title: The contribution of RCTs to quality management and their feasibility in practice.
abstract: 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. From the searches, 130 RCTs were included, 95 from Cochrane Reviews and systematic reviews, and 35 from additional search. No study comparing surgery with sham surgery was identified. The first RCT in spine surgery was published in 1974 and compared debridement and ambulatory treatment in tuberculosis of the spine. The contribution of RCTs in spinal surgery has markedly increased over the last 10 years, which indicates that RCTs are feasible in this field. The results demonstrate missing quality specifications. Despite the number of published trials there is conflicting or limited evidence to support various techniques of instrumentation. 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.
authors.affiliation: Section for Back Surgery and Physical Medicine and Rehabilitation, Orthopaedic Department, Rikshospitalet Medical Centre, University of Oslo, Rikshospitalet, Sognsvannsveien, 0027 Oslo, Norway. jens.ivar.brox@rikshospitalet.no
authors.forename: Jens Ivar
authors.initials: JI
authors.lastname: Brox
mesh_terms: D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery; D009493:Neurosurgery / Q000379:methods* / Q000592:standards*; D017063:Outcome Assessment, Health Care / Q000379:methods* / Q000592:standards* / Q000639:trends; D010818:Practice Patterns, Physicians' / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards* / Q000639:trends; D012585:Sciatica / Q000601:surgery; D013122:Spinal Diseases / Q000601:surgery*