Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial).

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding.

Praziquantel Targets M1 Macrophages and Ameliorates Splenomegaly in Chronic Schistosomiasis.

Splenomegaly is a common feature of many infectious diseases, including schistosomiasis japonica. However, the immunopathogenesis and the treatment of splenomegaly due to schistosomiasis have been largely neglected. Praziquantel (PZQ), a classical schistosomicide, has been demonstrated by us and others to have antifibrotic and anti-inflammatory activities against schistosomiasis. In this study, we investigated the effect of PZQ on alleviating the splenomegaly caused by Schistosoma japonicum infection in mice. The results showed that the number of macrophages, especially the number of M1 macrophages, was significantly increased in the enlarged spleens of infected mice (P < 0.001). After PZQ treatment for 4 weeks, the number of splenic macrophages, especially the number of M1 macrophages, was significantly reduced (P < 0.001) by the way of apoptosis, and another schistosomicide, mefloquine, had no effect either on the splenomegaly or on reducing the number of macrophages. Furthermore, by using the murine macrophage line RAW 264.7, we found that PZQ could inhibit the formation of the NLRP3 inflammasome and attenuate phagocytic activity in M1 macrophages. Thus, our studies suggest that PZQ plays a powerful role in ameliorating the splenomegaly caused by S. japonicum infection, which presents a new strategy for the therapy of splenomegaly resulting from other pathological conditions.

Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves.

BACKGROUND: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. METHODS: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks [TIAs]). RESULTS: Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007). CONCLUSIONS: Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).

Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves.

AIMS: Four-dimensional volume-rendered computed tomography (4DCT) has demonstrated instances of hypo-attenuating leaflet thickening (HALT) with or without hypo-attenuation affecting motion (HAM) after transcatheter and surgical aortic valve implantation (TAVI, SAVR). The temporal pattern of evolution of these phenomena is uncertain. METHODS AND RESULTS: The SAVORY registry enrolled patients treated by TAVI (n = 75) or SAVR (n = 30) with two 4DCT scans fully interpretable for HALT and HAM as well as unchanged anti-thrombotic medication between the scans. Logistic regression analysis was performed to examine the evolution of HALT and HAM while accounting for demographic and baseline variables, timing of both CT scans, valve type and antithrombotic therapy. The analysis population consisted of 84 patients, in whom first and second CT scans were performed at 140 ± 152 days and 298 ± 141 days after valve implantation, respectively. Hypo-attenuating leaflet thickening was noted in 32 patients (38.1%), with HAM in 17 (20.2%). Both findings were dynamic, showing progression in 13 (15.5%) and regression and 9 (10.7%) patients. Compared with antiplatelet therapy, progression was less likely among patients on oral anticoagulation with vitamin-K antagonists or non-VKA oral anticoagulants (odds ratio: 0.014, P = 0.036). Maintenance on chronic oral anticoagulation was not a significant predictor of regression. These findings were similar for both transcatheter and surgical bioprosthetic aortic valves. No patients developed symptoms of valve dysfunction and leaflet thickening was not clearly associated with any clinical events. CONCLUSIONS: Subclinical leaflet thrombosis is a common finding after TAVI and SAVR, and may progress from normal leaflet over HALT to the more severe HAM. The phenomenon can develop and regress at variable intervals after valve implantation. Anticoagulants may have a protective effect against the development of HALT, but HALT can also regress without anticoagulation therapy. REGISTERED AT CLINICALTRIALS.GOV: NCT02426307.

MHC II-, but not MHC II+, hepatic Stellate cells contribute to liver fibrosis of mice in infection with Schistosoma japonicum.

Hepatic stellate cells (HSCs) are considered as the main effector cells in vitamin A metabolism and liver fibrosis, as well as in hepatic immune regulation. Recently, researches have revealed that HSCs have plasticity and heterogeneity, which depend on their lobular location and whether liver is normal or injured. This research aimed to explore the biological characteristics and heterogeneity of HSCs in mice with Schistosoma japonicum (S. japonicum) infection, and determine the subpopulation of HSCs in pathogenesis of hepatic fibrosis caused by S. japonicum infection. Results revealed that HSCs significantly increased the expressions of MHC II and fibrogenic genes after S. japonicum infection, and could be classified into MHC II+ HSCs and MHC II- HSCs subsets. Both two HSCs populations suppressed the proliferation of activated CD4+T cells, whereas only MHC II- HSCs displayed a myofibroblast-like phenotype. In response to IFN-γ, HSCs up-regulated the expressions of MHC II and CIITA, while down-regulated the expression of fibrogenic gene Col1. In addition, praziquantel treatment decreased the expressions of fibrogenic genes in MHC II- HSCs. These results confirmed that HSCs from S. japonicum-infected mice have heterogeneity. The MHC II- α-SMA+ HSCs were major subsets of HSCs contributing to liver fibrosis and could be considered as a potential target of praziquantel anti-fibrosis treatment.

Retention of Homeless Smokers in the Power to Quit Study.

INTRODUCTION: Concerns about retention are a major barrier to conducting studies enrolling homeless individuals. Since smoking is a major problem in homeless communities and research on effective methods of promoting smoking cessation is needed, we describe strategies used to increase retention and participant characteristics associated with retention in smoking cessation study enrolling homeless adults. METHODS: The parent study was a 2-group randomized controlled trial with 26-week follow-up enrolling 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/Saint Paul, MN, USA. Multiple strategies were used to increase retention, including conducting visits at convenient locations for participants, collecting several forms of contact information from participants, using a schedule that was flexible and included frequent low-intensity visits, and providing incentives. Participant demographics as well as characteristics related to tobacco and drug use and health status were analyzed for associations with retention using univariate and multivariate analysis. RESULTS: Overall retention was 75% at 26 weeks. Factors associated with increased retention included greater age; having healthcare coverage; history of multiple homeless episodes, lower stress level; and higher PHQ-9 (Patient Health Questionnaire-9) score. A history of excessive drinking and drug use were associated with decreased retention. CONCLUSIONS: It is possible to successfully retain homeless individuals in a smoking cessation study if the study is designed with participants' needs in mind.

Smoking cessation in homeless populations: who participates and who does not.

INTRODUCTION: Although homeless individuals smoke at an alarmingly high rate, few smoking cessation clinical trials have focused on this vulnerable population. Little is known about recruitment efforts and suitable eligibility criteria for tobacco control research in homeless populations. METHODS: The aim of this article is to describe the recruitment, eligibility, and enrollment of homeless smokers who participated in the Power to Quit smoking study, a randomized smoking cessation clinical trial funded by the National Institutes of Health. The study compared motivational interviewing and standard counseling while participants received an 8-week treatment of the nicotine patch. RESULTS: Working with local emergency shelters, a total of 839 adult smokers were screened for study eligibility, 580 of whom (69.1%) met eligibility criteria. Of those eligible, 430 (74.1%) returned for randomization. Those who returned for randomization were older and more likely to have a phone number compared with eligible participants not enrolled. The most common reasons for exclusion included exhaled carbon monoxide levels less than or equal to 5 parts per million (indicating nonsmoking status), use of smoking cessation aid during the past 30 days, and not meeting the study definition of homelessness. CONCLUSION: Knowledge of these factors may help researchers tailor criteria that accurately identify and include homeless smokers in future research.

Cotinine and tobacco-specific carcinogen exposure among nondaily smokers in a multiethnic sample.

BACKGROUND: Nondaily smoking has increased among current U.S. smokers during the past decade and is practiced by a significant percentage of smokers. Although research in nondaily smoking has grown, little is known about levels of exposure to tobacco toxicants among nondaily smokers and their variation across ethnic groups. METHODS: We examined urinary levels of cotinine and a tobacco-specific nitrosamine (NNAL) in community participants. Associations between the biomarker data and smoking characteristics were evaluated with Spearman's correlation analysis. RESULTS: Participants included 28 Blacks, 4 Latinos, and 25 Whites who smoked at least 1 cigarette on 4-24 days in the past 30 days. Participants averaged 3.3 (SD = 2.1) cigarettes per day (cpd) on days smoked, they smoked an average of 13.0 (SD = 5.4) days in the past month, and they smoked nondaily for 10.5 (SD = 10.5) years. Median levels of creatinine-normalized cotinine and NNAL were 490.9 ng/mg and 140.7 pg/mg, respectively. NNAL and cotinine were highly correlated (r = .84); NNAL and cotinine were modestly correlated with cpd (r = .39 and r = .34; all p values <.05). The number of days smoked per month was not associated with any biomarker levels. CONCLUSIONS: Our findings demonstrate that nondaily smokers are, on average, exposed to significant levels of nicotine and carcinogenic nitrosamines, with exposures of 40%-50% of those seen in daily smokers. This level of exposure suggests a significant health risk. Nicotine and carcinogen exposure is most closely related to number of cigarettes smoked per day but not to number of days per month of smoking.

Development and application of emotion recognition technology - a systematic literature review.

BACKGROUND: There is a mutual influence between emotions and diseases. Thus, the subject of emotions has gained increasing attention. OBJECTIVE: The primary objective of this study was to conduct a comprehensive review of the developments in emotion recognition technology over the past decade. This review aimed to gain insights into the trends and real-world effects of emotion recognition technology by examining its practical applications in different settings, including hospitals and home environments. METHODS: This study followed the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines and included a search of 4 electronic databases, namely, PubMed, Web of Science, Google Scholar and IEEE Xplore, to identify eligible studies published between 2013 and 2023. The quality of the studies was assessed using the Critical Appraisal Skills Programme (CASP) criteria. The key information from the studies, including the study populations, application scenarios, and technological methods employed, was summarized and analyzed. RESULTS: In a systematic literature review of the 44 studies that we analyzed the development and impact of emotion recognition technology in the field of medicine from three distinct perspectives: "application scenarios," "techniques of multiple modalities," and "clinical applications." The following three impacts were identified: (i) The advancement of emotion recognition technology has facilitated remote emotion recognition and treatment in hospital and home environments by healthcare professionals. (ii) There has been a shift from traditional subjective emotion assessment methods to multimodal emotion recognition methods that are grounded in objective physiological signals. This technological progress is expected to enhance the accuracy of medical diagnosis. (iii) The evolving relationship between emotions and disease throughout diagnosis, intervention, and treatment processes holds clinical significance for real-time emotion monitoring. CONCLUSION: These findings indicate that the integration of emotion recognition technology with intelligent devices has led to the development of application systems and models, which provide technological support for the recognition of and interventions for emotions. However, the continuous recognition of emotional changes in dynamic or complex environments will be a focal point of future research.

A fused multi-subfrequency bands and CBAM SSVEP-BCI classification method based on convolutional neural network.

For the brain-computer interface (BCI) system based on steady-state visual evoked potential (SSVEP), it is difficult to obtain satisfactory classification performance for short-time window SSVEP signals by traditional methods. In this paper, a fused multi-subfrequency bands and convolutional block attention module (CBAM) classification method based on convolutional neural network (CBAM-CNN) is proposed for discerning SSVEP-BCI tasks. This method extracts multi-subfrequency bands SSVEP signals as the initial input of the network model, and then carries out feature fusion on all feature inputs. In addition, CBAM is embedded in both parts of the initial input and feature fusion for adaptive feature refinement. To verify the effectiveness of the proposed method, this study uses the datasets of Inner Mongolia University of Technology (IMUT) and Tsinghua University (THU) to evaluate the performance of the proposed method. The experimental results show that the highest accuracy of CBAM-CNN reaches 0.9813 percentage point (pp). Within 0.1-2 s time window, the accuracy of CBAM-CNN is 0.0201-0.5388 (pp) higher than that of CNN, CCA-CWT-SVM, CCA-SVM, CCA-GNB, FBCCA, and CCA. Especially in the short-time window range of 0.1-1 s, the performance advantage of CBAM-CNN is more significant. The maximum information transmission rate (ITR) of CBAM-CNN is 503.87 bit/min, which is 227.53 bit/min-503.41 bit/min higher than the above six EEG decoding methods. The study further results show that CBAM-CNN has potential application value in SSVEP decoding.

Psychosocial distress and stroke risk in older adults.

BACKGROUND AND PURPOSE: To investigate the association of psychosocial distress with risk of stroke mortality and incident stroke in older adults. METHODS: Data were from the Chicago Health and Aging Project, a longitudinal population-based study conducted in 3 contiguous neighborhoods on the south side of Chicago, IL. Participants were community-dwelling black and non-Hispanic white adults, aged 65 years and older (n=4120 for stroke mortality; n=2649 for incident stroke). Psychosocial distress was an analytically derived composite measure of depressive symptoms, perceived stress, neuroticism, and life dissatisfaction. Cox proportional hazards models examined the association of distress with stroke mortality and incident stroke over 6 years of follow-up. RESULTS: Stroke deaths (151) and 452 incident strokes were identified. Adjusting for age, race, and sex, the hazard ratio (HR) for each 1-SD increase in distress was 1.47 (95% confidence interval [CI]=1.28-1.70) for stroke mortality and 1.18 (95% CI=1.07-1.30) for incident stroke. Associations were reduced after adjustment for stroke risk factors and remained significant for stroke mortality (HR=1.29; 95% CI=1.10-1.52) but not for incident stroke (HR=1.09; 95% CI=0.98-1.21). Secondary analyses of stroke subtypes showed that distress was strongly related to incident hemorrhagic strokes (HR=1.70; 95% CI=1.28-2.25) but not ischemic strokes (HR=1.02; 95% CI=0.91-1.15) in fully adjusted models. CONCLUSIONS: Increasing levels of psychosocial distress are related to excess risk of both fatal and nonfatal stroke in older black and white adults. Additional research is needed to examine pathways linking psychosocial distress to cerebrovascular disease risk.

Smoking characteristics and comorbidities in the power to quit randomized clinical trial for homeless smokers.

INTRODUCTION: Smoking prevalence in homeless populations is strikingly high (∼70%); yet, little is known about effective smoking cessation interventions for this population. We conducted a community-based clinical trial, Power To Quit (PTQ), to assess the effects of motivational interviewing (MI) and nicotine patch (nicotine replacement therapy [NRT]) on smoking cessation among homeless smokers. This paper describes the smoking characteristics and comorbidities of smokers in the study. METHODS: Four hundred and thirty homeless adult smokers were randomized to either the intervention arm (NRT + MI) or the control arm (NRT + Brief Advice). Baseline assessment included demographic information, shelter status, smoking history, motivation to quit smoking, alcohol/other substance abuse, and psychiatric comorbidities. RESULTS: Of the 849 individuals who completed the eligibility survey, 578 (68.1%) were eligible and 430 (74.4% of eligibles) were enrolled. Participants were predominantly Black, male, and had mean age of 44.4 years (S D = 9.9), and the majority were unemployed (90.5%). Most participants reported sleeping in emergency shelters; nearly half had been homeless for more than a year. Nearly all the participants were daily smokers who smoked an average of 20 cigarettes/day. Nearly 40% had patient health questionnaire-9 depression scores in the moderate or worse range, and more than 80% screened positive for lifetime history of drug abuse or dependence. CONCLUSIONS: This study demonstrates the feasibility of enrolling a diverse sample of homeless smokers into a smoking cessation clinical trial. The uniqueness of the study sample enables investigators to examine the influence of nicotine dependence as well as psychiatric and substance abuse comorbidities on smoking cessation outcomes.

Evaluation of dose modulation software through the assessment of body mass index, radiation dose and image noise.

PURPOSE: This study attempts to establish a quantitative link between a patient's body mass index (BMI), the delivered radiation dose, and the image noise. METHODS: The CARE Dose4D computed tomography (CT) acquisitions from 206 patients undergoing "eyes-to-thighs" contrast-enhanced positron emission tomography/CT studies were retrospectively examined. Computed tomography dose index volume (CTDIVOL), mAs, and dose-length product were recorded from the dose report card. The image noise was quantified by evaluating the SD of regions of interest placed over the contrast enhanced aorta. RESULTS: The multivariate regressions f(BMI, mAs) and f(BMI, CTDIVOL) had R values of 0.4840 and 0.4802, respectively. Unpaired t tests demonstrate that statistically significant difference in image noise required more than 12.17 kg/m of separation between the average BMI values for the groups compared. CONCLUSIONS: The evaluation of image noise with BMI and CTDIVOL or mAs is a means to evaluate the consistency of dose modulation software. There is considerable variability in the radiation dose generated by the CARE Dose4D software.

Long-term consequences of kidney donation.

BACKGROUND: The long-term renal consequences of kidney donation by a living donor are attracting increased appropriate interest. The overall evidence suggests that living kidney donors have survival similar to that of nondonors and that their risk of end-stage renal disease (ESRD) is not increased. Previous studies have included relatively small numbers of donors and a brief follow-up period. METHODS: We ascertained the vital status and lifetime risk of ESRD in 3698 kidney donors who donated kidneys during the period from 1963 through 2007; from 2003 through 2007, we also measured the glomerular filtration rate (GFR) and urinary albumin excretion and assessed the prevalence of hypertension, general health status, and quality of life in 255 donors. RESULTS: The survival of kidney donors was similar to that of controls who were matched for age, sex, and race or ethnic group. ESRD developed in 11 donors, a rate of 180 cases per million persons per year, as compared with a rate of 268 per million per year in the general population. At a mean (+/-SD) of 12.2+/-9.2 years after donation, 85.5% of the subgroup of 255 donors had a GFR of 60 ml per minute per 1.73 m(2) of body-surface area or higher, 32.1% had hypertension, and 12.7% had albuminuria. Older age and higher body-mass index, but not a longer time since donation, were associated with both a GFR that was lower than 60 ml per minute per 1.73 m(2) and hypertension. A longer time since donation, however, was independently associated with albuminuria. Most donors had quality-of-life scores that were better than population norms, and the prevalence of coexisting conditions was similar to that among controls from the National Health and Nutrition Examination Survey (NHANES) who were matched for age, sex, race or ethnic group, and body-mass index. CONCLUSIONS: Survival and the risk of ESRD in carefully screened kidney donors appear to be similar to those in the general population. Most donors who were studied had a preserved GFR, normal albumin excretion, and an excellent quality of life.

Overexpression of lncRNA A2M-AS1 inhibits cell growth and aggressiveness via regulating the miR-587/bone morphogenetic protein 3 axis in lung adenocarcinoma.

Lung adenocarcinoma (LUAD) is a malignant tumor that occurs in the lungs. Numerous reports have substantiated the participation of long non-coding RNAs (lncRNAs) in the tumorigenesis of LUAD. Previously, lncRNA alpha-2-macroglobulin antisense RNA 1 (A2M-AS1) was confirmed to be an important regulator in the biological processes of LUAD and dysregulation of A2M-AS1 was associated with non-small cell lung cancer (NSCLC) progression. However, the precise mechanism of A2M-AS1 in LUAD has not been elucidated. Therefore, our study was designed to investigate the detailed molecular mechanism of A2M-AS1 in LUAD. Herein, the expression of lncRNA A2M-AS1, microRNA (miRNA) miR-587, and bone morphogenetic protein 3 (BMP3) in LUAD cell lines and tissues were detected by real-time quantitative polymerase chain reaction (RT-qPCR) and western blotting. The viability, proliferation, migration and invasion of LUAD cells were tested by cell counting kit-8 (CCK-8), colony formation and Transwell assays. In vivo tumor growth was investigated by xenograft animal experiment. Interactions among A2M-AS1, miR-587 and BMP3 were measured by RNA pulldown and luciferase reporter assays. In this study, A2M-AS1 was downregulated in LUAD tissues and cells and related to poor prognosis in LUAD patients. A2M-AS1 overexpression suppressed LUAD cell proliferation, migration and invasion in vitro and inhibited tumor growth in vivo. Mechanistically, A2M-AS1 directly bound with miR-587 to promote BMP3 expression in LUAD cells. Low expression of BMP3 was found in LUAD tissues and cells and was closely correlated with poor prognosis in LUAD patients. BMP3 deficiency reserved the inhibitory influence of A2M-AS1 overexpression on LUAD cell behaviors. Overall, A2M-AS1 inhibits cell growth and aggressiveness via regulating the miR-587/BMP3 axis in LUAD.

Neighborhood cohesion is associated with reduced risk of stroke mortality.

BACKGROUND AND PURPOSE: Greater social cohesion is related to lower rates of coronary heart disease, but its relation to stroke risk is unstudied. This study examined whether neighborhood social cohesion was protective against stroke mortality and incidence. METHODS: Data come from 5789 participants (60% female; 62% black; mean age, 74.7 years) in a longitudinal study of chronic diseases in the elderly. Stroke mortality, ascertained through December 31, 2007, was verified through the National Death Index; 186 stroke deaths were identified in 11 years of follow-up. Stroke incidence was determined in a subset (N=3816) with linkage to Medicare claims files; 701 first-ever strokes were identified. Cohesion was measured by 6 items assessing frequency of contact and social interactions with neighbors; items were z-scored and averaged. Individual scores were averaged across 82 census block groups, forming a neighborhood-level measure of social cohesion. Marginal Cox proportional hazard models tested the association of neighborhood-level cohesion with stroke mortality and incidence. RESULTS: Each 1-point increase in cohesion related to a 53% reduced risk of stroke mortality (hazard ratio, 0.47; 95% CI, 0.24 to 0.90), adjusting for relevant covariates, including sociodemographics, known stroke risk factors, and neighborhood-level socioeconomic status. A race×cohesion interaction (P=0.04) revealed cohesion was protective in whites (hazard ratio, 0.34; 95% CI, 0.17 to 0.67) but not blacks (hazard ratio, 1.17; 95% CI, 0.35 to 3.86). Cohesion was unrelated to stroke incidence (P>0.5). CONCLUSIONS: Neighborhood-level social cohesion was independently protective against stroke mortality. Research is needed to further examine observed race differences and pathways by which cohesion is health-protective.

Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial.

BACKGROUND: Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. PURPOSE: To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants (n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. METHODS: Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. RESULTS: Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication. LIMITATIONS: The study's limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable. CONCLUSIONS: Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.

Predictors of adherence to nicotine gum and counseling among African-American light smokers.

BACKGROUND: A high proportion of African-American smokers are light smokers, and they experience low smoking cessation rates and disproportionately high tobacco-related morbidity; yet no studies have examined tobacco treatment adherence in this group. OBJECTIVES: To determine the predictors of adherence to nicotine gum and counseling among African-American light smokers (defined as smoking < or =10 cigarettes/day), and the effects of adherence on smoking cessation. DESIGN: Data were from a 2 x 2 randomized, placebo-controlled smoking cessation trial of nicotine gum (2 mg versus placebo) and counseling (motivational interviewing versus health education). PARTICIPANTS: Seven hundred fifty-five African-American light smokers at a community-based clinic. MEASUREMENTS: Demographic and health-related information, smoking behaviors, psychosocial variables, adherence to nicotine gum and counseling, and cotinine-verified 7-day abstinence from smoking at week-26 follow-up. RESULTS: A logistic regression model showed that having a higher body mass index (OR = 1.03, 95% CI = 1.01 to 1.05), more quit attempts in the past year (OR = 1.04, 95% CI = 1.01 to 1.07), higher baseline exhaled carbon monoxide (OR = 1.22, 95% CI = 1.01 to 1.48), and higher perceived stress (OR = 1.12, 95% CI = 1.03 to 1.22) increased the likelihood of adherence to nicotine gum. Being a high school graduate was a predictor of adherence to counseling (OR = 1.58, 95% CI = 1.02 to 2.44). Surprisingly, being adherent to nicotine gum significantly reduced the odds of smoking cessation (OR = 0.50, CI = 0.28 to 0.87). On the other hand, adherence to counseling dramatically increased the likelihood of smoking cessation (OR = 3.32, CI = 1.36 to 8.08). CONCLUSIONS: Individual risk factors may influence adherence to nicotine gum and counseling. Improving psychological interventions and promoting adherence to counseling may increase overall smoking cessation success among African-American light smokers.

Relationship between smoking reduction and cessation among light smokers.

INTRODUCTION: To determine the smoking reduction patterns of light smokers (≤ 10 CPD) and whether reduction predicts future cessation. METHODS: Study is a secondary analysis of data that were derived from a 2 × 2 randomized study that assessed the efficacy of nicotine gum (vs. placebo) and counseling (motivational interviewing vs. health education) for smoking cessation among 755 light smokers. Participants were categorized into three groups based on self-reported CPD smoked at time of study enrollment compared with CPD smoked a year prior to enrollment. That is, (a) those who reduced number of cigarettes per day (CPD), (b) those who smoked the same number of CPD, and (c) those who increased their number of CPD. Sociodemographic and smoking characteristics were assessed at enrollment as well as cotinine-verified 7-day smoking abstinence rates at the Week 26 follow-up assessment. A stepwise logistic regression model to predict the probability abstinence at 26-week follow-up was also performed. RESULTS: Compared with a year prior to enrollment, 43.7% of participants reduced, 35.2% smoked the same, and 21.2% increased their CPD. Compared with those who smoked the same or increased their CPD, those who had reduced their CPD were older, more likely to be males, smoked fewer CPD at enrollment, initiated smoking at a younger age, and less likely to be nicotine dependent. Adjusted logistic regression showed that those who had reduced their smoking prior to enrollment were more likely to quit at Week 26 (odds ratio [OR] = 1.77; 95% CI = 1.062-2.957; p = .029). DISCUSSION: Findings suggest that reducing number of CPD smoked prior to enrolling in a clinical trial is a positive predictor of abstinence. Therefore, encouraging smoking reduction prior to attempting cessation may enhance cessation outcomes for light smokers.