Study design: Retrospective literature review.
Objective: To assess the quality of randomized controlled trial reporting in spine surgery.
Summary of background data: The use of the Consolidated Standards of Reporting Trials (CONSORT) criteria in clinical trials aims to improve adherence to a set of generally accepted practices in the reporting of randomized controlled trials. Randomized controlled trials in spine surgery are important sources of evidence-based practice, but the quality of their execution and reporting have not been reported adequately.
Methods: All randomized controlled trials published in three selected dedicated spine journals from 2008 were reviewed with respect to the 40 criteria derived from CONSORT descriptors; 10 criteria applying to the abstract, and 30 to the body of the article. Each article was scored by three reviewers in group format for each criterion and was assigned a score. Reviewers always came to a consensus before assigning a score.
Results: A total of 32 RCTs met the inclusion criteria for this review. The average modified CONSORT score was 65%. Disclosing certain criteria was associated with a higher overall score, including method of generation of random sequence (P < 0.000071), allocation concealment (P < 0.00014), inclusion of a flow chart or description of patient numbers at different stages (P < 0.00034), and identification of outcome measures (P < 0.00064).
Conclusion: Conclusions drawn from current randomized controlled trials in the spine literature may thus be difficult to interpret. Greater effort must be put into compliance with these guidelines to improve data quality.