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1.  A cluster-randomized trial of task shifting and blood pressure control in Ghana: study protocol 
Background
Countries in sub-Saharan Africa (SSA) are experiencing an epidemic of cardiovascular disease (CVD) propelled by rapidly increasing rates of hypertension. Barriers to hypertension control in SSA include poor access to care and high out-of-pocket costs. Although SSA bears 24% of the global disease burden, it has only 3% of the global health workforce. Given such limited resources, cost-effective strategies, such as task shifting, are needed to mitigate the rising CVD epidemic in SSA. Ghana, a country in SSA with an established community health worker program integrated within a national health insurance scheme provides an ideal platform to evaluate implementation of the World Health Organization (WHO) task-shifting strategy. This study will evaluate the comparative effectiveness of the implementation of the WHO Package targeted at CV risk assessment versus provision of health insurance coverage, on blood pressure (BP) reduction.
Methods
Using a cluster randomized design, 32 community health centers (CHCs) and district hospitals in Ghana will be randomized to either the intervention group (16 CHCs) or the control group (16 CHCs). A total of 640 patients with uncomplicated hypertension (BP 140–179/90–99 mm Hg and absence of target organ damage) will be enrolled in this study (20 patients per CHC). The intervention consists of WHO Package of CV risk assessment, patient education, initiation and titration of antihypertensive medications, behavioral counseling on lifestyle behaviors, and medication adherence every three months for 12 months. The primary outcome is the mean change in systolic BP from baseline to 12 months. The secondary outcomes are rates of BP control at 12 months; levels of physical activity, percent change in weight, and dietary intake of fruits and vegetables at 12 months; and sustainability of intervention effects at 24 months. All outcomes will be assessed at baseline, six months and 12 months. Trained community health nurses will deliver the intervention as part of Ghana’s community-based health planning and services (CHPS) program.
Discussion
Findings from this study will provide policy makers and other stakeholders needed information to recommend scalable and cost-effective policy with respect to comprehensive CV risk reduction and hypertension control in resource-poor settings.
Trial registration
NCT01802372.
doi:10.1186/1748-5908-9-73
PMCID: PMC4063247  PMID: 24923300
Hypertension; Cluster randomized controlled trial; Task shifting; Blood pressure control; Community health centers; Community health nurses; Ghana
2.  Centralized, Stepped, Patient Preference–Based Treatment for Patients With Post–Acute Coronary Syndrome Depression: CODIACS Vanguard Randomized Controlled Trial 
JAMA internal medicine  2013;173(11):997-1004.
Importance
Controversy remains about whether depression can be successfully managed after acute coronary syndrome (ACS) and the costs and benefits of doing so.
Objective
To determine the effects of providing post-ACS depression care on depressive symptoms and health care costs.
Design, Setting, and Participants
We performed a multicenter randomized controlled trial with 150 patients with elevated depressive symptoms (Beck Depression Inventory [BDI] score ≥10) 2 to 6 months after an ACS. Patients were recruited from 2 private and 5 academic ambulatory centers across the United States between March 18, 2010, and January 9, 2012.
Intervention(s)
Patients were randomized to 6 months of centralized depression care (patient preference for problem-solving treatment given via telephone or the Internet, pharmacotherapy, both, or neither), stepped every 6 to 8 weeks, (active treatment group; n=73) or to locally determined depression care after physician notification about the patient’s depressive symptoms (usual care group; n=77).
Main Outcome Measure(s)
Change in depressive symptoms during 6 months and total health care costs.
Results
Depressive symptoms decreased significantly more in the active treatment group than in the usual care group (differential change between groups, −3.5 BDI points; 95% CI, −6.1 to −0.7; P = .01). Although mental health care estimated costs were higher for active treatment than for usual care, overall health care estimated costs were not significantly different (difference adjusting for confounding, −$325; 95% CI, −$2639 to $1989; P=.78).
Conclusions
For patients with post-ACS depression, active treatment had a substantial beneficial effect on depressive symptoms. This kind of depression care is feasible, effective, and may be cost-neutral within 6 months; therefore, it should be tested in a large phase 3 pragmatic trial.
Trial Registration
clinicaltrials.gov Identifier: NCT01032018
doi:10.1001/jamainternmed.2013.915
PMCID: PMC3681929  PMID: 23471421
3.  Men’s and women’s health beliefs differentially predict coronary heart disease incidence in a population-based sample 
Objective
To examine gender differences in the association between beliefs in heart disease preventability and 10-year incidence of coronary heart disease (CHD) in a population-based sample.
Methods
2,688 non-institutionalized Nova Scotians without prior CHD enrolled in the Nova Scotia Health Study (NSHS95) and were followed for 10 years. Risk factors, health behaviors and incident CHD were assessed. Participants responded “yes” or “no” to a question about heart disease preventability.Survival models, adjusted for age, income,total and high density lipoprotein (HDL) cholesterol, and systolic blood pressure, were used to estimate the relation between health belief and incident CHD. Gender differences in the relation between health beliefs and health behaviors were assessed.
Results
Gender was a significant moderator of the relation between belief and CHD incidence;specifically,women who believed heart disease could be prevented were less likely to have incident CHD events compared to women who believed heart disease could be not prevented (HR=0.36, 95% CI0.24-0.55, p <.001). This relation was not found for men. Belief was also related to smoking behavior for women (β = −0.70, OR= 0.50, 95% CI = 0.33-0.74, p =.001), but not men. Smoking significantly mediated the relation between health beliefs and incident CHD for women (z = −1.96, p =.05), but not for men.
Conclusion
Health belief in prevention and subsequent smokingwas an important independent predictor of incident coronary heart disease in women, but not men.
doi:10.1177/1090198112449461
PMCID: PMC3676270  PMID: 22991050
health beliefs; gender differences; cardiovascular disease
4.  Revision and Validation of the Medication Adherence Self-Efficacy Scale (MASES) in Hypertensive African Americans 
Journal of behavioral medicine  2008;31(6):453-462.
Background
To date, no studies have validated the Medication Adherence Self-Efficacy Scale (MASES) in an independent sample of hypertensive African Americans.
Purpose
The purpose of this study was to revise and assess the validity of the MASES.
Methods
Study sample included 168 African Americans followed in primary care practices. Mean age was 54 (SD = 12.36); 86% was female; and 76% reported high school education or greater. Participants provided demographic information; completed the MASES, self-report and electronic measures of medication adherence for prescribed antihypertensive medications at baseline and three months.
Results
Confirmatory (CFA), exploratory (EFA) factor analyses, and classical test theory (CTT) analyses, suggested that MASES is a unidimensional and internally reliable measure with relatively stable scores over 3 months. Results of item response theory (IRT) analyses led to revision of the scale to a 13-item version: the MASES-R. EFA, CTT, and IRT results for the MASES-R supported its reliability and validity.
Conclusions
Findings suggest that the MASES-R is a brief scale that is quick to administer and can capture useful data on adherence self-efficacy for African Americans. Research examining its psychometric properties in other ethnic groups will improve generalizability of findings and utility of the scale in diverse groups.
doi:10.1007/s10865-008-9170-7
PMCID: PMC3763496  PMID: 18784996
5.  A Practice-based Trial of Motivational Interviewing and Adherence in Hypertensive 065African Americans1 
American journal of hypertension  2008;21(10):1137-1143.
BACKGROUND
Poor medication adherence is a significant problem in hypertensive African Americans. Although motivational interviewing (MINT) is effective for adoption and maintenance of health behaviors in patients with chronic diseases, its effect on medication adherence remains untested in this population.
METHODS
This randomized controlled trial tested the effect of a practice-based MINT counseling versus usual care (UC) on medication adherence and blood pressure (BP) in 190 hypertensive African Americans (88% women; mean age 54 years). Patients were recruited from two community-based primary care practices in New York City. The primary outcome was adherence measured by electronic pill monitors; the secondary outcome was within-patient change in office BP from baseline to 12 months.
RESULTS
Baseline adherence was similar in both groups (56.2% and 56.6% for MINT and UC respectively, p = 0.94). Based on intent-to-treat analysis using mixed effects regression, a significant time X group interaction with model-predicted post-treatment adherence rates of 43% and 57% were found in the UC and MINT groups, respectively (p = 0.027), with a between-group difference of 14% (95% CI, −0.2% to −27%). The between-group difference in systolic and diastolic BP was −6.1 mm Hg (p = .065) and −1.4 mm Hg (p = .465), respectively, in favor of the MINT group.
CONCLUSIONS
A practice-based MINT counseling led to steady maintenance of medication adherence over time, compared to significant decline in adherence for UC patients. This effect was associated with a clinically meaningful net reduction in systolic BP in favor of the MINT group.
doi:10.1038/ajh.2008.240
PMCID: PMC3747638  PMID: 18654123
Motivational Interviewing; Medication Adherence; African American; Hypertension
6.  Prospective investigation of autism and genotype-phenotype correlations in 22q13 deletion syndrome and SHANK3 deficiency 
Molecular Autism  2013;4:18.
Background
22q13 deletion syndrome, also known as Phelan-McDermid syndrome, is a neurodevelopmental disorder characterized by intellectual disability, hypotonia, delayed or absent speech, and autistic features. SHANK3 has been identified as the critical gene in the neurological and behavioral aspects of this syndrome. The phenotype of SHANK3 deficiency has been described primarily from case studies, with limited evaluation of behavioral and cognitive deficits. The present study used a prospective design and inter-disciplinary clinical evaluations to assess patients with SHANK3 deficiency, with the goal of providing a comprehensive picture of the medical and behavioral profile of the syndrome.
Methods
A serially ascertained sample of patients with SHANK3 deficiency (n = 32) was evaluated by a team of child psychiatrists, neurologists, clinical geneticists, molecular geneticists and psychologists. Patients were evaluated for autism spectrum disorder using the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule-G.
Results
Thirty participants with 22q13.3 deletions ranging in size from 101 kb to 8.45 Mb and two participants with de novo SHANK3 mutations were included. The sample was characterized by high rates of autism spectrum disorder: 27 (84%) met criteria for autism spectrum disorder and 24 (75%) for autistic disorder. Most patients (77%) exhibited severe to profound intellectual disability and only five (19%) used some words spontaneously to communicate. Dysmorphic features, hypotonia, gait disturbance, recurring upper respiratory tract infections, gastroesophageal reflux and seizures were also common. Analysis of genotype-phenotype correlations indicated that larger deletions were associated with increased levels of dysmorphic features, medical comorbidities and social communication impairments related to autism. Analyses of individuals with small deletions or point mutations identified features related to SHANK3 haploinsufficiency, including ASD, seizures and abnormal EEG, hypotonia, sleep disturbances, abnormal brain MRI, gastroesophageal reflux, and certain dysmorphic features.
Conclusions
This study supports findings from previous research on the severity of intellectual, motor, and speech impairments seen in SHANK3 deficiency, and highlights the prominence of autism spectrum disorder in the syndrome. Limitations of existing evaluation tools are discussed, along with the need for natural history studies to inform clinical monitoring and treatment development in SHANK3 deficiency.
doi:10.1186/2040-2392-4-18
PMCID: PMC3707861  PMID: 23758760
22q13 deletion syndrome; Autism; Microarrays; Mutation; Phelan-McDermid syndrome; SHANK3
7.  The Effect of Enhanced Depression Care on Anxiety Symptoms in Acute Coronary Syndrome Patients: Findings from the COPES Trial 
Psychotherapy and psychosomatics  2012;81(4):245-247.
doi:10.1159/000332439
PMCID: PMC3640416  PMID: 22678227
anxiety; depression; acute coronary syndrome; randomized controlled trial; problem solving therapy; antidepressant
8.  The Effect of Patient-Provider Communication on Medication Adherence in Hypertensive Black Patients: Does Race Concordance Matter? 
Background
Despite evidence of a positive effect of collaborative patient-provider communication on patient outcomes, our understanding of this relationship is unclear.
Purpose
To determine whether racial composition of the relationship modified the association between ratings of provider communication and medication adherence.
Methods
Effect modification of the communication-adherence association, by racial composition of the relationship, was evaluated using general linear mixed models while adjusting for selected covariates.
Results
390 patients were in race-concordant (black patient, black provider) relationships, while 207 were in race-discordant (black patient, white provider) relationships. The communication-adherence association was significantly modified in race-discordant relationships (p=0.04). Communication rated as more collaborative in race-discordant relationships was associated with better adherence, while communication rated as less collaborative was associated with poor adherence. There was no significant association between adherence and communication in race-concordant relationships (p=0.24).
Conclusions
Collaborative patient-provider communication may play an influential role in black patients’ adherence behaviors when receiving care from white providers.
doi:10.1007/s12160-011-9342-5
PMCID: PMC3665951  PMID: 22270266
hypertension; medication adherence; communication; race concordance
10.  Development and evaluation of a novel, real time mobile telesonography system in management of patients with abdominal trauma: study protocol 
Background
Despite the use of e-FAST in management of patients with abdominal trauma, its utility in prehospital setting is not widely adopted. The goal of this study is to develop a novel portable telesonography (TS) system and evaluate the comparability of the quality of images obtained via this system among healthy volunteers who undergo e-FAST abdominal examination in a moving ambulance and at the ED. We hypothesize that: (1) real-time ultrasound images of acute trauma patients in the pre-hospital setting can be obtained and transmitted to the ED via the novel TS system; and (2) Ultrasound images transmitted to the hospital from the real-time TS system will be comparable in quality to those obtained in the ED.
Methods
Study participants are three healthy volunteers (one each with normal, overweight and obese BMI category). The ultrasound images will be obtained by two ultrasound-trained physicians The TS is a portable sonogram (by Sonosite) interfaced with a portable broadcast unit (by Live-U). Two UTPs will conduct e-FAST examinations on healthy volunteers in moving ambulances and transmit the images via cellular network to the hospital server, where they are stored. Upon arrival in the ED, the same UTPs will obtain another set of images from the volunteers, which are then compared to those obtained in the moving ambulances by another set of blinded UTPs (evaluators) using a validated image quality scale, the Questionnaire for User Interaction Satisfaction (QUIS).
Discussion
Findings from this study will provide needed data on the validity of the novel TS in transmitting live images from moving ambulances to images obtained in the ED thus providing opportunity to facilitate medical care of a patient located in a remote or austere setting.
doi:10.1186/1471-227X-12-19
PMCID: PMC3546944  PMID: 23249290
Telesonography; Abdominal trauma; Patients; Pre-hospital; Novel; Real-time; Mobile
11.  Intranasal oxytocin versus placebo in the treatment of adults with autism spectrum disorders: a randomized controlled trial 
Molecular Autism  2012;3:16.
Background
There are no effective medications for the treatment of social cognition/function deficits in autism spectrum disorder (ASD), and adult intervention literature in this area is sparse. Emerging data from animal models and genetic association studies as well as early, single-dose intervention studies suggest that the oxytocin system may be a potential therapeutic target for social cognition/function deficits in ASD. The primary aim of this study was to examine the safety/therapeutic effects of intranasal oxytocin versus placebo in adults with ASD, with respect to the two core symptom domains of social cognition/functioning and repetitive behaviors.
Methods
This was a pilot, randomized, double-blind, placebo-controlled, parallel design trial of intranasal oxytocin versus placebo in 19 adults with ASD (16 males; 33.20 ± 13.29 years). Subjects were randomized to 24 IU intranasal oxytocin or placebo in the morning and afternoon for 6 weeks. Measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive behaviors (Repetitive Behavior Scale Revised) were administered. Secondary measures included the Social Responsiveness Scale, Reading-the-Mind-in-the-Eyes Test and the Yale Brown Obsessive Compulsive Scale – compulsion subscale and quality of life (World Health Organization Quality of Life Questionnaire – emotional/social subscales). Full-information maximum-likelihood parameter estimates were obtained and tested using mixed-effects regression analyses.
Results
Although no significant changes were detected in the primary outcome measures after correcting for baseline differences, results suggested improvements after 6 weeks in measures of social cognition (Reading-the-Mind-in-the-Eyes Test, p = 0.002, d = 1.2), and quality of life (World Health Organization Quality of Life Questionnaire – emotion, p = 0.031, d = 0.84), both secondary measures. Oxytocin was well tolerated and no serious adverse effects were reported.
Conclusions
This pilot study suggests that there is therapeutic potential to daily administration of intranasal oxytocin in adults with ASD and that larger and longer studies are warranted.
Trial registration
NCT00490802
doi:10.1186/2040-2392-3-16
PMCID: PMC3539865  PMID: 23216716
Autism; Adults; Oxytocin; Clinical trial; Social cognition
12.  Observed Hostility and the Risk of Incident Ischemic Heart Disease: A Prospective Population Study from the 1995 Canadian Nova Scotia Health Survey 
OBJECTIVES
To examine the relation between hostility and incident ischemic heart disease (IHD) and to determine whether observed hostility is superior to patient-reported hostility for the prediction of IHD in a large, prospective observational study.
BACKGROUND
Some studies have found that hostile patients have an increased risk of incident IHD. However, no studies have compared methods of hostility assessment, nor considered important psychosocial and cardiovascular risk factors as confounders. Further, it is unknown whether all expressions of hostility carry equal risk, or whether certain manifestations are more cardiotoxic.
METHODS
We assessed the independent relationship between baseline observed hostility and 10-year incident IHD in 1,749 adults of the population-based Canadian Nova Scotia Health Survey.
RESULTS
There were 149 (8.5%) incident IHD events (140 non-fatal, 9 fatal) during the 15,295 person-years of observation (9.74 events/1000 person-years). Participants with any observed hostility had a greater risk of incident IHD than those without (p=0.02); no such relation was found for patient-reported hostility. After adjusting for cardiovascular (age, sex, Framingham Risk Score) and psychosocial (depression, positive affect, patient-reported hostility, and anger) risk factors, those with any observed hostility had a significantly greater risk of incident IHD (HR 2.06, 95% CI 1.04–4.08, P=0.04).
CONCLUSIONS
The presence of any observed hostility at baseline was associated with a two-fold increased risk of incident IHD over 10 years of follow-up. Compared to patient-reported measures, observed hostility is a superior predictor of IHD.
doi:10.1016/j.jacc.2011.04.044
PMCID: PMC3188395  PMID: 21903054
Observed hostility; patient-reported hostility; ischemic heart disease; depression; positive affect
13.  Psychosocial Vulnerabilities to Depression after Acute Coronary Syndrome: The Pivotal Role of Rumination in Predicting and Maintaining Depression 
Psychosocial vulnerabilities may predispose individuals to develop depression after a significant life stressor, such as an acute coronary syndrome (ACS). The aims are (1) to examine the interrelations among vulnerabilities, and their relation with changes in depressive symptoms 3 months after ACS, (2) to prospectively assess whether rumination interacts with other vulnerabilities as a predictor of later depressive symptoms, and (3) to examine how these relations differ between post-ACS patients who meet diagnostic criteria for depression at baseline versus patients who do not. Within 1 week after hospitalization for ACS, and again after 3 months, 387 patients (41% female, 79.6% white, mean age 61) completed the Beck Depression Inventory (BDI) and measures of vulnerabilities (lack of pleasant events, dysfunctional attitudes, role transitions, poor dyadic adjustment). Exclusion criteria were a BDI score of 5–9, terminal illness, active substance abuse, cognitive impairment, and unavailability for follow-up visits. We used hierarchical regression modeling cross-sectionally and longitudinally. Controlling for baseline (in-hospital) depression and cardiovascular disease severity, vulnerabilities significantly predicted 3 month depression severity. Rumination independently predicted increased depression severity, above other vulnerabilities (β = 0.75, p < 0.001), and also interacted with poor dyadic adjustment (β = 0.32, p < 0.001) to amplify depression severity. Among initially non-depressed patients, the effects of vulnerabilities were amplified by rumination. In contrast, in patients who were already depressed at baseline, there was a direct effect of rumination above vulnerabilities on depression severity. Although all vulnerabilities predict depression 3 months after an ACS event has occurred rumination plays a key role to amplify the impact of vulnerabilities on depression among the initially non-depressed, and maintains depression among those who are already depressed.
doi:10.3389/fpsyg.2012.00288
PMCID: PMC3417406  PMID: 22905030
psychosocial vulnerabilities; post-ACS; depression; rumination; cardiovascular disease
15.  Directionality of the relationship between depressive symptom dimensions and C-reactive protein in patients with acute coronary syndromes 
Psychosomatic medicine  2011;73(5):370-377.
Objective
Previous theoretical models predict that elevated inflammation may predict later depressive symptoms, but bidirectional associations are possible. We examined whether depressive symptoms or inflammation predict change in the other over a 3-month period in a sample of post-acute coronary syndrome (ACS) adults.
Methods
During hospitalization for their index ACS event (baseline), and then again 1 and 3 months later, 163 post-ACS patients completed the Beck Depression Inventory, a measure of depressive symptom severity with cognitive-affective and somatic-affective subscales. C-reactive protein (CRP) was also assessed at each visit; known correlates of depression and CRP were assessed at baseline. Path analyses were conducted to evaluate prospective associations among depressive symptoms and log-transformed CRP values and whether strength and/or directionality varied by specific depressive symptom dimensions.
Results
Baseline total depressive symptom severity predicted a smaller decrease in CRP from baseline to 1 month (unstandardized parameter estimates (B) = .04; p < .001) controlling for all covariates, as did baseline cognitive-affective depressive symptom severity (B = .10; p = .02). Baseline somatic-affective depressive symptom severity did not predict change in CRP (B = −.002; p = .94). CRP did not predict 1- or 3-month change in total, cognitive-affective, or somatic-affective depressive symptom severity. Results did not differ for men and women.
Conclusion
Greater cognitive-affective and total depressive symptom severity at the time of a cardiac event predicts a smaller decrease in CRP 1 month later, but there was no evidence in this study that CRP predicts change in depressive symptoms.
doi:10.1097/PSY.0b013e31821deafd
PMCID: PMC3110525  PMID: 21636659
depression; inflammation; acute coronary syndrome; depressive symptoms; risk factors; cardiovascular disease
16.  Maintenance of Quality of Life Improvements in Diverse Rural Older Adults 
Psychology and aging  2011;26(2):475-479.
The maintenance of effects from home-delivered cognitive-behavioral therapy (CBT) was examined. One hundred thirty-four participants, predominantly African American and primarily rural, low-resource, and physically frail, were randomly assigned to either immediate or delayed CBT. The six-month follow-up assessments indicated that among those who remained in the study, participants evidenced significantly improved quality of life and reductions in psychological symptoms at follow-up, relative to pretreatment levels. Posttreatment gains were maintained at follow-up. These data suggest that treatment effects can be achieved and perhaps maintained with a disadvantaged sample of older adults and suggest that evidence-based treatments delivered through nontraditional means can have effects beyond posttreatment.
doi:10.1037/a0022130
PMCID: PMC3222293  PMID: 21417535
quality of life; rural; CBT; older adults; African American
17.  Prolonged exposure for the treatment of Spanish-speaking Puerto Ricans with posttraumatic stress disorder: a feasibility study 
BMC Research Notes  2011;4:415.
Background
Most of the empirical studies that support the efficacy of prolonged exposure (PE) for treating posttraumatic stress disorder (PTSD) have been conducted on white mainstream English-speaking populations. Although high PTSD rates have been reported for Puerto Ricans, the appropriateness of PE for this population remains unclear. The purpose of this study was to examine the feasibility of providing PE to Spanish speaking Puerto Ricans with PTSD. Particular attention was also focused on identifying challenges faced by clinicians with limited experience in PE. This information is relevant to help inform practice implications for training Spanish-speaking clinicians in PE.
Results
Fourteen patients with PTSD were randomly assigned to receive PE (n = 7) or usual care (UC) (n = 7). PE therapy consisted of 15 weekly sessions focused on gradually confronting and emotionally processing distressing trauma-related memories and reminders. Five patients completed PE treatment; all patients attended the 15 sessions available to them. In UC, patients received mental health services available within the health care setting where they were recruited. They also had the option of self-referring to a mental health provider outside the study setting. The Clinician-Administered PTSD Scale (CAPS) was administered at baseline, mid-treatment, and post-treatment to assess PTSD symptom severity. Treatment completers in the PE group demonstrated significantly greater reductions in PTSD symptoms than the UC group. Forty percent of the PE patients showed clinically meaningful reductions in PTSD symptoms from pre- to post-treatment.
Conclusions
PE appears to be viable for treating Puerto Rican Spanish-speaking patients with PTSD. This therapy had good patient acceptability and led to improvements in PTSD symptoms. Attention to the clinicians' training process contributed strongly to helping them overcome the challenges posed by the intervention and increased their acceptance of PE.
doi:10.1186/1756-0500-4-415
PMCID: PMC3212994  PMID: 22005187
18.  Anxiety is a better predictor of platelet reactivity in coronary artery disease patients than depression 
European Heart Journal  2010;31(13):1573-1582.
Aims
Depression and anxiety are linked to coronary events but the mechanism(s) remains unclear. We investigated the associations of depression and anxiety with serotonin-mediated platelet hyperactivity in coronary artery disease (CAD) patients in a cross-sectional study.
Methods and results
Three months after an acute coronary event, stable CAD patients (n = 83) on aspirin and clopidogrel were evaluated for depression (beck depression inventory) and anxiety (hospital anxiety and depression scale), and their platelet reactivity was measured (optical aggregometry and flow cytometric fibrinogen binding in response to adenosine diphosphate (ADP = 5 µM) and two serotonin + epinephrine doses [5HT:E (L) = 4 µM + 4 µM and 5HT:E (H) = 10 µM + 4 µM]. Platelet reactivity was significantly higher in depressed and anxious than in depressed only or non-depressed-and-non-anxious patients. Aggregation (mean ± SE) was 41.9 ± 2.6% vs. 32.2 ± 2.6% vs. 30.4 ± 3.7% with 5HT:E (L) and 46.9 ± 2.7% vs. 35.6 ± 2.7% vs. 31.7 ± 3.8% with 5HT:E (H) (P < 0.05 for both). Differences in ADP aggregations were not significant, perhaps because of clopidogrel therapy. Flow cytometry findings were similar. In a multivariate linear regression model adjusted for age, body mass index, and each other, anxiety symptoms independently predicted all 5HT:E-mediated platelet reactivity measures, whereas depression predicted none.
Conclusion
Anxiety is associated with elevated serotonin-mediated platelet reactivity in stable CAD patients and symptoms of anxiety show strong, independent correlations with platelet function.
doi:10.1093/eurheartj/ehp602
PMCID: PMC2895160  PMID: 20097703
Anxiety; Coronary artery disease; Depression; Myocardial infarction; Platelets
19.  Divalproex Sodium vs Placebo for the Treatment of Irritability in Children and Adolescents with Autism Spectrum Disorders 
Neuropsychopharmacology  2009;35(4):990-998.
Autism spectrum disorders (ASDs) are neurodevelopmental disorders characterized by social and language deficits and by repetitive behaviors and interests. Irritability/aggression is a significant comorbid symptom in this population, which greatly impacts burden of care. This study examined the effect of divalproex sodium for irritability/aggression in children and adolescents with ASD. This was a 12-week randomized, double-blind, placebo-controlled trial. All efficacy measures were obtained by an independent evaluator blinded to randomization condition and side effects. A total of 55 subjects gavetheir consent and 27 were randomized in a 1 : 1 manner (mean age 9.46±2.46, mean nonverbal IQ 63.3±23.9). Two subjects from the active group and one subject from the placebo group discontinued the study because of either a lack of efficacy or side effects (increased irritability). Primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement, which focused on irritability. Overall, 62.5% of divalproex subjects vs 9% of placebo subjects were responders (CGI-irritability OR: 16.7, Fisher's exact p=0.008). A statistically significant improvement was also noted on the ABC-Irritability subscale (p=0.048). There was a trend for responders to have higher valproate blood levels compared with nonresponders. This study suggests the efficacy of divalproex for the treatment of irritability in children and adolescents with ASD. Larger sample follow-up studies are warranted.
doi:10.1038/npp.2009.202
PMCID: PMC2846602  PMID: 20010551
ASD; irritability; divalproex; children; adolescents; Development/Developmental Disorders; Psychiatry & Behavioral Sciences; Psychopharmacology; Clinical Pharmacology/Trials; autism; adolescents; children; EEG; divalproex
20.  THE RELATIONSHIP BETWEEN WHOLE BLOOD SEROTONIN AND REPETITIVE BEHAVIORS IN AUTISM 
Psychiatry research  2009;175(3):274.
This study was conducted to examine the relationship between whole blood serotonin level and behavioral symptoms in 78 subjects with autism. No significant associations were found between serotonin level and the primary behavioral outcome measures. However, a significant inverse relationship between serotonin level and self-injury was demonstrated.
doi:10.1016/j.psychres.2009.02.008
PMCID: PMC2815211  PMID: 20044143
autism; serotonin; repetitive behavior; self-injury; aggression
21.  Hostility and Platelet Reactivity in Individuals Without A History of Cardiovascular Disease Events 
Psychosomatic medicine  2009;71(7):741-747.
Objective
Hostility is associated with incident cardiovascular disease (CVD) events, independent of traditional risk factors. Increased platelet reactivity and thrombus formation over a disrupted coronary plaque is fundamental for CVD event onset. We examined the association between hostility and platelet reactivity in individuals without a prior history of CVD events.
Methods
Hypertensive patients (n=42) without concomitant CVD event history completed the 50-item Cook-Medley Hostility Scale, and a subset score of 27-items (Barefoot Ho) was derived. We examined the relation between Barefoot Ho scores and platelet aggregation. We also examined individual components of Barefoot Ho (aggressive responding, cynicism, and hostile affect) and their associations with platelet aggregation. Platelet reactivity, induced by ADP, was assessed by standard light transmission aggregometry, the current gold standard method of platelet aggregation assessment.
Results
Barefoot Ho scores were significantly related to increased rate of platelet aggregation in response to ADP. Further, of the three Barefoot Ho components, only aggressive responding was independently associated with increased platelet aggregation rate. The strength of these relationships did not diminish after adjusting for several standard CVD risk factors.
Conclusions
These data demonstrate that hostility, particularly the aggressive responding subtype, is associated with platelet reactivity, a key pathophysiological pathway in the onset of CVD events.
doi:10.1097/PSY.0b013e3181ad18b6
PMCID: PMC2957180  PMID: 19592519
platelets; hostility; coronary heart disease
22.  DIVALPROEX SODIUM VS. PLACEBO FOR THE TREATMENT OF IRRITABILITY IN CHILDREN AND ADOLESCENTS WITH AUTISM SPECTRUM DISORDERS 
Objective
Autism Spectrum Disorders (ASDs) are neurodevelopmental disorders characterized by social and language deficits and repetitive behaviors and interests. Irritability/aggression is a significant co-morbid symptom in this population, which greatly impacts burden of care. This study examined the effect of divalproex sodium for irritability / aggression in children and adolescents with ASD.
Methods
This was a 12 week randomized, double-blind, placebo-controlled trial. All efficacy measures were obtained by an independent evaluator blinded to randomization condition and side effects. Fifty five subjects signed consent and 27 were randomized in a 1:1 fashion (mean age 9.46±2.46, mean non verbal IQ 63.3±23.9). Two subjects from the active group and one subject from the placebo group discontinued the study due to either lack of efficacy or side effects (increased irritability).
Results
The primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement, focused on irritability. 62.5% of divalproex subjects vs. 9% of placebo subjects were responders (CGI-irritability OR:16.7, Fisher’s exact p=0.008). A statistically significant improvement was also noted on the ABC-Irritability subscale (p=0.048). There was a trend for the responders to have higher valproate blood levels than the non-responders.
Conclusions
This study suggests efficacy of divalproex for the treatment of irritability in children and adolescents with ASD. Larger sample follow-up studies are warranted.
doi:10.1038/npp.2009.202
PMCID: PMC2846602  PMID: 20010551
ASD; irritability; divalproex; children; adolescents
23.  Collaborative Care for Depressed Patients With Chronic Medical Conditions: A Randomized Trial in Puerto Rico 
Objective
This study examined whether a collaborative care model for depression would improve clinical and functional outcomes for depressed patients with chronic general medical conditions in primary care practices in Puerto Rico.
Methods
A total of 179 primary care patients with major depression and chronic general medical conditions were randomly assigned to receive collaborative care or usual care. The collaborative care intervention involved enhanced collaboration among physicians, mental health specialists, and care managers paired with depression-specific treatment guidelines, patient education, and follow-up. In usual care, study personnel informed the patient and provider of the diagnosis and encouraged patients to discuss treatment options with their provider. Depression severity was assessed with the Hopkins Symptom Checklist; social functioning was assessed with the 36-item Short Form.
Results
Compared with usual care, collaborative care significantly reduced depressive symptoms and improved social functioning in the six months after randomization. Integration of collaborative care in primary care practices considerably increased depressed patients' use of mental health services.
Conclusions
Collaborative care significantly improved clinical symptoms and functional status of depressed patients with coexisting chronic general medical conditions receiving treatment for depression in primary care practices in Puerto Rico. These findings highlight the promise of the collaborative care model for strengthening the relationship between mental health and primary care services in Puerto Rico.
doi:10.1176/appi.ps.61.2.144
PMCID: PMC2900833  PMID: 20123819
24.  Provider communication effects medication adherence in hypertensive African Americans 
Patient education and counseling  2008;75(2):185-191.
Objective
To evaluate the effect of patients’ perceptions of providers’ communication on medication adherence in hypertensive African Americans.
Methods
Cross-sectional study of 439 patients with poorly-controlled hypertension followed in community-based healthcare practices in the New York metropolitan area. Patients’ rating of their providers’ communication was assessed with a perceived communication style questionnaire,while medication adherence was assessed with the Morisky self-report measure.
Results
Majority of participants were female, low-income, and had high school level educations, with mean age of 58 years. Fifty-five percent reported being nonadherent with their medications; and 51% rated their provider’s communication to be non-collaborative. In multivariate analysis adjusted for patient demographics and covariates (depressive symptoms, provider degree), communication rated as collaborative was associated with better medication adherence (β = -.11, p = .03). Other significant correlates of medication adherence independent of perceived communication were age (β = .13, p = .02) and depressive symptoms (β = -.18, p = .001).
Conclusion
Provider communication rated as more collaborative was associated with better adherence to antihypertensive medications in a sample of low-income hypertensive African-American patients.
Practice Implications
The quality of patient-provider communication is a potentially modifiable element of the medical relationship that may affect health outcomes in this high-risk patient population.
doi:10.1016/j.pec.2008.09.018
PMCID: PMC2698021  PMID: 19013740
Patient-provider communication; medication adherence; African American; Hypertension
25.  Advance Care Planning in Nursing Homes: Correlates of Capacity and Possession of Advance Directives 
The Gerontologist  2003;43(3):309-317.
Purpose
The identification of nursing home residents who can continue to participate in advance care planning about end-of-life care is a critical clinical and bioethical issue. This study uses high quality observational research to identify correlates of advance care planning in nursing homes, including objective measurement of capacity.
Design and Methods
The authors used cross-sectional, cohort study between 1997 and 1999. Seventy-eight residents (M age = 83.97, = 8.2) and their proxies (M age = 59.23, SD = 11.77) were included across five nursing homes. The authors obtained data via chart review, proxy interviews, resident assessments, survey completion by certified nursing assistants, and direct observation of residents' daily behaviors.
Results
Capacity assessments revealed that most residents could state a simple treatment preference (82.4%), but a sizable number did not retain capacity to understand treatment alternatives or appreciate the consequences of their choice. Global cognitive ability (Mini-Mental State Examination score) was related to understanding and appreciation. When the authors removed the effects of global cognitive ability, understanding and appreciation were related to time spent by residents in verbal interaction with others. Residents were more likely to possess advance directives when proxies possessed advance directives, proxies were less religious, and residents were socially engaged.
Implications
Assessment of proxy beliefs and direct determination of residents' decisional capacity and social engagement may help nursing home staff identify families who may participate in advance planning for end-of-life medical care. Measures of global cognitive ability offer limited information about resident capacity for decision making. Decisional capacity assessments should enhance the verbal ability of individuals with dementia by reducing reliance on memory in the assessment process. Interventions to engage residents and families in structured discussions for end-of-life planning are needed.
PMCID: PMC2666093  PMID: 12810894
Advance planning; Nursing homes; Capacity; Observational research

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