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Definitions & Guidelines
Definitions & Guidelines
Brighton case definitions and guidelines are intended to enhance data comparability within and across clinical trials, surveillance systems, and retrospective epidemiologic studies. They neither provide a causal assessment of a given adverse event with immunization, nor are they intended to establish criteria for management of patients. The case definitions are designed to define the levels of diagnostic certainty of reported adverse events following immunization. The guidelines aim to standardize the collection, analysis, and presentation of immunization safety data.
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Format of a Case Definition
A document is developed for each adverse event following immunization (AEFI) defined including four sections:
- A preamble to highlight the rationale for essential decisions made and to briefly describe the methodology of how working groups arrived at a particular Brighton document.
- The case definition itself, which is structured in a three level format taking into account current scientific evidence and different levels of resources available in different research and geographic settings.
- Guidelines for data collection, analysis, and presentation of a given AEFI.
- References for selected points discussed in the preamble.
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Levels of Diagnostic Certainty of a Case Definition
Each case definition is categorized into three levels of diagnostic certainty. Each level is defined by a set of clinical and/or additional diacnostic criteria. All three levels should be applied to all Case Definitions. However, for some definitions (e.g., those based solely on clinical signs and symptoms) Level 2 and/or Level 3 may not be applicable.
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Template of the Case Definition Format
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Guidelines for Data Collection, Analysis, and Presentation
The Brighton Collaboration Working Groups recognized the essential need for guidelines to enable meaningful collection, analysis, and presentation of information about a given AEFI. It is understood that levels of reporting detail may vary depending upon available resources, geographical region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance study, or an individual report of an adverse event following immunization.
Guidelines include recommendations regarding:
- Case classification.
- Case assessment, e.g. patient demographics, duration of follow-up, duration of AEFI, concurrent signs and symptoms and medication, increments of measured variables, outcomes, reporting source, vaccine details, numerator and denominator, reported cases which do not meet the case definition, etc.
- Data presentation, e.g. mention of search strategy in surveillance databases, data distribution in predefined increments.
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