1. 2013;16;E331-E348The Effects of Randomized Controlled Trials on Vertebroplasty and Kyphoplasty: A Square Peg in a Round Hole
   Editorial Perspective
   Sheri L. Albers, DO, and Richard E Latchaw, MD.

Evidence based medicine (EBM) is currently dominated by the randomized controlled trial (RCT). The addition of a placebo arm to the trial in hopes of further elimination of bias in the outcome gives it a higher position in the hierarchy of the levels of evidence, resulting in a higher grade of recommendation for its use and subsequent reimbursement. While such a model works well for medicinal treatments, it is inappropriate for determining the safety and efficacy of a device or a procedure. Using such a model to test a new device or procedure requires the addition of a sham procedure as an analog for the placebo. Along with the sham come all of the ethical implications of a nontreatment arm.

This perspective discusses the formulation of the RCT and its inherent problems with randomization, blinding, and trial size when used to test devices and procedures. These issues are analyzed using recent trials to test vertebroplasty (VP) and kyphoplasty (KP) as examples. The redefining of EBM, and its role in government programs that proclaim lofty goals of improved patient outcomes while they are actually focused on cost containment, is discussed in detail. The implications for our specialty are enormous as this methodology is increasingly used for reimbursement of procedures such as VP and KP. Not only will this deleteriously affect any medical specialty employing devices or procedures, but its effect on patient care will likely be even more detrimental with delayed or limited patient access and delay or attrition in the development of new devices and procedures.

This perspective acts as an introduction to papers both in this issue, in the upcoming issue of the journal, and to ideas forthcoming later this year. Any or all of these papers can be viewed as having a part to play in the ongoing controversies of EBM, forced utilization of RCTs, and the repercussions of negative trials.

It is essential to recognize the validity of non-RCT studies, randomized nonblinded trials, and observational outcomes-related research in the evaluation of devices and procedures. After all, good patient outcomes are the most important goal of any procedure and of any trial or study. A number of papers have demonstrated the equal validity of well-designed non-blinded trials and well-designed observational studies (with either cohort or case-control design) relative to the RCT. Most importantly, as cost containment and regulation exert an ever-tighter hold on the medical profession, we need to take a very sober and sanguine view of how we judge our clinical research on procedures and devices.