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Am J Manag Care. 2004 Jul;10(7 Pt 2):487-92.

The potential role of community-based registries to complement the limited applicability of clinical trial results to the community setting: heart failure as an example.

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1
Zena and Michael A. Wiener Cardiovascular Institute, Mount Sinai School of Medicine, New York, NY 10024, USA. josephafranciosa@aol.com

Abstract

BACKGROUND:

Clinical trials do not represent community settings, making widespread implementation of evidence-based medicine problematic. New heart failure treatments are an example, as results comparable to those of clinical trials have not been observed in the community. Alternatives to clinical trials could provide useful complementary information.

OBJECTIVES AND METHODS:

To review the clinical trials and community experiences in heart failure management by searching Pubmed with key words "observational studies," "clinical trials," and "heart failure," to present the preliminary results of a community-based heart failure registry as a complementary database, and to assess the potential value and limitations of the registry approach.

RESULTS:

Recent advances in the treatment of heart failure led to guidelines using clinical trial evidence as the rationale for transferring newer therapeutic technologies to the community practice setting. Implementation of such guidelines is slow, reflecting concerns over applicability of clinical trial results to the community setting. A community-based registry of beta-blocker treatment for heart failure showed outcomes comparable to those of clinical trials, despite significant differences between physicians and their patients in these settings.

CONCLUSION:

Registries can complement clinical trials to expedite technology transfer to the community setting.

PMID:
15298235
[Indexed for MEDLINE]
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