Peanut allergic patients are usually advised to avoid foods that are labelled as may contain peanut. A recent study by Madsen et al. (2012) has showed that it is understood and accepted by clinicians, patients and food producers that zero risk is not a realistic or attainable option [18]. However clinical risk communications that are not specific may increase anxiety and risk taking behaviours without increasing awareness, confidence or safety [7].
Okay-- this makes more sense now. I thought as much.
Two of the authors are Hourihane (he of the "epi is being WAyyyyyyyyy overprescribed" and "handing out epipens makes patients too nervous") and Taylor ("oil is free of protein"). In other words, they have a particular axe to grind here and have been doing so for YEARS.... in order to "prove" that some patients are just... erm-- "misguided" in their belief that low-level exposures are actually...
dangerous or anything. In other words, they are
admirably concerned that a majority of diagnosed patients are being freaked out unnecessarily, and avoiding WAY more than they need to. This
is probably the case. On the other hand, I think that most of their efforts are ripe for misuse and abuse on the part of those who would seek to deny needed accommodations and information to those at the very sensitive end of things, too-- and BOTH of these researchers have a long history of attaching their names to print information which is simply
not factual. In other words, it's rank speculation, and in the direction that they personally
prefer.Some of the interesting features-- only OBJECTIVE criteria for reaction are going to 'count' and some of what they consider "subjective" seems pretty harsh to me personally.
Inclusion criteria
Each patient must meet all of the following criteria to be enrolled in this study.
Age between 1 to 18 years old and
Demonstrate evidence of peanut allergy as defined by either
(a) History of unequivocal exposure (including accidental) and typical acute
allergic reaction within the preceding 2 years and positive peanut SPT/sIgE, or
(b) Positive oral food challenge with peanut performed within 2 years - either
open oral food challenge or DBPCFC (Double-blind, placebo-controlled food challenges)
(c) Peanut never ingested, but sensitisation to peanut above the 95% positive predictive value (PPV) for clinical allergy, i.e. peanut serum IgE ≥ to 15 kU/L (by CAP FEIA) and/or peanut SPT wheal size ≥ to 8 mm within 2 months of the single dose challenge.
Exclusion criteria
Patients meeting any of the following criteria will be excluded from the study
Family or child does not consent to participate
Medically unfit for challenge according to local unit OFC guidelines/protocol (e.g., high fever, unwell with intercurrent illness,
Any objective sign of an acute allergic reaction
Oral corticosteroids within 14 days prior to challenge
Episode of anaphylaxis of any cause in 4 weeks prior to challenge
Use of antihistamines within 5 days of oral food challenge
Asthma that is not well controlled as demonstrated by FEVI < 85% of predicted best
emphasis mine--
I still cannot fathom that anyone with a child like mine WOULD consent. Seriously. Honestly, given that they do not issue exclusion criteria related to severe anaphylaxis history, this is going to have to be SOME kind of "informed" consent to gain IRB approval, actually... which means that I doubt that they are going to capture the low end, particularly in younger children.
In a more positive note, though-- they do plan to ask such patients/families to fill out some kind of questionnaire re: their decision to opt out. No doubt that will all get rolled into "some families remain too anxious."
Given the authors heading things up, I think that VERY likely.
I wish that I could be more positive about that. But this study seems almost
intended to alienate and discredit families that refuse to participate by labeling them neurotic rather than rationally wary of provoking anaphylaxis in a protocol that will refuse to treat until symptoms become fairly severe.
positive OFC result are any objective signs occurring within 2 hours of ingestion. All objective signs will be recorded:
3 or more concurrent noncontact urticaria persisting for at least 5 minutes;
perioral or periorbital angioedema;
rhinoconjunctivitis
diarrhoea
vomiting (excluding gag reflex); or
evidence of circulatory or respiratory compromise (anaphylaxis eg, persistent cough, wheeze, change in voice, stridor, difficulty breathing, and collapse) [10].
I don't necessarily think that they are on the wrong track, by the way, with a single-dose challenge. Nor do I think that they are on the wrong track in establishing an ED
05. I just think that this study is designed to not be very sensitive to the fact that they COULD be way, way, WAY wrong about where that level actually is...
and either way, they may well be eliminating the 1%-ers, and it would really, really, really be awesome to know who those people are, and it seems to me that DOUBLE-blinding things would be a
much more sound means of doing this. Actually, there is a lot of anecdote to suggest that even doctors can be fooled by things on that list which are inherently somatic, when you look at what happens in DBPCFC.
