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.

Fat in the lumbar multifidus muscles - predictive value and change following disc prosthesis surgery and multidisciplinary rehabilitation in patients with chronic low back pain and degenerative disc: 2-year follow-up of a randomized trial

“…New surgical interventions should be compared with conservative treatment [27] and the present study is an analysis of the lumbar multifidus muscles of patients included in the first randomized trial of TDR surgery with such a design [3]. Our a priori aims were 1) to investigate whether pre-treatment multifidus muscle fat infiltration predicts outcome 2 years after treatment with TDR surgery or multidisciplinary rehabilitation, and 2) to compare changes in fat infiltration between the two treatment groups from pre-treatment to 2-year follow-up.…”

The Quality of Randomized Controlled Trial Reporting in Spine Literature

“…It is encouraging to note that within spine surgery, RCTs have been published at an increasing rate in the last decade. 18 It is important to focus on the quality of study design and reporting to ensure the utility of this time honored gold standard.…”

The Michel Benoist and Robert Mulholland yearly European Spine Journal Review: a survey of the “surgical and research” articles in the European Spine Journal, 2009

“…We have to be able to fully inform patients about outcomes because ''the basis of trust and faith has diminished and given way to increased scepticism and demands for accountability on the part of the patient. Information they gain from the internet frequently represents ''personal opinion at best, or marketing tools at worse'' [7]. All the articles in the supplement merit reading, and some can be dipped into as they frequently contain gems of information and philosophy very relevant to the practicing spinal surgeon.…”