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:
- 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.
- 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