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

i have a simultaneous telecon on the last tuesday of each month.  i plan
to join COI for first 30 minutes and MGED for last 30 minutes.
talk with you soon!
 
....jennifer

________________________________

From: Kashyap, Vipul [mailto:VKASHYAP1@PARTNERS.ORG] 
Sent: Monday, February 25, 2008 11:42 PM
To: Rachel Richesson; public-hcls-coi@w3.org
Cc: public-semweb-lifesci@w3.org
Subject: 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
=AttachFile&do=get&target=SDTM-example-Patient1.xls
<http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability?actio
n=AttachFile&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
=AttachFile&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/Projec
tPlan.html
<http://esw.w3.org/topic/HCLS/ClinicalObservationsInteroperability/Proje
ctPlan.html> 
	[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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