Hmmm…a Study About INR Machine Inaccuracies in APS Patients
First of all, has it been over a year since I’ve posted here?? I can’t believe that!!! I do have a few stories to add and will during the next week, but first I need to comment about this study that i ran across this evening.
http://clinicaltrials.gov/ct2/show/NCT00878137?cond=%22Antiphospholipid+Syndrome%22&rank=8
Ok…a few things about this study.
I do think it’s good that they are conducting a study and collecting data. I don’t know that 2 months is long enough to collect "accurate” data, but what do I know.
I don’t like a few things about it though…#1, the study is by “Invitation Only”…hmm, wonder why that is. And #2, the study is being run by ITC, who, if you will recall, had a recall of their machines in 2007. http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900
So…why the Invite Only? And who’s doing the inviting?
Are they getting a good mix of patients? Who knows…
I guess we’ll have to wait for the results of the study to come out.
Sounds like a bunch of butt covering to me.
Also, then there’s going to be the issues of certain people who sing the praises of such machines, despite their obvious problems with APS patients (I mean, it’s even written in their machine inserts!). If this study should prove there to be no issues with these machines and APS patients, I am pretty sure that those people are going to take the study results as gospel and run with it!!
In my opinion, if this study does “prove” these machines to be accurate, it’s still questionable and I’d still not trust it with MY life. I’ve done side by side comparisons, I’ve seen the differences between machine vs vein draws. I’m not going to be one of those “add .5 to the results on the 2nd Wednesday of the month and minus .3 on the 3rd Friday” type of people. 66% is not enough.
I’ll be awaiting the results and will update when they come out. I’m curious to see what the findings are.
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