Deficiencies in the reporting quality of RCTs in neurosurgery: How can we do better?

Abstract

Background: Deficiencies in design and reporting of randomized controlled trials (RCTs) limit their validity. The quality of recent RCTs in neurosurgery was analyzed to assess adequacy of design and reporting. Methods: A high-yield search of the MEDLINE and EMBASE databases (2000-present) was conducted. The CONSORT and Jadad scales were used to assess the quality of design/reporting. A PRECIS-based scale was used to designate studies on the pragmatic-explanatory continuum. Spearman’s test was used to assess correlations. Regression analysis was used to assess associations. Results: Sixty-one articles were identified. Vascular was the most common sub-specialty (37%). The median CONSORT and Jadad scores were 36 (IQR 27.5-39) and 3 (IQR 2-3). Blinding, sample size calculation and allocation concealment were most deficiently reported. The quality of reporting did not correlate with the study impact. The majority of studies (83%) had pragmatic objectives; while pragmatic studies had compatible design factors, trials with explanatory objectives were less successful. Conclusions: The prevalence and quality of neurosurgical RCTs is low. Many study designs are not compatible with stated objectives. Given the role of RCTs as one of the highest levels of evidence, it is critical to improve on their methodology and reporting. Alternative methodologies merit discussion.