protocol definition (was maximum heart rate)

Is a protocol a cluster archetype or a component of an observation?
http://www.openehr.org/137-OE.html defines the term ‘protocol’ as an attribute of CARE_ENTRY.

A clinical trial protocol document may define a collection of trial specific observations (as used in the openEHR protocol sense), for example a trial specific definition (e.g. of an MI) or reference ranges of blood chemistry that differ for males and females and by country of birth, or a new procedure not yet in SNOMED.

A ‘Protocol’ cluster archetype seems to me to be a ‘protocol document’ or a reference set of such specialisations.

Or am I trying to overload too much onto the meaning?

Colin Sutton
NHMRC Clinical Trials Centre
http://www.ctc.usyd.edu.au

Hi Colin

Yes - this name for the data that relates to how the information was collected or other ‘extraneous’ information that does not impact directly on the health of the patient (but does potentially attest to the ‘quality’ of the data) is called protocol. It is used in research as well as you have stated but is not really of this type.

A CLUSTER imbedded in a protocol would generally allow reuse of some protocol information across a lot of CARE_ENTRY instances (obs, eval, act, intr).

So you are overloading too much here… There is a guideline ID that can be recorded which does provide something of what you seek - otherwise it will need to be recorded in the protocol. (Enrolled in study X)

Cheers, Sam

Colin Sutton wrote:

(attachments)

OceanCsmall.png

Hi all.
Does not the protocol definition discussion belong here?
http://www.openehr.org/wiki/display/healthcare/openEHR+Healthcare
+Dictionary

I would say that a protocol is a clinical guideline that has been
adapted to suit a local context (e.g. if the local hospital do not
posess a resource that is described in a clinical guideline (e.g.
"MRI of the aorta in an aortitis management guideline") it may choose
an alternative resource to be described in the protocol (e.g CT of
the aorta)).

Protocol in the context of a randomized clinical trial (RCT) falls
outside the context of individual-directed healthcare. In RCTs, the
healthcare actors actions are conducted with the purpose of inferring
new knowledge (e.g. what is the effect of drug x on patients with
disease y). The purpose of these actions are not to solve an
individual patients health problem but to explore a scientific
hypothesis. A clinical trial protocol is a plan which describe the
clinical data that should be collected and recorded when enacting the
protocol/plan.

A guideline is a universal / class.
A protocol is an inventory (?)
A plan is an instance of a guideline and/ or a protocol
A healthcare plan is a description of which healthcare acts should occur
A healthcare act may or may not have been described in a healthcare
plan before it is enacted
A healthcare act may or may not have been conducted according to its
description in the plan.
What shall end up in the documentation – the description of the
healthcare act - is what actually happened with the patient and not
what was supposed to happen with the patient.

what U think?

regards
Arild Faxvaag

Hi all.
Does not the protocol definition discussion belong here?
http://www.openehr.org/wiki/display/healthcare/openEHR+Healthcare
+Dictionary

I would say that a protocol is a clinical guideline that has been
adapted to suit a local context

Agreed

(e.g. if the local hospital do not
posess a resource that is described in a clinical guideline (e.g.
"MRI of the aorta in an aortitis management guideline") it may choose
an alternative resource to be described in the protocol (e.g CT of
the aorta)).

Protocol in the context of a randomized clinical trial (RCT) falls
outside the context of individual-directed healthcare. In RCTs, the
healthcare actors actions are conducted with the purpose of inferring
new knowledge (e.g. what is the effect of drug x on patients with
disease y). The purpose of these actions are not to solve an
individual patients health problem but to explore a scientific
hypothesis. A clinical trial protocol is a plan which describe the
clinical data that should be collected and recorded when enacting the
protocol/plan.

A guideline is a universal / class.
A protocol is an inventory (?)
A plan is an instance of a guideline and/ or a protocol
A healthcare plan is a description of which healthcare acts should
occur
A healthcare act may or may not have been described in a healthcare
plan before it is enacted
A healthcare act may or may not have been conducted according to its
description in the plan.
What shall end up in the documentation – the description of the
healthcare act - is what actually happened with the patient and not
what was supposed to happen with the patient.

This is correct. Healthcare plans belong in a separate 'workflow
management system (WMS)' that 'instruct/ suggest' what should happen
and 'oversees' what has happened. This is not part of the EHR itself
and should be registered elsewhere. Nonetheless it is an important
feature to support and (qualitity) management of procedures, which
most healthcare providers might want to have.

In my opinion a WMS for routine and clinical trial purposes will
function similarly but with different guidelines/ protocols.

Cheers,

Stef

Hi Stef,

This is correct. Healthcare plans belong in a separate 'workflow
management system (WMS)' that 'instruct/ suggest' what should happen
and 'oversees' what has happened. This is not part of the EHR itself
and should be registered elsewhere. Nonetheless it is an important
feature to support and (qualitity) management of procedures, which
most healthcare providers might want to have.

In my opinion a WMS for routine and clinical trial purposes will
function similarly but with different guidelines/ protocols.

Cheers,

Stef
  

I don't get your point when you write that "suggesting what should
happen" and "overseeing what has happened" shouldn't be part of the EHR
itself.
To make it short, what remains if you put this away?

Cheers,

Philippe

Hi Phillipe

Hi Stef,

This is correct. Healthcare plans belong in a separate 'workflow
management system (WMS)' that 'instruct/ suggest' what should happen
and 'oversees' what has happened. This is not part of the EHR itself
and should be registered elsewhere. Nonetheless it is an important
feature to support and (qualitity) management of procedures, which
most healthcare providers might want to have.

In my opinion a WMS for routine and clinical trial purposes will
function similarly but with different guidelines/ protocols.

Cheers,

Stef

I don't get your point when you write that "suggesting what should
happen" and "overseeing what has happened" shouldn't be part of the
EHR
itself.

Rethinking this I think I see you point: the steps in the guideline/
protocol are instructions, which are part of the EHR and the protocol
itself should also be a part of the EHR as well. A WMS merely
executes those instructions.

Yesterday we had a lengthy discussion about quality assessment for
management purposes: f.i. how many people in ward A have post-op
wound infection and how does that relate to the overall rate of wound
infection. This typically doesn't belong in an EHR but in a separate
system. I was mixing these two things up:-)

As for the clinical trial data and guidelines. Reasoning along the
line above, this also should belong in the same EHR since it's about
(the treatment, albeit experimental) of a patient.

Cheers,

Stef

Hi all,

Remember.

EN13606, openEHR are about documenting by a healthcare provider what he has (or want) to document about the treatment of his patient in an EHR.
So any investigation or treatment protocol, used as a plan, is part of the EHR.
Based on the protocol

And is not about a complete hospital information system, a system to perform quality control management related information.
Although these types of systems will use data and information documented in the EHR.

When talking about these concepts may I point at the European Norm System of Concepts for Continuity of Care. (ContSys)
The next url downloads the definitions.
http://tinyurl.com/2gfm42

The next url download the complete ContSys standard
http://tinyurl.com/2xx7g4

The next couple of relevant definitions occur in ContSys:

3.1
activities bundle
internally consistent set of health care activities (3.39) to be performed, being performed, or having been
performed for a subject of care (3.89) by one or more health care providers (3.52), in the context of one or
more care plans (3.6), within the framework of a programme of care (3.76)

3.6
care plan
description of planned and duly personalised activities bundles (3.1), addressing one or more health issues
(3.55), and encompassing all health care activities (3.53) to be provided to a subject of care (3.89) by one
health care professional (3.49), or several health care professionals having the same health care
professional entitlement (3.51)

3.10
clinical guideline
set of systematically developed statements to assist the decision of health care parties (3.48) about health
care activities (3.39) to be provided with regard to a health issue (3.55) in specified clinical circumstances

3.39
health care activity
activity performed for a subject of care (3.89) by a health care agent (3.40) with the intention of directly or
indirectly improving or maintaining the health of that subject of care

NOTE: Health Care Activity is an abstract construct, without any direct instantiation.

3.45
health care goal
desired achievement of a care plan (3.6), considered as an intermediate operational step to reach the
ultimate objective of a programme of care (3.76)

3.46
health care objective
desired ultimate achievement of a programme of care (3.76)

3.76
programme of care
description of planned and duly personalised activities bundles (3.1) adopted by one healthcare organisation,
typically informed by one or more protocols (3.77), addressing one or more health issues (3.55), accounting
for one or more health issue threads (3.56), and encompassing all health care activities (3.39) to be
performed for a subject of care (3.89) by one or more health care parties (3.48)

3.77
protocol
customisation of a clinical guideline (3.10) for use in a local context

NOTE: critical path(s), care plan(s), clinical pathway(s): plan, based on data gathered during (subject’s of
care) assessment, that identifies the care needs, lists the strategy for providing services to meet those needs,
documents treatment goals and objectives, outlines the criteria for terminating specified interventions, and
4
documents the (subject’s of care) progress in meeting specified goals and objectives. [ISO TR 18307:2001]
[JCAHO]

Gerard

Hi Gerard,

Thanks for pointing this out. This is very helpful. It’s also good to be reminded about the distinction between an EHR and a Hospital (or whatever) information system.

Stef

Shouldn't each of these terms be given a shelf on
http://www.openehr.org/wiki/display/healthcare/openEHR+Healthcare+Dictionary
or how do we proceed from here?
(each term deserves an URI)
Arild Fax