A CONSORT diagram is a visual representation of the flow of participants in a clinical trial. CONSORT stands for Consolidated Standards of Reporting Trials, and the diagram is a key component of the CONSORT statement, which provides guidelines for the reporting of clinical trials.

The CONSORT diagram typically includes information about the number of participants screened for the trial, the number of participants who were eligible and enrolled in the trial, and the number of participants who completed the trial or dropped out. The diagram may also include information about the reasons for dropout and any deviations from the protocol.

The CONSORT diagram is used to provide transparency and clarity about the conduct and results of a clinical trial. It is often included in published reports of clinical trials, and can be useful for researchers, healthcare providers, and patients in understanding the study design, participant characteristics, and outcomes.

In addition to the CONSORT diagram, the CONSORT statement also provides guidelines for reporting other important aspects of clinical trials, such as the methods used for randomization and blinding, the statistical analysis plan, and any adverse events or serious adverse events that occurred during the trial. The aim of these guidelines is to improve the quality and transparency of clinical trial reporting and to facilitate the interpretation and synthesis of trial results.

The reviewer can clearly understand the trial design, conduct, analysis, and interpretation, and assess the validity of its results if the manuscript includes the Consolidated Standards of Reporting Trials (CONSORT) statement flow diagram 1).

The purpose of a study was 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 2).

Schulz KF, Altman DG, Moher D: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med 8:18, 2010
Liampas I, Chlinos A, Siokas V, Brotis A, Dardiotis E. Assessment of the reporting quality of RCTs for novel oral anticoagulants in venous thromboembolic disease based on the CONSORT statement. J Thromb Thrombolysis. 2019 Aug 10. doi: 10.1007/s11239-019-01931-9. [Epub ahead of print] Review. PubMed PMID: 31401718.
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