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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
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----------------------------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.
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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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