Trial registration in pediatric surgery trials.

Area of Science:

• Clinical Trials
• Pediatric Surgery
• Research Transparency

Background:

• Prospective clinical trial registration enhances transparency and reduces selective reporting bias.
• Previous studies indicated poor registration practices in adult surgical trials.
• The status of pediatric surgical trial registration was previously unknown.

Purpose of the Study:

• To determine the proportion of pediatric surgical trials published in 2014 that were prospectively registered.
• To assess the adequacy and completeness of the registration data for these trials.

Main Methods:

• A systematic search of MEDLINE identified prospective pediatric intervention studies published in 2014.
• Pediatric surgical trials were selected, and their registration numbers were verified in trial registries.
• Data completeness was assessed using the WHO minimum data set, comparing registry information with publication data.

Main Results:

• Only 28% of the 54 analyzed pediatric surgical trials published a registration number.
• Among registered trials, 40% were registered retrospectively, and 40% altered their primary/secondary outcomes.
• One trial reported an incorrect registration number.

Conclusions:

• Pediatric surgery trials published in 2014 demonstrated a low rate of prospective registration and incomplete registration data.
• Initiatives to improve prospective trial registration are crucial for generating high-quality, transparent, and reproducible evidence in pediatric surgery.