Are randomised controlled trials involving adenotonsillectomy well reported?

Area of Science:

• Otolaryngology
• Clinical Trial Methodology
• Evidence-Based Medicine

Background:

• Adenotonsillectomy evidence base requires high-quality clinical trial reports for guideline development.
• Current clinical practice relies on evidence-based medicine, necessitating robust trial reporting standards.
• The Consolidated Standards for Reporting Trials (CONSORT) statement provides guidance for reporting randomized controlled trials (RCTs).

Purpose of the Study:

• To assess the quality of reporting for randomized controlled trials (RCTs) on adenotonsillectomy.
• To evaluate adherence to CONSORT statement guidelines in published adenotonsillectomy trials.
• To identify areas for improvement in the reporting of adenotonsillectomy clinical trials.

Main Methods:

• Systematic review of adenotonsillectomy randomized controlled trials (RCTs) published after 2001.
• Assessment of each trial report using the CONSORT checklist.
• Inclusion of 25 identified RCTs in the quality assessment.

Main Results:

• Only 20% of trials reported sample size calculations.
• Approximately one-third of trials detailed their random sequence generation and allocation concealment methods.
• A mere one-fifth of trials presented participant flow clearly, with only one using a diagram.

Conclusions:

• Significant improvements are needed in the reporting quality of adenotonsillectomy RCTs.
• Poor reporting can lead to erroneous conclusions, despite rigorous trial conduct.
• Authors are strongly encouraged to consult and adhere to the CONSORT statement for enhanced trial transparency and reliability.