Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement

Ioannis Liampas; Antonios Chlinos; Vasileios Siokas; Alexandros Brotis; Efthimios Dardiotis

doi:10.1007/s11239-019-01931-9

Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement

J Thromb Thrombolysis. 2019 Nov;48(4):542-553. doi: 10.1007/s11239-019-01931-9.

Authors

Ioannis Liampas¹, Antonios Chlinos², Vasileios Siokas², Alexandros Brotis³, Efthimios Dardiotis²

Affiliations

¹ Department of Neurology, School of Medicine, University Hospital of Larissa, University of Thessaly, Biopolis, Mezourlo Hill, 41100, Larissa, Greece. liampasioannes@gmail.com.
² Department of Neurology, School of Medicine, University Hospital of Larissa, University of Thessaly, Biopolis, Mezourlo Hill, 41100, Larissa, Greece.
³ Department of Neurosurgery, School of Medicine, University Hospital of Larissa, University of Thessaly, Larissa, Greece.

PMID: 31401718
DOI: 10.1007/s11239-019-01931-9

Abstract

Randomized controlled trials (RCTs) are the cornerstone of evidence based medicine. Ιt is crucial that RCTs have transparent reporting to facilitate their interpretation. The purpose of the present study is the evaluation of the reporting quality of RCTs for novel oral anticoagulants (NOACs) in venous thromboembolism (VTE) based on the CONSORT statement. MEDLINE was meticulously searched, while quoted references by retrieved RCTs were manually screened. The primary objective was to establish the mean CONSORT compliance of RCTs for NOACs in VTE. Secondary objectives were the calculation of compliance per CONSORT item and the investigation for probable determining factors with regards to the reporting quality of RCTs. Reporting above 70% of the items was defined as adequate compliance to the CONSORT statement. A total of 83 articles were considered eligible. Mean adherence to the CONSORT statement was 61.84%, standard deviation (SD) = 18.72. Among retrieved studies, 35 (42.17%) reported above 70% of the items, while 48 (57.83%) described less than 70% of the items. Inter-rater agreement was satisfactory (Cohen's kappa ≥ 0.75). Items with respect to randomization and blinding were principally underreported, whereas the rest of the methodological features and results were more sufficiently reported. Logistic regression failed to demonstrate significant effect for any of the factors investigated. Impact factor [odds ratio (OR) = 1.347, 95% confidence interval (CI) (0.994, 1.826), p = 0.055], number of authors [OR = 1.277, 95% CI (0.975, 1.672), p = 0.076] and presentation of participant flow-diagram [OR = 55.358, 95% CI (0.914, 3351.765), p = 0.055], came closer to significance. Exploratory analysis revealed significant, strong, positive correlation between abstract and article adherence to the CONSORT guidelines (r = 0.851, p < 0.001). Reporting quality of RCTs for NOACs in VTE is moderate. A superior reporting quality is desirable, especially relating to randomization and blinding.

Keywords: CONSORT; Deep vein thrombosis; New Oral Anticoagulants; Pulmonary embolism; Randomized Controlled Trials; Venous thromboembolism.

Publication types

Review

MeSH terms

Administration, Oral
Anticoagulants / administration & dosage*
Guideline Adherence
Humans
Randomized Controlled Trials as Topic / standards*
Venous Thromboembolism / drug therapy*

Substances

Anticoagulants