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We report mild COVID-19 manifestation in high-risk patient with sufficient plasma 25-OH-Vitamin D3 level. Given the global pandemic of vitamin D deficiency, as well as its likely beneficial effects during SARS-CoV-2 infection, report highlights importance of routine 25-OH-Vitamin D3 measurement, either for clinical course prediction or deciding on supplementation.

Background: Composite outcomes, which combine multiple types of clinical events into a single outcome, are common in clinical trials. The usual analysis considers the time to first occurrence of any event in the composite. The major criticisms of such an approach are (1) this implicitly treats the outcomes as if they were of equal importance, but they often vary in terms of clinical relevance and severity, (2) study participants often experience more than one type of event, and (3) often less severe events occur before more severe ones, but the usual analysis disregards any information beyond that first event. Methods: A novel approach, referred to as the win ratio, which addresses the aforementioned criticisms of composite outcomes, is illustrated with a re-analysis of data on fatal and non-fatal cardiovascular disease time-to-event outcomes reported for the Multiple Risk Factor Intervention Trial. In this trial, 12,866 participants were randomized to a special intervention group ( n = 6428) or a usual care ( n = 6438) group. Non-fatal outcomes were ranked by risk of cardiovascular disease death up to 20 years after trial. In one approach, participants in the special intervention and usual care groups were first matched on coronary heart disease risk at baseline and time of enrollment. Each matched pair was categorized as a winner or loser depending on which one experienced a cardiovascular disease death first. If neither died of cardiovascular disease causes, they were evaluated on the most severe non-fatal outcome. This process continued for all the non-fatal outcomes. A second win ratio statistic, obtained from Cox partial likelihood, was also estimated. This statistic provides a valid estimate of the win ratio using multiple events if the marginal and conditional survivor functions of each outcome satisfy proportional hazards. Loss ratio statistics (inverse of win ratios) are compared to hazard ratios from the usual first event analysis. A larger 11-event composite was also considered. Results: For the 7-event cardiovascular disease composite, the previously reported first event analysis based on 581 events in the special intervention group and 652 events in the usual care group yielded a hazard ratio (95% confidence interval) of 0.89 (0.79–0.99), compared to 0.86 (0.77–0.97) and 0.91 (0.81–1.02) for the severity ranked estimates. Results for the 11-event composite also confirmed the findings of the first event analysis. Conclusion: The win ratio analysis was able to leverage information collected past the first experienced event and rank events by severity. The results were similar to and confirmed previously reported traditional first event analysis. The win ratio statistic is a useful adjunct to the traditional first event analysis for trials with composite outcomes.

PURPOSE OF REVIEW: The importance of composite risk factor control for reducing CVD risk in type 2 diabetes (T2DM) has gained increased attention and here we review the latest findings in the field.RECENT FINDINGS: The Steno-2 study was the first to show that early intensive risk factor control could improve risk factor status and halve the CVD risk in patients with diabetes with lasting impact. A range of observational studies have added further insight to the importance of multiple risk factor control showing an incremental association between number of risk factors controlled and reduction in CVD risk. Noteworthy, a Swedish population-based study recently showed that optimal risk factor status in patients with T2DM was associated with a CVD risk similar to the general population. Early intensive intervention to achieve optimal risk factor control reduces CVD risk and should be of principal focus in T2DM management.

The attributable fraction is the candidate tool to quantify individual shares of each risk factor on the disease burden in a population, expressing the proportion of cases ascribable to the risk factors. The original formula ignored the presence of other factors (i.e. multiple risk factors and/or confounders), and several adjusting methods for potential confounders have been proposed. However, crude and adjusted attributable fractions do not sum up to their joint attributable fraction (i.e. the number of cases attributable to all risk factors together) and their sum may exceed one. A different approach consists of partitioning the joint attributable fraction into exposure-specific shares leading to sequential and average attributable fractions. We provide an example using Italian case–control data on oral cavity cancer comparing crude, adjusted, sequential, and average attributable fractions for smoking and alcohol and provide an overview of the available software routines for their estimation. For each method, we give interpretation and discuss shortcomings. Crude and adjusted attributable fractions added up over than one, whereas sequential and average methods added up to the joint attributable fraction = 0.8112 (average attributable fractions for smoking and alcohol were 0.4894 and 0.3218, respectively). The attributable fraction is a well-known epidemiological measure that translates risk factors prevalence and disease occurrence in useful figures for a public health perspective. This work endorses their proper use and interpretation.

Zusammenfassung Untersucht wurde die deutsche Adaptation des aus Iowa stammenden suchtpraventiven, familienbasierten Strengthening Families Program 10-14 (SFP) in einer Langsschnittstudie mit 2-Jahres-Katamnese. Studienteilnehmer waren N = 292 zu t0 im Mittel zwolf Jahre alten Kinder und N = 292 Eltern. Das Studiendesign war multizentrisch, randomisiert-kontrolliert und zweiarmig (SFP vs. Minimalintervention). Wir vermuten hier gemas der „risk moderation hypothesis“, dass Kinder mit erhohter Risikoexposition R(+) unabhangig von der Interventionsform mehr profitieren als Kinder mit geringer Risikoexposition R(−), und dass R(+) speziell unter SFP mehr profitieren als unter der Minimalintervention. „Risikoexposition“ wurde vor allem gemas des Fragebogens zum Communities That Care Youth Survey bestimmt, danach waren 28 % der Kinder multipel bzw. hoch risikoexponiert. Die Elternberichte bestatigen zwar unsere Hypothesen, die Selbstberichte der Kinder fallen noch deutlicher aus: R(+) berichten insgesamt von elf...

While economists have posited that health investments increase earnings, isolating the causal effect of health is challenging due both to reverse causality and unobserved heterogeneity. We examine the labor market effects of a randomized controlled trial, the Multiple Risk Factor Intervention Trial (MRFIT), which monitored nearly 13,000 men for over six years. We find that this intervention, which provided a bundle of treatments to reduce coronary heart disease mortality, increased earnings and family income. We find few differences in estimated gains by baseline health and occupation characteristics. Reductions in serious illnesses and work-limiting disabilities likely contributed to the observed gains.

Background: Healthy lifestyles are modifiable risk factors for acute coronary syndrome (ACS) onset and recurrence. While unhealthy lifestyles tend to cluster together within the general healthy population, little is known about the prevalence and clustering of these behaviours in people with ACS before and after the first acute event. The aim of this study was to identify lifestyle profiles of patients with ACS and to explore their change after their first coronary event. Methods: Three hundred and fifty-six patients completed self-report measures of healthy habits at the beginning of cardiac rehabilitation and 6months later. By adopting a person-oriented approach, we analysed lifestyle clustering and its change over time. Differences in depression, anxiety, and negative illness perception among lifestyle profiles were assessed. Results: We identified seven profiles, ranging from more maladaptive to healthier clusters. Findings showed a strong interrelation among unhealthy habits in patients. We highlighted a moderate individual and group stability of cluster membership over time. Moreover, unhealthier lifestyle profiles were associated with higher levels of depression, anxiety, and negative illness perception. Conclusion: These results may have implications for the development and implementation of multimodal interventions addressing wider-ranging improvement in lifestyles by targeting multiple unhealthy behaviours in patients with ACS.

There is enormous potential to reduce deaths and disability from cardiovascular disease by widening the use and simplifying access to blood pressure and cholesterol-lowering preventive treatment. The main obstacles to realizing this potential are the complexity of multiple risk factor-based risk estimation, an excessively high risk cut-off for treatment and a focus on testing rather than prevention. A fresh approach to prevention is needed that replaces complex multiple risk factor-based assessments with a simple age cut-off as the means of selecting people for preventive drug treatment. This review examines the evidence for such an approach and its potential impact.

The paper focuses on the contradictory issues related to metabolic syndrome (MS), its criteria, and real-world prognostic value. Different types of obesity, which result from a variety of combinations of general and visceral obesity, are described. The authors emphasise the need for two separate definitions of MS (a wider one and a more specific one), which are characterised by different pathogenetic mechanisms and require different therapeutic approaches. The more specific MS definition could benefit from the inclusion of such criteria as fatty liver and polycystic ovary syndrome. More detailed definitions for the multiple risk factor cluster syndrome, as an alternative to the current MS definition, are proposed for further discussion.

The widely accepted cut-point for normal blood pressure (BP) in the office setting evolved over several decades, based on data derived from a variety of sources. The Actuarial Society of America was one of the first organizations to publish BP data on thousands of community residents, followed by other classic studies such as Framingham, Western Electric Company, Kaiser Permanente, and the Multiple Risk Factor Intervention Trial.1,2 In every instance, BP readings were based on measurements taken by specially trained health professionals following guidelines for proper BP measurement. As a result of these and other population studies examining the association between different BP levels and cardiovascular outcomes, the importance of systolic and diastolic hypertension was recognized and an office BP of 140/90 mm Hg became the universally established cut-point for separating normal BP from hypertension. There are robust scientific data to support the use of 140/90 mm Hg to define hypertension in clinical practice guidelines. However, the guidelines do not take into account widely recognized problems associated with the quality of manual BP measurement in routine clinical practice.3 More recent recommendations4 for diagnosing hypertension clearly acknowledge that an increase in BP attributable to the “white coat response” is frequently associated with manual BP recordings performed in community-based practice. In recognizing this limitation of manual office BP, some guidelines have gone so far as to recommend that home BP and 24-hour ambulatory BP monitoring (ABPM) may need to be performed to obtain an accurate measure of a patient’s BP status. The greater reliance on 24-hour ABPM and home BP in the diagnosis and management of hypertension is the result of numerous clinical outcome studies5,6 that show that these measurement techniques are better predictors of cardiovascular events when compared to manual BP readings, even when manual readings are taken …

Background Increased heart rate (HR) and metabolic syndrome are risk factors for cardiovascular morbidity and mortality, but their relationship has not been studied in a large, screened cohort. Methods and Results The association between HR and multiple risk factor syndrome, resembling metabolic syndrome, was examined in participants of a health evaluation program in 1997. Of the 8,432 subjects (5,223 males, 3,209 females, 18‐89 years of age), 1,502 (1,185 males, 317 females) were diagnosed with multiple risk factor syndrome and these subjects had higher HR than those without the syndrome (p

Data collected at 4 Behavioral Change Consortium sites were used to assess social desirability bias in self-reports derived from a dietary fat screener (PFat), a dietary fruit and vegetable screener (FVS), and a 1-item question on fruit and vegetable intake. Comparisons were made with mean intakes derived from up to 3 24-h recall interviews at baseline and follow-up (at 12 mo in 3 sites, 6 mo in the fourth). A social-desirability-related underestimate in fat intake on the PFat relative to the 24HR (percentage energy as fat) was evident in women [baseline b = -0.56 (P = 0.005); follow-up b = -0.62 (P < 0.001)]. There was an overestimate in FVS-derived fruit and vegetable consumption (servings/week) in men enrolled in any intervention at follow-up (b = 0.39, P = 0.05) vs. baseline (b = 0.04, P = 0.75). The 1-item fruit and vegetable question was associated with an overestimate at baseline in men according to SD score (b = 0.14, P = 0.02), especially men with less than college education (b = 0.23, P = 0.01). Women with less than college education expressed a similar bias at follow-up (b = 0.13, P = 0.02). Differences in the magnitude of bias according to gender, type of instrument used, and randomization condition are comparable to what has been seen for other instruments and have important implications for both measuring change in studies of diet and health outcomes and for developing methods to control for such biases.

PURPOSE OF REVIEW We examined the role of blood pressure-lowering compared with class-specific properties of antihypertensive drugs in cardiovascular prevention. RECENT FINDINGS We reviewed recently published trials and meta-regression analyses. SUMMARY From 150,000 to 180,000 randomized patients followed up from 3 to 5 years were required to demonstrate a 10-15% benefit 'beyond blood pressure lowering' of newer antihypertensive drugs, such as calcium channel blockers or angiotensin-converting enzyme inhibitors in the prevention of cause-specific cardiovascular complications. Assuming an absolute risk of new-onset diabetes mellitus on older drugs of approximately 10% over 5 years and a relative benefit on the newer drugs of approximately 30%, about 100 patients would have to be treated for 5 years with the newer agents to avert approximately three iatrogenic cases of diabetes. Whether or not new-onset diabetes is associated with increased risk is uncertain. In most patients, optimization of treatment at acceptable tolerance requires rotation through and combination of several drug classes. Combination of different classes of antihypertensive drugs not only enhances the blood pressure-lowering efficacy, but likely decreases the risk of metabolic adverse effects as well. True benefit beyond blood pressure lowering in hypertensive patients comes from multiple risk factor intervention.

Background During the design phase of a clinical trial, sample size estimates should take into account medical screening criteria, the ‘healthy volunteer’ effect, consequences of run-in phases, and secular trends in the event rate of interest. All of these have been shown to relate to subsequent event rates, and hence trial power to detect intervention effects. The Multiple Risk Factor Intervention Trial (MRFIT) used three successive screenings of 361 662 men to enroll 12 866; observed coronary heart disease (CHD) mortality after a mean of 6.9 years was substantially lower than projected during design. We explore factors which may have contributed to these mortality differences and whether they persisted throughout follow-up. Methods Proportional hazards models were used to compare 25-year mortality according to trial eligibility, self-exclusions, medical exclusions, and participation. Results After adjustment for baseline risk factors and age, there was higher mortality among men excluded for presence of disease [hazard ratio (HR) 1.52, 95% confidence interval (CI) 1.43–1.61, for total; HR 1.92, CI 1.75–2.11, for CHD] compared to those not excluded which persisted throughout follow-up. Volunteers had lower total (HR 0.82, CI 0.76–0.87) and CHD (HR 0.79, CI 0.70–0.88) mortality than those discontinuing participation. Men excluded with characteristics deemed likely to interfere with adherence had higher total (HR 1.19, CI 1.07–1.33) and noncardiovascular disease (CVD) (HR 1.32, CI 1.14–1.53) mortality but no higher CVD (HR 1.04, CI 0.88–1.23) or CHD (HR 0.98, CI 0.80–1.20) mortality compared to those not excluded. Differences in mortality were stronger during the first five years, but declined only slightly over 25 years. Conclusions 25-year mortality was significantly higher for non-volunteers and exclusions. Differences between observed and predicted six-year total mortality for trial participants were largely attributable to volunteers and exclusions, but there were additional differences for CHD mortality, which were likely due to downward secular trends. These results emphasize the importance of anticipating these factors during clinical trial design, even for trials of short duration.

Background Forced expiratory volume in 1 second (FEV 1 ) may be useful for identifying smokers at higher risk of lung cancer. We examined the association of FEV 1 with lung cancer mortality (LCM) among cigarette smokers in the Multiple Risk Factor Intervention Trial (MRFIT). Methods In all, 6613 MRFIT baseline smokers alive at trial end in 1982 had acceptable FEV 1 measures and complete smoking history; men were classified as during-trial long-term quitters (N = 1292), intermittent quitters (1961), and never quitters (3360). Proportional hazards models for LCM were fit with quintiles of average FEV 1 , adjusted for age, height, race, smoking history, and other risk factors. Results For long-term, intermittent, and never quitters respectively, mean baseline cigarettes/ day was 28, 32, and 35; trial-averaged FEV 1 was 3201, 3146, and 3082 ml; and average decline in FEV 1 was ‐46.0, ‐54.6, and ‐62.5 ml/year. With median posttrial mortality follow-up of 18 years, there were 363 lung cancer deaths. Ageadjusted LCM rates varied across FEV 1 quintiles from 50 (lowest quintile) to 11 (highest quintile), 58 to 11, and 76 to 20, per 10 000 person-years, for long-term quitters, intermittent quitters, and never quitters, respectively. Multivariate adjusted hazard ratios for 100 ml higher FEV 1 were 0.92 [P = 0.004], 0.95 [P = 0.003], and 0.95 [P � 0.0001] respectively. Conclusions These results demonstrate the strong predictive value of FEV 1 for lung cancer among cigarette smokers independent of smoking history; results did not differ by during-trial quit status. FEV 1 may be a biological marker for smoking dose or it may be that genetic susceptibilities to both decreased FEV 1 and lung cancer are associated.

Using cross-sectional and prospective analyses, the risk factors for macroangiopathy (MA) in nonobese Type 2 diabetic patients were evaluated. In the cross-sectional study, we determined a cutoff point for each variable at which changes in the prevalence of total MA reached statistically significant levels. In the prospective study, those who met more than four out of seven control criteria as set forth in the Multiclinical Study for Diabetic Macroangiopathy (MSDM) had less risk of MA in Type 2 diabetes initially diagnosed without MA compared with those who fulfilled less than three factors. These results suggest that multiple risk factor control is the most effective and reasonable way to lower the incidence of MA in Type 2 diabetes.

It is surprising that only about ten years after the concept of insulin resistance in diabetes mellitus was established, the role of insulin resistance in the development of atherosclerosis has been discussed and clarified. Insulin resistance predisposes the development of glucose intolerance, hyperlipidemia, and hypertension; the cluster of these abnormalities is referred to as multiple risk factor syndrome and it increases the risk of atherosclerosis. A few insulin sensitizers have recently begun to be used in the therapy for diabetic patients. However, the inhibitory effects of these insulin sensitizers against atherosclerosis have not been studied in large-scale clinical trials because these drugs were approved for clinical treatment only several years ago. Accordingly, this review presents a summary of the previous studies on the anti-atherogenic effects of insulin sensitizers by different strategies and provides information on why it is expected that insulin sensitizers will be used as anti-atherogenic drugs.

This cross sectional study was undertaken to determine whether serum leptin levels were associated with multiple risk factor (MRF) clustering syndrome. We examined the relationship between serum leptin concentrations and blood pressure (BP), serum lipids levels, calculated insulin resistance (HOMA-ratio) and adiposity among 581 Japanese adult women. The serum leptin was increased in female subjects with systolic (or =160 mmHg) and diastolicor =90 mmHg) hypertension compared with the normotensive females (mean+/-SE; 9.3+/-0.5 vs 7.7+/-0.3; 10.2+/-0.6 vs 7.1+/-0.3 ng/ml, both p0.001). Serum leptin was elevated in those with hyper-cholesterolemia (C;or =220 mg/dl) and triglyceridemia (TG;or =150 mg/dl) compared with the normolipidemia (9.4+/-0.4 vs 7.8+/-0.3; 11.7+/-0.6 vs 7.5+/-0.2 ng/ml, both p0.001). Serum leptin was also elevated in those with adiposity (BMIor =26.4 kg/m2) and insulin resistance (HOMA-ratioor =2.5) compared with the normal females (14.8+/-0.7 vs 5.2+/-0.2; 11.3+/-1.1 vs 7.1+/-0.4ng/ml, both p0.001). Even after adjusting for BMI or percent body fat mass (BFM), leptin levels remained to be elevated significantly in all these diseases. There was a positive correlation between serum leptin and systolic, diastolic BP, TC, TG, BMI, BFM, IRI and HOMA-ratio (r=0.12, p=0.005; r=0.24, p0.0001; r=0.19, p0.0001; r=0.35, p0.0001; r=0.72, p0.0001; r=0.73, p0.0001; r=0.47, p0.0001; r=0.44, p0.0001), and a negative correlation with HDL-C levels (r= -0.20, p0.0001). These correlations were also observed in leptin levels after adjusting for the BMI or BFM. Multiple regression analysis showed that BFM, HOMA-ratio and TG were significant determinants of leptin concentration before (t=12.6, p0.0001; t=3.33, p=0.001; t=3.22, p=0.001) and after adjusting for BMI or BFM. These results suggest that because serum leptin levels were elevated in components of MRF clustering syndrome, leptin may have a pathophysiological role in MRF clustering syndrome.

In a recent study of fall prevention in 301 community-living older persons (the Yale FICSIT Trial, 1990-1993), participants in the multifactorial targeted intervention (TI) group experienced significantly fewer falls than participants in the social visit (SV) control group. In the present paper, the authors explore the relation between changes in the studied risk factors and the occurrence of falling. In comparison with SV participants, TI participants showed significantly greater improvements in postural blood pressure change (p = 0.01), step length (p = 0.004), use of > or = 4 medications (p = 0.003), and unsafe tub and toilet transfers (p = 0.05), while change in balance was of borderline significance (p = 0.08). Reduction in the occurrence of falling, in turn, was at least marginally associated with improvements in balance, postural blood pressure change, step length, lower extremity strength/range of motion, and transfers. When participants were divided into tertiles based on a composite risk factor change score, a significantly higher percentage of TI participants (42%) than SV participants (22%) were in the greatest risk factor reduction tertile. Among TI participants, there was a progressively lower fall rate per person per year in the tertiles with the least, intermediate, and greatest risk reduction (0.832, 0.624, and 0.260), respectively. A similar but weaker relation between risk factor reduction and fall rate was seen in the SV group. When compared within tertiles, essentially adjusting for the amount of risk factor reduction, the fall rates among TI and SV participants in the greatest risk factor reduction tertile were identical (0.260 falls per person per year), and the rates in the least reduction tertile were similar (0.832 vs. 1.040 falls per person per year); this suggests that risk factor reduction at least partially mediated the treatment effect. These results support the feasibility of implementing and analyzing the effectiveness of a multiple risk factor reduction strategy in the aged.

Aim: Multiple risk factor syndrome is a target for the prevention of coronary artery disease (CAD). A cluster of multiple risk factors, such as hypertension, glucose intolerance, and/or dyslipidemia, is encountered in Japanese without and with excess visceral fat. The present study investigated the relationship between multiple risk factor accumulation and CAD in Japanese without and with visceral fat accumulation. Methods: The study subjects comprised 257 Japanese with suspected CAD (males/females =153/ 104), who underwent 64-row multislice computed tomography (CT) coronary angiography and visceral fat area (VFA) measurement by CT. Based on the Japanese criteria for visceral fat accumulation, they were divided into those with VFA ＜100 and ≥ 100 cm 2 . Results: In subjects with VFA ＜100 cm 2 , the age- and sex-adjusted odds ratios (ORs) for 2 and 3 risk factors were 5.33 (95% confidence intervals; 1.04-27.38, p=0.0449) and 4.07 (0.72-23.15, p=0.1138), respectively, compared with VFA ＜100 cm 2 and 0 risk factor set at 1.0 (p=0.0569 for trend). In contrast, the respective ORs for subjects with VFA ≥ 100 cm 2 were much higher [6.46 (1.25-33.44, p=0.0261) and 20.42 (3.60-115.73, p=0.0007)] (p＜0.0001 for trend). The multivariate adjusted model demonstrated a significant relative excess CAD risk of 1.08 (p=0.0484) and 5.01 (p＜0.0001) for the interactions of 2 risk factors and VFA ≥ 100 cm 2 , and 3 risk factors and VFA ≥ 100 cm 2 , whereas multiple risk factor accumulation was not related with the increase of CAD risk in subjects with VFA ＜100 cm 2 . Conclusions: Coexistence of visceral fat and risk factor accumulations is strongly associated with CAD in Japanese. J Atheroscler Thromb, 2012; 19:000-000.

Objective: To examine whether patients with type 2 diabetes enrolled in community-based clinics uniformly benefit from interventions designed to achieve multiple risk factor targets. Methods: Using data from community-based clinics in Alberta, Canada, we examined whether patients achieved targets for blood pressure (

There is insufficient evidence for the efficacy of comprehensive multiple risk factor interventions by pharmacists in the primary prevention of cardiovascular disease (CVD). Given the proven benefits of pharmacist interventions for individual risk factors, it is essential that evidence for a comprehensive approach to care be generated so that pharmacists remain key members of the health care team for individuals at risk of initial onset of CVD.To establish the feasibility of an intervention delivered by community pharmacists to reduce the risk of primary onset of CVD.A single-cohort intervention study was undertaken in 2008-2009. Twelve community pharmacists from 10 pharmacies who were trained to provide lifestyle and medicine management support to reduce CVD risk recruited 70 at-risk participants aged 50-74 years who were free from diabetes or CVD. Participants received a baseline assessment to establish CVD risk and health behaviors. An assessment report provided to patients and pharmacists was used to collaboratively establish treatment goals and, over 5 sessions, implement treatment strategies. Follow-up assessment at 6 months measured changes in baseline parameters. The primary outcome was the average change to overall 5-year risk of CVD onset.Sixty-seven participants were included in the analysis. The mean participant age was 60 years and 73% were female. We observed a 25% (95% CI 17 to 33) proportional risk reduction in overall CVD risk. Significant reductions also occurred in mean blood pressure (-11/-5 mm Hg) and waist circumference (-1.3 cm), with trends toward improvement for most other observed risk factors.Findings support previous evidence of positive cardiovascular health outcomes following pharmacist intervention in other patient groups; we recommend generating randomized controlled trial evidence for a primary prevention population.

Culturally appropriate interventions are needed to assist Latinas in making multiple healthful lifestyle changes.The purpose of this study was to test a cultural adaptation of a successful multiple health behavior change program, ¡Viva Bien!Random assignment of 280 Latinas with type 2 diabetes to usual care only or to usual care + ¡Viva Bien!, which included group meetings for building skills to promote the Mediterranean diet, physical activity, stress management, supportive resources, and smoking cessation.¡Viva Bien! participants compared to usual care significantly improved psychosocial and behavioral outcomes (fat intake, stress management practice, physical activity, and social-environmental support) at 6 months, and some improvements were maintained at 12 months. Biological improvements included hemoglobin A1c and heart disease risk factors.The ¡Viva Bien! multiple lifestyle behavior program was effective in improving psychosocial, behavioral, and biological/quality of life outcomes related to heart health for Latinas with type 2 diabetes.

BACKGROUND: Multiple risk factor interventions using counselling and educational methods assumed to be efficacious and cost-effective in reducing coronary heart disease (CHD) mortality and morbidity and that they should be expanded. Trials examining risk factor changes have cast doubt on the effectiveness of these interventions. OBJECTIVES: To assess the effects of multiple risk factor interventions for reducing total mortality, fatal and non-fatal events from CHD and cardiovascular risk factors among adults assumed to be without prior clinical evidence CHD.. SEARCH STRATEGY: We updated the original search BY SEARCHING CENTRAL (2006, Issue 2), MEDLINE (2000 to June 2006) and EMBASE (1998 to June 2006), and checking bibliographies. SELECTION CRITERIA: Randomised controlled trials of more than six months duration using counselling or education to modify more than one cardiovascular risk factor in adults from general populations, occupational groups or specific risk factors (i.e. diabetes, hypertension, hyperlipidaemia, obesity). DATA COLLECTION AND ANALYSIS: Two authors extracted data independently. We expressed categorical variables as odds ratios (OR) with 95% confidence intervals (CI). Where studies published subsequent follow-up data on mortality and event rates, we updated these data. MAIN RESULTS: We found 55 trials (163,471 participants) with a median duration of 12 month follow up. Fourteen trials (139,256 participants) with reported clinical event endpoints, the pooled ORs for total and CHD mortality were 1.00 (95% CI 0.96 to 1.05) and 0.99 (95% CI 0.92 to 1.07), respectively. Total mortality and combined fatal and non-fatal cardiovascular events showed benefits from intervention when confined to trials involving people with hypertension (16 trials) and diabetes (5 trials): OR 0.78 (95% CI 0.68 to 0.89) and OR 0.71 (95% CI 0.61 to 0.83), respectively. Net changes (weighted mean differences) in systolic and diastolic blood pressure (53 trials) and blood cholesterol (50 trials) were -2.71 mmHg (95% CI -3.49 to -1.93), -2.13 mmHg (95% CI -2.67 to -1.58 ) and -0.24 mmol/l (95% CI -0.32 to -0.16), respectively. The OR for reduction in smoking prevalence (20 trials) was 0.87 (95% CI 0.75 to 1.00). Marked heterogeneity (I(2) > 85%) for all risk factor analyses was not explained by co-morbidities, allocation concealment, use of antihypertensive or cholesterol-lowering drugs, or by age of trial. AUTHORS' CONCLUSIONS: Interventions using counselling and education aimed at behaviour change do not reduce total or CHD mortality or clinical events in general populations but may be effective in reducing mortality in high-risk hypertensive and diabetic populations. Risk factor declines were modest but owing to marked unexplained heterogeneity between trials, the pooled estimates are of dubious validity. Evidence suggests that health promotion interventions have limited use in general populations.

Objectives To describe recruitment of Latinas in a randomized clinical trial conducted within 2 health care organizations. Methods The study relied on project-initiated telephone calls as part of a multifaceted recruitment approach. Chi-square and t tests were conducted to compare participants and nonparticipants on a number of variables. Results From 4045 telephone contacts, 280 Latinas agreed to participate. Most were ineligible due to non-Latino ethnicity (89%). Of eligible candidates, 61% took part. Few significant differences were found on participant vs nonparticipant characteristics. Conclusions Using appropriate recruitment procedures, a representative sample of Latinas can be obtained.

The CRUCIAL trial was designed to compare the relative reduction in calculated Framingham coronary heart disease risk when a multiple risk factor intervention strategy, based on single-pill amlodipine besylate/atorvastatin calcium, was compared with a usual-care strategy. Eligible patients had treated or untreated hypertension, >or=3 additional cardiovascular risk factors, and baseline total cholesterol

Cigarette smoking cessation was examined for its impact on diastolic blood pressure, weight, and plasma lipids in 3,470 special intervention males in the Multiple Risk Factor Intervention Trial. Change in smoking status (quitters vs nonquitters) was not independently associated with change in diastolic blood pressure or the subsequent use of antihypertensive medication for smokers who were normotensive at entry. More quitters (35%) became hypertensive than nonquitters (27%, P P

The 356 222 men aged 35 to 57 years, who were free of a history of hospitalization for myocardial infarction, screened by the Multiple Risk Factor Intervention Trial (MRFIT) in its recruitment effort, constitute the largest cohort with standardized serum cholesterol measurements and long-term mortality follow-up. For each five-year age group, the relationship between serum cholesterol and coronary heart disease (CHD) death rate was continuous, graded, and strong. For the entire group aged 35 to 57 years at entry, the age-adjusted risks of CHD death in cholesterol quintiles 2 through 5 (182 to 202, 203 to 220, 221 to 244, and ≥245 mg/dL [4.71 to 5.22, 5.25 to 5.69, 5.72 to 6.31, and ≥6.34 mmol/L]) relative to the lowest quintile were 1.29, 1.73, 2.21, and 3.42. Of all CHD deaths, 46% were estimated to be excess deaths attributable to serum cholesterol levels 180 mg/dL or greater (≥4.65 mmol/L), with almost half the excess deaths in serum cholesterol quintiles 2 through 4. The pattern of a continuous, graded, strong relationship between serum cholesterol and six-year age-adjusted CHD death rate prevailed for nonhypertensive nonsmokers, nonhypertensive smokers, hypertensive nonsmokers, and hypertensive smokers. These data of high precision show that the relationship between serum cholesterol and CHD is not a threshold one, with increased risk confined to the two highest quintiles, but rather is a continuously graded one that powerfully affects risk for the great majority of middle-aged American men.See PDF for full text of the original JAMA article.

The Multiple Risk Factor Intervention Trial (MRFIT) was a randomized controlled trial on primary prevention of coronary heart disease (CHD) death in men with elevated blood pressure (BP), serum cholesterol, and/or smoking habit. In all, 361,662 men were screened in 18 U.S. cities; 12,866 men were randomized to multifactor Special Intervention (SI) or Usual Care (UC). With a 7 year average follow-up, the CHD death rate was 7.1% lower for SI than UC [relative difference in proportion dead; 90% CI (−15%, 25%)]. UC men made more extensive risk factor reductions than anticipated in trial design, and the number of UC deaths was substantially smaller than expected. This result led to an underpowered comparison. Post-hoc assessments showed significantly lower rates of combined morbidity/mortality outcomes for SI than UC. Other findings from MRFIT substantially changed the treatment of hypertension, and long-term epidemiologic follow-up of all 361,662 screenees yielded important findings of great impact on major public health and medical care issues. Keywords: coronary heart disease; hypercholesterolemia; hypertension; randomized trial; smoking cessation

The metabolic syndrome is highly prevalent worldwide, and its cardiovascular toll is expected to rise with the growing obesity epidemic. Mounting evidence points to an association between metabolic syndrome and first or recurrent stroke. This article discusses the emerging data supporting a link between stroke and the metabolic syndrome and underscores the need to better understand the syndrome's pathophysiology, with a goal to appropriately and intensively limit the burden of this multiple risk factor entity.

There is emerging evidence that suggests that multiple risk factor interventions may be effective strategies for improving overall cancer risk in U.S. adults. Further research is needed to determine the optimal intervention approaches, the cost-effectiveness of multiple risk factor interventions, and the long-term impact of multiple risk factor change on cancer morbidity and mortality.

Three decades ago, the primary results of the Multiple Risk Factor Intervention Trial (MRFIT) were published in JAMA; that trial attempted to demonstrate benefits from lowering cholesterol (with diet) and managing other known risk factors for reducing cardiovascular morbidity and mortality.1 Since then, multiple trials have shown cardiovascular benefit from lowering cholesterol, especially low-density lipoprotein cholesterol (LDLC).2,3 However, as of 1993, no trial had demonstrated a clear reduction in total mortality and, thus, debate still raged as to whether it was beneficial to reduce cholesterol.3

Sex offender recidivism risk is a multifaceted phenomenon requiring consideration across multiple risk factor domains. The impact of treatment involvement and subsequent recidivism is given limited attention in comparison to other forensic mental health issues. The present analysis is a retrospective study of sex offenders treated at a secure facility utilizing a cognitive-behavioral program matched with an untreated correctional sample. Variables studied included demographic, criminal history, offense related, and treatment progress. Recidivism was assessed through arrest data. Multivariate analysis suggests that recidivism is significantly related to quality of treatment involvement, offender demographics, offense characteristics, and criminal history. Successfully treated offenders were significantly less likely to subsequently reoffend. Recidivists were also significantly younger, less likely married, had engaged in more victim grooming or less violent offending behavior, and had significantly more prior property charges. The authors discuss the clinical and policy implications of the interrelationship between treatment involvement and recidivism.

Since the pioneering publications of the Hypertension Detection and Follow-up Program (HDFP) and the Multiple Risk Factor Intervention Trial (MRFIT) in the late 1970s and early 1980s, it has become established that lowering blood pressure in high-risk patients is a highly effective form of primary prevention for stroke. Over the subsequent 25 years, over 30 large clinical trials have extended these initial observations to allow us to conclude that treatment of mild, moderate or severe hypertension, and isolated systolic hypertension in the elderly, all produce important absolute benefits. In addition, excellent specific evidence of benefit is now accumulating for certain groups of normotensive patients, including those with previous stroke, and those with established cardiovascular disease. Although the importance of vigorous antihypertensive therapy for the primary and secondary prevention of stroke is increasingly clear, a large number of unanswered questions remain. For example, while it is apparent that diuretics, β-blockers, calcium channel blockers (CCBs) and angiotensin-converting enzyme (ACE) inhibitors are all effective antihypertensive agents, the question remains as to which drug, or combination of drugs, is best for which patients. The results of several ongoing comparative trials of different drug regimens, including the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), may elucidate this further.

In a previously published randomized 6-year study we observed that multiple risk factor intervention reduced cardiovascular risk in high-risk hypertensive men, and that this effect was confined to patients with carotid artery plaques. Hypothetically, the underlying mechanism might have been a stabilization of echolucent, instable, rupture-prone plaques. The aim of the present study was to examine plaque characteristics by B-mode ultrasound in the previous intervention study, and also to investigate the relationship between plaque characteristics at baseline and cardiovascular events during the 6-year follow-up in the two randomization groups.High resolution B-mode ultrasound was used to characterize plaque echogenicity in four subgroups - dominantly echolucent, substantially echolucent, dominantly echogenic, and uniformly echogenic.In the usual care group 17 of 32 (53%) patients with echolucent plaques at baseline suffered from a combined end-point (any death or nonfatal myocardial infarction or nonfatal stroke) during follow-up compared with seven of 28 (25%) patients in the intervention group (P = 0.036). The corresponding numbers in patients with echogenic plaques were n = 4/13 (31%) and n = 4/17 (24%), respectively (NS). In the usual care group 11 of 33 (33%) patients with no plaques suffered from a combined end-point during follow-up compared with 11 of 30 (37%) in the intervention group.Our data indicate that the beneficial effect of the multiple risk intervention programme was confined to those patients with echolucent plaques. The data have to be confirmed with a large-scale trial.

Chlorthalidone (CTD) reduces 24-hour blood pressure more effectively than hydrochlorothiazide (HCTZ), but whether this influences electrocardiographic left ventricular hypertrophy (LVH) is uncertain. One source of comparative data is the Multiple Risk Factor Intervention Trial (MRFIT), which randomly assigned 8,012 hypertensive men to special intervention (SI) or usual care (UC). SI participants could use CTD or HCTZ initially; previous analyses have grouped clinics by their main diuretic used (C-clinics: CTD; H-clinics: HCTZ). After 48 months, SI participants receiving HCTZ were recommended to switch to CTD, in part, because higher mortality was observed for SI compared to UC participants in H-clinics, while the opposite was found in C-clinics. In this analysis, we examined change in continuous measures of electrocardiographic LVH using both an ecologic analysis by previously-reported C- or H-clinic groupings, and an individual participant analysis where use of CTD or HCTZ by SI participants was considered and updated annually. Through 48 months, differences between SI and UC in LVH were larger for C-clinics compared to H-clinics (Sokolow-Lyon: −93.9 vs −54.9 μV, P=0.049; Cornell voltage: −68.1 vs −35.9 μV, P=0.019; Cornell voltage product: −4.6 vs −2.2 μV/ms, P=0.071; left ventricular mass: −4.4 vs −2.8 gm, P=0.002). At the individual participant level, Sokolow-Lyon and left ventricular mass were significantly lower for SI men receiving CTD compared to HCTZ through 48 months and 84 months of follow-up. Our findings on LVH support the idea that greater blood pressure reduction with CTD than HCTZ may have led to differences in mortality observed in MRFIT.