Thanks for all the responses. I?m glad I?m not the only one  
struggling with this.

If I try to summarize what I?ve learned form these responses is that  
there is ?real? data (although that also can be subjective scales  
f.i. for pain) and there is a ?personal? interpretation that can make  
the data ?trustworthy and therefore re-useable by others.
As far as I?m concerned my questions aren?t about accuracy itself.  
That part will be taken care of by the certifying instance. A device  
can only be certified if its accuracy is within a certain tight  
bandwidth. They?re also not about modelling data reliability. They?re  
about modelling trust by applying quality systems.

My point is that if we?re not able to provide ?trustworthy? data for  
large groups of healthcare providers people will only use data  
provided by themselves or their ?trusted? peers. All other data will  
be ?rejected?. The latter will even become an argument against the  
use of EHR?s when healthcare providers will be forced to ?compete?  
for efficacy. In order to maintain an affordable healthcare system  
healthcare professionals will be forced to re-use data generated by  
others. This then could result in (the perception of a) lower income  
for the ?user? of that data. In such circumstances ?lack of trust?  
will be a strong argument against re-using data. If data can?t/ won?t  
be re-used what?s the use of an EHR and why should society invest in it.

Therefore it?s important to install quality assurance systems that  
prove that data is trustworthy. Luckily there is a lot of experience  
with such quality systems, for instance in clinical research used for  
the development and testing of potentially new pharmaceuticals (GCP,  
GMP, GLP). Also in most clinical laboratories quality systems are in  
place and working well.

The crux of a quality system is that al parties involved agree upon  
what the criteria are for ?something? to become reliable. I agree  
that it can be cumbersome to establish those criteria (although in  
many cases they?re already known, f.i. see the NHS criteria for ?self  
blood pressure measurement at home). I disagree with the suggestion  
that it will become an infinite loop, with the possible exception of  
experimental and non-regular processes. In a normal situation every  
aspect in a process has criteria and those can be described. If they  
can?t be described one should seriously reconsider what he?s doing.  
Without criteria it becomes a lottery: the lucky ones win something,  
but most people will leave empty handed.


So I guess I have several questions, which I try to separate.

The first part is: how/where can we add the accessory data that  
necessary to establish data quality. As Thomas pointed out, most of  
these things are already recorded. In would like to have clarity on  
to things:

1. device information (calibration, maintained etc, etc.). Thomas  
suggested that one should store those in the protocol part of an  
observation. That?s a possibility but then one has to fill out that  
data every time an observation is made. Imagine a GP that performs 20  
blood pressure measurements per day. I?m certain that that?s not  
going to work.
Sam suggested that you could re-use this data once it?s registered  
once (and unchanged) with a cluster. Sam can you please explain how  
that works/ could work. I don?t really understand that cluster  
concept well enough.

My suggestion to create a separate archetype (similar to the  
demographic one) originates from the idea that (especially in  
hospitals) devices will be maintained by a technical staff (third  
party). This could result in a situation where a health care provider  
doesn?t know all this details about calibration and maintenance and  
therefore is unable to provide that data. This service person should  
be the one to record data for that device.
On user interface/ application level the healthcare provider will get  
a reminder if (based on the data in that device archetype) the device  
isn?t calibrated/maintained properly. In that case the device  
shouldn?t be used, because its ?outcome? isn?t trustworthy.

So if we can do all of this through a cluster and everybody feels  
that?s the way to go, it?s fine with me. If not I still would suggest  
creating a separate device archetype.

2. capabilities of a non-professional, f.i. to determine whether  
someone is capable of self-measuring x, y or z. Here in the  
Netherlands patients determine their INR by themselves at home and  
adjust their medication accordingly! One can imagine that you want to  
test the capabilities of that person rigorously on forehand. If they  
pass that test, they?re capable I my suggestion is to store that  
capability a part of the demographic archetype. Thomas stated  
?whether the person who did the observation is professionally capable of

doing it is another matter not really controllable by the ICT alone

(other than by access control).? This remark I don?t understand  
either. Thomas can you please elaborate on that. Form what I  
understood form the demographic IM , there is a capability class in  
which ? the qualifications of the performer of the role for this  
capability?. I guess my question is, is there a role self/ citizen/  
non-professional (I don?t know how we should call that role) and can  
we attach capabilities to that role?

The second part is about the data quality criteria. Although these  
criteria are subjective, they?re real and useful for the parties who  
agreed upon those criteria. Look for instance at the ?report of the  
independent advisory group on blood pressure monitoring in clinical  
practice? by the MHRA.  This is an example of quality criteria one  
could agree upon. Based on such criteria one could rate the recorded  
data as good or poor (or even an more refined scale if required)
Now my question. Where can/ should we store such a data quality  
marker. I figured that since these are local/subjective criteria you  
don?t want to put them in the original/ root archetype that?s  
intended for ?worldwide? use. So my suggestion is to create a ?local?  
specialization of this root archetype in which both the criteria and  
the data quality label are added (see my previous mail).
Is this a good suggestion and if not where can I store that data  
after all. I don?t want to create a second system for this and in my  
opinion this type of data belong somewhere in an EHR.


Cheers,

Stef
  
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