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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 [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] %%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%