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 Den 21. des. 2007 kl. 06.38 skrev Sam Heard: > 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: >> >> 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 >> -----Original Message----- >> From: openehr-clinical-bounces at openehr.org [mailto:openehr- >> clinical-bounces at openehr.org] On Behalf Of Gerard Freriks >> Sent: Tuesday, 18 December 2007 10:16 AM >> To: For openEHR clinical discussions >> Cc: ?mer Hotomaroglu >> Subject: Re: maximum heart rate >> >> Dear all, >> >> I agree with Sam. >> States. Protocols are Cluster archetypes that can be/will be re- >> used in ENTRY Archetypes.. >> Are there more? >> Demographics/Localisations, ... >> >> Gerard >> >> >> -- <private> -- >> Gerard Freriks, MD >> Huigsloterdijk 378 >> 2158 LR Buitenkaag >> The Netherlands >> >> T: +31 252544896 >> M: +31 620347088 >> E: gfrer at luna.nl >> >> >> Those who would give up essential Liberty, to purchase a little >> temporary >> Safety, deserve neither Liberty nor Safety. Benjamin Franklin 11 >> Nov 1755 >> >> >> >> >> >> On Dec 17, 2007, at 1:31 AM, Sam Heard wrote: >> >>> Hi Andrew >>> >>> We now have a reason to provide a cluster for exercise related >>> state - to share this between the heart rate and bp and possibly >>> other archetypes. So I would suggest that we think about the >>> state as a cluster. It would seem that there is the idea of a >>> category of exercise - maximal or some such. We need to hear from >>> people who are experts in this area (Omer may have some answers). >>> >>> So I would suggest that the investigation is a stress test - it >>> will be a composition probably as a report. I do not think it >>> will be recorded as a procedure in the EHR - but it can be. I >>> would see recording the action (from a request) that the order >>> was completed as the main form. >>> >>> It will contain measurements of BP and Heart rate. Each will have >>> state data on exercise level. This should be a cluster archetype >>> which is about the level of exercise at a point in time. >>> >>> So my suggestion is that we go for a cluster on exercise level >>> for use in State on a few observations. Who has the data that >>> will need to be entered. >>> >>> % of Maximal for age is like a percentile chart in weight or >>> height (normal). At the moment the normal range can be added to >>> the data point. I am not sure that we have the idea of percentile >>> as part of this - the closest thing is the normal_status >>> attribute which provides a means of stating whether the level is >>> very high or low as for HL7 v2. We could extend this to include >>> the idea of percentiles based on normal range (eg 25 if 25% of >>> people have a level at or below this level). The idea of maximal >>> heart rate for age is a reference range and can be added to the >>> peak heart rate - with a percentage as part of the normal_status. >>> >>> The alternative is adding data points for these measurements - >>> which is not a great problem but would mean adding to the weight >>> and height archetypes. >>> >>> I am interested in what others think. >>> >>> Cheers, Sam >> >> This e-mail message has been scanned for Viruses and Content and >> cleared by MailMarshal >> >> IMPORTANT NOTICE: This e-mail and any attachment to it are >> intended only to be read or used by the named addressee. It is >> confidential and may contain legally privileged information. No >> confidentiality or privilege is waived or lost by any mistaken >> transmission to you. The CTC is not responsible for any >> unauthorised alterations to this e-mail or attachment to it. Views >> expressed in this message are those of the individual sender, and >> are not necessarily the views of the CTC. If you receive this e- >> mail in error, please immediately delete it and notify the sender. >> You must not disclose, copy or use any part of this e-mail if you >> are not the intended recipient. >> >> >> _______________________________________________ openEHR-clinical >> mailing list openEHR-clinical at openehr.org http:// >> lists.chime.ucl.ac.uk/mailman/listinfo/openehr-clinical > > -- > <OceanC_small.png> Dr Sam Heard > Chief Executive Officer > Ocean Informatics > Director, openEHR Foundation > Senior Visiting Research Fellow, University College London > Aus: +61 4 1783 8808 > UK: +44 77 9871 0980 > <OceanC_small.png> > _______________________________________________ > openEHR-clinical mailing list > openEHR-clinical at openehr.org > http://lists.chime.ucl.ac.uk/mailman/listinfo/openehr-clinical -- Arild Faxvaag MD, PhD Associate professor / Rheumatologist Norwegian Research Centre for Electronic Patient Records (NSEP) Medisinsk teknisk forskningssenter N-7489 Trondheim Phone: +47 9821 6825 http://folk.ntnu.no/arildfa/
