I just noticed that we are really saying close to the same thing, but what got me was that we both chose the "crazy" icon to represent how we feel about this topic.

Kewl!
Peg

Peggy,

Thank you for saying this out loud- it needs to be addressed by the AAN or FDA or whatever acronymic bureaucratic beasty oversees our research design and trials. I've been wondering this question for some time now-especially as I had to go through a 12 hour drug washout to be re-evaluated by a new neurologist-I worried he would try to 'stage me' and be off given rebound effect and such. I survived it and it was an eye opener. It led me to think of how this washout is used in clinical trials and just how precise then are those 'readings' and 'scores'?

Given the imprecise tools used for measuring both disease stage and disease progression (paper and pencil, some observation, and an arbitrary rating scale) - what is it Hahn & Yahr plus the UPDRS (Parkinson's Disease Rating Scale)? I'm in amazement at over how subjective one of these measurement tools might be -they are solely based on interview and clinical observation, and how rather unscientific it all really is in practice. I simply can't believe all the hulabaloo the research community and clinicians make over the results of clinical trials given the very inexact, unscientific rating tools employed in testing us. I can't even think of how this affects placebo- we can't even be assured that the measuring and staging tools are accurate, so how can there even be any 'control group' in the first place?!?

Again, we ask "why aren't more sophisticated diagnostic and testing tools being developed and used as a standard source of measurement in our clinical trials?" SPECT scans may not be perfect, but they are a far cry more an accurate reflection of disease stage and progression than anything else we have- last I checked the literature, these actually measured striatal dopamine levels in our noggins'. Imagine if they did use these more precise images of our brains to conduct research; I think they may just begin to find commonalities and anomalies in our brains that could actually lead us on the road to a <gasp> cure!

Who wants that?

This also begs the question, how can we be certain that our trial participants all conform to the same disease stage when designing a research trial. If we can't be sure that our subjects are all in the same general stage of the disease, don't we lose our test validity in a major way? I suppose it will be pointed out that we turn to levadopa naive PWP to represent the early course of the disease but given how variable this disease treats us all in the first place, isn't this an overly simplistic approach? Do they also choose Parkinson's newbies who have been diagnosed for five years or less?

I'm with you Peg- this whole research thing rests on quite a precarious ledge.

The reality is for some reason, SPECT scans are not routinely used in staging or marking progresion? There must be reasons for it. Anyone know?

JeanB or any other kind soul who has participated in clinical research...could you please share with us just how researchers select participants and accurately stage them beyond using paper and pencil rating scales? If this is all we have to go on could we please use Rick's Misery Scale? I think this most accurately captures how we all feel at this point :P

Laura

Laura said: I simply can't believe all the hulabaloo the research community and clinicians make over the results of clinical trials given the very inexact, unscientific rating tools employed in testing us.

I woke up to correct my math in an earlier post, so I may as well reply to you. Very well said, BTW. Yes the Hoehn and Yahr is used, but is worthless for any kindn of research in my opinion. One can be staged (on a scale of 0-5) at stage 3 juat by having balance problems.
From Wikipedia: (hope this isn't copyrighted.)

The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The scale allocates stages from 0 to 5 to indicate the relative level of disability.

Stage zero: No signs of disease.
Stage one: Symptoms on one side of the body only.
Stage two: Symptoms on both sides of the body. No impairment of balance.
Stage three: Balance impairment. Mild to moderate disease. Physically independent.
Stage four: Severe disability, but still able to walk or stand unassisted.
Stage five: Needing a wheelchair or bedridden unless assisted

I remember the staging using this scale was set at 3.0 - or higher in the study I participated in at Emory. So I know it has been used as part of the protocol.

Also, the UPDRS has been under scrutiny for some time, as the doctors recognized there was too much play subjective areas. But hey; we are even DIAGNOSED using observation only (and what the patient tells the doctor)!

As far as Spect scans, they are still not sure how accurate they are (but how accurate can "observing" be?), and the scans are very expensive. Did you know it costs around $800 million - or it may be up a billion - to market a drug from lab to shelf?

Now, about this question: If we can't be sure that our subjects are all in the same general stage of the disease, don't we lose our test validity in a major way? A statistician would tell you that this can be taken of (validity) if the formula used is correct and the power is correctly applied. They need to explain that to me a little better.

But for real, we can do little more than whine until someone of power and influence (Hmmmm - thinking) makes a move on these obvious deficiencies. And until changes are made, we won't find the cure. That's the way it's been for 40 years (sigh)

Thanks for your support guys and gals, now let's kick brains (cleaned that up lol)

Peg back to zzzzzzzzzzzzzzzzzzz

Jaye wrote:
“WHAT neurologists manage total care for PD patients?? I'd rather have a psychiatrist as my primary, since they are right there with us where the rubber meets the road, and notice how things affect us. Our disorder falls squarely into the chasm between neurology and psychiatry, IMHO, so why deprive us of a GP or internist to referee the proceedings?”

When I received the PAN Action alert, I scratched my head and also wondered if my neuro was to become my primary care provider if the amendment was passed? In fact on a number of occasions when I asked her (A Movement Disorders specialist) about other problems like neck and shoulder pain, a referal for physical therapy, disc poblems (all of which I think are related to PD) she told me to see my primary care provider (i.e. Family Medicine doctor) for the referrals and that she “didn’t deal with pain management.”
Will this amndment change the way PWP receive treatment from their neuros?

I did a litle web searching and found that the “bonus pay” really is about Medicare reimbursement. Doctors who “provide a high percentage of evaluation and management “are eligible for higher reimbursement s from Medicare, I found the amwndment was initiated by the American Academy of Neurology earlier this year --see http://www.aan.com/news/index.cfm?ev...rticle_id=8564

But now is being heartily advocated for by most of the PD orgs, and many of the other neurological disease advocacy groups – epilepsy, ALS, headache etc. who have initiated a coordinated email campaign to the Senators . I’m not against our neuros receiving fair reimbursement, but It seems what they mean by “primary care” is not the same meaning that Jaye and I were thinking of. Could we expect our neurologists to cooordinate all our medical problems and manage our PD in the usual 15 minute visit? I don’t think so, but given the general understanding of the term “primary care physician” the amendment is vague about what it really means to patients. Wondering if any of the orgs discussed the amendment with patients before initiating the email campaign? Mainly will Medicare bonus payments to neurologists help PWP receive better and coordinated care and how?

says it all! Quoting LindaH:
"Mainly will Medicare bonus payments to neurologists help PWP receive better and coordinated care and how?" AMEN and AMEN AGAIN!

Veryu well, said, Linda, and I am wondering what the deal is here w ith the ANA and orgs pushing th is thing.


I guess those living with the disease will be the last to know!

Peg

That ended with a punch!


paula

Linda,

Thanks for the further clarification. I noticed too that other "brain orgs" were also calling for action in notifying our legislators. I thought leaving out neurologists may in fact impact our care, but I don't necessarily think that is the case. What dismays me in our posts here about neuros and in our discussion on the role of the neuro in our care is that it only highlights how woefully under-served we are as patients. Given all that affects us systemically with PD; behavior, sleep, diet, motor symptoms, we should have a team of doctors coordinating our care- this holistic approach is now starting to take shape in places like Maryland, Seattle (I think Carey has posted on this), etc- there are centers starting to design a treatment approach that is much more reflective of what we need. I'm hoping this becomes the norm eventually, so we can worry about revising the Health Act then

Laura