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EVIDENCE-BASED-HEALTH  February 2000

EVIDENCE-BASED-HEALTH February 2000

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Subject:

RE: RCTs that changed medicine (fwd)

From:

"Djulbegovic, Benjamin" <[log in to unmask]>

Reply-To:

Djulbegovic, Benjamin

Date:

Wed, 2 Feb 2000 11:06:23 -0500

Content-Type:

text/plain

Parts/Attachments:

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	Joining Roy's and David's debate, I want to add that at our recently
held Evidence-based Oncology Symposium (St. Pete, November 1999) we also
organized a panel discussion on "Evidence, Guidelines and Reimbursment"
(details are also published in Managed Care and Cancer, 2000:2:39-46).
During the discussion an interesting idea was proposed, which was to have
the amount of reimbursment linked to the level of evidence (that is, the
closer is you evidence to the truth, the more money you will get!).
Although, Dr. van Amerongen, who serves as the National Medical Director at
Anthem Blue Cross & Blue Shields and an industry representative on the
panel, did state that "the insureance industry is not at the stage where
reimbursment decisions are linked to quality of evidence" but that he
predicts that "outcomes will be the final arbiter how services will be paid
for-those with poor outcomes should not paid for as often as they are now". 
Any comments?

ben

Benjamin Djulbegovic, MD
Associate Professor of Medicine
H. Lee Moffitt Cancer Center & Research Institute
at the University of South Florida
Division of Blood and Bone Marrow Transplant
12902 Magnolia Drive
Tampa, FL 33612

Editor: Evidence-based Oncology

e-mail:[log in to unmask]
http://www.hsc.usf.edu/~bdjulbeg/
phone:(813)979-7202
fax:(813)979-3071

> -----Original Message-----
> From:	Roy Poses [SMTP:[log in to unmask]]
> Sent:	Wednesday, February 02, 2000 9:14 AM
> To:	EBH List; D Doggett
> Subject:	Re: RCTs that changed medicine (fwd)
> 
> 
> 
> ---------------------------------------------------------
> ROY M. POSES MD
> BROWN UNIVERSITY CENTER FOR PRIMARY CARE AND PREVENTION
> MEMORIAL HOSPITAL OF RI
> 111 BREWSTER ST.
> PAWTUCKET, RI   02860
> USA
> 401 729-2383
> FAX: 401 729-2494
> [log in to unmask]
> ----------------------------Original message----------------------------
> From: "Doggett, David" <[log in to unmask]>
> To: [log in to unmask]
> 
> Also, examination of these RCT-unnecessary discoveries (let's call them
> un-RCT situations) will be useful for recognizing situations when an RCT
> might not be necessary for a decision.  It will never be practical to
> carry
> out large double-blind RCTs for every new development and minor innovation
> on a previously proven intervention.  Yet, in this era of cost-conscious
> payers (private as well as public sector), there is a knee-jerk tendency
> to
> refuse payment for any intervention that can't show conclusive RCT
> "proof".
> This introduces the oft ignored potential for Type II error.  I understand
> that up until now people have worked so hard to get the need for RCTs
> recognized that many people are wary of even discussing situations where
> RCTs are unnecessary, but the fact remains that the real task is to
> understand when an RCT is definitely required, and when other evidence is
> trustworthy enough that an RCT would be unnecessary or even unethical.
> ------------------------------------------------------------------------
> I am somewhat surprised to hear about a "knee-jerk tendency to refuse
> payment
> for any intervention that can't show conclusive RCT 'proof.'"
> I have not seen any instances in the US of insurers or managed care
> organizations refusing to pay for interventions because of insufficient
> evidence from well done RCT's.  I would be very interested in hearing
> about
> such examples.
> 
> In fact, it seems to me one (of many) reasons managed care has proved to
> be
> unsuccesful in controlling costs in the US is that MCO's have not been
> good
> at even reducing the amounts paid for expensive interventions for which
> there
> is little evidence that benefits outweigh harms.
> 
> One recent example.  We just completed a quick,dirty but fairly systematic
> review of evidence about coronary revascularization procedures (CABG,
> PTCA,
> stents, etc.) in stable CAD.  These procedures are very fequently done in
> the
> US, and still seem to be very generously reimbursed.  There is evidence
> from
> several RCT's that CABG improves survival for patients with left main
> disease, and perhaps marginally for other high risk groups, although all
> this
> comes from post hoc sub-group analyses.  There is also evidence that it
> improves symptoms, at least in the short term.  However no RCT of CABG vs.
> medical management even bothered to record adverse effects of therapy so
> it is impossible to assess the benefits/harms of CABG in patients in sub-
> groups who did not have a mortality benefit.
> 
> Further, PTCA when compared to medical management for low-risk patients
> did not improve any outcome other than symptoms, but did result in
> higher rates of performance of subsequent revascularization.  PTCA
> compared
> to surgical management for patients with multi-vessel disease resulted in
> no improvement in any outcome (and clinically signifcantly worse mortality
> could not be excluded.)  Stents have only been compared to PTCA, not to
> CABG or medical management, and their only advantage over PTCA is a lower
> rate of subsequent revascularization.
> 
> I can include references for all this if anyone is interested, but it
> will
> take a little time to drag them out of the file.
> 
> In any case, I can make a good argument that the only situation in which
> there is evidence in support of revascularization for stable CAD short of
> left main or perhaps high risk 3-vessel disease is when the patient has
> severe, disabling symptoms despite maximal medical management.  I bet,
> though,
> that most MCO's in the US will pay for revascularization for stable CAD
> under nearly any circumstances without protest.
> 
> I'm sure it would be easy to come up with lots of other interventions
> which
> are not strongly supported by evidence from RCT's, yet for which managed
> care
> organizations pay without protest.
> most educational for us all.  It will address the two main problems we
> have
> in technology assessment: 1) not enough RCTs (give us the ammunition to
> fight for more), and 2) how do we recognize and handle analysis and
> decisions in un-RCT situations.
> 
> David L. Doggett, Ph.D.
> Senior Medical Research Analyst
> Technology Assessment Group
> ECRI, a non-profit health services research organization
> 5200 Butler Pike
> Plymouth Meeting, PA 19462-1298, USA
> Phone: +1 (610) 825-6000 ext.5509
> Fax: +1(610) 834-1275
> E-mail: [log in to unmask]


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