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Author Topic: What constitutes a "FAIL"?  (Read 4112 times)

Description: Food Challenges with Medical Supervision

Offline ajasfolks2

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What constitutes a "FAIL"?
« on: March 05, 2013, 08:04:52 PM »
So, is it defined and published ANYWHERE as to exactly WHAT constitutes a FAIL on a food challenge in doctor's office or hospital setting?

Was this mentioned anywhere in recent seminars?

Or is this always highly individualized as to patient, history, AND the physician?

Comments and links, please!

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Offline booandbrimom

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Re: What constitutes a "FAIL"?
« Reply #1 on: March 06, 2013, 08:04:09 AM »
It definitely depends on the venue.

For the clinical trial, they had a list of observable symptoms they used. There were categories of them. I didn't see the list, but I know because at one point my son was feeling really terrible during one of the challenges but they kept (slowly) pushing because they were waiting for one of the objective symptoms to pop up before they could call it.

This is a real problem with food allergy challenges. Psychosomatic symptoms and panic attacks have many of the same subjective attributes as a real food allergy reaction. I understand how in many cases the doctors walk away and check the "pass" box while the parent walks away and checks the "fail" box.

I'm not blaming the patient in all cases...I do think there are situations where reactions build slowly or doctors miss symptoms. But really -- there's a huge disconnect here. We either need to get doctors and patients reconnected by pushing this testing longer/further, or asking parents to push harder through subjective symptoms.
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Offline CMdeux

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Re: What constitutes a "FAIL"?
« Reply #2 on: March 06, 2013, 10:08:18 AM »
OR--

and this is how our allergist INSISTS on conducting food challenges with my child, because of her particular anaphylaxis history:

with SINGLE-BLINDED PLACEBO CONTROLS.

That is, HE knows when he switches over to the allergen during the challenge-- but she does not.

Now, we haven't had a situation where low-level subjective symptoms have been an issue, but honestly, that adds to our credibility with our allergist.  That is, even in a challenge with a known (and historically quite potent) anaphylaxis trigger, she manifested pretty much NO somatic symptoms at all.  None.

Seriously, I think that more clinicians ought to run challenges this way.  Because this way they have a VERY good idea when to be concerned with psychosomatic things and when not to be-- that probably varies by patient and by allergen, and maybe by the environment on the day of the challenge.  But it has to be accounted for.

This is also very important when conducting challenges outside of a hospital setting with a person like my DD, who has a history of really rapid and unconventionally presenting anaphylaxis-- because there really are NOT a lot of early objective symptoms.  It's dangerous to push and wait for them when what you might be looking for is "loss of consciousness."   :-/

If it ever became an issue, I'd press our allergist for monitoring continuously (as opposed to periodically the way we've done them) in the ways that are most likely (in my experience) to show early objective warning signs-- pulse, pulse ox, and blood pressure. 
« Last Edit: March 06, 2013, 10:11:20 AM by CMdeux »
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Offline hopechap

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Re: What constitutes a "FAIL"?
« Reply #3 on: March 06, 2013, 07:43:17 PM »
I find it annoying that the Dr is not present for the challenges. A nurse walks in and out. We sit and watch. Then the Dr. reads chart on computer before appointment and has it all wrong as to what EXACTLY took place.

Offline CMdeux

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Re: What constitutes a "FAIL"?
« Reply #4 on: March 06, 2013, 07:47:24 PM »
Wow-- that is not how our doc runs his challenges.

He comes in about every ten minutes or so throughout the entire 3-5 hours.

Oh sure, the nurses check more frequently, and I can ALWAYS pop my head out of the room or give a holler and someone will be there in SECONDS.
Resistance isn't futile.  It's voltage divided by current. 

Western U.S.

Offline ajasfolks2

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Re: What constitutes a "FAIL"?
« Reply #5 on: March 07, 2013, 09:51:48 PM »
THANK YOU ALL!

I feel like I did back in 2000 when I was trying to find out exactly HOW and WHAT was even being tested in order to diagnose food allergy . . .

I want answers and a strategy.

More than that, SO DO MY KIDS!!

Is this where I blame iPhone and cuss like an old fighter pilot's wife?

**(&%@@&%$^%$#^%$#$*&      LOL!!   

Offline PurpleCat

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Re: What constitutes a "FAIL"?
« Reply #6 on: March 08, 2013, 08:10:56 AM »
Our office challenges were supervised by both an allergy nurse and the allergist.  The nurse was in and out of the room constantly monitoring DD the whole time and the doctor about every 30 minutes or so but available if needed and I saw her walk by and peek in a few times too.

In ours, there was no placebo.  DD knew what she was eating and how much.  She was actually curious.  She thought the hard-boiled egg was kind of cool looking.  She'd never been close to one before.  We made lots of jokes about the shrimp.   

She did not have symptoms due to fear or anxiety....I on the other hand was freaked but kept it to myself.

I think for DD, she just wanted to pass and that was what drove her to eat the foods.  I'm not saying she was not nervous, but for her, being nervous did not make her feel sick.  She also knew the nurse very well.  We have worked with the same nurses since her first allergy skin testing.  I think each child handles it differently and age is a factor too.

In our office, a pass was determined by no changes to DD's vital signs, no changes to her peak meter readings and oxygen levels, no skin rashes, no changes in her mouth and her ability to consume and hold down the foods.  We were there for 4 or 5 hours and not one thing changed.  She did not feel sick in anyway.  She was happy, alert, herself.

Months later, she her egg allergy did return.  So if none of those things changed and she passed, yet this happened, did she really pass?  I don't know how they could have know it would return based on what happened the day of the challenge and that there were no symptoms at home after.

As for shrimp, she continues to eat shrimp without incident.  I do hesitate when I serve it, but that is me....wanting to protect her.....why she can eat shrimp and not clam or lobster I do not know.  She is allergic to all dust mite species.  They are all in the same family.  So a little voice in me will nag....is this really ok.

Food allergies are a weird science and there isn't a good guide book.  Testing has never seemed clear to me.
« Last Edit: March 08, 2013, 08:13:29 AM by PurpleCat »

Offline LinksEtc

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Re: What constitutes a "FAIL"?
« Reply #7 on: March 08, 2013, 11:33:04 AM »
NIH Guidelines for the diagnosis and: management of FA (2010)

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"Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-Sponsored Expert Panel"
http://www.jacionline.org/article/S0091-6749(10)01566-6/fulltext

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4.2.2.8. Oral food challenges

Guideline 11: The EP recommends using oral food challenges for diagnosing FA. The DBPCFC is the gold standard. However, a single-blind or an open-food challenge may be considered diagnostic under certain circumstances: if either of these challenges elicits no symptoms (ie, the challenge is negative), then FA can be ruled out; but when either challenge elicits objective symptoms (ie, the challenge is positive) and those objective symptoms correlate with medical history and are supported by laboratory tests, then a diagnosis of FA is supported.

Rationale: DBPCFC is the most specific test for diagnosing FA. However, due to the expense and inconvenience of DBPCFCs, single-blind and open-food challenges may be used in the clinical setting.

Balance of benefits and harms: The DBPCFC markedly reduces potential bias of patients and supervising health care professionals that may interfere with the appropriate interpretation of oral food challenges, and corresponds most closely to the natural ingestion of food. Other diagnostic tests lack specificity and may lead to the unnecessary exclusion of foods from patients' diets. However, the DBPCFC is time consuming, expensive, and, like any form of oral food challenge, subjects the patient to potential severe allergic reactions. Single-blind and open-food challenges are frequently used to screen patients for FA. When negative, they may be considered diagnostic in ruling out FA, and when positive (ie, when “immediate” objective allergic symptoms are elicited), they may be considered diagnostic in patients who have a supportive medical history and laboratory data.

Quality of evidence: High

Contribution of expert opinion: Moderate

Note: Because of the inherent risk, an oral food challenge must be conducted at a medical facility that has onsite medical supervision and appropriate medicines and devices on hand.

A positive SPT or sIgE test result is indicative of allergic sensitization, but these findings alone may or may not be clinically relevant. Most investigators in the field agree that verification of clinical reactivity requires well-designed oral food challenge testing.102, 103, 129, 130, 131, 132, 133

Prior to initiating an oral food challenge, suspected foods are eliminated from the diet for 2 to 8 weeks, depending on the type of food-induced allergic reaction being examined (for example, urticaria vs EoE).133, 134 All foods in question must be strictly avoided simultaneously. An infant's diet can be limited to a hypoallergenic formula. For exclusively breast-fed infants, either the suspected food is eliminated from the mother's diet or the baby is fed a hypoallergenic formula until the allergic food is identified.

After documenting significant improvement on dietary elimination, the challenge test is carried out while the patient is on minimal or no symptomatic medication. The test should be designed and performed under medical supervision to document the dose that provokes the reaction and to administer symptomatic treatment, which may require management of anaphylaxis (section 6), and the medical personnel should have experience in carrying out such challenges. Oral food challenge begins with a low dose (intended to be lower than a dose that can induce a reaction135, 136). While monitoring for any allergic symptoms, the dose is gradually increased, until a cumulative dose at least equivalent to a standard portion for age is consumed. The challenge may be carried out in an open fashion in infants, but in older children, single-blind food challenges or DBPCFCs may be necessary to minimize patient and physician bias.

Using DBPCFC, several studies have shown that only about one third of the suspected foods are found to be truly allergic.103 In addition to verifying FA, challenge testing prevents unnecessary dietary avoidance and enhances compliance with the elimination diet. Nevertheless, because of the risk of a severe reaction, intentional challenge should be avoided in patients who have recently experienced a life-threatening reaction to a particular food, particularly if it occurred more than once. In the case of post-prandial exercise-induced reactions, food challenge should be followed by exercise.92

There is currently no internationally accepted, standardized protocol for performing and interpreting DBPCFCs, although reviews outlining benefits and deficiencies have been published.133, 135, 136, 137

Offline LinksEtc

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Re: What constitutes a "FAIL"?
« Reply #8 on: March 08, 2013, 11:43:43 AM »
I'll cross ref this here also since, although rare, there can be a fail after a pass.

Allergy after passing peanut challenge?

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One article in there has a lot of other good info on OFC:
"Oral food challenges for diagnosis and management of food allergies"
http://www.uptodate.com/contents/oral-food-challenges-for-diagnosis-and-management-of-food-allergies

« Last Edit: March 08, 2013, 11:48:00 AM by LinksEtc »

Offline Macabre

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Re: What constitutes a "FAIL"?
« Reply #9 on: March 08, 2013, 01:03:16 PM »
You are so nice to have around Links.  I'm so glad you're a part of this community.  :yes:
Me: Sesame, shellfish, chamomile, sage
DS: Peanuts

Offline LinksEtc

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Re: What constitutes a "FAIL"?
« Reply #10 on: March 08, 2013, 02:49:35 PM »
You all have been so kind to me lately <blush>

It's great to have a community like this to be a part of.

 :grouphug:



Offline ajasfolks2

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Re: What constitutes a "FAIL"?
« Reply #11 on: March 08, 2013, 03:23:13 PM »
Amen, sister Mac, amen!

Is this where I blame iPhone and cuss like an old fighter pilot's wife?

**(&%@@&%$^%$#^%$#$*&      LOL!!