Help this study reach 1,000 participants!

I've written on this blog before about our family's participation in the Children's Memorial Food Allergy Study. I also feel a sense of obligation to encourage others to sign up, too, because they need 1,000 participants to make the whole thing worthwhile. (Well, that's not how they put it - I'm sure there's a more technical statistical term for it.) Anyway, I had been meaning to do something but finally today just got around to sending an email to certain friends attempting to drum up support. So I figured while I was at it that I would post some of the same information on this blog. (The info below is from the AllergyMoms.com website.)

According to a recent survey, 86% of all U.S. clinical trials fail to recruit
the required number of participants on time. Never have there been so many
studies of promising therapies for food allergies-but without qualified
participants, this life-saving research cannot move forward. By participating in
a clinical trial, your family will contribute directly to the search for better
treatments and a cure.

Of course, participating in a research study is
an important commitment. You're sure to have questions about the therapy being
tested, the medical exams you'll need to take, the demands on your time, safety
issues, and more.

To learn more, check out the following resources,
which provide information on current food allergy clinical trials, how these
studies work, questions to ask if you're thinking of participating, and more.

FAI
www.faiusa.org/clinicaltrials

FAAN
www.foodallergy.org/page/research-activities

To learn more about the specific study our family participates in, go to: http://www.childrensmrc.org/allergy/study/

Blood Test Results from Food Allergy Study

They told us it would take about 2 months to get back the blood test results from our participation in the food allergy study, and they were true to their word.

This is science-y stuff, so I'm not even going to attempt to summarize or paraphrase. I'm just typing in excerpts of what they mailed us now:

Interpretation of Blood Test Results

...The purpose of this testing is for an epidemiologic study and not for diagnosis.

IgE is the antibody that causes immediate hypersensitivity to proteins, such as foods or airborne allergens. The total IgE value is a general indicator of how "allergic" a patient is. For example, patients with hay fever (allergic rhinitis) or eczema (atopic dermatitis) may have an elevated IgE level. For total IgE, the lower limit of detection is 2.0kU/L and the upper limit is 5000 kU/L.

The blood tests called "CAP-RASTs" determine the quantity of IgE to a specific allergen. For specific IgE, the lower limit of detection is 0.1 kUA/L., and the upper limit is 100 kUA/L.. Values outside this range will be noted as "<0.1>100 kUA/L." Please note that CAP-RASTs, especially to foods, can be falsely positive. The main limitation of these tests is that a positive result does NOT necessarily mean that the food will trigger symptoms...

POSITIVE BLOOD TEST ALONE DOES NOT EQUAL DIAGNOSIS OF ALLERGY

Sometimes, CAP-RASTs can also lead to false-negative results (although a negative test result generally rules out an allergy)...

In addition, the blood test results do not reflect the severity of an allergy. A higher value does not mean that a reaction will be more severe. Rather, the value reflects the probability that you or your child may be allergic to that particular allergen: the higher the value, the more likely that the result is a true positive....

	Mother	Father	Daughter
Allergen tested	Value (kU/L)	Value (kU/L)	Value (kU/L)
Alternaria (mold)	<0.1	1.300	<0.1
Cat Dander	<0.1	<0.1	0.417
Cockroach	0.143	<0.1	0.102
Codfish	<0.1	<0.1	20.871
Dog Dander	<0.1	<0.1	0.110
Dust Mite 1 (Df)	<0.1	1.397	<0.1
Dust Mite 2 (Dp)	<0.1	0.872	<0.1
Egg White	<0.1	<0.1	0.887
Milk, Cow	<0.1	<0.1	0.672
Peanut	<0.1	<0.1	4.182
Sesame	<0.1	<0.1	6.615
Shrimp	0.236	<0.1	<0.1
Soy	<0.1	<0.1	1.148
Total IgE	16.151	23.727	108.137
Walnut	<0.1	<0.1	6.049
Wheat	<0.1	<0.1	4.020

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Okay - me here again. So, my thoughts on what we can take away from any of this:

--One more thing to keep in mind when looking at these results - you can't compare CAP-RAST scores for different allergens and infer that equivalent scores mean equivalent likelihood of being allergic (i.e., true positives). In other words, a 4.0 on peanut may not mean the same thing as a 4.0 on wheat.

--Obviously, we'll have to wait to get in to see the doc this fall for further testing and discussion, but Georgia's egg test result confirms my suspicion that she may have outgrown this allergy. I don't really know how to judge it, but that number looks low to me! I believe it's lower than her score from 2008, which is great news.

--Definitely true what they say about false positives, because I eat shrimp with no problems, and Georgia consumes milk, wheat and soy with no problems as far as we can tell.

--Based on what little I know of Peanut CAP-RAST scores, I am pleased with Georgia's score on that one. It's definitely well below the 95% certainty threshhold. It may indicate that even if she's allergic now that she's among the 20% of people who have a decent chance of outgrowing a peanut allergy.

--Bummer about the codfish score for Georgia. Her reactions to fish started around February or March, which was so weird, because she had been eating salmon with no problem and loving it for about 6 months prior to that. I wonder if or when we can find out which fish she's allergic to? We'll have to ask the doctor about that. I hope she doesn't have to avoid ALL fish forever.

Initial impressions of the Children's Memorial Food Allergy Study

Woops. I really had high hopes of coming home and recording our thoughts and impressions of our participation in the Children's Memorial Food Allergy Study on the same day that we did it so that everything would be fresh in our minds. Unfortunately, we were too busy that night, Georgia happened to get pretty sick the next day, and yada yada yada, here we are over 10 days later. Oh well, better late than never.

Believe it or not, this was our first ever trip to the local children's hospital since Georgia was born. (Knocking on wood as I type this....) The place seemed very nice, clean, and child-friendly, but of course there's something just sobering about setting foot in such a place and thinking of all of the immense joy, and hardship, and healing and suffering that is going on all around you. I wonder what it must be like to work there.

The folks running the food allergy study were EXTREMELY well organized. As soon as we told the ground floor information desk attendant that we were there for the food allergy study, she called upstairs to confirm that they were expecting us, and someone came down to meet us and escort us to the room where the tests would be conducted.

The setting was bigger than, and more stocked with all sorts of equipment than, a typical doctor's office, but it was not a regular hospital room, either. It did have a bed but did not feel super "hospital-y." We were surprised by the number of people involved in carrying out the whole appointment, but as I mentioned, they ran a tightly run ship and each seemed to serve a purpose.
In attendance in this room were:
--Georgia, Joe and me
--Deanna, who I guess you'd call the coordinator of the process - and the one asking all of the umpteen questionnaire questions of us
--2 nurses (or nurse practitioners? I'm nor sure of their titles) carrying out the height, weight, BMI, blood pressure, blood draw, and skin prick tests
--a student intern from Loyola, who in addition to observing gave Georgia a goody bag and tried to keep her happy
--another helper of some sort whose primary job was to tell Joe how to breathe during the lung capacity test

A few noteworthy things (and I'm compiling these from Joe's input and mine):

--Joe saw stars during the lung capacity test, which basically involves blowing really hard into a tube thing while this woman yells, "KEEP BREATHING! KEEP BREATHING! KEEP GOING! KEEP BREATHING! KEEP PUSHING!" at you the whole time to encourage you to reach your true max. Georgia didn't have to do this because she's too young; I didn't have to do it because I'm pregnant.

--Same is true for BMI -- only Joe had his tested (17%). Although, they did take my height and weight, and I made sure that they included a big "pregnant" annotation in their records!

--They had a tiny infant sized blood pressure cuff for Georgia. Joe had the lowest BP readings he's ever had. In his non-professional medical opinion, this was because he was holding Georgia at the time. "A natural sedative. It was like measuring the effect that holding a baby actually has on someone."

--The room had these small TV monitors that swung out on an arm, which they had tuned to cartoons in an attempt to keep Georgia happy and/or distracted. Great idea, but too loud. Also, they kinda spent their big ammo too early. I think they should've saved that distraction for the hard part (i.e., the blood draw), which was later during the appointment, rather than starting it during the simple blood pressure test, which was the first thing they did, and which Georgia didn't mind. The other funny thing about the TVs was that all of these nurse types totally knew all of the characters and songs and kept pushing the TV and getting all up in Georgia's face about it, like, "Oooooh! Super Pets!" (or whatever they're called), except that Georgia hadn't seen these shows before, so it was all lost on her. You'd think that due to not watching TV at home that she would've been enthralled, and I suppose she was for a few minutes, but really she doesn't seem to have "trained" her attention span for TV consumption yet, so it only worked for about 3 minutes at a time, if that.

--One of the biggest (and certainly most time consuming) parts of the session was orally answering a TON of questions. I expected this but the downside was that at times I felt like I was being pulled in two directions at once. Like, I'd be answering questions and have to stop and say, "Wait - I need to watch this," so as not to miss out on what they were doing to Joe and Georgia. The questions were of course about what Georgia eats and when she first started eating each food. But it was more than that -- lots of questions about all of our sleep habits, lots of very detailed questions about what I ate (and how often) while I was breastfeeding. I mean, really exact - like how many times per week did you have beans? how many times per week did you have orange vegetables? how many times per week did you have green vegetables? I tried my best to remember. Both Joe and I had to answer certain questions about ourselves, but for the Georgia or "family" questions I served as primary answerer. You know how it is with questionnaires when you can tell what they're trying to get at, but your literal answer doesn't quite fit? Well, that happened to us, and Joe and I sometimes found ourselves trying to answer the question behind the question - which of course was not what we had been asked to do. Like, for instance, when they asked us whether in the last 6 months your allergist had adequately explained our child's allergies, we were thinking, well, yes, the allergist is thorough and all, but no, we haven't had an appointment in over 6 months, so um....not sure??? That kind of thing.

--Skin prick tests were performed on Joe's forearm and on Georgia's back. With a single tool they pricked the skin in 8 spots at once. Joe says it felt like a bunch of tiny simultaneous pinches. Then they waited 15 minutes to test for any reaction and measured the "wheal" (aka, welt) size in any spot where a reaction occurred. Joe says the waiting period sort of felt like wearing a wool sweater in the heat - hot and scratchy. He only reacted to mold and dust mites. Georgia reacted to fish, wheat, egg, cat, peanut, sesame and walnut. (But keep in mind that a positive skin test doesn't necessarily mean an allergy -- we have never had trouble with feeding Georgia wheat or cats - har har.)

--The blood draw was the worst part. (Well, except for Joe's which went better than any he could remember. He said he didn't even feel it. Mine also went fine, and it did not hurt, but I do think that they screwed mine up a little bit because I ended up with a bruise for several days afterwards.) As for Georgia - they had to try two different times, once in each arm. She pretty much cried and screamed the whole time. Even when they just put that little rubber-band like tourniquet on her before inserting the needle. (Side note: we're talking maybe 2 tsp of blood here - nothing major.) The nurses looked nervous about dealing with her tiny veins and seemed to get easily flummoxed. I know that Georgia was more freaked out than she was in any real pain, but still, it's hard to watch your child go through that. Joe was more at peace than I was during Georgia's blood draw, I think because he was the one in charge of holding her in his lap, basically in a big bear hug to steady her arms. So, he knew that she was safe and snug. Rationally, so did I, but it was hard to just be standing there. Overall, though, I think we both hid our emotions, so I give us points for not being the type of parents that only further freak out their kid in a scary situation by looking freaked out themselves. Anyway, I would certainly recommend that other parents participate in the food allergy study and not get dissuaded by the prospect of the blood draw. That said, I was surprised that the woman who drew Georgia's blood was not a particularly "good stick" given that she works in a children's hospital. As she said herself, "the guys down in the lab could get blood from a rock." I don't know - maybe she was kind of new at it?

--Georgia actually asked to go home at one point, which was a first. I really think this had to do with her being a little bored and fed up with being in a small room for so long (about 2 and half hours, total) and not with actually being upset by the experience.

--I'm saving the best for last: We got free valet parking (on a day when it was pouring rain - woo-hoo!). We also got about $100 of Target gift certificates for participating! I knew that the study gave away gift cards to participants, (as a nod towards off-setting any travel expenses or inconvenience), but my understanding was that it would be a nominal amount, maybe $10 total. Well, maybe they're overstocked with donated gift cards or something, because I got home to realize that they had given us several more - and to a store where we'll actually use them!

Overall:
The study was well run and organized. Everyone involved behaved professionally and treated us and our daughter fantastically. It was a long morning, and a surprisingly tiring experience for all of us, but I would strongly encourage anyone else with a food allergic child to sign up and participate in this study. I have high hopes that the data they collect will one day lead to research breakthroughs, or maybe at least a clinical study.