Opportunities for Pragmatic Design Elements in Surgical Trials

Area of Science:

• Medical research methodology
• Surgical innovation
• Evidence-based medicine

Background:

• Randomized clinical trials (RCTs) are crucial but infrequent in surgery due to unique challenges.
• Surgeon concerns, recruitment difficulties, and standardization issues hinder surgical RCTs.
• The US Food and Drug Administration (FDA) is exploring pragmatic trial designs.

Purpose of the Study:

• To advocate for the increased use of pragmatic clinical trials (PCTs) in surgery.
• To address the limitations of traditional surgical RCTs.
• To enhance the generalizability and applicability of surgical evidence.

Main Methods:

• Discusses the principles of pragmatic clinical trials (PCTs) in contrast to exploratory trials.
• Highlights the potential of pragmatic design elements in surgical settings.
• Suggests leveraging existing surgical registries and electronic health records for data collection.

Main Results:

• Pragmatic clinical trials (PCTs) can lower costs and complexity in evidence generation.
• Flexibility in patient enrollment and surgical technique enhances applicability to routine practice.
• Utilizing existing data sources streamlines data collection for PCTs.

Conclusions:

• Increasing PCTs in surgery can overcome traditional RCT challenges.
• Prioritizing patient-centered research questions is essential.
• Enhanced training, funding, and institutional support are needed for surgical PCTs.