CORR Insights^®: Have Levels of Evidence Improved the Quality of Orthopaedic Research?

Excerpt

Condemnation of what is generally perceived as the highest level of evidence is, by extension, condemnation of the entire system; and, to some degree, condemnation (or at least open-eyed critique) is called for. So we must first focus on randomized clinical trials, our so-called Level I evidence. Even among such trials, some are far better than others methodologically. One of the most popular assessment tools is the Jadad score [8], which ranges from zero to five. One particular trial that was rated a perfect five turned out to be so chock full of flaws that it might have served medical science better as a case study in how not to conduct clinical research [4]. Granted, this trial was in rheumatology, not orthopaedics, but the phenomenon of the scandal of poor medical research [1] transcends any one therapeutic area. The heart of the matter is an unwavering, unquestioning, and uncritical acceptance of “reasonable assumptions,” an important one being that Level I studies of surgical therapy are reliable and important merely because they are randomized and prospective. Tenuous assumptions like this permeate and underlie almost all aspects of clinical trials research, so the entire structure is built on a house of cards. This is where we are now. …