Background: Randomized controlled trials (RCTs) are the cornerstone of modern medical research, and their reporting may not always be optimal. The Consolidated Standards of Reporting Trials (CONSORT) statement is an evidence-based means to improve the quality of RCTs' reporting by providing a checklist of recommended items.The aim of this study was to assess the reporting quality of published RCTs on the restless legs syndrome (RLS), based on a checklist arising from the CONSORT statement.
Methods: Medical electronic databases were searched for RCTs involving patients with RLS. Inclusion criteria were follows: articles must have been published in English and RLS patients must have been randomized into a minimum of two treatment cohorts of different medicinal orientations. CONSORT-recommended items were marked as "reported" or "not reported," and an overall CONSORT compliance metric was calculated. Comparisons among different time periods, CONSORT-endorsing and non-endorsing, and different levels of impact factor journals were made.
Results: Fifty-four eligible trials, published in 21 different scientific journals, were found. The average CONSORT compliance score was 56.6% (23.68-84.21%). CONSORT-endorsing journals had a mean CONSORT compliance of 58.47%, whereas non-endorsing journals had a mean CONSORT compliance of 50.4%. The median CONSORT compliance for articles published in low- (IF<2), medium- (IF 2-7), and high-ranked (IF>7) journals was 52.63, 56.57, and 59.21%, respectively. Only 14 of the 38 CONSORT items (36.8%) were reported in >75% of the articles.
Discussion: This study shows that the reporting of RLS-related RCTs is suboptimal, regardless of the time period, the quality of the publishing journal, and the endorsing or non-endorsing of the CONSORT statement.
Keywords: CONSORT; RCTs; RLS; Randomized controlled trials; Willis-Ekbom Disease.