A perioperative medicine platform trial (PROMPT) evaluating interventions to reduce the risk of infection and other major complications after surgery: rationale and design.

Summary

PROMPT is a multicentre Bayesian adaptive platform trial designed to evaluate multiple perioperative interventions against surgical site infection and other major postoperative complications. Its master protocol permits interventions to be added, replaced, or stopped as evidence accumulates, while incorporating patient-centered outcomes such as quality of recovery and days alive and at home.

Key Findings

• PROMPT is a multicentre Bayesian adaptive platform trial with a master protocol and domain-specific appendices.
• The design can determine superiority, efficacy, equivalence, inferiority, harm, or futility and can incorporate new interventions over time.
• The primary outcome is surgical site infection through 30 days, with additional outcomes including major complications, quality of recovery, and days alive and at home.

Clinical Implications

PROMPT may establish a more efficient framework for evaluating oxygen strategies, infection-prevention measures, and other perioperative interventions across diverse surgical populations. Its results could inform future guidelines, although the present publication describes the protocol rather than clinical outcomes.

Limitations

• This publication reports rationale and design, so effectiveness and safety results are not yet available.
• The first intervention and subsequent domain-specific interventions may have different eligibility criteria and outcome structures, which can complicate cross-domain interpretation.
• The protocol does not establish whether the platform will recruit rapidly enough to provide timely conclusions across all planned domains.

Future Directions

The priority is completion and transparent reporting of the first and subsequent platform domains, with prespecified adaptation rules, subgroup analyses, and sharing of statistical code and aggregate data where feasible. External validation across health systems and surgical settings will determine the generalizability of the platform.