COMET Initiative | The Brighton Collaboration: Creating a Global Standard for Case Definitions (and Guidelines) for Adverse Events Following Immunization.

The Brighton Collaboration: Creating a Global Standard for Case Definitions (and Guidelines) for Adverse Events Following Immunization.

Background: To advance the science of immunization safety and “vaccinovigilance,” a globally acceptable, common vocabulary for adverse events following immunization (AEFIs) is needed to promote comparability of data.
Methods: The Brighton Collaboration develops standardized case definitions and guidelines for data collection, analysis, and presentation via participation of more than 500 experts from 57 countries from public health, clinical care, academia, regulatory organizations, and industry.
Results: The first six Brighton case definitions and guidelines have been finalized. Work continues on 17 additional topics. Formal evaluation studies of definitions are underway. More than 67 investigators in 30 countries have begun or are considering implementation of the definitions and guidelines.
Conclusions: Standardized and globally implemented case definitions and guidelines for AEFIs will enhance comparability of vaccine safety data and ultimately maintain trust in immunization programs worldwide. The Brighton Collaboration may be a useful model for other realms of patient safety.

Contributors

Kohl KS, Bonhoeffer J, Braun MM, Chen RT, Duclos P, Heijbel H, Heininger U, Loupi E, Marcy SM.
Editors

In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors.
Source

Advances in Patient Safety: From Research to Implementation (Volume 2: Concepts and Methodology). Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Feb.
Advances in Patient Safety.

Publication

Journal: Agency for Healthcare Research and Quality (US)
Volume:
Issue:
Pages: -
Year: 2005
DOI:

Further Study Information

Current Stage: Not Applicable
Date: September 2000
Funding source(s): We are currently funded largely by the U.S. Centers for Disease Control and Prevention (CDC), with additional funding from WHO and, for the first 3 years, through a Research Grant for Improved Vaccine Safety Surveillance (EUSAFEVAC) from the European Commission.

Health Area

Disease Category: Other

Disease Name:

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Vaccines

Stakeholders Involved

- Academic research representatives
- Clinical experts
- Device manufacturers
- Regulatory agency representatives

Study Type

- Recommendations made

Method(s)

- Literature review
- Semi structured discussion

Documents are being developed by working groups of 5–20 volunteers per AEFI. The documents are based on a review of systematic literature searches on the respective AEFI and existing case definitions from other groups or surveillance systems, as well as on consensus-building activities. Working groups use a Web-based platform for file sharing to facilitate international participation, to accommodate volunteers with varying e-mail capacities, and to permit online revision of documents. Draft documents developed by the respective working groups are first reviewed by representatives of the Brighton steering committee and then posted on the Brighton Web site, together with a Web-based survey asking detailed questions about all aspects of the case definitions and guidelines. The surveys are completed by the “reference group,” which is drawn from an e-mail list of all Brighton Collaboration volunteers and announcements to numerous professional organizations. Typically,
20–40 scientists comment on draft documents. Scientists come from all aspects of immunization safety (i.e., clinical care, regulatory, public health, academic,
professional, and manufacturing organizations). Comments received are reviewed and incorporated into the final documents, as deemed appropriate by the
respective working groups.

Linked Studies

No related studies