Abstract

The association of surgeons' and hospitals' operative volumes with postoperative patient outcomes has been studied for decades and holds important policy implications; however, in many volume-outcome analyses, this association is described without the envisioning of a clear intervention, which often introduces unintentional bias. Acting on such results may lead to unintended consequences from policy interventions or patient recommendations. To specify how (hypothetical) target trials would be designed to estimate the association between postoperative mortality of patients undergoing operations and a range of surgeon and hospital volume conditions and then to emulate these trials by using observational data. This observational data analysis emulated 4 hypothetical target trials of increasing complexity, ranging from a poorly defined trial that would randomly assign participants only to surgeon volume to one that would randomly assign participants to surgeon volume, hospital volume, and specific surgeon and hospital. This population-based cohort study included 9136 Medicare beneficiaries with a first diagnosis of pancreatic malignant neoplasm who did not require neoadjuvant therapy and underwent pancreatectomy between January 1, 2012, and September 30, 2016. Data analysis was performed between September 1, 2019, and October 8, 2021. Number of pancreatectomies performed by surgeon and hospital during the prior year. Ninety-day mortality. The analyses included 9136 Medicare beneficiaries treated by 1358 surgeons at 697 hospitals; median age was 73.3 years (IQR, 69.1-78.1 years), and 4642 were men (51%). When trials with poorly defined interventions on surgeon volume were emulated, the estimated 90-day mortality was 7.9% (95% CI, 6.4%-9.4%) for lower-volume surgeons and 5.2% (95% CI, 2.7%-10.9%) for higher-volume surgeons. When trials with better-defined interventions were emulated, the difference was reduced: 7.8% (95% CI, 6.3%-9.3%) for lower-volume surgeons and 7.2% (95% CI, 6.0%-8.7%) for higher-volume surgeons. In this cohort study that emulated 4 different target trials with data from Medicare beneficiaries undergoing pancreatectomy, mortality differences across surgical volume levels were attenuated when the interventions were well defined. The application of the hypothetical target trial framework to this specific volume-outcomes scenario revealed the complexities of this research question and the unintentional biases introduced in prior studies, which emulated poorly defined trials whose results are therefore difficult to interpret. The target trial framework may be of value to outcomes researchers asking questions that correspond to well-defined interventions for the real world.

Highlights

  • Efforts to make surgery safer often focus on operative volume, or the frequency with which a surgeon or hospital has performed a certain operation

  • The application of the hypothetical target trial framework to this specific volume-outcomes scenario revealed the complexities of this research question and the unintentional biases introduced in prior studies, which emulated poorly defined trials whose results are difficult to interpret

  • Among patients planning to undergo elective resection of a pancreatic malignant neoplasm, we specified 4 hypothetical randomized trials—target trials—with increasingly better-defined interventions on operative volumes. Each of these trials was emulated with observational data from Medicare claims. In sequentially considering these 4 scenarios, we demonstrated how the hypothetical target trial framework may be of value to outcomes researchers asking research questions that correspond to well-defined interventions for the real world

Read more

Summary

Introduction

Efforts to make surgery safer often focus on operative volume, or the frequency with which a surgeon or hospital has performed a certain operation. A correlation between the “number of surgical procedures done in a hospital and the in-hospital mortality rate for those patients” was first reported in 1979.1(p1367) Subsequently, other studies[2-4] echoed these findings, including a large-scale study of Medicare beneficiaries concluding that “patients can often improve their chances of survival substantially, even at high-volume hospitals, by selecting surgeons who perform the operations frequently.”5(p2117) In response to these reports, patient safety organizations, such as the Leapfrog Group, recommended minimum hospital and surgeon volume standards for credentialing certain procedures,[6,7] which have since been adopted by several major academic hospital networks.[8]. Among patients planning to undergo elective resection of a pancreatic malignant neoplasm, we specified 4 hypothetical randomized trials—target trials—with increasingly better-defined interventions on operative volumes Each of these trials was emulated with observational data from Medicare claims. In sequentially considering these 4 scenarios, we demonstrated how the hypothetical target trial framework may be of value to outcomes researchers asking research questions that correspond to well-defined interventions for the real world

Methods
Results
Discussion
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call