Provider-Level Variation in Smoking Cessation Assistance Provided in the Cardiology Clinics: Insights From the NCDR PINNACLE Registry.

Background Studies show suboptimal provision of smoking cessation assistance (counseling or pharmacotherapy) for current smokers attempting to quit. We aimed to identify smoking cessation assistance patterns in US cardiology practices. Methods and Results Among 328 749 current smokers seen between January 1, 2013, and March 31, 2016, in 348 NCDR (National Cardiovascular Data Registry) PINNACLE (Practice Innovation and Clinical Excellence)-affiliated cardiology practices, we measured the rates of cessation assistance. We used multivariable hierarchical logistic regression models to determine provider-, practice-, and patient-level predictors of cessation assistance. We measured provider variation in cessation assistance using median rate ratio (the likelihood that the same patient would receive the same assistance at by any given provider; >1.2 suggests significant variation). Smoking cessation assistance was documented in only 34% of encounters. Despite adjustment of provider, practice, and patient characteristics, there was large provider-level variation in cessation assistance (median rate ratio, 6 [95% CI , 5.76-6.32]). Practice location in the South region (odds ratio [OR], 0.48 [0.37-0.63] versus West region) and rural or suburban location (OR, 0.92 [0.88-0.95] for rural; OR, 0.94 [0.91-0.97] for suburban versus urban) were associated with lower rates of cessation assistance. Similarly, older age (OR, 0.88 [0.88-0.89] per 10-year increase), diabetes mellitus (OR, 0.84 [0.82-0.87]), and atrial fibrillation (OR, 0.93 [0.91-0.96]) were associated with lower odds of receiving cessation assistance. Conclusions In a large contemporary US registry, only 1 in 3 smokers presenting for a cardiology visit received smoking cessation assistance. Our findings suggest the presence of a large deficit and largely idiosyncratic provider-level variation in the provision of smoking cessation assistance.

Psychiatric history, post-discharge distress, and personality characteristics among incident female cases of takotsubo cardiomyopathy: A case-control study.

BACKGROUND: The role of psychological factors in the onset of takotsubo cardiomyopathy (TC) is still controversial. Associations with previous psychiatric conditions are registry-based; associations with personality characteristics and psychological sequelae of TC have been largely unexplored. This case-control study sought to study pre-admission psychiatric morbidity, personality traits, and post-discharge distress in incident cases of TC. METHODS: TC cases (Mayo clinic criteria) and acute myocardial infarction (MI) controls were recruited among women admitted to two Emergency Departments in New England. Healthy controls (HC) were recruited from a volunteers' registry. Preadmission psychiatric history (DSM-IV-TR) was abstracted from the medical record. PTSD symptoms (Impact of Events Scale); distress (Hospital Anxiety and Depression Scale); perceived stress (PS scale) and personality traits (optimism; hostility, type D personality) were collected via phone interview one month after discharge. RESULTS: From March 2013 through October 2015, 107 participants (45 TC, 32 MI and 30 HC) were enrolled. The prevalence of preadmission anxiety disorders was 24.4% in TC, 9.4% in MI, and 0 in HC (p = 0.007) while that of mood disorders was similar across groups. TC had higher psychological distress, perceived stress, and PTSD symptoms post-discharge vs. MI and HC. In adjusted models, PTSD symptoms remained higher in TC vs. MI (b = 0.55, p < 0.05) and vs. HC (b = 0.92, p < 0.01). Optimism and hostility scores were similar across groups, while type D (social inhibition) scores were higher in TC and MI vs. HC. CONCLUSIONS: Preadmission anxiety, but not depression, was associated with the occurrence of TC. High distress and PTSD symptoms post-discharge indicate that TC women may be at risk for poor psychological adjustment.

Impact of incident diabetes on atherosclerotic cardiovascular disease according to statin use history among postmenopausal women.

To compare impact of incident diabetes on atherosclerotic cardiovascular disease (ASCVD) risk among postmenopausal women according to statin use. Prospective data from 120,499 postmenopausal women without prevalent diabetes or cardiovascular disease at baseline from the Women's Health Initiative were used. Incident diabetes was self-reported annually and defined as treatment with pills or injectable medication for diabetes. Current statin use was determined at enrollment and years 1, 3, 6, 9 and 13.5 in the three clinical trial arms, and at baseline, year 3, and 13.5 for the observational study. The primary outcome was incident ASCVD events, self-reported annually and adjudicated by blinded local and central physicians. Incident diabetes and statin use status were fitted as time-varying covariates in Cox regression models to assess ASCVD risk during an average follow-up of 13.6 years. For those not on statins at the time of diabetes diagnosis, there was a 42 % increased risk of ASCVD [hazard ratio (HR) 1.42, 95 % CI 1.28-1.58] among women with incident diabetes versus those without diabetes. Among women on statins, there was a 39 % increased risk of ASCVD (HR 1.39, 95 % CI 1.12-1.74) in women with incident diabetes versus those without diabetes. The increased ASCVD risk due to diabetes was similar between women before or after initiating statins (P = 0.89). Whether diabetes was diagnosed before or after statin use did not alter the increased risk of ASCVD associated with diabetes. Mitigating the increased incidence of diabetes in statin users could increase the ASCVD benefit-to-risk ratio of statins.

Perspective: Randomized Controlled Trials Are Not a Panacea for Diet-Related Research.

Research into the role of diet in health faces a number of methodologic challenges in the choice of study design, measurement methods, and analytic options. Heavier reliance on randomized controlled trial (RCT) designs is suggested as a way to solve these challenges. We present and discuss 7 inherent and practical considerations with special relevance to RCTs designed to study diet: 1) the need for narrow focus; 2) the choice of subjects and exposures; 3) blinding of the intervention; 4) perceived asymmetry of treatment in relation to need; 5) temporal relations between dietary exposures and putative outcomes; 6) strict adherence to the intervention protocol, despite potential clinical counter-indications; and 7) the need to maintain methodologic rigor, including measuring diet carefully and frequently. Alternatives, including observational studies and adaptive intervention designs, are presented and discussed. Given high noise-to-signal ratios interjected by using inaccurate assessment methods in studies with weak or inappropriate study designs (including RCTs), it is conceivable and indeed likely that effects of diet are underestimated. No matter which designs are used, studies will require continued improvement in the assessment of dietary intake. As technology continues to improve, there is potential for enhanced accuracy and reduced user burden of dietary assessments that are applicable to a wide variety of study designs, including RCTs.

Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial.

BACKGROUND: Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components. OBJECTIVE: To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines. DESIGN: Randomized, controlled trial from June 2009 to January 2014. (ClinicalTrials.gov: NCT00911885). SETTING: Worcester, Massachusetts. PARTICIPANTS: 240 adults with the metabolic syndrome. INTERVENTION: Participants engaged in individual and group sessions. MEASUREMENTS: Primary outcome was weight change at 12 months. RESULTS: At 12 months, mean change in weight was -2.1 kg (95% CI, -2.9 to -1.3 kg) in the high-fiber diet group versus -2.7 kg (CI, -3.5 to -2.0 kg) in the AHA diet group. The mean between-group difference was 0.6 kg (CI, -0.5 to 1.7 kg). During the trial, 12 (9.9%) and 15 (12.6%) participants dropped out of the high-fiber and AHA diet groups, respectively (P = 0.55). Eight participants developed diabetes (hemoglobin A1c level ≥6.5%) during the trial: 7 in the high-fiber diet group and 1 in the AHA diet group (P = 0.066). LIMITATIONS: Generalizability is unknown. Maintenance of weight loss after cessation of group sessions at 12 months was not assessed. Definitive conclusions cannot be made about dietary equivalence because the study was powered for superiority. CONCLUSION: The more complex AHA diet may result in up to 1.7 kg more weight loss; however, a simplified approach to weight reduction emphasizing only increased fiber intake may be a reasonable alternative for persons with difficulty adhering to more complicated diet regimens. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Access to healthy food stores modifies effect of a dietary intervention.

BACKGROUND: Recent evidence suggests that opening a grocery store in a food desert does not translate to better diet quality among community residents. PURPOSE: This study evaluated the influence of proximity to a healthy food store on the effect of a dietary behavioral intervention on diet among obese adults randomized to either a high fiber or American Heart Association diet intervention. METHODS: Participants were recruited from Worcester County, Massachusetts, between June 2009 and January 2012. Dietary data were collected via 24-hour recalls at baseline and 3, 6, and 12 months post-intervention. Based on in-store inspection data, a store was considered as having adequate availability of healthy foods if it had at least one item available in each of 20 healthy food categories. Linear models evaluated maximum change in dietary outcomes in relation to road distance from residence to the nearest June healthy food store. The analysis was conducted in January to June 2014. RESULTS: On average, participants (N=204) were aged 52 years, BMI=34.9, and included 72% women and 89% non-Hispanic whites. Shorter distance to a healthy food store was associated with greater improvements in consumption of fiber (b=-1.07 g/day per mile, p<0.01) and fruits and vegetables (b=-0.19 servings/day per mile, p=0.03) with and without covariate adjustment. CONCLUSIONS: The effectiveness of dietary interventions is significantly influenced by the presence of a supportive community nutrition environment. Considering the nationwide efforts on promotion of healthy eating, the value of improving community access to healthy foods should not be underestimated. CLINICAL TRIAL REGISTRATION NUMBER: NCT00911885.

Severity of depressive symptoms and accuracy of dietary reporting among obese women with major depressive disorder seeking weight loss treatment.

An elevation in symptoms of depression has previously been associated with greater accuracy of reported dietary intake, however this association has not been investigated among individuals with a diagnosis of major depressive disorder. The purpose of this study was to investigate reporting accuracy of dietary intake among a group of women with major depressive disorder in order to determine if reporting accuracy is similarly associated with depressive symptoms among depressed women. Reporting accuracy of dietary intake was calculated based on three 24-hour phone-delivered dietary recalls from the baseline phase of a randomized trial of weight loss treatment for 161 obese women with major depressive disorder. Regression models indicated that higher severity of depressive symptoms was associated with greater reporting accuracy, even when controlling for other factors traditionally associated with reporting accuracy (coefficient  =  0.01 95% CI = 0.01 - 0.02). Seventeen percent of the sample was classified as low energy reporters. Reporting accuracy of dietary intake increases along with depressive symptoms, even among individuals with major depressive disorder. These results suggest that any study investigating associations between diet quality and depression should also include an index of reporting accuracy of dietary intake as accuracy varies with the severity of depressive symptoms.

A population-based dietary inflammatory index predicts levels of C-reactive protein in the Seasonal Variation of Blood Cholesterol Study (SEASONS).

OBJECTIVE: To perform construct validation of the population-based Dietary Inflammatory Index (DII) using dietary data from two different dietary assessments and serum high-sensitivity C-reactive protein (hs-CRP) as the construct validator. DESIGN: Using data derived from (i) three 24 h dietary recalls (24HR) at baseline and at the end of each subsequent quarter (i.e. up to fifteen over a year) and (ii) a 7 d dietary recall (7DDR) measured at baseline and then quarterly, regression analyses were conducted to test the effect of the DII score on serum hs-CRP as dichotomous (≤3 mg/l, >3 mg/l), while controlling for important potential confounders. SETTING: Existing data from the Seasonal Variation of Blood Cholesterol Study (SEASONS), a longitudinal observational study of healthy participants recruited in Worcester, MA, USA and participants were followed for 1 year. SUBJECTS: Participants who had at least one hs-CRP measurement over her/his 1-year participation (n 495 for 24HR, n 559 for 7DDR). RESULTS: Higher DII scores were associated with values of hs-CRP >3 mg/l (OR = 1·08; 95 % CI 1·01, 1·16, P = 0·035 for the 24HR; and OR = 1·10; 95 % CI 1·02, 1·19, P = 0·015 for the 7DDR). CONCLUSIONS: The population-based DII was associated with interval changes in hs-CRP using both the 24HR and 7DDR. The success of this first-of-a-kind attempt at relating individuals' intakes of inflammation-modulating foods using this refined DII, and the finding that there is virtually no drop-off in predictive capability using a structured questionnaire in comparison to the 24HR standard, sets the stage for use of the DII in a wide variety of other epidemiological and clinical studies.

All-cause, cardiovascular, and cancer mortality rates in postmenopausal white, black, Hispanic, and Asian women with and without diabetes in the United States: the Women's Health Initiative, 1993-2009.

Using data from the Women's Health Initiative (1993-2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.1% were Hispanic, and 2.6% were Asian), we compared all-cause, cardiovascular, and cancer mortality rates in white, black, Hispanic, and Asian postmenopausal women with and without diabetes. Cox proportional hazard models were used for the comparison from which hazard ratios and 95% confidence intervals were computed. Within each racial/ethnic subgroup, women with diabetes had an approximately 2-3 times higher risk of all-cause, cardiovascular, and cancer mortality than did those without diabetes. However, the hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups. Population attributable risk percentages (PARPs) take into account both the prevalence of diabetes and hazard ratios. For all-cause mortality, whites had the lowest PARP (11.1, 95% confidence interval (CI): 10.1, 12.1), followed by Asians (12.9, 95% CI: 4.7, 20.9), blacks (19.4, 95% CI: 15.0, 23.7), and Hispanics (23.2, 95% CI: 14.8, 31.2). To our knowledge, the present study is the first to show that hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups when stratified by diabetes status. Because of the "amplifying" effect of diabetes prevalence, efforts to reduce racial/ethnic disparities in the rate of death from diabetes should focus on prevention of diabetes.

Phone-delivered mindfulness training for patients with implantable cardioverter defibrillators: results of a pilot randomized controlled trial.

BACKGROUND: The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. PURPOSE: This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. METHODS: Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables. RESULTS: We enrolled 45 patients (23 mindfulness and 22 control; age, 43-83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta = -1.15; p = 0.059) improved in the mindfulness group. CONCLUSIONS: Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.

Quality of life and baseline characteristics associated with depressive symptoms among patients with heart disease.

We sought to examine factors associated with depressive symptoms among patients with heart disease. Data from 197 patients admitted for coronary artery disease were examined using multivariate predictive models. Women and unmarried patients were more likely to report depressive symptoms. In multivariate models, we observed that depressive symptoms were associated with the level of tangible social (but not emotional) support, bodily pain, and vitality, but not the number of comorbidities, gender, or marital status.

Determinants of racial/ethnic disparities in incidence of diabetes in postmenopausal women in the U.S.: The Women's Health Initiative 1993-2009.

OBJECTIVE: To examine determinants of racial/ethnic differences in diabetes incidence among postmenopausal women participating in the Women's Health Initiative. RESEARCH DESIGN AND METHODS: Data on race/ethnicity, baseline diabetes prevalence, and incident diabetes were obtained from 158,833 women recruited from 1993-1998 and followed through August 2009. The relationship between race/ethnicity, other potential risk factors, and the risk of incident diabetes was estimated using Cox proportional hazards models from which hazard ratios (HRs) and 95% CIs were computed. RESULTS: Participants were aged 63 years on average at baseline. The racial/ethnic distribution was 84.1% non-Hispanic white, 9.2% non-Hispanic black, 4.1% Hispanic, and 2.6% Asian. After an average of 10.4 years of follow-up, compared with whites and adjusting for potential confounders, the HRs for incident diabetes were 1.55 for blacks (95% CI 1.47-1.63), 1.67 for Hispanics (1.54-1.81), and 1.86 for Asians (1.68-2.06). Whites, blacks, and Hispanics with all factors (i.e., weight, physical activity, dietary quality, and smoking) in the low-risk category had 60, 69, and 63% lower risk for incident diabetes. Although contributions of different risk factors varied slightly by race/ethnicity, most findings were similar across groups, and women who had both a healthy weight and were in the highest tertile of physical activity had less than one-third the risk of diabetes compared with obese and inactive women. CONCLUSIONS: Despite large racial/ethnic differences in diabetes incidence, most variability could be attributed to lifestyle factors. Our findings show that the majority of diabetes cases are preventable, and risk reduction strategies can be effectively applied to all racial/ethnic groups.

Depression severity, diet quality, and physical activity in women with obesity and depression.

Major depressive disorder (MDD) is prevalent in clinical weight-loss settings and predicts poor weight-loss outcomes. It is unknown whether the severity of depressive symptoms among those with MDD is associated with diet quality or physical activity levels. This knowledge is important for improving weight-loss treatment for these patients. It was hypothesized that more severe depression is associated with poorer diet quality and lower physical activity levels among individuals with obesity and MDD. Participants were 161 women with current MDD and obesity enrolled in the baseline phase of a weight-loss trial between 2007 and 2010. Depression severity was measured with the Beck Depression Inventory II. The Alternate Healthy Eating Index was applied to data from three 24-hour diet recalls to capture overall diet quality. Daily metabolic equivalents expended per day were calculated from three 24-hour physical activity recalls. Greater depression severity was associated with poorer overall diet quality (estimate=-0.26, standard error 0.11; P=0.02), but not with physical activity (estimate=0.07, standard error 0.05; P=0.18), in linear regression models controlling for income, education, depression-related appetite change, binge eating disorder, and other potential confounds. Associations with diet quality were primarily driven by greater intake of sugar (r=0.20; P<0.01), saturated fat (r=0.21; P<0.01), and sodium (r=0.22; P<0.01). More severe depression was associated with poorer overall diet quality, but not physical activity, among treatment-seeking women with MDD and obesity. Future studies should identify mechanisms linking depression to diet quality and determine whether diet quality improves with depression treatment.

Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project.

OBJECTIVES: We tested the effectiveness of a community-based, literacy-sensitive, and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income, Spanish-speaking Latinos at increased diabetes risk. METHODS: Three hundred twelve participants from Lawrence, Massachusetts, were randomly assigned to lifestyle intervention care (IC) or usual care (UC) between 2004 and 2007. The intervention was implemented by trained Spanish-speaking individuals from the community. Each participant was followed for 1 year. RESULTS: The participants' mean age was 52 years; 59% had less than a high school education. The 1-year retention rate was 94%. Compared with the UC group, the IC group had a modest but significant weight reduction (-2.5 vs 0.63 lb; P = .04) and a clinically meaningful reduction in hemoglobin A1c (-0.10% vs -0.04%; P = .009). Likewise, insulin resistance improved significantly in the IC compared with the UC group. The IC group also had greater reductions in percentage of calories from total and saturated fat. CONCLUSIONS: We developed an inexpensive, culturally sensitive diabetes prevention program that resulted in weight loss, improved HbA1c, and improved insulin resistance in a high-risk Latino population.

Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative.

BACKGROUND: This study investigates whether the incidence of new-onset diabetes mellitus (DM) is associated with statin use among postmenopausal women participating in the Women's Health Initiative (WHI). METHODS: The WHI recruited 161,808 postmenopausal women aged 50 to 79 years at 40 clinical centers across the United States from 1993 to 1998 with ongoing follow-up. The current analysis includes data through 2005. Statin use was captured at enrollment and year 3. Incident DM status was determined annually from enrollment. Cox proportional hazards models were used to estimate the risk of DM by statin use, with adjustments for propensity score and other potential confounding factors. Subgroup analyses by race/ethnicity, obesity status, and age group were conducted to uncover effect modification. RESULTS: This investigation included 153,840 women without DM and no missing data at baseline. At baseline, 7.04% reported taking statin medication. There were 10,242 incident cases of self-reported DM over 1,004,466 person-years of follow-up. Statin use at baseline was associated with an increased risk of DM (hazard ratio [HR], 1.71; 95% CI, 1.61-1.83). This association remained after adjusting for other potential confounders (multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59) and was observed for all types of statin medications. Subset analyses evaluating the association of self-reported DM with longitudinal measures of statin use in 125,575 women confirmed these findings. CONCLUSIONS: Statin medication use in postmenopausal women is associated with an increased risk for DM. This may be a medication class effect. Further study by statin type and dose may reveal varying risk levels for new-onset DM in this population.