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Introduction. Most patients with type 2 diabetes mellitus (T2DM) in the U.S. receive diabetes care in primary care settings. Self-management support (SMS) is a key factor in diabetes care, focusing on the central role of patients in managing their illness[1–4].SMS provides tools and skills for patients to manage their care, typically with a focus on medication adherence, diet, …
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Clusters of health events, such as chronic diseases, injuries, and birth defects, are often reported to health agencies. In many instances, the health agency will not be able to demonstrate an excess of the condition in question or establish an etiologic linkage to an exposure. Nevertheless, a systematic, integrated approach is needed ...
As used in these guidelines, the term "cluster" is an unusual aggregation, real or perceived, of health events that are grouped together in time and space and that are reported to a health agency. Several breakthroughs and triumphs in infectious disease control have resulted from the epidemiologic evaluation of clusters of cases.
Well-known examples include the epidemic of cholera in London in the 1850s (1), the investigation of cases of pneumonia at the Bellevue-Stratford Hotel in Philadelphia in 1976 (2), and the report in 1981 that seven cases of Pneumocystis carinii pneumonia had occurred among young, homosexual men in Los Angeles (3).
The investigation of clusters may be best viewed as a form of public health surveillance (i. e., the ongoing collection, analysis, and dissemination of information important to public health practice) that responds to community needs. It is not necessarily a primary mechanism for investigating etiologic relationships.
A process for involving concerned groups and individuals.The health agency should consider the establishment of an advisory committee (or similar group) to oversee the decision-making process for evaluating clusters.
Cluster activities. The European Medicines Agency (EMA) holds regular meetings by phone or videoconference with other non-EU regulators in so-called 'clusters'. The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.
The objective of the cluster is the alignment on scientific approaches to the evaluation of biosimilar medicines in order to increase convergence, so that data developed for one regulatory authority could be acceptable to another regulatory authority.
EMA and FDA have developed a joint strategy to encourage the use of innovative approaches in medicine development for Gaucher disease, which can apply to rare diseases in children in general. The approach aims to reduce the number of patients needed for clinical trials.