gms | German Medical Science

GMS Health Technology Assessment

Deutsche Agentur für Health Technology Assessment (DAHTA)

ISSN 1861-8863

Effectiveness of programmes as part of primary prevention demonstrated on the example of cardiovascular diseases and the metabolic syndrome

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  • corresponding author Dieter Korczak - GP Forschungsgruppe, Institut für Grundlagen- und Programmforschung, München, Deutschland
  • Markus Dietl - GP Forschungsgruppe, Institut für Grundlagen- und Programmforschung, München, Deutschland
  • Gerlinde Steinhauser - GP Forschungsgruppe, Institut für Grundlagen- und Programmforschung, München, Deutschland

GMS Health Technol Assess 2011;7:Doc02

DOI: 10.3205/hta000093, URN: urn:nbn:de:0183-hta0000930

This is the original version of the article.
The translated version can be found at: http://www.egms.de/de/journals/hta/2011-7/hta000093.shtml

Published: April 1, 2011

© 2011 Korczak et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

The complete HTA Report in German language can be found online at: http://portal.dimdi.de/de/hta/hta_berichte/hta300_bericht_de.pdf


Outline

Abstract

Background

The HTA-report (HTA = Health Technology Assessment) deals with the primary prevention of cardiovascular diseases and diabetes mellitus type 2. In 2009 approximately 356,000 people died in Germany due to cardiovascular diseases. According to estimations about 6.3 million people are suffering from diabetes mellitus type 2. The interventions that are subsidized by the public health insurance are mainly focused on sufficient physical activities, healthy nutrition, stress management and the reduction of the consumption of addictive drugs and luxury food.

Objectives

Which lifestyle-related measures and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are effective? To what extent will the health status be improved by these offers? To what extent will existing health resources and skills be strengthened by these offers? Are there any differences regarding the effectiveness among the interventions with respect to different settings or subgroups?

Which lifestyle-related interventions and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are sustainable and cost-effective? Which outcome parameters are in the view of the contributors decisive for the evaluation of the effectiveness? In the view of the contributor are there different values between the outcome parameters? In the view of the payers and other actors are there different values between the outcome parameters?

Which ethical and juridical factors have to be considered? Which social and/or socio-economic parameters influence the use of the services and effectiveness?

Methods

A systematic literature research is done in 35 databases. For the period 2005 to 2010, reviews, epidemiological and clinical studies as well as economical evaluations which deal with primary prevention programmes regarding cardiovascular diseases or the metabolic syndrome are included.

Results

44 publications meet the inclusion criteria. These studies confirm the effectiveness of the primary prevention programmes. Physical activity programs seem to have a stronger effect than nutrition programmes. Psychological programmes prove as well effectiveness, if they include cognitive behaviour therapy. The identified economical studies indicate that programmes for cardiovascular prevention can be conducted cost-effectively. Interventions that focus on the general population turn out to be particularly cost-effective and sustainable.

Discussion

There is a wide range of primary preventive effective lifestyle-related interventions with high evidence. The outcomes and results are consistent with the recommendations of the two identified evidence-based guidelines regarding the recommendations on lifestyle and healthy nutrition. Furthermore, the cost-effectiveness of primary prevention services is proven. With regard to the economical studies it is however worth noting that this result is based on very few publications. The transferability has to be critically assessed as the studies mainly originate from the American health system.

Conclusion

On the whole a comprehensive setting approach with educative, somatic, psychosocial and activity therapeutic components is recommended. The sustainability of a prevention intervention must be ensured from programme to programme. Long-term studies are necessary to make valid statements regarding the sustainable effectiveness: There is an essential deficit in the current practiced evaluation of the use of primary prevention services provided by the health insurance – mainly regarding the comprehensive setting approach – regarding the evidence-based evaluation of the prescribed preventive interventions. With regard to the ethical, social and economical evaluation the research situation is deficient. The situation has to be particularly analyzed for the socially deprived and one has to respond to their specific needs for prevention.

Keywords: accident, adiposity, apoplexia, apoplexy, behavior therapy, biomedical technology assessment, blinded, blinding, blood glucose, blood sugar, cardiovascular diseases, care, cerebrovascular accident, clinical trial, clinical trials as topic, controlled clinical trial, controlled clinical trials as topic, cost analysis, cost control, cost effectiveness, cost reduction, cost-cutting, cost-effectiveness, costs, costs and cost analysis, decision making, diabetes mellitus, EBM, economic aspect, economics, economics, medical, effectiveness, effectiveness, cost, efficacy, efficiency, ethics, evaluation studies as topic, evidence based medicine, evidence-based medicine, health, health campaign, health care action, health care sector, health economic studies, health economics, health education, health policy, health promotion, health technology assessment, heart disease, heart diseases, high blood pressure, HTA, humans, hypertension, insulin resistance, insult, judgment, juridical, life qualities, life style, lipid metabolism, lipometabolism, medical assessment, medical costs, medical evaluation, meta analysis, meta analysis as topic, meta-analysis, metabolic syndrome, metabolic syndrome X, methods, models, economic, movement, multicenter studies as topic, multicenter trial, nutritional physiological phenomena, overweight, peer review, pharmaeconomics, placebo, placebo effect, prevention, prevention program, prevention research, preventive care, preventive medicine, primary prevention, program effectiveness, program evaluation, prophylaxis, prospective studies, quality of life, random, randomisation, randomised clinical trial, randomised controlled trial, randomised trial, randomization, randomized clinical trial, randomized controlled trial, randomized controlled trials as topic, randomized trial, RCT, rehabilitation, relaxation, research article, research-article, review, review literature, review literature as topic, risk assessment, sensitivity, sickness costs, social economic factors, socioeconomic factors, socioeconomics, specifity, stroke, systematic review, technical report, technology, technology assessment, technology assessment, biomedical, technology evaluation, technology, medical, therapy, treatment, validation studies


Summary

Health political background

The HTA-report (HTA = Health Technology Assessment) deals with the primary prevention of cardiovascular diseases and diabetes mellitus type 2. In 2009 approximately 356,000 people died in Germany due to cardiovascular diseases. According to estimations about 6.3 million people are suffering from diabetes mellitus type 2. The compulsory health insurance (GKV) defined as a goal for primary prevention the reduction of cardiovascular diseases as this disease has the highest epidemiological importance regarding morbidity, mortality and costs. Within the national health targets the reduction of the occurrence of the metabolic syndrome and the incidence of diabetes mellitus type 2 in the field of primary prevention is formulated as national health target. Due to the importance of cardiovascular diseases and the metabolic syndrome the HTA-report focus on the analysis of effectiveness of primary prevention interventions for the prevention of these two diseases.

Scientific background

In industrial countries mainly seven risk factors are responsible for the majority of cardiovascular diseases and the metabolic syndrome: high blood pressure, smoking, alcohol, high cholesterol level, overweight, too little fruit and vegetables consumption as well as too little exercise. The main prevention target is the reduction of these factors by a change of lifestyle. The interventions which are subsidized by the public health insurance are mainly focused on physical activities, healthy nutrition, stress management and the reduction of the consumption of addictive drugs and luxury food.

Medical research questions

  • Which lifestyle-related interventions and/or programmes for primary prevention of cardiovascular diseases and/or of the metabolic syndrome are effective?
  • To what extent will the health status be improved by these offers?
  • To what extent will existing health resources and skills be strengthened by these offers?
  • Are there any differences regarding the effectiveness among the interventions with respect to different settings or subgroups?

Economic research questions

  • Which lifestyle-related measures and/or programmes for primary prevention of cardiovascular diseases and of the metabolic syndrome are sustainable and cost-effective?
  • Which outcome parameters are in the view of the contributors decisive for the evaluation of the effectiveness?
  • In the view of the contributor are there different values between the outcome parameters?
  • In the view of the payers and other actors are there different values between the outcome parameters?

Ethical and juridical research questions

  • Which ethical and juridical factors have to be considered?
  • Which social and/or socio-economic parameters influence the use of the services and effectiveness?

Methods

A systematic literature research is done by the German Institute for Medical Documentation and Information (DIMDI). Additionally, the authors look for related studies and literature. HTA-reports, systematic reviews/meta-analysis, randomized controlled trials (RCT), observational studies, intervention studies, cost studies, cost minimization studies, cost-benefit-analyses and cost-effectiveness studies are included which report on primary prevention programmes regarding cardiovascular diseases or the metabolic syndrome from 2005 to 2010. With respect to the outcomes the studies have to deliver results about effectiveness, benefit and efficacy. The scientifically based classification according to the evidence levels of the Oxford Centre of Evidence-based Medicine of 2006 is used for a critical evaluation of the available literature.

Medical results

A total of 27 medical studies meet the inclusion criteria. These studies prove the efficacy of lifestyle interventions regarding cardiovascular diseases and the reduction of multiple metabolic deviances. In particular the affected persons can reduce their weight, the body mass-index (BMI), fat intake, the blood pressure, blood lipids and smoking. Furthermore, the mortality and morbidity rate, the quality of life, the prevalence of the metabolic syndrome, the cost-effectiveness can be improved and the physical activity and fitness can be increased.

The evaluation of the medical research results shows that the activity programmes have a stronger effect than the nutrition programmes. The efficacy also applies for psychological programmes, if they contain cognitive behaviour therapy. Strengthening the health resources with educative input leads in the sense of a comprehensive rehabilitation to a positive outcome of the risk factors such as blood lipid or blood pressure and thus towards a necessary lifestyle intervention.

Economic results

Seven economical studies are included in the HTA-report. Despite the enormous effects of cardiovascular diseases on the health system, there is a lack of economical studies in Germany.

So far only a few results exist regarding the cost-effectiveness of lifestyle related interventions. The identified studies however show that mainly programmes for prevention of hypertension, hypercholesterolaemia and diabetes turn out as cost-effective. Interventions that focus on the general population prove to be particularly cost-effective and sustainable. These include initiatives to reduce the salt content in bread or media campaigns.

Ethical and juridical results

Ten ethical studies meet the including criteria – but ethical and juridical aspects are not taken into account. The identified studies deal basically with primary prevention interventions which should neutralize social inequality and allow a better access to health care. The studies prove the effectiveness of psychological treatments. They show positive effects on the quality of life and depression. Furthermore, lifestyle programmes can counteract smoking. The level of education, distance, age and gender are identified as factors regarding the influence on the use of prevention programmes.

Discussion

The identified studies prove the effectiveness of primary prevention programmes. There is a wide range of lifestyle-related interventions and/or programmes for primary prevention of cardiovascular diseases and the metabolic syndrome. Interventions to change the lifestyle include mainly guidelines, training courses, movement training, cognitive behaviour therapy, nutrition interventions, information campaigns, and focus groups.

Compared to a normal diet nutritional advice has only small effects on weight loss which further reduce in the course of time. As a result, cognitive behaviour therapy can have an influence on nutrition and physical activity and this can result in permanent loss in weight. The outcomes and results are consistent with the recommendations of the two identified evidence-based guidelines regarding the recommendations on lifestyle and healthy nutrition. Every three identified cost-effectiveness-analyses prove the cost-effectiveness of the analyzed programmes. The number of identified studies in German-speaking countries is low. The transferability of the foreign results to the German situation has to be critically assessed. The surveys are often conducted on the basis of few or very short follow-up periods. The research process is often not adequately described in the identified reviews and guidelines. Based on the studies it cannot be concluded to what extent there is an empowerment of the participants by the interventions.

Conclusion

On the whole a comprehensive, structured setting approach with educative, medical, psychosocial and activity therapeutic components is recommended. Due to the evidence the catalogue of interventions comprises controlled intake of salt, endurance training, BMI < 25 kg/m², nicotine abstinence and limited alcohol consumption. Furthermore, nutrition with few saturated fatty acids and less cholesterol, especially fruit, vegetables as well as fiber-rich, low fat nutrition, whole grain products and proteins of vegetable origin turn out to be useful. A cognitive behaviour therapy combined with stress management can also be included in the catalogue. The sustainability of a prevention measure must be ensured from programme to programme. Long-term studies are necessary to make valid statements regarding the sustainable effectiveness. In the current practiced evaluation of the use of primary prevention services by the health insurance there is an essential deficit regarding the evaluation of the prescribed preventive intervention. With regard to the ethical, social and economical evaluation the research situation is deficient. Primarily, evaluation studies about the success of primary prevention measures for socially deprived are needed.