Few randomized trials in preterm birth prevention meet predefined usefulness criteria

Area of Science:

• Obstetrics and Gynecology
• Clinical Trial Methodology
• Public Health

Background:

• Preterm birth remains a significant global health challenge, necessitating high-quality research to inform effective prevention strategies.
• Randomized controlled trials (RCTs) are crucial for evaluating interventions, but their usefulness depends on adherence to specific methodological and reporting standards.

Purpose of the Study:

• To operationalize a research usefulness tool for preterm birth prevention RCTs.
• To assess the extent to which these RCTs meet predefined criteria for research usefulness.
• To identify trends in usefulness over time and areas for improvement.

Main Methods:

• A literature search and consensus process identified a usefulness tool with eight criteria and 13 items.
• 347 RCTs from 56 Cochrane reviews on preterm birth prevention were evaluated by multiple assessors.
• Compliance with usefulness criteria was assessed, with comparisons made between trials published before and after 2010.

Main Results:

• Only 10% of evaluated RCTs met more than half of the usefulness criteria.
• Recent trials (post-2010) were more likely to use less informative composite or surrogate outcomes (25% vs. 13%).
• Few trials (5%) reflected real-world practice (pragmatism), and none involved patient input on priorities or outcomes; however, transparency improved.

Conclusions:

• Most preterm birth prevention RCTs exhibit limited research usefulness based on established criteria.
• Improvements in usefulness criteria are noted post-2010, but critical areas like informative outcomes, patient-centeredness, pragmatism, and transparency require focused attention for future research.
• Enhancing the usefulness of RCTs is vital for advancing effective preterm birth prevention strategies.