Classics in spine: Surgery literature revisited

Study Design. This article reviews the criteria for evaluating the quality of clinical trials. Objectives. To outline the current methodologic standards by which the validity of controlled trials need to be evaluated. Summary of Background Data. Weber's study, published in 1983 in Spine, is the only randomized trial comparing surgery and conservative management of sciatica in herniated lumbar discs. Methods. Weber's article is revisited to illustrate basic principles in the design of clinical trials. Results. Weber's study is a classic in spine surgery and has changed thinking regarding the benefit of surgery in sciatica related to herniated lumbar discs. However, the authors found potentially critical flaws in this study: a large number of crossovers, inadequate sample size, and insensitive outcome measurements. Conclusions. A randomized, controlled trial is the most rigorous way to evaluate health intervention. Despite the difficulties of performing such studies, investigators should use the most appropriate scientific methodology.