European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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The randomized controlled trial (RCT) is generally accepted as the most reliable method of conducting clinical research. To obtain an unbiased evaluation of the effectiveness of spine surgery, patients should be randomly assigned to either new or standard treatment. The aim of the present article is to provide a short overview of the advantages and challenges of RCTs and to present a summary of the conclusions of the Cochrane Reviews in spine surgery and later published trials in order to evaluate their contribution to quality management and feasibility in practice. ⋯ The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica. For future trials, authors, referees, and editors are recommended to follow the CONSORT statement. RCTs provide evidence to support clinical opinions before implementation of new techniques, but the individual clinical experience is still important for the doctor who has to face the patient.
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Studies comparing the relative merits of microdiscectomy and standard discectomy report conflicting results, depending on the outcome measure of interest. Most trials are small, and few have employed validated, multidimensional patient-orientated outcome measures, considered essential in outcomes research. In the present study, data were collected prospectively from six surgeons participating in a surgical registry. ⋯ Though not equivalent to an RCT, the study included every single eligible patient in our Spine Center and allowed surgeons to use their regular procedure; it hence had extremely high external validity (relevance/generalisability). There was no clinically relevant difference in outcome after lumbar disc excision dependent on the use of the microscope. The decision to use the microscope should rest with the surgeon.
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The Swedish Spine Register enables monitoring of surgical activities focusing on changes in trends over time, techniques utilized and outcome, when implemented in general clinical practice. Basic requirements for a prosperous register are unity within the profession, mainly patient-based documentation and a well functioning support system. This presentation focuses on the development and design of the register protocol, problems encountered and solutions found underway. ⋯ Over the last 10 years, surgical treatment for spinal stenosis has increased gradually while disc herniation surgery decreases regarding yearly number of procedures. An added function to the register enables more complex prospective clinical studies to include register data together with data suitable for the individual study. A common core set of demographic, surgical and outcome parameters would enable comparisons of clinical studies within and between nations.