RE: SDTM mapping Pt1 data - [COI] Clinical Observations Interoperability

Jennifer and Rachel,
 
This is awesome work! A very big thank you to the two of you.

	
	A first attempt at mapping the free text narrative mock data into the
SDTM model is posted at:
http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability?action=AttachF
ile&do=get&target=SDTM-example-Patient1.xls
<http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability?action=Attach
File&do=get&target=SDTM-example-Patient1.xls> 
	 
	[VK] An RDF representation of the above is available at:
http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability?action=AttachF
ile&do=get&target=SDTMRDFPatient1.ppt

	 

	Caveat -- This CDISC (SDTM) model is for FDA reporting of data from a
completed clinical trial - with planned visits, exposures, etc.  Therefore we
are not using it as intended. I can't think of any logical reason that narrative
data such as this would ever be put into SDTM, but I do hope that this exercise
will give everyone a flavor of the model. I give a little background on the
model below, and then make some suggestions for our next discussion.
	 
	[VK]  Based on the initial attempt at RDF-ization a minor tweak to the
SDTM model actually gives us a lot of mileage! 

	        The key here is to "decouple" patient related information from
the use context, i.e., clinical trial reporting... Once we are able to do that,
this model seems to work well!

	        The logical reason then is that we now get a model which is
fairly widely used in the CT world for describing clinical data. Also, according
to our conversation with Bron Kissler,

	        they are planning to standardize on the SDTM across the Clinical
Trials Lifecycle. 

	       

	        You raise another interesting issue though! On the healthcare
delivery side we have Encounters, Episodes, Visits; whereas on the Clinical
Trials side we have Exposures, Planned Visits, Studies

	        Am not sure whether this is relevant for Patient Recrutiment,
but we may need to align these constructs for other use cases such as Adverse
Drug Event Reporting, Clinical Trials Data Collection.

	 

	There have been several pointers on our threads to good works on
Eligibility Criteria and rule representation that should be reviewed.
Additionally, both Vipul's requirements documents and my early work on the use
case clearly show that Eligibility Criteria fall into several vocabulary domains
(medications, diagnoses, procedures, etc.) Perhaps, to simplify this project for
demonstration purposes, we could consider using these domains + vocabulary, and
not a formal information model, for the Eligibility Criteria?
	[VK] I think we are using different terms to talk about the same
thing...? Medications, Diagnoses, Procedures, etc. in my mind are a description
of paitent data. 

	 

	I hear from the calls that there is a strong desire to map between CDISC
and HL7 models. I admit that I do not have a complete understanding of our
strategy for this demonstration, but I would like to see some discussion of the
high-level steps that ensure that all of our efforts are directly related to the
use case. As I understand it, ultimately there will be a matching of Eligibility
Criteria from research protocols to clinical patient data. I am not sure that
CDISC's SDTM model practically fits into this scenario.  If it does, then it
would seem that we would map the DCM elements directly to the SDTM, as I believe
is specified in step 6.2 of the Project Plan at:
http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability/ProjectPlan.ht
ml
<http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability/ProjectPlan.h
tml> 
	[VK] Based on the initial work so far, I think that should be feasible.
However that said, we need to at least specify the different models and
implement them in a repository. Then we should be ready for Step 6,2

	 Here is a proposal:

	- Represent the following using SDTM, DCM and HL7/RIM/CDA

	- Medications

	- Medical History

	- Diagnoses

	- Lab Results

	- Vital Signs

	- Signs and Symptoms

	- Procedures

	- Contrainidications

	- Therapies

	- Family History

	 

	Look forward to a good discussion tomorrow.

	 

	Cheers,

	 

	---Vipul


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