Changes in Glycemic Load Are Positively Associated with Small Changes in Primary Stress Markers of Allostatic Load in Puerto Rican Women.

BACKGROUND: Puerto Ricans experience a high prevalence of type 2 diabetes. Dietary glycemic load (GL) and allostatic load (AL) have been linked with diabetes. AL, the wear and tear on the body from chronic stress, starts with secretion of primary stress markers from activation of the hypothalamic-pituitary-adrenal (HPA) axis, sympathetic nervous system (SNS), and immune system. GL can act as a physiological stressor, contributing to the primary AL response. OBJECTIVE: We examined the relation between GL and a composite score of primary stress markers of AL in Puerto Rican adults. METHODS: Data were from the Boston Puerto Rican Health Study, a cohort study of Puerto Ricans, aged 45-75 y, including 262 men and 697 women with complete data at baseline and 2-y follow-up. GL was calculated from dietary intake obtained with an FFQ. Sex-specific composite primary AL scores included markers of the HPA axis (cortisol and dehydroepiandrosterone sulfate), SNS (epinephrine and norepinephrine), and immune system (C-reactive protein). Linear regression models were stratified by sex and adjusted for covariates. RESULTS: Mean ± SD baseline GL score was 155 ± 28 for men and 135 ± 34 for women. Mean primary stress AL score was 1.25 ± 1.14 for men and 1.25 ± 1.06 for women. GL was not associated with AL score in men. In women, increasing GL from baseline to 2 y was significantly associated with increasing AL, after adjusting for sociodemographics, physical activity, smoking, BMI, menopause, and baseline AL score (ß = 0.03; P = 0.049). Results became marginally significant after further adjustment for chronic diseases (P = 0.06) and intake of fats (P values: saturated fats = 0.08; trans fats = 0.06; unsaturated fats = 0.07), but the magnitude of the association remained unchanged. CONCLUSIONS: Increasing GL over 2 y was positively associated with increasing composite score of primary markers of AL in Puerto Rican women. More studies are needed to confirm our findings.

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.

Reproductive History of Women With Takotsubo Cardiomyopathy.

Takotsubo cardiomyopathy (TC) occurs predominantly in postmenopausal women, suggesting a possible role of reproductive and hormonal factors in the pathophysiology of this condition. Yet reproductive characteristics of women with TC have received limited attention. This prospective case-control study sought to explore reproductive characteristics associated with TC. Incident TC cases and myocardial infarction (MI) controls were recruited among consecutive women presenting at the emergency departments of 2 large medical centers in Massachusetts and Connecticut. Female healthy controls were recruited from a registry of research volunteers. Information about reproductive history was collected 1 month after discharge using standardized questionnaires completed during phone interviews. Linear and logistic regression models were used to estimate associations with reproductive factors. From March 2013 to October 2015, 209 women were screened for eligibility and 107 (45 TC, 32 MI, and 30 healthy controls) were enrolled. Conditions uniquely associated with TC were a history of irregular menses (adjusted OR, TC vs MI 8.30; 95% CI 1.01 to 69.18), number of pregnancies (adjusted ß coefficient 0.69; SE 0.35, p = 0.05), and use of post-menopausal hormone replacement therapy (OR 5.79; CI 1.20 to 28.02). We did not find associations with history of infertility, breastfeeding, hysterectomy or oophorectomy, oral contraceptive use, and age at menopause. In conclusion, our findings suggest that premenopausal reproductive factors may play an important role in the onset of TC at a later age. These results need to be confirmed in future studies with larger populations.

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.

An exploration of the role of religion/spirituality in the promotion of physicians' wellbeing in Emergency Medicine.

BACKGROUND: Burnout is highly prevalent among Emergency Medicine (EM) physicians and has significant impact on quality of care and workforce retention. The objective of this study was to determine whether higher religion/spirituality (R/S) is associated with a lower prevalence of burnout among EM physicians (primary outcome). A history of malpractice lawsuits and maladaptive behaviors were the secondary outcomes. METHODS: This was a cross-sectional, survey-based study conducted among a random sample of physicians from the Massachusetts College of Emergency Physicians mailing list. Burnout was measured using a validated 2-item version of the Maslach Burnout Inventory. Maladaptive behaviors (smoking, drinking, and substance use) and medical malpractice were self-reported. R/S measures included organized religiosity, religious affiliation, private R/S practice, self-rated spirituality, religious rest, and religious commitment. Logistic regression was used to model study outcomes as a function of R/S predictors. RESULTS: Of 422 EM physicians who received the invitation to participate, 138 completed the survey (32.7%). The prevalence of burnout was 27%. No significant associations were observed between burnout and R/S indicators. Maladaptive behaviors (adjusted OR = 0.42, CI: 0.19 to 0.96; p = 0.039) and history of medical malpractice (adjusted OR = 0.32; CI: 0.11 to 0.93; p = 0.037) were less likely among physicians reporting to be more involved in organized religious activity and to observe a day of rest for religious reasons, respectively. CONCLUSION: This study provides preliminary evidence for a possible protective association of certain dimensions of R/S on maladaptive behaviors and medical malpractice among EM physicians.

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.

Feasibility of Pairing Behavioral Activation With Exercise for Women With Type 2 Diabetes and Depression: The Get It Study Pilot Randomized Controlled Trial.

Major depressive disorder is often comorbid with diabetes and associated with worse glycemic control. Exercise improves glycemic control and depression, and thus could be a parsimonious intervention for patients with comorbid diabetes and major depression. Because patients with diabetes and comorbid depression are often sedentary and lack motivation to exercise, we developed a group exercise intervention that integrates strategies from behavioral activation therapy for depression to increase motivation for and enjoyment of exercise. We conducted a 6-month pilot randomized controlled trial to test the feasibility of the behavioral activation exercise intervention (EX) for women with diabetes and depression. Of the 715 individuals who contacted us about the study, 29 participants were randomized to the EX condition or an enhanced usual care condition (EUC), which represents 4.1% of participants who initially contacted us. Inclusion criteria made recruitment challenging and limits the feasibility of recruiting women with diabetes and depression for a larger trial of the intervention. Retention was 96.5% and 86.2% at 3 and 6months. Participants reported high treatment acceptability; use of behavioral activation strategies and exercise class attendance was acceptable. No condition differences were observed for glycemic control, depressive symptoms, and physical activity, though depressive symptoms and self-reported physical activity improved over time. Compared to participants in the EUC condition, participants in the EX condition reported greater exercise enjoyment and no increase in avoidance behavior over time. Using behavioral activation strategies to increase exercise is feasible in a group exercise setting. However, whether these strategies can be delivered in a less intensive manner to a broader population of sedentary adults, for greater initiation and maintenance of physical activity, deserves further study.

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.

Decrease in Glycemic Index Associated with Improved Glycemic Control among Latinos with Type 2 Diabetes.

BACKGROUND: Glycemic index and glycemic load are used to facilitate glucose control among adults with type 2 diabetes, with a low glycemic index diet associated with improved glycemic control. OBJECTIVE: To examine long-term longitudinal associations between changes in glycemic index and glycemic load with glycemic and metabolic control among Latino adults with diabetes. DESIGN: Secondary data from intervention and comparison participants in the Latinos en Control trial (2006 to 2008) were analyzed. PARTICIPANTS/SETTING: Data on dietary intake and metabolic characteristics were from low-income, Latino adults (N=238; 87.7% Puerto Rican) with type 2 diabetes. INTERVENTION: The Latinos en Control trial was a randomized clinical trial targeting diabetes self-management among Latinos with type 2 diabetes. Participants were randomized to a group-based behavioral intervention or usual care and followed through 12 months. MAIN OUTCOME MEASURES: Outcomes included hemoglobin A1c (HbA1c) levels, fasting blood glucose, lipid profiles, anthropometrics, and blood pressure. STATISTICAL ANALYSIS: Glycemic index and load were analyzed using data from three 24-hour dietary recalls conducted at baseline, 4 months, and 12 months. Repeated measures regression models were used to examine change in glycemic index and load associated with metabolic characteristics at 12 months. Covariates included sex, age, body mass index, blood pressure, total energy intake, medication use and intensity, physical activity, intervention status (intervention vs usual care), and time. RESULTS: Increases in glycemic index from baseline to 12 months were associated with increased logarithm of HbA1c levels (ß=0.003; P=0.034) and waist circumference (ß=0.12; P=0.026) over time, but not with fasting glucose, blood lipids, or body mass index. There was modest evidence to support small, positive associations between glycemic load and HbA1c levels and waist circumference. CONCLUSIONS: Lowering glycemic index is associated with improvements in certain metabolic risk factors among Latinos with diabetes. Targeting glycemic index may be an important component of dietary strategies for diabetes self-management.

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.

Statin therapy and the risk for diabetes among adult women: do the benefits outweigh the risk?

PURPOSE OF REVIEW: The purpose of this review was to examine statin therapy and the risk for diabetes among adult women using a selective review. RECENT FINDINGS: The literature contains reports of new-onset diabetes associated with statin use. While many studies do not report sex-specific results, there is evidence indicating the risk to benefit ratio may vary by gender. However, the absolute effects are not clear because women have historically been under-represented in clinical trials. SUMMARY: A review of the literature indicates that the cardiovascular benefits of statins appear to outweigh the risk for statin-related diabetes. However, the effect may depend upon baseline diabetes risk, dose, and statin potency. Rigorous, long-term studies focused on the risks and benefits of statins in women are unavailable to sort for gender-specific differences. Until this changes, individualized attention to risk assessment, and strong prevention with lifestyle changes must prevail.

Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

OBJECTIVE: Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental. METHODS: Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet. RESULTS: At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC. CONCLUSIONS: AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00217919.

Spiritual well-being may buffer psychological distress in patients with implantable cardioverter defibrillators (ICD).

Psychological distress is common in patients with implantable cardioverter defibrillators (ICDs) and has been associated with a worse prognosis. The authors examined whether spiritual wellbeing is associated with reduced psychological distress in patients with ICDs. The Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-SWB) questionnare and the Hospital Anxiety and Depression Scale (HADS) were used to measure spiritual wellbeing and overall psychological distress. Multivariate linear regression was used to explore the relationship between these variables.The study sample included 46 ICD outpatients (32 M, 14 F; age range 43-83). An inverse association between HADS and FACIT-SWB scores was found, persisting after adjustment for demographics, anxiety/depression, medications, therapist support, and functional status (F = 0.001; ß= -0.31, CI: -0.44, -0.19). In conclusion, spiritual wellbeing was independently associated with lower psychological distress in ICD outpatients. Spiritual wellbeing could act as a protective factor against psychological distress in these high-risk patients.