Reporting quality of randomized controlled trials in Restless Legs Syndrome based on the CONSORT statement

  • Dimitrios Rikos
  • Efthimios Dardiotis
  • Athina-Maria Aloizou
  • Vasileios Siokas
  • Elias Zintzaras
  • Georgios M. Hadjigeorgiou

Abstract

Randomized Controlled Trials (RCTs) are the cornerstone of modern medical research and their reporting may not always be optimal.  The  CONSORT (CONsolidated Standards of Reporting Trials) statement is an evidence-based means of improving and assessing the quality of these trials.

The aim of the present study was to assess the reporting quality of published RCTs on the Restless Legs Syndrome (RLS) based on a checklist stemming from the CONSORT statement.

RCTs involving patients with RLS were searched for into medical electronic databases. Inclusion criteria were English language of publication and the randomization of RLS patients in a minimum of two treatment cohorts of different medicinal orientations. The reporting quality was evaluated by the means of the aforementioned 38-item CONSORT checklist and the articles were divided into three 6-year periods. Descriptive statistics were used to make the comparisons.

Fifty four (54) eligible trials were found, published in 21 different scientific journals. 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 50.4%. The median CONSORT compliance for articles published in low (IF<2), medium (IF 2-7) and high (IF>7) ranked journals was 52.63%, 56.57% and 59.21% respectively.  Throughout the whole 1998-2016 period, 14 items (36.8%) were reported in >75% of the articles.

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 not of the CONSORT statement.