How well do orthodontic RCTs comply with CONSORT guidelines?

Area of Science:

• Orthodontics
• Clinical Trial Methodology
• Scientific Publishing

Background:

• The Consolidated Standards of Reporting Trials (CONSORT) guidelines are crucial for enhancing the transparency and reproducibility of randomized controlled trials (RCTs).
• Assessing adherence to CONSORT guidelines in specialized fields like orthodontics is essential for evaluating the quality of published research.

Purpose of the Study:

• To evaluate changes in CONSORT guideline compliance for orthodontic randomized controlled trials (RCTs) across four leading journals.
• To determine if the reporting of randomization, allocation concealment, and blinding has improved over time.

Main Methods:

• A systematic search identified orthodontic RCTs published in the American Journal of Orthodontics and Dentofacial Orthopaedics, Angle Orthodontist, European Journal of Orthodontics, and Journal of Orthodontics.
• Studies were analyzed for CONSORT checklist item reporting in two periods: January 2016-June 2017 (T1) and January 2019-June 2020 (T2).

Main Results:

• The overall median CONSORT score increased significantly from 48.7% in T1 to 67% in T2 (P = 0.001).
• Improved reporting was noted in the Angle Orthodontist (P = 0.016) and European Journal of Orthodontics (P = 0.023), but not significantly in the other two journals.
• Reporting of random allocation sequence generation (OR 2.09) and allocation concealment (OR 2.27) significantly increased in T2 compared to T1, while blinding reporting did not show significant change.

Conclusions:

• Reporting quality of orthodontic RCTs, based on CONSORT guidelines, significantly improved from 2016-2017 to 2019-2020.
• Further enhancements in reporting can be achieved through diligent adherence to CONSORT guidelines by authors, peer reviewers, and editors.