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Fatigue: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
Jones JF, Kohl KS, Ahmadipour N, Bleigenberg G, Buchwald D, Evengard B, Jason LA, Klimas NG, Lloyd A, McCleary K, Oleske JM, White PD.
Fatigue: Case definition and guidelines for collection, analysis, and presentation of immunization safety data
Vaccine 25:5685-5696, 2007.
The complete electronic version of this article is available at www.sciencedirect.com.
Summary
This article was written by a Brighton Collaboration Fatigue Working Group. The Brighton Collaboration is an international voluntary collaboration to facilitate the development, evaluation, and dissemination of high quality information about the safety of human vaccines. The Collaboration’s primary aim is to develop globally accepted and implemented standardized case definition of adverse events following immunization. Although standardized case definitions for the study of CFS have been developed, the Brighton Collaboration identified the need for a case definition that covered the broad range of fatigue states applicable to immunization safety, because: a] fatigue itself (which may or may not fulfill all of the diagnostic criteria for CFS-which are rarely available in vaccine safety surveillance), has not been previously defined in a standardized way; b] previous criteria did not accommodate the varied availability of data in different study settings; c] and, guidelines for the standardized collection, analysis, and presentation of data on fatigue following immunization have not previously been developed. This paper lists the case definition and guidelines for data collection, analysis, and presentation that the Working Group developed for the standardized collection and assessment of fatigue with applicability in study settings with different availability of resources and access to health care. Widespread use of this definition with its guidelines in studies focusing on fatigue as an adverse event following immunization will enable data comparability and lead to a better understanding of this event in the context of immunization.
Page last modified on October 23, 2007
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