Cardiovascular Risk Management Guidelines Research Articles

Supporting health care professionals to improve the processes of shared decision making and self-management in a web-based intervention: randomized controlled trial.

BackgroundResearch to assess the effect of interventions to improve the processes of shared decision making and self-management directed at health care professionals is limited. Using the protocol of Intervention Mapping, a Web-based intervention directed at health care professionals was developed to complement and optimize health services in patient-centered care.ObjectiveThe objective of the Web-based intervention was to increase health care professionals’ intention and encouraging behavior toward patient self-management, following cardiovascular risk management guidelines.MethodsA randomized controlled trial was used to assess the effect of a theory-based intervention, using a pre-test and post-test design. The intervention website consisted of a module to help improve professionals’ behavior, a module to increase patients’ intention and risk-reduction behavior toward cardiovascular risk, and a parallel module with a support system for the health care professionals. Health care professionals (n=69) were recruited online and randomly allocated to the intervention group (n=26) or (waiting list) control group (n=43), and invited their patients to participate. The outcome was improved professional behavior toward health education, and was self-assessed through questionnaires based on the Theory of Planned Behavior. Social-cognitive determinants, intention and behavior were measured pre-intervention and at 1-year follow-up.ResultsThe module to improve professionals’ behavior was used by 45% (19/42) of the health care professionals in the intervention group. The module to support the health professional in encouraging behavior toward patients was used by 48% (20/42). The module to improve patients’ risk-reduction behavior was provided to 44% (24/54) of patients. In 1 of every 5 patients, the guideline for cardiovascular risk management was used. The Web-based intervention was poorly used. In the intervention group, no differences in social-cognitive determinants, intention and behavior were found for health care professionals, compared with the control group. We narrowed the intervention group and no significant differences were found in intention and behavior, except for barriers. Results showed a significant overall difference in barriers between the intervention and the control group (F 1=4.128, P=.02).ConclusionsThe intervention was used by less than half of the participants and did not improve health care professionals’ and patients’ cardiovascular risk-reduction behavior. The website was not used intensively because of time and organizational constraints. Professionals in the intervention group experienced higher levels of barriers to encouraging patients, than professionals in the control group. No improvements were detected in the processes of shared decision making and patient self-management. Although participant education level was relatively high and the intervention was pre-tested, it is possible that the way the information was presented could be the reason for low participation and high dropout. Further research embedded in professionals’ regular consultations with patients is required with specific emphasis on the processes of dissemination and implementation of innovations in patient-centered care.Trial RegistrationNetherlands Trial Register Number (NTR): NTR2584; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2584 (Archived by WebCite at http://www.webcitation.org/6STirC66r).

SAT0152 High Cardiovascular Risk in Patients with Rheumatoid Arthritis: is Screening Effective?

BackgroundSince 2011, RA is regarded as an independent risk factor for cardiovascular disease (CVD) in the Dutch cardiovascular risk management (CV-RM) guidelines*.ObjectivesTo investigate the effect of cardiovascular risk screening on...

FRI0056 Half of RA Patients Does not Receive Adequate Cardiovascular Risk Management despite A Very High 10-Year Cardiovascular Risk

BackgroundPatients with rheumatoid arthritis (RA) have an increased risk for cardiovascular (CV) events. Since 2011, RA is considered as an independent risk factor for cardiovascular disease (CVD) in the Dutch...

AB0391 Cardiovascular risk assessment in rheumatoid arthritis patients using the score chart

BackgroundThe European League Against Rheumatism (EULAR) published evidence-based recommendations to guide in the cardiovascular (CV) risk management in rheumatoid arthritis (RA) patients and other forms of inflammatory arthritis. In RA...

A Web-Based Intervention for Health Professionals and Patients to Decrease Cardiovascular Risk Attributable to Physical Inactivity: Development Process

BackgroundPatients with cardiovascular risk factors can reduce their risk of cardiovascular disease by increasing their physical activity and their physical fitness. According to the guidelines for cardiovascular risk management, health professionals should encourage their patients to engage in physical activity.ObjectiveIn this paper, we provide insight regarding the systematic development of a Web-based intervention for both health professionals and patients with cardiovascular risk factors using the development method Intervention Mapping. The different steps of Intervention Mapping are described to open up the “black box” of Web-based intervention development and to support future Web-based intervention development.MethodsThe development of the Professional and Patient Intention and Behavior Intervention (PIB2 intervention) was initiated with a needs assessment for both health professionals (ie, physiotherapy and nursing) and their patients. We formulated performance and change objectives and, subsequently, theory- and evidence-based intervention methods and strategies were selected that were thought to affect the intention and behavior of health professionals and patients. The rationale of the intervention was based on different behavioral change methods that allowed us to describe the scope and sequence of the intervention and produced the Web-based intervention components. The Web-based intervention consisted of 5 modules, including individualized messages and self-completion forms, and charts and tables.ResultsThe systematic and planned development of the PIB2 intervention resulted in an Internet-delivered behavior change intervention. The intervention was not developed as a substitute for face-to-face contact between professionals and patients, but as an application to complement and optimize health services. The focus of the Web-based intervention was to extend professional behavior of health care professionals, as well as to improve the risk-reduction behavior of patients with cardiovascular risk factors.ConclusionsThe Intervention Mapping protocol provided a systematic method for developing the intervention and each intervention design choice was carefully thought-out and justified. Although it was not a rapid or an easy method for developing an intervention, the protocol guided and directed the development process. The application of evidence-based behavior change methods used in our intervention offers insight regarding how an intervention may change intention and health behavior. The Web-based intervention appeared feasible and was implemented. Further research will test the effectiveness of the PIB2 intervention.Trial RegistrationDutch Trial Register, Trial ID: ECP-92

Cardiovascular screening in general practice in a low SES area

BackgroundLower social economic status (SES) is related to an elevated cardiovascular (CV) risk. A pro-active primary prevention CV screening approach in general practice (GP) might be effective in a region with a low mean SES. This approach, supported by a regional GP laboratory, was investigated on feasibility, attendance rate and proportion of persons identified with an elevated risk.MethodsIn a region with a low mean SES, men and women aged ≥50/55 years, respectively, were invited for cardiovascular risk profiling, based on SCORE 10-year risk of fatal cardiovascular disease and additional risk factors (family history, weight and end organ damage). Screening was performed by laboratory personnel, at the GP practice. Treatment advice was based on Dutch GP guidelines for cardiovascular risk management. Response rates were compared to those in five other practices, using the same screening method.Results521 persons received invitations, 354 (68%) were interested, 33 did not attend and 43 were not further analysed because of already known diabetes/cardiovascular disease. Eventually 278 risk profiles were analysed, of which 60% had a low cardiovascular risk (SCORE-risk <5%). From the 40% participants with a SCORE-risk ≥5%, 60% did not receive medication yet for hypertension/hypercholesterolemia. In the other five GPs response rates were comparable to the currently described GP.ConclusionScreening in GP in a low SES area, performed by a laboratory service, was feasible, resulted in high attendance, and identification and treatment advice of many new persons at risk for cardiovascular disease.

Cholesterol Level Goal Attainment with Statins: Clinical Management Guideline Recommendations versus Management in Actual Clinical Practice

To compare the cholesterol level goal attainment rates in patients receiving simvastatin doses recommended in clinical practice guidelines and simvastatin doses most frequently prescribed in clinical practice versus other statins at various dose levels, and to assess statin adherence rates in patients receiving all statins. Retrospective cohort study. PHARMO database, which contains linked prescription drug information, hospitalization records, and laboratory test results of over 1 million patients in the Netherlands. A total of 7355 new statin users with available cholesterol level measurements before and 12 months after starting statin treatment between 1999 and 2006. Simvastatin was chosen as the reference drug because policy makers in the Netherlands have promoted the use of generically available statins to reduce costs. Cholesterol level goal attainment rates were compared in patients receiving simvastatin 40 mg/day, which was the statin dose promoted in the 2006 Dutch cardiovascular risk management guidelines, or simvastatin 20 mg/day, which was the most frequently prescribed dose up to 2006, versus other statins at various dose levels. Relative risks (RRs) were adjusted for age, sex, year of therapy initiation, cardiovascular disease, type 2 diabetes mellitus, hypertension, baseline low-density lipoprotein cholesterol level, and adherence during the 3 months before the 12-month follow-up cholesterol measurement. Compared with simvastatin 40 mg/day, cholesterol goal attainment rates were significantly higher with atorvastatin 40 mg/day (RR 1.15, 95% confidence interval [CI] 1.04-1.28) and rosuvastatin 10 mg/day (RR 1.13, 95% CI 1.04-1.23), were similar with atorvastatin 20 mg/day (RR 1.06, 95% CI 0.97-1.16) and rosuvastatin 20 mg/day (RR 1.14, 95% CI 0.93-1.39), and were significantly lower with all other frequently used statin dose levels. Compared with simvastatin 20 mg/day, cholesterol goal attainment was significantly higher with any dose of atorvastatin and rosuvastatin, but were lower with any dose of pravastatin. Goal attainment rates were similar among patients with lower and higher cardiovascular risk. Among the 13-18% of patients who had follow-up cholesterol level measurements at 12 months in all statin groups, the proportion of adherent patients was approximately 75%; this was higher than the proportion of adherent patients in the total population (48-55%), which included patients without follow-up cholesterol levels. A larger proportion of patients reached cholesterol lipid goals with simvastatin 40 mg/day. Cholesterol level goals were achieved by many patients using the recommended simvastatin 40 mg/day, but by fewer patients among those using the more commonly prescribed simvastatin 20 mg/day. Therefore, especially in high-risk patients, the choice of statin should be based on baseline cholesterol levels and expected reductions in these levels, and treatment should be adapted if targets are not met. Improved cholesterol level monitoring may increase adherence and cholesterol management.

Revised guidelines for cardiovascular risk management

With interest we read the study by van Duijn et al regarding the revised Dutch guidelines for cardiovascular risk management.1 The authors conducted a practice-based intervention study to explore the feasibility and consequences of a re-evaluation programme for patients without target organ damage, who were treated for hypertension and/or hypercholesterolemia under the previous guidelines. After reading their conclusions some questions remained First, the authors conclude that stopping medication in this group of …

Health benefits and costs of functional foods with phytosterols/-stanols in addition to statins in the prevention of cardiovascular disease

The Dutch guidelines for cardiovascular risk management recommend that all persons with a 10-year SCORE risk ≥5% should be given lifestyle recommendations, including encouragement of the use of phytosterols/-stanols as part of a healthy diet. Treatment with a statin is recommended for all persons with a 10-year SCORE risk of fatal cardiovascular disease (CVD) ≥10%. In the Netherlands the detection of high cholesterol values and other CVD risk factors occurs primarily through clinical case finding. The current study aimed to assess whether functional foods enriched with phytosterols/-stanols add to the benefits of statins in terms of effects and costs. Cost-effectiveness of bread spread with phytosterols/-stanols (PS) was evaluated both in a 'case-findingsituation' and in a hypothetical 'universal screening-situation' (assuming free population-based screening resulting in known SCORE risks). We compared two scenarios per situation: One with and one without additional PS use in all subjects that were known to qualify according to the guidelines. Since many people discontinue the use of PS and statins in the first two year we included discontinuation rates for new users based on empirical data. Long term health benefits were estimated using the RIVM Chronic Disease Model and measured in terms of Quality Adjusted Life Years (QALYs) gained. This simulation model also gave estimates for long term differences in health care costs between the scenarios. Intervention costs were estimated bottom-up from resource use and Dutch unit costs. Finally, health care and intervention costs per QALY were calculated and compared with standards for cost effectiveness. Uncertainty of these outcomes will be assessed using probabilistic sensitivity analysis. Preliminary results showed that addition of phytosterols/-stanols was not cost-effective, meaning that the costs of the addition were relatively high compared to the health gains.

Practice variation in a longitudinal perspective: a multilevel analysis of the prescription of simvastatin in general practices between 2003 and 2009

The Dutch national guideline for Cardiovascular Risk Management advised in 2006 initiation of statin therapy in new patients with simvastatin. After the introduction of this guideline several measures were taken to increase the prescription of simvastatin in general practice. The aim of this paper is to describe the trend and interpractice variation in the relative share of simvastatin in statin prescription over a 7-year period (2003-2009) in Dutch general practices. Data were used from the National Registration Network of General Practice (LINH) in the Netherlands. We used multilevel logistic regression analysis with individuals nested within practices. We evaluated the variance at different time points by the intra-class correlation (ICC). The share of simvastatin prescriptions of all statin prescriptions increased from 40% in 2003 to 82% in 2009. While the ICC was above 20% during the periods 2005 to 2007, it decreased rapidly from 25% in 2007 to only 9% in 2009. Our results indicate that a combination of several intervention measures seems to have been successful. While it seems like the implementation of the guidelines alone had some effect, there was an additional effect when reimbursement measures were implemented. Furthermore, the practice seemed to have affected the adoption of the national CVRM guideline as the variation initially increased after the guideline implementation. By including information on both the proportion of simvastatin prescribed and interpractice variation, we achieved a more complete evaluation of how simvastatin prescription developed over time and how it was related to the different measures taken.

Revised guidelines for cardiovascular risk management — time to stop medication? A practice-based intervention study

According to the new Dutch guideline for cardiovascular risk management, patients with a low risk of cardiovascular mortality may have insufficient benefit to warrant medication. Therefore, numerous patients per general practice may be treated unnecessarily. To explore the feasibility and consequences of a re-evaluation programme for patients without target organ damage who were treated for hypertension and/or hypercholesterolaemia. Practice-based intervention study in six general practices. Patients treated for hypertension and/or hypercholesterolaemia without target organ damage (n = 833) were invited to re-evaluate their cardiovascular risk and were advised whether or not to stop medication. Patients who discontinued medication were followed for 6 months. To determine indicators for successful stopping, logistic regression analyses were performed, and differences between practices were analysed. About two-thirds of the patients were re-evaluated and 61% of them had a low calculated risk, especially younger patients, females, and non-smokers. Of these, 42% were advised to stop medication, especially younger patients and non-smokers. Of those who discontinued medication, 40% had restarted within 6 months. After 6 months, 80 of the 833 patients (9.6%) had not restarted medication. There were no important side effects related to stopping medication. Over 50% of patients without target organ damage treated for hypertension and/or hypercholesterolaemia may have insufficient benefit to warrant medication. Younger patients, females, and non-smokers in particular are more likely to have an insufficient indication for medication. GPs' and nurse practitioners' views seem to play a role in advising to stop or to restart medication.

Application of a Cardiovascular Disease Risk Prediction Model Among Commercial Pilots

It has been suggested that integrated cardiovascular risk management guidelines and absolute cardiovascular risk prediction scores should be used routinely in aeromedical risk assessment. In this study a cardiovascular disease (CVD) risk prediction model has been applied to UK commercial pilots as an occupational group. This retrospective cross-sectional study measured the variables age, sex, body mass index (BMI), blood pressure, use of antihypertensive medication, current smoking, and diabetes status of commercial pilots. Individual 10-yr absolute CVD risk scores (also referred to as 10-yr global CVD risk) were calculated using a non-laboratory based Framingham Heart Study developed model. Of the 14,379 subjects eligible for the study, none had missing values for risk factors. None of the female pilots and 9.7% of all male pilots were found to be high risk. The mean 10-yr absolute CVD risk for the entire pilot population was 8.41% (median 5.6). High-risk pilots are concentrated around 60 yr of age, (mean 59, median 60 yr) with an age range of 40-81 yr. A sub-analysis of high-risk pilots younger than 65 revealed 1137 pilots in this group. The application of a 10-yr absolute CVD risk prediction model identified a group of pilots, previously unidentified, who may require a more comprehensive risk assessment. Pilots are continuing to fly commercially beyond the age of 60, which results in substantial increase in the CVD risk burden of the pilot population as a whole.

Statin Prescribing in the Elderly in the Netherlands

There is some evidence that the beneficial effects of HMG-CoA reductase inhibitors (statins) in the elderly are at least comparable to the effects in middle-aged people. However, several studies have shown prescription rates of statins to be significantly lower in the elderly than in younger populations. The aim of the present study was to monitor statin prescribing trends in the elderly in the Netherlands over time in terms of prevalence, incidence, type of statin, dose prescribed and adherence to clinical guidelines. The database of a community pharmacy in Utrecht, which includes prescription data for approximately 11,000 people, was analysed to investigate trends in statin prescriptions from January 1999 to December 2008. The 1-year prevalence and incidence of statin use stratified by age were determined for each calendar year. Rate ratios (RRs) and 95% confidence intervals were calculated with 1999 as the reference year. Furthermore, the following trends of interest were calculated for each calendar year: the percentage of statin users prescribed simvastatin or atorvastatin, the median dose of simvastatin and atorvastatin prescribed, and the percentage of simvastatin users prescribed a dosage of 40 mg/day (which is recommended by the Dutch multidisciplinary guideline). The 1-year prevalence of statin use in medication users aged >or=50 years increased from 13.9% in 1999 to 22.8% in 2008 (RR 1.6; 95% CI 1.4, 1.9; p < 0.001). Overall, the lowest prevalence (5.1% in 1999 and 15.2% in 2008) and incidence rates (3.2% in 2000 and 4.2% in 2008) were found in patients aged >or=80 years. Before 2006, simvastatin was the most commonly prescribed statin, but the number of users declined as the percentage of patients with new simvastatin prescriptions decreased (from 43.4% in 2000 to 36.5% in 2005) and the percentage of patients treated with new atorvastatin prescriptions increased (from 37.7% in 2000 to 47.3% in 2005). As from 2006, when the Dutch multidisciplinary guideline for Cardiovascular Risk Management was introduced, recommending treatment with a daily simvastatin dose of 40 mg, the number of simvastatin users increased again and most treatment-naive patients were started on simvastatin (62.3% in 2006, increasing to 66.7% in 2008). The median simvastatin dose increased from 10 mg in 1999 to 20 mg in 2001, remaining at the same dose until 2008, and appeared to be related to the patient's age. From 2006, patients aged >or=80 years were the least likely group to receive the recommended dose of 40 mg simvastatin daily (10.0-20.0% of simvastatin users aged >or=80 years compared with 32.5-36.9% of simvastatin users aged 60-69 years). Despite the benefits of statin treatment previously reported in older patients, the prevalence and incidence of statin use were lower in elderly patients compared with younger patients. In addition, lower dosages of statins were prescribed. These findings suggest the beneficial effects of statins in the elderly observed in clinical trials may not be achieved in everyday practice.

Evaluation of cardiovascular risk predicted by different SCORE equations: The Netherlands as an example

In Europe, for primary prevention of cardiovascular diseases (CVD), the Systematic COronary Risk Evaluation (SCORE) risk charts for high-risk and low-risk regions (SCORE-high and SCORE-low, respectively) are used. For the Dutch 'Clinical Practice Guideline for Cardiovascular Risk Management' an adapted SCORE risk chart (SCORE-NL) was developed in collaboration with the SCORE group. We evaluated these three SCORE equations using Dutch risk factor and mortality data. Prospective cohort study with 10-year follow-up. Baseline data were collected between 1987 and 1997 in 32 885 persons aged 37.5-62.5 years. Vital status was checked and causes of death were obtained from Statistics Netherlands. On the basis of the level of risk factors, the expected number of CVD deaths was calculated by applying the three SCORE equations and compared with the observed number. The observed CVD mortality was three-fold higher in men (n=242; 1.6%) than in women (n=83; 0.5%). On the basis of SCORE-NL, 8.5% of the men and 0.8% of the women had a CVD mortality risk of 5% or more. The ratio of the observed-to-expected number of CVD deaths was 0.75 for men and 0.55 for women using SCORE-NL, 0.54 and 0.56 using SCORE-high, and 1.11 and 0.95 using SCORE-low. At the population level, SCORE-low predicts the number of CVD deaths well, whereas both SCORE-NL and SCORE-high overestimate the number of CVD deaths by a factor 1.5-2.

Effectiveness of nurse-delivered cardiovascular risk management in primary care: a randomised trial

A substantial part of cardiovascular disease prevention is delivered in primary care. Special attention should be paid to the assessment of cardiovascular risk factors. According to the Dutch guideline for cardiovascular risk management, the heavy workload of cardiovascular risk management for GPs could be shared with advanced practice nurses. To investigate the clinical effectiveness of practice nurses acting as substitutes for GPs in cardiovascular risk management after 1 year of follow-up. Prospective pragmatic randomised trial. Primary care in the south of the Netherlands. Six centres (25 GPs, six nurses) participated. A total of 1626 potentially eligible patients at high risk for cardiovascular disease were randomised to a practice nurse group (n = 808) or a GP group (n = 818) in 2006. In total, 701 patients were included in the trial. The Dutch guideline for cardiovascular risk management was used as the protocol, with standardised techniques for risk assessment. Changes in the following risk factors after 1 year were measured: lipids, systolic blood pressure, and body mass index. In addition, patients in the GP group received a brief questionnaire. A larger decrease in the mean level of risk factors was observed in the practice nurse group compared with the GP group. After controlling for confounders, only the larger decrease in total cholesterol in the practice nurse group was statistically significant (P = 0.01, two-sided). Advanced practice nurses are achieving results, equal to or better than GPs for the management of risk factors. The findings of this study support the involvement of practice nurses in cardiovascular risk management in Dutch primary care.

The cost-effectiveness of implementing a new guideline for cardiovascular risk management in primary care in the Netherlands

A new Dutch guideline for cardiovascular disease management substantially extends the number of individuals for whom treatment with statins and/or antihypertensive agents is recommended. We estimated the cost-effectiveness of implementing the new guideline at the national level. First, the number of currently untreated individuals who would become eligible for cholesterol-lowering or antihypertensive treatment under the new guideline was estimated using data from a recent population study. Cost-effectiveness of treating this group of patients was then assessed using a mathematical model. Implementing the guideline in the age category 30-69 years would lead to an additional 465,000 individuals requiring treatment. Over a period of 20 years, the cumulative incidence of acute myocardial infarction in the whole population would drop by 3.0%, that of stroke by 3.9%, and all-cause mortality would drop by 0.9%. The lifetime cost-effectiveness ratio was calculated to be 15,000 Euro per quality-adjusted life year gained. In the age categories 70-79 years and 80 years or above, an additional 600,000 and 450,000 persons, respectively, would need to be treated, resulting in corresponding reductions in cumulative incidences of 14 and 18% (acute myocardial infarction), 17 and 22% (stroke), and 1.2 and 0.6% (all-cause mortality) with cost-effectiveness ratios of 20,800 and 32,300 Euro, respectively, per quality-adjusted life year. Complete implementation of the new guideline would lead to a considerable increase in the number of individuals requiring treatment. This would be cost-effective up to the age of 70 years.

Estimation of cardiovascular risk: a comparison between the Framingham and the SCORE model in people under 60 years of age

The Framingham Heart Study risk model has been used in the majority of cardiovascular risk management guidelines. Recently, a new model based on the SCORE system has been proposed. We compared both risk models with regard to their ability to predict cardiovascular mortality in the Netherlands. Cohort study. In a Dutch cohort study of 39 719 persons, three properties of the risk models were investigated: discriminating ability (ranking persons in order of risks, expressed in area under the curve); calibrating ability (prediction of events compared with actual events expressed in goodness of fit); and the number of persons assigned to treatment according to the guideline. The discriminative ability of both models was similar: the area under the curve of Framingham was 0.86 and of SCORE 0.85. Calibration of both functions was inadequate. The goodness of fit of the SCORE model was 35 and of the Framingham model 64, whereas a goodness of fit less than 20 is considered acceptable. Using the Dutch guideline treatment threshold of 10% mortality risk, the SCORE risk function assigned 0.4% of the population to drug treatment where the Framingham function assigned 0.7%. The findings of this study show that both the SCORE and the Framingham model function have a good discriminative ability but are insufficient in predicting absolute risks. SCORE assigned fewer participants to treatment than Framingham. If a new risk model is implemented in treatment guidelines, comparison with the model in use and evaluation of calibrating features is needed.

Suspected Nonalcoholic Fatty Liver Disease and Mortality Risk in a Population-Based Cohort Study

Case series suggest that nonalcoholic fatty liver disease (NAFLD) is associated with increased all-cause and cardiovascular mortality. The current study compared the survival of subjects with and without suspected NAFLD in a population-based cohort, and placed the finding in the context of previously published case series. Primary analysis assessed mortality for NHANES-III participants with and without suspected NAFLD using the National Death Index. Suspected NAFLD was based upon unexplained ALT elevation. The Olmsted County and Cleveland Clinic case series were also used for comparison. Survivals were compared using Proportional Hazards Model and direct age standardization. The NHANES cohort included 980 with and 6,594 subjects without suspected NAFLD. Over a mean of 8.7 yr, suspected NAFLD had a hazards ratio of 1.37 (95% CI 0.98-1.91) for all-cause mortality. In the 45-54 age group, suspected NAFLD had significantly higher all-cause (4.40 95% CI 1.27-13.23) and cardiovascular mortality (8.15, 95% CI 2.00-33.20) after adjusting for conventional cardiovascular risk factors. The age-standardized rate per 10,000 per year was 129 (95% CI 118-140) for the NHANES non-NAFLD cohort, 154 (95% CI 116-198) for the NHANES suspected NAFLD cohort, 214 (95% CI 157-279) for the Olmsted County series, and 426 (95% CI 298-573) for the Cleveland Clinic series. The magnitude of mortality risk in NAFLD depends on the setting and method of ascertainment. Suspected NAFLD in the 45-54 age group is a strong independent risk factor for cardiovascular death and warrants further cardiovascular risk management guidelines.

Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol).

BackgroundMany patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management.MethodsA cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited.In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline.Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52 weeks. Clinical endpoints will not be measured, but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year.DiscussionThe combined use of risk communication, a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention.Trial registrationCurrent Controlled Trials ISRCTN51556722

Evidence-based guidelines, time-based health outcomes, and the Matthew effect

Cardiovascular risk management guidelines are 'risk based'; health economists' practice is 'time based'. The 'medical' risk-based allocation model maximises numbers of deaths prevented by targeting subjects at high risk, for example, elderly and smokers. The time-based model maximises numbers of life years gained by treating the young and non-smokers, or 'the one who has will be given more' (Matthew 25:29). We explored practical consequences of risk- or time-based allocation. We used epidemiological modelling to generate semi-quantitative scenarios comparing the distributional effects of allocating a fixed number of prescriptions of a (hypothetical) preventive cardiovascular drug ('CVStop') either to avert the maximum number of deaths (risk-based) or to save the maximum number of life years (time based) in the male Dutch population. We subsequently asked 123 Dutch guideline developers which distribution they preferred. Time- and risk-based allocations resulted in different distributions of the drug across the population. There were also differences in absolute numbers of life years gained and deaths averted, and in the distribution of these across the population. For example, risk-based allocation of 'CVStop' resulted in preferential treatment of elderly, leading to more deaths averted (mostly among 70 and above) but fewer life years gained, if compared with time-based allocation. The guideline developers experienced the choice dilemmas as difficult. No priority choice was dominant among the respondents. In evidence-based resource allocation the choice to save time or to avert deaths may introduce moral choices because of the various origins of increased disease risk. Evidence-based guideline development inevitably has moral implications.