Heart failure programmes in countries with a primary care-based health care system. Are additional trials necessary? Design of the DEAL-HF study.

BACKGROUND: Several randomised studies of heart failure (HF) management programmes in the United States, Australia and Europe have shown a considerable reduction in hospitalisation rates for HF. In this article, a comprehensive review of these studies will be provided and their applicability to countries, with a primary care-based healthcare system, will be discussed. In addition, the design of the Deventer-Alkmaar HF Project (DEAL-HF), a randomised study of the effect of a nurse and physician-directed intervention over 1 year in The Netherlands, will also be presented. AIM: To discuss the applicability of the results of available studies on heart failure management programmes to countries with well-structured primary care facilities and to determine whether additional trials should be conducted in these countries.
METHODS: We performed a literature search in PubMed. In a review of the available studies, essential methodological aspects, in particular, the population involved, the sample size, follow-up period, setting, type of intervention, and the outcome parameters, are discussed critically. Also, the applicability of these studies to countries with a primary care-based healthcare system and easy access to medical care is evaluated.
CONCLUSION: Applicability of the results of the available studies on the efficacy of heart failure management programmes to countries with a primary care-based health care system is doubtful. An efficacy trial in a country with a well-established primary care-based healthcare system, such as The Netherlands, is due to report soon (DEAL-HF).