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The PAncreatic Surgery Composite Endpoint (PACE): Development and Validation of a Clinically Relevant Endpoint
Felix Nickel1,2, Christoph Kuemmerli3, Philip C Müller3
1Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.
Annals of Surgery
|January 12, 2024
Summary
A new PAncreatic surgery Composite Endpoint (PACE) effectively predicts prolonged hospital stays and mortality in pancreatic surgery patients. This composite endpoint improves trial feasibility by significantly reducing required sample sizes.
Area of Science:
- Surgical Oncology
- Clinical Trials Methodology
- Outcomes Research
Background:
- Single endpoints in pancreatic surgery trials are often impractical due to low event frequency.
- New interventions in pancreatic surgery studies show marginal benefits, necessitating efficient outcome measures.
- Developing a robust composite endpoint is crucial for advancing pancreatic surgery research.
Purpose of the Study:
- To develop and validate a composite endpoint for pancreatic surgery.
- To assess the association of the composite endpoint with prolonged hospital stay and mortality.
- To evaluate the impact of the composite endpoint on sample size calculations for clinical trials.
Main Methods:
- A composite endpoint (PACE) was developed using data from 1273 patients and validated in 544 patients.
- PACE incorporates pancreatic fistula, hemorrhage, reoperation, and reintervention events.
- External validation was performed using a separate institutional database (n=2666).
Main Results:
- PACE demonstrated good predictive performance for prolonged hospital stays in both internal (AUC 78.0%) and external (AUC 76.9%) validation cohorts.
- A positive PACE was significantly associated with higher 90-day mortality in all cohorts (P < 0.001).
- PACE enabled substantial sample size reductions (up to 80.5%) compared to single outcome measures.
Conclusions:
- The PAncreatic surgery Composite Endpoint (PACE) is a clinically relevant and standardized measure for pancreatic surgery.
- PACE improves the feasibility of prospective trials by enabling smaller sample sizes.
- This composite endpoint can facilitate more efficient research and evaluation of new interventions in pancreatic surgery.
