Cardiovascular prevention in the Hartslag Limburg project: effects of a high-risk approach on behavioral risk factors in a general practice population.

BACKGROUND: This study describes a general-practice-based high-risk cardiovascular prevention approach in Maastricht, The Netherlands (1999-2003). The intervention consisted of a complete registration of risk factors, optimization of medical treatment and health counseling on high fat consumption, smoking and physical inactivity. METHODS: Behavioral effects were assessed in a trial, randomization by practice and usual care as control. Validated questionnaires were completed by 1300 patients at baseline, 1174 after 4 months (90.3%) and 1046 (80.5%) after 18 months. RESULTS: After 4 months, intention-to-treat analyses revealed a decrease in saturated fat intake of 1.3 points (scale ranging from 7 to 30 points, p=0.000). This was partly sustained after 18 months (-0.5 points, p=0.014). After 18 months, obese intervention patients were more likely to be sufficiently physically active than their control counterparts (OR=1.90, p=0.023). No intervention effects were found for smoking. CONCLUSION: Given the multiple factor and multiple component high-risk approach, the intervention had modest effects on only some of the behavioral risk factors addressed. Process data showed that the registration of risk factors and the optimization of medical treatment were only partly implemented, that the health counseling component could be further improved and that the intervention could benefit from additional health promoting strategies.

Effects of health counseling on behavioural risk factors in a high-risk cardiology outpatient population: a randomized clinical trial.

BACKGROUND: An evaluation study of an individual lifestyle advice intervention to reduce cardiovascular risk behaviours (high fat consumption, smoking, physical inactivity). METHODS: A randomized, controlled trial at the cardiology outpatient clinic of the University Hospital Maastricht. Participants were at high risk of incurring a cardiovascular event. Changes in risk behaviours and behavioural determinants were assessed with self-administered validated questionnaires. RESULTS: Questionnaires were completed by 1270 patients at baseline, 1169 after 4 months (92%), and 1032 after 18 months (81.3%). After 4 months, intention-to-treat analyses revealed a decrease in fat consumption (-5.6%, P = 0.000), a reduction in the percentage of smokers [odds ratio (OR) 0.57, 95% confidence intervals (CI) 0.33-0.97] and a trend towards a maintained physical activity level (OR 1.28, 95% CI 0.97-1.70). No long-term effects were found. CONCLUSION: The lifestyle advice intervention was potentially effective in changing cardiovascular risk behaviours, but should be further improved to be effective in secondary cardiovascular prevention. The main limitations of the study were related to the randomization procedure and the self-selection of patients and cardiologists.

Implementation of an innovative health service a "real-world" diffusion study.

BACKGROUND: Although reporting on the healthcare-setting level of continuance or discontinuance of an intervention once a trial is completed has been recommended, such "real-world" diffusion studies are rare. The present example was made possible by funding to explore opportunities for post-trial implementation of an innovative health counseling intervention for cardiovascular prevention in The Netherlands. METHODS: Between 2001 and 2004, in a longitudinal case study, we compared two healthcare settings: a cardiology outpatient clinic and general practices. Rogers' diffusion of innovations theory served as the theoretical background. Information was extracted from minutes of meetings and informal conversations with health counselors, and checked by the project manager. Additional data were collected from physicians with a short questionnaire. RESULTS: Implementation of the health counseling intervention was successful in the cardiology outpatient clinic, but was unsuccessful in the general practices. Success was related to a centralized diffusion system, stronger "change agent" efforts, avoidance of post-trial interruption of service delivery, easily achievable "reinventions," and positive physician perceptions of the service (i.e., not complex and compatible with current practice routines). Support came from changes in the organization of care that created opportunities for, instead of competition with, the innovative service. However, coincidental events may also have played a part. CONCLUSIONS: Our findings confirm the importance of most theoretically predicted individual and organizational diffusion variables. This implies that the implementation of innovative healthcare services requires attention at both levels.

A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease.

AIMS: To identify the characteristics, treatment, and outcomes of contemporary patients with valvular heart disease (VHD) in Europe, and to examine adherence to guidelines. METHODS AND RESULTS: The Euro Heart Survey on VHD was conducted from April to July 2001 in 92 centres from 25 countries; it included prospectively 5001 adults with moderate to severe native VHD, infective endocarditis, or previous valve intervention. VHD was native in 71.9% of patients and 28.1% had had a previous intervention. Mean age was 64+/-14 years. Degenerative aetiologies were the most frequent in aortic VHD and mitral regurgitation while most cases of mitral stenosis were of rheumatic origin. Coronary angiography was used in 85.2% of patients before intervention. Of the 1269 patients who underwent intervention, prosthetic replacement was performed in 99.0% of aortic VHD, percutaneous dilatation in 33.9% of mitral stenosis, and valve repair in 46.5% of mitral regurgitation; 31.7% of patients had > or =1 associated procedure. Of patients with severe, symptomatic, single VHD, 31.8% did not undergo intervention, most frequently because of comorbidities. In asymptomatic patients, accordance with guidelines ranged between 66.0 and 78.5%. Operative mortality was <5% for single VHD. CONCLUSIONS: This survey provides unique contemporary data on characteristics and management of patients with VHD. Adherence to guidelines is globally satisfying as regards investigations and interventions.

The influence of methodologic quality on the conclusion of a landmark meta-analysis on thrombolytic therapy.

OBJECTIVE: We studied the influence of the methodologic quality of individual trials on the outcome of a landmark meta-analysis on thrombolytic therapy in acute myocardial infarction. From each study we extracted the number of patients in both groups who died in hospital or during follow-up. Methodologic quality was assessed using the Delphi list. We first recalculated pooled odds ratios (ORs) and 95% confidence intervals (CIs), on the studies found and compared them with the original results of Yusuf et al. Next we incorporated the results of quality assessment in five different ways in the calculation of the pooled ORs: a) component analysis; b) visual plot; c) quality score as a threshold score; d) quality score as a weighting factor; and e) cumulative pooling. RESULTS AND CONCLUSION: No correlation between quality scores and ORs was found. Studies with a proper description of the different quality components provided an estimate close to the true treatment effect. No major differences were found between the results of the five different methods of incorporating the quality scores into the final conclusion.