Spontaneous reports on anaphylaxis : the applicability of Brighton case definition

Anaphylaxis is a clinical diagnosis with no gold standard confirmatory investigation. The need to have a uniformly accepted case definition for anaphylaxis led to the development of the Brighton definition [1] for anaphylaxis following immunizations (Box 1). It ascertains diagnostic certainty and classifies it into 3 levels. The level 1 classification is associated with the greatest diagnostic certainty. The objective of this study was to examine the applicability of the Brighton case definition to drug induced anaphylactic reactions.

Over the period of 13 years, 58 cases have been reported as anaphylaxis.Of these, 39 (sensitivity = 67%) fulfilled the Brighton case definition for anaphylaxis; 12 with level 1, 23 with level 2 and 4 with level 3 diagnostic certainty.The mean age of the patients was 36 years with
The Brighton case definition for anaphylaxis following immunisation is applicable with high sensitivity for spontaneous reports on drug induced anaphylaxis.However the number of reports assessed as level 2 diagnostic certainty is almost double the number of reports assessed as level 1.This was mainly due to missing data in the reports because detailed records of clinical manifestations are required to apply the Brighton case definition for anaphylaxis.In the absence of detailed records of symptoms, chances are high that the anaphylaxis being classified as level 2 rather than level 1.The routine

Research letters
ADR form if completed properly should capture all the information which is necessary to ascertain the diagnostic certainty.Since there will be no missing data in the reports, cases can be accurately classified as level 1 or level 2 diagnostic certainty.However given the workload and time constraints, health care personnel in Sri Lanka are unlikely to spontaneously report enough symptoms and signs to allow application of the Brighton case definition which was clearly evident in the ADR forms analysed.
A checklist, based on the terms used in the case definition, should be developed in order to remind health care personnel to note whether specific features of anaphylaxis were present.An anaphylaxis reporting form should be designed by incorporating this checklist into the routine ADR form, and used in spontaneous reporting of anaphylaxis.This would allow subsequent classification using the Brighton case definition and yield more reports with higher degree of diagnostic certainty.
Case fatality rate of 22.4% could be an overestimate as fatal cases would be reported more than the non fatal cases.However, it is higher than what is reported in the literature

For all levels of diagnostic certainty
Anaphylaxis is a clinical syndrome characterized by • 1 minor cardiovascular OR respiratory criterion AND • 1 minor criterion from each of  2 different systems/categories (1%) from many population based studies prompting further investigation and interventions [3,4,5].

Level 3 of diagnostic certainty
1 major cardiovascular AND 1 major respiratory criterion OR • 1 major cardiovascular OR respiratory criterion AND • 1 minor criterion involving 1 different system (other than cardiovascular or respiratory systems) OR • (1 major dermatologic) AND (1 minor cardiovascular AND/OR minor respiratory criterion)