a critical-related question. What is the relationship between marketing activities, food culture, and health disparities? This commentary posits that food culture shapes the demand for food and the meaning attached to particular foods, preparation styles, and eating practices, while marketing activities shape the overall environment in which food choices are made. We build on prior research that explores the socio-cultural context in which marketing efforts are perceived and interpreted. We discuss each element of the marketing mix to highlight the complex relationship between food culture, marketing activities, and health disparities.

Long-term (three-year) safety and efficacy of everolimus-eluting stents compared to paclitaxel-eluting stents (from the SPIRIT III Trial).

The safety and efficacy of the XIENCE V everolimus-eluting stent (EES) compared to the Taxus Express(2) paclitaxel-eluting stent (PES) has been demonstrated through 2 years in the SPIRIT II and III randomized clinical trials, but limited longer-term data have been reported. In the SPIRIT III trial, 1,002 patients with up to 2 lesions in 2 coronary arteries were randomized 2:1 to EESs versus PESs at 65 United States sites. At completion of 3-year follow-up, treatment with EES compared to PES resulted in a significant 30% decrease in the primary clinical end point of target vessel failure (cardiac death, myocardial infarction, or ischemic-driven target vessel revascularization, 13.5% vs 19.2%, hazard ratio 0.70, 95% confidence interval 0.50 to 0.96, p = 0.03) and a 43% decrease in major adverse cardiovascular events, cardiac death, myocardial infarction, or ischemic-driven target lesion revascularization (9.1% vs 15.7%, hazard ratio 0.57, 95% confidence interval 0.39 to 0.83, p = 0.003). In a landmark analysis, major adverse cardiovascular events were decreased to a similar extent with EES compared to PES 0 through 1 year and 1 year through 3 years (hazard ratio 0.56, 95% confidence interval 0.35 to 0.90; hazard ratio 0.59, 95% confidence interval 0.31 to 1.11, respectively). In conclusion, patients treated with EES rather than PES in the SPIRIT III trial had significantly improved event-free survival at 3 years. From 1 year to 3 years hazard curves continued to diverge in favor of EES, consistent with an improving long-term safety and efficacy profile of EES compared to PES, with no evidence of late catchup.

Evaluation of the effects of everolimus-eluting and paclitaxel-eluting stents on target lesions with jailed side branches: 2-year results from the SPIRIT III randomized trial.

OBJECTIVE: To evaluate whether an everolimus-eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. BACKGROUND: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS(2) paclitaxel-eluting stent (PES) compared to the bare metal EXPRESS(2)® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. METHODS: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS(2) PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two-year clinical outcomes were evaluated. RESULTS: A periprocedural increase in Creatine Kinase-MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). CONCLUSIONS: In this post-hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley-Liss, Inc.

Side branch occlusion with everolimus-eluting and paclitaxel-eluting stents: three-year results from the SPIRIT III randomised trial.

AIMS AND METHODS: The rates of side branch occlusion and subsequent periprocedural MI during everolimus-eluting stent (EES) and paclitaxel-eluting stent (PES) placement were examined in the randomised SPIRIT III trial. Periprocedural myocardial infarction (MI) following drug-eluting stent placement is associated with long-term adverse outcomes. Occlusion of side branches may be an important factor contributing to periprocedural MIs. Consecutive procedural angiograms of patients randomly assigned to EES (n=669) or PES (n=333) were analysed by an independent angiographic core laboratory. Side branch occlusion was defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0 or 1. Clinical outcomes through three years were compared by stent type and presence of side branch occlusion. CONCLUSIONS: A total of 2,048 side branches were evaluated (EES N=1,345 side branches in 688 stented lesions, PES N=703 side branches in 346 stented lesions). Patients with compared to those without transient or final side branch occlusion had significantly higher non-Q-wave MI (NQMI) rates in-hospital (9.0% vs. 0.5%, p<0.0001). By multivariable analysis side branch occlusion was an independent predictor of NQMI (OR 4.45; 95% CI [1.82, 10.85]). Transient or final side branch occlusion occurred less frequently in patients receiving EES compared to PES (2.8% vs. 5.2%, p=0.009), contributing to the numerically lower rates of in-hospital NQMI with EES arm compared to PES (0.7% vs. 2.3%, p=0.05). Patients treated with EES rather than PES were less likely to develop side branch occlusion during stent placement, contributing to lower rates of periprocedural MI with EES compared to PES.

Clustering of unhealthy outdoor advertisements around child-serving institutions: a comparison of three cities.

Using GPS devices and digital cameras, we surveyed outdoor advertisements in Austin, Los Angeles and Philadelphia. GIS and hot spot analysis revealed that unhealthy ads were clustered around child-serving institutions in Los Angeles and Philadelphia but not in Austin. Multivariate generalized least square (GLS) regression models showed that percent black (p<0.04) was a significant positive predictor of clustering in Philadelphia and percent white (p<0.06) was a marginally significant negative predictor of clustering in Los Angeles after controlling for several land use variables. The results emphasize the importance of zoning and land use regulations to protect children from exposure to unhealthy commercial messages, particularly in neighborhoods with significant racial/ethnic minority populations.

A cross-sectional prevalence study of ethnically targeted and general audience outdoor obesity-related advertising.

CONTEXT: Commercial marketing is a critical but understudied element of the sociocultural environment influencing Americans' food and beverage preferences and purchases. This marketing also likely influences the utilization of goods and services related to physical activity and sedentary behavior. A growing literature documents the targeting of racial/ethnic and income groups in commercial advertisements in magazines, on billboards, and on television that may contribute to sociodemographic disparities in obesity and chronic disease risk and protective behaviors. This article examines whether African Americans, Latinos, and people living in low-income neighborhoods are disproportionately exposed to advertisements for high-calorie, low nutrient-dense foods and beverages and for sedentary entertainment and transportation and are relatively underexposed to advertising for nutritious foods and beverages and goods and services promoting physical activities. METHODS: Outdoor advertising density and content were compared in zip code areas selected to offer contrasts by area income and ethnicity in four cities: Los Angeles, Austin, New York City, and Philadelphia. FINDINGS: Large variations were observed in the amount, type, and value of advertising in the selected zip code areas. Living in an upper-income neighborhood, regardless of its residents' predominant ethnicity, is generally protective against exposure to most types of obesity-promoting outdoor advertising (food, fast food, sugary beverages, sedentary entertainment, and transportation). The density of advertising varied by zip code area race/ethnicity, with African American zip code areas having the highest advertising densities, Latino zip code areas having slightly lower densities, and white zip code areas having the lowest densities. CONCLUSIONS: The potential health and economic implications of differential exposure to obesity-related advertising are substantial. Although substantive legal questions remain about the government's ability to regulate advertising, the success of limiting tobacco advertising offers lessons for reducing the marketing contribution to the obesigenicity of urban environments.

Randomized comparison of everolimus-eluting and paclitaxel-eluting stents: two-year clinical follow-up from the Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial.

BACKGROUND: In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported. METHODS AND RESULTS: A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length < or =28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for > or =6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10). CONCLUSIONS: Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.

Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial.

CONTEXT: A thin, cobalt-chromium stent eluting the antiproliferative agent everolimus from a nonadhesive, durable fluoropolymer has shown promise in preliminary studies in improving clinical and angiographic outcomes in patients with coronary artery disease. OBJECTIVE: To evaluate the safety and efficacy of an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent. DESIGN, SETTING, AND PATIENTS: The SPIRIT III trial, a prospective, randomized, single-blind, controlled trial enrolling patients at 65 academic and community-based US institutions between June 22, 2005, and March 15, 2006. Patients were 1002 men and women undergoing percutaneous coronary intervention in lesions 28 mm or less in length and with reference vessel diameter between 2.5 and 3.75 mm. Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months. INTERVENTIONS: Patients were randomized 2:1 to receive the everolimus-eluting stent (n = 669) or the paclitaxel-eluting stent (n = 333). MAIN OUTCOME MEASURES: The primary end point was noninferiority or superiority of angiographic in-segment late loss. The major secondary end point was noninferiority assessment of target vessel failure events (cardiac death, myocardial infarction, or target vessel revascularization) at 9 months. An additional secondary end point was evaluation of major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization) at 9 and 12 months. RESULTS: Angiographic in-segment late loss was significantly less in the everolimus-eluting stent group compared with the paclitaxel group (mean, 0.14 [SD, 0.41] mm vs 0.28 [SD, 0.48] mm; difference, -0.14 [95% CI, -0.23 to -0.05]; P < or = .004). The everolimus stent was noninferior to the paclitaxel stent for target vessel failure at 9 months (7.2% vs 9.0%, respectively; difference, -1.9% [95% CI, -5.6% to 1.8%]; relative risk, 0.79 [95% CI, 0.51 to 1.23]; P < .001). The everolimus stent compared with the paclitaxel stent resulted in significant reductions in composite major adverse cardiac events both at 9 months (4.6% vs 8.1%; relative risk, 0.56 [95% CI, 0.34 to 0.94]; P = .03) and at 1 year (6.0% vs 10.3%; relative risk, 0.58 [95% CI, 0.37 to 0.90]; P = .02), due to fewer myocardial infarctions and target lesion revascularization procedures. CONCLUSIONS: In this large-scale, prospective randomized trial, an everolimus-eluting stent compared with a paclitaxel-eluting stent resulted in reduced angiographic late loss, noninferior rates of target vessel failure, and fewer major adverse cardiac events during 1 year of follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00180479.