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MC, 20110126: class renamed from "adverse event following immunization continuant" following AR suggestion

MC, 20110126: this should be linked to the different adverse events reported. AR suggests using a new relation to appear in BFO2, maybe "ascription"

20121115, MC: originally "a categorical measurement datum whose instances are used to classify adverse events according to whether or not they have some likelihood of being a seizure and if so, to what degree"

MC, 20110120: This class was initially labeled "adverse event continuant". After discussion with AR, and due to the fact that the word "event" implicitely refers to a process, we renamed this class.

I initialy made adverse event a defined class: is_a sign and preceded by administration. However, by doing so, and as the range of preceded by is processual entities, I was implicitely making adverse event a subclass of processual entity, therfore making adverse event rash (a continuant) inconsistent.

temporary placeholder - to be removed This class just helps me group some terms during development of the structure

I included the usage of a device into the definition of adverse event as I am aiming at being inclusive, and cover cases such as those described by MAUDE - Manufacturer and User Facility Device Experience. See for example http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1942591 - a patient get fitted with bioprosthetic heart valves and dies within the following 4 months.

MC, 20110126: this needs to be linked to the Brighton guideline defined under directive information entity

MC, 20110126: this needs to be linked to the Brighton guideline defined under directive information entity

MC, 20110126: this needs to be linked to the Brighton guideline defined under directive information entity

MC, 20110126: The Brighton guideline on which this is based needs to be checked. Email correspondance with Brighton: [MC] One thing is unclear to me: Level 1 of diagnostic certainty is defined as "witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic–clonic, or atonic motor manifestations." A footnote adds: atonic in the absence of: hypotonic hyporesponsive episode (as defined by the Brighton Collaboration), syncope, and myoclonic jerks.

If we define syncope as being a loss of consciousness, how can I have a witnessed sudden loss of consciousness and a generalized atonic motor manifestation in the absence of syncope?

[Brighton] Thank you for your question. You are right, that there is an overlap between the clinical presentation of an atonic seizure and a Syncope. This is also true for HHE. This is the very reasonf or the footnote to alert the user of the definition to this differential diagnosis.

If you are working on a database and only have the clinical criteria vailable, you may have some false positives for the atonic seizure cases, unless you obtain additional information, e.g. that the Syncope was vasovagal or orthostatic, or arrhythmic, etc.

MC, 20110126: AR suggest that "history of consciousness is not a process. definition reads "the sudden loss of consciousness was not observed, but the patient was found unconscious", so maybe updating the label would be better : "unwitnessed loss of consciousness with history of unconsciousness" would help

while in some cases the particular may not be actually caused by the intervention, it is an adverse side effect nonetheless.

20130423, MC: in the anaphylaxis case definition, angioedeme can be localized or generalized. There was no need as of today to create specialized subclasses representing those.

20120821, MC: placeholder for development

loss of counsciousness is a subclass of decreased consciousness, so saying "is about some decreased level of consciousness" I cover all cases

The reduced peripheral circulation diagnosis is the minor cardiovascular criterion for anaphylaxis according to Brighton. The diagnosis is established by observing the combination of at least 2 reduced peripheral circulation findings, but at most one of each type.

Following the ICPE meeting in Montreal 2013, MC clarified with JB that the guideline should be understood as "if there is a minor cardiovascular criteria, then we need 2 other systems involved, including respiratory, dermatologic, gastrointestinal and laboratory" and similarly if there is a respiratory criteria. The first iteration was interpreted as (1 minor cardiovascular OR respiratory criterion) AND 2 minors from systems that are neither respiratory nor cardiovascular (dermatologic, gastrointestinal , laboratory systems) to mimic behavior of the ABC tool.

Following meeting at ICPE Montreal 2013, MC and JB clairfied that "difficulty breathing without wheeze or stridor" should be understood as "difficulty breathing"

Following meeting at ICPE Montreal 2013, MC and JB clairfied that "genralized pruritus withou rash" should be understood as "generalized pruritus"

20130912: In the paper http://dx.doi.org/10.1016/j.vaccine.2010.04.041 "Can the Brighton Collaboration case definitions be used to improve the quality of Adverse Event Following Immunization (AEFI) reporting? Anaphylaxis as a case study", the form used by PHAC and shown in Appendix E states as a footnote "for level III, a skin MAJOR can count as a minor criterion"