RE: [BIONT-DSE] Clinical Observations Interoperability Telcon September 11th, Tuesday 11:00am - 12:00pm US EDT

Thanks, Landen.... Please upload it to the wiki as soon as you get a chance.

 

Regards,

 

---Vipul

 

=======================================

Vipul Kashyap, Ph.D.

Senior Medical Informatician

Clinical Informatics R&D, Partners HealthCare System

Phone: (781)416-9254

Cell: (617)943-7120

http://www.partners.org/cird/AboutUs.asp?cBox=Staff&stAb=vik

 

To keep up you need the right answers; to get ahead you need the right questions

---John Browning and Spencer Reiss, Wired 6.04.95

________________________________

From: Landen Bain [mailto:lbain@topsailtech.com] 
Sent: Tuesday, September 11, 2007 2:17 PM
To: Kashyap, Vipul
Cc: Bron W. Kisler; Andersson, Bo H; Joey Coyle; public-hcls-dse@w3.org;
public-semweb-lifesci@w3.org; Rachel Richesson; Stanley Huff; Oniki, Tom (GE
Healthcare, consultant); Yan Heras
Subject: RE: [BIONT-DSE] Clinical Observations Interoperability Telcon September
11th, Tuesday 11:00am - 12:00pm US EDT

 


Vipul et al, 

Here is my 'to do' from today's meeting. 

I have visited several sites which do patient care as their primary activity,
and conduct clinical research on the side.  Here is my impression of the steps
in the process, and how I have observed them being done. 

1. A sponsor sends a package to the site, requesting that they consider
participating in a trial. 
2. The site's study coordinator evaluates the protocol and decides if it is
worthwhile to participate.  This decision is based on economics, and an
assessment if their patient pool is likely to provide matches to the desired
criteria, and a determination if a site physician is willing and able to serve
as clinical investigator for the study. 
3. Assuming all goes well, the site agrees to participate, names an
investigator, and commits to recruit a cadre of patients, and 'builds' the
protocol into the local systems: EHR, site management software, clinical
research billing software. 
4. The study coordinator searches the EHR database for candidate subjects, based
on inclusion/exclusion criteria contained in the protocol.  The processes I
witnessed used Boolean searches of the EHR data base based on demographic data
and diagnostic codes. 
5.  The study coordinator narrows the candidate pool by doing individual patient
level searches of the EHR to determine if a particular patient meets the more
fine grain criteria. 
6. The study coordinator recruits patients to participate as subjects in the
trial by calling the patient on the phone, explaining the trial and the
requirements, and getting the patient to sign the confidentiality forms, release
forms, etc. 
7. A successfully recruited patient is randomized into the study as a subject. 
8. A series of visits are scheduled to gather data for the trial. 
9. The subject visits the clinic as scheduled, and data are captured on case
report forms specified by the protocol, either on paper (60%) or using an
Electronic Data Capture system provided by the sponsor. 

That's it in a nutshell.  Rachel's use case addresses steps 4 and 5.  My use
case addresses step 9. 

Landen 





"Kashyap, Vipul" <VKASHYAP1@PARTNERS.ORG> 

09/10/2007 11:20 PM 

To

"Andersson, Bo H" <Bo.H.Andersson@astrazeneca.com>, "Landen Bain"
<lbain@topsailtech.com>, "Rachel Richesson" <Rachel.Richesson@epi.usf.edu>,
<public-semweb-lifesci@w3.org>, <public-hcls-dse@w3.org> 

cc

"Stanley Huff" <Stan.Huff@intermountainmail.org>, "Yan Heras"
<Yan.Heras@intermountainmail.org>, "Oniki, Tom (GE Healthcare, consultant)"
<Tom.Oniki@ge.com>, "Joey Coyle" <joey@xcoyle.com>, "Bron W. Kisler"
<bkisler@earthlink.net> 

Subject

RE: [BIONT-DSE] Clinical Observations Interoperability Telcon  September 11th,
Tuesday 11:00am - 12:00pm US EDT

 

 

 




The latest use case description  is available at: 
  
http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM?action=AttachFile&do=
get&target=Eligibility-EMR+Use+Case_Draft+%232_Richesson_9-10-07.doc
<http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM?action=AttachFile&do
=get&target=Eligibility-EMR+Use+Case_Draft+%232_Richesson_9-10-07.doc>  
  
---Vipul 
  

 

________________________________


From: public-hcls-dse-request@w3.org [mailto:public-hcls-dse-request@w3.org] On
Behalf Of Andersson, Bo H
Sent: Monday, September 10, 2007 5:48 AM
To: Landen Bain; Rachel Richesson; public-semweb-lifesci@w3.org;
public-hcls-dse@w3.org
Cc: Stanley Huff; Yan Heras; Oniki, Tom (GE Healthcare, consultant); Joey Coyle;
Bron W. Kisler
Subject: RE: [BIONT-DSE] Clinical Observations Interoperability Telcon September
11th, Tuesday 11:00am - 12:00pm US EDT 
  
Dear Rachel and Landen, 
  
Following up from the Clinical Observations Interoperability Telcon two weeks
ago, I do think your presentations where very interesting. >From my perspective
working in early clinical development within AstraZeneca I do think Landen's
slide 10
<http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM?action=AttachFile&do
=get&target=W3C-BIONTDSEDCM-08-28-07.ppt>   (secondary use) point out where why
we all have a common interest to get the interoperability in place. 
  
I like your proposal Rachel to use patient recruitment as use case for this
activity. Patient recruitment is a major challenge for us and I guess most
pharma companies. It fits well with the future desire to get a better "Real
Life" picture of our health care environment. With better information at hand we
would understand patient requirements, diseases, etc. much better. This
understanding are important for health care providers, pharma companies, health
organizations, disease registries, safety organizations etc. 
  
Slide 10 represents in my mind this desire for a "Real Life" picture. To achieve
this objective data interoperability is only one challenge of many, however if
we in this activity can show how semantic web technologies have the potential to
solve the interoperability issue, we will create good conditions for this to
become a reality! 
  
AstraZeneca participate in "Electronic Medical Record Task Force 2007 - EU
region", a joint effort by European Federation of Pharmaceutical Industries and
Associations (EFPIA) and EC. Within this task force the EHR are discussed in the
context of enhancing clinical research for better health and high quality
healthcare, i.e. well in line with slide 10. 
  
In other words, I support Rachel's proposal and suggest we keep the bigger
picture presented by Landen in mind. 
  
Regards, 
Bosse 
_______________________________________________________ 
Bo Andersson 
Senior Informatician 
Discovery Medicine 
AstraZeneca R&D Lund, S-221 87 Lund, Sweden 
Tel: +46 46 33 76 21 Mobile: +46 709 13 16 21
Fax: +46 46 33 71 92 
E-mail: bo.h.andersson@astrazeneca.com 
-----Original Message-----
From: public-hcls-dse-request@w3.org [mailto:public-hcls-dse-request@w3.org]On
Behalf Of Kashyap, Vipul
Sent: 7 september 2007 16:03
To: public-semweb-lifesci@w3.org; public-hcls-dse@w3.org
Cc: Stanley Huff; Yan Heras; Oniki, Tom (GE Healthcare, consultant); Joey Coyle;
Landen Bain; Bron W. Kisler
Subject: [BIONT-DSE] Clinical Observations Interoperability Telcon September
11th, Tuesday 11:00am - 12:00pm US EDT 
Clinical Observations Interoperability Telcon 
  
http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM
<http://esw.w3.org/topic/HCLS/OntologyTaskForce/BIONTDSEDCM>  
  
Date and Time: 
Spetember 11th, Tuesday 11:00am - 12:00pm EDT 
  
Agenda 
Discussion and Finalization of Use Case 
  
Telcon Details: 
  

Phone 

+1 617 761 6200, conference 24668 ("BIONT") 

IRC 

irc://irc.w3.org:6665/hcls 

Browser-based IRC client 

http://www.w3.org/2001/01/cgi-irc


  
  
Feel free to annotate wiki page above with feedback and suggestions. 
  
Cheers, 
  
---Vipul 
  
======================================= 
Vipul Kashyap, Ph.D. 
Senior Medical Informatician 
Clinical Informatics R&D, Partners HealthCare System 
Phone: (781)416-9254 
Cell: (617)943-7120 
http://www.partners.org/cird/AboutUs.asp?cBox=Staff&stAb=vik
<http://www.partners.org/cird/AboutUs.asp?cBox=Staff&stAb=vik>  
  
To keep up you need the right answers; to get ahead you need the right questions

---John Browning and Spencer Reiss, Wired 6.04.95 
  
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