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Introduction: The ACCESS trial showed that those who received a copayment elimination benefit had a modest improvement in their adherence to medications, but no improvement in clinical outcomes. This is consistent with other studies that have demonstrated that time-limited copayment elimination was welcomed by participants. However, the removal of such benefits can be problematic, as participants may have become accustomed to receiving the benefit, and made changes to their spending that would need to be reconsidered. We aimed to explore participants' experience with resuming cost sharing for their medications at the end of the ACCESS trial and if this experience influenced their willingness to participate in future trials like ACCESS. Methods: We conducted semi-structured interviews with 21 former participants of the ACCESS trial who were receiving the copayment elimination intervention, with discussions focused on the loss of the copayment elimination. The interviews were recorded, transcribed, and analyzed in duplicate using thematic analysis. Results: Four primary themes emerged from the analysis, including emotionality regarding loss of benefits; notification of benefit termination, describing tangible losses from coverage ending, but resistance to acknowledging negative impacts; and acceptability of receiving a temporary financial benefit. Many participants described negative emotions around the loss of coverage and concern about affording care for their chronic diseases. Despite negative emotions about the end of their study benefit, participants generally had a positive view of the study and would participate again in a future study of this nature. Conclusion: The positive tangible and emotional benefits of the copayment elimination over 3 years outweighed the negative emotions and impacts associated with having to become reaccustomed to life without it. Patient and public contribution: Within the ACCESS trial, participants were involved in the design, modification, and implementation of the program using multiple focus groups. The current study aimed to engage patients to provide input on their experience and engagement with the copayment elimination program. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease is a major cause of mortality and morbidity worldwide, and primary prevention efforts are poorly developed in people at high cardiovascular risk. On this background, we performed the Hjerteløftet Study and demonstrated that participation over 36 months in a multimodal primary prevention programme, significantly reduced validated cardiovascular risk scores. In the current substudy we aimed to further explore several elements and effects following the intervention programme. Methods: A random sample from the original Hjerteløftet Study was included for further examinations (n = 255, 40% women), and these patients were already randomized to an intervention group (IG) (n = 127), or a control group (CG) (n = 128). We compared changes from baseline to 36-months follow-up in physical activity, cardiorespiratory fitness, psychological well-being (WHO-5), cardiovascular medication use, smoking habits, and cardiometabolic risk factors (blood pressure, lipids, blood glucose, HbA1c, Apolipoprotein A-I, Apolipoprotein B and high-sensitive C-reactive protein). Results: Self-reported physical activity increased significantly with absolute difference in mean delta Physical Activity Index score in the IG compared to the CG: 0.90, 95% CI: 0.10 to 1.70, p = 0.028 (ANCOVA). There were no corresponding differences in cardiorespiratory fitness. The participation resulted in psychological well-being improvement in both groups with a larger increase in the IG compared to the CG. The mean difference in delta WHO-5 score was 5.06, 95% CI: 0.68 to 9.45, p = 0.024, and 3.28, 95% CI: -0.69 to 5.25, p = 0.104 when controlled for baseline values (ANCOVA). The use of antihypertensive medication increased significantly more in the CG (p = 0.044). Only minor, nonsignificant changes were observed for traditional risk factors and cardiometabolic variables. Conclusions: Participation in the Hjerteløftet Study intervention programme resulted in an improved physical activity level, but without changing cardiorespiratory fitness. Participation in the programme also tended to improve psychological well-being, possibly related to increased physical activity, less smoking and less use of cardiovascular medication. Concerning the metabolic status, no major differences were observed, but minor changes may have been concealed by a larger increase in cardiovascular medication use in the control group. Trial registration: ClinicalTrials.gov (NCT01741428), 04/12/2012. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes (T2D) is expected to worsen the prognosis of inpatients with heart failure (HF) but the evidence from observational studies is inconsistent. We aimed to compare mortality outcomes and life expectancy among inpatients with HF with or without T2D and explored whether chronic kidney disease (CKD) influenced these associations. Methods: We collected hospital and civil registry records of consecutive inpatients from a tertiary hospital in Switzerland with a diagnosis of HF from the year 2015 to 2019. We evaluated the association of T2D with mortality risk using Cox regression and adjusted for confounders. Results: Our final cohort consisted of 10,532 patients with HF of whom 27% had T2D. The median age (interquartile range [IQR]) was 75 [68 to 82] and 78 [68 to 86] for the diabetes and non-diabetes groups, respectively. Over a median follow-up [IQR] of 4.5 years [3.3 to 5.6], 5,347 (51%) of patients died. T2D patients had higher risk of all-cause mortality (hazard ratio [HR] 1.21, 95% confidence interval [CI] 1.14 to 1.29). Compared to control (i.e. no T2D nor CKD), average life expectancy (95% CI) among T2D patients, CKD, or both was shorter by 5.4 months (95% CI 1.1 to 9.7), 9.0 months (95% CI 8.4 to 9.6), or 14.8 months (95% CI 12.4 to 17.2), respectively. No difference by sex or ejection fraction category was observed. Conclusions: T2D is associated with a significantly higher risk of all-cause mortality and shorter life expectancy compared to those without among middle-aged and elderly inpatients with HF; presence of CKD may further increase these risks. [ABSTRACT FROM AUTHOR]

Background: Healthy lifestyle habits are recommended in prevention of cardiovascular disease (CVD). However, there is limited knowledge concerning the change in lifestyle-related factors from before to after a CVD event. Thus, this study aimed to explore if and how lifestyle habits and other lifestyle-related factors changed between two health assessments in individuals experiencing a CVD event between the assessments, and if changes varied between subgroups of sex, age, educational level, duration from CVD event to second assessment and type of CVD event. Methods: Among 115,504 Swedish employees with data from two assessments of occupational health screenings between 1992 and 2020, a total of 637 individuals (74% men, mean age 47 ± SD 9 years) were identified having had a CVD event (ischemic heart disease, cardiac arrythmia or stroke) between the assessments. Cases were matched with controls without an event between assessments from the same database (ratio 1:3, matching with replacement) by sex, age, and time between assessment (n = 1911 controls). Lifestyle habits included smoking, active commuting, exercise, diet, alcohol intake, and were self-rated. Lifestyle-related factors included overall stress, overall health (both self-rated), physical capacity (estimated by submaximal cycling), body mass index and resting blood pressure. Differences in lifestyle habits and lifestyle-related factors between cases and controls, and changes over time, were analysed with parametric and non-parametric tests. Multiple logistic regression, OR (95% CI) was used to analyse differences in change between subgroups. Results: Cases had, in general, a higher prevalence of unhealthy lifestyle habits as well as negative life-style related factors prior to the event compared to controls. Nevertheless, cases improved their lifestyle habits and lifestyle factors to a higher degree than controls, especially their amount of active commuting (p = 0.025), exercise (p = 0.009) and non-smoking (p < 0.001). However, BMI and overall health deteriorated to a greater extent (p < 0.001) among cases, while physical capacity (p < 0.001) decreased in both groups. Conclusion: The results indicate that a CVD event may increase motivation to improve lifestyle habits. Nonetheless, the prevalence of unhealthy lifestyle habits was still high, emphasizing the need to improve implementation of primary and secondary CVD prevention. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular diseases are often accompanied by comorbidities, which require good coordination of care. Especially in fragmented healthcare systems, it is important to apply strategies such as case management to achieve high continuity of care. The aim of this study was to document continuity of care from the patients' perspective in ambulatory cardiovascular care in Germany and to explore the associations with patient-reported experience of cardiovascular prevention. Methods: This cross-sectional observational study was performed in primary care practices in Germany. The study included patients with three recorded chronic diseases, including coronary heart disease. Continuity of care was measured with the Nijmegen Continuity Questionnaire, which addresses personal/relational and team/cross-boundary continuity. From aspects of medical care and health-related lifestyle counselling a patient-reported experience of cardiovascular prevention index was formed with a range of 0–7. The association between continuity of care within the family practice and patient-reported experience of cardiovascular prevention was examined, using a linear multilevel regression model that adjusted for sociodemographics, structured care programme and numbers of contacts with the family practice. Results: Four hundred thirty-five patients from 26 family practices participated. In a comparison between general practitioners (GPs) and cardiologists, higher values for relational continuity of care were given for GPs. Team/cross-boundary continuity for 'within the family practice' had a mean of 4.0 (standard deviation 0.7) and continuity between GPs and cardiologists a mean of 3.8 (standard deviation 0.7). Higher personal continuity of care for GPs was positively associated with patient-reported experience (b = 0.75, 95% CI 0.45–1.05, P < 0.001). Conclusions: Overall, there was high patient-reported continuity, which positively influenced the experience of cardiovascular prevention. Nevertheless, there is potential for improvement of personal continuity of the cardiologists and team/cross-boundary continuity between GPs and cardiologists. Structured care programs may be able to support this. Trial registration: We registered the study prospectively on 7 November 2019 at the German Clinical Trials Register (DRKS) under ID no. DRKS00019219. [ABSTRACT FROM AUTHOR]

Background: Coronary artery disease (CAD) detection in asymptomatic patients still remains controversial. The aim of our study was to evaluate the usefulness of ophthalmologic findings as predictors of the presence of CAD when added to cardiovascular classic risk factors (CRF) in patients with acute coronary cardiopathy suspicion. Methods: After clinical stabilization, 96 patients with acute coronary cardiopathy suspicion were selected and divided in two groups: 69 patients with coronary lesions and 27 patients without coronary lesions. Their 192 eyes were subjected to a complete routine ophthalmologic examination. Samples of tear fluid were also collected to be used in the detection of cytokines and inflammatory mediators. Logistic regression models, receiver operating characteristic curves and their area under the curve (AUC) were analysed. Results: Suggestive predictors were choroidal thickness (CT) (OR: 1.02, 95% CI 1.01–1.03) and tear granulocyte colony-stimulating factor (G-CSF) (OR: 0.97, 95% CI 0.95–0.99). We obtained an AUC of 0.9646 (95% CI 0.928–0.999) when CT and tear G-CSF were added as independent variables to the logistic regression model with cardiovascular CRF: sex, age, diabetes, high blood pressure, hypercholesterolemia, smoking habit and obesity. This AUC was significantly higher (p = 0.003) than the prediction derived from the same logistic regression model without CT and tear G-CSF (AUC = 0.828, 95% CI 0.729–0.927). Conclusions: CT and tear G-CSF improved the predictive model for CAD when added to cardiovascular CRF in our sample of symptomatic patients. Subsequent studies are needed for validation of these findings in asymptomatic patients. [ABSTRACT FROM AUTHOR]

Background: Medication adherence is a recognized key factor of secondary cardiovascular disease prevention. Cardiac rehabilitation increases medication adherence and adherence to lifestyle changes. This study aimed to evaluate the impact of in-hospital cardiac rehabilitation (IH-CR) on medication adherence as well as other cardiovascular outcomes, following an acute myocardial infarction (AMI).Methods: This is a population-based study. Data were obtained from the Health Information Systems of the Lazio Region, Italy (5 million inhabitants). Hospitalized patients aged ≥ 18 years with an incident AMI in 2013-2015 were investigated. We divided the whole cohort into 4 groups of patients: ST-elevation AMI (STEMI) and non-ST-elevation AMI (NSTEMI) who underwent or not percutaneous coronary intervention (PCI) during the hospitalization. Primary outcome was medication adherence. Adherence to chronic poly-therapy, based on prescription claims for both 6- and 12-month follow-up, was defined as Medication Possession Ratio (MPR) ≥ 75% to at least 3 of the following medications: antiplatelets, β-blockers, ACEI/ARBs, statins. Secondary outcomes were all-cause mortality, hospital readmission for cardiovascular and cerebrovascular event (MACCE), and admission to the emergency department (ED) occurring within a 3-year follow-up period.Results: A total of 13.540 patients were enrolled. The median age was 67 years, 4.552 (34%) patients were female. Among the entire cohort, 1.101 (8%) patients attended IH-CR at 33 regional sites. Relevant differences were observed among the 4 groups previously identified (from 3 to 17%). A strong association between the IH-CR participation and medication adherence was observed among AMI patients who did not undergo PCI, for both 6- and 12-month follow-up. Moreover, NSTEMI-NO-PCI participants had lower risk of all-cause mortality (adjusted IRR 0.76; 95% CI 0.60-0.95), hospital readmission due to MACCE (IRR 0.78; 95% CI 0.65-0.94) and admission to the ED (IRR 0.80; 95% CI 0.70-0.91).Conclusions: Our findings highlight the benefits of IH-CR and support clinical guidelines that consider CR an integral part in the treatment of coronary artery disease. However, IH-CR participation was extremely low, suggesting the need to identify and correct the barriers to CR participation for this higher-risk group of patients. [ABSTRACT FROM AUTHOR]

Background: This cross-sectional study aimed to identify actionable factors to improve LDL-cholesterol target achievement and overcome underuse of lipid-lowering treatments in high- or very-high-cardiovascular risk patients. Methods: We evaluated healthcare records of 934,332 subjects from North-Italy, including subjects with available lipid profile and being on statin treatments up to December 2018. A 6-month-period defined adherence with proportion-of-days-covered ≥ 80%. Treatment was classified as high-intensity-statin (HIS) + ezetimibe, HIS-alone, non-HIS (NHIS) + ezetimibe or NHIS alone. Results: We included 27,374 subjects without and 10,459 with diabetes. Among these, 30% and 36% were on secondary prevention, respectively. Adherence was high (78–100%) and increased with treatment intensity and in secondary prevention. Treatment intensity increased in secondary prevention, but only 42% were on HIS. 2019-guidelines LDL-cholesterol targets were achieved in few patients and more often among those with diabetes (7.4% vs. 10.7%, p < 0.001). Patients in secondary prevention had mean LDL-cholesterol levels aligned slightly above 70 mg/dl (range between 68 and 73 mg/dl and between 73 and 85 mg/dl in patients with and without diabetes, respectively). Moreover, the differences in mean LDL-cholesterol levels observed across patients using treatments with well-stablished different LDL-lowering effect were null or much smaller than expected (HIS vs. NHIS from − 3 to − 11%, p < 0.001, HIS + ezetimibe vs. HIS—from − 4 to + 5% n.s.). These findings, given the observational design of the study, might suggest that a "treat to absolute LDL-cholesterol levels" approach (e.g., targeting LDLc of 70 mg/dl) was mainly used by physicians rather than an approach to also achieve the recommended 50% reduction in LDL-cholesterol levels. Our analyses suggested that female sex, younger age, higher HDL-c, and elevated triglycerides are those factors delaying prescription of statin treatments, both in patients with and without diabetes and in those on secondary prevention. Conclusions: Among patients on statin treatment and high adherence, only a small proportion of patients achieved LDL-cholesterol targets. Late initiation of high-intensity treatments, particularly among those with misperceived low-risk (e.g., female subjects or those with high HDL-cholesterol), appears as pivotal factors needing to be modified to improve CVD prevention. [ABSTRACT FROM AUTHOR]

Since 1985, the thiazolidinedione pioglitazone has been widely used as an insulin sensitizer drug for type 2 diabetes mellitus (T2DM). Although fluid retention was early recognized as a safety concern, data from clinical trials have not provided conclusive evidence for a benefit or a harm on cardiac function, leaving the question unanswered. We reviewed the available evidence encompassing both in vitro and in vivo studies in tissues, isolated organs, animals and humans, including the evidence generated by major clinical trials. Despite the increased risk of hospitalization for heart failure due to fluid retention, pioglitazone is consistently associated with reduced risk of myocardial infarction and ischemic stroke both in primary and secondary prevention, without any proven direct harm on the myocardium. Moreover, it reduces atherosclerosis progression, in-stent restenosis after coronary stent implantation, progression rate from persistent to permanent atrial fibrillation, and reablation rate in diabetic patients with paroxysmal atrial fibrillation after catheter ablation. In fact, human and animal studies consistently report direct beneficial effects on cardiomyocytes electrophysiology, energetic metabolism, ischemia–reperfusion injury, cardiac remodeling, neurohormonal activation, pulmonary circulation and biventricular systo-diastolic functions. The mechanisms involved may rely either on anti-remodeling properties (endothelium protective, inflammation-modulating, anti-proliferative and anti-fibrotic properties) and/or on metabolic (adipose tissue metabolism, increased HDL cholesterol) and neurohormonal (renin–angiotensin–aldosterone system, sympathetic nervous system, and adiponectin) modulation of the cardiovascular system. With appropriate prescription and titration, pioglitazone remains a useful tool in the arsenal of the clinical diabetologist. [ABSTRACT FROM AUTHOR]

Background: Patients with high cardiovascular risk are usually cared for in primary care settings. Assessment of the effectiveness of long-time care was a subject of many European studies in the last two decades. This paper aims to present two Hungarian primary care cross sectional surveys and to compare their results to the primary care arms of the European Action on Secondary and Primary Prevention by Intervention to Reduce Events (EUROASPIRE) III. and IV. studies. Methods: Between 2010 and 2011, 679 patients with high cardiovascular risk were recruited in 20 Hungarian primary care practices and 628 patients were selected in 40 practices between 2015 and 2016. The actual national recommendations were used for classification, all based on European guidelines. Achievements of target levels for blood pressure, total-, LDL-and HDL-cholesterols, triglyceride, and HbA1c (in diabetics) were recorded and analyzed. Further cardiovascular risk factors, such as smoking, BMI, waist-circumference were also evaluated. Results: There was a statistically significant improvement in the management of blood-pressure and plasma LDL-cholesterol levels among high risk patients, while there was no change in the plasma triglyceride values. The effectiveness of diabetes care deteriorated. In international relation, the management of blood pressure and plasma LDL-cholesterol values were better in Hungary when compared to the results of EUROASPIRE III-IV. studies, while the previous advantage in diabetes care disappeared. A higher proportion of diabetic patients was above the target values in Hungary than the means of the European surveys. There was a higher proportion of smokers in the Hungarian samples, while the proportion of obese and overweight patients was similar to the European sample. Conclusions: Primary care has a unique role in cardiovascular prevention. Although many of the patients are managed appropriately, there is a need to improve primary care services in Hungary, giving more competences to GPs in prescription and introducing structural changes in the healthcare system. [ABSTRACT FROM AUTHOR]

Background: Since the first position statement on diabetes and cardiovascular prevention published in 2014 by the Brazilian Diabetes Society, the current view on primary and secondary prevention in diabetes has evolved as a result of new approaches on cardiovascular risk stratification, new cholesterol lowering drugs, and new anti-hyperglycemic drugs. Importantly, a pattern of risk heterogeneity has emerged, showing that not all diabetic patients are at high or very high risk. In fact, most younger patients who have no overt cardiovascular risk factors may be more adequately classified as being at intermediate or even low cardiovascular risk. Thus, there is a need for cardiovascular risk stratification in patients with diabetes. The present panel reviews the best current evidence and proposes a practical riskbased approach on treatment for patients with diabetes. Main body: The Brazilian Diabetes Society, the Brazilian Society of Cardiology, and the Brazilian Endocrinology and Metabolism Society gathered to form an expert panel including 28 cardiologists and endocrinologists to review the best available evidence and to draft up-to-date an evidence-based guideline with practical recommendations for risk stratification and prevention of cardiovascular disease in diabetes. The guideline includes 59 recommendations covering: (1) the impact of new anti-hyperglycemic drugs and new lipid lowering drugs on cardiovascular risk; (2) a guide to statin use, including new definitions of LDL-cholesterol and in non-HDL-cholesterol targets; (3) evaluation of silent myocardial ischemia and subclinical atherosclerosis in patients with diabetes; (4) hypertension treatment; and (5) the use of antiplatelet therapy. Conclusions: Diabetes is a heterogeneous disease. Although cardiovascular risk is increased in most patients, those without risk factors or evidence of sub-clinical atherosclerosis are at a lower risk. Optimal management must rely on an approach that will cover both cardiovascular disease prevention in individuals in the highest risk as well as protection from overtreatment in those at lower risk. Thus, cardiovascular prevention strategies should be individualized according to cardiovascular risk while intensification of treatment should focus on those at higher risk. [ABSTRACT FROM AUTHOR]

Background: The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease.Design: Population-based randomized clinically controlled screening trial.Methods: Participants: 45,000 Danish men aged 65-74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used.Interventions: One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings.Objective: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective.Outcome: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome).Randomization: Each of the 45,000 individuals is, by EPIDATA, given a random number from 1-100. Those numbered 67+ will be offered screening; the others will act as a control group.Blinding: Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014.Outcome: A 5% reduction in overall mortality (HR=0.95), with the risk for a type 1 error=5% and the risk for a type II error=80%, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70%.Discussion: The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65-74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance.Trial Registration: Current Controlled Trials: ISRCTN12157806 (21 March 2015). [ABSTRACT FROM AUTHOR]

Background: Metabolic syndrome (MetS) comprises a spectrum of clinical phenotypes in which dyslipidemia, dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease. This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS. Methods: In a double blind placebo controlled randomized trial, 50 persons with MetS, as defined by the ATPIII criteria, received the study product or placebo for 8 weeks. The study product contained 10.82 mg of monacolins and 9,32 mg of hydroxytyrosol per capsule, and is commercialized as Cholesfytol plus. The primary outcome measure was the difference in LDL reduction between intervention and control groups. Furthermore, differences in changes of CH, HDL, ApoA1, ApoB, HbA1c and oxLDL were measured, as well as side-effects, CK elevation, changes in clinical parameters and in cardiovascular risk. Results: In the intervention group, LDL cholesterol was lowered by 24% whereas it increased by 1% in the control group (p < 0.001). Other effects observed were a change in total cholesterol (−17% in the intervention group vs +2% in the control group, p < 0.001), apolipoprotein B (−15% vs +6%, p < 0.001), and TG (−9% vs + 16%, p = 0.02). Oxidized LDL decreased by 20% vs an increase of 5% in the control group (p < 0.001). Systolic and diastolic arterial blood pressure decreased significantly by 10 mmHg (vs 0% in the control group, p = 0.001) and 7 mmHg (vs 0% in the control group, p = 0.05) respectively. One person in the intervention group, who suffered from Segawa’s syndrome, dropped out because of severe muscle ache. Conclusions: The combination of active products in this study may be an alternative approach to statins in people who do not need, or cannot or do not want to be treated with chemical statins. Side effects, effects on oxidative stress and on glucose metabolism need to be examined more thoroughly. Trial registration: Clinicaltrials.gov NCT02065180 (February 2014). [ABSTRACT FROM AUTHOR]

Background Cardiovascular disease (CVD) is the leading cause of death and disability worldwide. Despite the widespread availability of evidence-based clinical guidelines and validated risk predication equations for prevention and management of CVD, their translation into routine practice is limited. We developed a multifaceted quality improvement intervention for CVD risk management which incorporates electronic decision support, patient risk communication tools, computerised audit and feedback tools, and monthly, peer-ranked performance feedback via a web portal. The intervention was implemented in a cluster randomised controlled trial in 60 primary healthcare services in Australia. Overall, there were improvements in risk factor recording and in prescribing of recommended treatments among under-treated individuals, but it is unclear how this intervention was used in practice and what factors promoted or hindered its use. This information is necessary to optimise intervention impact and maximally implement it in a post-trial context. In this study protocol, we outline our methods to conduct a theory-based, process evaluation of the intervention. Our aims are to understand how, why, and for whom the intervention produced the observed outcomes and to develop effective strategies for translation and dissemination. Methods/design We will conduct four discrete but inter-related studies taking a mixed methods approach. Our quantitative studies will examine (1) the longer term effectiveness of the intervention posttrial, (2) patient and health service level correlates with trial outcomes, and (3) the health economic impact of implementing the intervention at scale. The qualitative studies will (1) identify healthcare provider perspectives on implementation barriers and enablers and (2) use video ethnography and patient semi-structured interviews to understand how cardiovascular risk is communicated in the doctor/patient interaction both with and without the use of intervention. We will also assess the costs of implementing the intervention in Australian primary healthcare settings which will inform scale-up considerations. Discussion This mixed methods evaluation will provide a detailed understanding of the process of implementing a quality improvement intervention and identify the factors that might influence scalability and sustainability. Trials registration 12611000478910. [ABSTRACT FROM AUTHOR]

Background: In recent years, red yeast rice (RYR) supplements have been marketed aggressively as a natural way to lower cholesterol; however, the large majority of commercially available products have not been studied according to current research standards. Methods: In a double blind placebo controlled randomized trial, 52 physicians and their spouses with a total cholesterol level of > 200 mg/dL were randomly allocated to receive a RYR extract or placebo for 8 weeks. As a primary outcome measure, we compared the before-after difference in lipid levels between both groups. As secondary outcome measures we looked at side-effects, CK elevation and a change in cardiovascular risk. Results: LDL (low density lipoprotein) cholesterol was lowered with 36 mg/dL (22%) and total cholesterol with 37 mg/dL (15%) in the intervention group. This result was statistically significant as compared to the control group, in which no reduction in total cholesterol and LDL was observed (p < 0.001). There was no marked difference in CK (creatine kinase)-elevation or reported side-effects between study groups. In 5/31 participants in the intervention group, the lipid lowering effect resulted in lower cardiovascular risk as measured with SCORE (Systematic COronary Risk Evaluation). Conclusions: The RYR formulation under study was effective in lowering cholesterol and LDL cholesterol in this study population. RYR therapy may be an attractive and relatively well studied alternative in patients who are intolerant for statins or who have objections against pharmacological lipid lowering. However, consumers need to be warned that the actual content of commercially available preparations is not assured by governmental regulations, which raises effectiveness and safety issues. [ABSTRACT FROM AUTHOR]

Background: Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. Methods/Design: We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. Discussion: Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. [ABSTRACT FROM AUTHOR]

Background: The well-established benefit of Low-Dense-Lipoprotein-cholesterol (LDL-c) lowering treatments (LLTs) has led clinical guidelines to lower the cardiovascular prevention targets. Despite this, there is a surprising scarcity of real-world studies (RWS) evaluating whether recommendations are applied in the routine clinical management of patients with type 2 diabetes (T2D). We therefore evaluated, in a large RWS, the pattern of LLTs use and the achievement of LDL-c targets in patients with T2D in Italian diabetes specialist clinics. Methods: We collected data from 46 diabetes outpatient clinics (following 281,381 subjects), including 104,726 T2D patients, for whom use of LLTs between 2015 and 2016 was ascertained. We used the 2016 and 2019 European Atherosclerosis Society and European Society of Cardiology (EAS-ESC) guidelines to define cardiovascular risk categories, LDL-c targets, and the expected LDL-c reduction and cardiovascular benefit achievable with LLT intensification. Results: 63,861 patients (61.0%) were on statin therapy, 9.2% of whom were also on ezetimibe. Almost all subjects were at high (29.3%) or very high (70.4%) cardiovascular risk, including 17% being in secondary prevention. Among very high-risk patients, 35% were not on statin despite half of them had LDL-c > 2.6 mmol/l, and only 15% of those on statins had LDL-c < 1.4 mmol/l. 83% of subjects in secondary prevention were on a statin, but half of them had LDL-c > 1.8 mmol/l. Overall, 35% and 14% of subjects achieved the LDL-c targets as suggested by 2016 and 2019 EAS-ESC Guidelines, respectively. Based on anticipated response to treatment, we estimated that 38% of the entire population would require high-intensity-statin (HI-statin), 27% a combination of HI-statin plus ezetimibe, and 27% the addition of proprotein-convertase-subtilisin/kexin-9 (PCSK9) inhibitors. These LLT intensifications would reduce the incidence of cardiovascular events by 32%, from 23.511 to 16.022 events per 100.000 patients/10-years (incidence-rate-ratio 0.68; 95% C.I 0.67–0.70, p < 0.001). Conclusions: Despite the increase in use of LLT in T2D over the last decades, a large proportion of subjects with T2D did not achieve their LDL-c targets. Given the very high cardiovascular risk of these patients, improving LLT is expected to have a dramatic impact on cardiovascular event prevention. [ABSTRACT FROM AUTHOR]