Methodological and ethical quality of surgical trials from 2016 to 2020

Area of Science:

• Medical Research
• Surgical Trials
• Clinical Research Quality

Background:

• Randomized controlled trials (RCTs) are essential for evaluating surgical interventions.
• Previous analyses indicate a need for improvement in both methodological and ethical standards of published RCTs.
• Assessing recent surgical RCTs is crucial for identifying areas of progress and persistent challenges.

Purpose of the Study:

• To evaluate the methodological and ethical quality of randomized clinical trials in surgery.
• To identify specific areas of strength and weakness in surgical trial conduct and reporting.
• To provide insights for enhancing the rigor and ethical integrity of future surgical research.

Main Methods:

• A systematic review of randomized controlled surgical trials published in 10 leading international journals from 2016 to 2020.
• Methodological quality assessed using the Jadad scale.
• Ethical quality evaluated using the Berdeu score, alongside checks for informed consent and ethics committee approval.

Main Results:

• Methodological quality was satisfactory in approximately 70% of trials (mean Jadad score: 10.0 ± 1.54), with 31.2% deemed insufficient (score ≤ 9).
• Ethical quality was generally high (mean Berdeu score: 0.8 ± 0.11), with 90% of trials adhering to fundamental ethical principles.
• However, 10% of studies failed to report informed consent, and 4% lacked documented ethics committee approval. Less than 8% reported planned interim analyses, stopping rules, or independent monitoring.

Conclusions:

• Surgical randomized controlled trials demonstrate generally satisfactory methodological and ethical standards.
• Significant deficiencies remain in reporting critical elements like informed consent, ethics approval, and trial oversight mechanisms.
• Future research should prioritize robust reporting of methodological rigor and ethical conduct, including planned interim analyses and independent monitoring.