Marguerite would have to confirm, but my understanding is that they
noted the disturbing signal in their electronic pharmacy data (before
the EHR was implemented, as Margeurite notes) and removed it from their
formulary before any experimental studies confirmed the signal.
Again as I understand it, this was feasible because Vioxx had not been
demonstrated to be anything but a me-to drug.
Jim
James M. Walker, MD, FACP
Chief Medical Information Officer
Geisinger Health System
The best way to predict the future is to invent it.
- Alan Kay
>>> "Djulbegovic, Benjamin" 11/04/11 4:09 PM >>>
Jim, this is very interesting statement "...such information was almost
certainly adequate to motivate Kaiser to remove a me-to drug with no
safety or effectiveness advantage (Vioxx) from its formulary".
Did Kaiser remove Vioxx from its formulary it BEFORE or AFTER randomized
trials were published (related to Vioxx safety and efficacy)? If they
did it before the trials became available, then it would constitute a
fascinating example of the use of EMR that may provide some important
lessons for all of us (including skeptics like me).
Thanks
ben
-----Original Message-----
From: Evidence based health (EBH)
[mailto:[log in to unmask]] On Behalf Of Jim Walker
Sent: Friday, November 04, 2011 12:45 PM
To: [log in to unmask]
Subject: Re: Evidence-Based Medicine in the EMR Era
I agree that we should be extremely cautious about identifying
appropriate methodologies for determining when such information can
appropriately inform clinical action.
But it is the case that so much more information is so much more
accessible than on paper that it does represent a quantum leap
(qualitative difference) in the information-gathering phase of
observational research (while doing nothing to address the
methodological limitations of observational research).
So, for example, such information was almost certainly adequate to
motivate Kaiser to remove a me-to drug with no safety or effectiveness
advantage (Vioxx) from its formulary.
On the other hand, it is hard to imagine how such information could
justify "preventitive" hormone-replacement therapy.
So for me, the interesting questions here are: What is the patient's
prognosis without the therapy being considered? What is the
pathophysiological credibility of the observed difference? How large are
the (apparent) OR and CI? What are the potential adverse effects of the
therapy? Is some form of effective near-real-time monitoring available?
Best regards.
Jim
James M. Walker, MD, FACP
Chief Health Information Officer
Geisinger Health System
>>> "Dahm,Philipp" 11/4/2011 12:21 PM
>>>
It is unclear to me how the reported EMR quest for evidence provides any
qualitative advancement.
Isn't it in essence the same as sending your medical student into the
dungeons of the medical records department (as it has been commonplace
for decades) to research some question based on your institutional
experience? The only difference is the speed with which it can occur.
I'm concerned that articles such as these will "knight" those
specializing in retrospective data-mining....
Ph*
On Nov 3, 2011, at 10:40 AM, Dr. Carlos Cuello wrote:
Quite interesting on how electronic medical records can become a part of
observational evidence and apply when there is no other evidence at
hand.
Good read
http://www.nejm.org/doi/full/10.1056/NEJMp1108726
--
Carlos A. Cuello-García, MD
Centre for Evidence-Based Practice & Knowledge Translation Tec de
Monterrey School of Medicine Cochrane Collaboration Iberoamerican branch
CITES piso 3. Morones Prieto 3000 pte. Col. Doctores 64710 Monterrey,
NL. Mexico.
☎ +52.81.8888.2223 & 2154. Fax: +52.81.8888.2052 Skype:
dr.carlos.cuello
www.cmbe.net ⚫
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