Reporting Quality of Randomized Controlled Trials in Restless Legs Syndrome Based on the CONSORT Statement

Tremor and Other Hyperkinetic Movements

article

Dimitrios Rikos¹  Efthimios Dardiotis¹  Athina-Maria Aloizou¹  Vasileios Siokas¹  Elias Zintzaras²  Georgios M. Hadjigeorgiou¹ 

[1] Department of Neurology, University of Thessaly, University Hospital of Larissa;Department of Biomathematics, University of Thessaly School of Medicine;The Institute for Clinical Research & Health Policy Studies, Tufts Medical Center and Pharmacology & Drug Development Program, Sackler School of Graduate Biomedical Sciences, Tufts University School of Medicine;Department of Neurology, Medical School, University of Cyprus

关键词: RLS;    CONSORT;    Randomized controlled trials;    Willis-Ekbom Disease;    RCTs;   

DOI  :  10.5334/tohm.457

学科分类：社会科学、人文和艺术（综合）

来源: Ubiquity Press

【 摘 要 】

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- (IF7) 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.

【 授权许可】

CC BY