Applicability, reliability, sensitivity, and specificity of six Brighton Collaboration standardized case definitions for adverse events following immunization

Immunization Safety Office, Office of the Chief Science Officer, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-03, Atlanta, GA, USA.
Vaccine (Impact Factor: 3.62). 10/2008; 26(50):6349-60. DOI: 10.1016/j.vaccine.2008.09.002
Source: PubMed


We evaluated the applicability, reliability, sensitivity, and specificity of six standardized case definitions for adverse events following immunization (AEFI) (for fever, generalized convulsive seizure, hypotonic-hyporesponsive episode, intussusception, nodule, and persistent crying) developed by the Brighton Collaboration using the U.S. Vaccine Adverse Event Reporting System (VAERS). The evaluation included: (a) the development of codified search strings using standardized coding terminology, and (b) for sensitivity and specificity analyses, the development of a "gold standard" for case determination by clinical expert reviews, and its comparison against the application of the definitions to VAERS reports by nonclinicians. Application of the case definitions in an automated approach proved to be valid, feasible, and unlikely to miss confirmed cases of the reported clinical event. The definitions had variable but generally high sensitivity and specificity compared to clinician review, which in itself yielded inconsistent case determination. The study demonstrated the need for the developed standardized definitions for AEFI and their usefulness in passive surveillance.

10 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: In the early 1990s, Xerox synthesized a vision for the next generation of environmentally friendly products. The goal became to design, in waste free offices, a digital platform for a new category of products, to manufacture it in waste free factories, and to ensure that none of its parts end up in the landfill. The vision would incorporate benchmark levels of noise, energy consumption, emissions and environmental friendly materials. The Beta Site (test program) for the vision was code named “Lakes”, a mid-volume networked digital multifunction platform. The first product from the Lakes family, the Document Centre 265, a sixty-five print per minute black and white digital copier, has completed its first year of production with over twenty five thousand installed around the world. A new paradigm had to be established where engineers and management considered the environment in every aspect of the design. Hundreds of managers, engineers and technicians were given a week of ecology training. Design standards were changed to include environment and remanufacturing codes. New processes were developed to support “product take-back” and complete end-of-life recycling. In turning this vision into reality, the Lakes program has provided Xerox with many lessons learned. These included establishing the necessary infrastructure all along the value chain, using consultants to break barriers and facilitate change, working with suppliers to achieve a common goal, and removing myths within the corporation to reflect reality. In short, changing the product design paradigm
    Electronics and the Environment, 1999. ISEE -1999. Proceedings of the 1999 IEEE International Symposium on; 02/1999
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The aim of the review was to analyze conceptual and operational aspects of systems for surveillance of adverse events following immunization. Articles available in electronic format were included, published between 1985 and 2009, selected from the PubMed/Medline databases using the key words "adverse events following vaccine surveillance", "post-marketing surveillance", "safety vaccine" and "Phase IV clinical trials". Articles focusing on specific adverse events were excluded. The major aspects underlying the Public Health importance of adverse events following vaccination, the instruments aimed at ensuring vaccine safety, and the purpose, attributes, types, data interpretation issues, limitations, and further challenges in adverse events following immunization were describe, as well as strategies to improve sensitivity. The review was concluded by discussing the challenges to be faced in coming years with respect to ensuring the safety and reliability of vaccination programs.
    Revista de saude publica 02/2011; 45(1):173-84. DOI:10.1590/S0034-89102011000100020 · 0.73 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: To assess a new, fully-liquid, hexavalent DTaP-IPV-Hep B-PRP-T vaccine (diphtheria toxoid (D), tetanus toxoid (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (Hep B), and Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (PRP-T) antigens) compared to a licensed DTaP-IPV-Hep B//PRP-T vaccine following primary series co-administration with a 7-valent pneumococcal conjugate vaccine (PCV7). This was a randomized, phase III, observer-blind study in Thai infants (N=412), who received DTaP-IPV-Hep B-PRP-T or DTaP-IPV-Hep B//PRP-T at 2, 4, and 6 months of age, co-administered with PCV7. All received Hep B at birth. Non-inferiority for Hep B ≥ 10 mIU/ml and PRP ≥0.15μg/ml was analyzed (DTaP-IPV-Hep B-PRP-T relative to DTaP-IPV-Hep B//PRP-T) at 1 month post-primary. Seroprotection/seroconversion and geometric mean titers (GMTs) were analyzed descriptively for all hexavalent components. Safety was evaluated from parental reports. Anti-Hep B and anti-PRP antibody seroprotection rates were high for DTaP-IPV-Hep B-PRP-T (n=189) and DTaP-IPV-Hep B//PRP-T (n=190), and non-inferiority was demonstrated. Anti-D and anti-T ≥ 0.01 IU/ml, anti-polio types 1, 2, and 3 ≥ 8 (1/dil), and anti-PT and anti-FHA seroconversion were high and similar in each group. For DTaP-IPV-Hep B-PRP-T and DTaP-IPV-Hep B//PRP-T, anti-Hep B ≥ 100 mIU/ml was 98.4% and 99.5% (GMTs 2477 and 2442 mIU/ml), respectively; anti-PRP ≥ 1.0 μg/ml was 85.2% and 71.1% (GMTs 5.07 and 2.41 μg/ml), respectively. Safety profiles were comparable. There were no vaccine-related serious adverse events. Following co-administration with PCV7 the investigational DTaP-IPV-Hep B-PRP-T vaccine was safe and immunogenic. Non-inferiority to DTaP-IPV-Hep B//PRP-T was shown for Hep B and PRP.
    International journal of infectious diseases: IJID: official publication of the International Society for Infectious Diseases 02/2011; 15(4):e249-56. DOI:10.1016/j.ijid.2010.12.004 · 1.86 Impact Factor
Show more